Winncare A671-00 User manual

2020_02_13 580261 English
4 Le Pas du Château
85670 SAINT PAUL MONT PENIT
TEL: [phone]
FAX: [phone]
Email: [e-mail]
Website: http://www.winncare.fr
USER MANUAL,
fixed footboard bed rail
A671-00 RIGHT RAIL
A672-00 LEFT RAIL

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1. TRANSPORT CONDITIONS 3
2. STORAGE CONDITIONS 3
3. ASSEMBLY CONDITIONS 4
3.1. ASSEMBLING AND INSTALLING THE A671-00/A672-00 FIXED RAILS 5
4. USAGE CONDITIONS 7
4.1. FUNCTION 7
4.2. PRECAUTIONS 7
4.3. RESIDUAL RISKS 8
5. MAINTENANCE CONDITIONS 8
5.1. IDENTIFICATION 8
5.2. MAINTENANCE 8
5.3. CLEANING 8
5.4. DISINFECTION 8
5.4.1. OBJECTIVE 8
5.4.2. INDICATION 8
5.4.3. EQUIPMENT 8
5.4.4. TECHNIQUE 9
5.5. SHELF LIFE 9
5.6. GUARANTEES 10
6. SCRAPPAGE CONDITIONS 10

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Stackingpackagesthatweighmorethan60kg/m²iscompletelyprohibited,regardlessofposition.
Dear Sir, Madam,
Thank you for choosing a WINNCARE medical accessory.
Our beds and accessories are designed and manufactured in compliance with the applicable essential
requirements, according to European Directive 2007/47/EC.
The commercial configurations, including boards and accessories manufactured by us, are tested in
compliance with IEC 60601-2-52 (2009) to ensure maximum safety and performance.
Consequently, adhering to WINNCARE’s recommended usage conditions, and using original boards and
accessories, is a condition of upholding the clauses of the guarantee and ensures that the fixed footboard
bed rail is used safely.
1. TRANSPORT CONDITIONS
During transport, rails should be strapped and protected by packaging.
NB: stacking packages on the rail is completely prohibited.
2. STORAGE CONDITIONS
The rails must be stored at an ambient temperature between -10 °C and +50 °C, with relative humidity
between 30% and 75%.
Atmospheric pressure between 700 hPa and 1060 hPa , adhering to the same conditions as during transport.
Adhere to the specified
environmental conditions

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3. ASSEMBLY CONDITIONS
FIXED FOOTBOARD BED RAILS should always be combined with A637-00 or A638-00 rails and a bed
board distributed by Winncare.
Bed code number
Reference number of the fixed rail
XN…
A671-00/A672-00
XO…
A671-00/A672-00
XH…
A671-00/A672-00
AL…
A671-00/A672-00
MS…/ML…
A671-00/A672-00
AE…
A671-00/A672-00
AF…
A671-00/A672-00
AG…
A671-00/A672-00
AH…
A671-00/A672-00
AX…
A671-00/A672-00
XA…
A671-00/A672-00
XB…
A671-00/A672-00
Beds compatible with the FIXED RAIL
Fixed rail
Foot of the
bed
Head of
the bed
Folding rail
The fixed rail is not compatible with DUO 140/160 beds or the PITCHOUNE KALIN bed.
The fixed rail is not compatible with bed extensions, or CIC and WINNEA boards.

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3.1. Assembling and installing the A671-00/A672-00 fixed rails
Using a 13-mm socket wrench, remove the board mount and replace with the new part.
Attach the footboard to the bed.
Bed rail lock mechanism
1
2

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Attach the fixed rail to the bed.
Attach the screw and the plastic nut to lock the rail in place
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4

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Poor positioning of the rail may be harmful to safety or cause malfunction. Using the rail with
patients who are not adults or who measure 146 cm is prohibited.
The user or staff must be trained and informed of the risks related to using the fixed rail. Use
by children is prohibited and vigilance is required when being used by confused or disoriented
people.
There must be at least 220 mm between the top of the rail and the surface of any non-
therapeutic or non-compressed mattress. This specification should also be used when using
a therapeutic mattress.
To ensure safety and maintain product compliance, only use original parts and accessories
distributed by WINNCARE.
4. USAGE CONDITIONS
4.1. Function
The fixed footboard bed rail, attached to the ¾ metal rail, aims to prevent patients falling during sleep and
when being moved.
BUT, there is a risk of injuries, falling after trapping a limb in the gaps, asphyxia after trapping the head, neck,
or chest. When deciding whether or not to use the fixed footboard bed rails, a risk/benefit ratio assessment
should be first be performed.
This assessment should take account of:
- the department’s monitoring ability: A standardized institutional protocol for using the fixed footboard bed
rail can be prepared.
- the patient’s physical and mental health: their needs, abilities, lucidity, size and level of agitation. This
assessment should be repeated regularly.
4.2. Precautions
The fixed rail is not compatible with bed extensions.
The fixed rail should be handled by someone outside the bed, who should ensure that no objects or bodies
can be found in the area of operation.
The rails should not be used to handle or move the hospital bed.
The fixed footboard bed rail is a medical device. Accordingly, please be advised that it should not be modified
in any way. You must ensure traceability. A risk analysis and CE declaration must be performed if you are
assembling various types of medical device.
If assistance is required during assembly, use or maintenance or to report malfunction or unexpected events,
call your supplier or Winncare.

