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 - info@parsys.com
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
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SUMMARY
1 KIT CONTENTS........................................................................................................................................ 3
1.1 COMPONENTS ......................................................................................................................................... 3
1.2 LIST OF SYMBOLS USED ........................................................................................................................... 4
1.3 WARNINGS ............................................................................................................................................. 5
2 EQUIPMENT 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
3 INSTALLATION OF TELECARDIALYS PC SOFTWARE ..................................................................... 12
4 BLUETOOTH PAIRING PROCEDURE OF THE TELECARDIA TO A PC ........................................... 13
4.1 WINDOWS XP OPERATING SYSTEM ................................................................................................... 14
4.2 WINDOWS 7 OPERATING 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
5 USING TELECARDIALYS PC SOFTWARE .......................................................................................... 47
6 ECG CAPTURE ...................................................................................................................................... 48
6.1 2-LEAD PERIPHERAL PATIENT CABLE MODEL ........................................................................................... 48
6.2 3-LEAD PERIPHERAL PATIENT CABLE MODEL ........................................................................................... 54
7 UPDATING THE PC SOFTWARE / DEVICE FIRMWARE .................................................................... 60
8 TECHNICAL 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
9 ELECTROMAGNETIC 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
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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 Telecardia portable 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.
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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.
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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 realtime clock: we recommend to regularly charge Telecardia battery.
On/Off
indicator
Telecardia
charging indicator
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2.5 ECG reading
Viewing and/or transmission of the trace on a PC
Following capture, the data is sent to the PC automatically via the Bluetooth radio link which has a free field
range of approximately 100 meters. This requires the presence of a Bluetooth USB adapter, supplied in the
kit, connected to the PC used to operate Telecardia.
On the operating PC, the Telecardialys software (See the User Manual Telecardialys Software - 37-063 V1.0)
is used to:
dialogue with the equipment via Bluetooth,
display the captured ECGs,
print the ECGs in several report modes,
send the captured ECGs by e-mail,
archive and view the captured ECGs.
ECG captured with
Télécardia ou Cardialys
PC equipped with Bluetooth device
Reading – Printing - Sending
Marine Medical Consultation Centre
PARSYS ECG reading centre
Cardiologist or dedicated centre
Charging base
GSM Bluetooth phone
Internet – GPRS
Satellite
Wireless
Bluetooth transmission
Capture
Transmission
Reading Interpretation
Wireless
Bluetooth transmission
Wireless
Bluetooth
transmission
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3 Installation of Telecardialys PC Software
See the User Manual Telecardialys Software - 37-063 V1.0
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4 Bluetooth pairing procedure of the Telecardia to a PC
Windows XP
Windows Vista
Windows 7 and above
External adapter
External adapter
Internal module
External adapter
Internal module
Installation CD
§xxx
Installation CD
§xxx
Nothing to do
Insert adapter
+ Internet
Nothing to do
The pairing procedure of the Telecardia ECG with a PC running Windows 7 and
above is specific: it is essential to follow the appropriate procedure for the operating
system of your PC.
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4.1 Windows XP Operating System
Pairing of Telecardia with a Windows XP PC
The Bluetooth USB adapter is pre-associated by us with your Telecardia.
Use the following procedure in the following cases:
a. you change your Bluetooth USB adapter,
b. you do not use the supplied adapter to the benefit of an internal Bluetooth
module,
c. you use another Telecardia with the same adapter (potential After-Sales
return).
Insert the USB Bluetooth adapter into an USB port on the PC, then run the installation CD.
If the CD does not run automatically, please run it manually in Windows Explorer.
Do nothing until this window appears. Click on “Install Bluetooth© Device”.
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Click on “Next >”.
Accept the agreement, then click on “Next >”.
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Click on “Next >”.
Click on “Install”.
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Wait until the installation completes.
Click on “Finish”.
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Make a “right click” on the Bluetooth icon at the bottom right of the screen.
Click on “Quick Connect”,
then, on “Bluetooth Serial Port”,
then, on “Find Devices…”.
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Open the drop down menu:
“Show devices” and select
“Show all devices”.
Open the Telecardia housing.
Note the ID of the used device:
Number starting with a T
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Make the connection.
Simultaneously press the ON and OUT buttons until the device’s ignition.
Select the device.
In the list, select your Telecardia and click on “Next >”.
If necessary, click on “Search Again”.
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Pairing.
Pairing starts with Telecardia.
Enter the pairing passkey:
The installer asks for a passkey:
Type the code: 02101124 and click on “Next >”.
