CARESCAPE ONE Service Manual sw ver 3 4th edition

Due to continuing product innovation, specifications in this manual are subject to change without notice. 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.

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Contents 1

About this manual ...13 Intended use of this manual... 13 Intended audience of this manual ... 14 Manual conventions ... 14 Monitor naming conventions ... 14 Other naming conventions ... 14 Illustrations and names ... 15 Related documents... 15 Revision history ... 15 Product availability ... 15 Trademarks ... 16 Third party trademarks ... 16 Manufacturer responsibility ... 16

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Safety ...17 Safety message signal words... 17 Safety symbols ... 17 System safety... 18

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System introduction ...19 Short description of the equipment ... 19 Software ... 20 Battery ... 20 CARESCAPE ONE system components... 20 CARESCAPE Parameters ... 21 CARESCAPE ECG ... 21 CARESCAPE Pressure... 22 CARESCAPE Temperature ... 23 CARESCAPE SpO2 devices ... 24 SpO2 equipment to patient connection with CARESCAPE ONE ... 25 Masimo SET SpO2 equipment to patient connection with CARESCAPE ONE ... 26 Nellcor™ with OxiMax™ technology SpO2 equipment to patient connection with CARESCAPE ONE ... 27

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Pulse oximetry measurement principle ... 27 CARESCAPE CO₂... 29 Non-invasive blood pressure measurement ... 30 Device compatibility... 30 NIBP equipment to patient connection with CARESCAPE ONE... 30 NIBP measurement principle... 30 Docks ... 31 CARESCAPE Dock F0... 31 Mini Dock ... 32 Parameter Docks ... 32 Controls and connectors ... 33 CARESCAPE ONE front and back views... 33 CARESCAPE ONE side view ... 34 CARESCAPE Dock F0 side views... 35 Indicators... 35 Power status indicator ... 35 Battery status indicator ... 36 IEC 60601-1 ... 36 IEC 60601-1-2... 36 IEC 60529... 36 Equipment symbols ... 37 User interface indicators ... 42 Service requirements... 44 Masimo SpO2 safety precaution... 44 Unique Device Identifier (UDI)... 44 Equipment identification ... 45 Product security ... 46 Access control ... 46 Authentication ... 46 Authorization ... 47 Audit ... 47 Network traffic protection ... 47 Malicious software protection ... 47 4

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Using service applications...49

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Using the service applications ... 49 Service interface ... 49 User accounts and passwords for service applications... 49 Accessing the service interface with a service PC... 50 Service PC network settings ... 50 Supported web browsers in service PC ... 50 Secure access with service PC ... 50 Accessing the service interface locally with a service PC ... 50 5

Pre-installation requirements...53 Unpacking ... 53 Pre-installation checklist... 53 System compatibility ... 53 Mounting solutions ... 54 Power and environmental requirements... 54 Power requirements... 54 Environmental requirements... 55 Electromagnetic compatibility safety precautions ... 55

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Hardware installation ...57 Hardware installation ... 57 Masimo SpO2 safety precautions ... 57 Installing batteries ... 58 Testing the battery charge ... 58 Inserting and removing the CARESCAPE ONE battery ... 58 Checking the battery charge with the software... 60 Installing the CARESCAPE Dock F0... 60 Mounting the CARESCAPE Dock F0 power supply... 61 Mounting the CARESCAPE ONE ... 61 Installing CARESCAPE Parameters ... 62 Mounting the LoFlo Sidestream Module ... 63 Connecting CARESCAPE CO2 to an anesthesia cart exhaust circuit ... 63 Connecting to the mains power... 63 Masimo SpO2 safety precaution... 64

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Configuration ...65 Platform configuration... 65

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Configuring date and time ... 65 Setting power frequency ... 66 Selecting language and locale ... 66 Configuring modules... 66 Configuring the ECG Filter... 66 Configuring host asset settings... 67 Configuring host asset number... 67 Configuring serial number ... 67 Password management ... 68 User accounts and passwords ... 68 Changing passwords ... 68 Resetting passwords... 69 Restarting the monitor... 70 Settings management ... 70 Settings transfer process... 70 Downloading clinical and platform settings... 72 Activating settings... 72 Resetting to factory settings ... 74 License management ... 75 Software packages ... 75 Backup and restore... 75 Taking a backup ... 76 Restoring a backup ... 76 Certificate management ... 77 Creating a certificate signing request (CSR) ... 77 Installing the certificate ... 78 Viewing the current certificate ... 78 Software management ... 79 Software upload ... 79 Software activation ... 79 Uploading software... 79 Activating the host software ... 80 8

