Winncare PITCHOUNE KALIN User manual

2
1. TRANSPORT AND STORAGE 4
2. BED ENVIRONMENT CONDITIONS 4
3. GENERAL USE 4
3.1. PREREQUISITES BEFORE USE AND INSTRUCTIONS FOR USE 4
3.1.1. TRAINING AND QUALIFICATIONS OF THE PERSON USING THE DEVICE 4
3.1.2. INDICATIONS 5
3.1.3. CONTRAINDICATIONS 5
3.2. CLINICAL BENEFIT,DEVICE PERFORMANCE,ACTION MECHANISM DEPENDING ON THE FUNCTIONS,OPTIONS OR ACCESSORIES USED 5
3.2.1. DEVICE PERFORMANCE CHARACTERISTICS 5
3.2.2. EXPECTED CLINICAL BENEFITS 5
3.2.3. INFORMATION FOR HEALTHCARE PROFESSIONALS 5
3.3. PRECAUTIONS FOR USE 5
3.4. ELECTRICAL CHARACTERISTICS 7
3.4.1. ELECTRICAL DATA 7
3.4.2. ELECTROMAGNETIC COMPATIBILITY 8
3.4.3. EQUIPOTENTIALITY 9
4. BED BOARDS 80CM WIDTH COMPATIBLE 10
5. COMPATIBLE ACCESSORIES 80CM WIDTH 10
6. USE 11
6.1. PURPOSE OF MEDICAL DEVICE 11
6.2. SPECIFIC PRECAUTIONS FOR USE 11
6.2.1. RESIDUAL RISKS AND ADVERSE SIDE EFFECTS 11
6.3. GENERAL DESCRIPTION 12
6.4. TECHNICAL CHARACTERISTICS 12
6.4.1. DIMENSIONAL 12
6.4.2. BED WEIGHT 13
6.4.3. NOISE 13
6.4.4. ELECTRICAL COMPONENTS 13
6.4.5. PROTECTION LEVEL AGAINST DUST AND LIQUID PENETRATION 14
6.5. ELECTRICAL CONNECTION 14
6.6. REMOTE CONTROL 15
6.7. BRAKING 17
6.7.1. SEPARATE BRAKING 17
6.7.2. CENTRALIZED BRAKING 18
7. SLEEPING PLAN 18
7.1. BACK REST 18
7.1.1. PUTTING THE BACK REST FLAT 18
7.1.2. IF THE BED IS FITTED WITH AN EMERGENCY RELEASE FOR THE BACK REST (CARDIO PULMONARY RESUSCITATION) 19
7.2. LEG REST 19
7.2.1. VERSION WITH ELECTRIC FOLDING (P/) 19
8. INSTALLATION OF ACCESSORIES 20
8.1. BOARDS 20

3
8.2. WOODEN BARRIERS 21
8.2.1. INSTALLATION OF THE BARRIER 21
8.2.2. USE OF THE BARRIER 24
8.2.3. WALL STOP A551-00 26
8.3. ANGLED LIFTING POLE AND IV STAND 27
8.3.1. POSITIONING OF THE STEM AND THE IV POLE ON THE BED BASE 27
8.3.2. SPECIFIC FEATURES OF THE JIB CRANE AND LIFTING HANDLE 27
9. MAINTENANCE 28
9.1. IDENTIFICATION 28
9.2. INSTRUCTIONS FOR DISMANTLING THE MOTORS 28
9.3. MAINTENANCE 29
9.4. QUALITY INSPECTION OF MEDICAL BEDS 30
9.5. CLEANING AND DISINFECTION 31
9.6. LIFETIME 32
9.7. GARANTIES 32
9.8. TROUBLESHOOTING GUIDE 33
10. SCRAPPING 34