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Click on “Finish”.
Create shortcuts.
Click on “Do not display this message again”, then on “OK”.
To finalize the installation of the Bluetooth device,
make a "right click" on the Bluetooth icon in the bottom right of the screen.
Then, click on “Bluetooth Configuration”.
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Go to the “Local Services” tab.
Click on “Bluetooth Serial Port”.
Then, click on “Properties…”.
Check “Start up automatically” and uncheck “Secure connection”.
Click on “Apply”, then on “OK”.
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Go to the “Client Applications” tab.
Click on “Bluetooth Serial Port”.
Then, click on “Properties…”.
Uncheck “Secure connection”.
Click on “Apply”, then on “OK”.
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4.2 Windows 7 Operating System
4.2.1 Requirements
4.1.1.1 Check if the PC (fixed, portable PC, ultraportable, Tablet PC...) to pair with the ECG includes
a preinstalled Bluetooth internal module.
Note: In the case of a fixed PC, there is a good chance that there is no internal module; but, mobile computers
often have a preinstalled Bluetooth internal module.
4.1.1.2 If no internal module is preinstalled, use the Bluetooth USB adapter supplied with your kit.
It is fundamental that your computer has an active Internet connection.
Just plug your Bluetooth USB adapter on a USB port, driver installation is automatic via the Internet.
In this case, your computer must be connected to the Internet to install the Bluetooth
USB adapter (driver updating).
4.1.1.3 If your computer is equipped with a preinstalled Bluetooth internal module, check the origin
of its stack.
Microsoft / WidComm stack: Pairing is automatic between Telecardia and the computer, you have no other
manipulation to perform
Another provider stack: We recommend you to communicate the name of the stack provider to the
PARSYS Telemedicine After-Sales Service before any installation.
In the latter case, we recommend not to try the installation before obtaining
confirmation procedure by the PARSYS Telemedicine After-Sales Service.
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4.2.2 Pairing of Telecardia with a Windows 7 PC
Insert the USB Bluetooth adapter into an USB port on the PC, then run the installation CD.
If the CD does not run automatically, please run it manually in Windows Explorer.
Do nothing until this window appears. Click on “Install Bluetooth© Device”.
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Click on “Next >”.
Accept the agreement, then click on “Next >”.
Click on “Next >”.
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Click on “Install”.
Wait until the installation completes.
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Click on “Finish”.
Open the “Program Files” folder (32-bit processors) or “Program Files (x86)” (64-bit processors).
Then, open the “Parsys” folder and start the “TCP.EXE” software.
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When the software is opened, set the device “Call (Client)” mode.
Open the Telecardia housing.
Note the ID of the used device:
Number starting with a T
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Make the connection.
Simultaneously press the ON and OUT buttons until the device’s ignition.
The different connectable Bluetooth devices are recognized by the system.
You can refine the search by type of equipment (Telecardia, Cardialys, etc.).
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If the search is unsuccessful you can click on “Refresh…”,
which will start a new search.
Once the desired device is visible, click its icon (although check the serial number).
Then, click on “Choose”.
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The interface window with the medical device is then visible.
Click on "Remote Mac Address”.
Then, click on “Local Device”.
The PC MAC address will be registered.
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Click on “Remote Mac Address”.
Then, click on “Write” to save the new MAC address.
In the field "Max Number of ECG" replace the number by "1", if you only want to do an ECG at a time.
This is preferable to avoid any mistake in ECG / Patient assignments.
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Click on “Configuration”.
Then, click on “Write” to save all the changes.
Click on “Disconnect”.
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Back to the start window of the “TCP” software.
Close the window to exit.
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4.3 Windows 8 / 8.1 Operating System
4.3.1 Requirements
4.3.1.1 Check if the PC (fixed, portable PC, ultraportable, Tablet PC...) to pair with the ECG includes a
preinstalled Bluetooth internal module.
Note: In the case of a fixed PC, there is a good chance that there is no internal module; but, mobile computers
often have a preinstalled Bluetooth internal module.
4.3.1.2 If no internal module is preinstalled, use the Bluetooth USB adapter supplied with your kit.
It is fundamental that your computer has an active Internet connection.
Just plug your Bluetooth USB adapter on a USB port, driver installation is automatic via the Internet.
In this case, your computer must be connected to the Internet to install the Bluetooth
USB adapter (driver updating).
4.3.1.3 If your computer is equipped with a preinstalled Bluetooth internal module, check the origin
of its stack.
