Schiller FRED easy User manual

FRED easy®
User Guide
Automated external defibrillator (AED)
FRED easy® - SD Card
- Ethernet/Online
- Life
Art. no.: 0-48-0013 Rev. m *0-48-0013*

Manufacturer and responsible for the marking (first declaration 2002)
SCHILLER Medical S.A.S. Tel.: [phone]
4, rue Louis Pasteur Fax: [phone]
F- 67162 Wissembourg E-mail: [email protected] ;ar[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
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]
Article no.: 0-48-0013 Rev. m
Issue date: 13.01.15
FRED easy® 2G software ≥07.04
(except 20.00)
FRED easy® 1G software ≥9.08

Page 1
User Guide
FRED easy
Art. no.: 0-48-0013 Rev. m
Table of Contents
1 Safety Notes ..............................................5
1.1 User profiles.......................................................................... 5
1.2 Responsibility of the User ................................................... 5
1.3 Intended Use......................................................................... 6
1.4 Organisational Measures..................................................... 7
1.5 Safety-Conscious Operation ............................................... 7
1.6 Operation with other Devices.............................................. 8
1.7 Maintenance.......................................................................... 8
1.8 General Notes Regarding the Unit...................................... 8
1.9 Additional Terms .................................................................. 9
1.9.1 Implied authorisation.......................................................................... 9
1.9.2 Terms of Warranty ............................................................................. 9
1.10 Display Symbols/Indicators............................................... 10
1.10.1 Symbols used in this user guide ...................................................... 10
1.10.2 Symbols used on the device ............................................................ 10
1.10.3 Symbols used on the battery............................................................ 11
1.10.4 Symbols used on the electrode packaging ...................................... 12
2 Components and Operation ..................13
2.1 General Information ........................................................... 13
2.2 Design.................................................................................. 14
2.3 Function .............................................................................. 16
2.3.1 Overview on the configurable settings ............................................. 17
2.4 Operating and Display Elements ...................................... 18
2.4.1 Overview on versions and operating modes .................................... 18
2.4.2 Operation and display ...................................................................... 20
2.4.3 Display ............................................................................................. 21
2.4.4 Symbols used on the display ........................................................... 21
3 Initial operation .......................................22
3.1 Inserting the battery........................................................... 22
3.1.1 Switching device On and Off............................................................ 23
3.2 Battery monitoring ............................................................. 24
3.2.1 Sufficient battery capacity ................................................................ 24
3.2.2 Low battery capacity during use ...................................................... 25
3.2.3 Battery depleted during use, limited mode (CPR)............................ 26

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FRED easy
Art. no.: 0-48-0013 Rev. m
4 Defibrillation ............................................27
4.1 Instructions and Safety Notes........................................... 27
4.1.1 Instructions ...................................................................................... 27
4.1.2 Safety notes for AED use................................................................. 27
4.2 Defibrillation procedure ..................................................... 29
4.3 Applying the adhesive electrodes..................................... 34
4.3.1 General information ......................................................................... 34
4.3.2 Apply the adhesive electrodes and connect them to the device ...... 35
4.3.3 Checking the electrodes .................................................................. 37
4.4 Semi-automatic defibrillation ............................................ 38
4.5 Automatic defibrillation...................................................... 40
4.5.1 Functional description of automatic AEDs ....................................... 40
4.5.2 Safety notes for automatic defibrillation ........................................... 40
4.6 Manual Defibrillation (option)............................................ 43
4.6.1 Manual defibrillation - description .................................................... 44
4.6.2 Manual defibrillation procedure........................................................ 45
4.6.3 Switching to semi-automatic operational mode ............................... 46
4.7 Internal safety discharge ................................................... 47
4.8 Finishing the therapy ......................................................... 47
5 Versions ...................................................48
5.1 SD card version .................................................................. 48
5.1.1 Inserting the SD card ....................................................................... 49
5.2 Ethernet version ................................................................. 50
5.2.1 Connecting the Ethernet adapter ..................................................... 50
5.2.2 Data transmission procedure ........................................................... 51
5.2.3 Installing the ferrite core................................................................... 53
5.3 Online version..................................................................... 54
5.3.1 Ensuring data transmission.............................................................. 55
5.3.2 Placing the FRED easy® in the docking station .............................. 56
5.3.3 Activating the maintenance mode.................................................... 57
5.4 Configuration Ethernet/Online using FRECO .................. 58
5.4.1 Configuring the "Network" tab.......................................................... 58
5.4.2 Configuring the "Online" Tab ........................................................... 60
5.4.3 Configuring the date and time as well as IP addresses without
using FREDCO® ............................................................................. 61
6 Options ....................................................62
6.1 ECG display......................................................................... 62
6.2 Metronome .......................................................................... 62
6.3 Rechargeable NiCd battery................................................ 63
6.4 Silent mode ......................................................................... 64
6.4.1 Silent mode ...................................................................................... 64
6.4.2 Switching to silent mode .................................................................. 65
6.4.3 Deactivating silent mode.................................................................. 66
6.4.4 Erasing the memory card................................................................. 66
6.5 Special operating conditions............................................. 67
6.5.1 Maritime use .................................................................................... 67

