GE Healthcare
3F Building 1, GE Technology Park
1 Huatuo Road
Shanghai PRC 201203
Tel: +86 21 3877 7888
Fax: +86 21 3877 7451
Intended purpose (Indications for use)
The B30 patient monitor is intended for multiparameter patient monitoring. The B30 monitor is indicated
for continuous monitoring of hemodynamic parameters (including arrhythmia and ST segment analysis)
and respiratory status and creation of limit alarms.
The B30 monitor is intended for all hospital patients and all hospital departments including intra-hospital
transport but excluding harsh physical environment like MRI.
The Patient side module E-PSM(P)W and accessories are indicated for monitoring of hemodynamic
parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including
ST-Segment and arrhythmia), impedance respiration, oscillometric NIBP (sys/dia/mean), temperature,
SpO
2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure.
Impedance respiration measurement is indicated for patients ages three years and up. The NIBP
measurement is indicated for patients who weight 5kg (11 lb) or up.The E-PSM(P)W is intended for all
hospital departments including intra-hospital transport but excluding harsh physical environment like
MRI.
The extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring of CO
respiration rate of all hospital patients. CO
2 measurements are indicated for patients who weight over 5
2 and
kg (11 lb).
The B30 monitor and N-F(C)(REC) Extension Module and E-PSM(P)W Patient Side Module are indicated for
use by qualified medical personnel only.
Classifications
In accordance with IEC 60601-1
CLASS I AND INTERNALLY POWERED EQUIPMENT – the type of protection against electric shock.
TYPE BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on
each parameter module.
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR
WITH OXYGEN OR NITROUS OXIDE.
CONTINUOUS OPERATION according to the mode of operation.
PORTABLE MONITOR
In accordance with IEC 60529
IPX1 - degree of protection against harmful ingress of water.
In accordance with EU Medical Device Directive
The B30 monitor is classified as IIb.
In accordance with CISPR 11: Group 1, Class B
• Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is intentionally
generated and/or used conductively coupled radio-frequency energy which is necessary for the
internal functioning of the equipment itself.
• Class B equipment is suitable for use in domestic establishments and in establishments directly
connected to a low voltage power supply network which supplies buildings used for domestic
purposes.
Responsibility of the manufacturer
GE Medical Systems Information Technologies, Inc. (GE) is responsible for the effects on safety, reliability
and performance of the equipment only if:
• assembly, extensions, readjustments, modifications, servicing and repairs are carried out by
personnel authorized by GE.
• the electrical installation of the monitor room complies with appropriate requirements.
• the equipment is used in accordance with the “User's Guide.”
Trademarks
Dash, Datex, Ohmeda, S/5, D-fend, D-fend+, Mini D-fend, OxyTip+, ComWheel, ComBar, EarSat, FingerSat,
FlexSat are trademarks of GE Healthcare. All other product and company names are property of their
respective owners.
Product availability
Some of the product parts and accessories mentioned in this manual may not be available in all
countries.
Please, consult your local representative for the availability.
This Technical reference manual is meant for service representatives and technical personnel
who install, configure, maintain, administer, troubleshoot or repair B30 monitor running the
software license L-DICU08.
Notes to the reader
As the monitor setup may vary, some functions described may not be available in the monitor
you are using.
•The order code for the manual is 2044677-001.
•Read the manual through and make sure that you understand the procedures described
before the installation of the monitor. To avoid risks concerning safety or health, strictly
observe the warning indications. If you need any assistance concerning the installation,
please do not hesitate to contact your authorized distributor.
The manufacturer reserves the right to change product specifications without prior notice.
Although the information in this manual is believed to be accurate and reliable, the
manufacturer assumes no responsibility for its use.
Installation and service are allowed by authorized service personnel only.
GE Healthcare assumes no responsibility for the use or reliability of its software in equipment
that is not furnished by GE.
Related documentation
For instructions for daily use including cleaning and daily maintenance, clinical aspects and
basic methods of measurement see:
B30 patient monitor, User’s Guide
B30 patient monitor, User’s Reference Manual
Software options and default settings are described in the “Default Configuration Worksheet”
delivered with each monitor.
