Crossvent-2i+ Stand-Alone: Operation & Service Manual

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Crossvent-2i+

Stand-Alone
INTENSIVE CARE/TRANSPORT
VENTILATOR

OPERATION & SERVICE MANUAL

CATALOG #2204K
Revision: 050216

Bio-Med Devices, Inc.


61 Soundview Road, Guilford, CT 06437
800-224-6633 FAX 203-458-0440
Web Site: www.biomeddevices.com

COPYRIGHT 2009 BIO-MED DEVICES, INC.


TABLE OF CONTENTS

I. PATIENT SAFETY, WARNINGS, AND CAUTIONS ............................................................ 1


WARNINGS ............................................................................................................................................................................................ 1
CAUTIONS.............................................................................................................................................................................................. 3
NOTES...................................................................................................................................................................................................... 4
SYMBOLS ................................................................................................................................................................................................ 6
II. UNPACKING AND ACCESSORIES....................................................................................... 7
A- UNPACKING ................................................................................................................................................................................... 7
B- ACCESSORIES.................................................................................................................................................................................. 7
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE .................................... 8
A- GENERAL DESCRIPTION.......................................................................................................................................................... 8
B- SPECIFICATIONS ........................................................................................................................................................................... 9
C- ADDITIONAL SPECIFICATIONS ............................................................................................................................................ 9
D- MANUAL CONTROLS AND CONNECTIONS ................................................................................................................. 10
1- FRONT OF VENTILATOR ................................................................................................................................................ 10
FLOW CONTROL KNOB ............................................................................................................................. 10
MAXIMUM PRESSURE KNOB................................................................................................................... 10
PEEP KNOB .................................................................................................................................................. 10
AUDIBLE TONE GENERATOR .................................................................................................................. 10
ALARM LED ................................................................................................................................................. 10
2- RIGHT SIDE OF VENTILATOR ...................................................................................................................................... 11
GAS SUPPLY INLET .................................................................................................................................... 11
GAS SUPPLY WITH BLENDER .................................................................................................................. 11
BLEED EXHAUST ........................................................................................................................................ 11
3- LEFT SIDE OF VENTILATOR ......................................................................................................................................... 11
POWER ON/OFF SWITCH ........................................................................................................................... 11
EXTERNAL ELECTRICAL SUPPLY CONNECTOR ................................................................................. 11
CHARGING LED & BATTERY ................................................................................................................... 12
FLOW SENSOR (PNEUMOTACH) ............................................................................................................. 13
OXYGEN SENSOR CONNECTOR .............................................................................................................. 13
EXHALATION VALVE CONNECTOR ...................................................................................................... 13
AIRWAY PRESSURE CONNECTOR .......................................................................................................... 13
PATIENT GAS CONNECTOR ..................................................................................................................... 13
ALARM RESET SWITCH ............................................................................................................................ 13
4- REAR OF VENTILATOR .................................................................................................................................................... 13
MAXIMUM PRESSURE RELIEF VALVE .................................................................................................. 13
NEGATIVE PRESSURE RELIEF VALVE .................................................................................................. 13
CE MARK ...................................................................................................................................................... 14
E- DISPLAY INTERFACE & MENUS .......................................................................................................................................... 14
1- DISPLAY OVERVIEW ......................................................................................................................................................... 14
2- BACKLIGHT & PRESSURE BAR GRAPH .................................................................................................................... 14
BACKLIGHT ................................................................................................................................................. 14
AIRWAY PRESSURE BAR GRAPH ........................................................................................................... 15
3- MAIN MENU ........................................................................................................................................................................... 15
ASSIST CONTROL (A/C) ............................................................................................................................. 15
SIMV .............................................................................................................................................................. 15
CPAP .............................................................................................................................................................. 15
MANUAL....................................................................................................................................................... 15
CONSTANT FLOW....................................................................................................................................... 15
FLOW TRIGGER........................................................................................................................................... 16
PRESSURE SUPPORT .................................................................................................................................. 16
RATE.............................................................................................................................................................. 16
SIMV RATE ................................................................................................................................................... 16
BACKUP RATE ............................................................................................................................................ 16
TIDAL VOLUME (TV) ................................................................................................................................. 16
INSP ............................................................................................................................................................... 16
I, E, I/E KEY .................................................................................................................................................. 16
FLOW KEY.................................................................................................................................................... 17
4- ALARM MENUS ..................................................................................................................................................................... 17
ALARM KEY ................................................................................................................................................ 17
NOTES REGARDING ALARMS ................................................................................................................. 18
5- KEYS COMMON TO ALL MENUS ................................................................................................................................. 19
LOCK ............................................................................................................................................................. 19
ALARM QUIET ............................................................................................................................................. 19
ARROW KEYS .............................................................................................................................................. 20
AUTO SET ..................................................................................................................................................... 20
POWER SOURCE KEY ................................................................................................................................ 20
INSPIRATORY SOURCE KEY .................................................................................................................... 20
SETUP KEY................................................................................................................................................... 21
IV. SETUP AND OPERATING INSTRUCTIONS....................................................................22
A- PATIENT CIRCUIT ...................................................................................................................................................................... 22
B- OPERATING INSTRUCTIONS ................................................................................................................................................ 23
1- PRELIMINARY STEPS ................................................................................................................................................................. 23
2- DETAILED OPERATING INSTRUCTIONS ........................................................................................................................ 24
3- SUMMARY OF OPERATING INSTRUCTIONS .................................................................................................................. 25
V. SETUP MENU AND TROUBLESHOOTING......................................................................26
A- SETUP MENU ................................................................................................................................................................................ 26
1- OXYGEN SENSOR CALIBRATION ............................................................................................................................... 26
2- LEAK TEST ............................................................................................................................................................................. 26
3- TV/INSP PREFERENCE..................................................................................................................................................... 26
4- LANGUAGES.......................................................................................................................................................................... 26
5- VER (Version) ........................................................................................................................................................................... 26
6- SN (Serial Number) .................................................................................................................................................................. 26
B- CALIBRATION MENU (CAL) ................................................................................................................................................... 27
C- OPERATIONAL TROUBLESHOOTING .............................................................................................................................. 28
VI. CLEANING, STERILIZATION AND PACKING ...............................................................30
A- CLEANING AND STERILIZATION ...................................................................................................................................... 30
B- PACKING FOR SHIPMENT ...................................................................................................................................................... 31
VII. THEORY OF OPERATIONS ..............................................................................................33
A- SYSTEM COMPONENTS ........................................................................................................................................................... 34
SUPPLY INLET FILTER .............................................................................................................................. 34
AIRWAY PRESSURE TRANSDUCER ........................................................................................................ 34
DIFFERENTIAL PRESSURE TRANSDUCER ............................................................................................ 34
DIAPHRAGM ACTUATED RELIEF VALVE (D.A.R.V.) .......................................................................... 34
2-WAY PRESSURE RELIEF VALVE .......................................................................................................... 34
B- ASSIST CONTROL MODE......................................................................................................................................................... 35
C- SIMV (Synchronized Intermittent Mandatory Ventilation) MODE ...................................................................................... 36
D- CPAP (Continuous Positive Airway Pressure) ........................................................................................................................... 37
E- BACKUP MODALITY ................................................................................................................................................................. 38
VIII. MAINTENANCE AND SERVICE ....................................................................................39
A- SETUP & CALIBRATION MENU OVERVIEW .................................................................................................................. 39
1- SETUP MENU OVERVIEW ............................................................................................................................................... 39
OXYGEN SENSOR CALIBRATION ........................................................................................................... 39
LEAK TEST ................................................................................................................................................... 39
INSP/TV ......................................................................................................................................................... 39
LANGUAGES ................................................................................................................................................ 39
VER (Version) ................................................................................................................................................ 39
SN (Serial Number) ........................................................................................................................................ 40
2- CALIBRATION MENU OVERVIEW ............................................................................................................................. 40
BATTERY ...................................................................................................................................................... 40
PRESSURE TRANSDUCER ......................................................................................................................... 40
FLOW CALIBRATION ................................................................................................................................. 40
TOUCHSCREEN (CALIBRATION)............................................................................................................. 40
KEYS (Touchscreen Test) .............................................................................................................................. 40
DISPLAY (LCD) TEST ................................................................................................................................. 40
VALVES ........................................................................................................................................................ 41
HOURS........................................................................................................................................................... 41
FACTORY SERVICED ................................................................................................................................. 41
B- PERFORMANCE CHECKS ........................................................................................................................................................ 42
1- SETUP MENU ......................................................................................................................................................................... 42
OXYGEN SENSOR CALIBRATION ........................................................................................................... 42
LEAK TEST ................................................................................................................................................... 42
2- CALIBRATION (CAL) MENU ........................................................................................................................................... 42
KEYS.............................................................................................................................................................. 42
DISPLAY ....................................................................................................................................................... 42
FLOW VERIFICATION ................................................................................................................................ 42
FLUSH ........................................................................................................................................................... 43
BASE FLOW .................................................................................................................................................. 43
POP OFF ........................................................................................................................................................ 43
3- MAIN MENU ........................................................................................................................................................................... 43
BAR GRAPH ACCURACY .......................................................................................................................... 43
PEEP PRESSURE SIGNAL........................................................................................................................... 43
BATTERY ALARM ...................................................................................................................................... 43
EXTERNAL POWER FAILURE ALARM ................................................................................................... 43
POWER FAILURE ALARM ......................................................................................................................... 44
ALARM QUIET ............................................................................................................................................. 44
BACKLIGHT ................................................................................................................................................. 44
LOCK ............................................................................................................................................................. 44
AUTO SET ..................................................................................................................................................... 44
RATE.............................................................................................................................................................. 44
TIDAL VOLUME .......................................................................................................................................... 44
ALARM MENUS ........................................................................................................................................... 45
FLOW TRIGGER........................................................................................................................................... 45
CONSTANT FLOW MODE .......................................................................................................................... 45
SIMV BACKUP RATE.................................................................................................................................. 45
PRESSURE SUPPORT .................................................................................................................................. 45
MANUAL....................................................................................................................................................... 45
C- RECOMMENDED TOOLS AND TEST EQUIPMENT .................................................................................................... 46
1- Special Tools and Test Equipment ............................................................................................................. 46
D- PREVENTATIVE MAINTENANCE ...................................................................................................................................... 47
1- RECOMMENDED MAINTENANCE SCHEDULE .................................................................................................... 47
TIMELINE ..................................................................................................................................................... 47
GAS INLET FILTER ..................................................................................................................................... 47
BATTERY CHECK ....................................................................................................................................... 47
2- PREVENTIVE MAINTENANCE PARTS KITS ........................................................................................................... 47
E-SOFTWARE UPGRADES ............................................................................................................................................................ 48
F- PNEUMATIC CALIBRATION ................................................................................................................................................... 49
G- DISASSEMBLY & REASSEMBLY INSTRUCTIONS ......................................................................................................... 55
1. REAR PANEL .......................................................................................................................................................................... 55
2. BATTERY REMOVAL & REPLACEMENT ................................................................................................................... 55
3. FRONT BEZEL ....................................................................................................................................................................... 56
4. DISPLAY/TOUCHSCREEN ............................................................................................................................................... 56
5. PRINTED CIRCUIT BOARD (PCB) ................................................................................................................................. 56
6. COMPLETE PNEUMATICS AS AN ASSEMBLY ......................................................................................................... 57
7. PNEUMATIC VALVE BRACKET ASSEMBLY ............................................................................................................. 58
8. FLOW, MAX PRESSURE & PEEP VALVES .................................................................................................................. 58
9. SOLENOIDS ............................................................................................................................................................................ 59
10. GAS INPUT FILTER ........................................................................................................................................................... 59
11. PREVENTIVE MAINTENANCE KITS ........................................................................................................................ 60
H- TECHNICAL TROUBLESHOOTING.................................................................................................................................... 61
IX. PARTS LIST AND SCHEMATIC DIAGRAMS ...................................................................63
A- REPLACEMENT PARTS LIST .................................................................................................................................................. 63
B- SCHEMATICS ................................................................................................................................................................................. 64
1- PNEUMATIC SCHEMATICS ............................................................................................................................................. 64
3- CIRCUIT SCHEMATICS ...................................................................................................................................................... 66
WARRANTY .................................................................................................................................77
APPENDIX A................................................................................................................................78
ABBREVIATIONS .............................................................................................................................................................................. 78
APPENDIX B ...............................................................................................................................79
DEFAULT SETTINGS ....................................................................................................................................................................... 79
APPENDIX C ...............................................................................................................................80
SUMMARY OF DISABLED FUNCTIONS .................................................................................................................................. 80
APPENDIX D ............................................................................................................................... 81
AUDIBLE ALARM CODES ............................................................................................................................................................. 81
APPENDIX E ...............................................................................................................................82
CHARGERS AND INVERTERS ..................................................................................................................................................... 82
APPENDIX F ................................................................................................................................83
FLOWMETER USE WITH THE CROSSVENT & BLENDER .............................................................................................. 83
APPENDIX G ...............................................................................................................................84
Authorized Representative in the European Community .............................................................................................................. 84
APPENDIX H ...............................................................................................................................85
EMC Compatibility................................................................................................................................................................................ 85
Additional Guidance and manufacture’s declaration – electromagnetic emissions/immunity ....................................... 85
INDEX ..........................................................................................................................................89
I. PATIENT SAFETY, WARNINGS, AND CAUTIONS
The Crossvent-2i+ ventilator is intended for use only by a qualified practitioner, under the direction of a qualified physician.
All personnel operating the ventilator must be completely familiar with the warnings and operating procedures in this manual
prior to using the Crossvent-2i+ with patients. As with any life support device, competent personnel should visually monitor
the patients on the Crossvent-2i+ at all times since life-threatening conditions may arise that may not be detected by the
alarms. It is essential to test all life-support devices for proper function prior to each use on patients.

A- WARNINGS, CAUTIONS, AND NOTES


The following terms are used throughout this manual:
WARNING - INDICATES A PROCEDURE OR CONDITION THAT COULD
CAUSE BODILY INJURY.
CAUTION - Signifies a procedure or condition that could damage the equipment.
NOTE - Refers to a procedure or condition that requires special attention.
WARNINGS

 Whenever the Crossvent-2i+ is connected to a patient, a skilled operator should always be present at all times at
the ventilator or within visual or hearing range of the ventilator’s alarm system.

 High oxygen concentrations may be hazardous to the patient.

 If the gas supply fails or there is a total electrical power failure, the patient may breathe atmospheric gas through
the failsafe valve. This is, however, only a temporary emergency measure, which requires elevated inspiratory
effort and it should be corrected immediately.

 Always operate the CV-2i+ on battery prior to use to confirm that the battery is functioning.

 In the event of an AC power failure, the Crossvent-2i+ will automatically switch over to battery operation and
sound an alarm. The audible alarm may be silenced by pressing the POWER SOURCE window. On a fully
charged battery, there will be approximately 2 ¾ hours of autonomous operation. No further alarm will be
sounded until the battery is low. It is imperative to restore AC power at this time to assure continued safe
operation of the ventilator.

 A patient filter should always be used in the patient breathing circuit to prevent cross contamination. Breathing
through the negative pressure relief valve in a contaminated environment can be hazardous.

 Extreme care should be taken to assure that the patient circuit components are connected correctly. Improper
connection can cause malfunction.

 A test lung should be ventilated prior to each use to insure that all modes are functioning correctly. An external
spirometer should be used to verify correct volumes and flow rates.

 The patient should never be left unattended after the ALARM QUIET key is depressed since this is followed by a
period when the audible alarms are deactivated.

 An audible alarm always indicates an anomalous state that should always be rectified.

 While the oxygen alarm may be turned off to permit use of the Crossvent-2i+ without this sensor, it is
recommended that it be used at all times.

 Always be certain that the Maximum Pressure Limit is set correctly and is operative even when volume limiting,
to prevent possible inadvertent administration of high pressure. Increased pressure can be caused by blocked
tubes, changes in patient compliance or resistance, or system malfunction.

 If it is desired to temporarily disconnect the patient for clinical interventions such as suctioning, the alarms
should be silenced by pressing the ALARM QUIET key. Pressing once will give a 60 second period and pressing
twice a 2 minute period, during which time the alarms are silenced. If more time is needed, the ALARM QUIET
key may be pressed again after the alarm sounds. Never turn the power switch off in order to silence the alarms,
since this permanently deactivates all alarms.
1
I . P A T I E N T S A F E T Y - C O N T .

 Under certain conditions in SIMV, when the low peak pressure alarm is set correctly for assisted breaths, there
may be no low peak pressure alarm following a patient disconnect until the next assisted breath. This period may
be up to 100 seconds. As an added precaution, set the low PEEP/CPAP, low exhaled tidal volume and rate
alarms so that they are operative.

 Backup Rate is inoperative in Constant Flow/CPAP mode.

 When an alarm parameter is turned off, Auto Set is deactivated for that parameter.

 The alarm ports on the front of the CV-2i+ should never be obstructed.

 For proper operation only the O2 sensor supplied by Bio-Med Devices may be used.

 Never operate the Crossvent-2i+ without a battery since it will fail to operate if the plug-in power supply is
removed.

 To avoid risk of electrical shock when using the CROSSVENT with AC power connected, this equipment must
only be connected to a supply mains with protective earth.

 The screened ports on the unit should not be obstructed when the ventilator is in use.

 Only qualified, trained, service technicians should attempt repairs and service when needed. Serious personal
injury and/or equipment damage can result if repairs are performed by unqualified personnel.

 It is imperative to verify that clinically appropriate alarm limits are fully operational following connection of the
ventilator to a patient.

 It is important to note that once a sensor has been turned off, the alarms for that sensor are inoperative.

 Breathing through the negative pressure relief valve requires a greatly increased work of breathing and only air is
provided. A situation in which the patient is breathing through this valve should be rectified immediately in order
to prevent possible adverse affects to the patient.

 It is extremely important that the Flow Trigger control be carefully adjusted to assure proper operation in the
CPAP mode.

 Under certain conditions in CPAP, in particular with high flows and low CPAP pressures, if the low peak pressure
alarm is set so that no false alarms occur, this alarm may be inoperative if a disconnect occurs. It is therefore
extremely important to have the low PEEP/CPAP and low Exhaled Tidal Volume alarms set correctly

 It is important in Backup modality to always set a correct rate, tidal volume and flow to insure proper ventilation in
case the patient becomes apneic.

 To obtain the full 3-minute duration of the Power Failure alarm, the Crossvent must have been powered on for at
least 1 minute.

 All safety measures must be observed when servicing this device. In particular, the ventilator must be turned off
and the power supply disconnected.

 Bio-Med Devices cannot be held responsible for any failure to adhere to the recommendations set forth in this
manual.

 Because this is a CE marked device, it must never be modified without prior expressed written consent from Bio-
Med Devices.

2
I . P A T I E N T S A F E T Y - C O N T .
 Auto-triggering or missed breaths may occur due to various conditions including, but not limited to, compliance,
resistance, rate, flow, PEEP, I:E ratio, and circuit characteristics.

 Do not re-use disposable breathing circuits. Re-use of disposable (single-use) breathing circuits can result in
contamination (patient infection) or circuit degradation (circuit can fall apart, develop holes, or exhibit polymer
decay).

 The pneumotach must be in the circuit and connected to the ventilator when using Flow Triggering. If the
pneumotach is not being used, then Constant Flow should be the ventilator mode.

 Without the pneumotach in the circuit and connected to the ventilator, there will be no patient
triggered breaths.

 If using the 0-4 LPM and 0-8 LPM Dial Flowmeters, BMD part #2016, with the Crossvent and Blender, the supply
pressure is critical for flowmeter accuracy. The ventilator should be turned off when using the flowmeters. Refer
to Appendix G for further information regarding this.

 Do not continue using a ventilator which has been significantly impacted or abused.

 Volume-limited ventilators should not be used on unattended patients.

CAUTIONS

 Clean, dry, medical grade gas sources supplied at 17 – 55 psi (117 kPa – 380 kPa) unrestricted flow must be used at
all times to assure proper operation of the Crossvent-2i+ Ventilator.

 The Crossvent-2i+ should not be steam or gas sterilized as this will result in damage to some of its components.

 When connecting the pneumotachograph (optional) it is important that the proximal and distal tubes be connected
to the proper connector to assure correct operation. It is also important that the side ports of the flow sensor
head point upward to prevent condensate from collecting in the two pressure tubes. Condensate can cause
improper readings and this in turn can cause possible system malfunction. These tubes should be periodically
inspected and any condensate should be removed.

 Always connect both flow sensor tubes to the ventilator before attaching sensor head to patient circuit to prevent
possible damage to the internal sensing device and also to prevent humidified gas from possibly flowing up the
tubes.

 Never block the patient proximal or patient distal connections or flow sensor head with gas supply connected to the
ventilator as this can possibly damage the flow transducer.

 Connect the oxygen sensor (optional) upstream of the humidifier since the fuel cell functions better in non-
humidified gas.

 Touch screen control keys should be pressed by hand only. Care should be taken not to allow keys to be contacted
by sharp objects as damage may result.

 Clean touch screen only with alcohol. Clean the rest of the Crossvent-2i+ unit with mild, non-abrasive, anti-
bacterial cleanser.

 Do not place liquids on or near the Crossvent-2i+. Liquid entering the unit can cause severe damage and
malfunction.

 It is recommended that the Crossvent-2i+ never be left with its battery discharged as this will reduce battery life.
After discharge of the battery, recharge fully before disconnecting the plug-in power supply.

3
I . P A T I E N T S A F E T Y - C O N T .

 Only replace the battery pack with Bio-Med Devices part #PRT2268. Do not substitute. The cells are non-
standard high capacity

 When using an AC power source, only the power supply provided with the Crossvent is approved for use with this
ventilator. Any other power supply may cause damage and/or unreliable operation (See Appendix E).

 Any more comprehensive DC power supply than that which is supplied must be short circuit protected and must
comply with all of the specifications and standards as listed in Section III, Part B.

 Do not use in an MRI room.

 Antistatic or electrically conductive hoses or tubing should not be used.

 When it is necessary to operate the Crossvent from an AC inverter, only inverters in compliance with NEMA
standards should be used (see Appendix E).

 Do not allow the temperature of the battery to go above 131° F (55° C) whether the unit is on or off as this may
cause damage resulting in a shorter life expectancy of the battery.

 Do not position the equipment in such a way as to make it difficult to operate the disconnect device (applies to
either end of the power cord: the wall plug or the connector to the AC adapter).

NOTES
 Battery Backed Memory- When the Crossvent-2i+ is turned on, it automatically recalls all of the settings stored in
memory before it was turned off. . The parameters stored are: all the main functions; high and low alarm limits;
secondary modes; oxygen and flow calibrations; and which sensors are on or off. Several factors can cause the
battery backed memory to be lost. These are: low battery backed memory battery voltage (service required);
defective random access memory (service required); or if the microprocessor is, by chance, storing data in the
battery backed memory at the time power is turned off. In this case it is necessary to re-enter the previously set
parameters.

 The Maximum Pressure should always be set higher than PEEP in order to achieve the PEEP setting.

 To conserve gas, the Maximum Pressure and PEEP controls should be turned off (fully counter clockwise) when
the CV-2i+ is not in use.

 When an alarm parameter is turned off, auto set is deactivated for that parameter. Whenever an alarm limit is
manually entered, it takes precedence over the auto-limit already in memory. When peak pressure is computed in
SIMV, if no assisted or controlled breaths are sensed within the 5 breath computation period, another 5 breath
period is used. This is repeated until at least 1 assisted or controlled breath is measured.

 Auto Set is inactive in CPAP in the Constant Flow mode.

 The Power Failure alarm may not be silenced using the Alarm Quiet key. The Power Failure alarm may be silenced
by pressing the alarm reset button or by pressing a mode key.

