Parts and Accessories ................... .........................................30
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Foreword
Thank you for Purchasing Arjo Equipment
Your Walker aid is a part of a series of quality products
designed especially for hospitals, nursing homes and
other health care use.
Please contact us if you have any questions about the
operation or maintenance of your Arjo equipment.
Please Read this Instructions for Use
Thoroughly!
Please read this Instructions for Use (IFU) in its entirety
before using your Walker aid. Information in this IFU is
crucial to the proper operation and maintenance of the
equipment, will help protect your product, and make
sure that the equipment performs to your satisfaction.
Some of the information in this IFU is important for
your safety and must be read and understood to help
prevent possible injury .
Unauthorized modifications on any Arjo equipment
may affect its safety. Arjo will not be held responsible
for any accidents, incidents or lack of performance that
occur as a result of any unauthorized modification to its
products.
Definitions in this IFU
WARNING
Means:
Safety warning. Failure to understand and obey this
warning may result in injury to you or to others.
CAUTION
Means:
Failure to follow these instructions may cause damage
to all or parts of the system or equipment.
NOTE
Means:
This is important information for the correct use of this
system or equipment.
Means:
The name and address of the manufacturer .
Serious incident
If a serious incident occurs in relation to this medical
device, affecting the user, or the patient then the user or
patient should report the serious incident to the medical
device manufacturer or the distributor . In the European
Union, the user should also report the serious incident to
the Competent Authority in the member state where
they are located.
Service and Support
A service routine has to be done on your Walker aid to
ensure the safety and operating procedures of your
product. See section Care and Preventive Maintenance
on page 19.
If you require further information, please contact Arjo
for comprehensive support and service programs to
maximize the long-term safety , reliability and value of
the product.
Contact Arjo for replacement p arts. The contact
information is found on the last page of this IFU.
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Intended Use
This equipment is intended for therapeutic
raising and walking training of adult
residents under the supervision of trained
caregivers with the adequate knowledge of
the care environment, its common practises
and procedures, and in accordance with the
guidelines in Instructions for Use.
The Walker should only be used for the
purpose specified in its Instructions for Use.
Any other use is prohibited.
Resident Assessment
We recommend that facilities establish regular
assessment routines. Caregivers should assess each
resident according to the following criteria prior to use:
•The resident’s weight should not exceed 136 kg /
300 lbs.
•The resident must be able to stand and sit in an
upright position, normally defined as active
•The resident must understand and be able to
respond to instructions to stand and stay seated in
an upright position.
•The resident’s length must be in the range of 140
and 195 cm (4 feet 7 inches - 6 feet 4 inches).
If the resident does not meet these criteria an alternative
equipment/system shall be used.
Installation and Service Requirements
The expected lifetime of this equipment, unless
otherwise stated, is ten (10) years, subject to preventive
maintenance being carried out in accordance with the
instructions for care and maintenance found in the
Instructions for Use.
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Safety Instructions
WARNING
To avoid explosion or fire, never use the
equipment in oxygen rich environment, in
presence of heat source or flammable
anaesthetic gases.
WARNING
To avoid the device in use from tipping, do
not raise or lower other equipment close to
it and be aware of stationary object when
lowering.
WARNING
To avoid injury, make sure that the patient
is not left unattended at any time.
WARNING
To prevent cross-contamination, always
follow the disinfection instructions in this
IFU.
WARNING
To avoid entrapment, make sure to keep
the patient's hair, arms and feet close to
the body and use designated grab
supports during any movement.
WARNING
To avoid the device from tipping and the
patient from falling, do not use the
equipment on floor with recessed drains,
holes or slopes exceeding a ratio of 1:50
(1.15°).
WARNING
To avoid entrapment of the patient's or
caregiver's legs or feet, make sure that
they are kept clear of all obstacles.
WARNING
To avoid falling, make sure that the patient
is positioned correctly and that the safety
belt is being used, properly fastened and
tightened.
WARNING
To avoid falling during transfer, always
make sure that the brakes are applied on all
equipment being used.
WARNING
To avoid falling during patient transfer,
always make sure that the brakes on the
equipment receiving the patient are
applied.
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Preparations
Rear
Front
Right
Left
Fig. 1
Fig. 2
Actions Before First Use
(9 steps)
1Visually check the package for damage.
2The package should be recycled according to
local regulations.
3Check that all parts of the product are supplied.
Compare with Parts Designation on page 8. If
any part is missing or damaged - do NOT use the
product!
4Unpack the battery charger. Select and attach the
adapter correctly suited to your power outlet. See
Battery Charger IFU.
5Charge the battery until indicator indicates full
charge.
6Disinfect the product according to Cleaning and
Disinfection Instructions on page 15.
7Prepare an area, dry with good ventilation for
storage of the lift.
6If you have any questions, please contact your
local Arjo representative for support and service.
The telephone number appears on the last page of
this IFU.
Walker Directions
The directions right, left, rear and front given in this
IFU refers to the directions in below illustration.
