SCHILLER - Fred Easy - Manual

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FRED easy®

Automated external defibrillator (AED)


FRED easy® - SD Card
- Ethernet/Online
- Life
Art. no.: 0-48-0013 Rev. m *0-48-0013*

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 2002)

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] ; [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.: 0-48-0013 Rev. m


Issue date: 13.01.15
FRED easy® 2G software ≥ 07.04
(except 20.00)
FRED easy® 1G software ≥ 9.08
FRED easy 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 ......................................................................... 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
Art. no.: 0-48-0013 Rev. m

3.2.3 Battery depleted during use, limited mode (CPR)............................ 26

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FRED easy

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

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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FRED easy User Guide

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

Page 3
Page 4
FRED easy

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


Safety Notes 1
FRED easy User Guide User profiles 1.1

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.

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

Page 5
1 Safety Notes
1.3 Intended Use 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 %.

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

Page 6
Safety Notes 1
FRED easy User Guide Organisational Measures 1.4

1.4 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.

1.5 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.
 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.
Art. no.: 0-48-0013 Rev. m

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1 Safety Notes
1.6 Operation with other Devices FRED easy

1.6 Operation with other Devices


 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.

1.7 Maintenance
 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.
Art. no.: 0-48-0013 Rev. m

1.8 General Notes Regarding the Unit


A defibrillation can fail with certain disease patterns.

Page 8
Safety Notes 1
FRED easy User Guide Additional Terms 1.9

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

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1 Safety Notes
1.10 Display Symbols/Indicators 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.

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.

1.10.2 Symbols used on the device

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

Caution! High voltage!

Observe the user guide


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

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 10
Safety Notes 1
FRED easy User Guide Display Symbols/Indicators 1.10

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


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

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1 Safety Notes
1.10 Display Symbols/Indicators 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

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

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Components and Operation 2
FRED easy User Guide General Information 2.1

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.

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.

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

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.: 0-48-0013 Rev. m

Page 13
2 Components and Operation
2.2 Design 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

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

Page 14
Components and Operation 2
FRED easy User Guide Design 2.2

Available versions and options


Version Available options for Available options for
automatic operation semi-automatic operation
• Metronome • ECG display
• Rechargeable NiCd • Switchover to manual defibrillation
SD card battery • Metronome
• Rechargeable NiCd battery
• Silent mode
• Metronome • ECG display
• Rechargeable NiCd • Switchover to manual defibrillation
Ethernet battery • Metronome
• Rechargeable NiCd battery
• Silent mode
• Metronome • ECG display
• Switchover to manual defibrillation
Online
• Metronome
• Silent mode

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).

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

Page 15
2 Components and Operation
2.3 Function 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
Fig. 2.1 Button to switch the device on
and off, and to start the analysis
with a beep. If a problem is detected in the course of this self-test:
(only in semi-automatic opera-
tion) – 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 .

When a rechargeable Ni/Cd battery (option) is inserted, the device performs a self-
test every day.

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

Page 16
Components and Operation 2
FRED easy User Guide Function 2.3

2.3.1 Overview on the configurable settings

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.

SCHILLER's service centre can configure the following parameters:

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
• 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
a. Sound recording — The owner needs to inform users that the device
records ambient noise during interventions.
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Page 17
2 Components and Operation
2.4 Operating and Display Elements 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 Automatic operational mode
for switchover to manual 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
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Page 18
Components and Operation 2
FRED easy User Guide Operating and Display Elements 2.4

FRED easy Life


FRED easy Life has got the same functions as the versions listed above; the only ex-
ceptions are: different printing on the foil, not possible to switch to manual or silent
mode.

SD card-Online-Ethernet version

SD card, semi-automatic operation Online/Ethernet SD card, automatic operation


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

Page 19
2 Components and Operation
2.4 Operating and Display Elements FRED easy

2.4.2 Operation and display

3 4 5

1
6

8a 8b

9 8

The FRED easy® versions SD Card (removable memory card), ETHERNET (with Ether-
net adaptor) and ONLINE (with docking station) only differ from each other in point 8.

(1) The green indicator is blinking if no problem was detected during the last self-
test (see Fig. 2.2 Green indicator blinking).
(2) The yellow indicator is lit when the device has not detected an acceptable resist-
ance between the electrodes (i.e. when the electrodes are not applied and/or the
electrode cable is not connected).
(3) Port for the adhesive pads.
(4) Display.
(5) The green button has got the following functions:
Art. no.: 0-48-0013 Rev. m

Fig. 2.2 Green indicator blinking – Switch on the device (press for max. 1 second)
– Switch the device off (press and hold for 3 seconds)
– Start the analysis in semi-automatic mode (only press the button for 1 second!)
(6) Battery.
(7) Speaker.
(8) SD card slot.The Ethernet interface (8a) is used to connect the Ethernet adapter
(Ethernet version) and to connect the device to the docking station (8b) (Online
version).
(9) Orange button to trigger the defibrillation shock (in semi-automatic mode on-
ly).

Page 20
Components and Operation 2
FRED easy User Guide Operating and Display Elements 2.4

2.4.3 Display

2
DO NOT TOUCH THE PATIENT
ANALYSING!

Fig. 2.3 FRED easy® display

(1) Symbol display line.


(2) Text display lines. The written instructions issued by the FRED easy® are dis-
played on these 3 lines.

2.4.4 Symbols used on the display

Number of shocks delivered since the device was turned on.

Sufficient battery capacity (see 3.1 Inserting the battery).

Low battery capacity (see 3.1 Inserting the battery).

SD card detected, percentage of memory used.

SD card not recognised (see 5.1 SD card version).

Adult pads detected.

Paediatric pads detected.

Time elapsed since device was turned on (minutes : seconds).


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

Page 21
3 Initial operation
3.1 Inserting the battery FRED easy

3 Initial operation
Danger of explosion — The FRED easy® 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. Dangerous, 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 by the device when inserting it and is allocated to this
device. It must not be inserted in another device.
 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
and keep a spare battery on hand.
 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 battery must remained packed in its original plastic packaging (blister) dur-
ing the entire storage time. The plastic packaging must only be removed when
the battery is used.
 Do not expose the FRED easy® to direct sunlight or to extreme hot or cold. An
ambient temperature higher than 25°C has an adverse effect on the battery life.
Art. no.: 0-48-0013 Rev. m

Page 22
Initial operation 3
FRED easy User Guide Inserting the battery 3.1

• The device is normally operated with a non rechargeable lithium battery.


• Alternatively, a rechargeable NiCd battery can be used (see 6.3 Rechargeable
NiCd battery).
• Each time the device is turned on, it verifies that the battery is functioning proper-
ly.
Equipment damage —
 The connector in the battery compartment must only be used for maintenance
purposes.
 Do not use rechargeable batteries to operate the FRED easy® TRAINER be-
cause its voltage is not suitable for this device.
 Do not use the lithium battery to power the FRED easy® TRAINER, because its
voltage is not adapted to this device.

 Insert the battery as indicated in the illustration on the left.


– Firmly press the battery into the battery compartment until it clicks into place.
– As soon as the battery is inserted, the FRED easy® runs a self-test to check the
condition of the device and the battery.
– After this self-test, the date, time and IP configuration for the FRED easy Ether-
net/Online can be set (see section 5.4.2 page 60).
If this test does not reveal any problems, the green indicator starts blinking and the
information is displayed.

Fig. 3.1 Inserting the battery

3.1.1 Switching device On and Off

Switching ON  Press the green button for max. 1 second.

Switching OFF  Press the green button and hold for 3 second.

Forced shutdown procedure


If the device cannot be switched off via the above procedure, remove the battery and
inserting again.
Art. no.: 0-48-0013 Rev. m

Page 23
3 Initial operation
3.2 Battery monitoring FRED easy

3.2 Battery monitoring


• The FRED easy® checks the capacity of the rechargeable NiCd battery or the lith-
ium battery and warns the user when the battery is "low" or "depleted".
• 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.
 Whatever its remaining capacity, the battery must be replaced once the expira-
tion date (indicated on the packaging) has been reached.
 The old battery must be recycled in accordance with local regulations.

3.2.1 Sufficient battery capacity


FRED easy® displays the symbol to indicate that the battery capacity is "suffi-
cient".

The FRED easy®symbol remains displayed on the screen for as long as the bat-
tery capacity is "sufficient".

DO NOT TOUCH THE PATIENT


ANALYSING!

Fig. 3.2 Sufficient battery capacity

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

Page 24
Initial operation 3
FRED easy User Guide Battery monitoring 3.2

3.2.2 Low battery capacity during use

• Despite the acoustic and written warnings, 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 the "low" threshold while the device is in use, the
green indicator is turned off, the symbol starts blinking on the display and the
device emits an audible signal.

These warnings are issued until the battery is replaced (or recharged). The battery
must be replaced as quickly as possible.

Fig. 3.3 The green indicator is not lit

DO NOT TOUCH THE PATIENT


ANALYSING!

Fig. 3.4 Low battery capacity

Low battery capacity during self-test or after the battery has been inserted
• If low battery capacity is detected during a self-test or when the battery is inserted,
the device emits an audible signal and the green indicator is not lit until the battery
is replaced (see Fig. 3.3 The green indicator is not lit).
Art. no.: 0-48-0013 Rev. m

Page 25
3 Initial operation
3.2 Battery monitoring FRED easy

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, a message is displayed


prompting the user to replace the battery and to perform CPR. An audible signal is
emitted and the indicator remains off until the battery is replaced (or charged).

The message stays displayed until the battery is replaced.

REPLACE BATTERY
30 CHEST COMPRESSIONS THEN
2 RESCUE BREATHS

Depleted battery during self-test


• When a depleted battery has been detected, the green indicator is off and an au-
dible signal is emitted.
• When the device is next switched on, a message is displayed, prompting the user
to replace the battery and continue with CPR until the device is fully operational
again.
Depleted battery after the battery has been inserted
• If a battery inserted in the device is identified as depleted, an audible signal is emit-
ted, the green indicator is turned off and a message indicating that the battery must
be replaced is displayed.
Green indicator is off

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

Page 26
Defibrillation 4
FRED easy User Guide Instructions and Safety Notes 4.1

4 Defibrillation
4.1 Instructions and Safety Notes
4.1.1 Instructions

• FRED easy® 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 easy® if
local law approves of this practice. Make sure that the FRED easy® is only accessi-
ble to persons who are legally authorised to use an AED.
• 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 decide
about any additional measures (e.g. adrenaline).
• According to AHA/ERC guidelines, even children under 8 years may be defibrillat-
ed.
• The electrodes should be applied in the anterior-anterior position. With infants, an-
terior-posterior placement can be advised to prevent a short-circuit between the
two defibrillation electrodes.
• A defibrillation can fail with certain disease patterns.

