Service Manual
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GE Healthcare CARESCAPE Monitor B450 Service Manual Software Version 2 Hardware Version B450-01
All specifications subject to change without notice. English 2nd edition 2106778-003 June 19, 2018 © 2018 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... 2 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 introduction 3.1 3.2
1
9
Short description of the equipment... 9 System components... 10 3.2.1 Monitor... 10 3.2.2 Software... 11 3.2.3 Input devices... 11 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 IEC 60601-1 classifications... 20 Service information... 21 3.5.1 Service requirements... 21 3.5.2 Equipment identification... 21 Product security... 23 3.6.1 Security features... 23 3.6.2 Security operations... 24 3.6.3 Product change management... 25 3.6.4 Communication... 26 i 2106778-003
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3.7 3.8
4
Using Webmin service interface 4.1 4.2 4.3 4.4 4.5 4.6 4.7
5
5.4 5.5 5.6
39
Local access to Webmin using the integrated browser on the patient monitor... 39 Local access to Webmin with a service PC... 40 Remote access to Webmin using a service PC over the IX Network... 41 Login to Webmin... 43 Webmin configuration modules... 44 Webmin information modules... 46 Webmin diagnostics modules... 47
Pre-installation requirements 5.1 5.2 5.3
6
Equipment symbols... 26 User interface symbols... 35
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... 62 6.6 Connecting to the MC Network or the S/5 Network... 63 6.7 Connecting to the IX Network... 64 6.8 Connecting to a Unity Network ID connectivity device... 64 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 2106778-003
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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
7.19
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 radio settings... 69 7.2.5 Configuring WLAN security settings... 73 7.2.6 Creating WLAN custom configuration files... 75 7.2.7 Configuring ADT server settings... 76 Setting time and date... 76 Setting unit and bed name... 77 Configuring printers... 77 7.5.1 Installing a printer... 77 7.5.2 Deleting a printer... 78 7.5.3 Printing a test page... 78 Configuring Citrix... 78 Configuring MUSE/12SL... 79 Admit settings... 80 7.8.1 Patient ID prefix... 80 7.8.2 Barcode settings... 80 7.8.3 Configuring length delimited parser information... 81 7.8.4 Configure character delimited parser information... 83 7.8.5 Barcode data specifications... 85 Setting power frequency... 87 Selecting language and locale... 87 Selecting national requirements... 87 Configuring modules... 87 7.12.1 Module asset settings... 88 Setting the host asset number... 88 Password management... 89 7.14.1 User accounts and passwords... 89 7.14.2 Changing passwords... 89 7.14.3 Resetting the password... 90 Restarting the patient monitor... 90 Setting up the remote service... 90 7.16.1 Configuring the remote service... 90 7.16.2 Enabling remote service agent/ connection... 91 7.16.3 Testing the connectivity... 92 Transferring settings from one patient monitor to other patient monitors... 92 7.17.1 Saving settings... 92 7.17.2 Loading settings... 93 7.17.3 Activating settings... 93 7.17.4 Canceling pending settings activation... 95 License management... 96 7.18.1 Enabling and activating host software package... 96 7.18.2 Enabling and activating host software feature licenses... 96 7.18.3 Uploading license file... 97 Certificate management... 97 7.19.1 Generating a certificate and a private key... 98 7.19.2 Generating a certificate signing request (CSR)... 98 7.19.3 Importing the certificate and the private key... 99
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7.19.4 Managing the current certificate or private key... 99 7.19.5 Managing the Webmin certificate or key... 99 7.20 Software management... 100 7.20.1 Transferring the software... 100 7.20.2 Activating the installed software... 100 7.20.3 Canceling pending host software activation... 105 7.20.4 Erasing an inactive software version... 105
8
Installation checkout 8.1 8.2
8.3
9
Visual inspection... 107 Electrical safety tests... 107 8.2.1 Test setup... 108 8.2.2 Power outlet... 108 8.2.3 Power cord and plug... 108 8.2.4 Ground integrity check... 109 8.2.5 Ground leakage current test... 110 8.2.6 Testing touch current... 111 8.2.7 Patient leakage current tests – overview... 113 8.2.8 Patient (source) leakage current tests... 114 8.2.9 Patient (sink) leakage current tests... 116 8.2.10 Test completion... 117 Functional check... 117 8.3.1 Start-up... 117 8.3.2 Display... 117 8.3.3 Device Information... 118 8.3.4 Configuration Information... 118 8.3.5 Trim knob, keypad, and remote... 118 8.3.6 Mouse... 119 8.3.7 Alphanumeric keyboard... 119 8.3.8 Barcode reader... 119 8.3.9 MC Network and S/5 Network... 120 8.3.10 Wireless LAN... 120 8.3.11 IX printers... 121 8.3.12 iPanel connection... 121 8.3.13 InSite RSvP... 121 8.3.14 Test completion... 122
