Cardioline 200P User manual

Rev.01 –08.04.2019
200P
User manual

200P
All rights reserved © Cardioline SpA.
CARDIOLINE®is a registered trademark of Cardioline SpA.
This publication may not be reproduced, in whole or in part, in any form or manner, without prior written authorisation
by:
Cardioline Spa
Via Linz, 151
38121 Trento
Italy

200P
Table of Contents
1. GENERAL INFORMATION .........................................................................................................................1
1.1. Other important information...........................................................................................................1
2. SAFETY INFORMATION.............................................................................................................................2
3. ELECTROMAGNETIC COMPATIBILITY (EMC).............................................................................................5
3.1. Guidance and Manufacturer's declaration - Electromagnetic emissions.........................................6
3.2. Guidance and Manufacturer's declaration - Electromagnetic immunity .........................................6
3.3. Guidance and Manufacturer's declaration - Electromagnetic immunity .........................................7
3.4. Recommended separation distances between portable and mobile RF communications
equipment and the device ...........................................................................................................................8
4. SYMBOLS AND LABEL ...............................................................................................................................9
4.1. Explanation of the symbols..............................................................................................................9
4.2. Device label......................................................................................................................................10
5. INTRODUCTION........................................................................................................................................11
5.1. Purpose of the manual.....................................................................................................................11
5.2. Description of the device.................................................................................................................11
5.2.1. General overview.....................................................................................................................11
6. PREPARATION FOR USE............................................................................................................................13
6.1. Installing the printer ........................................................................................................................13
6.2. Loading the paper............................................................................................................................16
6.3. Switching the device ON/OFF ..........................................................................................................17
6.4. Power connection............................................................................................................................17
6.5. Battery operation.............................................................................................................................18
7. MAINTENANCE AND TROUBLESHOOTING ...............................................................................................19
7.1. Precautions ......................................................................................................................................19
7.2. Switching off the device...................................................................................................................19
7.3. Regular maintenance.......................................................................................................................19
7.3.1. Functional check ......................................................................................................................19
7.3.2. Device cleaning ........................................................................................................................20
7.3.3. Cleaning the thermal head of the printer ................................................................................20
7.3.4. Operation check.......................................................................................................................20
7.4. Recommendations...........................................................................................................................21
7.5. Battery maintenance .......................................................................................................................21

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7.6. Troubleshooting table......................................................................................................................22
8. TECHNICAL SPECIFICATIONS ....................................................................................................................24
8.1. Harmonised standards applied ........................................................................................................24
9. WARRANTY ..............................................................................................................................................25
10. DISPOSAL .................................................................................................................................................26

200P
1. GENERAL INFORMATION
1
1. GENERAL INFORMATION
This manual is an integral part of the device and should always be available as support material the operator.
Strict compliance with the information contained in this manual is an essential prerequisite for a proper and
reliable use of the device.
Have the operator read the manual thoroughly as the information related to the different chapters is only
described once.
1.1. Other important information
This manual was written with the utmost care. Should you find any details which do not correspond to those
contained in this manual, please inform Cardioline SpA who will correct such inconsistencies as soon as
possible.
The information contained in this manual is subject to change without notice.
All changes will be in compliance with the regulations governing the manufacturing of medical equipment.
All trademarks mentioned in this document are property of their respective owners. Their protection is
guaranteed.
No part of this manual may be reprinted, translated or reproduced without the manufacturer's written
authorisation.
The code relating to this manual is listed below.
Language
Code
ENGLISH
36519137_ENG

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2. SAFETY INFORMATION
2
2. SAFETY INFORMATION
Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if:
1. the assembly operations, modifications or repairs are carried out by Cardioline SpA or by its
Authorised Service Centre;
2. The device is used in compliance with the instructions provided in the use manual.
Always contact Cardioline SpA should you wish to connect any devices not mentioned in this manual.
Warnings
This manual provides important information on proper use and safety of the device. Failure to
comply with the described operating procedure, improper use of the device, ignoring the
specifications and recommendations supplied, may cause severe physical injuries to the operators,
patients and bystanders, or may damage the device.
No modification of this equipment is allowed.
To avoid the risk of electric shock, this equipment must only be connected to a supply main with
protective earth.
If in doubt regarding the integrity of the external earth conductor, use the device with its inner
battery.
When connecting the printer to other devices, to avoid undermining the safety of the operator and
patient, keep in mind the requirements of IEC 60601-1:2005+A1 chapter 16 and measure the
leakage current to confirm that there is no risk of electric shock.
For the correct operation of the device and for the safety of the operators, patients and bystanders,
the device and the accessories must be exclusively connected as outlined in this manual.
Only use the power supply cable provided with the printer, which must not be used for other
equipment.
To guarantee the safety of the operator and of the patient, the equipment connected to the same
line as the device must comply with IEC 60950 or IEC 60601-1 standards.
There is a risk of explosion. Do not use the device in the presence of flammable anaesthetics.
There is no safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
The operation may be adversely affected by the presence of strong magnetic fields such as those
produced by electro surgery equipment.
The use of the device is not recommended in the presence of medical diagnostic imaging equipment
such as the Magnetic Resonance Imaging (MRI) or Computerised Axial Tomography (CAT) in the
same environment.

