Technical Manual
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GE Healthcare CARESCAPE Monitor B650 Technical Manual Software Version 2 Hardware Version B650 VER02
All specifications subject to change without notice. English 2062978-001 DVD 2062978-002 DVD, 510(k) 2081903-001 paper 29 January 2015 © 2015 General Electric Company. All rights reserved.
The information in this manual applies to the software and hardware versions listed on the first page of this manual. Due to continuing product innovation, specifications in this manual are subject to change without notice.
Table of contents
Table of contents 1
About this manual 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9
2
3
Intended use of the manual... 1 Intended audience of the manual... 1 Conventions used in this manual... 1 1.3.1 Product naming conventions... 1 Illustrations and names... 2 Ordering manuals... 2 Related documents... 2 Trademarks... 3 1.7.1 Third party trademarks... 3 Responsibility of the manufacturer... 3 Product availability... 3
Safety information 2.1 2.2 2.3
3.3
3.4 3.5
3.6
5
General safety statements... 5 Safety message signal words... 5 Safety symbols... 6
System overview 3.1 3.2
1
9
System introduction... 9 System components... 9 3.2.1 Monitor... 9 3.2.2 Software... 10 3.2.3 Input devices... 10 3.2.4 Acquisition modules... 12 3.2.5 CARESCAPE Network MC or S/5 Network... 12 3.2.6 CARESCAPE Network IX... 13 3.2.7 Unity Network ID connectivity device... 14 3.2.8 Secondary display... 14 3.2.9 Printers and recorders... 15 3.2.10 Service Interface... 16 Controls and connectors... 17 3.3.1 Front view... 17 3.3.2 Side views... 18 3.3.3 Rear views... 19 Service information... 20 3.4.1 Service requirements... 20 3.4.2 Equipment identification... 21 Product security... 22 3.5.1 Security features... 22 3.5.2 Security operations... 23 3.5.3 Product change management... 24 3.5.4 Communication... 24 Equipment symbols... 25 i 2081903-001
CARESCAPE Monitor B650
3.7
4
Using Webmin service interface 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8
5
5.4 5.5 5.6
37
Local access to Webmin using the integrated browser on the patient monitor... 37 Local access to Webmin with a service PC connected to the IX connector... 38 Local access to Webmin with a service PC connected to the MC connector... 40 Remote access to Webmin using a service PC over the IX Network... 41 Login to Webmin... 42 Webmin configuration modules... 44 Webmin information modules... 46 Webmin diagnostics modules... 46
Pre-installation requirements 5.1 5.2 5.3
6
User interface symbols... 33
49
Unpacking... 49 Compatibility check... 49 Network infrastructure... 50 5.3.1 MC Network... 50 5.3.2 Wireless MC Network... 50 5.3.3 S/5 Network... 50 5.3.4 S/5 Wireless Network... 50 5.3.5 IX Network... 51 Installing the mounting hardware... 51 Unity Network ID connectivity device installation... 51 Power and environmental requirements... 52
Hardware installation
55
6.1
Installing a battery into the patient monitor and the PDM module... 55 6.1.1 Testing the battery charge... 55 6.1.2 Installing the battery into the patient monitor... 56 6.1.3 Installing the battery into the PDM module... 56 6.2 Mounting the patient monitor... 57 6.3 Connecting a secondary display... 58 6.3.1 Connections to D15K and D19KT displays... 58 6.4 Installing parameter modules... 60 6.4.1 Installing a PSM or a PDM module... 60 6.5 Connecting to the mains power... 61 6.6 Connecting to the MC Network or the S/5 Network... 63 6.7 Connecting to the IX Network... 63 6.8 Connecting to a Unity Network ID connectivity device... 63 6.9 Connecting USB devices... 64 6.10 Connecting iCollect and other data acquisition systems... 64 6.11 Connecting a remote-on cable... 65 6.12 Connecting a local printer to the IX connector... 65
7
Configuration 7.1
7.2 ii 2081903-001
67
