Winncare A579-00 User manual
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Stackingpackagesweighingover60kg/m²isstrictlyprohibited,irrespectiveoftheirposition.
1. TRANSPORT CONDITIONS 2
2. STORAGE CONDITIONS 2
3. ASSEMBLY CONDITIONS 3
3.1. GENERAL DESCRIPTION 3
4. CONDITIONS FOR USE 3
4.1. FUNCTION 3
4.2. .ASSEMBLY OF WOODEN BARRIERS FOR JUNIOR BED A680-00 AND ADULT BEDS A579-/A580-00 AND A581-00 4
4.3. USE OF THE BARRIER 8
4.4. PRECAUTIONS FOR USE 10
4.5. RESIDUAL RISKS 10
5. MAINTENANCE CONDITIONS 10
5.1. IDENTIFICATION 10
5.2. UPKEEP 10
5.3. CLEANING 11
5.4. DISINFECTION 11
5.5. LIFETIME 11
5.6. WARRANTIES 11
6. CONDITIONS FOR SCRAPPING 11
Dear Sir/Madam,
You have acquired a WINNCARE medical accessory, and we thank you for your custom.
This class 1 medical device complies with Regulation (EU) 2017/745 relating to medical devices
They are tested in conformity with standard EN60601-2-52 (2010) in their commercialconfigurations, including
the boards and accessories that we manufacture, so as to ensure you maximum safety and performance.
As a result, maintenance of the contracted good’s warranty depends on compliance with the conditions for use
recommended by WINNCARE and the use of original accessories, which also guarantees you safe use of the
medical bed and its accessories.
1. TRANSPORT CONDITIONS
During transport, the side rails must be strapped and protected by plastic packaging.
NB: stacking packages on the side rails is strictly prohibited.
2. STORAGE CONDITIONS
The side rails must be stored at a room temperature of between -10°C and +50°C, and relative humidity of
between 30% and 75%.
Atmospheric pressure between 700hPa and 1060hPa under the same conditions as for transporting.
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3. ASSEMBLY CONDITIONS
3.1. General description
4. CONDITIONS FOR USE
4.1. Function
The side rails are designed to prevent patients from falling while asleep or being transported
BUT are not designed to prevent a patient from leaving his or her bed voluntarily. Many accidents happen
when the patient tries to leave his or her bed despite the side rails being in place.
In some cases, the side rails helps to prevent falls, BUT it can pose a hazard: injuries, falling after trapping a
limb in the side rails, suffocation after trapping the head, neck or chest. A risk/benefit assessment should
preferably be carried out of the side rails to decide whether or not to use it.
Observe the specified
environmental conditions
Cross beam
Sliding finger
High cross-beam guide
Low cross-beam guide
Adult bed : section 92x29 Lg 2012
Cross beam
Children bed : section 92x29 Lg 1712
Cross beam
High cross-beam guide
Cross beam
Low cross-beam guide
Sliding finger
Be sure to check the position of the panels and the correct sliding of the barrier.
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This assessment must take the following into account:
- the department’s surveillance capacities: A standardized protocol of the establishment for using the side
rails may be drawn up.
- the physical and mental condition of the patient: his/her needs, capacities, lucidity, size, agitation. This
assessment should be repeated at regular intervals.
4.2. .Assembly of wooden barriers for junior bed A680-00 and adult beds A579-/A580-00 and
A581-00
WINNCARE wooden barriers are designed to be used on all WINNCARE beds that have panels with recesses
needed for their assembly
The wooden barriers are designed to be used on WINNCARE beds with a bed frame length of 1,700 mm for
junior beds and 2,000 mm for adult beds that have panels with recesses needed for their assembly and that
are not equipped with bed frame extensions.
The barrier has been tested in accordance with the test method of standards NF EN 50637 and
NF EN 60601-2-52. These barriers must be combined with mattresses whose technical characteristics are
included in the bed’s instructions.
For installation of the wooden fence, refer to the attached installation instructions.
To facilitate the installation of the barrier, use the variable height of the bed up to a minimum height of 35 cm
between the ground and the underside of the foot or head panel.
Mini 35 cm
These barriers must be provided if specified in the medical prescription. The
benefit/risk ratio must be reassessed every 24 hours.
Barriers that go from the patient’s feet to their head are recommended for children
who have lost their autonomy.
INCOMPATIBLE SIDE BARRIERS CAN CREATE HAZARDS.
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Make sure that the high
cross-beam guide is
engaged in the correct
direction in the low cross-bar
guide.
The assembly is identical for all full length wooden
barriers and only
the barrier of the A680-00 junior bed is composed
of a low wood / metal cross member to respect the
standard spacings.
