Telefunken AED User Manual English V2.3 2012 · Servicing check list 39 8.3. Dispatching the DEFITEQ™ Telefunken AED 40 9. Disposal 41 ... Telefunken AED is a public access defibrillator

Telefunken AED Model HR 1

User Manual

Version 2.3

2

Publisher

DefiTeq International BV

Mispelhoefstraat 31B

5651 GK Eindhoven

The Netherlands

www.defiteq.com

Proprietary note

DefiTeq reserves all rights to these operating instructions. Without approval from DefiTeq

these operating instructions may not be duplicated or made accessible to third parties. The

same applies to individual parts or excerpts of these operating instructions.

Non-compliance with this gives rise to a right to claim damages and can have consequences

under criminal law (refer to DIN 34).

3

Table of contents

1. Introduction 5

1.1. Foreword 5

1.2. Validity 5

1.3. Warranty 5

1.4. Disclaimers 5

1.5. Symbols used in these operating instructions 6

1.6. Pictograms on the device 7

1.7. Pictograms on the Battery 7

1.8. Pictograms on Electrodes 8

2. Intended use 9

2.1. Essential Performance 10

2.2. Indication/Contraindication for Defibrillation 10

2.2.1. Indications 10

2.2.2. Contraindications 10

3. Safety information 11

3.1. General information 11

3.2. General safety instructions 13

3.3. Safety notes for you, the user 13

3.4. Safety notes for protection of the patient 14

3.5. Safety notes for the protection of third parties 16

3.6. Safety notes for the protection of the device 16

4. Description of device 17

4.1. General description 17

4.2. Description of device details 18

4.3. Status display 22

4.4. Data management 23

4.5. Description of the accessories 24

4.5.1. Telefunken AED Electrodes 24

4.5.2. Optional accessories 24

5. Preparatory measures before (initial) start-up 25

5.1. Unpacking 25

5.2. Inserting / Changing the power supply unit (Battery) 26

5.2.1. Inserting the battery 26

5.2.2. Removing the battery from the device 27

5.3. DEFITEQ™ Battery 28

6. Device self-test 29

6.1. Self-test after switching on the Telefunken AED 29

6.2. Automatic, periodic self-tests 29

4

7. Operating the device and sequence of reanimation 30

7.1. Switching the DEFITEQ™ Telefunken AED on / off 30

7.1.1. Switching the DEFITEQ™ Telefunken AED on 30

7.1.2. Switching the DEFITEQ™ Telefunken AED off 30

7.2. Voice output by the device / Preliminary examination of the patient 31

7.3. Undressing the patient 31

7.4. Determining the position of the electrodes 32

7.5. Removing hair growth from chest 32

7.6. Drying the skin 33

7.7. Opening and positioning electrodes 34

7.8. Plugging in the electrode plugs 34

7.9. Checking the electrodes 35

7.10. Carrying out the ECG analysis 36

7.11. Defibrillation required 36

7.12. Defibrillation not required 37

7.13. Keep the defibrillator ready for use 37

8. Cleaning, maintenance and dispatch 38

8.1. Cleaning 38

8.2. Servicing 39

8.2.1. Servicing check list 39

8.3. Dispatching the DEFITEQ™ Telefunken AED 40

9. Disposal 41

10. Technical Data 42

11. Warranty conditions 43

12. Technical Description 44

13. Rhythm detection system 46

14. Guidelines and manufacturer's declaration – Electromagnetic emissions 47

15. Safety checks 50

16. Index of diagrams 51

17. Annex – Rhythm Analysis Detector 52

18. Contact details 56

5

1 Introduction

1.1 Foreword

Dear User,

You are faced with the task of using the DEFITEQ™ Telefunken AED a medical emergency on

human beings.

To ensure that you can react quickly and correctly in this special situation and can optimally use

the options given with the device, it is necessary for you to read through these operating

instructions in your own time beforehand to familiarise yourself with the device, its functions

and the areas of application.

Keep these operating instructions near the device so that you consult any queries, which may

arise.

If you should have any questions regarding the device or other DEFITEQ™ products, we are at

your entire disposal.

You will find our contact address on the masthead at the start of these operating instructions.

1.2 Validity

The descriptions in these operating instructions refer to the Telefunken AED made by DefiTeq.

1.3 Warranty

The warranty period is 72 months and starts on the day of purchase. It is important to keep

the receipt as proof of purchase.

The general guarantee and warranty provisions of DefiTeq are applicable. Any repairs or

changes to the device may only be carried out by the manufacturer or by a person or

company authorised by the manufacturer.

1.4 Disclaimers

Liability claims in the event of damages to people or property are excluded if they are based

on one or more of the following reasons:

• Using the device in a manner for which it was not intended.

• Improper use and maintenance of the device.

• Operating the device with the protective covers removed or when there is obvious

damage to cables and/or electrodes.

• Non-observance of the advice given in these operating instructions with regard to

operation, maintenance and repair of the device.

• Using accessories and spare parts made by other manufacturers.

• Autonomous intervention, repairs or constructional changes to the device.

• Autonomous overrunning of the performance limits.

• Lack of monitoring parts that are subject to wear and tear.

• Treatment of patients without prior indication.

• Behandeling van patiënten zonder voorafgaande indicatie.

1.5 Symbols used in thes

Note This symbol indicates text which contains important

comments or tips.

This point identifies the first step of a sequence of actions you should take.

Second step of an action you should take.

etc.

• This line marks lists

(3) Numbers in brackets refer to items in diagrams.

< ... > Texts set in angle brackets denote acoustic information / instructions of the

device which are shown simultaneously on the monitor, depending on the device

model.

6

used in these operating instructions

DANGER

Texts marked DANGER indicate an extraordinarily serious, actual

danger which will definitely lead to serious injury or even death if

no preventative measures are adopted.

It is imperative that you pay attention to these texts.

WARNING

Texts marked WARNING indicate extraordinarily serious, possible

dangers which, should no preventative measures be taken, may

lead to serious injury or even death.


CAUTION

Texts marked with CAUTION indicate a possible dangerous

situation which could lead to minor injuries or damage to

property.


This symbol indicates text which contains important advice /

comments or tips.


Second step of an action you should take.

Numbers in brackets refer to items in diagrams.

Texts set in angle brackets denote acoustic information / instructions of the


Texts marked DANGER indicate an extraordinarily serious, actual

danger which will definitely lead to serious injury or even death if

these texts.

Texts marked WARNING indicate extraordinarily serious, possible

dangers which, should no preventative measures be taken, may


Texts marked with CAUTION indicate a possible dangerous

situation which could lead to minor injuries or damage to


advice /


Texts set in angle brackets denote acoustic information / instructions of the


1.6 Pictograms on the device

1.7 Pictograms on the Battery

Consult instructions for use

item

Protect device from wet

Do not expose device to hard knocks or shocks

Do not open device by force

Protect device from heat

Do not dispose of device in domestic waste

7

on the device

on the Battery

Consult instructions for use

item only intended for single use

Protect device from wet

Do not expose device to hard knocks or shocks

Do not open device by force

Protect device from heat

Do not dispose of device in domestic waste

Protected against water jets

Please observe the operating instructions.

Do not dispose of device in domestic refuse.

Dangerous electric voltage (high voltage)

Defibrillation protection

1.8 Pictograms on Electrodes

Not to be reused

Expiry date

Batch ID

Only for adults

Reference

Storage temperature

information

in Celsius and Fahrenheit

8

Electrodes

Not to be reused

Expiry date

Only for adults

number

Storage temperature

information

in Celsius and Fahrenheit

2 Intended use

Telefunken AED is a public access defibrillator (PAD) as well as an automatic external defibrillator

(AED). The device is a tool for the reanimation of patients that weight at least 20 kg and show signs

of a cardiac arrest, mostly by ventricular fibrillation.

