B155M ,B125M,B125P,B105M and B105M Technical Manual Rev 5 Feb 2021

Revision history Revision

Date

Reason for change

1

2020-01-07

Initial release.

2

2020-04-20

Design change.

3

2020-05-19

Manufacture release.

4

2020-09-08

Update Disassembly, Service parts chapters, and some places of wordings.

5

2021-02-04

Update for 802.1x contents, after CPU replacement procedure.

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Contents About this manual ...1 Intended use of this manual ... 1 Intended audience of this manual... 1 Manual conventions ... 1 Acquisition module naming conventions... 1 Illustrations and names ... 2 Related documents... 2 Accessing manuals online... 2 Accessing manuals on monitor ... 2 Trademarks... 3 Third party trademarks... 3 Manufacturer responsibility... 3 Product availability ... 3

Safety...4 Safety message signal words ... 4 System safety... 4 Service requirements... 5 Equipment symbols ... 5 Unique Device Identifier (UDI)... 9

Using service interface ... 11 Using service interface ... 11 Service menu on monitor...11 InSite RSvP... 12 Field Force Automation ...12 Accessing the remote service with a service PC...13 Checking the network settings of the target monitor ...13 FFA supported web browser in service PC...14 Accessing Field Force Automation (FFA) over network with a service PC ...14 Using the remote service with a service PC...14 Starting an FFA workflow...14 Enabling or disabling the remote service connection ...15 Transferring logs via InSite RSvP...15 Viewing logs ... 15

Pre-installation requirements ... 16 Unpacking... 16 Pre-installation checklist... 16

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Checking the compatibility of all system components...16 Network infrastructure ... 17 Checking MC Network infrastructure...17 Checking wireless MC Network infrastructure...17 Checking HL7 Network infrastructure ...17 Mounting solutions ... 17 Power and environmental requirements ...18 Checking power requirements ...18 Checking environmental requirements ...18 EMC warnings... 18 EMC cautions... 20

Hardware installation... 21 Hardware installation ... 21 Mounting the monitor and frame ...22 Installing mounting plate to monitor...22 Installing L-type mounting plate to B1X5-F2 Frame...22 Connecting a display ... 23 Connecting B1X5-F2 module...23 Connecting E-module ... 23 Connecting the B1X5-REC recorder ...24 Inserting the B1X5-REC recorder...24 Connecting to the mains power...24 Connecting network... 24 Network compatibility ...24 Network diagram... 25 Connecting to the MC Network ...26 Connecting iCollect... 26 After hardware installation ...26

Configuration ... 27 Platform Configuration... 27 Password management... 27 Setup password at first time to use ...27 Import settings from USB at first time to use...27 Setup password manually ...27 Changing passwords ...28 Setup the password policy...28 Bad password ... 29 Password expired...29 Generate and export recovery key ...29 Reset passwords... 29 Resetting password via activation code ...29 Resetting password via recovery key in USB ...30 5828003-EN Revision 5

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Configuring wired CARESCAPE Network...30 Configuring LAN 802.1X...30 Configuring HL7 Network...32 Configuring iCollect serial port ...32 Configuring wireless CARESCAPE Network ...32 Configuring wireless network via USB disk...32 Configuring wireless Network basic settings manually...33 Configuring wireless network advanced settings manually...36 Certificate build up and import...37 Generating and importing the Client Certificate...37 Importing CA Certificate to the monitor ...37 Setting time and date ... 38 Setting time zone... 38 Setting national requirements...39 Setting power filter ... 39 Setting roving... 39 Configuring remote service ...39 Settings management ... 40 Saving current settings ...40 Resetting to factory settings ...40 Selecting default mode ...40 Transferring settings from a monitor to another ...41 Exporting settings ...41 Importing settings...41 License management... 41