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User Guide
FRED easy
Art. no.: 0-48-0013 Rev. m
7 Maintenance ............................................69
7.1 Maintenance Intervals........................................................ 69
7.1.1 Visual inspection of the device and accessories.............................. 69
7.1.2 Green indicator................................................................................. 70
7.1.3 Functional check .............................................................................. 70
7.1.4 Internal backup battery..................................................................... 70
7.2 Cleaning and disinfection.................................................. 71
7.3 Accessories and disposables ........................................... 71
7.4 Disposal information.......................................................... 72
7.4.1 Battery Disposal............................................................................... 72
7.4.2 Disposal of accessories that come into contact with the patient ...... 72
7.4.3 Disposal at the end of its useful life.................................................. 72
7.5 Trouble Shooting................................................................ 73
7.5.1 Error messages................................................................................ 73
7.5.2 Transmission error Ethernet/Online FRED easy®........................... 75
7.5.3 Trouble Shooting.............................................................................. 78
7.5.4 Measures to prevent electromagnetic interferences ........................ 80
8 Technical Data ........................................81
8.1 System Specifications ....................................................... 81
8.2 Classification and safety standards ................................. 82
8.3 Defibrillation pulse ............................................................. 83
8.4 Electromagnetic interferences.......................................... 85
8.4.1 Electromagnetic emissions .............................................................. 85
8.4.2 Electromagnetic immunity ................................................................ 85
8.4.3 Recommended minimum distances ................................................. 87
9 Appendix .................................................88
9.1 Order Information............................................................... 88
9.2 Required accessories ........................................................ 88
9.3 Literature............................................................................. 89
9.4 Glossary .............................................................................. 89
9.5 Inspection report ................................................................ 90
10 Index ........................................................92

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FRED easy
Art. no.: 0-48-0013 Rev. m

Page 5
Safety Notes 1
User Guide User profiles 1.1
Art. no.: 0-48-0013 Rev. m
FRED easy
1 Safety Notes
1.1 User profiles
The following people may use the FRED easy:
• Physicians or other trained medical personnel
• other people (non-professionals) trained in early defibrillation
• other people not trained in early defibrillation, as long as they can understand and
follow the spoken and displayed instructions.
1.2 Responsibility of the User
Even though untrained people may use the device, training and instructions are rec-
ommended to guarantee an optimal resuscitation procedure.
Regulations on who is allowed to use devices like the FRED easy® 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's required by the local
regulations.
The indications given by this equipment are not a substitute for the regular
checking of vital functions.
The numerical and graphical results as well as any interpretation suggested by
the device must be examined with respect to the patient's overall clinical condi-
tion and the quality of the recorded data.
Make sure that the user has read and understood the user guide, and especially
these safety notes.
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.

1 Safety Notes
1.3 Intended Use
Page 6
Art. no.: 0-48-0013 Rev. m
FRED easy
1.3 Intended Use
The FRED easy® 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
The device must not be used if the patient:
– is responsive
– is breathing
– has pulse
The FRED easy® 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 and that a
spare battery is at hand
– An empty battery must not be reused and must be disposed of immediately.
Only operate the device in accordance with the specified technical data.
Do not use this device in areas where there is any danger of explosion or in the
presence of flammable liquids, flammable anaesthetic agents or in places where
the ambient air's oxygen concentration is higher than 25 %.

Page 7
Safety Notes 1
User Guide Organisational Measures 1.4
Art. no.: 0-48-0013 Rev. m
FRED easy
1.4 Organisational Measures
1.5 Safety-Conscious Operation
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.
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.
Before switching on, check that the unit's casing and electrode connections are
not damaged.
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. Therefore:
– immediately replace a damaged unit or damaged cables and connections.

