FRED PA 1 User Manual

FRED PA-1
Automated external defibrillator (AED)

Art. no.: 0-48-0240 Rev. c *0-48-0240*
User Guide
Sales and service information
The SCHILLER sales and service centre network is world-wide. For the address of your
local distributor, contact your nearest SCHILLER subsidiary.
In case of difficulty, a complete list of all distributors and subsidiaries is provided on our
internet site:
http://www.schiller.ch
Sales information can also be obtained from:
[email protected]
Manufacturer and responsible for the marking (first declaration October 2015)
SCHILLER Medical S.A.S. Tel.: +33 (0) 388 63 36 00

4, rue Louis Pasteur Fax: +33 (0) 388 94 12 82
F- 67162 Wissembourg E-mail: [email protected]
Web: www.schiller-medical.com
Address Headquarters
SCHILLER AG Phone: +41 (0) 41 766 42 42
Altgasse 68 Fax: +41 (0) 41 761 08 80
CH-6341 Baar, Switzerland E-mail: [email protected]
Web: www.schiller.ch
Article no.: 0-48-0240 Rev. c

Issue date: 23.03.17
Corresponds to: original
Software: 03
FRED PA-1 User Guide
Table of Contents
1 Safety Notes .............................................. 5
1.1 User profiles.......................................................................... 5
1.2 Responsibility of the User ................................................... 5
1.3 Intended Use ......................................................................... 5
1.4 Contraindication for use ...................................................... 6
1.5 Organisational Measures ..................................................... 6
1.6 Safety-Conscious Operation ............................................... 6
1.7 Operation with other Devices .............................................. 7
1.8 Maintenance and Cleaning .................................................. 7
1.9 General Notes Regarding the Unit ...................................... 7
1.10 Additional Terms .................................................................. 8
1.10.1 Implied authorisation .......................................................................... 8
1.10.2 Terms of Warranty ............................................................................. 8
1.11 Symbols/Indicators .............................................................. 9
1.11.1 Symbols used in this user guide ........................................................ 9
1.11.2 Symbols used on the device .............................................................. 9
1.11.3 Symbols used on the battery............................................................ 10
1.11.4 Symbols used on the electrode packaging ...................................... 11
2 Components and Operation .................. 12

2.1 General Information ........................................................... 12
2.2 Design.................................................................................. 13
2.2.1 Overview of the configurable settings .............................................. 14
2.3 Operating and Display Elements ...................................... 15
2.3.1 Overview FRED PA-1 ...................................................................... 15
2.3.2 Display and Operating Elements...................................................... 16
2.4 Function .............................................................................. 17
3 Initial operation ....................................... 18

3.1 Inserting the battery ........................................................... 18
3.1.1 Adding Emergency numbers stickers............................................... 19
3.1.2 Switching device On and Off............................................................ 20
3.2 Battery monitoring ............................................................. 21
3.2.1 Sufficient battery capacity ................................................................ 21
3.2.2 Low battery capacity indication ........................................................ 21
Art. no.: 0-48-0240 Rev. c
3.2.3 Battery depleted during use, limited mode (CPR)............................ 22

3.3 Replacing the “pre-connected” pads ............................... 23
3.3.1 Connect the electrodes .................................................................... 23
Page 3
FRED PA-1
4 Defibrillation ............................................24
4.1 Instructions and Safety Notes ........................................... 24
4.1.1 Instructions ...................................................................................... 24
4.1.2 Safety notes for AED use................................................................. 24
4.2 Applying the adhesive electrodes..................................... 26
4.2.1 General information ......................................................................... 26
4.2.2 Unpacking and applying electrodes ................................................. 26
4.2.3 Applying the electrodes to the patient’s chest.................................. 27
4.2.4 Checking the electrodes .................................................................. 29
4.3 Semi-automatic defibrillation ............................................ 30
4.4 Automatic defibrillation...................................................... 32
4.4.1 Functional description of automatic AEDs ....................................... 32
4.4.2 Safety notes for automatic defibrillation ........................................... 32
4.5 Internal safety discharge ................................................... 35
4.6 Finishing the therapy ......................................................... 35
4.7 Removing the battery ......................................................... 35
5 Communication .......................................36
5.1 Retrieving intervention data .............................................. 36
6 Maintenance ............................................37
6.1 Maintenance Intervals ........................................................ 37
6.1.1 Exemption from the technical safety inspection............................... 38
6.1.2 Service/Shelf life .............................................................................. 38
6.1.3 Visual inspection of the device and accessories.............................. 39
6.1.4 Mains status LED............................................................................. 40
6.1.5 Functional check .............................................................................. 40
6.1.6 Internal backup battery .................................................................... 40
6.2 Cleaning and disinfection .................................................. 41
6.3 Accessories and disposables ........................................... 42
6.3.1 Order Information............................................................................. 42
6.3.2 Required accessories ...................................................................... 42
6.4 Disposal information .......................................................... 43
6.4.1 Battery Disposal............................................................................... 43
6.4.2 Disposal of accessories that come into contact with the patient...... 43
6.4.3 Disposal at the end of its useful life ................................................. 43
6.5 Troubleshooting ................................................................. 44
6.5.1 Error messages................................................................................ 44
6.5.2 Troubleshooting ............................................................................... 45
6.5.3 Measures to prevent electromagnetic interferences ........................ 46
Art. no.: 0-48-0240 Rev. c
Page 4
FRED PA-1 User Guide
7 Technical Data ........................................ 47

7.1 System Specifications ....................................................... 47
7.2 Classification and safety standards ................................. 48
7.3 Defibrillation pulse ............................................................. 49
7.3.1 Shock Advisory System ................................................................... 51
7.4 Electromagnetic interferences .......................................... 52
7.4.1 Electromagnetic emissions .............................................................. 52
7.4.2 Electromagnetic immunity ................................................................ 52
7.4.3 Recommended minimum distances ................................................. 54
7.5 Literature ............................................................................. 55
7.6 Glossary .............................................................................. 55
7.7 Inspection report ................................................................ 56
8 Index ........................................................ 58
Art. no.: 0-48-0240 Rev. c
Page 5
Page 6
FRED PA-1
Art. no.: 0-48-0240 Rev. c

Safety Notes 1
FRED PA-1 User Guide User profiles 1.1
1 Safety Notes
1.1 User profiles
The following people may use the FRED PA-1®:
• people trained in early defibrillation

• other people not trained in early defibrillation, as long as they can understand and
follow the spoken and displayed instructions.
Even though untrained people may use the device, training and instructions are rec-
ommended to guarantee an optimal resuscitation procedure.
1.2 Responsibility of the User

 Regulations on who is allowed to use devices like the FRED PA-1® and which
training is required, are country-specific. In any case, legal regulations have to
be observed.
 Before using the device, a SCHILLER representative must perform a presenta-
tion on the device's operation and safety measures, if it is required by the local
regulations.
 Interpretation suggested by the device must be examined with respect to the pa-
tient's overall clinical condition and the quality of the recorded data.
 Damaged or missing components must be replaced immediately.
 The device must be stored in a place inaccessible to children.
 Properly dispose of the packaging material and make sure it is out of children's
reach.
 The FRED PA-1® is an emergency device and must be ready for operation at any
time and in all situations. Make sure that:
– the device is always equipped with a sufficiently charged battery
– An empty battery must not be reused and must be disposed of immediately
– A set of adult or children electrodes is pre-connected and a spare set of elec-
trodes can be stored in the device.
1.3 Intended Use

 The FRED PA-1® is an automated external defibrillator (AED) used for the treat-
ment of ventricular fibrillation (VF) and ventricular tachycardia (VT).
Art. no.: 0-48-0240 Rev. c
 The device may be used with the appropriate electrodes on either adults or chil-
dren.
 The device must only be used if the following symptoms are found:
– not responsive
– no respiration
– no pulse
Page 7
1 Safety Notes
1.4 Contraindication for use FRED PA-1
1.4 Contraindication for use

 The defibrillator must not be used when the person:
– is responsive
– is breathing normally
– has pulse
 Do not use the device in or near magnetic resonance imaging equipment (MRI).
 Danger of explosion! — The device must not be used in areas where there is
any danger of explosion. There might be a danger of explosion in areas where
flammable products (petrol), flammable anaesthetic agents or products for skin
cleaning/disinfection are in use, or where the ambient air's oxygen concentration
is higher than 25 %.
 The FRED PA-1 must not be used in ambulances and emergency vehicles.
1.5 Organisational Measures

 Before using the unit, ensure that an introduction regarding the unit functions
and the safety precautions has been provided and understood.
 Keep these operating instructions in an accessible place for reference when re-
quired. Make sure that they are always complete and legible.
1.6 Safety-Conscious Operation

 Danger of electric shock! - Danger for user, rescuer and patient.
The energy applied to the patient can be conducted through the patient to other
persons, who may suffer a lethal electric shock. Therefore:
– do not touch the patient, the electrodes or other conducting objects during defi-
brillation.
– do not defibrillate the patient in a puddle of water or on other conducting surfac-
es,
– switch the device off when it is no longer used.
 Danger of explosion! — The device must not be used in areas where there is
any danger of explosion. There might be a danger of explosion in areas where
flammable products (petrol), flammable anaesthetic agents or products for skin
cleaning/disinfection are in use, or where the ambient air's oxygen concentration
is higher than 25 %.
 Immediately report any changes that impair safety (including operating behav-
iour) to the responsible person.
 Only use original SCHILLER electrodes.
 Check that the unit's casing and electrode connections are not damaged.
 After use, refer to the chapter 6 Maintenance.
 Immediately replace a damaged unit, or damaged cables and connections.
Art. no.: 0-48-0240 Rev. c
 Operating the device with a defective casing or damaged cables constitutes a

danger to life.
 Only operate the device in accordance with the specified technical data.
Page 8
Safety Notes 1
FRED PA-1 User Guide Operation with other Devices 1.7
1.7 Operation with other Devices

