Professional Documents
Culture Documents
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.
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
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
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.
Page 1
1 Safety Notes
1.4 Contraindication for use EASY PULSE
Page 2
Safety Notes 1
EASY PULSE User Guide Operation with other Devices 1.6
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
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.
Note For possibly dangerous situations which could lead to damage to property or
system failure. Important or helpful user information.
Page 4
Safety Notes 1
EASY PULSE User Guide Safety Symbols and Pictograms 1.8
Notified body of the CE certification (CE 0123; TÜV-SÜD Produkte Service GmbH)
Symbol for the recognition of batteries as well as electrical and electronic equipment
Improper disposal harms the environment and human health due to the presence of
dangerous substances in electrical and electronic equipment.
Page 5
1 Safety Notes
1.8 Safety Symbols and Pictograms EASY PULSE
IP33 The device is protected against solid foreign bodies with a diameter of 2,5 mm,
and against spraying water.
Protective cap for the pressure pad. Risk of cross-contamination. Intended for single
use only.
Keep dry
Page 6
Safety Notes 1
EASY PULSE User Guide Safety Symbols and Pictograms 1.8
Page 7
1 Safety Notes
1.9 Additional Terms EASY PULSE
Page 8
Components and Operation 2
EASY PULSE User Guide Design 2.1
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)
Page 9
2 Components and Operation
2.2 Accessories, options EASY PULSE
Page 10
Components and Operation 2
EASY PULSE User Guide Operating elements 2.3
Battery
Battery capacity indicator
Buckle hook
External mains supply
Solid green light = device is switched on Strap with buckle
On/Off key
Page 11
2 Components and Operation
2.3 Operating elements EASY PULSE
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.
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
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.
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
Page 14
Initial operation 3
EASY PULSE User Guide Mains and Battery Operation 3.1
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
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.
Page 16
Initial operation 3
EASY PULSE User Guide Switching off and disconnecting from mains 3.2
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.
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
• 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.
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
Page 18
Use on the Patient 4
EASY PULSE User Guide Securing the device to the patient 4.3
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
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.
Page 21
5 Maintenance
5.2 Restoring Operational Readiness EASY PULSE
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!
Page 22
Maintenance 5
EASY PULSE User Guide Functional test 5.3
Important
Defective devices, damaged cables, heavily soiled and worn straps and damaged or
expired accessories must be replaced immediately.
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.
Page 23
5 Maintenance
5.4 Maintenance interval for the battery EASY PULSE
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.
Page 24
Maintenance 5
EASY PULSE User Guide Cleaning the casing and accessories 5.5
• Ethyl alcohol
• Acetone
• Hexane
Art. no.: 2.511093 Rev.: a
Page 25
5 Maintenance
5.5 Cleaning the casing and accessories EASY PULSE
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:
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.
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).
• 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
Inspector:
Page 28
Maintenance 5
EASY PULSE User Guide Inspection checklists 5.7
Date of replacement:
Inspector:
Art. no.: 2.511093 Rev.: a
Page 29
5 Maintenance
5.8 Error detection EASY PULSE
Page 30
Maintenance 5
EASY PULSE User Guide Error detection 5.8
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
3.5 12 23
d = ------- P d = ----------------- P d = ----------------- P
3V 10V/m 10V/m
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
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.
Page 32
EASY PULSE Charger 6
EASY PULSE User Guide Battery charging options 6.1
LED Function
LEDs are flashing: battery charger connected to mains and
ready for use
inserted
Page 33
7 Technical Data
7.1 System Data EASY PULSE
7 Technical Data
The technical data result from the standard test conditions.
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)
• 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
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
Page 34
Technical Data 7
EASY PULSE User Guide Safety standards 7.2
Page 35
7 Technical Data
7.3 Charging unit EASY PULSE
Weight 0.622 kg
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)
EMC/safety -marking
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