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Art. no.: 2.511093 Rev.: a *2.

511093*

User Guide
EASY PULSE®
Sales and Service Information
SCHILLER has a worldwide sales and service centre network. Contact your nearest
SCHILLER subsidiary to obtain the address of your local distributor.
A comprehensive list of all distributors and subsidiaries is available on our website:
http://www.schiller.ch
Sales information can also be obtained from:
sales@schiller.ch

Manufacturer
SCHILLER AG Phone: +41 (0) 41 766 42 42
Altgasse 68 Fax: +41 (0) 41 761 08 80
CH-6341 Baar, Switzerland E-mail: sales@schiller.ch
Web: www.schiller.ch

The EASY PULSE bears the CE-0123 mark (Notified Body TÜV-SÜD Produkte Service GmbH, Rid-
lerstr. 65, 80339 Munich, Germany), indicating its compliance with the essential requirements of the
Annex I of the Medical Device Directive 93/42/EE regarding safety, functionality and labelling. The
requirements apply to patients, users and third persons who come into contact with this device within
the scope of its intended use.

Article no.: 2.511093 Rev.: a


Issue date: 19.08.16
Translation: DE version a
EASY PULSE User Guide

Contents
1 Safety Notes .............................................. 1
1.1 Responsibility of the User .................................................. 1
1.2 Organisational Measures ..................................................... 1
1.3 Intended Use ........................................................................ 1
1.4 Contraindication for use ...................................................... 2
1.5 Safety-Conscious Operation ............................................... 2
1.6 Operation with other Devices .............................................. 3
1.7 Maintenance.......................................................................... 3
1.8 Safety Symbols and Pictograms ......................................... 4
1.8.1 Symbols used in this document ......................................................... 4
1.8.2 Symbols used in different locations.................................................... 5
1.8.3 Symbols used on the device .............................................................. 6
1.8.4 Symbols used on the transport bag ................................................... 6
1.8.5 Symbols used on the battery.............................................................. 6
1.8.6 Symbols used on the battery charger ................................................ 7
1.9 Additional Terms .................................................................. 8
1.9.1 Terms of Warranty ............................................................................. 8

2 Components and Operation .................... 9


2.1 Design.................................................................................... 9
2.1.1 Applied parts ...................................................................................... 9
2.2 Accessories, options ......................................................... 10
2.3 Operating elements ............................................................ 11
2.3.1 EASY PULSE operating and display elements ................................ 11

3 Initial operation ....................................... 13


3.1 Mains and Battery Operation............................................. 13
3.1.1 Battery operation.............................................................................. 13
3.1.2 Connecting the device to the mains ................................................. 15
3.2 Switching off and disconnecting from mains .................. 17
3.2.1 Isolating the device from the mains supply ...................................... 17
3.2.2 Mains supply interruption ................................................................. 17
3.3 Ensuring Operational Readiness. ..................................... 17

4 Use on the Patient .................................. 18


Art. no.: 2.511093 Rev.: a

4.1 Instructions ........................................................................ 18


4.2 Safety notes ........................................................................ 18
4.3 Securing the device to the patient .................................... 19
4.4 Finishing the Therapy ........................................................ 20

Page 1
EASY PULSE

5 Maintenance ............................................21
5.1 Maintenance intervals ........................................................ 21
5.1.1 Maintenance interval table ............................................................... 21
5.2 Restoring Operational Readiness ..................................... 22
5.2.1 Removing the protective cap from the pressure pad ....................... 22
5.3 Functional test .................................................................... 23
5.3.1 Visual inspection of the device......................................................... 23
5.3.2 Battery charging state. ..................................................................... 23
5.3.3 Proper operation .............................................................................. 23
5.4 Maintenance interval for the battery ................................. 24
5.4.1 Battery disposal ............................................................................... 24
5.4.2 Disposal at the end of the device's useful life .................................. 24
5.5 Cleaning the casing and accessories............................... 25
5.5.1 Approved cleaning solutions ............................................................ 25
5.5.2 Approved washing powder............................................................... 25
5.5.3 Cleaning solutions that are not approved ........................................ 25
5.5.4 Notes on cleaning and disinfection .................................................. 26
5.6 Disinfection ......................................................................... 27
5.6.1 Approved disinfectants..................................................................... 27
5.6.2 Disinfectants that are not approved ................................................. 27
5.7 Inspection checklists ......................................................... 28
5.7.1 Every 12 months .............................................................................. 28
5.7.2 Lifed-item replacement every 2 years.............................................. 29
5.8 Error detection .................................................................... 30
5.8.1 Normal operating state..................................................................... 30
5.8.2 General Errors ................................................................................. 30
5.8.3 Error Indicators ................................................................................ 30
5.8.4 Measures to prevent electromagnetic interferences ........................ 31
5.8.5 Accessories and disposables........................................................... 32

6 EASY PULSE Charger ............................33


6.1 Battery charging options ................................................... 33

7 Technical Data ........................................34


7.1 System Data ........................................................................ 34
7.2 Safety standards................................................................. 35
7.3 Charging unit ...................................................................... 36

8 Index ........................................................37
Art. no.: 2.511093 Rev.: a

Page 2
Safety Notes 1
EASY PULSE User Guide Responsibility of the User 1.1

1 Safety Notes
1.1 Responsibility of the User
 The EASY PULSE must only be used for cardiopulmonary resuscitation by med-
ical personnel that has been trained on the device.
 Using this device to provide mechanical chest compressions must be weighed
against the patient's general condition.
 The responsibilities of the personnel for the operation and maintenance of the
device must be specified.
 Ensure that the personnel have read and understood this user guide, in particu-
lar this section Safety Notes.
 Damaged or missing components must be replaced immediately with original
parts.
 The device must be stored in a place inaccessible to children.
 The EASY PULSE is intended for use in an electromagnetic environment as
stated in the technical data (see Page 35). The operator or user must ensure that
the EASY PULSE is used in such an environment.

