Technical Reference Manual
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GE Healthcare
B20i Patient Monitor Technical Reference Manual
B20i Patient Monitor English 2068338-002 F (Paper) © 2021 General Electric Company All Rights Reserved.
B20i Patient Monitor Technical Reference Manual
0537
Conformity according to the Council Directive 93/42/EEC concerning Medical Devices All specifications subject to change without notice. Order code 2068338-002 Revision F 28 March, 2021 Manufacturer address: GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki Finland
www.gehealthcare.com Copyright © 2021 General Electric Company. All rights reserved.
Classifications In accordance with IEC 60601-1 −
Class I and internally powered equipment - the type of protection against electric shock.
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Type BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on each parameter module.
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Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
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Continuous operation according to the mode of operation.
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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.
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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 Dash, ProCare, DINAMAP, EK-Pro, Trim Knob, Unity Network, Datex, Ohmeda, S/5, D-fend, D-fend+, Mini D-fend, OxyTip+, EarSat, FingerSat, FlexSat are trademarks of GE Healthcare. All other product and company names are property of their respective owners.
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 Software loading... 12 Parameter modules... 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 NIBP board... 24 4.2.3 ECG board in 5-lead measurement... 26 4.2.4 ECG filtering... 28 4.2.5 STP board... 29 4.2.6 Power supply... 35 Connectors and signals... 36 4.3.1 Front panel connectors... 36 Measurement principle... 38 4.4.1 NIBP... 38 4.4.2 ECG... 38 4.4.3 Pulse oximetry... 38 4.4.4 Temperature... 42 4.4.5 Invasive blood pressure... 42 4.4.6 Respiration... 42
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Hardware installation 1
Hardware installation 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9
3
1
Unpacking instructions... 1 Choosing location... 1 Mounting the monitor... 1 Connection to mains... 2 1.4.1 Install the batteries... 2 Connection to Network... 2 1.5.1 Pre-installation requirements... 3 1.5.2 Network configuration... 3 Inserting and removing the E-miniC module... 5 Monitor connections... 7 Visual indicators... 8 Installation checkout... 8
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 2.11
3
4
13
Visual inspection... 13 Functional inspection... 13 3.2.1 Start-up... 13 3.2.2 Display... 14 3.2.3 Frame unit... 14 3.2.4 Parameters measurements... 14 3.2.5 Recorder... 14 3.2.6 Network connection... 14 3.2.7 Conclusion... 15
Maintenance and checkout 4.1
3
General... 3 Recommendations... 3 Test Equipment... 3 Power Outlet Test... 3 Power cord and plug... 4 Ground (Earth) Integrity... 4 2.6.1 Ground Continuity Test... 4 2.6.2 Impedance of Protective Earth Connection... 5 Ground (earth) wire leakage current tests... 5 Enclosure (Touch) leakage current test... 7 Patient (source) leakage current test... 9 Patient (sink) leakage current test... 10 Test completion... 12
Installation checkout 3.1 3.2
1
Introduction... 1 Recommended tools... 2
16
Visual inspection/preparation... 16 4.1.1 Before beginning... 16 4.1.2 General... 16
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4.2
5
Adjustments and calibrations 5.1 5.2 5.3
4
23
NIBP calibrations... 23 Temperature calibration... 24 Invasive pressure calibration... 25
Troubleshooting 1
Introduction 1.1 1.2
2 3
3.5 3.6 3.7 3.8 3.9
4
NET section troubleshooting... 6
Hemo Troubleshooting 3.1 3.2 3.3 3.4
1
General troubleshooting... 2 Software troubleshooting chart... 3
Frame troubleshooting 2.1
5
Functional inspection... 16 4.2.1 General... 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 Batteries... 21 4.2.10 Network... 22 4.2.11 Final cleaning... 22
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NIBP troubleshooting flowchart... 7 ECG troubleshooting flowchart... 8 STP troubleshooting flowchart... 9 NIBP... 10 3.4.1 NIBP toubleshooting... 10 3.4.2 NIBP error code explanation... 12 ECG... 13 Impedance respiration... 14 Pulse oximetry (SpO2)... 15 Temperature... 16 Invasive blood pressure... 16
Service Menu 1
Introduction 1.1 1.2
2
SW Management 2.1 2.2 2.3
1
Service Menu structure... 1 Service Menu... 2
3
SW Download... 4 Active Inactive SW... 4 Country Settings... 4
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3
Frame 3.1 3.2
3.3
4
Keyboard 4.1
5