 Magnetic and electrical fields from X-ray or tomographic devices, portable radio
equipment, HF radios and devices labelled with the symbol can affect the
operation of this device (see section 7.4). Avoid using such devices or keep a
sufficient distance from them.
 FRED PA-1® is not intended to be operated while using high-frequency surgical
devices.
 Interference with other devices - The charging of energy and the release of the
defibrillation impulse can disturb other devices. Check these devices before their
further use.
1.8 Maintenance and Cleaning

 Danger of electric shock! Do not open the device. No serviceable parts inside.
Refer servicing to qualified personnel only.
 Before cleaning, switch the unit off and remove the battery.
 Do not use high-temperature sterilisation processes (such as autoclaving). Do
not use E-beam or gamma radiation sterilisation.
 Do not use aggressive or abrasive cleaners.
 Do not, under any circumstances, immerse the device or cable assemblies in 
liquid.
 To ensure patient safety, only use original SCHILLER accessories. The user is
responsible for the use of third-party accessories. The warranty does not cover
damage resulting from the use of accessories or consumables other than those
marketed by SCHILLER.
1.9 General Notes Regarding the Unit

A defibrillation can fail with certain disease patterns.
Art. no.: 0-48-0240 Rev. c
Page 9
1 Safety Notes
1.10 Additional Terms FRED PA-1
1.10 Additional Terms

1.10.1 Implied authorisation
Possession or purchase of this device does not convey any express or implied license
to use the device with replacement parts which would alone, or in combination with
this device, fall within the scope of one or more patents relating to this device.
1.10.2 Terms of Warranty

Your SCHILLER FRED PA-1® is warranted against defects in material and manufac-
ture according the general terms of condition. Excluded from this warranty is damage
caused by an accident or as a result of improper handling. The warranty entitles to
free replacement of the defective part. Any liability for subsequent damage is exclud-
ed. The warranty is void if unauthorised or unqualified persons attempt to make re-
pairs.
In case of a defect, send the device to your dealer or directly to the manufacturer. The
manufacturer can only be held responsible for the safety, reliability, and performance
of the apparatus, and assume the warranty, if:
• assembly operations, extensions, readjustments, modifications, or repairs are

carried out by persons authorised by him,
• spare parts used for assembly operations, extensions, readjustments, modifica-
tions or repairs are recommended or supplied by SCHILLER, and,
• the SCHILLER FRED PA-1® and approved attached equipment is used in accord-
ance with the manufacturer's instructions.
There are no express or implied warranties which extend beyond the warranties here-
inabove set forth. SCHILLER makes no warranty of merchantability or fitness for a
particular purpose with respect to the product or parts thereof.
Art. no.: 0-48-0240 Rev. c
Page 10
Safety Notes 1
FRED PA-1 User Guide Symbols/Indicators 1.11
1.11 Symbols/Indicators
1.11.1 Symbols used in this user guide
The safety levels are classified according to ANSI Z535.6. The following overview
shows the safety symbols and pictograms used in this user guide.
The terms Danger, Warning, and Caution are used in this User Guide to point out poten-
tial dangers and to indicate risk levels. Familiarise yourself with their definitions and sig-
nificance.
For a direct danger which could lead to severe personal injury or death.
For a possibly dangerous situation which could lead to severe personal injury or to
death.
For a possibly dangerous situation which could lead to personal injury. This symbol is
also used to indicate possible damage to property.
For general safety notes as listed in this section.
For electrical hazards, warnings or precautionary measures when dealing with elec-
tricity.
Important or helpful user information.
1.11.2 Symbols used on the device
BF symbol. The device's signal input is defibrillation-protected.
Caution! High voltage!
CE-0459 marking (notified body LNE/G-MED).
Do not dispose of the FRED PA-1® and its accessories in the household waste.
Art. no.: 0-48-0240 Rev. c
Manufacturer symbol, manufacturing date.
Observe the user guide
Page 11
1 Safety Notes
1.11 Symbols/Indicators FRED PA-1
1.11.3 Symbols used on the battery
The battery is recyclable
Do not recharge
Do not short-circuit
Do not incinerate
Do not cut
Do not crush
Normal storage temperature duration and allowed out-of-range temperature dura-

tion (see chapter 7 Technical Data)
Battery must not be disposed of in the household waste
Observe the user guide
Battery expiry date
Art. no.: 0-48-0240 Rev. c
Page 12
Safety Notes 1
FRED PA-1 User Guide Symbols/Indicators 1.11
1.11.4 Symbols used on the electrode packaging

• Remove the patient's clothes
• Open the electrode packaging
• Peel off the protective foil
Disposable item; do not reuse
Do not bend packing
Storage temperature for the electrodes
Expiry date of the electrodes
An open package cannot be conserved more than one day.
Do not expose to sunlight
Does not contain latex
Do not expose to rain
Consult the user guide
Manufacturer symbol, manufacturing date
CE-0408 marking notified body
For use by or on the order of a physician or person licensed by state law

Art. no.: 0-48-0240 Rev. c
Page 13
2 Components and Operation
2.1 General Information FRED PA-1
2 Components and Opera-

tion
2.1 General Information
FRED PA-1® is an automated external defibrillator (AED).
AEDs are semi-automatic or fully automatic defibrillators
The regulations governing the use and training requirements for AEDs such as the
FRED PA-1® differ from country to country. The laws and regulations for the use of
automatic defibrillators need to be strictly observed.
Local laws and regulations regarding the use of an AED vary from country to country.
While some countries allow laypersons to use AEDs without any special training, oth-
er countries restrict the use of AEDs to an Emergency Medical Technician or First Re-
sponders after they have undergone special training.
Highly frequented areas are typical places for the operation of a FRED PA-1®. Some
examples below:
– airports
– train stations
– shopping centres
– public swimming pools
– sport centres
– public institutions
Biocompatibility
The parts of the product described in this user guide, including all accessories, that
come in contact with the patient during the intended use, fulfil the biocompatibility re-
quirements of the applicable standards. If you have any questions in this matter,
please contact SCHILLER.
Art. no.: 0-48-0240 Rev. c
Page 14
Components and Operation 2
FRED PA-1 User Guide Design 2.2
2.2 Design
Defibrillator FRED PA-1® is a defibrillator featuring the BTE (biphasic truncated exponential)
waveform. The patient receives a defibrillation shock using disposable electrodes.
The ECG signal is analysed using the same electrodes. 
Moreover, the user is guided by voice prompts and pictograms (loudspeaker/LEDs
next to pictograms). The device recognises the connected electrodes (adult or chil-
dren electrodes) and selects the defibrillation energy accordingly. An RFID tag in the
connector (for electrodes with article no. 0-21-0040) allows checking the shelf life of
the electrodes, when connected to the device.
Languages The device can be provided with different languages. Optional configuration with 3
languages, selectable after switching the device on.
Metronome The FRED PA-1® sets a configurable pace for the cardiopulmonary resuscitation
(CPR).
FreeCPR (option) Information on the chest compression frequency using impedance variation acquired
with defibrillation pads.
Data memory The device is equipped with an internal memory. During the intervention, data can
therefore be saved, including the analysed ECG data. In addition, technical data
(logs) will be stored.
Data transmission The FRED PA-1® has a SD card slot in order to retrieve the data via SD card.
Power supply (standard) The device is operated with a non rechargeable, disposable lithium battery. The bat-
tery capacity is sufficient for:
• more than 140 shocks at maximum energy, if the device is stored/used in optimal
temperature conditions between 15 ... 25 °C.
Available versions Semi- or fully automatic defibrillator

Art. no.: 0-48-0240 Rev. c
Page 15
2.2 Design FRED PA-1
2.2.1 Overview of the configurable settings
Important!
 Modifications that can be made via software program are only performed if re-
quested by the customer, or if required by legal requirements.
 These modifications need to be registered in the device documentation as well
as communicated to all users.
SCHILLER's service centre can configure the following parameters:.
Configurable parameters
• Selection of the default language at device start
• Energy level for 1st, 2nd and 3rd shock (separate settings for adults and children)
• Number of chest compressions for children (15 or 30)
• Self-test frequency (daily or weekly)
• Choice between "continuous chest compressions" or "alternating chest compres-
sions/breaths" during CPR cycles
• Date and time
• Update of the software/change of the device language
• Selection of the AED protocol (short or long instructions)
• Activation of notification if no RFID defibrillation pads are detected
• Activation of notch filter (50/60Hz)
• Activation of 16,7Hz Filter
• Activation of sound notification in case of elapsed maintenance interval
• Temperature warning
Art. no.: 0-48-0240 Rev. c
Page 16
FRED PA-1 User Guide Operating and Display Elements 2.3
2.3 Operating and Display Elements

2.3.1 Overview FRED PA-1
Service status LEDs:
• Modem
• Battery
Main status LED
• Service
• Electrodes
Battery
The device is switched

on when the cover is
opened.
Art. no.: 0-48-0240 Rev. c
Compartment for additional electrode

Wall cradle
Page 17
2.3 Operating and Display Elements FRED PA-1
2.3.2 Display and Operating Elements

In addition to the voice prompts, the resuscitation steps are indicated by pictograms
and the current step is highlighted with a flashing LED.
Basic device with one language

As soon the cover of the device is opened, the device starts issuing acoustic advices.
With the “Repeat Key”, the last message is repeated.
Repeat the last message
Emergency number
The emergency number can be

customised with the provided
stickers
Electrode connector
Multiple language device

As soon as the cover of the device is opened, the device starts issuing acoustic ad-
vices in the default language. The two other languages can be selected at any time
during the resuscitation procedure by pressing the button above the flag label.
Selection of the preferred language
Emergency number
The emergency number can be

customised with the provided
stickers
Art. no.: 0-48-0240 Rev. c
Electrode connector
Page 18
FRED PA-1 User Guide Function 2.4
2.4 Function
Immediately after a battery has been inserted, the FRED PA-1® performs a test of the
device and battery. If this test is completed successfully, the green status LED is blink-
ing and all service status LEDs are off, showing that the device has not detected an
error.
If a problem is detected during this test:

Service
Status LED • an acoustic alarm is issued,
LEDs
• the status LED stops blinking
• additional information are given by the service LEDs
Fig. 2.1 LED indicator
• If an alarm is in progress (visual and/or acoustic), the battery autonomy is reduced.

