GE Carescape V100 Monitor - Service Manual
GE Carescape V100 Monitor - Service Manual
GE Carescape V100 Monitor - Service Manual
Systolic
Silence
HIGH MAP/Cuff Inflate/Stop
ADULT
LOW NEONATE
Alarms Diastolic AUTO CYCLE Cycle
HIGH
HISTORY History
LOW
To clear hold
2 seconds
BATTERY OK Print
INFLATE PRESSURE Pulse Rate
Menu ALARM VOLUME HIGH BATTERY LOW
PULSE VOLUME CHARGING
LOW
SpO Temperature On / Off
HIGH C
LOW F
NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical
Systems Information Technologies, Inc.
Listed below are GE Medical Systems Information Technologies, Inc. trademarks. All other trademarks contained herein
are the property of their respective owners.
Ohmeda Oximetry and other trademarks (OxyTip++, PIr, TruSat, TruSignal, TruTrak+) are the property of GE Medical
Systems Information Technologies, Inc., a division of General Electric Corporation. All other product and company names
are the property of their respective owners.
CARESCAPE, CRITIKON, DINALINK, DINAMAP, DURA-CUF and SOFT-CUF Blood Pressure Cuffs, and SuperSTAT are
trademarks of GE Medical Systems Information Technologies, Inc.
Turbo TempTM, Alaris Tri-Site, and IVAC are trademarks of CareFusion Corporation.
Masimo SET, LNOP, and LNCS are trademarks of Masimo Corporation. Possession or purchase of this device does not
convey any express or implied license to use the device with replacement parts which would, alone, or in combination
with this device, fall within the scope of one or more of the patents relating to the device.
Nellcor, OxiMax, C-LOCK and SatSeconds are trademarks of Nellcor Puritan Bennett.
1 Introduction . . . . . . . . . . . . . . . . . . . . . . 1-1
Equipment ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
3 Installation . . . . . . . . . . . . . . . . . . . . . . . 3-1
4 Maintenance . . . . . . . . . . . . . . . . . . . . . 4-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Cleaning schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Cleaning the monitor, monitor accessories, and the Exergen
temporal scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Cleaning and disinfecting blood pressure cuffs . . . . . . . . . . . . . . . . . .4-5
Cleaning the exterior surfaces of the Alaris temperature devices .4-6
SpO2 sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
5 Troubleshooting . . . . . . . . . . . . . . . . . . 5-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Revision history
Each page of this manual has a revision letter located at the bottom of the page.
This letter identifies the revision level of the entire manual. This may be important
if you have different manuals and you do not know which is the most current.
For the initial release, all pages have the revision letter A. For the second update,
all pages receive the revision letter B. The latest letter of the alphabet added to
the table below corresponds to the most current revision.
Revision Comment
Manual purpose
This manual supplies technical information for service representatives and
technical personnel so they can maintain the equipment to the assembly level.
Use it as a guide for maintenance and electrical repairs considered field
repairable. Where necessary the manual identifies additional sources of relevant
information and technical assistance. See the operator's manual for the
instructions necessary to operate the equipment safely in accordance with its
function and intended use.
Intended audience
This manual is intended for service representatives and technical personnel who
maintain, troubleshoot, or repair this equipment.
Ordering manuals
A paper copy of this manual will be provided upon request. Contact your local GE
representative and request the part number on the first page of the manual.
Intended use
General use
The monitor is intended to monitor one patient at a time in a clinical setting.
CAUTION
Federal law (U.S.A.) restricts this device to sale by or on the
order of a physician.
Safety information
The information presented in this section is important for the safety of both the
patient and operator. This chapter describes how the terms Danger, Warning,
Caution, and Note are used throughout the manual. In addition, standard
equipment symbols are defined.
General
This device is intended for use under the direct supervision of a licensed health
care practitioner.
This device is not intended for home use. Federal law (U.S.A.) restricts this device
to be sold by or on the order of a physician.
Contact GE for information before connecting any devices to the equipment that
are not recommended in this manual.
Parts and accessories used must meet the requirements of the applicable IEC/
EN 60601 series safety standards, and/or the system configuration must meet
the requirements of the IEC 60601-1-1 medical electrical systems standard.
Periodically, and whenever the integrity of the device is in doubt, test all
functions.
The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the
resulting system. Consideration relating to the choice shall include:
use of the accessory in the patient vicinity; and
evidence that the safety certification of the accessory has been performed
in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1
harmonized national standard.
If the installation of the equipment, in the U.S.A., will use 240V rather than 120V,
the source must be a center-tapped, 240V, single-phase circuit.
DANGER indicates a hazardous situation that, if not avoided, will result in death
or serious injury.
NOTE provides application tips or other useful information to assure that you get
the most from your equipment.
DANGER
Do not service the battery while the monitor is connected to
external power.
WARNING
Do not immerse the monitor in water. If the monitor is splashed
with water or becomes wet, wipe it immediately with a dry
cloth.
WARNING
Do not immerse sensors in water, solvents, or cleaning
solutions (the sensors and connectors are not waterproof).
WARNING
Do not perform any testing or maintenance on a sensor while it
is being used to monitor a patient.
WARNING
Place the monitor on a rigid, secure surface or use the monitor
with mounting hardware, poles, and stands recommended by
GE.
WARNING
Only use the monitor in areas where adequate ventilation
exists.
WARNING
Arrange the external AC/DC power converter, air hoses, and all
cables carefully so they do not constitute a hazard.
WARNING
If powering the monitor from an external power adapter or
converter, use only GE-approved power adapters and
converters.
WARNING
The speaker is tested during unit power-up. If the power-up
tones are not heard, audible alarms will also not be heard.
WARNING
If the Power-On Self Test fails, do not use the monitor.
WARNING
Inspect the device for damage prior to use.
WARNING
Do not disassemble, modify, or destroy the battery. Doing so
can cause battery fluid leakage, heat generation, fire, and/or
explosion.
WARNING
Do not incinerate the battery or store it at high temperatures.
Doing so may cause the battery to explode.
WARNING
Do not short-circuit the battery terminals by directly
connecting the metal terminals together. Be certain that no
metal objects (e.g., coins, paper clips, etc.) touch both battery
terminals simultaneously. Doing so can cause the battery to
overheat and/or explode, resulting in possible caustic burns
and/or battery damage.
WARNING
Do not use any battery other than a GE-recommended battery.
Other batteries may not provide the same operating time and
may cause unexpected monitor shutdown. Other batteries
may be incompatible with the internal charger and may cause
battery acid leakage, fire, or explosion.
WARNING
The battery will completely discharge if the monitor is stored
for a prolonged period of time with the battery left inside and
not periodically recharged. Configuration settings may be lost
as a result.
WARNING
Charge the battery pack with the monitors internal charger
only. Use of an unrecommended charger may cause battery
fluid leakage, overheating of the battery, and possible
explosion.
WARNING
The electromagnetic compatibility profile of the monitor may
change if accessories other than those specified for use with
the monitor are used. Please refer to the Accessories list
provided with your monitor.
WARNING
Use only accessories approved for use with the monitor. Failure
to use recommended accessories may result in inaccurate
readings.
WARNING
Use of portable phones or other radio frequency (RF) emitting
equipment near the monitor may cause unexpected or adverse
operation.
WARNING
Verify calibration of NIBP parameter (temperature and pulse
oximeter do not require calibration; refer to the Maintenance
section for instructions). Ensure that the display is functioning
properly before operating the monitor.
WARNING
Keep the Exergen scanner secured when it is not in use.
WARNING
Failure on the part of the responsible individual, hospital or
institution using this equipment to implement a satisfactory
maintenance schedule may cause undue equipment failure
and possible health hazards.
WARNING
The use of accessories, transducers, and cables other than
those specified may result in increased emissions and/or
increased susceptibility to electromagnetic interference. This
may result in impaired operation of the monitor and/or devices
in the area, leading to inaccurate readings or loss of operation.
CAUTION
To avoid personal injury, do not perform any servicing unless
qualified to do so.
CAUTION
The equipment or system should not be used adjacent to, or
stacked with, other equipment. If adjacent or stacked use is
necessary, the equipment or system should be tested to verify
normal operation in the configuration in which it is being used.
CAUTION
Magnetic and electrical fields are capable of interfering with
the proper performance of the monitor. For this reason make
sure that all external devices operated in the vicinity of the
monitor comply with the relevant EMC requirements.
CAUTION
The monitor does not include any user-replaceable fuses. Refer
servicing to qualified service personnel.
CAUTION
Do not use replacement batteries other than the type supplied
with the monitor. Use only batteries recommended by GE.
Other batteries could result in monitor shutdown. Replacement
batteries are available from GE.
CAUTION
The monitor is designed to conform to Electromagnetic
Compatibility (EMC) standard IEC 60601-1-2 and will operate
accurately in conjunction with other medical equipment which
also meets this requirement. To avoid interference problems
affecting the monitor, do not use the monitor in the presence of
equipment which does not conform to these specifications.
CAUTION
Do not exceed a load weighing 5 lbs. (2.7 kg) in the accessory
basket.
CAUTION
The monitor meets standards IEC 60601-1 and ISO 9919 for
shock and vibration. If the monitor is subjected to conditions
exceeding these standards, performance may be degraded.
CAUTION
The performance of the monitor may be degraded if it is
operated or stored outside of the environmental conditions
specified in this manual.
CAUTION
To prevent cross-contamination, clean exterior surfaces of the
monitor, monitor accessories, and reusable sensors on a
regular basis in compliance with your institutions infection
control unit and/or biomedical departments local policy.
CAUTION
Do not sterilize the monitor by irradiation, gas-, heat- or
chemical-based sterilization.
NOTE
This equipment is suitable for use in the presence of electrosurgery.
NOTE
Medical electrical equipment requires special electromagnetic compatibility
(EMC) precautions which must be considered when installing and putting
this equipment into operation. For detailed information, refer to the
Electromagnetic compatibility (EMC) appendix in this manual.
Equipment symbols
The following symbols are associated with the CARESCAPE V100 vital signs
monitor.
NOTE
The model of the monitor determines which symbols appear on it.
Alarms Silence
Battery Power
Charging
Class II equipment
Humidity limitations.
IPX1 water and conforms with the IEC 60529 standard at level of
IPX1. No harmful effects will come of vertically falling drops
of water making contact with the monitor.
Temperature limitations.
Service requirements
Follow the service requirements listed below.
Refer equipment servicing to GE-authorized service personnel only.
Any unauthorized attempt to repair equipment under warranty voids that
warranty.
It is the users responsibility to report the need for service to GE or to one of
GEs authorized agents.
Failure on the part of the responsible individual, hospital or institution using
this equipment to implement a satisfactory maintenance schedule may
cause undue equipment failure and possible health hazards.
Regular maintenance, irrespective of usage, is essential to ensure that the
equipment will always be functional when required.
Equipment ID
Every GE device has a unique serial number for identification. A sample of the
information found on a serial number label is shown below.
### ## ## #### # #
A B C D E F
Description
A product code1
B year manufactured
C fiscal week manufactured
E manufacturing site
F miscellaneous characteristic, indicating prototype, refurbish, etc.
1. The current CARESCAPE V100 Vital Signs Monitor product codes are
SDT or SH6.
Related manuals
Manual Title
Service policy
The warranty for this product is enclosed with the product in the shipper carton.
All repairs on products under warranty must be performed or approved by
Product Service personnel. Unauthorized repairs will void the warranty. Only
qualified electronics service personnel should repair products not covered by
warranty.
Service contracts
Extended warranties can be purchased on most products. Contact your Sales
Representative for details and pricing.
