Stryker EOLE DC 32”, 2871, EOLE DC 35” Operation And Maintenance Manual

2017/12 836002-5210 V3.4 www.stryker.com
EOLE DC Powered Support Surface
2871
Operations/Maintenance Manual
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Symbols and Denitions................................................................ 4
Symbols ......................................................................... 4
Warning/Caution/Note Denition ...................................................... 5
Technical Specication................................................................. 6
Introduction.......................................................................... 7
Contraindications.................................................................. 7
Intended Use of Product ............................................................ 7
Expected Service Life .............................................................. 7
Product Description ................................................................ 7
Contact Information ................................................................ 7
Product Serial Number Location/Identication ........................................... 8
Summary of Safety Precautions.......................................................... 9
Product Description .................................................................. 10
Control Unit Front................................................................. 10
Control Unit Rear ................................................................. 10
Control Panel .................................................................... 10
Instructions ..........................................................................11
Installing the Control Unit............................................................11
Product Functions ................................................................ 12
Transport mode .................................................................. 13
Storage ........................................................................ 13
Cleaning and Disinfection.............................................................. 14
Troubleshooting ..................................................................... 15
Service Information .................................................................. 16
Top Cover Replacement ........................................................... 16
Air Cell Replacement .............................................................. 16
Control Unit Replacement .......................................................... 16
Hose Replacement ............................................................... 16
CPC Tube Replacement ........................................................... 16
Filter Replacement................................................................ 16
Preventive Maintenance............................................................... 17
Checklist ....................................................................... 17
Appendix A: EMC Information .......................................................... 19
Guidance and Manufacturer’s Declaration- Electromagnetic Emissions: ...................... 19
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity: ....................... 20
Warranty........................................................................... 22
Limited Warranty ................................................................. 22
To Obtain Parts and Service ........................................................ 22
Return Authorization .............................................................. 22
Damaged Merchandise ............................................................ 22
International warranty clause........................................................ 22
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Symbols and Denitions
SYMBOLS
TUV marking
CE marking
Warning / Caution, consult accompanying documentation
Type BF equipment
Double Insulation
Fuse
Temperature Limitation, Operating: 10°C to 40°C, Storage: -15°C to 50°C
Humidity Limitation, 10% - 90%
Refer to instruction manual/ booklet
Disposal: Contact local distributor who will take the necessary steps according to your national market.
Do Not Iron
Maximum washing temperature 60°C, normal process, only for top cover of mattress.
Chlorinated Bleach
Do Not Tumble Dry
Do Not Dry Clean
Allow to Completely Air Dry
Manufacturer
IP24
First Digit (Solids) Protected against touch by ngers (>12.5mm); Second Digit (Liquids) Water splashing against the enclosure from any direction shall have no harmful effect.
Authorized representative in the European community
Catalogue Number (model)
SN
Serial Number
CPR
Do Not Open with Cutter
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WARNING/CAUTION/NOTE DEFINITION
The words WARNING, CAUTION and NOTE carry special meanings and should be carefully reviewed.
WARNING
Alert the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards.
CAUTION
Alert the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. This includes special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse.
NOTE
Provide special information to make maintenance easier or important instructions clearer.
Symbols and Denitions
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Item Specication
Power Supply AC 230V, 50Hz, 0.07A Fuse Rating T1AL, 250V Dimension (L x W x H) 29.5 x 14.5 x 19.2 cm / 11.5” x 5.7” x 7.6” Weight 2.4 kg / 5.3 lb Cycle Time 12 minutes
Environment
Atmospheric Pressure
Operation: 70-106 hPa
Temperature
Operation: 10°C to 40°C (50°F to 104°F)
Storage: -15°C to 50°C (5°F to 122°F)
Shipping: -15°C to 70°C (5°F to 158°F)
Humidity
Operation: 10% to 90% non-condensing
Storage: 10% to 90% non-condensing
Shipping: 10% to 90% non-condensing
Classication
Class II, Type BF, IP24
Applied Part: Air Mattress
Not suitable for use in the presence of a ammable anesthetic
mixture (No AP or APG protection)
Air Mattress Specication
Model EOLE DC 32” (80cm) EOLE DC 35” (90cm) Model Number 2871 Flame Retardant Standards EN 597-1 and EN 597-2 Safe Working Load 200 kg / 441 lb
Dimension (L x W x H)
200 X 80 X 20 cm
78.74 X 32 X 7.84 inches
200 X 90 X 20 cm
78.74 X 35.43 X 7.84 inches
Weight 4.75 kg / 10.47 lb 5.45 kg / 12 lb
Technical Specication
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This manual is designed to assist with the operation and maintenance of the EOLE DC Powered Support Surface. Carefully read this manual thoroughly before using or beginning maintenance on the support surface. To ensure safe operation of this equipment, it is recommended that methods and procedures are established for educating and training staff.
