Technical Manual
272 Pages
Preview
Page 1
GE Healthcare
B125/B105 Patient Monitor Technical Manual
B125/B105 Patient Monitor English 2105518-001 E © 2019 General Electric Company All rights reserved.
The information in this manual applies to the software version listed on the first page of the manual. Due to continuing product innovation, specifications in this manual are subject to change without notice.
2
B125/B105 Patient Monitor
2105518-001 2019-02-25
Contents 1
About this manual ...15 Intended use of this manual... 15 Intended audience of this manual ... 15 About these devices... 15 Safety precautions ... 15 Manual conventions ... 15 Related documents... 16 Ordering manuals ... 16 Manufacturer responsibility ... 16 Product availability ... 16
2
System overview...19 General safety statements ... 19 Safety message signal words... 19 IEC 60601-1 ... 19 System components ... 20 Network central station ... 21 Other devices... 21 Controls and connectors ... 22 Front view ... 22 Main side view ... 22 Main back view... 23 Hemodynamics connectors ... 24 E-COP module... 24 E-miniC module ... 25 E-sCAiO, E-sCO and N-CAiO module ... 25 E-Entropy module... 26 B1X5-F2 Frame... 26 Recorder ... 27 Keypad ... 27 Service information... 28 Service requirements ... 28
2105518-001
B125/B105 Patient Monitor
3
Equipment identification... 28 Equipment symbols ... 29 User interface symbols ... 35 3
Theory of operation...37 System block diagram ... 37 Main components ... 38 CPU board... 38 Carrier board ... 40 AC/DC unit ... 41 Display subsystem ... 41 Recorder unit ... 42 Battery ... 42 User interface parts ... 42 Hemo module... 42 Non-standard connectors and signals... 52 Multi I/O connector ... 52 Nurse call connector... 53 Serial port connector ... 54 Recorder connectors... 54 Defibrillator synchronization connector ... 55 Measurement principle... 55 ECG measurement principle ... 55 Respiration measurement principle... 55 Pulse oximetry measurement principle ... 56 NIBP measurement principle... 57 Invasive blood pressure measurement principle ... 58 Temperature measurement principle ... 58
4
Pre-installation requirements...59 Unpacking ... 59 Checking the compatibility of all system components... 59 Network infrastructure ... 60 Checking MC Network infrastructure... 60 Checking wireless MC Network infrastructure ... 60 Checking HL7 Network infrastructure ... 60
4
B125/B105 Patient Monitor
2105518-001
Installing the mounting hardware ... 60 Power and environmental requirements... 61 Checking environmental requirements ... 61 Checking power requirements ... 61 Checking EMI & RFI interference ... 61 5
Hardware installation ...63 Hardware installation ... 63 Installing battery ... 64 Battery test button ... 64 Inserting and removing battery ... 65 Checking the battery charge with monitor software... 65 Mounting the monitor and frame ... 65 Installing L-type mounting plate to B1X5-F2 Frame ... 66 Connecting a display ... 66 Connecting B1X5-F2 module ... 66 Connecting E-module ... 67 Connecting the recorder... 67 Inserting the recorder ... 68 Removing the recorder ... 68 Connecting Multi I/O adapter... 69 Connecting to the mains power... 69 Connecting network... 69 Network compatibility... 69 Network diagram ... 70 Connecting to the MC Network ... 71 Connecting iCollect ... 71 After hardware installation... 71
6
Using service interface ...73 Service interface ... 73 Parameters... 74 Gas Unit ... 75 STP module ... 77 ECG module ... 78 NIBP module ... 78
2105518-001
B125/B105 Patient Monitor
5
COP module ... 79 Entropy module ... 81 Country settings ... 83 License... 83 Service log ... 85 Enter/Exit Demo Mode... 86 Set/test ... 86 Network ... 87 Network configuration ... 87 TCP/IP ... 88 HL7 configuration... 89 Diagnosis ... 90 Wireless ... 91 WLAN status ... 91 WLAN Configuration - Basic ... 92 WLAN Configuration - Advanced... 96 Software management... 99 Software upgrade ... 99 Module upgrade ... 100 USB disk upgrade ... 100 7
Configuration ...103 Platform Configuration ... 103 Adjusting display ... 103 Adjusting the display brightness ... 103 Adjusting the slave display ... 103 Configuring wired CARESCAPE Network ... 103 Configuring HL7 Network ... 104 Configuring wireless CARESCAPE Network... 104 Configuring wireless network via USB disk... 104 Configuring wireless Network basic settings manually ... 105 Configuring wireless Network advanced settings manually ... 109 Setting time and date ... 110 Setting time zone ... 110 Setting national requirements... 111
6
B125/B105 Patient Monitor
2105518-001
Setting power frequency ... 111 Changing passwords ... 111 Resetting password... 111 Transferring settings from a monitor to another ... 112 Exporting settings ... 112 Importing settings ... 112 License management ... 112 Software management... 113 Software download... 113 Activating the software... 113 8