In these cases Telefunken AED can be used to carry out the needed defibrillation.

The user is guided through the process of reanimation with clear and comprehensible commands in

form of speech output and optical directions. The device automatically stores and analy

patient's ECG curve. In case of need it prepares an electrical charge. After this the device requests

the user to press a button in order to release the shock.

In case an electrical charge needs to be applied to the patient, there are two versions

AED, depending on the country where the device is sold:

Semi-automatic defibrillator (e.g. in Germany):

The device requests the user to press a button in order to release the shock.

Full-automatic defibrillator:

The defibrillator gives audio warnings to not touch the patient. After the capacitor is charged

the device releases the shock on its own.

Telefunken AED is only to be used for the purpose described above.

Note The DEFITEQ™

described an

instructions.

The operator of the Telefunken AED

by authorised specialist personnel.

9

is a public access defibrillator (PAD) as well as an automatic external defibrillator


of a cardiac arrest, mostly by ventricular fibrillation.

can be used to carry out the needed defibrillation.


form of speech output and optical directions. The device automatically stores and analy


the user to press a button in order to release the shock.

In case an electrical charge needs to be applied to the patient, there are two versions

, depending on the country where the device is sold:

automatic defibrillator (e.g. in Germany):


audio warnings to not touch the patient. After the capacitor is charged

the device releases the shock on its own.

is only to be used for the purpose described above.

The DEFITEQ™ Telefunken AED devices may only be used as

described and under the conditions detailed in these operating

instructions.

Telefunken AED has to make sure that the Telefunken AED

by authorised specialist personnel.

WARNING

Any use above or beyond this is not considered as intended use

and can lead to personal injury or damage to property.

Improper use of the defibrillator can lead to ventricular

fibrillation, asystolia or other dangerous dysrhythmia.

is a public access defibrillator (PAD) as well as an automatic external defibrillator


can be used to carry out the needed defibrillation.


form of speech output and optical directions. The device automatically stores and analysis the


In case an electrical charge needs to be applied to the patient, there are two versions of Telefunken


audio warnings to not touch the patient. After the capacitor is charged

devices may only be used as

d under the conditions detailed in these operating

Telefunken AED is only used

Any use above or beyond this is not considered as intended use

and can lead to personal injury or damage to property.

Improper use of the defibrillator can lead to ventricular

fibrillation, asystolia or other dangerous dysrhythmia.

10

2.1 Essential Performance

The DEFITEQ™ Telefunken AED will:

• Deliver defibrillation therapy

• Accurately differentiate between shockable and nonshockable rhytms

2.2 Indication/ Contraindication for Defibrillation

2.2.1 Indications

The DEFITEQ™ Telefunken AED may only be used if the patient:

• is unconscious and

• not breathing

2.2.2 Contraindications

The DEFITEQ™ Telefunken AED may not be used if the patient:

• is conscious or

• breathing normally or

• a normal pulse can be felt

3 Safety information

3.1 General information

Both in conjunction with its accessories and the optional accessories, and also individually,

the DEFITEQ™ Telefunken AED

with the provisions of the medical products regulations.

The device and its accessories are safe when used as intended and taking into account the

descriptions and information detailed in these operating instructions.

Despite this, if used incorrectly, the device and its accessories can be dangerous to the user,

the patient or third parties.

11

information


Telefunken AED fulfils the currently applicable safety standards and complies

with the provisions of the medical products regulations.

its accessories are safe when used as intended and taking into account the

descriptions and information detailed in these operating instructions.


r third parties.

DANGER

We emphatically advise that before using for the first time, all

those who are supposed to use this device or want to use it

• Must be instructed in a training session about the medical

background of defibrillation and the indications or

contraindications and thus need to be authorised.

• Need to read and take note of these operating instructions

and in particular the safety tips and warnings detailed in

them.

WARNING

The DEFITEQ™ Telefunken AED may only be used by trained and

authorised personnel. Reading the operating instructions does not

replace training.

The DEFITEQ™ Telefunken AED is not licensed for use in explosive

areas.


fulfils the currently applicable safety standards and complies

its accessories are safe when used as intended and taking into account the


We emphatically advise that before using for the first time, all

those who are supposed to use this device or want to use it

Must be instructed in a training session about the medical

indications or

contraindications and thus need to be authorised.

Need to read and take note of these operating instructions

and in particular the safety tips and warnings detailed in

may only be used by trained and

authorised personnel. Reading the operating instructions does not

is not licensed for use in explosive

Note

Observe the information and rules in the appendix on using the

DEFITEQ™

Applicable for Europe:

• The device complies with the Medical Device

Also applicable for Germany and Austria:

• The device complies with the Medical Devices Law (MPG) and is subject to the Ordinance

on the Operation and Use of Medical Devices (MPBetreibV).

• According to the Ordinance on the Operation and Use

the device is to be subjected to the regular checks explained in the appendix.

• According to the Ordinance on the Operation and Use of Medical Devices (MPBetreibV),

a medical devices log needs to be kept for the device. Reg

be documented in it.

For the other states in the European Community, national regulations for operating medical

devices apply.

12

DANGER

Not using the device as intended or using it improperly, exposes

the user, the patient or third parties to the danger

• of an electric shock from the high voltage generated by the

device,

• of influencing active implants,

• of burns from incorrectly applied electrodes.

Apart from that, the device can be damaged or destroyed through

improper use.


DEFITEQ™ Telefunken AED.

The device complies with the Medical Device Directive (MDD).

Also applicable for Germany and Austria:

The device complies with the Medical Devices Law (MPG) and is subject to the Ordinance

on the Operation and Use of Medical Devices (MPBetreibV).

According to the Ordinance on the Operation and Use of Medical Devices (MPBetreibV),



a medical devices log needs to be kept for the device. Regular checks of the device are to

be documented in it.


improperly, exposes

the user, the patient or third parties to the danger

of an electric shock from the high voltage generated by the

of burns from incorrectly applied electrodes.

Apart from that, the device can be damaged or destroyed through


The device complies with the Medical Devices Law (MPG) and is subject to the Ordinance

of Medical Devices (MPBetreibV),



ular checks of the device are to


3.2 General safety instructions

3.3 Safety notes for you, the user

13

safety instructions

DANGER

The device may not be used in the vicinity of flammable materials

(e.g. cleaning solvents or similar) or in an atmosphere enriched

with oxygen or flammable gases/vapours.

notes for you, the user

WARNING

Only use the device on a patient if

• you have been authorised to do so as a result of training!

• you have ensured its operational safety before you use it and

that it is in good condition.

• the state of the patient requires or allows an application.

Before using it, check whether the device is in the operating

temperature range. This applies for example, if the defibrillator is

stored in a rescue vehicle in the winter.

Do not apply the device if it has been damaged or is defective

(e.g. if the electrode cable is damaged or the housing has been

damaged)

Do not touch the patient during defibrillation. Avoid any contact

between parts of the patient's body (such as bare skin on head or

legs), as well as conductible liquids (such as gels, blood or salt

solutions) and metallic objects around the patient (such as bed

frame or traction devices) which present unintended paths for the

defibrillation current.

flammable materials

(e.g. cleaning solvents or similar) or in an atmosphere enriched

result of training!

you have ensured its operational safety before you use it and

the state of the patient requires or allows an application.


is applies for example, if the defibrillator is

Do not apply the device if it has been damaged or is defective

cable is damaged or the housing has been

ng defibrillation. Avoid any contact

between parts of the patient's body (such as bare skin on head or

legs), as well as conductible liquids (such as gels, blood or salt

solutions) and metallic objects around the patient (such as bed

ces) which present unintended paths for the

3.4 Safety notes for protection of the patient

14

notes for protection of the patient

DANGER

Only use the device on a patient if

• you have been authorised to do so as a result of training.