Respect the direction and the position of this
element.
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The element
composed of the wood
and metal bar is
always placed in the
lower part. The arrow
down and to the inside
of the bed
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4.3. Use of the barrier
➢To lower the side rail :
Take the upper bar and lift it up to its locking at the top of the panel.
Check if it is properly engaged.
➢To lower the side rail:
1) l Lift the upper bar
2) Press the locking buttons of each panel.
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1) Slide the barrier gently down the bed (make sure that no objects or parts of the patient's body or nursing
staff are in the operating area) until the stop is stopped . The upper bar comes to rest on the lower
metal / wood bar assembly.
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Positioning the side rails A579-00 / A580-00 / A581-00
poorly may undermine safety and cause a malfunction.
Side rails must not be used when patients are not adults or are 146 cm tall.
The user and staff must be trained and aware of the risks associated with using the bed. He
must not allow it by children and be vigilant when used by confused or disoriented people.
There must be at least 220 mm between the top of the side rail and uncompressed and no
therapeutic mattress surface. It will be advisable to tend towards this specification in the case
of the use of a therapeutic mattress.
Incorrect positioning of the A680-00 barriers can lead to safety hazards or malfunctions. These
barriers are used for children with a height of between 125 cm and 145 cm for the
“KALIN” junior medical bed.
4.4. Precautions for use
The side rails must beused by someone outside of the bed, who must ensure that nothing or nobody is situated
in the area in which the bed is being used.
Side rails are a medical device, and in this regard we inform you that it must not be modified under any
circumstances. You must ensure its traceability. If you assemble different types of medical devices, you are
responsible for conducting the risk analysis and making the CE declaration.
We recommend putting the bed in its low position after every use and while the patient is resting, to reduce the
height of falls by a confused or agitated person.
For assistance, if necessary, in mounting, operation or maintenance or to report unexpected operation or
events, call your supplier or Winncare.
4.5. Residual risks
DANGER
RESULT
REQUIREMENTS FOR THE USER
Trapping
Hands pinched
Handle barrier by the upper bar
Trapping
Crushing body or object
Check beforelowering the barrier that
the movement area is free
5. MAINTENANCE CONDITIONS
5.1. Identification
5.2. Upkeep
Manufacturer's address and
contact details
Warning
Complies with regulations (EU)
Product reference and name
Read the instruction manual
Product serial number
YY : Year of manufacture
MM : Month of manufacture
XXXXX :Internal numbering
PP : Product empty weight
Color code and designation
Medical device)
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A detailed examination must be carried out on the side rails at least once a year on such parts as : cross-beam
guides, cross-beams and unlocking fingers.
5.3. Cleaning
High pressure cleaning, machine cleaning, washing tunnel or jet cleaning is prohibited.
Clean the structure with soapy water and a soft cloth then rinse and wipe dry. All aggressive or scouring
products such as detergents, powders, solvents and bleach are prohibited.
5.4. Disinfection
Isolate the side rails in a disinfection room equipped with a particle filtering system and disposal for washing
the floors and walls after disinfection.
Use a disinfectant with bactericidal, fungicidal and virucidal properties, either by spraying it evenly onto
surfaces, applying it with a disposable cloth or spraying a disinfectant aerosol from a distance of 30 cm.
NB:
Comply with the precautions for using disinfectants indicated on these products.
Leavy to dry and protect the disinfected equipment from other equipment that has not been disinfected by a
film and a label indicating the disinfection date.
5.5. Lifetime
The lifetime under normal conditions of use and maintenance is 5 years for accessories, especially for wooden
side rails.
5.6. Warranties
➢All of our products carry a warranty against any manufacturing defect, provided the normal conditions
for use and maintenance are complied with.
➢Labour costs due to changes in structures or parts under warranty are not taken into account.
➢Please refer to the standard terms of sale for the specific terms of warranty for each product.
➢Every time you contact us for possible maintenance, you must quote us the information on the
identification label located under the cross-beam.
➢Original parts shall be supplied for replacement, within the term of warranty, by our customer sales
network determining the beginning of the term of warranty.
➢Defective parts must be returned to ensure proper application of this warranty and also to avoid any
invoicing.
6. CONDITIONS FOR SCRAPPING
➢The product must be scrapped if the main requirements are no longer met, particularly when the product
no longer has its original characteristics andhas not been subject to corrective action duringthe manufacturing
process.
➢Measures should therefore be taken to ensure that the product is no longer used for the purpose it was
originally intended.
➢When scrapping, the current environmental standards must be complied with.
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