Technical Reference Manual
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GE Healthcare
B30 Patient Monitor Technical Reference Manual
B30 Patient Monitor English 2044677-001 D (Paper) 2044678-001 D (CD) © 2010 General Electric Company. All Rights Reserved.
B30 Patient Monitor Technical Reference Manual
Conformity according to the Council Directive 93/42/EEC concerning Medical Devices All specifications subject to change without notice. Order code 2044677-001 Revision D 24 May, 2010 GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI USA Zip: 53223 Tel: 1 414 355 5000 (outside US) 800 558 5102 (US only) Fax: 1 414 355 3790 www.gehealthcare.com Copyright © 2010 General Electric Company. All rights reserved.
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, 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 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.
1
Introduction About this manual
1
1
3
Overview 1.1
1.2
2
System description 2.1 2.2 2.3 2.4 2.5 2.6
3
3.2 3.3
4.5 4.6
16
Main components... 16 3.1.1 Keyboards... 16 3.1.2 Display... 16 3.1.3 CPU board... 18 3.1.4 DC/DC board... 19 3.1.5 AC/DC unit... 21 3.1.6 Interconnection board... 21 3.1.7 Display connection cable... 22 3.1.8 Front cover parts... 23 3.1.9 Batteries... 23 Interfacing computer... 23 Connectors and signals... 24 3.3.1 External connectors... 24 3.3.2 Digital and analog outputs... 28
E-PSM(P)W module introduction 4.1 4.2 4.3 4.4
13
Introduction... 13 Bus structure... 13 Distributed processing... 14 Module communication... 14 Software loading... 15 Parameter modules... 15
Frame functional description 3.1
4
Symbols... 4 1.1.1 Symbols on transport packaging... 4 1.1.2 Symbols on equipment... 4 1.1.3 Equipment safety symbols... 5 1.1.4 Other symbols... 6 Safety... 9 1.2.1 Safety precautions... 9 1.2.2 ESD precautionary procedures... 12 1.2.3 Disposal... 12
29
Intended purpose (Indications for use)... 29 Monitor software compatibility... 29 Equipment safety symbols... 30 Main components... 30 4.4.1 E-PSMPW/E-PSMW modules ... 30 4.4.2 NIBP board... 31 4.4.3 ECG board in 5-lead measurement... 33 4.4.4 ECG filtering... 35 4.4.5 STP board... 36 Connectors and signals... 41 4.5.1 Module bus connector... 41 4.5.2 Front panel connectors... 41 Measurement principle... 43 4.6.1 NIBP... 43
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4.6.2 4.6.3 4.6.4 4.6.5 4.6.6
2
Installation 1
System installation 1.1 1.2 1.3 1.4 1.5 1.6 1.7
3
ECG... 43 Pulse oximetry... 44 Temperature... 46 Invasive blood pressure... 46 Respiration... 46
1
Unpacking instructions... 1 Choosing location... 1 Mounting the B30... 1 1.3.1 E-PSM(P)W Mounting Accessories... 2 Monitor connections... 4 Connection to mains... 6 1.5.1 Connection to Network... 6 1.5.2 Inserting and removing the parameter modules... 6 Functional check... 7 Visual indicators... 7
Maintenance 1
Instructions 1.1 1.2
2
Electrical Safety Tests 2.1 2.2 2.3 2.4 2.5 2.6
2.7 2.8 2.9 2.10
3
4
General... 4 Recommendations... 4 Test Equipment... 4 Power Outlet Test... 4 Power cord and plug... 4 Ground (Earth) Integrity... 5 2.6.1 Ground Continuity Test... 5 2.6.2 Impedance of Protective Earth Connection... 5 2.6.3 Acceptance criteria... 6 Ground (earth) wire leakage current tests... 6 2.7.1 Acceptance criteria NC (Normal condition)... 7 2.7.2 Acceptance criteria SFC (Single fault condition) - ground (earth), line or neutral open7 Enclosure (Touch) leakage current test... 8 2.8.1 Acceptance criteria NC... 9 2.8.2 Acceptance criteria SFC ñ ground (earth), line or neutral open... 9 Patient (source) leakage current test... 10 2.9.1 Acceptance criteria NC... 11 2.9.2 Acceptance criteria SFC - ground (earth), line or neutral open... 11 Patient (sink) leakage current test (mains voltage on the applied part)... 12 2.10.1 Acceptance criteria... 13
Functional check 3.1
1
Introduction... 1 Recommended tools... 2
14
Visual inspection... 14
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3.2
4
Planned maintenance 4.1