Assistance
If the product fails to function properly, or if assistance, service or spare parts
are required, contact Customer Support. Before contacting Customer Support, it
is helpful to attempt to duplicate the problem and to check all accessories to
ensure that they are not the cause of the problem. If you are unable to resolve
the problem after checking these items, contact GE. Prior to calling, please be
prepared to provide:
product name, model number, and serial number
a complete description of the problem
If repair parts or service are necessary, you will also be asked to provide:
the facility's complete name, address, and account number
a purchase order number if the product needs repair or when you order
spare parts
the facility's GE account number, if possible
the appropriate part number for spare or replacement parts
Service
If your product requires warranty, extended warranty or non-warranty repair
service, contact GE Technical Support or contact your local GE representative. To
facilitate prompt service in cases where the product has external chassis or case
damage, please advise the representative when you call.
The representative will record all necessary information and will provide a
Return Authorization Number. Prior to returning any product for repair, a Return
Authorization Number must be obtained.
Packing instructions
If you have to return goods for service, follow these recommended packing
instructions.
Remove all hoses, cables, sensors, and power cords from the monitor before
packing.
Pack only the accessories you are requested to return; place them in a
separate bag and insert the bag and the product inside the shipping carton.
Use the original shipping carton and packing materials, if available.
Observe the environmental conditions detailed in the Specifications on
page A-2.
It is recommended that all returned goods be insured. Claims for loss or
damage to the product must be initiated by the sender.
Insurance
Insurance is at the customer's discretion. The shipper must initiate claims for
damage to the product.
Repair parts
To order parts, contact Service Parts at the address or telephone number listed
on the How To Reach Us... page found in the front of this manual.
Please allow one working day for confirmation of your order. All orders must
include the following information.
Facility's complete name, address, and phone number
FAX number
Your purchase order number
Your GE account number
Batteries
WARNING
Do not incinerate the battery or expose it to fire or high
temperatures. Doing so may cause the battery to explode.
The sealed, rechargeable main battery contains lead and can be recycled.
The rechargeable battery is of the sealed lead-acid form. Discharge this battery
prior to disposal. Place the battery in packaging which electrically isolates its
contents. Do not puncture or place the battery in a trash compactor. Dispose
any battery in accordance with regional body controlled guideline.
Other patient applied parts, such as blood pressure cuffs, should be cleaned
according to instructions. Inspect reusable applied parts for wear, replace as
necessary, and dispose of used product as medical waste in accordance with
regional body controlled guideline.
Packaging material
Retain original packaging materials for future use in storing or shipping the
monitor and accessories. This recommendation includes corrugated shippers
and foam/corrugated spacers.
Monitor
At the end of its service life, the product described in this manual, as well as its
accessories, must be disposed of in compliance with the guidelines regulating
the disposal of such products. If you have questions concerning disposal of the
product, please contact GE or its representatives.
Equipment description
The CARESCAPE V100 vital signs monitor provides a small, portable, easy-to-use
monitoring alternative for sub-acute hospital and non-hospital settings. The
monitor is for use on adult, pediatric, or neonatal patientsone at a time. The
battery-operated monitor offers noninvasive determination of systolic blood
pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen
saturation, and temperature. Monitors are available with or without integrated
printers as well as the following parameters and technologies.
The model of the CARESCAPE V100 vital signs monitor determines which
parameters are in your monitor. Please refer to applicable sections.
Using the CARESCAPE V100 vital signs monitor, a clinician can measure, display,
and record patient vital sign data that is derived from each parameter. The
monitor is also capable of alerting the clinician to changes in the patients
condition or when it is unable to effectively monitor the patients condition. All of
the main operations of the CARESCAPE V100 vital signs monitor are easy-to-use
and only a button-touch away. Please review the factory default settings and,
where applicable, enter settings appropriate for your use.
Product configurations
Each CARESCAPE V100 vital signs monitor is supplied with an accessory pack.
The contents of the pack vary according to model. Unpack the items carefully. If
an accessory is missing or if an item is in a nonworking condition, contact GE
Customer Service immediately.
It is recommended that all the packaging be retained, in case the monitor must
be returned for service in the future.
1. Silence button: mutes audible alarms. Any other active alarm that can be
acknowledged is also cleared and the alarm condition is reset whenever this
key is pressed. When pressed, the alarm silence indicator (bell) lights solid
red to indicate that audible alarms have been silenced for 2 minutes. Alarm
silence can be cancelled by pressing the Silence button again.
2. Alarms button: used to view or adjust parameter alarm limit settings.
3. +/- buttons (Plus/Minus): used when you are in the following modes: limit,
menu, cycle, and history.
When you are in limit or menu setting, pressing the +/- button increases
and decreases an adjustable setting.
When you are in cycle or history mode, pressing the +/- buttons
displays the next or previous cycle selection or entry in the history list,
respectively.
When you reach the beginning or ending of a list, a negative key-click
sounds.
4. Menu button: accesses menu settings that can be adjusted: INFLATE
PRESSURE (ADULT and NEONATE), ALARM VOLUME, and PULSE VOLUME.
(Refer to Operating modes on page 3-5 for a description of clinical mode.)
NOTE
ADULT indicator encompasses both adult and pediatric patients.
9. Cycle button: used to select NIBP mode of manual, auto cycle, or Stat mode.
10. Temperature probe cover storage: stores Alaris probe covers.
11. History button: activates the history mode to view stored patient data. The
most recent entries are displayed first. Press and hold the button for 2
seconds to clear all entries stored.
12. Print button: prints currently displayed values or all stored entries when in
history mode.
13. On/Off button: controls on/off state of monitor; push for power on and push
again for power off.
14. Alaris temperature probe connector: attach temperature probe cable here.
(The Exergen scanner connects to the host communication port at the back
of the system. Refer to Rear panel on page 2-6).
Systolic
MAP/Cuff
HIGH 24
15
16 LOW ADULT 25
NEONATE 26
Diastolic AUTO CYCLE
27
HIGH
28
17 LOW
HISTORY
29
18
Pulse Rate BATTERY OK
28
30
19
INFLATE PRESSURE
ALARM VOLUME HIGH 31
29
20 PULSE VOLUME
LOW
CHARGING
32
30
21 SpO
HIGH
Temperature
C
22 LOW F
31
33
23
21. Pulse Rate window: shows pulse rate in beats per minute.
22. SpO2 pulse indicator: flashing red LED bar indicates that pulses are being
derived from SpO2 signals.
23. SpO2 window: indicates oxygen saturation in %.
24. MAP/Cuff window: indicates measured mean arterial pressure (MAP) in
mmHg and shows cuff pressure during NIBP determination.
25. ADULT indicator: lights to indicate you are making a change to adult/ped
NIBP limits or inflation pressure settings.
26. NEONATE indicator: lights to indicate you are making a change to neonate
NIBP limits or inflation pressure settings.
27. AUTO CYCLE indicator: lights green to indicate auto mode is the chosen
NIBP mode; flashes to indicate you are making a change to the auto mode.
28. Min window: displays the NIBP mode if manual or Stat as well as the cycle
time when taking auto NIBP determinations.
29. HISTORY indicator: flashes to indicate you are in history mode.
30. BATTERY OK indicator: lights green to indicate the monitor is operating on
battery power and that the battery is sufficiently charged.
31. BATTERY LOW indicator: lights amber to indicate low charge for the battery
(less than 45 minutes when solid; 5 minutes or less when flashing).
32. CHARGING indicator: lights green to indicate presence of external power
source and battery charging.
33. Temperature window: indicates measured temperature.
Right-side panel
Rear panel
2. Host communication port (15 pin D-type) for use only with equipment
conforming to IEC 60601-1 or configured to comply with IEC 60601-1-1. The
Exergen scanner connects to this port.
NOTES
For connection details, see Host communication connector on page 3-
15.
Attach one accessory to this port.
3. Printer door.
Product compliance
The CARESCAPE V100 vital signs monitor is classified in the following categories
for compliance with IEC 60601-1:
Internally powered or Class II when powered from external supply.
Transportable.
For continuous operation.
Not suitable for use in the presence of flammable anesthetics.
Not for use in the presence of an oxygen-enriched atmosphere (oxygen
tent).
Type BF defibrillation-proof applied parts.
IPX1, degree of protection against ingress of water.
Sterilization/Disinfection, see Cleaning on page 4-3.
Software is developed in accordance with IEC 60601-1-4.
The monitor complies to IEC 60601-2-49.
The alarm system is developed in accordance with IEC 60601-1-8.
This equipment is suitable for connection to public mains via power
adapters as defined in CISPR 11.
The SpO2 parameter complies to ISO 9919.
The NIBP parameter complies to IEC 60601-2-30, EN 1060-1, EN 1060-3, and
ANSI/AAMI SP10.
The Temperature parameter complies to ASTM E-1112-00.
Defibrillation protected. When used with the recommended accessories, the
monitor is protected against the effects of defibrillator discharge. If
monitoring is disrupted by the defibrillation, the monitor will recover.
This product conforms with the essential requirements of the Medical
Device Directive 93/42/EEC. Accessories without the CE mark are not
guaranteed to meet the Essential Requirements of the Medical Device
Directive.
The monitor is a portable unit that receives power from an internal rechargeable
lead-acid main battery.
When the On/Off button is pressed, the Main Board is brought out of a sleep
mode and turns on the power regulators. The power regulators provide
conditioned power from the main battery. The external DC source is used only to
charge the main battery. Once the monitor is energized, a self-test is performed.
The self-test automatically tests the main functions of the monitor. Failure of the
self-test will set the monitor into a fail-safe mode with an audio alarm.
Under normal operating conditions, the monitor is ready to record the patient
vital signs using three external attachments: the temperature probe, SpO2
sensor, and cuff. Interface with a central station or other device is accomplished
through the host communication port on the back of the monitor.
NOTES
Prior to each use, inspect the power supply cord to ensure proper
connection and condition.
Be sure to unplug the monitor before transport.
SpO2
The SpO2 probe has a built-in sensor. When the SpO2 sensor is attached to the
SpO2 connector and patient, the probe senses both heart rate and oxygen
saturation. The analog signals are routed to the SpO2 Printed Wiring Assemblies
(PWA) for Ohmeda, Nellcor, or Masimo. The analog signals are analyzed on the
SpO2 PWA. The results are digitized and sent to the Main Board via opto
couplers. The couplers provide patient isolation as well as serial data interface.
The Main Board temporarily stores the data and routes it to the UI Board for
display and/or printer.
A reset signal to the SpO2 PWA is also provided so that power up sequencing is
correct. If the SpO2 circuit quits communicating to the Main Board, the Main
Board will attempt to reset the SpO2 PWA.
NOTE
For neonatal populations, the reference is always the intra-arterial pressure
monitoring method.
When the cuff and hose are attached to the monitor and a Non-Invasive Blood
Pressure (NIBP) determination is initiated, the pump inflates the cuff. Pressure
transducers PT1 and PT2 monitor pressure information. The pneumatic manifold
has one valve, which is used to deflate the cuff. Valve control is through the Main
Board. When the cuff pressure data acquisition for the determination is
complete, the processor on the Main Board calculates the systolic NIBP, the
diastolic NIBP, the Mean Arterial Pressure (MAP), and the pulse rate. The results
are then displayed on the UI Board and sent to the printer (if the user presses the
Print button).
The Pneumatics are controlled by the NIBP processor. The NIBP processor
monitors pressure information from PT2. If an over-inflation condition occurs,
the OVERPRESSURE signal is routed to the Pneumatics to release the air
pressure. The Main Board also generates an alarm condition with the speaker
sounding and error code message on the UI Board.
The first determination settles at an initial target pressure of 135 mmHg (adult
mode) and 100 mmHg (neonate mode), depending on initial target pressure
preset. To allow for rapid settling of cuff pressure, the monitor will momentarily
inflate to a higher pressure then immediately deflate to the target pressure. After
inflating the cuff, the NIBP parameter begins to deflate. The oscillations versus
cuff pressure are measured to determine the mean pressure and calculate the
systolic and diastolic pressures.