Available accessories are described in the “Supplies and Accessories” catalog delivered with
each monitor.
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Conventions used
To help you find and interpret information easily, the manual uses consistent text formats:
Sign the check form after performing the procedure.
"
Hard KeysNames of the hard keys on the Command Board, side panel and modules are written in the
following way:
Menu ItemsSoftware terms that identify window parts or menu items are written in bold italic: ECG Setup.
Menu access is described from top to bottom. For example, the selection of the
Setup hard key, the Screen Setup menu item and the Waveform Fields menu item would be
shown as
‘Messages’Messages (alarm messages, informative messages) displayed on the screen are written inside
single quotes: ‘Please wait’.
“Sections”When referring to different sections in this manual or to other manuals, manual names and
section names are enclosed in double quotes:
See section "Cleaning and care."
Please refer to "User's Reference Manual: Alarms."
Hypertext links Hypertext links on PDF versions are written in blue color.
WARNINGWarnings are written in the following way:
Others.
Monitor
Monitor Setup - Screen Setup - Waveform Fields.
WARNINGThis is a WARNING.
CAUTIONCautions are written in the following way:
CAUTIONThis is a CAUTION.
NOTENotes are written in the following way:
NOTE: This is a NOTE.
In this manual, the word “select” means choosing and confirming.
Illustrations and names
All illustrations in this manual are only examples, and may not necessarily reflect your system
settings or data displayed in your system. If a particular selection is not available in your
system, the selection is shown grayed.
WARNINGThis Technical Reference Manual is available in English only except as
otherwise expressly required by local law or agreed to at a local level. If a
customer’s service provider requires a language other than English, it is the
customer’s responsibility to provide translation services. Do not attempt to
service the equipment unless this Technical Reference Manual has been
consulted and is understood. Failure to heed this Warning may result in
injury to the service provider, operator or patient from electric shock,
mechanical or other hazards.
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1Overview
The B30 is a modular multiparameter patient monitor. The monitor is especially designed for
monitoring in intensive care units. It can also be used during transportation within the hospital.
The modular design makes the system flexible and easy to upgrade.
NOTE: Your system may not include all these components. Consult your local representative
for the available components.
1
2
Overview
Figure 1B30 monitor with N-FCREC (1) and E-PSM(P)W (2) modules
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1.1Symbols
1.1.1Symbols on transport packaging
The contents of the transport package are fragile and must be handled with
care.
Indicates the correct upright position of the transport package.
The transport package must be kept in a dry environment.
Indicates the temperature limitations within which the transport package
should be stored.
This package can be recycled.
1.1.2Symbols on equipment
This battery contains lead and can be recycled.
LI-ION
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1.1.3Equipment safety symbols
- Attention, consult accompanying documents.
- On the modules or frames indicates that modules with identical
measurements should not be used in the same monitor. If such modules
have been inserted, remove the module that has been most recently
connected. You can also remove both modules and reconnect the new
module after five second.
- On the N-FC(REC) module indicates that the airway gases should be
calibrated every 6 months in normal use and every two months in
continuous use to ensure that the measurement accuracy remains within
specifications.
- On the E-PSM(P)W module indicates that protection against cardiac
defibrillator discharge is due in part to the accessories for pulse oximetry
(SpO
), temperature (T) and invasive pressure (P) measurement.
2
- On the rear or bottom panel this symbol indicates the following warnings
and cautions:
- Electric shock hazard. Do not open the cover or the back. Refer servicing
to qualified service personnel.
- For continued protection against fire hazard, replace the fuse only with
one of the same type and rating.
- Do not touch a battery-operated monitor during defibrillation procedure.
- Disconnect from the power supply before servicing.
- Do not use the monitor without manufacturer approved mounting
attached.
Overview
- Do not touch the monitor during defibrillation procedure.
- On top of the monitor beside the battery cover
- Use manufacturer recommended batteries only. Follow the regional
regulations for disposal.
Type BF (IEC 60601-1) protection against electric shock.
Type BF (IEC 60601-1) defibrillator-proof protection against electric shock.
Type CF (IEC 60601-1) protection against electric shock.
Type CF (IEC 60601-1) defibrillator-proof protection against electric shock.