CONTRAINDICATIONS
None known.
INTENDED USE OF PRODUCT
EOLE DC is a constant low pressure powered support surface intended to provide pressure redistribution to aid in the prevention and treatment of pressure ulcers. The system consists of a control unit combined with an alternating air cell mattress. The air cells redistribute the weight of the patient over the surface and aid in the reduction of tissue interface pressure. It is recommended that the product be operated by personnel who are qualied to perform general nursing procedures and have received adequate training in the prevention and treatment of pressure ulcers.
This support surface is intended to be used with human patients in a general hospital, nursing home or homecare environment and for patients at risk of developing pressure ulcers, as well as those who require therapy for pre- existing pressure ulcers. The safe working load for EOLE DC is 200 kg/ 441 lb; the patient must not exceed safe working load specied by the support surface, frame, and accessories. Patients shall meet the minimum age requirement of 2 years old.
EOLE DC shall be used with a mattress cover at all times.
The support surface is not intended to be a sterile product nor is it intended to include a measuring function.
EXPECTED SERVICE LIFE
The products are intended to offer safe and reliable operation when in use or installed according to the instructions provided by Stryker Medical. Stryker Medical recommends that the system be inspected and serviced by authorized technicians if there are any signs of wear or concerns with device function and indication on products. Otherwise, service and inspection of the devices generally should not be required. The control unit thereof has an expected service life of 3 years and the mattress thereof has an expected service life of 2 years.
PRODUCT DESCRIPTION
EOLE DC is powered support surface focusing on equalizing pressure and enhancing comfort.
Introduction
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CONTACT INFORMATION
Contact Stryker Customer Service or Technical Support at: (800) 327-0770 or (269) 324-6500.
Stryker Medical 3800 E. Centre Avenue Portage, MI 49002
USA
Please have the serial number (A) of your Stryker product available when calling Stryker Customer Service or Technical Support. Include the serial number in all written communication.
PRODUCT SERIAL NUMBER LOCATION/IDENTIFICATION
The serial number (A) is located at the mattress cover near foot right corner of the mattress as shown in Figure 1. To access the serial number, unzip the cover about one foot.
Figure 1
EOLE DC Mattress
Air CellCPR
A
Format:
2871
M Y Y M M - S S S S S
M = Mattress
YY = Year
MM = Month
SSSSS = Sequence (Numeric)
Model Number Legend (X)
2871 EOLE DC
Month Legend (MM) January 01 February 02 March 03 April 04 May 05 June 06 July 07 August 08 September 09
October 10 November 11 December 12
Year Legend (YY)
2014 14 2015 15 2016 16 2017 17 2018 18
Introduction
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WARNING
Check patient’s skin regularly. Consult physician if any redness or skin break occurs. Serious injury could result if the patient’s skin condition is left untreated.
Do not place the control unit in the patient’s bed, in contact with the patient, or under sheets or other coverings. Doing so could cause serious injury or could affect control unit performance.
Do not use in the presence of a ammable anesthetic mixture or with oxygen (O2) or nitrous oxide (N2O).
Verify bed side rails are compatible with bed frame and existing mattress. A risk assessment must be
performed by a suitably qualied person, especially when side rails are prescribed, to ensure that the bed meets the IEC 60601-2-52 bed standard.
Use with appropriate top sheet and minimize layers of bedding between patient and mattress.
Assess patient’s risk of entrapment according to protocols and monitor accordingly.
Close supervision is necessary when this product is used on or near children. Electrical burns or choking
may result from a child swallowing a small part detached from the device.
Use this product only for its intended use as described in this manual.
Do not operate product if the power cord or plug has been damaged.
Keep the power cord away from heated surfaces.