5.2 5.3 5.4
5.5
6
17
Keyboard... 17 4.1.1 Keyboard Log... 17
Parameters 5.1
5
Country Settings... 6 Network... 8 3.2.1 Network... 8 3.2.2 Dri Config (in S/5)... 8 3.2.3 Dri Comm (in S/5)... 9 3.2.4 Unity Config (in Unity)... 11 3.2.5 TCP/IP Config... 11 Power supply... 13 3.3.1 WPM Battery... 14
18
Gas Unit... 19 5.1.1 General... 19 5.1.2 Gases... 20 ECG Module... 21 5.2.1 ECG Setup... 22 STP Module (for GE SpO2)... 23 5.3.1 Calibrations... 25 NIBP Module... 26 5.4.1 NIBP Calibration... 27 5.4.2 NIBP Safety Valve... 29 5.4.3 NIBP Pneumatics... 30 SpO2 (for Masimo/Nellcor SpO2)... 31
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Set/Test
32
7
Service Log
33
Field replaceable unit 1
Spare part 1.1 1.2 1.3 1.4 1.5 1.6 1.7
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Disassembly 2.1 2.2 2.3 2.4 2.5 2.6 2.7
1
Front cover... 1 Back cover unit... 2 Frame... 3 Extension rack... 3 Hemo box... 4 FRU parts list... 4 Other parts... 5
6
Before disassembly... 6 Tools needed... 6 To separate the frame... 7 To disassemble the frame... 9 To disassemble the extended rack and the recorder... 15 Handling and storage of LCD display component... 17 Batteries... 18 2.7.1 Battery indicators... 18
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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
8
2.7.2 To check the battery... 19 2.7.3 Conditioning the batteries... 19 To replace the fuses... 20 To download the software... 20
3
ECG specifications... 3 Impedance respiration specifications... 5 GE SpO2 specifications... 5 Nellcor SpO2 specifications... 6 Masimo SpO2 specifications... 6 NIBP... 7 Invasive blood pressure... 8 Temperature... 8 Airway gases... 9
E-MiniC Module 1 2
Introduction
1
Specifications
2
2.1 2.2
2.3
3
Functional description 3.1 3.2
3.3
4
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... 2 2.2.3 Normal conditions... 3 2.2.4 Conditions exceeding normal... 4 Respiration Rate (RR)... 4
Maintenance and checkout 4.1 4.2
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Measurement principle... 5 3.1.1 CO2 measurement... 5 Main components... 5 3.2.1 Gas sampling system... 6 3.2.2 MiniC sensor... 8 3.2.3 CPU board... 9 Connectors and signals... 10
11
Replacement of planned maintenance parts... 12 4.1.1 Required parts... 12 4.1.2 Replacement procedure... 12 Visual inspections... 13
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4.3
5
E-MiniC module disassembly and reassembly 5.1
5.2
6
Functional checkout... 13
Troubleshooting 6.1 6.2 6.3 6.4
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
17
5.0.1 Before disassembly... 17 5.0.2 Tools needed... 17 To disassemble the module... 17 5.1.1 Pump unit... 17 5.1.2 MiniCO2 assy... 18 5.1.3 Instructions after replacing MiniCO2 assy... 18 Adjustments and calibrations... 19 5.2.1 Calibrating... 19 5.2.2 Gas sampling system adjustment... 21 5.2.3 Flow rate measurement... 21 5.2.4 Flow rate adjustment... 21 5.2.5 Gas calibration... 22
23
Troubleshooting chart for CO2 measurement... 23 6.1.1 CO2 measurement... 24 Gas sampling system troubleshooting... 24 6.2.1 Sampling system leak test... 25 MiniC unit troubleshooting... 25 Error messages... 25
Software download instruction
A-1
Overview... 1 Contents of the upgrade kit... 1 Related documents... 1 Connection methods... 1 Required equipment... 2 Workflow... 2 Prepare the connections... 2 Prepare the patient monitor(s)... 3 Prepare the service PC... 4 Start the Software Transfer Utility... 5 Specify the IP address(es) of the target patient Monitor(s)... 6 Transfer the software... 7 Activate the software... 8 Perform post software activation checkout... 9
Appendix B:
ElectroMagnetic Compatibility
B-1
Appendix C:
Installation and checkout form, B20i
C-1
Appendix D:
Maintenance and checkout form, B20i
D-1
Appendix E:
Service check form, Single-width Airway Module E-miniC
E-1
vi Document no. 2068338-002
1 Introduction
About this manual
Intended purpose of this device (Indications for use) This device is a portable multiparameter 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 B20i Patient Monitor is intended for use under the direct supervision of a licensed health care practitioner. The B20i iPatient Monitor is not intended for use during MRI. The B20i Patient Monitor monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), 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, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.
Intended audience This Technical reference manual is meant for service representatives and technical personnel who install, configure, maintain, administer, troubleshoot or repair B20i monitor running the software license VSP-A.
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 2068338-002. 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.