4.1.2 Safety notes for AED use

 Before each use, the user must verify that the device operates reliably and is in
proper working order. It is especially important to check that connection cables
are not damaged. Damaged cables and connectors must be replaced immedi-
ately.
 Changes, including concerning operational behaviour, affecting safety must be
immediately reported to the responsible.
 Equipment damage! Sensors and devices that are not defibrillation-proof must
be disconnected from the patient before a shock is triggered.
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.
 If, in the course of treatment, a patient spontaneously regains consciousness, a
defibrillation shock that may have been advised just before must not be deliv-
Art. no.: 0-48-0013 Rev. m

ered.

Page 27
4 Defibrillation
4.1 Instructions and Safety Notes FRED easy

Shock hazard — for user and assistants


 Wear gloves when performing a defibrillation, if possible.
 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 user and all assistants must be briefed regarding the defibrillation procedure
(preparation and execution). The assistants' tasks must be clearly defined.
• 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),
– instruct bystanders to not touch the patient or conducting objects.
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,
– have an external pacemaker at hand.
 The pacemaker must be checked for proper functioning as soon as possible af-
ter defibrillation. Art. no.: 0-48-0013 Rev. m

Page 28
Defibrillation 4
FRED easy User Guide Defibrillation procedure 4.2

4.2 Defibrillation procedure


The user is informed of each step by a voice prompt as well as a text instruction on
the display.

Both the voice prompts and text instructions can be issued as "long instructions" as
well as "short instructions".

Contact your SCHILLER distributor for more information.

The following procedure is applicable when "long instructions" have been config-
ured.

Switch on the device and call the Once the device is turned on (by pressing thre green button ), an instruction text
emergency medical service reminds the user to call the emergency medical service.

 Assess the patient's condition The device then prompts the user to assess the patient’s condition.

The device must only be used if the following symptoms are found:

– not responsive,
– no respiration,
– no pulse.

Preparing the patient Once you made sure that the patient does not show any signs of circulation, you are
prompted to remove the clothes from the patient's upper body.
Art. no.: 0-48-0013 Rev. m

The patient’s chest may be shaved, if necessary.

Page 29
4 Defibrillation
4.2 Defibrillation procedure FRED easy

 Open the electrode packaging Open the electrode packaging and connect the electrodes to the device (unless the
and connect the electrodes electrodes are pre-connected).

Applying the electrodes FRED easy® prompts the user to apply the electrodes on the patient’s chest.

• The yellow indicator is lit and the device repeats the instructions twice until the
electrodes are applied, or until the electrode connector is connected to the device,
respectively, and the electrode-skin resistance (impedance) has reached an ac-
ceptable level.
• After the second prompt to apply the electrodes, the device recommends to per-
form a cardiopulmonary resuscitation cycle. The device will switch off if it has not
detected an acceptable impedance between the two electrodes after 5 minutes of
CPR.

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

Page 30
Defibrillation 4
FRED easy User Guide Defibrillation procedure 4.2

ECG analysis Before each analysis, the device informs the user that the patient must not be
touched.

In semi-automatic mode, the device prompts the user to start an ECG analysis by
pressing the green button .

• If no analysis has been initiated after a few seconds following the prompt to start
the analysis, the device recommends to perform a cardiopulmonary resuscitation
cycle. At the end of the CPR cycle, the device repeats the prompt to start the anal-
ysis.
• The semi-automatic FRED easy® can be configured to automatically start the ECG
analysis without pressing the green button .

In automatic as well as semi-automatic mode (with automatic analysis activated), the


FRED easy® informs the user that the analysis is going to be performed. The ECG
analysis is started without any intervention by the user.

The analysis takes approximately 10 seconds.

• Motion detection During ECG analysis, the patient must lie as still as possible and the user must suspend
CPR; otherwise, artefacts may lead to an incorrect analysis.

The FRED easy® includes a motion detection function. When the ECG analysis is
disturbed by CPR or patient movements, the device informes the user via a voice
prompt and a written message on the display. The analysis is automatically resumed
as soon as the cause of disturbance has been eliminated.

If no correct analysis has been obtained by the time the instruction has been repeated
5 times, the device recommends to perform a cardiopulmonary resuscitation cycle.
Art. no.: 0-48-0013 Rev. m

Page 31
4 Defibrillation
4.2 Defibrillation procedure FRED easy

Shock advised The device has detected a shockable rhythm.

Before each shock delivery, the device warns the user not to touch the patient.

If the analysis algorithm detects a shockable rhythm, the device will automatically
charge the required defibrillation energy. Once the energy is charged, the user is
prompted to deliver the shock by pressing the orange button (only in semi-auto-
matic mode).

In automatic mode, the device alerts the user that the shock will be delivered, and
then delivers the shock without user intervention.

Then the FRED easy® informs the user via spoken and written message that the
shock has been delivered.

Shockable conditions include:

– ventricular fibrillation or
– ventricular tachycardia with a rate higher than 150 bpm.

If the device detects a shockable rhythm, the shock must only be released if the patient
does not show any signs of circulation.

If the device detects that the patient’s heart rhythm has changed to an non shockable
rhythm, the previously recommended shock is immediately cancelled and the energy
is discharged internally. FRED easy® informs the user that the shock has been can-
celled.

• Each shock is The FRED easy® informs the user that the patient can be touched again and prompts
followed by CPR the user to perform a cardiopulmonary resuscitation cycle.

According to the configuration of the device, a CPR cycle consists of:

– performing chest compressions during the set period of time, or


– performing alternatively 30 chest compressions and 2 breathes during the set
period of time.
Before each CPR cycle, the device informs the user that the patient can be touched.

The device indicates the position of the hands and the rhythm of chest compressions
with beeps ("metronome"), if applicable. Art. no.: 0-48-0013 Rev. m

• For children, the number of chest compressions can be configured to 15 or 30 us-


ing FREDCO®. The device recognises the connected electrodes (adult or child
electrodes) and selects the number of chest compressions accordingly.
• CPR duration can be configured in FREDCO® and is the same for adults and
children: it can be set between 30 seconds and 7.5 minutes, in steps of 30 sec-
onds.

Page 32
Defibrillation 4
FRED easy User Guide Defibrillation procedure 4.2

• Followed by a new Once the CPR cycle has been finished, the device prompts the user to run a new ECG
analysis analysis (in semi-automatic mode).

In automatic as well as semi-automatic mode (with automatic analysis activated), this


new analysis starts without any intervention required of the user.

If the device again detects a shockable rhythm, it will automatically charge the defi-
brillation energy necessary for the 2nd or 3rd shock. For all subsequent shocks, the
energy remains the same for the 3rd shock.

The energy levels can be configured by SCHILLER's customer service (see


8 Technical Data).

• Successful shock After a successful shock (no further shocks advised by the ECG analysis),
followed by CPR FRED easy® prompts the user to perform CPR.

 No shock advised The device has not detected a shockable rhythm.

If the analysis algorithm does not detect a shockable rhythm, the FRED easy® in-
forms the user that no shock is necessary and prompts him or her to perform CPR.

According to the configuration of the device, the user may be asked to check the pres-
ence of pulse before performing the CPR cycle.

Finishing the therapy Once the therapy has been finished, the defibrillation pads must be removed from the
patient's chest and disconnected from the device. The defibrillation pads are not re-
usable.
The device can then be switched off by pressing and holding the green button for
3 seconds.
Art. no.: 0-48-0013 Rev. m

Page 33
4 Defibrillation
4.3 Applying the adhesive electrodes FRED easy

4.3 Applying the adhesive electrodes


4.3.1 General information

 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.
 The pads are sufficiently pre-gelled. Do not use extra contact agent.
 Do not reuse the pads.

After having removed the clothes from the patient's upper body, perform the following
steps:

– open the electrode packaging, connect the electrode cable to the device
– and apply the electrodes to the patient's chest.

2
3

(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) Electrode connector, to be inserted into the electrode port.

• The yellow indicator is lit and the device repeats the instructions twice 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.
• After the second prompt to apply the electrodes, the device recommends to per-
Art. no.: 0-48-0013 Rev. m

form a cardiopulmonary resuscitation cycle. The device will then switch off if it has
not detected an acceptable impedance between the two electrodes after 5 minutes
Fig. 4.1 Yellow indicator
of CPR.

• If using "pre-connected" pads, it is only necessary to apply the pads to the pa-
tient's chest.

Page 34
Defibrillation 4
FRED easy User Guide Applying the adhesive electrodes 4.3

4.3.2 Apply the adhesive electrodes and connect them to the device

Step 1 Open the electrode packaging

Fig. 4.2 Opening the electrode packaging

 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).

When using pre-connected electrodes, go directly to Step 3 Applying the electrodes


to the patient’s chest.

Step 2 Connecting the electrode cable to the device

Fig. 4.3 Inserting the connector into the port

Pre-connected electrodes, which are already connected to the device, only need to
Art. no.: 0-48-0013 Rev. m

be applied to the patient’s chest (Step 3). In this case, Step 2 is not required. Elec-
trodes that are not pre-connected, need to be connected (Step 2) and applied (Step
3).

Page 35
4 Defibrillation
4.3 Applying the adhesive electrodes FRED easy

Step 3 Applying the electrodes to the patient’s chest

 Risk of skin burns/equipment damage — Do not apply the defibrillation pads on


top of:
– the sternum or clavicle,
– the nipples,
– an implanted pacemaker or defibrillator device.
 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

Large electrodes The large adult electrodes with a surface area of 80 cm² are used for adults and chil-
dren weighing 25 kg or more.

Small electrodes The small paediatric electrodes with a surface area of 42 cm² are used for children
weighing less than 25 kg (younger than 8 years of age).

Electrode placement is the same for adults and for children (see Fig. 4.5 Electrode
application sites for children). The device automatically distinguishes between adult
electrodes and paediatric electrodes.

1. Before applying the adhesive electrodes, verify that the application sites on the
patient’s chest are clean and dry.
2. The skin must be cleaned by rubbing the application points vigorously with a dry
cloth. Do not use alcohol or alcohol wipes. This could significantly increase the
contact impedance between the electrodes and the skin.
Fig. 4.4 Electrode application sites 3. Carefully shave the application sites if the patient’s chest is hairy.
4. Apply the positive electrode at the right sternal edge at the level of the 2nd inter-
costal space. Do not apply the positive electrode on top of the clavicle (uneven
surface).
5. Apply the negative electrode on the left axillary line at the level of the 5th intercos-
tal 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 to the patient's chest, then gradually smooth it out toward the other edge to
remove any air.

6. Place the electrodes on the patient's chest so that the connections point to either
Fig. 4.5 Electrode application sites for side of the patient in order not to hinder CPR.
children

When defibrillating small children, it is recommended to choose the anterior-posterior


position to avoid short-circuiting the electrodes.
Art. no.: 0-48-0013 Rev. m

Fig. 4.6 Application sites for small chil-


dren

Page 36
Defibrillation 4
FRED easy User Guide Applying the adhesive electrodes 4.3

4.3.3 Checking the electrodes


If the resistance (impedance) reaches an unacceptable value, the device interrupts
and prompts the user to check the electrode application and connection(CHECK
CONNECTOR IS FITTED AND ELECTRODE APPLIED ON CHEST). In addition, the
yellow indicator is lit.

