AR600 ADV
ar600adv
user manual
English
This User Manual is prepared with the objective of giving the user all the information
necessary to obtain the best use of the CARDIOLINE® ar600adv. Together with the
traditional descriptions of the equipment's functions the following documentation will
be found:
- Certificate of Guarantee
General information
CARDIOLINE® is a registered trademark of et medical devices SpA
All rights reserved © et medical devices SpA ITALY.
et medical devices SpA, continuously in search of technological improvement and
customer satisfaction, reserves the right to modify this publication without prior
notice at any time.
um_ar600adv_cardioline_01_eng1.doc Rev. 01/sr/GZ 20/06/2007 Ref: 36519095
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Index
1 Introduction 5
1.1 How to read the manual 6
1.2 Information and recommendations relating to safe use 7
1.3 The electrocardiograph 9
2 Installation and initial preparation 13
2.1 Selection of the installation site 13
2.2 Loading the thermal paper 13
2.3 Power supply; control and management of the rechargeable batteries 14
Recharging the batteries 15
Battery charger: precautions for use 16
2.4 How to switch on the electrocardiograph 16
2.5 How to switch off the electrocardiograph 16
Auto power off 16
3 Preparation for use: the menu 18
3.1 How to access the menu 18
3.2 Structure of the menu 18
3.3 Menu-activated operation and personalization of the electrocardiograph 20
The “Operating mode” 20
“Print format” 21
The “ECG archive” 22
“Settings” 22
“Tools” 24
4 Preparing for an ECG recording 26
4.1 Connecting the patient cable 26
4.2 Preparing the patient and applying the electrodes 26
4.3 Selection of recording characteristics: operating mode, print format, speed,
sensitivity, filters 27
5 Recording of an ECG at rest 30
5.1 Patient data entry 30
5.2 Recording in manual mode 31
5.3 Recording in automatic mode 31
Automatic calculation of ECG parameters 32
Automatic ECG interpretation 32
Copy of an automatic ECG recording
ECG memory: saving an ECG 34
5.4 Recording in ECG autotimer mode 35
5.5 Recording in "PC ECG" mode 36
5.6 “Paper saving” mode 36
33
3
5.7 Recording in “HRV analysis mode” 37
5.8 Recording in “Arrhythmia mode” 38
5.9 Defibrillation! 39
6 Management and control of electrocardiograph functionality’s 40
6.1 Disconnected electrodes, potential defibrillation 40
6.2 Batteries low or in need of recharging 40
6.3 Print system control out of paper 41
6.4 Status messages and error indication: description and related event 41
6.5 Troubleshooting 41
7 Maintenance 43
7.1 Self-test 43
7.2 Replacing the thermal paper 44
7.3 How to clean the device and the electrodes 44
7.4 How to replace the batteries 44
7.5 Periodic checks 45
Technical information 45
8 Technical specifications 46
Basic accessories supplied 47
4
1 Introduction
ar600adv combines generous levels of performance in a portable
electrocardiograph with all the features of reliability, modularity, versatility
and upgradeability that characterise the latest generation of CARDIOLINE®
electrocardiographs.
ar600adv is a portable electrocardiograph with dual power supply, (mains
and rechargeable internal batteries), which in the basic configuration will:
record an ECG exam in automatic, manual and timed mode;
reproduce the ECG signal on 60 mm paper in various formats thanks to
high resolution thermal printer: 1, 2, 2+R and 3 channels;
store the most recent recording in automatic mode and print additional
copies.
Thanks to the flexibility of the software used and to the infrared interface,
the ar600adv can be adapted at any given moment to suit your individual
requirements. The range of “options” offered is particularly generous and
there are no restrictions or constraints, as the selection can be made either
at the moment of purchase or later on at your clinic or surgery without
having to interrupt day-to-day activity.
