Medicomp TelePatch PM750 User manual

Brand
Medicomp
Model
TelePatch PM750
Type
User manual
Have a question or need assistance?
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Tele
Patch™
Cardiac Monitor PM750
User Manual
INSTRUCTIONS FOR USE
Tele
Patch is intended for use as prescribed by a physician who wants to follow
cardiac activity. TelePatch is not intended for diagnostic use. A physician must
review and interpret ECG findings recorded during procedure.
Tele
Patch™ Cardiac Monitor PM750
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Table of Contents
GETTING STARTED AND INTRODUCTION 6
Notices, Cautions, and Copyrights 6
TelePatch Cardiac Monitor User Kit 7
Contact Us 9
ABOUT TELEPATCH CARDIAC MONITOR PM750 10
INDICATIONS FOR USE 10
OVERVIEW 11
SAFETY SPECIFICATIONS AND COMPLIANCE 11
Contraindication 11
Safety Classification 11
Modifications 11
Defibrillation 11
System Safety 11
COMPLIANCE 12
Safety Classification 12
Radio Frequency Regulatory Compliance 12
BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION 13
TELEPATCH SYSTEM OVERVIEW 15
Universal Pendant Description 17
TelePatch Handset Description 20
Accessories to the TelePatch System 21
TelePatch Charger Cord 22
Connecting Charger Cord: Handset 24
TelePatch Battery Charger 26
Connecting Charger Cord To Battery Charger: 27
TelePatch Electrode Patch 29
STANDARD PROCEDURE SET-UP 32
Patient Preparation 32
Step 1 - Identify Electrode Patch Site 32
Step 2 - Prepare the Skin 33
Step 3 - Electrode Patch Application 34
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Patch™ Cardiac Monitor PM750
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Step 4 - Turn on Pendant and Connect 35
Step 5 - Starting the Handset 38
Step 6 - Procedure Set Up 39
Step 7 - Procedure Settings 39
Pacemaker Settings 40
Protocol Setting 41
Set Up 42
Start Over: 42
Step 8 - Initial Procedure Screens 43
Recording Symptoms: Standard TelePatch Procedure 45
Manual Diary Entry: 46
Audio Diary Entry: 47
PROCEDURE SET-UP: Cable Cradle with Patient Cable 47
Step 1 - Identify Electrode Sites 48
Step 2 - Prepare the Skin 49
Step 3 - Snap on Electrodes and Set Up Cable Cradle 50
Step 4 - Start Pendant: 52
Step 5 - Starting the Handset: 52
Step 6 - Procedure Set Up: 52
Step 7 - Procedure Settings: 52
Step 8 - Initial Procedure Screens: 52
Recording Symptoms: Cable Cradle Procedure 52
PROCEDURE SET-UP: Fingertip Electrodes 53
Step 1 - Start Pendant: 53
Step 2 - Starting the Handset: 53
Step 3 - Procedure Set Up: 53
Step 4 - Procedure Settings: 53
Step 5 - Initial Procedure Screens: 53
Recording Symptoms: Fingertip Electrode Procedure 53
COMMON QUESTIONS 54
How Do I Wear TelePatch System: Electrode Patch and Pendant? 54
How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes? 55
Can I Shower? 55
Tip For During Shower 55
Tip For After Shower 55
Stress Loops 56
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Patch™ Cardiac Monitor PM750
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EMERGENCY AND SUPPORT NUMBERS 56
Call 911 56
PROCEDURE INFORMATION AND CAUTIONS 57
TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH 57
SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH 57
TELEPATCH SYSTEM WHEN USING CABLE CRADLE 58
SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE 58
H
ANDSET / HANDSET 59
BATTERY CHARGER 59
PENDANT PRECAUTIONS 60
ADVERSE REACTIONS 60
MAINTENANCE 61
Cleaning the TelePatch System 61
VISUAL AND AUDIBLE INDICATORS 61
Normal Performance Indicators 61
Error Indicators 62
TROUBLESHOOTING 63
Setup Details and Troubleshooting Overview 63
TelePatch System Hookup Testing Information 64
Quality Hookup Tests Overview 64
The Setup/Normal Setting 64
Pacemakers 64
Lead Position Test 65
Skin Prep Results 65
Error Displays 65
Voltage Errors after Several Attempts 66