This can occur if:


– the cable is diconnected from the device and/or,
– if the electrodes are not properly applied to the patient’s chest.

• Then the device recommends to perform a cardiopulmonary resuscitation cycle.


• The device resumes the intervention where it has been interrupted when it detects
that the resistance between both electrodes is again acceptable.
• The device switches off if it still does not detect acceptable resistance between
both electrodes after 5 minutes of CPR.

Follow these steps to check the electrodes:

1. insert the connector as specified in Step 2 on page 35.


2. press strongly one after the other the defibrillation pads to the patient’s chest to
find which one makes the yellow indicator switched off,
3. Carefully press this electrode on the patient's skin.

If the electrode defect is not corrected:

1. remove both electrodes,


2. wipe the remaining contact agent off with a cloth,
3. shave both application points to improve the contact between the electrodes and
the skin,
4. apply new defibrillation electrodes.

To remove the electrodes from the patient's chest, see 4.8 Finishing the therapy.
Art. no.: 0-48-0013 Rev. m

Page 37
4 Defibrillation
4.4 Semi-automatic defibrillation FRED easy

4.4 Semi-automatic defibrillation


Patient hazard — The guidelines given in 4.1 Instructions and Safety Notes must be
observed.

Semi-Automatic Defibrillation

Step 1 Switching on and preparing the device

1. Briefly press the green button (max. 1 second) to switch on the device.
2. Assess the patient's condition (see 4.2 Defibrillation procedure).
3. Connect the electrode cable to the device (see 4.3 Applying the adhesive elec-
trodes).
4. Apply the defibrillation electrodes to the patient's chest (see 4.3 Applying the ad-
hesive electrodes).

Fig. 4.7 Button to turn the device on/off


and to start analysis

Step 2 Analysing the ECG signal


5. Briefly press the green button (max. 1 second). A message prompts the user
to stay clear of the patient.

Briefly press the green button (max. 1 second) to start the analysis. Otherwise, the de-
vice will switch off.

• The semi-automatic version of the FRED easy® can be configured so that the ECG
analysis is initiated automatically. In this case, the device prompts the user to con-
nect the electrodes and then automatically runs the analysis without any interven-
tion by the user.
• 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.
Art. no.: 0-48-0013 Rev. m

Page 38
Defibrillation 4
FRED easy User Guide Semi-automatic defibrillation 4.4

Step 3 Shock delivery


When the energy is charged, the user is prompted to trigger the shock by pressing the
lit orange button.

Shock hazard!
 Do not, under any circumstances, touch the patient during shock delivery.
Fig. 4.8 Button to deliver the shock  Make sure that the patient does not touch any conducting objects.

6. Deliver the shock by pressing the button .


After the shock delivery, proceed with Step 4 Performing cardiopulmonary resus-
citation.

Step 4 Performing cardiopulmonary resuscitation


7. 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
of time.
Art. no.: 0-48-0013 Rev. m

After the CPR cycle, the device continues with Step 2 Analysing the ECG signal.

If the device is configured to start the ECG analysis automatically, the device will not
require any action from the user to run the ECG analysis.

Finishing the therapy See 4.8 Finishing the therapy.

Page 39
4 Defibrillation
4.5 Automatic defibrillation FRED easy

4.5 Automatic defibrillation


The laws and regulations for the use of automatic defibrillators differ 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.

4.5.1 Functional description of automatic AEDs

This device delivers defibrillation shocks automatically, i.e. there is no need to start
the analysis or trigger the shock.

Voice and text prompts displayed on the screen keep the user informed regarding the
therapy.

If a shock is advised, the energy is automatically charged. A countdown accompanies the


last 3 seconds before the shock is delivered.

Fig. 4.9 FRED easy® Automatic

4.5.2 Safety notes for automatic defibrillation

Risks for patient, users and assistants!

Once the device has been switched on with the green button and the electrodes
have been applied, the ECG analysis is started automatically and a shock is delivered
automatically if a shockable rhythm is present. The user is informed of an ongoing
analysis or shock release via written and 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 27 must be ob-
served. Art. no.: 0-48-0013 Rev. m

Page 40
Defibrillation 4
FRED easy User Guide Automatic defibrillation 4.5

Automatic defibrillation

Step 1 Switching on and preparing the device

1. Briefly press the green button (max. 1 second) to switch on the device.
2. Assess the patient's condition (see 4.2 Defibrillation procedure).
3. Connect the electrode cable to the device (see 4.3 Applying the adhesive elec-
trodes).
4. Apply the defibrillation electrodes to the patient's chest (see 4.3 Applying the ad-
hesive electrodes).

Fig. 4.10 Button to turn the device on/off


and to start analysis

Step 2 Automatic ECG analysis


The analysis is automatically triggered, without user intervention. A message prompts
the user not to touch the patient.

If the device detects ventricular fibrillation or ventricular tachycardia with a heart rate
exceeding 150 bpm, Step 3 Automatic shock deliveryfollows; otherwise, continue with
Step 4, Performing cardiopulmonary resuscitation.
Art. no.: 0-48-0013 Rev. m

Page 41
4 Defibrillation
4.5 Automatic defibrillation FRED easy

Step 3 Automatic shock delivery


As soon as the energy charge is completed, the device automatically delivers the
shock, without user intervention. A countdown is displayed on the screen and the or-
ange 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


5. Perform a CPR cycle. According to the configuration of the device, a CPR cycle
consists of:
– performing chest compressions for the period of time configured, or
– performing alternatively 30 chest compressions and 2 breathes during the peri-
od of time configured.
After the CPR cycle, the device proceeds with Step 2 Automatic ECG analysis.
Art. no.: 0-48-0013 Rev. m

Finishing the See 4.8 Finishing the therapy.

therapy

Page 42
Defibrillation 4
FRED easy User Guide Manual Defibrillation (option) 4.6

4.6 Manual Defibrillation (option)


The option to switchover to manual mode is only available for the semi-automatic ver-
sion of FRED easy®.

The FRED easy® with manual mode is indicated by a red foil on the casing. If the user
does not activate the manual mode after switchon, the unit remains in semi-automatic
mode. The defibrillation will then be carried out as described in section 4.4.

Even though non physicians are legally authorised to use semi-automatic defibrilla-
tors, the FRED easy® must not be used by non physicians when it is in manual mode.

In some countries, however, the option to switch from semi-automatic mode to manual
mode is made available to EMTs and medical personnel (non physicians). In this sit-
uation, individual protocols must be determined in cooperation with the EMTs. These
protocols must be based on AHA or ERC protocols or on the regulations of the country
in question. Furthermore, the emergency service is required to ensure that the proce-
dures established are observed and that the staff is trained accordingly.

Fig. 4.11 FRED easy® semi-automatic


with manual option

• The device cannot be turned on directly in manual mode.


• It is not possible to switch to manual mode while the device is powering on. There-
fore, do not press the orange button while the device is powering on.
• It is not possible to switch the defibrillator to manual mode while a defibrillation pro-
cedure is in progress (analysis, charging, shock delivery).
• The patient's ECG signal is automatically displayed when the FRED easy® is
switched to manual mode.
Art. no.: 0-48-0013 Rev. m

Page 43
4 Defibrillation
4.6 Manual Defibrillation (option) FRED easy

4.6.1 Manual defibrillation - description


The user is informed of each step by a voice prompt as well as text instructions on the
display.

Turning on the device and Press the green button to switch on the device.
switching to manual mode
Wait until the device has fully started up and is prompting you to connect and apply
the electrodes.

Simultaneously press the green and orange button + . You are prompted to
press the buttons a second time to confirm switchover to manual mode. You need to
confirm this within 5 seconds.

Connect the electrode cable and apply the electrodes to the patient's chest (see sec-
tion 4.3 Applying the adhesive electrodes).

The patient's ECG signal is automatically displayed when the FRED easy® is
switched to manual mode.

Defibrillator charging In manual defibrillation, the energy values of the first 3 shocks are those defined for
the semi-automatic mode. For all subsequent shocks, the energy level of the 3rd
shock is used.

The device prompts the user to press the green button to charge the energy. The
charging progress is displayed on the screen.

Shock delivery As soon as the set energy is charged, the orange button is lit and the user is
prompted to deliver the shock (by voice prompt as well as written instructions).

Once the shock is delivered, the device repeats the prompt to charge the energy for
the following shock.

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

Page 44
Defibrillation 4
FRED easy User Guide Manual Defibrillation (option) 4.6

4.6.2 Manual defibrillation procedure

Patient hazard — Only a physician is allowed to enable manual mode. Observe the
instructions given in section 4.1 Instructions and Safety Notes.

Step 1 Switching on and preparing the device


1. Briefly press the green button (max. 1 second) to switch on the device.
2. Switch to manual mode by simultaneously pressing the green and orange buttons
+ . Confirm the switching by simultaneously pressing these same buttons
a second time.

3. Connect the electrode cable to the device.


4. Apply the electrodes on the patient's upper body (see 4.3 Applying the adhesive
electrodes).

Step 2 Charging the energy


5. Briefly press the green button (max. 1 second).

Patient hazard — Press the green button only briefly (max. 1 second) to start the
energy charging. If you press the button for too long, the device is switched off.
Art. no.: 0-48-0013 Rev. m

Page 45
4 Defibrillation
4.6 Manual Defibrillation (option) FRED easy

Step 3 Shock delivery


As soon as the energy is charged, the device prompts the user to deliver the shock by
pressing the orange button . The orange button remains lit until the shock is
delivered.

Shock hazard!
 Only deliver a shock when a shockable heart rhythm is present.
Fig. 4.12 Button to deliver the shock
 Do not, under any circumstances, touch the patient during shock delivery.
 Make sure that the patient does not touch any conducting objects.

6. Deliver the shock by pressing the button .


After the shock delivery, proceed with Step 2 Charging the energy.

Finishing the See 4.8 Finishing the therapy.

therapy
Art. no.: 0-48-0013 Rev. m

4.6.3 Switching to semi-automatic operational mode


To return to semi-automatic mode, turn off the FRED easy® and leave it turned off for
at least 5 minutes before switching it on again.

Page 46
Defibrillation 4
FRED easy User Guide Internal safety discharge 4.7

4.7 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:

– after the defibrillation energy has been charged, the heart rate changes into a
non shockable rhythm
– 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.

4.8 Finishing the therapy


• Switch off the device once the therapy has been completed (press and hold the
green button for approx. 3 seconds).
• Disconnect the electrode cable.
• Carefully peel the pads off the patient’s skin (see Fig. 4.13 Removing the adhesive
pads).
• Recycle the disposable pads immediately after use to keep them from being reused by
mistake (hospital waste).