Installation check ...115 Installation check procedure... 115 Performing visual inspection... 115 Functional check ... 115 Checking the startup... 116 Checking display ... 116 Checking the time and date ... 116 Checking the device information ... 116 Testing the B1X5-F2 frame ... 117 Checking parameters... 117 Testing the recorder ... 117 Testing MC Network ... 118 Testing wireless LAN configuration... 118 Completing the check procedure... 118 Verification procedure for wireless MC Network infrastructure... 118 Purpose and scope... 118 Test equipment and documentation needed... 119 Test plan... 119 Test setup... 120 Test execution ... 121 Summary and reporting ... 121
9
Electrical safety tests ...123 Electrical safety tests ... 123 Test setup... 123
2105518-001
B125/B105 Patient Monitor
7
Verifying power outlet... 124 Verifying power cord and plug ... 124 Ground earth integrity check ... 124 Testing ground continuity... 124 Checking impedance of protective earth connection ... 125 Testing earth leakage current ... 125 Testing enclosure (touch) leakage current... 127 Patient leakage current tests ... 128 Testing patient (source) leakage current ... 129 Testing patient (sink) leakage current ... 130 Completing electrical safety tests ... 131 10 Maintenance check...133 Planned and corrective maintenance procedures ... 133 Planned maintenance... 133 Corrective maintenance ... 134 Performing visual inspection... 134 Functional check ... 134 Checking the startup... 134 Checking display ... 135 Checking the time and date ... 135 Checking the device information ... 135 Testing the B1X5-F2 frame ... 136 Checking parameters... 136 Testing MC Network ... 142 Testing wireless LAN configuration... 143 Testing the recorder ... 143 Testing defibrillator synchronization marker out signals... 143 Completing the check procedure... 144 11 Calibration and adjustments ...145 NIBP calibration... 145 Required tools for NIBP ... 145 Making connections... 145 Calibrating NIBP ... 146 Invasive pressure calibration ... 146
8
B125/B105 Patient Monitor
2105518-001
Required tools... 147 Making connections... 147 Calibrating invasive pressure ... 147 Calibrating invasive pressure (by simulator)... 148 Temperature calibration... 148 Required tools... 148 Making connections... 149 Calibrating temperature ... 149 12 Troubleshooting...151 Troubleshooting guidelines ... 151 Performing basic troubleshooting... 151 Viewing and downloading service log ... 152 Checking the battery charge with monitor software... 153 Network diagnostics ... 153 Messages... 154 Messages related to various situations ... 154 Messages related to ECG measurement ... 157 Messages related to impedance respiration measurement ... 158 Messages related to SpO2 measurement ... 158 Messages related to NIBP measurement ... 160 Messages related to invasive pressures measurement... 162 Messages related to temperature measurement ... 164 Problems and solutions ... 165 Start-up failures... 165 Battery issue ... 166 User interface issues... 166 B1X5-F2 frame issues ... 167 Recorder issue ... 167 Acquisition module problems... 167 Troubleshooting CARESCAPE Network communication ... 168 Parameter issues... 171 13 Disassembly and reassembly...173 Disassembly guidelines ... 173 ESD precautions ... 173
2105518-001
B125/B105 Patient Monitor
9
Reassembly precautions... 174 Required tools... 174 Preparing for disassembly ... 175 Replacing the main fuses ... 175 Detaching the extension rack, hemo module and wireless module... 176 Detaching the frame... 177 LCD converter board connectors ... 178 Replacing the user interface parts... 178 Replacing LCD converter board, display, and front cover ... 179 Detaching the middle cover ... 179 Replacing the handle ... 180 Detaching the battery chamber... 180 Replacing the AC/DC module ... 180 Replacing the carrier board... 181 Detaching the recorder ... 181 14 Service parts...183 Service parts... 183 Ordering parts ... 183 Front cover... 183 Back cover ... 184 Frame... 185 Hemo box ... 185 Rack and recorder... 186 List of FRUs ... 186 15 E-COP module...191 About this chapter ... 191 Maintenance check... 191 About the maintenance check procedures ... 191 Performing visual inspection ... 192 Performing electrical safety test *... 192 Performing functional check ... 192 Configuration ... 195 Calibration and adjustments... 195
10
B125/B105 Patient Monitor
2105518-001
