SCHILLER MEDICAL SAS FRED easy User manual

FRED easy®
Semiautomatic Defibrillator (PAD)
User Guide
SCHILLER MEDICAL SAS
4, Rue Louis Pasteur
F-67162 Wissembourg – Cedex, France
Telephone **33 (0) 3 88 63 36 00
FAX **33 (0) 3 88 94 12 82
E-mail [e-mail]
Part No. 0-48-0013
1
3
2
SCHILLER
FRED easy
- 0459

Contents
FRED easy® 3
1Intended Use 5
2Product Description and Function 6
3Controls and Indicators 9
4Putting the Device into Operation and Functional Test 11
4.1 Safety Information 11
4.2 Inserting the Battery 13
4.3 NiCd Batteries (Option) 14
5Defibrillation 15
5.1 Defibrillator Application Guidelines 15
5.2 Safety Information for the Use of a PAD 16
5.3 Defibrillating the Patient 17
6Options and Variants 22
6.1 ECG Display (Option) 22
6.2 Manual Mode (Option) 22
6.3 Ethernet Data Transmission (Option) 24
6.4 Automatic Defibrillation (Variant) 29
7Cleaning, Maintenance, Disposal 30
7.1 Cleaning and Disinfection 30
7.2 Maintenance 31
7.3 Disposal at the End of Its Service Life 31
8Error Messages, Troubleshooting 32
8.1 Error Messages 32
8.2 Troubleshooting 33
9Technical Specifications 35
10 Order Information 37
Appendix
Literature 37
Index 38
Inspection Checklist 39
Revision History
Version Date Comment
0-48-0013 25 October 2002 1st edition
0-48-0013 09 January 2003 Revised Edition
0-48-0013 11 April 2003 Revised Edition
0-48-0013 24 June 2003 Revised Edition
0-48-0013 09 October 2003 Revised Edition
0-48-0013 10 July 2004 Revised Edition
0-48-0013 10 July 2006 Revised Edition

General Information
FRED easy®
4
General Information
•FRED easy®bears the CE mark
CE-0459
indicating its compliance with the provisions
of the Council Directive 93/42/EEC about
medical devices and fulfills the essential re-
quirements of Annex I of this directive. FRED
easy® is a class IIb device.
•The product complies with the electromag-
netic immunity requirements of standard IEC
60601-1-2/EN 60601-1-2 "Electromagnetic
Compatibility - Medical Electrical Equipment".
•The radio interference emitted by this device
is within the limits specified in the CISPR 11
standard.
•The user guide is an integral part of the
device and should always be kept near the
device. Close observance of the information
given in the user guide is a prerequisite for
using the device as intended for and correct
operation and ensures patient and operator
safety. Therefore, be sure to read the
complete user guide.
•To ensure patient safety, the specified meas-
uring accuracy, and interference-free opera-
tion, we recommend to use only original
SCHILLER accessories. The user is respon-
sible if accessories from other manufacturers
are used. The warranty does not cover dam-
age resulting from the use of unsuitable ac-
cessories and consumables from other
manufacturers.
•SCHILLER is responsible for the effects on
safety, reliability, and performance of the de-
vice, only if
−assembly operations, extensions, read-
justments, modifications, or repairs are
carried out by SCHILLER or by persons
authorized by SCHILLER
−the device is used in accordance with the
instructions given in this manual.
•The customer is responsible, if the device is
employed in a manner different from the
method described in this manual.
•On request SCHILLER will provide a detailed
field service manual.
•The manufacturer is only liable for
SCHILLER-supplied accessories.
•The user guide informs the device operator
about the intended use, exact function, op-
eration and required preventive maintenance.
It is not a substitute for a product training.
•The safety information given in this manual is
classified as follows:
Danger
indicates an imminent hazard. If not
avoided, the hazard will result in death or
serious injury.
Warning
indicates a hazard. If not avoided, the
hazard can result in death or serious in-
jury.
Caution
indicates a potential hazard. If not
avoided, this hazard may result in minor
personal injury or product/property dam-
age.
•This manual conforms with the device speci-
fications and safety standards valid at the
time of printing. All rights are reserved for de-
vices, circuits, techniques, software pro-
grams, and names appearing in this manual.
•The SCHILLER quality management system
complies with the international standards ISO
9001 and ISO 13458.
•No part of this manual may be reproduced
without written permission from SCHILLER.
Manufacturer
SCHILLER MEDICAL SAS
4, Rue Louis Pasteur
F-67162 Wissembourg – Cedex, France
Telephone **33 (0) 3 88 63 36 00
FAX **33 (0) 3 88 94 12 82
E-mail [e-mail]