During an NIBP determination, the parameter deflates the cuff one step each
time it detects two pulsations of relatively equal amplitude. The time between
deflation steps depends on the frequency of these matched pulses (pulse rate of
the patient). However, if the monitor is unable to find any pulse within several
seconds, it will deflate to the next step. The process of finding two matched
pulses at each step provides artifact rejection due to patient movement and
greatly enhances the accuracy of the monitor. The figure shows a full
determination sequence for an adult patient. In Stat mode, some steps may
require only one pulse.
At each step the microprocessor stores cuff pressure, the matched pulse
amplitude, and the time between successive pulses. The stepped deflation and
matched pulse detection continues until diastolic pressure is determined or total
cuff pressure falls below 8 mmHg. The parameter then deflates the cuff (to zero
detected pressure), analyzes the stored data, and updates the screen.
The operating cycle is composed of four parts: inflation time, deflation time,
evaluation time, and wait time. Wait time, which varies from mode to mode, is
affected by the cycle time (auto mode) or operator intervention (manual mode).
The figure shows the basic operating cycle for an NIBP determination.
Inflation
Time
CUFF PRESSURE
Wait Time
Evaluation Time
Deflation Time
Determination Time
Cycle Time
TIME
Systolic search
If systolic pressure is not found, the SuperSTAT algorithm can search at cuff
pressures higher than the initial target pressure. The algorithm will inflate above
the initial target pressure to obtain more data in the systolic region. The pressure
is limited to the maximum allowed for the selected patient type.
The SuperSTAT algorithm evaluates the data obtained during the determination,
and the prior determination if it is available, to determine if additional data is
needed to complete the determination. It can then selectively pump to a single
cuff pressure to obtain the data it needs and then return to the existing deflation
sequence. This search process makes SuperSTAT more efficient.
Accuracy of the DINAMAP NIBP measurements was validated against the intra-
arterial method. Do not use the auscultatory method to verify the accuracy of
the SuperSTAT NIBP parameter. The auscultatory method (using the cuff and
stethoscope) determines the systolic and diastolic pressures from sounds that
occur during cuff deflation. Mean arterial pressure cannot be determined by the
auscultation method. The oscillometric method used with all DINAMAP
technologies determines systolic, mean and diastolic pressures from the
oscillation pattern that occurs in the cuff during deflation.
NOTE
Arrhythmias will increase the time required by the NIBP parameter to
determine a blood pressure.
The monitor deflates the cuff one step each time it detects two pulsations of
relatively equal amplitude. The time between deflation steps depends on the
frequency of these matched pulses (pulse rate of the patient). However, if the
monitor is unable to find any pulse within several seconds, it will deflate to the
next step. The process of finding two matched pulses at each step provides
artifact rejection due to patient movement and greatly enhances the accuracy
of the monitor. The figure shows the NIBP determination sequence.
At each step the microprocessor stores cuff pressure, the matched pulse
amplitude, and the time between successive pulses. The stepped deflation and
matched pulse detection continues until diastolic pressure is determined or total
cuff pressure falls below 7 mmHg. The monitor then deflates the cuff (to zero
detected pressure), analyzes the stored data, and updates the screen.
The operating cycle is composed of four parts: inflation time, deflation time,
evaluation time, and wait time. Wait time, which varies from mode to mode, is
affected by the cycle time (auto mode) or operator intervention (manual mode).
The figure shows the basic operating cycle.
Systolic search
If systolic pressure is not found, the NIBP parameter can search at cuff pressures
higher than the initial target pressure. The parameter will inflate the cuff above
the initial target pressure to get more data in the systolic region. The pressure is
limited to the maximum allowed for the selected patient type.
In manual mode, if a previous valid systolic pressure is displayed and less than 2
minutes old, and the new systolic pressure oscillations are compared with the
previous valid determination and the monitor "thinks" that the systolic was not
obtained, the monitor will inflate the cuff to a pressure above the immediately
preceding inflation.
NOTE
For neonatal mode, the reference is always the intra-arterial pressure
monitoring method.
NOTE
For neonatal determinations the SuperSTAT algorithm is always used.
Temperature
The monitor uses the following technologies to measure patient temperature:
Alaris Turbo Temp, Alaris Tri-Site, or Exergen.
Alaris temperatures
The Alaris temperature probes contain a heating element that preheats the
probe to reduce determination time. The heating function is controlled by the
Main Board. The Alaris probes also contain a thermistor that indicates the
temperature. When the probe is attached to the temperature connector and
patient, the signal generated by a thermistor that senses temperature is routed
to the Main Board. When the probe makes contact with the patient, the
resistance of the thermistor is sensed by circuitry on the Main Board. The Main
Board then processes the digital signal and displays the patient temperature on
the UI Board and printer in Celsius or Fahrenheit.
When the monitor is powered on, the monitor automatically calibrates the
temperature circuit to account for ambient room temperature. This is done by
measuring a high precision resistor of known value, computing a calibration
factor, and applying this factor to all subsequent measurements.
NOTE
If large changes occur in the ambient temperature, the temperature system
can be recalibrated by cycling power using the On/Off button.
Furthermore, at one minute intervals, the monitor verifies the voltage supplied to
the temperature circuit to ensure that readings calculated using that factor are
accurate. If the voltage is found to be out of tolerance, the monitor issues an
alarm.
The Turbo Temp temperature option can take a fast (predictive) oral or rectal
Exergen temperature
The Exergen TemporalScanner Temporal Artery Thermometer uses ultrafast
infrared scanning technology with arterial heat balance algorithms to quickly
and non-invasively measure the patient's temperature. As the caregiver passes
the scanner over the patient's skin, its infrared sensor samples at 1000 times per
second the radiant heat emanating from the body, which reaches a maximum
over the temporal artery. The scanner then derives the patient's body
temperature from the peak infrared sensor readings and the local ambient
temperature as measured by the scanner. A scan behind the ear is included in
the use protocol to prevent errors due to perspiration.
Refer to the operator's manual for complete instructions for use. For more
information on the theory of operation, scientific, educational and technical
information, access the following website: www.TAThermometry.org.
Functional description
The following paragraphs provide the functional interface relationship. The
monitor contains a number of electrical and electro-mechanical assemblies.
These assemblies are:
Main Board PWA
User Interface (UI) Board PWA
SpO2 PWA (optional)
Printer (optional)
Pneumatic Valve/Manifold (PVM)
Optical Switch (optional)
The NIBP processor controls pneumatic safety interlock, timing check, and NIBP
control. The temperature processor controls the temperature parameter.
Upon entering a FAILSAFE condition, the Main Board will perform the following
tasks:
Parameter monitoring disabled
Alarm tone sounding from speaker
Pneumatic FAILSAFE (deflate the cuff, pump off)
Normal communications interface disabled
Remote alarm is in alarm state
Hard keys except On/Off key inactive
The On/Off key can reset the monitor and end the FAILSAFE condition. The
FAILSAFE condition will terminate automatically after 5 minutes to preserve
battery power.
The UI assembly also provides hardkey switches for the monitors Main Board.
The primary processor asserts a HIGH on the 16 outputs of the 1-of-16 decoder/
demultiplexer one at a time and then reads at the signal on SW_MUX. A LOW on
SW_MUX indicates that the switch is asserted.
SpO2 PWA
The monitor can be configured for use with either an Ohmeda, Nellcor, or
Masimo SpO2 PWA. The SpO2 PWA provides continuous readings of oxygen
saturation and pulse rate. Additional circuitry on the Main Board provides power,
data communications, and isolation between SpO2 PWA and primary processor.
Patient data received from the finger sensor is filtered, amplified, and analyzed
on the SpO2 PWA. The information is sent to the Main Board via the optically
coupled electrically isolated serial connection. The primary processor receives
the data and routes it to the UI board for display. The data is also sent to the
printer if specified.
Printer
The printer receives power from the Main Board and communicates with the
primary processor. Printer presence and print head temperature is indicated by
PR_TH signal to the primary processor. When a print command is sent to the
printer from the primary processor, the following will occur:
Together these signals (CONTROL DATA) cause the printer to print a graphic
hardcopy of the patient vital sign values and trend data. It also causes the
printer to print a hardcopy of error logging and service record data.
The printer has a built-in sensor to monitor the printer paper presence. When the
printer is out of paper, it sends a PAPER OUT signal to the primary processor.
Pneumatics
The pneumatics consists of a pump, a deflate valve, and a dump valve. The
pneumatics inflates/deflates the cuff during NIBP determinations. During normal
operation the pneumatics are controlled by the primary processor. If a FAILSAFE
mode or overpressure condition occurs, the NIBP processor provides the
appropriate control signals to ensure a safe condition, where the cuff vents to
ambient atmosphere pressure.
Optical switch
The optical switch indicates whether the Alaris temperature probe is inserted in
the probe holder or not. The Main Board powers the switch.
Control/Data
Speaker Printer
2-17
Equipment overview: Functional description
NOTE
The monitor is not designed to operate without a functional internal main
battery.
NOTE
Repeated failure to fully recharge the battery will, over time, lead to a
significant reduction in the batterys capacity.
With external DC power connected, the green CHARGING indicator will light to
indicate that the main battery is charging. This indicator remains active whether
the unit is on or off. An audible two beep sounds whenever the DC charger is
connected/disconnected.
When connected to the monitor, the battery charger sounds a single low-
pitched tone followed by a single higher-pitched tone. Upon disconnection from
the monitor, the battery charger sounds a single high-pitched tone followed by a
single lower-pitched tone.
Battery charging will take place as long as the monitor remains connected to an
external DC power source.
Charge battery pack for 8 hours before first use or after prolonged periods
of storage.
If the monitor is idle for extended periods, it should be fully charged at least
once a month to ensure optimum performance. If the monitor is to be stored
for longer than one month, first charge the battery and then remove it and
store it separately from the monitor.
The battery pack should be charged before use, because a charged battery
loses charge when left in storage. Sealed lead-acid batteries can discharge
to less than 80% of charge within 60 days of storage. Charging is done
automatically by the monitor when the external DC power is connected.
The battery pack should be charged at room temperature: 16C to 30C
(59F to 86F).
You can charge or top-off
the battery pack at any time.
Sys
to lic
HIGH
LOW
Diast
HIGH AUTO
CYCL
E
HISTO
RY
SpO HIGH
LOW
BATTERY OK
When the monitor is operating on main battery power and the BATTERY LOW
alarm is not active, the BATTERY OK indicator is backlit green.
Battery alarms
When about 45 minutes of main battery charge remains:
The low-priority BATTERY LOW alarm is issued.
The BATTERY LOW indicator illuminates.
This alarm can be acknowledged and cleared by pressing the Silence
button.
The BATTERY LOW alarm will re-alarm every 10 minutes after it has been
acknowledged.
If the alarm is not acknowledged, the alarm is re-issued every 8 seconds.
The monitor continues to operate normally.
NOTE
At this time, it is highly recommended to plug the monitor into external DC
power.
Clinical mode
Clinical mode is the monitors normal operating mode. While this mode is active,
alarm limits and a few other commonly used settings are adjustable. All
parameters are available for monitoring in this mode.
Configuration mode
Configuration and advanced configuration modes display the software revision
and allow you to configure defaults for some settings that are available in
clinical mode, as well as some less commonly used settings that are only
adjustable in these modes. A fatal error history is also available in the advanced
configuration mode. No parameters are operable in these modes, therefore,
patient monitoring is suspended.
To enter the configuration mode: with the monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds. The monitor enters the configuration mode.
For a few seconds immediately after power up in this mode, the Systolic and
Diastolic windows display the major and minor version codes. The version codes
are numbers that represent the letters of the English alphabet, which are
designated to the currently loaded version of the monitor firmware (e.g., 1
indicates A, 2 indicates B, etc.).