 Pressure Support may be set any time, but is only active during SIMV and CPAP. It is disabled when using
Constant Flow.

 The wall plug-in power supply is furnished for 117 vac, 60 hz or 220 vac, 50 hz operation, as required. It is not
possible to overcharge the battery. Always keep the battery fully charged when not in use.

 It is important to use the correct reference gases (100 and 21%) when performing the Oxygen sensor calibration.
A worn out sensor will not calibrate accurately.

 Since it is not possible to damage the Crossvent-2i+ ventilator by normal use of its keys and control knobs, the
user is encouraged to experiment with the Crossvent-2i+ settings while the unit is not connected to a patient.

4
I . P A T I E N T S A F E T Y - C O N T .
 A highlighted field on the display indicates that a parameter has been selected and may be adjusted using the arrow
keys.

 The Auto Set key should always be used to establish initial alarm limits. These may be used for patient monitoring,
in order to facilitate setup or may be set temporarily until “custom limits” are entered to suit specific clinical
requirements. Any or all of the limits may then be manually changed.

 If it is desired to deactivate the oxygen sensor alarm, select OXYGEN in the Alarm 2 menu. Scroll the lower limit
down to off. The function is now inoperative. The function may be reactivated at any time by pressing it and
scrolling the low limit up. It is now reactivated. This allows the ventilator to be used without the oxygen sensor.
When the alarm is set to off, the sensor may be disconnected while the ventilator is in use without causing an
alarm..

 For blended gas, the Bio-Med Devices blender should be used.

 It is recommended that an external filter/water trap be used at all times in order to provide greater protection to the
internal components of the Crossvent-2i+.

 If ventilator internal contamination results from not using a patient filter, do not try to clean the ventilator
internally; instead return it to the factory for evaluation.

 When checking or calibrating flows, for greatest accuracy verify flow using a 60% O2 gas supply if this Crossvent is
used with an air/oxygen blender. Otherwise, use 100% oxygen. Make certain that the supply pressure to the CV-
2i+ inlet remains within specified pressure limits (17-55 psi (117-380 kPa) at all flows.

 If a period longer than 60 sec passes before pushing BATTERY block when the Crossvent is first turned on, an
audible alarm will sound. When BATTERY block is pushed, the audible alarm will also be silenced.

 Due to the fact that O2 sensors sometimes change output over time once exposed to atmosphere, a calibration
should be performed periodically (once a month) in order to assure optimal accuracy. When the sensor is
consumed and does not calibrate properly, it should be discarded and a new sensor installed and calibrated.

 Exhaled minute volume indicates a projected or anticipated minute volume based on the current exhaled tidal
volume readings.

 With Constant Flow on, inspiratory time is used exclusively.

 20 minutes of operation after low battery alarm assumes a properly maintained battery in good condition.

 The battery should be replaced at least every two years. Only use batteries supplied by Bio-Med Devices, part
#PRT2268.

 When first turned on, the unit displays “Bio-Med Devices, Inc.” until the initialization process is complete. If this
does not clear, submit the unit for service.

 While scrolling parameters, some hesitation may be observed.

 The possibility of hazards arising from errors in the software program is minimized via the use of the standards EN
62304 & ISO 14971 in design control.

 Negative pressure (subatmospheric) is not available with this ventilator during the expiratory phase.

5
I . P A T I E N T S A F E T Y - C O N T .

SYMBOLS

Follow Instructions for Use

Product should be kept dry

MR Unsafe

Type BF Equipment

Manufacturer

Date of Manufacture

Direct Current (DC)

It is essential that these instructions be read and complied with prior to operating this product.

Must be disposed of in accordance with WEEE Directive.


At the unit’s “end of life”, it may be returned to the manufacturer for proper reclamation.

Do not rotate the power supply plug when it is engaged with the jack.

Power On

Power Off/Valve Closed

Valve Open

European Authorized Representative Service

6
II. UNPACKING AND ACCESSORIES

A- UNPACKING
CAUTION: Prior to turning the unit on for the first time, the battery must be charged fully
using the included power supply.

Examine the shipping carton for signs of damage. Examine the Crossvent-2i+ carton to ascertain whether it has
sustained any damage during shipment. Inspect the contents of the shipping carton. If damage is observed, notify the
carrier at once. Only you, the consignee, can make a claim against the carrier for damage in shipment.

Prior to using the Crossvent, charge the unit until the green charging indicator stops blinking and remains solidly lit.
Refer to the performance checks in the service section prior to placing this ventilator in service.

B- ACCESSORIES
The following is a list of the equipment supplied with the Crossvent-2i+ Ventilator.

Quantity. Cat. No. Description

1 2200KC CROSSVENT-2i+ Ventilator


1 2003KC1 Air/Oxygen Blender
1 2013 Pole Mounting Bracket
1 1010 High Pressure Supply Hose – Oxygen
1 PFIT1502 DISS Male to Male Coupler
1 10112 High Pressure Supply Hose - Air
1 20011 Disposable Infant Breathing Circuit
1 1021 Infant Test Lung
1 4401 Disposable Patient Filter
1 4409 Disposable Infant Pneumotach
1 4434 Oxygen Sensor Cell w/2.5mm Plug
1 4418 Oxygen Sensor Cell Tee
1 44141 Oxygen Filter/Water Trap
1 44153 Air Filter/Water Trap
1 2204K Instruction Manual
21202 Blender Instruction Manual
1 -------- Warranty Card
1 4419A Charger w/Cord, U.S.A. AC Adapter
1 4419B3 Charger w/Cord, International AC Adapter

NOTE: 1 - OPTIONAL
2 - STANDARD WITH BLENDER
3 - STANDARD WITH INTERNATIONAL ORDERS

7
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE
A- GENERAL DESCRIPTION
The Crossvent-2i+ Intensive Care/Transport Ventilator is an ultra compact, electronically controlled, time cycled, volume or
pressure limited ventilator with intensive care capabilities designed with a wide range of operating parameters to allow
ventilatory support of neonate through infant patients. It may be used either as a pulsatile flow device or with constant flow.
The Crossvent-2i+ delivers the same oxygen concentration as the supply gas.
Caution: Do not use in an MRI room.

The ventilator’s microprocessor provides all operational functions, as well as monitoring the patient and providing alarms.
It allows the user to enter many different operational and alarm parameters to accommodate a wide variety of clinical
situations. It also makes possible such advanced functions as automatic setting of alarm limits and the computation of more
complex parameters such as mean pressure.

Using its auto-set feature, the main alarms of the Crossvent-2i+ may all be set in a matter of seconds with a single keystroke.

Airway pressure is sensed using an internal pressure transducer, and pressure is displayed as a bar graph on the LCD. A
flow transducer is used to measure exhaled tidal and minute volume and to sense effort for flow triggering. An absolute
pressure transducer monitors atmospheric pressure and automatically compensates for altitude changes.

The Crossvent-2i+ has an internal battery that provides power during transport and in the event of an AC power failure. If
the external power should fail, the ventilator automatically switches to its internal battery and sounds an alarm . The
ventilator will function on a fully charged battery for approximately 2 ¾ hours. If more time than that is required, the
backlight may be turned off as described in this manual. Whenever external power is restored, the Crossvent-2i+ switches
back to external power operation. It will charge the battery whenever external power is available.

The Crossvent-2i+ Ventilator’s extreme reliability is made possible by:


1- The absence of rotating or sliding mechanical parts.
2- An absolute minimum of moving parts.
3- An extremely low total parts count.
In addition to increased patient safety, the high reliability insures low downtime and thus more economical use.

The Crossvent-2i+ provides a complete array of features and ventilation modes and functions, some of which include:
Microprocessor control of all operational functions and monitoring.
Displays and alarms for Peak, Mean and PEEP pressures.
Exhaled Tidal Volume and Minute Volume displays & alarms.
Programmability and expandability.
Built-in triggered demand flow for minimum work of breathing during SIMV and CPAP and a simplified system
design.
Integral Assist Control, SIMV, CPAP, PEEP, Pressure Support.
RS-232 input for PC interface for software updates.

8
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.

B- SPECIFICATIONS

Parameter Range Resolution of Display Accuracy


Rate 5- 150 bpm 1 bpm ±10%
Tidal Volume 5- 750 ml 1 ml below 200; 10 ml above 200 ±10%
Inspiratory Time 0.1- 3.0 seconds .05 below 1.00, 0.1 above 1.00 ±10%
Flow Rate 1- 15 lpm 0.1 lpm below 10; 1 lpm above 10 ±10%
Peak Pressure (PIP) 0- 80 cmH2O 1 cmH2O ±3% FS
PEEP Pressure 0- 20 cmH2O 1 cmH2O (above baseline) ±3 cmH2O
Flow Trigger 1-20 (scale) 1 unit N/A
Pressure Support 1- 50 cmH2O 1 cmH2O (above baseline) ±3 cmH2O
SIMV Rate 0.6- 50 bpm 0.1 bpm below 1; 1 bpm above 1 ±10%
O2 Sensor 0- 100 % 1% ±3% FS
EXHTV 0- 1300 ml 0.1 ml below 50; 1 ml from 50-200; 10 ml ±15%1
thereafter
EXHMV 0- 45 L 0.1 L below 10, 1 L thereafter ±15%1

1- Readings below 10 ml may be considered relative rather than absolute values.


2- NOTE: All values are expressed under ATPD conditions (ambient temperature & pressure dry)

C- ADDITIONAL SPECIFICATIONS

Base Flow 2.5 lpm


Continuous Flow 1 – 15 lpm
Maximum Safety Pressure: 96 cmH2O
Pneumatic Power Source 17 – 55 psi (117 kPa – 380 kPa)1
Audible Alarm Characteristics 90 dB at 10cm (25°C)
Electrical Power Source
See Appendix E

Output: 16.0 VDC, 3 A


Output Protection: Short Circuit and Overload
Isolation: Meets IEC601.1, classification BF, UL 544 Patient Care, CSA 125 Risk Class
2G
Maximum Ripple: <100 mVp-p
Safety: Approved to UL 544/2601.1, CLU (CSA) 22.1 #125/601.1, TUV
EN60601.1 & CE LVD
EMC: Designed to Level B Requirements of FCC part 15, CISPR11 (EN55011).
Less than 1 Volt Output Deviation for IEC801-2, 3, 4, 5, Immunity Tests.
Overall Dimensions
Height: 10" (25.4 cm)
Width: 11" (28.0 cm)2
Depth: 5.5" (14 cm)
Weight: 10.5 lbs. (4.8 kg)3
Operating Temperature: 32 to 104 degrees F. (0 to 40 degrees C)4
Storage Temperature: 32 to 122 degrees F. (0 to 50 degrees C)
1- If an air/oxygen blender is used, then 45 – 75 PSI (310 – 517 kPa) should be supplied to the blender.
2- 14.25” (36.2 cm) with optional mounted blender
3- 13.25 lbs. (6 kg) with optional mounted blender

9
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
4- When using the oxygen sensor, then 41° – 104° F (5° – 40° C); battery will not fast charge below 41° F (5° C) nor above 125° F (51° C).

Breathing circuit resistances:


Breathing circuit model Flow case Inspiratory Resistance Expiratory resistance
(lpm) (cmH2O / lpm) (cmH2O / lpm)
20011 5 0.03 0.06

D- MANUAL CONTROLS AND CONNECTIONS

1- FRONT OF VENTILATOR
FLOW CONTROL KNOB
A pneumatic needle valve which sets the inspiratory flow from 0- 15
lpm. The Flow window displays the flow setting. It is accurate from 1 to
15 lpm.

MAXIMUM PRESSURE KNOB


A pneumatic needle valve, which sets the pressure, which is applied to
the exhalation valve and to the internal diaphragm, actuated relief valve
(D.A.R.V.) and determines the maximum pressure during assisted and
controlled inspirations. It is adjustable from 0 - 80 cmH2O. It should
always be operative and properly adjusted.
NOTE: To conserve gas, the Maximum Pressure and
PEEP controls should be turned off (fully counter 2i+
clockwise) when the CV-2i+ is not in use. MAX PRESS PEEP FLOW

FIG. 1 FRONT VIEW


PEEP KNOB
(Positive End Expiratory Pressure)- A pneumatic needle valve which sets the PEEP or CPAP (Continuous Positive Airway
Pressure) level which is applied to the exhalation valve. It is adjustable from 0- 20 cmH2O. The PEEP level is determined
by observing the system pressure bar graph or with the PEEP/CPAP readout on the secondary alarm menu.
NOTE: The Maximum Pressure should always be set higher than PEEP in order to achieve the
PEEP setting.
NOTE: To conserve gas, the Maximum Pressure and PEEP controls should be turned off (fully
counter clockwise) when the CV-2i+ is not in use.

AUDIBLE TONE GENERATOR


Located in the front of the unit, it emits the audible tones to indicate an alarm condition or keyboard actuation. The tone
for a standard alarm is rated at 90 dB.
WARNING: It should never be obstructed.
NOTE: Refer to Appendix D for all the beeper codes.

ALARM LED
It flashes on and off in equal duration during any alarm providing full frontal visibility. When the unit is turned off or loses
power, it flashes for 3 minutes. This time may be less if the Crossvent was not powered on for at least 1 minute prior to
loss of power.

10
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.

2- RIGHT SIDE OF VENTILATOR

 
 
 
 
 

STANDARD WITH BLENDER

FIG. 2- RIGHT SIDE VIEWS

CAUTION: Antistatic or electrically conductive hoses or tubing should not be used.


GAS SUPPLY INLET
Male DISS 9/16-18 fitting. Clean, dry, medical grade gas, delivered at 17 to 55 psi (117 kPa to 380 kPa) pressure at 15 lpm is
required. These requirements apply to the inlet of the ventilator in order to ensure proper flows. A serviceable 48-micron
filter is contained within the supply fitting.

GAS SUPPLY WITH BLENDER


When using a blender, oxygen and air supplies are connected to the blender and the output of the blender is then connected
to the Crossvent Supply Inlet. For optimum performance, 45 – 55 PSI (310 – 380 kPa) should be supplied to the blender.
Oxygen concentrations set by the blender are then delivered to the patient. Refer to the Blender Operation Manual for
instruction on its use.
WARNING: If using the 0-4 LPM and 0-8 LPM Dial Flowmeters, BMD part #2016,
with the Crossvent and Blender, the supply pressure is critical for flowmeter
accuracy. The ventilator should be turned off when using the flowmeters. Refer to
Appendix G for further information regarding this.

BLEED EXHAUST
Internal bleeds from the pneumatic controls exhaust through this screened port. This area must not be obstructed when the
ventilator is in use.

3- LEFT SIDE OF VENTILATOR


POWER ON/OFF SWITCH
It is located on the left side of the unit and is recessed in order to reduce inadvertent or
unauthorized use. It controls the main power to the electronics. If the battery is allowed to
fall below 6 volts (well below the Low Battery alarm limit) with the unit operating, the 

ventilator will turn off independently of this switch. If this occurs, this switch must be 

turned to OFF before the ventilator will operate again, regardless of power source. 


WARNING: Never use the On/Off switch to silence the alarms 

since this renders the alarms permanently disabled. !

WARNING: If using the 0-4 LPM and 0-8 LPM Dial Flowmeters,
BMD part #2016, with the Crossvent and Blender, the ventilator


should be turned off when using the flowmeters. Refer to Appendix   

G for further information regarding this.  





EXTERNAL ELECTRICAL SUPPLY CONNECTOR 

This receptacle accepts the plug from the factory supplied, U.L. approved, power supply
module. The plug and receptacle are keyed so they will only go together when the red dot on FIG. 3- LEFT SIDE
the plug faces to the front of the unit and the cord is hanging down within the protective
guard. By necessity, this power supply meets all the specifications and standards listed in Section III, Part B. Use only Jerome
Industries model WSZ116M (16VDC, 3A) with the appropriate mating plug. The Crossvent should not be used with any
other wall plug-in or desktop AC adapter. This is used to operate the ventilator and to charge the battery whenever it is
below full charge. The wall plug-in power supply is furnished for 117 VAC, 60 Hz or 220 VAC, 50 Hz operation, as
required. It is not possible to overcharge the battery. Always keep the battery fully charged when not in use.

11
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
CAUTION: Do NOT attempt to rotate the power connector while it is plugged into the
ventilator. It must only be pushed straight in and pulled straight out with the cord hanging
straight down.
CAUTION: When using an AC power source, only the power supply provided with the
Crossvent is approved for use with this ventilator. Any other power supply may cause
damage and/or unreliable operation.
CAUTION: Any more comprehensive DC power supply than that which is supplied must
be short circuit protected and must comply with all of the specifications and standards as
listed in Section III, Part B.
CAUTION: When it is necessary to operate the Crossvent from an AC inverter, only
inverters in compliance with NEMA standards should be used (see Appendix E).

CHARGING LED & BATTERY


The Charging LED indicates the charging mode when the external power supply is plugged into the Crossvent. Its states are:
1. Slow Blinking (approximately once per second)- unit is in rapid charge mode.
2. Rapid Blinking- Battery is depleted and must be trickle charged to appropriate voltage before it can be fast charged;
the temperature of the battery is above 125°F (52°C) or below 32° (0°C) and must be trickle charged until the
temperature is within acceptable range; there is a failure in the charging system.
3. On Steady- trickle-charge mode.

The battery operation is approximately 2 ¾ hours on a fully charged battery. Turning off the backlight can extend this time
(refer to Backlight in Part D of this section). The power level of the battery may be observed at any time at the bottom of
the display in the Power Key.
To charge the battery, only the power supply provided by Bio-Med Devices should be used. With the red dot on the supply’s
connector facing the front of the Crossvent, plug the external power supply into the side of the unit and into an AC outlet.
Charge the battery until the charging LED indicates it is in trickle charge mode and the battery is fully charged (solid LED).
The amount of time required to fully charge the battery depends on many factors, including the state of charge when it
begins. The maximum time for an exhausted battery is approximately 2 ½ hours. When done, verify battery power by
unplugging the external power cord from the side of the unit while it is turned on. The Crossvent should alarm and the
power source key at the bottom of the display should flash “BATT”. Press this key to cancel this alarm. The battery bar
indicating the remaining battery power should span the entire battery key unless the battery was fully discharged, in which
case it may indicate something less than 100%. Continued charging will bring it to 100%.

The battery cannot accept a charge if the temperature is over 125°F (51°C) or below 32° (0°). This situation should be
avoided. If the battery is above or below these temperatures during a rapid charge, it will go into trickle charge mode until it
is below this temperature.
CAUTION: Do not allow the temperature of the battery to go above 131° F (55° C)
whether the unit is on or off as this may cause damage resulting in a shorter life expectancy
of the battery.

When the state of the battery is determined to be within approximately 20 minutes of remaining autonomous operation, the
Alarm 3 menu will flash “LOW BATTERY, CONNECT EXTERNAL POWER” and sound the audible alarm. The
ventilator should be switched to external power or removed from service and recharged when this alarm occurs. If the
battery is allowed to expend energy to a point below 6 volts (well below the Low Battery alarm limit), the ventilator will shut
down independent of the On/Off switch. If this occurs, the external power supply must be used to recharge the battery and
the On/Off switch must be turned to Off and then back to On before the unit will operate.
NOTE: 20 minutes of operation after the low battery alarm assumes a properly maintained battery in
good condition.

The NiMH rechargeable battery is located internally and should only be accessed by trained service personnel. To prolong
life and maintain performance, it is recommended that the Crossvent be stored with the power supply plugged in or with the
battery fully charged at a relative humidity of 65% (±20%) whenever possible. Because NiMH batteries will naturally “self-
discharge”, it is strongly recommended the battery be cycled through at least one charge/discharge according to the table
below if left off the power supply for an extended period of time.

Storage Temperature Range Time to Charge/Discharge


104°F to 122°F (40°C to 50°C) Less than 30 Days
86°F to 103°F (30°C to 39°C) 30 to 60 Days
32°F to 85°F (0°C to 29°C) 61 to 90 Days
WARNING: Never operate the CROSSVENT without a battery since it will fail to
operate if the plug-in power supply is removed.
CAUTION: The battery should be replaced at least every two years. Only use batteries
supplied by Bio-Med Devices, part #PRT2268. Do not substitute.

12
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
FLOW SENSOR (PNEUMOTACH)
The pneumotach (use is optional) plugs in here. It is used to display Exhaled Tidal (or Minute) Volume as well to trigger
breaths using flow trigger. Only the infant pneumotach (Cat. #4409) can be used.
These two connectors provide the pressure signals to the internal transducer that permits the measurement of flow, which is
used to display Exhaled Tidal Volume as well as sense effort for Flow Trigger. The pneumotach should be placed in the
circuit such that the striped tube is closest (proximal) to the patient. This tube, which also has a blue cuff on its end, should
be connected to the blue, proximal connector. The other tube, which is more distant from the patient (distal) should be
connected to the fitting directly below the blue fitting. Flow is measured as the differential pressure across the orifice of the
pneumotach.
WARNING: The pneumotach must be in the circuit and connected to the ventilator
when using Flow Triggering. If the pneumotach is not being used, then Constant
Flow should be the ventilator mode
CAUTION: Do not apply tension to the flow sensor tubing. Do not allow the sensor to be
in the patient circuit, but not connected to the ventilator when ventilating.
CAUTION: The pressure connection tubes of the pneumotach should always be mounted
vertically to prevent collection of condensate in the pressure tubes. The tubes should be
inspected periodically and condensate should be removed. This condensate may cause
erroneous readings and thus improper operation of the CROSSVENT. Never block these
connections with the unit operating as this can damage the internal transducer. Always
securely connect the pneumotach to its connector before inserting the pneumotach in the
flow stream. This will prevent possible damage to the internal transducer and will also
prevent humidified gas from inadvertently blowing up the pneumotach sensing lines.
OXYGEN SENSOR CONNECTOR
O2 sensor (use is optional) plugs in here. This measures the oxygen concentration of the gas mixture being delivered to the
patient and is displayed in the Alarm 2 menu.
WARNING: For proper operation, only the O2 sensor supplied by Bio-Med Devices
may be used.

EXHALATION VALVE CONNECTOR


The tube to the exhalation valve on the patient circuit connects here and provides the pressure signal to operate the
exhalation valve. During inspiration it applies a pressure signal to the exhalation valve diaphragm, which sets the Maximum
Pressure Limit. During expiration it provides zero or PEEP/CPAP level pressure to the exhalation valve diaphragm.

AIRWAY PRESSURE CONNECTOR


The proximal airway pressure tube on the patient circuit connects here. This allows the CROSSVENT to monitor airway
pressure and also to detect patient inspiratory efforts when using Pressure Trigger.

PATIENT GAS CONNECTOR


The main patient corrugated hose is attached here. It provides the un-humidified breathing gas mixture to the patient circuit.

ALARM RESET SWITCH


Pressing this button silences the alarm of the Power Failure circuit, which is a separate section of the main circuit board.
This circuit monitors the power to the main circuit board. If power is lost, either as a result of turning the main power
switch off or a total power failure to the circuit board, i.e., no external power and no battery, it sounds an audible alarm (long
tone) and flashes the LED, which will continue for at least 3 minutes after failure. Pressing the Alarm Reset Switch
permanently silences the audible alarm.

WARNING: To obtain the full 3-minute duration of the


Power Failure alarm when power is lost, the Crossvent
must have been powered on for at least 1 minute prior to
the failure. 

4- REAR OF VENTILATOR
EXPLOSION HAZARD IF USED IN THE PRESENCE OF
FLAMMABLE ANESTHETICS.












MAXIMUM PRESSURE RELIEF VALVE










A preset, relief valve exits the rear of the unit. This valve establishes the




maximum safety pressure deliverable. It is set at 80 cmH2O.


