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P100

Stryker P100 Operation And Maintenance Manual

P100 Powered Support Surface
2880
Operations/Maintenance Manual
2017/12 476004 - 5210 V1.5 www.stryker.com
Table of Contents
Symbols and Definitions.................................................................................4
Technical Specification..................................................................................6
Introduction............................................................................................7
Summary of Safety Precautions ..........................................................................9
Product Description ...................................................................................10
Instructions ...........................................................................................11
Cleaning and Disinfection ..............................................................................12
Troubleshooting .......................................................................................13
Service Information ....................................................................................14
Preventive Maintenance ................................................................................15
Appendix A: EMC Information ...........................................................................17
Warranty .............................................................................................20
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SYMBOLS
SN
Symbols and Definitions
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
Damp Wipe Only
Chlorinated Bleach: concentration less than or equal to 1000 ppm chlorinate or 70% alcohol
Do Not Tumble Dry
Do Not Dry Clean
Allow to Completely Air Dry
Manufacturer
Protected against solid foreign objects of 12,5 mm and greater; Protection against vertically falling water drops
Authorized representative in the European community
Catalogue Number (model)
Serial Number
Minimum inflation level of the mattress
Maximum inflation level of the mattress
CPR
Do Not Open with Cutter
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Introduction
WARNING/CAUTION/NOTE DEFINITION
The words WARNING, CAUTION and NOTE carry special meanings and should be carefully reviewed.
WARNING
Alerts 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
Alerts 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
Provides special information to make maintenance easier or important instructions clearer.
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Technical Specification
Item Specification
Power Supply AC230V 50Hz, 0.05A ( for 230V system )
Fuse Rating T1AL, 250V
Dimension (L x W x H) 25 x 12.5 x 8.5 cm / 9.8” x 4.9” x 3.3”
Weight 1.4 kg / 3.1 lbs
Cycle Time 8 min/60 Hz, 9.6 min/50 Hz
Atmospheric Pressure 700 hPa to 1013.25 hPa
• Operation: 10°C to 40°C (50°F to 104°F)
Temperature
Environment
Humidity
Classification
• Storage: -15°C to 50°C (5°F to 122°F)
• Shipping: -15°C to 70°C (5°F to 158°F)
• Operation: 10% to 90% non-condensing
• Storage: 10% to 90% non-condensing
• Shipping: 10% to 90% non-condensing
• Class II, Type BF, IP21
• Applied Part: Air Mattress
• Not suitable for use in the presence of a flammable anesthetic mix­ture (No AP or APG protection)
Air Mattress Specification
Model P100
Model Number 2880
Flame Retardant Standards EN 597-1 and EN 597-2
Safe Working Load 135 kg / 297 lbs
Dimension (L x W x H) 193 x 89 x 18 cm / 76”x 35” x 7.1”
Weight 5.75 kg / 12.7 lbs
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Introduction
This manual is designed to assist with the operation and maintenance of the P100 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 on the safe operation of the support surface.
CONTRAINDICATIONS
Air support therapy is not recommended when spinal stability is a concern. This support surface is not intended to support a patient in the prone position.
INTENDED USE OF PRODUCT
P100 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 patient’s weight over the surface and aid in the reduction of tissue interface pressure. It is recommended that the product be operated by personnel who are qualified 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 P100 is 135 kg /297 lbs; the patient must not exceed safe working load specified by the support surface, frame, and accessories. Patients shall meet the minimum age requirement of 2 years old.
P100 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. P100 has an expected service life of 2 years.
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Introduction
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. Also on the foam crib and air cell with stamp on it, to reference the serial number, unzip the cover about one foot to access the foam crib and air cell. The serial number is also located at the bottom casing of control unit.
▼
Figure 1
Format:
2880
M Y Y M M - S S S S S
Model Number Legend (X)
2880 P100
P100 Mattress
Foam and Air Cell
• M = Mattress
• YY = Year
• MM = Month
• SSSSS = Sequence (Numeric)
Month Legend (MM)
January 01
February 02
March 03
April 04
May 05
June 06
July 07
August 08
September 09
October 10
A
Year Legend (YY)
2012 12
2013 13
2014 14
2015 15
2016 16
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November 11
December 12
Summary of Safety Precautions
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 flammable 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 qualified 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 cord away from heated surfaces.