At the same time, the NIBP Algorithm selected in the monitor is displayed in the
min (minutes display) window as follows:
Display Window
These displays appear only during the first part of the power up sequence and
are not selectable and cannot be changed. After a moment, this version
information is cleared, and the monitor displays the first page of configuration
mode which simply displays in the Systolic window.
Pressing the Menu button cycles through all the configuration option pages.
After all options pages have been displayed, the display returns to the first
configuration mode page (displaying ). You can use the + and - buttons to
make changes to settings. After making changes, simply cycle the power to
return to normal operation (clinical) mode. Changes are automatically retained.
NOTES
If a parameter is not enabled, its options are not displayed.
Menu selections for SpO2 settings are different depending upon the SpO2
technology your monitor contains.
The Menu selections appear in the following order. Refer to the manual section
for settings options.
Pulse Rate
Setting Window LED display window Comment
display
Inflate pressure Systolic XXX (numeric) XXX (numeric) ADULT indicator illuminated,
(adult/ped) INFLATE PRESSURE indicator
flashing
Inflate pressure Systolic XXX (numeric) XXX (numeric) NEONATE indicator illuminated,
(neonate) INFLATE PRESSURE indicator
flashing
SpO2 sat SpO2 0, 10, 25, 50, 100 User selects the SMART Sat
(Nellcor only) tolerance level *
SpO2 mode SpO2 4, 6, 8, 10, 12, 14, 16 User selects the number of
(Masimo only) seconds over which data is
averaged 4 to 16*
Pulse Rate
Setting Window LED display window Comment
display
Setting the date and time To set the date and time on the monitor, you must
access the configuration mode. Press Menu to skip the default settings that do
not require changes. Refer to the table above.
NOTE
While in configuration mode, all entries stored in the clinical history are
erased when the time and/or date is changed.
Procedures
1. Press the Menu button to move from one setting to another. Use the +/-
buttons to increment or decrement the setting.
NOTE
For the date and time to be saved, you must advance the menu through
the minute setting.
and select the parameter function. To change alarm settings, press the
Alarms button.
Procedures
1. Enter the configuration mode: with the monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds.
2. Use the +/- buttons to increment or decrement the inflate pressure default
setting.
3. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press Menu.
1. Enter the configuration mode: with the monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds. After the unit enters the configuration mode, press Alarms. At any
point in the configuration mode menu, Alarms default can be selected.
2. To set or change the default setting, press the Alarms button to select alarm
setting. Use the +/- buttons to increment or decrement the individual
settings.
NOTE
For the Alarms default setting to be saved, you must advance the menu
through the SpO2 settings.
3. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press Menu.
Reverting to the factory default vital sign alarm limits
WARNING
The Line Frequency mode (for Datex-Ohmeda oximetry) must
be set according to each countrys electrical power utilities
implementation; and it must be checked and reset any time the
monitor is set to or reverts to factory default settings.
To revert to the factory default vital sign alarm limit settings, the monitor must
be disconnected from the DC power supply and from the monitor battery. Refer
to Replacing the main battery on the monitor on page 4-8 for DC power supply
and battery disconnection/reconnection instructions.
When reverting to factory default settings, the user settings (including alarm
limits and inflation pressure), date/time, and the Ohmeda TruSignal SpO2 Line
Frequency mode (LF) will go back to default values. Refer to Configuration mode
settings on page 3-5 to configure the factory default user settings.
NOTE
For monitors configured for Ohmeda TruSignal SpO2 only, verify that the
setting for Line Frequency mode (LF) is correct for your country. Refer to
SpO2 configuration settings on page 3-9.
1. With the monitor off, press and hold the Menu button at the same time as
pressing the On/Off button until the display test completes.
2. Press the Menu button until LF appears in the Pulse Rate window.
3. Use the +/- buttons to select the option.
4. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press the Menu button.
WARNING
The Line Frequency (LF) mode must be set according to each
countrys electrical power utilities implementation. The LF
mode must be checked and reset any time the monitor is set to
or reverts to factory default settings.
1. With the monitor off, press and hold the Menu button at the same time as
pressing the On/Off button until the display test completes.
2. Press the Menu button until n0d (response mode) appears in the Pulse Rate
window.
3. Use the +/- buttons to select the option.
4. Press the Menu button once. SAt (SatSeconds) appears in the Pulse Rate
window.
5. Use the +/- buttons to select the option.
6. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press the Menu button.
Procedure for units with Masimo technology
1. With the monitor off, press and hold the Menu button at the same time as
pressing the On/Off button until the display test completes.
2. Press the Menu button until n0d (averaging time) appears in the Pulse Rate
window.
3. Use the +/- buttons to select the option.
4. Press the Menu button once. SAt (FastSAT) appears in the Pulse Rate window.
5. Use the +/- buttons to select the option.
6. Press the Menu button once. SEn (sensitivity mode) appears in the Pulse
Rate window.
7. Use the +/-buttons to select the option.
8. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press the Menu button.
1. With the monitor off, press and hold the Menu button at the same time as
pressing the On/Off button until the display test completes.
2. Press the Menu button until Unt (unit of measurement) appears in the Pulse
Rate window.
3. Use the +/- buttons to select the option.
4. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press the Menu button.
Procedure for units with Exergen scanner
The Exergen scanner comes preset with the requested unit of temperature
measurement, but can be changed. To change the scanners unit of
measurement (C or F):
Cover
Single screw
F/C switch
NOTE
This procedure applies to both the Alaris probe and the Exergen scanner.
1. With the monitor off, press and hold the Menu button at the same time as
pressing the On/Off button until the display test completes.
2. Press the Menu button until tdt (temperature display time) appears in the
Pulse Rate window.
3. Use the +/- buttons to select the option.
4. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press the Menu button.
For a few seconds immediately after power up in this mode, the Systolic and
Diastolic display windows will display the major and minor version codes. The
version codes are numbers that represent the letters of the English alphabet
which are designated to the currently loaded version of the monitor firmware
(e.g., 1 indicates A, 2 indicates B, etc.).
After a moment, this version information is cleared, and the monitor displays the
first page of configuration mode which simply displays ACF in the Systolic
display window indicating that the monitor is in advanced configuration mode.
You can then press the Menu button to cycle through all the advanced
configuration mode option pages. After all options pages have been displayed,
the display will return to the first advanced configuration mode page (displaying
ACF). You can use the + and - buttons to make changes to settings. After making
changes, simply cycle the power to return to normal operation mode. Changes
are automatically be retained.
NOTE
For the Exergen temperature to appear on
the monitor, the host communication bit rate
must be set to 9600 bps.
Service mode
Service mode is entered by holding the Cycle button while powering on with the
On/Off button. You can press the Cycle button to advance through the available
service mode pages. You can use the + and - buttons to make changes to
settings.
NOTE
Only transducer calibration pages are available until calibration is valid.
Save settings
Calibration and other service mode setting changes will not be retained unless
the Save Settings operation is executed (on the final Service Mode options
page). To save settings in service mode, advance to the last page (page 6), then
press and hold the Menu button until the second of two tones sound.
NOTE
The first tone sounds as you first press the Menu button and the second
tone sounds after the monitor has saved the settings.
After all options pages have been displayed, the display will return to the first
service mode page (initial calibration page). The Service Mode option pages are
as follows:
NOTE
Changing setting effects NIBP performance.
NOTE
Use the Alarms button to toggle between
the available options.
Refer to the Alarms section of the
operators manual for a detailed
description of the alarm modes.
NOTE
Incorrect setting will cause fatal 930 alarm
during operation.
0 English
1 Not used
2 Czech
3 Danish
4 Dutch
5 Finnish
6 French
7 German
8 Greek
9 Hungarian
10 Italian
11 Japanese
12 Korean
13 Norwegian
14 Polish
15 Not used
16 Portuguese
17 Russian
18 Slovak
19 Spanish
20 Swedish
NOTE
You must be in option page 6 (in min window) to save any changes made in
service mode.
CAUTION
Auxiliary equipment connected to the CARESCAPE V100 vital
signs monitor will result in the formation of an electromedical
system and thus, must comply with the requirements of IEC
60601-1-1. All host port signals are NON-ISOLATED and should
be connected to equipment conforming to IEC-60601-1 or
configured to comply with IEC 60601-1-1 only.
If external alarm control is required, the Isolated Remote Alarm Cable (GE part
number 487208CR) should always be used.
NOTE
When using the Isolated Remote Alarm Cable, the visual and audible alarms
of the monitor should still be considered the primary alarm delivery method.
The Remote Alarm connection should be considered a secondary method.
Pin # Function
1 Common
4 +5 volts
5 No connection
6 No connection
7 Common
8 Remote Alarm
9 No connection
10 No connection
14 No connection
15 No connection
Communication protocol
GE offers resources to assist customers in the development of software to
exchange data with the monitor, including the Host Communications Reference
Manual and the DINAWIN Application Programming Interface library. Contact
your GE sales representative for further information.
Preventative maintenance
WARNING
Failure on the part of all responsible individual, hospital, or
institution using this equipment to implement a satisfactory
maintenance schedule may cause undue equipment failure
and possible health hazards.
WARNING
Calibration equipment should always be kept dry and free of
particulate matter. Moisture or foreign substances introduced
to the pneumatic system may cause damage to the monitor
and/or the accessories, leading to impaired performance and/
or inaccurate readings.
NOTE
GE does not, in any manner, assume the responsibility for performing the
recommended maintenance schedule, unless an Equipment Maintenance
Agreement exists. The sole responsibility rests with the individuals, hospitals,
or institutions utilizing the device.
Maintenance schedule
To ensure the monitor and its components remain in proper operational and
functional order, the following maintenance schedule is recommended:
Long term storage recommendations: every time the monitor is stored for
an extended period of time.
Electrical safety tests: Upon receipt of the equipment, every 12 months
thereafter, and each time the unit is serviced.
Visual inspection
The monitor and its components should be carefully inspected prior to
installation, once every 12 months thereafter and each time the equipment is
serviced.
WARNING
Do not use damaged sensors, cables, or connectors.
Carefully inspect the equipment for physical damage to the case, the display
screen, and the keypad. Do not use the monitor if damage is determined.
Refer damaged equipment to qualified service personnel.
Inspect all external connections for loose connectors or frayed cables.
Have any damaged connectors or cables replaced by qualified service
personnel.
Inspect the display face for marks, scratches, or other damage.
Safety labels and inscription on the device are clearly legible.
Cleaning
Cleaning schedule
CAUTION
To prevent cross-contamination, clean the exterior surfaces of
the monitor, monitor accessories, and reusable sensors on a
regular basis in compliance with your institutions infection
control unit and/or biomedical departments local policy.
Cleaning the monitor, monitor accessories, and the Exergen temporal scanner
WARNING
Never pour or spray water or any cleaning solution on the
equipment or permit fluids to run behind switches, into
connectors, into the recorder, or into any ventilation openings
in the equipment. Do not let fluid pool around connection
pins.
WARNING
Use of unapproved cleaning agents can cause case damage
resulting in unintended fluid ingress and a potential for
compromising electrical safety.
Water
Mild soap
Household bleach (5.25% sodium hypochlorite). Mix 10:1 with distilled water.
Sagrotan (dilution 3:100, containing 75 mg tartaric acid per 100 ml solution).
Exergen temporal scanner only: Alcohol-based cleaning agents can be used
on the scanners probe head and metal neck only.
Never use the following cleaning agents on the monitor or the Exergen temporal
scanner:
Abrasive cleaners or solvents of any kind
Acetone
Ketone
Betadine
Alcohol-based cleaning agents. (However, an alcohol-based cleaning agent
can be used on the Exergen scanners probe head and metal neck only.)
Petroleum-based cleaning agents
Any type of solution that contains ammonium chloride, conductive
solutions, wax or wax compounds
Sodium salts
NOTE
Never autoclave or steam clean the monitor, cuffs, or accessories.