• you have ensured its operational safety before using it and

that it is in good condition.



stored in a rescue vehicle in the winter.

Do not use the device if it is defective (e.g. if the housing or the

defibrillation cable are damaged).

Only use the device with accessories, wearing parts and

disposable items which have proven to be completely safe to use

by being tested by a testing authority licensed to test the device

when equipped ready for use. These conditions are fulfilled by all

original DEFITEQ™ accessories and wearing parts.

Use new, undamaged and unexpired defibrillation electrodes for

every patient to avoid any possible burns to the skin!

Only connect the adhesive electrodes to the DEFITEQ™

Telefunken AED. Using the electrodes with other devices can

cause the patient to be given dangerous leakage currents.

Do not use the device in the immediate vicinity of other sensitive

equipment (e.g. measuring equipment that is sensitive to

magnetic fields) or strong sources of interference which could

affect the way the DEFITEQ™ Telefunken AED

sufficient distance away from other therapeutic and diagnostic

energy sources (e.g. diathermy, high frequency surgery, magnetic

resonance tomography). These devices can affect the DEFITEQ™

Telefunken AED and disrupt the way it operates. For this reason,

disconnect the patient from the connections of the interfering

devices.

you have been authorised to do so as a result of training.

you have ensured its operational safety before using it and



Do not use the device if it is defective (e.g. if the housing or the

Only use the device with accessories, wearing parts and

disposable items which have proven to be completely safe to use

testing authority licensed to test the device

when equipped ready for use. These conditions are fulfilled by all

original DEFITEQ™ accessories and wearing parts.

Use new, undamaged and unexpired defibrillation electrodes for

possible burns to the skin!

Only connect the adhesive electrodes to the DEFITEQ™

. Using the electrodes with other devices can

cause the patient to be given dangerous leakage currents.

Do not use the device in the immediate vicinity of other sensitive

equipment (e.g. measuring equipment that is sensitive to

magnetic fields) or strong sources of interference which could

Telefunken AED works. Keep a

istance away from other therapeutic and diagnostic

energy sources (e.g. diathermy, high frequency surgery, magnetic

resonance tomography). These devices can affect the DEFITEQ™

and disrupt the way it operates. For this reason,

patient from the connections of the interfering

15

DANGER During defibrillation, disconnect the patient from all other

medically used devices which do not have a defibrillation

resistance application part.

Keep the defibrillation electrodes away from other electrodes and

from metallic parts which are in contact with the patient.

Position the electrodes precisely according to the description.

Dry the chest and carefully remove any large amount of hair on

the patient before applying the defibrillation electrodes.

Do not place the defibrillation electrodes directly over an

implanted pacemaker to avoid a possible misinterpretation by the

device and to avoid any damage to the pacemaker from the

defibrillation impulse.

Do not touch the patient during the ECG analysis and avoid any

vibrations.

If the ECG analysis is being carried out in a vehicle, the vehicle has

to stop and switch off the engine to guarantee a correct analysis.

Stop any reanimation while the DEFITEQ™ Telefunken AED

analysing the ECG.


between

• parts of the patient's body (such as bare skin on head or legs),

as well as

• conductible liquids (such as gels, blood or salt solutions) and

• metallic objects around the patient (such as bed frame or

traction devices) which present unintended paths for the

defibrillation current.

During defibrillation, disconnect the patient from all other

medically used devices which do not have a defibrillation

Keep the defibrillation electrodes away from other electrodes and

from metallic parts which are in contact with the patient.

Position the electrodes precisely according to the description.

Dry the chest and carefully remove any large amount of hair on

the patient before applying the defibrillation electrodes.

Do not place the defibrillation electrodes directly over an

implanted pacemaker to avoid a possible misinterpretation by the

device and to avoid any damage to the pacemaker from the

Do not touch the patient during the ECG analysis and avoid any

If the ECG analysis is being carried out in a vehicle, the vehicle has

to stop and switch off the engine to guarantee a correct analysis.

Telefunken AED is


parts of the patient's body (such as bare skin on head or legs),

as gels, blood or salt solutions) and

metallic objects around the patient (such as bed frame or

traction devices) which present unintended paths for the

3.5 Safety notes for the protection of third parties

3.6 Safety notes for the protection of the device

16

notes for the protection of third parties

DANGER

Warn people in the vicinity loudly and clearly before the

defibrillation so that they step back from the patient and are no

longer in contact with him.

Safety notes for the protection of the device

CAUTION Damage to property

• Repairs, changes, extensions and installations of the

DEFITEQ™ Telefunken AED may only be carried out by

personnel authorised and trained by DEFITEQ

• The DEFITEQ™ Telefunken AED does not have any parts that

can be repaired by the user.

• The device may only be equipped and operated with original

accessories from DEFITEQ™.

• Only clean the device when it is switched off and the

electrodes have been removed and only clean it in the

prescribed manner.

Warn people in the vicinity loudly and clearly before the

defibrillation so that they step back from the patient and are no

CAUTION Damage to property

Repairs, changes, extensions and installations of the

may only be carried out by

personnel authorised and trained by DEFITEQ

does not have any parts that

e equipped and operated with original

Only clean the device when it is switched off and the

electrodes have been removed and only clean it in the

17

4 Description of the device

4.1 General description

The DEFITEQ™ Telefunken AED (PAD = Public Access Defibrillator) is an automatic external

defibrillator (AED) with an integrated single channel ECG.

The ECG is recorded using the DEFITEQ™ Electrodes. The algorithm implemented recognises

potentially fatal heart arrhythmia. The defibrillator generates the electric shock necessary to

reanimate a patient with a shockable ECG rhythm. This method is the generally recognised

therapy.

The DEFITEQ™ Telefunken AED product family has been designed to be safe and quick to use

in an emergency. All functional units are operating elements subject to the following

principles:

• Clear organisation of functional units

• Reduction of functions to what is necessary

• Intuitive and logical operator guidance

• Clear, self-explanatory operating elements

• Ergonomic layout.

The defibrillator unit has been optimised to be safe and very quickly ready to use. The

loading time for a defibrillation is approx. 12 seconds with a battery capacity of approx. 90 %

of the rated value.

The power supply of the DEFITEQ™ Telefunken AED comes from a disposable alkaline

battery.

The DEFITEQ™ Telefunken AED can be stored on a DEFITEQ™ wall mount rack which can be

affixed to a wall. It is easy and quick to remove the DEFITEQ™ Telefunken AED when you

need it.

Note The wall bracket and accessories are described in separate operating

instructions.

4.2 Description of the device d

Fig. 1: Telefunken AED

18

of the device details

Telefunken AED front view


19

Telefunken AED rear view

(1) Jack for electrode connector plug

(2) On/Off button

(3) "Do not touch patient" symbol (lights up during ECG analysis)

(4) Trigger button for defibrillation

(5) Loudspeaker

(6) Information button

(7) Status display

(8) Electrode LEDs

20

Fig. 3: Telefunken AED operating controls

"Do not touch patient" symbol (lights up during ECG analysis)

Fig. 4: Telefunken AED with accessories

(1) Stiff bag

(2) Telefunken AED

(3) Scissors

(4) Artificial respiration cloth

(5) Razor

(6) Rubber gloves, not sterilised

(7) USB cable

(8) Defibrillation electrodes

21

with accessories

Artificial respiration cloth

Rubber gloves, not sterilised

electrodes

22

4.3 Status display

In the table below is a list of the possible things displayed in the status display and their

meanings.

The battery is monitored using an electronic charge balance process.

Once the battery is exhausted, a warning tone will sound in connection with an audible

warning.

Audible warning.

