Cardioline ar2100view User Manual
ar2100view
user manual
english
This User Manual has been prepared with the objective of giving the user all the
information necessary to make the best use of the CARDIOLINE
®
ar2100view.
General information
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.
All rights reserved © et medical devices SpA ITALY.
CARDIOLINE
®
is a registered trademark of et medical devices SpA
CARDIOLINE
®
product support services
For any questions about a CARDIOLINE product:
consult the documentation and other printed material included in the package;
consult any guidelines available.
If you find no solution, you can obtain further information by contacting your
CARDIOLINE supplier.
Before calling, check you have the available documentation to hand and the product
nearby. It may also be necessary to supply the following information:
serial number and product reference number, if available;
type of hardware available, including any network hardware fitted;
operating system used, for software products;
exact contents of any error messages displayed;
description of the operation being executed when the problem occurred;
description of any action taken to solve the problem.
um_ar2100view_cardioline_01_eng1.doc Rev. 01/sr/GZ 16/09/2005 Ref: 66519127
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Contents
1 Introduction 6
1.1 How to read the manual 7
1.2 Information and recommendations relating to safe use 8
1.3 The electrocardiograph 11
Front view 11
Side view 11
Parts, symbols and controls 12
2 Installation and initial preparation 16
2.1 Selecting the installation site 16
2.2 Loading the thermal paper 16
2.3 Power supply; control and management of the rechargeable battery 17
Recharging the battery 17
2.4 How to switch on the electrocardiograph 18
2.5 How to switch off the electrocardiograph 18
Auto power off 19
3 Preparation for use: the menu 20
3.1 How to access the menu 20
3.2 Structure of the menu 20
3.3 Menu-activated operation and customization of the electrocardiograph 23
"Customise mode" 23
The “ECG archive” 24
“Settings” 24
“Tools” 29
4 Preparing for an ECG recording 30
4.1 Connecting the patient cable 30
4.2 Preparing the patient and applying the electrodes 30
4.3 Select recording characteristics operating mode, display and print format,
speed, sensitivity, filters 31
Operating mode 31
Display and print format 32
Speed of recording on the display and on paper 33
Sensitivity of recording on the display and on paper 33
Recording filters 34
5 Recording of a rest ECG 35
3
5.1 Patient data entry
5.2 Recording in manual mode 36
5.3 Recording in automatic mode 36
35
Editing a report 37
Automatic calculation of ECG parameters 38
Automatic ECG interpretation 39
Copy of an automatic ECG recording
ECG memory: saving a recording 40
ECG memory: archive management 41
Saving to Personal Computer archive
5.4 Recording in Emergency mode 42
5.5 Recording in ECG Autotimer mode 42
5.6 Recording in "PC ECG" mode 43
5.7 “Paper Saving” mode” 44
5.8 Recording in “HRV Analysis" mode 44
40
41
5.9 Recording in “Arrhythmia mode” 45
5.10 Defibrillation! 46
6 Management and control of electrocardiograph functionalities 47
6.1 Disconnected electrodes, potential defibrillation 47
6.2 Batteries low or in need of recharging 47
6.3 Print system control. Out of paper 48
6.4 Status messages and error indication: description and related event 48
6.5 Troubleshooting 49
7 Maintenance 50
7.1 Self-test 50
7.2 Replacing the thermal paper 50
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5
7.3 How to clean the device and the electrodes 51
7.4 Maintenance of the display 51
7.5 Periodic checks 51
Technical information 51
8 Technical specifications 52
Basic accessories supplied 54
1 Introduction
ar2100view combines optimised performance in multichannel ECG
recording equipped with graphic display and A4 format print system with all
the features of reliability, modularity, versatility and upgradeability that
characterise the latest generation of CARDIOLINE® electrocardiographs.
ar2100view is an 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;
real-time display of the ECG signal on the built-in graphic display in 3, 6
or 6+6 channel format;
reproduces the ECG signal on 210 mm paper in various formats thanks
to high resolution thermal printer: 3, 3x2, 6, 6x2, “Full Page 1” (3x4+R
for 1 page), “Full Page 3” (3x4+3R for 1 page) and 12 channels;
organize recordings thanks to the clock, date stamp and extended
alphanumeric keyboard to manage user and patient data;
store the most recent recording in automatic mode and print additional
copies;
set up to 4 different user profiles to tailor how the device functions to
differing requirements.