• In addition, the device performs a daily or weekly self-test (this setting must only
be configured by service personnel authorised by Schiller)
• An alarm (visual and/or acoustic) can only be reset by removing and reinserting the
battery.
• For the alarm details, refer to chapter 6.5.1 Error messages.
Art. no.: 0-48-0240 Rev. c
Page 19
3 Initial operation
3.1 Inserting the battery FRED PA-1
3 Initial operation
Danger of explosion — The FRED PA-1® must not be used in areas where there is any
danger of explosion. Areas may be susceptible to explosion if flammable substances
(gas), flammable anaesthetics, or products used to clean or disinfect the skin are used.
Moreover, the defibrillator must not be used in an environment that is favourable to com-
bustion. This is the case when ambient air contains more than 25% oxygen or nitrous ox-
ide (laughing gas). Oxygenation in the vicinity of the defibrillation pads must be strictly
avoided. Less than 25% oxygen in the ambient air is considered safe. Dangerously high
oxygen concentrations can only occur in oxygen masks or in enclosed areas, such as hy-
perbaric chambers.
3.1 Inserting the battery

 Danger of explosion! The battery must not be exposed to high temperatures or
disposed of with household waste.
 Do not expose the battery to chemicals that could dissolve ABS, polypropylene,
polyvinyl chloride, nickel, mylar or steel.
 Do not short-circuit, cut, destroy, burn or charge (Li/MnO2 battery) a battery.
Li/MnO2 Patient hazard! — Incorrect battery capacity indication
 A new battery is initialised at first insertion

 Replace the battery if the device indicates a battery problem. A defective battery
must not be used.
 Turn off the device before removing the battery.
Patient hazard — Ensuring operational readiness!
 Make sure that the device is always equipped with a sufficiently charged battery.
 The expiration date of a new battery, stored in its original packaging at a temper-
ature of 25°C, is indicated on its packaging. It must not be used beyond this date.
 The protective cap of the battery must remain on during the entire storage time.
The protective cap must only be removed when the battery is used.
 Do not expose the FRED PA-1® to direct sunlight or to extreme hot or cold. An
ambient temperature higher than 25°C has an adverse effect on the battery life.
• Each time the device is turned on, it verifies that the battery is functioning properly
Art. no.: 0-48-0240 Rev. c
Page 20
Initial operation 3
FRED PA-1 User Guide Inserting the battery 3.1
 Remove the protective cap from the battery contacts before inserting the battery
in the device.
Insert the battery as indicated in the illustration on the left.
<Click> 1. Insert the two stop blocks located at the bottom of the battery in the device slots.
2. Perform a rotational movement until the battery locks in place.
3. As soon as the battery is inserted, the FRED PA-1® runs a self-test to check the
condition of the device and the battery.
During the test, the modem LED is on and the electrodes LED is blinking. This test
can last for more than 1 minute.
If this test does not reveal any problems, the green indicator is blinking and all service
status LEDs are off, showing that the device has not detected an error.
Fig. 3.1 Inserting the battery
If the device is used on a patient, this test can be cancelled by opening the cover.
3.1.1 Adding Emergency numbers stickers

If your country’s emergency number differs, apply the sticker with the correct:
Art. no.: 0-48-0240 Rev. c
Page 21
3 Initial operation
3.1 Inserting the battery FRED PA-1
3.1.2 Switching device On and Off
Switching ON  Open the cover. The 3 LEDs for the resuscitation steps are briefly lit.
Switching OFF  Close the cover.
Forced shutdown procedure

If the device cannot be switched off via the above procedure, remove the battery and
insert it again.
 If a patient is detected while closing the cover, the device will remain ON and the
resuscitation process will go on.
If the cover is re-opened within 30 seconds after closing, the device will resume the
intervention.
Art. no.: 0-48-0240 Rev. c
Page 22
Initial operation 3
FRED PA-1 User Guide Battery monitoring 3.2
3.2 Battery monitoring

• The lithium battery ensures that the device stays fully operative (and performs the
self-test) for several years (at a temperature between 15 °C and 25 °C), provided
that the device is not being used.
• Battery service life depends on device use and ambient conditions.
 The battery must be replaced once the expiration date has been exceeded.
 The old battery must be recycled in accordance with local regulations.
3.2.1 Sufficient battery capacity

The main status LED (green) on the FRED PA-1® is blinking when the battery capacity
is sufficient to perform the resuscitation protocol.
3.2.2 Low battery capacity indication
• Low battery capacity indication is the same during self-test, after the battery has
been inserted, and during use.
• Despite the low battery indication, the device can still be used as normal and is still
able to perform defibrillations.
• Always switch off the device before removing the battery.
• The remaining battery capacity depends on the use and ambient conditions.
If the battery capacity falls below 10%, the main status LED (1) and the orange battery
LED (2) are blinking. These indications are issued until the battery is replaced. The
battery must be replaced as soon as possible.
1 2
Fig. 3.2 Low battery indication

Art. no.: 0-48-0240 Rev. c
Page 23
3 Initial operation
3.2 Battery monitoring FRED PA-1
3.2.3 Battery depleted during use, limited mode (CPR)
Patient hazard — Defibrillation is no longer possible if a depleted battery is detected.

The battery needs to be replaced immediately.
If a depleted battery is detected while the device is in use, the device will prompt the
user to replace the battery and perform CPR. An audible signal is emitted. The main
status LED is off and the orange battery LED is blinking until the battery is replaced.
Depleted battery during self-test

• An audible signal is emitted, the main status LED (1) is off and the battery LED (2)
is blinking until the battery is replaced.
1 2
Battery LED
Art. no.: 0-48-0240 Rev. c
Page 24
Initial operation 3
FRED PA-1 User Guide Replacing the “pre-connected” pads 3.3
3.3 Replacing the “pre-connected” pads

The FRED PA-1® is delivered with "pre-connected" pads. To replaced the pads after
use or if the shelf life has expired, proceed according to the following instructions:
 Only use the pads up to their expiration date.

 Please note that the expiration date of the pads only applies if the vacuum pack
is intact.
 Do not reuse the pads.
3.3.1 Connect the electrodes

1. Remove the battery
2. Remove the sticker with the LOT/Expiration date from the electrode pouch
and stick it above the main status LED.




3. Open the cover.

4. Connect the electrode cable to the device.
5. Put the electrode pack in the cover and close the cover.
6. Make sure that neither the electrode cable nor the electrode packaging are
squeezed by the cover.
7. Insert the battery after closing the cover.
8. The device is ready for use when the status LED is blinking and the service LEDs
are off.




9. If requested, add a spare set of electrodes in the compartment on the device’s un-
derside.
Electrode connector
Art. no.: 0-48-0240 Rev. c
Page 25
4 Defibrillation
4.1 Instructions and Safety Notes FRED PA-1
4 Defibrillation
4.1 Instructions and Safety Notes
4.1.1 Instructions
• The FRED PA-1® is a high-voltage electrotherapy device. Only personnel authorised

by local law are permitted to use these devices. Improper use can endanger life.
• Non medical personnel is only permitted to use an AED such as the FRED PA-1® if
local law approves of this practice.
• The success of the defibrillation depends on the correct application of the defibril-
lator but also on the heart's condition. It is the physician's responsibility to take any
additional measures (e.g. adrenaline).
• According to AHA/ERC guidelines, even children under 8 years may be 
defibrillated.
• The electrodes should be applied in the anterior-anterior position. With children,
anterior-posterior placement is advised to prevent a short-circuit between the two
defibrillation electrodes.
• A defibrillation can fail with certain disease patterns.
• Patients with implanted pacemakers — FRED PA-1® features an electronic pac-
er pulse suppression algorithm and therefore, pacemaker pulses are not taken into
account during the analysis. Depending on the pacemaker model and on the posi-
tion of the electrodes, the compensation pulse following every pacer pulse may be
considered as a QRS complex. In this case, the analysis can be distorted and in-
accurate. It depends on the pacer pulse parameters whether or not the compensa-
tion pulse is counted as a QRS complex.
4.1.2 Safety notes for AED use
 Changes, including the operational behaviour, affecting safety must be immedi-

ately reported to the responsible.
Shock hazard — for patients
 In unfavorable situations, the possibility of ECG analysis errors should not be
dismissed. The device must therefore only be used if the following symptoms are
found:
– not responsive,
– no respiration,
– no pulse.
Art. no.: 0-48-0240 Rev. c
Page 26
Defibrillation 4
FRED PA-1 User Guide Instructions and Safety Notes 4.1
Shock hazard — for user and assistants

 Position the patient flat on a firm, electrically insulated surface.
 Make sure that there are no conductive connections between the patient and
other persons during ECG analysis and defibrillation.
 The patient must not come into contact with metal parts, e.g. a bed or stretcher,
in order to prevent secondary contacts or paths for the defibrillation current that
could endanger the assistants. For the same reason, do not position the patient
on a wet surface (rain, swimming pool accidents).
 Do not allow the defibrillation electrodes to come into contact with other elec-
trodes or metal parts which are in contact with the patient.
 The patient's chest must be dry because moisture can cause unwanted path-
ways for the defibrillation current. For safety, wipe off flammable skin cleansing
agents.
 The assistants' tasks must be clearly defined as follows:
• During ECG analysis:
– suspend CPR,
– ensure that the patient lies as motionless as possible,
– do not touch the patient, otherwise, artefacts may lead to incorrect analysis re-
sults.
• Immediately prior to the shock:
– stop chest compressions and artificial respiration (CPR),
Risk of skin burns — for the patient
 Due to the high currents, there is a risk of skin burns at the electrode application
site. This is why the electrodes must not be placed on or above:
– the sternum,
– the clavicle or,
– the nipples.
Risk of malfunction of implanted pacemaker!
 Defibrillating a patient with an implanted pacemaker is likely to impair the pace-
maker function or cause damage to the pacemaker. 
For this reason:
– defibrillation pads must not be positioned near the pacemaker,
Art. no.: 0-48-0240 Rev. c
Page 27
4 Defibrillation
4.2 Applying the adhesive electrodes FRED PA-1
4.2 Applying the adhesive electrodes

