Technical Reference Manual
304 Pages
Preview
Page 1
GE Healthcare
Patient Monitor B40 Technical Reference Manual
Patient Monitor B40 English 2062472-001 H (Paper) © 2013 General Electric Company. All Rights Reserved.
Patient Monitor B40 Technical Reference Manual
0459
Conformity according to the Council Directive 93/42/EEC concerning Medical Devices All specifications subject to change without notice. Order code 2062472-001 Revision H 4 March, 2013 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 © 2013 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
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 is 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 −
IP21 - degree of protection against harmful ingress of water.
In accordance with EU Medical Device Directive −
IIb.
In accordance with CISPR 11: −
Group 1 Class A;
•
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 A equipment is equipment suitable for use in all establishments other than domestic and those directly connected to a low-voltage power supply network which supplies buildings used for domestic purposes.
Trademarks Listed below are GE Medical Systems Information Technologies and GE Healthcare Finland Oy
trademarks used in this document. All other product and company names contained herein are the property of their respective owners. Datex, Ohmeda, DINAMAP, Trim Knob, Unity Network, CARESCAPE, EK-Pro, TruSignal, Entropy, GE Healthcare, GE Medical system, General Electric Company.
1
Introduction About this manual
1
1
3
Overview 1.1 1.2
1.3
2
System description 2.1 2.2 2.3 2.4 2.5 2.6
3
3.2 3.3
4.3 4.4
14
Main components... 14 3.1.1 Keyboards... 14 3.1.2 Display... 14 3.1.3 CPU board... 16 3.1.4 Power board... 17 3.1.5 AC/DC unit... 19 3.1.6 Batteries... 19 Interfacing computer... 19 Connectors and signals... 20 3.3.1 External connectors... 20
Hemo-dynamic module introduction 4.1 4.2
11
Introduction... 11 Bus structure... 11 Distributed processing... 12 Module communication... 12 2.4.1 Serial communication... 12 Parameter modules... 13 Software loading... 13
Frame functional description 3.1
4
Symbols... 4 Safety information... 8 1.2.1 General... 8 1.2.2 Safety message signal words... 8 1.2.3 Safety precautions... 8 1.2.4 ESD precautionary procedures... 9 1.2.5 Disposal... 10 Service information... 10 1.3.1 Service requirements... 10 1.3.2 Equipment identification... 10
23
Monitor software compatibility... 23 Main components... 23 4.2.1 Hemo-dynamic module... 23 4.2.2 Signals and isolation barrier... 24 4.2.3 Power supply section... 24 4.2.4 NIBP board... 25 4.2.5 ECG board in 5-lead measurement... 27 4.2.6 STP board... 29 Connectors and signals... 34 4.3.1 Front panel connectors... 34 Measurement principle... 36 4.4.1 NIBP... 36 4.4.2 ECG... 36 4.4.3 Pulse oximetry... 36 4.4.4 Temperature... 40 4.4.5 Invasive blood pressure... 40
i Document no. 2062472-001
B40 Patient Monitor
4.4.6 Respiration... 40
2
Hardware installation 1
Installation 1.1 1.2 1.3 1.4 1.5 1.6
1.7 1.8 1.9 1.10
3
1
Unpacking instructions... 2 Choosing location... 2 Mounting the monitor... 2 Connection to power... 2 Check configuration... 3 Connection to Network... 4 1.6.1 Pre-installation requirements... 5 1.6.2 To connect the network... 6 1.6.3 Network configuration... 6 Inserting and removing the E modules... 8 Monitor connections... 9 Visual indicators... 10 Installation checkout... 10
