Winncare SAM Ergonom A649-00 User manual

2017_09_01 580175 Anglais
4 Le Pas du Château
85670 SAINT PAUL MONT PENIT
TEL : [phone]
FAX : [phone]
Email : [e-mail]
Site Internet : http://www.winncare.fr
USER’S MANUAL
Mobility Support Systems
A649-00 / A650-00
SAM Ergonom A647-00 / A648-00
SAM Ergonom plus A651-00 / A652-00 SAM Ergonom light
A628-00 / A629-00
SAM Ergonom light
A614-00 / A615-00
SAM Ergonom plus
A618-00 / A619-00
SAM Ergonom

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1. TRANSPORT CONDITIONS 3
2. STORAGE CONDITIONS 3
3. ASSEMBLY CONDITIONS 4
3.1. A SSEMBLING OF THE SIDERAILS A614-00/A615-00 A618-00/A619-00 A628-00/A629-00 5
3.2. A SSEMBLING OF THE SIDERAILS A64 -00/A648-00 A649-00/A650-00 A651-00/A652-00 6
4. CONDITIONS FOR USE
4.1. F UNCTION
4.2. U SE 8
4.3. P RECAUTIONS FOR USE 9
4.4. R ESIDUAL RISKS 9
5. MAINTENANCE CONDITIONS 9
5.1. I DENTIFICATION 9
5.2. U PKEEP 10
5.3. C LEANING 10
5.4. D ISINFECTION 10
5.4.1. O BJECTIVE 10
5.4.2. I NDICATION 10
5.4.3. E QUIPMENT 10
5.4.4. T ECHNIQUE 10
5.5. L IFETIME 11
5.6. W ARRANTIES 11
6. CONDITIONS FOR SCRAPPING 11

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Stackingpackagesweighingover60kg/m²isstrictlyprohibited,irrespectiveoftheirposition.
Dear Sir/Madam,
You have acquired a WINNCARE medical accessory, and we thank you for your custom.
Our medical support systems (MSSs) and their accessories are designed and manufactured in compliance with
the essential requirements applicable thereto of European Directives 2007/47/EC.
They are tested in conformity with standard EN 60601-2-52 (2010) in their commercial configurations,
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 boards and accessories, which also guarantees you safe
use of the medical MSS and its accessories.
1. TRANSPORT CONDITIONS
During transport, the mobility support system must be strapped and protected by plastic packaging.
NB: stacking packages on the mobility support systems is strictly prohibited.
2. STORAGE CONDITIONS
The mobility support system must be stored at a room temperature of between -10°C and +50°C, and relat ive
humidity of between 30% and 75%.
Atmospheric pressure between 700hPa and1060hPa under the same conditions as for transporting.

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3. ASSEMBLY CONDITIONS
Only WINNCARE beds listed below are compatible with SAMs :
Bed
reference
SAMs reference Bed reference SAMs reference
IAL1L* A614/A615-00 A618/A619-00
A628/A629-00 IEX1L A614/A615-00 A618/A619-00 A628/A629- 00
IAL2L* A614/A615-00 A618/A619-00
A628/A629-00 IEX2L A614/A615-00 A618/A619-00 A628/A629- 00
IAL3L* A614/A615-00 A618/A619-00
A628/A629-00 IEX3L A614/A615-00 A618/A619-00 A628/A629- 00
IAL4L* A614/A615-00 A618/A619-00
A628/A629-00 IEX4L A614/A615-00 A618/A619-00 A628/A629- 00
IAL5L / AL5* A647/A648-00 A649/A650-00
A651/A652-00 IEX5L A647/A648-00 A649/A650-00 A651/A652- 00
IXS1L A614/A615-00 A618/A619-00
A628/A629-00 IMS1L A614/A615-00 A618/A619-00 A628/A629- 00
IXS2L A614/A615-00 A618/A619-00
A628/A629-00 IMS2L A614/A615-00 A618/A619-00 A628/A629- 00
IXS3L A614/A615-00 A618/A619-00
A628/A629-00 IMS3L / MS3 A647/A648-00 A649/A650-00 A651/A652- 00
IXP1L A614/A615-00 A618/A619-00
A628/A629-00 IML1L A614/A615-00 A618/A619-00 A628/A629- 00
IXP2L A614/A615-00 A618/A619-00
A628/A629-00 IML2L / ML2 A647/A648-00 A649/A650-00 A651/A652- 00
IXP3L A614/A615-00 A618/A619-00
A628/A629-00 IAE1L A614/A615-00 A618/A619-00 A628/A629- 00
IXP4L A647/A648-00 A649/A650-00
A651/A652-00 IAE2L / AE2 A647/A648-00 A649/A650-00 A651/A652- 00
IXX1L A614/A615-00 A618/A619-00
A628/A629-00 IAE3L / AE3 A647/A648-00 A649/A650-00 A651/A652- 00
IXX2L A614/A615-00 A618/A619-00
A628/A629-00 IAF1L / AF1 A647/A648-00 A649/A650-00 A651/A652- 00
IXX3L A647/A648-00 A649/A650-00
A651/A652-00 IAF2L / AF2 A647/A648-00 A649/A650-00 A651/A652- 00
IXA1L / XA1 A647/A648-00 A649/A650-00
A651/A652-00 IAX1L / AX1 A647/A648-00 A649/A650-00 A651/A652- 00
IXB1L / XB1 A647/A648-00 A649/A650-00
A651/A652-00 IDO1L A614/A615-00 A618/A619-00 A628/A629- 00
IXL1L A614/A615-00 A618/A619-00
A628/A629-00 IDO2L A614/A615-00 A618/A619-00 A628/A629- 00
IXL2L A614/A615-00 A618/A619-00
A628/A629-00 IDO3L A614/A615-00 A618/A619-00 A628/A629- 00
IXL3L A614/A615-00 A618/A619-00
A628/A629-00 IDO4L A614/A615-00 A618/A619-00 A628/A629- 00
IXL4L A647/A648-00 A649/A650-00
A651/A652-00 IDO5L A647/A648-00 A649/A650-00 A651/A652- 00
IXN1L / XN1 A647/A648-00 A649/A650-00
A651/A652-00 IDO6L A647/A648-00 A649/A650-00 A651/A652- 00
IXO1L A614/A615-00 A618/A619-00
A628/A629-00 IDO7L A647/A648-00 A649/A650-00 A651/A652- 00
IXO2L A614/A615-00 A618/A619-00
A628/A629-00 IDO8L / DO8 A647/A648-00 A649/A650-00 A651/A652- 00
IXO3L / XO3 A647/A648-00 A649/A650-00
A651/A652-00
* ≥if height less than 240 mm
MSSs are delivered folded up.

