Schiller FRED PA-1 Series User manual

FRED PA-1
User Guide
Automated external defibrillator (AED)
Art. no.: 0-48-0240 Rev. c *0-48-0240*

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:
[e-mail]
Manufacturer and responsible for the marking (first declaration October 2015)
SCHILLER Medical S.A.S. Tel.: [phone]
4, rue Louis Pasteur Fax: [phone]
F- 67162 Wissembourg E-mail: [email protected]
Web: www.schiller-medical.com
Address Headquarters
SCHILLER AG Phone: [phone]
Altgasse 68 Fax: [phone]
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

Page 3
User Guide
FRED PA-1
Art. no.: 0-48-0240 Rev. c
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
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

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FRED PA-1
Art. no.: 0-48-0240 Rev. c
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

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User Guide
FRED PA-1
Art. no.: 0-48-0240 Rev. c
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

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FRED PA-1
Art. no.: 0-48-0240 Rev. c

Page 7
Safety Notes 1
User Guide User profiles 1.1
Art. no.: 0-48-0240 Rev. c
FRED PA-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).
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

1 Safety Notes
1.4 Contraindication for use
Page 8
Art. no.: 0-48-0240 Rev. c
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 puddleof 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.
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 9
Safety Notes 1
User Guide Operation with other Devices 1.7
Art. no.: 0-48-0240 Rev. c
FRED PA-1
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.

1 Safety Notes
1.10 Additional Terms
Page 10
Art. no.: 0-48-0240 Rev. c
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.

Page 11
Safety Notes 1
User Guide Symbols/Indicators 1.11
Art. no.: 0-48-0240 Rev. c
FRED PA-1
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.
Manufacturer symbol, manufacturing date.
Observe the user guide

1 Safety Notes
1.11 Symbols/Indicators
Page 12
Art. no.: 0-48-0240 Rev. c
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

Page 13
Safety Notes 1
User Guide Symbols/Indicators 1.11
Art. no.: 0-48-0240 Rev. c
FRED PA-1
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

2 Components and Operation
2.1 General Information
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Art. no.: 0-48-0240 Rev. c
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.

Page 15
Components and Operation 2
User Guide Design 2.2
Art. no.: 0-48-0240 Rev. c
FRED PA-1
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

2 Components and Operation
2.2 Design
Page 16
Art. no.: 0-48-0240 Rev. c
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
.

Page 17
Components and Operation 2
User Guide Operating and Display Elements 2.3
Art. no.: 0-48-0240 Rev. c
FRED PA-1
2.3 Operating and Display Elements
2.3.1 Overview FRED PA-1
Main status LED
Service status LEDs:
• Modem
•Battery
• Service
• Electrodes
Battery
The device is switched
on when the cover is
opened.
Wall cradle Compartment for additional electrode

2 Components and Operation
2.3 Operating and Display Elements
Page 18
Art. no.: 0-48-0240 Rev. c
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
Electrode connector

Page 19
Components and Operation 2
User Guide Function 2.4
Art. no.: 0-48-0240 Rev. c
FRED PA-1
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.
Status LED
Service
LEDs
If a problem is detected during this test:
• an acoustic alarm is issued,
• 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.

3 Initial operation
3.1 Inserting the battery
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Art. no.: 0-48-0240 Rev. c
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
Li/MnO2
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.
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