GE b30 Assembly instructions

GE Healthcare
B30 Patient Monitor
User’s Reference Manual
B30 Patient Monitor
English
2039820-001 C (Paper)
2044678-001 C (CD)
© 2009 General Electric Company.
All Rights Reserved.

B30 patient Monitor
User's Reference Manual
Related to software license L-DICU08
Monitoring functions
Conformity according to the Council Directive 93/42/EEC concerning Medical Devices.
All specifications are subject to change without notice.
Document no. 2039820-001
15th July, 2009
Copyright © 2009 General Electric Company. All rights reserved.
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI USA
Zip: 53223
Tel: [phone] (outside US)
800 558 5102 (US only)
Fax: [phone]
www.gehealthcare.com
GE Healthcare
3F Building 1, GE Technology Park
1 Huatuo Road
Shanghai PRC 201203
Tel: [phone]
Fax: [phone]
0459

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, SpO2 (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 CO2 and
respiration rate of all hospital patients. CO2 measurements are indicated for patients who
weight over 5 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 patient 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. 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."

Product availability
Some of the products mentioned in this manual may not be available in all countries. Please,
consult your local representative for the availability.
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.
End User License Agreement
THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE "LICENSEE," AND GE HEALTHCARE
(“GE”). IF YOU DO NOT AGREE TO ALL THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE
ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR
SALES RECEIPT TO GE FOR A FULL REFUND.
1. Grant of License. GE grants to Licensee a nonexclusive, nontransferable, restricted license,
without right to sublicense, to use the copy of the incorporated software/firmware("Software"),
and manuals and documentation related to the Software in connection with Licensee's use of
the product for their labeled purpose and only when the instrument is used with authorized
accessories and sensors, in accordance with this End User License Agreement ("Software
License"). GE reserves all rights not expressly granted to Licensee.
2. Ownership of Software/Firmware. Title to, ownership of, and all rights and interests in, any
software and/or firmware and the documentation, and all copies thereof, remain at all times
vested in GE or its partners, and they do not pass to Licensee.
3. Assignment. The rights and obligations of the Licensee under this Software License are
personal. Accordingly, neither this Software License nor any of such rights and obligations are
assignable or transferable by merger or by operation of law or otherwise without the prior
written consent of GE. You may not rent, lease, sell, or otherwise dispose of the software/
firmware or the products on a temporary basis. GE may assign this Software License and/or
any rights of Licensor hereunder, to any affiliate, or to any purchaser of substantially all of the
assets used by GE in the performance of this Software License.
4. Limitation of liability. Other than the attached limited warranty, the Software is being
licensed to Licensee "as is," without warranty of any kind, express or implied, including without
limitation the warranties of merchantability, fitness for a particular purpose, functionality, use
or performance of the Software and compatibility with particular computer systems, computer
peripherals or other software packages, title or non-infringement. Some jurisdictions do not
allow the disclaimer of implied warranties, so the above disclaimer may not apply to Licensee,
in which case the duration of any such implied warranties is limited to the longer of (i) minimum
required by law or (ii) thirty (30) days from the date the Software is received by Licensee.
In no case, including without limitation any breach of a fundamental term or a fundamental
breach of this Software license, shall GE be liable for any damages, including but not limited to
indirect, exemplary, special, consequential or incidental damages of any kind (including
without limitation lost profits), even if GE has been advised of the possibility of such damages.
These provisions hereof shall apply to the full extent permitted by law.
5. Copy Restrictions. The software/firmware and the accompanying written materials are
copyrighted. Unauthorized copying of the software, including software that has been modified,
merged, or included with other software, or other written materials is expressly forbidden. You

