Medicomp TelePatch PM750 User manual

Have a question or need assistance?

Call Medicomp’s Patient Support: 877-996-5553

Tele



Patch™

Cardiac Monitor PM750

User Manual

INSTRUCTIONS FOR USE

Tele



Patch is intended for use as prescribed by a physician who wants to follow

cardiac activity. TelePatch is not intended for diagnostic use. A physician must

review and interpret ECG findings recorded during procedure.

Tele

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Patch™ Cardiac Monitor PM750

USER MANUAL - UTM0000701-05E 

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

Table of Contents

GETTING STARTED AND INTRODUCTION 6

Notices, Cautions, and Copyrights 6

TelePatch Cardiac Monitor User Kit 7

Contact Us 9

ABOUT TELEPATCH CARDIAC MONITOR PM750 10

INDICATIONS FOR USE 10

OVERVIEW 11

SAFETY SPECIFICATIONS AND COMPLIANCE 11

Contraindication 11

Safety Classification 11

Modifications 11

Defibrillation 11

System Safety 11

COMPLIANCE 12

Safety Classification 12

Radio Frequency Regulatory Compliance 12

BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION 13

TELEPATCH SYSTEM OVERVIEW 15

Universal Pendant Description 17

TelePatch Handset Description 20

Accessories to the TelePatch System 21

TelePatch Charger Cord 22

Connecting Charger Cord: Handset 24

TelePatch Battery Charger 26

Connecting Charger Cord To Battery Charger: 27

TelePatch Electrode Patch 29

STANDARD PROCEDURE SET-UP 32

Patient Preparation 32

Step 1 - Identify Electrode Patch Site 32

Step 2 - Prepare the Skin 33

Step 3 - Electrode Patch Application 34

Tele

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Step 4 - Turn on Pendant and Connect 35

Step 5 - Starting the Handset 38

Step 6 - Procedure Set Up 39

Step 7 - Procedure Settings 39

Pacemaker Settings 40

Protocol Setting 41

Set Up 42

Start Over: 42

Step 8 - Initial Procedure Screens 43

Recording Symptoms: Standard TelePatch Procedure 45

Manual Diary Entry: 46

Audio Diary Entry: 47

PROCEDURE SET-UP: Cable Cradle with Patient Cable 47

Step 1 - Identify Electrode Sites 48

Step 2 - Prepare the Skin 49

Step 3 - Snap on Electrodes and Set Up Cable Cradle 50

Step 4 - Start Pendant: 52

Step 5 - Starting the Handset: 52

Step 6 - Procedure Set Up: 52

Step 7 - Procedure Settings: 52

Step 8 - Initial Procedure Screens: 52

Recording Symptoms: Cable Cradle Procedure 52

PROCEDURE SET-UP: Fingertip Electrodes 53

Step 1 - Start Pendant: 53

Step 2 - Starting the Handset: 53

Step 3 - Procedure Set Up: 53

Step 4 - Procedure Settings: 53

Step 5 - Initial Procedure Screens: 53

Recording Symptoms: Fingertip Electrode Procedure 53

COMMON QUESTIONS 54

How Do I Wear TelePatch System: Electrode Patch and Pendant? 54

How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes? 55

Can I Shower? 55

Tip For During Shower 55

Tip For After Shower 55

Stress Loops 56

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EMERGENCY AND SUPPORT NUMBERS 56