4.2.1 General information
 The pads are sufficiently pre-gelled. Do not use extra contact agent.
 Do not reuse the pads.
 The pre-connected electrodes are stored in the defibrillator cover and can be ac-
cessed when the cover is opened.
 A spare set of adult or children electrodes can be found in the compartment on
the bottom of the FRED PA-1.
4.2.2 Unpacking and applying electrodes
 Risks for the user and the patient — The packaging of pre-connected electrodes
is welded to the electrode cable. Do not remove the packaging from the elec-
trode cable (risk of damaging the cable).
After having removed the clothes from the patient's upper body, perform the following
steps:
 Open the electrode packaging and apply the electrodes to the patient's chest.
(1) Defibrillation pad to be placed at the right sternal edge at the level of the 2nd in-
tercostal space.
(2) Defibrillation pad to be placed at the left axillary line at the level of the 5th inter-
costal space.
(3) If not connected, insert the electrode connector into the electrode port.
Fig. 4.1 Opening the electrode packaging
• The green indicator is blinking and the device repeats the instructions until the elec-
trodes are applied, or until the electrode connector is connected to the device, re-
spectively, and the electrode-skin resistance (impedance) has reached an accept-
able level.
Art. no.: 0-48-0240 Rev. c
• After several repetitions to apply and connect the electrodes, the device recom-
mends performing a cardiopulmonary resuscitation cycle. The device will then
switch off if it has not detected an acceptable impedance between the two elec-
trodes after 5 minutes.
Fig. 4.2 Green indicator
Page 28
Defibrillation 4
FRED PA-1 User Guide Applying the adhesive electrodes 4.2
4.2.3 Applying the electrodes to the patient’s chest
 Skin covered in sea water, sand, sunscreen, or skin or body care products may
impair electrode contact or cause the electrodes to become disconnected.
Adult and paediatric electrodes
Adult electrodes The adult electrodes with the blue connector are used for adults and children weigh-
ing 25 kg or more.
Paediatric electrodes The paediatric electrodes with the yellow connector are used for children weighing
less than 25 kg (younger than 8 years of age). The device automatically distinguishes
between adult electrodes and paediatric electrodes.The energy setting is automati-
cally reduced when paediatric electrodes are connected.
Adults and children weighing 25 kg or more
Electrode placement is the same for adults and for children weighing 25 kg or more
(see Fig. 4.4 Electrode application sites for children weighing 25 kg or more). Before
applying the adhesive electrodes, verify that the application sites on the patient’s
chest are clean and dry.
4. Carefully shave the application sites if the patient’s chest is hairy.

5. Apply the electrode as shown at the right sternal edge at the level of the 2nd inter-
costal space. Do not apply the electrode on top of the clavicle (uneven surface).
6. Apply the electrode as shown in the picture on the left axillary line at the level of
Fig. 4.3 Adult electrode application sites
the 5th intercostal space.
The electrodes must have good contact with the patient’s skin. Air bubbles under the
electrodes must be avoided. To avoid air bubbles, place one edge of the adhesive
electrode on the patient's chest, then gradually smooth it out toward the other edge to
remove any air.
7. Place the electrodes on the patient's chest so that the connections point to either
side of the patient in order not to hinder CPR.
Art. no.: 0-48-0240 Rev. c
Fig. 4.4 Electrode application sites for

children weighing 25 kg or more
Page 29
4 Defibrillation
4.2 Applying the adhesive electrodes FRED PA-1
Children weighing less than 25 kg (younger than 8 years of age)
Electrode placement on children weighing less than 25 kg (see Fig. 4.5 Application
sites for children weighing less than 25 kg). Before applying the adhesive electrodes,
verify that the application sites on the patient’s chest are clean and dry.
When defibrillating children, it is recommended to choose the anterior-posterior posi-

tion to avoid short-circuiting the electrodes.
Fig. 4.5 Application sites for children

weighing less than 25 kg
Art. no.: 0-48-0240 Rev. c
Page 30
Defibrillation 4
FRED PA-1 User Guide Applying the adhesive electrodes 4.2
4.2.4 Checking the electrodes

If the resistance (impedance) reaches an unacceptable value, the device interrupts
and prompts the user to check the electrode application; in addition, the green indica-
tor is blinking
This can occur if:

– the cable is disconnected from the device and/or,
– if the electrodes are not properly applied to the patient’s chest.
In this case the device:
• Asks to check that the electrodes are connected and applied to the patient's chest
and then recommends performing a CPR cycle.
• resumes the intervention where it has been interrupted when it detects that the re-
sistance between both electrodes is acceptable again.
• switches off if it still does not detect acceptable impedance between both elec-
trodes after 5 minutes.
Follow these steps to check the electrodes:
1. Insert the connector as specified in 3.3.1 Connect the electrodes on page 25.
2. Press the defibrillation pads onto the patient’s chest one after the other to find out
which one makes the green indicator switch off,
3. carefully press this electrode onto the patient's skin.
If the electrode error remains:
Perform CPR even if the device switches off
To remove the electrodes from the patient's chest, see 4.6 Finishing the therapy.
Art. no.: 0-48-0240 Rev. c
Page 31
4 Defibrillation
4.3 Semi-automatic defibrillation FRED PA-1
4.3 Semi-automatic defibrillation

Patient hazard — The guidelines given in 4.1 Instructions and Safety Notes must be
observed.
Semi-Automatic Defibrillation
Depending on the configuration of the device, the instructions provided by the device
may be shortened.
Step 1 Switching on and preparing the device

1. Open the cover to switch the device on.
– If the cover is missing, remove the battery and insert it again to switch the device
on.
2. Assess the patient's condition: not responsive, no respiration, no pulse.
3. Apply the defibrillation electrodes to the patient's chest (see 4.2 Applying the ad-
hesive electrodes).
“Apply the electrodes" is blinking as long as the electrodes are not properly applied to
the patient's chest and/or the electrode connector is not properly connected to the de-
vice.
Fig. 4.6 Apply the electrodes
Step 2 Analysing the ECG signal

4. The analysis is automatically triggered, without user intervention. A message
prompts the user not to touch the patient and the green LED below the pictogram
is blinking.
Art. no.: 0-48-0240 Rev. c
Fig. 4.7 Analysing, do not touch the pa-

tient
• If the device detects ventricular fibrillation or ventricular tachycardia with a heart

rate exceeding 150 bpm, Step 3 Shock delivery follows; otherwise, continue with
Step 4, Performing cardiopulmonary resuscitation.
Page 32
Defibrillation 4
FRED PA-1 User Guide Semi-automatic defibrillation 4.3
Step 3 Shock delivery

When the energy is charged, the user is prompted to trigger the shock by pressing the
blinking orange button.
Shock hazard!
 Do not, under any circumstances, touch the patient during shock delivery.
 Make sure that the patient does not touch any conducting objects.
Fig. 4.8 Button to deliver the shock
5. Deliver the shock by pressing the button .
After the shock delivery, proceed with Step 4 Performing cardiopulmonary resus-
citation.
Step 4 Performing cardiopulmonary resuscitation
If the FreeCPR option is activated, the device instructs the rescuer to adjust the chest
compression frequency.
FreeCPR measures the compression rate based on the impedance measurement by

the defibrillation electrodes.
6. Perform a CPR cycle. According to the configuration of the device, a CPR cycle
Art. no.: 0-48-0240 Rev. c
consists of:
– performing chest compressions for the set period of time, or
– alternately performing 30 chest compressions and 2 breathes for the set period
of time.
After the CPR cycle, the device continues automatically with Step 2 Analysing the
ECG signal.
Finishing the therapy See 4.6 Finishing the therapy.
Page 33
4 Defibrillation
4.4 Automatic defibrillation FRED PA-1
4.4 Automatic defibrillation

The laws and regulations for the use of automatic defibrillators vary from country to
country. While some countries allow laypersons to use automatic defibrillators without
any special training, other countries restrict the use of AEDs to EMTs or First Re-
sponders who have undergone special training.
4.4.1 Functional description of automatic AEDs
Depending on the configuration of the device, the instructions provided by the device
may be shortened.
This device delivers defibrillation shocks automatically, i.e. there is no need to trigger
the shock.
Voice prompts and LEDs next to the pictogram keep the user informed regarding the
therapy steps.
If a shock is advised, a countdown accompanies the last 3 seconds before the shock is
delivered.
Fig. 4.9 FRED PA-1® Automatic
4.4.2 Safety notes for automatic defibrillation
Risks for patient, users and assistants!
Once the device has been switched on by opening the cover and the electrodes have
been applied, the ECG analysis is started automatically and a shock is delivered au-
tomatically if a shockable rhythm is present. The user is informed of an ongoing anal-
ysis or shock release via acoustic messages.
 Touching or transporting the patient during analysis may lead to an incorrect

analysis. Analysis results are only valid if the patient remained unconscious dur-
ing the entire analysis and was not touched.
 For this reason, chest compressions and artificial respiration must be suspended
during the analysis.
 The patient must not be touched or transported (e.g. stretcher) during analysis
and shock delivery.
 The notes in section 4.1 Instructions and Safety Notes page 26 must be ob-
served.
Art. no.: 0-48-0240 Rev. c
Page 34
Defibrillation 4
FRED PA-1 User Guide Automatic defibrillation 4.4
Automatic defibrillation
Step 1 Switching on and preparing the device

1. Open the cover to switch the device on.
– If the cover is missing, remove the battery and insert it again to switch the device
on.
2. Assess the patient's condition: not responsive, no respiration, no pulse.
3. Apply the defibrillation electrodes to the patient's chest (see 4.2 Applying the ad-
hesive electrodes).
“Apply the electrodes" LED is blinking as long as the electrodes are not properly ap-
plied to the patient's chest and/or the electrodes connector is not properly connected
Fig. 4.10 Apply the electrodes to the device.
Step 2 Automatic ECG analysis

4. The analysis is automatically triggered, without user intervention. A message
prompts the user not to touch the patient and the LED below the pictogram is
blinking.
Fig. 4.11 Analysing, do not touch the pa-

tient
If the device detects ventricular fibrillation or ventricular tachycardia with a heart rate
exceeding 150 bpm, Step 3 Automatic shock delivery follows; otherwise, continue
with Step 4, Performing cardiopulmonary resuscitation.
Art. no.: 0-48-0240 Rev. c
Page 35
4 Defibrillation
4.4 Automatic defibrillation FRED PA-1
Step 3 Automatic shock delivery