TYPE BF EQUIPMENT



WARNING: IT SHOULD NEVER BE


OBSTRUCTED. 









NEGATIVE PRESSURE RELIEF VALVE


A preset, negative pressure valve also exits the rear of the unit. It allows
the patient to breathe ambient air if the entire system should become FIG. 4 REAR VIEW

13
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
inoperative. It opens at approximately -4 cmH2O.
WARNING: IT SHOULD NEVER BE OBSTRUCTED.
WARNING: Should the use of the negative pressure relief valve become necessary,
the operation of the Crossvent in a contaminated environment can be hazardous.

CE MARK
The CE mark displayed on this product signifies that this device is in compliance with the European Medical Devices
Directive (Council Directive 93/42/EEC). As a prerequisite for the CE mark, Bio-Med Devices operates under an ISO 13485
compliant quality system (covering the design and manufacture of medical devices). The four-digit code underlying the CE
mark (0086) pertains to Bio-Med's Notified Body, the British Standards Institute, whose function is to investigate and attest to
the validity of CE-mark claims.

EU Classification: Internally-powered equipment


Continuous operation
BF type applied part
Not suitable for AP or APG

E- DISPLAY INTERFACE & MENUS

1- DISPLAY OVERVIEW
Careful attention has been paid to the human interface of the Crossvent-2i+. Its graphic LCD, with touch screen keypad,
makes it the most user friendly ventilator for today and tomorrow. Several menus are available on the LCD. These include:
Main functions
Primary Alarms
Secondary Alarms
NOTE: When first turned on, the unit displays “Bio-Med Devices, Inc.” until the initialization
process is complete. If this does not clear, submit the unit for service.

Procedure for selecting a function and adjusting its setting:


A menu or parameter is selected by simply pressing the corresponding key on the display. In this manual, when references
are made to keys, this is an area of the display containing text or values. There may not always be a “key” depicted
graphically. When instructed to press a key, it implies to press on the touchscreen over the word or value you want to select.
When a function is selected, the function will be highlighted.
Once a parameter is selected it may be adjusted using the UP and DOWN Arrow keys. The parameter key may be pressed
again to deselect it. If the arrow keys are not pressed for 30 sec., the highlighted key will automatically deactivate. The
following are exceptions to the procedure for setting functions:

 Arrows are not required to select a menu or mode. These are selected simply by pressing the desired key, i.e. ASSIST
CONTROL.
 CONSTANT FLOW and FLOW TRIGGER are mutually exclusive. Selecting one will turn the other off.
 Flow is displayed in the Flow key, but may only be changed with the FLOW Control Knob.
 I, E, I/E ratio is a display key only. I, E, I/E are set indirectly by setting Rate, Tidal Volume and Flow.

The display is graphically laid out for simplicity and ease of use. The left side of the display indicates Airway Pressure
information. The top and bottom rows of keys are always available to the user unless Setup is pressed. The top row allows
the user to move between menus as well as lock the display and quiet the alarms. The bottom row provides information on
what type of breath is being delivered, power conditions as well as allowing for AUTO SETTING the alarms and entering
SETUP. SETUP is replaced with the arrow keys by pressing any key other than the ALARM QUIET or BATTERY key or
if no key is pressed within 30 seconds of the unit being powered on. The center section of the display is what is considered
the “menu” and is the part that changes when a menu key is pressed.

2- BACKLIGHT & PRESSURE BAR GRAPH


BACKLIGHT
The LCD display requires a backlight in order to be visible. Therefore, the default setting for the backlight is that it is
always on. There may be circumstances in which the user may desire the backlight to be off (i.e., to extend the running time
while in battery mode). However, be aware that turning off the backlight means there is no visible display. It will be
completely blank. To turn off the display, press and hold the Pressure Bar Graph for 3 seconds until it beeps a second time.
The backlight will remain off until an alarm condition occurs, with the exception of a Power Failure Alarm, or the display is
touched. When the unit is powered off, it will revert to the default of always being on. It cannot be turned off while an
alarm condition exists.

14
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
AIRWAY PRESSURE BAR GRAPH
Displayed on the left side of the display is an analog readout in proximal airway pressure from -5 to +55 cmH2O. As the
airway pressure increase, a green bar rises to reflect the pressure. If the pressure exceeds the setting of the Peak High
Pressure limit in the Alarm 1 menu, then the portion of this bar above the limit will be red. When the pressure bar goes
below zero, it will be yellow. Above and below the bar graph are numerical values for PEAK and PEEP/CPAP
pressures respectively. The PEAK display at the top should be used for readings when the pressure exceeds the range of
the bar graph.

3- MAIN MENU
Pressing the MAIN key displays the Main menu. When in the Main menu,
ventilation modalities, Assist Control, SIMV, or CPAP, may be selected. The
selected mode will be highlighted and it becomes immediately operative.
A/C
Ventilation modes:
ASSIST CONTROL (A/C)
Provides controlled or assist/control ventilation depending upon the
Flow Trigger setting. If the patient fails to initiate an inspiration, the
Crossvent-2i+ will continue to cycle at the respiratory rate set with the
RATE control. This key is CMV when in Constant Flow mode.

SIMV FIG. 5 MAIN MENU


(Synchronized Intermittent Mandatory Ventilation) mode - Provides spontaneous and intermittent assisted breaths.
The patient is free to initiate spontaneous breaths at a flow rate set with the FLOW control and for the length of time
of a normal inspiration as set with the TIDAL VOLUME and FLOW controls or INSP key. During these
spontaneous breaths, a bolus of gas flows to the patient at PEEP or atmospheric pressure. The patient inspires the
amount desired and the rest is dumped to atmosphere. At intervals set with the SIMV RATE control, a triggered
breath is provided under pressure (synchronized mandatory breath).

CPAP
(Continuous Positive Airway Pressure)/Manual mode - Provides spontaneous breaths at PEEP or atmospheric
pressure (see spontaneous breaths under SIMV above). The manual key is operative in this mode. When in CPAP
mode, the rate key provides the backup rate and is displayed as BACKUP RATE.

MANUAL
This is operative only in the CPAP mode. Provides one normal controlled breath each time it is pressed, with
inspiratory time and tidal volume as established by the Tidal Volume and Flow controls or INSP key. Minimum
expiratory time of 0.2 sec is provided.

CONSTANT FLOW
This function provides a continuous flow of gas out the patient connector as set by the Flow Knob for continuous flow,
pressure limited ventilation. Pressing this key also will turn off Flow Trigger as patient triggering cannot be used when
Constant Flow is on. With Constant Flow on, the TIDAL VOLUME key becomes the INSPIRATORY TIME key,
allowing inspiratory time to be set directly. The Assist Control key changes to CMV and the SIMV key is eliminated. If the
unit is in SIMV mode when Constant Flow is pressed, it will shift to CMV mode and the SIMV RATE key changes to
RATE. The Rate key will provide machine breaths at the set rate and the patient can breathe spontaneously off the gas
provided by constant flow between machine breaths.
With CONSTANT FLOW on, the following additional limit is established: Maximum inspiratory time- 3.0 seconds. If the
Flow and Inspiratory settings are such that a tidal volume of 500 ml or greater will be delivered, then TV displayed below
the INSP key will flash and the alarm will sound. To correct this, either the Flow or Inspiratory time must be reduced.
In Constant Flow/CMV mode, if a situation arises that causes the Peak Pressure High Alarm limit to be exceeded, Max
Pressure and Flow will be terminated and the unit will alarm. They will be restored when the pressure decreases to what the
PEEP reading was prior to the occurrence.
WARNINGS: IN THIS MODE: FLOW TRIGGER AND PRESSURE SUPPORT
ARE INOPERATIVE. ADDITIONALLY, PEAK PRESSURE AND PEEP READ
CONTINUOUS PRESSURE DURING CPAP. REFER TO THE APPENDIXES
FOR ALL FUNCTIONS DISABLED BY CONSTANT FLOW.
NOTE: In CONSTANT FLOW mode with CPAP, Backup is inoperative.

15
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
FLOW TRIGGER
The pneumotach must be installed to use this function. Sets the level of sensitivity to detect a patient’s effort to breathe by
sensing flow through the pneumotach. The sensitivity can be adjusted within a scale of 1 - 20, where 1 is the most
sensitive and 20 is the least sensitive. When FLOW TRIGGER is on, a base flow of 2-3 LPM is activated during expiratory.
FLOW TRIGGER is off if CONSTANT FLOW is on. To turn on FLOW TRIGGER, press it. FLOW TRIGGER will
highlight and be set to the last used setting. CONSTANT FLOW will be turned off. To adjust the sensitivity, use the
arrow keys to scroll to the desired sensitivity.
WARNING: Without the pneumotach in the circuit and connected to the ventilator,
there will be no patient triggered breaths.
WARNING: Auto-triggering or missed breaths may occur due to various conditions
including, but not limited to, compliance, resistance, rate, flow, PEEP, I:E ratio, and
circuit characteristics.

PRESSURE SUPPORT
May be set from Off to 50 cmH2O above baseline using the UP and DOWN Arrows. When pressure support is on, it
pressurizes spontaneous breaths up to the pressure support setting. When this pressure is achieved, the exhalation valve is
allowed to return to baseline pressure, but flow remains on for the duration of a normal assisted breath as set by the RATE
and TIDAL VOLUME controls.
NOTE: Pressure Support may be set any time, but is only active during SIMV and CPAP. It is
disabled when using Constant Flow.

RATE
Sets the normal respiration rate. It is adjustable from 5 to 150 bpm. When in SIMV, this changes to SIMV RATE and when
in CPAP, to BACKUP RATE.

SIMV RATE
When in SIMV mode, the RATE key becomes the SIMV RATE key. It sets the rate at which assisted breaths are given in the
SIMV mode. It may be set from 0.6 to 50 bpm. This rate is also the backup rate in the event of apnea.
WARNING: When in SIMV, it is important to always set a correct SIMV RATE,
TIDAL VOLUME and FLOW to insure proper ventilation in case the patient
becomes apneic.
Note: Be aware that the SIMV rate is also the backup rate which is the rate the patient will get in the
event of apnea.

BACKUP RATE
Sets the rate at which backup breaths are delivered when in CPAP mode in the event of apnea.
WARNING: When in CPAP, it is important to always set a correct BACKUP RATE,
TIDAL VOLUME and FLOW to insure proper ventilation in case the patient
becomes apneic. When in CPAP with Constant Flow, this is inactive.

TIDAL VOLUME (TV)


Sets the volume of gas delivered during assisted or controlled inspirations. It is adjustable from 5 to 750 ml. This key may
be changed to set inspiratory time rather than tidal volume by selecting inspiratory in the SETUP menu. The Setup Menu is
accessible only when the unit is turned on and before any key has been pressed. Press the Setup key and then press
TV/INSP. The currently preferred parameter, Tidal Volume in this case, will be highlighted. Press INSP TIME if you want
to set an inspiratory time rather than tidal volume. If INSP TIME is chosen, you will also be given a choice of displaying TV
or not (see I, E, I/E KEY below). Return to the Main Menu by pressing the Setup Menu key and then the Main Menu key
twice. INSP will now be displayed where TV had been.
With Constant Flow on, this key changes to INSP and sets inspiratory time only.
INSP
Sets the inspiratory time. It may be set from .1 – 3 seconds. This key may be changed to set tidal volume rather than
inspiratory time by selecting TV in the SETUP menu. The Setup Menu is accessible only when the unit is turned on and
before any key has been pressed. Press the Setup key and then press TV/INSP. The currently preferred parameter, INSP
TIME in this case, will be highlighted. Press TIDAL VOLUME if you want to set a tidal volume rather than inspiratory
time. Return to the Main Menu by pressing the Setup Menu key and then the Main Menu key twice. TV will now be
displayed where INSP had been. If INSP is chosen, you will also have the choice of displaying the set tidal volume or not
(see I, E, I/E Key below).

I, E, I/E KEY
This is a display key for informational purposes only. It cannot be used to set any parameter, but rather is used to display
the corresponding inspiratory time, expiratory time and I:E ratio, which result from setting the Rate, Tidal Volume (or INSP,
16
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
if available) and Flow. When INSP replaces TV in the key above, as explained in the section defining the Tidal Volume key,
then TV (set Tidal Volume) is displayed here rather than Inspiratory time. If the user would rather not see the set Tidal
Volume here when using the INSP setting, then this may be turned off in the SETUP Menu. Refer to the SETUP Menu
instructions (Section V, A-3) for further information. Additionally, segments of this key will indicate alarm conditions as
defined in the ALARMS section of this manual.
If a value here calculates out to be an invalid value, i.e. a negative number as an example, question marks (?) will be displayed.

FLOW KEY
Displays the inspiratory flow that is set with the Flow knob control. It may be set from 0 – 15 lpm.

4- ALARM MENUS

DISABLE
BY FT

FIG. 6 ALARM 1 MENU FIG. 7 ALARM 2 MENU


ALARM KEY
Although there are three Alarm screens, only Alarm 1 and Alarm 2 are accessible by pressing a corresponding key. The Alarm
3 screen only appears when a specific condition, as explained later in this section, occurs. The Alarm 1 and Alarm 2 menus are
available through a shared key. To access these alarm menus, press the ALARM 1/ALARM 2 key once for ALARM 1 and
press it again for ALARM 2. The highlighted half of the ALARM1/ALARM2 key indicates which alarm menu is currently
displayed. When an alarm menu is displayed, pressing the ALARM1/ALARM2 key will display the other alarm menu.
When an alarm condition occurs, the appropriate alarm menu will automatically be displayed, unless it occurs while a
parameter is being scrolled or if ALARM QUIET was activated with no alarm condition occurring. To change menus during
an alarm condition, Alarm Quiet must be activated (see ALARM QUIET).

HIGH & LOW ALARM LIMITS- The high or low limits of an alarm parameter may be selected by pressing the
corresponding
key for that value. The value is changed using the UP and DOWN Arrows. The low limit may not be scrolled above the
high limit and vice versa. When an alarm sounds, the display shifts to the appropriate alarm menu and flashes the alarm
parameter that is out of limit. If more than one alarm sounds simultaneously, they each flash. If alarms occur in more than
one menu, the menus are prioritized. The CROSSVENT shifts first to the Alarm 1 menu and when these alarms are
rectified, it shifts to the Alarm 2 menu. Whenever an alarm is active in another menu while the Alarm Quiet is active, the
corresponding menu key(s) flashes.
NOTE: Pressing Alarm Quiet allows control of the menus while alarms are active.

MONITORED ALARM VALUE- the actual monitored value for an alarm is displayed in the center column between the
high and low limits for that alarm.

PRIMARY ALARM MENU (ALARM1) monitored parameters and alarms- Standard Alarms are Peak Pressure and Rate.
Alarms that can be turned off are Exhaled Tidal Volume and Exhaled Minute Volume.

SECONDARY ALARM MENU (ALARM2) monitored parameters and alarms- PEEP and CPAP, Mean Pressure, O2.
The last two may be turned off.

TERTIARY ALARMS (ALARM3) These alarms are not displayed in a menu, but rather only as they occur. Therefore,
there is no menu key. The monitored parameters and alarms are- Low Battery, and Ventilator Failure. These messages can
be displayed singularly or in any combination.

17
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.

ADDITIONAL ALARMS OUTSIDE OF THE ALARM MENUS

MODALITY CONDITION INDICATED BY FLASHING1

CONSTANT
TI + FLOW = TV >500 ml TV DISPLAY
FLOW ON
ALL MODES INSPIRATORY < 0.1 SECOND, > 3.0 SECONDS INSPIRATORY DISPLAY
ALL MODES EXPIRATORY < 0.2 SECOND EXPIRATORY DISPLAY
ALL MODES I/E > 3:1 or > 1:99 I/E DISPLAY
ALL MODES VENTILATOR HARDWARE FAILURE MAIN DISPLAY
ALL MODES NO EXTERNAL POWER BATTERY KEY
ALL MODES LOW BATTERY POWER MAIN DISPLAY
ALL MODES LOSS OF POWER LED
ALL MODES MICROPROCESSOR COMMUNICATION ERROR 2 LED
1 audible alarm accompanies any flashing alarm 2 see Appendix D for beeper codes

ALARM 3
In addition to the flashing “VENTILATOR FAILURE” message on the display, the following audible tones that
accompany the alarm may be used to identify which solenoid has failed:

MESSAGE FAILED COMPONENT AUDIBLE SEQUENCE


LOW BATTERY, CONNECT N/A 1 LONG ___
EXTERNAL POWER
VENTILATOR FAILURE SOLENOID A 1 LONG, 1 SHORT
VENTILATOR FAILURE SOLENOID B 1 LONG, 2 SHORT
VENTILATOR FAILURE SOLENOID D1 2 LONG, 1 SHORT
VENTILATOR FAILURE SOLENOID D2 2 LONG, 2 SHORT
VENTILATOR FAILURE SOLENOID D3 2 LONG, 3 SHORT
VENTILATOR FAILURE SOLENOID E2 2 LONG, 4 SHORT
VENTILATOR FAILURE PNEUMOTACH 1 LONG ___
TRANSDUCER

MANUAL LIMITS
PARAMETER
LOW HIGH
PEAK PRESSURE cmH2O 3-89 4-90
RATE bpm 4-159 5-160
O2 18-100 19-105
EXH. TIDAL VOLUME ml 0-1290 1-1300
EXH. MIN. VOLUME liters 0-44 1-45
PEEP/CPAP cmH2O -1 to 29 0-30
MEAN PRESSURE cmH2O 0-89 1-90
NOTE: For a full list of beeper codes, see Appendix D.

NOTES REGARDING ALAR MS


RATE- The monitored rate is calculated and displayed as a rolling average over 5 breaths. In CONSTANT FLOW
mode, the rate alarm is disabled.

18
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.

HIGH PEAK PRESSURE- Inspiratory is terminated if the peak pressure reaches the set high limit. In Constant
Flow/CMV mode, if a situation arises that causes the Peak Pressure High Alarm limit to be exceeded, Max Pressure
and Flow will be terminated and the unit will alarm. They will be restored when the pressure decreases to what the
PEEP reading was prior to the occurrence. When in Constant Flow/CPAP, this continuously follows the pressure.

LOW PEAK PRESSURE- This alarm is inactive during spontaneous and CPAP breaths

EXHALED TIDAL VOLUME- Exhaled Tidal Volume and Exhaled Minute Volume share the same line in the
ALARM 1 menu. Therefore, only one or the other may be displayed at any given time. To display one or the other,
press either EXHTV or EXHMV, depending on which is currently displayed, and press either arrow key. Repeatedly
pressing an arrow key will toggle between EXHTV and EXHMV. Once the desired parameter is displayed, it becomes
the active alarm.

Only the infant pneumotach, Bio-Med Devices Catalog #4409, can be used. Any other pneumotach will give faulty
readings.

Under certain circumstances, such as incompliant or large patients, the Peak Expiratory Flow may be too great for the
pneumotach to read. When this occurs, “EXCEEDS PEF” will be displayed in the Alarm 1 menu under EXHTV or
EXHMV and the Crossvent will alarm. This is to notify the user that the pneumotach may be too great a restriction
in the circuit for the patient.

Periodically, the pneumotach tubes are flushed with a very low flow of gas in order to prevent fluids from migrating
up these tubes. For breaths when this occurs, “CAL” is displayed instead of a volume. This may occur more
frequently after the unit is first turned on.
The displayed Exhaled Tidal Volume updates with each breath except for “CAL” breaths.

This alarm is disabled when Constant Flow is on.

EXHALED MINUTE VOLUME- (see EXHALED TIDAL VOLUME)


NOTE: EXHMV indicates a projected or anticipated minute volume based on the current exhaled
tidal volume readings.

PEEP/CPAP- Displays continuous pressure in Constant Flow/CPAP mode.

MEAN PRESSURE- is the average pressure of a single breath.

DEACTIVATING ALARMS- The alarms for Mean and O2 may be turned off by scrolling the low limit down past its
lowest limit to off.
WARNING: WHEN AN ALARM IS TURNED OFF, AUTO SET IS
DEACTIVATED FOR THAT ALARM.

WARNING: While some alarms may be turned off to permit use of the Crossvent
without them, it is recommended that they be used at all times.

5- KEYS COMMON TO ALL MENUS

LOCK
Locks all keys, except ALARM QUIET and the MENU keys, making them inactive if pressed. When active, this key is
highlighted and the touchscreen is locked. To unlock it, press this key once, then again within 5 seconds of the first

ALARM QUIET
Silences the audible alarm for a period of 60 seconds or 120 seconds if pressed twice consecutively. When set, the key is
highlighted and counts down showing the time remaining for which the alarms will be silenced. To cancel, press the key
once if the time remaining is ≥ 61 seconds or twice if it is ≤ 60 seconds. When you turn the ventilator on, the Alarm Quiet is
activated automatically for 60 sec.

When activated, the ALARM QUIET function will silence the audible alarm for any alarm conditions that exist at the time
it is activated. Should a new and different alarm condition occur while it is activated, ALARM QUIET will automatically be
canceled and the audible alarm will return. If Alarm Quiet is pressed with no alarm conditions existing at the time, then
while it is active, any new alarm will be silenced.

19
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
NOTE: The Power Failure alarm may not be silenced using this key. The Power Failure alarm may
be silenced by pressing the ALARM RESET button.

ARROW KEYS
Scroll up and down, at an accelerating rate, a selected parameter. When the value being changed reaches its upper or lower
limit as allowed by the software, it stops scrolling and a tone sounds.
NOTE: While scrolling, some hesitation may be observed.

AUTO SET
(use is optional)- This key must be depressed 2 times within 5 sec. The key is highlighted and counts from 5 to 1 while
average values are computed over 5 breaths and alarm limits are automatically set above and below the average as follows:
A/C SIMV CPAP
LOW HIGH LOW HIGH LOW HIGH
PEAK -30% +30% -30%* +30%* MINIMUM 80 cmH2O
RATE -30%2 +30% -30%2 +30%2 MINIMUM MAXIMUM
EXHTV UNAFFECTED
EXHMV UNAFFECTED
PEEP UNAFFECTED N/A N/A
CPAP N/A -3 cmH2O +3 cmH2O
MEAN OFF
O2 -5 +5 -5 +5 -5 +5
*Calculated from Assist or Control breaths only.
If a mode key (A/C, SIMV or CPAP) is pressed while Auto Set is computing, it will be canceled and will have to be pressed
again to repeat the process. In any mode, if the Auto Set calculation results in a value beyond the allowable range of that limit,
then the minimum setting for Low or maximum setting for High will be used, i.e., if the O 2 concentration is 23% or less, then
the low limit will be set to 18, the minimum allowable setting.
NOTE: When an alarm is turned off, auto set is deactivated for that alarm.
Whenever an alarm limit is manually entered, it takes precedence over the auto -limit already in
memory.
When Peak Pressure is computed in SIMV, if no assisted or controlled breaths are sensed within the
5-breath computation period, another 5 breath period is used. This is repeated until at least 1 assisted
or controlled breath is measured.
Auto Set is inactive in CPAP in the Constant Flow mode.