4
It is strictly forbidden to stack packages weighing over 60kg/m², whatever
position they are in.
Before transporting or dismantling the bed, make sure the back and leg rests
are fixed to the frame of the bed base.
Dear Sir/Madam,
You have acquired a WINNCARE medical bed equipped with its accessories, 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 IEC 60601-2-52 (2010) and IEC 50637 (2017) 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 accessories, which also guarantees you safe use
of the medical bed and its accessories.
1. TRANSPORT AND STORAGE
For transport, the bed should be in its low position, and strapped and protected. The wired control and supply
lead should be attached to the bed base.
The head and footboards are protected and strapped to the sleeping surface.
The bed should be transported upright when in its original packaging in compliance with the instructions printed
on the packaging.
2. BED ENVIRONMENT CONDITIONS
The bed, along with the boards and accessories, must be transported and stored
at a room temperature of between -10°C and +50°C,
The bed, along with the boards and accessories, must used at a room
temperature of between +10°C and +38°C,
Relative humidity of between 30% and 75%.
Atmospheric pressure between 700hPa and 1060hPa
3. GENERAL USE
Before use, it is essential to read these instructions carefully. They contain advice on using and looking after
the bed to guarantee optimum safety.
The latest updated version of this manual is available on our website www.winncare.fr.
The photos, images and diagrams included in this manual may not correspond to your product depending on
the versions or options you have.
3.1. Prerequisites before use and instructions for use
3.1.1. Training and qualifications of the person using the device
Users must be trained by people who have been trained and approved by the relevant business entities, in
particular when it comes to safety and reporting non-conformities.
Observe the specified
environmental conditions

5
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.
3.1.2. Indications
Suitable for patients with temporary or permanent decreased independence due to their illness or disability.
3.1.3. Contraindications
To be determined by the prescribing doctor based on the patient’s condition, the medical treatment and the
type of relevant accessories. Patient weight higher than the safe operating load defined.
3.2. Clinical benefit, device performance, action mechanism depending on the functions,
options or accessories used
3.2.1. Device performance characteristics
Variable height (ergonomics of care, transfer aid), low bed (reduces the severity of falls from the bed),
Trendelenburg, reverse Trendelenburg, chest rest, leg rest, flat, chair position (preserves or improves the
patient’s physical and/or psychological state, helps with administering care), 30° chest rest and/or with Fowler
or semi-Fowler positions (helps prevent pressure sores), According to our bed models 5° Trendelenburg (helps
lift the patient), rails (protects the patient and/or caregivers), lateral stop (stabilizes the mattress), removable
bed panels (prevents the patient from falling out of bed, acts as a fixed walking aid, helps with head and foot
care).
3.2.2. Expected clinical benefits
To preserve the patient’s state of health, mobility, activity and transfers. To reduce the repercussions of the
immobilization syndrome. To protect the health and safety of users or others.
3.2.3. Information for healthcare professionals
Identify possible combinations of risks and benefits for each intended use. Assess the patient’s ability to use
and understand the overhead remote control and the caregivers’ knowledge of how the medical bed and its
accessories work.
Any serious incident occurring in connection with the device must be reported to the manufacturer and to the
competent authority of the Member State in which the user and/or patient is established. Inform the competent
authority if you think or have a reason to believe that the device presents a serious risk or is faulty.
3.3. Precautions for use
Although the bed is conforming with Electromagnetic Compatibility, some devices may alter how it functions,
in which case they must be used at a distance or not used at all.
The bed is a medical device and must not be modified under any circumstances. You must ensure its
traceability, including that of the boards and its accessories.
If you assemble medical devices not provided by the supplier, you shall meet the manufacturer's general
obligations in accordance with Article 10 of Regulation (EU) 2017/745.

6
The electric parts (jack, supply box, wired control, etc.) shall only be repaired by the manufacturer Linak.
The loads permitted (see bed characteristics) must be distributed evenly over the bed base.
Do not activate all the motors at the same time when the patient is in the bed (only one motor is authorised at
one time, except elevation by 2 motors or simultaneous function).
After each use and while care is being administered to the patient, the brakes must be activated.
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. Remember to lock the function(s) (if the option is available).
On change of height or angle of the parts of the bed, make sure that there are no objects and no parts of the
patient’s or carer’s body caught between the bed, the boards, the accessories and the ground or between the
boards and base or between the cross braces.
Do not sit down on the side of the back rest or leg rest if this is not flat.
In the case of a prolonged more than 50 ° tilt bust semi-sitting position, it is recommended to vary the position
of the person in bed every 2 hours.
When the bed is being moved, keep the power lead well away from the ground and wheels.
When use of an adaptor, extension lead or connection plug proves necessary, you must check that its
characteristics are suitable for the bed.
Connection to the supply box must be done using a mains complying with the standards in force and
corresponding to a voltage of use indicated on the device.
The mains plug must be disconnected before the bed is moved.
Do not pull on the mains leads to disconnect the mains plug.
During any handling, try not to catch the leads of the motors and remote control and do not get them knotted.
The wired handset shall be attached to the head panel when not in use and protected in a lockable box in the
case of a bed intended for children.
In the case of the use of infrared remote control(s), WINNCARE allows the establishment of a single bed in the
same room (or in a close environment) or a second bed only if the infrared options of 2 beds concerned are
different (I and I1).
The condition of the leads must be checked frequently. If the slightest modification is observed, the person in
charge for maintaining the bed must be contacted to carry out the necessary repairs.
If repairs are required, the person in charge of maintenance must be contacted.
For assistance, if necessary, in mounting, operation or maintenance or to report unexpected operation or
events, call your supplier or Winncare.
The cleaning instructions recommended must be complied with.
Abnormal use of the bed may damage it or cause accidents to users, in which case the warranty shall be
annulled. Abnormal use means failure to comply with the precautions for use, maintenance instructions and
other uses not related to the bed’s normal purpose, such as:
-The use of the bed by several people at the same time (except DUO DIVISYS bed).
-Use outdoors or transporting the patient in a vehicle.
-The moving of the bed on a slope greater than 10° etc.
Put the bed in the designated room, foreseeing an appropriate perimeter of use for the different functions
(variable height, TR, etc.), especially if the bed has a lifting pole or side rails. Check that there is sufficient
ceiling height if a lifting pole is fitted.