4.2
5
18
Visual inspection/preparation... 18 4.1.1 Before beginning... 18 4.1.2 General... 18 4.1.3 E-PSM(P)W Module... 18 Functional inspection... 19 4.2.1 General... 19 4.2.2 Display... 19 4.2.3 Keyboard(s)... 20 4.2.4 E-PSM(P)W Module... 20 4.2.5 Loudspeaker... 26 4.2.6 Monitor software... 26 4.2.7 Content of the service log... 27 4.2.8 Voltages... 27 4.2.9 Watchdog circuitry... 27 4.2.10 Alarm LEDs... 28 4.2.11 Membrane keys... 28 4.2.12 ComWheel... 28 4.2.13 Module communication... 28 4.2.14 Batteries... 29 4.2.15 Network... 29 4.2.16 General test... 30
Adjustments and calibrations 5.1 5.2 5.3
4
Functional inspection... 14 3.2.1 General... 14 3.2.2 Display... 15 3.2.3 Keyboard(s)... 15 3.2.4 Frame unit... 15 3.2.5 Extension Module with CO2 measurement... 15 3.2.6 Multiparameter Hemodynamic Modules... 15 3.2.7 Recorder... 16 3.2.8 Network connection... 16 3.2.9 Final... 17
32
NIBP calibrations... 32 Temperature calibration... 34 Invasive pressure calibration... 34
Troubleshooting 1
Introduction 1.1 1.2
2
Frame troubleshooting 2.1
3
3.2
4
NET section troubleshooting... 6
E-PSM(P)W Troubleshooting 3.1
1
General troubleshooting... 2 Software troubleshooting chart... 3
8
Troubleshooting flowcharts... 8 3.1.1 Troubleshooting for NIBP parameter... 8 3.1.2 Troubleshooting for ECG and STP parameters... 9 NIBP... 10
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3.3 3.4 3.5 3.6 3.7
5
Service Menu 1
Introduction 1.1 1.2
2
2.3
3 4
4.2 4.3 4.4
11
Keyboard Log... 11
Parameters 4.1
3
Memory... 3 Network... 4 2.2.1 Network... 4 2.2.2 Dri Config... 4 2.2.3 Dri Comm... 5 Power supply... 7 2.3.1 WPM Battery... 8
Keyboard 3.1
1
Service Menu structure... 1 Service Menu... 2
Frame 2.1 2.2
12
Gas Unit... 12 4.1.1 General... 13 4.1.2 Gases... 14 ECG Module... 15 4.2.1 ECG Setup... 16 STP Module... 17 4.3.1 Calibrations... 19 NIBP Module... 20 4.4.1 NIBP Calibration... 21 4.4.2 NIBP Safety Valve... 23 4.4.3 NIBP Pulse Valve... 24 4.4.4 NIBP Buttons/Leds... 25 4.4.5 NIBP Pneumatics... 26
5
Set/Test
27
6
Service Log
28
SW Settings
29
7
7.1 7.2
6
3.2.1 NIBP toubleshooting... 10 3.2.2 NIBP error code explanation... 13 ECG... 14 Impedance respiration... 15 Pulse oximetry (SpO2)... 16 Temperature... 17 Invasive blood pressure... 17
SW Download... 29 Country Settings... 30 7.2.1 Languages... 30
Field replaceable unit
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Frame spare part 1.1 1.2 1.3 1.4 1.5 1.6
2 3
E-PSM(P)W spare parts
8
Frame disassembly
12
3.1 3.2 3.3
3.4 3.5
4
24
Before disassembly... 24 Tools needed... 24 To disassemble the module... 24
Technical specification 1
General Specifications 1.1 1.2 1.3 1.4 1.5 1.6
2
1
Frame... 1 1.1.1 Electrical requirements... 1 1.1.2 Environmental requirements... 1 LCD display... 1 Batteries... 2 Network... 2 Analog Outputs, direct ECG and synchronization... 2 Digital outputs... 2
E-PSM(P)W Specifications 2.1 2.2
8
Before disassembly... 12 Handling and storage of LCD display component... 19 Batteries... 20 3.3.1 Battery indicators... 20 3.3.2 To change the batteries... 21 3.3.3 To check the battery... 21 3.3.4 Conditioning the batteries... 22 To replace the fuses... 22 3.4.1 Primary fuses... 22 3.4.2 Fuse for external DC... 22 To download the software on CPU board... 22
E-PSM(P)W module disassembly 4.1 4.2 4.3
7
1
Front panel labeling... 1 B30, service software... 1 B30, back cover unit... 2 B30, front cover unit... 4 B30, AC/DC unit... 5 Frame for B30... 6
3
General specifications... 3 Typical performance... 3 2.2.1 NIBP... 3 2.2.2 ECG... 3 2.2.3 Pulse oximetry... 4 2.2.4 Temperature... 4 2.2.5 Invasive blood pressure... 4 2.2.6 Respiration... 5
N-F(C)(REC) Module 5 Document no. 2044677-001
B30 Patient Monitor
1 2
Introduction
1
Specifications
2
2.1 2.2
2.3 2.4
3
Functional description 3.1 3.2
3.3
4
4.2
6
7
7.3
26
Extension Modules, N-FCREC, N-FREC... 26 Front panel labeling, N-FC, N-FCREC:... 27 Extension Module, N-FC... 28
Troubleshooting 7.1 7.2
18