Theory of operation 9.1 9.2
9.3
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123
Power Supply/ Power management subsystem... 124 9.1.1 AC/DC Power Supply... 124 DC/DC Board... 125 9.2.1 PUIC controller and software... 126 9.2.2 DC/DC Subsystem... 126 9.2.3 User Interface Controller (UIC) subsystem... 127 CPU assembly... 128 9.3.1 CPU carrier board... 129 9.3.2 uDOM... 131 9.3.3 WLAN assembly... 131 9.3.4 CPU Module... 131
Table of contents
9.4
Other subsystems... 131 9.4.1 Display subsystem... 131 9.4.2 Touchscreen sensor... 132 9.4.3 E-Module board... 132 9.4.4 Alarm light board... 132 9.4.5 Speaker Unit... 132 9.4.6 Keypad & Buzzer... 132 9.4.7 Recorder unit/ assembly... 132 9.4.8 Battery board... 132 9.4.9 Module Rail Unit... 133
10 Maintenance and checkout
135
10.1 Visual inspection... 136 10.2 Electrical safety checks... 136 10.3 Functional check... 137 10.3.1 Start-up... 137 10.3.2 Display... 137 10.3.3 PSM / PDM identification... 137 10.3.4 E-module identification... 137 10.3.5 Keypad and remote... 137 10.3.6 Mouse... 137 10.3.7 Alphanumeric keyboard... 137 10.3.8 Barcode reader... 137 10.3.9 MC Network and S/5 Network... 137 10.3.10 Wireless LAN... 138 10.3.11 IX printers... 138 10.3.12iPanel connection... 138 10.3.13InSite RSvP... 138 10.3.14Recorder... 138 10.3.15Synchronization connector test... 138 10.3.16Test completion... 141 10.4 Monitor battery maintenance... 142 10.4.1 Use recommendations... 142 10.4.2 Storage recommendations... 142 10.4.3 Testing the battery charge... 142 10.4.4 Charging a battery... 142 10.4.5 Conditioning a battery... 143 10.4.6 Replacing a battery... 143 10.4.7 Battery recycling... 143
11 Troubleshooting
145
11.1 Visual inspection... 145 11.2 Webmin - Information tab... 145 11.2.1 Configuration information... 146 11.2.2 Device information... 147 11.3 Webmin - Diagnostics tab... 148 11.3.1 Hardware statistics... 149 11.3.2 Ping a TCP/IP network device... 151 11.3.3 WLAN diagnostics... 152
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11.4 11.5 11.6 11.7 11.8
11.3.4 Log files... 155 Power management LEDs... 158 Network status LEDs... 160 Battery diagnostics... 160 Error messages and codes... 162 Problems and solutions... 166 11.8.1 Start-up failures... 166 11.8.2 User interface issues... 168 11.8.3 Incorrect system time... 170 11.8.4 License issues... 171 11.8.5 Other issues... 171 11.8.6 Recorder issues... 172 11.8.7 Acquisition module problems... 172 11.8.8 CARESCAPE Network communication issues... 174 11.8.9 S/5 Network communication issues... 178
12 Disassembly and reassembly
181
12.1 Disassembly guidelines... 181 12.1.1 ESD precautions... 181 12.1.2 Reassembly precautions... 181 12.1.3 Required tools... 182 12.1.4 Before disassembly... 182 12.2 Disassembly procedures... 184 12.2.1 Replacing the recorder unit (FRU)... 184 12.2.2 Replacing the mains fuses (FRU)... 185 12.2.3 Replacing the CPU battery (FRU)... 186 12.2.4 Replacing the battery door unit (FRU)... 188 12.2.5 Replacing the module rail unit (FRU)... 189 12.2.6 Detaching the front unit and mid-frame assembly from the rear unit assembly . 190 12.2.7 Detaching the uDOM... 194 12.2.8 Detaching the CPU assembly (FRU)... 195 12.2.9 Replacing the AC/DC power supply unit (FRU)... 199 12.2.10Replacing the WLAN assembly (FRU)... 200 12.2.11Detaching the front unit assembly from the mid-frame assembly... 202 12.2.12Replacing LCD display unit (FRU)... 205 12.2.13Replacing the Speaker unit (FRU)... 206 12.2.14Detaching the user interface board and buzzer from the front unit assembly . . . 208 12.2.15Replacing the alarm light board (FRU)... 210 12.2.16Detaching DC/DC board and E-Module board assembly... 212 12.2.17Replacing the battery board (FRU)... 216
13 Service parts
219
13.1 Ordering parts... 219 13.2 List of FRUs... 219
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. The list below indicates the products (brands, models and descriptions as applicable) with which this manual is to be used:
CARESCAPE Monitor B450 B1
CARESCAPE Monitor B450-LI B1
2069156–001 Bedrail Hook Unit, B450
CARESCAPE Monitor B450-RM B1
Chapters 1 to 7 provide an overview of the CARESCAPE Monitor B450 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 B450 main unit. Where necessary the manual identifies additional sources of relevant information and technical assistance. See the Module Frames and Modules Service 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.