Calibration and adjustments ... 43 NIBP calibration... 43 Required tools for NIBP...43 Making connections... 43 Calibrating NIBP ... 44 Invasive pressure calibration...44 Required tools... 45 Making connections... 45 Calibrating invasive pressure ...45 Calibrating invasive pressure (by simulator) ...46 Temperature calibration ...46 Required tools... 46 Making connections... 47 Calibrating temperature...47

Checkout procedures... 48 About the checkout procedures...48 5828003-EN Revision 5

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Required checkout procedures...48 Installation check ... 49 Planned maintenance check ...49 Corrective maintenance check...50 Performing visual inspection ...50 Electrical safety tests *... 50 Test setup ... 51 Verifying power outlet...52 Verifying power cord and plug ...52 Ground integrity check...52 Testing ground continuity...52 Checking impedance of protective earth connection ...53 Testing earth leakage current ...53 Testing touch leakage current ...55 Patient leakage current tests...56 Testing patient (source) leakage current ...57 Testing patient (sink) leakage current...58 Completing electrical safety tests ...60 Performing functional check...60 Checking the startup...60 Checking display ... 60 Testing picture quality ...60 Testing touchscreen control...60 Checking the time and date...60 Checking the device information...61 Testing the B1X5-F2 frame...61 Testing the B1X5-REC recorder...61 Testing wired MC Network ...61 Testing wireless LAN Network...62 Testing wireless LAN configuration ...62 Checking performance of wireless MC Network infrastructure...63 Testing InSite RSvP connectivity...63 Checking parameters for installation ...63 Checking parameters for maintenance ...63 Required tools for functional check ...63 Configuring monitor for functional check...64 Configuring simulator for functional check...65 Testing ECG measurement * ...66 Testing impedance respiration measurement ...66 Testing SpO2 measurement * ...66 Testing NIBP measurement * ...67 Testing invasive pressure measurement * ...67 Testing temperature measurement *...68 Completing the check procedure ...68

Software download... 69 About this introduction... 69

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Contents of the USB storage device...69 Installing software, firmware and e-manuals ...69 Preparing the USB disk...69 Transferring the software, e-manuals, and firmware with USB...70 Performing post checkout ...71

Theory of operation ... 72 System block diagram... 72 Main components... 73 CPU board ... 73 Main board... 74 AC/DC power supply ...76 Battery ... 76 Display subsystem ... 76 Display... 76 LED backlight unit ...76 Touchscreen... 76 B1X5-F2 frame... 76 B1X5-REC Recorder ... 77 User interface parts... 77 Non-standard connectors and signals ...77 Nurse call connector ...77 Serial port connector ...77 B1X5-REC recorder connectors...78 B1X5-F2 frame connectors ...79 Defibrillator synchronization connector ...79 Measurement principle ... 80 ECG measurement principle...80 Respiration measurement principle...80 Pulse oximetry measurement principle...80 Plethysmographic pulse wave...81 Pulse rate ... 81 NIBP measurement principle ...82 Invasive blood pressure measurement principle ...82 Temperature measurement principle...82

Troubleshooting ... 84 Troubleshooting guidelines ...84 Performing basic troubleshooting ...84 Viewing and downloading service log ...85 Viewing service log ...85 Downloading logs to USB disk ...85 Viewing log files...85 Viewing monitor diagnosis...85 Network diagnostics ...89 Pinging a TCP/IP network device ...89

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Viewing Wireless status...89 Messages... 89 Messages related to various situations...89 Messages related to ECG measurement...92 Messages related to impedance respiration measurement...93 Messages related to SpO2 measurement...94 Messages related to NIBP measurement ...95 Messages related to invasive pressures measurement ...97 Messages related to temperature measurement ...99 Problems and solutions ... 99 Start-up failures ... 100 User interface issues... 100 Battery issue... 101 B1X5-F2 frame issues... 101 B1X5-REC recorder issue ... 102 Acquisition module problems ... 102 Incorrect system time issue... 103 Troubleshooting CARESCAPE Network communication... 103 MC network issues ... 103 Can't find the target monitor at the CARESCAPE Central Station... 104 Remote service connection issue... 106 Hemo parameter issues ... 106

