Service Manual
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GE Healthcare
CARESCAPETM VC150 Vital Signs Monitor Service Manual
CARESCAPETM VC150 Vital Signs Monitor English KO00094N © 2014, 2015 Innokas Medical All rights reserved.
NOTES The information in this manual applies to CARESCAPETM VC150 Vital Signs Monitor. 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 name, GE Medical Systems Information Technologies, Inc. Listed below are GE Medical Systems Information Technologies, Inc. trademarks. All other trademarks contained herein are the property of their respective owners. GE TruSignal is the property of GE Medical Systems Information Technologies, Inc., a division of General Electric Corporation. All other product and company names are the property of their respective owners. Description of NIBP algorithm © GE Medical Systems Information Technologies, Inc., reproduced by permission. CARESCAPE, DINAMAP, DURA-CUF, SOFT-CUF Blood Pressure Cuffs, and SuperSTAT are trademarks of GE Medical Systems Information Technologies, Inc. Welch Allyn® and SureTemp® Plus are registered trademarks of Welch Allyn, Inc. Exergen and TAT-5000S -USB are trademarks of Exergen Corporation. Betadine® is a trademark of Purdue-Frederick. Masimo rainbow® SET®, LNOP, LNCS and Signal IQ are registered trademarks of Masimo Corporation. Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device. Nellcor, OxiMax, C-LOCK and SatSeconds are trademarks of Covidien. Innokas Medical is a subsidiary of Innokas Yhtymä Oy. GE Medical Systems Information Technologies, Inc. is the exclusive distributor of the CARESCAPE VC150.
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CARESCAPETM VC150 Vital Signs Monitor
KO00094N 02 October 2015
Contents
1
Introduction... 1-1 Manual purpose... 1-2 Intended audience... 1-2 Intended use... 1-2 General use...1-4 Revision history... 1-4 Printed copies of this manual... 1-4 Conventions used in this manual... 1-5 Related manuals... 1-5 Equipment ID... 1-6 Safety information... 1-6 Responsibility of the manufacturer...1-6 General...1-7 Safety information and product-specific hazards...1-7 Dangers...1-8 Warnings...1-8 Cautions... 1-11 Notes... 1-13 Product compliance... 1-15 Equipment symbols... 1-17 Symbols for Exergen temporal scanner... 1-19 Service... 1-20 Contact information... 1-20 Service policy... 1-20 Service agreements... 1-20 Assistance... 1-20 Packing instructions... 1-20 Insurance... 1-21 Repair parts... 1-21 Disposal of product waste... 1-21 Batteries... 1-21 Patient applied parts... 1-21 Packaging material... 1-22 Monitor... 1-22 Product availability... 1-22
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Equipment overview... 2-1 Equipment description... 2-2 Product configurations...2-2 Front view... 2-3 Rear view and left side... 2-4 Right side... 2-4 User interface and connections... 2-5 Operating modes... 2-10 Clinical mode... 2-11 Spot-check mode and monitoring mode... 2-11 Monitor configuration... 2-11 Alarm setup... 2-12 Monitor Setup... 2-14 Default Setup... 2-15 Service Mode... 2-15 Start Remote Service... 2-16 Patient... 2-16 Printout... 2-17 Overall principles of operation... 2-18 SpO2... 2-19 NIBP and pulse measuring technologies... 2-19 DINAMAPTM SuperSTAT algorithm... 2-20 DINAMAP auscultatory reference algorithm... 2-22 Reference used to determine NIBP accuracy... 2-24 Temperature... 2-25 Welch Allyn temperature measurement... 2-25 Welch Allyn temperature options... 2-25 Exergen temperature measurement... 2-25 Functional description... 2-26 Motherboard... 2-27 NIBP module... 2-27 SpO2 module... 2-27 USB board... 2-27 Medical USB board... 2-27 Isolation board... 2-28 Printer (optional)... 2-28 Welch Allyn board (optional)... 2-28 Connectivity... 2-28 CARESCAPE VC150 Vital Signs Monitor connectivity options... 2-29 Connections... 2-30 Battery... 2-32
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Installation... 3-1 Introduction... 3-2 Installation checklist...3-2 Unpacking the unit...3-2 Tool required for unpacking...3-2 Unpacking the monitor...3-2 First charge of the battery...3-4 Procedure...3-4 Monitor on/off... 3-6 Turning the monitor on...3-6 Touch screen recalibration...3-7 Verification of the touch screen recalibration...3-8 Turning the monitor off...3-8 Resetting the monitor...3-8 Changes in settings due to standby/shutdown/reset...3-9 Connections... 3-10 Remote alarm... 3-11 Strain relief... 3-11 Configuring the monitor... 3-11
4
