Operators Manual
190 Pages
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GE Healthcare
CARESCAPE™ V100 Vital Signs Monitor Operator’s Manual
CARESCAPE V100 Vital Signs Monitor English 2036991-001 D (paper) © 2007 General Electric Company. All Rights Reserved.
Contents
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Introduction Description... 1-3 Indications for Use... 1-3 Contraindication... 1-3 Product Compliance... 1-6 Symbols... 1-7
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Getting Started Unpacking the Monitor and Accessories... 2-3 Setting up NIBP Connections... 2-3 Setting up SpO2 Connections... 2-4 Setting up Temperature Connections... 2-4 Setting up the Printer (Installing the Paper)... 2-5 Power Sources... 2-5 Turning the Monitor On and Off... 2-5 Automatic Shutdown...2-6 When in Clinical Mode...2-6 Procedure for Testing Alarms... 2-6 Configuration Mode Settings... 2-7 Entering Configuration Mode...2-7 Setting the Date and Time... 2-8 Procedures...2-8 SpO2 Configuration Settings... 2-9 Procedure for Units With Ohmeda TruSignal Technology...2-9 Procedure for Units With Nellcor Technology...2-9 Procedure for Units With Masimo Technology...2-9
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Product Overview Buttons... 3-3 Front Panel... 3-4 Rear Panel... 3-5 Right-Side Panel... 3-6 Windows... 3-6 Indicators... 3-6 Operating (System) Modes... 3-6 Clinical Mode... 3-7 How to enter and exit clinical mode... 3-7 To enter clinical mode:... 3-7 To exit clinical mode:... 3-7 While in clinical mode:... 3-7 Configuration Mode... 3-7 How to enter and exit configuration mode... 3-7 To enter configuration mode:... 3-7 To exit configuration mode:... 3-7 While in configuration mode:... 3-7 Advanced Configuration Mode... 3-8 How to enter and exit advanced configuration mode... 3-8 To enter advanced configuration mode:... 3-8 To exit advanced configuration mode:... 3-8 While in advanced configuration mode:... 3-8 Service Mode... 3-8 Battery Low Shutdown... 3-8 System Failure... 3-8 User Modes... 3-8 Menu Mode... 3-9 Inflate Pressure... 3-9 Alarm Volume... 3-9 Pulse Volume... 3-9 Procedure... 3-9 Cycle Mode... 3-10 Limit Adjustment Mode... 3-10 History Mode... 3-11 Sounds... 3-11 Start-up Sound... 3-11 User Interaction Sounds... 3-11 Positive Key Tone... 3-11 Negative Key Tone... 3-11 Alarm Sounds... 3-11 High priority... 3-11 Medium priority... 3-12 Low priority... 3-12
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Battery Low Shutdown and System Failure Sounds... 3-12 Battery Charger Sounds... 3-12 Power Sources... 3-12 Specifications... 3-13
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Printer Description... 4-3 Installing the Paper... 4-3 Print Button... 4-3 Printouts... 4-4 Current (Real Time)...4-4 Clinical History...4-5 Failure Alarm History...4-5 Paper Storage... 4-5 Alarms... 4-5 Specifications... 4-7
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Alarms Description... 5-3 Adjusting Alarm Limits... 5-3 Alarms Button...5-3 Adjusting the Alarm Volume... 5-4 Silencing and Acknowledging an Alarm... 5-4 Silence Button...5-4 Alarm Sounds... 5-4 Alarms and Priorities... 5-5 Limit Alarms...5-5 Parameter Status Alarms...5-5 Printer Alarms...5-6 Memory Alarm...5-6 Battery Alarms...5-6 Remote Alarm...5-6 System Failure...5-6 Alarms... 5-7 Factory Defaults... 5-8
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History Description... 6-3 Buttons Associated with History... 6-4 Erasing Stored History... 6-4 Windows Associated with History... 6-4 Indicators Associated with History... 6-4
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NIBP Description... 7-3 What is the Difference Between Intra-Arterial and Auscultatory Methods?... 7-4 Oscillometric Method... 7-4 Intra-Arterial Reference... 7-4 Auscultatory Reference... 7-4 Buttons Associated with NIBP... 7-6 Inflate/Stop Button... 7-6 Cycle Button... 7-6 Windows Associated with NIBP... 7-7 Indicators Associated with NIBP... 7-7 NIBP Modes of Operation... 7-8 Manual NIBP Determinations... 7-8 Auto Cycle Determinations... 7-8 Stat NIBP Determinations... 7-9 User Settings... 7-9 Mode Settings... 7-9 Limit Settings... 7-10 Menu Settings... 7-10 Sounds Associated with NIBP... 7-11 Procedures... 7-11 What to do When Taking NIBPs on Different Patients... 7-13 Alarms... 7-13 Specifications... 7-15 Factory Defaults... 7-16 GE Medical Systems Information Technologies Patents... 7-16