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2. SAFETY INFORMATION
3
Only use the recommended batteries. Using other types of batteries may cause danger of fire or
explosion.
The internal rechargeable battery is hermetically sealed NiMH and requires no maintenance. Should
the battery be faulty, contact Cardioline technical assistance service.
The low battery warning is designed for the recommended batteries only. Using other types of
batteries may lead to a lack of indication resulting in device failure. If the battery is low, connect the
device to the electrical mains.
Do not clean the device or the cables by submersing them in liquid, autoclaving, or steam cleaning.
This may cause serious damage to equipment or reduce its lifespan. Using non-specific
detergents/disinfectants, failure to comply with the recommended procedures or contact with non-
specific materials may cause additional risks to operators, patients or bystanders or may damage the
device. Do not sterilise the device or the cable with ethylene oxide gas (EO). Refer to Section 7 for
instructions on proper cleaning and disinfection.
Do not leave the cables unattended in the presence of children as they could be accidentally
strangled.
Attention
Do not pull or stretch the power supply cables as this could result in mechanical and/or electrical
failures. The cable should be wrapped in a loop and arranged correctly.
There are no user-serviceable parts inside the device. The device can only be dismantled by qualified
service personnel. Any malfunctioning or defective device must be excluded from use and be
checked/repaired by qualified service personnel before being reused.
The device does not require any calibration or special instrumentation for correct use and
maintenance.
When it is necessary to dispose of the device, its components and accessories (e.g.: batteries, cables,
electrodes) and/or packaging material, comply with local standards for waste disposal.
Notes
In order to prevent damage to the device during transportation and storage (when still in its original
packaging), comply with the following environmental conditions:
Ambient temperature .....................
+5°C to +40°C
Relative humidity ............................
20% to 90%
Atmospheric pressure .....................
700 hPa to 1060 hPa

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2. SAFETY INFORMATION
4
The device is intended for use in hospitals or doctor's offices and should comply with the following
environmental requirements:
Ambient temperature .....................
+10°C to +40°C
Relative humidity ............................
50% to 90%
Atmospheric pressure .....................
700 hPa to 1060 hPa
After using the device on battery power, always reconnect the power cable. This will guarantee that
the batteries are recharged automatically the next time the device is used.

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3. ELECTROMAGNETIC COMPABILITY (EMC)
5
3. ELECTROMAGNETIC COMPATIBILITY (EMC)
This device requires particular precautions regarding Electromagnetic Compatibility. It must therefore be
installed and commissioned in compliance with the information on Electromagnetic Compatibility contained
in this manual.
Portable and mobile radio communication equipment can affect operation of the device.
Using accessories, transducers or cables different than those specified in par. Errore. L'origine riferimento
non è stata trovata. can increase the emissions or decrease the immunity of the appliance.
Warnings
This device could generate radio interference or disturb operation of the equipment in the vicinity.
Therefore it could be necessary to take measures to mitigate these effects, such as re-directing or
repositioning the device or shielding the room.
The use of accessories and cables other than those recommended by Cardioline may cause an
increase in emissions or a lowering in the protection of the system.
The device must not be used near or superimposed to other equipment. If necessary, check that the
device works according to its standard operation.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
Notes
Electromagnetic compatibility during the use of the device is required with the surrounding devices.
An electronic device can generate or receive electromagnetic interference. The electromagnetic
compatibility test (EMC) has been carried out on the device in compliance with the international EMC
directive for medical equipment (IEC 60601-1-2). This IEC standard has been adopted as a European
standard (EN 60601-1-2).
Fixed, portable and mobile equipment for RF communication may affect the protection of the medical
equipment. See par. 3.4 for the recommended separation distance between the radio equipment and the
device.

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3. ELECTROMAGNETIC COMPABILITY (EMC)
6
3.1. Guidance and Manufacturer's declaration - Electromagnetic
emissions
The device is intended to operate in the electromagnetic environment specified below. The customer or the
user of the device must guarantee that it is used in this environment.
Emission test
Compliance
Electromagnetic environment –guidance
Radiated radio frequency emissions
(RF) CISPR 11
Class B
Group 1
The device 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.
Conducted radio frequency emissions
(RF) CISPR 11
Class B
Group 1
The device is suitable for use in all establishments other than domestic
environments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonics emissions
IEC 61000-3-2
Class B
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
3.2. Guidance and Manufacturer's declaration - Electromagnetic
immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device assure that it is used in such an environment.
Immunity test
Conformity
Compliance level
Electromagnetic Environmental Information
Electrostatic discharge
(ESD)
IEC 61000-4-2
in contact +/- 8 kV
airborne +/- 15 kV
air
in contact +/- 8 kV
airborne +/- 15 kV
air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical Fast Transient/
Burst
IEC 61000-4-4
+/- 2 kV for power
lines
+/- 1 kV for
input/output lines
+/- 2 kV for power
lines
+/- 1 kV for
input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
+/- 0.5, 1 kV line-to-
line
+/- 0.5, 1, 2 kV
between phase and
earth
+/- +/- 0.5, 1 kV line-
to-line
+/- +/- 0.5, 1, 2 kV
between phase and
earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips,
short interruption and
voltage variations
on power supply
input
lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(60% dip in UT)
for 25 cycles
<5% UT
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(60% dip in UT)
for 25 cycles
<5% UT
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the device requires continued operation during
power mains interruptions, it is recommended that
device be powered from an uninterruptible power
supply or a battery.