In just a few minutes your ar600adv can be equipped with:
- “memory option”: storage of up to 20 full ECG exams, with no need to
print out immediately on paper (“paper saving” mode);
- "ECG measurements option": automatic ECG parameter measurement
program;
- "ECG signal interpreter option": a useful and dependable diagnostics
support.
- "arrhythmia option": program enabling detection of arrhythmia events
during continuous recording;
- “HRV analysis option”: program enabling detection of variations in heart
rate;
- "PC archive option": for saving the exam to archive stored in a personal
computer running CARDIOLINE software. The data upload to the PC is
made by use of the wireless “IR” interface; no direct connection to the
PC is required.
- “PC-ECG option": for real time display of the twelve leads on your
computer screen to allow management of patient medical records and
archiving of exams in digital format using CARDIOLINE software. The
software has an optional module for automatic interpretation of the ECG
signal.
For more information on available options, contact your selected dealer.
CONGRATULATIONS ON YOUR PURCHASE. Your new computerised
electrocardiograph CARDIOLINE® has been designed and built in
compliance with the applicable regulations in force at the time when et
medical devices SpA, Cavareno (Trento) - ITALY drew up this manual. et
medical devices operates in accordance with the requirements for quality
management systems defined by EN ISO 9001: 2000 and EN ISO 13485:
5
...
2003 standards. The system is covered by a Nemko Certification AS (Cert.
N. 800278). Your new electrocardiograph has also been built in compliance
with the Medical Device Directive 93/42/EEC and is therefore marked by the
relevant CE0470 mark.
1.1 How to read the manual
In order to ensure the CARDIOLINE® ar600adv is operated in a safe and
correct manner, and to appreciate its ease of use and high reliability, the
user instructions must be read carefully.
This documentation describes the functions of your electrocardiograph
including those provided by all the possible "options" available. It is
therefore possible that some of the functions described may not be present
in the model you have purchased. For details of the options, consult the
"firmware configuration" chart which accompanies each individual appliance.
This symbol allows you to identify the functions not provided on all
models, which must be requested specifically at the time of purchase.
This symbol allows you to identify the functional, behavioural and
operational aspects that may be conditioned by the type of configuration
selected during the step of “Preparation for use: the menu”.
When a given key is depicted in the body of a sentence or a
paragraph, press the corresponding key on the device to perform the action.
The structure of this manual allows you to approach the use of the
electrocardiograph according to your level of knowledge. If you have already
had experience with CARDIOLINE® equipment, the initial fast-track part of
each paragraph will allow you to begin working immediately. In the
continuation of the paragraph, on the other hand, the single aspects of
operation are discussed in more depth.
The manual gives detailed information on the use of the model ar600adv in
traditional ECG procedures, and an introduction to the use of particular
functionalities involving interaction with software and a Personal Computer.
For instructions on the use of the software applications for Personal
Computer, consult the special online guides.
The quick guide to the electrocardiograph (at power-up the display shows
the message “ ? Press 1 ” to obtain the printout) sums up the operations
linked to the single commands presented in the manual.
Further information and clarifications can be requested directly from:
CARDIOLINE® - Product Support
Strada Rivoltana Nuova, 53, I - 20060 Vignate (MI) ITALIA
e-mail: et.service@etmed.biz
tel. +39 02 95 05 181 fax: +39 02 95 66 013
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1.2 Information and recommendations relating to
safe use
- Safety information and recommendations.
- The device is equipped with a set of standard accessories. For reasons
of safety, reliability and conformity with the Medical Devices Directive
93/42/EEC, use only original accessories or accessories approved by the
manufacturer.
- The device is equipped with a special long-life thermal head writing
system, which allows maximum writing precision. To avoid frequent and
costly replacements and repairs, always use the original paper or paper
approved by the manufacturer. The manufacturer will not accept liability
for any damage to the device or any other adverse effect caused by the
use of unsuitable paper.
- Do not subject the device to impact or excessive vibrations.
- Do not allow liquids to penetrate inside the device. If this should
accidentally occur, have the device tested by an Authorized Assistance
Centre to verify its functional efficiency, before using it again.