Lead Position Tests 66
Lead Test Error 66
High/Low Voltage Notifications 67
LOW VOLTAGE IN CHANNEL A 67
LOW VOLTAGE IN CHANNEL B 68
HIGH VOLTAGE IN CHANNEL A 68
HIGH VOLTAGE IN CHANNEL B 68
SAMPLE SCREEN WARNINGS 69
Screen Warnings 69
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Patch™ Cardiac Monitor PM750
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Unable to find Pendant 69
Pendant is Turned Off 69
Procedure Has Ended 69
Start Procedure Exceptions 70
Selecting a Pendant 70
SAFE BATTERY USE AND DISPOSAL 70
Safely Loading the Pendant Battery 71
Battery Maintenance 72
Disposal of Rechargeable Lithium Ion Batteries 72
EXPLANATION OF MARKINGS 73
EXPECTED LIFE 75
PENDANT SPECIFICATIONS 75
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS 76
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY 77
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY 78
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE PM750 79
Tele
Patch™ Cardiac Monitor PM750
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GETTING STARTED AND INTRODUCTION
Notices, Cautions, and Copyrights
CAUTION: FEDERAL LAW RESTRICTS TELE
PATCH CARDIAC MONITOR PM750 FOR
SALE BY, OR ON THE ORDER OF, A LICENSED MEDICAL PRACTITIONER. THE DATA
OBTAINED FROM THE PENDANT IS FOR THE REVIEW BY A PHYSICIAN. IT IS
RECOMMENDED THAT A PHYSICIAN OVERREAD THE RESULTS.
THIS TELE
PATCH CARDIAC MONITOR PM750 IS NOT INTENDED FOR USE BY USERS WHO ARE
UNABLE TO ACTIVATE THE SYMPTOM BUTTON WHEN THEY ARE EXPERIENCING A SYMPTOM.
USERS SHOULD BE SUPERVISED IF UNABLE TO ACTIVATE THE SYMPTOM BUTTON ON THEIR
OWN.
Tele
Patch™ Cardiac Monitor PM750 is a product of Medicomp, Inc.
Medicomp, Inc. is the manufacturer and provider of Tele
Patch products and services. Tele
Patch
is a trademark of Medicomp, Inc. ©2019 Medicomp, Inc. All rights reserved.
NO PART OF THIS PUBLICATION MAY BE REPRODUCED OR DISTRIBUTED IN ANY FORM OR BY
MEANS WITHOUT PRIOR WRITTEN PERMISSION FROM MEDICOMP, INC.
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Patch™ Cardiac Monitor PM750
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TelePatch Cardiac Monitor User Kit
The standard TelePatch Cardiac Monitor PM750 kit comes with:
1. Universal Pendant
2. Electrode Patch with Cradle
3. Rechargeable Batteries
4. TelePatch Handset
5. Battery Charger
6. Charger Cord for both Handset and Battery Charger
7. Electrode Prep Pad
8. Quick Start Patient Guide
9. Survey Invitation
10. Return Envelope with Prepaid Shipping Label
11. Legal Booklet
Tele
Patch Cardiac Monitor Kit
Tele
Patch™ Cardiac Monitor PM750
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TELE
PATCH KIT CONTENTS
Item
Quantity
Picture
Legal Booklet 1
Tele
Patch
Pendant 1
Electrode Patch
with Cradle*
1 - 4
*Kit will have one or the other patch style, single or dual is based on
procedure prescribed by physician
Rechargeable Battery 2
Tele
Patch
Handset* 1
Motorola: LG:
*Holter procedures do not require a Handset
Battery Charger 1
Charger Cord
for Handset
and Battery Charger 1
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Patch™ Cardiac Monitor PM750
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Quick Start
Patient Guide 1
Electrode Prep Pad 1
Survey Invitation 1
Return Envelope with
Prepaid Shipping Label
1
Cable Cradle 1
Cable
3-lead or 5-lead 1
Electrodes
(3-5 per pouch) 1- 4
Breakaway Lanyard 1
Contact Us
Contact Medicomp, Inc. for any issues concerning the Tele
Patch product such as:
• General questions about our product
• Product safety
• Safe disposal of component parts
• Return of product
Contact information
Medicomp, Inc. Telephone: 800-23 HEART (800-234-3278)
Tele
Patch™ Cardiac Monitor PM750
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Have a question or need assistance?