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1.1.4Other symbols
When displayed in the upper left corner of the screen, indicates that the alarms
are silenced. When displayed in the menu or digit fields, indicates that the alarm
source has been turned off or alarm does not meet the alarm-specific activation
criteria.
ESD warning symbol for electrostatic sensitive devices. Pins of connectors
identified with the ESD warning symbol should not be touched. Connections
should not be made to these connectors unless ESD precautionary procedures
are used. For details, see section “1.2.2. ESD precautionary procedures”.
Symbol for non-ionizing electromagnetic radiation. Interference may occur in
the vicinity of equipment marked with this symbol.
Equipotentiality. Monitor can be connected to potential equalization
conductor.
Alternating current
SN, S/N
B
A
B
B
B
Fuse. Replace the fuse only with one of the same type and rating.
Serial Number
Submenu. Selecting an alternative marked with this symbol in a menu opens a
new menu.
Battery operation and remaining capacity. The height of the green bar
indicates the charging level.
Battery (A) charging (white bar)
Battery (A) failure
Both batteries have failed
B
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Battery (A) is missing
Overview
In the front panel: mains or external DC power
The monitor is connected to Network,
A blinking heart next to the heart rate or pulse rate value indicates the beats
detected.
A lung next to the respiration rate value indicates that respiration rate is
calculated from the impedance respiration measurement.
Do not reuse.
Use by. Indicates the last use day.
IPX class:
IPX0
IPX1
IPX2
IPX3
IPX4
IPX7
IPX8
Date of manufacturer
Does not contain Latex.
Do not immerse the sensor in liquids.
Degree of protection against harmful ingress of water as detailed in the
IEC 60529:
- Ordinary equipment
- Protection against vertically falling water drops.
- Protection against vertically falling water drops when enclosure tilted
up to 15 °.
- Protected against spraying water.
- Protected against splashing water.
- Protected against the effects of temporary immersion in water.
- Protected against the effects of continuous immersion in water.
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This symbol indicates that the waste of electrical and electronic equipment
must not be disposed as unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the manufacturer
for information concerning the decommissioning of your equipment.
The separate collection symbol is affixed to a battery, or its packaging, to
advise you that the battery must be recycled or disposed of in accordance
with local or country laws. To minimize potential effects on the environment
and human health, it is important that all marked batteries that you remove
from the product are properly recycled or disposed. For information on how
the battery may be safely removed from the device, please consult the service
manual or equipment instructions. Information on the potential effects on the
environment and human health of the substances used in batteries is available
at this url: http://www.gehealthcare.com/euen/weeerecycling/index.html
This symbol indicates the product contains hazardous materials in excess of
the limits established by the Chinese standard SJ/T11363-2006 Requirements
for Concentration Limits for Certain Hazardous Substances in Electronic
Information Products. The number in the symbol is the Environment-friendly
Use Period (EFUP), which indicates the period during which the toxic or
hazardous substances or elements contained in electronic information
products will not leak or mutate under normal operating conditions so that the
use of such electronic information products will not results in any severe
environmental pollution, any bodily injury or damage to any assets, the unit of
the period is "Year".
In order to maintain the declared EFUP, the product shall be operated normally
according to the instructions and environmental conditions as defined in the
product manual, and periodic maintenance schuedules specified in Products
Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP value
less than the products.Periodic replacement of those consumables or parts to
maintain the declared EFUP shall be done in accordance with the Product
Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must
be collected separately and handled properly after decommissioning.
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This product consists of devices that may contain mercury, which must be
recycled or disposed of in accordance with local, state, or country laws. (Within
this system, the backlight lamps in the monitor display contain mercury.)
Overview
1.2Safety
The following list contains general warnings and cautions you should know before installing,
maintaining or servicing the system. Warnings and cautions specific to the use of the system
can be found in the User’s Guide and User’s Reference Manual.
1.2.1Safety precautions
Warnings
WARNINGA WARNING indicates a situation in which the user or the patient may be in
danger of injury or death.
Power connection
•Use only hospital-grade grounded power outlets and power cord. Do not remove the
grounding pin from the power plug.