Theory of operation...83 CARESCAPE ONE theory of operation ... 83

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CARESCAPE Dock F0 theory of operation ... 83 CARESCAPE ECG theory of operation... 83 CARESCAPE Pressure theory of operation ... 84 CARESCAPE Temperature theory of operation... 84 Pulse oximetry theory of operation... 84 CARESCAPE CO2 theory of operation ... 84 Non-invasive blood pressure theory of operation ... 85 9

Checkout procedures ...87 About the checkout procedures... 87 Required checkout procedures ... 87 CARESCAPE SpO2 - Nellcor checkout procedures... 89 Installation check ... 90 Planned maintenance check... 90 Corrective maintenance check ... 91 Performing visual inspection... 91 Performing electrical safety tests ... 92 Test setup... 92 Verifying power outlets ... 93 Verifying power cords and plugs... 93 About leakage current ... 93 Testing ground leakage current ... 93 Testing chassis leakage current to the ePort connection... 94 Testing chassis leakage current to the Ethernet connection ... 95 Patient leakage current tests ... 95 Testing patient source leakage current ... 95 Testing patient sink leakage current - system test... 96 Testing patient sink leakage current - single CARESCAPE Parameter test ... 97 Completing electrical safety tests ... 98 Performing functional check of the system ... 98 Preparing for the functional check... 98 Testing the alarm light ... 99 Checking the startup... 99 Checking display ... 99

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Checking CARESCAPE Parameters identification ... 100 Checking the status of connected devices... 101 Checking that the CARESCAPE Dock F0 is charging a battery ... 101 Performing functional check of the measurement parameters ... 102 Required tools for CARESCAPE ONE Parameters’ functional check... 102 Making connections for CARESCAPE ONE Parameters’ functional check... 103 Configuring the CARESCAPE ONE for CARESCAPE Parameters’ functional check ... 105 Configuring simulator/manometer for CARESCAPE ONE Parameters’ functional check ... 107 Testing ECG measurement *... 108 Testing impedance respiration measurement ... 109 Testing invasive pressure measurement * ... 109 Testing temperature measurement * ... 110 Testing SpO2 measurement * ... 110 Testing LoFlo CO₂ ... 110 Testing NIBP measurement ... 112 Testing analog output and defibrillator synchronization marker out signals ... 113 Zeroing CO2 to room air... 114 Required tools for zeroing CO2 to room air ... 114 Making connections to zero CO2 to room air... 114 Configuring CARESCAPE ONE for zeroing CO2 to room air ... 115 Zeroing CO2 to room air ... 115 Completing the functional check ... 115 10 Battery maintenance ...117 About the lithium-ion battery... 117 Improving battery performance ... 117 Battery storage recommendations... 118 Testing the battery charge ... 118 Charging a battery inside the CARESCAPE ONE ... 118 Charging and conditioning a battery using an external battery charger ... 118 Checking the battery charge with the software ... 118

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Conditioning the battery... 119 Inserting and removing the CARESCAPE ONE battery ... 119 Battery recycling ... 121 11 Calibration and adjustments ...123 Calibration and adjustments... 123 Calibration and adjustments ... 123 NIBP calibration... 123 Analog outputs calibration ... 127 12 Messages and error codes...133 Messages related to ECG measurement ... 133 Messages related to impedance respiration measurement with CARESCAPE ONE... 134 Messages related to SpO2 measurement with CARESCAPE ONE... 134 Messages related to NIBP measurement ... 137 Messages related to invasive pressures measurement ... 138 Messages related to temperature measurement ... 140 Messages related to CO2 measurement... 141 Messages related to various technical issues... 143 13 Troubleshooting...147 Troubleshooting guidelines ... 147 Performing basic troubleshooting... 147 Viewing configuration and device information... 148 Information... 148 Viewing hardware statistics ... 148 Hardware statistics ... 149 Viewing log files... 149 Downloading log files ... 150 Checking the battery charge with the software ... 150 Battery status - Advanced > Page 1... 150 Battery status - Advanced > Page 2... 151 Battery status - Advanced > Page 3... 151 Battery status - Manufacturing Information ... 152 Messages related to various technical issues... 152 Messages related to servicing the CARESCAPE ONE ... 154