As soon as the energy charging is completed, the device automatically delivers the
shock, without user intervention. An acoustic countdown starts and the orange button
blinks until the shock is delivered.
Shock hazard!
 Do not, under any circumstances, touch the patient during shock delivery.
 Make sure that the patient does not touch any conducting objects.
After the shock delivery, proceed with Step 4 Performing cardiopulmonary resuscita-
tion.
Step 4 Performing cardiopulmonary resuscitation

If the FreeCPR option is activated, the device instructs the rescuer to adjust the chest
compression frequency.
FreeCPR measures the compression rate based on the impedance measurement by

the defibrillation electrodes.
5. Perform a CPR cycle. According to the configuration of the device, a CPR cycle
consists of:
– performing chest compressions for the set period of time, or
– alternately performing 30 chest compressions and 2 breathes for the set period
Art. no.: 0-48-0240 Rev. c
of time.
After the CPR cycle, the device continues automatically with Step 2 Analysing the
ECG signal.
Finishing the See 4.6 Finishing the therapy.
therapy
Page 36
Defibrillation 4
FRED PA-1 User Guide Internal safety discharge 4.5
4.5 Internal safety discharge

 If the device's behaviour differs from the description given in this user guide, the
device is defective and must be repaired.
An internal safety discharge ensures that the stored energy is discharged within the
device every time a defibrillation shock was not delivered correctly. An internal dis-
charge is performed if:
– the shock has not been delivered within the 20 seconds following the end of de-
fibrillation energy charging
– an electrode error is detected
– the battery voltage is insufficient
– the device is defective
– the device is switched off before the shock is delivered.
4.6 Finishing the therapy

• Disconnect the electrode cable.
• Switch off the device once the therapy has been completed (close the cover).
• Carefully peel the pads off the patient’s skin (see Fig. 4.12 Removing the adhesive
pads)
• Recycle the disposable pads immediately after use to keep them from being reused by
mistake (hospital waste).
• Connect a new "pre-connected" pad see 3.3.1 Connect the electrodes.
• Retrieve the intervention data see 5.1 Retrieving intervention data
Fig. 4.12 Removing the adhesive pads
• If the device is turned off for less than 5 minutes, all data is stored (even if the bat-
tery is removed), and the device continues to count the number of shocks deliv-
ered, to measure the time elapsed since the device was turned on, and to store
intervention events from the point at which the device was turned off.
Art. no.: 0-48-0240 Rev. c
4.7 Replacing the battery

1. Close the cover of the device.
2. Press the two ends of the battery lock down as indicated to remove the battery.
3. Insert a new battery (see 3.1 Inserting the battery page 20)
Page 37
5 Communication
5.1 Retrieving intervention data FRED PA-1
5 Communication
5.1 Retrieving intervention data
 Only use standard SD cards (do not use mini or micro SD cards).
• To read the intervention data, use the appropriate SCHILLER software. Contact
your SCHILLER representative.
To retrieve the intervention data, an SD card is required. The SD card must be con-
figured according to the following instructions.
1. With a computer, create a directory called "from_device" on the SD card.
2. Remove the battery from the device.



3. Insert the SD card in the slot.

4. Insert the battery. The device is switched on automatically.


5. The modem LED (1) is on and the service LED (2) is blinking throughout the data
transfer process, which can last more than 5 minutes.
2 6. The data transfer is finalized when the modem LED (1) and the service LED (2)
are off.
1
7. Remove the battery and then remove the SD card from the device.
8. Insert the battery.
Art. no.: 0-48-0240 Rev. c
Page 38
Maintenance 6
FRED PA-1 User Guide Maintenance Intervals 6.1
6 Maintenance
6.1 Maintenance Intervals
• Because FRED® PA-1 is an emergency device, some verification has to be done
as written in the following table in order to maintain the device operational, including
the accessories.The test results must be recorded and compared to the values ac-
companying the documents (see 7.7 Inspection report)
• If used in optimal conditions (see Chapter 6.1.1 Exemption from the technical safe-
ty inspection), the FRED® PA-1 does not need any particular maintenance tests
since the device is able to test itself automatically on a regular basis, and it issues
a warning if any action either from the user or from a technician is required.
• Local regulations in your country may stipulate additional or different inspection in-
tervals and tests.
• The following table indicates the intervals and competence of the maintenance
work required.
Interval Maintenance - replacement Responsible

• Replace the electrodes.  User
• After battery insertion, check that the status LED is blinking and that
After each use the other LEDs are off (see 6.1.4 Mains status LED)
• Visual inspection of the device see 6.1.3 Visual inspection of the de-
vice and accessories.
• Check that the green main status LED is blinking and all other LEDs  User
are off (see 6.1.4 Mains status LED)
Once a Week/Month
• Visual inspection of the device and accessories, see 6.1.3 Visual in-
spection of the device and accessories.
• Technical safety inspection is advised according to SCHILLER doc-  Service staff authorised
umentation (available for technical departments authorised by by SCHILLER
SCHILLER), see 6.1.5 Functional check.
Every 3 years
Note:
For an exemption from the 3-year technical service inspection, see
section 6.1.1 Exemption from the technical safety inspection
• Replacement of internal backup battery. A technical safety inspec-  Service staff authorised
tion and a software update (if needed) are advised after opening the by SCHILLER
device, see 6.1.5 Functional check
Every 6 years Note:
The replacement of the internal backup battery is advised. Should this
internal backup battery not be replaced every 6 years, SCHILLER can-
not ensure the proper time stamping of the intervention.
Art. no.: 0-48-0240 Rev. c
Page 39
6 Maintenance
6.1 Maintenance Intervals FRED PA-1
6.1.1 Exemption from the technical safety inspection

Exemption from the 3-year technical safety inspection is possible if the FRED PA-1®
is exclusively used within the optimal conditions as stated below:
Optimal factors Fulfilled Not fulfilled

• Environmental conditions before use:
– Temperature between +15...25 °C  
– No daily temperature variation over 10°C  
– Protection against direct sunlight  
– Humidity 30 to 65 % (no condensation)  
– Protection against dust  
• Operation sites
– no mobile operation sites (e.g train, car, bus, airplane, …)  
– not placed on walls with risk of vibrations (e.g. near doors, windows, ...)  
Yes  No 
Exemption from the technical safety inspection of the FRED PA-1 if all factors are fulfilled
Location: Date:
Carried out by:
6.1.2 Service/Shelf life
Device The device has defined Service Life of 10 years if maintenance intervals have been
observed according to section 6.1 Maintenance Intervals and the directive IEC/EN
62353.
Battery Main battery (approx.6 years), see expiring date on the battery and internal battery
cell (approx. 6 years)
Electrodes Electrode packaging (2 years), see expiring date on the electrodes pouch.
Art. no.: 0-48-0240 Rev. c
Page 40
Maintenance 6
FRED PA-1 User Guide Maintenance Intervals 6.1
6.1.3 Visual inspection of the device and accessories

Regularly and after each use, inspect visually the device and the cables in order to
detect possible mechanical damages.
If you observe damages or dysfunctions which can endanger the safety of the patient
or user, only use the device once it has been serviced.
Points to inspect: • Check that the main status LED is blinking and all the other LEDs are off, see
6.5.1 Error messages
• Device casing undamaged?
• No excessive clogging or damage?
• Legible nameplate at the rear of the device?
• Legible inscriptions on the front face of the device?
• Expiration date of the electrode elapsed? (see section 3.3.1 Connect the electrodes
page 25.
• Expiration date of the battery elapsed?
 Electrodes past their expiration date must be replaced immediately (Electrode

and Service LEDs are on, only by using the electrodes reference 0-21-0040)
 Batteries past their expiration date must be replaced immediately. (see expiring
date on the batteries)
 Defective units or damaged cables must be replaced immediately.
 Replace or repair immediately the device, if the main status LED is not blinking.
(see details in chapter 6.5.1 Error messages)
Art. no.: 0-48-0240 Rev. c
Page 41
6 Maintenance
6.1 Maintenance Intervals FRED PA-1
6.1.4 Mains status LED

If the device is defective or if problems have been detected by the device during the
self-test, the device must be repaired before use.
If a problem is detected during this self-test:

Service
• an acoustic alarm is issued,
LEDs
Mains • the main status LED is blinking if a non-critical error is detected as:
status LED – battery almost empty
– electrode nearly expired (only with electrodes reference 0-21-0040)
• the main status LED is no more blinking if the device is no more operational
• the corresponding service LED is blinking
 see detail in chapter 6.5.1 Error messages.
6.1.5 Functional check
Patient hazard — If the device's behaviour differs from the description given in this
user guide or the main status LED is not blinking, the device is defective and must be
repaired.
 In case of intensive use of the device, SCHILLER recommends that these in-
spections be performed at shorter interval.
 The regulations in force in each country regarding inspection frequency must be
observed (if shorter intervals than those recommended by SCHILLER are im-
posed).
Points to inspect: • Visually inspect the device and the accessories (see 6.1.3 Visual inspection of the
device and accessories).
• Check for proper functioning.
• Measure the energy delivered at 50 Ohms.
Art. no.: 0-48-0240 Rev. c
Page 42
Maintenance 6
FRED PA-1 User Guide Cleaning and disinfection 6.2
6.2 Cleaning and disinfection

Shock hazard — Remove the battery before cleaning the device. This ensures that
the device will not be turned on inadvertently while you are cleaning it. 
Risk of death! Disconnect the defibrillation pads before cleaning the device.
Risk of shock, equipment damage — Liquids must not enter the device. If a liquid has
penetrated the device, it must not be used until it has been checked by a service tech-
nician.
Equipment damage! Do not clean the surface of the device with phenol-based
disinfectants or peroxide compounds.
Device casing  Wipe the device with dampened cloth; make sure no liquid enters the device. All
cleaning or disinfection products commonly used in hospitals and containing al-
cohol (maximum 70 %) are appropriate. If liquids enter the device, it can only be
re-operated after it has been checked by the technical support department.
Cables, electrodes  Discard the disposable electrodes immediately after use to prevent their reuse
(hospital waste).
Art. no.: 0-48-0240 Rev. c
Page 43
6 Maintenance
6.3 Accessories and disposables FRED PA-1
6.3 Accessories and disposables