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The mobility support system is intended to be used on 2,000 mm long WINNCARE beds with a square tube
frame of no more than 40 mm.
3.1. Assembling of the siderails A614-00/A615-00 A618-00/A619-00 A628-00/A629-00
The mobility support system is marked left and right by the grip jaws. Position the grip jaws as shown in the
diagrams below.
In order to assemble them on the bed, the longest section on the head end must be positioned by tightening
the two adjustment knobs under the grip jaws. Then unfold the last one towards the foot end and tighten the
knobs. Check that they are well locked.
Pole Support Bars
Loosening
Feet side
Head side
Tightening
4 cm space max
Feet side
Head side
Tighten the grip jaws
Tighten the grip jaws
Head side

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3.2. Assembling of the siderails A647-00/A648-00 A649-00/A650-00 A651-00/A652-00
Fixing jaw on the bed if it is not already installed, for this :
1
1
2
3
n°4
1 Remove the cap of the siderail by pushing inside or outside (depending on the assembly) then remove
it with a screwdriver if necessary.
2 Clip the jaw in the slots provided for this purpose, by positioning the nut on the inner side of the bed.
3 Screw the jaw with the screw and nut provided with an Allen wrench n°4.
Insert pole of the side rail in the jaw on the head side fixed on the bed until to hear the «CLIC»
Block the jaw on feet side through the clamping rondo and ensure its blocking.
To remove the siderail, loosen the rondo on the feet side then disengage the pole without removing it
by pulling the index finger on the side of the head side jaw . Take the side rail with one hand at each end
to remove it completely.
Feet side
Head side
4
4
5
5
5
4

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2
3
4
4. CONDITIONS FOR USE
4.1. Function
The mobility support system (S.A.M.) helps people to be independent.
The mobility support system is 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 mobility support system being in place.
In some cases, the mobility support system helps to prevent falls, BUT it can pose a hazard: injuries, falling
after trapping a limb in the mobility support system, suffocation after trapping the head, neck or chest. A
risk/benefit assessment should preferably be carried out of the mobility support system to decide whether or
not to use it.
This assessment must take the following into account:
- the department’s surveillance capacities: A standardized protocol of the establishment for using the mobility
support system 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.
To lower the mobility support system.
1Take hold of the half mobility support system by the top bar.
To lift the mobility support system.
1Take hold of the half mobility support system by the top bar and lift, making sure that the side handle is
folded over the pole.
Make sure that the barrier is locked properly by attempting to fold it without acting
on the unlocking finger
Pull on the locking buttons.