Invasive pressure calibration... 195 16 E-sCAiO, E-sCO, N-CAiO module...199 About this chapter ... 199 Maintenance check... 199 About the maintenance check procedures ... 199 Replacement of planned maintenance parts... 200 Performing visual inspection ... 202 Performing functional check ... 202 Configuration ... 206 Calibration and adjustments... 206 Sample flow rate adjustment ... 206 Gas calibration ... 207 17 E-miniC module...211 About this chapter ... 211 Maintenance check... 211 About the maintenance check procedures ... 211 Replacement of planned maintenance parts... 212 Performing visual inspection ... 213 Performing functional check ... 213 Configuration ... 216 Calibration and adjustments... 216 Sample flow rate adjustment ... 216 Gas calibration ... 217 18 E-Entropy module ...221 About this chapter ... 221 Maintenance check... 221 About the maintenance check procedures ... 221 Planned maintenance... 221 Corrective maintenance ... 222 Performing visual inspection ... 222 Performing electrical safety test *... 222 Performing functional check ... 222 Configuration ... 223 Calibration and adjustments... 223
2105518-001
B125/B105 Patient Monitor
11
19 Product privacy and security ...225 Introduction ... 225 Privacy & Security Environment ... 225 Privacy & Security capabilities ... 225 Access controls... 226 Privacy & security audit logging and accountability controls ... 227 Information protection ... 227 Network security ... 228 Wireless Security ... 229 Removable media security ... 229 Data integrity capabilities... 230 De-identification capabilities ... 230 Business continuity ... 230 System protection ... 230 Malicious software protection ... 230 System (product) change management ... 231 Personal information collected by the product... 231 Additional privacy & security considerations ... 232 MDS2... 232 20 Networking disclosure to facilitate network risk management ...233 Purpose and scope ... 233 Purpose for B125/B105 monitor connection to network ... 233 Network interface technical specifications ... 233 Network information flows... 235 Required characteristics and configuration for support ... 236 Potential risks to safety, effectiveness or security resulting from failure of IT network to provide the required ... 236 A
Software download instruction...239 Introduction ... 239 Contents of the USB storage device ... 239 Tools needed ... 239 Installing software with PC ... 239 Connecting a service PC to a patient monitor or to the Network for multiple patient monitors ... 239
12
B125/B105 Patient Monitor
2105518-001
Checking the network settings of the patient monitors ... 240 Checking and configuring the network settings of the service PC ... 240 Launching the Software Transfer Utility ... 240 Specifying the IP addresses of the target patient monitors ... 241 Entering the IP addresses manually... 241 Uploading the IP addresses from text file... 242 Transferring the software ... 243 Installing software with USB... 244 Preparing the USB disk... 244 Transferring the software with USB ... 245 Activating the software... 245 Performing post software activation checkout... 246 B
Installation checkform ...247 B125/B105 Patient Monitor installation check... 247
C
Electrical safety tests checkform ...251 Electrical safety tests ... 251
D
Maintenance checkform ...255 B125/B105 Patient Monitor maintenance check ... 255
E
E-COP module checkform ...259 Maintenance check form, E-COP ... 259
F
E-sCAiO, E-sCO, N-CAiO modules checkform ...261 Maintenance check form, E-sCAiO, E-sCO, N-CAiO ... 261
G
E-miniC module checkform ...265 Maintenance check form, E-miniC ... 265
H
E-Entropy module checkform...267 Maintenance check form, E-Entropy ... 267
I
Wireless network infrastructure checkform ...269 Wireless MC Network infrastructure checkform ... 269
2105518-001
B125/B105 Patient Monitor
13
14
B125/B105 Patient Monitor
2105518-001
About this manual
1
Intended use of this manual As the monitor configuration may vary, some menus, displays and functions described may not be available in the monitor you are using. This manual contains instructions necessary to install, maintain and service the device to the assembly level. It gives an overview of the patient monitoring system and contains information needed for system installation. Information for the planned and corrective maintenance of the device is also provided. Use the manual as a guide for installation, maintenance and repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and technical assistance. See each module’s Technical Manual for introduction, troubleshooting, disassembly and reassembly, service parts section. See the supplemental information manual for the technical specifications, default settings and compatibility information, including electromagnetic compatibility. See the user’s manual for the instructions necessary to operate the device safely in accordance with its function and intended use.