1.2 Organisational Measures


 Before using the device, ensure that a medical product representative has ex-
plained its functions as well as the safety requirements.
 For additional trainings, please contact your local SCHILLER representative. A
comprehensive list of all SCHILLER representatives can be found on the SCHIL-
LER website (www.schiller.ch).
 Keep this user guide in an accessible place for reference purposes. Make sure
that it is always complete and legible.
 The EASY PULSE is an emergency device and must be ready for use at any
time and in all situations. Ensure that the device is always equipped with two suf-
ficiently charged batteries and keep a spare battery on hand.
 If no charged battery is available, the device can be operated with an external
power supply unit if a mains connection is available.
 Observe the operating and maintenance instructions.

1.3 Intended Use


 The EASY PULSE is used to perform mechanical, multidirectional chest com-
pressions on patients suffering from acute cardiac arrest, which is defined as ab-
Art. no.: 2.511093 Rev.: a

sence of spontaneous breathing, lack of pulse and loss of consciousness.


 The EASY PULSE is used as a complement to manual chest compressions.
 The EASY PULSE may only be used in cases where a cardiac massage is nor-
mally indicated.
Important
As with manual chest compressions, the proper use of the EASY PULSE cannot
exclude the possibility of rib fractures or chest contusion, however, they bear no
proportion to the consequences of a cardiac arrest. Use over a long period can also
lead to skin irritation.
Refer to the ERC and AHA resuscitation protocols for additional information on the
proper performance of chest compressions.

Page 1
1 Safety Notes
1.4 Contraindication for use EASY PULSE

1.4 Contraindication for use


 The EASY PULSE must never be used without permanent supervision and vital
signs monitoring.
 The EASY PULSE must not be used in the following cases:
– if the device cannot be positionend and fastened properly on the torso because
the patient's chest circumference is smaller than 76 or larger than 135 cm and
the chest width is smaller than 22 or larger than 40 cm,
– female patients with artificial breast implants
– pregnant women
– if upper body trauma in the area of the strap and pressure pad is present.
 Do not use this device in potentially explosive areas or in the presence of flam-
mable gases such as anaesthetic agents.
 Do not use the EASY PULSE in or near magnetic resonance imaging equipment.
 Mains operation with the external medical-grade power supply unit is only pos-
sible in protected areas (IP20) and a public low-voltage power supply network
with a protective earth connection and not suitable for use in vehicles or air-
crafts.

1.5 Safety-Conscious Operation


 Ensure that the personnel have read and understood this user guide and in par-
ticular this section "Safety Notes".
 Switch off the device when no longer in use.
 Always store the device in the transport bag.
 Danger of electric shock! Immediately report any changes that impair safety (in-
cluding operating behaviour) to the responsible person.
 Before switching on the device, check that the casing and strap are not dam-
aged.
 Operating a device with a defective casing represents a danger for the patient
or the user! Therefore:
– immediately replace a damaged unit or damaged cables and connections.
 Only operate the device in accordance with the specified technical data.
 The device is compliant with IP33 and is therefore protected against insertion of
solid foreign bodies with a diameter of 2.5 mm and it is protected against spray-
ing water when the battery is inserted.

Art. no.: 2.511093 Rev.: a

Page 2
Safety Notes 1
EASY PULSE User Guide Operation with other Devices 1.6

1.6 Operation with other Devices


 Only use acessories and disposables recommended or supplied by SCHILLER.
The use of third-party accessories (including disposables) may result in injury,
inaccurate information and/or damage to the device.
 Ancillary equipment connected to the analogue and/or 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 electrical equipment).
Furthermore, all configurations shall comply with the valid version of the system
standard IEC/EN 60601-1. Everyone who connects additional equipment to the
signal input part or signal output part configures a medical system and is there-
fore responsible that the system complies with the requirements of the valid ver-
sion of the system standard IEC/EN 60601-1. If in doubt, contact the technical
service department or your local representative.
 It is safe to use this device simultaneously with other electrical stimulation equip-
ment.

 Portable communication devices, HF radios and devices labelled with the


symbol (non ionising electromagnetic radiation) can impair the proper function-
ing of this device (see Page 31).
 This device can safely be used for patients with a pacemaker fitted.
 This device is not designed for use in an MRI system.

1.7 Maintenance
 Electric shock hazard. Do not open the devie or accessories and do not perform
any modifications on the device. There are no serviceable parts inside. Servicing
may only be carried out by a qualified technician authorised by SCHILLER.
 Before cleaning, switch off the device 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 (see page Page 25).
 Do not, under any circumstances, immerse the device or cable assemblies in liq-
uid.
Art. no.: 2.511093 Rev.: a

Page 3
1 Safety Notes
1.8 Safety Symbols and Pictograms EASY PULSE

1.8 Safety Symbols and Pictograms


1.8.1 Symbols used in this document
The safety levels are classified according to ISO 3864-1. The following overview
shows the safety symbols and pictograms used in this user guide.

For a direct danger which could lead to severe personal injury or to death.

For a possibly dangerous situation, which could lead to serious bodily 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 chapter.

Note For possibly dangerous situations which could lead to damage to property or
system failure. Important or helpful user information.

Reference to other guidelines.

Art. no.: 2.511093 Rev.: a

Page 4
Safety Notes 1
EASY PULSE User Guide Safety Symbols and Pictograms 1.8

1.8.2 Symbols used in different locations

Manufacturer symbol, manufacturing date

Notified body of the CE certification (CE 0123; TÜV-SÜD Produkte Service GmbH)

Observe safety notes and accompanying documents!

Observe the user guide

Symbol for the type of voltage used (DC voltage)

Rechargable battery (Li-Po)

Symbol for the recognition of batteries as well as electrical and electronic equipment

This unit must be disposed of in a municipally approved collection point or recycling


centre.

Improper disposal harms the environment and human health due to the presence of
dangerous substances in electrical and electronic equipment.

The device/component can be recycled.


Art. no.: 2.511093 Rev.: a

Page 5
1 Safety Notes
1.8 Safety Symbols and Pictograms EASY PULSE

1.8.3 Symbols used on the device


BF symbol with defibrillation protection. The applied parts (pressure pad, slider,
straps with buckles) are isolated from the device and offer protection against elec-
trical shocks under consideration of the leakage current. Moreover, the device is de-
fibrillation-protected.

IP33 The device is protected against solid foreign bodies with a diameter of 2,5 mm,
and against spraying water.

Power supply indicator. For a detailed descroption, see Page 13.

