Operating Manual and

Introduction to the Device

Model: CT0207

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Operating Manual and Introduction to the Device

Contents

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1 Introduction to the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.1 Objective of use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.3 User qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.4 Description of the functions . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.5 Important points in an emergency. . . . . . . . . . . . . . . . . . . . . 10

2 Operating Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.1 Description of Operating Manual . . . . . . . . . . . . . . . . . . . . . 11

2.2 Special Markings On The Device . . . . . . . . . . . . . . . . . . . . . 12

2.3 Safety rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.4 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3 Preparing CardiAid for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.1 Wall Mount. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4.1 Before using the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4.2 Application of reanimation . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

4.3 After using the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

4.4 Intervention documentation . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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5 Hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6 Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

6.1 Durations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

6.2 Function test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

7.1 Visual and acoustic failure messages. . . . . . . . . . . . . . . . . . 34

8 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

9 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

10 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

11 Delivery Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

12 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

12.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

12.2 Pulse waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

13 Address Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

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Overview

3 Information key

1 Shock key

6 Indicator: “You can touch the patient (again)”

4 Indicator: “Remove clothing from chest and stick on electrodes.”

13 Defibrillator electrodes

12 Battery symbol

10 Loudspeakers

15 OK symbol

14 Case

11 Repair symbol

8 Socket for electrode plug

2 Indicator: Ready for shock

9 Emergency kit

7 Device cover

5 Indicator: “Do not touch the patient”

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1 Shock Key

After shock preparation, shock key is flashing. Press this key to apply electric shock for defibrillation.2 Indicator: Ready for Shock

This indicator is lit when CardiAid is ready to apply shock.3 Information Key

When pressed, an audible notification indicating the duration of device use and number of shocks applied is heard.4 Indicator: “Open the clothing on the chest and stick

electrodes on”

When this indicator is lit, you should apply the electrodes on patient’s chest.5 Indicator: “Do not touch the patient!”

This indicator is lit when you should not touch the patient. For example: During heart rhythm analysis and shock application.6 Indicator: “You can touch the patient (again)”

This indicator is lit when you can touch the patient. For example: During artificial respiration and cardiopulmonary resuscitation.7 Device Cover

CardiAid is turned on and off by opening and closing the cover. Electrodes should be removed to turn off the device.8 Socket for Electrode Plug

Electrodes are connected to CardiAid through this plug. Electrodes supplied with the device are already connected to this plug.9 Emergency Kit

Emergency kit includes scissors, shaver and respiration mask. Kit should be replaced after use.10 Loudspeaker

Audio warnings of the CardiAid are heard through the loudspeaker.

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11 Repair Symbol

If the repair symbol flashes or lights up, device should not be used. In this case you should get the device repaired by CardiAid manufacturer CardiaTech or an authorized service centre.12 Battery Symbol

If the battery symbol flashes or lights up, it means device is not ready for use. Immediately contact CardiaTech.13 Self-Adhesive Defibrillation Electrodes

Shock energy is applied to the patient through electrodes. Electrodes should be replaced by new ones after each device use.14 Case With Handle

The case with handles is used to carry the device.15 OK Symbol

The device is ready for use when the OK symbol is flashing when cover is closed.

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1. Introduction to the Device

1.1 Objective of UseCardiAid is not only a public access defibrillator (PAD), but also an automated external defibrillator (AED). It’s a practical device used for resuscitation of patients over 20 kg and exhibiting acute cardiac arrest due to fibrillation. In these situations, CardiAid can perform the defibrillation. The user is directed with clear and specific instructions during resuscitation. The device records the ECG of the patient automatically and prepares an electro-shock when required. The user is asked to press the shock key to deliver the shock. Use of the CardiAid is only for the purposes indicated here.

1.2 OperationCardiAid is developed for the application of basic life support and defibrillation and used directly at the emergency site. CardiAid is designed for patients weighing over 20 kg

1.3 User QualificationIn some countries the CardiAid may only be used by persons with the following qualifications:

• Trained in basic life support and the use of automatic defibrillators

• Instructed about operating CardiAid from CardiaTech authorized persons

In most countries specially developed public access defibrillators (PAD’s) like CardiAid can be used by anyone who is present when someone suffers a sudden cardiac arrest.

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1.4 Description of the FunctionsCardiAid is a lightweight and compact device with an ergonomic design. Distinct visual and acoustic instructions direct the user clearly. Therefore people with limited medical training can perform basic life support with CardiAid after a short briefing.

Visual and Acoustic Instructions for the User

Visual and acoustic support for the user contains application images and verbal instructions supported with light diodes. The CardiAid starts giving verbal instructions as soon as its cover is opened and directs the user in the resuscitation procedure step by step. At the same time lit application diagrams clearly indicate the stages during the resuscitation process in which the patient can or cannot be touched.

Metronome Function

In the basic life support phase, the metronome function becomes activated and transmits a metronome acoustic signal at a 100 pulse per minute frequency. Perform the heart massage in accordance with the rhythm of this signal tone. A verbal instruction is heard after 30 signal tones: “Now give 2 mouth to mouth breaths”. For chest massage, you have few seconds after hearing the verbal instruction “Now give

30 times chest compressions”. Then the device gives 30 signal tones again. This consecutive process continues until basic life support stage ends and the application diagram in the middle (“Do not touch the patient”) lights up. If the Information key is pressed during basic life support stage, device information can be heard. The timer for basic life support continues in the background.

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ECG and its Analysis

When electrodes are applied correctly to the patient, CardiAid starts immediate ECG analysis. ECG record and analysis continues until the device is turned off. The Defibrillator is turned off by unplugging the electrodes and closing the cover of the device.

Warning!

Warning!

Closing the cover of the device when electrodes are plugged in does not stop the operation.

Defibrillation

When the ECG analysis shows a Rhythm that can be treated by electro shock (Ventricular tachycardia (VT) or Ventricular fibrillation (VF) ) the CardiAid will prepare the delivery of a shock. Then it warns the user to press the shock key to apply shock.

Application Documentation

CardiAid records ECG data and incident data. These data then can be analyzed by specialists to define subsequent treatment.

Self-testing

CardiAid performs a periodical self-test each time the cover is opened (when the device is switched on). The status of the device is indicated with lit symbols on the front side of the device.