Microsoft / WidComm stack: Pairing is automatic between Telecardia and the computer, you have no other
manipulation to perform
Another provider stack: We recommend you to communicate the name of the stack provider to the
PARSYS Telemedicine After-Sales Service before any installation.
In the latter case, we recommend not to try the installation before obtaining
confirmation procedure by the PARSYS Telemedicine After-Sales Service.
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4.3.2 Pairing of Telecardia with a Windows 8 / 8.1 PC
Insert the USB Bluetooth adapter into an USB port on the PC, then run the installation CD.
If the CD does not run automatically, please run it manually in Windows Explorer.
Do nothing until this window appears. Click on “Install Bluetooth© Device”.
Click on “Agree and Install Bluetooth Software”.
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Wait until the installation completes.
Click on “Finish”.
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Open the “Program Files” folder (32-bit processors) or “Program Files (x86)” (64-bit processors).
Then, open the “Parsys” folder and start the “TCP.EXE” software.
When the software is opened, set the device “Call (Client)” mode.
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Open the Telecardia housing.
Note the ID of the used device:
Number starting with a T
Make the connection.
Simultaneously press the ON and OUT buttons until the device’s ignition.
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The different connectable Bluetooth devices are recognized by the system.
You can refine the search by type of equipment (Telecardia, Cardialys, etc.).
If the search is unsuccessful you can click on “Refresh…”,
which will start a new search.
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Once the desired device is visible, click its icon (although check the serial number).
Then, click on “Choose”.
The interface window with the medical device is then visible.
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Click on "Remote Mac Address”.
Then, click on “Local Device”.
The PC MAC address will be registered.
Click on “Remote Mac Address”.
Then, click on “Write” to save the new MAC address.
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In the field "Max Number of ECG" replace the number by "1", if you only want to do an ECG at a time.
This is preferable to avoid any mistake in ECG / Patient assignments.
Click on “Configuration”.
Then, click on “Write” to save all the changes.
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Click on “Disconnect”.
Back to the start window of the “TCP” software.
Close the window to exit.
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5 Using Telecardialys PC Software
See the User Manual Telecardialys Software - 37-063 V1.0
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6 ECG capture
If you have the Telecardia ECG, please follow the following procedures to capture a simultaneous 12-lead
ECG trace on the patient:
Press the "Start Telecardia (ECG)" button on the software, the message "ECG waiting" appears.
You can capture the ECG, the trace will be automatically transmitted to the PC.
6.1 2-lead peripheral Patient cable model
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6.2 3-lead peripheral Patient cable model
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7 Updating the PC software / device firmware
We shall contact you periodically by e-mail concerning download of updated software / firmware versions.
The updates are performed during maintenance.
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8 Technical features
8.1 General features
Portable, event-driven, 12-lead temporary electrocardiograph.
Radio data transmission (Bluetooth).
Lithium polymer rechargeable battery power supply.
8.2 Mechanical features
Material: two half-body unit + one hinged hatch made
of flame-retardant ABS
Color: RAL 9002 white with marking
Surface condition: 26 arbours
Electrode on unit:
o chest on lower section VN - V1 - V2 - V3 - V4 - V5 - V6 (7/10µ chromium-plated brass)
Electrodes with cable:
o VR, VL and VF peripheral limb clips cable
Connectors:
o "female cylinder connectors with collar" under bushing cover for electrocardiograph connection
- analogue trace output
Protection index: IP20
Folded overall dimensions: 210 mm x 100 mm x 50 mm
Weight: < 550 g
8.3 Electrical specifications
Device intended for temporary use.
Device not protected against defibrillation shocks.
Device with internal electricity supply: rechargeable lithium polymer batteries
Battery life: 50 peri-critical ECG captures and Bluetooth
transmission in one battery charge
Battery: Built-in Lithium Polymer battery
3,7V/1300mAh
Battery life: 3 years life cycle
Automatic power off after transmission.
Internal protection using 500mA resettable fuse.
Type B class 2A machine, diagnostic function.
Measurement with internal electrodes, 9 simultaneous leads: VR, VL, VF, V1 - V2 - V3 - V4 - V5 -
V6 with reference to VN.
Reproduction of 12 leads: D1, D2, D3, VR, VL, VF, V1, V2, V3, V4, V5,
V6
Input impedance: 10 MΩ.
Bandwidth: 0.16Hz to 70Hz at -3db
(Adjustable to 30Hz by configuration)
Measurement linearity: 0,01%
Measurement sensitivity: 2264 pt/mV
Sampling frequency: 271 pt/s
Backup of 6 (peri-critical) 15-second ECGs (rotating or fixed list backup management with saving
maintained even without stack).