POWER SOURCE KEY


This key indicates whether the unit is operating on external or battery power and shows the level of battery power
regardless of the power source.
EXTERNAL POWER- Displays “EXTRNL” whenever external power is connected to the CROSSVENT.
BATTERY OPERATION- Displays “BATT” when operating on battery. Flashes “BATT” whenever external power
is lost and the CROSSVENT shifts to battery power. When this happens, a simultaneous audible alarm sounds which
may be silenced only by pressing this key. Restoration of external power will automatically switch the unit to external
power operation and begin charging of the battery until full charge is reached.
Whenever the CROSSVENT is powered on without external power, the Power Source key will alarm alerting the user
the unit is operating on battery power. This alarm will continue until the user acknowledges this by pressing the flashing
BATTERY key.
The Power Source key also displays a graphical representation of battery life remaining. It reduces it in 2% increments
as the battery power is depleted.
WARNING: Always operate the CROSSVENT on battery prior to use to confirm
that the battery is functioning.
CAUTION: It is recommended that the CROSSVENT never be left with its battery
discharged as this will reduce battery life. After discharge of the battery, recharge fully
before disconnecting the plug-in power supply.
NOTE: For more on the battery, refer to Section III, Part C-2, Battery.

INSPIRATORY SOURCE KEY


This key indicates type of breath being delivered.

SPONTANEOUS BREATH- Displays SPONT whenever an inspiration is initiated by the patient’s spontaneous
effort during SIMV or CPAP, delivered at PEEP or atmospheric pressure or pressurized when pressure support is on.

ASSISTED BREATH- Displays ASSIST whenever an inspiration is initiated by the patient’s spontaneous efforts and
delivered under pressure (volume or pressure limited breath) during Assist Control and SIMV breaths.
20
III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.

CONTROLLED BREATH- Displays CONTROL whenever an inspiration is initiated by the CROSSVENT timer
(volume or pressure limited breath), during Assist Control, SIMV backup and CPAP backup breaths.

MANUAL BREATH- Displays MANUAL whenever a manual breath is delivered by pressing the MANUAL key in
CPAP mode.

SETUP KEY
This key is only accessible immediately after powering on the unit. Pressing it will display the SETUP menu which allows
the user to make changes to the unit’s setup as well as calibrate the oxygen sensor (see setup procedures in Section V). It is
deactivated and replaced by the ARROW keys by pressing any key other than the ALARM QUIET or BATTERY key or if
no key is pressed within 30 seconds of powering on the unit.

CALIBRATION
This menu is accessed from the SETUP menu. It is reserved for maintenance procedures for service personnel.

21
IV. SETUP AND OPERATING INSTRUCTIONS
A- PATIENT CIRCUIT
WARNING: A patient filter should always be used in the patient breathing
circuit to prevent cross contamination
WARNING: Do not re-use disposable breathing circuits.









NOTES 
!

When using a patient filter, connect


it directly to the patient connector on 

the side of the Crossvent (or O2 tee


if the sensor is being used) and then
 
connect the patient circuit (or 24"  


hose if using a humidifier) to the filter. Oxygen Sensor



w/ Tee
For use with a (use is optional)

support arm, clip 

the holding arm Patient Filter


goes here
onto the exhalation
valve as shown here
and then capture the
ball in the support
arm.
Blue Cuff

When using a humidifier, use the 24"


hose between the Crossvent and
humidifier. Then connect the circuit Exhalation Airway
to the output of the humidifier and Valve Pressure

make all the connections as would


normally be made.

Pneumotach Distal Pneumotach Proximal


(use is optional) (use is optional)

Clear
Exhalation Valve Tube Pneumotach
#4409
Striped
Tube
To The Patient
Infant circuit, catalog #20011, shown

FIG. 8 CIRCUIT CONNECTIONS

22
IV. SETUP AND OPERATING INSTRUCTIONS- CONT.

B- OPERATING INSTRUCTIONS
The following describes the procedure for setting up and operating the Crossvent-2i+ Ventilator. It is assumed that the
operator is thoroughly familiar with the Specifications, Theory of Operation, Tests and Calibration procedures as
outlined in this manual. It is also assumed that the ventilator is already fully assembled, has been tested and calibrated
and is connected to a test lung.

This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to CE. These
limits are designed to provide reasonable protection against harmful interferences in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures: reorient or relocate the receiving antenna, increase the separation
between the equipment and the receiver, connect the equipment into an outlet on a circuit different from that to which
the receiver is connected, or consult the dealer or an experienced radio/TV technician for help.

WARNINGS

ONLY QUALIFIED MEDICAL PERSONNEL SHOULD OPERATE THE


VENTILATOR.

DO NOT ATTEMPT TO VENTILATE A PATIENT UNTIL THOROUGHLY


FAMILIAR WITH ALL OF THE OPERATING INSTRUCTIONS.

THE OPERATING INSTRUCTIONS ARE NOT INTENDED AS


RECOMMENDED CLINICAL PROTOCOLS.

ALWAYS TEST THE VENTILATOR PRIOR TO EACH USE. AFTER SET UP,
VENTILATE A TEST LUNG TO VERIFY PROPER OPERATION PRIOR TO
CONNECTING THE VENTILATOR TO A PATIENT.

IF A MALFUNCTION SHOULD OCCUR, THE UNIT SHOULD BE REMOVED


FROM USE AND REPAIRED PRIOR TO USING IT AGAIN ON PATIENTS.

WHENEVER AN ALARM CONDITION EXISTS IT SHOULD BE RECTIFIED


IMMEDIATELY. NEVER ALLOW VENTILATION WITH AN ALARM
CONDITION FOR AN EXTENDED LENGTH OF TIME.

NOTE: Since it is not possible to damage the Crossvent-2i+ Ventilator by normal use of its keys and
control knobs, the user is encouraged to experiment with the Crossvent -2i+ settings while the unit is
not connected to a patient.

1- PRELIMINARY STEPS
Verify the BMD power supply output connector is plugged into to the mating connector of the ventilator and plug the
power supply into an external electrical outlet.

Connect a patient circuit to the ventilator. Connect a test lung (BMD #1021) to the proximal airway connector.

Turn on the gas supply source to the input connector.

23
IV. SETUP AND OPERATING INSTRUCTIONS- CONT.

2- DETAILED OPERATING INSTRUCTIONS


Turn the ON/OFF switch to the ON position. The unit comes on in the Main menu in the same mode it was in when last
turned off.

Press the ALARM QUIET key to increase the temporary audible alarm silence period from 60 seconds to 120 seconds if
desired. It may be used as many times as necessary to cancel the audible alarm until the alarm limits are set. The
EXTERNAL POWER or BATTERY indicator will come on depending on the condition of the power supply. The
ventilator will cycle at the rate set on the rate key and the inspiratory source CONTROL indicator will come on during each
inspiration. If the ventilator auto-cycles, indicated by ASSIST or SPONT in the Inspiratory Source Window, the inspiratory
effort should be increased using the Flow Trigger key.

Select desired mode, e.g., SIMV.

The Crossvent-2i+ primary function keys and control knobs should be set to the desired initial values, for example:

CONTROL METHOD SETTING


RATE ARROWS 40 BPM
TIDAL VOLUME (TV) or ARROWS 100 ml

INSPIRATORY TIME (INSP), if displayed ARROWS .5 sec.


FLOW KNOB 10 LPM
MAX PRESSURE (PIP) KNOB High

PEEP/CPAP KNOB Zero


FLOW TRIGGER ARROWS 5

NOTE: A highlighted field indicates that a parameter has been selected and may be adjusted using the
arrow keys.

Press the AUTO SET key. It is necessary to press this key twice within 5 seconds in order to activate the auto-limit
function. This initiates the automatic computation of high and low limits for all primary alarm parameters.
NOTE: The AUTO SET key should always be used to establish initial limits. These may be used
for patient monitoring, in order to facilitate setup or may be set temporarily until “custom limits” are
entered to suit specific clinical requirements. Any or all of the limits may then be manually changed.

Verify proper operation.

Connect the ventilator to the patient.

Adjust Flow Trigger and/or other controls for the particular patient. Observe operating parameters and make fine
adjustments.

If it is desired to manually change alarm limits, they may now be entered. Press the Alarm 1/Alarm 2 key until the desired
alarm menu is displayed. Select the desired alarm parameter, e.g., e.g., the HIGH PEAK PRESSURE key. This will appear
highlighted. Use the arrow keys to select the desired value. This sequence of keys, i.e., alarm parameter limit and arrow
keys must be used when entering all limits. Once the limit has been entered in memory it may be changed at any time by
repeating the sequence.

WARNING: IT IS IMPERATIVE TO VERIFY THAT CLINICALLY


APPROPRIATE ALARM LIMITS ARE FULLY OPERATIONAL FOLLOWING
CONNECTION OF THE VENTILATOR TO A PATIENT.

WARNING: IT IS IMPORTANT TO NOTE THAT ONCE THE O2 SENDOR


HAS BEEN TURNED OFF, THE ALARM FOR THAT SENSOR IS
INOPERATIVE.

24
IV. SETUP AND OPERATING INSTRUCTIONS- CONT.
NOTE: If it is desired to deactivate the oxygen sensor, select it in the Alarm 2 menu. Scroll the
lower limit down to off. The function is now inoperative. The function may be reactivated at any time
by pressing it and scrolling the low limit up. It is now reactivated. This allows the ventilator to be
used without the oxygen sensor. When this sensor is off, it may be disconnected while the ventilator is
in use, without causing an alarm.

3- SUMMARY OF OPERATING INSTRUCTIONS


Turn on.

Select mode.

Set primary functions in MAIN Menu.

Press AUTO SET.

Verify proper operation.

Connect to patient.

Make patient appropriate adjustments to settings.

Press the alarm menus key and adjust alarm limits if desired.

IMPORTANT NOTES:

1- Flashing I, E or I/E Ratio display indicates a timing limit violation and can be permanently silenced only by
adjusting the settings to bring them into permissible ranges.

2- In Constant Flow mode with CPAP, Backup is inoperative.

25
V. SETUP MENU AND TROUBLESHOOTING
A- SETUP MENU
The SETUP key is only available immediately after powering on the unit and is disabled as soon as any other key except
ALARM QUIET or BATTERY is pressed or if no key is pressed within 30 seconds of powering on the unit. This menu
allows the user to set preferences and perform test and calibration procedures relative to patient use. To access this menu,
turn the ON/OFF switch to ON and press the SETUP key in the lower right corner of the display. The SETUP menu will
be displayed and the alarm LED will light. From this menu, pressing the CAL MENU key can access the CALIBRATION
menu or you can exit back to the MAIN menu by pressing the MAIN MENU key.

1- OXYGEN SENSOR CALIBRATION


This function is used to calibrate the Oxygen sensor cell. Due to the fact that O2 sensors sometimes change output over time
once exposed to atmosphere, a calibration should be performed once a month in order to ensure optimal accuracy. When
the sensor is consumed and does not calibrate properly, it should be discarded and a new sensor installed and calibrated.
To calibrate:
1. With the O2 Sensor cable plugged into the side of the CROSSVENT and the sensor out of the breathing circuit and
open to atmosphere, press the OXYGEN key.
2. If the sensor has been exposed to a higher level of oxygen than just air in the last 5 minutes or so, then wait 3-4
minutes for the sensor to acclimate and then press the 21% key. Otherwise, you may press the key immediately.
When the 21% is calibrated, it will return to the OXYGEN menu and the 21% will be green. If it is red, the
calibration failed. Either replace the sensor and/or confirm no elevated level of oxygen is present.
3. Place the oxygen sensor tee onto the patient connector on the Crossvent and connect a breathing circuit with a test
lung to the tee.
4. With the O2 sensor cable still plugged into the ventilator, install the O 2 sensor into the tee.
5. Apply 100% oxygen to the ventilator input and set 15 cmH2O of PEEP and 5 LPM flow.
6. Wait 3-4 minutes and then push the 100% key. When the 100% is calibrated, it will return to the OXYGEN menu
and the 100% key will be green. If it is red, the calibration failed. Either replace the sensor and/or confirm the
oxygen supply concentration is stable.
NOTE: It is important to use the correct reference gases (100 and 21%) when performing this
calibration. A worn out sensor will not calibrate accurately.

2- LEAK TEST
This test may be used to confirm the integrity of the patient circuit and its connections. To perform, proceed as follows:
1. Set the Max Pressure to its maximum setting.
2. Connect the patient circuit with a test lung to the Crossvent.
3. Set the flow control to 10 LPM.
4. Press enter. The Crossvent will pressurize the system and indicate “TESTING”, followed by either “PASSED” or
“FAILED” depending on the results. If it fails the test, check the patient circuit and all connections for leaks and
retest.

3- TV/INSP PREFERENCE
Allows the user to choose between setting Inspiratory Time or Tidal Volume in the Main Menu when not using Constant
Flow. To select inspiratory time as the preferred setting, press INSP TIME and then the SETUP MENU key. Next is
displayed a screen asking whether or not to display Tidal Volume in the MAIN Menu. This is the set tidal volume, not the
corrected tidal volume. Respond YES or NO according to preference and press the SETUP MENU key. When the user
returns to the MAIN Menu, INSP (inspiratory) will be displayed below the RATE key in the MAIN menu, thereby allowing
the user to set an inspiratory time directly. If the user would prefer to set a Tidal Volume directly rather than an inspiratory
time, then pressing TIDAL VOLUME in the SETUP menu will accomplish this. Whichever is chosen will remain in effect
until it is changed in this menu.

4- LANGUAGES
Allows for the menus to be displayed in a different language.

5- VER (Version)
Indicates the software version installed.

6- SN (Serial Number)
Indicates the serial number of this unit.

26
V. SETUP MENU AND TROUBLESHOOTING- CONT.

B- CALIBRATION MENU (CAL)


This menu is to be used only by someone skilled in the service and repair of the CROSSVENT Ventilator. Refer to the
MAINTENANCE & SERVICE SECTION of this manual under Setup & Calibration Menu Overview for explanations of
functions contained in this menu.
WARNING: Only qualified, trained, service technicians should attempt repairs and
service when needed. Serious personal injury and/or equipment damage can result
if unqualified personnel perform repairs.

27
V. SETUP MENU AND TROUBLESHOOTING- CONT.

C- OPERATIONAL TROUBLESHOOTING

PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION

Fails to respond to touch 1. Keys locked 1. Press LOCK key twice to unlock
selection of a key 2. Defective touchscreen key 2. Submit for service

Parameter value seems Wrong parameter selected Select correct parameter


inappropriate

Unit fails to turn on when 1. Battery low and plug-in power supply 1. Plug in charger to active outlet and
“ON/OFF” switch is set to on. not connected. charge battery
2. No power at outlet and battery low. 2. Plug into active outlet and charge
battery

Unit hangs with Bio-Med Initialization error. Submit for service.


Devices, Inc. on the display.

Internal regulator output Low pressure/flow from gas source; fault in gas Increase gas volume/pressure
pressure varies supply

Low internal pressure regulator 1. Output pressure not set; insufficient gas 1. Set output pressure; check gas
output supply 2. Submit for service.
2. Dirty or clogged filter

System pressure reads zero 1. Peak pressure limit control is fully off 1. Adjust the maximum pressure limit
2. Tube disconnected between patient and control
ventilator 2. Connect tube

Incorrect peak pressure and 1. Pressure transducer disconnected or 1. Submit for service.
PEEP/CPAP reading malfunction
2. Pressure transducer is out of calibration 2. Submit for service.

Uncontrolled auto-cycle; 1. Flow Trigger setting is too sensitive 1. Increase Flow Trigger setting
remains in inspiratory mode 2. Pressure transducer malfunction 2. Submit for service.

Peak pressure high limit alarm 1. Accumulation of secretion 1. Examine patient


activates 2. Change in compliance; blockage in 2. Remove the blockage or replace
airway or tubing the airway/tube
3. Patient tries to breathe independently 3. Re-evaluate patient status and vent
4. Endotracheal tube has slipped down settings
into a bronchus 4. Correct the tube position
5. Change in patient positioning 5. Re-evaluate patient and vent
6. Pneumothorax settings
7. Sigh 6. Treat patient
7. Set the high alarm limit higher

Peak Pressure Low limit alarm 1. Disconnected patient circuit 1. Reconnect patient circuit
activates 2. Endotracheal tube has slipped down 2. Reposition endotracheal tube
into a bronchus 3. Empty water from patient circuit
3. Water in patient circuit 4. Re-evaluate patient
4. Decrease in lung compliance

Ventilator does not start 1. Power cable not connected and battery 1. Connect power cable; charge or
discharged replace battery
2. Low battery and no power in electrical 2. Change outlet; charge or replace
outlet battery
3. Blown fuse in plug-in power supply 3. Replace transformer
4. ON/OFF switch in the OFF position 4. Switch to ON

28
V. SETUP MENU AND TROUBLESHOOTING- CONT.

PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION

Crossvent-2i+ fails to operate 1. Low battery 1. Charge battery


on battery 2. Missing battery 2. Insert and attach battery
3. Defective battery 3. Replace battery

Battery fails to charge properly 1. Plug-in power supply not connected 1. Connect plug-in power supply
2. No voltage at outlet 2. Connect to an active outlet
3. Defective battery 3. Replace battery
4. Defective charger 4. Replace charger

LOW BATTERY indicator on Battery discharged AC power must be restored and battery
charged

No exhaled tidal volume reading 1. Pneumotach disconnected 1. Reconnect the pneumotach


2. Problem with flow channel or and/or tubes
differential 2. Service needed

Incorrect tidal volume reading 1. Incorrect flow calibration 1. Review flow calibration procedure
2. Blocked or kinked pneumotach tubes and recalibrate
3. Leak in patient circuit or endotracheal 2. Check pneumotach tubes and
4. Inspiratory terminated by Peak correct blockage
Pressure high alarm limit 3. Check and correct the patient
circuit and endotracheal tube for
leaks
4. Adjust Peak Pressure high alarm
limit

Incorrect O2 reading 1. O2 sensor not connected 1. Connect sensor


2. Incorrect calibration procedure 2. Review calibration procedure and
3. Faulty sensor cell recalibrate
3. Replace cell

No O2 readings O2 sensor turned off Turn on

29
VI. CLEANING, STERILIZATION AND PACKING

A- CLEANING AND STERILIZATION


The Crossvent-2i+ Ventilator should be thoroughly cleaned and inspected following each patient use. The entire
exterior of the unit should be cleaned with a suitable cleaning agent. During cleaning, power should be turned off and
the plug-in power supply should be disconnected. Care should be taken not to allow cleaning agents to enter the unit
as this could cause damage and subsequent malfunction.

CAUTION: UNDER NO CIRCUMSTANCES SHOULD THE Crossvent-2i+ UNIT BE


GAS STERILIZED, STEAM AUTOCLAVED OR SUBMERGED IN LIQUID. THE
COMPONENTS OF THE UNIT ARE INCOMPATIBLE WITH THESE
STERILIZATION METHODS AND SEVERE DAMAGE CAN RESULT.

1- Ventilator- The entire unit, with the exception of the LCD touch screen can be cleaned using an appropriate
bactericidal or germicidal agent. Care should be used not to allow foreign material, e.g., cleaning agent, pieces of gauze,
etc., to enter the unit. Particular care should be taken when cleaning near the connectors and vent screens.

2- LCD Touch Screen Keypad- The touch screen of the Crossvent-2i+ is made of transparent plastic
and may be damaged by chemical solvents and abrasive cleaners. Use only alcohol when cleaning this area. Great care
should be taken not to touch it with sharp objects, since it may be punctured, which could damage the keys.

3- Patient Circuit- The complete patient circuit supplied with the Crossvent-2i+ is disposable and intended for
single use.

4- Re-usable Circuit- The optional Bio-Med Devices re-usable patient circuit may be gas or chemically
sterilized as follows:
 Pasteurization at 150° to 170°F (65.6° to 76.6°C) for a minimum of 30 minutes.
 Ethylene Oxide (ETO) cold cycle not to exceed 130° F (54.4° C) with adequate aeration time

5- Oxygen Tee- The supplied blue oxygen tee may be sterilized with EtO (12%-88% or 100%) gas. Do not
exceed 100°F. Aerate for at least 8 hours at 120°F.

30
VI. CLEANING, STERLIZATION AND PACKING- CONT.

B- PACKING FOR SHIPMENT


In the event the CROSSVENT must be returned to the factory, it is very important to pack the unit properly. The following
is the correct packing procedure to insure safe transport:

Packing Materials Required:


Double Wall Carton
Suitable Shock Absorber - Foam or Air Bubble Wrap
Poly Bag

For the safety of all concerned, please thoroughly clean and disinfect the unit prior to packing. If the unit is being returned
for service, please include all information relative to its need for service as well as the name and phone number of the person
we may contact regarding return.

If the unit you are returning is one that you received for evaluation, then all the accessories that came with the unit must also
be returned as outlined here.

Procedure:

1. Cover CROSSVENT with the poly bag and secure with twist tie or tape.
2. Wrap the CROSSVENT in the foam or bubble wrap, with at least 2 inches of material on all sides, and place it into
the carton.
3. Wrap oxygen sensor and any other adapters with bubble wrap (if returned).
4. Thoroughly wrap the plug-in power supply and power cord with bubble wrap and place it into the carton, making
certain that it cannot damage the CROSSVENT while in transit.
5. Place the gas supply hose, if returned, between the rear of the CROSSVENT and the carton wall.
6. Place the patient circuits, pneumotachs and instruction manual in an orderly fashion into the remaining space (if
returned).
7. Fill the carton on all sides with packing material to prevent the unit from shifting during transit.
8. Close the carton with tape, noting serial number on the outside of the carton.
9. Ship to:
BIO-MED DEVICES, INC.
61 Soundview Road
Guilford, CT 06437 USA

31
MAINTENANCE AND SERVICE SECTION

32
VII. THEORY OF OPERATIONS

The Crossvent-2i+ is a time cycled, volume or pressure limited ventilator. Its basic principle of operation is extremely
simple. Supply gas, either air, oxygen, or a blended mixture, is connected to the Crossvent-2i+ inlet fitting.

NOTE: For blended gas, the Bio-Med Devices blender should be used.

For pneumatic schematics, refer to the Schematic section of this manual.

Gas flows first to an internal pressure regulator that provides output gas regulated to approximately 16 psi. This is used
both for patient gas and to set PEEP and maximum pressure levels.

From the regulator the gas flows to a normally closed, 2-way pilot valve operated by a miniature solenoid valve (valve A).
The gas exits the pilot valve and goes to an electronically encoded flow valve. The encoding is accomplished via a
precision potentiometer. Since the upstream (supply) pressure is constant and much greater than the downstream
(patient) pressure, changes in downstream pressure may be neglected. Therefore, since the supply pressure is accurately
regulated, the flow rate becomes a function solely of the flow valve setting. The length of time that gas flows is the
inspiratory time. The volume of gas that flows during the time it is on is the Tidal Volume and is equal to the on-time
(inspiratory time) multiplied by the flow rate.

From here the gas goes into the patient circuit through the patient connector. Pre-set pressure relief valves in the manifold
limit the maximum pressure, and allow the patient to draw in ambient air if the entire system becomes inoperative.

During the period of time when valve A is open and gas flows, solenoid valve B is actuated, allowing gas from the
Maximum Pressure valve to pressurize the diaphragm of the exhalation valve. This assures that all gas will flow to the
patient. At the end of inspiration, valve A closes and gas flow ceases. Simultaneously, valve B is de-energized, connecting
the PEEP valve signal to the exhalation valve diaphragm. This allows the patient to exhale to atmosphere and the pressure
in the patient circuit to fall to PEEP or atmospheric pressure.

A low flow flush system is provided to prevent humidity from traveling back up the pneumotach sensing lines (if used) and
damaging the pressure transducer. This is accomplished with two solenoid valves, D1 & D3. A third solenoid valve, D2,
is used to zero the pressure transducer to compensate for drift. During inspiratory, these solenoids actuate. A very low
flow is passed through solenoids D1 & D3 and out the pneumotach tubes. At the same time, the transducer ports are
shunted through solenoid D2. This zeros the transducer by equalizing the pressure across it. During expiratory, these
solenoids are de-energized and the pressure differential from the pneumotach is then passed through D1 and D3 to the
transducer.

