PARSYS TELECARDIA User manual

PARSYS Telemedicine
5-7, avenue de Paris 94300 Vincennes - France
Tel.: + 33 (0)1 60 31 70 40 - Fax: + 33 (0)1 64 02 31 93 - [e-mail]
01/15/2016 Version
37-021 V4.0
Date of the first placing on the market of the product: 01/03/2007
User Manual
TELECARDIA

User Manual Telecardia
Ver 4.0
01/15/2016 Version Page 2 of 72
SUMMARY
1KIT CONTENTS........................................................................................................................................ 3
1.1 COMPONENTS......................................................................................................................................... 3
1.2 LIST OF SYMBOLS USED........................................................................................................................... 4
1.3 WARNINGS ............................................................................................................................................. 5
2EQUIPMENT DESCRIPTION................................................................................................................... 6
2.1 OVERVIEW.............................................................................................................................................. 6
2.2 ELECTRODES POSITION ........................................................................................................................... 6
2.2.1 Precordial leads ........................................................................................................................... 6
2.2.2 Peripheral leads........................................................................................................................... 7
2.3 DEVICE CONTROL BUTTONS..................................................................................................................... 9
2.4 CHARGING BASE ................................................................................................................................... 10
2.5 ECG READING...................................................................................................................................... 11
3INSTALLATION OF TELECARDIALYSPC SOFTWARE..................................................................... 12
4BLUETOOTH PAIRING PROCEDURE OF THE TELECARDIA TO A PC........................................... 13
4.1 WINDOWS XP OPERATING SYSTEM................................................................................................... 14
4.2 WINDOWS 7OPERATING SYSTEM...................................................................................................... 25
4.2.1 Requirements............................................................................................................................. 25
4.2.2 Pairing of Telecardia with a Windows 7 PC............................................................................... 26
4.3 WINDOWS 8/8.1 OPERATING SYSTEM.............................................................................................. 37
4.3.1 Requirements........................................................................................................................... 37
4.3.2 Pairing of Telecardia with a Windows 8 / 8.1 PC .................................................................. 38
5USING TELECARDIALYSPC SOFTWARE.......................................................................................... 47
6ECG CAPTURE...................................................................................................................................... 48
6.1 2-LEAD PERIPHERAL PATIENT CABLE MODEL........................................................................................... 48
6.2 3-LEAD PERIPHERAL PATIENT CABLE MODEL........................................................................................... 54
7UPDATING THE PC SOFTWARE / DEVICE FIRMWARE.................................................................... 60
8TECHNICAL FEATURES....................................................................................................................... 61
8.1 GENERAL FEATURES ............................................................................................................................. 61
8.2 MECHANICAL FEATURES........................................................................................................................ 61
8.3 ELECTRICAL SPECIFICATIONS................................................................................................................. 61
8.4 FUNCTIONAL FEATURES......................................................................................................................... 62
8.5 FUNCTIONAL FLOW CHART..................................................................................................................... 63
9ELECTROMAGNETIC EMISSIONS....................................................................................................... 64
10 MAINTENANCE...................................................................................................................................... 67
10.1 CLEANING /DISINFECTION................................................................................................................. 67
10.2 PROCEDURE IN THE EVENT THAT THE INSTRUMENT IS DROPPED OR FALLS............................................ 67
10.3 RESET PROCEDURE.......................................................................................................................... 67
10.4 METROLOGICAL CHECKS................................................................................................................... 68
10.5 DISCHARGED BATTERY...................................................................................................................... 68
10.6 PRODUCT SCRAP TREATMENT ........................................................................................................... 68
11 USERS’ TRAINING ................................................................................................................................ 69
12 FAULT OR FAILURE ............................................................................................................................. 70
12.1 THE TELECARDIA ECG DOES NOT SEND ANY TRACE........................................................................... 70
12.2 THE ECG IS SUBJECT TO INTERFERENCE........................................................................................... 70
12.3 THE TELECARDIA ECG IS NOT CHARGING .......................................................................................... 70
12.4 THE TELECARDIA ECG REMAINS BLOCKED......................................................................................... 71
12.5 THE TELECARDIA ECG HAS LOST IS TIME STAMPING........................................................................... 71
13 PARSYS TELEMEDICINE WARRANTY AND AFTER-SALES SERVICE ........................................... 72

User Manual Telecardia
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01/15/2016 Version Page 3 of 72
1 Kit contents
We thank you for having chosen PARSYS Telemedicine equipment. We hope that it will bring you full
satisfaction in your daily electrocardiography practice.
1.1 Components
Firstly, please check the contents of your Telecardia Kit (Ref: 100-004).
It must contain the following items:
1 Telecardiaportable electrocardiograph (ECG) Ref: 25-001
1 Bluetooth USB adapter Ref: 36-002
1 Peripheral Patient cable (depending on the model supplied):
2-lead 10 mm clips Ref: 23-011 V1.1
2-lead 4 mm banana plugs Ref: 23-011 V1.2
3-lead 4 mm banana plugs Ref: 23-029
2 or 3 Adapters for Patient cable (depending on the model supplied) :
2 expandable bracelets - 10 mm clips Ref: 33-010/11
2 or 3 arm limb clips - 4 mm banana plugs Ref: 36-007/8/11
1 Charging base DC 5V/1,1A Ref: 25-002
1 Medical (EN 60601) 5V power supply and cord Ref: 16-001
1 Water spray Ref: 36-006
1 Reset black cord (for device reset) Ref: 23-051
1 Carry case Ref: 34-003
1 User Manual Telecardia - EN Ref: 37-021
1 Warranty Card - EN Ref: 37-003
If any of the items are missing, please contact us at the address specified in this manual.