Fig. 4.13 Removing the adhesive pads


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

• 5 minutes after the device has been switched off, the number of shocks delivered
as well as the time elapsed since the device was turned on, are reset to zero.
• 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.

Page 47
5 Versions
5.1 SD card version FRED easy

5 Versions
5.1 SD card version
Equipment damage hazard —
 The memory card slot must always be covered with the rubber cover. This is to
prevent moisture penetrating the device.
 Always turn off the device before inserting or removing the SD card.
 Do not insert the Ethernet adapter into the SD card slot.
Malfunction hazard —
 The SD card must only be used in one single device.
Before being used in another device, the SD card must be reformated with the
Schiller data viewing software; otherwise, the recorded information will be incor-
rect.
 Only use SD cards supplied by SCHILLER.

Operating principle
This version records all defibrillation-related events on a removable SD card.

The SD card is able to record:

– 2 hours of ECG signal,


– 2 hours of sound recording (if this parameter has been activated using FRED-
CO® and unless ambient noises are too loud).
– 500 events concerning the intervention (see table below).

Overview of recorded events, with date and time:


• Power on
• Movement detection (beginning and end)
• Operating mode
• Start of analysis
• Analysis result
• Defibrillator charging
• Defibrillation shock
• Defibrillation shock cancelled
• Internal dischargea
• Electrode alarm
Art. no.: 0-48-0013 Rev. m

• "Battery low" alarm


• Critical error
• Power off
a. This event is only recorded when the defibrillator has switched to "limited mode"
due to a technical problem.

Page 48
Versions 5
FRED easy User Guide SD card version 5.1

5.1.1 Inserting the SD card


1. Make sure that the SD card is not write-protected.
2. Switch off the device before inserting the card.
3. Insert the card as shown in Fig. 5.2 SD card inserted (text facing up, in the direc-
tion indicated by the arrow). Otherwise, the device will not recognise the card and
the symbol is displayed.

Fig. 5.1 Inserting the memory card

4. Once the card is inserted, close the rubber cover of the card slot.

If the symbol is not displayed even though the card has been inserted, check that
the card has been recommended by SCHILLER for the use in this type of device.

Inserting the SD card automatically activates the memory function and the symbol
is displayed (see Fig. 5.2 SD card inserted).

DO NOT TOUCH THE PATIENT


ANALYSING!

Fig. 5.2 SD card inserted

The symbol starts blinking when the SD card is full. No further data is stored; how-
ever, previously recorded data remains stored on the card.
Art. no.: 0-48-0013 Rev. m

SD cards can be read on a PC using the Schiller data viewing and "LifeDataNet®"
software.

Page 49
5 Versions
5.2 Ethernet version FRED easy

5.2 Ethernet version


Operating principle
This version is able to send intervention data (stored on the internal memory) as well
as detailed device configuration data to the LifeDataNet® web server.

The data is transmitted via a network infrastructure.

The internal memory is able to record:

– 2 hours of ECG signal,


– 2 hours of ambient noise (if the sound recording parameter is activated using
FREDCO®),
– 500 events concerning the intervention.
Fig. 5.3 Ethernet version Once the internal memory (SD card) is full, the symbol starts blinking and no more
data can be stored. Stored data will be cleared once it has been transmitted. Trans-
mitted data can be viewed using LifeDataNet®.

• The memory card cannot be removed for the FRED easy® Ethernet version.
• All events transmitted by the device are listed on page 48.
• In order to protect other electrical devices from interference during data transmis-
sion, a ferrite core must be placed on the Ethernet cable in close proximity to the
Ethernet adapter (see 5.2.3 Installing the ferrite core).

To ensure correct data transmission:

1. the "Network" and "Online" sections of the device settings must first be configured
using the FREDCO® software program (see 5.2.1 Connecting the Ethernet
adapter and 5.4.2 Configuring the "Online" Tab),
2. the Ethernet adapter must be connected to the network hosting the LifeDataNet®
web server, via an Ethernet cable,
3. the Ethernet adapter must be inserted in the Ethernet interface of the device (see
5.2.1 Connecting the Ethernet adapter).
Fig. 5.4 Ethernet adapter

5.2.1 Connecting the Ethernet adapter


The Ethernet adapter needs to be inserted in the Ethernet interface (see Fig.
5.5 Inserting the Ethernet adapter in the Ethernet interface).

1 2
Art. no.: 0-48-0013 Rev. m

Fig. 5.5 Inserting the Ethernet adapter in the Ethernet interface

Page 50
Versions 5
FRED easy User Guide Ethernet version 5.2

5.2.2 Data transmission procedure


1. Switch off the device and disconnect the electrode cable.
2. Connect the FRED easy to a network to establish a connection to the LifeDa-
taNet® web server.
.
Network cable
RJ45

The defibrillator is switched on automatically and enters data transmission mode.

TRANSMISSION MODE

If the device is configured with a static IP address, the following message is displayed:
NETWORK CONFIGURATION
NETWORK PARAMETERS
CONFIGURATION

The device configures the necessary parameters, logs on and sends its authentifica-
tion information to the server on which LifeDataNet® is installed.
CONNECTION AND
Once a connection has been established, the internal time of the FRED easy® is syn-
AUTHENTIFICATION
chronised with the server clock.

If the message “MEMORY CARD EMPTY” is displayed, the device can be switched
off and the Ethernet adapter can be removed. If the device is not switched off by the
MEMORY CARD EMPTY user, it switches off automatically after one minute.
NO DATA TO TRANSFER

If information is stored on the internal memory, the transmission starts automatically


and the percentage of data transmitted is displayed.
DATA TRANSFER
Art. no.: 0-48-0013 Rev. m

22 %

Once the transmission is finished, the message "CLOSE SESSION" is displayed .

CLOSE SESSION

Page 51
5 Versions
5.2 Ethernet version FRED easy

MEMORY ERASING After transmission, the data is deleted from the internal memory. The percentage of
data removed is indicated.
25 %

The data stored on the internal memory is deleted once the transfer of the entire data
record is completed.
If the transfer is interrupted, data remains stored on the internal memory and the
transfer can be restarted.

At the end of the transmission procedure, the following message is displayed:


You can switch off the device and remove the Ethernet adapter.
TRANSMISSION COMPLETE

FRED easy automatically aborts the connection 5 minutes after the data transfer has
been completed, or if the Ethernet connection is interrupted.

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

Page 52
Versions 5
FRED easy User Guide Ethernet version 5.2

5.2.3 Installing the ferrite core

1. Form a loop and route the Ethernet cable through the open ferrite core (see Fig.
5.6 Installing the cable within the ferrite core).

2. Shut the ferrite core – without closing it completely – and check the cable position.

3. Reduce the size of the loop to place the ferrite core as closely as possible to the
Ethernet plug. To do so, pull the long end of the cable (see Fig. 5.7 Reducing the
loop).

4. Close the ferrite core (see Fig. 5.8 Correctly installed ferrite core).
Fig. 5.6 Installing the cable within the fer-
rite core

Fig. 5.7 Reducing the loop

Fig. 5.8 Correctly installed ferrite core

FRED easy® Ethernet accessories

Part No. Description


1-58-5303 Ethernet adapter
5-30-0003 Ethernet cable (3 m, category 5)
4-33-0002 Ferrite core
0-05-0026 Ethernet cable (3 m, with ferrite core)
Art. no.: 0-48-0013 Rev. m

Page 53
5 Versions
5.3 Online version FRED easy

5.3 Online version


Operating principle
This version is intended to ensure communication between the device and the LifeD-
ataNet® web server.

Just as with the Ethernet version, this version is able to send intervention data (stored
on the internal memory) as well as detailed device configuration data to the LifeDa-
taNet® web server. It also allows a total remote control of the FRED easy® using Life-
DataNet® (see table below).

Communication takes place via a network infrastructure using the SNMP (Simple Net-
work Management Protocol) communication protocol.

Fig. 5.9 Online version with docking sta-


tion

• The SD card is not removable in the FRED easy® Online version.


• All events transmitted by the device are listed on page 48.

Overview of actions that may be performed remotely, using LifeDataNet®:


• Monitoring of battery capacity and self-test result
• Update of device’s software
• Modification of device configuration
• Modification of device language
• Triggering of audible alarms or visual indications on the devices
• Viewing the device status
• Geographic location of devices (Google Maps)

The internal memory is able to record:

– 2 hours of ECG signal,


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

– 2 hours of ambient noise (if the sound recording parameter is activated using
FREDCO®),
– 500 events concerning the intervention.
Once the internal memory is full, the symbol starts blinking and no more data can
be stored. Stored data will be cleared once it has been transmitted.

Page 54
Versions 5
FRED easy User Guide Online version 5.3

5.3.1 Ensuring data transmission

The user and installation handbook for the docking station (part no. 0-48-0156) pro-
vides further information on the use of the docking station and configuration of the
FRED easy® Online.

• The "Network" and "Online" sections of the device settings must be configured us-
ing the FREDCO® software program,
• The FRED easy® Online needs to be inserted in the docking station (see section
5.3.2 page 56).
• Only use lithium batteries with the Online version. Do not use rechargeable NiCd
batteries.
• Do not remove the battery from the device while the device is inserted in the dock-
ing station.
• Turn off the device before inserting it in the docking station. Otherwise, no data will
be transmitted.
Art. no.: 0-48-0013 Rev. m

Page 55
5 Versions
5.3 Online version FRED easy

5.3.2 Placing the FRED easy® in the docking station


1. Switch off device.
2. Position the device as shown in illustration (1).
3. Push the device into the docking station (2) until it clicks into place (3).

1 2 3

Fig. 5.10 Inserting the device into the docking station

– The device switches on and starts transmitting the data from its internal memory
in the same way as the Ethernet version (see 5.2.2 Data transmission proce-
dure).
– The indicator (see Fig. 5.11 Communication indicator) is blinking when the de-
vice is able to communicate with the data network.
– The same screens are displayed as during data transmission with the Ethernet
version (see 5.2.2 Data transmission procedure).
Once all data has been transmitted, the display illumination switches off and the mes-
sage "FREDeasy Online READY" is displayed. This message is displayed whenever
the device is able to communicate with the data network. In addition, the indicator is
blinking (see Fig. 5.11 Communication indicator).

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

Fig. 5.11 Communication indicator

If communication is interrupted, the message "


NO SERVER" is displayed and the indicator remains lit.

You can read and edit the transmitted data using the LifeDataNet® web server.

Page 56
Versions 5
FRED easy User Guide Online version 5.3

5.3.3 Activating the maintenance mode


While inserted in the docking station, the device can be switched to maintenance mode.
To do so, simultaneously press the buttons and . The message "MAINTE-
NANCE IN PROGRESS" is displayed.

While in maintenance mode, the device can be removed from the docking station for
service purposes. In this case, the server recognises that the device was not removed
for defibrillation purposes and does not generate any alarms.
After the device has been returned to the docking station, maintenance mode must
be switched off by again simultaneously pressing both buttons.
Art. no.: 0-48-0013 Rev. m

Page 57
5 Versions
5.4 Configuration Ethernet/Online using FRECO FRED easy

5.4 Configuration Ethernet/Online using FRECO

A password provided by SCHILLER must be entered to access the network parameters.