Call 911 56

PROCEDURE INFORMATION AND CAUTIONS 57

TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH 57

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH 57

TELEPATCH SYSTEM WHEN USING CABLE CRADLE 58

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE 58

H

ANDSET / HANDSET 59

BATTERY CHARGER 59

PENDANT PRECAUTIONS 60

ADVERSE REACTIONS 60

MAINTENANCE 61

Cleaning the TelePatch System 61

VISUAL AND AUDIBLE INDICATORS 61

Normal Performance Indicators 61

Error Indicators 62

TROUBLESHOOTING 63

Setup Details and Troubleshooting Overview 63

TelePatch System Hookup Testing Information 64

Quality Hookup Tests Overview 64

The Setup/Normal Setting 64

Pacemakers 64

Lead Position Test 65

Skin Prep Results 65

Error Displays 65

Voltage Errors after Several Attempts 66

Lead Position Tests 66

Lead Test Error 66

High/Low Voltage Notifications 67

LOW VOLTAGE IN CHANNEL A 67

LOW VOLTAGE IN CHANNEL B 68

HIGH VOLTAGE IN CHANNEL A 68

HIGH VOLTAGE IN CHANNEL B 68

SAMPLE SCREEN WARNINGS 69

Screen Warnings 69

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Unable to find Pendant 69

Pendant is Turned Off 69

Procedure Has Ended 69

Start Procedure Exceptions 70

Selecting a Pendant 70

SAFE BATTERY USE AND DISPOSAL 70

Safely Loading the Pendant Battery 71

Battery Maintenance 72

Disposal of Rechargeable Lithium Ion Batteries 72

EXPLANATION OF MARKINGS 73

EXPECTED LIFE 75

PENDANT SPECIFICATIONS 75

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS 76

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY 77

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY 78

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF

COMMUNICATIONS EQUIPMENT AND THE PM750 79

Tele

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GETTING STARTED AND INTRODUCTION

Notices, Cautions, and Copyrights

CAUTION: FEDERAL LAW RESTRICTS TELE



PATCH CARDIAC MONITOR PM750 FOR

SALE BY, OR ON THE ORDER OF, A LICENSED MEDICAL PRACTITIONER. THE DATA

OBTAINED FROM THE PENDANT IS FOR THE REVIEW BY A PHYSICIAN. IT IS

RECOMMENDED THAT A PHYSICIAN OVERREAD THE RESULTS.

THIS TELE



PATCH CARDIAC MONITOR PM750 IS NOT INTENDED FOR USE BY USERS WHO ARE

UNABLE TO ACTIVATE THE SYMPTOM BUTTON WHEN THEY ARE EXPERIENCING A SYMPTOM.

USERS SHOULD BE SUPERVISED IF UNABLE TO ACTIVATE THE SYMPTOM BUTTON ON THEIR

OWN.

Tele



Patch™ Cardiac Monitor PM750 is a product of Medicomp, Inc.

Medicomp, Inc. is the manufacturer and provider of Tele



Patch products and services. Tele



Patch

NO PART OF THIS PUBLICATION MAY BE REPRODUCED OR DISTRIBUTED IN ANY FORM OR BY

MEANS WITHOUT PRIOR WRITTEN PERMISSION FROM MEDICOMP, INC.

Tele

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TelePatch Cardiac Monitor User Kit

The standard TelePatch Cardiac Monitor PM750 kit comes with:

1. Universal Pendant

2. Electrode Patch with Cradle

3. Rechargeable Batteries

4. TelePatch Handset

5. Battery Charger

6. Charger Cord for both Handset and Battery Charger

7. Electrode Prep Pad

8. Quick Start Patient Guide

9. Survey Invitation

10. Return Envelope with Prepaid Shipping Label

11. Legal Booklet

Tele



Patch Cardiac Monitor Kit

Tele

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Patch™ Cardiac Monitor PM750

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TELE



PATCH KIT CONTENTS

Item

Quantity

Picture

Legal Booklet 1

Tele



Patch

Pendant 1

Electrode Patch

with Cradle*

1 - 4

*Kit will have one or the other patch style, single or dual is based on

procedure prescribed by physician

Rechargeable Battery 2

Tele



Patch

Handset* 1

Motorola: LG:

*Holter procedures do not require a Handset

Battery Charger 1

Charger Cord

for Handset

and Battery Charger 1

Tele

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Quick Start

Patient Guide 1

Electrode Prep Pad 1

Survey Invitation 1

Return Envelope with

Prepaid Shipping Label

1

Cable Cradle 1

Cable

3-lead or 5-lead 1

Electrodes

(3-5 per pouch) 1- 4

Breakaway Lanyard 1

Contact Us

Contact Medicomp, Inc. for any issues concerning the Tele



Patch product such as:

• General questions about our product

• Product safety

• Safe disposal of component parts

• Return of product

Contact information

Medicomp, Inc. Telephone: 800-23 HEART (800-234-3278)

Tele

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Patch™ Cardiac Monitor PM750

USER MANUAL - UTM0000701-05E 

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Have a question or need assistance?