Monitor configuration... 4-1 Monitor configuration checklist... 4-2 Monitor configuration verification checklist... 4-2 Connectivity configuration checklist... 4-3 Connectivity verification checklist... 4-3 Entering service mode... 4-4 Service mode... 4-5 Using the home icon...4-5 Enable licenses...4-5 Import license information...4-6 Manual entry...4-7 Verify licenses...4-9 Disabling a license...4-9 System Info...4-9 Monitor information... 4-11
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Maintenance... 4-12 Software update... 4-12 Local history... 4-12 Day/Night mode threshold adjustment... 4-13 Measurement settings... 4-14 Calibration... 4-16 Preventive maintenance (PM)... 4-17 Logging... 4-17 EMR log... 4-18 Passwords... 4-19 USB import and export... 4-20 Barcode... 4-20 Regional Settings... 4-21 Time Zone TZ -variable... 4-22 Connectivity... 4-23 Connectivity Licenses... 4-24 Connectivity diagram... 4-24 WPA Custom configurations... 4-25 Certificates... 4-29 Private keys... 4-30 Setting up SSID profile... 4-31 Connecting to SSID profile... 4-33 WLAN diagnostics... 4-35 PDQ Query Configuration... 4-38 EMR Outbound Configuration... 4-40 Caregiver settings... 4-43 Hospital EMR encoding... 4-44 Web server... 4-48 Device certificate... 4-48 Print... 4-49 Reverting to the factory default alarm setting... 4-49 Clearing local history... 4-50 Adding a caregiver... 4-50 Providing identification... 4-50 Using a barcode reader for caregiver ID (if option available)... 4-53 Selecting or adding a patient... 4-54 Using a barcode reader for patient ID... 4-55 Positive patient identification... 4-56 Snapshot output... 4-56 Export to PDF... 4-57 Print... 4-59 Send... 4-59
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Checkout procedures... 5-1 Introduction... 5-2 Parameter-level functional testing... 5-2 NIBP...5-2 Temperature...5-3 Welch Allyn...5-3 Exergen...5-3 SpO2 technologies (GE TruSignal, Masimo and Nellcor)...5-3 Calibration procedures and tests... 5-4 NIBP tests and calibration...5-5 Setup...5-5 Pneumatic leakage testing...5-5 Pressure transducer verification...5-6 Pressure transducer calibration...5-7 Monitor overpressure verification...5-8 NIBP overpressure verification...5-8 Testing the inflation icon...5-9 NIBP functional test... 5-10 Changing the NIBP configuration... 5-11 Temperature... 5-12 Welch Allyn temperature calibration verification... 5-12 Exergen temperature calibration verification... 5-13 External DC verification... 5-14 SpO2... 5-15 Printer output test... 5-16 Board tests... 5-17 Motherboard voltages... 5-17 Power membrane... 5-19 Printer interface... 5-19 NIBP interface... 5-20 Isolation interface... 5-22 Left side USB connectors... 5-24 Back panel USBs... 5-25 LCD backlight... 5-26 LCD interface... 5-27 Touch panel interface... 5-27 Safety testing... 5-28 Electrical safety tests... 5-28 Requirements... 5-28 Test equipment... 5-28 Power cord and plug... 5-29 Earth leakage current... 5-29 Enclosure leakage current (touch current) test... 5-30 Patient leakage current test... 5-32 Patient leakage current test (mains voltage on the applied part) 5-34 Patient auxiliary current test... 5-36 Total patient leakage current test... 5-38
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Installation and checkout form, CARESCAPE VC150... 5-40
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Troubleshooting... 6-1 Overview... 6-2 Alarm message interpretation... 6-2 System failures...6-2 Alarm conditions...6-2 Logging... 6-3 Error log...6-3 Exporting error logs...6-3 Productivity metrics...6-3 EMR transaction log...6-4 Log file samples...6-5 Alarms and priorities... 6-6 Physiological alarm conditions...6-6 Technical error conditions...6-8 Module specific messages... 6-12 GE TruSignal... 6-12 Exergen messages... 6-13 Host messages... 6-14 Masimo messages... 6-21 Nellcor messages... 6-25 NIBP messages... 6-26 Suretemp+ messages... 6-28 Exergen-specific error codes... 6-30 Battery low... 6-31 When battery charge for at least 10 NIBP measurements remains 631 When battery charge for 5 minutes or less of unit operation time remains... 6-31 Troubleshooting flow charts... 6-32 Monitor does not start without power source... 6-32 Monitor does not turn on... 6-33 Touch function does not work... 6-34 SpO2 not available... 6-35 Welch Allyn temp not available... 6-36 Monitor does not shut down... 6-37 Other troubleshooting topics... 6-38 Measurements not saved into local history... 6-38 Fuses... 6-38 Fuse replacement... 6-39
