TelePatch PM750 User Manual

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TelePatch™

Cardiac Monitor PM750

User Manual

INSTRUCTIONS FOR USE

TelePatch 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.

TelePatch™ Cardiac Monitor PM750

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Table of Contents

GETTING STARTED AND INTRODUCTION .................................................................................................... 5

Notices, Cautions, and Copyrights ............................................................................................................ 5

TelePatch Cardiac Monitor User Kit .......................................................................................................... 6

Contact Us ................................................................................................................................................. 9

ABOUT TELEPATCH CARDIAC MONITOR PM750 ......................................................................................... 9

INDICATIONS FOR USE .............................................................................................................................. 9

OVERVIEW ............................................................................................................................................... 10

SAFETY SPECIFICATIONS AND COMPLIANCE ............................................................................................. 10

Contraindication ..................................................................................................................................... 10

Safety Classification ................................................................................................................................ 10

Modifications .......................................................................................................................................... 10

Defibrillation ........................................................................................................................................... 10

System Safety .......................................................................................................................................... 10

COMPLIANCE .............................................................................................................................................. 11

Safety Classification ................................................................................................................................ 11

Radio Frequency Regulatory Compliance ............................................................................................... 11

BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION ....................................................................... 12

TELEPATCH SYSTEM OVERVIEW ................................................................................................................. 14

TelePatch Pendant Description ............................................................................................................... 16

.................................................................................................................................................................... 18

TelePatch Smartphone Description ........................................................................................................ 18

Accessories to the TelePatch System ...................................................................................................... 19

TelePatch Charger Cord ...................................................................................................................... 19

Connecting Charger Cord: Smartphone .............................................................................................. 21

TelePatch Battery Charger .................................................................................................................. 22

Connecting Charger Cord: Battery Charger ........................................................................................ 23

TelePatch Electrode Patch .................................................................................................................. 26

STANDARD PROCEDURE SET-UP ................................................................................................................ 28

Patient Preparation ................................................................................................................................. 29

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Step 1 - Identify Electrode Patch Site...................................................................................................... 29

Step 2 - Prepare the Skin ......................................................................................................................... 29

Step 3 - Electrode Patch Application ....................................................................................................... 30

Step 4 - Turn on Pendant and Connect ................................................................................................... 32

Step 5 - Starting the Smartphone ........................................................................................................... 34

Step 6 - Procedure Set Up ....................................................................................................................... 35

Step 7 - Procedure Settings ..................................................................................................................... 36

Pacemaker Settings ............................................................................................................................. 36

Protocol Setting................................................................................................................................... 37

Set Up .................................................................................................................................................. 38

Start Over ............................................................................................................................................ 38

Step 8 - Initial Procedure Screens ........................................................................................................... 39

Recording Symptoms: Standard TelePatch Procedure ........................................................................... 41

Manual Diary Entry ............................................................................................................................. 42

Audio Diary Entry ................................................................................................................................ 44

PROCEDURE SET-UP: Cable Cradle with Patient Cable ............................................................................ 44

Step 1 - Identify Electrode Sites .............................................................................................................. 44

Step 2 - Prepare the Skin ......................................................................................................................... 45

Step 3 - Snap on Electrodes and Set Up Cable Cradle............................................................................. 46

Step 4 - Start Pendant ............................................................................................................................. 48

Step 5 - Starting the Smartphone ........................................................................................................... 48

Step 6 - Procedure Set Up ....................................................................................................................... 48

Step 7 - Procedure Settings ..................................................................................................................... 48

Step 8 - Initial Procedure Screens ........................................................................................................... 48

Recording Symptoms: Cable Cradle Procedure ...................................................................................... 48

PROCEDURE SET-UP: Fingertip Electrodes ................................................................................................ 49

Step 1 - Start Pendant ............................................................................................................................. 49

Step 2 - Starting the Smartphone ........................................................................................................... 49

Step 3 - Procedure Set Up ....................................................................................................................... 49

Step 4 - Procedure Settings ..................................................................................................................... 49

Step 5 - Initial Procedure Screens ........................................................................................................... 49

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Recording Symptoms: Fingertip Electrode Procedure ............................................................................ 49

COMMON QUESTIONS ............................................................................................................................... 50

How Do I Wear TelePatch System: Electrode Patch and Pendant? ........................................................ 50

How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes? ........................................ 51

Can I Shower? ......................................................................................................................................... 51

Tip For During Shower ............................................................................................................................ 51

Tip For After Shower ............................................................................................................................... 51

Stress Loops ............................................................................................................................................ 52

EMERGENCY AND SUPPORT NUMBERS ..................................................................................................... 52

Call 911 .................................................................................................................................................... 52

PROCEDURE INFORMATION AND CAUTIONS ............................................................................................ 53

TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH ................................................................ 53

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH ........................... 53

TELEPATCH SYSTEM WHEN USING CABLE CRADLE ............................................................................. 54

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE .................................. 54

SMARTPHONE / HANDSET .................................................................................................................. 55

BATTERY CHARGER ............................................................................................................................. 55

PENDANT PRECAUTIONS ............................................................................................................................ 56

ADVERSE REACTIONS ................................................................................................................................. 56

MAINTENANCE ........................................................................................................................................... 57

Cleaning the TelePatch System ............................................................................................................... 57

VISUAL AND AUDIBLE INDICATORS ........................................................................................................... 57

Normal Performance Indicators ............................................................................................................. 57

Error Indicators ....................................................................................................................................... 58

TROUBLESHOOTING ................................................................................................................................... 59

Setup Details and Troubleshooting Overview ........................................................................................ 59

TelePatch System Hookup Testing Information ..................................................................................... 60

Quality Hookup Tests Overview .............................................................................................................. 60

The Setup/Normal Setting ...................................................................................................................... 60

Pacemakers ............................................................................................................................................. 60

Lead Position Test ................................................................................................................................... 61

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Skin Prep Results ..................................................................................................................................... 61

Error Displays .......................................................................................................................................... 61

Voltage Errors after Several Attempts .................................................................................................... 62

Lead Position Tests.................................................................................................................................. 62

Lead Test Error ........................................................................................................................................ 62

High/Low Voltage Notifications .............................................................................................................. 64

LOW VOLTAGE IN CHANNEL A ............................................................................................................ 64

LOW VOLTAGE IN CHANNEL B ............................................................................................................ 64

HIGH VOLTAGE IN CHANNEL A ............................................................................................................ 64

HIGH VOLTAGE IN CHANNEL B ............................................................................................................ 65

SAMPLE SCREEN WARNINGS ..................................................................................................................... 65

Screen Warnings ..................................................................................................................................... 65

Unable to find Pendant ........................................................................................................................... 65

Pendant is Turned Off ............................................................................................................................. 66

Procedure Has Ended .............................................................................................................................. 66

Start Procedure Exceptions ..................................................................................................................... 66

Selecting a Pendant ............................................................................................................................. 66

SAFE BATTERY USE AND DISPOSAL ............................................................................................................ 66

Safely Loading the Pendant Battery ........................................................................................................ 67

Battery Maintenance .............................................................................................................................. 69

Disposal of Rechargeable Lithium Ion Batteries ..................................................................................... 69

EXPLANATION OF MARKINGS .................................................................................................................... 69

EXPECTED LIFE ............................................................................................................................................ 71

PENDANT SPECIFICATIONS......................................................................................................................... 72

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ................................................ 73

Recommended separation distances between portable and mobile RF communications equipment and

the PM750 ................................................................................................................................................... 75

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GETTING STARTED AND INTRODUCTION

Notices, Cautions, and Copyrights

CAUTION: FEDERAL LAW RESTRICTS TELEPATCH 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 TELEPATCH 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.

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

Medicomp, Inc. is the manufacturer and provider of TelePatch products and services. TelePatch

BE REPRODUCED OR DISTRIBUTED IN ANY FORM OR BY MEANS WITHOUT PRIOR WRITTEN

PERMISSION FROM MEDICOMP, INC.

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TelePatch Cardiac Monitor User Kit

The standard TelePatch Cardiac Monitor PM750 kit comes with:

1. TelePatch Pendant

2. Electrode Patch with Cradle

3. Rechargeable Batteries

4. TelePatch Smartphone

5. Battery Charger

6. Charger Cord for both Smartphone and Battery Charger

7. Electrode Prep Pad

8. Quick Start Patient Guide

9. Survey Invitation

10. Return Envelope with Pre-paid Shipping Label

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TelePatch Cardiac Monitor Kit

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Item

Quantity

Picture

TelePatch

Pendant

Electrode Patch

with Cradle*

1 - 4

*Kit will have one or the other patch style, single or double is based on procedure prescribed by physician

Rechargeable Battery

TelePatch

Smartphone*

*Holter procedures do not require a Smartphone

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TELEPATCH KIT CONTENTS

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Battery Charger

Charger Cord

for Smartphone

and Battery Charger

Quick Start

Patient Guide

Electrode Prep Pad

1 Survey Invitation

Return Envelope with

Pre-paid Shipping Label

1 Legal Booklet

PICTURE TO BE ADDED

These items are not standard in TelePatch Kit. By physician request only

Cable Cradle

Cable

3-lead or 5-lead

Electrodes

(3-5 per pouch)

1- 4

Breakaway Lanyard

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Contact Medicomp, Inc. for any issues concerning the TelePatch product such as:

• General questions about our product

• Product safety

• Safe disposal of component parts

• Return of product

Contact information

Medicomp, Inc.

600 Atlantis Rd. Melbourne, FL, 32904 Website: www.medicompinc.com

Telephone: 800-23 HEART (800-234-3278) Fax: 321-676-2282

email: [email protected]

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ABOUT TELEPATCH 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.

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The TelePatch Cardiac Monitor System

OVERVIEW

Users of the TelePatch System should be able to activate the Symptom button unassisted or be supervised and assisted. The TelePatch 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 TelePatch System is not intended for diagnostic use.