Thanks to the flexibility of the software used and to the infrared interface,
the ar2100view 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 ar2100view can be equipped with:
- “memory option”: storage of up to 40 full ECG exams, with no need to
print out immediately on paper (“paper saving” mode);
- "ECG parameters option": automatic ECG parameter measurement
program;
- "ECG signal interpretive option": a useful and dependable diagnostic
support;
- "arrhythmia option": a program enabling detection of arrhythmia events
during continuous recording;
- “HRV analysis option”: a 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
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7
software has an optional module for automatic interpretation of the ECG
signal.
- “Emergency option”: allows to perform and eventually transmit, an ECG
exam taken in emergency situation in completely automatic mode.
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:
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® ar2100view 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 that 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”.
SMB
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 ar2100view
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
1
the message “ ? Press 1 ”:
Q
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® - Supporto Prodotto
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
1.2 Information and recommendations relating to
safe use
- The electrical system used by the device must be in accordance with the
standard in force.
- Always use the equipment according to the instructions in this manual.
- 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 Authorised 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.
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- 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 recognises 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.
- Periodically check the efficiency of all accessories and of the device
itself. Contact the Authorised Assistance Centre whenever the device
seems to be operating irregularly. To prolong the life of your device,
have it checked periodically by an Authorised Assistance Centre.
- Warning: The electrocardiograph can be used for intracardial
applications.
- Warning: It is therefore necessary before activating the equipment, to
make sure of the connection to ground (normally secured by the power
supply cable). If grounding of the main electrical service is not certain,
do not connect the device and use it powered only by the rechargeable
internal battery.
- Warning: do not use the device in the presence of anaesthetics or
volatile gases!
- Warning: 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.
- Warning: the indications obtained using automatic interpreting
programs or other diagnostic aids must be reviewed and countersigned
by a qualified medical person!
- Warning: 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:
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o modifications and repairs are performed by the
manufacturer or by an Authorised 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
6
1
Side view
5
8
2
5
4
3
7
10 9
11
Parts, symbols and controls
1. Keyboard:
Function
key
on/ off
select start operating
mode
Messages & Symbols displayed /
Associated LED
- LED on: device connected
to mains power; internal
battery charging
-
“full” symbol: battery
charged
-
“part empty” symbol
battery power less than
30%
- “empty” symbol: internal
battery flat; the device
must be connected to the
mains power for
recharging
- indicated electrodes not
connected or insufficient
contact; saturation
interrupt current
operation; stop
select operating mode
Select ECG display
format
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Auto
Man
Custom
- Automatic recording
- Manual recording
- Recording mode selected
in configuration phase
(“Custom mode”)
Automatic mode:
formats available
3, 3x2, 6, 6x2
Manual mode:
formats available
3, 3x2, 6, 6x2
In manual mode, print and
display format selections are
homogeneous
select print format
a.c. mains and muscle
interference filter
Automatic mode:
formats available
3, 6x1, 6x2, 12, Full
Page 1, Full Page 3.
Manual mode:
formats available
3, 6, 12
On Display: On / Off
On paper:
In manual mode, print and
display format selections are
homogeneous
Filter on
Select ECG scroll speed
on display
Select paper scroll speed
Select ECG recording
sensitivity on screen
Select ECG recording
sensitivity on paper
Enter patient data
Copy last recording
Speeds available: 12.5 – 25
– 50 mm/s
Speeds available: 5 25 50
mm/s
Wavelengths available 5, 10,
20
Wavelengths available 5, 10,
20
Automatic
Displays patient data file
2. Display: to display the ECG signal, management of functioning
operations, patient data, report data and settings.
