ApexPro Telemetry System User Manual sw ver 5 or later 1st issue Feb 2020

The information in this manual applies to the software version and product models on the first page of the manual. Due to continuing 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., and GE Healthcare Finland Oy.

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Contents 1

Introduction... 9 Manual intended use ... 9 Manual intended audience... 9 Manual conventions ... 9 Manual naming conventions... 9 Illustrations and names ... 10 Related documents... 10 Additional resources ... 11 Product availability ... 11 Ordering manuals ... 11 Trademarks ... 11 Third party trademarks... 11

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Safety ...13 Safety message signal words... 13 Safety symbols ... 13 System danger safety messages... 14 System warning safety messages ... 14 System caution safety messages ... 21 System notice safety messages... 24 Indications for use... 24 Contraindications for use ... 24 User profile ... 24 Required training and skills ... 25 Safety tests... 25 Verifying proper operation ... 25

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System description ...27 System description overview ... 27 Transmitters ... 27 Antenna infrastructure ... 27 ApexPro receiver system ... 28 CARESCAPE Telemetry Server... 28

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Central station ... 28 Bedside monitors ... 28 CARESCAPE Network... 28 System interoperability... 28 Device symbols ... 28 Telemetry monitoring device symbols ... 31 ApexPro receiver system and ApexPro antenna system device symbols... 31 Telemetry server device symbols ... 32 Unique Device Identifier (UDI)... 33 CE marking application year ... 34 Manufacturer’s responsibility... 34 Service requirements... 34 4

Monitoring basics ...37 Transmitter controls, indicators, and connections ... 37 Installing the transmitter batteries ... 39 Admitting telemetry patients to a central station... 40 Admitting telemetry patients to a bedside monitor... 41 Printing... 42 Patient discharge report... 43 Telemetry monitoring device battery status report... 44

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Alarms ...45 Alarms overview... 45 Pausing audio alarms ... 45

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ECG ...47 ECG safety precautions ... 47 Monitoring ECG ... 48 Preparing the patient’s electrode sites ... 51 Applying the electrodes to the patient ... 51 6-lead ECG electrode placement ... 51 3- lead or 5-lead ECG electrode placement ... 52 Connecting ECG leadwire sets ... 53 Checking ECG lead status... 53 Monitoring pacemaker patients... 54

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SpO₂ ...57 SpO2 safety precautions ... 57 Monitoring SpO2 ... 58 SpO2 measurement and interference... 59 Checking the SpO2 measurement... 59 SpO2 functional testers ... 59

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Messages ...61 ECG messages... 61 SpO2 messages ... 63 Technical alarm messages... 64

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Periodic maintenance ...67 Periodic maintenance overview... 67 Planned maintenance... 67 Daily checks... 67 Cleaning and disinfection overview... 67 Cleaning ... 68 Disinfecting ... 69 Biocompatibility ... 72 Telemetry monitoring device care ... 72 Telemetry monitoring device storage... 72 Battery recycling ... 73 Disposal ... 73

10 Troubleshooting...75 Telemetry monitoring device troubleshooting ... 75 ECG monitoring troubleshooting... 76 SpO2 monitoring troubleshooting ... 79 A

Compatibility ...81 Compatible transmitters... 81 Compatible central stations ... 81 Compatible monitoring devices ... 81 Other compatible systems ... 82

B

Compliance...83 ApexPro CH transmitter standards compliance ... 83 ApexPro CH transmitter IEC 60601-1... 83

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CARESCAPE T4 transmitter standards compliance... 83 CARESCAPE T4 transmitter IEC 60601-1... 84 CARESCAPE T14 transmitter standards compliance... 84 CARESCAPE T14 transmitter IEC 60601-1... 84 ApexPro 400 MHz receiver standards compliance ... 84 ApexPro 400 MHz receiver IEC 60601-1 ... 85 ApexPro 600 MHz receiver standards compliance ... 85 ApexPro 600 MHz receiver IEC 60601-1 ... 85 ApexPro antenna system IEC 60601-1 ... 85 Telemetry server standards compliance ... 85 C