Warnung Risk of hand injuries

Protective cap for the pressure pad. Risk of cross-contamination. Intended for single
use only.

1.8.4 Symbols used on the transport bag

Min./max. temperature for transport/storage

Min./max. atmospheric pressure for transport/storage

Min./max. atmospheric humidity for transport/storage

Keep dry

Fragile, handle with care

1.8.5 Symbols used on the battery


Art. no.: 2.511093 Rev.: a

Warning Danger of explosion and burns!


Do not incinerate, cut or crush the battery.

Batter operating temperature: -20...+40 °C

Page 6
Safety Notes 1
EASY PULSE User Guide Safety Symbols and Pictograms 1.8

1.8.6 Symbols used on the battery charger

The device is intended for indoor use only.

Complies with safety class III according to IEC 60335-1


Art. no.: 2.511093 Rev.: a

Page 7
1 Safety Notes
1.9 Additional Terms EASY PULSE

1.9 Additional Terms


1.9.1 Terms of Warranty
Your SCHILLER EASY PULSE is warranted (as of the date of purchase) against
defects in material and manufacture in accordance with the Standard Terms and
Conditions. Excluded from this warranty is damage resulting from negligence or
improper use. The warranty entitles to free replacement of the defective part. Any
liability for subsequent damage is excluded. The warranty is void if unauthorised or
unqualified persons attempt to make repairs.
In case of a defect, send the device to your local SCHILLER representative or
directly to the manufacturer. The manufacturer can only be held responsible for the
safety, reliability and performance of the device if:
• assembly operations, extensions, readjustments, modifications or repairs are car-
ried out by persons authorised by him, and
• the SCHILLER device and approved attached equipment is used in accordance
with the manufacturer's instructions, and
• the maintenance intervals as stated in section Maintenance are observed.
There are no express or implied warranties which extend beyond the warranties
hereinabove set forth. SCHILLER makes no warranty of merchantability or fitness for
a particular purpose with respect to the product or parts thereof.

Art. no.: 2.511093 Rev.: a

Page 8
Components and Operation 2
EASY PULSE User Guide Design 2.1

2 Components and Opera-


tion
SCHILLER’s EASY PULSE is a portable, battery-powered device that delivers high-
quality chest compressions automatically at a consistent rate and depth over a long
time span.
The EASY PULSE is such a simple device that a single person can operate it –
whether a paramedic or a lay rescuer.

Biocompatibility
The product parts and accessories described in this user guide that come into
contact with the patient when the device is used as intended, fulfil the
biocompatibility requirements of the applicable standards. If you have any questions
in this matter, please contact SCHILLER.

2.1 Design
Device Battery-operated hoist motor that drives the pressure pad.

Power supply Replaceable and rechargeable lithium polymer battery with a running time of approx.
45 minutes or:
• mains operation (100 - 240 VAC) with external medical-grade power supply unit
(48 VDC)
• Vehicle or aircraft power supply (12 to 48 VDC)

Fastening system • Straps with buckles and a slider (adjustable for chest circumference between 76
and 135 cm)

Charging unit Charger for 2 rechargeable lithium polymer batteries.


Slot 1 for fast charging in approx. 50 minutes; if two batteries are charged
simultaneously, normal charging time of approx. 2 h.

2.1.1 Applied parts


• Disposable protective cap for the pressure pad
• Covering foil slider
• Slider
• Straps with buckles
Art. no.: 2.511093 Rev.: a

Page 9
2 Components and Operation
2.2 Accessories, options EASY PULSE

2.2 Accessories, options


• Spare battery
• Disposable protective cap for the pressure pad
• Bellows

Art. no.: 2.511093 Rev.: a

Page 10
Components and Operation 2
EASY PULSE User Guide Operating elements 2.3

2.3 Operating elements


2.3.1 EASY PULSE operating and display elements

Battery
Battery capacity indicator

Keyboard and operating display Button to display battery


capacity

Battery release button


Connection for external power
supply (red socket)

and interface (black socket)


Strap with buckle

Buckle hook
External mains supply
Solid green light = device is switched on Strap with buckle

Battery operation LED


Solid green light = device switched on, battery OK
Flashing green light = replace battery
Flashing red light = battery empty
Solid red light = battery defective
Green LED = 30:2 activated

On/Off key for 30:2 mode


Art. no.: 2.511093 Rev.: a

Start / pause compressions

On/Off key

Fig. 2.1 EASY PULSE operating and display elements

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2 Components and Operation
2.3 Operating elements EASY PULSE

Transport safety straps with


clip buckles

Strap with buckle Slider Strap with buckle

Fig. 2.2 EASY PULSE slider with straps

Art. no.: 2.511093 Rev.: a

Page 12
Initial operation 3
EASY PULSE User Guide Mains and Battery Operation 3.1

3 Initial operation
 Electrical shock hazard. Do not operate the device if the earth connection is sus-
pect or if the power cord is damaged or suspected of being damaged.
 Carefully read the safety notes in section 1 before initial operation.
 Explosion hazard! This device is not intended for use in potentially explosive ar-
eas. Furthermore, it is not permitted to operate the EASY PULSE in an oxygen-
enriched environment or in the presence of flammable substances (fuel) or an-
aesthetics. Oxygenation in the vicinity of the EASY PULSE must be strictly
avoided.

3.1 Mains and Battery Operation


 Except for initial operation and functional testing, the device must not be
switched on before securing it to the patient, as otherwise there is a risk of inad-
vertently pressing key 2 while fastening the device.

3.1.1 Battery operation

The battery must only be recharged in the external battery charger (see section 6).

Battery check

1. Press the (P) key. The LEDs indicate the current charging level of the battery.
80 - 100 %
33 - 80 %
5 - 33 %
This check can be performed at any time, even when the battery is not in use.
P
Art. no.: 2.511093 Rev.: a

Page 13
3 Initial operation
3.1 Mains and Battery Operation EASY PULSE

Switching on the device in battery mode

 Risk of hand injuries! If the pressure pad is not in its initial position, it will retract
to its initial position when the device is switched on

1. Switch on the device using the On/Off key (1). This is signalled acoustically
(beep-beep). The device runs a self-test.
If the pressure pad is fully extended before switching on the device, it will retract
upon power up.
2. Check the battery LED.
3. Switch off the device using the On/Off key (1). All LEDs are off.