- Make sure that the value of the supply voltage corresponds to that
indicated on the data plate of the device.
- If you are using the device in connection with others, ensure that: all
connections are made by skilled persons; all connections comply with
safety regulations; all other devices connected respond likewise to
regulations. Non-compliance with regulations can cause physical harm to
the patient connected and to the person operating the device. Should it
be difficult to obtain the necessary information for assessing the risk of
the individual connections, apply directly to the manufacturers
concerned or avoid making the connections.
- In the event of other equipment being connected directly or indirectly to
the patient, check for the possible risks caused by the sum of the
leakage currents on the body of the patient.
- The device is protected against defibrillation discharges in accordance
with IEC standard 601-1-25; to ensure that the signal is restored, use
only original electrodes or electrodes responding to IEC and AAMI
standards.
- If an electrosurgical scalpel is in use, the patient cable should be
disconnected from the device.
- At all events, when defibrillators or high-frequency surgical devices are
being used at the same time, it is essential to take the greatest care. If
there is any doubt when such devices are in use, disconnect the patient
from the electrocardiograph temporarily.
- The device recognizes the impulses generated by a pacemaker and does
not interfere with its operation, as prescribed by standards in use at the
time of drafting this manual.
- Avoid exposing the equipment to extreme temperatures, excessive dust
or dirt, and very salty or damp environments; observe the ambient
conditions described in detail under the "Technical specifications”
heading.
7
- Periodically check the efficiency of all accessories and of the device
itself. Use the built-in test function to make a first check on the
efficiency of the device. Contact the Authorized Assistance Centre
whenever the device seems to be operating irregularly.
- To prolong the life of your device, have it checked periodically by an
Authorized Assistance Centre.
- Caution: do not use the electrocardiograph for intracardiac applications
or for monitoring activities in the operating theatre!
- Caution: do not use the device in the presence of anaesthetics or
volatile gases!
- Caution: devices for medical applications must be used only by persons
who by virtue of training or practical experience are able to ensure
maximum safety and effectiveness in operation. Operators must in any
event read this manual carefully and familiarise themselves with the
instrument before using it on a patient.
- Caution: the indications obtained using automatic interpreting
programs or other diagnostic aids must be reviewed and countersigned
by a qualified medical person!
- Caution: use only original "battery chargers" as indicated alongside the
connector and in the “Accessories supplied” heading. The original
battery charger ensures the electrical isolation of the patient and the
operator, guaranteeing essential conditions of safety. Do not use
replacement accessories that have not been approved by the
manufacturer.
- Caution: the device is provided with an IR interface for the transfer of
data to other devices. The IR interface must not be masked , even
accidentally, as this will adversely affect its capability and its operation,
interrupting and preventing the correct flow of data.
- The manufacturer will acknowledge liability for the safety, reliability and
functional efficiency of the device only if:
o modifications and repairs are performed by the manufacturer or by
an Authorized Assistance Centre;
o the a.c. mains power supply of the building responds to current
regulations;
o the device is operated according to user instructions;
o any accessories in use are those approved by the manufacturer.
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1.3 The electrocardiograph
In order to simplify the installation and the use of your electrocardiograph,
it is recommended that you become familiar with the component parts and
with the logic of its operation.
Front view
3
1
2
Side view and bottom
9
8
REF: 6308.
4
5
7
5
6
3
9
Parts, symbols and controls
1. display: for the management of operations and patient data.
Auto 3 ch. ►
Recording …
♥ 68
.
In normal operating mode:
line 1: information relating to selected recording parameters;
line 2: operating information and error messages;
line 3: indication of battery charge status; heart rate; menu;
▲▼◄► these indicate the presence of additional information or menu
options.
cancel operation, delete text, return to previous menu.
Menu u
. view menus and information.
Access and select menu. Executes the action highlighted at the
bottom right of the display (e.g.
Select
).