Saving of identification and configuration data in encrypted form.
Real-time clock for ECG dating (autonomy of 1 year from full charging level under normal storage
conditions).
Displayed and/or voice task procedure or action messages.
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2-line, 16-character screen: task procedure message display
Operating mode setting (computer configuration):
o maximum number of ECGs
o voice prompt
o rotating stack/locking
o connection type
Bluetooth type interface for computer link and transmission base link:
o Bluetooth version 2.0 (EDR)
o Class 1 (100 mW)
Average transmission speed: 115.2 Kb/s (depends on medium used)
Operating conditions:
o Temperature: +10°C to +35°C
o Relative humidity level: 30% to 75%
o Atmospheric pressure: 700 mb to 1060 mb.
Storage and transport conditions:
o Temperature: -10°C to +50°C
o Relative humidity level: 10% to 85%
o Atmospheric pressure: 500 mb to 1060 mb
8.4 Functional features
Front panel:
start-up button,
configuration button (under housing cover),
blue/green LED indicating:
o steady green - machine power on
o steady blue - Bluetooth transmission to PC or base
1 LCD 2 x 16-character line screen without backlighting.
Curved lower section:
3 chromium-plated brass convex round electrodes
Upper section:
Hatch opening outwards and used to support the unit
Upper section under hatch:
10 x 4 mm "female cylindrical" connectors with attachment collar between the two bodies
1 signal transfer control button to electrocardiograph (analogue output), or configuration
Rear panel (back):
Instruction label
2 charging contacts
Edges:
1 folding articulated arm on either side, supporting electrodes V1, V2 and V5, V6.
2-lead model:
o Under the left arm, 1 output of the wire VF electrode (iliac), with automatic winding system.
o Under the right arm, 1 connecting socket for VR and VL cable.
3-lead model:
o Under the right arm, 1 connecting socket for VR, VL and VF limb clips cable.
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8.5 Functional flow chart
TELECARDIA
..PARSYS Telemed.
…TELECARDIA…
TECHNICAL PROB
…TELECARDIA…
BATTERY LOW
06/06/2007
17 : 15
Stop
No LCD dialogue?
Defective technical self-
tests
Low Battery?
3s
On
TELECARDIA
Memory full!
Electrode test OK?
Time without event > 4 min?
2 clear 1s beeps
…TELECARDIA…
….goodbye.
Y
PARSYS Santé….hello
TELECARDIA menu and
voice message flow chart
"OUT" button enabled?
Battery low …. Charge immediately
Technical problem please contact
number on base
NB: OUT button = Button 1 diagram
ON button = Button 2 diagram
The text marked in red
represents the voice prompts or
information played
Check that wired electrode
is positioned correctly on
Press machine against chest
as in photo
Position fingers as in photo
Do not move during the 15 beeps
Y
3s
3s
Y
Start of capture
Y
1 x 250ms beep
On button AND
‘OUT ‘ button active?
Y
Setting=1
Setting=1?
TELECARDIA
…playback
Start last ECG playback
1 x 250ms beep every
second for 15s
N
Y
ON button pressed for > 3s?
Y N N
Y
3
3s
1 x 250ms beep every second for 15s
Input completed
Trace recording
TELECARDIA
Connection
Transmission in progress
Put machine on base
Transmission=0
TELECARDIA
Configuration
1 x 250ms beep
Transmission =0?
Setting=1?
N
Y
Transmission=1
ECG transmission in
progress?
ECG transmission
Transmission
complete?
Transmission =1
Y N N
250 ms beep
No more space in
memory?
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9 Electromagnetic emissions
Table 1: Directives and MANUFACTURER’S statement – ELECTROMAGNETIC EMISSIONS
For all DEVICES and EM SYSTEMS
Directives and manufacturer’s statement – electromagnetic emissions
The device is made to be used in the electromagnetic environment specified below. The client or user of the device must
ensure that the device is used in such environment.
Emission trials
Conformity
Electromagnetic environment – directives
RF Emissions
CISPR 11
Group 1
The device uses RF energy only through his internal
functions. As a consequence, its RF emissions are very
weak and are not likely to cause interferences in a
nearby electronic device.
RF Emissions
CISPR 11
Class B
The charging power box (catalogue product) must
solely be used with the device in sleep mode,
disconnected from the patient.