Technical specifications...87 Specifications overview ... 87 Telemetry monitoring device specifications... 87 Telemetry monitoring device environmental specifications ... 88 Telemetry monitoring device physical specifications ... 88 Antenna infrastructure specifications ... 89 Enterprise Access System specifications... 90 Receiver specifications ... 91 Receiver performance specifications ... 91 Quad receiver module performance specifications... 91 Receiver power requirements ... 91 Receiver environmental specifications ... 91 Receiver physical specifications... 92 Telemetry server specifications ... 92 Telemetry server general performance specifications ... 92 Telemetry server hardware specifications ... 92 Telemetry server software specifications ... 93 Telemetry server power requirements... 93 Telemetry server environmental specifications ... 93 Telemetry server physical specifications ... 93

D

Alarm specifications...95 Alarm standards compliance ... 95 Alarm delay specifications ... 95 Alarm delay specifications for ECG alarms... 95

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Alarm delay specifications for SpO2 alarms ... 96 Alarm delay specifications for technical alarms ... 96 Alarm priorities and escalation times ... 97 E

Parameter specifications...99 ECG standards compliance ... 99 ECG performance specifications... 99 SpO2 standards compliance... 101 SpO2 displayed saturation values ... 101 SpO2 summary of clinical studies used to establish accuracy claims... 101 SpO2 test methods used to establish accuracy claims during motion... 101 SpO2 test methods used to establish accuracy claims during low perfusion... 101 SpO2 test methods used to establish pulse rate accuracy... 102 SpO2 supplemental accuracy information ... 102 SpO2 performance specifications ... 102

F

Defaults...105 Presets, custom defaults, and control settings ... 105 ECG presets (defaults) ... 106 SpO2 presets (defaults)... 106 Technical alarm priority level presets (defaults)... 107

G

Electromagnetic compatibility...109 Standards compliance... 109 Essential performance in EMC ... 109 Electromagnetic compatibility safety precautions ... 110 Telemetry monitoring device electromagnetic emissions... 110 Telemetry monitoring device electromagnetic immunity ... 111 FCC compliance in the 608 to 614 MHz bands ... 112 FCC compliance in the 1395 to 1400 MHz bands ... 113 Radio Equipment Directive 2014/53/UE compliance... 114 Receiver electromagnetic emissions ... 114 Receiver electromagnetic immunity ... 115 Electromagnetic immunity for RF ... 116 Recommended separation distances... 118

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Proximity field immunity compliance... 119 Compliant cables and accessories ... 119 Minimizing electromagnetic interference... 120 H

Abbreviations ...121 List of abbreviations... 121

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Introduction Manual intended use

This manual is an integral part of the device and describes its intended use. It should always be kept in a place accessible to users, and information indicating that place should be available close to the equipment. Observance of the manual is mandatory for proper performance and correct operation and ensures patient and user safety.

Manual intended audience This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices and terminology required to provide patient care. Using the system should never replace nor impede the human intervention and required patient care provided by clinical professionals.

Manual conventions This manual uses the following styles to emphasize text or indicate action. Item

Description

bold

Indicates hardware terms.

bold italic

Indicates software terms.

italic

Indicates terms for emphasis.

Manual naming conventions This manual uses the following terms to simplify common terms:

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Term

Description

antenna

Refers to an ApexPro antenna that is part of the ApexPro antenna system.

applied part

Refers to the part of ME equipment that in normal use necessarily comes into physical contact with the patient for ME equipment or an ME system to perform its function.

bedside monitor

Refers to bedside monitors, including patient monitors, transport monitors, or wireless monitors on the network.

central station

Refers to the CARESCAPE Central Station or the CIC Pro Clinical Information Center.

external serial device

Refers to the ECG leadwire set or pulse oximetry cable.

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Introduction

Term

Description

monitoring device

Refers to bedside monitors or telemetry monitoring devices.

network

Refers to the CARESCAPE Network. The Unity Network has been renamed to the CARESCAPE Network. Not all references to the Unity Network will be changed immediately; Unity may appear in some places and CARESCAPE in others. It is important to understand that while the CARESCAPE Network replaces the Unity Network name, they refer to the same GE monitoring network.

patient environment

Refers to any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system (IEC 60601-1).

printer

Refers to direct digital writers or laser printers.

pulse oximetry cable

Refers to Masimo SET uSpO2 Pulse Oximetry Cable.

receiver

Refers to the ApexPro 400 MHz Receiver and/or the ApexPro 600 MHz Receiver that is part of the ApexPro receiver system.