Intended Use
FRED easy® 5
1 Intended Use
FRED easy® is a so-called Public Access Defi-
brillator (PAD).
PADs are devices for semiautomatic defibrillation
by non-medical staff. They are particularly easy to
operate and their use is relatively harmless for
both the patient and the operator.
FRED easy® is also available as an automatic
external defibrillator.
Note
This document describes the semiautomatic
version of FRED easy®. Refer to section 6.4 for
information on operating the device in the auto-
matic mode.
The regulations governing the use and training
requirements for PADs such as FRED easy®
differ from country to country. The local laws and
regulations must be observed in each case.
Note
The laws and regulations for the use of PADs
differ from country to country. While some coun-
tries allow laypersons to use PADs without any
special training, other countries restrict the use of
PADs to EMTs or First Responders after they
have undergone a special training. For teaching
purposes, we offer the FRED easy® TRAINER
version.
Typical sites for the installation of FRED easy®
units would be much-frequented buildings such
as
−airports
−railway stations
−shopping malls
−public swimming pools
−sports centers
−municipal/public offices
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,
fulfill the biocompatibility requirements of the
applicable standards if applied as intended. If
you have questions in this matter, please con-
tact SCHILLER.

Product Description and Function
FRED easy®
6
2 Product Description and Function
Product Description
FRED easy® is a battery-powered, semi-
automatic defibrillator that delivers biphasic
defibrillation pulses.
The patient is defibrillated via disposable adhesive
electrodes (pads) which also acquire the ECG
signal for analysis. The operator can choose
between adhesive electrodes for children and for
adults. The device identifies the connected elec-
trode type and automatically preselects the corre-
sponding energy levels for defibrillation.
The device prompts the operator by text and
audio messages (display/speaker).
The intervention is documented on a memory
card that records the ECG, speech and events
(see section "Intervention Summary" on page
21).
The device is powered by a plug-in, disposable
lithium battery. The battery capacity is sufficient
for
−180 shocks at maximum energy or
−7 hours of monitoring (alternately 30 minutes
ON and 30 minutes OFF) or
−5 years standby operation.
As an alternative, we can supply a rechargeable
NiCd battery. When new or fully charged, its
capacity is sufficient for
−45 shocks at maximum energy or
−1.5 hours of monitoring
Our customer service can configure various
device functions via a special PC connection (see
section “Functional Description”).
Variants and Options
Semiautomatic Defibrillator
Options
−ECG display (see section "ECG Display" on
page 22)
−Configurable for manual defibrillation (see
section "Manual Defibrillation", page 22)
−Ethernet data transmission (see section
"Ethernet Data Transmission", page 24)
Automatic Defibrillator
Options
−Ethernet data transmission
Functional Description
Ensure Operational Readiness
As soon as a battery is inserted, FRED easy®
runs a self-test of the device and the battery. If
this test does not reveal any problems, the green
indicator starts blinking to indicate that the device
is ready for operation, and the displayed informa-
tion disappears. The device also runs a self-test
each time it is turned on.
If the device identifies a problem during these
self-tests
−it emits an alarm tone
−the green indicator does not blink.
The alarm tone continues until the battery is
depleted. With the button (arrow, Figure 2-1)
the self-test can be repeated and the correspond-
ing error message will appear.
In addition, the device runs a self-test every 7
days; this self-test is announced by a beep. If the
device identifies a problem during this self-test
−it emits an alarm tone
−the green indicator does not blink.
When equipped with the optional NiCd battery,
the device runs a daily self-test.
By pressing the key (arrow, Figure 2-1) you
can view the corresponding error message.
In this situation a new self-test must be initiated
by insertion of a battery. Depending on the result
of the self-test, the error message will disappear
or a new one appears.

