CARESCAPE VC150 Vital Signs Monitor Operators Manual Oct 2015

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 registered 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 CARESCAPETM VC150. T-2

CARESCAPETM VC150 Vital Signs Monitor

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Contents

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Introduction... 1-1 About this device... 1-2 Intended use... 1-3 Contraindications... 1-4 Dangers, warnings, cautions, and notes... 1-4 Safety precautions... 1-6 Product compliance... 1-11 CARESCAPETM VC150 vital signs monitor... 1-11 Exergen temporal scanner... 1-14 Monitor symbols... 1-14 About this manual... 1-17 Service requirements... 1-19 Product availability... 1-19

2

Product overview... 2-1 Front view... 2-2 Rear view and left side... 2-2 Right side... 2-3 User interface and connections... 2-4 Operating modes... 2-9 Clinical mode... 2-10 Monitor configuration... 2-10 Printout... 2-14 Remote Management... 2-15 Battery low shutdown or system failure... 2-15 Sounds... 2-15 Battery charger sounds... 2-15 Essential performance... 2-16 Product specifications... 2-20 Printer specifications... 2-21 Connectivity specifications... 2-21 Open source software notice... 2-23

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Getting started... 3-1 Introduction... 3-2 Setting up NIBP connections... 3-2 Setting up SpO2 connections... 3-4 Setting up temperature connection... 3-4 Welch Allyn (optional)... 3-4 Connecting USB accessories... 3-6 Installation/replacement of printer paper... 3-6 Paper storage... 3-7 Electrical connection... 3-7 Power sources... 3-7 Monitor on/off... 3-8 Touch screen recalibration... 3-9 Standby... 3-10 Monitor standby... 3-10 Turning the monitor off... 3-11 Summary... 3-11 Procedure for testing alarms... 3-12 Configuration mode settings... 3-12 Using the numeric keypad... 3-12 Icons on the monitor... 3-13 Using the home icon... 3-13 Alarm limit setup... 3-15 Changing limits for a single parameter box... 3-15 Changing multiple alarm limits... 3-17 Nellcor feature setup... 3-18 Masimo feature setup... 3-18 Monitor setup... 3-19 Shortcut to setup screens... 3-19 Menu selection for setup screens... 3-20 Audible & Visual... 3-20 NIBP setup... 3-22 SpO2 setup... 3-24 Temperature setup... 3-26 Advanced... 3-26 Patient... 3-27 Patient identification... 3-27 Snapshot... 3-27 Help... 3-28

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Alarms... 4-1 Description... 4-2 Alarm types... 4-2 Physiological alarms... 4-2 Technical alarms... 4-2 Battery alarms... 4-3 Alarm signals... 4-3 Alarms and priorities... 4-7 Physiological alarm conditions... 4-8 Technical alarm conditions... 4-10 Alarm specifications... 4-24 Factory default settings for alarm limits... 4-24 Logs... 4-24

5

Patient and caregiver data... 5-1 Description... 5-2 Adding a caregiver... 5-3 Providing identification... 5-3 Using a barcode reader for caregiver ID... 5-5 Selecting or adding a patient... 5-6 Positive patient identification... 5-8 Snapshots... 5-9 Obtaining vital signs snapshots for a patient... 5-9 Viewing snapshots... 5-10 Notes... 5-11 Snapshot output... 5-13 Assigning snapshots to a patient... 5-16 Assigning snapshots to a caregiver... 5-17 Deleting snapshot and notes... 5-18 Deleting patient history... 5-19 Troubleshooting... 5-20 The printer does not print... 5-20 Transmission to the EMR is unavailable... 5-20 Patient search is unavailable... 5-21 Forgotten password or ID... 5-21 Barcode reader does not work... 5-21 Red light in barcode reader... 5-21

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NIBP... 6-1 Description... 6-2 Differences in intra-arterial and auscultatory references... 6-3 NIBP on the monitor screen... 6-5 Alarms associated with NIBP... 6-7 NIBP modes of operation... 6-8 Adaptive target inflation pressure... 6-8 Single NIBP determinations... 6-9 STAT NIBP determinations... 6-9 Auto cycle determinations... 6-10 Profile cycle determinations... 6-10 Venous return for cycle and profile... 6-11 NIBP alarm limits... 6-11 NIBP settings... 6-12 Taking NIBP measurements... 6-12 Procedure... 6-12 Taking NIBP measurements on different patients... 6-16 Alarms... 6-17 NIBP specifications... 6-17 NIBP troubleshooting... 6-18 Overpressure... 6-18 Increase in determination time... 6-18 No determination... 6-19