•Use only an intact power cord. Replace the power cord if it is cracked, frayed, broken or
otherwise damaged.
•Do not apply tension to the power cord otherwise the cord may get damaged.
•Do not use an additional multiple socket outlet, extension cord or adapters of any kind.
•Before starting to use the system, ensure that the whole combination complies with the
international standard IEC 60601-1-1 and with the requirements of the local authorities.
Do not connect any external devices to the system other than those specified.
•When detaching Patient Side modules, be careful not to drop them. Always support with
one hand while pulling out with the other.
•If the integrity of the external protective earth conductor arrangement is in doubt, use
the monitor with battery operation.
•To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
Installation
•Do not incinerate a battery or store at high temperatures as it will explode.
•The monitor or its components should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the monitor and its components
should be observed to verify normal operation in the configuration in which it will be
used.
•Pins of connectors identified with the ESD warning symbol should not be touched.
Connections should not be made to these connectors unless ESD precautionary
procedures are used. For details, see section “1.2.2. ESD precautionary procedures”
•After transferring or reinstalling the monitor, always check that it is properly connected
and all parts are securely attached. Pay special attention to this in case of stacked
mounting.
•Do not use the monitor in high electromagnetic fields (for example, during MRI.)
•Never install the monitor so that it is above the patient.
•If you accidentally drop the monitor, modules or frames, have them checked by
authorized service personnel prior to clinical use.
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•To avoid explosion hazard, do not use the monitor in presence of flammable
•Do not touch the patient, table, instruments, modules or the monitor during defibrillation.
External connection
•Do not connect any external devices to the monitor other than those specified.
Fuse replacement
•Replace a fuse only with one of the same type and rating.
Explosion hazard
•To avoid explosion hazard do not use the monitor in the presence of flammable
•Do not incinerate a battery or store at high temperatures as it will explode.
Patient safety
•Do not perform any testing or maintenance on the monitor while it is being used on a
•PACEMAKER PATIENTS: The impedance respiration measurement may cause rate
•Never install the monitor so that it is above the patient.
anesthetics.The monitor measures only non-flammable anesthetics.
anesthetics.
patient.
changes in Minute Ventilation Rate Responsive Pacemakers. In this case, set the
pacemaker rate responsive mode off or turn the monitor impedance respiration
measurement off.
•The monitor must not be used without manufacturer approved mounting attached.
•Operation of the monitor outside the specified values may cause inaccurate results.
Cleaning and service
•Only trained personnel with proper tools and test equipment should perform the tests
and repairs described in this manual. Unauthorized service may void the monitor
warranty.
•Always unplug the monitor before cleaning or service. After cleaning or service ensure
that every part of the monitor is dry before reconnecting it to the power supply.
•Do not touch any exposed wire or conductive surface while any cover is removed and the
monitor is energized. The voltages present can cause injury or death.
•Pins of connectors identified with the ESD warning symbol should not be touched.
Connections should not be made to these connectors unless ESD precautionary
procedures are used. For details, see section “1.2.2. ESD precautionary procedures”.
•NOTE! The monitor is always internally powered when the batteries are connected.
•Always perform an electrical safety check and a leakage current test on the monitor after
service.
•Handle the water trap and its contents as you would any body fluid. Infectous hazard
may be present.
Accessories
•Use only accessories, including mounts and batteries, and defibrillator-proof cables and
invasive pressure transducers approved by GE Healthcare. For a list of approved supplies
and accessories, see the “Supplies and Accessories” catalog delivered with the monitor.
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Overview
Other cables, batteries, transducers and accessories may cause a safety hazard, damage
the equipment or the system, result in increased emissions or decreased immunity of the
equipment or system or interfere with the measurement. Protection against cardiac
defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2),
temperature (T) and invasive pressure (P) measurement.
•Single use accessories are not designed to be reused. Reuse may cause a risk of
contamination and/or affect the measurement accuracy.
Cautions
CAUTIONA CAUTION indicates a condition that may lead to equipment damage or
malfunction.
Installation
•Leave space for air circulation to prevent the monitor from overheating.
•Before connecting the power cord to the power supply, check that the local voltage and
frequency correspond with the rating stated on the device plate.