Intended audience of this manual This manual is intended for service representatives and technical personnel who install, maintain, troubleshoot, or repair this device.
About these devices Refer to the user’s manual for important information about the Patient Monitor B125/B105, including intended use of these devices, important safety information and detailed instructions for clinical use of these products.
Safety precautions Refer to the user’s manual for important system safety messages. Safety messages specific to parts of the system are found in the relevant section. Read all the safety information before using the monitor for the first time.
Manual conventions This manual uses the following styles to emphasize text or indicate action.
2105518-001
B125/B105 Patient Monitor
15
About this manual
Item
Description
bold
Indicates hardware terms.
bold italic
Indicates software terms.
italic
Indicates terms for emphasis.
>
Indicates menu options to select consecutively.
CARESCAPE Network
CARESCAPE Network is used to refer to the MC Network.
select
The word select means choosing and confirming.
NOTE
Note statements provide application tips or other useful information.
Related documents ●
B125/B105 Patient Monitor User’s Manual
●
B125/B105 Patient Monitor Supplemental Information Manual
●
B125/B105 Patient Monitor Supplies and accessories
●
B125/B105 Patient Monitor Software Installation Instructions
●
WLAN configuration guide
●
WLAN Deployment Guide
●
iCollect user’s manual
●
CARESCAPE Network Configuration Guide
●
CIC Pro Clinical Information Center Operator's Manual
●
CARESCAPE Central Station User’s Manual
●
HL7 Reference Manual
●
B125/B105 Patient Monitor service for depot instruction
Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.
Manufacturer responsibility GE is responsible for the effects on safety, reliability, and performance of the equipment only if: ●
Assembly operations, extensions, readjustments, modifications, servicing, or repairs are carried out by authorized service personnel.
●
The electrical installation of the relevant room complies with the requirements of the appropriate regulations.
●
The equipment is used in accordance with the instructions for use.
Product availability NOTE
16
Due to continual product innovation, design and specifications for these products are subject to change without notice.
B125/B105 Patient Monitor
2105518-001
About this manual
Some of the products mentioned in this manual may not be available in all countries. Please consult your local representative for the availability.
2105518-001
B125/B105 Patient Monitor
17
About this manual
18
B125/B105 Patient Monitor
2105518-001
System overview
2
General safety statements 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 Clause 16 medical electrical systems standard. Refer to the patient monitor’s supplemental information manual for compatible parts and accessories. Periodically, and whenever the integrity of the product 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
●
evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1 Clause 16 harmonized national standard.
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.
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.
NOTICE
Indicates a hazardous situation not related to personal injury that, if not avoided, could result in property damage.
IEC 60601-1 Monitor
2105518-001
B125/B105 Patient Monitor
19
System overview
● ● ● ● ● ● ●
Type of protection against electrical shock: Class I. Internally powered ME equipment. Degree of protection against electrical shock: applied parts are marked with a symbol indicating degree of protection. Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide: Not suitable. Degree of protection against harmful ingress of water: IP21. Mode of operation: Continuous. Method(s) of sterilization or disinfection recommended by the manufacturer: see the User’s Manual. Portable monitor.
B1X5–F2 Frame ● ● ● ● ● ● ●
Type of protection against electrical shock: Class I. Degree of protection against electrical shock: applied parts are marked with a symbol indicating degree of protection. Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide: Not suitable. Degree of protection against harmful ingress of water: IP21. Mode of operation: Continuous. Method(s) of sterilization or disinfection recommended by the manufacturer: see the User’s Manual. Portable frame.
System components All components listed below can be used within the patient environment as long as an additional transformer providing at least basic isolation is used with non-medical grade secondary displays and printers. Your system may not include all these components. Consult your local representative for the available components. NOTE
20
It is not recommended the system be connected to other non-isolated monitoring equipment or communication networks. In this event it is the end user's responsibility to ensure compliance with IEC60601-1 or other IEC standards.
B125/B105 Patient Monitor
2105518-001