Adjusting display... 67 7.1.1 Adjusting the brightness of the integrated primary display... 67 7.1.2 Calibrating a touchscreen... 67 7.1.3 Adjusting optional secondary display... 67 Configuring the network... 67
Table of contents
7.3 7.4 7.5
7.6 7.7
7.8 7.9 7.10 7.11 7.12 7.13 7.14 7.15 7.16
7.17
7.18
8
7.2.1 Configuring hostname... 67 7.2.2 Selecting and configuring CARESCAPE Network... 68 7.2.3 Selecting and configuring S/5 Network... 69 7.2.4 Configuring WLAN... 69 Setting time and date... 74 Setting unit and bed name... 75 Configuring printers... 75 7.5.1 Installing a printer... 75 7.5.2 Deleting a printer... 76 7.5.3 Printing a test page... 76 Configuring MUSE/12SL... 76 Admit settings... 77 7.7.1 Patient ID prefix... 77 7.7.2 Barcode settings... 78 7.7.3 Configuring Length Delimited Parser information... 78 7.7.4 Configure character delimited parser information... 80 7.7.5 Barcode data specifications... 82 Setting power frequency... 84 Selecting language and locale... 84 Selecting national requirements... 84 Configuring modules... 84 7.11.1 Module asset settings... 85 Setting the host asset number... 85 Changing passwords... 85 Restarting the patient monitor... 86 Setting up the remote service... 86 7.15.1 Configuring the remote service... 86 7.15.2 Enabling remote service agent/ connection... 87 Transferring settings from one patient monitor to other patient monitors... 88 7.16.1 Saving settings... 88 7.16.2 Loading settings... 89 7.16.3 Activating settings... 89 7.16.4 Canceling pending settings activation... 91 License management... 92 7.17.1 Enabling and activating host software package... 92 7.17.2 Enabling and activating host software feature licenses... 92 7.17.3 Uploading license file... 92 Software management... 93 7.18.1 Transferring software... 93 7.18.2 Activating the installed software... 93 7.18.3 Canceling pending host software activation... 98 7.18.4 Erasing an inactive software version... 98
Installation checkout 8.1 8.2
99
Visual inspection... 99 Electrical safety tests... 99 8.2.1 Test setup... 99 8.2.2 Power outlet... 100 8.2.3 Power cord and plug... 100
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8.3
9
8.2.4 Ground (earth) integrity... 100 8.2.5 Earth leakage current test... 102 8.2.6 Enclosure leakage current (touch current) test... 103 8.2.7 Patient leakage current tests – overview... 105 8.2.8 Patient (source) leakage current tests... 106 8.2.9 Patient (sink) leakage current tests... 107 8.2.10 Test completion... 108 Functional check... 108 8.3.1 Start-up... 108 8.3.2 Display... 109 8.3.3 Device Information... 109 8.3.4 Configuration Information... 109 8.3.5 Keypad and remote... 110 8.3.6 Mouse... 110 8.3.7 Alphanumeric keyboard... 110 8.3.8 Barcode reader... 110 8.3.9 MC Network and S/5 Network... 111 8.3.10 Wireless LAN... 111 8.3.11 IX printers... 112 8.3.12 Insite with EXC... 113 8.3.13 Test completion... 113
Theory of operation 9.1
115
Main components... 116 9.1.1 Power management subsystem... 116 9.1.2 CPU subsystem... 118 9.1.3 Display subsystem... 120 9.1.4 User interface subsystem... 120 9.1.5 External Interfaces... 122 9.1.6 Pivoting module frame... 124
10 Maintenance and checkout
127
10.1 Visual inspection... 128 10.2 Electrical safety checks... 129 10.3 Functional check... 129 10.3.1 Start-up... 129 10.3.2 Display... 129 10.3.3 PSM / PDM identification... 129 10.3.4 E-module identification... 129 10.3.5 Keypad and remote... 129 10.3.6 Mouse... 129 10.3.7 Alphanumeric keyboard... 130 10.3.8 Barcode reader... 130 10.3.9 MC Network and S/5 Network... 130 10.3.10 Wireless LAN... 130 10.3.11 IX printers... 130 10.3.12Insite with Exc... 130 10.3.13Recorder... 130 10.3.14Synchronization connector test... 130
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10.3.15Test completion... 134 10.4 Monitor battery maintenance... 135 10.4.1 Use recommendations... 135 10.4.2 Storage recommendations... 135 10.4.3 Testing the battery charge... 135 10.4.4 Charging a battery... 135 10.4.5 Conditioning a battery... 136 10.4.6 Replacing a battery... 136