General
The cuff must be thoroughly cleaned with the specified detergent before reuse.
The additional use of household bleach as described below provides at least
intermediate-level disinfection.
NOTE
Never autoclave or steam clean the monitor, cuffs, or accessories.
Apply cuff hose caps before cleaning. See NIBP accessories on page 6-2
for the orderable part numbers of cuff hose caps.
While this procedure is adequate for cleaning/disinfection, it may not
remove all stains.
Do not immerse hoses.
Do not immerse cuffs without prior application of the cuff hose caps.
Materials
Enzymatic detergent such as ENZOL enzymatic detergent (US) or
Cidezyme enzymatic detergent (UK)
Distilled water
10% solution of household bleach (5.25% sodium hypochlorite) in distilled
water
Soft cloths and soft-bristled brushes
Spray bottles
Procedure
1. Prepare the enzymatic detergent according to the manufacturers
instructions and the 10% bleach solution, in separate spray bottles.
2. Spray the detergent liberally on the cuff. If the material is dried on, allow the
detergent to set for 1 minute. For soil on the soft part of the closure or the
cuff itself, wipe the material off with a soft cloth. For persistent
contamination on the soft part of the closure, use a soft-bristled brush to
loosen particles. Rinse with copious amounts of distilled water. Repeat until
no visible contamination remains. For soil on the hook part of the closure,
use a soft-bristled brush to remove the material, and rinse with copious
amounts of distilled water. Repeat until no visible contamination remains.
3. Spray the 10% bleach solution on the affected area until the area is
saturated. Allow the solution to set for 5 minutes.
4. Wipe away any excess solution and rinse the cuff again with distilled water.
Allow 2 hours for drying.
The user has the responsibility to validate any deviations from the
recommended method of cleaning and disinfection.
NOTE
Betadine may discolor the case. Use a 10% solution of bleach to remove the
discoloration. Apply the listed solutions with a dampened sponge, soft
brush, or a cloth, then wipe dry with a clean cloth or towel.
CareFusion Corporation does not recommend Ethylene Oxide (EtO)
sterilization of the Turbo Temp or Tri-Site temperature probes.
SpO2 sensors
Adhesive sensors are sterile and for single use only. For reusable temperature
sensors, consult the sensor manufacturer instructions for cleaning, sterilization,
or disinfecting methods.
Long-term storage
NOTE
When storing the product for extended periods, it is highly recommended to
disconnect the battery. Otherwise, the battery may over-discharge,
resulting in a significant reduction in battery life.
Main battery life is significantly reduced if the battery is left in a discharged state.
For long-term storage, fully charge the battery, then remove the battery from
the unit and periodically charge the battery. For more information, refer to the
Battery care section below.
NOTE
When the monitors battery has been completely discharged, the monitor
must be connected to an external power supply before monitoring can
resume.
Battery care
Main battery
WARNING
Keep the monitor connected to an external DC power source
when not in use to ensure maximum battery charge.
NOTE
The expected lifetime of the battery largely depends on the way in which the
monitor is used. If the battery is allowed to discharge to 50%, it should
survive approximately 400 charge/discharge cycles. Deeper discharge will
reduce battery life expectancy. It is never recommended to fully discharge
the battery.
If it becomes necessary to store the monitor for an extended period of time, first
fully charge, then remove the main battery. Then store the monitor and the main
battery in the original packaging materials.
Batteries should always be fully charged before being placed in storage. Even
after 6 months of storage, a fully charged battery can retain about 80% of its
charge. It is recommended that batteries should not be left in storage more than
6 months without a full recharge. A fully charged battery in good condition will
provide sufficient power to operate a monitor for approximately 5-11 hours,
depending upon configuration and use.
With the usage scenario of auto NIBP every 5 minutes with adult cuff,
printout after every determination, SpO2 parameter active at 60 bpm,
temperature parameter active in monitor mode, the average run time is 5
hours.
With the usage scenario of NIBP determinations every 15 minutes, without
SpO2 technology and temperature function active, the run time is up to 11.5
hours.
It is best to keep the battery charged as fully as practical and never store the
monitor with the battery in a discharged condition. When the battery will no
longer hold a charge, remove the battery and replace it with a GE-approved
battery. Failure to use a GE-approved battery may cause the monitor to shut
down. Refer to Power accessories on page 6-13 for the reorder part number.
NOTE
After replacing batteries, an E00 error code is normal. To clear the E00
error code, press the Silence button on the monitor. The user settings and
date/time revert to the factory default setting and all entries in clinical
history are erased.
For units with Ohmeda TruSignal technology, it is important to verify the Line
Frequency mode setting.
Battery charging will take place as long as the monitor remains connected to an
external DC power source.
DANGER
Before replacing the battery, disconnect the monitor from the
DC power supply.
NOTES
Record the configuration settings on your monitor before replacing the
battery. When the battery is replaced, all user settings are lost and return to
default values.
Replacement batteries can be obtained from GE.
WARNING
When reconnecting the battery, ensure the battery maintains
the correct polarity by connecting the red lead to the positive
terminal and the black lead to the negative terminal.
4. Remove the old battery and disconnect the wires. Attach the battery wires
to the new battery, ensuring the red terminal (+) is connected to the red wire
and the black terminal (-) is connected to the black wire.
5. When reconnecting battery power, the monitor enters fatal mode. To clear
the alarm, press the On/Off button.
7. Replace the cover, help card tray, and screws. Insert the external DC power
converter plug into the external DC power socket and plug into an AC outlet.
NOTES
Error code E00 appears (MEMORY LOST) alerting you that the user
settings (including alarm limits and inflation pressure) and date/time will
go back to default values and all entries in clinical history are erased.
For units with Ohmeda TruSignal technology, it is important to verify the
Line Frequency mode setting.
Configured settings and time/date will not be lost when reset due to
pressing and holding the On/Off button regardless of whether the DC
charger is attached.
8. Reset the date/time and applicable user settings.
9. Verify the configuration settings prior to returning the monitor to clinical use.
2. Loosen the single screw at the bottom, on the back of the scanner, and
remove the battery cover.
Cover
9-volt battery
Single screw
3. Disconnect the old battery and replace with a new, high quality 9-volt
alkaline battery in the same location.
Fuses
The monitor contains three fuses. The fuses are mounted within the monitor. The
fuses protect the low voltage DC input, the main battery, and the remote alarm
output. The +5 V output on the host port connector is regulated by internal
supply. Fuses are not replaceable.
NIBP
1. Perform an NIBP determination on yourself.
a. Connect the supplied air hose and cuff together.
b. Connect the end of the air hose to the NIBP connector on the front of
the monitor.
c. Attach the adult cuff to the upper part of your arm.
NOTE
If you are uncertain as to the proper technique, consult the
operators manual.
NOTE
While an NIBP simulator device may be useful to verify that the monitor
responds to oscillometric pulsations, it should not be used as a basis for
assessing the accuracy of measurement. For more information, see
Appropriate use of NIBP simulators on page B-2.
Temperature
Alaris
NOTES
Predictive temperature measurements cannot be performed when a
resistor is used in place of the probe.
The accuracy of predictive temperature measurements made in a water
bath will not be representative of performance with actual patients.
Exergen
1. Connect the Exergen temporal scanners modular plug to the host
communication port at the back of the monitor.
2. Take a temperature reading of yourself (i.e., not on a resistor simulator).
3. Verify that the temperature displays both on the Exergen temporal scanner
and in the Temperature window on the monitor.
NOTE
All devices are tested and calibrated during manufacturing and are certified
for operation at installation.
To adequately test the safety and integrity of the monitor, the following test
equipment is recommended:
12VDC power supply
IEC 60601-1 safety tester
Digital manometer (with range to 350 mmHg)
Stopwatch/timer (capable of measuring seconds)
Adult NIBP cuff, Neonate NIBP cuff, hose, inflation bulb, and associated
tubing
Calibration kit (p/n 320246, available through GE)
SpO2 cable (for appropriate SpO2 type, if SpO2 is installed)
TE 1811 Temperature Probe Simulator (if TEMP is installed) available from
CareFusion Corporation.
Exergen Calibration Verification Kit (if Exergen option is installed) (p/n
EX129003)
Printer paper (if printer is installed)
3 diameter rigid cylinder (mandrel)
SpO2 connector with all leads shorted
Temperature connector with all leads shorted
DC input connector with both wires shorted
WARNING
Calibration equipment should always be kept dry and free of
particulate matter. Moisture or foreign substances introduced
to the pneumatic system will likely cause damage to the
monitor and/or the accessories.
NOTES
This test is written so that a knowledgeable technician who is familiar with
the monitor and the test equipment will be able to follow the test procedure.
To enter Service Mode press and hold Cycle button while pressing the On/
Off button.
Setup
1. Connect manometer to unit as shown.
2. T an inflation bulb into the pneumatic setup.
3. Consult the following diagram for pneumatic setup guidelines.
NIBP tests
Pneumatic leakage testing
NOTE
To enter Service Mode press and hold the Cycle button while pressing the
On/Off button.
The leakage rate is the difference between the first and second readings.
8. Record and verify the leakage rate on the Test results form on page 4-29.
9. Turn the monitor off.
NOTE
To enter service mode press and hold Cycle button while pressing the On/
Off button.
Overpressure verification
NOTE
To enter service mode press and hold Cycle button while pressing the On/
Off button.
1. Wait a few seconds after entering service mode. Press Cycle button so that
the min window changes from 0 to 1.
2. Use the inflation bulb to inflate close to 300 mmHg. Slowly inflate (1 to 2
mmHg/sec) until valve opens and pressure is released.
3. Record and verify pressure at which valve opens on the Test results form
on page 4-29.
4. Press Cycle button and 2 should appear in the min window.
5. Use the inflation bulb to inflate close to 150 mmHg. Slowly inflate (1 to 2
mmHg/sec) until valve opens and pressure is released.
6. Record and verify pressure at which valve opens on the Test results form
on page 4-29.
7. Turn unit off.
Button testing
1. Disconnect the cuff/hose assembly and power on the unit.
2. Press Inflate/Stop button.
3. Verify a NIBP determination has been initiated.
4. Block pump port and verify E80 alarm.
5. Press Silence button, verify alarm has been cleared.
6. Verify that the alarm silence indicator (bell) is lit.
7. Press Alarm button several times, verify unit cycles through all alarm
settings (i.e., SYS, DIA, SpO2).
8. Confirm all test results are recorded on the Test results form on page 4-29.
9. Turn unit off.
LED tests
1. Power on the monitor.
2. During the power-up self-test verify all 7 segment LEDs and all discrete LEDs
illuminate and they are the correct color.
NOTE
In the following figure, the items with a solid border are segment LEDs,
and the items with a dotted border are discrete LEDs.
Segment LED
Discrete LEDs
External DC verification
1. Plug the power supply into the monitor.
2. Verify that the CHARGING indicator is illuminated.
3. Confirm all test results are recorded on the Test results form on page 4-29.
1. Turn the monitor off. Make sure the temperature probe is properly stored in the
probe well.
2. Disconnect the temperature probe cable from the monitor.
3. Connect Temp simulator; set to 80.2F.
4. Turn the monitor on.
5. If your measurement units are set to C, switch the measurement units to F.
Refer to Temperature unit of measurement configuration settings on
page 3-10 for instructions.
6. Put the monitor into temperature monitor mode:
a. Remove the probe from the well.
b. Press the + key.
c. Verify that a blinking temperature appears quickly. If not, return the
probe to the holder and repeat steps 6a and 6b.
7. Record and verify the reading in the temperature display is 80.2F 0.2F.
8. Set the simulator to 98.6F.
9. Record and verify the reading in the temperature display is 98.6F 0.2F.
10. Set the simulator to 107.8F.
11. Record and verify the reading in the temperature display is 107.8F 0.2F.
12. If necessary, switch the measurement units to C. Refer to Temperature unit
of measurement configuration settings on page 3-10 for instructions.