NOTE: The flush circuit activates every 30 seconds, but may activate more frequently when the unit is
initially turned on. If the inspiratory time is greater than .250 seconds, the flush circuit lasts for the
duration of the I-time. For shorter inspiratory times, then the flush is fixed at .280 seconds and
therefore continues into the expiratory phase of the breath.
Solenoid E2 provides a base flow of 2.5 lpm during expiratory when using Flow Trigger.

33
VII. THEORY OF OPERATION- CONT.

A- SYSTEM COMPONENTS

SUPPLY INLET FILTER


The supply gas passes through an inlet filter. This filter should be changed periodically. It filters particles down to 48
microns.
NOTE: It is recommended that an external filter/water trap be used at all times in order to provide
greater protection to the internal components of the Crossvent.

AIRWAY PRESSURE TRANSDUCER


Connected to the proximal airway, the pressure transducer converts the pressure signal into an electrical signal. This
electrical signal, which represents the pressure waveform is then used by the Crossvent’s microprocessor to accomplish a
multitude of tasks. The transducer output also establishes the levels for the all of the pressure related alarms

DIFFERENTIAL PRESSURE TRANSDUCER


It is utilized to measure the pressure drop across an orifice in a pneumotachograph. The pneumotach is placed at the
proximal airway. As exhaled gas passes through the orifice, it creates a pressure drop from one side of the orifice to the
other. This highly sensitive pressure transducer measures this small difference in pressure. The signal from the transducer
is then converted by the microprocessor into a measurement of exhaled tidal volume and minute volume. This transducer
is also used to sense effort for flow triggering.

DIAPHRAGM ACTUATED RELIEF VALVE (D.A.R.V.)


It is controlled by the output signal from the Maximum Pressure needle valve (front panel), which is also applied to the
exhalation valve. It sets the relief pressure at approximately the same level as the exhalation valve.

2-WAY PRESSURE RELIEF VALVE


This valve vents gas to atmosphere whenever the pressure in the breathing circuit exceeds the preset level of 96 cmH2O. It
also allows gas to enter the breathing circuit whenever a negative pressure greater than approximately 4-5 cmH2O is
generated. This acts as a failsafe mechanism and in the event of a total system power failure allows the patient to inhale
ambient air.
WARNING: Breathing through this valve requires a greatly increased work of
breathing and only air is provided. A situation in which the patient is breathing
through this valve should be rectified immediately in order to prevent possible
adverse affects to the patient.

WARNING: Should the use of the negative pressure relief valve become necessary,
the operation of the Crossvent in a contaminated environment can be hazardous.

34
VII. THEORY OF OPERATION- CONT.

B- ASSIST CONTROL MODE


In this mode the Crossvent-2i+ will function either as an assist or controller. If the patient is inspiring, the ventilator will
sense flow past the pneumotach with Flow Trigger being used and this will initiate an assisted inspiration. If the patient fails
to breathe, the ventilator will continue to give controlled breaths at the backup rate set by the main RATE setting.

Inspiration may be initiated by either a patient inspiratory effort or, in the absence of that, the backup setting. At the start of
inspiration, gas flows to the patient at the flow rate established by the FLOW control, for the duration of the inspiratory
time. Simultaneously, the exhalation valve is pressurized to the Maximum Pressure level. The maximum pressure attainable is
established by the MAXIMUM PRESSURE control on the front of the ventilator. At the end of the inspiratory time, the
patient gas flow is terminated and zero or PEEP pressure is applied to the exhalation valve. This allows the pressure in the
patient circuit to fall only to the PEEP level.

35
VII. THEORY OF OPERATION- CONT.

C- SIMV (Synchronized Intermittent Mandatory Ventilation) MODE


In the SIMV mode, the Crossvent-2i+ delivers two main types of breaths: ASSISTED and SPONTANEOUS. Both are
initiated by the patient’s inspiratory effort, which is sensed by the ventilator. The assisted breaths are the same as assisted
breaths in the Assist Control mode. The rate of administration of assisted breaths is set using the SIMV RATE key and
entering the desired value.

In-between the assisted breaths, patient inspiratory efforts initiate spontaneous breaths. When the ventilator detects an effort
to breathe, it initiates inspiration and delivers gas to the patient at a rate determined by the FLOW control and for a period of
time equal to the inspiratory time of a normal assisted breath.

The difference between a spontaneous and assisted breath is that during a spontaneous breath, Maximum Pressure is not
applied, only the PEEP pressure signal is applied to the exhalation valve, thus delivering gas to the patient at zero or PEEP
pressure, if PEEP is on.

The full tidal volume is made available at the proximal airway. Whatever gas is not inspired by the patient is vented to
atmosphere. At the end of the inspiratory time, should the patient desire a greater tidal volume than that which is set, he
need only continue to inhale. As long as pressure below baseline (zero or PEEP) is detected, the ventilator will continue to
deliver boluses of gas as determined by the TV setting. The patient is free to trigger as many spontaneous breaths as needed
between assisted breaths. At the end of the time interval established by the SIMV RATE control, the ventilator administers
an assisted breath, synchronized to the patient’s breathing effort.

Pressure Support: When pressure support is turned on, the patient circuit pressure is allowed to increase above baseline (zero
or PEEP) by the number of cmH2O as set by PRESSURE SUPPORT. This occurs only during spontaneous breaths. When
the airway pressure reaches the pressure support level, the baseline pressure is restored, allowing the exhalation valve to open,
but the patient gas continues to flow for the duration of a normal assisted breath as set by the RATE and TIDAL VOLUME
controls.

WARNINGS: IT IS EXTREMELY IMPORTANT THAT THE FLOW TRIGGER


CONTROL BE CAREFULLY ADJUSTED TO ASSURE PROPER OPERATION IN THE
SIMV MODE. ALSO, UNDER CERTAIN CONDITIONS IN SIMV WITH PEEP, EVEN
THOUGH THE LOW PEAK PRESSURE ALARM IS SET CORRECTLY FOR ASSISTED
BREATHS, THERE MAY BE NO LOW PEAK PRESSURE ALARM FOLLOWING A
PATIENT DISCONNECT UNTIL THE NEXT ASSISTED BREATH. (THIS PERIOD
MAY BE UP TO 2 MINUTES.) AS AN ADDED PRECAUTION, SET THE LOW
PEEP/CPAP AND LOW EXHALED TIDAL VOLUME ALARMS SO THAT THEY ARE
OPERATIVE.

36
VII. THEORY OF OPERATION- CONT.

D- CPAP (Continuous Positive Airway Pressure)


In the CPAP mode, the breaths are delivered in exactly the same manner as a spontaneous breath in the SIMV mode. Each
breath is triggered by the patient’s inspiratory effort. Gas flows to the patient for a period of time equal to the inspiratory
time of a normal assisted breath (established with the Tidal Volume and Flow controls). The flow rate during a CPAP
breath is set with the Flow control. During CPAP breaths, Maximum Pressure is inactive and the gas is delivered at zero or
CPAP pressure. The full volume is made available at the proximal airway, with additional boluses available with continued
effort until the patient is satisfied. Whatever gas is not inspired by the patient is vented to atmosphere.

Pressure Support: See SIMV above.

When Constant Flow is on, the gas flows to the patient continuously rather than being triggered on by the patient. The
flow rate is set by the Flow control and is provided at the CPAP level.

WARNING: IT IS EXTREMELY IMPORTANT THAT THE FLOW TRIGGER


CONTROL BE CAREFULLY ADJUSTED TO ASSURE PROPER OPERATION
IN THE CPAP MODE.

WARNING: UNDER CERTAIN CONDITIONS IN CPAP, IN PARTICULAR


WITH HIGH FLOWS AND LOW CPAP PRESSURES, IF THE LOW PEAK
PRESSURE ALARM IS SET SO THAT NO FALSE ALARMS OCCUR, THIS
ALARM MAY BE INOPERATIVE IF A DISCONNECT OCCURS. IT IS
THEREFORE EXTREMELY IMPORTANT TO HAVE THE LOW PEEP/CPAP
AND LOW EXHALED TIDAL VOLUME ALARMS SET CORRECTLY.

37
VII. THEORY OF OPERATION- CONT.

E- BACKUP MODALITY
When in SIMV mode, the SIMV Rate is also the backup rate. When in CPAP mode, the backup rate is set with the Backup
Rate key. In the event of apnea, the ventilator will deliver control breaths at this rate.

WARNING: IT IS IMPORTANT TO ALWAYS SET A CORRECT RATE, TIDAL


VOLUME AND FLOW TO INSURE PROPER VENTILATION IN CASE THE
PATIENT BECOMES APNEIC.

38
VIII. MAINTENANCE AND SERVICE
WARNINGS: TECHNICAL REPAIRS SHOULD BE PERFORMED BY
QUALIFIED PERSONNEL, TRAINED EITHER BY BIO-MED DEVICES, INC
OR THEIR AUTHORIZED TRAINERS. BIO-MED DEVICES, INC. IS NOT
RESPONSIBLE FOR UNAUTHORIZED REPAIRS, OR REPAIRS MADE BY
UNAUTHORIZED PROCEDURES.

THE CV-2i+ SHOULD PASS A FULL TECHNICAL PERFORMANCE CHECK


AFTER ANY REPAIR PROCEDURE THAT REQUIRES THE CASE TO BE
OPENED.

ALL SAFETY MEASURES MUST BE OBSERVED WHEN SERVICING THIS


DEVICE. IN PARTICULAR, THE VENTILATOR MUST BE TURNED OFF
AND THE POWER SUPPLY DISCONNECTED.

BECAUSE THIS IS A CE MARKED DEVICE, IT MUST NEVER BE MODIFIED


WITHOUT PRIOR EXPRESSED WRITTEN CONSENT FROM BIO-MED
DEVICES.

A- SETUP & CALIBRATION MENU OVERVIEW


The following is an overview of the SETUP and CALIBRATION (CAL) menus. Some functions in these menus will be
used in the performance checks that follow this overview and will be further explained there.

To activate the SETUP and CALIBRATION menus, turn the ON/OFF switch to ON and press the SETUP key. This key
is only available immediately after power-on. It is replaced by the ARROW keys by either pressing any key, with the
exception of the ALARM QUIET or BATTERY key, or by timing out after 30 seconds with no key being pressed. When
pressing the SETUP key, the SETUP menu will appear and the alarm LED will turn on and remain on as long as this menu,
or any menu accessed from this menu, is displayed. It is possible to go to the CALIBRATION menu by pressing the CAL
MENU key or to return to normal operation at any time by pressing the MAIN MENU key.

1- SETUP MENU OVERVIEW


OXYGEN SENSOR CALIBRATION
This function is used to calibrate the Oxygen sensor cell.
NOTE: It is important to use the correct reference gases (100 and 21%) when performing this
calibration. A worn out sensor will not calibrate accurately.

NOTE: Due to the fact that O2 sensors sometimes change output over time once exposed to
atmosphere, a calibration should be performed once a month in order to assure optimal accuracy. When
the sensor is consumed and does not calibrate properly, it should be di scarded and a new sensor
installed and calibrated.

LEAK TEST
Tests the integrity of the patient circuit and its connections.

INSP/TV
Allows the user to choose between Inspiratory Time and Tidal Volume as it is displayed in the menus. When INSP TIME is
pressed and the SETUP menu is exited, INSP (inspiratory) will be displayed below the RATE key in the MAIN menu,
thereby allowing the user to set an inspiratory time directly. If tidal volume would rather be set, then press TIDAL
VOLUME in the SETUP menu and exit. Whichever is chosen will remain in effect until it is changed in this menu.

LANGUAGES
Allows for the menus to be displayed in a different language.

VER (VERSION)
Indicates the software version installed.

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VIII. MAINTENANCE AND SERVICE- CONT.
SN (SERIAL NUMBER)
Indicates the serial number of this unit.

2- CALIBRATION MENU OVERVIEW

WARNING: Improper changes made in the Calibration menu can be detrimental to


the performance of the ventilator.
The CALIBRATION menu can be accessed only from the SETUP menu. The CAL Menu is designed to aid service
personnel in the testing and calibration of the ventilator. A password is required for some calibration procedures to prevent
unauthorized or untrained personnel from gaining access to these procedures as changes made can affect the operation of the
ventilator. It is possible to exit the CAL menu and return to normal operation at any time by pressing the MAIN MENU
key. When returning to the MAIN menu from the SETUP or CAL menus, the ventilator may not cycle due to invalid
settings caused by changes to those settings made during test or calibration procedures. When the MAIN MENU key is
pressed, a reminder to reset parameters is displayed prior to returning to the Main Menu to help avoid this.

BATTERY
(Password required) This function is used to acclimate the battery gas gauge to a new battery when it is installed or to re-
acclimate the existing battery if it has been unplugged. Refer to the instructions for battery removal and replacement under
Disassembly and Reassembly Instructions in this manual for further details.
WARNING: This function should only be used on a discharged battery. Using it
otherwise can adversely affect the accuracy of the gauge.

PRESSURE TRANSDUCER
(Password required) Used to calibrate the pressure transducer for accurate display of airway pressure. Refer to the
Pneumatic Calibration section later in this manual for detailed instructions.

FLOW CALIBRATION
(Password required) This allows for the calibration of the flow that is set by the Flow Knob on the front of the Crossvent.
Flows are set and the flow value displayed here is compared with the actual flow being delivered as measured by a test
instrument. Refer to the Pneumatic Calibration section later in this manual for detailed instructions.

TOUCHSCREEN (CALIBRATION)
This function is used to calibrate the x and y coordinates for the touchscreen. This is only necessary when a new touchscreen
is installed or this calibration is lost due to a failure in the memory of the Crossvent. To calibrate the touchscreen, press
TOUCHSCREEN in the Calibration menu. Four boxes will be in the corner of the display. Press the center point where the
corners of these boxes converge. When the software registers the location that is pressed, these boxes will be replaced by a
second group of boxes in the opposite corner of the display. Press the center of these as before. When the second point of
reference has been registered, the calibration is complete and “CALIBRATED” is displayed. The unit then returns to the
Calibration menu.
Caution: Pressing anywhere other than the converging points of these boxes may
improperly calibrate the touchscreen.
KEYS (TOUCHSCREEN TEST)
Displays the Key Test menu. It is used to determine that the touchscreen is operating properly. Starting near the upper left
corner of the display, press several points as you move diagonally across the display towards the CAL MENU key. The
values for the x and y coordinates for each point pressed should increase. If not, there is a problem with the touchscreen and
it should be recalibrated. If calibrating does not fix the problem, then it should be serviced. Press the CAL MENU key to
end this test and return to the CAL Menu

DISPLAY (LCD) TEST


Tests all the pixels in the display by illuminating 16 boxes containing the 16 colors used by the Crossvent as shown below.
Press anywhere on the touchscreen to end the test and return to the Calibration menu.

BLACK BLUE GREEN CYAN

LIGHT
RED MAGNENTA BROWN
GRAY
LIGHT LIGHT LIGHT
GRAY
BLUE GREEN CYAN
LIGHT
LIGHT RED YELLOW WHITE
MAGENTA

40
VIII. MAINTENANCE AND SERVICE- CONT.
VALVES
May be used to activate the internal solenoid valves independently for calibration and troubleshooting purposes. The key
adjacent to the designated valve indicates its current state. Pressing this key will change its state from OFF to ON or vice
versa. Only three valves may be on simultaneously.
VALVE A - PILOT VALVE
VALVE B - SIGNAL PRESSURE TO EXHALATION VALVE
VALVE D1 -* PNEUMOTACH FLUSH
VALVE D2 - EQUALIZES PRESSURE TRANSDUCER
VALVE D3 -* PNEUMOTACH FLUSH
VALVE E2 - BASE FLOW
*Valve A must be on to have flow.

HOURS
Indicates the total accumulated hours the ventilator has been powered on.

FACTORY SERVICED
Indicates when the manufacturer last serviced the unit.

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VIII. MAINTENANCE AND SERVICE- CONT.

B- PERFORMANCE CHECKS
WARNING: If the CROSSVENT fails any of the following performance checks,
remove the unit from patient service and submit for maintenance.

1- SETUP MENU
Turn on the unit and press the SETUP key.
OXYGEN SENSOR CALIBRATION
NOTE: Due to the fact that O2 sensors sometimes change output over time once e xposed to
atmosphere, a calibration should be performed once a month in order to assure optimal accuracy. When
the sensor is consumed and does not calibrate properly, it should be discarded and a new sensor
installed and calibrated.
With the O2 Sensor cable plugged into the side of the CROSSVENT and the sensor open to atmosphere (not in the circuit
tee), press the OXYGEN key.
If the sensor has been exposed to a higher level of oxygen than just air in the last 5 minutes or so, then wait 3-4 minutes for
the sensor to acclimate and then press the 21% key. Otherwise, you may press the key immediately. When the 21% is
calibrated, it will return to the OXYGEN menu and the 21% key will be green.
Connect the oxygen sensor tee to the patient connector on the side of the Crossvent and to it connect a breathing circuit
with a test lung.
With the O2 sensor cable still plugged into the ventilator, install the O 2 sensor into the tee.
Apply 100% oxygen to the ventilator input and set 15 cmH 2O of PEEP and 5 LPM flow.
Wait 3-4 minutes and then push the 100% key. When the 100% is calibrated, it will return to the OXYGEN menu and the
100% key will be green.
You may now check the O2% readings in the Alarm Menu using a calibrated O 2 blender or Test Setup.

LEAK TEST
(This tests the integrity of the patient circuit and its connections)
Connect the patient circuit along with a test lung to the Crossvent.
Set the Max Pressure to its maximum setting.
Set the flow control to 10 LPM. Press enter.
The Crossvent will pressurize the system and indicate “TESTING”, followed by either “PASSED” or “FAILED” depending
on the results. If it fails the test, check the patient circuit and all connections, and retest.

2- CALIBRATION (CAL) MENU


If in the SETUP Menu, press the CAL key, otherwise turn the unit off and back on and press SETUP and then the CAL
menu key.

KEYS
Press KEYS. Press on the display in various locations. Each time it is pressed in a different location, the coordinates
displayed should change. If any location pressed fails this test, submit for service. Push CAL MENU to return to the CAL
Menu.

DISPLAY
Press the DISPLAY key. The display will illuminate allowing you to check for missing pixels. Some randomly missing pixels
is considered acceptable.

FLOW VERIFICATION
NOTE: For greatest accuracy, verify flow using a 60% O2 gas supply, making certain that the
pressure to the CROSSVENT inlet remains within specified pressure limits (17 -55 psi; 117 – 380
kPa) at all flows.

Remove the exhalation valve from the patient hose. Turn the Max Pressure knob fully clockwise. Make certain that the
proximal airway pressure line and the pneumotach (if so equipped) are connected. Connect the patient hose to a certified
flow measurement instrument. In the Cal menu, select VALVES and turn on Valve “A”.
With the supply pressure maintained as defined in the preceding NOTE, turn the Flow Knob to its maximum setting and
verify the flow indicated by the test instrument is within 13.5 – 16.5 LPM.
After verifying the maximum flow, adjust the flow knob to various flow levels, some high and some low, and verify that the
flow displayed in this menu is within ±10% of the actual flow as indicated by the test instrument.

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VIII. MAINTENANCE AND SERVICE- CONT.
FLUSH
(Valve D1, D3- if equipped with Exhaled Tidal Volume monitoring)
Using a length of tubing, connect the lower Flow Sensor fitting on the side of the Crossvent to a low flow test standard and
turn on the Crossvent.
Press SETUP and then CAL MENU.
Activate VALVES.
Turn ON valves A, D1 and D3, and set a flow of 10 LPM.
Check for a flow of 40 - 60 ml/min coming from the fitting.
Move the tubing connection from the lower fitting to the upper fitting (blue).
Check for a flow of 40 - 60 ml/min coming from this orifice also.

BASE FLOW
Connect a patient circuit to the unit and to a low flow test instrument.
Set the Max Pressure to its maximum setting.
Set the PEEP to its maximum setting.
Activate Valve E.
Check for 2 – 3 lpm.

POP OFF
Install a patient circuit with the end occluded (plugged, no test lung). Rather than connecting the airway pressure line to the
Crossvent, however, connect this to a low pressure test instrument.
Turn on the CROSSVENT and press the SETUP/CAL MENU/VALVES keys. (If the Crossvent is already on and the
Arrow keys are present, turn it off and back on to make the SETUP key available).
Set the Max Pressure Knob fully clockwise.
Set the flow to 5 lpm.
Turn on Valve A by pressing its corresponding ON/OFF key.
Occlude the exhaust opening of the exhalation valve on the circuit while observing the test instrument reading. It should
indicate between 64 and 96 cmH2O.
Increase the flow until it is at its maximum setting. The pressure should not exceed 96 cmH 2O.

3- MAIN MENU

BAR GRAPH ACCURACY


Disconnect the patient circuit.
Tee the airway pressure fitting on the side of the Crossvent to a low-pressure measurement instrument and a 10-25 ml
syringe (or similar).
Turn on the CROSSVENT in the MAIN menu and set:
RATE to 20
TV ml to 100
FLOW to 5
In the ALARM 1 menu, set the PEAK PRESS Alarm high limit to its maximum setting
In the ALARM 2 menu, set the PEEP alarm high and low limits to their maximum settings.
As the unit cycles, slowly depress the plunger on the syringe. Stopping at various pressures along the bar graph, verify the
readings on the bar graph are within ±10% of the readings on the test instrument.

PEEP PRESSURE SIGNAL


Connect the Exhalation Valve fitting on the side of the Crossvent to a low pressure test instrument.
With the PEEP Knob fully clockwise, the pressure reading should be 9-11 cmH2O.

BATTERY ALARM
(This alerts the user they are in battery mode)
Turn on the CROSSVENT without external power.
Power Source key will flash as well as the LED.
The audible alarm is silenced for 60 seconds when unit is initially powered on.
Press the Power Source key to acknowledge battery mode and to cancel the Battery Alarm.
The Power Source key will revert to its normal state with its bar graph indicating the percentage of battery charge left.

EXTERNAL POWER FAILURE ALARM


Connect the Bio-Med Devices Crossvent Power Supply to the power input on the side of the Crossvent. (This connector is
keyed, align dot to dot.).
With the CROSSVENT turned ON, EXTRNL will appear in the lower left of the display.

43
VIII. MAINTENANCE AND SERVICE- CONT.
After 1 minute of operation, remove external power plug.
EXTRNL will change to BATT and flash. The LED will flash and the audible alarm will sound.
Press BATT to stop the alarm.
The BATTERY key will revert its normal state with its bar graph indicating the percentage of battery charge left.

POWER FAILURE ALARM


(Occurs when CROSSVENT looses power or is turned off)
With the CROSSVENT operating for a minimum of 1 minute, turn the CROSSVENT off with the On/Off Power Switch.
The LED will flash along with an audible alarm. Press the reset button on the front of the unit to silence the alarm.

ALARM QUIET
With the CROSSVENT cycling and Alarm Quiet inactive, cause the unit to alarm, i.e., remove the patient circuit. The audible
alarm should sound along with a flashing LED.
Press the ALARM QUIET key and verify that the alarm silences for 60 sec.
Press the ALARM QUIET key twice and verify that the alarm silences for 120 sec.
Press it a third time to cancel.

BACKLIGHT
While operating on battery, press and hold the middle of Pressure Bar Graph until a second beep is heard (≈3 seconds).
Verify that the BACKLIGHT turns off. Press anywhere on the display to turn it back on.

LOCK
Press LOCK and verify that all functions except the MENU KEYS and ALARM QUIET are locked out.
Press LOCK once and then again within 5 seconds to unlock.