Never block any air openings of this product or place it on soft surfaces, where openings may be blocked.
Keep the air opening free of lint, hair, and other similar particles.
Do not modify this equipment without the authorization of the manufacturer.
Mattress covers have passed skin sensitization and skin irritation tests. However, if you suspect that
the patient or caregiver you may have had or is having an allergic reaction, please consult a physician immediately.
The power cord to the Control Unit should be positioned to avoid a strangulation hazard and/or damage to the cord. Careful consideration is required when routing the power cable. It is recommended that plac­ing the cord under the bed frame and attaching it to an electrical outlet at the head of bed.
Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. The safe use of the support surface is maximized when used in conjunc­tion with side rails; there may be an increased risk of falls when side rails are not present. Local poli­cies regarding the use of side rails should be taken into account. Whether and how to use side rails is a decision that should be based on each patient’s individual needs and should be made by the physician, operators, and responsible parties.
When cleaning the support surface, ensure that no liquid is allowed to seep into the zipper area and watershed cover barrier (underside); uids allowed to come in contact with the zipper may leak into the support surface.
Do not expose the mattress to excessive moisture. Personal injury or equipment damage could occur.
The use of quaternaries containing glycol ethers and/or accelerated hydrogen peroxides may compro-
mise the cover integrity and legibility.
Be aware of devices or equipment placed on the top of the support surface. Damage to the surface may occur due to the weight of the equipment, heat generated by the equipment, or sharp edges on the equipment.
Do not put overlays or accessories inside the cover. Doing so may reduce pressure redistribution performance.
It is the responsibility of the caregiver team to evaluate the appropriate CPR protocol to be used with the surface.
If there is a possibility of electro-magnetic interference with mobile phones, please increase the distance (3.3m/10.8 feet) between devices or turn off the mobile phone.
Ensure the waterproof cap to the power switch is present and unbroken before use. Failure to do so could increase risk of electric shock.
Mattress contains metal snap buttons and delrin zippers and should not be exposed under X-rays entirely. Always use X-ray cassette during portable X-ray procedure.
NOTE
The EOLE DC support surface must be used with a mattress cover at all times. The support surface cover may interact with all external skin.
Summary of Safety Precautions
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CONTROL UNIT FRONT
2
1 3
Figure 2
1. Power Switch On/Off
2. Front Panel
3. Power Socket
CONTROL UNIT REAR
4
5
Figure 3
4. Hanger
5. CPC Connector
Figure 4
6. EOLE DC Mattress
7. Air Cell
8. Air Hose
9. CPR Strap
CONTROL PANEL
10 11 12 13 14 15
Figure 5
10. Lock/Unlock
11. Mode Selection
12. Comfort Level
13. Maxrm/Seat mode
14. Alarm
15. Mute
Product Description
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INSTALLING THE CONTROL UNIT
1. Place control unit on at surface or suspend control unit on end of bed using attached hooks. See Fig-
ure 2 and Figure 3. Remove the plug to disconnect the device. Do not position the equipment such that it is difcult to operate the disconnecting device.
2. Position the mattress on bed frame.
3. Connect the hose assembly between the mattress air cell and the control unit. Connect the adaptor
from control unit onto the air valve.
4. Plug the power cord and Maxrm/Seat mode will be inated automatically. Note: The unit will take
approximately 40 minutes to inate the mattress. Nurse can adjust the comfort level or mode with the patient on the initial stage.
5. After installation, make sure the ap is not folding upwards to avoid uid seeping through mattress
cover.
NOTE
Make sure the control unit is suitable for the local power voltage and frequency.
6. Position patient on the mattress.
WARNING
Deate before CPR or CPR could be ineffective.
To deate mattress for CPR:
When there is an emergency to perform CPR on the patient, quickly pull the CPR strap from the mattress to release air. The quick connector on the pump unit can be disconnected for even faster deation. The air cell will deate in approximately 15 seconds. Proceed with CPR procedures.
Resetting CPR:
After CPR, re-plug CPR and make sure the CPR plug is xed on the mattress.