7

GE TruSignal SpO2... 7-1 Description... 7-2 SpO2 safety... 7-3 SpO2 on the screen... 7-7 Changing the SpO2 alarm limits... 7-8 SpO2 procedure... 7-9 SpO2 sounds... 7-10 Alarms... 7-10 Alarm timer... 7-10 TruSignal compatible accessories... 7-11 GE TruSignal enhanced SpO2... 7-11 TruSignal SpO2 measurement characteristics... 7-12 Calibration... 7-13 GE TruSignal SpO2 configuration... 7-14 GE TruSignal SpO2 default settings... 7-14

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GE TruSignal SpO2 specifications... 7-14 GE TruSignal SpO2 sensor accuracy specifications... 7-16 Troubleshooting... 7-18

8

Masimo SpO2... 8-1 Description... 8-2 SpO2 safety... 8-3 SpO2 on the screen... 8-6 Changing the SpO2 alarm limits... 8-8 SpO2 procedure... 8-11 SpO2 sounds... 8-11 Acoustic sensors... 8-12 Alarms... 8-13 Alarm timer... 8-13 Compatible Masimo accessories... 8-13 Masimo rainbow® SET® SpO2 and special features... 8-14 rainbow Pulse CO-Oximetry Technology... 8-14 Pulse CO-Oximetry vs. Drawn Whole Blood Measurements... 8-15 General Description for Total Arterial Oxygen Content (CaO2)... 8-16 General Description for SpOC... 8-17 Description for Carboxyhemoglobin (SpCO)... 8-17 Successful Monitoring for SpCO... 8-17 General Description for Total Hemoglobin (SpHb)... 8-17 Successful Monitoring for SpHb... 8-18 General Description for Methemoglobin (SpMet)... 8-18 Successful Monitoring for SpMet... 8-18 rainbow Acoustic Monitoring (RAM) Technology... 8-23 Masimo rainbow® SET® SpO2 configuration... 8-25 Masimo rainbow SET® SpO2 default settings... 8-31 Masimo rainbow SET® SpO2 specifications... 8-32 Masimo sensor accuracy specification... 8-35 Patent information... 8-43 Troubleshooting... 8-44 Masimo low perfusion... 8-45

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Nellcor SpO2... 9-1 Description... 9-2 SpO2 safety... 9-3 Inaccurate Sensor Measurement Conditions... 9-7 Signal Loss... 9-7 Recommended Usage... 9-7 Patient Conditions... 9-8 Related documents... 9-9 SpO2 on the screen... 9-9 Changing the SpO2 alarm limits... 9-10 SpO2 procedure... 9-12 SpO2 sounds... 9-12 Alarms... 9-13 Alarm timer... 9-13 Compatible Nellcor accessories... 9-14 Nellcor SpO2 and special features... 9-14 Theoretical principles... 9-14 Nellcor Respiration Rate theory of operations... 9-15 Nellcor™ Sensor Technology... 9-16 SatSeconds™ Alarm Management Parameter... 9-16 The SatSeconds Safety Net... 9-19 OxiMax SPD™ Alert Parameter... 9-19 Pulse Rate Delay Alarm Management Parameter... 9-21 Required Pulse Oximetry Sensor Usage (for respiration rate)... 9-21 Connection to Nellcor™ Sensors... 9-22 Nellcor SpO2 default settings... 9-26 Nellcor SpO2 configuration... 9-26 Nellcor SpO2 specifications... 9-30 Nellcor OxiMax sensor accuracy specifications... 9-32 Patent information... 9-33 Troubleshooting... 9-34

10

Pulse rate... 10-1 Description... 10-2 Pulse rate alarm limits... 10-2 Pulse rate sound and settings... 10-3

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Welch Allyn temperature... 11-1 Description... 11-2 Safety... 11-2 Measurement method... 11-4 Temperature probes... 11-5 Welch Allyn temperature measurement... 11-5 Welch Allyn temperature calibration and self-checks... 11-10 Welch Allyn temperature specifications... 11-11 Patent information... 11-11 Troubleshooting... 11-12 Cleaning... 11-13

12

Exergen temperature... 12-1 Description... 12-2 Temperature measurement mode... 12-3 Additional indicators... 12-4 Sounds... 12-4 Procedures for temperature determination... 12-4 Familiarize yourself with the scanner... 12-4 Basics of using the temporal scanner... 12-5 Exergen temperature specifications... 12-7 Exergen scanner battery specifications... 12-7 Patent information... 12-8 Troubleshooting... 12-8 Batteries... 12-10 Cleaning... 12-10

13

Battery... 13-1 Description... 13-2 Battery charging... 13-3 Battery charge level... 13-4 Storage, care, and replacement of batteries... 13-5 Disposal of batteries... 13-5