USE THESE SETTINGS FOR THE FOLLOWING TESTS UNLESS OTHERWISE INSTRUCTED:
Rate = 20 bpm; TV = 150 ml; Flow = 10 lpm

ASSIST CONTROL FUNCTIONS (SET TO Assist Control MODE)

AUTO SET
Connect patient circuit with Lung and O2 Sensor to CV-2i+.
Turn CV-2i+ ON, in ALARM 2 Menu turn ON O2.
Return to ALARM 1 Menu.
While CV-2i+ is cycling, press AUTO SET twice and verify that after 5 breaths the following occurs:
A/C SIMV CPAP
LOW HIGH LOW HIGH LOW HIGH
PEAK -30% +30% -30%* +30%* MINIMUM 80 cmH2O
RATE -30% +30% -30% +30% MINIMUM MAXIMUM
EXHTV UNAFFECTED
EXHMV UNAFFECTED
PEEP UNAFFECTED N/A N/A
CPAP N/A -3 cmH2O +3 cmH2O
MEAN OFF
O2 -5 +5 -5 +5 -5 +5
*Calculated from Assist or Control breaths only.
RATE
Connect a patient circuit to a Rate Test Standard and cycle the Crossvent.
Set various RATE settings and verify that delivered rates are within 10% of the set rate.

TIDAL VOLUME
Connect the patient circuit to a Tidal Volume Test Standard.
Turn on the unit and set the Max Pressure knob fully CW.
Set the TV (see note) to 50 and Flow to 5 and verify delivered Tidal Volume is within 10%. Repeat for TV 100, Flow 8; TV
200, Flow 15.
NOTE: If TV is not displayed under the RATE key, then go into SETUP, press TV/INSP and
select Tidal Volume as the preferred parameter.

44
VIII. MAINTENANCE AND SERVICE- CONT.
ALARM MENUS
Exceed each limit, HIGH and LOW, in the menu and verify the ventilator alarms.

SIMV FUNCTIONS (SET TO SIMV MODE)

FLOW TRIGGER
Connect an infant circuit with a pneumotach and test lung to the Crossvent.
Set the Rate to 10, TV to 50 and Flow to 5 LPM.
Set the Flow Trigger Level to 1. If the unit auto-cycles, increase the FLOW TRIGGER setting until it stops.
While in expiratory, lightly squeeze and release the test lung. The unit should cycle and ASSIST should appear in the
Inspiratory window in the lower left of the display.
Increase the level again and repeat. It should require slightly more effort this time to make the unit cycle.

CONSTANT FLOW MODE


Turn on Constant Flow Mode and verify flow remains ON. Turn OFF when done.

SIMV BACKUP RATE


Turn ON the Crossvent.
Connect the unit to a Rate Test Standard.
With the SIMV RATE set to 20 and without initiating a breath with effort, verify the unit delivers controlled breaths at the
set rate.

PRESSURE SUPPORT
Set PRESSURE SUPPORT to 10 cmH2O and initiate breaths using inspiratory effort. Verify that the high-pressure signal to
the exhalation valve is terminated when the circuit pressure equals 10 cmH 2O above PEEP during spontaneous breaths only,
and that the gas flow remains on for the duration of the set inspiratory time.

CPAP FUNCTIONS (SET TO CPAP MODE)

MANUAL
Press the MANUAL key and verify a pressurized breath is delivered and MAN is displayed in the lower left key during this
breath.

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VIII. MAINTENANCE AND SERVICE- CONT.

C- RECOMMENDED TOOLS AND TEST EQUIPMENT

1- SPECIAL TOOLS AND TEST EQUIPMENT


Items available from BMD
Part Number Description

1021 Test Lung

20011 Patient Circuit

2003K, 2003KC O2 Blender

Items NOT available from BMD


Item Description

Anti-Static Cable Anti-Static mat ground cable assembly.

Anti-Static Mat Workbench cover

Anti-Static Strap Wrist Strap

Digital Voltmeter Fluke 85 or Equivalent

Syringe and tee 25 or 50 ml. with .170" barb tee

DC Power Supply 0- 30 VDC @ 2A min.

Pressure Transducer -30 to +140 cmH20

Pressure Standard -30 to +140 cmH20 0.5 cmH2O

Oxygen Analyzer 21 to 100 %; 1%


Krytox® 240 AD Grease

Oscilloscope 100 MHz, Storage

Common Tools
Item Description

Allen Hex Drivers Up to 5/32"

Diagonal Cutters

Hemostat 4" or similar

Needle Nose Pliers

Screw Driver, Flat & Phillips Assorted

Open End Wrenches Assorted

46
VIII. MAINTENANCE AND SERVICE- CONT.

D- PREVENTATIVE MAINTENANCE

1- RECOMMENDED MAINTENANCE SCHEDULE


Periodic preventive maintenance should be performed to insure continued proper operation of the CROSSVENT
Ventilator. The frequency of preventative maintenance is determined by many factors, some of which are:
 Frequency & length of use
 Quality of the compressed gas source(s)
 Environmental conditions
The following is a list of routine maintenance procedures and maintenance schedule.

TIMELINE
The following is a list of routine maintenance procedures and maintenance schedule.
Interval Recommended Procedures
Prior to each use Check battery condition
Periodic Performance Check as shown below
Annual Verify Calibration
Every 2 years Major overhaul, cleaning and calibration
Battery replacement*
Recommend return to factory for this service
*Replace only with batteries supplied by Bio-Med Devices, part # PRT2268. Do not substitute.

GAS INLET FILTER


The filter element in the supply inlet fitting (DISS O2 Input) should be replaced during major overhauls or whenever it
becomes clogged.

BATTERY CHECK
The battery has an internal thermal fuse. This fuse will open if it gets hot due to excessive current flow or if the battery
itself becomes too hot. It will recover when the cause is eliminated. If the fuse is suspect, check for voltage across the red
and black wires coming from the battery. If the battery is hot and no voltage is present, allow it to cool and check again. If
there is no voltage and it won’t take a charge, but the charging circuit is good, replace the battery.

The battery should be checked before each use. To check:


Turn on the Crossvent and remove the external power supply connector. The ventilator should continue to operate
correctly. The Power Source key should display "BATT" and the audible alarm should sound. Pressing the Power Source
key should permanently silence the audible alarm. Restoring the external power should cause the Power Source key to show
"EXTRNL ". If a battery operation alarm does not sound when AC power is lost or if the unit fails to operate on battery,
the unit should be removed from service and tested.
One minute after turn-on observe the battery gauge. If the gauge originally showed 100% and now shows less than 50%
charge remaining, put the CROSSVENT on charge. Recheck in 2 hours. If the battery condition has not improved, remove
the unit and power supply from service until the problem is identified and corrected.

2- PREVENTIVE MAINTENANCE PARTS KITS

PART NUMBER- PRT2282

Included in the kits are the following parts: Filter, MAX/D.A.R.V. Pressure Line, PEEP Pressure Line, Flush Line, Base
Flow Line. Additionally recommended parts to replace are the Battery, Flow Valve, MAX Pressure Valve, and PEEP
Pressure Valve if the clear tubing off the regulator shows any contamination or discoloration inside it. A slightly cloudy
look to the large clear tube from the regulator to the flow valve may be normal in some units. The small, clear tubes should
be clear, however.
For instructions on replacing these parts, refer to the Disassembly & Reassembly Section later in this manual.

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VIII. MAINTENANCE AND SERVICE- CONT.

E-SOFTWARE UPGRADES
RS-232 COMPUTER INTERFACE - A 6 pin, modular jack is provided as a convenient PC interface for software
updates. It is located in the rear of the unit behind the rear panel.

On occasion, software upgrades may be released with further enhancements to the Crossvent. These are available through
Bio-Med Devices or your dealer. It is a rather simple task to install new software into the Crossvent, but this should be done
by qualified personnel as the rear panel of the ventilator must be removed to access the RS232 jack used to download the
software.

When requesting new software, the serial number of the Crossvent is required. Each software download is defined for a
specific Crossvent, identified by its serial number. Without the proper serial number, the software will not load.

When ordering software, use part #PRT4427C. Along with the software, a communication cable and adapter to connect it
to a computer are included. This adapter is custom and may not be substituted. Keep this cable and adapter in a safe place
for future use. If you have these, then often times any future software upgrades can be emailed.

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VIII. MAINTENANCE AND SERVICE- CONT.

F- PNEUMATIC CALIBRATION

11
SOLENOID PROXIMAL FLUSH
CONFIGURATION
A B D1 D2 D3 E2 12
DISTAL FLUSH

15
BASE FLOW

RS232

9 8
MAX DARV
4 PRESSURE

10
PEEP
1
5 3 6
2
7

FIG. 9 CALIBRATION POINTS

4. Logic Regulator/Pilot Valve 8. D.A.R.V. Variable Resistor


5. Potentiometer 9. Max Pressure Variable Resistor
2. Flow Valve 12. Distal Flush Variable Resistor
3. PEEP Valve 11. Proximal Flush Variable Resistor
1. D.A.R.V. (Diaphragm Actuated Relief Valve) 10. PEEP Variable Resistor
7. 2-Way Pressure Relief Valve 15. Base Flow Resistor
6. Maximum Pressure Valve

49
VIII. MAINTENANCE AND SERVICE- CONT.
The steps in these procedures are divided into two parts. The first part is “TO TEST”. This describes the procedure used to
test each specific component of the unit to determine its condition. The second part is “TO CALIBRATE”. This part
describes the calibration procedure of that component if it did not pass the preceding test.

IMPORTANT: The calibration steps need only be performed on those components that fail the “TO TEST”
procedure. Generally, calibration is only required when parts are serviced or replaced so be sure to troubleshoot
any failed test thoroughly prior to resorting to calibration.

CAUTION: With the PC Board and/or Solenoid Board removed, great care should be
taken to protect the board from stray voltages, static electricity, and any other environmental
concerns that may damage the board. Always handle the board with care and be sure you
and your work surface are properly grounded.

1. GAS SOURCE - 60% O2 / 100% O2


a. If this Crossvent is used with an air/oxygen blender, then to ensure the most accurate calibration
throughout all settings, a low flow blender set to 60% O 2 should be used.
b. If it is used only with oxygen, then use 100% oxygen.

2. SUPPLY PRESSURE – 17 - 55 PSI (117 – 380 kPa)


a. The pressure at the supply input to the ventilator should be maintained between 17 - 55 PSI (117 – 380 kPa) at
all times.

3. PEEP VALVE ZERO - 20 ML/M


TO TEST:
a. Connect the exhalation valve port on the side of the CV-2i+ to a low flow test instrument.
b. Using hemostats or a similar tool, clamp off the blue PEEP line between the small cross fitting and the white
bleed manifold mounted to the top of the D.A.R.V.. Also clamp off the yellow line between the PEEP
Variable Resistor (10) and the bleed manifold.
c. Turn the PEEP Valve (3) shaft fully CCW until a flow 20 ML/M is obtained as observed on the test
instrument (Slight resistance in the valve at this point is normal, however, do not force the valve. If abnormal
resistance is felt prior to the valve closing to within this specification, it should be replaced.)

IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:


d. Clamp off the blue PEEP line between the small cross fitting and the white bleed manifold mounted to the
top of the D.A.R.V. Also clamp off the yellow line between the PEEP Variable Resistor (10) and the bleed
manifold.
e. Remove the shaft extender from the valve shaft by loosening the two setscrews. Turn the valve shaft until the
specification stated in step “c” is met. Position the shaft extender on the PEEP Valve shaft with its stop pin
against the left side of the stop. Tighten the setscrews in this position.
f. Remove hemostats.

4. MAXIMUM PRESSURE VALVE ZERO - 20 ML/M


TO TEST:
a. Connect the exhalation valve port on the side of the CV-2i+ to a low flow test instrument.
b. Using hemostats or similar tool, clip off the yellow tube coming off the side of the DARV. CAUTION:
Failure to do this could result in damage to the ventilator in the steps that follow
c. Using hemostats or a similar tool, clamp off the orange line between the D.A.R.V. Variable Resistor (8) and the
white bleed manifold mounted to the top of the D.A.R.V. Also clamp off the orange line between the MAX
Pressure Variable Resistor (9) and the bleed manifold.
d. In the Calibration menu, activate valves, and turn on valve B.
e. Turn the MAX Valve (6) shaft fully CCW until a flow 20 ML/M is obtained as observed on the test
instrument. (Slight resistance in the valve at this point is normal, however, do not force the valve. If abnormal
resistance is felt prior to the valve closing to within this specification, it should be replaced.)
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
e. Remove the D.A.R.V. orange test plug from the cross next to the D.A.R.V. Variable Resistor (8) and connect
this barb to a low flow test instrument.
f Clamp off the orange tube between the D.A.R.V. Variable Resistor and the white bleed manifold as well as the
orange tube between the MAX Pressure Variable Resistor and the bleed manifold.
g. Remove the shaft extender from the valve shaft by loosening the two setscrews.
h. Turn the valve shaft until the specification stated in step “e” is met. Position the shaft extender on the MAX
Valve shaft with its stop pin against the left side of the stop. Tighten the setscrews in this position.
i. Remove hemostats.

50
VIII. MAINTENANCE AND SERVICE- CONT.

5. FLOW VALVE/POTENTIOMETER ZERO - 500 ML/M


WARNING: Any time the flow valve(s) are disturbed, the flow calibration in the CAL
menu must be performed as explained in Step 13.
CAUTION: The Flow Valve (2) is geared to the Potentiometer (5) and it is the rotational
limits of the Potentiometer that stops the valve from turning.
NOTE: The PC Board must be removed if it’s determined the valve stop must be adjusted in this
step. See the caution at beginning of the calibration procedures.)

TO TEST:
a. Connect the Patient Connector on the side of the CV-2i+ to a low flow test instrument using a single length
of tubing.
b. Occlude the opening of the D.A.R.V. or turn up MAX Pressure fully if it’s calibrated.
c. In the Calibration menu, activate valves, and turn on valve A.
d. Turn the Flow Knob fully CCW to the stop. Flow should be 500 ML/M as observed on the test
instrument.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
e. Remove the PC Board. (See the caution at beginning of the calibration procedures.)
f. There are two setscrews per hole securing the gear to the shaft. Remove the gear from the Potentiometer by
removing the top set screws located in the teeth of the gear and then loosening the setscrews underneath.
g. Carefully disconnect the clear tube from the PEEP Valve (3). Be sure the supply pressure is off at this point.
Carefully remove the green tube connected to the Pilot Valve at the bottom of the Regulator and connect the
clear tube here. This will turn on the patient flow whenever the supply pressure is turned on, thus bypassing
the software and solenoid.
h. Connect the Patient Connector on the side of the CV-2i+ to a low flow test instrument using a single length of
tubing.
i. Turn on the supply pressure, occlude the opening of the D.A.R.V. or turn up MAX Pressure fully if it is
calibrated, and turn the Flow Valve shaft CW until the flow measured is 500 ml/M. DO NOT FORCE.
(Slight resistance in the valve at this point is normal. However, do not force the valve. If abnormal resistance
is felt prior to the valve closing to within this specification, it should be replaced.)
NOTE: In the zero position, the valve gear should be flush with the end of the shaft and the setscrews
should be on the bottom. If they are not, loosen them and reposition the gear so they are. These gears
will have two set screws per hole, one on top of the other. Remove the top setscrew and then loosen the
bottom one in both holes. To tighten, tighten the shorter one inside the hole first, then install and
tighten the second setscrew. Do not over tighten the second one or the gear may distort causing it to
bind.
j. While leaving the Flow Valve in the zero position, turn the Potentiometer shaft fully CCW until it stops. Place
the Potentiometer gear onto the shaft so it’s setscrews are facing 180 opposite the screws on the flow shaft, i.e.
at the top if the Flow Valve set screws are at the bottom. This helps prevent
binding as they mesh. This gear should only engage the flow gear to half its
thickness. This enables proper engagement throughout the full travel of the flow
shaft as it is turned and moves forward. Tighten the inner setscrews and replace
and tighten the outer setscrews.
k. Test again and ensure that the Potentiometer hits it stop at the same time the Flow FIG. 10 GEARS
Valve reaches zero. Reconnect all tubing to their original state.

6. LOGIC REGULATOR - APPROX. 16 PSI (perform first - 5)


TO TEST:
a. Connect the Patient Connector on the side of the CV-2i+ to a high flow test instrument using a single length
of tubing.
b. Occlude the opening of the D.A.R.V. or turn up MAX Pressure if it’s calibrated.
c. In the Calibration menu, activate valves, and turn on valve A.
d. Turn the Flow Valve fully CW. The maximum flow should be within 13.5 – 16.5 LPM.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
e. Remove the locking o-ring between the red locking ring and the Regulator Adjusting Knob and move the ring
towards the knob to unlock it.
f. Remove the orange test plug from the tee on the small, clear tube between the regulator and solenoid E2 and
connect a high pressure gauge here.
g. Connect the Patient Connector to a high flow test instrument using a single length of tubing.
h. Occlude the opening of the D.A.R.V. or turn up MAX Pressure if it’s calibrated.
i. In the Calibration menu, activate valves, and turn on valve A.
j. Turn the Flow Valve fully CW.

51
VIII. MAINTENANCE AND SERVICE- CONT.
k. Turn the Regulator Adjusting Knob until the specification stated in step “d” is met. The pressure as indicated
on the high pressure gauge should be approximately 16 PSI. This pressure will vary slightly from unit to unit
and is dependent upon the pressure required to obtain the maximum flow, therefore no specific pressure is
given. However, if the pressure required is significantly higher or lower than these values, then there may be a
problem such as a leak or restriction. In no instances should it be above 17 PSI.
l. Remove the test gauge and replace the test plug. Snap the locking ring back down in place and replace the o-
ring.

7. PEEP SIGNAL - 10 cmH2O (perform first - 3, 5, 6)


TO TEST:
a. Connect the exhalation valve port on the side of the CV-2i+ to a low pressure test instrument.
b. Fully open the PEEP Valve.
c. Pressure should be 9 - 11 cmH2O.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
d. Set up as in steps a & b.
e. Adjust the PEEP Variable Resistor (10) to obtain c.

8. MAXIMUM PRESSURE SIGNAL - 40 cmH2O (perform first - 4, 5, 6)


TO TEST:
a. Connect the exhalation valve port on the side of the CV-2i+ to a low pressure test instrument.
b. In the Calibration menu, activate valves and turn on valves A and B.
c. Set the flow to 10 LPM (if the flows are not calibrated, then set this using a test instrument).
d. Fully open the MAX Pressure Valve.
e. Pressure should be 36 - 44 cmH2O.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
f. Set up as in steps a - d.
g. Adjust the MAX Pressure Variable Resistor (9) to obtain 36 - 44 cmH2O.

9. D.A.R.V. SIGNAL - 45 cmH2O (perform first - 5, 6)


TO TEST:
a. Remove the orange test plug from the cross next to the D.A.R.V. Variable Resistor (8). Connect this barb to
a low pressure test instrument.
b. Fully open the Max Pressure Valve.
c. In the Calibration menu, activate valves and turn on valve A.
d. Set the flow to 10 LPM (if the flows are not calibrated, then set this using a test instrument)
e. Pressure should be 5 cmH2O above MAX Pressure as measured in previous step.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
f. Set up as in a - d.
g. Adjust D.A.R.V. Variable Resistor to obtain pressure in step “e”.

10. FLUSH - 50 ML/M (perform first - 5, 6)


TO TEST:
a. Using a length of tubing, connect the lower Flow Sensor fitting on the side of the Crossvent to a low flow test
standard and turn on the Crossvent.
b. Press SETUP and then CAL MENU. Activate VALVES.
c. Turn ON valves A, D1 and D3, and set a flow of 10 LPM (if the flows are not calibrated, then set this using a
test instrument).
d. Check for a flow of 40- 60 ml/min coming from the fitting.
e. Move the tubing connection to the upper fitting (blue) and check for the same flow.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
f. Set up as in a - c.
g. Adjust the Distal Variable Resistor (12) to obtain 40 - 60 ml/M (lower fitting).
h. Adjust the Proximal Flush Variable Resistor (11) to obtain 40 - 60 ml/M (blue fitting).

11. BASE FLOW – 2 to 3 LPM


TO TEST:
a. Connect the Patient Connector on the side of the CV-2i+ to a low flow test instrument using a single length
of tubing.
b. Set the Max Pressure to maximum.
c. In the Calibration menu, activate valves, and turn on valve E.
d. Verify the flow to be 2 - 3 LPM.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
52
VIII. MAINTENANCE AND SERVICE- CONT.
e. Set up the same as in steps a - c.
f. Adjust the Base Flow variable resistor (15) to obtain 2 - 3 lpm.

12. 2-WAY RELIEF VALVE - 96 cmH2O (perform first - 5, 6)


TO TEST:
a. Connect the Patient Connector on the side of the CV-2i+ to a low pressure test instrument using a single
length of tubing.
b. Occlude the opening of the D.A.R.V..
c. In the Calibration menu, activate valves, and turn on valve A.
d. Starting with the Flow Knob fully CCW, turn the Flow Knob fully CW while observing the test instrument.
The pressure should be no less than 64 cmH2O with 2 LPM and no greater than 96 cmH2O with 15 LPM.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
e. Set up the same as in steps a - c.
f. Turn off valve A and remove the Relief Valve (7).
g. From the top of the valve, hold the poppet in the center of the valve from turning with your finger. From the
bottom, adjust the tension on the spring to obtain pressure in step “d” by turning the spoked spring seat.
Turn CCW if pressure is too high and CW if too low.
h. Reinstall and test.

13. FLOW (perform first - 5, 6, 7, 8, 9)


NOTE: If this Crossvent is used with an air/oxygen blender, then verify flow using a 60% O2 gas
supply making certain that the pressure to the CV-2i+ inlet remains 17-55 psi (117-380 kPa) at all
times. If used only with 100% oxygen, then use that.

2i+
C ROS S VE N T
To
Blender
MAX PRESS PEEP FLOW

TO TEST
INSTRUMENT

FIG. 11 FLOW CALIBRATION SETUP


TO TEST:
a. Connect a patient circuit to the Crossvent as illustrated.
b. Turn Max Pressure and PEEP on fully, making certain that the proximal airway pressure line and
exhalation valve lines are connected.
c. Connect the patient circuit to an external test instrument capable of measuring flow.
d. After turning ON the CV-2i+, press the SETUP key and the CAL MENU key and then press VALVES.
e. Turn on Valve A.
f. Adjust the flow knob and observe the flow as indicated on the test instrument. It should be within 10%
of the displayed flow on the Crossvent where it indicates “FLOW” in the upper corner.
g. If not within specification, refer to table in the Technical Troubleshooting section before proceeding to
the calibration procedure below.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
h. Press “FLOW” in the Calibration menu and enter the authorization code.
i. Adjust the flow knob until the actual measured flow, as indicated on the test instrument, is equal to 2
lpm. Then compare this actual measured flow to the flow value indicated in the Crossvent display. If the
flow as indicated by the Crossvent is within ±10% of the actual flow, in this case 1.8 – 2.2 lpm, proceed
with the next flow point in the table. If it is not within the 10% limits, press the “2” in the table on the
display. The displayed flow on the Crossvent should now display 2 lpm. The flow knob is now
calibrated to the actual flow for that setting. Repeat for all other flow values in the table.

53
VIII. MAINTENANCE AND SERVICE- CONT.

14. PRESSURE CALIBRATION










Low Pressure
!