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1.5 To pay attention in an EmergencyIf you are suspecting sudden heart failure in a patient, you should consider the following points:

1. Keep calm and proceed rapidly2. Check the patient for the following vital signs of life

• Consciousness • Respiration (Breathing)

CardiAid should only be used when both of the above signsare missing , Defibrillation rescue can then proceed

Caution!

Caution!

3. Call professional assistance and provide the following information:

• Your name• Your current location• Number of patients• Type of emergency (suspicion of sudden heart failure)• Presence of a defibrillator (PAD/AED)

Warning!

Note:

While starting resuscitation, make sure that professional assistance is called without delay (preferably by other people around you).

4. Open the cover of the CardiAid. The device turns on automatically.

5. Follow the verbal instructions exactly. Detailed information regarding the specific verbal instructions can be found in the chapter “Operation” starting from page 21.

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2. Operating Manual

2.1 Description of Operating ManualIf you want to be assured of safe and effective use of CardiAid and be prepared for its first time of use, then you should read this operating manual carefully. If you have additional questions about information in the operating manual, please contact CardiaTech directly. Keep this manual within easy reach. The following safety warnings are used throughout the manual.

Danger!

Danger!

Describes a danger that can result in serious injury or death.

Caution!

Caution!

Defines a possible danger that can result in serious injury or death.

Attention!

Attention!

Defines a possible danger that can result in simple - mild injury. This symbol is also used to indicate user errors that can result in damage to the device.

Warning!

Warning!

Provides necessary additional information.

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2.2 Special Markings On The Device

Serial number of the device

Production date

Do not dispose the device in common household waste.

Protection class BF

Bluetooth

Attention, refer to operating manual

Resistant to water spraydicht

Manufacturer

2008

CardiaTech Holland BVJ.C. Beetslaan 155

2131 AL HoofddorpThe Netherlands

High voltage

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2.3 Safety RulesFor the safety of yourself and your patients, take care to the following points according to Directive 93/42/EEC:

General Rules

Danger!

Danger!

To prevent danger of explosion, keep the CardiAid away from oxygen sources, flammable anesthesia gases and other flammable substance/gas mixtures.

Caution!

Caution!

Never use the device on patients weighing less than 20 kg. Otherwise injuries that can threaten the patient’s life may occur.

Caution!

Caution!

If you are suspecting a sudden heart failure in the patient, check the following vital signs before using CardiAid:

• Consciousness • Respiration CardiAid can only be used when both of the above signs are

missing and Defibrillation rescue can then proceed.

Caution!

Caution!

Before using the CardiAid, check the device and equipment for visible damage. If you determine damage to the device or the accessories, do not use it. Otherwise functional faults may occur and can cause injury to both the user and the patient.

Caution!

Caution!

If the device is showing different operation procedures from the ones indicated in the manual, it shouldn’t be used. In this case you should get the device immediately repaired by CardiaTech or an authorized service centre.

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Caution!

Caution!

Operational status of CardiAid is only possible when no damage after self-test or misuse is recognized.

Caution!

Caution!

Regularly check whether the device and its accessories are ready for use. (see Function check, page 32)

Caution!

Caution!

Use the device only in dry and non-conductive environments. Otherwise it can cause injuries (electric shock, burning) of the user, patient or by-standers.

Caution!

Caution!

You should not apply shock when defibrillation electrodes are in contact with each other or are not connected to the patient.

Danger!

Danger!

When closing the cover, take care not to trap electrode cables. Otherwise it can cause damage to the electrode cables.

Caution!

Caution!

Charging and applying electro-shock can affect devices near the CardiAid. Check the function of these devices before using.

Attention!

Attention!

Operation of CardiAid can be affected from electrical and magnetic fields. Keep the CardiAid at least 2 meters away from electrical devices such as cellular phones, walkie-talkies, X-ray machines etc.

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Attention!

Attention!

Do not immerse CardiAid and its accessories in liquids. Liquid should not ingress in CardiAid and its accessories. Otherwise the device and its accessories can be damaged. Furthermore it may be dangerous for the user and patients.

Attention!

Attention!

Products of unknown manufacturers might be bio-incompatible and can cause function losses. Please note only to use accessories and genuine spare parts as indicated in the manual, otherwise guarantee may become invalid and manufacturer will not be responsible.

Defibrillation / Use

Caution!

Caution!

Always observe national / local rules and regulations regarding the use of a defibrillator.

Caution!

Caution!

To prevent injury to yourself and by-standers, make sure that no one touches the patient during defibrillation. Do not touch metal objects or equipment in contact with the patient during defibrillation. Do not perform defibrillation in very humid and wet environments.

Caution!

Caution!

Apply the electrodes on patient’s chest as indicated on the package. Applying electrodes in an incorrect manner can cause faulty analysis of ECG data and mistakes in defibrillation.

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Caution!

Caution!

In order to prevent faulty interpretation of ECG data due to movement during rhythm analysis, make sure that the patient is lying still , do not touch the patient. and do not perform basic life support during rhythm analysis.

Caution!

Caution!

When patients have an implanted pacemaker, do not stick the electrodes of the defibrillator near the pacemaker implant site.

Attention!

Attention!

During defibrillation, make sure that the patient is disconnected from other medical devices that don’t have defibrillation protection.

Attention!

Attention!

CardiAid is one of the safest devices in its class. However a wrong interpretation of the heart-rhythm may be possible.

Attention!

Attention!

The device is not protected against other devices’ defibrillation. Therefore when you need to use another defibrillator, make sure that CardiAid’s electrodes are removed from patient’s chest. Otherwise the CardiAid can be damaged.

Attention!

Attention!

Make sure that the electrodes are fully adhered to the patient’s chest. Otherwise the air between the patient’s skin and electrodes can cause burns.

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Electrodes

Caution!

Caution!

Only use electrodes supplied with the CardiAid. Product No: CA-10ES

Caution!

Caution!

Never use electrodes that are damaged, have signs of damage on the package or passed expiration date.

Caution!

Caution!

Defibrillation electrodes are for single use only. Immediately contact CardiaTech or authorized distributor after use for replacement electrodes.

Caution!

Caution!

Observe the storage and operating environmental conditions indicated in the technical data.

Caution!

Caution!

Keep and store the device away from children. Electrode cables can cause risk of suffocation.