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Battery alarms... 13-5 Battery low... 13-5 Monitor battery specifications... 13-6 Troubleshooting... 13-6

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Default setup... 14-1 Introduction... 14-2

A

Connections... A-1 Connections... A-2

B

Maintenance... B-1 Service and parts... B-2 Maintenance... B-2 User maintenance schedule... B-3 Calibration... B-4 Cleaning... B-4 List of approved cleaning agents... B-4 Cleaning schedule... B-5 Procedure... B-5 Battery and monitor storage care... B-8 Short-term storage... B-8 Extended storage... B-8 Repairs... B-9 Changing the Exergen temperature unit battery... B-9 Packaging material... B-10 Packing instructions... B-10 Disposal of product waste... B-11 Batteries... B-11 Patient-applied parts... B-11 Monitor... B-11

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C

Principles of noninvasive blood pressure determination (NIBP)... C-1 DINAMAPTM SuperSTAT algorithm... C-2 Systolic search... C-4 DINAMAPTM auscultatory reference algorithm... C-4 Systolic search... C-6 Reference used to determine NIBP accuracy... C-6

D

Supplemental analysis of clinical accuracy test data... D-1 GE TruSignal V2... D-2 Supplemental Analysis of Clinical Accuracy Test Data for GE TruSignal V2 SpO2 Measurement... D-2 Clinical test results... D-7 Nellcor accuracy study results... D-8 Masimo sensor accuracy... D-9 Performance Specifications for Masimo M-LNCS, LNCS, and LNOP Adhesive Sensors... D-9 Performance specifications for Rainbow ReSposable Pulse CO-Oximeter Sensor System... D-15 Performance Specifications for Masimo Sensors SpO2 Multisite Reusable Sensors... D-17 Performance Specifications for DBI™ Series... D-18

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Introduction

CARESCAPETM VC150 Vital Signs Monitor

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Introduction: About this device

About this device The CARESCAPETM VC150 vital signs monitor provides a small, portable monitoring alternative for sub-acute hospital and non-hospital settings. The monitor 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 (MAP), pulse rate, respiration rate (only available with Nellcor and Masimo technologies), oxygen saturation, and temperature. Monitors are available with or without (excluding NIBP, which is always available) integrated printers as well as the following parameters and technologies. •

NIBP (SuperSTAT or Auscultatory Reference Algorithms), Pulse Rate

•

SpO2: GE TruSignal, Nellcor OxiMax, or Masimo rainbow® SET®

•

Temperature: Welch Allyn SureTemp® Plus or Exergen

The model of the CARESCAPETM VC150 vital signs monitor determines which parameters are available in your monitor. Please refer to applicable sections. Using the CARESCAPETM VC150 vital signs monitor, a caregiver can measure, display and record patient vital sign data that is derived from each parameter. The monitor can transfer the patient’s electronic medical record to HIS (hospital information system). With the use of an optional monitoring mode the monitor is also capable of alerting to changes in the patient’s condition or when it is unable to effectively monitor the patient’s condition. The monitor also detects alarm limit conditions and gives audible and visual notification of these conditions. All of the main operations of the monitor are only a touch away. Please review the factory default settings and, where applicable, enter settings appropriate for your use. The monitor can use WLAN or Hostcomm to communicate with the EMR (Electronic Medical Record), export PDFs, print patient data with strip printer and use USB or Remote Management to export/import settings, license keys and update software.

EMR systems Patient IDs

Measurement

120 80

module 1

Measurement module 2

Caregiver

Patient

Vital signs monitor

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Introduction: Intended use

Intended use The CARESCAPE 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. 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 nonmotion conditions, and for patients who are well or poorly perfused. The optional Oximax SPD™ 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 CARESCAPE VC150 can also be used in satellite areas or alternate care settings.

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Introduction: Contraindications "Portable" refers to the ability of the CARESCAPE VC150 to be easily moved by the caregiver, such as on a roll stand. The CARESCAPE VC150 is not intended to be used for continuous monitoring during patient transport. 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.

Additional information on product use The CARESCAPETM VC150 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 similar equipment. Using this monitor, a caregiver can view, record, and recall clinical data derived from each parameter. The user interface has been localized into selected languages whereas the localized manual has more language options available. The CARESCAPETM VC150 vital signs monitor is intended to monitor one patient at a time in a clinical setting with a caregiver present. WARNINGS The monitor is not intended for use as critical care monitor. The monitoring system is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. The monitor is intended for spot check monitoring where caregiver is present by the patient. The monitor generates alarms and can be used for continuous monitoring only when applicable option license is installed.