7
- Check that the bed operates properly after installing it in accordance with the check-list
appended in this document. (Test all of its functions)
- The patient is a planned operator of the bed. Users must be trained in how to use the
equipment.
- Inform the patient and his visitors of the safety instructions to be observed.
Brake the wheels.
The mains socket should remain accessible to enable the bed to be disconnected quickly.
Plug in the power lead, checking that the mains comply with the standards in force and that it is suitable for the
supply box voltage.
Also ensure that the power lead, the remote control lead as well as the cables of possible other devices are
positioned correctly to prevent any risks of getting caught between the moving parts of the bed.
3.4. Electrical characteristics
3.4.1. Electrical data
Classe II (double
insulation)
Frequency
Protection level against
dust and liquid penetration
Operating time
In accordance with DEEE
Internal reference
Voltage
Current type
XXX-XXX-XXX
IP XX
xxxV ~ xxH
Z
FACTEUR DE SERVICE :
xx% max. x min/xx min
PUISSANCE ABSORBEE :
Xxx VA
ET-xxxxx
Protection level against
electric shocks (type BF)
Absorbed power
Internal reference

8
The bed is an electromedical device requiring special precautions with regard to electromagnetic
compatibility. The device must be installed and put into service according to the EMC information
provided in this manual.
The use of accessories, transducers, and cables other than those specified or supplied by the
manufacturer may cause increased electromagnetic emissions or a decrease in the immunity of
the device and may cause improper operation.
3.4.2. Electromagnetic compatibility
The bed will not move automatically when subject to electromagnetic disturbances within the limit of the values
indicated below.
Manufacturer’s declaration and guide – electromagnetic emissions
The medical bed (see references in contents) has been designed for use in the electromagnetic environment specified below. The user should ensure that it is used in such
an environment.
Emissions test
Compliance
ELECTROMAGNETIC ENVIRONMENT - GUIDE
RF emissions
CISPR 11
Group 1
The medical bed (see references in contents) uses RF energy only for its internal functions.
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
The medical bed (see references in contents) can be used in all domestic environments,
including those directly connected to the public low-voltage power supply network that supplies
buildings for domestic purpose.
[ ]
Harmonic emissions
EN 61000-3-2
Class A
Voltage fluctuations / Flicker
EN 61000-3-3
Compliant
RF emissions
CISPR 14-1
Not Applicable
The medical bed (see references in contents) has not been designed for connection to other
equipment.
Manufacturer’s declaration and guide - electromagnetic immunity
The medical bed (see references in contents) has been designed for use in the electromagnetic environment specified below. The user should ensure that it is used in such
an environment.
IMMUNITY TEST
IEC 60601
Severity level
COMPLIANCE LEVEL
Electrostatic discharge
EN 61000-4-2
8 kV contact
15 kV air
8 kV contact
15 kV air
Radiated RF
EN 61000-4-3
3 V/m
80Mhz –2,7Ghz
80% AM at 1kHz
3 V/m
80Mhz –2,7Ghz
80% AM at 1kHz
Proximity fields from RF
wireless communication
equipment
EN 610004-3
See table below
See table below
Electrical fast transients
EN 61000-4-4
2 kV for feeders
1 kV for input/output lines
Repetition frequency at 100 kHz
2 kV for feeders
1 kV for input/output lines
Repetition frequency at 100 kHz
Surges
EN 61000-4-5
Differential mode 1 kV
Common mode 2 kV
Differential mode 1 kV
Common mode 2 kV
Conducted RF
EN 61000-4-6
3V
0,15 –80 MHz
6V in ISM band between 0.15 and 80 MHz
3V
0,15 –80 MHz
6V in ISM band between 0.15 and 80 MHz
Magnetic fields
IEC 61000-4-8
30A/m
50 Hz or 60 Hz
30A/m
50 Hz or 60 Hz
Voltage dips
EN 61000-4-11
0% UT; 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% UT; 1 cycle
70% UT; 25/30 cycles at 0°
0% UT; 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% UT; 1 cycle
70% UT; 25/30 cycles at 0°
Voltage interruptions
EN 61000-4-11
0% UT ; 250/300 cycles
0% UT; 250/300 cycles
NB: UTis the nominal value of power voltage applied during the test.