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g
f
d
a
e
b
c
n
m
l
h
i
In normal operating mode:
a. Patient data area display Last and First Names.
b. ECG signal display area Each lead is preceded by its name.
c. Selected operating mode. In Menu mode, ▲▼◄► indicates scroll
functions active.
d. Heart rate
e. Selected speed of printing (value on left) and display (value on
right).
f. Selected sensitivity of printing (value on left) and display (value on
right).
g. Selected print format (value on left) and display format (value on
right).
h. Filters on/off indicator.
i. In automatic and paper saving mode displays number of tests in
memory and space available
, in Autotimer, HRV and Arrhythmia
mode displays duration of tests.
l. Time indicator.
m. Battery status indicator.
n. Operating information and error message area; In Menu mode
indicates the active keys and the presence of additional options.
3. Display management keyboard.
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5
Esc
Cancel operation, delete text, return to previous menu.
scroll menus and information. In main
screen, scroll leads on display.
symbol
Access to Menu. If available, scrolls multiple selections,
displayed.
4. QWERTY alphanumeric keyboard for patient data management.
Special characters are associated with each key, and can be
displayed by pressing the key in sequence.
SMB
displays the symbols and special characters map.
to select, to copy the symbol into
the text.
delete text.
confirm.
5. CF type patient cable connector protected against defibrillation as
indicated by the
symbol.
6. Paper compartment door.
7. Reset button
: used to re-establish normal operating conditions in
the event of an error that cannot be managed using the keyboard.
8. “Mains line” connector.
9. Equipotential earth connection / functional.
10. IR infrared interface.
1
2 Installation and initial preparation
This section describes the operations to be performed before using your new
CARDIOLINE® ar1200 electrocardiograph. Suggestions are given for
"selecting the installation site" and "recommendations for safe use in
conformity with current statutory regulations" are indicated. 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 battery", "switching on and off",
"the menu", "set-up".
2.1 Selecting the installation site
Your electrocardiograph complies 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 equipments not in
conformity with the aforementioned directives:
- avoid the use of mobile phones near the electrocardiograph;
- place the electrocardiograph as far as possible from electrical power
lines and sources of static electricity. The ECG signal can be disturbed if
the electrocardiograph is placed near sources of high voltage or
electricity 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 position the electrocardiograph at a distance from
other electrical equipment, switch the other equipment off while
recording an ECG.
Also, to avoid the effect of ambient conditions when recording ECG:
- record in a room where the temperature is between 20 and 25 degrees
Centigrade. This precaution prevents the patient from feeling cold, which
could increase shivering and contribute to muscle tremor;
- record using the battery, disconnecting the device from the mains power
supply. This avoids presence of mains power disturbance of the recorded
ECG signal.
2.2 Loading the thermal paper
CARDIOLINE® ar2100view is able to reproduce the ECG signal both on
thermal paper in Z-fold packs with A5 or A4 perforations. Thermal paper in
rolls with A4 perforations can also be used. No particular configuration
procedure is required. To correctly load the different types of paper:
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7
If using paper in packs:
a. Open the paper compartment.
b. Prepare a new pack and position it in the compartment. Check that the
red mark on the paper is on the upper left of the pack.
c. Position the paper, centring it between the two paper guides. Close the
cover, positioning the paper between the rubber roller and the device
case.
If using rolls of paper:
d. Open the paper compartment and remove the “roll guide”. To avoid
losing the “guide”, place it in a safe place. If replacing an empty roll,
retrieve the core before throwing away the empty roll.
e. Insert the core in a new roll of paper and place in the paper
compartment, fitting the pins into the guides provided. Check that the
black mark on the paper is on the upper part of the paper holder.
f. Position the paper, centring it between the two paper guides. Close the
cover, positioning the paper between the rubber roller and the device
case.
Caution: 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 battery
Your electrocardiograph uses a dual power supply system: a.c. mains and a
rechargeable lead battery.
The rechargeable battery is housed inside the device, and is protected
against short circuits.
Caution: before using the device, it is necessary to go through a complete cycle of
recharging of the battery!
Before connecting the electrocardiograph to the a.c. supply with the cable
supplied, check that the mains voltage is the right voltage for the device.
Caution: when the device is connected to the mains, the 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 battery
The battery must be recharged when the power indicator symbol is part
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