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
3
4
3
Test setup... 3 Power Outlet Test... 3 Power cord and plug... 4 Ground (earth) integrity... 4 2.4.1 Ground Continuity Test... 4 2.4.2 Impedance of Protective Earth Connection... 5 Earth leakage current test... 5 Enclosure (Touch) leakage current test... 7 Patient leakage current tests - overview... 8 2.7.1 Patient (source) leakage current test... 9 2.7.2 Patient (sink) leakage current tests... 10 Test completion... 12
Installation checkout 3.1 3.2
1
Introduction... 1 Recommended tools... 2
13
Visual inspection... 13 Functional inspection... 13 3.2.1 Start-up... 13 3.2.2 Display... 14 3.2.3 Time and date... 14 3.2.4 Parameters measurements... 14 3.2.5 Recorder... 14 3.2.6 MC or S/5 Network connection... 14 3.2.7 Conclusion... 15
Maintenance and checkout
ii Document no. 2062472-001
16
4.1 4.2
4.3
5
Adjustments and calibrations 5.1 5.2 5.3
4
24
NIBP calibrations... 24 Temperature calibration... 25 Invasive pressure calibration... 26
Troubleshooting 1
Introduction 1.1 1.2 1.3
2
3
3.5 3.6 3.7 3.8 3.9
4
Battery indicators... 6 NET section troubleshooting... 7
Hemo Troubleshooting 3.1 3.2 3.3 3.4
1
Visual inspection... 1 General troubleshooting... 2 Software troubleshooting chart... 3
Frame troubleshooting 2.1 2.2
5
Visual inspection... 16 Functional inspection... 16 4.2.1 Start-up... 16 4.2.2 Display... 17 4.2.3 Keyboard(s)... 17 4.2.4 Time and date... 17 4.2.5 Hemo Module... 17 4.2.6 Loudspeaker... 21 4.2.7 Monitor software... 21 4.2.8 Watchdog circuitry... 21 4.2.9 Network... 21 4.2.10 Final cleaning... 22 Monitor battery maintenance... 22 4.3.1 Use recommendations... 22 4.3.2 Storage recommendations... 22 4.3.3 Test the battery charge... 22 4.3.4 Charge the battery... 22 4.3.5 Condition the battery... 23 4.3.6 Replace the battery... 23
9
NIBP troubleshooting flowchart... 9 ECG troubleshooting flowchart... 10 STP troubleshooting flowchart... 11 NIBP... 12 3.4.1 NIBP toubleshooting... 12 3.4.2 NIBP error code explanation... 14 ECG... 15 Impedance respiration... 16 Pulse oximetry (SpO2)... 17 Temperature... 18 Invasive blood pressure... 18
Service Menu iii Document no. 2062472-001
B40 Patient Monitor
1
Introduction 1.1 1.2
2
SW Management 2.1 2.2 2.3 2.4 2.5 2.6
3
3.2
3.3
4 5
5.2 5.3 5.4
5.5 5.6
6
20
Keyboard Log... 21
Parameters 5.1
6
Country Settings... 7 3.1.1 Languages... 7 Network... 9 3.2.1 Network Config (MC)... 10 3.2.2 TCP/IP... 10 3.2.3 HL7... 11 3.2.4 Dri Config (S/5)... 13 3.2.5 Dri Comm (in S/5)... 13 Power supply... 15 3.3.1 Power page... 15 3.3.2 WPM Battery... 16
Keyboard 4.1
3
SW Download... 3 Active Inactive SW... 4 NIBP SW Upgrade... 4 Country Settings... 5 License... 5 Enter/Exit Demo Mode... 5
Frame 3.1
1
Service Menu structure... 1 Service Menu... 2
22
Gas Unit... 23 5.1.1 General... 23 5.1.2 Gases... 24 ECG Module... 25 5.2.1 ECG Setup... 26 STP Module (for GE SpO2)... 27 5.3.1 Calibrations... 29 NIBP Module... 30 5.4.1 NIBP Calibration... 31 5.4.2 NIBP Safety Valve... 32 5.4.3 NIBP Pneumatics... 33 SpO2 (for Masimo/Nellcor SpO2)... 34 Entropy... 34
6
Set/Test
36
7
Service Log
37
Field replaceable unit 1
Spare part 1.1 1.2 1.3 1.4
1
Front cover... 1 Back cover unit... 2 Frame... 3 Extension rack... 3
iv Document no. 2062472-001
1.5 1.6 1.7
2
Disassembly 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10
7
6