(See Fig. 1)
A void to move the lift backwards when using it together
with a patient. See illustration below for correct walking
direction, (See Fig. 2).
8Choose a designated area where the IFU should
be kept, accessible at all times for the users.
9If you have any questions, please contact your
local Arjo representative for support and service.
The telephone number appears on the last page of
this IFU.
Actions Before Every Use
(6 steps)
1Check that all parts of the lift are in place.
2Carry out a thorough inspection of the sling for
damage.
3If any part is missing or damaged - do NOT use
the lift!
4
WARNING
To prevent cross-contamination, always
follow the disinfection instructions in
this IFU.
The lift shall be disinfected and wiped dry before
every use to prevent cross-contamination.
5Make sure the battery is fully charged.
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Parts Designation
Type B. Applied part: protection
against electric shock in accordance
with EN 60601-1.
1Castor with brake (all four castors)
2Pillar (Electrical)
3Hand control (Electrical)
4Battery (Electrical)
5Hand grip
6Support table
7Safety belt
8Suspension straps
9Spade seat
10 Straight steering device
11 Quick coupling
12 Lowering button (Hydraulic)
13 Hand pump for raising (Hydraulic)
14 Pillar (Hydraulic)
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5
6
5
3
11
4
2
1
7
8
9
10
12
14
13
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Fig. 1 Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Product Description/Functions
Manual Raising and Lowering
(2 steps)
1The support table is raised by using the hand pump. Pump
evenly, using the full range of movement. (See Fig. 1)
2The support table is lowered by pressing the Lowering
button. (See Fig. 2)
Electric Raising and Lowering
(2 steps)
1Unhook the hand control from its holder. (See Fig. 3)
2T o raise the support table, press the Up arrow button on the
hand control. To lower the support table press the Down
arrow button.
Castor Brake
A
(2 steps)
1Apply brakes on the castors by pressing the lock tabs (A)
with your foot. (See Fig. 4)
B
A
B
2The castors brakes are released by pressing down the centre
tabs (B).
Straight Steering
(1 steps)
T o facilitate a transfer, for example in a corridor, the rear castors
on the Walker aid are fitted with straight steering devices.
1Press the green tab with your foot to activate straight
steering. (See Fig. 5)
Hand Grips
(2 steps)
The two hand grips are ergonomically designed to provide a firm
grip for the patient.
1Loosen the locking lever (A) and adjust the hand grips (B)
in both position and angle. Fasten the locking lever.
(See Fig. 6)
2Place the locking lever (A) in desired position by pushing it
down while turning it. (See Fig. 7)
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Fig. 1
A
Fig. 2
Fig. 3 Fig. 4
D
D
C
C
Fig. 5
B
Safety Belt and Suspension Straps
As standard equipment the Walker aid has an individually
adjustable safety belt and two suspension straps for body weight
reduction and added patient security .
Safety Belt (4 steps)
Depending on what fits the patient the most, the safety belt can be
straight across or crossed over the support table.
1The safety belt is attached to the knob on the front of the
support table (A). (See Fig. 1 & Fig. 2)
2Pass the safety belt over the support table, behind the
patient’s back and over the support table again.
3Attach to the other knob on the front of the support
table (B).
4Make sure the padding is placed in a convenient position.
Adjust safety belt by releasing the hook and loop strap in the
padding.
Suspension Straps, Male Patient (3 steps)
1Attach the suspension strap to the knob (C). (See Fig. 3)
NOTE
The suspension strap is attached with its adjustment
holes on the rear knobs (C), behind the patient.
2Pass it under the patient and attach it to the knob in
front (D).
3Repeat on the other side of the Walker aid.
Suspension Straps, Female Patient (3 steps)
1Attach the suspension strap to the knob (C). (See Fig. 4)
NOTE
The suspension strap is attached with its adjustment
holes on the rear knobs (C), behind the patient.
2Pass it under the patient and attach it to the knob on the other
side (D).
3Repeat on the other side of the Walker aid.
Spade Seat
(3 steps)
The spade seat is used when lifting the patient.
1Attach the spade seat to the support table by gently pushing
it into the quick coupling. (See Fig. 5)
Continue with the steps on the next page.
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Fig. 6
Fig. 7
Fig. 1
Fig. 2
Fig. 3
2Before lifting the patient, make sure the spade is securely
supported and locked by the quick coupling. (See Fig. 6)
3Loosen the spade seat by pressing the ejector and lift the
quick coupling upwards, holding the spade seat with the
other hand. (See Fig. 7)
Emergency Stop
If, for any reason, the Walker aid does not respond to the control
buttons, you can quickly stop lift movement by pressing the
button on the battery and disconnect it. (See Fig. 1)
Emergency High/Low
(4 steps)
If, for any reason, the Walker aid does not respond to the control
buttons, raise or lower the Walker aid by using the Emergency
High/Low .
1Unplug the hand control. (See Fig. 2)
2Control the Walker aid by pressing a blunt, thin object into
the holes at the panel. (i.e. a pen). (See Fig. 3)
CAUTION
Do not use an object with sharp tip when
pressing in the holes.