Battery. < battery is almost empty>

Note If the device is being used, the corresponding audible warning will

be repeated regularly in the selected language. The battery symbol

in the status display is activated.

Display. Meaning. Measures to be taken.

Sufficient battery

capacity. Device ready to use.

Low battery capacity.

Device can be used.

Nearly time to exchange

battery.

Device defective.

Carry out major self-test

by reinserting the

battery or switching the

device on again.

Have the device repaired

by a service centre

authorized by DefiTeq

23

4.4 Data management

Note The device automatically records all the data in internal memory.

The data saved can be displayed with the aid of a PC / Laptop and the software DEFITEQTM

Telefunken AED View (optional accessory). However, this data may not be used for

diagnostic purposes or for therapy for the patient. It should only be used for administrative

or legal purposes. In the software there is a deployment protocol into which further patient

data can be entered.

The data saved in memory should be filed externally after every deployment if possible.

Operating the software is described separately.

The software is not intended for end-users, but for service providers only.

4.5 Description of the accessories

The accessories need to be secured appropriately before being transported.

4.5.1 Telefunken AED Electrodes


(1) Plug of the defibrillation electrodes

(2) Defibrillation electrodes with protective film

The electrodes are for single use only..

After using the device, the electrodes should be

replaced exchanged for a new set.

The electrodes may be opened only before use

4.5.2 Optional accessories

• DEFITEQ™ Telefunken AED

• DEFITEQ™ Cabinet Article

Subject to change without notice.

24

of the accessories


Electrodes

Telefunken AED Electrodes

Plug of the defibrillation electrodes

Defibrillation electrodes with protective film

CAUTION

The electrodes are for single use only..

After using the device, the electrodes should be

replaced exchanged for a new set.

The electrodes may be opened only before use

Telefunken AED View (read out software) Article No.: 871.848.127.311

Article No.: 871.848.127.304



No.: 871.848.127.311

5 Preparatory measures before (initial) start

5.1 Unpacking

After delivery, first of all check the packaging and the device for transport damage.

If you notice any damage to the device, immediately contact your Transport Company,

dealer or directly contact technical services at DefiTeq, stating the device number and

describing the damage to the device.

Satisfy yourself that the scope of delivery is complete in accordance with the enclosed

delivery note.

Dispose of the packaging material in an environm

25

measures before (initial) start-up




describing the damage to the device.

DANGER

Definitely do not use the device if you know of any damage.

Endangering health cannot be ruled out.


Dispose of the packaging material in an environmentally-friendly manner.




Definitely do not use the device if you know of any damage.


friendly manner.

5.2 Inserting / Changing the power supply unit (Battery)

Before using the DEFITEQ™

in the appropriate slot.

Note The Telefunken AED

After you have used the device, the battery should be exchanged

for a new one.

5.2.1 Inserting the battery

Fig. 6: Inserting the battery

Procedure:

Lay the device on its front

Press the power module completely slots into place and the power module is flush with the outside edge of the device.

Note If the battery has been installed correctly, the device will run a self

test. Now the device is ready to use.

26

/ Changing the power supply unit (Battery)

DEFITEQ™ Telefunken AED for the first time, the battery has to be inserted

Telefunken AED is always supplied with a battery.


for a new one.

: Inserting the battery

Lay the device on its front.

Press the power module completely into the device until you hear the "click" when it slots into place and the power module is flush with the outside edge of the device.

If the battery has been installed correctly, the device will run a self

test. Now the device is ready to use.

for the first time, the battery has to be inserted


into the device until you hear the "click" when it slots into place and the power module is flush with the outside edge of the device.

If the battery has been installed correctly, the device will run a self-

5.2.2 Removing the battery from the device

In order to prevent the battery from falling out, the design allows a tool (e.g. a screwdriver) as a

means of leverage.

Fig. 7: removing the battery

Note Only change the power module when the device is switched off

and the defibrillation electrode plug is disconn

27

CAUTION

Monitor the Status Display. If the display is showing "OK", the

device is ready to use.

If the display does not show "OK", remedy the cause or contact

your nearest service station.

the battery from the device

prevent the battery from falling out, the design allows a tool (e.g. a screwdriver) as a

Only change the power module when the device is switched off

and the defibrillation electrode plug is disconnected.

Monitor the Status Display. If the display is showing "OK", the

If the display does not show "OK", remedy the cause or contact

prevent the battery from falling out, the design allows a tool (e.g. a screwdriver) as a

Only change the power module when the device is switched off

5.3 DEFITEQ™ Battery

The battery is a disposable alkaline

state-of-the-art and was selected due to its extremely long service life and power storage.

Note If the device has to be sent away to technical services, remove the

battery before sending it and put some adhesive insulation tape

over its contacts.

When sending the battery, observe the separate shipping

regulations.

28

Battery

alkaline battery. It is fully charged when delivered. This type of battery is

art and was selected due to its extremely long service life and power storage.

WARNING

On no account try to charge the battery.

There would be risk of an explosion!

CAUTION

Use the battery before its use-by date expires.

After using the device, the battery should be exchanged for a new

one (to guarantee a full period of operation when next deployed).

If the device has to be sent away to technical services, remove the


over its contacts.


regulations.

battery. It is fully charged when delivered. This type of battery is

art and was selected due to its extremely long service life and power storage.

by date expires.

After using the device, the battery should be exchanged for a new

when next deployed).

If the device has to be sent away to technical services, remove the



29

6 Device self-test

6.1 Self-test after switching on the Telefunken AED

The self-test is triggered by switching on the DEFITEQ™ Telefunken AED or by inserting the

battery in the device. The Telefunken AED runs a device self-test to check all the important

parameters and signal mechanisms.

If the power module has been changed and if the device had previously found a fault, then

the full self-test (FULL) is automatically triggered. Please proceed to follow the device

instructions.

6.2 Automatic / periodic self-tests

The Telefunken AED automatically carries out self-tests to ensure that it is ready to use.

Frequency Effect of test

SHORT Daily Software, operating membrane, ECG

calibration, clock, internal voltage supply and

HV part at 0 V

MEDIUM First day of the month Software, operating membrane, ECG


HV part at 300 V

FULL After changing the power module,

detection of an internal fault and when

turning on.

Software, operating membrane, ECG


HV part at 1600 V

30

7 Operating the device and sequence of reanimation

Note The sequence of reanimation has been devised in accordance with

the recommended guidelines of the European Resuscitation

Council (Resuscitation (2010) 67S1, p7—p23 ) in the device. Ensure

that you have completed appropriate training before using the

device.

7.1 Switching the DEFITEQ™ Telefunken AED on / off

7.1.1 Switching the DEFITEQ™ Telefunken AED on

Switch the device on by pressing the On/Off button. After this, acoustical signals are given

and all LEDs will light up, all buttons are activated, apart from the trigger button. Triggering

defibrillation is only activated once ventricular fibrillation (VF) has been ascertained.

Directly after switching it on, an internal self-test is carried out to check important functions

and signal devices.

7.1.2 Switching the DEFITEQ™ Telefunken AED off

The DEFITEQ™ Telefunken AED can be switched off in different ways:

• By pressing the On/Off button.

If the device detects a fault it will automatically switch off to avoid possible injuries.

31

7.2 Voice output by the device / Preliminary examination of the patient

Note During the course of the voice output, you will be asked to

examine the patient.

For this, you will need to take the rubber gloves out of the cover of

the device and put them on.

After the self-test has been successfully performed by the device, the following instructions are

given:

< If there are no signs of life, remove clothing from chest and stick on

electrodes >

< Phone alarm number >

< Stick electrodes on the patients bare chest >

7.3 Undressing the patient

Note If during your preliminary examination, you have ascertained that the patient may need defibrillation, undress the upper body to be able to position the electrodes.