Instructions
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PRODUCT FUNCTIONS
THERAPY
1. Maxrm / Seat mode When connected to the power for the rst time, the control unit automatically inates to maximum ination
and the indicator light of Maxrm/Seat comes on. This insures the control unit is able to reach its maximum operating pressure. Once the maximum pressure level is reached, the pump will automatically switch into alternating mode. User can also use this function as full mattress ination while ingress/egress the patient for better support. Nurse or professional operator can adjust the comfort level manually at the maxrm stage. On the alternating or static mode, nurse can operate the maxrm button to implement the maxrm or
return to the former stage.
a. Alternate mode
In Alternate therapy mode, the mattress system will alternate every 12 minutes. User can select for
best comfort.
b. Comfort level:
Press
and to adjust the pressure level for the patient’s comfort.
c. Static mode
Press THERAPY button to suspend alternating function, if needed. The pressure inside of air cells will be adjusted to the same softness. Press the THERAPY button again; it will switch back to alternating mode. Under the static mode, cell pressure level will be lowered compare to the same pressure level from alternating mode.
2. Alarm Mute
Press alarm mute to deactivate the alarm sound. If the problem continues, the alarm sounds again after 3 minutes.
a. Power Failure Alarm
During power failure situation, the Power Failure indicator will light on with sound. Upon power restoration, press the power switch to disable the audible and visual alarm and LED.
b. Low Pressure Alarm
The audible low pressure alarm is not active during initial mattress ination. The audible alarm will be active after approximately 50 minutes has elapsed from the time the unit has been turned on. If there is a loss of mattress pressure with the unit ON and the alarm switch activated, an alarm will sound and ash intermittently. In addition, the low pressure light will be illuminated.
c. Service Alarm
This feature will light during mechanical failure situation. User can notify the technician for repair.
3. Lock Patient or caregiver can hold the lock button 3 seconds to activate or deactivate lock mode. In lock mode,
Patient or caregiver can press Maxrm/Seat button for maximum ination. The panel of control unit will be lock automatically without any operation after 3 minutes.
Instructions
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TRANSPORT MODE
In case of power failure or transport: Disconnect the CPC connector and interconnect Male to Female part of the air hose connector to slow deation.
For transport purpose, interconnect Male to Female part of the air hose connector. When a “click” is felt or heard, the connection is completed and secured; then air from mattress is sealed off.
STORAGE
1. To quickly deate the mattress for storage, take off the CPR strap and the CPC connectors. It will make the air release quickly.
2. Lay the mattress out at and upsides down.
3. Fold in half and place the control unit inside.
4. Roll from the head end towards the foot end.
5. The power cord could be wrapped around the pump bumper on
the back of pump.
6. Place the whole system into the carrying bag.
Instructions
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Cleaning and Disinfection
The control unit housing, tubing, and mattress should be cleaned between patients.
To clean, use water and a clean cloth to wipe down the Control Unit, power cord, hoses, mattress top cover, and bottom cover. Do not use abrasive cleaners on the mattress. Note: Blood and other body uids must be thoroughly cleaned from all surfaces before applying disinfectants.
Apply disinfectants to the external surfaces of the control unit, hoses and mattress top cover, and bot­tom cover by wiping. Stryker recommends a chlorine-based solution with a concentration less than or equal to 1000 ppm or 70% alcohol twice a week.
To wash the top cover of mattress by washing machine with normal process under the temperature 60°C in 45 minutes.
It is not recommended to disinfect the internal parts of the mattress on a regular basis, but only as
needed for particular instance, the air cell could be wiped with a cloth and disinfectants as recommend­ed above.
Wipe down the mattress with a clean, dry cloth to remove any excess of disinfectant.
If other detergent or other cleaning agent is used, choose one that will not have adverse chemical ef-
fects on the surface of the plastic case of the control unit, mattress cover and any other component of the device.
When cleaning or disinfecting the support surface, ensure that no liquid is allowed to seep into the zip­per area and watershed cover barrier (underside); uids allowed to come in contact with the zipper may leak into the support surface.
Avoid dust and proximity to dusty areas.
All components should be air dried thoroughly before use.
The waterproof cap of power switch should be on the power switch.
Avoid using sharp tools on the waterproof cap over the power switch.
Please reply to your distributor if the cap is broken or missed off.
WARNING
Do not use phenolic based products for cleaning.
Do no dry the mattress in direct sunlight.
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Troubleshooting
Problem Solution
Loss of power Check if the plug is connected to mains.