• Never block any air openings of this product or place it on soft surfaces, such as a bed or couch, where openings may be blocked. Keep the air opening free of lint, hair, and other similar particles.
• Never drop or insert any object into any opening or hose.
• 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 you may have had or are 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 siderails or other restraints. The safe use of the support surface is maximized when used in conjunction with siderails; there may be an increased risk of falls when siderails are not present. Local policies regarding the use of siderails should be taken into account. Whether and how to use siderails is a decision that should be based on each pa­tient’s individual needs and should be made by the physician, operators, and responsible parties.
• The risk of entrapment can develop when the support surface is placed on bed frames that leave gaps of even a few inches between the support surface and the headboard, footboard, and siderails. The support surface is NOT to be used when such gaps are present.
• When cleaning the support surface, ensure that no liquid is allowed to seep into the zipper area and watershed cover barrier (underside); fluids 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 compromise 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) between devices or turn off the mobile phone.
NOTE
The P100 support surface must be used with a mattress cover at all times. The support surface cover may interact with all external skin.
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CONTROL UNIT FRONT
Figure 2
◄
1. Power Switch On/Off
2. Front Panel
1
2
CONTROL UNIT REAR
Figure 3
◄
3 4
5
3. Hanger
4. Air Hose Port
5. Power Cord
P100
Product Description
Figure 4
◄
6. P100 Mattress
7. Foam and Air Cell
8. Air Hose
CONTROL PANEL
9 10
6
Figure 5
◄
9. Pressure Adjust Knob Pressure adjust knob controls the air pressure output. When turning clockwise, the output pressure will increase. Vice versa for decreasing air pressure. Please consult your care giver for a suitable setting.
10. Power Switch To turn on/off the control unit: a. Power ON/OFF Switch on side of unit. b. COMFORT CONTROL DIAL adjusts for patient comfort.
Soft(
Firm (
7
)—Minimum inflation level of the mattress
)—Maximum inflation level of the mattress.
8
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12
Instructions
1. Place control unit on flat surface or suspend control unit on end of bed using attached hooks. See Figure 2 and Figure 3. Remove the plug to disconnect the device.
2. Position the mattress on bed frame.
3. Connect the hose assembly between the mattress air cell and the control unit. Unscrew the cap from the air valve of the mattress and screw the adaptor from control unit onto the air valve tightly.
4. Plug the power cord and adjust the pressure control knob to highest setting for quick inflation and turn control unit on using green on/off switch. The unit will take approximately 40 minutes to inflate the mattress.
5. After installation, make sure the flap is not folding upwards to avoid fluid 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 and adjust the pressure control knob for patient comfort.
7. A Hand Check must be performed every 8 hours to verify proper operation of the device. See Figure 6.
8. To perform the Hand Check: With the patient on his or her back, slide hand, flat and palm up, between the overlay and the mattress. Hand should be directly under the air cell that is under the patient’s buttocks (or other bony area). See Figure 6.
Figure 6
▼
HAND CHECK
Properly inflated Under-inflated
Wait for full inflation of the air cell directly above hand. If the patient’s body is not in direct contact with hand, the system is operating correctly. If, during full inflation of air cell, the patient’s body is in direct contact with flat hand, the system is not operating properly. Adjust the pressure control to a higher setting. Wait 10 minutes and repeat the Hand Check. If the Hand Check fails, check that the hoses are not kinked or pinched. If repeated Hand Check fails and hoses are not kinked, contact Stryker for further instruction.
WARNING
Deflate before CPR or CPR could be ineffective.
To deflate mattress for CPR:
Disconnect the hoses from the control unit. See Figure 7. The air cell will deflate in approximately 20 seconds. Proceed with CPR procedures.
Figure 7
▼
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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, middle layer and bottom cover. Do not clean the foam. Do not use abrasive cleaners on the mattress. Note: Blood and other body fluids 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, middle layer 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.
• 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 and the middle layer of the cover 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 effects on the surface of the plastic case of the control unit, mattress cover and any other component of the device.
• When cleaning the support surface, ensure that no liquid is allowed to seep into the zipper area and watershed cover barrier (underside); fluids 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.
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.