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4.2. Use
To sit, take the upper part of the handle of the SAM by the opposite hand and then bring the other hand to the
lower bar of the handle. A 'natural' movement causes the leg opposite the SAM to move towards the exit of the
bed when you pull toward you with your arms the handle of the SAM.
The turning handle is raised only when the barrier is
folded back. It allows the patient to remain during the
care of the caregiver.
The patient assisted by the caregiver catches the
handle (1) by the opposite hand and rotates the
pelvis (2) and thus maintains the vertical.
1
2

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Positioning the mobility support system poorly may undermine safety and cause a
malfunction. The mobility support system 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 thera
peutic mattress.
Only use original parts and accessories distributed by WINNCARE to guarantee safety and
maintain product conformity.
4.3. Precautions for use
Use of the mobility support system A614-00/0001, A615-00/00001, A647-00/0001 and A648-00/0001 is not
compatible with a bed base extension, panels Louis Philippe and does not allow for the use of accessory
holders under the bed base. On some XL and DUO beds 120/140/160, you may have to remove accessory
holders.
When stretching, fold the handle on the upright and make sure not to rub the side handle along vertical walls.
When the bedis placed in low position, ensure that nothing or no area of the patient’s orcarer’s bodyis between
the bed, boards, accessories and floor.
The mobility support system must be used 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.
The mobility support system is 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.
For assistance, if necessary, in mounting, operation or maintenance or to report unexpected operation or
events, call your supplier or Winncare.
4.4. Residual risks
DANGER
RESULT
REQUIREMENTS FOR THE USER
Trapping
Hands pinched
Handle barrier by the upper bar
Trapping Crushing body or object Check before lowering the barrier that
the
movement area is free
5. MAINTENANCE CONDITIONS
5.1. Identification
Address of
manufacturer
Refer to user’s manual
Warning
Serial number
Reference of product
CE marking
WINNCARE
MEDICATLANTIC
4 LE PAS DU CHATEAU ST PAUL MT PENIT.
85670 . FRANCE. [phone]
Ref
XXXXXXX
SN
FR03XXXX

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5.2. Upkeep
A detailed examination must be carried out on the mobility support system at least once a year on such parts
as: the adjustment Rondo screws, index pins, pins and rivets.
5.3. Cleaning
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
The Mobility Support System is a non-critical device justifying “Low-level” disinfection. We draw your
attention to the fact that the instructions below are given in compliance with good practice recommendations
but do not constitute protocol. Consult the hospital’s hygiene department.
5.4.1. Objective
Return the MSS to its original condition and prevent the transmission of germs from one patient to the next.
Get rid of any organic dirt through:
Mechanical action (cleaning)
Chemical action (disinfection)
5.4.2. Indication
Physical and bacteriological cleanliness of the MSS
5.4.3. Equipment
Microfibre wipes
Detergent or Detergent-Disinfectant (Surface DD°with CE marking and Surface Disinfectant) (Chlorinated
derivatives, alcohol base < 30%)
NB: DD products and bleach must not be used neat. Persistence time must be applied according to the
disinfectant manufacturer (drying time often equals the persistence time excluding human presence)
SANIVAP type steam device with accessories
5.4.4. Technique
-Daily upkeep using a surface DD product applied in one go.
-Upkeep once the patient leaves or periodically via the Bio cleaning process which involves 3
operations:
oCleaning is done using a cloth soaked in a detergent solution or surface Detergent-
Disinfectant (DD)
oRinsing is done using a cloth rinsed in clean water
oDisinfection is done using a cloth soaked in a surface disinfecting solution.
-Specific upkeep by the service providers once the MSS has been removed from the establishment.
oGet rid of the packaging after decontamination of the inside by DD solution spray
oBio cleaning process,or,
oSteam cleaning (accessory with microfibre strip) of the various flat surfaces and bed base
slats. Change washing mops at regular intervals to prevent any aqueous build-up. Clean any
parts that are difficult to access (casters, joints once they are open, corners, etc.) using a
steam nozzle. For the tubes, use the steam nozzle with a microfibre cloth. Do not point the
nozzle straight on to electric casing or actuators.
oDry joints with compressed air
oNB: Disinfect jacks, electric casing and remote controls using a microfibre cloth soaked in
disinfectant.

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Product for external use only. Do not swallow. Store in a cool place andavoid contact with eyes.
Do not rinse or wipe dry.
Inspection that the various functions of the MSS are in good working order.
Repairs if necessary
Packaging of the MSS with heat shrink wrap
NB:
-Apply the measures recommended by the hospital hygiene department in the event of additional
precautionary measures (Contact precautions, Drops, Air)
-Use of a bleach solution stronger than 5,000ppm (0.5% of active chlorine) must be justified by
microbiological risk and applied for the length of time necessary (Risk of ageing of certain materials
over time – particularly colour).
-The concentration of alcohol-based surface disinfecting solutions must be less than 30%.
NB: use of the terminal disinfection procedure is compatible with the medical bed and its accessories.
-Isolate the mobility support system 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 Mobility
Support Systems.
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 MSS
identification label and on the jack body, if this is concerned.
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 and has not been subject to corrective action during the 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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