Call Medicomp’s Patient Support: 877-996-5553
600 Atlantis Rd.
Melbourne, FL, 32904
Website: www.medicompinc.com
Fax: 321-676-2282
email: [email protected]
ABOUT TELE
PATCH CARDIAC MONITOR PM750
INDICATIONS FOR USE
The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device
designed specifically to record and transmit ambulatory ECG signals. The device is designated as
Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as
it is intended for use by patients who are experiencing symptoms that are transient and
infrequent in nature.
Motorola:
LG:
Tele
Patch™ Cardiac Monitor PM750
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The Tele
Patch Cardiac Monitor System
OVERVIEW
Users of the TelePatch System should be able to activate the Symptom button unassisted or be
supervised and assisted. The Tele
Patch System can be worn by users weighing less than 10kg.
TelePatch is intended for use as prescribed by a physician who wants to follow cardiac activity.
A physician must review and interpret ECG findings recorded during procedure. The Tele
Patch
System is not intended for diagnostic use.
SAFETY SPECIFICATIONS AND COMPLIANCE
Contraindication
There are no potential adverse effects of the Tele
Patch Cardiac Monitor, PM750 on health.
Safety Classification
In accordance with IEC 60601-1 Third Edition Am 1: 2012:
● This equipment is designed to be operated with one 3.7V 440mAh 1.62Wh lithium ion battery, and under no circumstances shall
power be supplied in any other manner.
● Type BF equipment.
● Rated for Continuous Operation.
● Ordinary Equipment. Enclosed equipment. The device is protected to IP55 as required by the standard.
●
This equipment shall not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide, or
flammable cleaning agents.
● Equipment with an Applied Part, specifically designed for applications where a Conductive Connection is made to the Patient, but
not directly to the heart.
● The equipment requires no adjustment.
● Operating and Storage Humidity: 10% to 95%, non-condensing
● Operating Temperature: 0°C to 45°C (32°F to 284°F).
● Storage Temperature: -15°C to 60°C (5°F to 140°F).
●
TelePatch System Shipment: Temperature limitation for shipment: -15°C to 60°C (5°F to 140°F).
●
Atmospheric Pressure: Operating: 700 hPa to 1060 hPa; Storage/Transport: Not Applicable to Tele
Patch System
The equipment contains no user-serviceable parts. It shall be serviced only by Medicomp, Inc. Unauthorized repairs of the equipment will void
the warranty.
Modifications
For continued safety, equipment should not be modified in any manner and must be used only as indicated.
Defibrillation
The external parts of the equipment may provide a source of the defibrillation voltage if it is not removed from the patient during defibrillation.
Due to the small size of the unit and patient connectors, the cable or connector may break down and cause the defibrillation voltage to be
shunted and make it less effective for the patient. The unit and cable MUST be removed prior to defibrillation.
System Safety
Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data
processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or
clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a
medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn
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Patch™ Cardiac Monitor PM750
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to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical
service department.
WARNINGS
● USE THE TELEPATCH SYSTEM ONLY WITH THE LEADS, ELECTRODES, AND ACCESSORIES RECOMMENDED BY MEDICOMP. USE OF
OTHER ACCESSORIES MAY ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE OR MAY RESULT IN STRONGER
ELECTROMAGNETIC EMISSIONS OR REDUCE THE ELECTROMAGNETIC IMMUNITY OF TELEPATCH CARDIAC MONITOR PM750.
● CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR CF APPLIED PARTS, INCLUDING NEUTRAL
ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH.
● USERS WHO ARE WEARING NEUROSTIMULATING PENDANTS CANNOT BE SET UP WHILE THAT DEVICE IS TURNED ON. THE
OPERATION OF THESE PENDANTS INTERFERES WITH THE TELEPATCH’S ABILITY TO ACQUIRE THE ECG SIGNAL. IF ALLOWED THESE
DEVICES SHOULD BE TURNED OFF WHILE THE PATIENT IS WEARING TELEPATCH.