Battery LED:
Solid green LED = The device is switched on, battery OK
Flashing green LED =The device emits an acoustic signal, replace the battery.
Flashing red LED = The device cannot perform any compressions. Replace the bat-
tery.

Changing the battery

 The device must be switched off first before taking out the battery.

• If no spare battery is available, the device can be operated via the external power
supply unit.
Caution
The device is only protected against spraying water (IP33) if a battery is inserted.

1. Press the release button (A). Remove the battery and replace it with a fully
charged battery.
2. Insert the new battery in the battery compartment and press until it clicks in place.
Art. no.: 2.511093 Rev.: a

3. Switch on the device using the On/Off key.


4. Switch off the device using the On/Off key (1). All LEDs are off.

Page 14
Initial operation 3
EASY PULSE User Guide Mains and Battery Operation 3.1

3.1.2 Connecting the device to the mains

 Whenever possible, connect the device to the mains (100-240 VAC).


 Mains operation with the external medical-grade power supply unit is only pos-
sible in protected areas (IP20) and a public low-voltage power supply network
with a protective earth connection and not suitable for use in vehicles or air-
crafts.
 The external power supply unit must be connected in a way that makes easy dis-
connection from the mains possible.
 The power supply source must not be changed during use (CPR). If the mains
power supply is connected or interrupted during use, this can lead to an error
and the device might have to be restarted.
 To prevent this, press the Pause button before connecting or interrupting the
mains power supply.

 Plug the mains cable into the external power supply unit, then connect it to the
DC input mains (100 - 240 VAC). Connect the output connector of the power supply unit
(48 VDC) to the EASY PULSE, or
 directly connect the EASY PULSE to an external DC power source of a vehicle
power supply. When doing so, observe the following:
• The connection must only be performed by qualified personnel.
• The negative terminal of the vehicle power supply must be connected to the chas-
sis.
• The connecting cable needs to have a diameter of at least 2,5 mm2. All terminals
and plugs must be designed to withstand high currents. Only use the supplied con-
nection cable.
• The positive lead must be protected with a fuse.
• For aircrafts, battery operation is preferrable.
• Connection data can be found in section 7.1.
Fig. 3.1 Connecting the device to the
mains
Art. no.: 2.511093 Rev.: a

Page 15
3 Initial operation
3.1 Mains and Battery Operation EASY PULSE

Switching on and checking the device in mains operation

 Risk of hand injuries! If the pressure pad is not in its initial position, it will retract
to its initial position when the device is switched on.

1. Switch on the device using the On/Off key (1). This is signalled acoustically
External power supply LED (A) (beep-beep). The device runs a self-test.
If the pressure pad is fully extended before switching on the device, it will retract
upon power up.
2. Check the external power supply LED (A)
3. Switch off the device using the On/Off key (1). All LEDs are off.

Art. no.: 2.511093 Rev.: a

Page 16
Initial operation 3
EASY PULSE User Guide Switching off and disconnecting from mains 3.2

3.2 Switching off and disconnecting from mains


1. Press the On/Off key (1).
2. All LEDs are off.

3.2.1 Isolating the device from the mains supply


To isolate the device from the mains supply, unplug the connector of the external
power supply unit.

3.2.2 Mains supply interruption

If the power supply to the device is interrupted, the device switches automatically to
battery operation. The user settings are maintained.
 If the power supply is interrupted during use (CPR), this can lead to an error and
the device might have to be restarted.

3.3 Ensuring Operational Readiness.


• Do not expose the device to direct sunlight or extremely high or low temperatures.
The ambient temperature should lie between 0...40 °C. Lower or higher ambient
temperatures will have a negative impact on battery life.
• Ensure that the device is always equipped with a sufficiently charged battery and
keep a spare battery on hand.
• If no charged battery is available, the device can also be operated with an external
power supply unit if a mains connection is available.
• Make sure that the indicated maintenance intervals are observed and that the list-
ed maintenance steps are performed (see Page 21).

 Press the P key on the battery to check the current battery level.
80 - 100 % If the middle LED is lit and if additionally the battery LED on the device flashes red,
33 - 80 % the battery's limit temperature has been exceeded.
5 - 33 %

P
Art. no.: 2.511093 Rev.: a

Page 17
4 Use on the Patient
4.1 Instructions EASY PULSE

4 Use on the Patient


4.1 Instructions
Observe the following instructions for use to ensure successful and safe
cardiopulmonary resuscitation (CPR):

• It is absolutely necessary to continue with manual CPR until the EASY PULSE has
been prepared and lies ready for use beside the patient.
• If a defibrillator is available on site, start by applying the defibrillation electrodes to
the patient's chest to prevent the mechanical chest compressions from being inter-
rupted.
• If the device cannot be positioned correctly on the patient or if the patient has con-
traindications, immediately continue with manual CPR. Such cases include:
– the patient's chest width is too small, or the chest circumference is too small or
too large.
– female patients with artificial breast implants
– pregnant women
– if upper body trauma in the area of the strap and pressure pad.
• The pressure pad is correctly positioned when it is placed on the middle of the ster-
num
• Securing the EASY PULSE to the patient should be practiced beforehand to ensure
minimal CPR interruption.
• If gel, sunscreen or any other type of lotion has been applied to the patient's chest,
wipe it off with alcohol to prevent the device from slipping.

4.2 Safety notes


In addition to the instructions for use provided in section 4.1, the following
instructions must be strictly adhered to when using the EASY PULSE, otherwise
there is a risk that the patient will get injured.

 The user is committed to verify the prerequisites for the use of the mechanical
chest compression device by checking for lack of consciousness, lack of breath-
ing and lack of circulatory signs using the ABCD system (BLS algorithm).
 The device must only be used if the suspected cardiac arrest victim shows the
following symptoms:
– not responsive
– no respiration
– no pulse
 Should the patient spontaneously regain consciousness during the course of
treatment, immediately stop the chest compressions.
Art. no.: 2.511093 Rev.: a

 If the EASY PULSE is positioned incorrectly, there is an increased risk of injuries


to the chest or internal organs and compromised blood flow.
 To prevent the device from slipping during transport on a stretcher, always fas-
ten the transport safety straps.
 Incorrect heart rhythm analysis – If the defibrillator performs a heart rhythm anal-
ysis, the chest compressions must be interrupted by pressing the Pause key.
 Risk of skin damage! Do not operate the device without the protective cap for the
pressure pad in place.