Test Instrument 

  
 






FIG. 12 PRESSURE CALIBRATION SETUP


TO TEST:
a. Tee a 10-25 ml syringe (or similar) into a tube that connects the airway pressure fitting on the Crossvent to a
low pressure test device.
b. Turn on the Crossvent and press the CPAP/MANUAL key.
c. While pushing in and varying the plunger on the syringe, observe the pressure bar graph and PEAK reading
above the graph.
d. The readings on the display should be within 3% of the readings on the test instrument. If not within
specification, refer to Troubleshooting in the following section before proceeding to calibration.
IF IT FAILS THE ABOVE TEST, CALIBRATE AS FOLLOWS:
e. Turn the unit on, press SETUP and then the CAL MENU key.
f. Press the PRESSURE key and enter the authorization code.
g. With the airway pressure connector on the side of the unit open to atmosphere (zero pressure), press the key
marked zero.
h. Set up as in “a”.
i. Apply 100 cmH2O pressure to the airway pressure connector and press the 100 cmH 2O key.

54
VIII. MAINTENANCE AND SERVICE- CONT.

G- DISASSEMBLY & REASSEMBLY INSTRUCTIONS


If the Crossvent is mounted within another piece of equipment, refer to the service manual for that equipment as provided
by the manufacturer for removal of the Crossvent.
WARNING: High voltage is present at the backlight connector (JBL) when power is
on.

CAUTION: All safety measures must be observed when servicing this device. In particular,
the ventilator must be turned off and the power supply disconnected.

CAUTION: With the PC Board removed, great care should be taken to protect the board
from stray voltages, static electricity, and any other environmental concerns that may damage
the board. Always handle the board with care and be sure you and your work surface are
properly grounded.

Note: Prior to disposal of any component, with particular attention to the battery and PCB, check with
your local controlling authority for disposal regulations.

Note: Whenever the battery is disconnected, the battery gauge must be reset. Refer to Battery Removal
& Replacement instructions in this section.
1. REAR PANEL
NOTE: The battery is loose once the rear panel is removed.
1. Remove the four (4) long screws located around the perimeter of the rear panel. These extend to the front bezel.
2. Remove the rear panel.
3. Reverse order to re-install. Be sure the battery cable grommet is set properly into the notch in the battery
compartment and no other wires or tubes are in a position to be pinched when the panel is installed.

2. BATTERY REMOVAL & REPLACEMENT


CAUTION: Only replace the battery pack with Bio-Med Devices part #PRT2268. Do not
substitute.
NOTE: After installing a new battery, it must be discharged, the battery gauge must be reset in the
calibration menu and the battery then fully charged and discharged as outlined in this procedure.

1. Remove the rear panel.


2. Remove the grommet on the battery wires from the notch in the battery
compartment and lift the battery out of the battery enclosure. Unplug the 1/8"
PADS
battery connector.
3. Verify six rubber pads similar to those supplied with the new battery are
adhered to the inside of the battery enclosure as illustrated. If there are
some missing or are none, then use the supplied new pads to replace what
is missing. There should also be three 1/8” thick pads on the inside of the
rear panel within the cutout in the battery enclosure gasket. If there are 1/6" PADS
some missing or are none, then use the supplied new 1/8” pads to replace FIG. 13 SIX PADS
what is missing as illustrated. Adhere pads as shown
4. Place the battery in the enclosure so that the label on the battery is facing 1/8” thick

the rear panel.


5. Plug the battery connectors together outside the enclosure and work the
1 3/4"

grommet on the wire into the notch in the side of the enclosure.
6. Replace the rear panel and four screws. Take care that the grommet
remains in the notch when the panel is replaced and no wires or tubing
are pinched.
1"
2 1/4"
3"

FIG. 14 1/8” PADS

If this is a new battery, a battery other than the original battery or if the current battery has been disconnected, then
proceed with the following steps to re-program the battery gauge to the battery.

55
VIII. MAINTENANCE AND SERVICE- CONT.
7. Turn on the Crossvent. Be sure the external power supply is not connected to the unit. If the battery is already
depleted and the unit will not power on without the external power supply, then go to Step 11.
8. When the MAIN menu appears, press the SETUP key in the lower right of the display and then press the CAL
MENU key.
9. Press VALVES and turn any three valves on by pressing OFF next to them.
10. Leave the unit like this until the battery is expended and the unit shuts down.
11. Set the ON/OFF switch to OFF if it is ON. Plug the Bio-Med Devices external power supply into the side of the
unit. This plug and jack are keyed so the red dot on the plug must be facing the front of the unit in order for them
to engage. Set the ON/OFF switch to ON.
12. Press the SETUP key and then the CAL MENU key.
13. Press BATTERY, press CONTINUE and enter the authorization code.
14. Press the key labeled RESET. It should display PASSED, indicating the gauge has been zeroed and you may
continue with this procedure. If it indicates FAILED, press the RESET key again. If repeated attempts still fail,
refer to the NOTE below.
15. Turn the unit off and allow it to charge the battery fully. This may take up to five hours.
16. When the Charging LED stops blinking, the battery will be fully charged. Unplug the external power supply, turn
on the unit and run it until the battery is expended and the unit shuts down. The battery gauge is now calibrated.
NOTE: If RESET changes to red when pressed, there has been an error. Press the key again. If it
is continually red, then there is a problem with the battery gauge chip, IC202, or communication
between this chip and the microprocessor.

3. FRONT BEZEL
1. Remove the rear panel.
2. Disconnect and remove the battery or, instead of removal, the battery may be held in place with tape.
3. Place the Crossvent on its back with the bezel facing up.
4. While holding down on the case, pull up on the edges of the bezel, first one side and then the other, working from
one side to the other until it is free. The knobs that are pressed onto the valve shaft extenders cause the resistance
to removal. The knobs will come off with the bezel as it is removed.
5. To re-install, make sure the RFI conductive gaskets are in place on the outside edges of the bezel as well as around
the display window. Also be sure the amplifying tube for the beeper on the PCB is positioned properly behind the
alarm holes in the front of the bezel. Then place the bezel over the valve shaft extenders and fit it into the case.
6. Press the knobs back on the extenders, turn the unit over and proceed in reverse order as before.

4. DISPLAY/TOUCHSCREEN
WARNING: With the backlight unplugged, high voltage is present at the backlight
connector (JBL) when the power is on.
NOTE: If the PC Board is to be removed, there is no need to separately remove the display from the
PCB.
1. Remove the rear panel.
2. Disconnect and remove the battery or, instead of removal, the battery may be held in place with tape.
3. Remove the bezel.
4. The display/touchscreen is connected to the PCB on the left side with two ribbon cables (some may have one), on
the right side with one connector to the backlight, and underneath by one ribbon cable. Unplug the
display/touchscreen on its left side where it connects to the PCB and separate the backlight plug on the right side.
Leave the ribbon cable underneath the display plugged into the PCB at this point.
5. Carefully lift the display/touchscreen assembly straight up and away from the PCB just until they separate. No
tools are required for this.
6. With the display separated from the PCB, tilt it slightly by lifting the right side and unplug the ribbon cable from the
PCB.
7. Re-install in reverse order.
8. If this is a new assembly, then refer to the Touchscreen calibration procedure in Part A-2 of this section to calibrate
the touchscreen once the unit is back together.

5. PRINTED CIRCUIT BOARD (PCB)


See Cautions at the beginning of this section.
1. Set the MAX Pressure and PEEP knobs fully off (CCW).
2. Remove the rear panel, battery and front bezel.
3. From the rear of the unit, unplug the tubes from the transducer(s).
4. Unplug the cable from the solenoid board to the PCB.
5. Unplug the cable from the RS232 board to the PCB.
56
VIII. MAINTENANCE AND SERVICE- CONT.
6. Unplug the O2 jack.
7. From the front, unplug the potentiometer cable (JPOT) and alarm LED cable (JLED).
8. Loosen the inside nut on the power connector on the side of the case and then remove the external round nut.
9. Remove the four corner screws and lock washers securing the PCB to the case.
10. To remove the PCB, it should be raised at an angle by lifting the edge opposite the power connector until the PCB
clears the valve shafts and then extract it from the power side of the case. The washer on the power jack will be
loose.
11. When re-installing, be sure the inside hex nut and the washer are on the power connector before inserting the
connector through the side of the case. The washer should be outside of the nut so it will be against the case.
Taking care not to pinch any wire harnesses, angle the PCB so it is under the O 2 sensor jack and the power
connector protrudes through its hole in the case and then lower the PCB over the valve shafts.
12. Check the gaskets on the power side of the case. The PCB should be underneath those that have double thickness.
13. Align the mounting holes to the case and install the four mounting screws, but do not tighten these screws at this
time.
14. Thread the round nut, shoulder first, onto the power connector until the face of the nut is flush, or nearly so, with
the outside edge of the connector, its shoulder is within the opening in the case and the red dimple is aligned with
the small notch on the inside surface of the connector (3:00 o’clock position as viewed from the side with the unit
upright).
15. Turn the inside nut on the power connector until it captures the lock washer tightly against the case. Be careful
during this process that the PCB remains properly aligned to the mounting holes.
16. Tighten the four PCB mounting screws.
17. Continue with the installation in reverse order of removal.

6. COMPLETE PNEUMATICS AS AN ASSEMBLY

Removing all of the pneumatics is usually not required for any servicing, but may be deemed necessary for other reasons such
as full case replacement. Make a note of tube routing when they are cut or removed to facilitate reassembly.
.
1. Remove rear panel, battery, front bezel and PCB
2. Remove the two screws at the bleed exhaust screen next to the gas supply fitting. This will free the 9-port bleed
manifold inside the case. Watch for the o-ring inside this manifold. Do not misplace this if it should fall out.
3. Remove the external gas supply input fitting and remove the filter that will be exposed once this fitting is removed.
When reinstalling, align the inside hex fitting on the regulator with the opening in the case, insert the filter (cone to
the outside) and thread in the outside fitting. It is best to hold the inside hex with a second wrench while tightening
the outside fitting as these must be very tight to seal the filter and fittings.
4. On the opposite side of the case, locate the manifold into which the patient connector threads. From the back of
the unit, there is a setscrew recessed into this manifold. Using a 1/16” hex key, loosen this setscrew. The patient
connector may now be unscrewed. Watch for a gasket between the manifold and connector. When reassembling,
do not over-tighten this connector or the gasket will distort. Thread it in until it is seated and then turn it another
half turn and secure it with the setscrew.
5. Cut the brown tubing to the exhalation valve fitting on the side of the case. Do this as close to the fittings as
possible to leave as much tubing as possible. If tubing is to be reattached to this fitting when reassembled, carefully
cut off the tubing left on the barb, taking care not to damage or nick the barb (refer to Fig. 15 in Preventive
Maintenance Kits later in this section). This is easiest to do after the pneumatics have been completely removed.
6. Tubing from the MAX Pressure valve is routed between the case and the rear panel screw guide on the side of the
case. Work these tubes out from behind this guide.
7. Remove the three screws from the bottom of the case. These retain the pneumatic bracket assembly.
8. Although not necessary, the RS232 connector may be removed from the side of the case to facilitate removal of the
solenoid assembly. To remove it, remove the single retaining screw. The lower corner snaps onto a stud. Pry it off
this stud and remove the part.
9. Unplug the Solenoid PC Board from the Main PCB. For reassembly, note of the position of the tubes from this
assembly to the transducer on the PCB is blue to the right and clear to the left. Carefully (the transducer ports are
delicate) disconnect the two tubes to the transducer on the PCB. Remove the two nuts and lock washers used to
retain the solenoid manifold assembly to the top of the case. Lower the assembly off the studs.
10. The pneumatics are now free from the case and may be removed.
11. Reassemble in the reverse order.

57
VIII. MAINTENANCE AND SERVICE- CONT.

7. PNEUMATIC VALVE BRACKET ASSEMBLY


1.
Remove rear panel, battery, and front bezel. It is not necessary to remove the PCB to remove the Valve Bracket,
but it may be easier if it is removed. This instruction assumes it is not removed.
2. Unplug the potentiometer from the front of the PCB (JPOT).
3. From the outside of the Crossvent, remove the two screws at the bleed exhaust screen next to the gas supply fitting.
This will free the 9-port bleed manifold inside the case. Watch for the o-ring inside this manifold. Do not misplace
this if it should fall out.
4. It is best to remove the Pressure Regulator along with the valve bracket so the tubing between it and the Flow
Valve are not disturbed. To remove the regulator, unscrew the supply fitting on the outside of the case and remove
it along with the filter inside. The regulator is now free from the case and will come out with the bracket assembly.
5. On the opposite side of the case, locate the manifold into which the patient connector threads. From the back of
the unit, there is a setscrew recessed into this manifold. Using a hex key, loosen this setscrew. The patient manifold
may now be unscrewed. Watch for a gasket between the manifold and connector. When reassembling, do not
over-tighten this connector or the gasket will distort. Thread in until it is seated and then turn it another half turn
and secure it with the setscrew.
6. Tubing from the MAX Pressure valve is routed between the case and a rear panel screw guide on the side of the
case. Work these tubes out from behind this guide.
7. Prior to cutting any tubing, always make a note of its location or label it for reference when reassembling. Cut this
tubing as close to the barb as possible-
a. Yellow tube on MAX Pressure Valve (6, Fig. 9).
b. Yellow tube on DARV Manifold (1)
c. Blue tube from the PEEP Variable Resistor (10). Cut where it connects to the tee with the yellow tube.
d. Green tube from the bottom of the regulator to the solenoid manifold. Cut at the manifold barb.
e. Clear tube to the manifold at solenoid A. Cut at the manifold barb.
f. Clear tube from the regulator to the Flush Variable Resistors (11 & 12). Cut at the tee.
g. Red tube on the patient connector manifold.
8. Cut the cable tie and remove the 1/8” tube from the check valve between the regulator and the 9-port manifold.
9. Remove the three screws on the bottom of the Crossvent. The bracket along with the regulator can now be
removed. Pull it straight back while guiding the potentiometer cable under the PCB.
Reassemble in the reverse order. Prior to reassembling, carefully cut off the tubing left on any barbs, taking care not to
damage or nick the barbs (refer to Fig. 15 in Preventive Maintenance Kits later in this section).

8. FLOW, MAX PRESSURE & PEEP VALVES


1. Remove the rear panel, battery, front bezel and PCB. In lieu of removing the PCB, the Pneumatic Valve Bracket
assembly can be removed to access the valves.

2. FLOW VALVE
WARNING: Any time the flow valve is disturbed, the flow calibration in the CAL
menu must be performed after reassembly. Refer to the Pneumatic Calibration
section.
a. From the rear of the unit, cut the tubing from the flow valve barb to the Regulator/Pilot Valve. Take care not
to damage or nick the barb.
b. From the front, rotate the gear on the Flow Valve until the setscrews can be accessed. There will be two
setscrews per hole, one on top of the other, for a total of four. Remove the top setscrews and then loosen the
ones underneath. Remove the gear.
c. Remove the retaining nut and washer from the front of the valve.
d. Slide the valve towards the potentiometer to disengage the brass connecting tube from the D.A.R.V. Manifold
and remove the valve.
e. To replace the valve, first turn the valve shaft CW until slight resistance is felt indicating it is closed. Place a
very light film of oxygen-safe grease on the o-ring at the end of the connecting tube. From the rear of the
bracket, insert the valve shaft through the open slot in the bracket and position the valve so the raised shoulder
on the front of the valve is within the slot and the brass connecting tube is aligned with the hole in the side of
the D.A.R.V. Manifold.
f. Slide the valve towards the D.A.R.V. Manifold so the o-ring on the brass connecting tube engages the hole in
the D.A.R.V.
g. Place the washer over the threads on the front of the valve and then thread on the nut loosely so the valve can
still be moved within the slot.

58
VIII. MAINTENANCE AND SERVICE- CONT.
h. The valve must now be positioned in the slot for proper engagement with the gear on the potentiometer. Place
the Flow Valve gear on the shaft of the Flow Valve and temporarily tighten one setscrew just enough to hold
the gear in place.
i. To aid in establishing an acceptable engagement of these two gears, place a small strip of paper (standard
copier paper approx. 5-6 mil thick) between the gears and slide the valve towards the potentiometer until the
gears mesh snugly with the paper formed around the teeth between them.
j. Hold the valve in this position within the slot, remove the gear and tighten the retaining nut. Be careful the
valve does not move within the slot and the relationship between the two gears is lost.
k. Remove the gear from the potentiometer shaft. Within the gear teeth there will be two setscrews per hole, one
on top of the other, for a total of four. Remove the top setscrews and then loosen the ones underneath.
Remove the gear.
l. Rotate the Flow Valve shaft 180° CCW from the closed position.
m. Position the gear on the shaft so that the setscrews are at the top (approximately 11 & 1 o’clock positions) and
secure the gear to the shaft by tightening the setscrews and replacing the second setscrews. Turn the valve CW
back to the off position. The setscrews should now be at the bottom.
n. From the Regulator/Pilot Valve, remove the remaining clear tubing that was previously cut from the Flow
Valve. Be careful not to damage or nick the barb.
o. Replace this tubing between the Pilot Valve and Flow Valve with a new piece and tighten a cable tie around
each barb for added security.
p. To properly secure the potentiometer gear to the valve shaft, refer to the Pneumatic Calibration section and
perform Flow Valve/Potentiometer Zero, skipping the “To Test” and going right to the “Calibrate as follows”
section. Once this has been completed, reassemble the rest of the unit and then proceed to the Flow
Calibration in the Pneumatic Calibration section.

3. MAX PRESSURE & PEEP VALVES


The procedure for either of these valves is the same.
a. Loosen the two setscrews in the valve shaft extender and remove the extender,
b. Remove the retaining nut and withdraw the valve from the bracket, making note of the orientation of the barbs
as they were when mounted.
c. Taking note of which color tube goes to each barb, cut the tubing from the barbs on the valve as close to the
fitting as possible (refer to the illustration in Preventive Maintenance Kits later in this section).
d. To install, press the appropriate tubing onto each barb and install the valve into the bracket with the barbs
positioned as previously noted.
e. Secure with its nut.
f. Refer to the Pneumatic Calibration section on PEEP Valve Zero and MAX Pressure Valve Zero for
instructions on reinstalling the valve extender and then check the PEEP Signal and MAX Pressure Signal
calibration.

9. SOLENOIDS
See Cautions at the beginning of this section.
1. Remove the rear panel and battery.
2. Remove the two Solenoid Manifold retaining nuts and washers and lower the assembly off its mounting studs.
3. Position the assembly so the component side of the Solenoid PCB is facing you.
4. Locate the solenoid pins on the PCB. They will have resistors across them. Carefully de-solder all the solenoids.
Remove the two screws holding the board to the manifold and separate the PCB from the solenoids.
5. Unscrew the two screws holding the solenoid to be replaced to the manifold and remove the solenoid.
6. Making sure the gasket is properly fitted around the new solenoid’s ports, secure it to the manifold with the screws.
7. Re-solder each solenoid to the Solenoid PCB and reassemble in reverse order.

10. GAS INPUT FILTER


1. Remove the Rear Panel. Be careful of the battery, which is now free. It may be secured by taping it in place or it
may be removed.
2. Remove the two screws holding the fittings plate to the bottom of the battery compartment.
3. Using a ¾” open end wrench, hold the inside input fitting on the regulator and remove the outside fitting with a
second wrench.
4. Remove the conical filter that is inside this fitting and replace it with a new one.
5. Reassemble in the reverse order. Be sure to tighten these fittings enough to seal the filter (approximately 25 foot-
pounds [3.5 kg]).

59
VIII. MAINTENANCE AND SERVICE- CONT.

11. PREVENTIVE MAINTENANCE KITS


1. The simplest way to replace the pneumatic logic lines is to do them one line, one point at a time.
2. Once all the logic lines in the kit have been replaced, they will need to be
calibrated. Refer to the Pneumatic Calibration Procedures for these
instructions.
3. The process for removal and replacement is the same for each line as
described here.
a. Observe the new logic line and locate the existing, matching line in the
Crossvent. Study how it is installed and where each end is
connected.
b. It does not matter which end you start with so pick an end on the new
line and match it up with the line to be replaced.
c. Using a sharp X-Acto style knife, remove the tube from the barb by FIG. 15 TUBING REMOVAL
slicing it along the length of the barbed fitting starting at the base and
stopping at the barb (see illustration). It is important not to damage the actual barb in any way or leakage may
occur after reassembly.
d. Using needle nose pliers, grab the cut tubing and peel it back and remove it from the fitting.
e. Push the matching end of the new line onto the barbed fitting with the needle nose pliers being careful not to
damage the tubing in the process. Push it on far enough to reach the base of the barb.
f. Repeat this process for each end of the new line, one at a time, until the old line is completely removed and the
new one is completely installed.
g. When done, ensure that no part of the pneumatic logics can make contact with the PCB. Use cable ties if
necessary, but use them loosely.
h. Before the Crossvent can be returned to service, these parts must be calibrated as outlined in the Pneumatic
Calibration section.

60
VIII. MAINTENANCE AND SERVICE- CONT.

H- TECHNICAL TROUBLESHOOTING
NOTE: A performance test should always be completed before proceeding with repairs.

CAUTION: Always follow proper static grounding procedures when removing or replacing
electronic parts, LCD assembly, etc.

SYMPTOM POSSIBLE CAUSE CORRECTIVE ACTION

Audible alarm with no visible Hardware Failure Refer to Appendix D


indication

Auto cycling of the ventilator. Flow Trigger set too low. Increase Flow Trigger setting.

Low battery. Charge battery.


Battery low audible and visual alarm.

Battery open. Replace battery.


Battery internal fuse open due to heat or Allow to cool or replace battery
Battery will not charge. External short
power ok. Battery cable open
Repair cable.
D101, D104, DC101 open
Replace defective part

Battery not charged. Charge battery.


No battery operation.
D103 or DC103 open. Replace D103 or DC103.

Loss of external power. Check input mains.


External power failure alarm – AC adaptor defective. Replace ac adaptor.
“BATT” flashing. Fuse F101 open. Change fuse F101.
Defective D101, D104, DC101 Replace defective part

Ventilator will not power up from Fuse F101 open. Replace F101.
external power. Battery operation AC adaptor defective. Replace AC adaptor.
ok. D101, DC101 or D104 open. Replace defective part.

Defective touchscreen. Replace touchscreen.


Ventilator fails key test. All other
Bad IC401. Replace IC401.
functions normal.
Poor Connection at JTS Reconnect JTS or return to factory.

Poor connection at JLCD. Reconnect JLCD


Defective LCD. Replace LCD.
Ventilator fails display test.
Defective IC403. Replace IC403.

Bad connection at JLCD or JBL Correct connection


No Display Defective LCD Replace LCD
Defective IC403 or Inverter Replace defective part

Aged sensor. Replace sensor.


Bad IC602, L301 (no +5V analog) Replace IC602, L301.
Oxygen will not calibrate.
Bad cable. Replace cable.

61
VIII. MAINTENANCE AND SERVICE- CONT.

SYMPTOM POSSIBLE CAUSE CORRECTIVE ACTION

Tubing leak. Replace tubing.


Pressure will not calibrate. TD-AIRWAY bad. Replace TD-AIRWAY.

Loosing pressure through Pressure Clean, re-cal or replace Relief Valve.


Relief Valve.
Pressure unable to reach 70 cmH2O
during operation. Clean seat, repair leak, re-cal or
D.A.R.V. leaking at seat or signal replace.
pressure.

Bad connection at JPOT Reconnect


Flow will not cal. Defective flow encoder. Replace 10K pot.
Bad IC603. Replace IC603.
(See following symptom also) Defective atmospheric compensation Check TD-ATMOS.
circuit.

Supply pressure too low. Check supply pressure at ventilator


input fitting while gas is flowing.
Should meet specification on side of
case.
Flow will not reach 15 LPM or Max Pressure not on or defective. Turn Max Pressure fully on or repair.
displayed flow does not agree with Check for restrictions and leaks in
actual flow. Flow restriction or leak. flow path.
Replace filter and resolve cause
Input filter clogged. Calibrate regulator pressure.
Regulator set too low. Check flow valve.
Flow valve defective.