SAFETY SPECIFICATIONS AND COMPLIANCE

Contraindication

There are no potential adverse effects of the TelePatch 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 TelePatch 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

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medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn 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: TAS0000700 FCC ID: 2AGDTPM750 IC account number/IC company number: 21061-PM750 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.

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TELEPATCH APPLICABLE BUTTONS

The Smartphone POWER Button

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

Front View Side View

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—Consult the dealer or an experienced radio/TV technician for help. Part 15 Clause 15.21 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 SMARTPHONE APPLICATION ONLY AND NOT FOR NORMAL CELLULAR PHONE USAGE.

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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 Smartphone)

The Smartphone Needs Charging Indicator Smartphone will have red flashing LED at top of Smartphone when battery is low. This LED

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

The Smartphone Charged Light Indicator There is no light indicator showing Smartphone is charging or full charged. Smartphone

battery percentage will read 100%.

TELEPATCH APPLICABLE TOUCH KEYS - Smartphone

Start Procedure

Initiates procedure for the TelePatch system.

Symptom Button

Press when experiencing a symptom.

FREQUENT SCREEN ICONS AND INDICATORS

Cell Network Strength Icon

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3G Connectivity Icon

Bluetooth Connectivity Icon

The Smartphone Battery Strength Indicator

This is the Smartphone Battery Strength Indicator in percentages. This is located in the lower left corner of the Smartphone screen once Bluetooth communication has been set up. In this example, the Smartphone 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 Smartphone 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 Smartphone screen.

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TELEPATCH SYSTEM OVERVIEW

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Below is a graphical overview of the TelePatch System. Detailed description of icons, buttons, and screen indicators are in previous section.

KEY DESCRIPTIONS PROVIDED BELOW ARE FOR USE WITH THE TELEPATCH APPLICATION ONLY. KEY DESCRIPTIONS ARE NOT INTENDED FOR NORMAL CELLULAR PHONE USAGE.

Front of TelePatch Pendant Back of TelePatch Pendant

Front of TelePatch Smartphone Back of TelePatch Smartphone

PENDANT AND SMARTPHONE PICTURED ARE NOT ACTUAL SIZE.

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TELEPATCH CARDIAC MONITOR DESCRIPTION

TelePatch Pendant Description

Below is an overview of the TelePatch Pendant, which is part of the TelePatch Cardiac Monitor System. The TelePatch Pendant is very light-weight. It is a light gray, pager-sized ECG data collecting Pendant.

The Pendant SYMPTOM Button

The TelePatch Pendant has a Symptom* button which is located in the center of the face of the Pendant. (*Symptoms can also be initiated on the Smartphone 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.

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Fingertip Electrode Accessory

The fingertip electrode is built into the TelePatch pendant. Fingertip electrodes are used when the patient cannot tolerate wearing the Electrode Patch or individual electrode patches.

Fingertip electrode procedures should be performed only after consulting your physician. Detailed directions about fingertip electrode procedures begin on page 49.

TelePatch Battery

Bottom and top views of the TelePatch lithium ion battery

TelePatch Pendant operates on a rechargeable, lithium ion battery. The battery locks into the battery well of the back of the TelePatch Pendant.

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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

TelePatch Pendant

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 Smartphone Description

Below is an overview of the TelePatch

Smartphone, which is part of the

TelePatch System.

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MicroUSB Cable

SKN6430A / S13239-0403532

AC Power Supply

SPN5504A / S004ASU0510085

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Accessories to the TelePatch System

TelePatch Charger Cord

The TelePatch Charger Cord is compliant for use with the Smartphone and the Battery Charger. Both are components of the TelePatch System. The Charger Cord is a two piece device:

MicroUSB Cable AC Power Supply

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MicroUSB cable Connector type

Micro-USB

AC Power Supply INPUT

100-240V~ 50/60Hz 0.2A

OUTPUT

5.1V=850mA 13262-1109957

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Details pertaining to pertinent electrical specifications are provided below.

The TelePatch Charger Cord will replenish battery power when the Smartphone power or Pendant Battery is depleted. When the Smartphone is turned on, the Smartphone battery indicator lets users know when the battery life of the Smartphone and the Pendants Lithium Ion Battery are depleting. Icons are displayed on the screen of the Smartphone.

For optimal performance from the Smartphone, it is recommended to plug the charger cord into the Smartphone overnight until the Smartphone is fully charged. Instructions on charging the Smartphone are on page 22 of this User Manual.

TelePatch Pendant Batteries will need to charge every seven (7) days on average. There are two (2) lithium ion batteries in the TelePatch Kit, so the procedure will not be interrupted. Instructions about how to charge the Pendant Battery can be found in the charging the Batteries section of this User Manual.

How to attach USB Cable to AC Power Supply block:

Should the Charger Cord come apart or if the Charger Cord is in two pieces (the MicroUSB cable and the Power Supply) when the TelePatch Kit is received, insert the USB connector into the port on the power supply. Keep the two pieces connected for the duration of the procedure.

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Charger properly inserted

Correct direction of charger head

Incorrect direction of charger head

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SMARTPHONE AND BATTERY CHARGER ARE POWERED BY THE CHARGER CORD ONCE

CHARGER CORD IS PLUGGED IN TO SMARTPHONE OR BATTERY CHARGER AND THEN A

WALL OUTLET.

CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED.

Connecting Charger Cord: Smartphone

The port for the Charger Cord is located on the left side of the smartphone near the bottom

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Connecting the Charger Cord to the Smartphone:

Take the end of the Charger Cord and insert it into the lower left side of the Smartphone as displayed in the graphic. The side of the Charger Cord plug-in with the indented circle is the correct way to insert in the Charger Cord into the Smartphone.

WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE POWER

OUTLET AND THE SMARTPHONE.

MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH.

SMARTPHONE IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED

IN TO BOTH SMARTPHONE AND WALL OUTLET.

CHARGER CORD MUST NOT BE OBSTUCTED BY FURNITURE OR LARGE OBJECTS AND

REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED.

UNPLUG THE CHARGER CORD FROM THE SMARTPHONE BEFORE PLACING SMARTPHONE IN POCKET OR PURSE/BRIEFCASE. DO NOT WEAR THE SMARTPHONE

WHILE THE CHARGER IS ATTACHED TO THE SMARTPHONE.

TelePatch Battery Charger

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Battery Charger – Top Battery Charger - Bottom

TelePatch rechargeable batteries have an approximate seven (7) day life before needing to be recharged. The TelePatch Kit has two (2) batteries, a Battery Charger and a Charger Cable (also used to charge the Smartphone). TelePatch Pendant batteries need to be changed when the Pendant indicates the battery is low on power: the orange LED will blink continuously on the face of the Pendant, and the Pendant will chirp every 4 minutes. The battery level can also be seen on the Smartphone screen.

Using the Charger Cord with the TelePatch Battery Charger The TelePatch Battery Charger will replenish battery power when lithium ion battery power is depleted. The same Charger Cord used to charge the Smartphone is used to power the Battery Charger.

For optimal performance from the Battery Charger, it is recommended to plug the Charger Cord into the Battery Charger and a wall outlet until the battery is fully charged. The indicator light on the flat end of the charger, next to the Charger Cord outlet, is flashing orange while charging, and steady green when fully charged. The Battery Charger will stop charging the battery once fully charged.

Connecting Charger Cord: Battery Charger

● Place the Battery Charger on a flat, dry surface, near a wall outlet

● Plug Charger Cord into the corresponding outlet on the Battery Charger

● Plug the Charger Cord into the wall outlet

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Charger Cord properly inserted into Battery Charger

Correct direction of Charger Cord head

Incorrect direction of Charger Cord head

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Charging a Battery in the Battery Charger

THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. TO ENSURE SAFE CHARGING AND MAXIMUM PERFORMANCE OVER THE LIFE OF THE PRODUCT ALWAYS USE THE MEDICOMP PROVIDED CHARGER. DO NOT ATTEMPT TO CHARGE THE BATTERY ON ANOTHER MANUFACTURER’S CHARGER.

 Place a Battery from the TelePatch Kit into the Battery Charger, with the Medicomp

label facing up and the two small tabs into the notches

 Slide the latch at the back of the Battery to the left, securing the battery in place. The

Battery is locked in place when the latch is below the BLUE lock icon

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Battery IS NOT locked in the charger Battery IS correctly locked into charger

 A light at the end of the Battery Charger, next to the Charger Cord, will turn green when

the battery is fully charged.

Flashing Orange Light: Battery is charging Green Light: Battery is charged

MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH.

BATTERY CHARGER IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED IN TO BOTH BATTERY CHARGER AND WALL OUTLET.

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Single Channel Electrode Patch with Cradle

Dual Channel Electrode Patch with Cradle

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CHARGER CORD MUST NOT BE OBSTUCTED BY FURNITURE OR LARGE OBJECTS AND

REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED.

THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. ALL BATTERIES WILL SLOWLY DISCHARGE OVER TIME EVEN IF THEY AREN’T USED. TO

ENSURE OPTIMAL PERFORMANCE AND LIFETIME OF THE BATTERY PACK, PLEASE FULLY CHARGE THE BATTERY AT LEAST ONCE EVERY 6 MONTHS REGARDLESS OF USE. IT IS FURTHER RECOMMENDED THAT IF THE BATTERY HASN’T BEEN CHARGED MORE RECENTLY THAN A MONTH AGO THAT IT BE FULLY CHARGED PRIOR TO THE START OF A PATIENT PROCEDURE.

DO NOT STORE BATTERIES IN THE BATTERY CHARGER.

TelePatch Electrode Patch

The TelePatch Pendant slides into the cradle on the Electrode Patch.

Placing Pendant into Electrode Patch cradle

● Slide Pendant into cradle with lock facing down into cradle.