may be held legally responsible for any copyright infringement that is caused or incurred by
your failure to abide by the terms of this license.
6. Use Restriction. As the Licensee, you may physically transfer the products from one location
to another provided that the software/firmware is not copied. You may not electronically
transfer the software/firmware from the products to any other device. You may not disclose,
publish, translate, release or distribute copies of the software/firmware to others. You may not
modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works
based on the software/firmware, unless and to the extent specifically permitted by local law.
Your license to the software is not valid for use with any unauthorized data acquisition device.
When information of the internal structure of the Software is necessary in order to obtain
interoperability of the Software with other software programs, Licensee shall immediately
contact GE.
The Software contains proprietary and confidential information of GE and its suppliers and is
considered by GE and its suppliers to constitute valuable trade secrets. Licensee will hold the
Software in confidence and shall protect the Software with at least the same degree of care
with which Licensee protects its own similar confidential information but in no event less than
a reasonable standard of care. Licensee agrees that its officers and employees shall protect
the confidentiality of the Software and all confidential and non-public information relating
thereto and shall not disclose such information to any third party. This obligation of
confidentiality shall survive the termination of the Software License.
Licensee agrees to comply with all applicable export and re-export restrictions and regulations
imposed by the government of the United States or of the country to which the Software is
shipped to Licensee. Licensee shall not commit any act or omission, which will result in a
breach of any such export requirements. Licensee shall defend, indemnify and hold GE and all
GE's suppliers harmless from any claims arising out of Licensee's violation of such export
control laws.
Upon termination by GE or its suppliers of this Software License, Licensee shall (as advised by
GE) immediately destroy the Software and all copies thereof or return the same to GE and
within two (2) business days thereafter certify to GE in writing that in accordance with
instructions from GE or its suppliers, all copies of the Software have been either destroyed or
returned to GE, whether same is in tangible or intangible form and Licensee shall further certify
that all use thereof is and shall remain terminated.
7. No waiver. The failure of GE to enforce any provision of this Software License shall not be
considered a waiver of any subsequent breach of that provision or as a waiver of any other
provision hereof.
8. Amendments. This Software License may be modified only by a written instrument expressly
agreed to by the parties hereto.

Warranty
This Product is sold by GE Healthcare (“GE”) under the warranty set forth in the following
paragraphs. Such warranty is extended only with respect to the purchase of this Product
directly from GE or GE’s Authorized Dealers as new merchandise and is extended to the Buyer
thereof, other than for the purpose of resale.
For a period of twelve (12) months from the date of original delivery to Buyer, this Product,
other than expandable parts, is warranted against functional defects in materials and
workmanship and to conform to the description of the Product contained in this manual and
accompanying labels and/or inserts, provided that the same is properly operated under the
conditions of normal use, that regular periodic maintenance and service is performed and that
the replacements and repairs are made in accordance with the instructions provided, using
genuine parts and performed by a trained person. The foregoing warranty shall not apply if the
Product has been repaired by anyone other than GE or otherwise than in accordance with
written instructions provided by GE, or altered by anyone other than GE, or if the Product has
been subject to abuse, misuse, negligence, or accident.
GE’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above
warranty is limited to repairing or replacing, free of charge, at GE’s option, a Product, which is
telephonically reported to the nearest GE office or GE’s Authorized Dealers office and which, if
so advised by GE, is thereafter returned with a statement of observed deficiency, not later than
seven (7) days after the expiration date of the applicable warranty, to the GE office or GE’s
Authorized Dealers office during normal business hours, transportation charges prepaid, and
which, upon GE’s examination, is found not to conform to the above warranty. GE shall not be
otherwise liable for any damages including but not limited to incidental damages,
consequential damages, or special damages.
There are no express or implied warranties, which extend beyond the warranty hereinabove
set forth. GE makes no warranty of merchantability or fitness for particular purpose with
respect to the product or parts thereof.

Table of contents
i
Table of contents
About this manual
1 Safety precautions
2 System description
3 Monitoring basic
4 Alarms
5 Monitor setup
6Trends
7 Patient data management
8 Printing and recording
9 Cleaning and care
10 Troubleshooting
11 ECG
12 Pulse oximetry
13 Temperature
14 Invasive blood pressure
15 Impedance respiration
16 Non-invasive blood pressure
17 Airway gas (CO2)
Index

Table of contents
ii

Table of contents
i
Table of contents
About this manual 1
Intended audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About-1
Illustrations and names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About-1
Conventions used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About-2
Related documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About-2
Installation and service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About-3

Table of contents
ii

About this manual
1
About this manual
Intended audience
This manual is intended for clinical professionals. Clinical professionals are expected to have a
working knowledge of medical procedures, practices, and terminology, as required for
monitoring critically ill patients.
Overview
This User’s Reference Manual describes the functions offered by the B30 patient monitor
running the software license L-DICU08. As the monitor setup may vary, some menus, displays
and functions described may not be available in the monitor you are using.
This manual is an integral part of the product and describes its intended use. Keep it always
close to the equipment. Observance of the manual is a prerequisite for proper product
performance and correct operation and ensures patient and operator safety.
NOTE: Before using your monitor, please read the “User’s Guide” or this manual thoroughly.
This User’s Reference Manual gives you more specific information about the clinical and
technical aspects. Pay special attention to WARNING and CAUTION statements.
The new user of the monitor should begin with sections “Safety precautions” “System
description” and “Monitoring basic.” These sections describe the system and the basic
operation of the monitor.
The measurement sections describe the measurement technique, setup and how to adjust
displays and menus for patient monitoring and special views.
Section “Monitor setup” gives instructions about setting up the system and making changes in
the default settings. Section “Cleaning and care” describes cleaning and daily maintenance
procedures.
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 in the menu.
All names used in examples and illustrations are fictitious.