13. Confirm all test results are recorded on the Test results form on page 4-29.
14. Calibration is complete. If the monitor does not pass the calibration
verification, contact GE Technical Support.
Year Week
NOTE
If calibration is needed, return the unit to the manufacturer.
NOTE
Comparisons between the CM and the instrument being tested should
always be conducted under the same conditions.
1. Turn on the verifier device, using either a 9-volt battery or the power supply.
Make sure the red LED is illuminated.
Power On LED
On/Off switch
Battery
compartment
Power supply
jack
Portable black
body verifier
6. Record and verify the difference between the temperature reading of the
CM and the instrument being verified is 0.2C (0.4F).
If the readings differ by more than the acceptable field limits, repeat this
procedure. If the readings still differ by more than the acceptable limits, the
device fails.
7. Confirm test results are recorded on the Test results form on page 4-29.
3. Remove the sensor from your finger to generate a --- (SpO2 SENSOR OFF
FINGER) alarm and to sound the speaker.
4. Press the Silence button.
5. Verify the sound has stopped and the --- (SpO2 SENSOR OFF FINGER) error
is cleared.
6. Re-apply the SpO2 sensor to your finger.
7. Verify the unit displays a:
Pulse value
Saturation value
Signal Strength Bar Graph
8. Confirm all test results are recorded on the Test results form on page 4-29.
c. Place the roll of paper into the compartment so that the end of the
paper comes off the right-side of the roll (paper is wound around the roll
clockwise). Place the roll of paper in the holding bracket that is
integrated in the door of the printer, making sure the paper extends out
of the printer cavity at least two inches.
Safety testing
Electrical safety tests
Electrical safety tests provide a method of determining if potential electrical
health hazards to the patient or operator of the device exist.
Recommendations
Qualified personnel must perform all safety tests presented in this document:
Test equipment
The recommended test equipment required to perform electrical safety tests is
listed below.
Item Specification
NOTE
This kit contains the Temperature
Test Body.
Perform electrical safety tests using an electrical safety analyzer per IEC 60601-
1, UL 60601-1, or CSA C22.2 No. 601. The schematics in the section provide a
general understanding of the test equipment. Actual configuration of test
equipment may vary.
Failure of the power cord strain relief is very common. Often times users of
the equipment pull on the power cord itself, rather than the power cord plug,
to unplug the patient monitor from a wall receptacle.
Inspect the power cord for wear or damage regularly. If damage is
suspected, test for continuity through each conductor of the power cord
connector.
Verify line, neutral, and earth conductors are properly connected to the
power cord plug and are not short-circuited. Replace the power cord, as
necessary, with a regulatory-approved cord for the country of use.
WARNING
Use only AC power cords recommended or manufactured by
GE.
Perform tests in both Normal Condition (NC) and in Single Fault Condition (SFC),
where one of the supply conductors is open at a time. Perform the test with
normal and reverse polarity.
NOTE
*The MD represents the network and voltage measuring instrument and its
frequency characteristics per IEC 60601-1.
The patient connector test body shorts all signals in the connector together.
Refer to the instructions contained with the safety analyzer to perform this test.
NOTES
Perform this test once for SpO2 and once for Temperature.
This test applies only to the Alaris temperature option; it is not intended for
the Exergen temperature option.
1. Connect the appropriate Test Body to the input connector of the device
under test.
2. Configure leakage tester as follows:
Polarity NORMAL
Neutral CLOSED
GND (Earth) CLOSED
3. Apply the AC mains voltage to the device under test.
4. Read the current leakage indicated on the tester and record the results on
the Test results form on page 4-29.
5. Change leakage tester switches to:
Polarity NORMAL
Neutral OPEN
GND (Earth) CLOSED
6. Read the current leakage indicated on the tester and record the results on
the Test results form on page 4-29.
7. Change leakage tester switches to:
Polarity NORMAL
Neutral CLOSED
GND (Earth) OPEN
8. Read the current leakage indicated on the tester and record the results on
the Test results form on page 4-29.
9. Change leakage tester switches to:
Polarity REVERSED
Neutral CLOSED
GND (Earth) OPEN
10. Read the current leakage indicated on the tester and record the results on
the Test results form on page 4-29.
11. Change leakage tester switches to:
Polarity REVERSED
Neutral OPEN
GND (Earth) CLOSED
12. Read the current leakage indicated on the tester and record the results on
the Test results form on page 4-29.
13. Change leakage tester switches to:
Polarity REVERSED
Neutral CLOSED
GND (Earth) CLOSED
14. Read the current leakage indicated on the tester and record the results on
the Test results form on page 4-29.
15. Remove the AC mains voltage from the device under test.
16. Repeat the steps in this procedure using the appropriate Test Body for any
additional devices requiring safety testing.
If measured reading is greater than the acceptance criteria below, the device
under test fails. Contact GE Technical Support.
Acceptance criteria NC
All readings must be less than or equal to 100 A.
The patient connector test body shorts all signals in the connector together.
Refer to the instructions contained with the safety analyzer to perform this test.
Connect the appropriate Test Body to the input connector of the device under
test.
LINE
AC MAINS
NORM Power Cord LINE
NEUTRAL
NEUTRAL
EARTH
EARTH
RVS
**
Closed Device
Patient connector Under
Test Body Test
NOTE
*The MD represents the network and voltage measuring instrument and its
frequency characteristics per IEC 60601-1.
**Per IEC 60601-1, the resistance to protect the circuitry and the person
performing the test. The resistance must be low enough to accept currents
higher than the allowable values of the leakage current to be measured.
WARNING
Shock hazard. The following step causes high voltage at the
test body. Do not touch the test body.
NOTE
Perform this test once for SpO2 and once for Temperature.
Acceptance criteria
All readings must be less than or equal to 5 mA.
Overview
The symptoms and solutions in this chapter represent only a few of the
problems that you may encounter and are not intended to cover every possible
problem that may occur.
Problems
Before starting any detailed troubleshooting, complete a thorough visual
inspection of the following.
System failures
System failure mode is entered when the monitor has a depleted battery, or a
hardware or software failure. A distinctive alarm tone is generated for up to 5
minutes, after which if the monitor isnt turned off, it shuts down completely.
When a system failure is encountered, the error code is displayed on the screen
for > 5 seconds and the system enters FAILSAFE mode. The error code is logged
in the history log.
Error log
You can view and print an error log that stores up to 40 error code entries. The
log is a rolling list thatonce 40 entries are storeddeletes the oldest entry in
order to add the most recent entry. The error log is saved until the monitor
experiences a memory loss, then all entries are deleted.
9. The Pulse Rate window shows the error code that occurred at the recorded
time.
10. To print the error log, press the Print button while viewing the log.
Error codes
Can be
Error code or
Source Definition acknowledged Probable source
problem
(silenced)?*
Display System FAILSAFE error No Mains PWA issue
blank, high
pitch alarm
920 NIBP Comm timeout between main No Mains PWA issue
processor and NIBP subprocessor
930 SpO2 No status from module for 60 10 sec. No Verify SpO2 configuration
Fatal error reported by module is correct type
Parameter turned on - no
hardware installed in unit
940 Temp TEMP data samples less than 45 in 5 No Mains PWA issue
sec while idle
950 NIBP NIBP pump on during idle or over No Pneumatic assembly failure
current detected
951 NIBP NIBP valve stuck closed during cuff No Pneumatic assembly failure
typing
952 NIBP NIBP PT2 higher than 150 for greater No Pneumatic assembly failure
than 15 seconds while idle
975 System Could not save calibration data No Mains PWA issue
Can be
Error code or
Source Definition acknowledged Probable source
problem
(silenced)?*
976 System Power supply voltage has peaked No External power brick issue
above 18 Volts (incorrect power
supply)
985 System RTK 400hz timer re-entry No Return unit for evaluation
BATTERY Battery Main battery is running low Yes Plug monitor in to recharge
LOW
--- SpO2 SpO2 Sensor off finger Yes Reposition SpO2 sensor
Can be
Error code or
Source Definition acknowledged Probable source
problem
(silenced)?*
E61 Temp Temp probe broken (Alaris only) No Replace temperature probe
E63 Temp Temp probe disconnected (Alaris only) Yes Check for correct probe
E66 Temp Temp probe too hot (Alaris only) Yes Replace probe
E-- Temp Temp scanner error (Exergen only) Yes Check Exergen battery, and
check for valid temperature
value. Also check the
scanners display for
Exergen error information.
Refer to the Exergen-
specific error codes section
for more information.
Err Processing Error Restart scanner. If unit is defective, it will have to be returned to the
manufacturer. Contact GE Technical Support.
Ordering parts
This section of the manual provides parts lists for the monitor. Parts lists should
be used in conjunction with the other chapters of this manual.
NOTE
Fabrication drawings are not contained in this manual.