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Ohmeda TruSignal SpO2 Description... 8-3 TruSignal Enhanced SpO2...8-3 PIr pulsatile value...8-3 Configuration Settings Associated with SpO2... 8-5 Buttons Associated with SpO2... 8-5 Windows Associated with SpO2... 8-6 Indicators Associated with SpO2... 8-6 User Settings... 8-6 Limit settings...8-6 Menu Settings... 8-6 Sounds Associated with SpO2... 8-6 Procedures... 8-7 Alarms... 8-8 SpO2 Hold-off Period...8-8 Alarm Timer...8-8 Specifications... 8-10 Factory Default Settings... 8-11 GE Medical Systems Information Technologies Patents... 8-11 Troubleshooting... 8-13
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Nellcor OXIMAX SpO2 Description... 9-3 Configuration Settings Associated with SpO2... 9-4 SatSeconds™...9-5 Buttons Associated with SpO2... 9-5 Windows Associated with SpO2... 9-5 Indicators Associated with SpO2... 9-5 User Settings... 9-6 Limit settings...9-6 Menu Settings... 9-6 Sounds Associated with SpO2... 9-6 Procedures... 9-6 Alarms... 9-8
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SpO2 Hold-off Period... 9-8 Alarm Timer... 9-8 Specifications... 9-9 Factory Default Settings... 9-11 Nellcor Patents... 9-11 Troubleshooting... 9-13
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Masimo SET SpO2 Description... 10-3 Indications and Contraindications... 10-3 Configuration Settings Associated with SpO2... 10-6 Buttons Associated with SpO2... 10-6 Windows Associated with SpO2... 10-6 Indicators Associated with SpO2... 10-7 User Settings... 10-7 Limit settings... 10-7 Menu Settings... 10-7 Sounds Associated with SpO2... 10-7 Procedures... 10-7 Alarms... 10-9 SpO2 Hold-off Period... 10-9 Alarm Timer... 10-9 Specifications... 10-11 Factory Default Settings... 10-14 Masimo Patents... 10-14 Troubleshooting... 10-15
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Alaris Turbo Temp Description... 11-3 Predictive Mode... 11-3 Monitor Mode... 11-3 Configuration Settings Associated with Temperature... 11-5 Buttons Associated with Temperature... 11-5 Windows Associated with Temperature... 11-5
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Indicators Associated with Temperature... 11-5 Measurement in Progress Indicators... 11-5 Predictive Mode... 11-5 Monitor Mode... 11-6 Measurement NOT in Progress Indicators... 11-6 User Settings... 11-6 Menu Settings... 11-6 Sounds Associated with Alaris Turbo Temp... 11-6 Procedures for Oral Predictive Mode Determinations... 11-7 Procedures for Rectal Predictive Mode Determinations... 11-8 Procedures for Monitor Mode Determinations (Axillary Determinations)... 11-8 Specifications... 11-11 Factory Default Settings... 11-11 Alaris Patents... 11-11
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Pulse Rate Description... 12-3 Buttons Associated with Pulse Rate... 12-3 Windows Associated with Pulse Rate... 12-3 Indicators Associated with Pulse Rate... 12-4 User Settings... 12-4 Limit settings... 12-4 Menu Settings... 12-4 Sounds Associated with Pulse Rate... 12-4 Factory Defaults... 12-4
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Battery Description... 13-3 Buttons Associated With the Battery... 13-4 Windows Associated With the Battery... 13-4 Indicators Associated With the Battery... 13-4 First Use... 13-4 Battery Charging... 13-4
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Disposal of Batteries... 13-5 Storage, Care, and Replacement of Batteries... 13-5 Alarms... 13-6 Battery Low... 13-6 When about 45 minutes of battery charge remains:... 13-6 When about 5 minutes of battery charge remains:... 13-6 When 5 minutes of battery charge expires:... 13-6 After plugging the monitor into DC power:... 13-7 E13 Battery Low... 13-7 Specifications... 13-9 Troubleshooting... 13-11
A
Connections
B
Accessories
C
Maintenance
Connection Details... A-3 Host Port Connector (rear panel)... A-3
Accessories... B-3
Assistance and Parts... C-3 Maintenance, Calibration, and Cleaning... C-3 Calibration and Leak Testing... C-3 Cleaning... C-3 Cleaning the Monitor... C-3 Monitor Exterior... C-4 Never use the following cleaning agents:... C-4 Monitor Display... C-4 Cuff Cleaning and Disinfection... C-5 General... C-5 Procedure... C-5 Temperature Devices... C-6 SpO2 Sensors... C-6 Battery and Storage Care... C-6 Replacing the Battery... C-7 Repairs... C-8
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Packaging Material... C-9 Packing Instructions... C-9 Disposal of Product Waste... C-9 Batteries... C-9 Patient Applied Parts... C-9 Monitor... C-10