Page 18
Use on the Patient 4
EASY PULSE User Guide Securing the device to the patient 4.3

4.3 Securing the device to the patient


• Read the instructions for use and safety requirements in section 4.1 first.
• The standard protocol is set to continuous compressions. To deliver breaths, acti-
vate the 30:2 compression-ventilation cycle (button 3).

1. Interrupt the manual chest compressions.


2. Slightly lift the patient on one side and slide the belt with the slider at armpit level
underneath the patient.
3. Slightly lift the patient's upper body and slide the belt with the slider lengthwise to
the armpits. The centre of the buckle must be aligned with the device's correct po-
sition relative to the sternum.
4. Place the device on the middle of the sternum in such a way that the pressure pad
is facing the sternum.
Note – Do not let electrode cables get caught between the strap and the device.
5. Attach the buckles to the hooks on either side of the EASY PULSE. Lengthen the
strap if it is too short.
Note
It is easiest to move the straps when the buckle is lying flat on the straps.

Fig. 4.1 Correct position

6. Pull the straps tight on both sides.

Note – Make sure that the strap and device don't move while tightening the strap. If
the EASY PULSE is positioned incorrectly, there is an increased risk of chest
injuries.

7. Switch the device on using the On/Off button (press and hold button 2 for two sec-
onds. Switch on is confirmed with two beeps.
8. Start the chest compressions by pressing the key 2 - PLAY/PAUSE.
9. Depending on the resuscitation protocol followed, the 30:2 compression-ventila-
tion cycle can be activated by pressing the key 3. The LED (30:2) lights up.
Art. no.: 2.511093 Rev.: a

After 30 compressions, the device will emit an acoustic signal (beep – beep) to
indicate that two rescue breaths should be given. After 3 seconds the device re-
sumes the compressions.

10. Permanently monitor the patient as well as the device's position during mechan-
ical chest compressions. In order to correctly position the device, press the Pause
button, loosen the straps, adjust the device and pull the straps tight again.

Page 19
4 Use on the Patient
4.4 Finishing the Therapy EASY PULSE

11. Before transporting the patient, apply the transport safety straps (1) arount the pa-
tient's neck and tighten them; this prevents the device from tilting or sliding during
transport on a stretcher.

1 1

Fig. 4.2 Transport safety straps

4.4 Finishing the Therapy


1. Press the Pause (2) button to retract the pressure pad into its initial position.
2. Switch the device off using the On/Off key (1).

3. Press the buckle upwards to loosen the straps.


4. Detach the buckles from the device.
5. Undo the transport safety straps and remove the device.
6. Only remove the slider if the patient's condition allows.
7. Carry out maintenance work as described in section 5.2.

Art. no.: 2.511093 Rev.: a

Fig. 4.3 Loosening the straps

Page 20
Maintenance 5
EASY PULSE User Guide Maintenance intervals 5.1

5 Maintenance
5.1 Maintenance intervals
Note
The device must be serviced on a regular basis. The test results must be recorded
and compared with the values in the accompanying documents.
Maintenance work not described in this section may only be performed by a qualified
technician authorised by SCHILLER.
The following table indicates the intervals and responsibilities of the maintenance
work required.

5.1.1 Maintenance interval table


Interval Maintenance Responsible
After each use • After use, ensure that the device is ready again for immediate use  User
(section 5.2.1).
• Visual inspection of the device and accessories (see section 5.3.1)
• Check that the batteries have enough capacity (section 3.1.1).
Every 6 months • Charge the spare battery  User
Every 12 months or • Inspection and functional test of the motor according to the instruc-  Technician authorised by
after 150 tions given in the service manual. SCHILLER
interventions
Art. no.: 2.511093 Rev.: a

Page 21
5 Maintenance
5.2 Restoring Operational Readiness EASY PULSE

5.2 Restoring Operational Readiness


Carry out the following steps after each use:
• Replace the protective cap on the pressure pad.
• Check the bellows for cracks and clean them, if necessary.
• Clean the device, slider with straps as well as accessories, see chapters 5.5 and
5.6.

5.2.1 Removing the protective cap from the pressure pad

 To exclude the risk of cross-contamination, replace the disposable protective


cap after every patient. Do not attempt to clean the protective cap.

In order to remove the protective cap from the pressure pad, activate the service
mode so that the pressure pad fully extends.

1. Press and hold keys 2 and 3 simultaneously, then press and hold key 1 for two
seconds. An acoustic signal confirms that the device is now in service mode.
1. Press simultaneously...

Risk of finger injuries – When button 2 is pressed, the pressure pad will be
extended or retracted. Keep your fingers away from the pressure pad mechanism!

2. Fully extend the pressure pad by pressing key 2 (PLAY/PAUSE).


...then press the On/Off key for 3. Switch the device off using the On/Off key. The pressure pad remains fully ex-
two seconds tended to allow the protective cap to be replaced and the pad/bellows to be
cleaned.
4. Replace the protective cap on the pressure pad and clean the bellows.
5. Switch the device on again by pressing button 1 so that the pressure pad retracts
to its original position.
6. Switch off the device.

Fig. 5.1 Service mode


Art. no.: 2.511093 Rev.: a

Page 22
Maintenance 5
EASY PULSE User Guide Functional test 5.3

5.3 Functional test


Functional checks
The following checks must be performed after each intervention. Enter the results in
the check list, see Page 28.

5.3.1 Visual inspection of the device


Inspect the device and accessories for the following.
 Sufficient number of all required disposables available?
 Device and battery casing undamaged?
 Slider, hooks and straps undamaged?
 Power connectors undamaged?
 Power supply unit including power cord available.

Important
Defective devices, damaged cables, heavily soiled and worn straps and damaged or
expired accessories must be replaced immediately.

5.3.2 Battery charging state.

 Press the button P both on the battery inserted in the device as well as on the re-
80 - 100 % placement battery to check the capacity.
33 - 80 % Charge the batteries using the batter charger provided, if necessary.
5 - 33 %

For more information on the battery capacity indicator and battery maintenance, see
sections 3.1.1 Page 13 and 5.4 Page 24.