Call Medicomp’s Patient Support: 877-996-5553

600 Atlantis Rd.

Melbourne, FL, 32904

Website: www.medicompinc.com

Fax: 321-676-2282

email: [email protected]

ABOUT TELE



PATCH CARDIAC MONITOR PM750

INDICATIONS FOR USE

The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device

designed specifically to record and transmit ambulatory ECG signals. The device is designated as

Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as

it is intended for use by patients who are experiencing symptoms that are transient and

infrequent in nature.

Motorola:

LG:

Tele

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Patch™ Cardiac Monitor PM750

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The Tele



Patch Cardiac Monitor System

OVERVIEW

Users of the TelePatch System should be able to activate the Symptom button unassisted or be

supervised and assisted. The Tele



Patch System 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. The Tele



Patch

System is not intended for diagnostic use.

SAFETY SPECIFICATIONS AND COMPLIANCE

Contraindication

There are no potential adverse effects of the Tele



Patch Cardiac Monitor, PM750 on health.

Safety Classification

In accordance with IEC 60601-1 Third Edition Am 1: 2012:

● 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.

● Type BF equipment.

● Rated for Continuous Operation.

● Ordinary Equipment. Enclosed equipment. The device is protected to IP55 as required by the standard.

●

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.

● Equipment with an Applied Part, specifically designed for applications where a Conductive Connection is made to the Patient, but

not directly to the heart.

● The equipment requires no adjustment.

● Operating and Storage Humidity: 10% to 95%, non-condensing

● Operating Temperature: 0°C to 45°C (32°F to 284°F).

● Storage Temperature: -15°C to 60°C (5°F to 140°F).

●

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 Tele



Patch System

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

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Patch™ Cardiac Monitor PM750

USER MANUAL - UTM0000701-05E 

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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.

WARNINGS

● 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.

COMPLIANCE

Safety Classification

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.

Radio Frequency Regulatory Compliance

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

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Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the

equipment.

This Pendant complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this

Pendant may not cause interference, and (2) this Pendant must accept any interference, including interference that may cause undesired

operation of the Pendant.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux

deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage

radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. »

Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved

for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen

that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.

Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d'un type et d'un gain

maximal (ou inférieur) approuvé pour l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à

l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne

dépasse pas l'intensité nécessaire à l'établissement d'une communication satisfaisante.

BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION

Below is a detailed description of TelePatch Icons and Screen Indicators.

USER GUIDE DESCRIPTIONS FOR SCREEN INDICATORS AND ICONS ARE FOR USE WITH THE

TELEPATCH Handset APPLICATION ONLY AND NOT FOR NORMAL CELLULAR PHONE USAGE.

TELEPATCH APPLICABLE BUTTONS

The Handset POWER Button

This is the Handset POWER button. It is located on the top, RIGHT side of the Handset.

Motorola Front and Side View

LG Front and Side View

Tele

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The Pendant POWER Button

This is the Pendant POWER button. It is located on the FACE of the Pendant.

The Pendant Symptom Button

This is the Pendant Symptom button. It is located in the center of the FACE of the Pendant.

Users push the Symptom* button to manually initiate the recording of symptoms that they

may be experiencing. (*Symptom capture can also be initiated on the Handset)

The Handset Needs Charging Indicator

Handset will have red flashing LED at the top of Handset when battery is low. This LED will

stop flashing when plugged into the Charger Cord and Handset is charging.

The Handset Charged Light Indicator

There is no light indicator showing Handset is charging or fully charged. Handset battery

percentage will read 100%.