32

7.4 Determining the position of the electrodes

Fig. 8: Positions of electrodes on the patient

The positions of the electrodes are:

• On the right chest area, below the collar bone (1) and

• On the left chest area above the apex of the heart on the axillary line (2).

7.5 Removing hair growth from chest

If the patient has hair growing where the electrodes need to be positioned, you must remove

it.

Use the enclosed razor to remove the hair from the electrode positions.

Note Excessive hair can greatly increase the resistance between the adhesive

electrodes and the surface of the skin thus reducing the effectiveness of

the electric shock.

33

7.6 Drying the skin

In certain situations (e.g. after an acute myocardial infarction), it may be necessary to dry the

skin in the respective positions. A dry surface is essential for the adhesive electrodes to stick

on.

7.7 Opening electrodes

The DEFITEQ™ Telefunken AED

apply the defibrillation electrodes to the patient.

chest >

Procedure:

Open the defibrillation electrodes bag by tearing open the protective cover along the tear strip.

Remove the protective film (1) from one of the electrodes (2) and then immediately place the electrode on the positionon the back of the electrodes.

Proceed to remove the protective film from the second electrode and place it in its position.

Smooth the electrodes onto the patient ensuring there are no air bubbles electrodes!

7.8 Plugging in the electrode plugs

After positioning the electrodes on the patientTelefunken AED.

The red electrodes symbol LEDs on the membrane keyboard

< Do not touch the patient from now on >

Fig. 9: Plugging in the e

34

electrodes and positioning electrodes

Telefunken AED will give spoken instructions for you to

apply the defibrillation electrodes to the patient. < Stick electrodes on the

Open the defibrillation electrodes bag by tearing open the protective cover along the

Remove the protective film (1) from one of the electrodes (2) and then immediately place the electrode on the position you had ascertained previously. Refer to label stuck on the back of the electrodes.

Proceed to remove the protective film from the second electrode and place it in its

Smooth the electrodes onto the patient ensuring there are no air bubbles

DANGER Do not touch the floor, other objects, clothing or other parts of

the body with the electrodes (after removing the protective film)

as it may remove the conducting layer of gel on the electrodes.

A reduced layer of gel could cause burns on the skin under the

electrodes during defibrillation.

Plugging in the electrode plugs

positioning the electrodes on the patient insert the plug of the electrode cable into the jack on the

The red electrodes symbol LEDs on the membrane keyboard must go out, followed by the instruction

< Do not touch the patient from now on >

Plugging in the electrode plugs

on the patients bare

Open the defibrillation electrodes bag by tearing open the protective cover along the

Remove the protective film (1) from one of the electrodes (2) and then immediately you had ascertained previously. Refer to label stuck

Proceed to remove the protective film from the second electrode and place it in its

Smooth the electrodes onto the patient ensuring there are no air bubbles under the

Do not touch the floor, other objects, clothing or other parts of

the body with the electrodes (after removing the protective film)

as it may remove the conducting layer of gel on the electrodes.

A reduced layer of gel could cause burns on the skin under the

insert the plug of the electrode cable into the jack on the

must go out, followed by the instruction

35

7.9 Checking the electrodes

If the device notifies a fault, this could be for several reasons:

• Electrode plug not plugged in

• There is contact between the defibrillation electrodes or

a conductive gel connection.

• Hair on patient has not been removed

• Air pockets between skin and defibrillation electrodes cause a bad contact.

• Dried out electrodes.

Remedy the cause of the fault.

• Check if electrode plug is inserted correctly

• Check if electrodes are positioned on the correct part of the body

• Check if electrodes don’t touch each other

• Check if Excessive hair on chest has been removed, if not than do so

• Check on air bubbles between electrodes and skin, if yes smooth them

• Check expiration date of the electrodes

7.10 Carrying out the ECG analysis

If the defibrillation electrodes have been applied, the device will automatically start the analysis.

Now the patient has to be put in an immobile position and may no longer be touched.

The device announces: < Do not touch the patient from now on, Anal

The algorithm of the device program will now check the ECG for ventricular fibrillation. This process

takes approx. 7 - 12 seconds. If the device identifies VF, it will recommend defibrillation.

The rhythm identification detector continuously analyses the ECG, even after a rhythm in need of

defibrillation has been identified.

7.11 Defibrillation required

If the device clearly identifies VF, then it will recommend defibrillation which is automatically

prepared inside the device.

The device announces:

< Shock necessary >

< Preparing shock >

Once the capacitor has been loaded internally, the energy for th

available for 15 seconds and is signalled by a continuous beep and the trigger button lighting

up "green". If you do not defibrillate within this period, an internal safety discharge will

follow and the ECG will be analysed agai

< Press the flashing shock button >

36

Carrying out the ECG analysis



< Do not touch the patient from now on, Analysing heart rhythm >


12 seconds. If the device identifies VF, it will recommend defibrillation.

DANGER

Observe the patient during the entire reanimation.

It is possible at any time that the patient may regain

consciousness and does not need to be defibrillated.

If that is the case, do not carry out the defibrillation under any

circumstances.


defibrillation has been identified.

required


prepared inside the device.

Once the capacitor has been loaded internally, the energy for the defibrillation impulse is



follow and the ECG will be analysed again.

< Press the flashing shock button >



ysing heart rhythm >


12 seconds. If the device identifies VF, it will recommend defibrillation.

Observe the patient during the entire reanimation.

It is possible at any time that the patient may regain

consciousness and does not need to be defibrillated.

If that is the case, do not carry out the defibrillation under any



e defibrillation impulse is



Press the trigger button for defibrillation, which will happen immediately after the

button is pressed.

This process is repeated in accordance with the ERC Guidelines 2010. After that, there will be

a pause, depending on the set

The charge time of the capacitor for defibrillation depends on the available b

If the power module is slightly discharged, the charge time can be slightly longer.

If an error should occur during charging, an intermittent warning beep will sound.

Note If, when the device is switched on, no ECG is done for 10 minut

or no button is pressed, the device automatically switches off. An

intermittent warning beep is signalled for approx. 30 seconds

before switching off. Pressing any button or any other activity will

interrupt the switching off process.

7.12 Defibrillation not required

If the device cannot find a shockable rhythm, then it recommends cardiopulmonary

resuscitation (CPR).

< Shock not advised >

< Patient may be touched, carry on resuscitation, alternately give 30

chest compressions and 2 mouth to mouth breaths >

Once the CPR time has expired, the device returns to ECG analysis

7.13 Keep the defibrillator ready for use

• At the end of a reanimation, clean the device, replace the electrodes and battery so that

the DEFITEQ™ Telefunken AED

possible.

• If any malfunctions or noticeable problems occur, please contact your nearest

station.

37

DANGER Before pressing the trigger button, ensure that all devices

connected to the patient are removed if they are not defibrillation

protected.

Before and during the energy discharge all those

the reanimation have to step back and all contact with the patient

or conductive parts (e.g. a stretcher) must be avoided.


button is pressed.


a pause, depending on the set-up setting for cardiopulmonary resuscitation (CPR).

The charge time of the capacitor for defibrillation depends on the available b



If, when the device is switched on, no ECG is done for 10 minut




interrupt the switching off process.

not required

find a shockable rhythm, then it recommends cardiopulmonary

< Shock not advised >

Patient may be touched, carry on resuscitation, alternately give 30


Once the CPR time has expired, the device returns to ECG analysis

the defibrillator ready for use

At the end of a reanimation, clean the device, replace the electrodes and battery so that

Telefunken AED is ready to use again for the next time as soon as

If any malfunctions or noticeable problems occur, please contact your nearest

Before pressing the trigger button, ensure that all devices

connected to the patient are removed if they are not defibrillation

Before and during the energy discharge all those participating in

the reanimation have to step back and all contact with the patient

or conductive parts (e.g. a stretcher) must be avoided.



up setting for cardiopulmonary resuscitation (CPR).

