Compliance; Safety Classification; Radio Frequency Regulatory Compliance - Medicomp TelePatch PM750 User Manual

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Call ​ M edicomp​ ' s Patient Support: ​
to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical
service department.
●
USE THE TELEPATCH SYSTEM ONLY WITH THE LEADS, ELECTRODES, AND ACCESSORIES RECOMMENDED BY MEDICOMP. USE OF
OTHER ACCESSORIES MAY ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE OR MAY RESULT IN STRONGER
ELECTROMAGNETIC EMISSIONS OR REDUCE THE ELECTROMAGNETIC IMMUNITY OF TELEPATCH CARDIAC MONITOR PM750.
● CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR CF APPLIED PARTS, INCLUDING NEUTRAL
ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH.
●
USERS WHO ARE WEARING NEUROSTIMULATING PENDANTS CANNOT BE SET UP WHILE THAT DEVICE IS TURNED ON. THE
OPERATION OF THESE PENDANTS INTERFERES WITH THE TELEPATCH'S ABILITY TO ACQUIRE THE ECG SIGNAL. IF ALLOWED THESE
DEVICES SHOULD BE TURNED OFF WHILE THE PATIENT IS WEARING TELEPATCH.
● DO NOT USE THE TELEPATCH IN COMBINATION WITH EXTERNAL CARDIAC DEFIBRILLATORS OR HIGH FREQUENCY SURGICAL
EQUIPMENT.
●
PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. THIS PENDANT
SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT.
●
LOAD ONLY 3.7V LITHIUM ION BATTERIES DELIVERED IN THE TELEPATCH KIT INTO THE TELEPATCH CARDIAC MONITOR BATTERY
COMPARTMENT.
● LEAD FAILURES ARE DETECTED BY A 10 MV PEAK, 50% DUTY CYCLE RECTANGULAR PULSE, WHICH IS APPLIED TO EACH PATIENT
ELECTRODE CONNECTION THROUGH A 4.9MOHM RESISTOR AT A RATE OF 15 HZ WITH RESPECT TO THE SYSTEM GROUND.
● THIS IS A PRESCRIBED MEDICAL DEVICE, NOT A TOY, INFANTS AND CHILDREN MUST BE SUPERVISED.
●
WARNING: CHOKING HAZARD – ADULT SUPERVISION REQUIRED.
●
IN THE EVENT OF A DAMAGED PENDANT, DISCONTINUE USE AND CALL MEDICOMP PATIENT SUPPORT: 800-234-3278 EXT. 2370,
FOR RETURN AND REPLACEMENT.
In accordance​ with IEC 60601-1 Third Edition Am 1:2012 :
Conformance to Standards – non-clinical testing demonstrated conformance to voluntary safety IEC 60601-1 and to IEC 60601-1-2-2001 Class B
Medicomp, Inc.'s Quality System conforms to 21 CFR 820 and ISO 13485:2003.
Conformance to Standards
Non-clinical testing demonstrated conformance to voluntary safety IEC 60601-1 and to IEC 60601-1-2-2001 Class B
Medicomp, Inc.'s Quality System conforms to 21 CFR 820 and ISO 13485:2003.
This Pendant contains transmitter module FCC ID​ :
Model Name: TAS0000750
FCC ID: 2AGDTPM700
IC account number/IC company number: 21061-PM700
CAN ICES-3 (B)/NMB-3(B)"
This Pendant complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This Pendant may not cause
harmful interference, and (2) this Pendant must accept any interference received, including interference that may cause undesired operation.
Part 15 Clause 15.105
Note: This equipment has been tested and found to comply with the limits for a Class B digital Pendant, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates
uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
Part 15 Clause 15.21
Tele ​ P atch™ ​ C ardiac Monitor PM750
USER MANUAL - UTM0000701-05E ​
12
8 77-996-5553
WARNINGS

COMPLIANCE

Safety Classification

Radio Frequency Regulatory Compliance

| APRIL 4, 2019