Product Description and Function
FRED easy® 7
1
3
2
SCHILLER
FRED easy
Figure 2-1. FRED easy®, button to turn the
device on and off and to initiate the analysis
Defibrillation (semiautomatic defibrillator)
The operator is informed of each operating step
by voice and text which is displayed on the
screen.
After activation of the button, an introductory
text tells the operator what to do, if the patient is
unconscious or does not breathe.
FRED easy® will continue repeating this introduc-
tory text until defibrillation pads are attached to
the patient. The device can also be configured to
skip the introductory text and to prompt the
operator immediately to attach the pads.
After that FRED easy® will ask the operator to
start ECG analysis and warns not to touch the
patient any more. The analysis takes approx. 10
seconds. Depending on its configuration, the
device may automatically start the ECG analysis.
Note
−With signals from the AHA (American
Heart Association) database, FRED easy®
achieved a detection accuracy of 98.43 %
(sensitivity) and 99.80 % (specificity).
−The device may be configured to auto-
matically start the ECG analysis.
Device identifies a shockable rhythm
If the analysis algorithm identifies a shockable
rhythm, the device will automatically charge the
required defibrillation energy and, when charged,
prompts the user to deliver the shock.
Shockable conditions are
−ventricular fibrillation or
−ventricular tachycardia with a rate greater than
180 B/min.
If the algorithm detects a shockable rhythm, the
shock may still only be released if the patient
does not show any signs of circulation.
After an unsuccessful shock FRED easy®
prompts the user to perform CPR for two minutes
(in Norway: three minutes): 30 chest compres-
sions to every two breaths.
Warning
Patient Hazard In the treatment of children
only 15 chest compressions must be per-
formed to every two breaths.
After these two (three) minutes, the device again
prompts the user to start ECG analysis. The
device may be configured to automatically restart
analysis.
If the device again detects a shockable rhythm, it
will automatically charge the defibrillation energy
necessary for the second or third shock. For all
subsequent shocks the energy remains fixed at
the level of the third shock.
Note
The energy levels can be set to the default
values or the SCHILLER customer service
can adjust customer-specific energy settings
(see 9 „Technical Specifications“).
After a successful shock FRED easy®prompts
the user to perform CPR (30 chest compressions
to every two breaths) until the patient starts
breathing or until new instructions are given.

Product Description and Function
FRED easy®
8
Device identifies no shockable rhythm
If the algorithm does not identify a shockable
rhythm, FRED easy®informs the user that a
shock is not necessary and prompts to perform
CPR (30 chest compressions to every two
breaths) until the patient starts breathing or until
new instructions are given.
Configurable device parameters
The SCHILLER customer service can configure
the following device parameters:
−upon power up: introductory text or immediate
prompt to apply the defib pads
−volume of the voice prompts
−energy levels for the 1st, 2nd and 3rd shock,
separate adjustments for adults and children
−initiation of ECG analysis with button or auto-
matic
−activation/deactivation of a 16.7-Hz filter

Controls and Indicators
FRED easy® 9
3 Controls and Indicators
1
3
2
SCHILLER
FRED easy
ab c d f eg
Figure 3-1. Controls and indicators
a Green indicator blinks when device is ready for operation
b Yellow indicator is illuminated while no pads are connected
c Connection for defib pads
d Green button to turn the device on and off and to initiate the analysis
e Button to trigger the defibrillation shock
f Memory card
g Battery
Figure 3-2. FRED easy®for semiautomatic and
manual defibrillation
Figure 3-3. FRED easy®for automatic defibrillation

Controls and Indicators
FRED easy®
10
Explanation of Symbols
Symbols on the device and accessories
Type BF signal input, defibrillation-
proof
Caution! High Voltage!
Defibrillation pad expiration date
Consult accompanying documents
GB
I
D
E
NL
F
N
SF
S
Open defib pad package
Peel off protective foil
Disposable item, do not reuse
Do not bend packing
Storage temperature range for the
electrodes
Product is recyclable
Do not dispose of with household waste,
separate disposal required
Do not recharge
Do not short-circuit
Do not incinerate
Do not destroy with a saw
Do not destroy
48h
+
60 ˚C
+ 20 ˚C
+ 25 ˚C
+ 15 ˚C
0 ˚C
Unlimited storage between +15 °C and
+25 °C, storage for 48 hours max. between
+25 °C and +60 °C and between +15 °C
and 0 °C
Symbols used on the display
Number of shocks delivered since
device was turned on
Battery capacity
Memory card
Memory card not identified
AAdult pad identified
CPediatric pad identified
Time elapsed since device was turned
on (minutes, seconds)