ESD precautions... 6 Reassembly precautions... 6 Required tools... 6 Before disassembly... 6 To separate the frame... 7 To disassemble the frame... 9 To disassemble the extended rack and the recorder... 15 Handling and storage of display component... 17 To replace the fuses... 17 To download the software... 17
Technical specification 1
General Specifications 1.1 1.2
2
1
Genenral specifications... 1 Defibrillator synchronization connector... 2
Parameters specifications 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10
8
Hemo box... 4 FRU parts list... 4 Other parts... 5
3
ECG specifications... 3 Impedance respiration specifications... 5 GE TruSignal SpO2 specifications... 5 Nellcor SpO2 specifications... 7 Masimo SpO2 specifications... 7 NIBP... 8 Invasive blood pressure... 9 Temperature... 9 Airway gases... 10 Entropy... 13
E-miniC Module 1
Product overview 1.1 1.2 1.3
1.4
2
Maintenance and checkout 2.1 2.2
1
Introduction... 1 Measurement principle... 1 1.2.1 CO2 measurement... 1 Main components... 2 1.3.1 Gas sampling system... 3 1.3.2 MiniC sensor... 5 1.3.3 CPU board... 5 Connectors and signals... 6
7
Replacement of planned maintenance parts... 7 2.1.1 Required parts... 7 2.1.2 Replacement procedure... 8 Visual inspections... 9 v Document no. 2062472-001
B40 Patient Monitor
2.3
3
Calibration and adjustments 3.1 3.2
4
4.3
5.2
6
9
19
Disassembly guidelines... 19 5.1.1 Serviceable parts... 19 5.1.2 Service limitations... 19 5.1.3 ESD precautions... 19 5.1.4 Before disassembly... 20 5.1.5 Tools needed... 20 Disassembly and reassembly procedure... 20 5.2.1 Replacing the pump unit... 21 5.2.2 Replacing the miniCO2 assembly... 21
Service parts 6.1 6.2
16
Visual inspection... 16 Troubleshooting checklist... 17 4.2.1 Gas sampling system troubleshooting... 17 4.2.2 MiniC sensor troubleshooting... 17 Troubleshooting charts... 18
Disassembly and reassembly 5.1
13
Sample flow rate adjustment... 13 3.1.1 Calibration setup... 13 3.1.2 Sample flow rate adjustment... 13 Gas calibration... 14 3.2.1 Calibration setup... 14 3.2.2 Procedure... 15
Troubleshooting 4.1 4.2
5
Functional checkout... 9 2.3.1 Test setup... 9 2.3.2 Procedure... 9 2.3.3 Test completion... 12
22
Ordering parts... 22 Spare parts for E-miniC... 22
E-sCO and E-sCAiO Module 1
Product overview 1.1 1.2 1.3
2
Maintenance and checkout 2.1
1
Introduction... 1 Measurement principle... 2 1.2.1 CO2, N2O, and agent measurement... 2 1.2.2 O2 measurement... 4 Main components... 4 1.3.1 Controls and connectors... 5 1.3.2 Gas sampling system... 5 1.3.3 MiniTPX measuring unit... 9 1.3.4 MiniOM Oxygen sensor... 10 1.3.5 CPU board... 12 1.3.6 MiniOM board... 12 1.3.7 Main Component Interactions... 13
14
Replacement of planned maintenance parts... 15 2.1.1 Required parts... 15
vi Document no. 2062472-001
2.2 2.3
3
Calibration and adjustments 3.1 3.2
4
4.3 4.4
5.2
6
6.2
30
Disassembly guidelines... 30 5.1.1 Serviceable parts... 30 5.1.2 Service limitations... 30 5.1.3 ESD precautions... 30 5.1.4 Protection from dust... 31 5.1.5 Before disassembly... 31 5.1.6 Required tools... 32 Disassembly and reassembly procedure... 32 5.2.1 Disassembly workflow... 32
Service parts 6.1
24
Visual inspection... 24 Troubleshooting checklist... 25 4.2.1 Gas sampling system troubleshooting... 25 4.2.2 MiniOM Measuring unit troubleshooting... 25 4.2.3 MiniTPX Measuring unit troubleshooting... 25 4.2.4 CPU board troubleshooting... 25 Messages... 26 4.3.1 Gas measurement... 26 Troubleshooting charts... 29 4.4.1 Gas measurement... 29