5.4.1 Configuring the "Network" tab


• Start the FREDCO® software program and select the "Network" tab (1).

1
2
3 8

4
5 9
6 10
7
11

12

Fig. 5.12 Network configuration ("Network" tab)

(1) "Network" tab in FREDCO®


(2) IP address configuration section
(3) Selection of IP address configuration mode: dynamic or static
(4) IP address of the FRED easy® Ethernet version
(5) IP address of the network mask (depends on the network infrastructure)
(6) IP address of the network gateway (depends on the network infrastructure)
(7) IP address of the domain name system (depends on the network infrastructure)
(8) MAC address of the FRED easy® Ethernet version (located on the label on the
underside of the device)
(9) IP address of the server's network interface, used by FRED easy® to connect
and transmit data
(10) Login of a user with access to the server on which LifeDataNet® is installed
Art. no.: 0-48-0013 Rev. m

(11) User password


(12) Confirmation of "Network" tab configuration

• The parameters of the "IP Configuration" section (2) depend on the network infra-
structure:
– in "Static" mode (3), your network administrator will provide this information and
you are required to fill in (4), (5), (6), and (7).
– In "Dynamic" mode (3), the 4 parameters are automatically configured (see Fig.
Fig. 5.13 Configuring the dynamic mode 5.13 Configuring the dynamic mode).

• Check that the "MAC Address" (8) displayed on the screen is identical to the ad-
dress indicated on the underside of the device.

Page 58
Versions 5
FRED easy User Guide Configuration Ethernet/Online using FRECO 5.4

• Fill in the Server IP address field (9).


• Enter a login (10).
• Enter the password (11).
• Click the "Update" button (12) to apply any changes.

• Login (10) and password (11) can be freely changed but they must be the same as
those specified in the "SNMP Parameters" tab of LifeDataNet® (see user manuel
of LifeDataBox/LifeDataNet® (0-48-0117)). By default, the login is "fredeasy" and
the password is "schiller".
• To apply any changes to the parameters, click the "Update" button (12).
• Once the battery is inserted, FRED easy® Ethernet offers the option to manually
configure the IP addresses without using FREDCO®, if configured so.
Art. no.: 0-48-0013 Rev. m

Page 59
5 Versions
5.4 Configuration Ethernet/Online using FRECO FRED easy

5.4.2 Configuring the "Online" Tab


• Start the FREDCO® software program and select the "Online" tab (1).

A password provided by SCHILLER must be entered to access the network parameters.

Fig. 5.14 Network configuration ("Online" tab)

(1) "Online" tab in FREDCO®.


(2) "RO and RW Community" password.
(3) Confirmation of "Online" tab configuration.
• Enter the "RO and the RW Community" password (2). You can choose any pass-
word, but it must be identical to the password entered in the "FREDeasy®" section
of the "SNMP Parameters" tab in LifeDataNet® (see Fig. 5.15 SNMP parameter
in LifeDataNet®).

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

Fig. 5.15 SNMP parameter in LifeDataNet®

• Click the "Update" button (3) to apply any changes.

Page 60
Versions 5
FRED easy User Guide Configuration Ethernet/Online using FRECO 5.4

5.4.3 Configuring the date and time as well as IP addresses without using
FREDCO®

• Date and time setting can also be done on non Ethernet/Online devices if the pa-
rameter has been activated in FREDCO.
• When the battery has been inserted, a self-test is performed. If no errors are de-
tected during this self-test, the date and time as well as IP address for the Ethernet/
Online version can be set, if configured so.
• If the green button is not pressed within a couple of seconds, the message disap-
pears automatically and the device status indicator starts blinking. (For the Online
and Ethernet version, the device first recommends configuring the IP address be-
fore the message disappears).

Setting the date/time and/or IP ad- This is only available if the parameter "Setting date and time" and/or “IP Address” has
dress for Ethernet/Online versions been activated in FREDCO®.

1. Insert the battery and wait for the prompt to set the date and time and/or to con-
figure the IP address.
2. Press the green button . Three fields are displayed: date, time, summer/winter
and/or 3 IP address fields.
3. Press the orange button to change the value.

4. Press the green key to jump to the next value.


5. Press the green button to jump to "Apply" and press the orange button to
confirm and apply the changes.
When you have confirmed the values, the menu disappears and the device can be
switched on.
Art. no.: 0-48-0013 Rev. m

Page 61
6 Options
6.1 ECG display FRED easy

6 Options
6.1 ECG display
When the "ECG Display" option is activated, the ECG signal obtained by the elec-
trodes is displayed on the screen (see Fig. 6.1 ECG display).

PRESS GREEN BUTTON

Fig. 6.1ECG display

• The "ECG Display" option is only available for the FRED easy® semi-automatic.
• This option is automatically activated when the FRED easy® is switched to manual
mode.
• When the ECG signal is displayed, messages are only displayed on one single
line.

6.2 Metronome
When the "Metronome" is enabled, the device sets the rhythm for chest compres-
sions during CPR at 100 bpm.

The FREDCO® software program allows you to:

– set the metronome frequency to a value between 80 and 150 bpm (in steps of
5 bpm).
– the metronome can be set to signal to the user to give 2 rescue breaths (the
metronome is stopped for 8 seconds after 30 chest compressions).
Art. no.: 0-48-0013 Rev. m

Page 62
Options 6
FRED easy User Guide Rechargeable NiCd battery 6.3

6.3 Rechargeable NiCd battery


The battery must remained packed in its original plastic packaging (blister) during the
whole storage time. The plastic packaging must only be removed when the battery is
used.

 Danger of explosion! The battery must not be incinerated, exposed to high


temperatures, or disposed 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 or incinerate the battery.

As an alternative, a rechargeable NiCd battery (12 V, 650 mAh) is available for the
defibrillator. The capacity of a new, fully charged battery is sufficient for:

– 45 shocks at maximum energy, or


– 40 minutes operating

Like the lithium battery, the device warns the user when the NiCd battery has reached
the "low" battery threshold. The device will still allow the user to perform defibrillation,
Fig. 6.2 NiCd battery charging unit but the battery must be recharged/replaced as soon as possible.

The FRED easy® also detects when the NiCd battery is "depleted". In this case, the
device does not allow the user to perform defibrillation and instead prompts him or her
to perform CPR. The battery must be recharged/replaced immediately.

For further details, see 3.1 Inserting the battery.

• This option is only available for the FRED easy® SD Card and Ethernet versions.
• This option is only available for FRED easy® devices that have a 2nd generation
CPU board.
These devices can be recognised by their 12-digit serial number.

When charging NiCd batteries, make sure to observe the values 100 – 240 V, 50 – 60
Hz (see 9.1 Order Information). The charging time is max. 1 hour.

When the device is equipped with a NiCd battery, it runs a daily self-test.

Battery service life — Unused batteries (whether or not inserted in the device) should
be charged at least every 2 months.
Art. no.: 0-48-0013 Rev. m

Page 63
6 Options
6.4 Silent mode FRED easy

6.4 Silent mode


The FRED easy with silent mode option is intended for locations where a quick trans-
ferral to a hospital cannot be guaranteed. If in Silent mode a change in the cardiac
rhythm is detected the device reactivates the AED mode and the user will be prompt
to check the patient.

In silent mode, operating time is approx. 6.5 hours if no analysis or defibrillation is per-
formed.

6.4.1 Silent mode


If a patient has been successfully defibrillated or if the device does not detect a shock-
able rhythm, the device can be switched to silent mode in order to detect changes of
the patient's cardiac rhythm without the user or patient being disturbed by the AED's
repeated voice prompts.

If the device detects a change in the cardiac rhythm or if the green button is pressed,
silent mode is abandoned and voice prompts instruct the user about the next steps to
be taken.

Moreover, the heart rhythm is recorded and can be transmitted via network with the
FRED easy Ethernet/Online (see 5.2.2 Data transmission procedure).

 Even though the device issues voice prompts if a change in rhythm occurs, this
is not a substitute for the regular checking of the patient's vital functions.
 Silent mode must only be activated if the device does not detect a shockable
rhythm and if the patient is responsive.

 The silent mode must not be carried out while the device is starting up.
 The silent mode must not be carried out during an analysis or defibrillation.
Art. no.: 0-48-0013 Rev. m

Page 64
Options 6
FRED easy User Guide Silent mode 6.4

6.4.2 Switching to silent mode

Defibrillation is performed according to the safety notes in section 4.1 Instructions and
Safety Notes and the procedure in section 4.4 Semi-automatic defibrillation.

Switchover to silent mode can be done at the earliest after Step 2, as long as no
shockable rhythm has been detected, or after a successful defibrillation (Step 3) fol-
lowed by a "normal" cardiac rhythm.

After Step 2, or 3, respectively, simultaneously press the green button and


the orange button until the message "Confirm Silent Mode" is displayed. Imme-
2x diately release both buttons and press shortly them again to confirm the silent mode.

Procedure for semi-automatic defibrillation

Step 1 Switching on and preparing the device


See section 4.4 Semi-automatic defibrillation.

Step 2 ECG analysis


• Press the green button for max. 1 second.
– If the device detects ventricular fibrillation or ventricular tachycardia with a heart
rate exceeding 150 bpm, Step 3 Shock delivery follows.
– If the device does not detect a shockable rhythm, the user is prompted to con-
tinue with cardiopulmonary resuscitation.

2x  In this case, the device can be switched to silent mode if the patient is responsive.

Step 3 Shock delivery


Once the shock has been delivered, the user is prompted to continue with cardiopul-
monary resuscitation.
2x
 If the therapy has been successful and if the patient is responsive, the device can
Art. no.: 0-48-0013 Rev. m

be switched to silent mode.

 Even though the device issues voice prompts if a change in rhythm occurs, this
is not a substitute for the regular checking of the patient's vital functions.

Page 65
6 Options
6.4 Silent mode FRED easy

6.4.3 Deactivating silent mode

 If the patient is no longer responsive (i.e. loses consciousness), immediately


press the green button (max. 1 second) to deactivate the silent mode and
again start an analysis (Step 2).

6.4.4 Erasing the memory card

The function "Erasing memory" without transferring the data is only available in silent
mode.

In silent mode, since the heart rhythm is recorded over a prolonged period of time, the
message "Not enough memory" might be displayed. To ensure further recording of
the ECG signal, the data can be transmitted via Ethernet (see page 51); the data is
automatically deleted after transmission.

Alternatively, you can erase the memory during recording in silent mode as follows:

Simultaneously press the green button and the orange button until the mes-
2x sage "Erase memory?" is displayed. Immediately release both buttons and press
them again to erase the memory.