Putting the Device into Operation and Functional Test
FRED easy® 11
4 Putting the Device into Operation and Functional Test
4.1 Safety Information
Danger
Explosion Hazard FRED easy® is not de-
signed for use in areas where an explosion
hazard may occur.
Also, it is not permitted to operate the defibrilla-
tor in an oxygen-enriched environment or in the
presence of flammable substances (gas) or
flammable anesthetics.
Oxygenation in the vicinity of the defibrillation
electrodes must be strictly avoided.
Oxygen concentrations below 25% of the am-
bient air are not considered dangerous. Dan-
gerous, high oxygen concentrations can only
occur in oxygen masks or in enclosed areas,
such as hyperbaric chambers.
Warning
Shock Hazard Observe the following warn-
ings. Failure to do so endangers the lives of the
patient, the user and other persons present.
−FRED easy® is a high-voltage electrotherapy
device. Only authorized personnel is permit-
ted to use these devices. Improper use of the
device can endanger life. Always follow the
instructions given in this user guide.
−Before using the device, the operator is re-
quired to ascertain that it is functioning cor-
rectly and in good operating condition. In par-
ticular, the cables, connectors and electrodes
must be inspected. Damaged parts must be
replaced immediately, before use.
−The operator is required to ensure that during
ECG analysis and defibrillation there is no
conductive connection between the patient
and other persons.
−Devices may be connected to other devices
or to parts of systems only when it has been
made certain that there is no danger to the
patient, the operators, or the environment as
a result.
In those instances where there is any ele-
ment of doubt concerning the safety of con-
nected devices, the manufacturers con-
cerned or other informed experts must be
contacted as to whether there is any possible
danger to the patient, the operator, or the en-
vironment as a result of the proposed combi-
nation of devices. Standard IEC 60601-1-1
must be complied with in all cases.
−The device is suitable for application in a
humid environment provided the regulations
concerning splash-proof equipment of IEC
60601-2-4 are strictly observed.
Warning
Equipment Failure 
−Magnetic and electrical fields are capable of
interfering with the proper performance of the
device. For this reason make sure that all ex-
ternal devices operated in the vicinity of the
defibrillator comply with the relevant EMC re-
quirements. X-ray equipment, MRI devices,
radio systems, and cellular telephones are
possible sources of interference as they may
emit higher levels of electromagnetic radia-
tion.
Keep the equipment away from these de-
vices and verify its performance before use.
−If the devices are used in the vicinity of
power networks operating at a frequency of
16.7 Hz (railway systems in some coun-
tries), the 16.7-Hz filter should be activated
via the configuration menu. The filter should
be turned off, when the device is not used in
the vicinity of these networks.

Putting the Device into Operation and Functional Test
FRED easy®
12
Warning
−Equipment Failure The defibrillator may
disturb equipment operating in its vicinity
when charging or delivering the shock. Verify
the performance of these devices before use.
−Operational Readiness FRED easy® is an
emergency device and must be ready for op-
eration at any time and in all situations. En-
sure that the device is always equipped with
a charged battery and always have a spare
battery at hand.
−Suffocation Hazard Dispose of the pack-
aging material, observing the applicable
waste-control regulations. Keep the packing
material out of children's reach.
Caution
Equipment Damage 
−Exercise great care when using HF surgery
equipment on the patient at the same as the
defibrillator. As a general rule, the distance
between the defib pads and the HF surgery
electrodes should not be less than 15 cm. If
this is not ensured, disconnect the electrodes
and transducer leads while using the HF sur-
gery device.
−Disconnect all transducers and devices that
are not defibrillation-proof from the patient
before defibrillation.