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•
Note statements provide application tips or other useful information.
1.3.1 Product naming conventions In this manual, the CARESCAPE Monitor B450 is referred to as the patient monitor. The following naming conventions are used to refer to different modules and module categories:
PDM: Patient Data Module
PSM: Patient Side Module: E-PSMP.
Cardiac output and SvO2 E-modules: E-COP and E-COPSv.
Pressure and Temperature E-modules: E-PP and E-PT.
Continuous Cardiac Output Module: E-PiCCO.
CARESCAPE respiratory modules: E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, and EsCAiOVX.
Single-width airway module: E-miniC
E-LoFlo module: E-LoFlo
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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CARESCAPE Monitor B850, B650, B450 User’s Manual
CARESCAPE Monitor B850, B650, B450 Supplemental Information Manual
Module Frames and Modules Service 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
About this manual
iCentral and iCentral Client Technical Reference Manual
S/5 Network Installation Guide
iCollect user’s manual
Patient Monitoring Network Configuration Guide
User documentation for displays
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. iPanel is a trademark of General Electric Company or one of its subsidiaries. MUSE, Trim Knob, and UNITY NETWORK are trademarks of GE Medical Systems, Information Technologies, Inc. Entropy is a trademark of GE Healthcare Finland Oy.
1.7.1 Third party trademarks 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 service 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 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; and
•
evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 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 sign. ISO 7010. This symbol is identified by a yellow background, black triangular band, and a black symbol. In this manual this symbol is used only in connection with those warning statements that the labels on the equipment refer to. Caution. ISO 7000. This symbol is identified by a white background, black triangular band, and a black symbol. Follow instructions for use. ISO 7010. 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. ISO 7010. 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 introduction
3
System introduction
3.1 Short description of the equipment The CARESCAPE Monitor B450 is a modular portable multi-parameter patient monitor that is meant for low-acuity applications. The monitor can be used with most patient populations within a professional healthcare facility, but acquisition modules may have limitations for use based on the patient’s age, weight, or clinical condition, or on the type of the care unit (for example, OR or ICU only). There are several types of acquisition modules to choose from based on care requirements and patient needs. The modular system design is inherent in electronics and algorithms: some processing of the measurement signals is done by the acquisition modules and further processing happens on the monitor. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. The monitor has a 12-inch display with an alarm light and it supports one independent display. Screen contents is user-configurable. The user interface can be used as a touchscreen, or with a Trim Knob or a mouse and a keyboard. The most important and commonly used functions have main keys either on the main menu (soft keys) or on the monitor front panel (hard keys). The menu structure design allows access to all functions needed by the clinical user with just a few clicks. The monitor transfers the measurement data to central stations and to the hospital patient data depositories. It communicates with a variety of other bedside medical devices and monitoring systems, and it can also use a wireless network for interfacing. For all physical and performance specifications, refer to the supplemental information provided.
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3.2 System components 3.2.1 Monitor
The patient monitor can be mains voltage or battery powered. It has an integrated AC/DC power supply unit and it supports up-to two detachable lithium-ion batteries. The DC/DC board provides the supply voltages for the electronics of the device, takes care of the power path logic and battery management. The CPU subsystem 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 and external interfaces. The main software and all platform and clinical settings are stored in a detachable flash memory, uDOM. The patient monitor supports two optional multi-parameter hemodynamic modules: Patient Data Module (PDM) and Patient Side Module (PSM). In addition, it supports one single-width, E-series parameter module that extends the monitoring capability to other hemodynamic modules, gas measurement, brain monitoring and relaxation measurement. The optional integrated recorder enables local printing to a thermal paper. The patient monitor has a 12" LCD display with integrated LED backlights and a resistive touchscreen sensor. It supports one independently configurable secondary display. The patient monitor is compatible with wired and wireless CARESCAPE Network MC and S/5 network infrastructures. The wired CARESCAPE Network IX provides access for example to MUSE reports, iPanel applications and IX printers. The touch user interface is the main method for user input. The patient monitor supports also various USB input devices, including a mouse, an alphanumeric keyboard, a barcode reader and a remote controller. The monitor frame has an integrated handle and GCX mounting. The alarm system includes a speaker for audible alarms and a separate alarm light for visual alarms. The thermal recorder and WLAN options are also available as a field upgrade.
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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. 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.
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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.
3.2.4 Acquisition modules The patient monitor includes standard docking for the following multiparameter hemodynamic modules: PSMP and PDM.
E-PSMP
PDM
The integrated E-module slot can occupy one single-width E-module 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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