Disassembly and reassembly 5.1
21
Sample Flow Rate Adjustment... 21 3.1.1 Prepare... 21 3.1.2 Sample Flow Rate Adjustment... 21 Gas Calibration... 22 3.2.1 Calibration setup... 22 3.2.2 Procedure... 23
Troubleshooting 4.1 4.2
5
2.1.2 Planned Maintenance Kits... 15 2.1.3 Replacement procedures... 15 Visual inspections... 16 Functional check... 17 2.3.1 Test setup... 17 2.3.2 Procedure... 17 2.3.3 Test completion... 21
33
Ordering parts... 33 6.1.1 Planned Maintenance Kits... 33 Spare parts for E-sCAiO, E-sCO... 34 6.2.1 Front covers... 36
10 E-Entropy Module 1
Product overview 1.1 1.2
1
Introduction... 1 Measurement principle... 1 1.2.1 EntrEEG... 2 1.2.2 FEMG... 2 1.2.3 RE and SE... 2
vii Document no. 2062472-001
B40 Patient Monitor
1.3
2
Maintenance and checkout 2.1 2.2 2.3
3
4.2
5
Appendix A: 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13 1.14
1.15
10
Disassembly guidelines... 10 4.1.1 ESD precautions... 10 4.1.2 Before disassembly... 10 4.1.3 Required tools... 11 Disassembling and reassembling procedure... 11 4.2.1 To replace the front cover... 11 4.2.2 To replace the Entropy board... 11 4.2.3 Reassembling the module... 11
Service parts 5.1 5.2
8
Visual inspection... 8 Troubleshooting chart... 9
Disassembly and reassembly 4.1
5
Visual inspections... 5 Electrical safety tests... 6 Functional check... 6 2.3.1 Test setup... 6 2.3.2 Entropy tests... 6 2.3.3 Test completion... 7
Troubleshooting 3.1 3.2
4
1.2.4 Impedance measurement... 3 Main components... 3 1.3.1 Controls and connectors... 3 1.3.2 Entropy board... 4
12
Ordering parts... 12 Spare parts for E-ENTROPY... 12
Software download instruction
A-1
Overview... 1 Contents of the upgrade kit... 1 Connection methods... 1 Required equipment... 2 Workflow... 2 Prepare the connections... 2 Prepare the patient monitor(s)... 2 Prepare the service PC... 3 Start the Software Transfer Utility... 4 Specify the IP address(es) of the target patient Monitor(s)... 5 Transfer the software... 6 Activate the software... 7 Perform post software activation checkout... 8 Configuration and setup... 8 1.14.1 Language configuration... 8 1.14.2 Network setup (if required)... 8 1.14.3 User settings restore... 8 User settings record... 8
Appendix B:
ElectroMagnetic Compatibility
B-1
Appendix C:
Installation and checkout form, B40
C-1
viii Document no. 2062472-001
Appendix D:
Maintenance and checkout form, B40
D-1
Appendix E:
Service check form, E-miniC
E-1
Appendix F:
Service check form, E-sCO, E-sCAiO
F-1
Appendix G:
Service check form, E-Entropy
G-1
Appendix H:
Networking disclosure to facilitate network risk managment
H-1
ix Document no. 2062472-001
B40 Patient Monitor
x Document no. 2062472-001
1 Introduction
About this manual
Intended purpose of this device (Indications for use) This device is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40 Patient Monitor is intended for use under the direct supervision of a licensed health care practitioner. The B40 Patient Monitor is not intended for use during MRI. The B40 Patient Monitor can be a stand-alone monitor or interfaced to other devices via a network. The B40 Patient Monitor monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardia l/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), and Entropy.