Disassembly and reassembly... 108 Disassembly guidelines... 108 ESD precautions... 108 Reassembly precautions ... 109 Required tools... 109 Preparing for disassembly ... 110 Disassembly procedures ... 110 Replacing battery... 110 Remove back cover... 110 Remove rack ... 111 Remove speaker, multi I/O, and battery chamber... 111 Remove Hemo input assembly (parameter assembly)... 112 Remove NIBP pneumatic system ... 113 Remove the Masimo/Nellcor board... 113 Remove AC/DC module... 114 Remove WiFi board and antenna... 114 Detach the middle unit from front unit... 115 Remove user interface parts (Trim Knob, power key, alarm light)... 116 Remove the LCD... 117 Remove mainboard and CPU... 117 After replace the mainboard ... 118 About CPU board replacement ... 118 Before replace the CPU board ... 118 5828003-EN Revision 5

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After replace the CPU board... 119 Detaching the recorder... 120

Service parts ... 122 Service parts ... 122 Front cover and LCD... 122 Trim Knob, Power key, and Alarm light ... 123 Rack, inner frame, and back cover ... 124 Speaker, multi I/O, battery and ACDC assembly... 125 Hemo input parts ... 126 WLAN, Masimo, and Nellcor SpO2 board ... 127 Mainboard and CPU board... 128 B1X5-REC Recorder ... 129 Others... 129

E-COP module ... 130 About this chapter ... 130 Maintenance check... 130 About the maintenance check procedures... 130 Planned maintenance... 130 Corrective maintenance... 131 Performing visual inspection... 131 Performing electrical safety test * ... 131 Performing functional check... 131 Required tools for E-COP module functional check... 131 Making connections for the functional check... 132 Configuring monitor for E-COP module functional check ... 132 Configuring simulator for E-COP module functional check... 132 Testing invasive pressure measurement * ... 133 Testing cardiac output measurement *... 133 Completing the check procedure ... 134 Configuration ... 134 Invasive pressure calibration... 134 Required tools... 134 Making connections... 134 Calibrating invasive pressure ... 135

E-sCAiO, E-sCO, N-CAiO module... 136 About this chapter ... 136 Maintenance check... 136 About the maintenance check procedures... 136 Corrective maintenance... 136 Planned maintenance... 137 Replacement of planned maintenance parts ... 137 Planned maintenance kits... 137 Replacing planned maintenance parts ... 138 Performing visual inspection... 138 5828003-EN Revision 5

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Performing functional check... 139 Required tools for the functional check ... 139 Making connections for the functional check... 139 Configuring monitor for functional check... 139 Testing gas module features ... 139 Completing the check procedure ... 142 Configuration ... 143 Calibration and adjustments ... 143 Sample flow rate adjustment... 143 Required tools... 143 Making connections ... 143 Adjusting sample flow rate ... 143 Gas calibration... 144 Required tools... 144 Making connections ... 145 Calibrating gases ... 145

E-miniC module ... 147 About this chapter ... 147 Maintenance check... 147 About the maintenance check procedures... 147 Corrective maintenance... 147 Planned maintenance... 148 Replacement of planned maintenance parts... 148 Required parts ... 148 Replacing the parts... 148 Performing visual inspection... 149 Performing functional check... 149 Required tools for the functional check ... 149 Making connections for the functional check... 150 Configuring monitor for functional check... 150 Testing CO2 measurement... 150 Completing the check procedure ... 152 Configuration ... 152 Calibration and adjustments ... 152 Sample flow rate adjustment... 152 Required tools... 152 Making connections ... 152 Adjusting sample flow rate ... 153 Gas calibration... 153 Required tools... 153 Making connections ... 154 Calibrating gases ... 154