Putting the Device into Operation and Functional Test
FRED easy® 13
1
3
2
SCHILLER
Figure 4-1. Inserting the battery
Warning
Shock Hazard When the green indicator
blinks, the device is ready for operation. In ad-
dition, the cables, connectors and electrodes
must be visually inspected on a regular basis. If
problems are identified which may impair the
patient's or operator's safety, the device must
be repaired before it can be used again.
Warning
Erroneous capacity indication 
−Replace the battery when the device indi-
cates a battery problem. In some cases the
device may continue to operate with the old
battery but the indicated capacity may be in-
correct.
−Turn off the device before removing an
intact battery. Otherwise the device is unable
to determine the exact capacity when the bat-
tery is reinserted and will report a battery
problem, which makes the battery useless.
Caution
Equipment Damage Use the connector in
the battery compartment for service purposes
only.
4.2 Inserting the Battery
The device is normally powered by a disposable
lithium battery. As an alternative, a rechargeable
NiCd battery can be used (see section 4.3 "NiCd
Batteries").
With the lithium battery, the device is ready for
operation for a minimum of 5 years (including the
weekly functional test), provided it is not used on a
patient.
Each time the device is turned on it checks the
battery and indicates the remaining capacity on the
display.
After five years – if the device has not been used
on a patient – the battery must be replaced with a
new one.
Insert the battery as shown in Figure 4-1. Make
sure that the battery locks properly into place.
As soon as a battery is inserted, FRED easy® runs
a self-test of the device and the battery.
If there are no problems with the device and the
battery, the green indicator starts blinking to indi-
cate that the device is ready for operation, and the
displayed information disappears.
Note
−Do not expose FRED easy® to direct
sunlight or temperature extremes. The am-
bient temperature should be between 0 and
50 °C. Higher or lower temperatures ad-
versely affect the life of the battery.
−FRED easy® automatically monitors the
battery capacity. When the capacity drops
below the minimum level
- an alarm tone sounds
- the green indicator stops blinking.
−If the device is turned off for less than 5
minutes (e.g. to replace the battery), all data
remains stored and, after the self-test, the
device continues to operate as if it had
never been turned off.

Putting the Device into Operation and Functional Test
FRED easy®
14
4.3 NiCd Batteries (Option)
Figure 4-2. Charging unit
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
−1.5 hours of monitoring
With this type of battery, however, the remaining
capacity is not indicated. The symbol appears
when a battery is inserted; it starts blinking when
the capacity reaches a given minimum value.
Replace the battery in this case and recharge.
Note
The battery symbol appears only when the device
is equipped with a new version of the CPU board
(these boards have a 12-digit serial number).
To recharge these batteries, use the charging unit
with part no. 3-55-0030. The charging time is 1
hour maximum.
When equipped with the NiCd battery, the device
runs a daily self-test.

Defibrillation
FRED easy® 15
5 Defibrillation
5.1 Defibrillator Application Guidelines
Observe the following guidelines to ensure suc-
cessful and safe defibrillation. Otherwise the lives
of the patient, the user and bystanders are in
danger.
Non-medical staff is permitted to use a PAD such
as FRED easy® only if local jurisdiction approves
of this practice. Make sure that FRED easy® is
only accessible to persons who are legally author-
ized to use a PAD.
Warning
Risk for patients, users and assistants 
−Position the patient flat on a surface which is
not too soft and where he is electrically insu-
lated. The patient must not be allowed to
come into contact with metal parts, e.g., bed
or litter, to prevent unwanted pathways for the
defibrillation current which may endanger the
assistants. For the same reason, do not posi-
tion the patient on wet ground (rain, accident
in swimming pool).
Do not allow the defibrillation electrodes to
come into contact with other electrodes or
metal parts which are in contact with the pa-
tient.
The patient's chest must be dry, because
moisture can cause unwanted pathways for
the defibrillation current.
For safety, wipe off flammable skin cleansing
agents.
−The operator and all assistants must be
briefed regarding the preparations for and
execution of defibrillation.
All tasks must be clearly assigned.
Immediately prior to the shock
- heart massage and artificial respiration
must be interrupted and
- bystanders must be warned.
−Ensure that there are no conductive connec-
tions between the patient and other persons
during defibrillation.
Warning
−Pacemaker Patients Defibrillating a patient
with an implanted pacemaker is likely to im-
pair the pacemaker function or cause dam-
age to the pacemaker.
For this reason
- do not apply the defib pads near the
pacemaker,
- have an external pacemaker at hand,
- check the implanted pacemaker for proper
functioning as soon as possible after the
shock.
−Risk of Skin Burns Owing to the high cur-
rents, there is a risk of skin burns.
Note
Depending on the clinical aspects, defibrillation
may not be successful.