The charge time of the capacitor for defibrillation depends on the available battery capacity.



If, when the device is switched on, no ECG is done for 10 minutes




find a shockable rhythm, then it recommends cardiopulmonary

Patient may be touched, carry on resuscitation, alternately give 30


At the end of a reanimation, clean the device, replace the electrodes and battery so that

is ready to use again for the next time as soon as

If any malfunctions or noticeable problems occur, please contact your nearest service

8 Cleaning, maintenance and dispatch

8.1 Cleaning

Clean the device and all its accessories, such as the wall bracket, with commercially available

household cleaners.

Use a slightly damp, clean cloth.

Use normal disinfectant to disinfect it

(e.g. Gigasept FF, Bacillol or Spitacid).

38

Cleaning, maintenance and dispatch

WARNING Only clean the device when it is switched off and with the

electrodes unplugged. Beforehand, remove the power module

from the device

Do not use any dripping wet cloths to clean it. Do not spill any

liquids over the device and do not immerse it in any liquids.


Use a slightly damp, clean cloth.

Use normal disinfectant to disinfect it

(e.g. Gigasept FF, Bacillol or Spitacid).

Only clean the device when it is switched off and with the

electrodes unplugged. Beforehand, remove the power module

clean it. Do not spill any

liquids over the device and do not immerse it in any liquids.


8.2 Servicing

Independently of the use of the device, we recommend regular visual inspection / servicing

of the DEFITEQ™ Telefunken AED

once a year.

Make sure that the housing, cable, electrodes and all the other accessories are undamaged.

8.2.1 Servicing check list

Check the expiry date

• of the electrodes

• of the battery pack (optional) and

• if necessary replace the parts.

Check whether

• the status display "OK" is showing.

• you can switch on the device.

• the device automatically carries out the self

• the slot for the power supply is clean.

• the device is fully equipped.

When doing so, pay attention to the following:

Note For more detailed information on the regular safety and

metrological checks in accordance with the Ordinance on the

Operation and Use of Med

Appendix.

39


Telefunken AED and the accessories by the user / service technician at least


Check the expiry date

(optional) and

if necessary replace the parts.

the status display "OK" is showing.

you can switch on the device.

the device automatically carries out the self-test after being switched on.

the slot for the power supply is clean.

the device is fully equipped.

When doing so, pay attention to the following:

DANGER

• If parts of the housing or insulation are damaged, they must

be repaired or exchanged immediately.

• If parts of the housing or insulation are damaged, do not use

the device or switch it off immediately.

• Have the device repaired as soon as possible by the

manufacturer.

For more detailed information on the regular safety and


Operation and Use of Medical Devices (MPBetreibV), refer to the

Appendix.


and the accessories by the user / service technician at least


test after being switched on.

If parts of the housing or insulation are damaged, they must

If parts of the housing or insulation are damaged, do not use

Have the device repaired as soon as possible by the

For more detailed information on the regular safety and


ical Devices (MPBetreibV), refer to the

40

8.3 Dispatching the DEFITEQ™ Telefunken AED

Note If you want to return the device for additional equipping or for a

service, it is important that you remove the battery from the

device first and include it with the device, but packaged separately.

Where possible, use the original box.

9 Disposal

Fig. 10: Disposal

In accordance with the founding principles of the company DefiTeq, your product has been

developed and made using high quality materials and components which are recyclable.

At the end of its serviceable life, recycle the device through disposal companies registered

under public law (council recycling facilities). Proper disposal of this product helps with

environmental protection.

Through registration of DefiTeq with the res

and utilisation of electronics devices introduced onto the market by us is secure in

accordance with the EU

(WEEE-directive).

For business customers in the European Union

Please contact your dealer or supplier if you want to dispose of electrical and electronic

equipment. He will have further informat

Information for disposal in countries outside the European Union

This symbol is only applicable within the European Union.

41





environmental protection.

Through registration of DefiTeq with the responsible authorities, we ensure that the disposal


directive on the disposal of electronic and electrical equipment

CAUTION Improper disposal of the device or its individual parts can lead to

injury.

For business customers in the European Union


equipment. He will have further information on this for you.

Information for disposal in countries outside the European Union

This symbol is only applicable within the European Union.





ponsible authorities, we ensure that the disposal


directive on the disposal of electronic and electrical equipment

Improper disposal of the device or its individual parts can lead to


42

10 Technical Data

Parameter Value

Dimensions 220 x 275 x 85mm

Weight 2,6 kg

Device class IIb

Operation

Temperature range

Pressure

Humidity

0° C – + 35° C (without electrodes)

800 – 1060 hPa

0% – 95%

Protection class against water and dust IP 55

Standby time of the batteries 3 years

Number of shocks (with a new battery) > 200

Applied norms EN 60601-1:2006

EN 60601-1-4:1996

EN 60601-1:2007

EN 60601-2-4:2003

More as specified in requirements specifications

Resuscitation protocol ERC 2010

ECG analysis Automated ECG analysis including:

Shockable rhythms (VF, fast VT)

Non-shockable rhythms (asystole, NSR, etc.)

Sensitivity > 90%, typ. 98%

Specificity > 95%, typ. 96%

Asystole threshold < ±80µV

Impedance control Continuous Impedance measurement

Motion detection

Respiration detection

Control of electrode contact quality

Languages Danish, Dutch, English, French, German, Italian,

Mandarin Chinese, Norwegian, Russian, Spanish,

Swedish

Communication interface USB 2.0 interface

(Configuration, Service communication)

User interface Three-button operation (Power-,Shock- and Info

Button), LED Indicators for the status and

resuscitation flow

Defibrillation impulse Biphasic current controlled

Maximal shock energy High Energy: 300J (patient impedance 75Ω)

Low Energy: 200J (patient impedance 100Ω)

Maximum time from the initiation of rhythm

analysis with a clear shockable ECG signal to

readiness for discharge:

• 24seconds with new battery

• 24seconds after 6 discharges

Maximum time after 6 discharges from initially

switching power on to ready for discharge at

maximum energy:

35 seconds


43

11 Warranty conditions

The warranty period is 72 months and starts on the day of purchase. It is important to keep

the receipt as proof of purchase.

Within this time period, DefiTeq will remedy any defects in the device free of charge if they

are based on material or manufacturing errors. The device can be reinstated to its original

condition as selected by DEFITEQ either by repair or replacement.

A claim under warranty does not extend the original warranty period.

Warranty and also legally entitled warranty claims are not applicable if the usefulness of the

device is only negligibly affected, or in the case of normal wear and tear (e.g. consumables

such as battery pack) or damage caused after transfer of risk as a result of incorrect or

negligent handling, excessive wear or are caused by special external influences which are not

provided for according to the contract. The same applies if inappropriate changes or

incorrect repair work is carried out by the buyer or by a third party.

All other claims against DEFITEQ are excluded out unless such claims are based on intent or

gross negligence or compulsory legal liability standards.

Warranty claims made by the buyer against the seller (dealer) are not affected by this

guarantee.

In the case of a warranty claim, please return the device with proof of purchase (e.g. invoice)

stating your name and address to your dealer. Always obtain a return authorization first

before shipping (RMA number).

DEFITEQ After-Sales Service is glad to be at your disposal, even after the warranty period has

expired.

44

12 Technical Description

The cardio-biphasic shock pulse

The cardio-biphasic shock pulse is characterized by limitation of the maximum current. Myocardial

dam-age, usually caused by electric currents which are too high, in particular at low patient

impedances, is considerably reduced.

Functional principle If the current exceeds the specified nominal value, the supply of current is

interrupted. Inductance in the conductive path means that current continues to flow to the patient,

but gradually falls. If the current drops below the specified value by more than one ampere, the cur-

rent supply is switched back on. The current flowing to the patient accordingly rises again. A saw

tooth-type pulse forms.