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● The Pendant is correctly placed when it clicks into cradle

Single Channel Electrode Patch

Dual Channel Electrode Patch

 Single Channel Electrode Patch supports modified lead II with reference right leg drive.  Dual Channel Electrode Patch supports Channel A modified lead II, Channel B modified

III and a reference electrode.

THE TELEPATCH ELECTRODE PATCH IS A SINGLE USE ITEM. ONCE THE ELECTRODE PATCH

IS REMOVED FROM THE SKIN IT SHOULD BE DISCARDED AS HOUSHOLD WASTE.

MAKE SURE TO REMOVE THE TELEPATCH PENDANT FROM THE CRADLE BEFORE

DISCARDING THE ELECTRODE PATCH. THE PENDANT IS TO BE INSERTED IN CRADLE OF FRESH

ELECTRODE PATCH TO CONTINUE PROCEDURE.

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Electrode Patch

Description

Medical sensor electrode, Foam, 1.5”

teardrop shape, wet gel

Gel

Wet Gel 7% KCL

Gel Sponge

Polyurethane (reticulated foam)

Substrate

Polyester printed with black ink

Foam

polyethylene foam with acrylic adhesive

Conductive Ink

Ag/AgCl

Insulator

Blue UV Dielectic

Release Liner

Polystyrene (HIPS) with silicone release

Connector

5 Pin Housing

Packaging

Pouch

Material

25# Paper/7.2#LOPE/.0003 Foil/14# LDPE (minimum)

Dimensions

7”x11”

Pouch Contents

Printed Circuit Sensor

Call Medicomp Patient Support: 800-234-3278 ext. 2370

Description of Patch and Patch Packaging

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STANDARD PROCEDURE SET-UP

TelePatch Electrode Patch Procedure

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Patient Preparation

This section contains step-by-step instructions that describe how to prepare patient for a

TelePatch Cardiac Monitor procedure with the Electrode Patch. Follow the skin preparation

sequence as closely as possible. This will greatly enhance the ECG signal quality and optimize

analysis.

Patch Placement for the TelePatch Procedure

Step 1 - Identify Electrode Patch Site

Refer to the figure below for proper patch placement:

Dual Channel and Single Channel Electrode Patch Placement

Step 2 - Prepare the Skin

Because the Electrode Patch will be worn for up to seven (7) days, proper skin preparation is

important for the procedure. Good skin preparation means better ECG signal traces that, in

turn, are easier for the doctor to review and evaluate. In order to obtain the best ECG

recording, the following procedure is recommended for initial hookup:

1. Whenever possible, be in an upright sitting position. This may be useful if any setup

problems occur that concern the signal voltage.

2. Following the placement diagram, select sites that are flat. Avoid skin folds or creases,

irritated skin or scar tissue, and highly muscular areas.

3. If necessary, shave an area at the patch site slightly larger than the size of the Electrode

Patch.

4. If powder, lotion, sun block, etc. has been applied to the chest or if skin is excessively

oily, wash site with plain soap and water. Do not use a soap that contains lotion or oil.

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5. Skin-prep pads (found in alcohol prep-pad type packaging) can be used to clean and

prepare skin for initial application.

The above skin prep procedure is only required at the beginning of the procedure, during Smartphone initialization. Users will not be required to perform this type of preparation each time they apply a new Electrode Patch. It is best for users to have freshly showered with plain soap each time they apply new Electrode Patches (about every 7 days).

 If patch has connectivity issues the skin can be lightly abraded each electrode site with a

rough wash cloth, or an abrasive pad.

Step 3 - Electrode Patch Application

Applying TelePatch Patch

● Prepare skin, as shown in Step 2.

● When ready to position Electrode Patch on skin, remove backing from Electrode Patch,

apply to chest, using placement in the illustration. This can be done before inserting Pendant in the cradle or after.

● Press Electrode Patch firmly onto skin with fingers once correctly positioned on the left

side of chest (Below collarbone).

● Once it is firmly adhered to skin peel remaining white tabs on the patch so the whole

surface of the patch is adhered to skin.

THE MEDICOMP ECG ELECTRODE PATCH IS SINGLE USE, NON-STERILE, AND DISPOSABLE

AND IS TO BE USED ON INTACT (UNINJURED) SKIN.

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PRODUCT SHELF LIFE IN INTACT, ORIGINALLY SEALED PACKAGING IS 12 MONTHS.

ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP

PROCEDURE INITATION ERRORS FROM OCCURRING.

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.

Wearing TelePatch

● The Electrode Patch should stay in position about seven (7) days on average.

● The cradle on Electrode Patch holds the Pendant.

● Leave the Electrode Patch in place until it no longer remains adhered or as ordered by

physician.

● The Electrode Patch with the TelePatch Pendant in the cradle can be worn in shower

during procedure, pat dry with a towel once shower is complete.

● Do not go swimming while wearing Electrode Patch or Pendant during procedure.

● The Electrode Patch should be disposed of when changed for a fresh Electrode Patch or

at the completion of the procedure. For additional patches for your procedure contact Medicomp Patient Care: 877-996-5553

DO NOT WEAR ELECTRODE PATCH OR TELEPATCH PENDANT SWIMMING OR SUBMERGED IN WATER DURING PROCEDURE.

THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD BE REMOVED FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH ELECTRODE PATCH.

THE TELEPATCH ELECTRODE PATCH IS A SINGLE USE ITEM. ONCE THE ELECTRODE PATCH

IS REMOVED FROM THE SKIN IT SHOULD BE DISCARDED AS HOUSHOLD WASTE.

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Step 4 - Turn on Pendant and Connect

Insert a Battery into the Pendant

 Remove the Pendant from the TelePatch Kit.  Hold the Pendant face down in hand or place on a flat surface. There is a well where the

Battery will be inserted.

 Insert the Battery into the opening, with the Medicomp label facing up and the two

small tabs into the notches, as pictured.

 Slide the latch at the back of the Battery to the left, securing the Battery in place

Battery is NOT secure in Pendant – unlocked Battery IS secure in Pendant - Locked

 Turn the Pendant over, slide the Pendant into the Electrode Patch Cradle with the lock

facing down into the cradle.

 The Pendant is correctly placed when it clicks into the Electrode Patch Cradle.

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Turn the Pendant on:

 Press and hold the power button on the face of the Pendant until the Pendant green

LED flashes.

 For a Holter

procedure (24 hour

to 96 hour)

o Press the Symptom button three (3) times

 For all other procedures (7 day to 30 day)

o The Pendant will initiate on its own. o If Pendant does not turn on its own, press Power button to turn on pendant

During the TelePatch Procedure:

 Wear and Electrode Patch and TelePatch Pendant all day and all night.

 A physician will determine the duration of the TelePatch procedure.  The Electrode Patch will stay in position for seven (7) days, on average.  The Pendant should always be in the Electrode Patch Cradle.  TelePatch Pendant and Electrode Patch can be worn in the shower and during exercise.

All regular activities can be enjoyed during a TelePatch procedure.

TURN THE PENDANT ON BEFORE TAPPING “START PROCEDURE” ON THE SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT.

PENDANT BATTERY NEEDS TO BE CHANGED ABOUT EVERY SEVEN (7) DAYS

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IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE ON/OFF BUTTON IS LOCATED ON THE FACE OF THE PENDANT.

THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD BE REMOVED FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH ELECTRODE PATCH.

IMPORTANT NOTE: If setting up a 24 hour – 96 hour Holter procedure, the procedure set-up is complete at this point. The Smartphone is not used with Holter procedures.

Step 5 - Starting the Smartphone

Before using the Smartphone:

 Charge the Smartphone until it is fully powered. If it is not fully charged (low) a red LED

will flash in the upper left corner of the face of the Smartphone.

 Take the Smartphone and turn it on by pressing and holding the POWER button which is

located in the upper right side of the Smartphone.

 Wait for the Medicomp main screen to appear on the screen before continuing with

standard procedure setup.

 Tap “Start Procedure.”

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Medicomp TelePatch Smartphone Main Screen

Step 6 - Procedure Set Up

After identifying Electrode Patch site, preparing the skin, applying the Electrode Patch and, turning on the Pendant, turning on the Smartphone, the patient is now ready for 'Procedure Setup' with the TelePatch System. The steps are described below.

After following the instructions on the patient preparation screen, which may have already been completed, the next step is to select the correct settings before starting a procedure.

Medicomp TelePatch Smartphone

Patient Preparation Screen

 Tap “OK”

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Step 7 - Procedure Settings

After following the instructions on the patient preparation screen, the next step is to select the correct settings before starting a procedure. Follow the instructions below on how to select the necessary procedure settings from the TelePatch System.

The Procedure Setup screen will display the default settings, which are:

Patient has Pacemaker = No Protocol = Standard Setup = Normal

Medicomp TelePatch Smartphone

Procedure Set Up Screen

Choose “Accept Settings” or change settings from this screen.

To accept default settings:

 Tap “Accept Settings”

OR to change settings:

 Tap the setting to be changed

Pacemaker Settings

The following describes the steps and screens when 'Pacemaker' is selected as a setting. To select a setting for pacemakers:

 Tap “No”  Tap option desired.  If the patient desires to change more settings, then repeat the steps above for Protocol

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and Setup.

 After all the correct settings have been chosen.  Tap “Accept Settings”  If the 'Pacemaker' setting is selected, and if a paced beat was detected as typical, the

Smartphone displays a screen of QRS during the procedure setup. Then it will display the settings. Please select “Yes” to accept this step.

 After all the correct settings have been chosen.  Tap “Accept Settings”

Pacemaker Setup Screens

 For additional standard procedure setup instructions, go to patient preparation.

Protocol Setting

'Protocol' has three (3) sub-options. More information pertaining to those options is provided below.

 Standard - “Standard” is the default for adult users.  Atrial Fib - Use “Atrial Fib” for users who have permanent Atrial Fibrillation.  Pediatric - Use “Pediatric” for users under 16 years of age.