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

Page 66
Options 6
FRED easy User Guide Special operating conditions 6.5

6.5 Special operating conditions


The device may be approved for special operating conditions in consultation with the
manufacturer and/or the inspecting authority, as long as all guidelines and regulations
are observed (e.g. for the maritime sector).

6.5.1 Maritime use


The following device is approved for maritime use:

• FRED easy with silent mode


• Basic wall mounting without mains connection
• Sufficient spare batteries
• LAN cable for the transmission of the ECG
Accessory that is not included in the scope of delivery and needs to be provided by
the owner:

• Insulating mat for defibrillation on conducting surfaces.

The device needs to be stored before use (incl. inserted battery, electrodes and spare
batteries) according to the technical data.

Ambient conditions for storage before use


In order to guarantee operational readiness of the device and accessories, the device
preferably needs to be stored in a climatised room below deck, in the following climat-
ic conditions:

Temperature 15...25 °C Ensures operational readiness as well as maximum battery life.

Temperature -5...40 °C Ensures operational readiness but reduces battery life. (This is compensated by
spare batteries).

Ambient conditions for operation

Temperature -5...40 °C Operation is guaranteed if the storage conditions listed above are met for the storage
before use.

If higher or lower temperatures prevail during use, a limited operation time of up to


one hour is possible if the device incl. electrodes has been stored at a temperature of
15...25 °C. It is recommended to store spare batteries and spare electrodes at a tem-
perature of 15...20 °C.

Operating conditions on deck


• For the defibrillation, the patient needs to be placed on a dry and non conducting
surface to prevent leakage currents that could endanger the rescuers. Therefore,
Art. no.: 0-48-0013 Rev. m

the patient needs to be placed on an insulating mat.


• If the patient's skin is wet, it needs to be dried completely with a cloth so as not to
reduce the shock's efficiency.
• In extreme weather conditions such as rain and wind, the patient must not be treat-
ed on deck.

Page 67
6 Options
6.5 Special operating conditions FRED easy

Operating conditions below deck


In addition to the operating conditions on deck, the following regulations apply:

• If the patient is lying on a conducting surface (e.g. metal floor in the engine or stor-
age room), the patient needs to be positioned on an insulating mat prior to defibril-
lation.
• Make sure that even the patient's arms and legs are positioned on the insulating
mat.

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

Page 68
Maintenance 7
FRED easy User Guide Maintenance Intervals 7.1

7 Maintenance
7.1 Maintenance Intervals
• FRED easy® is an emergency device that must always be in proper working or-
der. The device must be serviced on a regular basis. The test results must be re-
corded and compared to the values in the accompanying documents (see
9.5 Inspection report).
• These checks and replacements can be performed within the framework of a main-
tenance contract by SCHILLER technical department or an authorised distributor.
• The following table indicates the intervals and competence of the maintenance
work required.

Interval Maintenance - replacement Responsible


• Visual inspection of the device and accessories, see 7.1.1 Visual in-  User
Before each use spection of the device and accessories.
• Check that the green indicator is blinking, see 7.1.2 Green indicator
• Visual inspection of the device and accessories.  User
Once a Week/Month
• Check that the green indicator is blinking, see 7.1.2 Green indicator.
• Technical safety inspections according to SCHILLER documenta-  Service staff authorised
Every 3 years tion (available for technical departments authorised by SCHILLER), by SCHILLER
see 7.1.3 Functional check.
 Service staff authorised
Every 6 years • Replacement of internal backup battery.
by SCHILLER

7.1.1 Visual inspection of the device and accessories


Before each use, inspect visually the device and the cables in order to detect pos-
sible mechanical damages.

Check that he important safety labels are legible. The lacking or illegible ones must
be replaced.

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 green indicator is blinking, see 7.1.2 Green indicator
• Device casing undamaged?
• Cables not twisted, without wear signs due to friction or deterioration?
• No excessive clogging or damage?
• All the signal inputs in perfect condition?
Art. no.: 0-48-0013 Rev. m

• Legible nameplate at the rear of the device?


• Legible inscriptions on the front face of th device?
• Expiration date of the accessories elapsed?

 Electrodes past their expiration date must be replaced immediately.


 Defective units or damaged cables must be replaced immediately.

Page 69
7 Maintenance
7.1 Maintenance Intervals FRED easy

7.1.2 Green indicator


If the device is defective or if problems have been detected by the device during the
self-test (green indicator not blinking), the device must be repaired before use.

Fig. 7.1 Blinking green indicator

7.1.3 Functional check

Patient hazard — If the device's behaviour differs from the description given in this
user guide, 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 7.1.1 Visual inspection of the
device and accessories).
• Check for proper functioning.
• Measure the leakage current.
• Measure the energy delivered at 50 Ohms.

7.1.4 Internal backup battery


The internal backup battery must be replaced at least every 6 years by SCHILLER
technical support department or an authorised distributor.

The old battery must be recycled in accordance with local regulations.

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

Page 70
Maintenance 7
FRED easy User Guide Cleaning and disinfection 7.2

7.2 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 reused until it has been checked by a service
technician.

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).

7.3 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 easy®. A full list of all SCHILLER representatives can be found on the SCHIL-
LER website (www.schiller.ch). In case of difficulty, contact our head office in Switzer-
land. Our staff will be pleased to help process your order or to provide details for all
SCHILLER products.
Art. no.: 0-48-0013 Rev. m

Page 71
7 Maintenance
7.4 Disposal information FRED easy

7.4 Disposal information


7.4.1 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 AG.

7.4.2 Disposal of accessories that come into contact with the patient

Disposable articles (e.g. pads, etc.) must be disposed of as hospital waste.

7.4.3 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.: 0-48-0013 Rev. m

dangerous substances in electrical and electronic equipment.

Page 72
Maintenance 7
FRED easy User Guide Trouble Shooting 7.5

7.5 Trouble Shooting


• 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.
Error • If the device switches to Limited mode (CPR) due to an error, the alarm messages
may differ.
INFO: XXX
Forced shutdown procedure
PERFORM
• If the device cannot be switched off via normal OFF procedure (press and hold the
CHEST COMPRESSIONS green button for approx. 3 seconds), remove the battery and inserting again.

7.5.1 Error messages

Error message Possible cause Remedy


• Technical errors that may occur  Switch the unit off and then on again to con-
during function tests: firm. If the message still appears, the device
must be repaired immediately.
TEST FAILURE
XXX

• xxx =
– ADC
– EEPROM
– RTC
– LCD
– OKI
– DSP
– SHOCK BUTTON
– CHARGE
DEFIBRILLATOR
– COMMUNICATION
DEFIBRILLATOR
– 5 WEEKS
CHARGE 150J
• Technical problems that can oc-  Switch the unit off and then on again to con-
cur during defibrillation firm. If the message still appears, the device
Error must be repaired immediately. Continue
INFO: XXX cardiopulmonary resuscitation until the res-
cue service arrives.
Art. no.: 0-48-0013 Rev. m

• xxx =
– CPU DEFI
– CRC DEFI
– SAFETY DEFI
– REF VOLTAGE DEFI
– ADC DEFI
– DEFI DISCHARGE
– DEFI EPROM
– DEFI SHOCK KEY

Page 73
7 Maintenance
7.5 Trouble Shooting FRED easy

Error message Possible cause Remedy


• Technical problem  Switch the unit off and then on again to con-
Error – The device has detected an firm. If the message still appears, the device
INFO: FREDEASY ONLINE error after having been placed must be repaired.
Error in the docking station.

• Wrong date  Turn device off and reconfigure. (see page


Error 60)
TIME AND DATE
RESET TO 01/01/98
>REINSERT BATTERY

• Battery depleted during use  Turn device off and insert a new battery (see
page 26).
REPLACE BATTERY
30 COMPRESSIONS
THEN 2 BREATHS

• Battery depleted  Turn device off and insert a new battery.

EMPTY BATTERY
>REPLACE BATTERY

• Battery problem  Turn device off and insert a new battery.

CONFIGURATION LOST
RESTORE DEFAULT CONF
>REINSERT BATTERY

• Technical problem  Switch the unit off and then on again to con-
firm. If the message still appears, the device
CRITICAL ERROR must be repaired.
PLEASE SWITCH OFF

• The device was switching on  Do not press the orange and green but-
while the orange and green ton while the device is switching on.
MANUEL MODE FORBBIDEN
button have been pressed.
AT START,
Art. no.: 0-48-0013 Rev. m

RELEASE SHOCK BUTTON

• The device has detected a  Switch the unit off and then on again to con-
charge transistor error firm. If the message still appears, the device
-!!LIMITED MODE!!- must be repaired.

Page 74
Maintenance 7
FRED easy User Guide Trouble Shooting 7.5

7.5.2 Transmission error Ethernet/Online FRED easy®


If the connection to the network fails, an error message is issued. Potential error mes-
sages include the following:

Error message Cause Remedy


• Error reading SD card  Disconnect and reconnect the device to
confirm. If the message still appears, the de-
TRANSMISSION FAILURE vice must be repaired.
ERROR CODE : 001
SD CARD READING

• Technical problem  Disconnect and reconnect the device to


confirm. If the message still appears, the de-
TRANSMISSION FAILURE vice must be repaired.
ERROR CODE : 002
NOT ENOUGH MEMORY

• Incorrect network IP configura-  Verify the network configuration; if message


tion or DHCP server not availa- is still displayed, the device must be re-
TRANSMISSION FAILURE ble paired.
ERROR CODE : 003
NETWORK CONFIGURATION

• Ethernet adapter not inserted in  Turn device off and connect the Ethernet
the Ethernet interface case adapter; if the message is still displayed, re-
TRANSMISSION FAILURE place the Ethernet adapter. If the message
ERROR CODE : 004 still appears, the device must be repaired.
ADAPTER DISCONNECTED

• The pads are connected to the  Disconnect the pads from the device.
device and are placed to the pa-
TRANSMISSION FAILURE tient
ERROR CODE : 005
PATIENT DETECTED

• Battery is empty  Insert a new battery.