telemetry monitoring device

Refers to telemetry monitoring devices, including transmitters, transceivers, and the established telemetry system.

telemetry server

Refers to the CARESCAPE Telemetry Server running the telemetry server software.

telemetry system

Refers to the entire telemetry system, comprised of telemetry monitoring devices, antenna infrastructure, receivers, and telemetry servers.

telemetry server software

Refers to the telemetry server software that runs on many components of the telemetry system.

transmitter

Refers to an ApexPro CH Transmitter, CARESCAPE T4 Transmitter, and/or CARESCAPE T14 Transmitter.

writer

Refers to direct digital writers (DDW).

Illustrations and names This manual uses illustrations as examples only. Illustrations in this manual may not necessarily reflect all 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

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●

ApexPro Telemetry System Service Manual

●

Enterprise Access System Service Manual

●

CARESCAPE Central Station User’s Manual

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CARESCAPE Central Station Technical Manual

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CIC Pro Clinical Information Center Operator’s Manual

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CIC Pro Clinical Information Center Service Manual

Additional resources For white papers, guides, and other instructional materials about our clinical measurements, technologies, and applications, please visit: http://clinicalview.gehealthcare.com

Product availability Some of the products mentioned in this manual may not be available in all countries. For more information, contact your local GE representative.

Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.

Trademarks GE, GE Monogram, APEXPRO, and CARESCAPE are trademarks of General Electric Company. Trademark names may vary in different countries. For more information, contact your local GE representative.

Third party trademarks All third party trademarks are property of their respective owners. Masimo®, LNCS®, and SET® 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.

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Safety Safety message signal words

Safety message signal words designate the severity of a potential hazard. The signal words danger, warning, caution, and notice are used throughout this manual to point out hazards and to designate a degree or level of seriousness. A hazard is defined as a source of potential injury to a person. Learn their definitions and significance. 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.

The order in which safety messages are presented in no way implies the order of importance. The following safety messages apply to the system. Safety messages specific to parts of the system are found in the relevant section of this manual.

Safety symbols The following safety symbols may display on one or more of the system devices: Caution. ISO 7000. This symbol is identified by a white background, black triangular band, and a black symbol. Consult operating instructions. Follow instructions for use. ISO 7010. This symbol indicates mandatory action and it is identified by a blue background and a white symbol.

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Safety

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. 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. Non-ionizing electromagnetic radiation. Interference may occur in the vicinity of this device. Potential equalization conductor (IEC 60601-1). Use this conductor to bring the processing unit to the same potential as other devices in the care unit by connecting a green and yellow potential equalization cable to the pin labeled with the equipotential symbol, and connecting the other end of the cable to the equalization bus bar for the care unit. Safety ground. Remove power cord from the mains source by grasping the plug. Do not pull on the cable. 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.

System danger safety messages No danger safety messages apply to this system.

System warning safety messages The following warning safety messages apply to this system. WARNING

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ACCESSORIES (EQUIPMENT). The use of accessory equipment not validated with the system and/or not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: ●

Use of the accessory in the patient vicinity; and

●

Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 harmonized national standard.

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ACCESSORIES (SUPPLIES). To ensure patient safety, use only parts and accessories manufactured or recommended by GE. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards, and/or the system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard.

WARNING

ACCURACY. If the accuracy of any value displayed or printed is questionable, first determine the patient's vital signs by alternative means. Then, verify the monitoring devices and printers are working correctly.

WARNING

ADJUSTING SYSTEM ALARM PRIORITY LEVELS. The LEADS FAIL alarm indicates that one or more electrodes are not connected to the patient and, as a result, there is loss of all waveforms and arrhythmia analysis. The ARR SUSPEND alarm indicates that arrhythmia conditions are not being detected and therefore alarms associated with arrhythmias will not occur. The LEADS FAIL and ARR SUSPEND alarms should be adjusted to a lower priority level only by experienced qualified personnel and with great caution. Adjusting these alarms to a lower priority level may result in reduced awareness of conditions that indicate the loss of patient monitoring.

WARNING

ALARM ACTIVATION. Audio alarms do not sound and visual alarm indicators do not display at the central station until a patient is admitted. The central station will not provide alarm notification if an unadmitted patient enters an alarm condition. You must admit the patient to activate the alarm notification, automatic alarm printing, and events storage.