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2.4 Side EffectsThe following unwanted side effects can occur when CardiAid is used:

• Burns on the skin surface

• Rashes on the skin

• Applying electroshock to patients with pacemakers or connected to other electronic devices, can cause damage to concerned device

• If a shock is applied in a rhythm that is not shock-able, it can cause fibrillation

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3. Preparing CardiAid for Use

Unpack the Device

Remove the CardiAid from its packaging carefully. Check all parts are present according to “Content of delivery” on Section 11, page 40. Check for signs of damage on all components. If there are missing or damaged components, contact with your sales agent or directly with CardiaTech manufacturer.

1 . Opening the Cover

Open the cover of CardiAid. Device switches on automatically.

2 . Connecting Electrode Plug

• Connect the electrode plug to assigned socket (see the Diagram). Plug is designed in a way that doesn’t allow any mistakes. It can only be connected as required

• When not already connected than place the electrode set in the device

Danger!

Danger!

When closing the cover, take care not to trap electrode cables. Otherwise electrode cables can be damaged.

3 . Installing Emergency kit

Place the emergency kit bag in the assigned bands on the inside of the CardiAid cover. Place the electrode pack in the section in front of the emergency kit. Emergency kit incorporates a single razor, scissors, respiration mask and gloves.

Closing the Cover

Close the cover of CardiAid.

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3.1 Wall MountInstallation

The CardiAid can be mounted to a wall when required by using the wall installation kit which is available as an optional accessory. You can find installation instructions and installation equipment in wall mount kit.

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4. Operation

In this section, you can find information on the following topics:• „Before using the device“ on page 21• „Providing CPR“ on page 22• „After using the device“ on page 29• „User documentation“ on page 30

4.1 Before using the DeviceHow to switch on the Device

Open the cover of CardiAid. Device will switch on automatically.

Self-testing

The device immediately starts a self-test when switched on. During this time, all indication and warning led’s light up. When self-test is completed, indication led’s show the status of the device. Therefore observe the following points continuing to use the CardiAid.

Caution!

Caution!

warning led is lit continuously then the device should not be used., because the device is not ready for use. In this case you should get the device repaired by CardiaTech or an authorized service centre.

Caution!

Caution!

If one or more than one of the instruction led’s is not lit during self-testing, it means that there are faulty light diodes. Use the device for that application only and get the device repaired by CardiaTech or an authorized service centre immediately after use.

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Attention!

Attention!

If the battery status led is lit continuously after turning on the device, than the capacity of the device will only be enough for 9 shocks. You can find all information regarding CardiAid’s warning led’s in section “Visual and Acoustic failure messages” on page 34.

Caution!

Caution!

The cover of the device should not be closed during operation.

4.2 Providing CPRAfter opening the cover, verbal and visual instructions will guide you through CPR. In this section, you can find details on how to act on each verbal and visual instruction given.

Preparation of defibrillation

1. “Phone alarm number” (verbal command can be deactivated by service centre). “Open patient’s airway” (verbal command can be deactivated by service centre). These verbal instructions are heard immediately after opening the device cover. The left illuminated instruction field lights up. You may touch the patient in this stage. If you have not already done so call ambulance service and give the following information:• Your name• Your current location• Number of patients• Type of emergency (suspicion of sudden cardiac arrest)• Availability of a defibrillator

While performing resuscitation, make sure that other people call for professional help.

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Check the following vital signs of the patient:• Consciousness• Respiration

Only when both of the above signs are missing CardiAid may be used and Defibrillation can be started.

Warning!

Warning!

Lift the patient’s chin a little and push his head gently backwards to open the airway (see Picture).

2. „If there are no signs of life, remove clothing from chest and

stick on electrodes.“ (verbal command can be deactivated by service centre). Position the patient on his back in a non-conductive and dry surface. Open the clothing on patient’s chest. His chest should be dry and not very hairy. If necessary remove hair using the shaver in the accessory kit.

3. „Stick electrodes on the patient‘s bare chest.“ Open the electrodes’ package. Stick the electrodes on patient’s bare chest as indicated in the figure. In order to guarantee a good electrical contact, press the electrodes firmly. Observe the instructions contained in electrode pack (see figure). The instruction „Stick electrodes on the patient‘s

bare chest.” is repeated every 8 seconds until the device recognizes the correctly connected electrodes.

Caution!

Caution!

During the whole application, make sure that the electrodes are adhered firmly and not damaged.

If an electrode is detached or damaged the instruction “Stick

electrodes on the patient‘s bare chest.” is repeated until the contact between the electrodes and the body is reestablished.

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4. „Do not touch the patient from now on.“ and „Analyzing

heart rhythm”

These instructions are heard when electrodes are correctly applied and device heart rhythm analysis (ECG) is being performed. At the same time the green light and LED’s in the second instruction field are lit.

Caution!

Caution!

Patient must not be moved or touched during analysis. Do not perform basic life support during analysis. This can cause wrong interpretation of the ECG and delay in the defibrillation process which can be life threatening.

After the analysis of ECG, CardiAid decides whether shock is required. If the patient is moved or touched during analysis, it can happen that the analizes detects the movement. In this case a signal tone and the instruction “Movement detected.” is heard. The device proceeds with verbal instructions according to the results of the analysis. These will be explained in the following section:

• „Shock necessary“ on page 24 • „Shock not advised“ on page 26

Shock is Required

If, in heart rhythm analysis (4. “Do not touch the patient from

now on! Analyzing heart rhythm”) ventricular tachycardia (VT) or ventricular fibrillation (VF) is detected, CardiAid gives the following verbal instructions:

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5. “Shock necessary” and “Do not touch the patient from now

on!” The middle instruction field is lit and indicates that it is no longer permissible to touch the patient.

6. “Preparing shock” and “Do not touch the patient from now

on!”

7. If the illuminated Arrow LED’s are lit and shock key light diodes starts to flash, shock preparation is completed. You will hear the following verbal instruction:

8. “Press the flashing shock button” This instruction is repeated with signal tone until the shock key is pressed. Press the shock key to deliver shock. Then you will hear “Shock has

been given” statement. If you do not press shock key, you will hear “Shock has not been given” statement. The device proceeds ECG analysis during shock preparations. If the rhythm of the heart changes, defibrillation is not carried out.