Intended audience This Technical reference manual is meant for service representatives and technical personnel who install, configure, maintain, administer, troubleshoot or repair B40 monitor running the software license VSP-B.
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 2062472-001. 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.
Installation without network are allowed by customer. The network 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.
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 operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE.
1-1 Document no. 2062472-001
B40 Patient Monitor
−
The electrical installation of the relevant room complies with the requirements of the appropriate regulations.
−
The equipment is used in accordance with the “User's Guide.”
−
The equipment is installed, maintained and serviced in accordance with this manual.
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.
Related documentation −
Clinical aspects, basic methods of measurement and technical background: Patient Monitor B40 User’s Reference Manual
−
Options and selections of the software: Patient Monitor B40 Default Configuration Worksheet
−
Compatible supplies and accessories: Patient Monitor B40 Supplies and Accessories
−
Other devices closely related to the monitor:
• •
iCentral and iCentral Client User's Reference Manual CIC Pro Clinical Information Center Operator's Manual
Conventions used To help you find and interpret information easily, the manual uses consistent text formats:
Sign the check form after performing the procedure.
Within this manual, special styles and formats are used to distinguish between terms viewed on screen, a button you must press, or a list of menu commands you must select: −
Names of hardware keys on the keypad are written in bold typeface: NIBP Start/Cancel.
−
Menu items are written in bold italic typeface: Monitor Setup.
−
Emphasized text is in italic typeface.
−
When referring to different sections in this manual, section names are enclosed in double quotes: “Cleaning and care”.
−
The word “select” means choosing and confirming.
−
Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: 'Learning.'
−
Note statements provide application tips or other useful information.
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.
1-2 Document no. 2062472-001
Overview
1
Overview The B40 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.
3
2
1, 4
1.
B40 monitor frame
2.
E modules: The compatible acquisition modules
3.
Extension rack
4.
Software: VSP-B
1-3 Document no. 2062472-001
B40 Patient Monitor
1.1 Symbols -
-
On the rear panel: -
Electric shock hazard. Do not open the cover or the back. Refer servicing to qualified personnel.
-
For continued protection against fire hazard, replace the fuse only with one of the same type and rating.
-
Disconnect from the power supply before servicing.
-
Do not use the monitor without manufacturer approved mounting attached.
On the hemo module: Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement
Follow operating instructions
Refer to instruction manual/booklet
Electrostatic sensitive device. Connections should not be made to this device unless ESD precautionary procedures are followed. Type BF (IEC 60601-1) protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF (IEC 60601-1) defibrillator-proof protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type CF (IEC 60601-1) protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient, including direct cardiac application. Type CF (IEC 60601-1) defibrillator-proof protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application. In the front panel: battery
Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current
1-4 Document no. 2062472-001
Overview
Audio pause.
Home. Return to the normal screen. ON/OFF. Fuse. Replace the fuse only with one of the same type and rating
Gas inlet.
Gas outlet. IP21 SN,S/N
Degree of ingress protection. Serial number Date of manufacture. This symbol indicates the date of manufacture of this device. The four digits identify the year. Maunfacturer. This symbol indicates the name and the address of the manufacturer. European authorized representative. European Union Declaration of Conformity.
Rx Only U.S.
Prescriptive Device. USA only. For use by or on the order of a Physician or persons licensed by state law. Fragile. Handle with care.
Keep dry. Protect from rain.
This way up.
Storage temperature
Humidity limitations.
1-5 Document no. 2062472-001
B40 Patient Monitor
Atmospheric pressure limitations.
Recycled materials or may be recycled. 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/weee-recycling/index.html
A B
B
Battery operation and remaining capacity. The height of the green bar indicates the charging level. Battery (A) charging (white bar)
Battery (A) failure
B Both batteries failed
Battery (A) missing
Submenu. Selecting a menu item with this symbol opens a new menu. 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.
1-6 Document no. 2062472-001