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Problems and solutions ... 156 Start-up failures... 156 Troubleshooting CARESCAPE Parameters and NIBP... 157 User interface issues... 161 Troubleshooting software package issues ... 161 Troubleshooting the battery... 162 14 Disassembly and reassembly...163 Disassembly procedures ... 163 Disassembly guidelines... 163 CARESCAPE ONE disassembly and reassembly ... 165 Replacing the CARESCAPE ONE battery... 165 Replacing the CARESCAPE ONE pull tab assembly ... 167 Replacing the CARESCAPE ONE patient block assembly ... 168 Replacing the CARESCAPE ONE handle assembly... 169 Replacing the CARESCAPE ONE speaker covers... 170 Opening and separating the CARESCAPE ONE front bezel and rear housing ... 171 Replacing the CARESCAPE ONE battery door ... 173 Replacing the CARESCAPE ONE NIBP pneumatics assembly ... 173 Replacing the CARESCAPE ONE dock flex assembly ... 178 Replacing the CARESCAPE ONE speaker assembly... 179 Replacing the CARESCAPE ONE main board... 180 Replacing the CARESCAPE ONE LCD ... 183 Replacing the CARESCAPE ONE alarm light PWA with power button ... 184 Replacing the CARESCAPE ONE front bezel assembly with lens ... 185 CARESCAPE Dock F0 disassembly and reassembly ... 186 Opening the CARESCAPE Dock F0 case ... 186 Replacing the CARESCAPE Dock F0 flex and rail assembly ... 187 Replacing the CARESCAPE Dock F0 interface board... 187 Replacing the CARESCAPE Dock F0 internal power cable ... 189 Replacing the CARESCAPE Dock F0 DC power supply and power cable... 191 CARESCAPE Parameters disassembly and reassembly ... 191 Replacing the CARESCAPE Parameter USB patient cable... 191

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Replacing the CARESCAPE Parameter cable ... 193 Replacing the CARESCAPE ECG dust cover ... 195 15 Service parts...197 Service parts... 197 Ordering parts ... 197 Returning failed CARESCAPE Parameters to the vendor ... 197 CARESCAPE ONE... 197 CARESCAPE Dock F0... 211 CARESCAPE Parameters... 213 A

Software License Information Summary ...219 Intended use... 219 GE proprietary software ... 219 Open source software ... 219 Accessing the software license archive... 219

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About this manual

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Intended use of this manual The list below indicates the compatible products (brands, models and descriptions as applicable) with which this manual is to be used. Supported products are covered by the manuals that were delivered with those products. ●

CARESCAPE ONE

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CARESCAPE ECG

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CARESCAPE Pressure

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CARESCAPE Temperature

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CARESCAPE SpO2

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CARESCAPE SpO2 - Masimo

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CARESCAPE SpO2 - Nellcor

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CARESCAPE CO2 - LoFlo

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CARESCAPE Dock F0

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Mini Dock

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Parameter Dock 1

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Parameter Dock 3

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Parameter Dock 4

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Parameter Dock 5

This manual contains instructions necessary to install, maintain and service the device to the assembly level. It gives an overview of the CARESCAPE ONE monitoring system, and contains information needed for system installation. Information for the planned and corrective maintenance of the CARESCAPE ONE, CARESCAPE Dock F0, and CARESCAPE Parameters is also provided. This manual supports the CARESCAPE ONE when used as a standalone multi-parameter physiological patient monitor. 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 the user manual for the technical specifications, default settings and compatibility information, including electromagnetic compatibility. See the user manual for the instructions necessary to operate the device safely in accordance with its function and intended use.

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About this manual

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 an action. Also note the terminology conventions. Item

Description

bold

Indicates hardware keys and connectors.

bold italic

Indicates menu options, software keys and messages.

italic

Indicates terms for emphasis.

>

Indicates menu options to select consecutively.

select

The word select means choosing and confirming.

NOTE

Note statements provide application tips or other useful information.

Supplemental information

In the CARESCAPE ONE Service Manual, the phrase supplemental information refers to the information that appears in the appendices of the CARESCAPE ONE User Manual.

Monitor naming conventions In this manual, the CARESCAPE ONE is also referred to as CS ONE. When a generic term is more appropriate, it is referred to as the device, acquisition platform, or monitor. In this manual, the CARESCAPE B450, CARESCAPE B650, and CARESCAPE B850 monitor are referred to as the host monitor.

Other naming conventions 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. In this manual, CARESCAPE Parameters is used as a generic term when referring to all of the following products: Graphic on the CARESCAPE Parameter

Explanation CARESCAPE Parameter for measuring ECG. Note that in the manual, the following name is used instead of the graphic: CARESCAPE ECG. CARESCAPE Parameter for measuring invasive pressures. Note that in the manual, the following name is used instead of the graphic: CARESCAPE Pressure. CARESCAPE Parameter for measuring temperature. Note that in the manual, the following name is used instead of the graphic: CARESCAPE Temperature.