Patient is bottoming out
Air cells fail to inflate
No air produced from some air outlets of the air tube connector
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.
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.
This is normal since there is alternating mode. Air outlets take turns to produce air during their cycle time.
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Service Information
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. Remove the air cell.
4. Unzip the middle layer at the patient’s right side and then remove the foam from the bottom part.
5. Discard the old cover.
6. Place the new cover, unzipped and open the top cover and middle layer.
7. Carefully slide the foam to the bottom part and zip the middle layer to close.
8. Carefully place the air cell on the top part and zip the cover to close.
9. 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 the top cover.
3. Remove and discard the old air cell.
4. Place the new air cell and zip the cover to close
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.
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.
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Preventive Maintenance
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. _______ Foam and other components have not degraded or come apart. _______ Check main power cord and do not plug if there is an abrasion or excessive wear. _______ Check airflow 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.
Product Serial Number:
Completed by: _____________________________________________ Date: _______________________
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Quick Reference Replacement Parts
The parts and accessories listed on this page are currently available for purchase. Some of the parts identified 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.
Part Name Part Number
P100 mattress cover assembly 2880-030-100
Air cell assembly 2880-030-400
P100 control unit 2880-030-500
Air hose, PVC, P100 2880-030-520
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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 specified below. The user of this device should make sure it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment-Guidance
RF emissions CISP R 11
RF emissions CISP R 11
Harmonic emissions IEC61000-3-2
Voltage fluctuations / Flicker emissions IEC61000-3-3
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 configuration in which it will be used.
2.Use of accessories, transducers and cables other than those specified 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 specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Group1
Class B
Class A
Complies
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
The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network
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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 specified below. The user of this device should make sure it is used in such an environment.
Basic EMC standard
Electrostatic Discharge (ESD) IEC61000-4-2
Electrical fast transient/ burst IEC61000-4-4
Immunity Test Levels Compliance HOME HEALTHCARE
Levels
ENVIRONMENT
±8kV contact ±15kV air
±2kV for power supply line ±1kV for input/output line
±8kV contact ±15kV air
±2kV for power supply line ±1kV for input/ output line
Electromagnetic Environment-Guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Mains power quality should be that of a typical commercial or hospital environment
Surge IEC61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11
Power frequency (50/60Hz) magnetic field IEC61000-4-8
Conducted RF IEC 61000-4-6
± 1 kV line(s) to line(s) ± 2 kV line(s) to earth
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
± 1 kV line(s) to line(s)
(1)
230V (U
)
T
Voltage Dips: i) 100% reduction for 0.5 period, ii) 100% reduction for 1 period, iii) 30% reduction for 25/30 period, Voltage
Mains power quality should be that of a typical commercial or hospital environment.
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.
Interruptions: 100% reduction for 250/300 period
30 A/m 30 A/m Power frequency magnetic fields should
be at levels characteristic of a typical location in a typical commercial or hospital environment.
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=√P 150kHz to 80MHz d=0.6√P 80MHz to 800MHz d=1.2√P 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 fixed 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
reflection from structures, objects and people NOTE 4: The ISM (industrial, scientific 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 fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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, field strengths should be less than 10 V/m.
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Warranty
LIMITED WARRANTY
Stryker Medical Division, a division of Stryker Corporation, warrants to the original purchaser P100 Powered Support Surface to be free from defects in material and workmanship for a period of one (1) 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 repaid 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 P100 Powered Support Surface 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 fitness 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, fire, flood, 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 defined 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, modified, or discontinued items not subject to return.
DAMAGED MERCHANDISE
ICC Regulations require that claims for damaged merchandise must be made with the carrier within fifth (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 notification, Stryker will file 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 fifteen (15) day 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 reflects U.S. domestic policy. Warranty outside the U.S. may vary by country. Please contact your local Stryker Medical representative for extra information.