WARNING

ALARMS OFF. When Allow Telemetry Alarm Audio OFF on this Central is enabled and the Alarm Audio On/Off option OFF is selected, the telemetry monitoring device alarms remain off until you manually select ON.

WARNING

AUDIO ALARM PAUSE (ALARM SILENCE). Audio alarms do not sound and alarms do not print during an audio alarm pause (alarm silence) condition.

WARNING

AUDIO ALARM PAUSE (ALARM SILENCE). All alarms are ignored except HIGH (CRISIS) priority alarms during an audio alarm pause (alarm silence) condition.

WARNING

BEFORE USE. Before putting the system into operation, verify the system is in correct working order and operating condition.

WARNING

BEFORE USE. Before using this device for the first time, see the documentation accompanying the central station for safety information.

WARNING

CABLES. Route all cables away from patient's throat to avoid possible strangulation.

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WARNING

CONDUCTIVE CONNECTIONS. Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground.

WARNING

CONTAMINATED LEADWIRES. Contaminated leadwires may cause infection. Always follow the skin preparation guidelines and leadwire cleaning instructions.

WARNING

DATA VALIDITY. Do not expose the SpO2 probe light detector to strong ambient light while monitoring a patient. A poor signal may result. Do not allow tape to block the SpO2 probe light detector.

WARNING

DEFIBRILLATOR PRECAUTIONS. Patient signal inputs labeled with the CF symbol with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation.

WARNING

DEVICE DAMAGE. Never store the telemetry monitoring device with the batteries inside. Storing the telemetry monitoring device with the batteries inside may result in damage to the telemetry monitoring device and could cause RF interference.

WARNING

DISCONNECTION FROM MAINS. When disconnecting the system from the power line, remove the plug from the wall outlet first. Then you may disconnect the power cord from the device. If you do not observe this sequence, there is a risk of coming into contact with line voltage by inserting metal objects, such as the pins of leadwires, into the sockets of the power cord by mistake.

WARNING

DISPOSAL. At the end of its service life, the products described in this manual, as well as its accessories, must be disposed of in compliance with guidelines regulating the disposal of each product. If you have any questions concerning disposal of a product, contact your local GE representative.

WARNING

DUST COVERS. If the dust covers for the interface connectors become detached from the transmitter, they may pose a choking hazard. Inspect the dust covers before each use to verify that they are securely attached. If the dust covers become detached and cannot be reinserted into their retaining slot, do not use them on the transmitter, and keep them out of patients’ reach.

WARNING

ELECTRIC SHOCK. Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.

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ELECTRODES. Whenever patient defibrillation is a possibility, use non-polarizing (silver/silver chloride construction) electrodes for ECG monitoring. Polarizing electrodes (stainless steel or silver constructed) may cause the electrodes to retain a residual charge after defibrillation. A residual charge will block acquisition of the ECG signal.

WARNING

ELECTROMAGNETIC INTERFERENCE. Operation of telemetry monitoring devices outside the designated WMTS frequency band is at increased risk for electromagnetic interference. WMTS is protected in the U.S. only. This interference could lead to lapses in patient monitoring and missed alarm events, putting the patient at risk and compromising patient safety.

WARNING

EMC INTERFERENCE. Magnetic and electrical fields are capable of interfering with the proper performance of the system devices. For this reason make sure that all external devices operated in the vicinity of the monitoring system comply with the relevant EMC requirements. X-ray equipment, MRI devices, and high frequency surgical units (ESU) are a possible source of interference as they may emit higher levels of electromagnetic radiation. Interference may cause changes to ECG baseline waveform, which may not be obvious to a clinician.

WARNING

EQUIPMENT DAMAGE. To avoid electric shock or device malfunction, liquids must not be allowed to enter the device. If liquids have entered a device, take it out of service and have it checked by authorized service personnel before it is used again.

WARNING

EXPLOSION HAZARD. Do not use this device in the presence of flammable anesthetics, vapors, liquids, or in an oxygen-rich environment.

WARNING

FALSE CALLS. False low heart rate indicators or false ASYSTOLE may result with certain pacemakers because of electrical overshoot.