Low pressure alarm noises
1. Check if the CPR is sealed.
2. Check if the air cell is broken.
3. Check if the connection tube is tightly secured.
4. Check if there is any leakage on air cells.
Patient is bottoming out
Pressure setting might be inadequate for the patient. Adjust comfort range 1 to 2 levels higher and wait for a few minutes for best comfort.
Air Mattress is not secure
1. Check if all the snap buttons or straps of mattress are all securely
fastened.
2. Check if the mattress is xed to the bed frame by elastic straps.
Air cells fail to inate
Make sure the air hose is not kinked, cracked, or split. Verify that the power switch is illuminated, signifying the control unit has power. Verify that the air hoses are fully inserted with a positive connection.
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TOP COVER REPLACEMENT
Tools Required: None Procedure:
1. Disconnect the hose assembly between the mattress air cell and control unit.
2. Unzip the top cover.
3. Discard the old cover.
4. Place the new cover.
5. Carefully zip the cover.
6. Verify proper operation of the unit before returning it to service.
AIR CELL REPLACEMENT
Tools Required: None Procedure:
1. Disconnect the hose assembly from the air valve of mattress.
2. Unzip 2-way zipper from either way to remove the top cover and remove the CPC tubes.
3. Remove and discard the old air cell.
4. Place the new air cell, connect the tubes and zip the cover to close.
5. Verify proper operation of the unit before returning it to service.
CONTROL UNIT REPLACEMENT
Tools Required: None Procedure:
1. Disconnect the plug from mains power and hose.
2. Discard the old control unit.
3. Place the new control unit and connect the plug to mains power and hose.
4. Verify proper operation of the unit before returning it to service.
HOSE REPLACEMENT
Tools Required: None Procedure:
1. Disconnect the hose from control unit and mattress.
2. Discard the old hose.
3. Connect the new hose to control unit and mattress.
4. Verify proper operation of the unit before returning it to service.
CPC TUBE REPLACEMENT
Tools Required: None Procedure:
1. Disconnect the tube from control unit and mattress.
2. Discard the old tube.
3. Connect the new tube to control unit and mattress.
4. Verify proper operation of the unit before returning it to service.
FILTER REPLACEMENT
Tools Required: None Procedure:
1. Discard the old lter.
2. Verify proper operation of the unit before returning it to service.
WARNING
Any replacement of non-authorized or wrong parts may cause the unpredictable risk rise. Please check the replaced part is suitable for Stryker Medical’s EOLE DC Powered Support Surface, Model 2871.
Service Information
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Preventative maintenance should be performed annually, at a minimum. A preventative maintenance program should be established for all Stryker Medical equipment. Preventative maintenance may need to be performed more frequently based on the usage level of the product.
CHECKLIST
_______ Cover zipper opens and closes properly and has no visible damage. _______ No tears, rips, holes, cracks, or other openings in the mattress cover. _______ Check labels for legibility, proper adherence, and integrity. _______ Support surface cover straps and snaps are intact and are not damaged. _______ Straps properly secure the support surface assembly to the crib. _______ Components have not degraded or come apart. _______ Check main power cord and do not plug if there is an abrasion or excessive wear. _______ Check airow from the air hose. _______ Check the air hose if there is kink or breaks _______ Verify proper operation of the unit before returning it to service. _______ Check the waterproof cap of power switch.
Preventive Maintenance
Product Serial Number:
Completed by: ___________________________________________ Date: _____________________
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The parts and accessories listed on this page are currently available for purchase. Some of the parts identied on the assembly drawing parts in this manual may not be individually available for purchase. Please call Stryker Customer service USA at 1-800-327-0770 for availability and pricing.