Principal form of the cardio-biphasic shock pulse.

The relationship of electrical charge delivered (integral of current over time) between the second

(negative) and first (positive) phase averages 0.38.

Impedance dependency

For safety reasons, voltages of no more than 2.000 V are used. The currents resulting from this as a

function of patient impedance are shown

In some patients, the standard quantity of energy is not adequate, as the myocardium has already

sustained too much prior damage, for example. In these cases, the American Heart Association and

the European Resuscitation Council both recommend increasing t

shock onwards.

On the Telefunken AED, it is therefore possible to select a second pulse form with higher energy in

Setup. The currents resulting from this pulse form as a function of patient impedance are shown in

the following graph.

45


function of patient impedance are shown in the following graph.



the European Resuscitation Council both recommend increasing the energy to 360 J from the third

, it is therefore possible to select a second pulse form with higher energy in





he energy to 360 J from the third

, it is therefore possible to select a second pulse form with higher energy in


46

13 Rhythm detection system

The rhythm detection system of the Telefunken AED analyses the patient's ECG and supports

you if the device identifies a shockable or a non-shockable rhythm.

The device's rhythm detection system includes:

Ascertaining the electrode contact

Automatic evaluation of the ECG

Operator control of the defibrillation shock therapy

The transthoracic impedance of the patient is measured by the defibrillation electrodes. If

the baseline impedance is greater that the maximum critical value, the device detects that

the electrodes are not in good enough contact with the patient or that, they are not

connected properly to the device. ECG analysis and dispensation of defibrillation shocks are

therefore prevented. The voice output says "Stick electrodes on the patients bare chest" if

the contact of the electrodes is insufficient.

Automatic Interpretation of the ECG

The device's rhythm detection system has been designed so that a defibrillation shock is

recommended if the system has been connected up to a patient who is unconscious, not

breathing and has no pulse and the system ascertains a shockable rhythm.

With all other ECG rhythms, including asystolia and normal sinus rhythms, the rhythm

detection system in the device does not recommend defibrillation.

Operator control of the output of defibrillation shocks

The device's rhythm detection system triggers automatic charging of power if the device

ascertains a shockable cardiac rhythm. Optical and acoustic messages are emitted to show

you that the device recommends giving a defibrillation shock. If a defibrillation shock is

recommended, you decide whether and when the shock is to be given.

47

14 Guidelines and manufacturer's declaration - Electromagnetic

emissions

Guidance and manufacturer's declaration - electromagnetic emissions

The PAD Telefunken AED is intended for use in the electromagnetic environment specified below. The costumer or the user of the

PAD Telefunken AED should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment -

guidance

RF emissions CISPR 11 Group 1

The PAD Telefunken AED 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 PAD Telefunken AED is suitable for

use in all establishments other than

domestic and those 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


The PAD Telefunken AED is intended for use in the electromagnetic environment specified bellow. The costumer or the user of the

PAD Telefunken AED should assure that it is used in such an environment.

Immunity test IEC 60601-1 test level Compliance level Electromagnetic environment -

guidance

Electrostatic discharge

(ESD)

IEC 61000-4-2

+/- 6kV contact

+/- 8 kV air

+/- 6kV contact

+/- 8 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered

with synthetic materials, the

relative humidity should be at least

30%.

Electrical fast transient/

burst

IEC 61000-4-4

+/- 2 kV for power supply lines

+/- 1 kV for input/ output lines Not applicable

Surge

IEC 61000-4-5

+/- 1 kV differential mode

+/- 2 kV common mode Not applicable

Voltage dips, short

interruptions and

voltage variations on

power supply input lines

IEC 61000-4-11

<5% for 5s

<5% for 0,5 cycles

40% for 5 cycles

70% for 25 cycles

Not applicable

Power frequency

(50/60Hz) magnetic

fields

IEC 61000-4-8

3 A/m 3 A/m

Power frequency magnetic fields

should be at levels characteristic of

the typical location in a typical

commercial or hospital

environment.

48


The PAD Telefunken AED is intended for use in the electromagnetic environment specified bellow. The costumer or the user

of the PAD Telefunken AED should assure that it is used in such an environment.

Immunity test IEC 60601-1 test level Compliance level Electromagnetic environment -

guidance

Portable and mobile RF

communications equipment should

be used no closer to any part of the

PAD Telefunken AED, including

cables, than the recommended

separation distance calculated from

the equation applicable to the

frequency of the transmitter.

Recommended Separation distance:

conducted RF

IEC 61000-4-6

3 Veff

150 kHz to 80 MHz

outside ISM bands Not applicable

10 Veff

150 kHz to 80 MHz

inside ISM-bands Not applicable

Radiated

IEC 61000-4-3

20 V/m (according IEC

60601-2-4)

80 MHz to 2,5 GHz 20 V/m

d= 0,6 * SQRT(P/W) for 80 MHz to

800 MHz

d= 1,15 * SQRT(P/W) for 800 MHz to

2,5 GHz

Where P is the maximum output

power rating of the transmitter in

watts (W) according to the

transmitter manufacturer and d is

the recommended separation

distance in meters (m).

Field strength from fixed RF

transmitters, as determined by an

electromagnetic site survey, should

be less than the compliance level in

each frequency range.

Interference may occur in the

vicinity of equipment marked with

the symbol "nonionising radiation".

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

Field strength from fixed transmitters, such as base stations for radio (Cellular/cordless) telephones and land mobile radios,

amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.

To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be

considered. If the measured field strength in the location in which the PAD Telefunken AED is used exceeds the applicable

RF compliance level above, additional measures may be necessary, such as reorientation or relocating the PAD Telefunken

AED .

49

Recommended separation distances between

portable and mobile RF communications equipment and the PAD Telefunken AED

The PAD Telefunken AED is intended for use in an electromagnetic environment in which the radiated RF

disturbances are controlled. The costumer or the user of the PAD Telefunken AED can help prevent

electromagnetic interference by maintaining a minimal distance between portable and mobile RF

communications equipment (transmitters) and the PAD Telefunken AED 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 MHz

outside ISM-bands

150 kHz to 80

MHz

in ISM-bands

d=0,6 * SQRT(P/W) d=1,15 * SQRT(P/W)

0,01 0,06 0,12

not applicable according IEC

60601-2-4:2010

not applicable

according IEC

60601-2-4:2010

0,1 0,19 0,36

1 0,60 1,15

10 1,90 3,64

100 6,00 11,50

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.

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.

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15 Safety checks

In accordance with the Ordinance on the Operation and Use of Medical Devices

(MPBetreibV) § 6 (Safety checks) the user is obliged to have regular checks carried out. In

accordance with the Ordinance on the Operation and Use of Medical Devices (MPBetreibV) §

6, DEFITEQ stipulate these checks be carried out in a 24-month cycle.

The safety checks may only be assigned to people who, because of their training, their

knowledge and their experience gained through practical activity, can carry the checks out

properly and do not need instruction to do so.

If defects are found during a safety check which could endanger

patients, device users or third parties, in accordance with the Ordinance on the Operation

and Use of Medical Devices (MPBetreibV) § 3, the operator must immediately inform the

responsible authority.

In the medical products log to be kept in accordance with the Ordinance on the Operation

and Use of Medical Devices (MPBetreibV) § 7, the following data is to entered:

• Time of carrying out the work

• Name of person or company carrying out the work

• Measures taken.

The responsibility of DEFITEQ only covers the information provided in the operating

instructions. This applies in particular for readjustments, repairs and changes to the device.

