Schiller FRED PA-1 Series User manual

FRED PA-1®TRAINER
Training Device for
Automated external defibrillator (AED)
User Guide
Art. no.: 0-48-0293 Rev. b *0-48-0293*

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
SCHILLER Medical Tel.: [phone]
4, rue Louis Pasteur
F- 67160 Wissembourg E-mail: [email protected]
Web: www.schiller-medical.com
Article no.: 0-48-0293 Rev. b
Issue date: 02.07.20
Corresponds to: original
Software: 02

Page 3
User Guide
FRED PA-1® TRAINER
Art. no.: 0-48-0293 Rev. b
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 ...................................................... 5
1.5 Safety-Conscious Operation ............................................... 5
1.6 Maintenance and Cleaning .................................................. 5
1.7 Additional Terms .................................................................. 6
1.7.1 Terms of Warranty ............................................................................. 6
1.8 Symbols/Indicators .............................................................. 7
1.8.1 Symbols used in this user guide ........................................................ 7
1.8.2 Symbols used on the device .............................................................. 7
1.8.3 Symbols used on the training electrode packaging............................ 8
2 Components and Operation .................... 9
2.1 General Information ............................................................. 9
2.1.1 Configurations .................................................................................. 10
2.2 Operating and Display Elements ...................................... 11
2.2.1 Overview FRED PA-1 TRAINER ..................................................... 11
2.2.2 Operating elements.......................................................................... 12
3 Initial operation ....................................... 13
3.1 Inserting the batteries ........................................................ 13
3.1.1 Switching device On and Off............................................................ 14
3.1.2 Device pairing .................................................................................. 14
4 Training ................................................... 15
4.1 Training procedure semi automated AED ........................ 15
4.2 Training procedure fully automated AED......................... 16
4.3 Accessories and disposables ........................................... 17
4.3.1 Order Information............................................................................. 17
4.3.2 Required accessories....................................................................... 17
4.4 Disposal information.......................................................... 18
4.4.1 Battery Disposal............................................................................... 18
4.4.2 Disposal at the end of its useful life.................................................. 18
4.5 Troubleshooting ................................................................. 19
4.5.1 Troubleshooting ............................................................................... 19
5 Technical Data ........................................ 20
5.1 System Specifications ....................................................... 20

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FRED PA-1® TRAINER
Art. no.: 0-48-0293 Rev. b

Page 5
Safety Notes 1
User Guide User profiles 1.1
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
1 Safety Notes
1.1 User profiles
The following people may use the FRED PA-1 TRAINER:
• Anyone who wants to be trained in the application of an AED under supervision
and with instructions of a trainer.
1.2 Responsibility of the User
1.3 Intended Use
1.4 Contraindication for use
1.5 Safety-Conscious Operation
1.6 Maintenance and Cleaning
Damaged or missing components must be replaced immediately.
Properly dispose of the packaging material and make sure it is out of children's
reach
Do not store the training electrodes together with the normal electrodes or with
the normal defibrillator.
The FRED PA-1 TRAINER is a simple cost-effective simulator of the
FRED PA-1 that is designed to be used exclusively for training.
It must only be used on a mannequin.
Do not use it as a conventional defibrillator.
Do not use the device in or near magnetic resonance imaging equipment (MRI).
The device must not be connected to a patient.
Immediately report any changes that impair safety (including operating behav-
iour) to the responsible person.
Only use original SCHILLER training electrodes.
Immediately replace a damaged unit, or damaged cables and connections.
Only operate the device in accordance with the specified technical data.
Before cleaning, switch the unit off and remove the batteries.
Do not use aggressive or abrasive cleaners.
Do not, under any circumstances, immerse the device or cable assemblies in
liquid.