Product Part Number
EOLE DC POWERED SUPPORT SURFACE 32” (80cm) 2871-000-002 EOLE DC POWERED SUPPORT SURFACE 35” (90cm) 2871-000-001 EOLE DC Control Unit 2871-001-000
Service Part Name Part Number
Manual, EOLE DC 2871-009-001 Mattress, Top Cover 32” (80cm) 2871-019-006 Single Air Cell, Orange PU 32” (80cm) 2871-019-007 Single Air Cell, Clear 32” (80cm) 2871-019-008 Mattress, Top Cover 35” (90cm) 2871-002-000 Single Air Cell, Orange PU 35” (90cm) 2871-004-001 Single Air Cell, Clear 35” (90cm) 2871-004-002 Air hose, PVC, EOLE DC 2871-004-003 Plug, Replacement, QTY 1 2871-004-004 Manifold 2871-004-005 Pump, Button Overlay, EOLE DC 2871-001-001 Pump, Fuse 2870-001-002 Tube, CPC 2870-001-003 Pump, Compressor 2870-001-004 Air Filter 2870-001-005
Accessory Part Number
Pump, UK Plug 2870-019-001 Transport Bag 2870-019-002 Pump, FR Plug 2870-019-003
Quick Reference Replacement Parts
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Appendix A: EMC Information
GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC EMISSIONS:
This device is intended for use in the electromagnetic environment specied below. The user of this device should make sure it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment-Guidance
RF emissions CISPR 11
Group1
The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment
RF emissions CISPR 11
Class B
Harmonic emissions IEC61000-3-2
Class A
The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network
Voltage uctuations / Flicker emissions IEC61000-3-3
Complies
WARNING
1. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the conguration in which it will be used.
2.Use of accessories, transducers and cables other than those specied or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
3. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Pump, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Appendix A: EMC Information
GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC IMMUNITY:
This device is intended for use in the electromagnetic environment specied below. The user of this device should make sure it is used in such an environment.
Basic EMC standard
Immunity Test Levels Compliance
Levels
Electromagnetic Environment-Guidance
HOME HEALTHCARE ENVIRONMENT
Electrostatic Discharge (ESD) IEC61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/ burst IEC61000-4-4
±2kV for power supply line ±1kV for input/output line
±2kV for power supply line ±1kV for input/ output line
Mains power quality should be that of a typical commercial or hospital environment
Surge IEC61000-4-5
± 1 kV line(s) to line(s) ± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11
Voltage Dips: i) 100% reduction for 0.5 period, ii) 100% reduction for 1 period, iii) 30% reduction for 25/30 period, Voltage Interruptions: 100% reduction for 250/300 period
230V (UT)
(1)
Voltage Dips: i) 100% reduction for 0.5 period, ii) 100% reduction for 1 period, iii) 30% reduction for 25/30 period, Voltage Interruptions: 100% reduction
for 250/300
period
Mains power quality should be that of a typical commercial or hospital environment. If the user of this device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
Power frequency (50/60Hz) magnetic eld IEC61000-4-8
30 A/m 30 A/m Power frequency magnetic elds
should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Conducted RF IEC 61000-4-6
3 Vrms
0,15 MHz – 80 MHz 6 Vrms in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
(4)
6Vrms Portable and mobile RF
communications equipment should be used no closer to any part of this device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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Appendix A: EMC Information
Radiated RF EM Fields IEC61000-4-3
10 V/m 80 MHz to 2,7 GHz 80 % AM at 1 kHz
385-6000 MHz, 9-28V/m, 80% AM(1kHz) pulse mode and other modulation
10V/m
Recommended separation distance d= 150kHz to 80MHz d=0.6 80MHz to 800MHz d=1.2 800 MHz to 2.7G Hz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
b
Field strengths from xed RF transmitters, as determined by an electromagnetic site survey ,a should be less than the compliance level in each frequency ranged.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: UT is the a.c. mains voltage prior to the application of the test level NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people NOTE 4:The ISM (industrial, scientic and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bandsbetween 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz,
5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz,10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
a)Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones
and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 10 V/m.
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LIMITED WARRANTY
Stryker Medical Division, a division of Stryker Corporation, warrants to the original purchaser EOLE DC Powered Support Surface, Model 2871 to be free from defects in material and workmanship for a period of two (2) years for the support surface assembly and the control unit after date of delivery under normal use*. Stryker’s obligation under this warranty is expressly limited to supplying replacement parts and labor for, or replacing, at this option, any product which is, in the sole discretion of Stryker, found to be effective. If requested by Stryker, products or parts for which a warranty claim is made shall be returned to the factory. Any improper use or any alteration or repair by others in such manner as in Stryker’s judgment affects the product materially and adversely shall void this warranty. Any repair of Stryker products using parts not provided or authorized by Stryker shall void this warranty. No employee or representative of Stryker is authorized to change this warranty in any way.