Danger!

Danger!

There is always the risk of electric shock. Before pressing the shock button, make sure that nobody is touching the patient and there are no electrical connections in the surroundings or on the floor that can transmit electricity. Otherwise user and by-standers can receive a life threatening injury. You can touch the patient only after clearly hearing the statement “Patient may be touched”. CardiAid proceeds as follows after the shock:

9. „Patient may be touched. Carry on resuscitation: alternately

give 30 chest compressions and 2 mouth-to-mouth breaths. ”

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See the figure .

Right instruction field is lit. Perform 30 times chest compression Frequency: 100/min) count out loud during chest compression, then give 2 rescue breaths. During this period, the airway should be kept open (head backwards, chin up).

If you detect vital signs like Consciousness or Respiration,proceed as indicated in section “Vital signs present” on page 29.

Caution!

Caution!

After basic life support, recheck the status of electrodes. If necessary, press again the electrodes on patient’s chest firmly

After 60-300 seconds (duration can be changed by service centre)a new heart rhythm analysis will start (from item 4, “do not touchthe patient from now on”) and middle instruction field will be lit.

Shock is not Required

If the heart rhythm analysis (item 4, “do not touch the patient fromnow on”) normal sinus rhythm, asystolic or another rhythm that isinappropriate for shock is detected CardiAid proceeds in thefollowing manner:

„Shock not advised“. Then proceeds as follows:

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„Patient may be touched. Carry on resuscitation: alternately

give 30 chest compressions and 2 mouth-to-mouth breaths. ”.

Right instruction field is lit.

Warning!

Warning!

Perform 30 heart compressions (Frequency: 100/min). Count out loud during CPR. Then perform two rescue breaths. During this process, the patient’s head should be pushed backwards to open the airway and to ensure easy air access to the lungs.

If you detect vital signs in the patient, proceed as indicated in section “Vital signs present” on page 29.

Warning!

Warning!

During basic life support, a metronome sound will guide you in performing correct heart compression rhythm at a frequency of 100/min and metronome signal will be repeated 30 times. Following you will hear “Now give 2 mouth-to-mouth breaths.” and “Now give 30 times chest compressions.” instructions. This process will be repeated until the end of basic life support. The metronome function can be turned off by service centre.

Caution!

Caution!

After basic life support, recheck the status of the electrodes. If necessary, press the electrodes on patient’s chest firmly. The device will proceed to “Do not touch the patient from now on” and application as in item 4. The middle instruction field will be lit.

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No analysis result

If the device cannot perform a clear heart rhythm analysis (item 4, “Do not touch the patient now!” and “Analysis is running”) within 15 seconds due to inadequate signal level or loose electrode connection for reasons such as touching the patient or movement of the patient, the device proceeds in the following manner:

„Movement detected, do not touch the patient” CardiAid will attempt another heart rhythm analysis. If the analysis is successful, device proceeds according to the results as explained in section either “Shock is

necessary” (page 24) or “Shock not advised” (page 26). If another movement is detected during analysis, the following instruction is heard:

„Patient may be touched” At the same time, 3rd indication field is lit. The following verbal instruction will be heard:

„Patient may be touched. Carry on resuscitation: alternately

give 30 chest compressions and 2 mouth-to-mouth breaths. “. Right instruction field is lit. If you detect vital signs in the patient, proceed as indicated in section “Vital signs present”.

Caution!

Caution!

After basic life support, recheck the status of electrodes. If necessary, press the electrodes on patient’s chest firmly. The device will proceed to “Do not touch the patient from now

on” and “Analizing Heart rthym” application as in item 4. The middle instruction field will be lit.

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Vital signs present

During operation of the device if you detect vital signs in the patient such as respiration, he should be placed in recovery position (lying on side). Electrodes should not be removed. The normal process continues. The new heart rhythm is analyzed in regular intervals.

If the patient loses consciousness again and “shock necessary” instruction is heard, patient should be placed on his back again. Follow the device’s verbal instructions.

Information Function

During operation of CardiAid, the number of shocks given and duration of application can be inquired. Press i key (Information key) for this. Information is only provided when electrodes are not connected or during pause in basic life support application. If information key is pressed at a different stage, the information is provided in the sections of operation of the device mentioned above.

4.3 After Using the Device• Remove the plug of the electrodes from the device• Close the cover• Immediately contact with CardiaTech after use• Do not forget that electrodes, scissors and shaver should

only be used once

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4.4 Operation DocumentationOperation Data

The following information is saved automatically at every use:• Date and time of use• Patient’s ECG• The time(s) at which shock(s) were delivered

Immediately contact with CardiaTech after use. Recorded information can only be read by CardiaTech or sales and service centres authorized by CardiaTech.

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5. Hygiene

CardiAid is kept clean by wiping with a tissue moistened, not wet with a simple disinfectant.

Caution!

Caution!

Do not immerse CardiAid in liquids..

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6. Function Test

CardiAid performs an extensive self-test periodically on stand-by status (cover closed). In addition a short test is performed at the start of each operation (when cover is opened). The status of the device at this time is indicated with battery symbol, repair symbol and OK symbol. In addition the function of the device should be checked regularly. Please observe the indicated timetables.

6.1 Periods

Battery Symbol

Repair Symbol

OK Symbol

Daily

Check the illuminated indicators of CardiAid daily. If the OK symbol flashes in standby position, it means that the device is ready for use.

Semi-annual

Perform a function test at every 6 months as explained in section 6.2.

Battery Change

Note that the battery of CardiAid should be exchanged every 2 years. The device indicates this requirement by lighting battery symbol. In addition, it gives a signal tone every 4 minutes. In this case, contact with CardiaTech or an authorized service centre by CardiaTech.

6.2 Function CheckPerform a function test at every 6 months as explained below. If you determine an error or discrepancy in the values do not use the device.

First try to solve the problem by yourself by referring to section 7, “Troubleshooting”. If you fail to solve the problem, contact with a CardiaTech manufacturer or authorized service centre.

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1. Check whether one or more illuminated indicators are lit when the cover is closed. When the OK symbol flashes, it means that the device is ready for use.