Users should check with child's Pediatrician to verify heart rate. The Pediatric protocol sets Normal Sinus Rhythm at 80-150bpm. To select a setting from protocol:

To apply 'Protocol' as a setting:

 Tap “Standard”  Tap desired Protocol  Press “Accept Settings”

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 For additional standard procedure setup instructions, go to PATIENT PREPARATION.

THE TELEPATCH SYSTEM CAN BE USED FOR INFANTS WEIGHING LESS THAN 10KG.

“TEST”SHOULD NEVER BE SELECTED AS A SETTING WITHOUT THE SUPERVISION AND GUIDANCE OF A MEDICOMP CARDIAC MONITORING CENTER (CMC) TECHNICIAN. CALL THE CMC FOR GUIDANCE IN “TEST” MODE.

Set Up

All TelePatch systems will be shipped in “Normal” mode. There is therefore, no need to instruct users on how to select the “Normal” mode. The following instructions describe the steps and screens for selecting “Test” mode. To apply the “Test” mode:

• Tap “Normal”

• Tap “Test” on drop down menu

If there are additional settings changes desired, repeat the steps above for Pacemaker and Protocol. After all the correct settings have been chosen,

• Tap “Accept Settings” An example of a test result screen for the Skin Prep is provided below.

Skin Prep Test Result

 For additional standard procedure setup instructions, go to PATIENT PREPARATION.

If a mistake is made during the procedure setup process, the set up can Start Over.

“START OVER” WILL ERASE ALL PREVIOUS SETTING SELECTIONS IN ORDER TO START THE ENTIRE PROCEDURE SETTINGS PROCESS FROM THE VERY BEGINNING.

Start Over

• Tap “Start Over” button

This will erase all previous setting selections in order to start the entire procedure settings

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Medicomp TelePatch Smartphone

Initializing Procedure

Medicomp TelePatch Smartphone

ECG Baseline Reading

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process over from the very beginning.

 Protocol: The protocol is an integral part of the auto capture capability. It may be

defined as a set of guidelines that the ECG analysis algorithm uses in identifying clinically-significant events. For example, the normal heart rate in Standard protocol is 60-100 bpm.

 Pediatric Protocol: this range is 80-150 bpm. Therefore, the TelePatch System would not

trigger to generate recordings for heart-rate events of 140 bpm if the protocol had been set to Pediatric, but would trigger if it had been set to Standard.

 For additional standard procedure setup instructions, go to PATIENT PREPARATION.

Step 8 - Initial Procedure Screens

After applying and accepting the procedure settings, the procedure will initialize.

Medicomp TelePatch Smartphone

Scanning for TelePatch Pendant

 The TelePatch system will first collect ECG data, then the ECG

Data will appear on the screen for a short time, then the screen

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will display “Monitoring.”

 'Monitoring' will be displayed the majority of the time during a procedure.

The Medicomp TelePatch Smartphone

Monitoring Screen

 The TelePatch procedure is now running.

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT.

DEPENDING ON THE SETTINGS, AND THE PATIENT PREPARATION, SOME INTERMITTENT CONFIRMATION AND/OR ERROR SCREENS MAY APPEAR DURING THE INITIALIZATION.

PLEASE PERIODICALLY CHECK THE PENDANT AND/OR SMARTPHONE TO ENSURE THEY ARE BOTH IN MONITORING MODE. THIS MEANS THE PENDANT IS BLINKING BLUE LED

LIGHTS, AND THE SMARTPHONE DISPLAY STATES ‘MONITORING’.

THE TELEPATCH SYSTEM IS DESIGNED TO OPERATE IN ENVIRONMENTS THAT MAY

EXPERIENCE TRANSIENT ELECTRICAL EVENTS LIKE ELECTROSTATIC DISCHARGE (ESD). TELEPATCH IS DESIGNED TO BE RESISTANT TO SUCH EVENTS AND WILL TYPICALLY CONTINUE TO OPERATE NORMALLY. A SEVERE ESD EVENT MAY CAUSE THE DEVICE TO SHUT DOWN IN ORDER TO PROTECT THE MEMORY. IF A SHUTDOWN OCCURS, MANUALLY POWER THE DEVICE ON USING THE POWER BUTTON ON THE FRONT OF THE DEVICE. ONCE POWERED ON, TELEPATCH SHALL RESUME NORMAL OPERATION WITH NO LOSS OF FUNCTIONALITY OR INFORMATION.

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The SYMPTOM button on the Pendant

has two raised bars so it can be easily located.

Press SYMPTOM on TelePatch Pendant

OR Press SYMPTOM on Smartphone

Call Medicomp Patient Support: 800-234-3278 ext. 2370

Best Practices for using the Smartphone and the Pendant

 Keep the Smartphone charged and turned on  Keep Smartphone within 10’ of the Pendant during procedure  Review how to record a SYMPTOM, make a Diary Entry  Review how to charge the Smartphone daily  Review how to change and charge the Pendant battery

Recording Symptoms: Standard TelePatch Procedure

When a Symptom is felt, or at other times as directed by your physician:

 Press the SYMPTOM button on the Pendant or on the Smartphone, to record heart’s

activity.

 The TelePatch Smartphone will display Recording in Progress for 60 seconds  The TelePatch Smartphone will light up with a message to make a Diary Entry

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Manual Diary Entry

 Tap “Manual”  Below the word Symptom Tap ”No

symptom selected”

 Choose a symptom from the list  Tap “Save”  Below the word “Location” Tap ”No

location selected”

 Choose a location from the list  Tap “Save”  Below the word “Activity” Tap” No

activity selected”

 Choose an activity from the list  Tap “Save”  From the Select Diary Options screen

(showing options picked) Tap “Save”

 The “Monitoring” display will return*

*The screen may return to “Recording in Progress”, Smartphone screen will return to “Monitoring” as soon as recording period is complete.

Call Medicomp Patient Support: 800-234-3278 ext. 2370

How to Make a Diary Entry:

It is important the prescribing physician to know when a symptom is felt and activity at the time the SYMPTOM button was pressed.

 While “Recording in Progress” is displayed on the Smartphone, Diary options will be

displayed

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Symptom Menu

Location Menu

Activity Menu

Select Diary Options Screen – Options chosen

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Audio Diary Entry

 Tap “Audio”  Cleary state the symptom, location

where symptom occurred, and activity during symptom

 Tap “Done”  The “Monitoring” display will return*

*The screen may return to “Recording in Progress”, Smartphone screen will return to “Monitoring” as soon as recording period is complete.

Call Medicomp Patient Support: 800-234-3278 ext. 2370

PROCEDURE SET-UP: Cable Cradle with Patient Cable

If wearing TelePatch Cradle and Pendant with individual electrodes, start preparation here

This section contains step-by-step instructions that describe how to prepare TelePatch System

and skin for a TelePatch Cable Cradle with Cable procedure - (requires individual chest

electrode patch application). Please follow the skin preparation sequence as closely as possible.

This will greatly enhance the ECG signal quality and optimize analysis.

Step 1 - Identify Electrode Sites

Leads V5/MCL5 and a modified Lead I are used with the TelePatch Cable Cradle procedure, two-

channel ambulatory monitoring. By convention in the symptom recording reports, V5 is

Channel A and the modified Lead I is Channel B. Refer to the figure below for proper electrode

placement:

Patient Preparation

Electrode Placement for the TelePatch Procedure

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3-Lead Wire Hook-Up

5-Lead Wire Hook-Up

A-

WHITE

A-

WHITE

A+ / B+

RED

A+

RED

B-

BLACK

B-

BLACK

B+

BROWN

GREEN

Call Medicomp Patient Support: 800-234-3278 ext. 2370

For women with large breasts, the following electrode positions are recommended:

 Red in the left axillary line  Black in the right axillary line

This lead placement may eliminate potential skin prep problems and minimizes occurrences of artifact.

Step 2 - Prepare the Skin

Individual electrodes may be worn for a few. In order to obtain the best ECG recording, the following procedure is recommended for initial patient hookup:

1. Whenever possible, be in an upright sitting position. This may be useful if any setup

problems occur that concern the signal voltage.

2. Following the lead placement diagram, select sites that are flat and bony. Avoid skin

folds or creases, irritated skin or scar tissue, and highly muscular areas.

3. If necessary, shave an area at each electrode site slightly larger than the size of the

electrode.

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4. If powder, lotion, sun block, etc. has been applied to the chest, or if skin is excessively

oily, wash each site with plain soap and water. Do not use a soap that contains lotion or oil.

5. Skin-prep pads (found in alcohol prep-pad type packaging) can be used to clean and

prepare skin for initial application.

The above skin prep procedure is only required at the beginning of the procedure, during Smartphone initialization. Users will not be required to perform this type of preparation each time they re-locate electrodes. It is best for users to have freshly showered with plain soap each time they apply new electrodes. When the Pendant is reconnected to the patient cable, the unit performs a less restrictive setup.

 If electrodes have connectivity issues the skin can be lightly abraded each electrode site

with a rough wash cloth, or an abrasive pad

ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP

PROCEDURE INITATION ERRORS FROM OCCURRING.

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.

Step 3 - Snap on Electrodes and Set Up Cable Cradle

Locate the Cable Cradle, one battery, lead wires, envelope of electrodes and lanyard (optional).

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● Snap the wires onto the electrodes while they are still attached to the plastic backing.

● One by one, peel each electrode from the backing and apply it to the chest.

● Position the electrodes at the appropriate color-coded sites.

● If wearing cable cradle on lanyard, clip lanyard onto the loop at the top of cradle. ○ Cable Cradle may also be carried in pocket, be careful Cable remains connected

to Cable Cradle

● Hold flat plug at the end of electrodes cable and connect cable to the base of cradle into

the corresponding outlet.

● Place the lanyard over head to wear the cradle with cable attached

LANYARD IS NOT TO BE WORN WHILE SLEEPING.