1 Safety Notes
1.7 Additional Terms
Page 6
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
1.7 Additional Terms
1.7.1 Terms of Warranty
Your SCHILLER FRED PA-1 TRAINER is warranted against defects in material and
manufacture 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 en-
titles to free replacement of the defective part. Any liability for subsequent damage is
excluded. The warranty is void if unauthorised or unqualified persons attempt to make
repairs.
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 TRAINER and approved attached equipment is used
in accordance 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 7
Safety Notes 1
User Guide Symbols/Indicators 1.8
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
1.8 Symbols/Indicators
1.8.1 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.
1.8.2 Symbols used on the device
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.
Important or helpful user information.
CE marking
• Symbol for the recognition of electrical and electronic equipment.
• The device must be disposed of in a municipally approved collection point or
recycling centre when it is no longer required.
• Improper disposal harms the environment and human health due to the presence
of dangerous substances in electrical and electronic equipment.
Manufacturer information
IP 21 The device is protected against foreign bodies with a diameter greater than 12.5 mm,
and against dripping water.
Device contains a HF transmitter (Bluetooth)

1 Safety Notes
1.8 Symbols/Indicators
Page 8
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
1.8.3 Symbols used on the training electrode packaging
These electrodes are only intended for training, not for clinical use.
Do not store these electrodes with your normal defibrillator.
• Remove the patient's clothes
• Open the electrode packaging
• Peel off the protective foil
Training Defibrillation electrodes for adult and children with body weight higher than
25 kg
Storage temperature for the electrodes
Use within one day after opening
Keep out of direct sunlight
Keep dry
Manufacturer information

Page 9
Components and Operation 2
User Guide General Information 2.1
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
2 Components and Opera-
tion
2.1 General Information
The FRED PA-1 TRAINER is a simple and cost-effective simulator of the
FRED PA-1 that is designed to be used exclusively for training.
Operating modes The operating mode can be selected by configuration. One device is enough to train
both the fully automatic and semi-automatic mode.
• One scenario can be predefined.
• Scenario can be changed live by using the Defi training application.
Languages All languages available on the FRED PA-1 are also available on the Trainer.
Language selection as well as scenario selection is done by configuration (at produc-
tion site or distributor).
Standard package The FRED PA-1 TRAINER standard package includes:
•1FRED PA-1 TRAINER
• 1 SD card with the scenario shock recommended / shock recommended / shock
not recommended
• 1 set of training electrodes
• 1 training electrodes cable
• 4x 1.5V AA/LR6 batteries
The FRED PA-1 TRAINER doesn’t deliver any energy, it simply plays through the re-
suscitation process with different scenarios. It is powered by 4 standard 1.5 V AA/LR6
batteries.
The FRED PA-1 TRAINER equipped with Bluetooth, identified by the symbol on
the device label, can be controlled and configured via your smart-phone/tablet PC with
the “Defi training application” which can be downloaded from:
The FRED PA-1 TRAINER provides simulation that aim to help to familiarise with the
FRED PA-1® and shows that the users have the knowledge required to use it if nec-
essary.

2 Components and Operation
2.1 General Information
Page 10
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
2.1.1 Configurations
Configuration Values
Device type (Automatic / semi-automatic) DA / DSA
Resuscitation protocol detailed/short instructions
Patient type Adult / Child
CPR duration (in minutes) 1 / 2 / 3
Metronome frequency (beat/min) 100/110/120
CPR mode Continuous /30:2 / 15:2 (if patient type is child
Audio language List of available language

Page 11
Components and Operation 2
User Guide Operating and Display Elements 2.2
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
2.2 Operating and Display Elements
2.2.1 Overview FRED PA-1 TRAINER
The status LEDs are not active!
4 x 1.5 V AA/LR6 batteries
Training cable with connector to simulate
preconnected electrodes
Confirmation button that elec-
trodes are applied and connected
Training electrodes (only
pads) to simulate opening
and applying the pads on the
patient’s body
Customizable emergency
number
Shock button

2 Components and Operation
2.2 Operating and Display Elements
Page 12
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
2.2.2 Operating elements
4 x 1.5 V AA/LR6 batteries
SD card with the scenario
On/Off switch
On/Off LED