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About this manual

Graphic on the CARESCAPE Parameter

Explanation CARESCAPE Parameter for measuring CO2 with Respironics LoFlo technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE CO2. CARESCAPE Parameter for measuring SpO2 with GE TruSignal technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE SpO2. CARESCAPE Parameter for measuring SpO2 with Masimo SET technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE SpO2 - Masimo. CARESCAPE Parameter for measuring SpO2 with Nellcor™ sensors with OxiMax™ technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE SpO2 - Nellcor.

In this manual, CARESCAPE SpO2 device is used as a generic term when referring to all of the following products: CARESCAPE SpO2, CARESCAPE SpO2 - Nellcor, and CARESCAPE SpO2 - Masimo. In this manual, acquisition platform refers to the CARESCAPE ONE. Note that software references to Monitor also apply to the acquisition platform when it is used as an independent device.

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 ●

CARESCAPE ONE User Manual

Revision history Revision

Description

1st Edition

Initial release.

2nd Edition

Minor editorial changes.

3rd Edition

Minor editorial changes.

4th Edition

Minor editorial changes.

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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About this manual

Trademarks GE, GE Monogram, and CARESCAPE are trademarks of General Electric Company. DINAMAP and TruSignal are trademarks of General Electric Company or one of its subsidiaries.

Third party trademarks Masimo SET is a trademark of Masimo Corporation. Nellcor and OxiMax are trademarks of a Medtronic company. Multi-Link is a trademark of CareFusion Corporation or one of its affiliates. LoFlo is a trademark of Koninklijke Philips Electronics N.V.

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.

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The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

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The equipment is used in accordance with the instructions for use.

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The equipment is installed, maintained and serviced in accordance with the instructions provided in the related service manuals.

WARNING

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SAFETY HAZARD. To avoid risks to personnel and patient, or damage to the equipment, only perform maintenance procedures described in this manual. Unauthorized modifications can lead to safety hazards.

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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.

Safety symbols Symbol

Explanation General warning sign. ISO 7010. This symbol is identified by a yellow background, black triangular band, and a black symbol. Unless noted otherwise, the DANGER, WARNING, and CAUTION statements within this manual correspond to the use of this symbol on the equipment. 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 indicates mandatory action and it is identified by a blue background and a white symbol. Consult operating instructions. / Operating instructions. WARNING - Electric shock hazard. This equipment must be serviced by qualified service personnel only. ISO 7010. This symbol is identified by a yellow background, black triangular band, and a black symbol.

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Safety

Symbol

Explanation MR Unsafe. Indicates that the device is not intended for use in an MR environment. This symbol is identified by a white background, red or black circular 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. 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.

U.S. only:

Safety ground. Remove power cord from the mains source by grasping the plug. Do not pull on the cable.

Class II equipment with Functional Earth.

System safety 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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System introduction

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Short description of the equipment

The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an acquisition device to a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE ONE includes an integrated display, touchscreen, alarm light, user input buttons, and an audio subsystem. Realtime physiological parameter measurements and waveforms are displayed on the integrated display. Visual alarms are conveyed using both the integrated display and alarm light. Audible alarms are conveyed using the integrated audio subsystem. User input for configuration control and interaction is provided via the touchscreen. In addition, both a power button and touchscreen lock button are provided. The CARESCAPE ONE can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, impedance respiration, SpO2, non-invasive blood pressure, invasive pressure, temperature, and CO2 airway gas parameter acquisition and monitoring. The CARESCAPE ONE can be connected as an accessory to a host monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, impedance respiration, SpO2, non-invasive blood pressure, invasive pressure, temperature, and CO2 airway gas parameter acquisition. It also enables ECG diagnostic analysis and measurement. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode.

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System introduction

Software The CARESCAPE ONE is highly configurable and provides many monitoring possibilities. The CARESCAPE ONE 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. The CARESCAPE ONE supports a Demo Mode providing simulated data and waveforms for demonstration purposes only.

Battery The CARESCAPE ONE is designed to operate on battery power when used in transport or whenever AC power is interrupted. A complete battery management system allows you to obtain maximum battery performance. On-screen capacity gauges indicate battery charge condition and capacity. The Lithium-Ion battery is a rechargeable battery containing Lithium-Ion cells. Each battery contains an integrated electronic fuel gauge and a safety protection circuit. The processor within the equipment communicates with both the battery and the charger.

CARESCAPE ONE system components Your system may not include all these components. Consult your local representative for the available components.

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