Risk to Persons, Equipment Damage — Always use SCHILLER replacement parts
and disposables, or products approved by SCHILLER. Failure to do so may endanger
life and/or invalidate the warranty.
Your local representative stocks all the consumables and accessories for the 
FRED PA-1®. A full list of all SCHILLER representatives can be found on the SCHIL-
LER website (www.schiller.ch). In case of difficulty, contact SCHILLER. Our staff will
be pleased to help process your order or to provide details for all SCHILLER products.
6.3.1 Order Information

Devices
Part No. Description
1-127-9902 FRED PA-1® semi-automatic
1-127-9901 FRED PA-1® fully automatic
1-127-3780 Multiple-language option
1-127-5180 Wall bracket
1-127-3580 FreeCPR (CPR feedback option)
Accessories/Disposable
Part No. Description
1 pair of disposable adhesive defibrillation pads for adults, 80cm²;
0-21-0040
pre-connected with RFID
2.155067 1 pair of disposable adhesive defibrillation pads for children, 80cm²;
4-07-0025 Battery pack FRED PA-1
5-35-0043 SD Card
6-39-0140 Set of emergency number stickers for device
6-39-0141 Set of flag stickers for device (for multi language option)
6-39-0148 Set of emergency number stickers for wall bracket
0-48-0240 User Guide, English
6.3.2 Required accessories

• User Guide
• One pair of adhesive pads
• 1 lithium battery
Art. no.: 0-48-0240 Rev. c
Page 44
Maintenance 6
FRED PA-1 User Guide Disposal information 6.4
6.4 Disposal information

6.4.1 Battery Disposal
 Danger of explosion! The battery must not be incinerated, exposed to high tem-
peratures or disposed of with household waste.
 Do not expose the battery to chemicals that could dissolve ABS, polypropylene,
polyvinyl chloride, nickel, mylar or steel.
 Do not cut, destroy, or incinerate the battery.
 Danger of acid burns! Do not open or heat up the battery.
The battery is to be disposed of in municipally approved areas or sent back to SCHIL-

LER.
6.4.2 Disposal of accessories that come into contact with the patient
Disposable articles (e.g. pads, etc.) must be disposed of as hospital waste.
6.4.3 Disposal at the end of its useful life
At the end of their service life, the device and its accessories must be recycled in
compliance with local regulations. Apart from the internal and plug-in batteries, the
device does not contain hazardous material and can be recycled like any other piece
of electronic equipment. In accordance with national law, the battery must be dis-
posed of at an appropriate waste disposal station or returned to SCHILLER.
According to European legislation, this device is considered as electronic waste

equipment. It can be returned to the distributor or manufacturer where the device will
be disposed of in compliance with legal requirements. The customer must bear the
shipping costs. This unit must be disposed of in a municipally approved collection
point or recycling centre when no longer used.
If no such collection point or recycling centre is available, you can return the unit to
your distributor or the manufacturer for proper disposal. In this way, you contribute to
the recycling and other forms of utilisation of old electrical and electronic equipment.
Improper disposal harms the environment and human health due to the presence of
Art. no.: 0-48-0240 Rev. c
dangerous substances in electrical and electronic equipment.
Page 45
6 Maintenance
6.5 Troubleshooting FRED PA-1
6.5 Troubleshooting
• If it is not possible to get the device back into operating condition within a reason-
able period of time, continue cardiopulmonary resuscitation until the rescue service
arrives.
• If the device cannot be switched off via normal OFF procedure (closing the cover)
remove the battery and insert it again.
6.5.1 Error messages
If a problem is detected during the self-test:

Service
LEDs  Refer to the table to identify the source of error with the different LEDs.
Main status
LED
Normal device state. The device is fully operational. A defibrillation shock can be 
given.
Restricted device state. The device is not able to charge the HV capacitor and to de-
liver a defibrillation shock. It only indicates to perform CPR.
Critical device state. The device is out of order.
Description Device Status Alarm Battery Electrode Service Remedy

State LED sound LED LED LED
Power supply problem or cor- ON  Contact your sales representative

rupted firmware
ON  Replace the battery
Battery pack defect
Main battery almost empty OFF  Replace the battery

(lower than 10%) or main bat-
tery shelf life expired
Electrodes will expire within 2 OFF  Replace the electrodes
months or no RFID defibrilla-
tion pads are detected (con-
figuration)
ON  Replace the electrodes and then
Art. no.: 0-48-0240 Rev. c
Electrodes expiration date ex-

remove the battery and insert it
ceeded
again
aTemperature configur-  Contact your sales representative

out of the limits able
OFF  Contact your sales representative

Device needs service
ON  Contact your sales representative

Service delay expired
ON  Replace the device

Device out of order
Page 46
Maintenance 6
FRED PA-1 User Guide Troubleshooting 6.5
a. If 2/3 of the single measurements over a duration of 48 hours are out of the limits, the device will give a warning (Electrode and
Service LEDs will light + sound alarm if configured); the status LED continues to blink.
The frequency of the temperature verification during the 48 hours can be configured from 1h to 24h
Alarm limits:
+50 °C for the high limit and -°5C for the low limit.
Art. no.: 0-48-0240 Rev. c
Page 47
6 Maintenance
6.5 Troubleshooting FRED PA-1
6.5.2 Troubleshooting

If the device cannot be switched off via normal OFF procedure remove the battery
and insert it again.
Problem Possible causes Remedy

The Status indicator is not • Battery defect.  Replace the battery.
blinking and the device can- • No battery inserted, or battery not  Insert the battery correctly.
not be turned on. correctly inserted.
• Device defective.  Have the device repaired.
The Status indicator is  • Device cover is missing  Remove the battery and insert it again to start the device
blinking and the device can- into the resuscitation process.
not be turned on.
The device prompts the user • Short-circuit between the pads.  Apply the pads exactly as described.
to check that the electrodes • Poor pad contact.  Firmly press down on the pads.
are properly applied and con-  Connect the electrodes connector to the device
• Electrodes connector not con-
nected.
nected to the device
• Dry contact agent.  Use new electrodes.
The device cannot be turned • Close the cover  Hold down the cover so that the magnetic sensor is acti-
off. vated
• Software hangs  Remove battery and insert it again.
Incorrect analysis result (e.g. • Insufficient ECG signal quality.  Repeat chest compressions.
the device does not detect a • Electromagnetic waves disturb  Turn off the source of interference (e.g. radio transmitter,
shockable rhythm, even the ECG signal. cellular telephone). Position the patient outside the
though the patient exhibits range of interference.
ventricular fibrillation).  Do not move patient during the analysis.
• Patient moved during analysis.
Defibrillation shock cannot be • Insufficient battery charge level.  Replace the battery.
delivered. • CPR caused pads error.  Re-apply the pads.
The alarm tone does not • Battery defect.  Replace the battery.
stop. • Device defective.  Have the device repaired.
Battery LED is ON. • Battery almost depleted.  Replace the battery.
No data recorded on the SD • Card defect.  Replace the card.
card. • Device defective.  Have the device repaired.
The electrodes LED continue • Alarms are not reset  Remove the battery and insert it again to force a test
to blink even after replacing
Art. no.: 0-48-0240 Rev. c
the electrodes
Difficulty to insert the battery • Protective cap not removed  Remove the contacts protective cap
The device does not start the • The battery contacts are dirty  Clean the battery contacts with alcohol dampened cloth
automatic test by inserting a • The battery is empty  Use a new battery
battery
Page 48
Maintenance 6
FRED PA-1 User Guide Troubleshooting 6.5
6.5.3 Measures to prevent electromagnetic interferences

The user can help avoid electromagnetic disturbances by keeping the minimum dis-
tance between portable and mobile RF telecommunication devices (transmitters) and
the FRED PA-1®. The distance depends on the output performance of the communi-
cation device as indicated below.
“Non-ionic electromagnetic radiation"
HF source Transmitter fre- Power P Distance d

quency [W] [m]
[MHz]
Radio telephone (microcellular) CT1+, CT2, CT3 885-887 0.010 0.23
Cordless DECT telephone, WLAN, UMTS phone 1880-2500 0.25 1.17
Mobile phone USA 850/1900 0.6 1.8
Mobile phone
- GSM900, 900 2 3.3
- GSM850, NMT900, DCS 1800 850,900,1800 1 2.3
Walkie-talkie (rescue service, police, fire bri-
81-470 5 2.6
gade, service)
Mobile telephone system (rescue service, po-
81-470 100 11.7
lice, fire brigade)
RFID (active and passive transponders and 433 0.85
0.5
reading devices) 865-868 1.62
It can be deducted from the table that portable RF telecommunication devices must
not be used within a radius of 3 m from the device and its cables.
 However, there is no guarantee that no interference can occur in certain instal-

lations. If the FRED PA-1® causes interferences, these can be prevented by
switching off the device.
Further measures to prevent electromagnetic interferences:
The user can take the following measures to prevent electromagnetic interferences:
• Increase distance to the source of interference.
• Turn the device to change the angle of radiation.
• Only use original accessories (especially defibrillation electrodes)
• The device should not be used adjacent to or stacked with other equipment.
For more detailed information, please refer to page 55.