5.3.3 Proper operation


1. Place the device on a CPR dummy.
2. Switch on the device.
3. Start the chest compressions.
4. Press the 30:2 mode key and carry out two cycles.
5. Switch off the device and charge the battery.
6. Store the device and its accessories in the carrying case.
Art. no.: 2.511093 Rev.: a

Page 23
5 Maintenance
5.4 Maintenance interval for the battery EASY PULSE

5.4 Maintenance interval for the battery


• Replace the lithium polymer battery every 2 years (or after 200 typical charge/dis-
charge cycles (i.e. not full charge/discharge cycles)).
• Operating and storing the battery outside of the temperature range of 15 to 25 °C
can reduce battery life.
• If the battery's running time falls significantly below 35 minutes, the battery must
be replaced.
• Replace the battery in any case every 2 years at the latest, even if it has not been
used.
• The battery is maintenance-free during its normal life.
• Only store fully charged batteries. If a battery is not used, recharge it every 6
months.

5.4.1 Battery disposal

The battery must be disposed of in municipally approved areas or sent back to


SCHILLER.
 Explosion hazard! The battery must not be burned or disposed of in domestic
waste.
 Acid burn hazard! Do not open the battery.
 Do not short-circuit the battery.

5.4.2 Disposal at the end of the device's useful life

Once the device has reached the end of its useful life, it must be collected separately
and disposed of in a municipally approved collection point or recycling centre.
If no such collection point or recycling centre is available, you can return the device
to your distributor or the manufacturer for proper disposal. In this way, you contribute
to the recycling and other forms of utilisation of old electrical and electronic
equipment.
Improper disposal harms the environment and human health due to the presence of
dangerous substances in electrical and electronic equipment.

Art. no.: 2.511093 Rev.: a

Page 24
Maintenance 5
EASY PULSE User Guide Cleaning the casing and accessories 5.5

5.5 Cleaning the casing and accessories


 Switch the device off before cleaning and disconnect it from the mains by remov-
ing the plug. Do not, under any circumstances, immerse the device in cleaning
liquid and do not sterilise it with hot water, steam or air.

 Do not autoclave the device and accessories.


 Do not immerse the device in liquid.
 The use of detergents with a high acid content or that are otherwise unsuitable
can damage the device (i.e. cracks and wear of the plastic casing).
 Always follow the diluting instructions provided by the manufacturer of the clean-
ing solution.
 Never use any of the following solutions or similar products to clean the equip-
ment: ethyl alcohol, acetone, hexane, abrasive or scouring powder or material,
any cleaning material that damages plastic.
 When cleaning, ensure that all labels and safety statements, whether etched,
printed or stuck to the device, remain in place and remain readable.

Thoroughly inspect the device and the accessories before cleaning.


• Look for any signs of damage and make sure that the keys and connectors work
correctly.
• Gently bend and flex cables, inspecting them for damage or extreme wear, ex-
posed wires, and bent connectors.
• Confirm that all connectors engage securely.

5.5.1 Approved cleaning solutions


• 50 % isopropyl alcohol
• neutral, mild detergent
• all products designed for cleaning plastic.

5.5.2 Approved washing powder


The straps can be washed using a commercially available heavy-duty washing
powder at 40 °C for synthetic fibres (polyamide). Use a laundry bag.

5.5.3 Cleaning solutions that are not approved


Never use products containing the following:

• Ethyl alcohol
• Acetone
• Hexane
Art. no.: 2.511093 Rev.: a

• Abrasive cleaning powder


• Plastic-dissolving products

Page 25
5 Maintenance
5.5 Cleaning the casing and accessories EASY PULSE

5.5.4 Notes on cleaning and disinfection

Casing/Slider The casing of the EASY PULSE can only be cleaned on the surface with a slightly
moistened (not wet) cloth. If necessary, a domestic non-caustic cleaner or a 50 %
alcohol solution can be used to remove grease stains and finger prints. Wipe the
equipment with a cloth slightly moistened (not wet) with one of the approved cleaning
solutions listed below.
Thoroughly wipe off any excess cleaning solution. Make sure that no cleaning
solution runs into or accumulates in connector openings or gaps. If liquid gets into
connectors, dry the area with warm air and check that the device operates properly.

Straps Remove heavy soiling (blod, vomit) as quickly as possible, make sure it does not dry!
If this is not sufficient, all straps (without buckles and fasteners) can be washed in
the washing machine. When doing so, observe the following instructions:

• Do not use bleach


• Do not iron
• Do not tumble dry
• Do not spin dry

• Observe the following when washing:


– Temperature: 40 °C.
– Select 'gentle cycle‘.
– Use a mild washing powder.
– Do not use fabric softeners, textile deodorants or any other additives - these
solutions may leave residues and damage the material.
– Leave to air-dry.

• Prepare the straps:


– Remove the metal buckles and fasteners
– Place the straps in a laundry bag.

Disinfection
• Disinfect by wiping the straps with an approved hospital-grade disinfectant.
• Use approved disinfecting washing powder (40 °C) for the washing machine.

As with any other textiles, frequent washing wears the straps out. Replace the straps
as soon as you discover damages to the fabric.

Art. no.: 2.511093 Rev.: a

Page 26
Maintenance 5
EASY PULSE User Guide Disinfection 5.6

5.6 Disinfection
Disinfection removes certain bacteria and viruses. Please refer to the manufacturer's
information. Use commercially available disinfectants intended for clinics, hospitals
and medical practices.
Disinfect the device in the same way as described for cleaning the device (previous
page).