TRANSMISSION FAILURE
ERROR CODE : 006
BATTERY LEVEL
Art. no.: 0-48-0013 Rev. m

• Device not used for more than 3  Disconnect and reconnect the device to
minutes confirm. If the message still appears, the de-
TRANSMISSION FAILURE vice must be repaired.
ERROR CODE : 007
TIME OUT INACTIVITY

• The device is not able to con-  Check the connection to the server and the
nect to the server network configuration, then restart data
TRANSMISSION FAILURE transmission; if the message is still dis-
ERROR CODE : 008 played, the device must be repaired.
SESSION OPENING

Page 75
7 Maintenance
7.5 Trouble Shooting FRED easy

Error message Cause Remedy


• The device is not able to con-  Check the connection to the server, the net-
nect to the server work configuration and check that the device
TRANSMISSION FAILURE is added in the "Device Manager" of LifeDa-
ERROR CODE : 009 taNet® ; if the message is still displayed, the
device must be repaired.
SESSION OPENING

• The device is not able to con-  Check the connection to the server and the
nect to the server network configuration, then restart data
TRANSMISSION FAILURE transmission; if the message is still dis-
ERROR CODE : 010 played, the device must be repaired.
SESSION OPENING

• The device is not able to con-  Check the connection to the server and the
nect to the server network configuration, then restart data
TRANSMISSION FAILURE transmission; if the message is still dis-
ERROR CODE : 011 played, the device must be repaired.
SESSION CLOSING

• The device is not able to con-  Check the connection to the server, the net-
nect to the server work configuration and check that the device
TRANSMISSION FAILURE is added in the "Device Manager" of LifeDa-
ERROR CODE : 012 taNet®; if the message is still displayed, the
device must be repaired.
SESSION CLOSING

• Erroneous data transmission  Check the connection to the server and the
network configuration, then restart data
TRANSMISSION FAILURE transmission; if the message is still dis-
ERROR CODE : 013 played, the device must be repaired.
DATA TRANSMISSION

• Erroneous data transmission  Check the connection to the server, the net-
work configuration, and the LifeDataNet®
TRANSMISSION FAILURE configuration, then restart data transmis-
ERROR CODE : 014 sion; if the message is still displayed, the de-
vice must be repaired.
DATA TRANSMISSION

• Erroneous data transmission  Check the connection to the server, the net-
work configuration, and the LifeDataNet®
TRANSMISSION FAILURE configuration, then restart data transmis-
ERROR CODE : 015 sion; if the message is still displayed, the de-
vice must be repaired.
DATA TRANSMISSION
Art. no.: 0-48-0013 Rev. m

• Erroneous erasing of the SD  Disconnect and reconnect the device to con-


card firm. If the message still appears, the device
TRANSMISSION FAILURE must be repaired.
ERROR CODE : 017
DATA ERASING

Page 76
Maintenance 7
FRED easy User Guide Trouble Shooting 7.5

Error message Cause Remedy


• The device is not able to con-  Check the connection to the server, the net-
nect to the server work configuration, and the LifeDataNet®
TRANSMISSION FAILURE configuration, then restart data transmis-
ERROR CODE : 021 sion; if the message is still displayed, the de-
vice must be repaired.
SUPERVISION START REQ

• The device is not able to con-  Check the connection to the server, the net-
nect to the server work configuration, and the LifeDataNet®
TRANSMISSION FAILURE configuration, then restart data transmis-
ERROR CODE : 022 sion; if the message is still displayed, the de-
vice must be repaired.
SUPERVISION START ACK

• The device is not able to con-  Check the connection to the server, the net-
nect to the server work configuration, and the LifeDataNet®
TRANSMISSION FAILURE configuration, then restart data transmis-
ERROR CODE : 023 sion; if the message is still displayed, the de-
vice must be repaired.
SUPERVISION STOP REQ

• The device is not able to con-  Check the connection to the server, the net-
nect to the server work configuration, and the LifeDataNet®
TRANSMISSION FAILURE configuration, then restart data transmis-
ERROR CODE : 024 sion; if the message is still displayed, the de-
vice must be repaired.
SUPERVISION STOP ACK

• These errors are not applicable for the FRED easy® SD Card version.
• Error 004 (ADAPTER DISCONNECTED) only applies to the FRED easy® Ethernet
version.
• Errors 023 and 024 (SUPERVISION STOP REQ and SUPERVISION STOP ACK)
only apply to the FRED easy® Online version.
Art. no.: 0-48-0013 Rev. m

Page 77
7 Maintenance
7.5 Trouble Shooting FRED easy

7.5.3 Trouble Shooting

Forced shutdown procedure


If the device cannot be switched off via normal OFF procedure (press and hold the
green button for approx. 3 seconds), remove the battery and inserting again.

Problem Possible causes Remedy


The green "OK" standby indi- • Battery defect.  Replace the battery.
cator does not blink and/or • No battery inserted, or battery not  Insert the battery correctly.
the device cannot be turned correctly inserted.
on.  Have the device repaired.
• Device defective.
The yellow indicator at the • The pads are past their expiration  Use new electrodes.
electrode connector does not date.
go out. • Dry contact agent.  Use new electrodes.
• High contact impedance between  Apply the pads exactly as described. Shave the elec-
the pads and the skin. trode application area.

• Device defective.  Have the device repaired.


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- Use new electrodes.
• The pads are past their expiration 
nected.
date.
• Dry contact agent.  Use new electrodes.
• Device defective.  Have the device repaired.
The device cannot be turned • On/Off button was pressed less  Hold down the on/off button for at least 3 seconds.
off. than 3 seconds.
• Software hangs  Remove battery and inserting again
• Device defective.  Have the device repaired.
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.
• Device defective.  Have the device repaired.
Defibrillation shock cannot be • Insufficient battery charge level.  Replace the battery.
delivered. • CPR caused a pad error.  Re-apply the pads.
• Cardiac rhythm has changed.
• Device defective.  Repeat the analysis.
 Have the device repaired.
The alarm tone does not • Battery defect.  Replace the battery.
Art. no.: 0-48-0013 Rev. m

stop. • Device defective.  Have the device repaired.


Message "ERROR xxx". • Device defective.  Have the device repaired.
Battery capacity indicator • Battery almost depleted.  Replace the battery.
blinks.
No data recorded on the SD • Card defect.  Replace the card.
card. • Device defective.  Have the device repaired.

Page 78
Maintenance 7
FRED easy User Guide Trouble Shooting 7.5

Problem Possible causes Remedy


• No SD card is inserted.  Switch the device off and insert the card the right way
The SD card symbol is not
around.
displayed, or the symbol • The card is inserted the wrong  Switch the device off and insert the card the right way
is displayed. way. around.
• The card was inserted with the  Switch the device off and then on again.
device turned on.
• SD card write-protected.  Turn off the device, remove the SD card, unlock the write
protection, and re-insert the card. Then, restart the de-
vice.
• Device defective.  Have the device repaired.
Incorrect date and time • Internal clock error.  Have the system parameters updated by an authorised
stored on SD card. person using the configuration/downloading kit.
• Device defective.  Have the device repaired.
Art. no.: 0-48-0013 Rev. m

Page 79
7 Maintenance
7.5 Trouble Shooting FRED easy

7.5.4 Measures to prevent electromagnetic interferences


The user can help avoid electromagnetic disturbances by keeping the minimum dis-
tance between portable and mobile HF telecommunication devices (transmitters) and
the FRED easy®. 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)

It can be deducted from the table that portable HF telecommunication devices must
not be used within a radius of 3 m from the FRED easy® and its cables.

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.

For more detailed information, please refer to page 85.

If the devices are used in the vicinity of power networks operating at a frequency of 16.7
Hz (railway systems in some countries), the 16.7 Hz filter must be activated via the con-
figuration software before use. The filter is by default activated.
Art. no.: 0-48-0013 Rev. m

Page 80
Technical Data 8
FRED easy User Guide System Specifications 8.1

8 Technical Data
Unless otherwise stated, all specifications are valid at a temperature of 25 °C.

8.1 System Specifications


Manufactured by SCHILLER MEDICAL

Device name FRED easy®

Dimensions
SD card version 70 x 230 x 220 mm (h x l x w)
Ethernet/Online Versions 70 x 237 x 220 mm (h x l x w)

Weight Approx. 1.5 kg

Protection class of the device


IP54 (protection against dust and splashing water)
housing

Recorded data ECG signal recording (2 hours)


Ambient noise recording (2 hours)
Event recording (500 events)

Power supply Internal power supply, suitable for continuous operation with intermittent loading

Standard battery type Lithium/MnO2 12 V, 2.8 Ah


Battery life • 180 shocks at maximum energy, or 3.75 hours of operating (alternately
30 minutes ON and 30 minutes OFF)
• Several years in standby (standby duration corresponding to laboratory tests at 25°C: 5
years with weekly self-tests)

Optional battery type NiCd 12 V, 650 mAh, rechargeable


Battery life • 45 shocks at maximum energy, or operating for 1 h 20 min.

Environmental conditionsa
Device
Operation • -5...40 °C at a relative humidity of 30 to 95% (no condensation)
Storage befor 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.
Art. no.: 0-48-0013 Rev. m

• 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- • 0 ... 60 °C (48h max. between 0...15 °C and 25°...60°C)
ature battery LiMnO2
Storage and transport temper- • 0 ... 50 °C
ature electrode pads

a. For additional information about operating and storage conditions see page 67 Chapter 6.5 Special operating conditions.

Page 81
8 Technical Data
8.2 Classification and safety standards FRED easy

Display
Type High-resolution LCD screen, electroluminescent backlighting, text and symbol display
100 x 37 mm
Dimensions

8.2 Classification and safety standards

Standards FRED easy® complies with IEC standard 60601-2-4.


According to IEC standard 60601-2-4, FRED easy® is a device for frequent use.

EMC See 8 Technical Data.

Compliance • FRED easy® 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 easy® is a class IIb device.

Patient Protection BF type, resistant to defibrillation shocks.

Explosions protection FRED easy® 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.: 0-48-0013 Rev. m

Page 82
Technical Data 8
FRED easy User Guide Defibrillation pulse 8.3

8.3 Defibrillation pulse

Form • Biphasic pulsed defibrillation pulse with approximately constant phases for opti-
mal physiological compatibility.
• Maintains the energy delivered to the patient at an approximately constant level
with regard to patient resistance by applying pulse-pause modulation that varies
according to measured patient resistance.

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:
1 – 2 – 4 – 6 – 8 – 15 – 30 – 50 – 70 – 90 –110 – 130 – 150 J (adults)
1 – 2 – 4 – 6 – 8 – 15 – 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-auto- matic mode)
matic mode) < 11 seconds
With full battery:

After 15 discharges with max. < 11 seconds


energy:

Cycle time: switch-on of the de- (Maximum time between the switch-on of the device and the shock availability, in
vice – shock availability (in semi-automatic mode)
Art. no.: 0-48-0013 Rev. m

semi-automatic mode)
< 22 seconds

Patient impedance at which


30 to 250 Ω (Impedance is compensated up to 175 Ω)
shock delivery is possible

Indication when ready to shock The orange button is lit

Page 83
8 Technical Data
8.3 Defibrillation pulse FRED easy

Shock delivery • With the orange button (in semi-automatic or manual mode)
• Via disposable pads applied to the patient in an anterior-anterolateral or anteri-
or-posterior 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 pads
• 80 cm² active surface
Paediatric pad
• 42 cm² active surface

VF/VT detection VF/VT detection is based only on the ECG signal.

Conditions for ECG analysis Minimum amplitude for signals suitable for analysis > 0.15 mV, signals < 0.15 mV
are considered asystole.

Shock recommendation For VF and VT (VT > 150 B/min).