CONDITIONS AND LIMITATIONS
Stryker Medical’s EOLE DC Powered Support Surface, Model 2871 is designed for an expected service life as listed below under normal use conditions, and with appropriate periodic maintenance as described in the operations/maintenance manual for each device. This statement constitutes Stryker’s entire warranty with respect to the aforesaid equipment. Stryker makes
no other warranty or representation, either expressed or implied, except as set forth herein. There is no warranty of merchantability and there are no warranties of tness for any particular purpose. in no event shall Stryker be liable here under for incidental or consequential damages arising from or in any manner related to sales or use of any such equipment. This warranty does not extend to, nor cover:
Normal wear and tear; or
Damage or product failure due to causes beyond Stryker’s control such as, but not limited to abuse,
theft, re, ood, wind , lightning, freezing, clogging of mattress pores due to tobacco smoke, unusual atmosphere conditions, material degradation due to exposure to moisture; or
Damage to support surface or support surface handles through the use of the support surface for pa­tient transfer or transport.
* Normal use is dened as normal hospital or facility usage. Damages arising from abnormal use such as those caused by needle punctures, burns, chemicals, negligent use or improper care or improper cleaning or staining resulting from it are exempt from warranty coverage.
TO OBTAIN PARTS AND SERVICE
Stryker products are supported by a nationwide network of dedicated Stryker Field Service Representatives. These representatives are factory trained, available locally, and carry a substantial spare parts inventory to minimize repair time. Simply call your local representative or call Stryker Customer Service USA at
1-800-327-0770.
RETURN AUTHORIZATION
Merchandise cannot be returned without approval from the Stryker Customer Service Department. An authorization number will be provided which must be printed on the returned merchandise. Stryker reserves the right to charge shipping and restocking fees on return merchandise. Special, modied, or discontinued
items not subject to return.
DAMAGED MERCHANDISE
ICC Regulations require that claims for damaged merchandise must be made with the carrier within fteen (15) days of receipt of merchandise. Do not accept damaged shipments unless such damage is noted on the delivery receipt at the time of receipt. Upon prompt notication, Stryker will le a freight claim with the appropriate carrier for damages incurred. Claim will be limited in amount to the actual replacement cost. In the event that this information is not received by Stryker within the fteen (15) days period following the delivery of the merchandise, or the damage was not noted on the delivery receipt at the time of receipt, the customer will be responsible for payment of the original invoice in full. Claims for any short shipment must be made within thirty (30) days of invoice.
INTERNATIONAL WARRANTY CLAUSE
This warranty reects U.S. domestic policy. Warranty outside the U.S. may vary by country. Please contact your local Stryker Medical representative for extra information.
Warranty
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Stryker Medical 3800 E. Centre Avenue Portage, Michigan 49002 USA
www.stryker.com
Stryker European Operations B.V. Herikerbergweg 110 Amsterdam 1101 CM Netherlands
2017/12 836002-5210 V3.4 www.stryker.com
Surface de soutien alimentée en DC EOLE
2871
Guide d'utilisation/de maintenance
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Sommaire
Symboles et dénitions ................................................................ 4
Symboles ........................................................................ 4
Avertissement/Attention/Remarque : Dénition........................................... 5
Spécications techniques............................................................... 6
Introduction.......................................................................... 7
Contre-indications ................................................................. 7
Utilisation prévue du produit ......................................................... 7
Durée de vie prévue................................................................ 7
Description du produit .............................................................. 7
Informations de contact ............................................................. 8
Emplacement du numéro de série du produit/Identication ................................. 8
Récapitulatif des précautions de sécurité .................................................. 9
Description du produit ................................................................ 10
Panneau avant de l'unité de commande ............................................... 10
Panneau arrière de l'unité de commande .............................................. 10
Panneau de commande............................................................ 10
Instructions ..........................................................................11
Installation de l'unité de commande....................................................11
Fonctionnalités du produit .......................................................... 12
Mode de transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Stockage ....................................................................... 13
Nettoyage et désinfection.............................................................. 14
Dépannage......................................................................... 15
Informations de maintenance ........................................................... 16
Remplacement du protège-matelas supérieur .......................................... 16
Remplacement de la cellule d'air ..................................................... 16
Remplacement de l'unité de commande ............................................... 16
Remplacement du tuyau ........................................................... 16
Remplacement du tube CPC ........................................................ 16
Remplacement du ltre ............................................................ 16
Maintenance préventive ............................................................... 17
Liste de contrôle.................................................................. 17
Annexe A : Information relative à la compatibilité électromagnétique . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Directive et déclaration du fabricant - Émissions électromagnétiques:........................ 19
Directive et déclaration du fabricant - Immunité électromagnétique:.......................... 20
Garantie ........................................................................... 22
Limite de garantie ................................................................ 22
Méthode d'obtention de pièces de rechange et de prestations de maintenance ................ 22
Autorisation de retour.............................................................. 22
Marchandise endommagée ......................................................... 22
Clause de garantie internationale .................................................... 22
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Symboles et dénitions
SYMBOLES
Marquage TÜV
Marquage CE
Avertissement/Attention : consulter la documentation fournie
Équipement BF
Isolation double
Fusible
Limites de température - De fonctionnement : 10 °C à 40 °C - De stockage : -15 °C à 50 °C
Limites d'humidité : 10 % - 90 %
Voir le manuel d'instructions
Mise au rebut : contacter le distributeur local, qui prendra les mesures nécessaires, en fonction du pays concerné.