WARNING

IMPROPER TELEMETRY MONITORING DEVICE/LEADWIRE APPLICATION. Applying a telemetry monitoring device and/or leadwire that is not thoroughly dry to a patient can result in an electrically conductive path being established and a LEADS FAIL alarm not being provided if leadwires come off the patient.

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Safety

WARNING

INACCURATE VALUES. The display of inaccurate pulse oximetry (SpO2) values has been linked to the presence of poor signal strength or artifact due to patient motion during signal analysis. This condition is most likely to be encountered when the equipment is used on pediatric patients. These same conditions in adults do not impact the SpO2 values to the same extent. When using pulse oximetry on pediatric patients, always observe the following precautions. We recommend the application of the following criteria when using the pulse oximetry function on pediatric patients: The peripheral pulse rate (PPR) as determined by the SpO2 function must be within 10% of the heart rate. ● The SpO2 signal strength indicator must have 2 or 3 asterisks displayed on the central station. ●

●

Stable SpO2 values are displayed for six seconds.

Alternate procedures or devices previously applied in your facility for SpO2 monitoring should be used in the event that the SpO2 value from the equipment cannot be validated by the above criteria.

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WARNING

INCORRECT ALGORITHMS, ARRHYTHMIA PROCESSING AND CALCULATIONS BASED ON PATIENT AGE. After manually updating or automatically retrieving patient demographic information from a network database, always confirm that the selected Patient Age value is appropriate. Otherwise the appropriate age-related algorithms, arrhythmia detection, and calculations will not be applied.

WARNING

INGESTION OF BATTERIES. Make sure the battery compartment is closed completely and closely observe patients to prevent ingestion of batteries.

WARNING

INSPECTION. Failure on the part of the responsible hospital or institution using this device to implement a satisfactory maintenance schedule may cause equipment failure and possible health hazards.

WARNING

INSTRUCTIONS FOR USE. For continued safe use of this device, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care.

WARNING

INTERFACING OTHER EQUIPMENT. Devices may only be interconnected with each other or to parts of the system when it has been determined by qualified personnel that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned (or other informed experts) for proper use. In all cases, safe and proper operation should be verified with the applicable manufacturer's instructions for use and system standards IEC 60601-1 must be complied with.

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LOSS OF ALARMS. Do not connect a pulse oximetry cable to the telemetry monitoring device without first connecting an ECG leadwire set. Failure to use pulse oximetry cables in the prescribed manner may result in a loss of alarms.

WARNING

LOSS OF DATA. Clinicians and telemetry patients should be made aware of telemetry coverage areas. Movement outside of the telemetry coverage area may result in loss of patient monitoring.

WARNING

LOSS OF MONITORING. Periodically, and whenever the integrity of the device is in doubt, test all functions.

WARNING

MISSED ALARMS. Audio alarms do not sound, events are not stored, alarms do not print, and alarms are not sent to the network when the Alarm Audio Pause - Smart Alarm (Alarm Pause - Smart Alarms) feature is enabled and an alarms off reason is selected.

WARNING

MISSED ALARMS. In the monitoring of patients the coincidence of adverse conditions may lead to an interrupted signal going unnoticed. In this situation, artifacts are capable of simulating a plausible parameter reading, and therefore an alarm might not sound. In order to ensure reliable patient monitoring, the proper application of the SpO2 probe and the SpO2 probe signal quality must be checked at regular intervals.

WARNING

MISSED ALARMS. VFIB/VTAC should not be considered a substitute for the V TACH arrhythmia call. Efforts to lower the V TACH alarm priority level can result in missed ventricular tachycardia alarms.

WARNING

MONITORING PACEMAKER PATIENTS. Monitoring of pacemaker patients can only occur with the pace program activated.

WARNING

NETWORK INTEGRITY. The telemetry server resides on the CARESCAPE network, and it is possible that inadvertent or malicious network activity could adversely affect patient monitoring. The integrity of the CARESCAPE network is the responsibility of the hospital or institution.

WARNING

PACEMAKER DETECTION. Do not monitor pacemaker patients with a 3-leadwire set when reliable pacemaker detection is required. Pacemaker pulse detection can be erratic when only a single vector is monitored. Always use a 5- or 6- leadwire set when reliable pacemaker detection is required.