User Manual Telecardia
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1.2 List of symbols used
Warning: consult attached documents
Please read the notice
CF type applied part
Do not dispose of in the bin but through the appropriate recycling channels.
Non-ionizing radiation
Product manufactured by PARSYS Telemedecine
Device climatic range of use or storage
S/N Serial number
Medical device European compliance

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1.3 Warnings
PARSYS Telemedicine draws the attention of the user on the following points regarding:
The device must not be used simultaneously with an electric surgery tool.
The device is not intended for cardiac direct use (reserved to CF class devices).
The ECG capture must not be performed when the device is charging on its charging base.
When the ECG is capturing, electrodes unplugged on the patient must not come into contact with
the ground or other exposed metal parts.
When the ECG is capturing, the device’s differentiator box must be in contact with the patient.
In case of a simultaneous use of the device and another, it should take care that the sum of the
patient leakage currents to the ground doesn’t exceed safety limits.
In case of a simultaneous use of the device with a defibrillator, do not place the defibrillator’s
electrodes into contact with the device’s electrodes.

User Manual Telecardia
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2 Equipment description
2.1 Overview
Telecardia represents a major advance in remote cardiac monitoring and portable medical equipment. It
enables health professionals to rapidly capture and send a patient's ECG under any circumstances, without
the constraints of a conventional device.
The trace captured is a digital, simultaneous 12-lead 12-tracing ECG, in keeping with standard
electrocardiographs usually used. It can be sent automatically to a care watch centre or be viewed on a PC
next to the patient.
Telecardia has CE marking (CE0459). This is an ECG device intended for temporary use, class IIa.
2.2 Electrodes position
Telecardia is an electrocardiograph:
simultaneous 12-lead 12-channel,
with fixed thoracic electrodes,
with dry electrodes,
no consumables.
2.2.1 Precordial leads
1. Precordial leads
The shape of the unit enables capture of the 6 precordial leads collected thanks to the 2 articulated arms.
These thoracic electrodes are dry and fixed, from V1 to V6.
The Neutral, usually captured on the right leg, is captured in the thorax via the fixed electrode on the housing
(see figure 1.).
v1
v2
v3
v4
v5
v6
Neutra
Neutral

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2.2.2 Peripheral leads
2.2.2.1 2-lead peripheral Patient cable model
With the 2-lead model, Telecardia contains:
1 rolling wire electrode, located under the device left arm for the AvF lead.
2. Dry wire electrode for AvF 3. Patient cable connecting
1 cable to plug on the Telecardia box right-side, capturing AvR and AvL with expandable bracelets
or limb clips dry electrodes (see figure 4 and 5).
4. Cordon Patient AvR & AvL Patient cable 5. Expandable bracelets or limb clips dry electrodes
AvR
AvR
AvL
AvL
AvR
AvL

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2.2.2.2 3-lead peripheral Patient cable model
With the 3-lead model, Telecardia contains a Patient cable to plug into the ECG box right-side. It enables the
capture of AvR, AvL and AvF with limb clips dry electrodes (see figure 6.).
6. Peripherals cable AvR, AvL and AvF - Limb clips electrodes
7. Peripheral cable connection
The insertion mark, a red point on the cord, must be facing the device’s top
AvL
AvF
AvR

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2.3 Device control buttons
To control the machine and start all the functions, Telecardia has 2 buttons:
1 button used to release the arms and switch the machine ON / OFF, located on the front of the
machine and marked with a green circle crossed by a black line.
1 button used to access the machine's advanced functions, located under the top cover and
marked "OUT".
In addition, combinations of these buttons are used to select the requested functions.
4. Telecardia buttons

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2.4 Charging base
Telecardia is equipped with a separate power supply provided by a rechargeable Lithium/Polymer battery,
allowing approximately 50 traces per charge. This battery is charged using the charging base, via 2 metal
contacts integrated in the back of the machine unit.
The charging base charges the machine completely in approximately 2.5 hours using a 220V/50Hz source,
via the mains adapter supplied.
ALWAYS USE THE MAINS ADAPTER SUPPLIED TO POWER THE BASE; OTHERWISE,
IRREVERSIBLE DAMAGE NOT COVERED BY THE MACHINE WARRANTY IS LIABLE TO OCCUR.
To charge Telecardia:
Connect your charging base to 220V power supply
Put Telecardia upon its charging base:
CHECK LIGHT INDICATORS ON THE CHARGING BASE’S SIDE TO CONFIRM THE GOOD CONTACT
OF THE DEVICE WITH CHARGING CONTACTS.
Light indicators located on the side of the base indicate the machine charging status, and whether the machine
is in contact with the support.
The ON/OFF indicator flashes BLUE to
indicate that the base power is on.
The CHARGING INDICATOR does not
light up when Telecardia is not correctly
inserted in its slot, without contact with
the charging contacts, or missing from
the slot.
The CHARGING INDICATOR remains
RED as long as Telecardia is charging.
The CHARGING INDICATOR is GREEN
when Telecardia is charged.
Not charging Telecardia for more than 1 year means losing the instrument's internal real-
time clock: we recommend to regularly charge Telecardia battery.
On/Off
indicator
Telecardia
charging indicator