Crossvent-2i+ Stand-Alone: Operation & Service Manual
Crossvent-2i+ Stand-Alone: Operation & Service Manual
Crossvent-2i+ Stand-Alone: Operation & Service Manual
Stand-Alone
INTENSIVE CARE/TRANSPORT
VENTILATOR
CATALOG #2204K
Revision: 050216
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.
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.
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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.
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.
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.
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.
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.
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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..
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.
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.
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.
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I . P A T I E N T S A F E T Y - C O N T .
SYMBOLS
MR Unsafe
Type BF Equipment
Manufacturer
Date of Manufacture
It is essential that these instructions be read and complied with prior to operating this product.
Do not rotate the power supply plug when it is engaged with the jack.
Power On
Valve Open
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.
NOTE: 1 - OPTIONAL
2 - STANDARD WITH BLENDER
3 - STANDARD WITH INTERNATIONAL ORDERS
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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+ 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.
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III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
B- SPECIFICATIONS
C- ADDITIONAL SPECIFICATIONS
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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).
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.
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.
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III. SPECIFICATIONS, CONNECTIONS AND USER INTERFACE- CONT.
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.
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
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
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.
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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).
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.
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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.
4- REAR OF VENTILATOR
EXPLOSION HAZARD IF USED IN THE PRESENCE OF
FLAMMABLE ANESTHETICS.
A preset, relief valve exits the rear of the unit. This valve establishes the
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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.
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.
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.
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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.
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.
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
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.
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:
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.
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.
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.
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.
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
!
Clear
Exhalation Valve Tube Pneumotach
#4409
Striped
Tube
To The Patient
Infant circuit, catalog #20011, shown
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
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.
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.
23
IV. SETUP AND OPERATING INSTRUCTIONS- CONT.
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.
The Crossvent-2i+ primary function keys and control knobs should be set to the desired initial values, for example:
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.
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.
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.
Select mode.
Connect to patient.
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.
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.
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.
27
V. SETUP MENU AND TROUBLESHOOTING- CONT.
C- OPERATIONAL TROUBLESHOOTING
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
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
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 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.
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
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
29
VI. CLEANING, STERILIZATION AND PACKING
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.
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.
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
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.
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.
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.
36
VII. THEORY OF OPERATION- CONT.
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.
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.
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.
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.
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.
39
VIII. MAINTENANCE AND SERVICE- CONT.
SN (SERIAL NUMBER)
Indicates the serial number of this unit.
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
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.
41
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.
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.
42
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
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.
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.
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
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.
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.
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.
MANUAL
Press the MANUAL key and verify a pressurized breath is delivered and MAN is displayed in the lower left key during this
breath.
45
VIII. MAINTENANCE AND SERVICE- CONT.
Common Tools
Item Description
Diagonal Cutters
46
VIII. MAINTENANCE AND SERVICE- CONT.
D- PREVENTATIVE MAINTENANCE
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.
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.
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.
47
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.
48
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
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.
50
VIII. MAINTENANCE AND SERVICE- CONT.
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.
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.
2i+
C ROS S VE N T
To
Blender
MAX PRESS PEEP FLOW
TO TEST
INSTRUMENT
53
VIII. MAINTENANCE AND SERVICE- CONT.
Low Pressure
!
54
VIII. MAINTENANCE AND SERVICE- CONT.
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.
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"
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.
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.
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.
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.
59
VIII. MAINTENANCE AND SERVICE- CONT.
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.
Auto cycling of the ventilator. Flow Trigger set too low. Increase Flow Trigger setting.
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.
61
VIII. MAINTENANCE AND SERVICE- CONT.
62
IX. PARTS LIST AND SCHEMATIC DIAGRAMS
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
2 B
TO "D" SOLENOIDS
POTENTIOMETER
PEEP
FROM SOLENOID E2
ATM.
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
FLOW VALVE
POTENTIOMETER
65
IX. PARTS LIST AND SCHEMATIC DIAGRAMS- CONT.
3- CIRCUIT SCHEMATICS
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.
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 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:
77
APPENDIX A
ABBREVIATIONS
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.
79
APPENDIX 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
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.
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
Telephone: 46-08-767 70 00
Fax: 46-08-731 90 09
84
APPENDIX H
EMC Compatibility
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.
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.
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.
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
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.
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.
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.
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
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
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