Art. no.: 0-48-0240 Rev. c
Page 49
7 Technical Data
7.1 System Specifications FRED PA-1
7 Technical Data
Unless otherwise stated, all specifications are valid at a temperature of 25 °C.
7.1 System Specifications

Manufactured by SCHILLER MEDICAL
Device name FRED PA-1®
Dimensions 310 x 255 x 100 mm (h x l x w)
Weight Approx. 2.5 kg with battery and standard accessories
Protection class of the device

IP55 (protection against dust and water jets)
housing
Recorded data ECG signal recording (2 hours)

Technical events (500 events)
Power supply Power supply, suitable for continuous operation with intermittent loading
Battery type Lithium/MnO2 15 V, 2.8 Ah

Battery life • more than 140 shocks at maximum energy, if device is stored/used in optimal tem-
perature conditions between 15 ... 25 °C.
• Several years in standby (standby duration corresponding to laboratory tests at 25°C: 6
years with weekly self-tests)
Environmental conditions
Device
Operation • -5...40 °C at a relative humidity of 30 to 95% (no condensation)
Storage before use • -5...40 °C with the battery inserted and incl. electrodes at a relative humidity of 30
to 95 % (no condensation) but resulting in a reduced battery life; optimal condi-
tions: 15...25 °C to ensure maximum battery life.
• Atmospheric pressure 700 to 1060 hPa
Storage and transport • -20 ... 50 °C at a relative humidity of 0 to 95% (no condensation)
• Atmospheric pressure 500 to 1060 hPa
Battery and Electrodes
Storage and Transport temper- • 5 ... 35 °C (48h max. between -20...5°C and 35...60°C)
Art. no.: 0-48-0240 Rev. c
ature battery LiMnO2

Storage and transport temper- • 0 ... 50 °C (max.10 days between -40...0°C and 50...75°C)
ature electrode pads
Page 50
Technical Data 7
FRED PA-1 User Guide Classification and safety standards 7.2
7.2 Classification and safety standards
Standards FRED PA-1® complies with IEC standard 60601-2-4.

According to IEC standard 60601-2-4, FRED PA-1® is a device for infrequent use.
EMC See 7 Technical Data.
Compliance • FRED PA-1® bears the (Notified Body LNE/G-MED) mark indicating its
compliance with the provisions of the Directive 93/42/EEC (modified by the Direc-
tive 2007/47/EEC) regarding medical devices and fulfils the essential require-
ments of Annex I of this directive.
• FRED PA-1® is a class IIb device.
Patient Protection BF type, resistant to defibrillation shocks.
Explosions protection FRED PA-1® is not designed to be used in the presence of flammable mixtures of
anaesthetic agents with air or oxygen.
The SCHILLER quality management system complies in full with the international
standards ISO 9001 and ISO 13485.
Art. no.: 0-48-0240 Rev. c
Page 51
7 Technical Data
7.3 Defibrillation pulse FRED PA-1
7.3 Defibrillation pulse

Form • Biphasic truncated exponential waveform
• Maintains the energy delivered to the patient at an approximately constant level
with regard to patient resistance
ϴϬ
ϳϬ
ϲϬ
ϮϱKŚŵ
ϱϬ
ϱϬKŚŵ
ϰϬ
ϳϬKŚŵ
ϯϬ ϭϬϬKŚŵ
ϮϬ ϭϮϱKŚŵ
ϭϬ ϭϱϬKŚŵ
Ϭ ƵƌĂƚŝŽŶ;ŵƐͿ ϮϮϬKŚŵ
ϮϱϬKŚŵ
ͲϭϬ
ͲϮϬ
ͲϯϬ
ͲϰϬ
Default energy settings Accuracy at 50Ω: ± 3 J or ± 15 % (the higher value is assumed)
SCHILLER's customer service department can change the default energy levels to
the following values:
70 – 90 –120 – 150 – 200 J (adults)
30 – 50 – 70 J (children)
(automatic adaptation when paediatric pads are connected)
Cycle time: rhythm analysis – (Maximum time between start of the analysis and shock availability, in semi-auto-
shock availability (in semi-automatic mode)
matic mode)
With full battery: < 20 seconds
After 15 discharges with max.

energy: < 20 seconds
Patient impedance at which

25 to 250 Ω (Impedance is compensated up to 200 Ω)
shock delivery is possible
Indication when ready to shock The orange button is lit

Art. no.: 0-48-0240 Rev. c
Page 52
Technical Data 7
FRED PA-1 User Guide Defibrillation pulse 7.3
Shock delivery • With the orange button (in semi-automatic)

• Via disposable pads applied to the patient in an anterior-lateral or anterior-pos-
terior position
Safety discharge when: • A non shockable rhythm has been detected

• The shock is not delivered within the 20 seconds after charging
• An electrode problem is detected
• Battery voltage is insufficient
• The device is defective
• The device is turned off.
Defibrillation pad connection BF type
Defibrillation electrodes Electrode cable, 2 m in length
Adult and Paediatric pads • 80 cm² active surface

Art. no.: 0-48-0240 Rev. c
Page 53
7 Technical Data
7.3 Defibrillation pulse FRED PA-1
7.3.1 Shock Advisory System

The Shock Advisory System (SAS) validation test set consists of 17,803 ECG wave-
forms coming from the PhysioNet databases [1]. These files (MIT-VFDB) are subsets
of the general PhysioNet databases recognised as standard in ECG tests. PhysioNet
databases are ECG Holter recordings with full diagnostic bandwidth [0.05 - 125] Hz.
The bandwidth of the devices that recorded the signals is larger than that of the FRED
PA-1®. However, when the analogue signals of the database are run on the PA-1 via
electrode connector, the PA-1's rhythm detector signal-processing characteristics are
applied. Moreover these signals are of appropriate length to allow decisions to be
made by the detector system.
The validation test set database used to establish compliance with the AHA require-
ments [2] and the IEC Standards [3] is used independently to develop the rhythm rec-
ognition detector.
The SAS validation test set contains the following ECG samples (see test sample size
in Table 1):
• coarse ventricular fibrillation (VF) (>200 μV peak-to-peak amplitude)

• shockable ventricular tachycardia (VT hi) (HR >150 bpm, rushes that last more
than 8s)
• asystole (≤100 μV peak-to-peak amplitude)
• normal sinus rhythm (NSR) (PQRS-T waves visible, HR 40-100 bpm)
• other organized rhythm (N) (includes all rhythms except those in other listed cate-
gories)
For each test sample, in function of the expert rhythm annotation and the SAS deci-
sion (shock/no shock), an interpretation table is built and shows the true positive (cor-
rect classification of a shockable rhythm), true negative (correct classification of a
non-shockable rhythm), false positive (non-shockable rhythm incorrectly classified as
a shockable rhythm), false negative (shockable rhythm incorrectly classified as non-
shockable). Finally, the results of the detector performance are reported in terms of:
specificity-Sp (TN/(TN+FP)), true predictive value (TP/(TP + FP)), sensitivity-Se (TP/
(FN + TP)), false positive rate (FP/(FP + TN)).
Table 1: FRED PA-1 SAS performance by rhythm category meets AHA recommen-
dations [2] and IEC Standards [3] for adult defibrillation on artefacts-free MIT-VFDB
signals:
Rhythms Test sample Performance goal Observed perfor-

size mance
[1]: The MIT-BIH Malignant Ventricular Arrhythmia Shockable Coarse VF 308 Sensitivity > 90% Meets [2-3]
Database
http://physionet.org/physiobank/database/vfdb/ VT hi 202 Specificity > 75% Meets [2-3]
[2]: Automatic External Defibrillators for Public Ac- Non Shockable NSR 1023 Sensitivity > 99% Meets [2-3]
cess Defibrillation : Recommendations for Specify-
ing and Reporting Arrhythmia Analysis Algorithm Asystole 4798 Sensitivity > 95% Meets [2-3]
Art. no.: 0-48-0240 Rev. c
Performance, Incorporating New Waveforms and

Enhancing Safety ; Circulation, 1997 ; 95 :1677- Other rhythms 1425 Sensitivity > 95% Meets [2-3]
1682.
Total NS 7246 Sensitivity > 95% Meets [3]
[3]: Standard IEC 2010 60601-2-4, ed 3.
The FRED PA-1 SAS test has been completed with a validation database consisting
of 2,475 couples of ECGs and transthoracic Impedance Cardiogram (ICG) from out-
of-hospital cardiac arrest (OHCA) interventions, recorded with Automated External
Defibrillators (FredEasy, Schiller Medical SAS, France) used by the fire brigade of
Paris.
This supplementary test completes the validation of the SAS and achieves the results
summarised in table 1. A report of the global validation test results is available on re-
quest.
Page 54
Technical Data 7
FRED PA-1 User Guide Electromagnetic interferences 7.4
7.4 Electromagnetic interferences

The FRED PA-1® is intended for use in the electromagnetic environment specified be-
low. The customer or the user of the FRED PA-1® should assure that it is used in such
an environment.
7.4.1 Electromagnetic emissions

Compliance with the regula-
Emission measurement Electromagnetic environment - explanations
tions
RF emissions Group 1 FRED PA-1® uses RF energy only for its internal function. There-
CISPR 11 fore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B
CISPR 11 FRED PA-1® is suitable for use in all establishments, including do-
Harmonics IEC 61000-3-2 Not applicable mestic establishments and those directly connected to the public
Voltage fluctuations Not applicable low-voltage power supply network that supplies buildings used for
IEC 61000-3-3 domestic purposes.
7.4.2 Electromagnetic immunity

Interference testing IEC 60601 test level Conformity level Electromagnetic environment - explanations
Electrostatic dis- ± 8 kV contact IEC 60601-1 Floors should be made of wood, concrete or ceramic tiles. If floors
charge ± 15 kV air conformity are covered with synthetic material, relative humidity should be at
IEC 61000-4-2 least 30%.
Electrical fast tran- ± 2 kV for power supply lines Not applicable No mains power is used
sient/burst ± 1 kV for input/output lines
IEC 61000-4-4
Surge ± 1 kV between conductors Not applicable No mains power is used
IEC 61000-4-5 ± 2 kV conductor-earth
Voltage dips, short in- < 5 % UT (> 95 % dip in UT) for Not applicable No mains power is used
terruptions and volt- 0.5 cycle
age variations on 40 % UT (60 % dip in UT) for 5 cy-
power supply input cles
lines 70 % UT (30 % dip in UT) for 25 cy-
IEC 61000-4-11
cles
< 5 % UT (> 95 % dip in UT) for 5 s
Power frequency (50/ 3 A/m IEC 60601-1 Power frequency magnetic fields should be that of a typical com-
60 Hz) magnetic field conformity mercial and/or hospital environment.
IEC 61000-4-8
Note: UT indicates the AC voltage of the mains before the test level.
Art. no.: 0-48-0240 Rev. c
Page 55
7 Technical Data
7.4 Electromagnetic interferences FRED PA-1
Interference testing IEC 60601 test level Conformity  Electromagnetic environment - explanations
level
Recommended minimum distances
Portable and mobile HF telecommunication devices must
keep the recommended minimum distance from the FRED
PA-1® and all its components, incl. cables; the recommended
minimum distance is calculated based on the transmitter's fre-
quency.
Conducted HF 3 Veff between 150 kHz and Not applicable