B30 Patient Monitor
2
Conventions used in this manual
To help you find and interpret information easily, the manual uses consistent text formats:
Hard keys Names of the hard keys on the Command board, side panel and
modules are written in the following way: Others.
Menu items Software terms that identify window parts or menu items are written
in bold italic: Lab Data.
Menu access Menu access is described from top to bottom. For example, the
selection of the Monitor Setup hard key, the Screen Setup menu
item and the Waveform Fields menu item would be shown as
Monitor Setup - Screen Setup - Waveform Fields.
File names etc. File names, file paths and text to be entered are written in the
following way: comm.exe.
Messages Messages (alarm messages, informative messages) displayed on the
screen are written inside single quotes: ‘Please wait.’
References 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 "Technical
Reference Manual: Installation."
WARNING This is a WARNING.
CAUTION This is a CAUTION.
NOTE This is a NOTE.
The following symbols are also used to distinguish procedures:
Related documentation
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.
For more information about the iCentral, see the “iCentral User’s Reference Manual”.
Press the menu key described.
Turn the ComWheel.
Push the ComWheel.
ECG

About this manual
3
Installation and service
A separate “Technical Reference Manual” describes installation, interfacing, connectors,
service, maintenance and reparation procedures of the monitor.
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the “Technical
Reference Manual” by qualified personnel.
Service and repairs are allowed for authorized service personnel only.

B30 Patient Monitor
4

Table of contents
i
Table of contents
1 Safety precautions 1-1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
ESD precautionary procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
ESD precautionary procedure training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Points to note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

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ii

Safety precautions
1-1
1 Safetyprecautions
The following list contains all the general warnings and cautions you should know before
starting to use the system. Warnings and cautions specific to parts of the system can be found
in the relevant section.
Warnings
WARNING A WARNING indicates a situation in which the user or the patient may be in
danger of injury or death.
•To avoid explosion hazard, do not use the monitor in presence of flammable anesthetics.
•Connect only one patient to the monitor at a time.
•Do not use the monitor without manufacturer approved mounting attached.
•Use only hospital-grade grounded power outlets and power cord.
•To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
•Do not use an additional multiple socket outlet, extension cord or adapter of any kind.
•Use only an intact power cord.
•Do not user the power cord for any other product or purpose.
•Do not apply mechanical tension to the power cord, otherwise it may be damaged.
•Some equipment malfunctions may not generate a monitor alarm. Always keep the
patient under close surveillance.
•Never install the monitor so that it is above the patient.
•Do not use the monitor in high electromagnetic fields (for example, during MRI).
•Do not connect any external devices to the system other than those specified.
•Do not touch the patient, table, instruments, modules or the monitor during defibrillation.
•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 ”ESD precautionary procedures” page 1-2.
•Use only approved accessories, including mounts and batteries, and defibrillator-proof
cables and invasive pressure transducers. For a list of approved supplies and accessories,
see the "Supplies and Accessories" catalog delivered with the monitor. Other cables,
transducers, batteries and accessories may cause a safety hazard, damage the
equipment or 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 re-used. Re-use may cause a risk of
contamination and affect the measurement accuracy.
•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 configuration in which it will be used.

B30 Patient Monitor
1-2
•When detaching modules, be careful not to drop them. Always support with one hand
while pulling out with the other.
•If you accidentally drop the monitor or modules, have them checked by authorized
service personnel prior to clinical use.
•If the integrity of the external protective earth conductor arrangement is in doubt, use the
monitor with battery operation.
•Vibrations during intrahospital transport may disturb SpO2, ECG, impedance respiration,
InvBP and NIBP measurements.
•If the unit fails to respond as described, do not use the monitor until tested and repaired
by authorized service personnel.
•The system is intended for use by qualified medical personnel only.
•When using the electrosurgery unit, ensure proper contact of the ESU return electrode to
the patient to avoid burns at monitor measurement sites.
•Make sure that the leadwire set clips or snaps do not touch any electrically conductive
material including earth.
Cautions
CAUTION A CAUTION indicates a situation in which the unit or the devices connected to it
may be damaged.
•Before connecting the power cord to a power supply, check that the local voltage and
frequency correspond with the rating stated on the device plate.
•Leave space for air circulation to prevent the monitor from overheating.
•Do not store or use the monitor outside the temperature and humidity ranges specified in
“Performance” in section “System description” of this manual.
•Refresh the batteries completely every six months.
ESD precautionary procedures
•To avoid electrostatic charges to build 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 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 content 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