● DO NOT USE THE TELEPATCH IN COMBINATION WITH EXTERNAL CARDIAC DEFIBRILLATORS OR HIGH FREQUENCY SURGICAL
EQUIPMENT.
● PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. THIS PENDANT
SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT.
●
LOAD ONLY 3.7V LITHIUM ION BATTERIES DELIVERED IN THE TELEPATCH KIT INTO THE TELEPATCH CARDIAC MONITOR BATTERY
COMPARTMENT.
● LEAD FAILURES ARE DETECTED BY A 10 MV PEAK, 50% DUTY CYCLE RECTANGULAR PULSE, WHICH IS APPLIED TO EACH PATIENT
ELECTRODE CONNECTION THROUGH A 4.9MOHM RESISTOR AT A RATE OF 15 HZ WITH RESPECT TO THE SYSTEM GROUND.
● THIS IS A PRESCRIBED MEDICAL DEVICE, NOT A TOY, INFANTS AND CHILDREN MUST BE SUPERVISED.
● WARNING: CHOKING HAZARD – ADULT SUPERVISION REQUIRED.
●
IN THE EVENT OF A DAMAGED PENDANT, DISCONTINUE USE AND CALL MEDICOMP PATIENT SUPPORT: 800-234-3278 EXT. 2370,
FOR RETURN AND REPLACEMENT.
COMPLIANCE
Safety Classification
In accordance with IEC 60601-1 Third Edition Am 1:2012 :
Conformance to Standards – non-clinical testing demonstrated conformance to voluntary safety IEC 60601-1 and to IEC 60601-1-2-2001 Class B
Medicomp, Inc.’s Quality System conforms to 21 CFR 820 and ISO 13485:2003.
Radio Frequency Regulatory Compliance
Conformance to Standards
Non-clinical testing demonstrated conformance to voluntary safety IEC 60601-1 and to IEC 60601-1-2-2001 Class B
Medicomp, Inc.’s Quality System conforms to 21 CFR 820 and ISO 13485:2003.
This Pendant contains transmitter module FCC ID:
Model Name: TAS0000750
FCC ID: 2AGDTPM700
IC account number/IC company number: 21061-PM700
CAN ICES-3 (B)/NMB-3(B)”
This Pendant complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This Pendant may not cause
harmful interference, and (2) this Pendant must accept any interference received, including interference that may cause undesired operation.
Part 15 Clause 15.105
Note: This equipment has been tested and found to comply with the limits for a Class B digital Pendant, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates
uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
Part 15 Clause 15.21
Tele
Patch™ Cardiac Monitor PM750
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Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the
equipment.
This Pendant complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this
Pendant may not cause interference, and (2) this Pendant must accept any interference, including interference that may cause undesired
operation of the Pendant.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux
deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. »
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved
for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen
that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.
Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d'un type et d'un gain
maximal (ou inférieur) approuvé pour l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à
l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne
dépasse pas l'intensité nécessaire à l'établissement d'une communication satisfaisante.
BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION
Below is a detailed description of TelePatch Icons and Screen Indicators.
USER GUIDE DESCRIPTIONS FOR SCREEN INDICATORS AND ICONS ARE FOR USE WITH THE
TELEPATCH Handset APPLICATION ONLY AND NOT FOR NORMAL CELLULAR PHONE USAGE.
The Handset POWER Button
This is the Handset POWER button. It is located on the top, RIGHT side of the Handset.
Motorola Front and Side View
LG Front and Side View
Tele
Patch™ Cardiac Monitor PM750
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The Pendant POWER Button
This is the Pendant POWER button. It is located on the FACE of the Pendant.
The Pendant Symptom Button
This is the Pendant Symptom button. It is located in the center of the FACE of the Pendant.
Users push the Symptom* button to manually initiate the recording of symptoms that they
may be experiencing. (*Symptom capture can also be initiated on the Handset)
The Handset Needs Charging Indicator
Handset will have red flashing LED at the top of Handset when battery is low. This LED will
stop flashing when plugged into the Charger Cord and Handset is charging.
The Handset Charged Light Indicator
There is no light indicator showing Handset is charging or fully charged. Handset battery
percentage will read 100%.