Harmonic Emissions
CEI 61000-3-2
Non applicable
Pulse fluctuations/
Flicker CEI 61000-3-3
Non applicable
Table 2 – Directives and MANUFACTURER’S statement – electromagnetic IMMUNITY
For all DEVICES and EM SYSTEMS
Directives and manufacturer’s statement – electromagnetic immunity
The device is made to be used in the electromagnetic environment specified below. The client or user of the device
must ensure that the device is used in such environment.
Immunity trials
Trial level
CEI 60601
Conformity
level
Electromagnetic environment –
directives
Electrostatic shocks (ES)
CEI 61000-4-2
+/- 6 kV in contact
+/- 8 kV in the air
Conforms
Floors must be made of wood, concrete or
ceramics. If the floors are topped with
synthetic materials, it is important that the
relative humidity remains at 30% at least.
Magnetic field at the rate of the
electric network (50/60 Hz)
CEI 61000-4-8
3 A/m
Conforms
Magnetic fields at the rate of the electric
network must have the distinctive levels of a
representative place located in a
commercial or hospital environment.
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Table 3 – Directives and MANUFACTURER’S statement – electromagnetic IMMUNITY
For all DEVICES and EM SYSTEMS
Directives and manufacturer’s statement – electromagnetic emissions
The device is made to be used in the electromagnetic environment specified below. The client or user of the device
must ensure that the device is used in such environment.
Emission trials
Trial level
CEI 60601
Conformity
level
Electromagnetic environment – directives
RF conducted disturbances
CEI 61000-4-6
RF radiated disturbances
CEI 61000-4-3
3 Veff
from 150kHz to
80MHz
3 V/m
from 80 to 2,5GHz
3 Veff
3 V/m
The portable and mobile RF communicating
devices should be not used nearer of any part of
the medical devices, including cables, than the
recommended separation distance, calculated
from the transmitter frequency applicable
equation.
Recommended separation distance
d= 1,2√P
d= 1,2√P from 80MHz to 800MHz
d= 2,3√P from 800MHz to 2,5GHz
where P is the maximum output power of the transmitter in
watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m) of
separation.
It should that field strengths from fixed RF transmitters, as
determined by an electromagnetic survey on site a , should be
less than the compliance level in each frequency range b..
Interferences may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1: to 80MHz and to 800MHz, the higher d range frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land
mobile radios, amateur radio, AM / FM radio and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, it should be considered to proceed
to an electromagnetic survey on site. If the measured field strength in the location where the medical device is
used, exceeds the applicable RF compliance level above, it is necessary to observe the behavior of the medical
device, to check that the operation is normal. If abnormal performances are observed, additional measures
may be necessary, such as reorienting or repositioning of the medical device on its operation site.
b
In the frequency range of 150kHz to 80MHz, it is appropriate that the field strengths are smaller than 3 V/m.
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Recommended separation distances between portable and mobile RF communicating devices and
the medical device.
The medical device is intended for use in an electromagnetic environment where radiated RF disturbances are controlled.
The customer or the user of the device can help to prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communicating device (transmitter), and the medical device, as recommended
below, according to the maximum power emission of the communication device.
Transmitter maximum
assigned power output
(W)
Separation distance according to the transmitter frequency (m)
from 150kHz to 80MHz
d= 1,2√P
from 150kHz to 80MHz
d= 1,2√P
from 150kHz to 80MHz
d= 2,3√P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73 1 1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters whose maximum assigned transmission power is not given above, the recommended separation distance
d in meters (m) can be estimated by using the transmitter frequency applicable equation, where P is the characteristic of
the transmitter maximum transmission power in watts (W) according to its manufacturer.
NOTE 1: to 80MHz and to 800MHz, the higher d range frequency 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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10 Maintenance
10.1 Cleaning / Disinfection
The Telecardia machine can be cleaned and disinfected by wiping the electrodes in contact with the skin and
the plastic unit, except on the self-adhesive label at the rear of the machine, with cotton wool or a wipe soaked
in a product such as STERANIOS or equivalent (2% glutaraldehyde solution).
Any other product would not ensure proper cleaning without damaging the Telecardia components.
10.2 Procedure in the event that the instrument is dropped or falls
Mechanical damage to the instrument necessarily implies discontinuation of use of the machine and return to
the PARSYS Telemedicine After-Sales Service.