1 Safety Notes
1.6 Operation with other Devices
Page 8
Art. no.: 0-48-0013 Rev. m
FRED easy
1.6 Operation with other Devices
1.7 Maintenance
1.8 General Notes Regarding the Unit
Accessory equipment connected to the analogue and digital interfaces must be
certified according to the respective IEC standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Further-
more, all configurations shall comply with the valid version of the system standard
IEC/EN 60601-1-1. Everybody who connects additional equipment to the signal
input part or signal output part configures a medical system and is therefore re-
sponsible that the system complies with the requirements of the valid version of
the system standard IEC/EN 60601-1-1. If in doubt, consult the technical service
department or your local representative.
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 8.4) . Avoid using such devices or keep a
sufficient distance from them.
A 16.7 Hz filter allows to operate the FRED easy in the vicinity of a mains network
with a frequency of 16.7 Hz (railway lines in some countries).
FRED easy® 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.
Sensors and devices that are not defibrillation-proof must be disconnected from
the patient before a shock is triggered.
If the patient has an implanted pacemaker, be sure not to position the electrodes
directly on top of it.
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 liq-
uid.
To ensure patient safety, the accuracy of displayed values and interference-free
operation, only use original SCHILLER accessories. The user is responsible for
the use of third-party accessories. The warranty does not cover damage result-
ing from the use of accessories or consumables other than those marketed by
SCHILLER.
A defibrillation can fail with certain disease patterns.

Page 9
Safety Notes 1
User Guide Additional Terms 1.9
Art. no.: 0-48-0013 Rev. m
FRED easy
1.9 Additional Terms
1.9.1 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.
1.9.2 Terms of Warranty
Your SCHILLER FRED easy® is warranted against defects in material and manufac-
ture for the duration of one year (as from date of purchase). Excluded from this war-
ranty is damage caused by an accident or as a result of improper handling. The war-
ranty entitles to free replacement of the defective part. Any liability for subsequent
damage is excluded. The warranty is void if unauthorised or unqualified persons at-
tempt 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 easy® and approved attached equipment is used in ac-
cordance 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.

1 Safety Notes
1.10 Display Symbols/Indicators
Page 10
Art. no.: 0-48-0013 Rev. m
FRED easy
1.10 Display Symbols/Indicators
1.10.1 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.
1.10.2 Symbols used on the device
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.
BF symbol. The device's signal input is defibrillation-protected.
Caution! High voltage!
Observe the user guide
CE-0459 marking (notified body LNE/G-MED)
Do not dispose of the FRED easy® and its accessories in the household waste.
Manufacturer symbol, manufacturing date

Page 11
Safety Notes 1
User Guide Display Symbols/Indicators 1.10
Art. no.: 0-48-0013 Rev. m
FRED easy
1.10.3 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
Battery storage:
– unlimited storage duration between +15°C and +25°C (within the limit of the
specified expiry date),
– max. 48 hours between +25 °C and +60 °C as well as between +15 °C and 0 °C.
Battery must not be disposed of in the household waste.
Observe the user guide
Battery expiry date

1 Safety Notes
1.10 Display Symbols/Indicators
Page 12
Art. no.: 0-48-0013 Rev. m
FRED easy
1.10.4 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
Do not use the electrodes if the packaging is damaged
Consult the user guide

Page 13
Components and Operation 2
User Guide General Information 2.1
Art. no.: 0-48-0013 Rev. m
FRED easy
2 Components and Opera-
tion
2.1 General Information
FRED easy® is an automated external defibrillator (AED).
AEDs are semi-automatic defibrillators or fully automatic defibrillators to be used by
non-physicians.
FRED easy® is available as a semi- or fully automatic defibrillator.
The regulations governing the use and training requirements for AEDs such as
FRED easy® differ from country to country. The laws and regulations for the use of
automatic defibrillators need to be strictly observed.
Typical sites of operation for a FRED easy® are much-frequented places such as:
– airports
– train stations
– shopping centres
– public swimming pools
– sport centres
– public institutions
Local laws and regulations regarding the use of an AED differs from country to coun-
try. While some countries allow laypersons to use AEDs without any special training,
other countries restrict the use of AEDs to EMTs or First Responders after they have
undergone special training.
For training purposes, SCHILLER offers the FRED easy® TRAINER.
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.

2 Components and Operation
2.2 Design
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Art. no.: 0-48-0013 Rev. m
FRED easy
2.2 Design
Defibrillator FRED easy® is a defibrillator featuring the biphasic pulsed defibrillation impulse,
Multipulse Biowave®. The patient is defibrillated using disposable electrodes. The
ECG signal is analysed using the same electrodes.
Moreover, the user is guided with acoustic and written instructions (display/loud-
speaker). The device recognises the connected electrodes (adult or children elec-
trodes) and selects the defibrillation energy accordingly.
Metronome When the "metronome" is activated, the FRED easy® sets a configurable pace for the
cardiopulmonary resuscitation (CPR).
Data memory The device is equipped with a memory card (SD card). During the intervention, data
can therefore be saved, including the analysed ECG data, ambient noise and events
(see 5.1 SD card version, 5.2 Ethernet version and 5.3 Online version).
Data transmission The FRED easy® SD card version features a removable SD memory card, facilitating
data transmission to other devices. For the Ethernet and Online versions, data trans-
mission is performed via Ethernet network (for these device versions, the memory
card cannot be removed).
Power supply (standard) The device is operated with a non rechargeable, disposable lithium battery. The bat-
tery capacity is sufficient for:
– 180 shocks at maximum energy (if the self-test is performed weekly), or,
– 3.75 hours operating (alternately 30 minutes ON and 30 minutes OFF).
Power supply (option) A rechargeable NiCd battery is available as option. The capacity of a new and fully
charged battery is sufficient for:
– 45 shocks at maximum energy, or
– 40 min operating