TELE
PATCH APPLICABLE TOUCH KEYS - Handset
Start Procedure
Initiates procedure for the Tele
Patch system.
Symptom Button
Press when experiencing a symptom.
FREQUENT SCREEN ICONS AND INDICATORS
Cell Network Strength Icon
Tele
Patch™ Cardiac Monitor PM750
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3G Connectivity Icon
Bluetooth Connectivity Icon
The Handset Battery Strength Indicator
This is the Handset Battery Strength Indicator in percentages. This is located in the lower left
corner of the Handset screen once Bluetooth communication has been set up. In this
example, the Handset battery strength is 100 percent.
Pendant Battery Strength Indicator
This is the Pendant Battery Strength Indicator in percentages. This is located in the lower
right corner of the Handset screen once Bluetooth communication has been set up. In this
example, the Pendant battery strength is 40 percent.
The Bluetooth Communication Indicator
This is the Bluetooth communication Indicator. Once Procedure Setup has been completed
and communication with the Pendant has been established, ' BT' will appear in the bottom
left side of the Handset screen.
TELE
PATCH SYSTEM OVERVIEW
Tele
Patch™ Cardiac Monitor PM750
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Below is a graphical overview of the Tele
Patch System. Detailed description of icons, buttons,
and screen indicators are in previous section.
KEY DESCRIPTIONS PROVIDED BELOW ARE FOR USE WITH THE TELE
PATCH APPLICATION
ONLY. KEY DESCRIPTIONS ARE NOT INTENDED FOR NORMAL CELLULAR PHONE USAGE.
Universal Pendant
Front of Universal Pendant
Back of Universal Pendant
Motorola Handset
Front of Tele
Patch Handset Back of Tele
Patch Handset
Tele
Patch™ Cardiac Monitor PM750
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LG Handset
Front of Tele
Patch Handset Back of Tele
Patch Handset
PENDANT AND Handset PICTURED ARE NOT ACTUAL SIZE.
TELE
PATCH CARDIAC MONITOR DESCRIPTION
Universal Pendant
Description
Below is an overview of the Universal Pendant, which is part of the TelePatch Cardiac Monitor
System. The Universal Pendant
is very light-weight. It is a light gray, pager-sized ECG data
collecting Pendant.
Tele
Patch™ Cardiac Monitor PM750
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The Pendant SYMPTOM Button
The Universal Pendant
has a Symptom* button which is located in the center of the face of the
Pendant. (*Symptoms can also be initiated on the Handset screen). The Symptom button has
two raised bars so it can be distinguished from power button by touch.
The Pendant POWER Button
The Pendant POWER button is located on the face of the Pendant, below the Symptom button.
Fingertip Electrode Accessory
The fingertip electrode is built into the Universal Pendant. Fingertip electrodes are used when
the patient cannot tolerate wearing the Electrode Patch or individual electrode patches.
Tele
Patch™ Cardiac Monitor PM750
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2
2
2
2
2
2
0
0
0
0
0
0
0
0
00
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
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Fingertip electrode procedures should be performed only after consulting your physician.
Detailed directions about fingertip electrode procedures begin on page 49.
Tele
Patch Battery
Bottom and top views of the Tele
Patch lithium ion battery
Universal Pendant
operates on a rechargeable, lithium ion battery. The battery locks into the
battery well of the back of the Universal Pendant
.
THE RECHARGEABLE BATTERY PROVIDED WITH THE TELEPATCH SYSTEM IS NOT TO BE
DISCARDED IN HOUSEHOLD WASTE. IF A BATTERY GETS DAMAGED CONTACT MEDICOMP, INC.:
877-996-5553.
Tele
Patch™ Cardiac Monitor PM750
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Battery Well Battery properly inserted in Battery Well
Detailed directions to change and charge the battery properly are found on page 25 or page 68.
IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY,
OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FRONT FACE OF THE
PENDANT BELOW THE SYMPTOM BUTTON.
TelePatch
Handset Description
Below is an overview of the Tele
Patch Handset, which is part of the Tele
Patch System.
Motorola Handset
Tele
Patch™ Cardiac Monitor PM750
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Medicomp TelePatch PM750 User manual

Brand
Medicomp
Model
TelePatch PM750
Type
User manual
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