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CHILDREN WEARING PENDANTS MUST BE SUPERVISED BY ADULTS.

PEOPLE WORKING WITH MACHINERY OR WORKING IN ENVIRONMENTS WHERE LOOSE HANGING ROPE- LIKE OBJECTS CAN POSE A POTENTIAL THREAT OR HARM TO THEMSELVES AND/OR THE MACHINERY ARE ADVISED TO CARRY CABLE CRADLE WITH

PENDANT IN POCKET.

THE BREAKAWAY LANYARD IS TO BE DISPOSED OF AS HOUSEHOLD WASTE FOLLOWING THE PROCEDURE.

WARNING: CHOKING HAZARD – ADULT SUPERVISION REQUIRED

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE LOADING BATTERIES,

OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE RIGHT SIDE OF THE PENDANT.

Step 4 - Start Pendant

● Follow directions for starting Pendant on page 32

Step 5 - Starting the Smartphone

● Follow directions for starting Smartphone on page 35

Step 6 - Procedure Set Up

● Follow directions for initiating procedure on page 35

Step 7 - Procedure Settings

● Follow directions for initial procedure set up on page 36

Step 8 - Initial Procedure Screens

● Follow directions for completing procedure set up on page 39

Recording Symptoms: Cable Cradle Procedure

● Follow directions for Recording a Symptom on page 41

Procedure while wearing the Cable Cradle

● Wear the Cable Cradle and Pendant all day and all night - except when showering

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● The Cable Cradle can be worn on the included break-away lanyard or can be kept in

pocket (make sure Cable stays firmly attached).

● The Cable Cradle and Pendant should go into a pocket of a nightshirt while sleeping

○ Do not wear the lanyard at night while sleeping

● The physician will tell you the duration of your procedure

● The Pendant should always be in the Cable Cradle, the Cable should remain plugged into

the Cable Cradle

● Enjoy all of your regular activities like exercise or gardening, while wearing the Pendant,

Cable Cradle and Cable

● DO NOT shower with the Cable Cradle and Cable

○ Turn off the Pendant by pressing the Power Button ○ Unsnap the cable heads from the electrodes ○ Leave Cable Cradle, Cable, Pendant (and lanyard) outside the shower ○ Electrodes may be worn in the shower - fresh electrodes may need to be

applied following the shower

● After showered and dry, place lanyard with Cable Cradle and Pendant back on, re-attach

electrodes, turn on Pendant

PROCEDURE SET-UP: Fingertip Electrodes

If using Fingertip Electrodes for procedure, start preparation here.

Step 1 - Start Pendant

● Follow directions for starting Pendant on page 32

Step 2 - Starting the Smartphone

● Follow directions for starting Smartphone on page 35

Step 3 - Procedure Set Up

● Follow directions for initiating procedure on page 35

Step 4 - Procedure Settings

● Follow directions for initial procedure set up on page 36

Step 5 - Initial Procedure Screens

● Follow directions for completing procedure set up on page 39

Recording Symptoms: Fingertip Electrode Procedure

When experiencing a symptom, or at other times as directed by physician,

● Remove the Pendant from pocket or cable cradle

● Press the SYMPTOM button on the Pendant or on the Smartphone

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● Place index fingers firmly on the Fingertip Electrodes (the silver-gray corners) on the top

edge of the Pendant for 30 seconds.

● Smartphone will display “Recording in Progress”, keep fingers on the Fingertip

Electrode corners until the Smartphone screen message says “Recording Complete”

● The Smartphone will light up and a message will remind user to make a Diary Entry.

○ See page 42 for instructions on making a Dairy entry

Procedure while using and Pendant and Fingertip Electrodes

 Carry the Pendant all day and have it nearby at night.  Charge Smartphone daily.  The physician will determine the duration of the procedure.  Enjoy all regular activities like exercise or gardening, during procedure.

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

The TelePatch Pendant is securely held in the Electrode Patch cradle, and won’t interfere with day to day activities. Make sure the Symptom button (on the Pendant or Smartphone) is easily accessible.

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

You can wear the Cable Cradle on the breakaway Lanyard, or keep it in your pocket. Make sure the cable stays plugged into the Cable Cradle at all times. When wearing Cable Cradle avoid areas where the buttons might accidentally be pressed. At bedtime place Cable Cradle next to you where its location is the most comfortable. Do not wear the Lanyard when sleeping.

Can I Shower?

When wearing the TelePatch Pendant with the Electrode Patch you can shower with the Pendant and patch on. When done in the shower gently pat (not rub) the face of the patch and the Pendant dry. You can remove the Pendant from the patch cradle if you would like to dry behind the Pendant, then reinsert in the cradle immediately.

When wearing the Cable Cradle with cable DONOT wear the Cable Cradle or cable in the shower.

1. Disconnect the cable from the Pendant and set the unit aside.

2. Unsnap the wires from electrodes. A diagram in the Patient Guide will help you to

replace them correctly when re-connecting.

Remove electrodes if skin is very irritated or if it has been 72 hours or more (per electrode manufacturer's directive) since the last electrode change. If you don't need to remove the electrodes, just make sure that water does not fall directly on them.

Tip For During Shower

The Electrode Patch and Pendant are water resistant. They will withstand brief periods in contact with water – such as when showering. You can and should wear the Electrode Patch and Pendant while showering but do not submerge or soak the devices in water.

If it is time to remove the electrodes, try removing them during your shower after they have become thoroughly soaked with water. This will make removal easier.

Tip For After Shower

Please make sure to dry both the pendant and the plastic on the patch that holds the pendant after getting wet.

If you are replacing Electrode Patch or single electrodes: After showering, determine where electrode will be placed (refer to the diagram in the Patient Guide for placement) and dry your skin well in those areas.

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If wearing the Cable Cradle with individual electrodes: Snap the wires onto the electrodes. Now, carefully remove the back plastic cover from each electrode in turn and press the electrodes to your skin so that complete contact is made with the adhesive backing. Plug the cable into the Cable Cradle if it has been unplugged. Make sure the Pendant is turned on. The Smartphone will resume receiving data from the Pendant.

Stress Loops

Stress Loops are only applicable to the TelePatch Cable Cradle procedure. Stress loops are recommended. Two examples of stress loops are shown below.

Lead Wire Stress Loops

This is a good way to secure lead wires to prevent pulling, thus minimizing noise interference during the procedure. Wear the Cable Cradle with the lanyard or keep the Cable Cradle in a pocket.

EMERGENCY AND SUPPORT NUMBERS

Call 911

Below are instructions on how to call 911 from the Smartphone. From the 'Monitoring' screen

 Tap “Call Option”  Tap “Call 911”  Tap “YES“

• Hang up the call with the End Key

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PROCEDURE INFORMATION AND CAUTIONS

TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH

 ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY

HELP PROCEDURE INITIATION ERRORS FROM OCCURRING.

 UNLESS OTHERWISE INSTRUCTED, WEAR THE TELEPATCH CONTINUOUSLY

DURING NORMAL DAILY ACTIVITIES.

 TURN THE PENDANT ON BEFORE TAPPING “START PROCEDURE” ON THE

SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT

 PENDANT BATTERY NEEDS TO BE CHANGED ABOUT EVERY SEVEN (7) DAYS  IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE REMOVING AND

LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM BUTTON.

 HEAVY EXERCISE OR OTHER ACTIVITIES THAT EXPOSE THE TELEPATCH TO

MOISTURE CAN AFFECT PATCH ADHESION DURATION. IF A PATCH SELFREMOVES DUE TO EXERCISE OR ACTIVITY, CLEAN THE AREA AS NOTED IN THE PATIENT GUIDE AND APPLY A NEW PATCH.

 THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD

BE REMOVED FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH ELECTRODE PATCH, NOT DISCARDED WITH REMOVED ELECTRODE PATCH.

 THE TELEPATCH PENDANT SHOULD NOT BE TREATED AS HOUSEHOLD WASTE.  ONLY THE ELECTRODE PATCH SHOULD BE DISCARDED AFTER USE.

 RETURN TELEPATCH PENDANT AND ALL COMPONENTS IN KIT PROVIDED, TO

MEDICOMP, INC., USING THE INCLUDED POSTAGE PAID ENVELOPE.

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH

 THE TELEPATCH PENDANT IS WATER RESISTANT. YOU CAN SHOWER WITH THE

TELEPATCH PENDANT AND ELECTRODE PATCH INTACT.

 TELEPATCH PENDANT AND ELECTRODE PATCH ARE NOT WATERPROOF,

MEANING THE PENDANT COULD CEASE TO FUNCTION IF FULLY SUBMERGED IN WATER FOR A PERIOD OF TIME. AVOID SWIMMING AND FULL SUBMERSION INTO WATER, WHILE WEARING TELEPATCH.

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 REMOVE TELEPATCH PENDANT BEFORE SWIMMING. THE PATCH WILL NOT

REMAIN INTACT ON THE SKIN IF SUBMERGED IN WATER FOR AN EXTENDED PERIOD OF TIME.

 DO NOT WEAR ELECTRODE PATCH OR TELEPATCH PENDANT SWIMMING OR

SUBMERGED IN WATER DURING PROCEDURE.

TELEPATCH SYSTEM WHEN USING CABLE CRADLE

 ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY

HELP PROCEDURE INITIATION ERRORS FROM OCCURRING.

 TURN THE PENDANT ON BEFORE TAPPING “START PROCEDURE” ON THE

 IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE REMOVING AND

LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM BUTTON.

 IF WEARING TELEPATCH WITH A CABLE CRADLE AND INDIVIDUAL ELECTRODES

IT IS RECOMMENDED TO PLACE THE PENDANT IN A POCKET DURING EXERCISE OR OTHER ACTIVITIES. IF INDIVIDUAL ELECTRODES SELF-REMOVE DURING ACTIVITY, CLEAN THE AREAS AND APPLY NEW ELECTRODES. AVOID FULL IMMERSION INTO WATER (POOLS, HOT TUBS, OPEN WATER SWIMMING).