11 Troubleshooting
137
11.1 Visual inspection... 137 11.2 Webmin - Information tab... 138 11.2.1 Configuration information... 138 11.2.2 Device information... 140 11.3 Webmin - Diagnostics tab... 141 11.3.1 Hardware statistics... 141 11.3.2 Ping a TCP/IP network device... 143 11.3.3 WLAN diagnostics... 144 11.3.4 Log files... 147 11.4 Power management LEDs... 149 11.5 Network status LEDs... 150 11.6 Battery diagnostics... 151 11.7 Error messages and codes... 152 11.8 Problems and solutions... 156 11.8.1 Start-up failures... 156 11.8.2 User interface issues... 158 11.8.3 Incorrect system time... 160 11.8.4 License issues... 161 11.8.5 Recorder issues... 162 11.8.6 Acquisition module problems... 162 11.8.7 CARESCAPE Network communication issues... 165 11.8.8 S/5 Network communication issues... 169
12 Disassembly and reassembly
171
12.1 Disassembly guidelines... 171 12.1.1 ESD precautions... 171 12.1.2 Reassembly precautions... 171 12.1.3 Required tools... 172 12.1.4 Before disassembly... 172 12.2 Module frame disassembly... 174 12.2.1 Detaching the module frame front cover... 174 12.2.2 Detaching the Recorder Unit... 177 12.2.3 Detaching the PDM docking mechanism... 178 12.2.4 Detaching the Module Frame cover unit... 179 12.2.5 Detaching the E-module Interface Board... 180 12.2.6 Detaching the Module Frame assembly... 181 12.3 Main unit disassembly... 182 12.3.1 Replacing the mains fuses... 182 12.3.2 Detaching the Interface Board... 183
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12.3.3 Detaching the Frame Side Housing Decorations... 184 12.3.4 Detaching the Top Cover... 185 12.3.5 Disassembling the main unit into Rear and Front units... 186 12.3.6 Detaching the uDOM... 188 12.3.7 Replacing the CPU timekeeper battery... 188 12.3.8 Detaching the DC/DC board... 189 12.3.9 Detaching the CPU Board... 189 12.3.10Detaching the AC/DC board and rear unit assembly... 191 12.3.11Detaching the Base unit... 192 12.4 Front Unit Assembly... 195 12.4.1 Detaching the Front Unit Assembly... 195 12.4.2 Detaching the LCD Display Unit... 197 12.4.3 Replacing the User Interface Board... 198 12.4.4 Replacing the Trim Knob and Trim Knob Encoder... 199 12.4.5 Replacing the Keypad... 199 12.4.6 Replacing the Front Unit Assembly FRU... 200 12.4.7 Replacing the WLAN Assembly FRU... 201
13 Service parts
203
13.1 Ordering parts... 203 13.2 List of FRUs... 203
Appendix A:
Installation check form
A-1
Appendix B:
Maintenance check form
B-1
Appendix C:
Verification procedure for wireless MC Network infrastructure C-1
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About this manual
1
About this manual
1.1 Intended use of the manual This manual contains instructions necessary to install, maintain and service the device to the assembly level. Use it as a guide for installation, maintenance and repairs considered field repairable. Chapters 1 to 7 provide an overview of the CARESCAPE Monitor B650 patient monitoring system and contains information needed for system installation. Chapters 8 to 13 provide information for the planned and corrective maintenance of the CARESCAPE Monitor B650 main unit. Where necessary the manual identifies additional sources of relevant information and technical assistance. See the Module Frames and Modules Technical Manual for the planned and corrective maintenance information about the parameter modules. 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.
1.2 Intended audience of the manual This manual is intended for service representatives and technical personnel who install, maintain, troubleshoot, or repair this device.
1.3 Conventions used in this manual 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: •
For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies Inc. and GE Healthcare Finland Oy.