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Field replaceable units (FRUs)... 7-1 Description... 7-2 FRU replacement checklist...7-2 FRU replacement checkout procedures...7-2 FRU list...7-3 FRU photos...7-5 FRU replacement instructions... 7-17 Electrostatic discharge (ESD) precautions... 7-17 Torques... 7-18 Battery replacement... 7-19 Disassembly... 7-19 Reassembly... 7-21 Monitor disassembly... 7-23 Front panel and motherboard... 7-23 NIBP module... 7-28 Handle frame and back cover... 7-31 NIBP pump and valve... 7-33 Side strips... 7-36 Handle... 7-37 Drain slope assembly... 7-38 Ventilation plates... 7-38 USB frame... 7-39 Remote alarm... 7-39 NIBP hose connector... 7-40 Isolation board, SpO2 module and SpO2 flex cable assembly . . . 7-40 Welch Allyn module... 7-43 USB door... 7-44 Monitor reassembly... 7-45 Tools required... 7-45 Required parts... 7-45 USB door... 7-45 NIBP hose connector... 7-46 Remote alarm cable... 7-46 Drain slope assembly... 7-47 Welch Allyn module or Welch Allyn cover plate... 7-48 USB frame... 7-49 SpO2 Board... 7-50 Isolation board... 7-53 Ventilation plates... 7-54 Handle... 7-55 Side strips... 7-55 NIBP pump and valve... 7-56 Dummy printer assembly or printer assembly... 7-58 Charge power cable... 7-59 Main assembly... 7-60 Motherboard... 7-64
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Changing the Exergen temperature unit battery... 7-70 Required tools and parts... 7-70 Changing the SpO2 technology... 7-71
8
Exploded view drawings... 8-1 Main assembly exploded view... 8-2 Board frame assembly exploded view...8-6 Back cover assembly exploded view... 8-10
9
Maintenance... 9-1 Introduction... 9-2 Preventive maintenance checklist... 9-3 Visual inspection checklist... 9-5 Connecting to the Service PC... 9-6 Disconnecting from the service PC... 9-7 Remote service mode... 9-7 Backing up and importing/restoring settings... 9-13 What can be copied... 9-13 File import... 9-14 Exporting settings... 9-14 Importing settings... 9-14 Cleaning... 9-15 List of approved cleaning agents... 9-15 Cleaning schedule... 9-16 Procedure... 9-16 Cleaning the exterior surfaces... 9-17 Cleaning the screen... 9-17 Cleaning the Exergen sensor lens... 9-17 Cleaning and disinfecting blood pressure cuffs and air hoses . . 9-17 Cleaning the Welch Allyn probe and probe well... 9-18 Cleaning SpO2 sensors... 9-19 Short-term storage... 9-19 Extended storage... 9-20 Storage temperature... 9-20 Packing... 9-21 Minimum requirements... 9-21 Procedure... 9-21 Missing original packing material... 9-22
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Disposal of product waste... 9-22 Batteries... 9-22
10
Software upgrade... 10-1 Introduction... 10-2 Software upgrade... 10-2 Software upgrade with USB... 10-2 Required tools... 10-2 Preparation for the upgrade... 10-2 Upgrade procedure... 10-3 Verification... 10-4 Software upgrade with hospital WLAN... 10-4 Required tools... 10-4 Procedure... 10-4 Verification... 10-5 Software update completed... 10-5
A
Specifications and default settings . . A-1 Product specifications... A-2 Printer specifications... A-3 NIBP specifications... A-3 GE TruSignal SpO2 specifications... A-5 GE TruSignal sensor accuracy specifications... A-8 GE TruSignal SpO2 default settings... A-10 Nellcor SpO2 specifications... A-11 Nellcor OxiMax sensor accuracy specifications... A-13 Nellcor SpO2 default settings... A-14 Masimo rainbow® SET® SpO2 specifications... A-15 Masimo sensor accuracy specification... A-17 Masimo rainbow SET® SpO2 default settings... A-24 Welch Allyn temperature specifications... A-26 Exergen temperature specifications... A-27 Exergen scanner battery specifications... A-27 Monitor battery specifications... A-28 Connectivity specifications... A-28 Alarm specifications... A-30
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Factory default settings for alarm limits... A-30 Patent information... A-30 Open source software notice... A-31
B
Appropriate use of NIBP simulators . B-1 Appropriate use of NIBP simulators... B-2 NIBP accuracy... B-2 Clinical vs. simulator readings... B-2 What do simulator manufacturers say?... B-4 Why use simulators?... B-4 Summary... B-4
C
Electromagnetic compatibility (EMC) C-1 Electromagnetic compatibility (EMC): CARESCAPE VC150 monitor... C-2 Guidance and manufacturer’s declaration... C-2 Electromagnetic emissions... C-2 Electromagnetic immunity... C-3 Electromagnetic immunity... C-4 Recommended separation distances... C-5 Compliant cables and accessories... C-6
D