Contraindications This device is not designed, sold, or intended for use except as indicated.

Dangers, warnings, cautions, and notes The terms Danger, Warning, Caution and Note are used throughout this manual to point out hazards and to designate a degree or level of 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.

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Introduction: Contraindications NOTE provides application tips or other useful information to assure that you get the most from your equipment.

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Introduction: Safety precautions

Safety precautions DANGER To protect against injury from electric shock, avoid placing the device on surfaces with visible liquid spills. Do not soak or immerse the device in liquids. Always turn off and disconnect the power cord from the AC power supply before cleaning the device. Use cleaning solutions sparingly. WARNINGS To ensure patient safety, use only parts and accessories manufactured specified in the CARESCAPE VC150 supplies and accessories manual. 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. To avoid personal injury, do not perform any service work on the monitor unless qualified to do so. If powering the monitor from an external power adapter or converter, use only an adapter that has been specified for this monitor. Refer to the CARESCAPETM VC150 supplies and accessories document. The monitor is not intended for use during transport of a patient outside a professional healthcare facility. If the monitor is dropped, it must be serviced immediately. Connect only IEC 60601 compliant, single isolated USB devices intended for patient care. Carefully route the external AC/DC power converter, air hoses, and all cables to reduce the possibility of entanglement or strangulation. 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 or patient cables in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Examine the power cord periodically. Discontinue use and replace if damaged. Replace the power cord, as necessary, with a regulatoryapproved cord for the country of use. CAUTION: Do not use extension cords or adapters of any type. Avoid swinging the monitor, or entangling the monitor and its accessories with a mount or roll stand, as this could cause the monitor to drop, leading to patient or user injury and equipment damage.

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Introduction: Safety precautions WARNINGS The accuracy of the vital sign values may be compromised 1) if you do not hear two beeps when the screen changes from power-up to home or 2) it is difficult to make selections on the touch screen and calibration of the screen does not solve the problem. Contact GE technical support in both cases. Do not perform any testing or maintenance on a sensor while it is being used to monitor a patient. Verify calibration of the NIBP parameter (temperature and pulse oximeter do not require calibration). Refer to the service manual for instructions. Keep the monitor and its accessories out of the patient’s reach when not in use. Place the monitor on a rigid, secure surface or use only mounting hardware that has been specified for this monitor. Refer to the CARESCAPETM VC150 supplies and accessories document. Only use the monitor in areas where adequate ventilation exists. Do not cover the ventilation plates at the bottom and the top of the monitor. Use only a battery type that has been specified for this monitor. Other batteries may not provide the same operating time and may cause unexpected monitor shutdown. Other batteries may be incompatible with the internal charger and may cause battery acid leakage, fire, or explosion. Refer to the CARESCAPETM VC150 supplies and accessories document. Caution should be taken to not set alarm limits to extreme values, as this can render the alarm system useless. Do not modify this equipment without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Periodically, and whenever the integrity of the monitor is in doubt, test all functions. The performance of the monitor may be degraded if it is operated or stored outside of the environmental conditions specified in this manual. The monitor meets standards IEC 60601-1 and ISO 9919 for shock and vibration. If the monitor is subjected to conditions exceeding these standards, performance may be degraded.

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Introduction: Safety precautions WARNINGS Do not use the 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. Explosion hazard. Do not use the monitor in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide. Do not use in the presence of an oxygen-enriched atmosphere (oxygen tent). Operating the monitor near equipment which radiates high-energy electromagnetic and radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the monitor and temperature probe away from the source of interference and perform a new measurement. Do not gas sterilize or autoclave the monitor. The monitor should not be used on patients who are connected to cardiopulmonary bypass machines. To reduce the risk of electric shock, do not remove the cover or the back. Refer service work to service personnel. If the accuracy of any determination reading is questionable, first check the patient’s vital signs by alternate means and then check the monitor for proper functioning. This equipment is not intended for use in the presence of electrosurgery/HF (high frequency) electrosurgical equipment. To prevent cross-contamination, clean exterior surfaces of the monitor, monitor accessories, and reusable sensors on a regular basis in compliance with your institution's infection control unit and/or biomedical department's local policy. Do not disassemble the monitor as personal injury may result. The monitor and its accessories are to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read and understood before use. Use only approved accessories. For a list of approved accessories, refer to the CARESCAPETM VC150 supplies and accessories document. Substitution of a component different from that supplied might result in measurement error. Other cables and accessories may cause a safety hazard or damage the equipment or system. The monitor cannot recognize whether a cable is disconnected from the nurse call interface. Do not leave the patient unattended and rely solely on remote alarm. The remote alarm is not intended to replace patient monitoring by trained nurses.

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