•
Names of hardware keys on the equipment, keypad, remote control, and modules are written in bold typeface: Start Cancel.
•
Menu items are written in bold italic typeface: Monitor Setup.
•
Emphasized text is in italic typeface.
•
Menu options or control settings selected consecutively are separated by the > symbol: Procedures > Cardiac Output.
•
The word “select” means choosing and confirming.
•
Messages (alarm messages, informative messages) displayed on the screen are written in bold italic typeface: Learning.
•
Note statements provide application tips or other useful information.
1.3.1 Product naming conventions In this manual, the CARESCAPE Monitor B650 is referred to as the patient monitor. The following naming conventions are used to refer to different modules and module categories:
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PDM: Patient Data Module
PSM: Patient Side Module: E-PSM, E-PSMP, E-PSMW and E-PSMPW.
E-modules: all modules with prefix E-.
Hemodynamic E-modules: E-PRESTN, E-PRETN and E-RESTN.
Cardiac output and SvO2 E-modules: E-COP and E-COPSv.
Pressure and Temperature E-modules: E-P, E-PP and E-PT.
Continuous Cardiac Output Module: E-PiCCO.
CARESCAPE respiratory modules: E-sCAiOV family.
Compact airway modules: E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX.
Single-width airway module: E-miniC
Specialty E-modules: E-NMT, E-EEG, E-BIS and E-ENTROPY
SpO2 E-modules: E-NSATX, E-MASIMO
The CARESCAPE Network MC is referred as MC network and the CARESCAPE Network IX as IX network. Menu naming varies within software packages:
Admit/ Discharge is also used in this manual for Start/End case menu (in OR and PACU software).
1.4 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.
1.5 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.
1.6 Related documents
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the patient monitor’s user’s manual
the patient monitor’s supplemental information manual
Module Frames and Modules Technical Manual
CARESCAPE Modular Monitors Software Installation Instructions
CARESCAPE Network Configuration Guide
CARESCAPE Wireless Network Configuration Guide
CARESCAPE Modular Monitors Mounting Solutions
Unity Network Interface Device (ID) Operator's Manual
iCentral and iCentral Client Technical Reference Manual
S/5 Network Installation Guide
iCollect user’s manual
User documentation for displays
About this manual
NOTE: The referred documents above are subject to change without notice. Please contact your local sales or service representative for possible updates.
1.7 Trademarks Listed below are GE Medical Systems Information Technologies, Inc. and GE Healthcare Finland Oy trademarks. All other product and company names contained herein are the property of their respective owners. GE, GE Monogram, and CARESCAPE are trademarks of General Electric Company. MUSE, TRAM, Tram-Rac, Trim Knob, and UNITY NETWORK are trademarks of GE Medical Systems, Information Technologies, Inc. D-lite and Entropy are trademarks of GE Healthcare Finland Oy.
1.7.1 Third party trademarks NELLCOR is a trademark of Covidien AG. Covidien is a trademark of Covidien AG. Masimo SET is a trademark of Masimo Corporation. PiCCO is a trademark of Pulsion Medical Systems. WMM, WPA and WPA2 are trademarks of Wi-Fi Alliance.
1.8 Responsibility of the manufacturer 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.
•
The equipment is installed, maintained and serviced in accordance with the instructions provided in the related technical manuals.
1.9 Product availability 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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For your notes:
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Safety information
2
Safety information
2.1 General safety statements See the user’s manual for a list of 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 60601-1-1 medical electrical systems standard. Refer to the 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; 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.
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.
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.
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2.3 Safety symbols NOTE: The following safety-related symbols appear on one or more of the devices. General warning. This symbol is identified by a yellow background, black triangular band, and a black symbol. General caution sign. IEC 60601-1, 2005 edition This symbol is identified by a white background, black triangular band, and a black symbol. ATTENTION: Consult accompanying documents. IEC 60601-1, 1988 edition. This symbol is identified by a white background, black triangular band, and a black exclamation mark. Follow instructions for use. This symbol is identified by a blue background and a white symbol. Consult operating instructions. / Operating instructions.