Defibrillation
FRED easy®
16
5.2 Safety Information for the Use of a PAD
In addition to the guidelines set forth in section 5.1,
the following rules must be observed when using a
PAD. Failure to do so may compromise the suc-
cess of the defibrillation or endanger the patient's
life.
Warning
−Patient Hazard Only patients without re-
sponse, respiration and signs of circulation
may be defibrillated with a PAD.
−During ECG analysis
– suspend CPR
– ensure that the patient lies as motionless
as possible
– do not touch the patient.
Otherwise, artifacts may lead to incorrect
analysis results.
−In unfavorable situations the analysis of the
ECG may occasionally be incorrect. There-
fore the user is obliged to make certain that
the conditions for use of a PAD are met:
- no response,
- no respiration,
- no signs of circulation.
Warning
Patient Hazard If, in the course of treatment,
the patient spontaneously regains conscious-
ness, a defibrillation shock that may have been
advised just before must not be delivered.
Special notes for devices with automatic ECG
analysis
Caution
Risk for patients, users and assistants 
With these devices it is not necessary to initiate
the ECG analysis with the green button. The
"analysing" status is indicated in written and
audible form. To achieve a correct analysis, do
not touch or move the patient during the analy-
sis.
Danger
Patient Hazard 
−Touching or transporting the patient during
analysis may impair the analysis. A valid
analysis result can only be obtained when the
patient does not move and is not touched
while the analysis is in progress.
−An ECG signal disturbed by CPR measures
may cause an incorrect analysis. For this
reason, heart massage and artificial respira-
tion must be suspended during the analysis.
The patient must not be touched during
analysis and shock delivery.

Defibrillation
FRED easy® 17
5.3 Defibrillating the Patient
1
b d
Figure 5-1. Operating controls
d Button to turn the device on
b Indicator is illuminated when the de-
fibrillation pads are not connected
and/or not attached to the patient
Figure 5-2. Pad application points
(+): right sternal edge at the level of the 2nd
intercostal space,
(-): left axillary line at the level of the 5th
intercostal space)
Warning
Risk of Skin Burns / Equipment Damage 
Do not apply the defibrillation pads over
−sternum or clavicle
−nipples
−implanted pacemaker or defibrillator de-
vices.
Poor Electrode Contact — Sea water, sand
and sunscreen products may impair electrode
contact or the electrodes may become dis-
connected.
Turn on the device by briefly (2 seconds maxi-
mum) pressing the button (d, Figure 5-1). The
device emits a beep upon power on. Then the
defibrillator addresses the operator with an intro-
ductory text and prompts the operator to deter-
mine the patient status. When no signs of circula-
tion can be identified, the device prompts the
operator to apply the defib pads.
The introductory text will be repeated until the
device detects the applied defib pads.
The device may also be configured to skip the
introductory text. In that case, the operator will be
asked to apply the defib pads immediately after
turning the device on.
Furthermore, the electrode indicator (b, Figure
5-1) is illuminated to signal that defib pads must
be attached to the patient and connected to the
device.
Applying the Defib Pads
For use with a PAD, the defibrillation electrodes
(pads) should be applied on the apex and ster-
num as usual. However, you may choose the
anterior-posterior positions to avoid shorting the
pads together, e.g., when defibrillating small
children.
•Before applying the pads, check the applica-
tion points on the patient’s chest (Figure 5-2);
they must be clean and dry. Then clean the
skin by rubbing the application points vigor-
ously with a dry cloth. Do not use alcohol or
alcohol wipes. This could increase the con-
tact impedance. Shave, if the patient’s chest
is hairy.
•Apply the STERNUM pad (+) above the right
nipple. Do not apply the pad on the clavicle
(uneven surface).
•The applied pads must have good contact
with the patient’s skin. Air bubbles under the
pad must be avoided. To do so, stick on one
end of the pad, then smooth it out to the
other end.

