telefunken aed user manual english v2.3 2012 · servicing check list 39 8.3. dispatching the...
TRANSCRIPT
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.
It is imperative that you pay attention to these texts.
CAUTION
Texts marked with CAUTION indicate a possible dangerous
situation which could lead to minor injuries or damage to
property.
It is imperative that you pay attention to these texts.
This symbol indicates text which contains important advice /
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.
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
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
It is imperative that you pay attention to these texts.
Texts marked with CAUTION indicate a possible dangerous
situation which could lead to minor injuries or damage to
It is imperative that you pay attention to these texts.
advice /
This point identifies the first step of a sequence of actions you should take.
Texts set in angle brackets denote acoustic information / instructions of the
device which are shown simultaneously on the monitor, depending on the device
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
(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.
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
, depending on the country where the device is sold:
automatic defibrillator (e.g. in Germany):
The device requests the user to press a button in order to release the shock.
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
(AED). The device is a tool for the reanimation of patients that weight at least 20 kg and show signs
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 analysis the
patient's ECG curve. In case of need it prepares an electrical charge. After this the device requests
In case an electrical charge needs to be applied to the patient, there are two versions of Telefunken
The device requests the user to press a button in order to release the shock.
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
Both in conjunction with its accessories and the optional accessories, and also individually,
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.
Despite this, if used incorrectly, the device and its accessories can be dangerous to the user,
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.
Both in conjunction with its accessories and the optional accessories, and also individually,
fulfils the currently applicable safety standards and complies
its accessories are safe when used as intended and taking into account the
Despite this, if used incorrectly, the device and its accessories can be dangerous to the user,
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.
Observe the information and rules in the appendix on using the
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),
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. Regular checks of the device are to
be documented in it.
For the other states in the European Community, national regulations for operating medical
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
Observe the information and rules in the appendix on using the
The device complies with the Medical Devices Law (MPG) and is subject to the Ordinance
of Medical Devices (MPBetreibV),
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),
ular checks of the device are to
For the other states in the European Community, national regulations for operating medical
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.
Before using it, check whether the device is in the operating
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.
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 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
Before using it, check whether the device is in the operating
temperature range. This applies for example, if the defibrillator is
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.
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.
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
Do not touch the patient during defibrillation. Avoid any contact
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
Fig. 2: Telefunken AED
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
Fig. 5: Telefunken AED
(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
The accessories need to be secured appropriately before being transported.
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
Subject to change without notice.
The accessories need to be secured appropriately before being transported.
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
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.
DANGER
Definitely do not use the device if you know of any damage.
Endangering health cannot be ruled out.
Satisfy yourself that the scope of delivery is complete in accordance with the enclosed
Dispose of the packaging material in an environmentally-friendly manner.
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
Definitely do not use the device if you know of any damage.
Satisfy yourself that the scope of delivery is complete in accordance with the enclosed
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.
After you have used the device, the battery should be exchanged
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
After you have used the device, the battery should be exchanged
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
battery before sending it and put some adhesive insulation tape
over its contacts.
When sending the battery, observe the separate shipping
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
battery before sending it and put some adhesive insulation tape
When sending the battery, observe the separate shipping
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
calibration, clock, internal voltage supply and
HV part at 300 V
FULL After changing the power module,
detection of an internal fault and when
turning on.
Software, operating membrane, ECG
calibration, clock, internal voltage supply and
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
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.
< Do not touch the patient from now on, Analysing heart rhythm >
The algorithm of the device program will now check the ECG for ventricular fibrillation. This process
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.
The rhythm identification detector continuously analyses the ECG, even after a rhythm in need of
defibrillation has been identified.
required
If the device clearly identifies VF, then it will recommend defibrillation which is automatically
prepared inside the device.
Once the capacitor has been loaded internally, the energy for the defibrillation impulse is
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 again.
< Press the flashing shock button >
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.
ysing heart rhythm >
The algorithm of the device program will now check the ECG for ventricular fibrillation. This process
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
The rhythm identification detector continuously analyses the ECG, even after a rhythm in need of
If the device clearly identifies VF, then it will recommend defibrillation which is automatically
e defibrillation impulse is
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
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.
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-up setting for cardiopulmonary resuscitation (CPR).
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.
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.
not required
find a shockable rhythm, then it recommends cardiopulmonary
< 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
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.
Press the trigger button for defibrillation, which will happen immediately after the
This process is repeated in accordance with the ERC Guidelines 2010. After that, there will be
up setting for cardiopulmonary resuscitation (CPR).
The charge time of the capacitor for defibrillation depends on the available battery capacity.
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.
If, when the device is switched on, no ECG is done for 10 minutes
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
find a shockable rhythm, then it recommends cardiopulmonary
Patient may be touched, carry on resuscitation, alternately give 30
chest compressions and 2 mouth to mouth breaths >
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.
Clean the device and all its accessories, such as the wall bracket, with commercially available
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.
Clean the device and all its accessories, such as the wall bracket, with commercially available
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
Independently of the use of the device, we recommend regular visual inspection / servicing
Telefunken AED and the accessories by the user / service technician at least
Make sure that the housing, cable, electrodes and all the other accessories are undamaged.
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
metrological checks in accordance with the Ordinance on the
Operation and Use of Medical Devices (MPBetreibV), refer to the
Appendix.
Independently of the use of the device, we recommend regular visual inspection / servicing
and the accessories by the user / service technician at least
Make sure that the housing, cable, electrodes and all the other accessories are undamaged.
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
metrological checks in accordance with the Ordinance on the
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
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 responsible authorities, we ensure that the disposal
and utilisation of electronics devices introduced onto the market by us is secure in
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
Please contact your dealer or supplier if you want to dispose of electrical and electronic
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.
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
ponsible authorities, we ensure that the disposal
and utilisation of electronics devices introduced onto the market by us is secure in
directive on the disposal of electronic and electrical equipment
Improper disposal of the device or its individual parts can lead to
Please contact your dealer or supplier if you want to dispose of electrical and electronic
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
Subject to change without notice.
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
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 the following graph.
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 the energy to 360 J from the third
, 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
For safety reasons, voltages of no more than 2.000 V are used. The currents resulting from this as a
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
he energy to 360 J from the third
, 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
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.
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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
Guidance and manufacturer's declaration - electromagnetic emissions
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.
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Guidance and manufacturer's declaration - electromagnetic emissions
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 .
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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