9
Test specification for immunity to RF wireless communications devices
Test frequency (MHz)
Modulation
Immunity test level (V/m)
385
Pulse Modulation : 18 Hz
27
750
FM + 5 Hz deviation : 1 kHz sine
28
710 –745 –780
Pulse Modulation : 217 Hz
9
810 –870 –930
Pulse Modulation : 18 Hz
28
1720 –1845 –1970
Pulse Modulation : 217 Hz
28
2450
Pulse Modulation : 217 Hz
28
5240 –5500 - 5785
Pulse Modulation : 217 Hz
9
3.4.3. Equipotentiality
Under the head-half of the bed base you will find an equipotentiality socket, identified by the label, enabling
you to connect any electromedical devices. The leads of these devices must pass through the head end and
not on the side.
Equipotentiality

10
There must be atleast 220 mm between thetop of the siderail 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.
Incompatible accessories and boards can pose RISKS
4. BED BOARDS 80cm WIDTH COMPATIBLE
➢Mattress
Observe the mattress dimensions prescribed. See user guide
Width of base in
cm
Characteristics of compatible mattresses
170x80cm
Width 170 X 82 cm minimum with a high-resilience foam of
27 kg/m³
5. COMPATIBLE ACCESSORIES 80cm WIDTH
Item
Reference
Kalin wooden barriers
P769-00
21
Pitchoune II Panels
P768-00
24.6
Ref.
Designation
Item
Max
(CFS)
A1700xx
IV stand, 2 hooks
0.6
8
A5800
Chrome-plated urine bottle holder
0.2
-
A8400xx
Telescopic IV stand, 2 hooks
1.7
8
A681-00
Lifting pole for Kalin Pitchoune bed
4
45
A193-00
Chrome-plated wall-mounted basin holder
0.3
-
A230-00
Remote-control lead holder
1.1
-
A260-00
Epoxy urinal holder
0.2
-
A680-00
Full length KALIN side rails
16
-75
A563-00
KALIN bed skirt
5
-
A551-00
Wall stop
1.5
-
A634-00
Kit for side loading bed
5.7
-
S0200
Stainless steel intravenous stand on base
2.5
8
Y0300
Lifting pole on U shaped base, fixed height
23.3
75
Only accessories and boards supplied by WINNCARE guarantee you a
compatibility with our products
Incompatible mattresses can pose RISKS.

11
6. USE
6.1. Purpose of medical device
➢The device is intended to compensate for a handicap and as a preventive measure.
➢These beds are intended :
-Application environments 3 (Senior care centres if adult person with atypical anatomy), 4 and 5 (Home care
and in-facility when equipped with the emergency CPR back-rest release option).
-Normal load when in use: 115 kg (Patient 70 kg, mattress 15 kg, accessories 30 kg)
-Children with a height of 125 cm to 145 cm
6.2. Specific precautions for use
The bed should only be used for stretcher work if it is fitted with centralised brakes.
6.2.1. Residual risks and adverse side effects
DANGER
RESULT
REQUIREMENTS FOR THE USER
Trapping
Hands pinched
Handle legsrest or backrest up by handles or at specified
locations or the barriers at the specified locations
Trapping
Crushing body or object
Before lowering the bed, check that the area between the
bed and the floor is free
Trapping
Crushing body or object
Check before operating the central brake pedal that the
area between the pedal and the floor is free
ADVERSE SIDE EFFECTS
Fall of the person. Immobilization syndrome. Aggravation of fractures that have not been stabilized and/or
procedural pain when the articulated parts of the bed frame are moved.
Description of the accepted size and positioning of the patient in the bed