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Principles of NIBP DINAMAP SuperSTAT Algorithm... D-3 Systolic Search... D-4 DINAMAP Classic and Auscultatory Reference Algorithm... D-5 Systolic Search... D-6 Reference Used to Determine NIBP Accuracy... D-6 CARESCAPE V100 Monitors With Intra-Arterial Reference (DINAMAP SuperSTAT and Classic Technology)... D-7 CARESCAPE V100 Monitors With Auscultatory Reference (DINAMAP Auscultatory Reference Technology)... D-7
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CARESCAPE V100 Vital Signs Monitor
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GE Healthcare
CARESCAPE™ V100 Vital Signs Monitor Operator’s Manual
CARESCAPE V100 Vital Signs Monitor English 2036991-001 D (paper) © 2007 General Electric Company. All Rights Reserved.
NOTE: The information in this manual also applies to CARESCAPE V100 Vital Signs Monitor software version RAA. There are no user-apparent differences among these software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies. Listed below are GE Medical Systems Information Technologies trademarks. All other trademarks contained herein are the property of their respective owners. Ohmeda Oximetry and other trademarks (OxyTip+, PIr, TruSat, TruSignal, TruTrak+) are the property of GE Medical Systems Information Technologies, a division of General Electric Corporation. All other product and company names are the property of their respective owners. Alaris Turbo Temp and IVAC are trademarks of Cardinal Health, Inc. CRITIKON, DINAMAP, SuperSTAT, and DURA-CUF and SOFT-CUF Blood Pressure Cuffs are trademarks of GE Medical Systems Information Technologies. Masimo SET, LNOP, and LNCS are trademarks of Masimo Corporation. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to the device. Nellcor, OxiMax, C-LOCK and SatSeconds are trademarks of Nellcor Puritan Bennett.
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CARESCAPE V100 Vital Signs Monitor
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Introduction
Silence
Systolic
HIGH
ADULT
LOW Alarms
Inflate/Stop
MAP/Cuff
NEONATE
Diastolic
AUTO CYCLE
Cycle
HISTORY
History
HIGH
LOW
Menu
INFLATE PRESSURE ALARM VOLUME PULSE VOLUME
BATTERY OK
Pulse Rate
HIGH LOW
SpO
BATTERY LOW CHARGING
On / Off
Temperature
HIGH
C
LOW
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CARESCAPE V100 Vital Signs Monitor
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Introduction: Description
Description The CARESCAPE V100 Vital Signs Monitor provides a small, portable, easy-to-use monitoring alternative for sub-acute hospital and non-hospital settings. The V100 is for use on adult, pediatric, or neonatal patients-one at a time. The battery-operated monitor offers noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature. Monitors are available with or without integrated printers as well as the following parameters and technologies.
NIBP, Pulse: SuperSTAT, Auscultatory, Classic
SpO2: Ohmeda TruSignal, Nellcor, or Masimo
Temperature: Alaris Turbo Temp
The model of the monitor determines which parameters are in your monitor. Please refer to applicable sections. Using the V100 Monitor, a clinician can measure, display, and record patient vital sign data that is derived from each parameter. The monitor is also capable of alerting the clinician to changes in the patient’s condition or when it is unable to effectively monitor the patient’s condition. The CARESCAPE V100 also detects alarm limit conditions and gives audible and visual notification of these conditions. All of the main operations of the V100 Monitor are easy-to-use and only a button-touch away. Please review the factory default settings and, where applicable, enter settings appropriate for your use.
Indications for Use The CARESCAPE V100 Vital Signs Monitor is for use as prescribed by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other qualified medical personnel trained in the use of the equipment. The V100 is intended to monitor and measure oscillometric noninvasive blood pressure (systolic, diastolic, and mean blood pressure), heart rate/pulse, oxygen saturation (SpO2) by noninvasive pulse oximetry, and predictive temperature with an electronic thermometer. Using this monitor, a clinician can view, record, and recall clinical data derived from each parameter. V100 Monitors are intended for use in various markets, from the physician’s office to sub-acute triage and medical/surgical units. The CARESCAPE V100 is intended to monitor one patient at a time in a clinical setting.