Before use
•Allow two minutes for warm-up and note any error messages or deviations from normal
operation.
Autoclaving and sterilizing
•Do not autoclave any part of the monitor.
•Do not gas sterilize the modules.
Cleaning and service
•Do not use hypoclorite, ammonia-, phenol-, or acetone based cleaners. These cleaners
may damage the monitor surface.
•Do not immerse any part of the device in any liquid, or allow liquid to enter the monitor or
modules.
•Do not apply pressurized air to any outlet or tubing connected to the monitor.
•Electrostatic discharge through the PC boards may damage the components. Before
handling PC boards, wear a static control wrist strap. Handle all PC boards by their
non-conductive edges and use anti-static containers when transporting them.
•Do not break or bypass the patient isolation barrier when testing PC boards.
•If liquid has accidentally entered the system or its parts, disconnect the power cord from
the power supply and have the equipment serviced by authorized service personnel.
Special components
•Special components are used in these monitors that are vital to assure reliability and
safety. GE Healthcare assumes no responsibility for damage, if replacement components
not approved by GE Healthcare are used.
• A lithium battery on the CPU Board. Dispose of the faulty IC containing the battery
according to local regulations.
Batteries
The Lithium Ion batteries are recyclable. Follow your local recycling guidelines.
Refresh the batteries completely every six months.
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B30 Patient Monitor
To replace the batteries safely, please refer to the service instructions in this manual.
•Do not short-circuit the battery terminals, this may produce a very high current, which
will damage the battery.
•Do not dispose of the battery into open flame, nor put the battery near fire, as it may
explode.
•Do not dismantle the battery.
See also section “Symbols”.
Storage and transport
Do not store or transport the monitor outside the specified temperature, pressure and humidity
ranges:
Temperature-20 to +60 °C/-4 to 140 °F
Atmospheric pressure670 to 1060 hPa/500 to 800 mmHg
Relative humidity10 to 90% noncondensing
1.2.2ESD precautionary procedures
To avoid electrostatic charges building up, it is recommended to store, maintain and use
•
the equipment at a relative humidity of 30% or greater. Floors should be covered by ESD
dissipative carpets or similar. Non-synthetic clothing should be used when working with
the component.
•To prevent applying a possible electrostatic discharge to the ESD sensitive parts of the
equipment, one should touch the metallic frame of the component or a large metal object
located close to the equipment. When working with the equipment and specifically when
the ESD sensitive parts of the equipment may be touched, a grounded wrist strap
intended for use with ESD sensitive equipment should be worn. Refer to the
documentation provided with the wrist straps for details of proper use.
ESD precautionary procedure training
It is recommended that all potential users receive an explanation of the ESD warning symbol
and training in ESD precautionary procedures.
The minimum contents of an ESD precautionary procedure training should include an
introduction to the physics of electrostatic charge, the voltage levels that can occur in normal
practice and the damage that can be done to electronic components if they are touched by an
operator who is electrostatically charged. Further, an explanation should be given of methods
to prevent build-up of electrostatic charge and how and why to discharge one’s body to earth
or to the frame of the equipment or bond oneself by means of a wrist strap to the equipment or
the earth prior to making a connection.
1.2.3Disposal
Dispose of the whole device, parts of it and its packing material and manuals in accordance
with local environmental and waste disposal regulations.
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2System description
2.1Introduction
The B30 monitors build up a freely configurable modular system. The architecture is designed
to enable different module combinations so that the user is able to get the desirable parameter
and feature set. This modular approach makes it possible to add new features when they are
needed.
2.2Bus structure
The operation of B30 is based on two communication channels, the CPU bus and module bus.
All units, including the modules, receive power from the same power supply, which is an
integral part of the monitor frame.
Patient
Monitor
System description
Module Bus
UPI
SRAM
Memory
SerialSound
SC520 Local Bus
Code
Memory
Data
Memory
SC520
Processor
Chipset
SDRAM
PCI Bus
MiniPCI
Ethernet
Display
Controller
Figure 2General bus structure of B30 monitor
The CPU bus is a communication channel used only for internal data transfer. It is based on the
SC520 local bus and PCI bus. Data is transferred on this 32 bit wide bus using the CPU clock
frequency.