TELE



PATCH APPLICABLE TOUCH KEYS - Handset

Start Procedure

Initiates procedure for the Tele



Patch system.

Symptom Button

Press when experiencing a symptom.

FREQUENT SCREEN ICONS AND INDICATORS

Cell Network Strength Icon

Tele

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3G Connectivity Icon

Bluetooth Connectivity Icon

The Handset Battery Strength Indicator

This is the Handset Battery Strength Indicator in percentages. This is located in the lower left

corner of the Handset screen once Bluetooth communication has been set up. In this

example, the Handset battery strength is 100 percent.

Pendant Battery Strength Indicator

This is the Pendant Battery Strength Indicator in percentages. This is located in the lower

right corner of the Handset screen once Bluetooth communication has been set up. In this

example, the Pendant battery strength is 40 percent.

The Bluetooth Communication Indicator

This is the Bluetooth communication Indicator. Once Procedure Setup has been completed

and communication with the Pendant has been established, ' BT' will appear in the bottom

left side of the Handset screen.

TELE



PATCH SYSTEM OVERVIEW

Tele

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Patch™ Cardiac Monitor PM750

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Below is a graphical overview of the Tele



Patch System. Detailed description of icons, buttons,

and screen indicators are in previous section.

KEY DESCRIPTIONS PROVIDED BELOW ARE FOR USE WITH THE TELE



PATCH APPLICATION

ONLY. KEY DESCRIPTIONS ARE NOT INTENDED FOR NORMAL CELLULAR PHONE USAGE.

Universal Pendant

Front of Universal Pendant



Back of Universal Pendant

Motorola Handset

Front of Tele



Patch Handset Back of Tele



Patch Handset

Tele

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Patch™ Cardiac Monitor PM750

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LG Handset

Front of Tele



Patch Handset Back of Tele



Patch Handset

PENDANT AND Handset PICTURED ARE NOT ACTUAL SIZE.

TELE



PATCH CARDIAC MONITOR DESCRIPTION

Universal Pendant



Description

Below is an overview of the Universal Pendant, which is part of the TelePatch Cardiac Monitor

System. The Universal Pendant



is very light-weight. It is a light gray, pager-sized ECG data

collecting Pendant.

Tele

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The Pendant SYMPTOM Button

The Universal Pendant



has a Symptom* button which is located in the center of the face of the

Pendant. (*Symptoms can also be initiated on the Handset screen). The Symptom button has

two raised bars so it can be distinguished from power button by touch.

The Pendant POWER Button

The Pendant POWER button is located on the face of the Pendant, below the Symptom button.

Fingertip Electrode Accessory

The fingertip electrode is built into the Universal Pendant. Fingertip electrodes are used when

the patient cannot tolerate wearing the Electrode Patch or individual electrode patches.

Tele

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2

0

00

0

1

9

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Fingertip electrode procedures should be performed only after consulting your physician.

Detailed directions about fingertip electrode procedures begin on page 49.

Tele



Patch Battery

Bottom and top views of the Tele



Patch lithium ion battery

Universal Pendant



operates on a rechargeable, lithium ion battery. The battery locks into the

battery well of the back of the Universal Pendant



.

THE RECHARGEABLE BATTERY PROVIDED WITH THE TELEPATCH SYSTEM IS NOT TO BE

DISCARDED IN HOUSEHOLD WASTE. IF A BATTERY GETS DAMAGED CONTACT MEDICOMP, INC.:

877-996-5553.

Tele

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Battery Well Battery properly inserted in Battery Well

Detailed directions to change and charge the battery properly are found on page 25 or page 68.

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY,

OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FRONT FACE OF THE

PENDANT BELOW THE SYMPTOM BUTTON.

TelePatch



Handset Description

Below is an overview of the Tele



Patch Handset, which is part of the Tele



Patch System.

Motorola Handset

Tele



Patch™ Cardiac Monitor PM750

USER MANUAL - UTM0000701-05E 

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Medicomp TelePatch PM750 User manual

Medicomp TelePatch PM750 User manual

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