SpO2 - Sensor TruSignal Soft Adult Sensor with integrated cable and D TS-SA-D
connector, 1 m
SpO2 - Sensor TruSignal Soft Adult Sensor with integrated cable and GE TS-SA4-GE
connector, 4 m
SpO2 - Accessory Foam wrap replacement, large, weight range > 3 kg OXY-RWL
SpO2 - Accessory Foam wrap replacement, medium, weight range > 3 kg OXY-RWM
SpO2 - Accessory Foam wrap replacement, small, weight range < 3 kg OXY-RWS
SpO2 - Accessory Infant Foam Sandal, use with OxyTip++ Sensitive Skin OXY-SND
sensor - 3/box
SpO2 Cable Assy 3 m Cable Assy SpO2 Nellcor OxiMax 3 m - Smart 2021406-001
SpO2 Cable Assy 3 m Cable Assy SpO2 Nellcor OxiMax 1.2 m - Smart 2021406-002
SpO2 - Sensor Max -AL Adult Long Finger Adhesive Sensor - 24/box 2028117-001
SpO2 - Accessory Nellcor Tape ADH-P/I, use with Oxi-P/I Sensors 2016131-001
SpO2 - Sensor Masimo LNOP Disposable Adhesive Sensor, LNOP Adt. 2010458-001
Adult - 20/box
SpO2 - Sensor Masimo LNOP Disposable Adhesive Sensor, LNOP Pdt. 2010459-001
Pediatric - 20/box
SpO2 - Sensor Masimo LNOP Disposable Adhesive Sensor, LNOP NeoPT. 2010461-001
Neonatal - 20/box
SpO2 - Sensor Masimo LNOP Disposable Adhesive Sensor Bridge, LNOP 2010460-001
Neo. Neonatal - 20/box
SpO2 - Sensor Masimo LNOP Disposable Adhesive Sensor, LNOP NeoPT- 2017090-001
L. Neonatal - 20/box
SpO2 - Sensor Masimo LNOP Adtx Disposable Adhesive Sensor 2027269-001
Transparent Tape LNOP, Adult - 20/box
SpO2 - Sensor Masimo LNOP Reusable Finger Sensor LNOP/DCI Adult, 2002800-001
LNOP/DCI
SpO2 - Sensor Masimo LNOP Reusable Tip-Clip Ear Sensor LKNOP TC-I 2027274-001
SpO2 - Sensor Masimo LNOP Reusable Finger Sensor Adult DC-195 2009745-001
SpO2 - Sensor Masimo LNCS TC-I TipClip Reusable Ear Sensor 2027261-001
SpO2 - Sensor Masimo LNCS Adult, Transparent Adhesive Sensor - 20/ 2027253-001
box
SpO2 - Sensor Masimo LNCS Pdtx Pediatric Adhesive Sensor - 20/box 2027254-001
SpO2 - Sensor Masimo LNCS Inf-L Infant Adhesive Sensor - 20/box 2027255-001
SpO2 - Sensor Masimo LNCS Neo-L Neonatal Adhesive Sensor - 20/box 2027256-001
SpO2 - Accessory Masimo Tape Standard Petite Wrap, LNOP-YI - 100/box 2010470-001
Alaris Temperature, Oral Probe Sensor Turbo Temp Temperature, Long, White Cord (Blue) 2008774-001
Alaris Temperature, Rectal Probe Sensor Turbo Temp Temperature, Long Rectal, White 2008775-001
Cord (Red)
Alaris Temperature, Oral Probe Sensor Tri-Site Temperature, Long, White Cord (Blue) 2041178-001
Alaris Temperature, Rectal Probe Sensor Tri-Site Temperature, Long Rectal, White Cord 2041179-001
(Red)
Alaris Probe Covers Probe covers - case 088015
Exergen Temporal Scanner, Exergen TAT-5000 temporal scanner with cable interface 2044860-001
Fahrenheit - arterial to the V100, reporting in F calibrated to arterial reference
Exergen Temporal Scanner, Celsius Exergen TAT-5000 temporal scanner with cable interface 2044860-002
- arterial to the V100, reporting in C calibrated to arterial
reference
Exergen Temporal Scanner, Celsius Exergen TAT-5000 temporal scanner with cable interface 2044860-003
- oral to the V100, reporting in C calibrated to an oral reference
Exergen Temporal Scanner, Exergen TAT-5000 temporal scanner with cable interface 2044860-004
Fahrenheit - oral to the V100, reporting in F calibrated to an oral reference
Exergen Scanner Disposable Caps Protective covers - rigid plastic covers probe cone, 1000/ EX134203
box
Exergen Scanner Disposable Caps Protective covers - rigid plastic covers probe cone, 5000/ EX134205
box
Calibration - Exergen, Fahrenheit - Exergen calibration verification kit for F calibrated to an EX129003
arterial arterial reference
Exergen Scanner Holder Exergen TAT-5000 holder and installation instructions 2051186-001
Power accessories
Battery - CARESCAPE V100 vital FRU CARESCAPE V100 vital signs monitor battery (X1 Batt) 2037103-016
signs monitor
12W Power Supply Power supply, Input 100-240VAC 50/60 Hz 0.5A; 2018859-001
Output 12VDC 1.0A
12W Power Supply (Japan) Power supply, Input 100-240VAC 50/60 Hz 0.5A; 2018859-004
Output 12VDC 1.0A
Power Cord (Japan) Power supply cord, Japan ST-ST PSE 10A 250V 12 FT 405535-014
Power Cord (US) Power supply cord, hospital grade 10A 125V 12FT 405535-002
Power Cord (Brazil) Power supply cord, Brazil ST- ST 10A 250V 2.5M. 401855-041
Power Cord (continental Europe Power supply cord, continental Europe 10A 250V 2.5M 401855-101
and Korea)
Power Cord (UK) Power supply cord, British 10A 250V 2.5M 401855-102
Power Cord (Italy) Power supply cord, Italian 10A 250V 2.5M 401855-103
Power Cord (Australia) Power supply cord, Australian 10A 250V 2.5M 401855-110
Power Cord (India) Power supply cord, Indian 10A 250V 2.5M 401855-108
Printer accessories
Mounting accessories
Power Supply Mounting Bracket 12W Power supply roll stand bracket 2047870-001
Wall Mount Bracket GCX wall mount bracket for DP100 - 400 monitors CR-0008-01
IR adapter cable roll mount bracket IR adapter cable roll mount bracket 2025344-001
Connectivity accessories
Cable Assy, use with 001932 Cable assembly to use with 001932 394119-008
Cable Assy, use with 001931 Cable assembly telemetry interface DINALINK 418497-002
Cable Assy, use with 001926, Cable assembly, DINAMAP to ILC 683235
001931, 001932
FRU list
The following table offers details of each of the corresponding bubble numbers
that appear on the exploded engineering-assembly drawing (drawing is located
after this table). Photos of each FRU follow.
NOTE
FRU numbers are subject to change.
53a, j 2037103-085 FRU CARESCAPE V100 BZL, (BP & SpO2) MS-2011
54a, h 2037103-054 FRU CARESCAPE V100 BZL, (BP & SpO2 & TEMP)
54a, j 2037103-086 FRU CARESCAPE V100 BZL, (BP & SpO2 & TEMP) MS-2011
a
All SpO2 technology labels included. Select applicable label per monitor configuration.
b
Main boards configured with SuperSTAT NIBP algorithm, Nellcor SpO2, and Temperature enabled. Reconfigure as applicable per monitor
configuration. Refer to Installation Chapter 3 for more details.
c
All UI board LEDs installed. Cover LEDs with applicable fascia per monitor configuration.
d
Check valve has directional arrow indicating correct orientation for assembly.
e
Fully charge battery before initial use. Refer to Installation Chapter 3 for more details.
f
Kit includes all versions of fascia and display covers. Install per monitor configuration.
g
Remove Print button for non-printer versions of monitor. Refer to following assembly drawings.
h This part number is compatible with product code SDT only. Refer to Equipment ID on page 1-13 to determine product code.
j This part number is compatible with product code SH6 only. Refer to Equipment ID on page 1-13 to determine product code.
FRU photos
Nellcor
Ohmeda
1
2 19
3
4 13 20
5
14 21
6 15
7 16
8
10 17
9 11
22
12
18
Torque
Item Description Qty
specifications
4 Screw, No6, Torx Pan, 1.0 Inch Vib 8 in-lb 0.5 in-lb 4
Torque
Item Description Qty
specifications
22 Filter 40 Micron 10
Disassembly/reassembly of FRUs
Electrostatic discharge (ESD) precautions
All external connectors of the monitor are designed with protection from ESD
damage. However if the monitor requires service, exposed components and
assemblies inside are susceptible to ESD damage. This includes human hands,
non-ESD protected work stations or improperly grounded test equipment.
The following guidelines may not guarantee a 100% static-free workstation, but
can greatly reduce the potential for failure of any electronic assemblies being
serviced:
Discharge any static charge you may have built up before handling
assemblies containing semiconductors.
A grounded, antistatic wristband (3M part number 2046 or equivalent) or
heel strap should be worn at all times while handling or repairing
assemblies containing semiconductors.
Use properly grounded soldering and test equipment.
Use a static-free work surface (3M part number 8210 or equivalent) while
handling or working on assemblies containing semiconductors.
Do not remove assemblies from antistatic containers (Velo-stat bags) until
absolutely necessary.
Make sure power to an assembly is turned off before removal.
Do not slide electrical/electronic assemblies across any surface.
Do not touch semiconductor leads unless absolutely necessary.
Electronic assemblies should be stored only in antistatic bags or boxes.
Handle all PCB assemblies by their edges.
Do not flex or twist a circuit board.
3. Remove the tab at the top of the new fascia that includes the part number.
4. Turn the fascia over and remove the protective liner from the three pieces of
double-sided adhesive tape.
5. Turn the fascia right side up and align the fascia with the bottom notch on
the monitor.
8. Place the tabs on the bottom edge of the face plate into the slots on the
monitor.
CAUTION
Internal electronic components are susceptible to damage by
electrostatic discharge. To avoid damage when disassembling
the monitor, observe the standard precautions and procedures
for handling static-sensitive components.
Main battery
1. Remove 4 screws securing the instruction cards.
Rear case
1. Remove remaining two screws from the bottom of the monitor.
2. Set monitor upright.
3. Carefully remove the front faceplate.
7. Unplug speaker cable and temperature module cable (if installed) from
circuit board.
Printer
1. Lift the 2 black tabs and remove printer cable.
5. Locate and release retention tab and slide back sub chassis.
SpO2 board
Front bezel
1. Remove 2 SpO2 connector screws.
2. Unplug 2 pneumatic hoses from bezel.
3. Remove 4 torx-head screws along the bottom of main board.
4. Lift unit and remove bezel.
Main board
1. Remove 9 torx-head screws.
Display board
1. Carefully lift the Main board away from the UI board.
NOTE
Updated Instructions may be included in your replacement parts kit. Always
Exergen TAT
Cable replacement
1. Turn off the monitor and unplug the cable from the host communication
port on the back of the monitor.
2. On the back of the scanner, loosen the single screw at the bottom.
5. Install the replacement cable. Making sure both keyways line up, install male
connector completely into the female jack inside the scanner.
6. Tighten the battery screw.
7. Screw the cable connector jack to the host communication port on the back
of the monitor.
Specifications
General
General specifications
Mechanical
Dimensions
Power requirements
Monitor
Protection against electrical shock Internally powered or Class II when powered from specified external
power supply.
Fuses The monitor contains three fuses. The fuses are mounted within the
monitor. The fuses protect the low voltage DC input, the main battery,
and the remote alarm output. The +5 V output on the host port connector
is regulated by internal supply.
Environmental
General specifications
Storage/transportation
Radio frequency Complies with IEC Publication 60601-1-2 Medical Electrical Equipment,
Electromagnetic Compatibility Requirements and Tests and CISPR 11
(Group 1, Class B) for radiated and conducted emissions
Printer
Printer specifications
Paper type The paper roll used by the printer must be compatible with GE PN
770137.
Languages printed English, German, French, Italian, Spanish, Portuguese, Hungarian, Polish,
Czech, Finnish, Swedish, Danish, Dutch, Norwegian, and Slovak
Languages not printed Russian, Greek, Korean, Japanese, Turkish and Lithuanian
(text printed in English only)
Alarms
Alarm specifications
Alarm volume 60 dB to 75 dB
Remote alarm The remote alarm signals an alarm in 0.5 seconds of the monitors
display of the alarm.
NIBP
WARNING
Use only GE CRITIKON blood pressure cuffs. The size, shape,
and bladder characteristics can affect the performance of the
instrument. Inaccurate readings may occur unless GE
CRITIKON blood pressure cuffs are used.
NIBP specifications
Blood pressure accuracy (Classic and Auscultatory) Meets ANSI/AAMI standard SP-10 (mean error 5 mmHg,
standard deviation 8 mmHg)
Blood pressure accuracy (SuperSTAT) Meets ANSI/AAMI standard SP-10 (mean error 5 mmHg,
standard deviation 8 mmHg)
BP range (SuperSTAT)
Ohmeda SpO2
Measurement range
SpO2 1 to 100%
Accuracy*
Saturation
Adult* 70 to 100% 2 digits, whichever is greater,
(without motion)
Pulse rate
NOTE
Accuracy may vary for some sensors; always check the instructions for the sensor.
SpO2 range
Sensor model
70% to 100%
OxyTip++
SpO2 range SpO2 range SpO2 range SpO2 range SpO2 range
Sensor model
70% to 100% 90% to 100% 80% to 90% 70% to 80% below 70%
TS-SA4-GE
2 digits 1 digits 2 digits 3 digits unspecified
TS-SA-D
Nellcor SpO2
WARNING
Nellcor-labeled monitors are only compatible with Nellcor
Oximax sensors and cables.
Measurement range
SpO2 1 to 100%
Accuracy
Saturation
Pulse Rate
OXIMAX
MAX-P 2 digits
MAX-I 2 digits
MAX-FAST 2 digits
SC-A (adult) 2 digits
SC-NEO 3 digits
OxiCliq
Masimo SpO2
WARNING
Use only Masimo oximetry sensor for SpO2 measurements.
Other oxygen transducers (sensors) may cause improper SpO2
performance.
WARNING
Monitors identified as having Masimo SET technology are
compatible only with Masimo SET sensors and cables.
Measurement range
SpO2 1 to 100%
Pulse rate
SpO2 range
Sensor model
70% to 100%
LNOP
LNOP NEO-L
Foot 3 digits without motion
Finger 2 digits without motion
LNOP Hi Fi-Neo/adult
Foot 3 digits without motion
Finger 2 digits without motion
LNOP YI Multi-Site
Foot/hand 3 digits without motion
Finger/toe 2 digits without motion
Resolution
Saturation (% SpO2) 1%
Temperature
WARNING
Alaris: Use only recommended probes and probe covers. The
size, shape, and thermal characteristics of the probe covers
can affect the performance of the instrument. Inaccurate
readings may occur unless recommended probes and probe
covers are used. Visually inspect the probe prior to use to be
sure it is defect free. Please refer to the Accessories list
provided with your monitor.