WARNING

PACEMAKER SPIKE. An artificial pacemaker spike is displayed in place of the actual pacemaker spike. All pacemaker spikes appear uniform. Do not diagnostically interpret pacemaker spike size and shape.

WARNING

PACKAGING DISPOSAL. Dispose of all packaging material, observing all applicable waste control regulations and keeping out of children’s reach.

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WARNING

PATIENT HAZARD. A pacemaker pulse can be counted as a QRS during ASYSTOLE in either pace mode. Keep pacemaker patients under close observation.

WARNING

PATIENT SAFETY AND EQUIPMENT DAMAGE. To avoid risks to personnel and patient, or damage to the equipment, no unauthorized modification of this equipment is allowed. Unauthorized alteration or modifications may affect patient safety, performance, and accuracy.

WARNING

POWER SUPPLY. All power outlets used by the telemetry system should have protective earth contacts. If the installation does not provide for a protective earth conductor, disconnect it from the power line and operate it on battery power, if possible. GE recommends a stable, non-interrupted power source for proper operation. If stable power source is not used, improper shutdowns of the system could result from power outages and cause lengthy disk scan delays when the unit reboots. Data could be lost in the event of a power outage. All devices of a system must be connected to the same power supply circuit. Devices which are not connected to the same circuit must be electrically isolated when operated.

WARNING

PROTECTED LEADWIRES. Only use protected leadwires and patient cables with this device. The use of unprotected leadwires and patient cables creates the potential for making an electrical connection to ground or to a high voltage power source which can cause serious injury or death to the patient.

WARNING

QUALIFIED PERSONNEL. The service mode and alarm service mode on the central station are intended for use only by qualified personnel with training and experience in their use. The consequences of misuse include loss of alarm configuration, loss of patient data, corruption of the operating system software, or disruption of the network.

WARNING

RATE METERS. Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See the monitoring device manual for disclosure of the pacemaker pulse rejection capability.

WARNING

RESTRICTED SALE. U.S. federal law restricts this device to sale by or on the order of a physician.

WARNING

SINGLE PATIENT USE. This telemetry monitoring device is designed for use on one patient at a time. Using this equipment to monitor different parameters on different patients at the same time compromises the accuracy of data acquired.

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WARNING

SITE REQUIREMENTS. For safety reasons, all connectors for patient cables and sensor leads are designed to prevent inadvertent disconnection, should someone pull on them. Do not route cables in a way that they may present a stumbling hazard. For devices installed above the user or patient, adequate precautions must be taken to prevent them from dropping on the user or patient.

WARNING

SKIN IRRITATION. Prolonged monitoring or incorrect sensor application may require changing the SpO2 probe site periodically. Move the SpO2 probe if there is any sign of skin irritation or impaired circulation. Change the SpO2 probe according to your hospital or institution’s policy. If a SpO2 probe is damaged in any way, discontinue use immediately.

WARNING

SpO2 PROBES. Use only approved SpO2 probes with the pulse oximetry cable. The reliability of SpO2 data obtained with any other probe has not been verified.

WARNING

SUPERVISED USE. This system is intended for use under the direct supervision of a licensed health care practitioner.

WARNING

SUSPENDED ANALYSIS. Certain conditions suspend arrhythmia analysis. When suspended, arrhythmia conditions are not detected and alarms associated with arrhythmias do not occur. The messages which alert you to the conditions causing suspended arrhythmia analysis are: ARR OFF, ARR SUSPEND, DISCHARGED, LEADS FAIL, and NO TELEM. Additionally, the alarms off with reason options and disabling the Alarm Pause Breakthrough feature also suspend arrhythmia analysis.

WARNING

UNTESTED SOFTWARE. Do not load any software other than the software specified onto this telemetry server. Installation of other software may cause damage to the server or loss or corruption of data.

WARNING

USER. Medical devices such as this monitoring system must only be used by medically trained persons who are familiar with the functions, features and workflows of this device and who are capable of applying this knowledge properly.

WARNING

VENTRICULAR ARRHYTHMIAS. The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect atrial or supraventricular arrhythmias, with the exception of atrial fibrillation. Occasionally it may incorrectly identify the presence or absence of an arrhythmia. Therefore, a qualified healthcare professional must analyze the arrhythmia information in conjunction with other clinical findings.

System caution safety messages The following caution statements apply to this system.

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