2. Open the cover of the device. If the following conditions are met, the device is ready to use:

• All indicators and illuminated instruction fields are lit for a short period of time

• Then OK symbol lights continuously • Device starts to give verbal instructions

3. Close the cover again and make sure that the device is in standby status. When verbal instructions stop and OK symbol flashes, it means that the device is ready for use.

4. Inspect the appearance of the device. Check if the device has external damage. If the device is damaged, it shouldn’t be used.

5. Check if all accessories are complete. Missing or faulty parts should be renewed.

6. Check whether the electrode connector is plugged in the socket correctly. If the electrode plug is not connected correctly press the plug firmly.

7. Check whether the electrode plug, electrode cables and electrode pack are in perfect condition. If one of the parts is faulty, electrode pack should be replaced with a new one.

8. Make sure that the electrode pack has not passed its expiration date. If it has expired, the electrode pack should be replaced with a new one.

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7. Troubleshooting

7.1 Visual and Acoustic Failure messages

Caution!

Caution!

Inspection, repair and other maintenance actions should be performed by CardiaTech or and authorized CardiaTech service centre. If the OK symbol flashes green, it means that CardiAid is ready for use.

LED STATUS FAILURE CAUSE REMEDY

Battery Symbol

OK Symbol

Battery symbol and OK symbol flashes in standby status.The device gives a signal tone every 4 minutes.

Battery is weak. It can only supply a limited number of shocks.

CardiAid can be used in emergencies. Contact with CardiaTech for battery replacement.

Battery Symbol

OK Symbol

Battery symbol and OK symbol lights constantly during operation. “Battery low” instruction is heard.

Battery is low. It can only supply limited number of shocks.

CardiAid can be used in emergencies. Contact with CardiaTech for battery replacement.

Battery Symbol

Repair Symbol

Battery symbol and repair symbol flashes in standby status.The device gives a signal tone every 4 minutes.

Battery is empty. Device cannot be used.

Device cannot be used. Immediately contact with CardiaTech.

Batteriesymbol

Repair Symbol

Battery symbol and repair symbol lights constantly during operation.

Battery is empty. Device cannot be used.

Device cannot be used. Immediately contact with CardiaTech.

Repair symbol

Repair symbol gives a signal in standby status.The device gives a signal tone every 4 minutes.

Device cannot be used Device cannot be used. Immediately contact with CardiaTech.

Repair symbolRepair symbol lights constantly during operation.

Device cannot be used Device cannot be used. Immediately contact with CardiaTech.

Any

One or more illuminated indicator and or instruction fields does not light for a period when operated.

Front folio of the defibrillator is faulty

CardiAid can be used in emergencies. Immediately contact with CardiaTech.

Any

CardiAid cannot be switched on.

Device is not ready for use.

Close the cover and turn on again. If the problem persists, immediately contact with CardiaTech.

Any

No verbal instructions are heard when CardiAid is operated.

Device is not ready for use.

Close the cover and turn on again. If the problem persists, immediately contact with CardiaTech.

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LED STATUS FAILURE CAUSE REMEDY

Repair symbolDevice gives “Device is not ready for use” verbal instruction.

Device is not ready for use.

Immediately contact with CardiaTech.

OK symbol

Even though the electrodes are connected, the device is giving “stick the electrodes on the bare chest” instruction repeatedly

Electrodes are not plugged correctly.

Plug the electrodes correctly.

Electrodes are not adhered correctly.

Apply the electrodes on dry skin and shave if necessary.

Electrodes are faulty. Change the electrodes. Do not use the faulty electrodes.

Wrong electrodes are used.

Only use CardiaTech’s genuine electrodes.

Device is faulty. Immediately contact with CardiaTech.

OK symbolEven though shock button flashes, no shock can be applied.

Device is faulty. Immediately contact with CardiaTech.

Any The device is not acting as indicated in the manual.

Any Contact with CardiaTech.

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8. Disposal

Do not dispose of the device as common household waste. You can find information regarding disposal on the CardiaTech web site. (www.cardiatech.com)

Disposal of used electrical and electronic devices (refer to

special collection system for these type of devices in European

Union countries and other European countries) .

The symbol on the product or its packaging indicates that this product cannot be disposed in common household waste. Electrical and electronic devices should be delivered to recycling facilities. With your contribution to disposal of this product, you can help in protection of both the environment and its inhabitants. Incorrect disposal methods threaten the environment and health of everybody. Material recycling reduces the use of raw materials.

You can find additional information regarding the recycling of this product in Municipal regional disposal facilities or from the dealer you purchased the product. Always consult a licensed electronic scrap analyzer for proper disposal of this device.

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9. Storage

Even if the device is used rarely or stored for long periods, always observe maintenance schedules. Device cannot be used if maintenance period is missed. Therefore always make sure that regular maintenance check-up is performed on time.

Observe the recommended temperature conditions for CardiAid (see page 41). Excessive ambient temperature can shorten the battery life considerably.

Do not keep CardiAid under direct sunlight.

Store CardiAid in dry environments.

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10. Maintenance

CardiAid should be technically checked periodically.

1 . Technical check after shock application: CardiAid should be subjected to a technical check after every shock application. In addition to the benefits of keeping the device in perfect working condition, downloading of application data in terms of technical check after device is used is also advantageous for continuous improvement.

Expired parts are renewed during the check and a technical Safety Check is performed.

The next standard check is performed at regular time (See 2).

2 . Technical Safety Check

CardiaTech strongly advises to have the CardiAid technically checked every 2 years. In some countries, like Germany, legal period for Technical Safety Check is 2 years according to Article 6 of Medical Products Operation Regulation. Therefore CardiAid should be subjected to maintenance within the framework of Technical Safety Check in every 2 years in these countries. Ask your sales agent for the regal rules on technical service in your country. The following date of check is indicated on the device. Technical Safety Check contains the following: • Visual Check - Mechanical Damages - Electrode Connections - Text• Completeness Check• Renewal of expiring parts - Battery replacement - Electrode replacement

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- Emergency kit replacement• Final and Process Check - Measuring the current - Normal Operation - Shock Operation - Delivery of test shock• Sticking a proof of check-up sticker

3 . Maintenance

In addition to Technical Safety Check ( see point 2, necessary in some countries but advised to carry out everywhere), CardiAid is also subjected to maintenance at every 6 years. This maintenance comes in the place of every 3rd Technical Safety Check.