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Stryker Medical 3800 E. Centre Avenue Portage, Michigan 49002 USA
Stryker European Operations B.V. Herikerbergweg 110 Amsterdam 1101 CM Netherlands
www.stryker.com
Support motorisé P100
2880
Manuel d’utilisation et d’entretien
2017/12 476004 - 5210 V1.5 www.stryker.com
Table des matières
Symboles et définitions .................................................................................4
Spécification technique .................................................................................6
Introduction............................................................................................7
La thérapie sur support à air n’est pas recommandée en cas de problèmes de stabilité rachidienne. Ce support
Résumé des consignes de sécurité .......................................................................9
Description du produit .................................................................................10
Instructions ...........................................................................................11
Nettoyage et désinfection ..............................................................................12
Résolution des problèmes..............................................................................13
Information relative à l’entretien .........................................................................14
Entretien préventif .....................................................................................15
Annexe A : Information relative à la compatibilité électromagnétique .........................................17
Garantie .............................................................................................20
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SYMBOLES
SN
Symboles et définitions
Marquage TUV
Marquage CE
Avertissement / Attention, se reporter à la documentation jointe
Appareil de type BF
Double isolation
Fusible
Limitation de température, fonctionnement : +10°C – +40°C, stockage : -15°C – +50°C
Limitation de l’humidité, 10 % – 90 %
Se reporter au manuel/livret d’instructions
Élimination : contactez votre distributeur local qui prendra les dispositions nécessaires conformément aux règles de votre marché national.
Ne pas repasser
Nettoyer uniquement avec un chiffon humide
Blanchiment au chlore : concentration en chlore inférieure ou égale à 1000 ppm ou 70 % en alcool
Ne pas sécher au sèche-linge
Ne pas nettoyer à sec
Laisser complètement sécher à l’air libre
Fabricant
Protégé contre les corps étrangers solides de 12,5 mm et plus ; protection contre les chutes de gouttes d’eau verticales
Représentant agréé dans la Communauté européenne
Numéro de référence (modèle)
Numéro de série
Niveau de gonflage minimum du matelas
Niveau de gonflage maximum du matelas
Réanimation cardio-respiratoire (RCR)
Ne pas ouvrir avec un couteau
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Introduction
DÉFINITION DES TERMES AVERTISSEMENT/ATTENTION/REMARQUE
Les termes AVERTISSEMENT, ATTENTION et REMARQUE ont une signification particulière et doivent faire l’objet d’une attention particulière..
AVERTISSEMENT
Avertit le lecteur d’une situation qui, si elle n’est pas évitée, pourrait avoir des conséquences mortelles ou entraîner des blessures graves. Il peut également décrire des effets indésirables potentiellement graves et des risques pour la sécurité.
ATTENTION
Avertit le lecteur d’une situation potentiellement dangereuse qui, si elle n’est pas évitée, peut entraîner des blessures légères ou modérées chez l’utilisateur ou le patient ou endommager l’équipement ou d’autres biens. Cela comprend le fait de veiller à utiliser l’appareil de manière efficace et en toute sécurité et de veiller à éviter les dommages qui peuvent se produire sur un appareil en raison de l’utilisation ou de la mauvaise utilisation qui en est faite.
REMARQUE
Fournit des informations spécifiques pour faciliter l’entretien ou clarifier des instructions importantes.
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Spécification technique
Dispositif de commande Spécification
Alimentation électrique CA 230 V 50 Hz, 0,05 A (pour une installation en 230 V)
Calibre du fusible T1AL, 250V
Dimensions (L x l x h) 25 x 12.5 x 8.5 cm
Poids 1,4 kg
Temps de cycle 8 min/60 Hz, 9.6 min/50 Hz
Environnementt
Classification
Pression atmosphérique
Température
Humidité
de 700 hPa à 1013,25 hPa
• Fonctionnement : de 10°C à 40°C
• Stockage de -15°C à 50°C
• Transport : de -15°C à 70°C
• Fonctionnement : de 10 % à 90 % sans condensation
• Stockage de 10 % à 90 % sans condensation
• Transport : de 10 % à 90 % sans condensation
• Classe II, Type BF, IP21
• Partie appliquée : Matelas à air
• Non approprié à une utilisation en présence d’un mélange anesthé­sique inflammable (pas de protection de type AP ou APG)
Matelas à air Spécification
Modèle P100
Numéro du modèle 2880
Normes ignifuges EN 597-1 et EN 597-2
Charge maximale d'utilisation 135 kg
Dimensions (L x l x h) 193 x 89 x 18 cm
Poids 5,75 kg
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6 476004- 5210 V1.5 www.stryker.com
Introduction
Ce manuel a été conçu pour aider à l’utilisation et à l’entretien du support motorisé P100. Veuillez lire attentivement ce manuel avant d’utiliser ou de commencer l’entretien du support. Pour assurer un fonctionnement en toute sécurité de cet équipement, il est recommandé d’établir des méthodes et procédures pour l’instruction et la formation du personnel concernant une utilisation en toute sécurité du support.