Ne pas repasser
Température de lavage maximale : 60 °C, lavage normal (uniquement du protège-matelas).
Blanchiment chloré
Ne pas utiliser de sèche-linge
Ne pas nettoyer à sec
Laisser l'appareil sécher totalement à l'air
Fabricant
IP24
Premier chiffre (Solides) P ro t ec ti o n co nt r e l e c on t a ct av e c l es doi g ts (>12 , 5 m m) ; Deuxième chiffre (Liquides) Les éclaboussures d'eau sur le boîtier sont sans conséquence.
Représentant agréé au sein de la Communauté européenne
Numéro catalogue (modèle)
SN
Numéro de série
CPR
Ne pas ouvrir avec un cutter
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AVERTISSEMENT/ATTENTION/REMARQUE : DÉFINITION
Les termes AVERTISSEMENT, ATTENTION et REMARQUE ont des signications spéciques et une attention particulière doit y être apportée.
AVERTISSEMENT
Alerter le lecteur au sujet d'une situation qui, s'il n'était pas possible de l'éviter, risquerait d'entraîner des blessures graves, voire mortelles. Description de réactions indésirables potentielles et de risques de sécurité graves.
ATTENTION
Alerter le lecteur quant aux situations potentiellement dangereuses risquant d'entraîner des blessures légères à modérées de l'utilisateur ou du patient, ou encore d'endommager l'équipement ou d'autres dispositifs. Une attention particulière doit être apportée an d'utiliser l'équipement de façon sécurisée et efcace, et d'éviter d'endommager l'équipement suite à une mauvaise utilisation de ce dernier.
REMARQUE
Fournir des informations spéciques visant à faciliter la maintenance ou la compréhension des instructions importantes.
Symboles et dénitions
6 836002-5210 V3.4 www.stryker.com
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Article Spécication
Alimentation CA 230 V, 50 Hz, 0,07 A Calibre des fusibles T1AL, 250 V Dimensions (l x L x H) 29,5 x 14,5 x 19,2 cm Poids 2,4 kg Durée d'un cycle 12 minutes
Environnement
Pression atmosphérique
De fonctionnement : 70-106 hPa
Température
De fonctionnement : 10 °C à 40 °C
De stockage : -15 °C à 50 °C
D'expédition : -15 °C à 70 °C
Humidité
De fonctionnement : 10 % à 90 %, sans condensation
De stockage : 10 % à 90 %, sans condensation
D'expédition : 10 % à 90 %, sans condensation
Classication
Classe II, Type BF, IP24
Pièce : Matelas à air
Non adapté à une utilisation en présence d’un mélange de
produits anesthésiques inammables (absence de protection AP ou APG)
Matelas à air Spécication
Modèle EOLE DC 32” (80cm) EOLE DC 35” (90cm) Référence modèle 2871 Normes applicables aux produits
ignifuges
EN 597-1 et EN 597-2
Charge maximale 200 kg Dimensions (l x L x H) 200 X 80 X 20 cm 200 X 90 X 20 cm Poids 4,75 kg 5,45 kg
Spécications techniques
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