 BREAKAWAY LANYARD IS NOT TO BE WORN WHILE SLEEPING.  CHILDREN WEARING PENDANTS MUST BE SUPERVISED BY ADULTS.  PEOPLE WORKING WITH MACHINERY OR WORKING IN ENVIRONMENTS WHERE

LOOSE HANGING ROPE- LIKE OBJECTS CAN POSE A POTENTIAL THREAT OR HARM TO THEMSELVES AND/OR THE MACHINERY ARE ADVISED TO CARRY CABLE CRADLE WITH PENDANT IN POCKET.

 THE CABLE CRADLE SHOULD NOT BE WORN IN THE SHOWER.  THE TELEPATCH PENDANT SHOULD NOT BE TREATED AS HOUSEHOLD WASTE.

 THE INDIVIDUAL ELECTRODES SHOULD BE DISCARDED AFTER USE.

 THE BREAKAWAY LANYARD SHOULD BE DISCARDED AFTER USE.  RETURN TELEPATCH PENDANT, AND ALL COMPONENTS IN KIT PROVIDED, TO

MEDICOMP, INC., USING THE INCLUDED POSTAGE PAID ENVELOPE.

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE

 THE CABLE CRADLE SHOULD NOT BE WORN IN THE SHOWER.  WHEN WEARING TELEPATCH WITH A CABLE CRADLE AND INDIVIDUAL

ELECTRODES: BEFORE TAKING A SHOWER OR BATH, UNSNAP THE LEAD WIRES FROM THE ELECTRODES (THAT ARE ATTACHED TO CHEST) REMOVE THE CABLES, CABLE CRADLE AND LANYARD BEFORE ENTERING SHOWER..

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 WATER WILL NOT AFFECT THE INDIVIDUAL ELECTRODES; DO NOT REMOVE

THEM BEFORE SHOWERING IF THEY ARE STILL FIRMLY ATTACHED TO THE SKIN. IF AN INDIVIDUAL ELECTRODE SELF-REMOVES IN SHOWER, PREPARE THE AREAS AND APPLY NEW ELECTRODES.

 IF SHOWERING WITH ELECTRODES, GENTLY PAT THEM DRY WITH A TOWEL

BEFORE RECONNECTING THE LEAD WIRES TO THE ELECTRODES

 IF SWIMMING, REMOVE CABLE, CABLE CRADLE AND PENDANT BEFORE

SUBMERGING INTO WATER. USER MAY LEAVE ELECTRODES ON IF THEY ARE STILL FIRMLY ATTACHED TO THE SKIN.

SMARTPHONE / HANDSET

 TURN THE PENDANT ON BEFORE TAPPING “START PROCEDURE” ON THE

 MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH.  CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE

OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED.

 SMARTPHONE IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS

PLUGGED INTO BOTH SMARTPHONE AND WALL OUTLET.

 WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE

POWER OUTLET AND THE SMARTPHONE.

 UNPLUG THE CHARGER CORD FROM THE SMARTPHONE BEFORE PLACING

SMARTPHONE IN POCKET OR PURSE/BRIEFCASE.

 DO NOT WEAR THE SMARTPHONE WHILE THE CHARGER IS ATTACHED TO THE

SMARTPHONE.

BATTERY CHARGER

 BATTERY CHARGER IS POWERED BY THE CHARGER CORD ONCE CHARGER

CORD IS PLUGGED INTO BATTERY CHARGER AND THEN A WALL OUTLET.

 MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH.  CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE

OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED.

 BATTERY CHARGER LIGHT WILL BE FLASHING AMBER OR ORANGE WHILE

BATTERY IS CHARGING.

 BATTERY CHARGER LIGHT WILL BE GREEN WHEN BATTERY IS FULLY

CHARGED.

 BATTERY CHARGER LIGHT MAY FLASH RED WHEN BATTERY IS NOT INSTALLED

IN CHARGER PROPERLY.

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 IF BATTERY CHARGER HAS NO LIGHT INDICATION LIT NEXT TO CABLE PLUG,

VERIFY CHARGER CORD IS PLUGGED INTO BATTERY CHARGER AND WALL PROPERLY.

 IF BATTERY CHARGER HAS NO LIGHT INDICATION LIT NEXT TO CABLE PLUG,

VERIFY BATTERY IS PLACED IN CHARGER PROPERLY.

 WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE

POWER OUTLET AND THE BATTERY CHARGER.

PENDANT PRECAUTIONS

CAUTION: Portable and mobile RF communications equipment can affect medical electrical

equipment. This Pendant should not be used adjacent to or stacked with other equipment in accordance with the directions described in the Practice Reference Manual.

NOTE: EUT (PM750 Pendant) shuts down between +/-8 and 15kV Air Discharge. It is recommended that you restart the device (wait 30 seconds after power down) upon occurrence of this event.

WARNING: When using lead wires, they should not contact other conductive equipment or electric ground, including earth.

 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 Pendant, not a toy; keep away from small children.  In the event of a damaged Pendant, discontinue use and call Medicomp Patient Support:

800-234-3278 ext. 2370, for return and replacement.

ADVERSE REACTIONS

In the event of irritation worse than minor itching, to the Electrode Patch or individual electrodes, consult your physician. Users may also contact Medicomp to discuss alternative, Physicians must request change of procedure to Medicomp. Medicomp cannot authorize change of patient procedure.

● Signs of significant irritation where the electrode patch is in contact with the skin.

● Any other unanticipated reaction to the adhesive or the electrode gel.

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Normal Performance Indicators

Pendant Action

Visual Indicator

Audible Indicator

Pendant power up

Green, blue, and orange lit simultaneously for 1.5 seconds.

Beep High-Low-High for 0.5 second per frequency while LEDs are lit.

Pendant ready to start procedure

Green LED blinks fast

None

Procedure initiated: Press Symptom button 3 times (Holter Only)

Green LED solid for 1.5 seconds

Beep High-Low-High for 0.5 second duration for each beep

Procedure initiated not in cradle: Press Symptom button 3 times (Holter procedure only)

Orange and blue blinks fast in unison

Beep 4 times in unison with LEDs Procedure in progress: not in cradle

3 LED sections: continuous flashing

None Pendant removed from

3 LED sections: continuous

None

Call Medicomp Patient Support: 800-234-3278 ext. 2370

MAINTENANCE

Cleaning the TelePatch System

The TelePatch pendant may need to be cleaned if for any reason it becomes exposed to biological materials, like body fluids or matter. The user should clean the TelePatch Monitoring System in order to maintain optimal use and functionality.

Use a tissue, lightly moistened with alcohol or a hospital-grade cleanser such as Sporicidin – (Do not saturate) - wipe off debris, dirt or other matter that may gather on either the Smartphone or Pendant of the TelePatch System. If the Pendant has been dropped in a basin water (i.e.: sink or toilet) and will not power back on, contact Customer Support for a replacement.

VISUAL AND AUDIBLE INDICATORS

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Cradle

flashing

Pendant placed in cradle with procedure running BT OFF/Holter

Green LED: every 4 seconds

Beep for 2 seconds before entering this mode for the first time

Symptom Button Press on cables or patch: Record Symptom

Green LED lit for 1 second

Beep for 1 second

Symptom Recording Complete on Cables or Patch

“Recording Complete” message

will be seen on screen of smartphone

None

Finger Tip Electrodes Start of Recording

Green LED 3 flashes 0.5 second each then Green LED lit for 1 second

Beep 3 times in unison with LED flashes then Beep for 1 second

Finger Tip Electrodes during Recording period

Green LED flashes during 32 second recording period

None

Finger Tip Electrode Recording complete

Green LED lit for 1 second

Beep for 1 second

Pendant communicating with Smartphone

Blue LED: every 4 seconds

None

Holter procedure end

Green and blue blink alternately at 2Hz

None

Pendant power down

All three LEDs simultaneously every 1.5 seconds

Beep 3 times in unison with lit LEDS.

Error Indicators

Pendant Action

Visual Indicator

Audible Indicator

Pendant configuration wrong

Blink all three LEDs 5 times for 0.5 seconds every second

Beep 5 times in unison with lit LEDs

New Holter procedure powerup – running cradle and lead-

Green blinks twice and blue blinks once repetitively

None

Call Medicomp Patient Support: 800-234-3278 ext. 2370

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on/lead-off tests.

New Holter procedure power-up, low main battery error detected.

Orange LED blinks fast

None RECORD button pressed, Pendant not in cradle

3 slow Green flashes, then Green LED flashing fast

3 beeps then none

RECORD button pressed while Pendant creating a recording

Green LED Flash

Long beep Early low main battery warning

Orange LED blink 1 per second

Beep 1 second duration every 4 minutes

Late low main battery warning

Orange LED blink 3 times per second

Beep 1 second duration every 30 seconds

Call Medicomp Patient Support: 800-234-3278 ext. 2370

TROUBLESHOOTING

Setup Details and Troubleshooting Overview

This section helps resolve any problems that may be encountered while you are setting up the TelePatch. Reduce the likelihood of seeing errors by making sure fresh Electrode Patch or fresh individual electrodes are used, as appropriate, the cable is in good condition and securely connected to the Cable Cradle, and care has been taken to perform the recommended skin preparation.

Some problems are unavoidable due to a patient's particular heart condition or the unexpected failure of a component. However, these cases are infrequently encountered.

When the TelePatch is connected begins its startup sequence, it assesses the quality of the ECG signal. The TelePatch system will signal if there is a problem with the connections or if the signal voltage is too high or too low for ideal auto-capturing. Messages on the Smartphone's display will direct any necessary corrections.

Information is also provided in this section to assist with the setup procedure of any replacement or exchanged TelePatch system component (e.g. Smartphone or Pendant).

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Replaced components of the TelePatch will follow a slightly different setup procedure to the standard method.