How To Reach Us…... D-1 Service Calls and Product Support... D-1 Ordering Accessories and Service Parts... D-1 Ordering Manuals... D-2 Other Questions or Problems... D-2
E x
Declaration of conformity...E-1
CARESCAPETM VC150 Vital Signs Monitor
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Introduction
CARESCAPETM VC150 Vital Signs Monitor
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Introduction: Manual purpose
Manual purpose This manual supplies technical information for service representatives and technical personnel so they can maintain the equipment to the assembly level. Use it as a guide for maintenance and electrical repairs considered field repairable. Where necessary, the manual identifies additional sources of relevant information and technical assistance. While the service manual and operator manual share some content, the service manual is more technically oriented and the operator manual is more everyday user oriented. Ordinary screen and default setup items are not repeated in the service manual. Refer to the operator's manual for the instructions necessary to operate the equipment safely in accordance with its function and intended use. Following checklists provide list of items to check for during initial installation or preventive maintenance:
“Installation checklist” on page 3-2
“Monitor configuration checklist” on page 4-2
“Monitor configuration verification checklist” on page 4-2
“Connectivity configuration checklist” on page 4-3
“Connectivity verification checklist” on page 4-3
“Installation and checkout form, CARESCAPE VC150” on page 5-40
“Preventive maintenance checklist” on page 9-3
“Visual inspection checklist” on page 9-5
Intended audience This manual is intended for service representatives and technical personnel who maintain, troubleshoot, or repair this equipment and who have been authorized and trained by GE.
Intended use The VC150 is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport. The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, diastolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients. The optional GE TruSignal pulse oximetry and accessories are indicated for continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.
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Introduction: Intended use The optional Masimo Rainbow SET® Pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of: •
functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients,
•
carboxyhemoglobin saturation (SpCO) for adult and pediatric patients,
•
methemoglobin saturation (SpMet) for adult, pediatric and neonatal patients,
•
total hemoglobin concentration (SpHb) for adult and pediatric patients, and/ or
•
respiratory rate (RRa) for adult and pediatric patients.
The optional Nellcor™ oximetry and accessories are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate of adult pediatric and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The optional Oximax SPDTM Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The optional Nellcor™ Respiration Rate parameter is intended for the continuous noninvasive monitoring of respiration rate in adult patients who are well perfused during non-motion conditions. The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure oral, axillary, and rectal temperature of adult and pediatric patients. The optional Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages. A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver. The portable device is designed for use in hospitals and hospital-type facilities. The VC150 can also be used in satellite areas or alternate care settings. "Portable" refers to the ability of the VC150 to be easily moved by the caregiver, such as on a roll stand. The VC150 is not intended to be used for continuous monitoring during patient transport.
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Introduction: Revision history
General use CARESCAPE VC150 vital signs monitors are intended for use in various markets, from the physician’s office to sub-acute triage and medical/surgical units. The CARESCAPE VC150 vital signs monitor is intended to monitor one patient at a time in a clinical setting. CAUTION This device is not intended for home use. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
To ensure patient safety, use only parts and accessories manufactured or recommended by Innokas Medical. Parts and accessories used shall meet the requirements of IEC 60601-1.
Disposable devices are intended for single use only. They should not be reused.
