ar600adv User Manual

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

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Rev. 01/sr/GZ 20/06/2007 Ref: 36519095

Index 1 Introduction 1.1 How to read the manual 1.2 Information and recommendations relating to safe use 1.3 The electrocardiograph

2 Installation and initial preparation 2.1 Selection of the installation site 2.2 Loading the thermal paper 2.3 Power supply; control and management of the rechargeable batteries Recharging the batteries Battery charger: precautions for use 2.4 How to switch on the electrocardiograph 2.5 How to switch off the electrocardiograph Auto power off

3 Preparation for use: the menu 3.1 How to access the menu 3.2 Structure of the menu 3.3 Menu-activated operation and personalization of the electrocardiograph The “Operating mode” “Print format” The “ECG archive” “Settings” “Tools”

4 Preparing for an ECG recording

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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

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5.1 Patient data entry 5.2 Recording in manual mode 5.3 Recording in automatic mode

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Automatic calculation of ECG parameters

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Automatic ECG interpretation

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Copy of an automatic ECG recording

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ECG memory: saving an ECG

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5.4 Recording in ECG autotimer mode

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5.5 Recording in "PC ECG" mode

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5.6 “Paper saving” mode

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5.7 Recording in “HRV analysis mode”

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5.8 Recording in “Arrhythmia mode” 5.9 Defibrillation!

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6 Management and control of electrocardiograph functionality’s

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6.1 Disconnected electrodes, potential defibrillation 6.2 Batteries low or in need of recharging 6.3 Print system control out of paper 6.4 Status messages and error indication: description and related event 6.5 Troubleshooting

40 40 41 41 41

7 Maintenance 7.1 Self-test 7.2 Replacing the thermal paper 7.3 How to clean the device and the electrodes 7.4 How to replace the batteries 7.5 Periodic checks Technical information

43 43 44 44 44 45 45

8 Technical specifications

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Basic accessories supplied

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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:

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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 to obtain the printout) sums up the operations the message “ ? Press 1 ” 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: [email protected] 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 -

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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

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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.

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

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Side view and bottom

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REF: 6308.

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Parts, symbols and controls 1. display: for the management of operations and patient data. Auto

3 ch.

►

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Menu u

Recording …

. 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.



.



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

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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

- indicated electrodes not connected or insufficient contact; saturation

start selected operating mode

interrupt current operation; stop

Select operating mode Automatic mode: 1, 2, 3, 3+R Select print format

Manual mode: 1, 2, 3

a.c. mains and muscle interference filter selection of paper speed

- filter on

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- paper speed 25 mm/s

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paper speed 50 mm/s -

automatic sensitivity: the device optimizes the ratio between n° channels and available space

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sensitivity 5 mm/mV sensitivity 10 mm/mV sensitivity 20 mm/mV

Selection of recording sensitivity 5 10 20

copy last recording

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+

N

Q

alphanumeric keys

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

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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:

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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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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

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 REF: 6308.

"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.

lit. The

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). ), it is still If the batteries should be completely discharged (symbol possible to make an ECG recording by connecting the device to the a.c. mains supply. The average life of the discharge/recharge cycles.

batteries

is

more

than

300

complete

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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After 1 min. has elapsed without any key being pressed: reserve power

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between 15 and 30% . After 10 sec. have elapsed without any key being pressed: reserve

power < 15% . If the auto power off function is activated, last ECG recorded, if any, and the relative settings, will be held in the memory. Auto power off is inhibited if: A recording is in progress in ECG Autotimer mode; a recording is in progress in PC-ECG mode; during the self-test routine; during "setup".

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3 Preparation for use: the menu Navigating within the menu of your ar600adv, there are options for intuitive personalization of the operating modes using the dedicated display keys. To ensure your electrocardiograph can be operated taking advantage of its simplicity and versatility of use to the maximum, it is advisable to select the preferred setup before the first recording is made.

3.1 How to access the menu From the main page: Auto

3 ch

►

Recording …

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Me Menu nu

to display the menu.

to scroll through the menu items.

to access the lower level menu or make a selection. Executes the action highlighted at the bottom right of the display (e.g. Select).

to return to the previous level.

3.2 Structure of the menu The menu is organized in five sections: “Operating mode”; “Print format”; “ECG archive”; “Settings” and “Tools”. The following tree layout of the menu illustrates the different levels of exploration possible, and the features that can be selected. Details on the single items are given in subsequent headings. 

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Operating mode o ECG Automatic o ECG Manual o

Paper Saving

o

PC ECG







o

ECG autotimer

o

Arrhythmia Monitor

o HRV analysis Print format o 1 channel o 2 channels o 3 channels o 2+R ♦ Rhythm lead selection ECG archive o View ♦ PC archive ♦ Print ♦ Delete o PC archive o Print list o Empty Settings o Use profile ♦ Patient data management  Always prompt  Data only  None ♦ Leads sequence  Standard  Cabrera ♦ No. pages Auto  1 page  2 pages

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Configure analysis  ECG measurements • Summary • ST amplitudes • Representative cycles  ECG interpretation • Summary • Rhythm • Interpretation • Parameters • Representative cycles  None

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PC archive  Hard copy  Copy to PC Archive management  Save • Automatic • Prompt

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 ♦



• None Deleting • Manual • Automatic

Analisi HRV  Duration: x  Lead ♦ Autotimer  Nr. intervals xxx  Duration of intervals  Print format • 12 leads • 3 leads • Leads selection ♦ Arrhythmia mode  RR Advance  RR Delay  Print Advance  Print Delay  Arrhythmia Monitor o General ♦ User name ♦ Date Time ♦ Mains filter  50 Hz  60 Hz ♦ Display  Illumination  Contrast Tools o About o Self-test ♦ User  Display  Keyboard  Printer  Memory  About ♦ Service  Not Available

3.3 Menu-activated operation and personalization of the electrocardiograph Listed below are the operating and configuration details associated with the single items of the menu. To operate the menu refer to the heading “How to access the menu”.

The “Operating mode” Different methods of recording are available. The selected mode is indicated in the main page of the display at the top left.

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