TelePatch System Hookup Testing Information

Quality Hookup Tests Overview

The TelePatch Quality Hookup tests evaluate cable connections, skin preparation, and signalvoltage conditions. This is a test that is performed automatically by the TelePatch System, with no indication to, or participation from, the user or patient until specifically directed by specific commands on the Smartphone.

The Quality Hookup test starts once either:

1. The patient has the electrode patch in place on the chest with the pendant secured in the

electrode patch cradle and the Smartphone is turned on to initiate the patient’s procedure.

2. The patient has the individual electrodes in place with the cable attached to both the

electrodes and the cable cradle, and the Smartphone is turned on to initiate the patient’s procedure.

The TelePatch System (Pendant and Smartphone) determines whether there is a problem and the problem will be displayed on the Smartphone.

The option that is used to define how the wireless system handles these conditions is called the 'Setup' option.

The Setup/Normal Setting

All TelePatch systems are shipped in the 'Setup/Normal' mode.

'TEST' SHOULD NEVER BE SELECTED AS A SETTING WITHOUT THE

SUPERVISION AND GUIDANCE OF MEDICOMP PATIENT SUPPORT. THE PATIENT SHOULD CALL MEDICOMP FOR GUIDANCE IN THE 'TEST' MODE.

During the Quality Hookup Tests, the Smartphone may display the following screens before the procedure begins:

Pacemakers

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If the 'Pacemaker' setting is selected, and if a paced beat was detected as typical, the Smartphone displays a screen to confirm the QRS prior to beginning the procedure.

Lead Position Test

If no QRS is found, the following screen may be displayed before the procedure begins. If this screen is displayed, the patient is to follow the guidance of a Cardiac Monitoring Center technician, or Patient Support technician.

Skin Prep Results

The results of the skin prep test may be displayed before the procedure begins.

• Go to PATIENT PREPARATION for additional steps.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278

ext. 2370

Error Displays

During procedure hookup, the TelePatch tests for flex circuit or cable breakage, and checks that its minimal requirements for skin prep and signal voltage are met. These tests could last only a few minutes or may take longer, depending on what the TelePatch detects. The Smartphone's “objective” is to make sure that it receives a good signal. This ensures optimal auto-capturing and good report results.

IMPORTANT POINTS With very few exceptions, only errors seen with 'Lead Position Test' require that electrodes be re-located on the patient's chest.

Most of the time, errors seen with “Lead Test Error” and “Testing Skin Prep” require reprepping or equipment changes.

Each time you make a change to correct a problem, you will need to tap 'Retry' for the TelePatch to continue testing.

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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.

• Go to PATIENT PREPARATION for additional steps.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278

ext. 2370

Voltage Errors after Several Attempts

For Cable Cradle Procedures If inadequate signal voltage (can be either low or high) in one channel while the other one is

acceptable, place the electrodes in a ”parallel”, or ”side-by-side” lead arrangement. Identify the channel that has the acceptable voltage and place the electrodes of the problem channel side-by-side with it. For example:

Channel A good, Channel B bad - place Black electrode next to White. Configuration will be: Black and white electrodes on the right upper chest, and red electrode underneath the left breast.

Channel B good, Channel A bad - place White next to Black. Configuration will be: black and white electrodes on the right lower chest.

• Go to PATIENT PREPARATION for additional steps.

• For additional troubleshooting instructions, go to TROUBLESHOOTING OVERVIEW

Lead Test Error

When a Lead Test Error occurs, the Smartphone displays a message similar to: THE WHITE ELECTRODE HAS A CONNECTION PROBLEM. White = White electrode site (A-)

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Red = Red electrode site (A+/B+) Black = Black electrode site (B-)

Lead errors occur when the lead wire connected to the Cable Cradle detects a very high resistance that may be caused by one or more of the following conditions:

 Very high resistance values  Expiration of Electrodes  Cables disconnected

Very high resistance values May indicate a problem with the cable. Try changing the cable first, if one is available, otherwise move on to the next step.

If not done so already, thoroughly wash the electrode site with PLAIN (no lotion or oil) soap and water. Apply a small amount (about the size of the tip of a cotton swab) of Skin Prep gel to a paper towel and firmly rub it into the skin at the gel cup site. Wipe off the excess gel. If no Skin Prep is available, this can also be done with a rough, wet, washcloth. Always apply a new electrode to the site. In difficult cases, light abrasion with a scrub pad may also be required; this may occur with users who have very oily skin. Press down on the center snap of the electrode and Tap 'Retry' on the Smartphone.

If the TelePatch Pendant and Smartphone proceed through to 'Lead Position Test', then after all tests are completed and the Smartphone is actively 'Monitoring,' change the electrode, this time making sure that it is in good contact with the skin.

Expiration Date of Electrodes Check the expiration date on the electrodes. Inspect the electrode(s) in question to verify moist gel cups. If the gel is dry, you will need to replace the electrode.

Cables (lead wires) not connected If the electrode cables are disconnected, this error message will also appear.

• Go to PATIENT PREPARATION for additional steps.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278

ext. 2370

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High/Low Voltage Notifications

LOW VOLTAGE IN CHANNEL A (WHITE [A-]/RED [A+] ELECTRODE PAIR) Although the TelePatch System automatically adjusts the signal size (voltage) to ensure optimal analysis, some users may have cardiac anomalies that result in unacceptable signal voltage. The signal may be too large or too small. The following section describes each error that might occur. Sometimes, just having the patient lean back in a chair will increase the ECG voltage.

The Smartphone's message for this error is: Low A, Move Red First, move the red electrode After repositioning, Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Red (A+/B+) electrode pictured. Don't try more than a few different locations.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278 ext. 2370

LOW VOLTAGE IN CHANNEL B (BLACK [B-], RED [A+] ELECTRODE PAIR The Smartphone's message for a low voltage in Channel B is: Low B, Move Black First, move the black electrode Low Voltage in Channel B, Move Black After repositioning, Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Black (B-) electrode. Don't try more than a few different locations.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278 ext. 2370

HIGH VOLTAGE IN CHANNEL A (RED [A+]/WHITE [A-] ELECTRODE PAIR) The Smartphone's message for this error is: High A, Move Red First, move the red electrode High Voltage in Channel A, Move Red After repositioning,

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Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Red (A+/B+) electrode. Don't try more than a few different locations.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278 ext. 2370

HIGH VOLTAGE IN CHANNEL B (BLACK [B-]/RED [A+] ELECTRODE PAIR) The Smartphone's message for a high voltage in Channel B is: High B, Move Black First, move the black electrode High Voltage in Channel B, Move Black After repositioning, Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Black (B-) electrode pictured. Don't try more than a few different locations.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278 ext. 2370

SAMPLE SCREEN WARNINGS

Screen Warnings

There are a number of screen warnings that may appear on the Smartphone screen. Below is a sampling of some of the most common screen warnings.

Unable to find Pendant

At the very start of a new procedure, if the Smartphone IS turned on and the Pendant is NOT turned on, the following warning or alert will be displayed. Turn on the Pendant to proceed. While continuing a procedure, if the Pendant is NOT turned on when the Smartphone IS turned on, the following warning or alert will be displayed. Turn on the Pendant to proceed.

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Pendant is Turned Off

If the Pendant is turned off while in the middle of monitoring, the following warning or alert will be displayed. Turn on the Pendant to proceed.

Procedure Has Ended

When the procedure ends, an alert will be displayed. Users should return the unit to the Medicomp address provided in the Patient Guide. Every TelePatch Kit has a postage paid return envelope. Include all components in the zippered kit and mail from any mailbox.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278 ext. 2370

Start Procedure Exceptions

Selecting a Pendant If more than one Pendant is identified after pressing 'Start Procedure,' the patient will be prompted to 'Select a Pendant to Use.' The instructions below provide detail steps to select a Pendant before starting a procedure. Select a Pendant to Use

● User chooses from the list of Pendants on the screen

● Select the Pendant with the unique serial number listed inside the well of the Pendant.

● Tap and highlight the Pendant serial number.

● Tap 'Select'

SAFE BATTERY USE AND DISPOSAL

The TelePatch Cardiac Monitor Pendant operates on a single, 3.7V lithium ion battery.

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Bottom and top views of the TelePatch Pendant Battery

IF PENDANT’S BACKUP BATTERY IS LOW, PATIENT SHOULD CALL MEDICOMP PATIENT SUPPORT: 800-234-3278 ext. 2370.

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE REMOVING AND LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM BUTTON.

THE BATTERY ON ANOTHER MANUFACTURER’S CHARGER.

THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. ALL BATTERIES WILL SLOWLY DISCHARGE OVER TIME EVEN IF THEY AREN’T USED. TO

PROCEDURE.

Safely Loading the Pendant Battery

TelePatch Pendant operates on a rechargeable, lithium ion battery. The battery locks into the battery well of the back of the TelePatch Pendant.

To safely load the battery into the Pendant:

● Remove the Pendant and one battery from the zippered kit

Insert battery into Pendant.

● Hold Pendant face down in hand or place on a flat surface. There is a well where

battery will be inserted

● Insert battery into well of Pendant: with the Medicomp label facing up, and the two

small tabs into notches in flat wall of the well

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Inserting battery into Pendant battery well

● Slide the latch at back of the battery to left, securing battery in place. Battery is locked

in place when moveable latch is under blue lock icon on label

Battery is unlocked (latch under RED icon) Battery Is locked (latch under BLUE icon)

LOAD ONLY 3.7V LITHIUM ION BATTERIES DELIVERED IN THE TELEPATCH KIT INTO THE

TELEPATCH CARDIAC MONITOR BATTERY COMPARTMENT.

Properly inserted TelePatch Battery

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.

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Icon

Description

Pendant, Lanyard

Operating instructions

Pendant

This symbol indicates type BF equipment classified in accordance with IEC Publication IEC 60417-5333 Safety of medical electrical equipment. Type BF equipment: equipment with isolated patient connections, connections not defibrillation-proof.