5.6.1 Approved disinfectants


• Isopropyl alcohol 50 %
• Propanol (35 %)
• Aldehyde (2-4 %)
• Ethanol (50 %)
• all products that are suitable for sensitive surfaces, such as:
– Bacillol® 30 foam/ Bacillol® 30 Tissues
(10% Propanol-1, 15 % Propanol-2, 20 % Ethanol)
– Mikrozid® AF (25 % Ethanol, 35 % 1Propanol-1)

Washing machine Eltra 40 for the straps

5.6.2 Disinfectants that are not approved


Never use products containing the following:

• Organic solvents
• Ammonia-based detergent
• Abrasive cleaning agents
• 100 % alcohol
• Conductive solution
• Solutions or products with the following ingredients:
– Acetone
– Quaternary ammonium compound
– Betadine
– Chlorine, wax or wax compound
– Ketone
– Sodium salt
Using these products or products containing similar active components can cause
discolouration of the product, corrosion of metal parts, reduction of the product life,
device errors, and may render the warranty invalid.
Art. no.: 2.511093 Rev.: a

Page 27
5 Maintenance
5.7 Inspection checklists EASY PULSE

5.7 Inspection checklists


The following checklists should be copied and used when carrying out maintenance
work in accordance with the maintenance schedule detailed previously.
Functional checks
The following tests (sections 11.2.1 to 11.2.6) need to be performed before or after
each intervention, respectively. Enter the results in the check list.
• Visual inspection of the device and accessories (section 5.3.1).
– Sufficient number of all required disposables available?
– Device housing undamaged?
– Power connectors undamaged?
– Check the expiration date on the battery
• Battery charging state (section 5.3.2).
• Funcional test (section 5.3.3))
Year Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Jan.
Feb.
March
April.
May
June
July
Aug.
Sept.
Oct.
Nov.
Dec.

5.7.1 Every 12 months


Maintenance step Results Maintenance step
Functional and safety checks
 Confirm the date of the last facto-
ry inspection and tests • Return the device to your nearest     
SCHILLER representative for
functional and safety checks.
Date of inspection:
Art. no.: 2.511093 Rev.: a

Inspector:

Page 28
Maintenance 5
EASY PULSE User Guide Inspection checklists 5.7

5.7.2 Lifed-item replacement every 2 years


Maintenance step Results Replacement
Batteries
 Replace the battery • Replace the battery:
– if the running time falls signifi-
    
cantly below 35 minutes
– in any case after 2 years, even
if not used (see expiration
date)     

Date of replacement:
Inspector:
Art. no.: 2.511093 Rev.: a

Page 29
5 Maintenance
5.8 Error detection EASY PULSE

5.8 Error detection


 If you cannot return the device to an operable state within a reasonable amount
of time, remove the device and continue performing manual cardiopulmonary re-
suscitation.

5.8.1 Normal operating state


Operating state Indicator Remedy
Device connected to exter- • LED A lights up green
nal power supply
A B C
Device operated by battery • LED B lights up green
30:2 mode • LED C lights up green
• Single, long beep tone upon acti-
Service mode vation of the mode

5.8.2 General Errors


Error Cause Remedy
• Battery not inserted correctly or  Insert the battery correctly or replace it
defective
LED is not lit when the de-
• Battery empty  Insert a charged battery or connect the device to the
vice is switched on
mains
• Device defective  Replace the device
• Battery too hot  If possible, let the battery cool down. Once its tempera-
Battery is not charging ture has reached an acceptable level, charging will re-
sume.

5.8.3 Error Indicators


Error Indicator Remedy
Low battery capacity, device • LED B is flashing and a beep is  Battery needs replacing
will only operate for a short emitted every two seconds  Connect the device to an external power supply
time
Discharged battery, the de- • LED B lights up red  Battery needs replacing
vice switches itself off auto-  Connect the device to an external power supply
matically
• LED B lights up red  Battery needs replacing
Battery failure
 Connect the device to an external power supply
• LED B lights up red  Test: press button P on the battery
Art. no.: 2.511093 Rev.: a

 If the middle LED is lit:

Battery temperature below/ P


above the threshold

– Battery needs replacing


– Connect the device to an external power supply
• LED A is flashing red (when exter-  Switch off the device and start it up again. If the device
nal power supply is used), or does not work, immediately continue with manual CPR.
Device error
• LED B is flashin red (when the de-  Send the device to your nearest service centre for in-
vice is battery-operated) spection

Page 30
Maintenance 5
EASY PULSE User Guide Error detection 5.8

5.8.4 Measures to prevent electromagnetic interferences


The user can help avoid electromagnetic disturbances by keeping the
recommendend minimum distance between portable and mobile HF
telecommunication devices (transmitters) and the EASY PULSE. The distance
depends on the output performance of the communication device as indicated below.
“Non ionising 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, servicing)
Mobile telephone system (rescue service, po-
81-470 100 11.7
lice, fire brigade)
RFID (active and passive transponders and 433 0.85
0.5
reading devices) 865-868 1.62

It can be deducted from the table that portable HF telecommunication devices must
not be used within a radius of 3 meters from the EASY PULSE and its cables.
For transmitters not included in the above table, the recommended distance (d in
meters) can be calculated using the following formulas

Frequency range Frequency range Frequency range


0.15 - 80 MHz 80 - 800 MHz 800 MHz - 2.5 GHz

3.5 12 23
d = -------  P d = -----------------  P d = -----------------  P
3V 10V/m 10V/m

d = recommended minimum distance in meters


P = transmitting power in watts

 There is no guarantee that interferences will not occur in a particular installation.


If the EASY PULSE causes interferences, these can be identified by switching
the device on/off.
Art. no.: 2.511093 Rev.: a

Measures to prevent electromagnet- The user can take the following measures to prevent electromagnetic interferences:
ic interferences • Increase the distance to the source of interference
• Turn the device to change the angle of radiation.
• Connect the device to a different mains connector.
• Only use original accessories (especially patient cables).

For a more detailed explanatins of IEC/EN 60601-1-2, consult the service manual.

Page 31
5 Maintenance
5.8 Error detection EASY PULSE

5.8.5 Accessories and disposables

 Always use SCHILLER spare parts and disposables or products approved by


SCHILLER. Failure to do so may endanger life and/or invalidate the warranty.

All EASY PULSE accessories and disposables are available from your local
SCHILLER representative. A comprehensive list of all SCHILLER representatives
can be found on the SCHILLER website (www.schiller.ch). In case of difficulty,
contact our head office in Switzerland. Our staff will be pleased to help process your
order or to provide information on all SCHILLER products.