In addition to Technical Safety Check context, the status of

technical components is also checked.

Manufacturer is responsible for Technical Safety Check andmaintenance.Manufactorer provides authorized service partners. For details check your warranty card or the CardiaTech website. www.cardiatech.com

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11. Delivery Contents

Caution!

Caution!

Packaging material can pose suffocation risk. Therefore store away from the reach of children or dispose of appropriately.

Standard package of CardiAid contains the following:• CardiAid AED, including the battery pack and case. • 1 pair of defibrillation electrodes• Emergency kit containing the following: - Shaver - Scissors - Respiration mask - Gloves - Disinfecting tissue• Operating Manual

The following can be ordered as accessries and spare parts:• Emergency kit containing the following: - Shaver - Scissors - Respiration mask - Gloves - Disinfecting tissue• Defibrillation electrodes• Battery pack• Wall mount set• CardiAid training unit

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12. TECHNICAL INFORMATION

12.1 SPECIFICATIONS

DEVICEDIMENSIONS / ENVIRONMENT / NORMSWeight with battery and electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3,1 kgProduct class according to Medical Product regulation or Regulation No. 93/42/EEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IIbOperation: Temperature limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Between 0°C and +50°CHumidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30% - 75%Air pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Between 800 and 1160 h/PaTransportation / Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Between 0°C and +50°CTemperature limits: Max. 2 weeks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Between -20°C and +60°CHumidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0% - 95%Air pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Between 500 and 1160 h/PaProtection Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IEC 529: IPX4 (spray water safety)Free drop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .IEC 601-1:1988+A1: 1991+A2:1995Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .EN 60601-1-2:2001. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CISPR 11 (EN 55011). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . EN 61000-4-3:2002/A1:2002. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .EN 61000-4-8:1993+A1:1001Norms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . EN 60601-2-4:2003, rare useReanimation protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ERC,AHA;2005

SELF TESTInterval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Daily, Monthly, when usedMoment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Can be programmed by service centreScope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery, electronics, software, high voltage

DEFIBRILLATION ELECTRODEDelivery status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Self-adhesive single use electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Packed by leaving the connection plug on the outside.Polarization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .No polarization (exchange is accepted)Length of the cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .130 cmElectrode size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125 cm2 eachDuration of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 months after the date of productionTransportation / Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Between 0°C and 35°C

ENERGY SOURCEType. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .AlkalineDimensions l x w x h (in mm). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260 x 59 x 30Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 930 gShock capacity*, ** . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Up to 210 shocksMinimum capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 shocksMonitor Capacity*, *** . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Up to 20 hoursSpecified capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3400 mAhBattery change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performed by Service CentreFuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15AStandby lifetime* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 yearsReal Time Clock battery lifetime. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 years* with a new battery pack, 20°C** at low energy setting*** at lowest sound level

DEFIBRILLATION / ANALYSISOperating mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Semi-Automatic (1 button control)Wave form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Biphasic, energy limitedDelivered energy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Low energy level (max. 181J at 75 Ω). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . High energy level (max. 237 J at 75 Ω)Delivered energy at 50 Ω. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Low energy 174 J < ± 15%. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . High energy 234 J < ± 15%

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Max. Patient impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .290 ΩShock sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Can be adjusted by service, constant or increasingCycle duration (Analysis and shock preparation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .With fully charged energy source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Max. 20 sec.After 15 shocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Max. 24 sec.After 6 shocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Max. 20 sec.Cycle duration (switch-on, analysis and shock preparation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .With fully charged energy source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . < 45 sec.After 15 shocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . < 50 sec.After 6 shocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . < 45 sec.CPR Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Can be adjusted by service, 60-300 sec.

ECG ANALYSIS SYSTEMDuration of analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . < 10 sec.Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .IIImpedance measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Controlled by electrode contactMovement and artifact recognition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Constant check of signal quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acoustic warning at patient movementReaction in pacemaker . . . . . . . . . . . . . . . . . . . . . Normal pacemaker rhythm is recognized correctly and indicated as not shock able.Asystolic wave . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . <0,2 mVPrecision VF/pVT*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > %90Specified NSR / Asystolic* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > %95* Report of analysis system can be obtained from CardiaTech.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

OPERATIONOperation Elements . . . . Automatic Switch-on. Shock key giving a signal upon opening the cover (1 button control) Information keyInformation mode . . . . . . . . . . . . . . . . . . . . . . . . . operating time and number of shocks since switch-on the device by pressing the key Indicator elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Illuminated symbols. . . . . . . . . . . . . . . . . . . . . . . . . . Device status indicators (Ready for operation, battery change, self-test result/maintenance indicator)Acoustic signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Verbal instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signal Tones (In use). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signal tone (in stand-by position at device failure or low battery)Communication channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bluetooth (only for service centre)

BLUETOOTHClass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Class 2Maximum output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4dBm

Warnings:- Medical electrical equipment needs special precautions regarding EMC. The following EMC guidelines must be

observed during installing and put into service of the device.- Portable and mobile RF communications equipment can affect medical electrical equipment.

43

Guidance and manufacturer's declaration - electromagnetic emissions

The Public Access Defibrillator CardiAid is intended for use in the electromagnetic environment specified bellow. The costumer or the user of the Public Access Defibrillator CardiAid should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11 Group 1 The Public Access Defibrillator CardiAid uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interface in nearby electronic equipment.

RF emissions CISPR 11 Class B The Public Access Defibrillator CardiAid is suitable for use in all domestic establishments and establishments other than domestic and directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

not applicable

Voltage fluctuations / flicker emissions IEC 61000-3-3

not applicable

44

Gui

danc

e an

d m

anuf

actu

rer‘s

dec

lara

tion

- ele

ctro

mag

netic

em

issi

ons

The

Publ

ic A

cces

s De

fibril

lato

r Car

diAi

d is

inte

nded

for u

se in

the

elec

trom

agne

tic e

nviro

nmen

t spe

cifie

d be

llow

. The

cos

tum

er o

r the

use

r of t

he P

ublic

Acc

ess

Defib

rilla

tor C

ardi

Aid

shou

ld a

ssur

e th

at it

is u

sed

in s

uch

an e

nviro

nmen

t.