12
6.3. General description
6.4. Technical characteristics
6.4.1. Dimensional
WINNCARE recommend the use of the XS 150 patient lift.
30 to 76 cm
Ø10 cm
42°
Slatted back lift
Slatted folding leg lift
Mattress.
Foot board
Intravenous holder
rod housing
Leg lift handle
Head board
Base and cross pieces
Gallows
housings
(corner)
Wheels
Storage box remote
control
Mattress stopper
12 cm

13
Maximum operating time: Read the recommendations on the electrical
label on the bed.
6.4.2. Bed weight
TOTAL
Bed with electric knee break leg lift
(without boards)
70 kg
6.4.3. Noise
The measurement of the maximum audible sound power in accordance with ISO 3746 is 45.2 dB(A).
6.4.4. Electrical components
626 mm
240 mm
470 mm
637 mm
637 mm

14
6.4.5. Protection level against dust and liquid penetration
Index
1st number (decade)
Protection against solids
2nd number (unit)
Protection against water intrusion
0
No protection.
No protection.
1
Protected against solid bodies greater than
50 mm.
Protected against vertical drops of water drops.
2
Protected against solid bodies greater than
12,5 mm.
Protected against falling drops of water up to 15°
from the vertical.
3
Protected against solid bodies greater than
2,5 mm.
Protected against rain water up to 60 ° from
vertical.
4
Protected against solid bodies greater than
1 mm.
Protected against splashing water from all
directions.
5
Protected against dust and other
microscopic residues.
Protected against jets of water from all directions at
the lance (6.3 mm nozzle, distance 2.5 m to 3 m,
flow 12.5 l / min ± 5%).
6
Totally protected against dust.
Protected against strong jets of water from all
directions to the lance (12.5 mm nozzle, distance
2.5 m to 3 m, flow 100 l / min ± 5%).
6.5. Electrical connection
Control box
CB6X03
Remote control
Legs or plug falls
Back rest jack
Variable height jack

15
6.6. Remote control
The remote control and its cable are protected in a lockable box when the functions of the bed are not modified.
This arrangement avoids any risk of involuntary activation and suffocation.
LOCATION OF THE
REMOTE CONTROL ON
THE BED

16
Carry out a test cycle when the bed is empty to familiarise yourself with the bed functions.
Lifting and lowering of back rest
Lifting and lowering of variable
height
Lifting and lowering of electric
folding
Simultaneous lifting and lowering
of back rest and folding

17
6.7. Braking
6.7.1. Separate braking
Check that the wheels are locked by trying to move the bed. If this is not done, the patient or another person
who leans on the bed may fall.
KEY IN VERTICAL
POSITION: THE
FUNCTION IS
UNLOCKED
TURN THE KEY SLIGHTLY TO
THE RIGHT TO LOCK THE
FUNCTION
KEY TO LOCK A
FUNCTION

18
6.7.2. Centralized braking
A.Braked wheels: press pedal (red side)
with the foot.
B.Freewheels: Press pedal (A or C)
with the foot to get the middle position.
C. Directional Wheel: Press pedal (green side)
with the foot
7. SLEEPING PLAN
7.1. Back rest
7.1.1. Putting the back rest flat
In the event of a power cut or failure, flatten the back rest as follows:
a) Disconnect the power supply.
b) Dismantle the headboard .
c) Stand at the head of the bed and take hold of the back rest handle with one hand. Push or lift to
compensate the pressure exerted by the patient and unhook the clip by the connecting rod with
the other hand. The back rest jack will then pivot downwards.
d) Put the headboard back.
A
C

19
1) Grasp the back rest with one hand.
2) With the other hand, activate one of the two handles on the back rest while
lowering.
If the handle is released, the back rest will stop moving.
.
Version with handle on the back rest Version without handle on the back rest
7.1.2. If the bed is fitted with an emergency release for the back rest (Cardio Pulmonary
Resuscitation)
7.2. Leg rest
7.2.1. Version with electric folding (P/)
Memory folding: This function keeps a position of the tibia section horizontal when the jack is activated
upwards. To use this function, the 1st crank catch must be engaged when the leg rest is flat.
Folding without memory: the end of the tibia section stays in contact with the bed base.
Release handles
2
3
1
1
2
3
1
1

20
3
Assemble the highest board on the head side.
8. INSTALLATION OF ACCESSORIES
8.1. Boards
➢Installing a bed board :
➢Removing a bed board :
O
K
1
2
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