IP55

Pendant

This symbol indicates Ingress protection- Solids: 5 – Ingress of dust is not entirely prevented, but it must not enter in sufficient quantity to interfere with the satisfactory operation of the equipment; complete protection against contact. Liquids: 5 - Water projected by a nozzle (6.3mm) against enclosure from any direction shall have no harmful effects.

Call Medicomp Patient Support: 800-234-3278 ext. 2370

Battery Maintenance

● Remove the battery from the Pendant during storage or if the Pendant is not to be used

for longer than two (2) weeks.

● Store in a cool, dry place, the best location is in the TelePatch Cardiac Monitor Kit

supplied for your procedure.

Disposal of Rechargeable Lithium Ion Batteries

In accordance with federal laws and regional regulations:

● RETURN all batteries to Medicomp, Inc.

● 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

EXPLANATION OF MARKINGS

Equipment markings and caution labels are important for safe and reliable use; they must not be removed. The following symbols are used in this user manual, patch packaging, lithium ion battery or the Pendant label. They may also appear on an accessory or accessory packaging.

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Pendant

This symbol informs the user that the respectively labeled component is not to be disposed of in the trash.

Users should properly dispose of components through Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling.

Pendant. Lithium Ion Battery

WEEE LOGO The WEEE logo on this product indicates that this product must not be disposed of with standard waste but rather recycled. Please contact Medicomp, Inc. for more information on proper component disposal.

RoHS Compliance This product is in compliance with Directive 2002/95/ EC of the European Parliament and of the Council of 27 January 2003, on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) and its amendments.

Pendant

Serial Number

Patch

Prescription Required

Patch

Caution, consult accompanying documents

Patch

Do not reuse. This is a single use item

Patch

Batch code of product

Patch

Use by date indicated Patch

Catalog Number/Part Number

Lithium Ion Battery

Item is recyclable.

Users should properly dispose of components through

Call Medicomp Patient Support: 800-234-3278 ext. 2370

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Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling.

REACH

Lithium Ion Battery

EU regulation of chemicals and safe use: Registration, Evaluation, Authorization and Restriction of Chemical substances. Component substances are REACH approved.

Lithium Ion Battery

Item must not be disposed of to the ‘normal’ household

waste, but be separately collected and recycled.

Users should properly dispose of components through Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling.

Lithium Ion Battery

Do not incinerate

Lithium Ion Battery

Product is lead free. Component and Assembly Pb content shall be less than 0.1% by weight of the device (in accordance with IPC/EIA J-STD-006) and shall not be intentionally introduced.

Lead Wire packaging

Lead wires comply with the Performance Standard for electrode lead wires

Shipping packaging

Temperature limitation for shipment of system is -15°C to 60°C (5°F to 140°F).

EXPECTED LIFE

TelePatch Pendant

Unit is expected to provide at least 7 years of normal use.

Call Medicomp Patient Support: 800-234-3278 ext. 2370

 The TelePatch Pendant should NOT be treated as household waste.  ONLY the Electrode Patch or individual electrodes should be discarded after use.  Return TelePatch, Pendant, and all components in kit provided, to Medicomp,

Inc., using the included postage paid envelope.

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Electrode Patch with cradle

When the patch no longer sticks well to skin, dispose of in a receptacle out of reach of children and pets.

Lithium Ion Battery

Each unit is expected to provide at least 7 years of normal use.

Battery Charger

Unit is expected to provide at least 7 years of normal use.

Cable Cradle

Unit is expected to provide at least 4 years of normal use.

3-Lead and 5-Lead Cables

Cables are expected to provide at least 6 months of normal use.

Electrodes

When the patch no longer sticks well to skin, dispose of in a receptacle out of reach of children and pets.

Lanyard

When procedure complete dispose of in a receptacle out of reach of children and pets.

PENDANT SPECIFICATIONS

Technical Features

Single button operation

Records symptomatic ECG

Memory Characteristics

ECG Channels Memory Card, Micro SD

1 and 2 Channel 4GB

Electrical Characteristics

Frequency Response Input Impedance Differential Range Sampling Rate Resolution

0.05Hz to 100 Hz ≥ 10.0 Mohm +/- 5.0mV A/D 250 samples/second 12 bits

Physical Characteristics

Dimensions Weight

58mm x 38.5mm x 15.5mm

37.5g (Pendant only)

Power Requirements

Battery Type Battery Life

1 Lithium Ion (rechargeable), 1 Coin cell (internal) 7 days, typical usage

Call Medicomp Patient Support: 800-234-3278 ext. 2370

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Environmental Durability

Pendant Waterproof Specification

IP55

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The PM750 is intended for use in the electromagnetic environment specified below.

Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF emissions CISPR 11

Group 1

The PM750 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The PM750 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

Harmonic emissions IEC 61000-3-2

Not Applicable

Voltage Fluctuations/ flicker emissions IEC 61000-3-3

Not Applicable Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The PM750 is intended for use in the electromagnetic environment specified below. The customer or user of the PM750 should assure that it is used in such an environment.

Call Medicomp Patient Support: 800-234-3278 ext. 2370

MEDICAL ELECTRICAL EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THIS MANUAL.

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.

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Immunity Standards per 60601-1-2 :2014, (Home Healthcare Environmental) and ETSI EN301 489-1 V1.9.2 (2011-09)

Immunity Test

IEC 60601 Test Level/Limits

Compliance Limits

Compliance Level

Electrostatic discharge (ESD) IEC 61000-4-2

2kV,4kV,6kV 8kV (+/-) Contact 2kV,4kV,8kV, 15kV (+/-) AIR

Electrical fast transient/burst IEC 61000-4-4

±2.0kV AC/DC Mains

±1kV Signal and Control Lines

±2.0kV AC/DC Mains

±1kV Signal and Control Lines

±2.0kV AC/DC Mains

±1kV Signal and Control Lines

Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

70% of Vnom, 25 cycles at 0deg

0% of Vnom, 0.5cycles at 0deg, 45deg, 90deg, 180deg, 225deg, 270deg, 315deg

0% of Vnom, 1.0 cycles at 0deg

0% of Vnom cycles at 0deg

70% of Vnom, 25 cycles at 0deg

0% of Vnom, 0.5cycles at 0deg, 45deg, 90deg, 180deg, 225deg, 270deg, 315deg

0% of Vnom, 1.0 cycles at 0deg

0% of Vnom cycles at 0deg

70% of Vnom, 25 cycles at 0deg

0% of Vnom, 0.5cycles at 0deg, 45deg, 90deg, 180deg, 225deg, 270deg, 315deg

0% of Vnom, 1.0 cycles at 0deg

0% of Vnom cycles at 0deg

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m (Both 50Hz, 60Hz)

NOTE: EUT PM750 Pendant shuts down between +/-8 and 15kV Air Discharge. It is recommended that you restart the device (wait 30 seconds after power down) upon occurrence of this event.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The PM750 is intended for use in the electromagnetic environment specified below. The customer or user of the PM750 should assure that it is used in such an environment.

Immunity Standards per 60601-1-2 :2014, (Home Healthcare Environmental) and ETSI EN301 489-1 V1.9.2 (2011-09)

Immunity Test

IEC 60601

Compliance Limits

Compliance Level

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Test Level/Limits

Conducted RF IEC 61000-4-6

3Vrms 150kHz to 80MHz, 80% AM 1kHz

Radio Frequency Electromagnetic Field Amplitude 61000-4-3

10 V/m, 80 MHz to 2.7 GHz, 80% AM 1kHz

Radiated RF IEC 61000-4-3

385MHz: 27V/m @ 18Hz pulse modulation

450MHz: 28V/m @ FM modulation

710MHz, 745MH, 780MHz: 9V/m @ 217 Hz pulse modulation

810MHz, 870MHz, 930MHz: 28V/m @ 18Hz Pulse modulation

1720MHz, 1845MHz, 1970MHz: 28V/m @ 217 Hz Pulse Modulation

2450MHz: 28V/m @ 217Hz Pulse modulation

5240MHz, 5500MHz, 5785MHz: 9V/m @ 217 Hz Pulse modulation

385MHz: 27V/m @ 18Hz pulse modulation,

450MHz: 28V/m @ FM modulation

710MHz, 745MH, 780MHz: 9V/m @ 217 Hz pulse modulation

810MHz, 870MHz, 930MHz: 28V/m @ 18Hz Pulse modulation

1720MHz, 1845MHz, 1970MHz: 28V/m @ 217 Hz Pulse Modulation

2450MHz: 28V/m @ 217Hz Pulse modulation

5240MHz, 5500MHz, 5785MHz: 9V/m @ 217 Hz Pulse modulation

385MHz: 27V/m @ 18Hz pulse modulation,

450MHz: 28V/m @ FM modulation

710MHz, 745MH, 780MHz: 9V/m @ 217 Hz pulse modulation

810MHz, 870MHz, 930MHz: 28V/m @ 18Hz Pulse modulation

1720MHz, 1845MHz, 1970MHz: 28V/m @ 217 Hz Pulse Modulation

2450MHz: 28V/m @ 217Hz Pulse modulation

5240MHz, 5500MHz, 5785MHz: 9V/m @ 217 Hz Pulse modulation Recommended separation distances between portable and mobile RF communications equipment and the

PM750

The PM750 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of PM750 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PM750 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

Separation distance according to frequency of transmitter

Call Medicomp Patient Support: 800-234-3278 ext. 2370

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of transmitter (W)

150 kHz to 80 MHz

d = 1.167√P

80 MHz to 800 MHz d =

1.167√P

800 MHz to 2,5 GHz d =

2.333√P

0.01

.12

.23

0.1

.37

1.2

2.3

3.7

7.4

100

For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE: 1 - At 80 MHZ and 800 MHZ, the separation distance for the higher frequency range applies. NOTE: 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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