Contraindication This device is not designed, sold, or intended for use except as indicated.
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Introduction: Contraindication
WARNINGS Do not use the V100 Monitor in the presence of magnetic resonance imaging (MRI) devices. There have been reports of sensors causing patient burns when operating in an MRI environment. Do not use the monitor in the presence of flammable anesthetics. The use of approved accessories will provide protection from burns during HF surgery. To help prevent unintended current return paths with the use of high frequency (HF) surgical equipment, ensure that the HF surgical neutral electrode is properly connected. To avoid personal injury, do not perform any servicing unless qualified to do so. These Monitors should not be used on patients who are connected to cardiopulmonary bypass machines. If powering the monitor from an external power adapter or converter, use only GE Medical Systems Information Technologies-approved power adapters and converters. The monitor does not include any user-replaceable fuses. Refer servicing to qualified service personnel. To reduce the risk of electric shock, do not remove the cover or the back. Refer servicing to a qualified service person. If the accuracy of any determination reading is questionable, first check the patient’s vital signs by alternate means and then check the V100 Monitor for proper functioning. Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation. The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used. The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system.
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Introduction: Contraindication
CAUTIONS Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Do not use replacement batteries other than the type supplied with the monitor. Use only batteries recommended by GE Medical Systems Information Technologies. Other batteries could result in monitor shut down. Replacement batteries are available from GE Medical Systems Information TechnologiesAccessories and Supplies. The V100 Monitor is designed to conform to Electromagnetic Compatibility (EMC) Standard IEC 60601-1-2, 1993 and will operate accurately in conjunction with other medical equipment which also meets this requirement. To avoid interference problems affecting the monitor, do not use the monitor in the presence of equipment which does not conform to these specifications. Place the V100 Monitor on a rigid, secure surface. The monitor must only be used with mounting hardware, poles, and stands recommended by GE Medical Systems Information Technologies. The weight of the accessory basket contents should not exceed 5 lb (2.7kg). Arrange the external AC/DC power converter, air hoses, and all cables carefully so they do not constitute a hazard. Verify calibration of NIBP parameter (temperature and pulse oximeter do not require calibration; refer to the service manual for instructions). Ensure that the display is functioning properly before operating the V100 Monitor. 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 gas sterilize or autoclave. Examine the power cord periodically. Discontinue use and replace if damaged. Caution should be taken to not set ALARM LIMITS to extreme values, as this can render the ALARM SYSTEM useless. The V100 Monitor, when used with GE Medical Systems Information Technologies-approved applied parts and accessories, is protected against defibrillator damage. NOTE: The electromagnetic compatibility profile of the V100 Monitor may change if accessories other than those specified for use with the V100 Monitor are used. Please refer to Appendix B “Accessories.”
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Introduction: Product Compliance
Product Compliance The CARESCAPE V100 Monitor is classified in the following categories for compliance with IEC 60601-1:
Internally powered or Class II when powered from external supply
Transportable
For continuous operation
Not suitable for use in the presence of flammable anesthetics
Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent)
Type BF applied parts
IPX1, degree of protection against ingress of water
Sterilization/Disinfection, see Appendix C “Maintenance”
Software is developed in accordance with IEC 60601-1-4.
This equipment is suitable for connection to public mains via power adaptors as defined in CISPR 11.
The SpO2 parameter complies to ISO 9919:2005.
Defibrillation protected. When used with the recommended accessories, the monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the monitor will recover. CARESCAPE V100 Monitor Classified with respect to electric shock, fire, and mechanical and other specified hazards only in accordance with CAN/CSA C22.2 No. 60601.1. Also evaluated to IEC-60601-2-30.
0086
IPX1
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This product conforms with the essential requirements of the Medical Device Directive 93/42. Accessories without the CE mark are not guaranteed to meet the Essential Requirements of the Medical Device Directive. The CARESCAPE V100 Monitor is protected against vertically falling drops of water and conforms with the IEC 529 Standard at level of IPX1. No harmful effects will come of vertically falling drops of water making contact with the monitor.
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Introduction: Symbols
Symbols The following symbols are associated with the V100 Vital Signs Monitor. NOTE: The model of the monitor determines which symbols appear on it. Attention, consult accompanying documents
Silence Alarms
+ / - Increase / decrease adjustable settings
Menu Inflate/Stop Cycle History
Print On/Off Battery Power External communications port connector Charging External DC power input Class II equipment according to IEC 60536
Defibrillator-proof type BF equipment
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