VENTILATOR FAILURE flashes Refer to Appendix D Replace solenoid.


on display Replace solenoid wire.
Power off/on. If persists, then
return to factory for service.

Leak in breathing circuit Check all circuit connections


Pneumotach reading greatly Bad transducer (TD-PNEUMO) Replace transducer and/or check
inaccurate associated circuitry

Microprocessor failure Return to factory


Unit hangs with Bio-Med Devices
on the display

Devices controlling the alarm beeper Return to factory


Continuous Audible Tone have failed.

62
IX. PARTS LIST AND SCHEMATIC DIAGRAMS

A- REPLACEMENT PARTS LIST


NOTE: SERIAL NUMBER OF VENTILATOR MUST ACCOMPANY ALL PARTS ORDERS

PART # DESCRIPTION
PRT2282 KIT, PREVENTIVE MAINTENANCE
PRT2268 ASSY, BATTERY 7.2V 6 C-CELL NiMH (Do not substitute)
PRT3316 ASSY, LCD DISPLAY WITH TOUCHSCREEN
PRT4410 LED, ALARM
PRT2281 PC BOARD - NO DISPLAY INCL’D*
PRT2280 PC BOARD - DISPLAY INCL’D*
EVAL006 SOLENOID VALVE
4419A CHARGER w/US HOSPITAL GRADE CORD (Do not substitute)
4419B CHARGER w/EURO UNTERMINATED CORD (Do not substitute)
PFIL008 FILTER, CONICAL SUPPLY

63
1

2 BASE FLOW TO
E2 PATIENT OUTPUT
MANIFOLD TO "A" SOLENOID
SOLENOID
VALVE

1 TYPICAL SOLENOID
2
B- SCHEMATICS

2
D2
3 1
SOLENOID ARROW NOT INDICATIVE OF
VALVE 1
DIRECTION OF FLOW
2
MICROPROCESSOR D3
CONTROL ATM.= ATMOSHERE
CIRCUITRY 3 SOLENOID
VALVE
1- PNEUMATIC SCHEMATICS

PS3

1
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

2
D1

3 SOLENOID
VALVE

64
PS4
AIRWAY PRESSURE

SOLENOID MAX PRESSURE


ATM. VALVE
3
A2 1

2 B
TO "D" SOLENOIDS
POTENTIOMETER
PEEP

FROM SOLENOID E2

ATM.

REG. D.A.R.V. PATIENT


2-WAY
RELIEF VALVE PATIENT OUTPUT
PILOT EXH. VALVE PNEUMOTACH
MANIFOLD
VALVE
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

ALARM LED

JLED
RS 232
BATTERY MAIN PC BOARD JCON PCB-
JCON
JTS- JBL
B
ESD
A
EXT C
TOUCH SCREEN K
POWER JPOWER
SOURCE JLCD* L
I SOLENOID
G JSOL PCB-
JTS H JSOL
DISPLAY T

TD-PNEUMO TD-AIRWAY
O2
JO2 TD-ATMOS
SENSOR PNEUMOTACH
AIRWAY
PRESSURE
TRANSDUCER
TRANSDUCER
ALTITUDE
TRANSDUCER
JPOT

*JLCD IS LOCATED UNDERNEATH THE DISPLAY

FLOW VALVE
POTENTIOMETER

CV-2i MAIN PCB BLOCK DIAGRAM

65
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

3- CIRCUIT SCHEMATICS

Main PCB schematic page 1 of 6


POWER SUPPLY

66
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

67
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

68
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

69
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

70
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

71
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

72
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

73
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

74
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

75
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.

RS232 CONNECTOR PCB

76
WARRANTY
BIO-MED DEVICES, INC. expressly warrants to the PURCHASER, this Ventilator to be free from defects in
material and workmanship for a period, from the date of purchase of one (1) year. BIO-MED DEVICES, INC.
will repair or, at its option, replace any part or all of this Ventilator which fails to conform to this warranty at no
cost to the PURCHASER for materials and labor. The warranty does not apply to the patient circuit and hoses
supplied with the instrument nor does the warranty cover abuse or misuse of the instrument, or damage due to
unauthorized servicing.

BIO-MED DEVICES, INC. will pay any shipping charges required in repairing or replacing any part or all of this
Ventilator within three (3) months from the date of purchase. Thereafter, shipping charges will be paid by the
PURCHASER.

THIS WARRANTY IS EXPRESSLY MADE IN LIEU OF THE WARRANTIES OF MERCHANTABILITY


AND FITNESS FOR A PARTICULAR PURPOSE AND ALL OTHER WARRANTIES EXPRESS OR
IMPLIED.

This warranty shall become null and void if the Ventilator is opened, otherwise tampered with or if repairs are
attempted by the PURCHASER, or if the Ventilator is operated by anyone other than trained and duly qualified
medical personnel, or if the “Warranty Registration Card” is not returned within four (4) weeks of the date of
purchase to:

BIO-MED DEVICES, INC.


61 Soundview Road
Guilford, CT 06437 USA
203-458-0202

77
APPENDIX A
ABBREVIATIONS

BPM - Breaths Per Minute


BPH - Breaths Per Hour
LPM - Liters Per Minute
ms - Milliseconds
ml - Milliliters
C - Degrees Centigrade
F - Degrees Fahrenheit
cmH2O - Centimeters of Water Pressure
ml/cmH2O - Milliliters Per Centimeter Water
L - Liters
VAC - Volts of Alternating Current
VDC - Volts of Direct Current
HZ - Hertz (Cycles Per Second)
LED - Light Emitting Diode
LCD - Liquid Crystal Display
psi - Pounds Per Square Inch
kPa - Kilopascals
Kg/cm2 - Kilograms Per Centimeter Square
PEEP - Positive End Expiratory Pressure
PIP - Positive Inspiratory Pressure
CPAP - Continuous Positive Airway Pressure
SIMV - Synchronized Intermittent Mandatory Ventilation
IMV - Intermittent Mandatory Ventilation
DISS - Diameter Index Safety System
I/E - Inspiratory To Expiratory Ratio
CF - Constant Flow
FT - Flow Trigger
I - Inspiratory Time
E - Expiratory Time
TV - Tidal Volume
INSP - Inspiratory
EXP - Expiratory
EXH - Exhalation
EXHTV - Exhaled Tidal Volume
EXHMV - Exhaled Minute Volume
PROX. - Proximal
TEMP - Temperature
dB - Decibels
PEF - Peak Expiratory Flow
D.A.R.V. - Diaphragm Actuated Relief Valve
WEEE - Waste from Electrical and Electronic Equipment
PCB - Printed Circuit Board
A/C - Assist Control
EXTRNL - External Power
DISABL - Disabled
BATT - Battery

78
APPENDIX B

DEFAULT SETTINGS
These are the settings that will be made by the software if all power to memory is lost or if a complete test routine
is performed.

Mode: Assist Control


Rate: 12 bpm
Tidal Volume: 100ml
Flow Trigger: 3
SIMV rate: 4 bpm
Pressure support: off
Alarm limits: Peak low 29
Peak high 30
Rate low 78
Rate high 79
ExhMV low 44
ExhMV high 45
ExhTV low 1290
ExhTV high 1300
PEEP low 29
PEEP high 30
Mean low 62
Mean high 63
O2 low 61
O2 high 62
Language: English

79
APPENDIX C

SUMMARY OF DISABLED FUNCTIONS

DISABLING MENU MESSAGE


PARAMETER DISABLED
FUNCTION DISABLED IN
FLOW TRIGGER OFF
MAIN
CONSTANT FLOW PRESSURE SUPPORT DISABL BY CF*
MODE RATE ALARM DISABL BY CF*
ALARM 1
EXHTV/EXHMV DISABL BY CF*
RATE DISABL CF CPAP*
NONE- REMOVED FROM
EXP. TIME
DISPLAY
NONE- REMOVED FROM
I:E RATIO
MAIN DISPLAY
CF/CPAP MODE AUTO SET NONE- KEY IS INACTIVE
FLOW TRIGGER OFF
PRESSURE SUPPORT DISABL BY CF*
RATE ALARM DISABL BY CF*
ALARM 1
EXHTV/ EXHMV DISABL BY CF*
ALARM 2 MEAN DISABL CF CPAP*
FLOW TRIGGER MAIN CONSTANT FLOW OFF
ASSIST CONTROL MAIN PRESSURE SUPPORT DISABL BY A/C*

*Any misspelled words are due to lack of room on the display to fully spell the word. These messages are as they appear
on the display.

80
APPENDIX D

AUDIBLE ALARM CODES

CAUSE AUDIBLE SEQUENCE


COMMON ALARM DUE TO VIOLATION OF 1 LONG ___
LIMITS
LOSS OF POWER (INCLUDES TURNING OFF) 1 LONG
INTERFACE PROCESSOR FAILURE 2 LONG ___ ___
SOLENIOD PROCESSOR FAILURE 3 LONG ___ ___ ___
SOLENOID A 1 LONG, 1 SHORT
SOLENOID B 1 LONG, 2 SHORT
PROCESSOR COMMUNICATION OR 1 LONG, 3 SHORT
TRANSDUCER ERROR
SOLENOID D1 2 LONG, 1 SHORT
SOLENOID D2 2 LONG, 2 SHORT
SOLENOID D3 2 LONG, 3 SHORT
SOLENOID E2 2 LONG, 4 SHORT
BEEPER CONTROL CIRCUIT CONTINUOUS CONTINUOUS

81
APPENDIX E
CHARGERS AND INVERTERS
This explains some of the requirements for connecting a Bio-Med Devices Crossvent ventilator to a charger or AC adapter.
It is important that the correct charger be used and if a Crossvent is to be used in a vehicle with an AC generating device
(inverter), it must comply with certain requirements.

1. LAND OPERATION
When using an AC adaptor to either run the Crossvent or to charge the batteries, only the Jerome Industries model
WSZ116M (16VDC 3A) charger supplied by Bio-Med Devices should be used.

The Bio-Med charger has been thoroughly tested for proper operation with the Crossvent to make sure that all standards are
met. This includes all of the applicable standards for safety, EMI/RFI, power surges, and leakage. It is approved for medical
applications and conforms to FDA, CE, UL, and other required standards.

Although other forms and brands of chargers may operate the Crossvent, there is no guarantee of system reliability or
conformance to required standards.

Should an emergency arise and it becomes necessary to operate the Crossvent without the Bio-Med charger, use only a
charger that is approved for medical use and complies with all applicable standards. It must produce filtered DC voltage
ranging between 12 and 28 volts DC and be rated for continuous 2.5 amps of current.
Should a Crossvent fail to operate or charge from a charger, both the Crossvent and the charger should be returned together
to Bio-Med Devices for evaluation.

2. AIR OPERATION – FIXED OR ROTARY WING AIRCRAFT


The aircraft industry is constantly making technical advancements in the areas of composite material construction and weight
reduction of installed equipment. Unfortunately, this can conflict with the safe operation of some electronic medical
equipment. Composite materials do not work well as a grounding agent for electronic equipment. The weight reduction
techniques used in AC inverters often create unsafe conditions when operating electronic medical equipment.

The Crossvent is designed to operate from an external power source delivering 12 to 28 volts DC at a continuous current of
2.5 amps.
It is best to operate the Crossvent from the aircraft’s 24-volt DC battery source, rather than an AC inverter. To insure the
best “grounding” between the Crossvent and the aircraft metal frame, connect the Crossvent directly to the 24-volt DC
power bus through appropriate fusing. This will keep extraneous interference and current leakage to a minimum.

3. INVERTER OPERATION
If it is necessary to operate the Crossvent from an AC inverter, similar to KGS Electronics brands, only those inverters in
compliance with NEMA standards should be used. Inverters with “split winding” output transformers should not be used
with the Crossvent and supplied charger.

The inverter output must be configured like standard household or industrial wiring, where the black wire is “hot”, the white
wire is “neutral”, and the green wire is “ground”. The neutral and ground wires should be connected together at one point
of the frame so that there is no voltage between them, and there should be 115 volts AC between the hot and neutral wires.

The inverter receptacles must be of the standard three-prong configuration to utilize the hospital-grade cord of the Bio-Med
supplied charger. This will keep voltage surges, spurious noise and leakages to a minimum.

Any other type of AC/DC power supply or charger, such as open frame devices, medically approved or not, is not
recommended by Bio-Med Devices.

82
APPENDIX F
FLOWMETER USE WITH THE CROSSVENT & BLENDER
Flowmeters offered by Bio-Med Devices that are set by rotating a dial on top of the flowmeter are not pressure
compensating. Not pressure compensating means that in order for the flowmeter to accurately deliver the flow rate indicated
by the dial, the supply pressure to the flowmeter input must at all times be the same pressure the flowmeter is rated for. If
the flowmeter is rated for a 50 PSI supply pressure, then 50 PSI is required at the input in order for the set flow rates to be
accurate.

In practice, these flowmeters are often connected to Air/Oxygen blenders and by doing so, the blender then becomes the
supply source to the flowmeters.

WARNING: Before use on a patient, the oxygen concentration of the delivered gas
should be checked at the setting intended for use. A separate, calibrated oxygen
analyzer (complying with ISO 7767) should be used whenever the blender is used on
a patient.

It is important to understand that although there may be 50 PSI at the input to the blender, this does not mean there is
always 50 PSI at the output of the blender (input to the flowmeters). As flow increases, there is an inherent reduction in
pressure at the blender’s output due to the restrictive nature, albeit slight, of the blender. Therefore, there is less than 50 PSI
at the input to the flowmeters in this situation and flow accuracy suffers. As the input pressure to the flowmeter decreases,
so does the flow rate relative to its setting.

Another variable to note with Air/Oxygen blenders is the concentration setting. As the concentration setting is varied, so
varies the restrictive nature of the blender, further affecting its output pressure. Think in terms of hot and cold water faucets.
When you have just the hot or just the cold faucet turned on, the water pressure is less than when you have them both turned
on. The blender acts in a similar fashion. More pressure is available when you are mixing air and oxygen than when you are
just using one or the other.

Still another variable is the pressure downstream from the flowmeter. Since flow is created by one pressure being greater
than another, it stands to reason that the less difference there is between the pressures, the less flow there will be. This
downstream pressure may be very low, but needs to be mentioned.

So what is stated above are some of the variables that need to be considered when flowmeters that are not pressure
compensating are used with blenders. Any additional device, other than the flowmeter, that delivers flow from the blender,
be it a ventilator or other device, must also be taken into account. The flow this additional device is delivering is exacerbating
the situation so that device should be turned off when using the flowmeters.

83
APPENDIX G

Authorized Representative in the European Community


Bio-Med Devices’ Official Agent in Europe is:

Medical Market I.N.T. AB


Sehlstedtsgatan 6
115 28 Stockholm
Sweden

Telephone: 46-08-767 70 00
Fax: 46-08-731 90 09

84
APPENDIX H
EMC Compatibility

Additional Guidance and manufacture’s declaration – electromagnetic


emissions/immunity

1. The Crossvent is compliant with relevant EMC requirements only when used with these cables and transducers:
BMD pn ESEN007 internal pressure trandsducer
BMD pn ESEN008 internal pressure trandsducer
BMD pn ESEN009 internal pressure trandsducer
BMD pn ESEN010 internal pressure trandsducer
BMD pn 4434 external oxygen cell with intrinsic cable < 12” long
BMD external power supply/charger with 6’ intrinsic output cable (and accessory 8’ IEC-320 input cable) Note: The
Crossvent is compliant when run on its charged battery alone, but if it is run with charger plugged in, charger must be as
specified above.
BMD internal battery pack with 8” red & black lead pair.
BMD touchscreen tails extending 2” (includes header length)
BMD LCD flat-ribbon cable extending 4”.
BMD input-gas pressure switch with 2.5” red, black, & blue leads.

2. Electromagnetic Compatibility Precautions

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Medical
equipment must be installed and put into service according to the EMC information provided in the following
documentation.

3. Replacement of Cables, Accessories or Transducers

The use of cables, accessories or transducers other than those specified below with the exception of transducers or
cables sold by the manufacturer of the equipment as replacement parts for internal components, may result in
increased emissions or decreased immunity of the medical equipment.

Other Equipment

The Crossvent should not be used immediately adjacent to or stacked with other electronic equipment. If adjacent or stacked
use is necessary, the Crossvent should be observed to verify normal operation in the configuration in which it will be used.

85
Recommended separation distance between portable and mobile RF
communications equipment and the Crossvent
The Crossvent is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Crossvent can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and
the Crossvent as recommended below, according to the maximum output of the communications equipment.

Rated maximum output Separation distance according to frequency of transmitter meters


power of transmitter

W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.17 P d = 1.17 P d = 2.33 P

0 . 0 1 0 . 1 1 7 0 . 1 1 7 0 . 2 3 3
0 . 1 0 . 3 7 0 . 3 7 0 . 7 3 7
1 1 . 1 7 1 . 1 7 2 . 3 3
1 0 3 . 7 3 . 7 7 . 3 6
1 0 0 1 1 . 7 1 1 . 7 2 3 . 3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Guidance and manufacturer’s declaration – electromagnetic emissions


The Crossvent is intended for use in the electromagnetic environment specified below. The customer or the user of the
Crossvent should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance


RF emissions The Crossvent uses RF energy only for its internal function.
Group 1 Therefore, its RF emissions are very low and are not likely to
CISPR 11 cause any interference in nearby electronic equipment.
RF emissions Class A {Professional The Crossvent is suitable for use in all establishments, including
equipment with domestic establishments and those directly connected to the
CISPR 11 warning} public low-voltage power supply network that supplies buildings
Harmonics emissions Class A used for domestic purposes, provided the following warning is
heeded.
IEC 61000-3-2
Voltage fluctuations/ Complies Warning: The equipment is intended for use by healthcare
flicker emissions professionals only. This may disrupt the operation on the nearby
equipment. It may be necessary to take migration measures, such
IEC 61000-3-3 as re-orienting the Crossvent or shielding the location.

86
Guidance and manufacturer’s declaration – electromagnetic immunity
The Crossvent is intended for use in the electromagnetic environment specified below. The customer or the
user of the Crossvent should assure that it is used in such an environment.

Immunity test IEC 60601 test Compliance level Electromagnetic environment -


level guidance
Electrostatic +/-6 kV contact +/-6 kV contact Floors should be wood, concrete or
discharge (ESD) ceramic tile. If floors are covered with
+/-8 kV air +/-8 kV air synthetic material, the relative humidity
IEC 61000-4-2 should be at least 30%.
Electrical fast +/- 2 kV for power +/- 2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital
environment.
IEC 61000-4-4 +/- 1 kV for +/- 1 kV for
input/output lines input/output lines
Surge +/- 1 kV +/- 1 kV Mains power quality should be that of a
line to line line to line typical commercial or hospital
IEC 61000-4-5 environment.
+/- 2 kV +/- 2 kV
line to earth line to earth
Voltage dips, short <5% UT (>95% dip <5% UT (>95% dip Mains power quality should be that of a
interruptions and in UT) for 0.5 cycle in UT) for 0.5 cycle typical commercial or hospital
environment. If the user of the
voltage variations Crossvent requires continued
on power supply 40% UT (60% dip in 40% UT (60% dip in operation during power mains
lines UT) for 5 cycles UT) for 5 cycles interruptions, it is recommended that
the Crossvent be powered from an
uninterruptible power supply or a
IEC 61000-4-11 70% UT (30% dip in 70% UT (30% dip in battery.
UT) for25 cycles UT) for25 cycles

<5% UT (>95% dip <5% UT (>95% dip


in UT) for 5 sec. in UT) for 5 sec.
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or
hospital environment.
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.

87
Guidance and manufacturer’s declaration – electromagnetic immunity
The Crossvent is intended for use in the electromagnetic environment specified below. The customer or the
user of the Crossvent should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance Electromagnetic environment - guidance
level
Portable and mobile RF communications
equipment should be used no closer to any part
of the Crossvent (including cables) than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.

Recommended separation distance

Conducted RF 3 Vrms 3 Vrms d = 1.17 P


IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m d = 1.17 P 80 MHz to 800 MHz


IEC 61000-4-3 80 MHz to 2.5GHz
d = 2.33 P 800MHz to 2.5GHz

where P is the maximum output rating of the


transmitter in watts (W) according to the
transmitter manufacture and d is recommended
separation distance in meters (m).

Field strengths from fixed RF transmitters, as


determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb.

Interference may occur in the vicinity of


equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Crossvent is used
exceeds the applicable RF compliance level above, the Crossvent should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Crossvent.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 v/m

88
INDEX

Abbreviations, 78 Factory Service, 41


AC Power, 8, 9, 11 Filter, 34, 47
Accuracies, 80 Filter Replacement, 59
Airway Pressure, 13 Flow, 10, 14, 17
Alarm Beeper, 10 Flow Calibration, 42, 53
Alarm Menus, 17 Flow Sensor, 12
Alarm Quiet, 4, 19 Flow Trigger, 15
Alarm Reset Switch, 13 Flowmeters, Dial, 11, 84
Alarms, 2, 11 Flush, 33
Arrow Keys, 20
Assist Control, 15, 35
Assisted Breath (ASIST), 21 Gas Supply, 3
Auto Set, 2, 20, 24
Auto Shift, 38
Hours, 41

Backlight Replacement, 47
Backup Rate, 16, 38 I/E Ratio, 14, 16
Battery, 1, 4, 8, 11, 12, 20, 47 Inspiratory, 16, 20, 26
Battery Backed Memory, 4
Battery Charging, 11
Battery Gauge Reset, 55 Keys, 14, 40
Battery Level Indicator, 55
Beeper. See Alarm Beeper
Breathing Circuit, 7, 22 Languages, 26
LCD, 30
Leak Test, 26
Calibration Menu (CAL), 40 LED, Alarm, 10, 13
Cautions, 1, 3 LED, Charging, 11
CE Mark, 13 Lock, 19
Charging LED, 11
Circuit, Patient, 7, 22
CMV, 15, 35 Main Menu, 15
Connectors, 11, 13 Maintenance, 32
Constant Flow, 15 Max Press. See Maximum Pressure
Controlled Breath (CONTRL), 21 Maximum Pressure, 10
CPAP, 10, 15, 37 Memory. See Battery Backed Memory
Mode Selection, 14

Deactivating Alarms, 19
Default Settings, 79 Notes, 1, 4
Disabled Functions, 81
Disassembly, 55
Display Test, 40 Oxygen Sensor, 3, 13, 26

Exhaled Tidal Volume, 80 Parameter Ranges, 80


Expiratory, 16 Parts List, 63
External Power, 9 Peak Pressure, 19
PEEP KNOB, 10

89
Performance Checks, 42 SIMV, 15, 16, 36
Pneumatic Calibration, 49 SIMV Rate, 16, 36
Pneumotach. See Flow Sensor Software Upgrade, 48
Power, 9 Specifications, 9
Power Failure Alarm, 4, 20 Spontaneous (SPONT), 20
Power Supply, 11 Spontaneous Breaths, 15
Pressure Calibration, 54
Pressure Support, 16, 36
Pressure Transducer Calibration, 54 Temperature, 9
Preventative Maintenance Parts, 60 Theory of Operation, 33
Preventive Maintenance, 47 Tidal Volume, 16, 26
Preventive Maintenance Parts Kits, 47 Touch Screen, 30
Touchscreen Calibration, 40
Troubleshooting, 28, 61
Quick Setup, 25 Turn Off Ventilator with Flowmeters, 11, 84
TV. See Tidal Volume

Rate, 19
Relief Valve, 13 Valves, 41
RS-232, 48

Warnings, 1
Setup, 21 Warranty, 77
Setup Menu, 26, 39

90

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