Imm

unity

test

IEC

6060

1-1

test

leve

lCo

mpl

ianc

e le

vel

Elec

trom

agne

tic e

nviro

nmen

t - g

uida

nce

Elec

trost

atic

dis

char

ge

(ESD

) IE

C 61

000-

4-2

+/- 6

kV c

onta

ct

+/-

8 kV

air

+/- 6

kV c

onta

ct

+/-

8 kV

air

Floo

rs s

houl

d be

woo

d, c

oncr

ete

or c

eram

ic ti

le. I

f floo

rs a

re c

over

ed w

ith s

ynth

etic

m

ater

ials

, the

rela

tive

hum

idity

sho

uld

be a

t lea

st 3

0%.

Elec

trica

l fas

t tra

nsie

nt/

burs

tIE

C 61

000-

4-4

+/- 2

kV

for p

ower

su

pply

line

s +

/- 1

kV fo

r inp

ut/

outp

ut li

nes

not a

pplic

able

Surg

eIE

C 61

000-

4-5

+/- 1

kV

diffe

rent

ial

mod

e +

/- 2

kV c

omm

on m

ode

not a

pplic

able

Volta

ge d

ips,

sho

rt in

terr

uptio

ns a

nd

volta

ge v

aria

tions

on

pow

er s

uppl

y in

put

lines

IEC

6100

0-4-

11

<5%

for

5s<5

% fo

r 0,5

cyc

les

40%

for 5

cyc

les

70%

for 2

5 cy

cles

not a

pplic

able

Pow

er fr

eque

ncy

(50/

60Hz

) mag

netic

fie

lds

IEC

6100

0-4-

8

3 A/

m3

A/m

Pow

er fr

eque

ncy

mag

netic

fiel

ds s

houl

d be

at l

evel

s ch

arac

teris

tic o

f the

typi

cal

loca

tion

in a

typi

cal c

omm

erci

al o

r hos

pita

l env

ironm

ent.

45

Gui

danc

e an

d m

anuf

actu

rer‘s

dec

lara

tion

- ele

ctro

mag

netic

em

issi

ons

The

Publ

ic A

cces

s De

fibril

lato

r Car

diAi

d is

inte

nded

for u

se in

the

elec

trom

agne

tic e

nviro

nmen

t spe

cifie

d be

llow

. The

cos

tum

er o

r the

use

r of t

he P

ublic

Acc

ess

Defib

rilla

tor C

ardi

Aid

shou

ld a

ssur

e th

at it

is u

sed

in s

uch

an e

nviro

nmen

t.

Imm

unity

test

IEC

6060

1-1

test

leve

lCo

mpl

ianc

e le

vel

Ele

ctro

mag

netic

env

ironm

ent -

gui

danc

e

cond

ucte

d RF

IE

C 61

000-

4-6

3 Ve

ff15

0 kH

z to

80 M

Hzou

tsid

e IS

M b

ands

not a

pplic

able

for

patie

nt le

ads

acco

rdin

g to

EN

606

01-2

-4

Porta

ble

and

mob

ile R

F co

mm

unic

atio

ns e

quip

men

t sho

uld

be u

sed

no c

lose

r to

any

part

of th

e Pu

blic

Acc

ess

Defib

rilla

tor C

ardi

Aid,

incl

udin

g ca

bles

, tha

n th

e re

com

men

ded

sepa

ratio

n di

stan

ce c

alcu

late

d fro

m th

e eq

uatio

n ap

plic

able

to th

e fre

quen

cy o

f the

tran

smitt

er.

Radi

ated

IEC

6100

0-4-

310

Vef

f15

0 kH

z to

80 M

Hzin

side

ISM

-ban

ds

10 V

/m80

MHz

to 2

,5 G

Hz

not a

pplic

able

for

patie

nt

lead

s ac

cord

ing

toEN

606

01-2

-4

3 V/

m

d= 4

* S

QRT(

P/W

) for

80

MHz

to 8

00 M

Hz F

or d

= 7

.67

* ro

ot (P

/W),

d= 7

,67

* SQ

RT(P

/W) f

or 8

00 M

Hz to

2,5

GHz

whe

re P

is th

e m

axim

um o

utpu

t pow

er ra

ting

of th

e tra

nsm

itter

in w

atts

(W)

acco

rdin

g to

the

trans

mitt

er m

anuf

actu

rer a

nd d

is th

e re

com

men

ded

sepa

ratio

n di

stan

ce in

met

res

(m).

Fiel

d st

reng

th fr

om fi

xed

RF tr

ansm

itter

s, a

s de

term

ined

by

an e

lect

rom

agne

tic s

ite

surv

ey, s

houl

d be

less

than

the

com

plia

nce

leve

l in

each

freq

uenc

y ra

nge.

Inte

rfere

nce

may

occ

ur in

the

vici

nity

of e

quip

men

t mar

ked

with

the

sym

bol

„non

ioni

sing

radi

atio

n“.

NOT

E: A

t 80

MHz

and

800

MHz

the

sepa

ratio

n di

stan

ce fo

r the

hig

her f

requ

ency

rang

e ap

plie

s.

NOT

E : T

his

guid

elin

es m

ay n

ot a

pply

in a

ll si

tuat

ions

. Ele

ctro

mag

netic

pro

paga

tion

is a

ffect

ed b

y ab

sorp

tion

and

refle

ctio

n fro

m s

truct

ures

, obj

ects

and

peo

ple.

.

Fiel

d st

reng

th fr

om fi

xed

trans

mitt

ers,

suc

h as

bas

e st

atio

ns fo

r rad

io (C

ellu

lar/c

ordl

ess)

tele

phon

es a

nd la

nd m

obile

radi

os, a

mat

eur r

adio

, AM

and

FM

radi

o br

oadc

ast

and

TV b

road

cast

can

not b

e pr

edic

ted

theo

retic

ally

with

acc

urac

y.

To a

sses

s th

e el

ectro

mag

netic

env

ironm

ent d

ue to

fixe

d RF

tran

smitt

ers,

an

elec

trom

agne

tic s

ite s

urve

y sh

ould

be

cons

ider

ed. I

f the

mea

sure

d fie

ld s

treng

th in

the

loca

tion

in w

hich

the

Pub

lic A

cces

s De

fibril

lato

r Car

diAi

d is

use

d ex

ceed

s th

e ap

plic

able

RF

com

plia

nce

leve

l abo

ve, a

dditi

onal

mea

sure

s m

ay b

e ne

cess

ary,

suc

h as

re

orie

ntat

ion

or re

loca

ting

the

Publ

ic A

cces

s De

fibril

lato

r Car

diAi

d .P

ublic

Acc

ess

Defib

rilla

tor C

ardi

Aid.