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The electrical installation of the relevant room complies with the requirements of the appropriate regulations.
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The equipment is used in accordance with the “User's Guide.”
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The equipment is installed, maintained and serviced in accordance with this manual.
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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: B20i Parient Monitor User’s Reference Manual
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Options and selections of the software: B20i Parient Monitor Default Configuration Worksheet
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Compatible supplies and accessories: B20i Parient Monitor Supplies and Accessories
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Other devices closely related to the monitor:
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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.
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Menu items are written in bold italic typeface: Monitor Setup.
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Emphasized text is in italic typeface.
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When referring to different sections in this manual, section names are enclosed in double quotes: “Cleaning and care”.
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The word “select” means choosing and confirming.
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Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: 'Learning.'
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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.
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Overview The B20i 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.
Figure 1
B20i monitor with hemo and extension rack modules
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1.1 Symbols -
-
On the rear panel this symbol indicates the following warnings and cautions: -
Electric shock hazard. Do not open the cover or the back. Refer servicing to qualified personnel.
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For continued protection against fire hazard, replace the fuse only with one of the same type and rating.
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Disconnect from the power supply before servicing.
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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.
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. Indicates that the audio off.
In the front panel: battery
Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current Bell cancel. Audio pause.
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Home. Return to the main display. Power 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
This symbol depicts the transportation and storage atmospheric pressure range of 700 to 1060 hPa Humidity limitations
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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 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.)
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.
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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.
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1.2 Safety information 1.2.1 General This device is intended for use under the direct supervision of a licensed health care practitioner. Contact GE for information before connecting any devices to the equipment that are not recommended in this manual. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. Periodically, and whenever the integrity of the device is in doubt, test all functions. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
• •
use of the accessory in the PATIENT VICINITY; and evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
If the installation of the equipment, in the USA, will use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.
1.2.2 Safety message signal words Safety message signal words designate the severity of a potential hazard. DANGER: Indicates a hazardous situation that, if not avoided, will result in death or serious injury. No danger messages apply to this system. WARNING: Indicates a hazardous situation that, if not avoided, could result in death or serious injury. CAUTION: Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. NOTE: Indicates a hazardous situation not related to personal injury that, if not avoided, could result in property damage.
1.2.3 Safety precautions 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.
Warnings • Use only GE recommended power cords • When disconnecting the system from the power line, remove the plug from the wall outlet first
• •
Due to high voltage, use insulated screw driver High voltage on test body; do not touch it during the test
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•
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• • • •
Always check that power cord and plug are intact and undamaged
• • • •
Biomed must determine interconnected parts are safe.
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Verify compatibility of all system components prior to installation
• • •
Regular preventive maintenance should be carried out every 24 months.
• • •
Incorrect power line frequency setting could adversely affect ECG processing.
All system devices must be connected to the same power supply circuit Only interconnect devices when determined safe by qualified biomedical personnel Only devices that are specified compliant with IEC 60950-1 or IEC 60601-1 may be connected to the Ethernet MC or IX ports Do not use without manufacturer approved mounting If the software package is changed, all clinical settings will reset to factory defaults. Do not use with iCentral software V5.0.2 and earlier or Mobile Care Server software earlier of V5.2. Use only approved accessories, including mounts, and defibrillator-proof cables and invasive pressure transducers. For a list of approved accessories, see the supplies and accessories list delivered with the monitor. Other cables, transducers 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. Do not use multiple modules with identical measurements in the same monitor. The user may only perform maintenance procedures specifically described in this manual. Make sure patient is not being monitored while servicing the equipment. Don’t press power key when changing language or doing factory reset.
Cautions • Set the time of a newly added network device as close as possible to the time of devices already on the network
1.2.4 ESD 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.
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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.
1.2.5 Disposal Dispose of the whole device, parts of it and its packing material and manuals in accordance with local environmental and waste disposal regulations.
1.3 Service information 1.3.1 Service requirements Follow the service requirements listed below.
• • •
Refer equipment servicing to GE authorized service personnel only.
•
Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.
•
Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.
Any unauthorized attempt to repair equipment under warranty voids that warranty. It is the user's responsibility to report the need for service to GE or to one of their authorized agents.
1.3.2 Equipment identification Every GE device has a unique serial number for identification. The device plate is located on the rear of the patient monitor. Serial number for B20i: SN: SJWXXXXXXXXHP
1.4 Product security The patient monitoring software incorporates an assortment of security features designed to allow a flexible approach to safe and secure implementation, focusing on the principles of confidentiality, integrity, and availability. These features assist you in using the system in a manner that protects patient privacy and security in your setting, and also addresses expectations for the environment where the system will be used.
1.4.1 Security features Access control Access control is the overall mechanism used to determine and enforce the following:
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