5.0.1 Instructions after replacing MiniC unit... 18 5.0.2 Before disassembly... 18 Adjustments and calibrations... 23 5.1.1 Calibrating... 23 5.1.2 Gas sampling system adjustment... 24 5.1.3 Flow rate measurement... 24 5.1.4 Flow rate adjustment... 25 5.1.5 Gas calibration... 25
Extension Modules Spare parts 6.1 6.2 6.3
11
General service information... 11 4.1.1 MiniC measuring unit... 11 4.1.2 Recorder unit... 11 Service check... 11 4.2.1 Recommended tools... 12 4.2.2 Recommended parts... 12 4.2.3 Inspection... 12
N-FCREC Module disassembly and reassembly 5.1
5
Measurement principle... 5 3.1.1 CO2 measurement... 5 Main components... 5 3.2.1 Gas sampling system... 6 3.2.2 MiniC measuring unit... 8 3.2.3 CPU board... 9 3.2.4 Recorder board... 9 Connectors and signals... 10 3.3.1 Module bus connector... 10
Service procedures 4.1
5
General specifications... 2 2.1.1 Environmental specifications... 2 2.1.2 Functional alarms... 2 CO2 measurement... 2 2.2.1 Typical performance... 2 2.2.2 Technical specifications... 3 2.2.3 Normal conditions... 3 2.2.4 Conditions exceeding normal... 4 Respiration Rate (RR)... 4 Recorder... 4 2.4.1 Typical performance... 4
29
Troubleshooting chart for recorder unit... 29 Troubleshooting chart for CO2 measurement... 29 7.2.1 CO2 measurement... 30 Gas sampling system troubleshooting... 31 7.3.1 Sampling system leak test... 31
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7.4 7.5
MiniC unit troubleshooting... 32 Error messages... 32
Appendix A:
Software download instruction
A-1
Appendix B:
ElectroMagnetic Compatibility
B-1
Appendix C:
Functional check form, B30
C-1
Appendix D:
Planned maintenance check form, B30
D-1
Appendix E:
Service check form, Extension Module, N-FC, N-FCREC, N-FREC E-1
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8 Document no. 2044677-001
1 Introduction
About this manual
Intended audience 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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B30 Patient Monitor
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 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: ECG Setup. 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.
‘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. WARNING
Warnings are written in the following way:
WARNING
This is a WARNING.
CAUTION
Cautions are written in the following way:
CAUTION
This is a CAUTION.
NOTE
Notes 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.
WARNING
This 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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Overview
1
Overview 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
Figure 1
B30 monitor with N-FCREC (1) and E-PSM(P)W (2) modules
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1.1 Symbols 1.1.1 Symbols 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.
1.1.2 Symbols on equipment
This battery contains lead and can be recycled. LI-ION
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Overview
1.1.3 Equipment 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 (SpO2), temperature (T) and invasive pressure (P) measurement.
-
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.
-
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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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.
1.1.4 Other symbols Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current Fuse. Replace the fuse only with one of the same type and rating.
SN, S/N
Serial Number Submenu. Selecting an alternative marked with this symbol in a menu opens a new menu.
A B
Battery operation and remaining capacity. The height of the green bar indicates the charging level.
B
B
B
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.
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:
IPX class: IPX0 IPX1 IPX2 IPX3 IPX4 IPX7 IPX8
- 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. 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.)
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