Abov

e fre

quen

cy fi

elds

bet

wee

n 15

0 KH

z and

80

MHz

, fiel

d st

reng

th s

houl

d be

less

than

3 V

/m.

Gui

danc

e an

d m

anuf

actu

rer‘s

dec

lara

tion

- ele

ctro

mag

netic

em

issi

ons

The

Publ

ic A

cces

s De

fibril

lato

r Car

diAi

d is

inte

nded

for u

se in

the

elec

trom

agne

tic e

nviro

nmen

t spe

cifie

d be

llow

. The

cos

tum

er o

r the

use

r of t

he P

ublic

Acc

ess

Defib

rilla

tor C

ardi

Aid

shou

ld a

ssur

e th

at it

is u

sed

in s

uch

an e

nviro

nmen

t.

Imm

unity

test

IEC

6060

1-1

test

leve

lCo

mpl

ianc

e le

vel

Elec

trom

agne

tic e

nviro

nmen

t - g

uida

nce

Elec

trost

atic

dis

char

ge

(ESD

) IE

C 61

000-

4-2

+/- 6

kV c

onta

ct

+/-

8 kV

air

+/- 6

kV c

onta

ct

+/-

8 kV

air

Floo

rs s

houl

d be

woo

d, c

oncr

ete

or c

eram

ic ti

le. I

f floo

rs a

re c

over

ed w

ith s

ynth

etic

m

ater

ials

, the

rela

tive

hum

idity

sho

uld

be a

t lea

st 3

0%.

Elec

trica

l fas

t tra

nsie

nt/

burs

tIE

C 61

000-

4-4

+/- 2

kV

for p

ower

su

pply

line

s +

/- 1

kV fo

r inp

ut/

outp

ut li

nes

not a

pplic

able

Surg

eIE

C 61

000-

4-5

+/- 1

kV

diffe

rent

ial

mod

e +

/- 2

kV c

omm

on m

ode

not a

pplic

able

Volta

ge d

ips,

sho

rt in

terr

uptio

ns a

nd

volta

ge v

aria

tions

on

pow

er s

uppl

y in

put

lines

IEC

6100

0-4-

11

<5%

for

5s<5

% fo

r 0,5

cyc

les

40%

for 5

cyc

les

70%

for 2

5 cy

cles

not a

pplic

able

Pow

er fr

eque

ncy

(50/

60Hz

) mag

netic

fie

lds

IEC

6100

0-4-

8

3 A/

m3

A/m

Pow

er fr

eque

ncy

mag

netic

fiel

ds s

houl

d be

at l

evel

s ch

arac

teris

tic o

f the

typi

cal

loca

tion

in a

typi

cal c

omm

erci

al o

r hos

pita

l env

ironm

ent.

46

Recommended separation distances betweenportable and mobile RF communications equipment and the Public Access Defibrillator CardiAid

The Public Access Defibrillator CardiAid is intended for use in an electromagnetic environment in which the radiated RF disturbances are controlled. The costumer or the user of the Public Access Defibrillator CardiAid can help prevent electromagnetic interference by maintaining a minimal distance between portable and mobile RF communications equipment (transmitters) and the Public Access Defibrillator CardiAid as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter in m

Rated maximum output

power of transmitter

P in W

80 MHz to 800 MHz

800 MHz to 2,5 GHz

150 KHz to 80 MHzoutside ISM-bands

150 kHz to 80 MHz

d=4 * SQRT(P/W) d=7,67 * SQRT(P/W) not applicable for patient leads according to EN

60601-2-4

not applicable for patient leads according to EN

60601-2-4

0,01 0,40 0,77

0,1 1,26 2,43

1 4,00 7,67

10 12,65 24,25

100 40,00 76,70

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.WARNING

1: At 80 MHz and 800 MHz, higher frequency field is applicable.

NOTE: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.

NOTE : This guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

47

12.2 Pulse FormA pulse form is drawn by applying a fixed maximum current.Myocardium damage typically caused by high electrical currents, with low patient’s impedance are reduced considerably with thispulse form.

Pulse form / shock energy can only be configured by service. Pre-adjustment is as follows:

1. Shock to be applied: low2. Shock to be applied: low3. And other shocks to be applied: high

Function Principle

If the current exceeds the specified value, current transmission is interrupted. Current continues to flow to the patient with inductivity in connection path. However, the current falls gradually. If the specified current value exceeds 1 amp, current transmission re-starts. In this way, current supplied to the patient rises again. It leads into s saw tooth impulse.

Proportion of supplied electrical current (integral of current in time) between 2nd (negative) and 1st (positive) phases is 0,38 on average. This value is determined as optimal in clinical studies.

Current flow normal Energy warning

-25

-20

-15

-10

-5

0

5

10

15

20

25

0 2 4 6 8 10 12

t in ms

I in A

25Ohm50Ohm75Ohm100Ohm125Ohm150Ohm175Ohm

25Ohm50Ohm75Ohm100Ohm125Ohm150Ohm175Ohm

Current flow is high Energy warning

-20

-15

-10

-5

0

5

10

15

20

25

0 5 10 15 20 25

t in ms

I in A

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Impedance Dependence

For safety reasons, a current of maximum 2000 Volt are used. Current resulting from this depending on the patient’s impedance is indicated in the following figure:

Energy flow in high patient resistance

Supplying a fixed current beforehand causes a determining effect on supplying energy to the patient. Ohm’s law requires a higher voltage with increasing impedance. Because the voltage enters the supplied energy quadratic, in increasing resistance, the supplied energy also rises considerably. This in turn provides a better treatment in patients with resistance and has a positive effect on decreasing death rate in this patient group.

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13. Address Information

Headquarter: CardiaTech Holland BV Ditlaar 7 1066 EE AmsterdamThe Netherlands

E-mail: info@cardiatech.comInternet: www.cardiatech.com

www.cardiatech.com