Article no. Article description


Device
4.350049 Battery
2.200190 Charging unit
2.200123 Power supply unit for battery charger 100-240 VAC max. 2 A, 24 VDC,
6.25A
2.200124 Power supply unit for Easypuls 100-240 VAC max. 2.1 A, 48 V. 8.3 A
4.430235 Protective cap for the pressure pad
4.430234 Bellows
4.520775 Communication cable (for service purposes only)
2.156093 Transport bag
4.120175 Straps
2.100857 Complete slider, incl. straps and buckles

Art. no.: 2.511093 Rev.: a

Page 32
EASY PULSE Charger 6
EASY PULSE User Guide Battery charging options 6.1

6 EASY PULSE Charger


 Rechargeable, 4.3 Ah lithium polymer batteries are provided with the device. On-
ly use rechargeable batteries supplied by SCHILLER.
 We recommend that batteries be replaced every 200 charge/discharge cycles.
 This battery charger is not intended for domestic private use and has to be stored
in a place inaccessible to children.

6.1 Battery charging options


The battery can be charged as follows:
• Fast charging in slot 1 within approx. 50 minutes
• Normal charging of two batteries simultaneously in slots 1 & 2 within approx. 2 h.
• Inserting a battery

Operating status LED Battery slot 1 & 2

Battery slot 1 & 2

LED Function
LEDs are flashing: battery charger connected to mains and
ready for use

Fast charging (50 min) only in slot 1.

LEDs are flashing: normal charging speed with two batteries


Art. no.: 2.511093 Rev.: a

inserted

LEDs are lit: batteries are fully charged

LEDs are flashing slowly: battery defective

Page 33
7 Technical Data
7.1 System Data EASY PULSE

7 Technical Data
The technical data result from the standard test conditions.

7.1 System Data


Manufacturer SCHILLER AG

Device name EASY PULSE

Dimensions 180 x 220 x 150 mm (h x l x w)

Weight • Device incl. batteries: 3,5 kg


• Slider with straps: 0,3 kg

Protection class of casing IP33 (protected against solid foreign bodies with a diameter of 2.5 mm and
against spraying water at any angle up to 60° from the vertical)

Device power supply

• external power supply unit Medical grade switching power supply, protection class I
(Note: because the protective earth (PE) ends in the power supply, the protective
earth test does not need to be performed.)
Input 100 - 240 VAC, 47-63 Hz, max. 4.6- 2.3 A
Output 48 VDC, 8.34 A (400 W)

• Battery Mains-independent operation with a battery

• DC input 12 -48 VDC vehicle power supply (75 W mean/480 W peak)

Battery
Battery type Lithium polymer battery, 18,5 V, 4.0 Ah (5 cells with 3.7 V each)
Charging time 45 minutes with fast charging of one battery, 2 h with two batteries simultaneously
Battery life 200 charge/discharge cycles
Capacity 45 minutes of chest compressions
Note:
Operating and storing the battery outside of the temperature range of 15 to 25 °C
can reduce battery life.

Ambient conditions
Art. no.: 2.511093 Rev.: a

Operation (transient) • -201... 40 ºCat relative humidity of 0...95 % (non condensing)


– Atmospheric pressure 540...1060 hPa

• -10... 40 ºC, relative humidity of 10...95 % (non-condensing)


Transport
• 5... 40 ºC, relative humidity of 10...95 % (non-condensing)
Storage
Atmospheric pressure 540...1060 hPa

1.If previously stored at at least 5° C (see ambient conditions for storage)

Page 34
Technical Data 7
EASY PULSE User Guide Safety standards 7.2

Connectors USB interface for service purposes only.


Attention:
Only the communication cable and the corresponding service program by Schiller
AG may be used.

DCin 48 VDC from power supply unit 100...240 VAC

Straps with slider Adjustable using the buckles


Chest circumference of 76 to 135 cm, chest width of 22 to 40 cm

7.2 Safety standards


EMC • IEC/EN 60601-1-2
Electromagnetic environment HF transmission according to CISPR11
• Group 1
The device only uses HF energy for its internal functions. Therefore, HF emissions
are very low and interferences with electronic devices nearby are unlikely.
• Class B
The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power supply
network that supplies buildings used for domestic purposes.
The device can be exposed to the following interferences without any impairment:
• static discharge up to 8 kV contact, 16 kV air
• Energy in the radio frequency range up to 10 V/m (80...2500 MHz, 2 Hz/1 kHz
modulated)
• Magnetic fields of 20 A/m, 50/60 Hz

Conformity CE according to directive 93/42/EEC, class IIa

Protection class Class I according to IEC/EN 60601-1


Art. no.: 2.511093 Rev.: a

Page 35
7 Technical Data
7.3 Charging unit EASY PULSE

7.3 Charging unit


Device name EASY PULSE CHARGER

Dimensions 60 x 170 x 110 mm (h x l x w)

Weight 0.622 kg

Charger power supply 24 VDC 150 W

Power supply with: Medical grade switching power supply, protection class I
• external power supply unit (Note: because the protective earth (PE) ends in the power supply, the protective
earth test does not need to be performed.)
Input 100 - 240 VAC, 50-60 Hz, max. 2 A
Output 24 VDC, 6.25 A

Ambient conditions
Operation • 5... 40 ºCat relative humidity of 0...95 % (non condensing)

Transport • -10... 40 ºC, relative humidity of 10...95 % (non-condensing)


Storage • 5... 40 ºC, relative humidity of 10...95 % (non-condensing)

Protection class Class III according to IEC 60335-1

EMC/safety -marking

Art. no.: 2.511093 Rev.: a

Page 36
Index8
EASY PULSE User Guide

8 Index
A
Accessories and disposables ..................... 32

B
Battery
Disposal................................................. 24
Battery disposal .......................................... 24
Biocompatibility............................................. 9

C
Charging Unit CS-1
Input and Output Supplies ..................... 34
Cleaning ..................................................... 24

E
Error detection ............................................ 30
Explosion hazard ........................................ 13

F
Functional test ............................................ 24

L
LCD indicators ............................................ 13

M
Maintenance
Lifed item replacement .......................... 29
Maintenance interval battery ...................... 24
Maintenance intervals................................. 21

O
Operating elements .................................... 11

S
Safety Symbols............................................. 4
Symbols used on the battery ........................ 6
Art. no.: 2.511093 Rev.: a

Page 37
8

Page 38
Index
EASY PULSE

Art. no.: 2.511093 Rev.: a

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