Page 13
Initial operation 3
User Guide Inserting the batteries 3.1
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
3 Initial operation
3.1 Inserting the batteries
1. Open battery cover as indicated in the illustration below
2. Insert the batteries with the correct polarity
Danger of explosion! The battery must not be exposed to high temperatures or
disposed of with household waste.
Do not short-circuit, cut, destroy, burn or charge a battery.
Replace the battery if the device indicates a battery problem. A defective battery
must not be used.
Insert the battery cover as indicated in the illustration on the left.
1. Insert the two stop blocks located at the bottom of the battery cover in the device
slots.
2. Perform a rotational movement until the battery cover locks in place.
Fig. 3.1 Inserting the battery cover
<Click>

3 Initial operation
3.1 Inserting the batteries
Page 14
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
3.1.1 Switching device On and Off
Switching ON 1. Open the battery cover.
2. Slide the On/Off switch to the right. The On/Off LED lights up.
3. Close the battery cover. The device is now ready for training.
Switching OFF 1. Open the battery cover.
2. Slide the On/Off switch to the left. The On/Off LED is off.
3. Close the cover.
3.1.2 Device pairing
Off On On/Off LED
If the cover is closed, the device will remind you periodically with an acoustic signal
that the device is switched on.
This is only possible with devices equipped with Bluetooth.
1. Open the Schiller Defi training App on your smart-phone or tablet PC.
2. Select the icon the Device list of Defi training application. Select the de-
vice you want to use in the list.
For additional information on the application, refer to the application: Settings
> Application > Help.

Page 15
Training 4
User Guide Training procedure semi automated AED 4.1
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
4 Training
4.1 Training procedure semi automated AED
• The following instructions comply with the scenario “shock recommended and then
shock not recommended” (A)
Trainee starts by opening cover and
follows the instructions
1. stay calm and follow instructions
2. call emergency service dial number written on the device
3. use only if patient is unresponsive
4. check that electrodes connector is correctly fitted in machine
5. remove clothes from upper body - cut if necessary
6. tear open electrode package located in device cover
7. as shown on package peel off the packing and apply both electrodes to the upper
body.
Trainer has to confirm correct per-
formance with the button on the de-
vice or via Defi training application
Trainer confirms that the above procedure was correctly performed by the train-
ee. Otherwise, the instructions are repeated from step 1. After the second repe-
tition, the instructions jump to step 15.
8. stand clear of patient heart rhythm analysis will be performed
9. analysing heart rhythm
10. shock advised
11. do not touch the patient
12. press orange button - now (if shock button is not pressed within 20 seconds it
jumps to 14.)
13. shock delivered
14. it is now safe to touch the victim
15. advise to do chest compression: according to configuration
16. repeat until next instruction (the next instruction starts with step 8)
– After the instruction “no shock advised” (step 10), it jumps to step 14.
Finishing resuscitation process To finish the resuscitation process and switch the device to standby mode, the
pads connection confirmation button must be pressed to simulate the disconnec-
tion of the patient and the cover closed. After 30 seconds the device will be in
standby mode.
• If the patient is not disconnected, the resuscitation process will continue even if the
cover is closed (like the real FRED PA-1).
• The device will remind the user with regular acoustic signals that it is in standby
mode. To switch the device off completely, the ON/OFF switch must be used.
• The training electrode cable is already connected (normally the pads are pre-con-
nected)
• As soon as the cover is opened, the voice prompt starts.
• Advise the trainee to follow the instructions.
If the trainer presses the confirm button during the resuscitation process it will
simulate disconnected pads.