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16 Index of diagrams

Fig. 1 Telefunken AED front view 18

Fig. 2 Telefunken AED rear view 19

Fig. 3 Telefunken AED operating controls 20

Fig. 4 Telefunken AED accessories 21

Fig. 5 Telefunken AED Electrodes 24

Fig. 6 Inserting the battery 26

Fig. 7 Removing the battery 27

Fig. 8 Positions of electrodes on the patient 32

Fig. 9 Plugging in the electrode plugs 34

Fig. 10 Disposal 41

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17 Annex - Rhythm Analysis Detector

According to IEC / EN60601-2-4 it is an essential performance requirement for a defibrillator to “accurately differentiate between shockable and nonshockable rhythms”. This is also defined in the Requirements for RHYTHM RECOGNITION DETECTOR where the sensitivity of the device to recognize VF at peak to peak amplitude of 200 µV or higher shall exceed 90% in the absence of artefacts. For devices which detect VT, the sensitivity shall exceed 75%. The specificity of the detector in correctly differentiating non-shockable rhythms shall exceed 95% in the absence of artefacts.

1. Test of the rhythm analysis detector

a. Test databank [Databank1]

For the tests of the VF/VT recognition algorithm, data was taken from the CU (Creighton University) Ventricular Tachyarrhythmia databank. This database includes 35 eight-minute ECG recordings of human subjects who experienced episodes of sustained ventricular tachycardia, ventricular flutter, and ventricular fibrillation. Record cu01 was obtained from a long-term ECG (Holter) recording (played back at real time for digitization); the other records were digitized in real time from high-level (1 V/mV nominal) analog signals from patient monitors. All signals were passed through an active second-order Bessel low-pass filter with a cut-off of 70 Hz, and were digitized at 250 Hz with 12-bit resolution over a 10 V range (10 mV nominal relative to the unamplified signals). Each record contains 127,232 samples (slightly less than 8.5 minutes). In episodes of cardiac failure, fibrillation is almost always preceded by a run of ventricular tachycardia, which eventually gives way to the fibrillation itself. The onset of fibrillation is extremely difficult to pinpoint in many cases. Any clinically useful detector should respond to the runs of tachycardia preceding fibrillation, since medical intervention is needed at the earliest opportunity. Thus any detector responding to the premonitory tachycardia can exhibit a negative “time to alarm” compared to the onset of fibrillation as recorded in the reference annotation files. For this reason, the database is defined as a tachyarrhythmia database rather than a fibrillation database. In these records, the minimum number of non-VF beats prior to the onset of a VF episode is 61. The mean time interval from the beginning of the record to the onset of VF is 5:47 (with a standard deviation of 2:01). Repeated defibrillation attempts are visible in many records. The reference annotation files supplied for this database have been included to aid users in locating events of interest. They are in no sense definitive. All beats are labelled normal (although many are ectopic). VF onset annotations mark only the approximate beginnings of VF episodes.

b. Rhythm selection criteria

The ECG data from the CU database was divided into two groups – “Shockable” and “Nonshockable” rhythms. All ECG signals from the CU databank were divided into 20 second segments. The 20 second period was chosen to accommodate both pre and post rhythm analysis cycles (Voice prompt delivery and analysis time). To avoid loss of signals, there is a 10 second overlap between two segments (see Figure 1).

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All 20 second segments together led to a total number of 1187 ECG signals in the nonshockable group and 200 ECG signals in the shockable group. These ECG segments were fed through to the device and the recognition decisions on rhythm analysis were recorded through the voice prompts.

ECG-signals prepared for Test

According to the standard • A true positive (A) is a correct classification of a shockable rhythm. • A true negative (D) is a correct classification of all rhythms for which a shock is not indicated. • A false positive (B) is an organized or perfusing rhythm or asystole that has been incorrectly classified as a shockable rhythm. • A false negative (C) is a VF or VT associated with cardiac arrest that has been incorrectly classified as non-shockable. The sensitivity of the device for shockable rhythms is A / (A+C) The true predictive value is expressed as A / (A+B) The specificity of the device for non-shockable rhythms is D / (B+D) The false positive rate is expressed as B / (B+D)

c. Test results

The results of the tests are shown in the tables below: True Positives (A) False Positives (B) False Negatives (C) True Negatives (D) 192 26 8 1161 Specifity Sensitivity True predictive value False positive rate 1161 / (1161+26) x 100% = 97,8%

192 / (192 + 8) x 100% = 96%

192 / (192 + 26) x 100% = 88%

26 / (26 + 1161) x 100% = 2,2%

d. Conclusion

Sensitivity and specificity comply with all requirements set by IEC/EN 60601-2-4 and ANSI/AAMI DF80.

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2. VERIFICATION OF ECG SIGNAL QUALITY ANALYSIS

The VF/VT Analysis algorithm evaluates the signal quality of ECG. Artefacts in the ECG signal that may have been introduced due to motion artefacts or noise are detected and taken into consideration. The VF/VT algorithm requires 9 seconds to decide whether the ECG rhythm is shockable or non-shockable. If artefacts are found in the signal, time taken for analysis is longer. The algorithm makes a decision only if no artefacts are present in the signal and if an accurate decision can be made. If no rhythm detection can be made 15 seconds after the analysis has begun, movement detection error is logged. The user is again advised not to touch or move the patient and the ECG analysis restarts. If artefacts are again found during the analysis re-run, the CPR cycle (Chest compressions and Ventilation) automatically begins.

a. Objective To evaluate and verify ECG signal quality analysis system.

b. Test Databank In this test, ECG data from a test databank is tested. The test is executed embedding the analysis algorithm Matlab/Simulink data is evaluated considering different parameters of the algorithms. The source for the ECG data is the Physionet Databank:

1. MIT-BIH Noise Stress Test Database [Databank2] This database includes 12 half-hour ECG recordings and 3 half-hour recordings of noise typical in ambulatory ECG recordings. The noise recordings were made using physically active volunteers and standard ECG recorders, leads, and electrodes; the electrodes were placed on the limbs in positions in which the subjects' ECGs were not visible. The three noise records were assembled from the recordings by selecting intervals that contained predominantly baseline wander (in record 'bw'), muscle (EMG) artefact (in record 'ma'), and electrode motion artefact (in record 'em'). Electrode motion artefact is generally considered the most troublesome, since it can mimic the appearance of ectopic beats and cannot be removed easily by simple filters, as can noise of other types. Noise was added at the beginning after the first 5 minutes of each record, consisting of two-minute segments alternating with two-minute clean segments. Since the original ECG recordings are clean, the correct beat annotations are known even when the noise makes the recordings visually unreadable. The reference annotations for these records are simply copies of those for the original clean ECGs.

2. Creighton University Ventricular Tachyarrhythmia Database [Databank1] (http://physionet.org/physiobank/database/cudb/ )

c. Procedure For the artefact free ECG signal, the analysis was complete in exactly 9 seconds. With the presence of artefacts, the analysis took longer to complete. After 15 seconds, when no analysis result could be determined, “Movement detected” was logged.

d. Results

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The signal quality analysis system recognizes artefacts in the signal and delays the decision of the algorithm in case of bad signal quality. Bad signal quality (caused e.g. by movement) is reported by voice prompt “Movement detected” after the defined timeout of 15 seconds.

3. REFERENCES:

[Databank1] http://physionet.org/physiobank/database/cudb/ [Databank2] http://physionet.org/physiobank/database/nstdb/

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18 Contact details

Manufacturer:

DefiTeq International BV

Mispelhoeftstraat 31B

5651 GK Eindhoven

The Netherlands

Email: [email protected]

Web: www.defiteq.com

Documents

Telefunken AED User Manual English V2.3 2012 · Servicing check list 39 8.3. Dispatching the DEFITEQ™ Telefunken AED 40 9. Disposal 41 ... Telefunken AED is a public access defibrillator