2. The keyboard.
Key
Function
On / Off
10
Display messages & symbols/
associated Leds
- LED alight: device connected
to a.c. power supply; internal
batteries charging
- “full” symbol: batteries
charged
- “part-empty” symbol: charge
level of batteries lower than
30%
- “empty” symbol: internal
batteries flat; the device must
be connected to the a.c.
supply and recharged
25
start selected
operating
mode
interrupt
current
operation;
stop
Select
operating
mode
Select print
format
a.c. mains
and muscle
interference
filter
selection of
paper speed
Selection of
recording
sensitivity
copy last
recording
+
1
Q
N
alphanumeric
keys
Automatic mode:
1, 2, 3, 3+R
Manual mode:
1, 2, 3
50
5
10
20
- indicated electrodes not
connected or insufficient
contact; saturation
- filter on
- paper speed 25 mm/s
paper speed 50 mm/s
- automatic sensitivity:
the device optimizes the ratio
between n° channels and
available space
- sensitivity 5 mm/mV
- sensitivity 10 mm/mV
- sensitivity 20 mm/mV
3. Paper compartment cover.
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4. IR interface.
5. Connector for CF type patient cable protected from defibrillation as
indicated by the symbol .
6. "Reset" key : allows normal operating conditions to be restored in
the event of an error that cannot be managed using the keys.
7. “Battery charger” connector.
8. Data plate. Always refer to the data indicated when communicating with
Authorized Assistance Centres,
9. Battery compartment cover.
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2 Installation and initial preparation
This section describes the operations to be performed prior to using your
new CARDIOLINE® ar600adv electrocardiograph. Suggestions are given
for “selecting the best installation site”, along with reminders of
“recommendations for safe use in conformity with current statutory
regulations”. Also introduced are the operations involved in preparing the
electrocardiograph for use, such as “loading the thermal paper”, “power
supply; control and management of the rechargeable internal batteries”,
“switching on and off”, “menu”, “setup”.
2.1 Selection of the installation site
The electrocardiograph is in conformity with European directives on
electromagnetic compatibility. The absence of emissions damaging to radio
and telecommunications transmissions is therefore assured, as also is
protection from interference emitted by other systems and equipment.
Nevertheless, in order to protect your device from other equipment not in
conformity with the aforementioned directives:
- avoid the use of cellular telephones in the vicinity;
- place the electrocardiograph as far as possible from electrical power
lines or from sources of static electricity. The ECG signal can in fact be
disturbed if the electrocardiograph is situated close to sources of high
voltage or power lines;
- avoid placing the electrocardiograph close to other diagnostic or
therapeutic equipment (e.g. X-ray machines, ultrasound machines,
electrically operated beds, etc.) that could be a source of excessive
interference and ECG signal distortion;
- if it is impossible to distance the electrocardiograph far enough from
other electrical equipment, turn this equipment off during ECG
recordings.
Also, to avoid ambient conditioning when conducting an exam:
- record in a room where the temperature is between 20 and 25 °C. This
measure will prevent the patient from shivering, which would increase
the incidence of muscle tremor;
- record the ECG using battery power, with the device unplugged from the
a.c. power supply. This will eliminate the possibility of the recorded ECG
signal being affected by a.c. mains disturbances.
2.2 Loading the thermal paper
CARDIOLINE® ar600adv will reproduce the ECG signal on thermal paper
procured either in rolls or in packs. No special setup procedure is required.
This sections gives the instructions for the correct loading of both types of
paper.
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3 3
2
2
1
1
If using rolls of paper:
a. Using a coin or similar implement, open the paper compartment and
remove the "roll guide" hub. If replacing a depleted roll, recover the hub
before throwing away the core of the previous roll.
b. Slot the hub into a new roll of paper (1) and locate in the paper
compartment, positioning the pins in the sockets (2). Ensure that the
black mark on the paper is on the lower part of the roll.
c. Close the cover, positioning the paper between the rubber roller and the
casing of the device (3).