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4.3. Residual risks
DANGER
CONSEQUENCE
USER RECOMMENDATION
Trapping
Pinched hands
Manipulate the legs using the
handles or in the specified
location
5. MAINTENANCE CONDITIONS
5.1. Identification
5.2. Maintenance
The fixed footboard bed rail should be carefully examined at least once a year, particularly parts such as the
tightening screws and locking bolts.
5.3. Cleaning
High-pressure cleaning is prohibited.
5.4. Disinfection
The fixed footboard bed rail is a non-critical device, requiring “low-level” disinfection.
Please be advised that the below recommendations were formalized in compliance with best practise
recommendations but do not constitute a protocol. Consult the hospital’s internal hygiene department.
5.4.1. Objective
Recondition the rail and avoid transmitting bacteria from one patient to another.
Remove any organic substance via:
Mechanical action (scrubbing)
Chemical action (disinfection)
5.4.2. Indication
Rails are physically and bacteriologically clean
5.4.3. Equipment
Microfibre wipes
Detergent or Detergent-Disinfectant (CE-marked Surface DD° and Surface Disinfectant (Chlorine derivatives,
< 30% alcohol)
NB: undiluted DD products and bleach should not be used. Retention time should be applied in accordance
with the recommendations of the disinfectant manufacturer (drying time often equals retention time outside
human presence)
SANIVAP steam device with accessories
Manufacturer’s
name and contact
details
Read the user manual
NB
Product serial
number
Product reference
In compliance with the
European medical
devices directive
WINNCARE
MEDICATLANTIC
4 LE PAS DU CHATEAU ST PAUL MT PENIT.
85670. FRANCE. [phone]
Ref. XXXXXXX
SN FR03AAMM/XXXXX
YY: Year of production
MM: Month of production

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Product for external use, do not swallow, keep away from heat and avoid contact with the eyes.
5.4.4. Technique
-Daily maintenance using a surface DD product, in one application.
-Maintenance when patient is discharged or periodic maintenance using the Biocleaning procedure,
involving 3 operations:
oClean using a cloth soaked with a surface detergent or Detergent-Disinfectant (DD) solution.
All harsh or scouring products such as detergents, powders, solvents and bleach are
prohibited.
oRinse with a cloth rinsed in fresh water
oDisinfect using a cloth soaked with a surface disinfectant solution.
-Specific maintenance by service providers after removing the rail from the institution:
oDispose of the packaging after decontaminating the inside using a Detergent-Disinfectant
spray solution.
oBiocleaning operation, or
oSteam cleaning (accessory with a microfibre mop) of the various flat surfaces and bed slats.
Regularly change the mop heads to avoid excess water. Clean hard-to-access areas (wheels,
opened moving parts, angles, etc.) with the steam nozzle. Use the steam nozzle with
a microfibre cloth for the tubes. Do not aim the nozzle directly on electrical components
or actuators.
oDry moving parts with compressed air
oNB: Disinfect actuators, electrical components and remote controls with microfibre wipes
soaked with disinfectant.
Do not rinse or dry.
Check for normal function and the various operations.
Repair if necessary
NB:
-Take the measures recommended by the hospital’s internal hygiene department in case of additional
precautionary measures (Contact, Droplets, Air precautions)
-Using a greater than 5000 ppm bleach solution (0.5% active chlorine must be justified by a
microbiological risk and applied for the required time (Risk that certain materials - particularly colour -
will age over time).
-The concentration of alcohol-based surface disinfectant solutions must be less than 30%.
Comment: use of terminal disinfection is compatible with the hospital bed and its accessories.
-Isolate the fixed rail in a disinfection room with a particle filtration system and an outlet for washing floors
and walls after disinfection.
-Use a disinfectant product with bactericide, fungicide and virucide properties, either by uniformly
spraying the surfaces or applying with a single-use cloth, or by spraying a disinfectant aerosol from a
distance of 30 cm.
NB:
Adhere to the precautions indicated on the disinfectant products.
Leave to dry and keep the disinfected material separate from other, non-disinfected material with a film
including a label indicating the disinfection date.
5.5. Shelf life
The shelf life of accessories under normal usage and maintenance conditions is 5 years.

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5.6. Guarantees
➢All of our goods are guaranteed against manufacturing defects, if normal usage and maintenance
conditions are adhered to.
➢Labour costs, corresponding to changes in structures or parts under warranty, are not taken into
account.
➢Please see the general sales conditions for the duration of the specific guarantees for each product.
➢During correspondence about potential maintenance, it is important to communicate the instructions
included on the product ID label.
➢Replacement is made by providing original parts within the limit of the guarantee period, with our
resale network determining the start of the guarantee period.
➢Returning defective parts is mandatory, so that the guarantee can be applied correctly and to avoid
receiving an invoice.
6. SCRAPPAGE CONDITIONS
➢The product must be scrapped if it no longer meets the essential requirements, particularly if it no
longer has its original features and has not been reworked as part of the production process.
➢Arrangements must be made so that it is no longer used for the previously defined function.
➢Adhere to the country’s applicable environmental standards during scrappage.

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