Temperature specifications
Units of measure Fahrenheit (F) or Celsius (C)
Range
Alaris
Predictive Mode
NOTE:
If large changes occur in the ambient
temperature, the temperature system
can be recalibrated by cycling the
monitors power using the On/Off
button.
Determination time
Turbo Temp
Oral or rectal As fast as 7 seconds
Tri-Site
Oral As fast as 12 seconds
Rectal As fast as 11 seconds
Axillary As fast as 13 seconds
Temperature specifications
Exergen
* Automatically applied when temperature is within normal body temperature range, otherwise reads surface temperature.
Battery
Monitor - main battery
Battery specifications
Charge time Approx. 5 hours from full discharge when the monitor is off
Approx. 8 hours when the monitor on
Battery specifications
Default settings
Alarms
The factory default for alarm volume is 5.
NIBP
Non-
Adult/ped Neonate patient
specific
Systolic (mmHg)
LOW 80 40
Diastolic (mmHg)
HIGH 120 60
LOW 30 20
Inflation pressure 160 100
(for Auscultatory)
Ohmeda SpO2
Nellcor SpO2
Response mode 1
(for Mode 1: Normal response)
SatSeconds 0
Masimo SpO2
Pulse rate
Alarm volume 5
Temperature
Alaris
Unit of measure F
Exergen
Unit of measure F or C
Defined by Exergen scanner
purchased.
GE Healthcare has established accuracy using the AAMI SP-10 standard (2) and
a similar standard exists in Europe (3). The AAMI standard specifies that the
accuracy of NIBP monitors can be determined using either an invasive (intra-
arterial) or noninvasive (auscultatory) blood pressure reference. Over the last 30
years, DINAMAP accuracy has been established using an invasive central
aortic blood pressure reference. More recently, the CARESCAPE V100 vital signs
monitor has also been validated against a manual auscultatory reference.
Unlike the transducers/electrodes used in these devices, the NIBP cuff has two
functions. In addition to sensing the pressure pulses in the cuff, the cuff occludes
and then releases the patient's artery to create the conditions that allow blood
pressure to be measured.
An "artificial arm" would need to test both the sensing and occluding functions of
the cuff, and mimic the nonlinear dynamics of the artery to provide an effective
clinical simulation. While this has been attempted (4), there are no effective
"arms" available.
Commercial NIBP simulators do attempt to test both functions of the NIBP cuff.
Pressure signals are generated by the simulator in response to the inflation and
deflation cycles of the monitor. While the cuff may be in the system, it is
wrapped on a mandrel. The ability of the cuff to transducer pressure signals or
to occlude the artery is not tested.
There are further limitations to the pressure pulses used by simulators. During
the deflation of the cuff, the shape of the generated pressure oscillations
changes as the cuff goes from systolic to diastolic pressures. This is due to the
fact that the artery is only open when the arterial pressure is above cuff
pressure. As can be seen in Figures 1A-1C, the shape of the oscillation changes
as the cuff pressure changes, and the artery opens. Commercial NIBP simulators
use one waveform shape at all pressure levels, which is simply scaled to reflect
the oscillometric envelope.
"Since the CuffLink produces the same response independent of the inflate/
deflate cycle or the algorithm used by the monitor, we offer the term "Target
Value" as an approximation of the patient's actual blood pressure" (5)
"Neither the monitor or the NIBP Pump 2 is broken. Some monitors were
designed to give readings close to those obtained by the Auscultatory method of
blood pressure determinations. Other monitors have been designed to agree
with Invasive blood pressure readings. It is well known that Invasive and
Auscultatory NIBP readings on the same subject can be quite different" (6)
Simulators can also be used to test for leaks and conduct static pressure
calibration of NIBP monitors and as part of preventive maintenance programs.
Summary
The accuracy of an NIBP monitor can only be determined by comparison to a
clinical blood pressure reference. NIBP simulators are useful for certain types of
testing, but should not be used for accuracy testing.
References
1. FDA, CDRH, Non-Invasive Blood Pressure (NIBP) Monitor Guidance, March 10,
1997
2. ANSI/AAMI SP10:2002, Manual, Electronic or Automated
Sphygmomanometers
3. EN 1060-4 2004 Specification for non-invasive sphygmomanometers - Part
4: Test procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
4. Mieke, S, Substitute of simulators for human subjects; Blood Press Monit,
October 1, 1997; 2(5): 251-256
5. DNI Nevada CuffLink Non-Invasive Blood Pressure Analyzer, Operating and
Service Manual; Revision E, 11/97
6. NIBP Pump 2 Noninvasive Blood Pressure Simulator and Tester, Operations
Manual; Revision C, January 2003
CAUTION
Use of portable phones or other radio frequency (RF) emitting
equipment near the system may cause unexpected or adverse
operation.
CAUTION
The equipment or system should not be used adjacent to, or
stacked with, other equipment. If adjacent or stacked use is
necessary, the equipment or system should be tested to verify
normal operation in the configuration in which it is being used.
RF Emissions Group 1 The equipment uses RF energy only for its internal function.
EN 55011 Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF Emissions Class B
EN 55011
Harmonic Emissions Class A The equipment is suitable for use in all establishments, including
IEC 61000-3-2 domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Voltage Fluctuations/ Complies
Flicker Emissions
IEC 61000-3-3
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
Electrical Fast 2 kV for power supply 2 kV for power Mains power should be that of a typical
Transient/Burst lines supply lines commercial or hospital environment.
IEC 61000-4-4
1 kV for input/output 1 kV for input/
lines output lines
Voltage dips, <40% Ut (>60% dip in Ut) <40% Ut (>60% dip Mains power should be that of a typical
short for 5 cycles in Ut) for 5 cycles commercial or hospital environment. If the
interruptions user of the equipment requires continued
and voltage <70% Ut (>30% dip in Ut) <70% Ut (>30% dip operation during power mains interruptions, it
variations on for 25 cycles in Ut) for 25 cycles is recommended that the equipment be
power supply powered from an uninterruptible power
input lines supply or a battery.
IEC 61000-4-11
NOTE:
Ut is the AC mains voltage prior to application of the test level.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
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 reflection from
structures, objects, and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile 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 equipment is used
exceeds the applicable RF compliance level above, the equipment should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the equipment.
bOver the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
The CARESCAPE V100 vital signs monitor is intended for use in the
electromagnetic environment on which radiated RF disturbances are controlled.
The customer or the user of the CARESCAPE V100 vital signs monitor can help
prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and
the CARESCAPE V100 vital signs monitor as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum output 150 kHz to 80 MHz a 80 MHz to 800 MHz a 800 MHz to 2.5 GHz a
power of transmitter in
watts d = 1.2 P d = 1.2 P d = 2.33 P
0.01 0.12 0.12 0.23
100 12 12 23
a
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
For transmitters rated at a maximum output power not listed above, the
recommended separation distance [d] in meters (m) can be estimated using the
equitation 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:
These guidelines may not apply in all instances. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
CAUTION
The use of accessories, transducers and cables other than
those specified may result in increased emissions or decreased
immunity performance of the equipment or system.
The table below lists cables, transducers, and other applicable accessories with
which GE Healthcare claims EMC compliance.
NOTE:
Any supplied accessories that do not affect EMC compliance are not
included.
2008774-001 Alaris Turbo Temp Oral Probe, White cord, Blue 3.0 m / 10 ft
2008775-001 Alaris Turbo Temp Rectal Probe, White cord, Red 3.0 m / 10 ft
2041178-001 Alaris Sensor Tri-Site Oral Probe, White Cord (Blue) 3.0 m / 10 ft
2041179-001 Alaris Sensor Tri-Site Rectal Probe, White Cord (Red) 3.0 m / 10 ft
2044860-001 Exergen TAT-5000, default F, arterial reference (DINAMAP version) Not specified
2044860-002 Exergen TAT-5000, default C, arterial reference (DINAMAP version) Not specified
2044860-003 Exergen TAT-5000, default C, oral reference (DINAMAP version) Not specified
2044860-004 Exergen TAT-5000, default F, oral reference (DINAMAP version) Not specified
70124026 SpO2 Sensor, Max-I Infant, Adhesive, Sensor, 24/box Not specified
70124032 SpO2 Sensor, Max-N Neonate Foot Adhesive Sensor, 24/box Not specified
70124022 SpO2 Sensor, Max-P Pediatric Finger Adhesive Sensor, 24/box Not specified
70124027 SpO2 Sensor, Max-A Adult Finger Adhesive Sensor, 24/box Not specified
2028117-001 SpO2 Sensor, Max-AL Adult Long Finger Adhesive Sensor, 24/box Not specified
2002800-001 Masimo LNOP Reusable Finger Sensor LNOP/DCI Adult 1.0 m / 3.3 ft
2002799-001 Masimo LNOP Reusable Finger Sensor LNOP/DCI Pediatric 1.0 m / 3.3 ft
2027258-001 Masimo LNCS Reusable Adult Sensor Not specified
2010458-001 Masimo Disp Adhesive Sensor, LNOP-ADT. Adult (20/box) Not specified
2010459-001 Masimo Disp Adhesive Sensor, LNOP-PDT. Pediatric (20/box) Not specified
2010461-001 Masimo Disp Adhesive Sensor, LNOP-NeoPT. Neonatal (20/box) Not specified
2010460-001 Masimo Disp Adhesive Sensor Bridge, LNOP-NEO. Neonatal (20/box) Not specified
2017089-001 Masimo Disp Adhesive Sensor, LNOP-Neo-L. Neonatal (20/box) Not specified
2017090-001 Masimo Disp Adhesive Sensor, LNOP-NeoPT-L. Neonatal (20/box) Not specified
2027269-001 Masimo Disp Adhesive Sensor Transparent Tape LNOP, Adult (20/box) Not specified
2027270-001 Masimo Disp Adhesive Sensor Transparent Tape LNOP, Pediatric (20/box) Not specified
2027271-001 Masimo LNOP Disposable LNOP Hi Fi Sensor Neonatal/Adult (20/box) Not specified
2027272-001 Masimo LNOP Disposable LNOP Hi Fi Sensor Neonatal/Adult (20/box) Not specified
2027273-001 Masimo LNOP Disposable LNOP Blue Infant Thumb/Toe Sensor (20/box) Not specified
2010463-001 Masimo LNOP Reusable Multisite Sensor LNOP-YI Not specified
2027274-001 Masimo LNOP Reusable Tip-Clip Ear Sensor LKNOP TC-I Not specified
2009745-001 Masimo LNOP Reusable Finger Sensor Adult DC-195 Not specified
2027259-001 Masimo LNCS DC-IP Reusable Pediatric Sensor Not specified
2027261-001 Masimo LNCS TC-I TipClip Reusable Ear Sensor Not specified
TS-SA4-GE TruSignal Soft Adult Sensor with integrated cable and GE connector, 4 m 4.0 m / 13.1 ft
TS-SA-D TruSignal Soft Adult Sensor with integrated cable and D connector, 1 m 1.0 m / 3.3 ft
Accessories
405535-002 Power supply cord, hospital grade (US) 10A 125V 3.7 m / 12 ft
405535-014 Power supply cord, Japan ST-ST PSE 10A 250V 12FT 3.7 m / 12 ft
401855-101 Power supply cord, continental Europe 10A 250V 2.5 m / 8.2 ft
GE Medical Systems Information Technologies, Inc., a General Electric Company, doing business as
GE Healthcare.
www.gehealthcare.com
0459