VF VT Non shockable
rhythms
NSR/N/Asystole
Shock 148 100 2
No Shock 2 2 1395
Performance criteria Sensitivity > 90 % Sensitivity > 75 % Specificity > 95 %
Observed performance 98.67 % 98.04 % 99.86 %

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

Page 84
Technical Data 8
FRED easy User Guide Electromagnetic interferences 8.4

8.4 Electromagnetic interferences


The FRED easy® is intended to be used in the electromagnetic environments listed
in the following tables. The owner or user of the FRED easy® has to ensure that the
device is operated in an adequate environment.

8.4.1 Electromagnetic emissions


Compliance with the regula-
Emission measurement Electromagnetic environment - explanations
tions
HF emissions Group 1 FRED easy® only uses HF energy for internal functions. Therefore,
CISPR 11 HF emissions are very low and interferences with electronic devices
nearby are unlikely.
HF emissions Class B
CISPR 11 FRED easy® 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
low-voltage power supply network that supplies buildings used for
Voltage fluctuations Not applicable domestic purposes.
IEC 61000-3-3

8.4.2 Electromagnetic immunity


Interference testing IEC 60601 test level Conformity level Electromagnetic environment - explanations
Electrostatic dis- ± 6 kV contact IEC 60601-1 Floors should be made of wood, concrete or ceramic tiles. If floors
charge ± 8 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
sient/burst ± 1 kV for input/output lines
IEC 61000-4-4
Surge ± 1 kV between conductors Not applicable
IEC 61000-4-5 ± 2 kV conductor-earth
Voltage dips, short in- < 5 % UT (> 95 % dip in UT) for Not applicable
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.: 0-48-0013 Rev. m

Page 85
8 Technical Data
8.4 Electromagnetic interferences FRED easy

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 easy® and all its components, incl. cables; the recom-
mended minimum distance is calculated based on the trans-
mitter's frequency.

Conducted HF 3 Veff between 150 kHz and Not applicable


IEC 61000-4-6 80 MHz outside of the ISM fre-
quency bandsa

10 Veff between 150 kHz and Not applicable


a
80 MHz in ISM frequency bands
Radiated HF 10 V/m Batterie 80 MHz to 2.5 10 V/m 12
IEC 61000-4-3 GHz 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
range.
Art. no.: 0-48-0013 Rev. m

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 easy® 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 easy®.

d. For the frequency range between 150 kHz and 80 MHz, the field strength must be lower than 3 V/m.

Page 86
Technical Data 8
FRED easy User Guide Electromagnetic interferences 8.4

8.4.3 Recommended minimum distances


The FRED easy® is intended to be used in electromagnetic environments in which it
is possible to control radiated HF interferences. The user of the FRED easy® can pre-
vent electromagnetic interferences by always keeping a minimum distance between
portable/mobile HF communication devices (transmitters) and the FRED easy®. 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
transmitting d = -------  P d = ------  P 12
d = ------  P
23
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 with a max. transmitting power that is not listed in the above table, the recommended minimum distance d in metres (m) can
be calculated using a formula based on the transmitter's frequency, where P is the max. transmitting power of the transmitter in Watts (W) (ac-
cording to manufacturer data).

Note 1 These guidelines might not always be applicable. Electromagnetic radiation is influenced by absorption and reflection on structures, ob-
jects and people.
Note 2 To calculate the recommended minimum distance of transmitters in the ISM frequency bands between 150 kHz and 80M Hz and
in the frequency band between 80 MHz and 2.5 GHz, the additional factor 10/3 is used to minimise the probability of interferenc-
es caused by mobile/portable communication equipment that accidentally happens to be in the patient environment.
Art. no.: 0-48-0013 Rev. m

Page 87
9 Appendix
9.1 Order Information FRED easy

9 Appendix
9.1 Order Information
Devices

Part No. Description


1-58-9913 FRED easy® SD Card, semi-automatic
1-58-9100 FRED easy® SD Card, automatic
1-58-9301 FRED easy® Ethernet/Online, semi-automatic
1-58-9401 FRED easy® Ethernet/Online, automatic
EASY T2 FRED easy® TRAINER

Accessories
Part No. Description
1-58-5303 Ethernet adapter
0-80-0013 Accessory bag for Online version
5-30-0003 Ethernet cable (3 m, category 5)
4-33-0002 Ferrite core
0-05-0026 Ethernet cable (3 m, with ferrite core)
EASY ELEC 1 pair of disposable adhesive defibrillation pads for adults, 80 cm²
0-21-0000 1 pair of disposable adhesive defibrillation pads for children, 42 cm²
1 pair of disposable adhesive defibrillation pads for adults, 80 cm²,
0-21-0020
"pre-connected"
1 pair of disposable adhesive defibrillation pads for children, 42 cm²,
0-21-0021
"pre-connected"
0-48-0013 User Guide, English
EASY BAT Disposable lithium battery
0-02-0003 Rechargeable NiCd battery
3-55-0030 Battery charger, 100 – 240 V, 50 – 60 Hz, UE
3-55-0033 Battery charger, 100 – 240 V, 50 – 60 Hz, UK
3-55-0034 Battery charger, 100 – 240 V, 50 – 60 Hz, US
EASY S Instrument bag
0-80-0008 Instrument bag, reinforced
EASY CARD Formatted SD card
5-35-0037 Formatted SD card (for FRED easy® with software version ≥ 06.00)
Art. no.: 0-48-0013 Rev. m

9.2 Required accessories


• User Guide
• One pair of adhesive pads
• 1 lithium batteries
• One SD card (only for the SD Card version)

Page 88
Appendix 9
FRED easy User Guide Literature 9.3

9.3 Literature

European Resuscitation Council European Resuscitation Council Guidelines for Resuscitation 2010 (doi:10.1016/j.re-
(2010) suscitation.2010.08.021).

American Heart Association (2010) International Consensus on Cardiopulmonary Resuscitation and Emergency Cardi-
ovascular Care Science With Treatment Recommendations (DOI: 10.1161/CIRCU-
LATIONAHA.110.971010).

Cansell A. Effectiveness and Safety of New Transthoracic Cardiac Defibrillation Waveforms – Bi-
phasic Pulses In "La Revue des SAMU 20": 280 - 294. 2000.

9.4 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.: 0-48-0013 Rev. m

Page 89
9 Appendix
9.5 Inspection report FRED easy

9.5 Inspection report


The user guide must be read before the inspection.

Serial number: _______________________________________

Checks - before each use


 Visual inspection of the device and accessories
 Device casing undamaged?     
 Cables not twisted, without wear signs due to friction or deterioration?     
 No excessive clogging or damage?     
 All the signal inputs in perfect condition?     
 Legible nameplate at the rear of the device?     
 Legible inscriptions on the front face of th 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 green indicator is lit

    
Date:
Performed by:

Checks - every 3 years


Visual inspection of the device and accessories
    
(see previous table)
Functional test
 Check for proper functioning.     
 Measure the leakage current.     
 Measure the energy delivered at 50 ohms.     
Date:
Art. no.: 0-48-0013 Rev. m

Performed by:

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 90
Appendix 9
FRED easy User Guide Inspection report 9.5
Art. no.: 0-48-0013 Rev. m

Page 91
10 Index
FRED easy

10 Index
Numerics Design.........................................................14 Maintenance Intervals ........................... 69
Disinfection .................................................71 Test........................................................ 70
16.7 Hz filter ............................................... 17
Display Symbols/Indicators Visual inspection.................................... 69
in this User Guide ..................................10 Memory card.........................................14, 48
A on the display.........................................11 Metronome.................................................. 62
Accessories.......................................... 53, 88 on the electrode packaging....................12 Motion detection ......................................... 31
AED...................................................... 13, 27 used on the battery ................................11
Appendix used on the device.................................10
Glossary ................................................ 89 Disposal information R
Accessories into contact with patients ...72 Rechargeable NiCd battery ........................ 63
Inspection Report .................................. 90
Literature ............................................... 89 At the end of useful life ..........................72
Order information .................................. 88 Battery ...................................................72
S
Required accessories............................ 88 Safety Notes ................................................. 5
E Self-test.......................................... 16, 20, 63
B ECG ............................................................62
Battery Electrodes
Adult and paediatric electrodes .............36
T
Battery Disposal .................................... 72 Technical Data
Battery is empty .................................... 26 Applying the pads ..................................35
Defibrillation impulse ............................. 83
Inserting the battery .............................. 22 Checking the electrodes ........................37
Insert connector into device ...................35 Dimensions ............................................ 81
Low battery............................................ 25 Energy levels ......................................... 83
Sufficient battery capacity ..................... 24 Open the electrode packaging ...............35
Environmental conditions ...................... 81
Biocompatibility .......................................... 13 Pre-connected pads...............................35
Electromagnetic interferences ....................81 Patient impedance................................. 83
Patient Protection .................................. 82
Events stored on the memory card .............48
C Power supply ......................................... 81
Cleaning ..................................................... 71 Protection class ..................................... 81
Configurable parameters F Standards .............................................. 82
FRED easy® Ethernet Weight ................................................... 81
16.7 Hz filter .......................................... 17
Energy levels......................................... 17 "Network" tab configuration....................50 Terms of Warranty ........................................ 9
"Online" tab configuration ......................60 Trouble Shooting ........................................ 73
Connection error ........................................ 75
Controls and indicators Connecting the Ethernet Adapter ..........50
-Display ................................................. 21 Data transmission ..................................51
Ethernet interface case ......................... 20 Dynamic IP addressing ..........................58
Green button ......................................... 20 Ethernet interface case ..........................20
Green indicator...................................... 20 Ferrite core ............................................50
Orange button ....................................... 20 Installing the ferrite core ........................53
Port for adhesive pads .......................... 20 MAC address .........................................58
SD card slot........................................... 20 Operating principle.................................50
SD card version..................................... 20 Read Community configuration..............60
Yellow indicator ..................................... 20 Static IP addressing ...............................58
FRED easy® Online
Ethernet interface case ..........................20
D Inserting in the Docking station..............56
Danger of electric shock!.............................. 7 Maintenance mode ................................57
Danger of explosion ............................... 7, 22 Operating principle.................................54
Defibrillation SNMP protocol.......................................54
Automatic defibrillation .......................... 40 FRED easy® SD Card
Art. no.: 0-48-0013 Rev. m

Biphasic pulsed defibrillation impulse ... 14 Controls and indicators ..........................20


Cardiopulmonary resuscitation.............. 32 Inserting the Memory Card ....................49
Defibrillation procedure ......................... 29 Operating principle.................................48
Defibrillator application guidelines......... 27 FREDCO® ........................................... 17, 50
Finishing the therapy............................. 47 Function ......................................................16
Internal safety discharge ....................... 47
Manual defibrillation
Switching to semi-automatic L
operational mode46 LifeDataNet® ..............................................54
Safety notes for AED use...................... 28
Semi-automatic Defibrillation ................ 38
Shockable condition .............................. 32
M
Maintenance
Ventricular fibrillation............................. 32
Green indicator ......................................70
Ventricular tachycardia.......................... 32
Internal backup battery ..........................70

Page 92

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