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Call M edicomp ' s Patient Support:
Users of the TelePatch System should be able to activate the Symptom button unassisted or be
supervised and assisted. The T ele P atch S ystem can be worn by users weighing less than 10kg.
TelePatch is intended for use as prescribed by a physician who wants to follow cardiac activity.
A physician must review and interpret ECG findings recorded during procedure . T he T ele P atch
System is not intended for diagnostic use.
Contraindication
There are no potential adverse effects of the T ele P atch C ardiac Monitor, PM750 on health.
Safety Classification
In accordance with IEC 6 0601-1 Third Edition Am 1: 2012:
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This equipment is designed to be operated with one 3.7V 440mAh 1.62Wh lithium ion battery, and under no circumstances shall
power be supplied in any other manner.
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Type BF equipment.
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Rated for Continuous Operation.
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Ordinary Equipment. Enclosed equipment. The device is protected to IP55 as required by the standard.
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This equipment shall not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide, or
flammable cleaning agents.
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Equipment with an Applied Part, specifically designed for applications where a Conductive Connection is made to the Patient, but
not directly to the heart.
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The equipment requires no adjustment.
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Operating and Storage Humidity: 10% to 95%, non-condensing
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Operating Temperature: 0°C to 45°C (32°F to 284°F).
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Storage Temperature: -15°C to 60°C (5°F to 140°F).
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TelePatch System Shipment: Temperature limitation for shipment: -15°C to 60°C (5°F to 140°F).
Atmospheric Pressure: Operating: 700 hPa to 1060 hPa; Storage/Transport: Not Applicable to T ele P atch System
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The equipment contains no user-serviceable parts. It shall be serviced only by Medicomp, Inc. Unauthorized repairs of the equipment will void
the warranty.
Modifications
For continued safety, equipment should not be modified in any manner and must be used only as indicated.
Defibrillation
The external parts of the equipment may provide a source of the defibrillation voltage if it is not removed from the patient during defibrillation.
Due to the small size of the unit and patient connectors, the cable or connector may break down and cause the defibrillation voltage to be
shunted and make it less effective for the patient. The unit and cable MUST be removed prior to defibrillation.
System Safety
Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data
processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or
clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a
medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn
Tele P atch™ C ardiac Monitor PM750
USER MANUAL - UTM0000701-05E
11
8 77-996-5553
The Tele P atch C ardiac Monitor System
OVERVIEW
SAFETY SPECIFICATIONS AND COMPLIANCE
| APRIL 4, 2019
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