10.3 Reset procedure
If, when using the device, it blocks for more than 1 min:
Use the reset cable or take a metal object (paper clip) and place it on the charging contacts for 1s,
Place the equipment back on the charger and wait for the Charger indicator to come on,
Establish radio connection with the PC in configuration mode in order to update the device's internal
real-time clock:
Open the cover as shown on the photo: press and hold the "OUT" button and press on the GREEN
ON/OFF button at the same time.
When the machine displays "PARSYS Santé", release both buttons.
The machine then indicates the time and date, before displaying "en cours" (in progress) and
"connexion BT" (BT connection).
Restart the device.
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10.4 Metrological checks
The device shall undergo metrological checks after 1 year maximum.
Checks should be carried out by the PARSYS Telemedicine technical department, it alone being able to
guarantee maintenance of the device's metrological performance.
10.5 Discharged battery
We recommend not to let Telecardia discharged for more than 1 year to keep the device's internal real-time
clock.
10.6 Product scrap treatment
According to the directive 2002/96/CE relating to DEEE electronic and electric devices, do not throw away in
regular trash. Please bring waste to specialized collection points.
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11 Users’ Training
Users of the Telecardia ECG must:
have kind of medical knowledge of physician, nurse or first aider,
hold the associate degree,
have been trained on this medical device.
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12 Fault or failure
12.1 The Telecardia ECG does not send any trace
After capturing the ECG, no trace is received by paired PC: the Bluetooth® connection is most certainly lost.
We therefore advise you:
NEVER ATTEMPT any direct manipulation on the PC;
Contact the PARSYS Telemedicine After-Sales Service.
12.2 The ECG is subject to interference
Check that the capture protocol described in section 6. has been followed, in particular:
that the correct color code has been followed for the limb clips: red on the right arm, yellow on the
left arm and green on the left leg,
that the electrodes and the skin have been humidified: using the spray.
The patient and the user must be as relaxed as possible in order to avoid any tense movements when capturing
the ECG.
12.3 The Telecardia ECG is not charging
Check that the protocol described in section 2.4 has been followed, in particular:
that the Telecardia is in the correct position on its charging base,
that the red LED on the charging base is on during charging,
that the charging base is correctly plugged into the mains.
Should you note a low battery level after 1 hour's charging, please contact the PARSYS Telemedicine AfterSales Service.
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12.4 The Telecardia ECG remains blocked
If, when using the device, it blocks for more than 1 min:
Use the reset cable or take a metal object (paper clip) and place it on the charging contacts for 1s,
Place the equipment back on the charger and wait for the Charger indicator to come on,
Establish radio connection with the PC in configuration mode in order to update the device's internal
real-time clock:
Open the cover as shown on the photo: press and hold the "OUT" button and press on the GREEN
ON/OFF button at the same time.
When the machine displays "PARSYS Santé", release both buttons.
The machine then indicates the time and date, before displaying "en cours" (in progress) and
"connexion BT" (BT connection).
Restart the device.
12.5 The Telecardia ECG has lost is time stamping
If your Telecardia ECG has lost is time stamping:
Establish radio connection with the PC in configuration mode in order to update the device's internal
real-time clock:
Open the cover as shown on the photo: press and hold the "OUT" button and press on the GREEN
ON/OFF button at the same time.
When the machine displays "PARSYS Santé", release both buttons.
The machine then indicates the time and date, before displaying "en cours" (in progress) and
"connexion BT" (BT connection).
Restart the device.
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13 PARSYS Telemedicine Warranty and After-Sales Service
The Customer agrees to comply with the Warranty Conditions listed on the Warranty Certificate accompanying
the Equipment.
The Equipment is supplied with a one-year (1) warranty during which period the Customer will be able to
exchange Equipment found to have a latent defect and subject to the Customer having informed PARSYS
Telemedicine thereof in writing and in detail.
In the event of a functional fault or failure of the Equipment, the Customer may contact PARSYS Telemedicine:
by sending an e-mail to support@parsys.com,
or by calling the PARSYS Telemedicine After-Sales Service:
o Monday to Friday, 10 a.m. - 12.30 p.m. and 2 p.m. - 6p.m., except for bank holidays,
o at +33 (0)1 60 31 51 71
or by sending a letter by recorded delivery with acknowledgement of receipt to:
PARSYS Telemedicine - After-Sales Service
5-7, avenue de Paris 94300 Vincennes - FRANCE
The PARSYS Telemedicine After-Sales Service identifies the nature of the fault or failure of the Equipment
before carrying out any repairs or replacing the defective Equipment.
Beyond the warranty period, the Customer has the possibility of subscribing to a maintenance contract with
the PARSYS Telemedicine sales department.
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