E-Entropy module... 156 About this chapter ... 156 Maintenance check... 156

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About the maintenance check procedures... 156 Planned maintenance... 156 Corrective maintenance... 157 Performing visual inspection... 157 Performing electrical safety test * ... 157 Performing functional check... 157 Required tools for Entropy module functional check ... 157 Making connections for the functional check... 157 Configuring monitor for Entropy module functional check ... 158 Testing entropy measurement *... 158 Completing the check procedure ... 158 Configuration ... 158 Calibration and adjustments ... 159

E-NMT module... 160 About this chapter ... 160 Maintenance check... 160 About the maintenance check procedures... 160 Planned maintenance... 160 Corrective maintenance... 161 Performing visual inspection... 161 Performing electrical safety test * ... 161 Performing functional check... 161 Required tools for NMT module functional check... 161 Making connections for the functional check... 162 Configuring monitor for NMT module functional check ... 162 Configuring simulator for NMT module functional check... 162 Testing NMT measurement * ... 162 Completing the check procedure ... 163 Configuration ... 163 Calibration and adjustments ... 163

Verification procedure for wireless MC Network infrastructure ... 164 Purpose and scope... 164 Test plan... 164 Overview of the test procedure ... 165 Test equipment needed ... 165 Hardwired monitor, the stationary monitor ... 165 Wireless monitor, the transport monitor... 165 Test setup... 166 Setting up the hardwired monitor... 166 Setting up the wireless monitor... 166 Performing the test... 166 Summarizing and reporting... 167

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Networking disclosure to facilitate network risk management ... 168 Purpose and scope... 168 Purpose of the monitor connection to a network... 168 Network interface technical specifications ... 168 Network information flows ... 169 Required characteristics and configuration for support... 171 Potential risks to safety, effectiveness or security resulting from failure of IT network to provide the required... 171

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About this manual 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 service 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.

Manual conventions This manual uses the following styles to emphasize text or indicate action. Item

Description

bold

Indicates hardware terms.

bold

Indicates software terms.

italic

Indicates terms for emphasis.

select

The word select means choosing and confirming.

NOTE

Note statements provide application tips or other useful information.

Acquisition module naming conventions In this manual, the following naming conventions are used to refer to different modules and module categories: • E-miniC: Single-width airway module • E-sCO, E-sCAiO: CARESCAPE respiratory modules • N-CAiO: Airway Gas Option 5828003-EN Revision 5

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Illustrations and names

• E-modules: All modules with the prefix E-

Illustrations and names This manual uses illustrations as examples only. Illustrations in this manual may not necessarily reflect all system settings, features, configurations, or displayed data. Names of persons, institutions, and places and related information are fictitious; any similarity to actual persons, entities, or places is purely coincidental.

Related documents • B155M/B125M/B125P/B105M/B105P Patient Monitor User’s Manual • B155M/B125M/B125P/B105M/B105P Patient Monitor Supplemental Information Manual • Supplies and accessories • Service manuals for acquisition modules • WLAN Deployment Guide • iCollect user’s manual • CARESCAPE Network Configuration Guide • CARESCAPE Wireless Network Configuration Guide • Patient Monitoring Network Configuration Guide • CIC Pro Clinical Information Center Operator's Manual • CARESCAPE Central Station User’s Manual • HL7 Reference Manual • Service for depot instruction

Accessing manuals online To access manuals online, 1. Go to https://www.gehealthcare.com/documentationlibrary. 2. Enter Customer Documentation Portal site. 3. Select Modality to Monitoring Solutions (MS) and Products to related products you want to search. Launch the search. 4. Identify and download the IFUs. The IFUs are in PDF format, make sure the device has software to open the PDF files (e.g. Adobe® Acrobat® Reader).

Accessing manuals on monitor To access manuals on monitor: 1. Press the On/Off button (more than 3 seconds) to turn on the monitor.

