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

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5.1	Patient data entry																																35
5.2	Recording in manual mode																																36
5.3	Recording in automatic mode																																36
Editing a report																																	37
Automatic calculation of ECG parameters																																	38
Automatic ECG interpretation																																	39
Copy of an automatic ECG recording																																	40
ECG memory: saving a recording																																	40
ECG memory: archive management																																	41
Saving to Personal Computer archive																																	41
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
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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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

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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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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

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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: [e-mail]

tel. [phone] fax: [phone]

1.2Information 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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omodifications and repairs are performed by the manufacturer or by an Authorised Assistance Centre;

othe a.c. mains power supply of the building responds to current regulations;

o the device is operated according to user instructions;

oany 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	2

5

4

3

Side view

5

7

8

9

10

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Parts, symbols and controls

1.Keyboard:

Function				Messages & Symbols displayed /
key					Associated LED
	-					LED on: device connected
						to mains power; internal
						battery charging
	-					“full” symbol: battery
						charged
	-					“part empty” symbol
						battery power less than
on/ off						30%
					-	“empty” symbol: internal
						battery flat; the device
						must be connected to the
						mains power for
						recharging
	-					indicated electrodes not
						connected or insufficient
select start operating						contact; saturation
mode

interrupt current operation; stop

Auto	-	Automatic recording
Man	-	Manual recording

- Recording mode selected

select operating mode Custom in configuration phase (“Custom mode”)

		Automatic mode:
		formats available	In manual mode, print and
		3, 3x2, 6, 6x2
			display format selections are
		Manual mode:
	Select ECG display		homogeneous
		formats available
	format
		3, 3x2, 6, 6x2

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		Automatic mode:
		formats available
		3, 6x1, 6x2, 12, Full
		Page 1, Full Page 3.
	select print format	Manual mode:
		formats available
		3, 6, 12

In manual mode, print and display format selections are homogeneous

On Display: On / Off

Filter on

On paper:

a.c. mains and muscle interference filter

Speeds available: 12.5 – 25

Select ECG scroll speed – 50 mm/s on display

	Speeds available: 5 25 50
	mm/s
Select paper scroll speed
Select ECG recording	Wavelengths available 5, 10,
sensitivity on screen	20
	Wavelengths available 5, 10,
	20
Select ECG recording	Automatic
sensitivity on paper
	Displays patient data file
Enter patient data
Copy last recording

2. Display: to display the ECG signal, management of functioning operations, patient data, report data and settings.

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d a

e

b

f

g

c

h

n

m

i

l

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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Esc

Cancel operation, delete text, return to previous menu.

scroll menus and information. In main screen, scroll leads on display.

Access to Menu. If available, scrolls multiple selections, symbol 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.

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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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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.

2.3Power 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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