DANGER - Shock hazard. Dangerous voltage. To reduce the risk of electric shock, do not remove cover. Refer servicing to qualified service personnel. This symbol is identified by a yellow background, black triangular band, and a black symbol. Electrostatic sensitive device. Connections should not be made to this device unless ESD precautionary procedures are followed.
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.
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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. Safety ground. Remove power cord from the mains source by grasping the plug. Do not pull on the cable.
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For your notes:
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System overview
3
System overview
3.1 System introduction The CARESCAPE Monitor B650 is a modular monitoring solution for multiple care areas and intrahospital transport within a professional healthcare facility. The patient monitor offers various hardware configurations, software options and parameter module support to expand from basic hemodynamic operations to demanding operating room applications. The patient monitor is backwards compatible and upgradeable for the future.
3.2 System components The CARESCAPE Monitor B650 monitoring system components are introduced below.
3.2.1 Monitor The CARESCAPE Monitor B650 consists of a main unit and a pivoting module frame.
Main unit The main unit consists of the following subsystems: power management, CPU, display, user interface and external interfaces. The power management subsystem provides the operating voltages for the electronics of the device and takes care of the battery management. It consists of an AC/DC power supply, a DC/DC power management board and an optional lithium-ion battery. The CPU board is the main board of the monitor. It takes care of the user input and acquisition data processing and displays the processed information on the screen. It controls the monitor operation and communication with the other subsystems. It also interfaces with synchronization connector, the optional WLAN card and the speaker. The main software and all platform and clinical settings are stored in a detachable flash memory. The display subsystem consists of a 15” touchscreen LCD display that has an integrated LED backlight unit. The display controller is integrated to the CPU board. The user interface board provides an interface between the CPU board and the keypad, Trim Knob control, alarm light board and touchscreen sensor.
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There are two different configurations of the interface board. They provide connectors for peripheral devices like USB input devices, network interfaces, a secondary clone display and other devices.
Module frame The monitor has a pivoting module frame that includes standard docking for the following multiparameter hemodynamic modules: Patient Data Module (PDM) and Patient Side Module (PSM). The optional E-module support extends the monitoring capabilities to other hemodynamic modules, gas measurement, brain monitoring and relaxation measurement. The optional integrated recorder enables local printing to a thermal paper. Both options also are available as field upgrades.
3.2.2 Software The patient monitor is highly configurable and provides many monitoring possibilities with a flexible software licensing model. The monitor supports care area specific software packages for OR, PACU, ICU, ED and NICU. Each dedicated software package provides a comprehensive feature set for the different monitoring needs and can be further extended with the optional feature licenses. Software license model supports trial licensing and easy field upgrades with license key activation.
3.2.3 Input devices You can connect several USB input devices to the patient monitor, including alphanumeric keyboard, mouse, remote control and barcode reader. Refer to the patient monitor’s supplemental information manual for a list of compatible USB input devices.
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System overview
Keyboard A washable, antibacterial keyboard is specified for use with the monitor. It may be connected to the monitor or display via one of the USB connectors. The keyboard allows you to enter data without using the touchscreen display. Mouse A standard mouse may be connected to the monitor or display via one of the USB connectors. The mouse allows you to select any on-screen items without a Trim Knob control or a touchscreen display. Remote control The remote control provides all patient monitor controls on a portable component with a Trim Knob control. The remote control is connected to the patient monitor via one of the USB connectors. Barcode reader The barcode reader can be used to scan a Technician ID and Patient Information from barcodes when admitting patients.
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3.2.4 Acquisition modules The patient monitor includes standard docking for the following multiparameter hemodynamic modules: PSM and PDM.
PSM
PDM
The optional E-module slot can occupy an E-PRESTN module.
E-PRESTN
The integrated E-module slots can occupy two single-width or one double-width E-modules at a time.
Refer to the patient monitor’s supplemental information manual for a list of compatible acquisition devices and to the patient monitor’s user’s manual for a list of parameters each module measures.
3.2.5 CARESCAPE Network MC or S/5 Network The patient monitor is compatible both with the CARESCAPE Network MC and the S/5 Network infrastructures. The optional WLAN support enables wireless network communication using IEEE 802.11a/b/g.
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