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2. Select

Trademarks

>

E-Manual.

3. Select related manuals.

Trademarks GE, GE Monogram, and CARESCAPE are trademarks of General Electric Company. 12RL, DINAMAP, Trim Knob, UNITY NETWORK, D-fend, and Entropy are trademarks of General Electric Company or one of its subsidiaries.

Third party trademarks Masimo and SET are trademarks of Masimo Corporation. Covidien, Nellcor and OxiMax are trademarks of a Medtronic company. HL7 is a registered trademark of Health Level Seven (HL7), Inc. All other third-party trademarks are the property of their respective owners.

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 Due to continual product innovation, design and specifications for these products are subject to change without notice. Some of the products mentioned in this manual may not be available in all countries. Please consult your local representative for the availability.

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Safety 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.

System safety WARNING Do not perform any service activities on the monitor in the patient vicinity while a patient is being connected to the monitor. CAUTION DISPOSAL. At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of each product. If you have any questions concerning disposal of a product, please contact GE or its representatives. For a complete list of system safety messages that apply to the entire system, refer to the user manual. For safety messages specific to parts of the system or to a certain installation or service task, refer to the relevant sections.

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Service requirements

Service requirements Follow the service requirements listed below. • Refer servicing of the equipment to qualified service personnel only. Service personnel servicing this product must have an appropriate technical qualification, or equivalent work experience, and be familiar with the service requirements described in this manual and in any related service documentation. Service training for the product is recommended. • 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. • 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.

Equipment symbols For user interface keys and symbols, please refer to “Monitoring basics” chapter. General warning sign.

Caution. Highlights the fact that there are specific warnings or precautions associated with the device.

Follow instructions for use.

Consult operating instructions.

Consult electronic instruction for use.

Instructions For Use are supplied in electronic format.

Electrostatic sensitive device. Connections should not be made to this device unless ESD precautionary procedures are followed.

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Equipment symbols

Non-ionizing electromagnetic radiation. Interference may occur in the vicinity of this device. 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. Power On/Off key.

On the front cover: power indicator. On the back cover: alternating current. On the front cover: battery indicator. On the side: battery inside. Equipotentiality. Connect device to a potential equalization conductor.

Recorder connector.

B1X5-F2 connector (On B1X5-F2 Frame).

Nurse call connector.

Serial port.

Defibrillator connector.

B1X5-F2 connector (On monitor).

USB connector.

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Equipment symbols

Ethernet connector.

HDMI connector.

Gas inlet.

Gas outlet.

Mini D-fend: Add date.

Recorder (On B1X5-REC recorder).

Recorder paper install direction.

B1X5-F2 communication indicator. Fuse. Replace with indentical type and rating fuse (On B1X5-F2 Frame). Degree of ingress protection (On monitor).

Degree of ingress protection (On B1X5-F2 Frame).

Date of manufacture. This symbol indicates the date of manufacture of this device. YY = year, MM = month, DD = day.

Manufacturer name and address.

Catalogue or orderable part number. Device serial number. Every device has a unique marking for identification. The UDI marking appears on the device label.

Atmospheric pressure limitations.

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Equipment symbols

Temperature limitations.

Humidity limitations.

Keep dry. Protect from rain.

Fragile. Handle with care.

This way up. 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.

Recycled materials or may be recycled.

Recyclable Lithium-Ion.

Prescriptive Device. USA only. For sale by or on the order of a Physician. Eurasian Economic Union countries only. Eurasian Conformity mark. Conformity to applicable technical regulations of Customs Union. Brazil only. Approved under ANATEL (Agência Nacional de Telecomunicações) requirements. China only. China Ministry of Industry and Information Technology identification number for Radio Transmission Equipment Type Approval. Australia and New Zealand only. Regulatory Compliance Mark (RCM). Indicates compliance with electrical safety, EMC, electromagnetic energy, and telecommunications requirements applicable to each product.

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