The module bus is for the parameter modules. The bus is based on the industry standard
RS-485, which uses a differential serial method to transfer data. This type of bus is robust and it
allows parameter modules to be inserted or removed while the power is on. The module bus
uses a 500 kbps data transfer rate.
The RS-485 type of serial communication supports so-called multidrop or party line
connections. This means that all parameter modules connected to the module bus use exactly
the same lines for communication. The advantage of this is that all bus connectors are
identical and the modules can be connected in any order and position.
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2.3Distributed processing
This is a multiprocessor system. All parameter modules have their own microprocessor, which
performs functions such as module key control, waveform filtering, parameter related
computing and pneumatic control, etc. At the same time the main CPU performs higher level
tasks such as trending and alarm control. While the parameter modules and CPU are
performing their tasks, the UPI (Universal Peripheral Interface) microprocessor handles all
functions needed to transfer data between the parameter modules and the CPU.
This kind of parallel processing gives one major advantage to centralized processing. When
new parameter modules are added to the system, the processing power is increased. As a
result, the system does not slow down when new features are added.
2.4Module communication
The communication master controlling data transfers between the CPU and parameter
modules is called UPI processor. It sends data to each connected module 100 times a second.
Modules respond to each data request immediately by sending a data package, whose length
depends on the type of the module. This communication protocol ensures that each module
receives and sends data every 10 ms. If a module does not respond to data requests, the UPI
processor presumes that the module is disconnected.
Parameter modules may hold a static (fixed) or dynamic address, which the UPI processor uses
when sending out data. Two parameter modules of the same type must not be fitted onto the
same monitor since they might reply to a data request simultaneously, thus causing
communication errors.
Voltage
Temp
Meas
UPI
Processor
Meas
Analog & Digital outputs
Module Bus
ComWheel Interface
Keypad Interface
Shared
SRAM
Control
PCI Bus
Logic
Figure 3Principle of UPI section operation
The UPI processor collects and stores all data that is received from the parameter modules into
a shared SRAM, which is mapped directly to the address space of the main CPU. The main CPU
reads data from the memory while the UPI processor guarantees that the data is up to date.
This operation also works in the other direction. In this the main CPU fills the shared SRAM with
data and the UPI processor distributes it to the parameter modules.
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2.5Software loading
The program memory on the CPU board is loaded with monitor software and selected
language files at the factory. The software is used for running all the functions that are
integrated into the PC board. For service upgrade main software and language files, please
refer to “Software download instruction” in Appendix A or the “B30 Patient Monitor Software
download instruction”(PN 2045710-001)
2.6Parameter modules
System description
PATIENT
Module
keys
Analog
electronics
Peripheral
drivers
A/D
converter
RAM
EEPROM
+5 V
+12 V
CPU
Isolation
transformer
Patient isolation
Opto
isolation
+13...16 V
VMOD
Data
RS485
drivers
Module Bus
Figure 4General structure of parameter modules with patient isolation
The detailed structure of a parameter module depends on the specific needs for each
individual parameter. However, some common parts are used in the parameter modules. The
electronics inside the module is usually divided into isolated (floating) and non-isolated
sections. Typically, the non-isolated section consists of buffers to interface the parameter
module to the module bus while the rest of the electronics is located in the isolated section. The
isolated section includes the microcontroller together with memory components, the front-end
analog electronics (amplifiers, etc.) and sensor drivers.
eneral_struct_of_parm_mod.vsd
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3Frame functional description
3.1Main components
3.1.1Keyboards
User interface parts
Vertical and Horizontal Membrane keypad containing 17 keys. The keypads are foil membrane
keypads. The keypads are connected to the UPI section of the CPU board.
ComWheel is used for menu selection.
3.1.2Display
The 10.4” LCD display with SVGA 800 x 600 resolution has bright long live lamps and a wide
viewing angle.
NOTE: The LCD display backlight circuit runs on a high voltage. Do not touch the inverter board
or the backlight tube leads when powered.
Backlights
Replaceable backlight lamp unit consists of two integrated cold cathode fluorescent lamps.
The backlight lamp unit is driven by a separate inverter board.
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