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3. ELECTROMAGNETIC COMPABILITY (EMC)
7
(>95% dip in UT)
for 5 s
(>95% dip in UT)
for 5 s
Power frequency and
magnetic field
(50/60 Hz)
30 A/m at a
frequency of 50 and
60 Hz
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
NOTE: UTis the AC mains voltage prior to the application of the test level.
3.3. Guidance and Manufacturer's declaration - Electromagnetic
immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Emission test
IEC 60601 test level
Compliance level
Electromagnetic Environmental Information
Conducted RF
IEC 61000-4-6
3 V rms
From 150 kHz to 80
MHz
With amplitude
modulation 80% 1
kHz sinusoidal
waveform
3 V
Portable and mobile RF communications equipment
should be used no closer to any part of the
ECG100L/ECG200L, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance:
From 80 MHz to 800 MHz
From 800 MHz to 2.5 GHz
where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey (a),
should be less than the compliance level in each
frequency range (b).
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated R
IEC 61000-4-3
(for RF wireless
communications
equipment 385 ÷ 5785
MHz
See table in the
standard
Complies with all
test levels
Radiated R
IEC 61000-4-3
3 V/m
From 80 MHz to 2.7
GHz
Modulation
amplitude
sinusoidal
waveform 80% 1
kHz
(Professional
facilities)
10 V/m
From 80 MHz to 2.7
GHz
(Homecare
Facilities)
3 V/m

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3. ELECTROMAGNETIC COMPABILITY (EMC)
8
NOTE 1: At 80 MHz and 800 MHz, 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.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
device is used exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the device.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
3.4. Recommended separation distances between portable and
mobile RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the device as recommended below, according to the maximum output power of the communications
equipment.
Maximum rated power output of the
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 KHz to 800 MHz
800 MHz to 2.5 GHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance
din metres (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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4. SYMBOLS AND LABEL
9
4. SYMBOLS AND LABEL
4.1. Explanation of the symbols
Symbol
Description
Comply with the instructions in the use manual
CE marking –compliance with the European Union directives
Manufacturer
Reference number (product code)
Serial Number
Year of manufacture
Separate collection of electrical waste and electronic equipment
Temperature variation
Humidity variation
No latex
Keep dry

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4. SYMBOLS AND LABEL
10
4.2. Device label

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5. INTRODUCTION
11
5. INTRODUCTION
5.1. Purpose of the manual
This manual deals with the 200P device.
The manual represents a guide for the execution of the following operations:
Reasonable use of the device.
Preparation of the device for use. (Section 6)
Troubleshooting and maintenance. (Section 7)
5.2. Description of the device
The device is a thermal printer that is able to print out 12-lead ECG traces on A4 graph and Letter paper.
The device features a type C USB port for connection to a Windows computer.
200P can be powered with an internal battery or from the power mains.
The printer was designed to work with the Cardioline Cubestress and TouchECG applications. It also comes
with a printing driver so that it can be used from any Windows application able to operate with Windows-
compatible printers.
The device includes:
1. Power supply cable
2. Paper
3. User manual
5.2.1. General overview
Front view:
Printer
LED

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5. INTRODUCTION
12
Rear view:
Power supply
USB
On/off
switch

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6. PREPARATION FOR USE
13
6. PREPARATION FOR USE
6.1. Installing the printer
Before connecting the printer to the PC, install the printing driver.
1. From the Windows Start menu, select “Settings” and then “Devices”;
2. Select “Printers and scanners” and then “Add a printer or a scanner”; the computer will start
searching for the printer and at the end of the search select “The printer that I want isn’t listed”

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6. PREPARATION FOR USE
14
3. Select “Add local or network printer with manual settings”;
4. Select “Use an existing port” and choose “USB001” from the drop-down menu;
5. Insert the supplied CD or USB drive, select “Driver Disc”, select the “Cardioline” driver and click
“Next”;

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6. PREPARATION FOR USE
15
6. Accept the suggested printer name and click “Next”;
7. Select “Always trust software …” and click “Install”;
8. Select “Do not share this printer” and click “Next”;

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6. PREPARATION FOR USE
16
9. Connect the printer to the computer with a USB cable and turn the printer on.
10. After loading in the paper, press “Print test page”
11. Click “End”.
6.2. Loading the paper
Load paper in the device as follows:
1. Remove the outer packaging of the ream of paper.
2. Open the printer compartment, lifting the panel and turning it anticlockwise around its pivot.