If using packs of paper:
a. Using a coin or similar implement, open the paper compartment and
remove the "roll guide" hub. To ensure the hub will not be lost
accidentally, store it in a safe place.
b. Prepare a new pack (1) and position it in the compartment (2). Ensure
that the red mark on the paper is at the top left of the pack.
c. Close the cover, positioning the paper between the rubber roller and the
casing of the device (3).
Warning: use only original thermal paper or paper approved by the manufacturer.
The use of paper that does not respond to the manufacturer's specifications could
jeopardise the correct operation of the device.
2.3 Power supply; control and management of the
rechargeable batteries
Your electrocardiograph is characterised by a dual power supply system:
a.c. mains and NiMh rechargeable internal batteries.
The rechargeable batteries come as a pack of 4+4 elements housed in the
14
REF: 6308.
battery compartment on the bottom of the device, and are protected
against short circuits.
Warning: before using the device, a full battery charge cycle must be carried out!
To connect the electrocardiograph to the a.c. power supply, plug the
"battery charger" (provided) into the connector
on the back of the
device. The "battery charger" is protected against short circuits by an
internal fuse (not replaceable) and against overheating.
Caution: before connecting the electrocardiograph to the a.c. supply, make certain
that the input voltage indicated on the battery charger is the same as the mains
voltage.
Caution: the battery charger is a class II power supply and therefore does not
require an earth connection.
Caution: when the device is connected to the a.c. supply, the internal batteries are
recharged automatically, even during use.
To gain maximum benefit from the characteristics of the dual power supply
system, follow the indications given below.
Recharging the batteries
The batteries must be recharged when the charge indicator symbol appears
part-empty : the reserve charge is lower than 30%.
Connect the electrocardiograph to the a.c. mains supply: Led
full recharge cycle takes about 14 hours.
For longer life, the batteries should be allowed to run down and recharged
completely at least every two months.
A complete recharge allows the recording of up to 500 complete ECGs
(automatic recording mode, 3 channel print format, speed 25 mm/s).
lit. The
If the batteries should be completely discharged (symbol ), it is still
possible to make an ECG recording by connecting the device to the a.c.
mains supply.
The average life of the batteries is more than 300 complete
discharge/recharge cycles.
Warning: do not dispose of spent batteries as ordinary refuse or litter. Use only
original batteries provide from the manufacturer. The battery lifetime is
approximately one year.
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Battery charger: precautions for use
- The "battery charger" can be damaged if dropped, struck or tampered
with.
- Do not immerse the "battery charger" in water or other liquids. Do not
place the battery charger on or near sources of heat when in use.
- Do not damage or tamper with the cables for connection to the mains
and to the electrocardiograph.
- Connect the "battery charger" to the electrocardiograph only by means
of the connector provided.
- Use the "battery charger" only at the specified mains voltage. If the
"battery charger" provided is not compatible with your a.c. mains
supply, ask the nearest Authorized Assistance Center for a suitable
model.
2.4 How to switch on the electrocardiograph
for at least two seconds.
The display lights up. When the device has powered up, the current
settings will be displayed and it is possible to proceed.
Caution: if the symbols and are displayed, internal power is insufficient
and the batteries must therefore be recharged by connecting the device to the mains
(see heading “Power supply; ...”). The batteries will recharge even if the device is in
use.
2.5 How to switch off the electrocardiograph
.
The display goes blank. The last ECG recorded, if any, and the relative
settings, remain stored in the memory.
Caution: switching off is not enabled 1. during the transmission of an ECG to a PC;
2. during the self-test routine; 3. if "setup" mode is active. In these cases, first stop
the device and then switch off.
Auto power off
To conserve the battery charge, the electrocardiograph is provided with an
auto power off function that will activate automatically, depending on the
amount of power still available and on the operating mode selected. The
procedure is activated only after the current operation has been completed.
- After 10 min. have elapsed without any key being pressed: reserve
power > 30%.
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