IEC 61000-4-6 80 MHz outside of the ISM fre-
quency bandsa No mains power is used
10 Veff between 150 kHz and Not applicable

a
80 MHz in ISM frequency bands
Radiated HF 10 V/m 80 MHz to 2.5 GHz 10 V/m 12
IEC 61000-4-3 d = ------  P between 80 MHz and 800 MHz
10
23
d = ------  P between 800 MHz and 2.5 GHz
10
where P is the maximum transmitting power of the transmitter

in Watt (W) according to manufacturer data, and d the recom-
mended minimum distance in metres (m)b.
The field strength of stationary HF transmitters (according to

an on-location measurement c) must not exceed the conform-
ity level for each frequency range d.
When operating the device near devices bearing the

symbol “ionising radiation”, interferences can occur.
Note 1 For 80 MHz to 800 MHz, the higher frequency range applies.
Note 2 These guidelines might not always be applicable. Electromagnetic radiation is influenced by absorption and reflection on struc-
tures, objects and people.
a. The ISM frequency bands (ISM = industrial, scientific, medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz
to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b. The conformity levels within the ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz serve to minimise
the probability of interferences caused by mobile/portable communication equipment that accidentally happens to be in the patient environ-
ment. The formula for the calculation of the recommended distance has been adapted by the factor 10/3 for transmitters in this frequency
Art. no.: 0-48-0240 Rev. c
range.
c. The field strength of stationary transmitters, e.g. base stations for radio telephones (mobile or cordless) and portable radio equipment, am-
ateur radios, AM and FM radios and TV signals cannot be predicted accurately in a theoretical way. In order to analyse electromagnetic
environments caused by stationary HF transmitters, an electromagnetic analysis on site should be considered. If the measured field
strength exceeds the HF conformity level, it needs to be checked whether the FRED PA-1® can be used in this environment. If an abnormal
behaviour is detected, additional measures need to be taken, e.g. reorientation or change of location of the FRED PA-1®.
d. For the frequency range between 150 kHz and 80 MHz, the field strength must be lower than 3 V/m.
Page 56
Technical Data 7
FRED PA-1 User Guide Electromagnetic interferences 7.4
7.4.3 Recommended minimum distances

The FRED PA-1® is intended to be used in electromagnetic environments in which it
is possible to control radiated HF interferences. The user of the FRED PA-1® can pre-
vent electromagnetic interferences by always keeping a minimum distance between
portable/mobile HF communication devices (transmitters) and the FRED PA-1®. The
recommended minimum distances are listed in the following table according to the
transmitters' max. transmitting power.
Distances according to the transmitter's frequency (m)

Max.
3 ,5 12 12 23
transmitting d = -------  P d = ------  P d = ------  P d = ------  P
3 10 10 10
power of the
between 150 kHz and 80 between 150 kHz and
transmitter (W) MHz outside of the ISM 80 MHz within the ISM between 80 MHz and between 800 MHz and
frequency band frequency band 800 MHz 2.5 GHz
0,01 0,12 0,23

0,1 0,38 0,73
1 1,2 2,3
Not applicable Not applicable
10 3,79 7,27
100 12 23
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 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
NOTE 3 An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended
separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range
80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if
it is inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Art. no.: 0-48-0240 Rev. c
Page 57
7 Technical Data
7.5 Literature FRED PA-1
7.5 Literature
European Resuscitation Council Guidelines 2015 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
(2015) Care
American Heart Association (2015) Guidelines 2015 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
Care
7.6 Glossary
ABCD The primary ABCD
A = Airways (check if airways are free)

B = Breathing (artificial respiration)
C = Circulation (circulatory signs or cardiac massage)
D = Defibrillation
AED Automated external defibrillator. This term is also used for semi-automatic defibrilla-
tors
BLS Basic Life Support (artificial respiration and cardiac massage)

CPR is frequently used synonymously
CPR Cardiopulmonary resuscitation
VT Ventricular tachycardia
VF Ventricular fibrillation
Art. no.: 0-48-0240 Rev. c
Page 58
Technical Data 7
FRED PA-1 User Guide Inspection report 7.7
7.7 Inspection report

The user guide must be read before the inspection.
Serial number: _______________________________________
Checks - after each use

 Check that the green indicator is blinking and all the other LEDs are off,
see 6.1.4 Mains status LED     
 Visual inspection of the device and accessories
 Device casing undamaged?
 No excessive clogging or damage?     
 Legible nameplate at the rear of the device?     
 Legible inscriptions on the front face of the device?     
 Expiration date of the accessories elapsed?     
Date:
Performed by:
Checks - once a Week/once a Month

Visual inspection of the device and accessories
    
(see previous table)
The main status indicator 1 is

lit green an no others LEDs are blinking see 6.1.4 Mains status
LED     
Date:
Performed by:
Checks - every 3 years

Visual inspection of the device and accessories
    
(see previous table)
Functional test
 Check for proper functioning (see 6.1.4 Mains status LED)     
 Measure the energy delivered at 50 ohms.     
Date:
Performed by:
Art. no.: 0-48-0240 Rev. c
Replacement - every 6 years

Internal backup battery replacement.     
Date:
Performed by:
In case of problems, please notify your Biomedical Department , your local SCHILLER distributor , or the authorized Custom-
er Service for your area :
Name: .................................................................. Tel.: ...................................................................
Page 59
8 Index
FRED PA-1
8 Index
A M
Accessories................................................ 44 Maintenance
Appendix Internal backup battery ..........................42
Glossary ................................................ 57 Maintenance Intervals............................39
Inspection Report .................................. 58 Test........................................................42
Literature ............................................... 57 Visual inspection ....................................41
Order information .................................. 56
Required accessories............................ 44
S
Safety Notes .................................................7
B Self-test.......................................................19
Battery
Battery Disposal .................................... 45
Battery is empty .................................... 24 T
Inserting the battery .............................. 20 Technical Data
Low battery............................................ 23 Defibrillation impulse..............................51
Sufficient battery capacity ..................... 23 Dimensions ............................................49
Biocompatibility .......................................... 14 Energy levels .........................................51
Environmental conditions.......................49
Patient impedance .................................51
C Patient Protection ..................................50
Cleaning ..................................................... 43 Power supply .........................................49
Configurable parameters Protection class .....................................49
Energy levels......................................... 16 Standards ..............................................50
Controls and indicators Weight....................................................49
-Display ................................................. 18 Terms of Warranty ......................................10
Trouble Shooting.........................................46
D
Danger of electric shock!.............................. 8
Danger of explosion ............................... 8, 20
Defibrillation
Automatic defibrillation .......................... 34
Defibrillator application guidelines......... 26
Finishing the therapy............................. 37
Internal safety discharge ....................... 37
Semi-automatic Defibrillation ................ 32
Design ........................................................ 15
Disinfection................................................. 43
Display Symbols/Indicators
in this User Guide.................................. 11
on the display ........................................ 12
on the electrode packaging ................... 13
used on the battery ............................... 12
used on the device ................................ 11
Disposal information
Accessories into contact with patients .. 45
At the end of useful life.......................... 45
Art. no.: 0-48-0240 Rev. c
Battery................................................... 45
E
Electrodes
Adult and paediatric electrodes............. 29
Checking the electrodes........................ 31
Open the electrode packaging .............. 28
F
Function ..................................................... 17
Page 60

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FRED PA-1

Automated external defibrillator (AED)

SCHILLER Medical S.A.S. Tel.: +33 (0) 388 63 36 00

Article no.: 0-48-0240 Rev. c

2 Components and Operation .................. 12

3 Initial operation ....................................... 18

3.2.3 Battery depleted during use, limited mode (CPR)............................ 22

7 Technical Data ........................................ 47

Art. no.: 0-48-0240 Rev. c

• people trained in early defibrillation

1.2 Responsibility of the User

1.3 Intended Use

1.4 Contraindication for use

1.5 Organisational Measures

1.6 Safety-Conscious Operation

 Operating the device with a defective casing or damaged cables constitutes a

1.7 Operation with other Devices

1.8 Maintenance and Cleaning

1.9 General Notes Regarding the Unit

1.10 Additional Terms

1.10.2 Terms of Warranty

• assembly operations, extensions, readjustments, modifications, or repairs are

Art. no.: 0-48-0240 Rev. c

For general safety notes as listed in this section.

Important or helpful user information.

1.11.2 Symbols used on the device

BF symbol. The device's signal input is defibrillation-protected.

Caution! High voltage!

CE-0459 marking (notified body LNE/G-MED).

Manufacturer symbol, manufacturing date.

Observe the user guide

1.11.3 Symbols used on the battery

The battery is recyclable

Normal storage temperature duration and allowed out-of-range temperature dura-

Battery must not be disposed of in the household waste

Observe the user guide

Battery expiry date

Art. no.: 0-48-0240 Rev. c

1.11.4 Symbols used on the electrode packaging

Disposable item; do not reuse

Do not bend packing

Storage temperature for the electrodes

Expiry date of the electrodes

An open package cannot be conserved more than one day.

Do not expose to sunlight

Does not contain latex

Do not expose to rain

Consult the user guide

Manufacturer symbol, manufacturing date

CE-0408 marking notified body

For use by or on the order of a physician or person licensed by state law

2 Components and Opera-

AEDs are semi-automatic or fully automatic defibrillators

Art. no.: 0-48-0240 Rev. c

Available versions Semi- or fully automatic defibrillator

2.2.1 Overview of the configurable settings

SCHILLER's service centre can configure the following parameters:.

Art. no.: 0-48-0240 Rev. c

2.3 Operating and Display Elements