Periodically, and whenever the integrity of the monitor is in doubt, test all functions.
Revision history Printed copies of this manual The first letter shown in this revision history table is the first customer-released version of this document. Revision KO00094N
Comments Release level of this document.
Printed copies of this manual A paper copy of this manual will be provided upon request (in the U.S.). Contact your local GE representative and request the part number on the first page of this manual.
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Introduction: Conventions used in this manual
Conventions used in this manual Within this manual, abbreviations, special styles and formats are used to refer to concepts, or distinguish among terms viewed on screen, an area you must select, or a list of menu commands you must select. Examples:
For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies, Inc.
Service or service personnel refers to service personnel trained by GE or a service provider trained and authorized by GE.
In this manual, the CARESCAPE VC150 vital signs monitor is referred to as the monitor.
Names of physical or hardware keys on the equipment are written in bold typeface: Reset switch.
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: Monitor Setup > NIBP.
When referring to different sections in this manual, section names are enclosed in double quotes: “Cleaning and care.”
The word “select” means choosing and confirming.
Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: 'Learning.'
Note statements provide application tips or other useful information.
Any illustrations appearing in this manual are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor.
Any names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.
Related manuals Manual
KO00094N
Title
KO00065
CARESCAPE VC150 Vital Signs Monitor Operator’s Manual (English). Contact your GE sales representative for information on other available languages.
KO00125
CARESCAPE VC150 Supplies and accessories (English). Contact your GE sales representative for information on other available languages.
CARESCAPETM VC150 Vital Signs Monitor
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Introduction: Equipment ID
Equipment ID Every GE device has a unique serial number for identification. A sample of the information found on a serial number label is shown below.
### ## ## #### # #
A
B
C
D
E
F
Description A
Product code. SK5 is the product code for CARESCAPE VC150.
B
Year manufactured
C
Fiscal week manufactured
D
Production sequence number
E
Manufacturing site
F
Miscellaneous characteristic
Safety information The information presented in this section is important for the safety of both the patient and operator. This section describes how the terms Danger, Warning, Caution, and Note are used throughout the manual. In addition, standard equipment symbols are defined.
Responsibility of the manufacturer Innokas Medical is responsible for the effects on safety, reliability, and performance only if:
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assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by Innokas Medical;
the electrical installation of the relevant room complies with the requirements of appropriate regulations; and
the monitor is used in accordance with the instructions of use.
CARESCAPETM VC150 Vital Signs Monitor
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Introduction: Safety information
General Service personnel must also read and understand the CARESCAPE VC150 Vital Signs Monitor Operator's Manual, pn KO00065. 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/ EN 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. Periodically, and whenever the integrity of the device 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.
If the device is going to be installed in the USA and use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.
Safety information and product-specific hazards The terms Danger, Warning, Caution and Note are used throughout this manual to point out hazards and to designate a degree or level or seriousness. Familiarize yourself with their definitions and significance. Hazard is defined as a source of potential injury to a person. DANGER indicates a hazardous situation that, if not avoided, will result in death or serious injury. WARNING indicates a potential hazard or unsafe practice which, 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. NOTE provides application tips or other useful information to ensure that you get the most from your equipment.
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Introduction: Safety information
Dangers The following dangers apply to this product: DANGERS Do not service the battery while the monitor is connected to external power. Electrical Shock Hazard. Before replacing the battery, disconnect the monitor from the DC power supply. Failure to do this may result in serious personal and/or device damage. ELECTRIC SHOCK - Do not touch the patient and the DC power input connector pins simultaneously. High voltages are present during touch current test, patient auxiliary current test and total patient leakage current test. Do not touch the unit and ensure that nobody else can touch the unit.
Warnings The following warnings apply to this product: WARNINGS Do not immerse the monitor in water. If the monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth. Do not immerse sensors in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Do not perform any testing or maintenance on a sensor while it is being used to monitor a patient. Place the monitor on a rigid, secure surface or use the monitor with mounting hardware, poles, and stands recommended by GE. Only use the monitor in areas where adequate ventilation exists. Arrange the external AC/DC power converter, air hoses, and all cables carefully so they do not constitute a hazard. If powering the monitor from an external power adapter or converter, use only an adapter that has been specified for this monitor. Refer to CARESCAPE VC150 Supplies and accessories (KO00125) for power accessories. The speaker is tested during unit power-up. If the power-up tones are not heard, audible alarms will also not be heard.
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