CONTRE-INDICATIONS
La thérapie sur support à air n’est pas recommandée en cas de problèmes de stabilité rachidienne. Ce support n’est pas prévu pour soutenir un patient couché sur le ventre.
UTILISATION PRÉVUE DU PRODUIT
P100 est un support motorisé à faible pression constante, conçu pour permettre une répartition de la pression afin d’aider à la prévention et au traitement des escarres de décubitus. Le système comprend un dispositif de commande associé à un matelas à cellules d’air à air alterné. Les cellules d’air répartissent le poids du patient sur toute la surface et aident à réduire la pression d’interface au niveau des tissus. Il est recommandé que le produit soit utilisé par du personnel qualifié pour effectuer des procédures générales de soins infirmiers et correctement formé en matière de prévention et de traitement des escarres de décubitus.
Ce support est destiné à être utilisé pour des patients humains dans un hôpital général, une maison de santé ou un environnement de soins à domicile, et pour des patients présentant des risques de développement d’escarres de décubitus, ainsi que pour ceux nécessitant une thérapie pour des escarres de décubitus préexistants. La charge maximale d’utilisation pour le support P100 est de 135 kg ; le patient ne doit pas dépasser la charge maximale d’utilisation spécifiée pour le support, le cadre et les accessoires. Les patients doivent être âgés au minimum de 2 ans.
P100 doit être à tout moment utilisé avec une housse de matelas.
Le support n’est pas conçu comme un produit stérile et n’est pas non plus destiné à inclure une fonction de mesure.
DURÉE DE VIE PRÉVUE
Les produits sont conçus pour offrir un fonctionnement fiable et en toute sécurité lorsqu’ils sont utilisés ou installés conformément aux instructions fournies par Stryker Medical. Stryker Medical recommande de confier l’inspection et l’entretien du système à des techniciens agréés en cas d’apparition de signes d’usures ou de problèmes concernant une fonction de l’appareil et une indication sur les produits. À part dans ces cas, les appareils ne devraient généralement pas nécessiter d’entretien ou d’inspection. La durée de vie prévue du support P100 est de 2 ansservice and inspection of the devices generally should not be required. P100 has an expected service life of 2 years.
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Introduction
NOUS CONTACTER
Contactez le service clientèle ou l’assistance technique de Stryker aux numéros suivants : +1 (800) 327-0770 or (269) 324-6500.
Stryker Medical 3800 E. Centre Avenue Portage, MI 49002 USA
Veuillez vous munir du numéro de série (A) de votre produit Stryker lorsque vous appelez le service clientèle ou l’assistance technique de Stryker. Indiquez le numéro de série dans toute communication écrite..
LOCALISATION/IDENTIFICATION DU NUMÉRO DE SÉRIE DU PRODUIT
Le numéro de série (A) est situé au niveau de la housse du matelas près du coin droit au pied du matelas, comme indiqué sur la Figure 1. Le numéro de série est également apposé sur la base en mousse et cellule d’air ; pour le consulter, ouvrez la fermeture éclair de la housse d’environ 30 cm pour accéder à la base en mousse et à la cellule d’air. Le numéro de série est également situé sur la partie inférieure du boîtier du dispositif de commande.
Matelas P100
Mousse et cellule d’air
▼
Figure 1
A
Format:
2880
M A A M M - S S S S S
Légende du numéro du modèle (X)
2880 P100
• M = Matelas
• AA = Année
• MM = Mois
• SSSSS = Séquence (Numérique)
Légende du mois
(MM)
Janvier 01
Février 02
Mars 03
Avril 04
Mai 05
Juin 06
Juillet 07
Août 08
Septembre 09
Octobre 10
Novembre 11
Légende de
l'année (AA)
2012 12
2013 13
2014 14
2015 15
2016 16
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8 476004- 5210 V1.5 www.stryker.com
Décembre 12
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