Defibrillation
FRED easy®
18
1
Figure 5-3. Yellow defib pad indicator
•Adhesive electrodes for adults / children
(AHA "Guidelines 2000 for Cardiopulmonary
Resuscitation and Emergency Cardiovascu-
lar Care”, page I-64)
−The large adult electrodes with a surface
area of 78 cm2should be used on adults
and on children weighing 25 kg or more.
−The small pediatric electrodes with a sur-
face area of 28 cm2should be used on
children weighing less than 25 kg (younger
than 8 years of age).
•Use the pads before their expiration date.
Please note that the indicated expiration date
only applies when the vacuum pack is intact.
The pads are pregelled. Do not use extra
contact agent (gel). Do not reuse the pads.
•Place the pads on the patient such that the
connectors point to either side of the patient
and that the cables are not hindering CPR
measures.
If the contact impedance is high, the message
“Check the electrodes” will appear and the yellow
indicator (Figure 5-3) remains illuminated.
Follow these steps to check the pads:
•Alternately press down firmly on the defibrilla-
tion pads and check when the message
“Check the electrodes” disappears.
•Press that pad for which the message disap-
peared again onto the skin.
If the message “Check the electrodes” does not
disappear,
•Remove the two defib pads.
•Wipe rests of contact agent off with a cloth.
•Shave the two application points to remove
the epidermal skin layer.
•Apply new defib pads to these points.

Defibrillation
FRED easy® 19
00:13 00 100% A
h i j k l
PRESS THE GREEN BUTTON
Figure 5-4. On-screen display
h Time since device was turned on
i Number of delivered shocks
j Residual battery capacity
k Memory card inserted
l Adult pads (A) or pediatric pads (C) con-
nected
1
3
2
Figure 5-5. Button to trigger the defibrillation
shock
Note
−If the patient’s rhythm changes to a non-
shockable rhythm after the message
“Shock advised”, the defibrillation energy
will be discharged internally.
−If an electrode becomes disconnected
during ECG analysis, the message "Con-
nect the electrodes" will be displayed and
the device suspends the analysis.
−If, during ECG analysis, the impedance at
one of the defib pads reaches an inadmis-
sible value, the message "Check the elec-
trodes" will appear and the device sus-
pends the analysis. The analysis contin-
ues as soon as the high impedance is
eliminated.
The rest of the workflow is described in
steps:
step 1: The device requests initiation of the
ECG analysis with the button or
automatically initiates ECG analysis
(as configured).
•During the analysis, the message „Do not
touch the patient – analysing” is displayed.
The analysis takes approx. 10 seconds.
•From now on contact with the patient must be
avoided and the bystanders must be warned.
•The following operation depends on whether
the device identifies a shockable rhythm
(continue with steps 2 and 3 in that case) or
whether no shockable rhythm is identified
(continue with step 4).
step 2: The device detects ventricular fibrilla-
tion or ventricular tachycardia with a
rate above 180 B/min and automati-
cally starts charging the defib for the
first shock.
step 3: As soon as the defib is charged, it
prompts the user to trigger the shock
with the button.
After delivery of shock the device checks the
outcome of the defibrillation by running an auto-
matic analysis.
If the shock was not successful, the device
prompts the user to perform CPR (30 chest
compressions to every two breaths) for two
minutes (in Norway: for three minutes). After
these two (three) minutes, the device again
prompts the user to start ECG analysis.
Steps 2 and 3 will be repeated until a delivered
shock is successful. For the second and third
shock, the device will charge to the configured
energy levels. For all subsequent shocks it will
charge to the energy level of the third shock.

Defibrillation
FRED easy®
20
After a successful shock, step 4will follow.
step 4: The device prompts the user to per-
form CPR (30 chest compressions to
every two breaths) until the patient
starts breathing or until new instruc-
tions are given.
Warning
Patient Hazard In the treatment of children
only 15 chest compressions must be per-
formed to every two breaths.
Internal Safety Discharge
A safety circuit ensures that the stored defibrilla-
tion energy is discharged internally if the shock
cannot be delivered correctly. This situation
exists when
−a non-shockable rhythm is identified
−the shock is not delivered within 20 seconds
of defibrillator charging
−an electrode problem is identified
−the battery voltage is insufficient
−the device is defective
−the device is turned off.
Warning
Patient Hazard If the device behavior dif-
fers from the description given in this user
guide, the device is defective and must be
repaired.
Ending Therapy
•Turn off the device after therapy (push
button for approx. 3 seconds).
•Disconnect the electrode lead.
•Carefully peel the pads off the patient’s skin
(Figure 5-6).
•Discard the disposable pads immediately
after use to prevent that they are reused
(hospital waste).
Figure 5-6. Removing the defibrillation pads