Page 15
Components and Operation 2
User Guide Design 2.2
Art. no.: 0-48-0013 Rev. m
FRED easy
Available versions and options
FRED easy Life Standard features for this device are the metronome and a non rechargeable Li/MnO2
battery. All other options listed above for semi-automatic operation are not available.
SCHILLER's service centre is able to configure various device functions by means of
a dedicated PC connection (see 2.3 Function).
Version Available options for
automatic operation Available options for semi-automatic operation
SD card
• Metronome
• Rechargeable NiCd
battery
• ECG display
• Switchover to manual defibrillation
• Metronome
• Rechargeable NiCd battery
• Silent mode
Ethernet
• Metronome
• Rechargeable NiCd
battery
• ECG display
• Switchover to manual defibrillation
• Metronome
• Rechargeable NiCd battery
• Silent mode
Online
• Metronome • ECG display
• Switchover to manual defibrillation
• Metronome
• Silent mode
Patients with implanted pacemakers — FRED easy® features an electronic pacer
pulse suppression algorithm and therefore, pacemaker pulses are not taken into ac-
count for the analysis. Depending on the pacemaker model and on the position of the
electrodes, the compensation pulse following every pacer pulse may exceptionally
not work and be considered as a QRS complex. In this case, the analysis can be dis-
torted and inaccurate. It depends on the pacer pulse parameters whether or not the
compensation pulse is counted as a QRS complex.

2 Components and Operation
2.3 Function
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Art. no.: 0-48-0013 Rev. m
FRED easy
2.3 Function
Immediately after a battery has been inserted, the FRED easy® performs a self-test
of the device and battery. If this test is completed successfully, the green indicator
starts blinking, showing that the device is ready for operation and the information is
displayed.
Also, every time the device is switched on, a self-test is performed.
If a problem is detected in the course of this self-test:
– an acoustic alarm is issued,
– the green indicator stops blinking and
– an alarm message is displayed.
The acoustic alarm is issued until the battery is flat.
In addition, the device performs a daily or weekly self-test (this setting must only be
configured by service personnel authorised by Schiller); the self-test is announced
with a beep. If a problem is detected in the course of this self-test:
– an acoustic alarm is issued,
– the green indicator stops blinking, and
– A corresponding symbol or message is displayed when the device is switched
on by pressing the green button .
Fig. 2.1 Button to switch the device on
and off, and to start the analysis
(only in semi-automatic opera-
tion)
When a rechargeable Ni/Cd battery (option) is inserted, the device performs a self-
test every day.

Page 17
Components and Operation 2
User Guide Function 2.3
Art. no.: 0-48-0013 Rev. m
FRED easy
2.3.1 Overview on the configurable settings
SCHILLER's service centre can configure the following parameters:
Important!
The “FRED CO” software is only available to service centres authorised by Schil-
ler.
Modifications that can be made via "FRED CO" are only performed if requested
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.
Configurable parameters (by means of FREDCO®)
• Volume of language output
• Energy level for 1st, 2nd and 3rd shock (separate settings for adults and children)
• Manual or automatic start of the ECG signal analysis (only in semi-automatic op-
eration)
• Activation/deactivation of the 16.7 Hz filter
•aSound recording Yes/No
a. Sound recording — The owner needs to inform users that the device
records ambient noise during interventions.
• Number of chest compressions for children (15 or 30)
• Self-test frequency (daily or weekly)
• Entering the device name
• Choice between "continuous chest compressions" or "alterning chest compres-
sions/breathes" during CPR cycles
• Time and date On
• Update the software/change the device language

2 Components and Operation
2.4 Operating and Display Elements
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Art. no.: 0-48-0013 Rev. m
FRED easy
2.4 Operating and Display Elements
2.4.1 Overview on versions and operating modes
SD Card
version
Semi-automatic operational mode Semi-automatic operational mode with option
for switchover to manual mode
Automatic operational mode
Semi-automatic operational mode with option
for switchover to silent mode
Online/Ethernet version
The Online/Ethernet versions are available with the same operational modes as the SD card version:
• semi-automatic
• semi-automatic with option for switchover to manual mode
• Automatic
• Silent mode
FRED easy® Online FRED easy® Online with docking station Online with Ethernet adapter