4 Training
4.2 Training procedure fully automated AED
Page 16
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
4.2 Training procedure fully automated AED
• The following instructions comply with the scenario “shock recommended and then
shock not recommended
Trainee starts by opening cover and
follows instructions
1. stay calm and follow instructions
2. call emergency service dial number written on the device
3. use only if patient is unresponsive
4. check that electrodes connector is correctly fitted in machine
5. remove clothes from upper body - cut if necessary
6. tear open electrode package located in device cover
7. as shown on package peel off the packing and apply both electrodes to the upper
body.
Trainer has to confirm correct per-
formance with the button on the de-
vice or via Defi training application
Trainer confirms that the above procedure was correctly performed by the train-
ee. Otherwise, the instructions are repeated from step 1. After the second repe-
tition, the instructions jump to step 15.
8. stand clear of patient heart rhythm analysis will be performed
9. analysing heart rhythm
10. shock advised
11. warning stand clear of patient shock will be delivered
12. 3-2-1
13. shock delivered
14. advise to do chest compression: according to configuration
15. repeat until next instruction (the next instruction starts with step 8.
– After the instruction “no shock advised” (step 10), it jumps to step 14.
Finishing resuscitation process To finish the resuscitation process and switch the device to standby mode, the
pads connection confirmation button must be pressed to simulate the disconnec-
tion of the patient and the cover closed. After 30 seconds the device will be in
standby mode.
• If the patient is not disconnected the resuscitation process will continue even if the
cover is closed (like the real FRED PA-1).
• The device will remind the user with regular acoustic signals that it is in standby
mode. To switch the device off completely the ON/OFF switch must be used.

Page 17
Training 4
User Guide Accessories and disposables 4.3
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
4.3 Accessories and disposables
Your local representative stocks all the consumables and accessories for the
FRED PA-1 TRAINER. A full list of all SCHILLER representatives can be found on the
SCHILLER 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.
4.3.1 Order Information
Devices
Accessories/Disposable
4.3.2 Required accessories
•UserGuide
• 1 set of training electrodes
• 1 training electrodes cable
• 4 x 1.5 V AA/LR6 alkaline batteries
• SD card with shock recommended and then shock not recommended scenario
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.
Part No. Description
1-134-9901/2.230379 FRED PA-1 TRAINER
0-21-0019 1 training electrodes cable
Part No. Description
0-21-0031 1 set of training electrodes

4 Training
4.4 Disposal information
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Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
4.4 Disposal information
4.4.1 Battery Disposal
4.4.2 Disposal at the end of its useful life
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.
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
dangerous substances in electrical and electronic equipment.

Page 19
Training 4
User Guide Troubleshooting 4.5
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
4.5 Troubleshooting
4.5.1 Troubleshooting
Problem Possible causes Remedy
The ON/OFF LED is off and
the device cannot be turned
on.
• Battery depleted or inserted with
the wrong polarity.
• Device defective.
Replace the battery.
Insert the battery correctly.
Have the device repaired.

5 Technical Data
5.1 System Specifications
Page 20
Art. no.: 0-48-0293 Rev. b
FRED PA-1®TRAINER
5 Technical Data
5.1 System Specifications
Manufactured by SCHILLER MEDICAL
Device name FRED PA-1 TRAINER
Dimensions 310 x 255 x 100 mm (h x l x w)
Weight Approx. 1.7 kg with battery and standard accessories
Protection class of the device
housing IP21 for indoor use only
Power supply
Voltage
with battery type
Power consumption
6V
4 x 1.5V AA/LR6 alkaline batteries
max. 3 W
Environmental conditions
Device
Operation
Storage before use
Storage and transport
Pollution degree
• 0...40 °C at a relative humidity of 30 to 95% (no condensation)
• 0...40 °C with the battery inserted
• Atmospheric pressure 700 to 1060 hPa / 0 to 3000 m
• -20 ... 50 °C at a relative humidity of 30 to 95% (no condensation)
• Atmospheric pressure 500 to 1060 hPa
• Class 2 (means can be used in office environmental)
Bluetooth
RF module
Bluetooth type
Frequency Band
Antenna type
Output maximum
CYPRESS EZ-BLE CYBLE-0220001
BLE
2400-2483,5 MHz
integral
0,3 mW, <20mW