3Press it into the hole next to the “up arrow” in order to raise
the Walker aid.
4Press it into the hole next to the “down arrow” in order to
lower the Walker aid.
NOTE
A continuous beeping sound is heard during action
“up” and “down”.
Contact your local Arjo representative before re-using the Walker
aid.
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Fig. 1
Fig. 2
Using the Walker
From Wheelchair or Bed Without Heavy
Lifting
(19 steps)
1Attach the spade seat and the safety belts to the Walker aid.
(Let the belts hang on the knob from where you attach it.)
(See Fig. 1)
2Brake the wheels on the wheelchair/bed.
3Make sure the patient is sitting safely in the wheelchair or
on the bedside.
4Move the Walker aid so the spade seat is next to the
wheelchair seat/bedside.
5Adjust the spade seat height so it is in level with the
wheelchair seat /bedside.
6If possible, move the spade seat gently in over the
wheelchair/ bed.
7Apply brakes on all castors of the Walker aid.
8Let the patient grip the hand grips. If necessary , adjust these.
9Move the patient over onto the spade seat. (See Fig. 2)
NOTE
Be carefully while transferring patient to/from the
spade or attaching the suspension straps. Make
sure the patient’s skin is not pinched by the spade
seat or suspension straps
10 Attach and adjust the safety belt.
11 Raise the patient to suitable height.
WARNING
To avoid the device in use from tipping, do not
raise or lower other equipment close to it and be
aware of stationary object when lowering.
12 Release the castor brakes and pull the Walker aid out from
the wheelchair/bed.
13 Apply brakes on all castors of the Walker aid.
Continue with the steps on the next page.
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14 Attach and adjust the suspension straps. (See Fig. 3)
Fig. 3
Fig. 4
Fig. 5
Fig. 6
NOTE
The suspension strap is attached with its adjustment
holes on the rear knobs, behind the patient.
15 Loosen the spade seat. (See Fig. 4)
16 Adjust the height of the Walker aid. The height adjustment
permits variable body weight reduction. (See Fig. 5)
17 Readjust the hand grips.
18 The training may start. (See Fig. 6)
19 If desired, apply straight steering.
WARNING
To avoid entrapment, make sure to keep the
patient's hair, arms and feet close to the body
and use designated grab supports during any
movement.
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Cleaning and Disinfection Instructions
Arjo Disinfectant
For optimal performance use only Arjo Disinfectant.
For any questions regarding the proper disinfection
procedure or for liquid product ordering information
(see Parts and Accessories on page 30), contact Arjo
Customer Service. Disinfection will minimize crosscontamination and removing tissue residue.
WARNING
To avoid eye and skin damage, always use
protective glasses and gloves. If contact
occurs rinse with plenty of water. If eyes or
skin becomes irritated, contact a physician.
Always read the IFU and the Material Safety
Data Sheet (MSDS) of the disinfectant.
Accessories for Disinfecting Walker
•Protective gloves
•Protective glasses
•Spray bottle with disinfectant
•Spray bottle with water
•Cloth – wet and dry
•Disposable towels
•Soft bristled brush
CAUTION
To avoid damage on the equipment only
use Arjo branded disinfectants.
WARNING
To prevent cross-contamination, always
follow the disinfection instructions in this
IFU.
WARNING
To avoid eye or skin irritation, never
disinfect in the presence of a patient.
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Always Follow these 11 Steps for
Proper Disinfection
If Arjo Shower Panels is used, see respective IFU.
9If disinfectant cannot be removed, spray water on
the affected part and wipe off with disposable
towels.
NOTE
Remove any removable parts, such as battery
and suspension straps, and clean these
separately according to the cleaning
instructions.
Removing visual residue (Step 1 of 11)
1Clean the Walker aid and its removable parts from
visible residue using a cloth soaked in water,
alternatively spray with water and wipe with a
clean cloth. Start from top and move downwards.
10 Repeat previous step until all of the disinfectant
has been removed.
11 Let all parts dry.
Cleaning (Step 2 to 5 of 11)
2Spray disinfectant on the Walker aid and its
removed parts.
3Use a brush or a cloth if needed for cleaning to
remove any deposits.
4Use a new wet cloth to wipe off all traces of
disinfectant or if more suitable by spraying water
and wipe with a clean cloth.
5Repeat previous step until all of the disinfectant
has been removed.
Disinfection (Step 6 to 11 of 11)
6Spray disinfectant on the Walker aid and its
removed parts.
7Allow appropriate contact time of the disinfectant
according to the instructions on the bottle.
8Use a new wet cloth to wipe off all traces of
disinfectant or if more suitable by spraying water
and wipe with a clean cloth.
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Battery Instructions
WARNING
To avoid bodily injury, do NOT crush,
puncture, open, dismantle or otherwise
mechanically interfere with the battery.
• Should the battery casing crack and
cause contents to come in contact with
skin or clothing, rinse immediately with
plenty of water.
• If contents come in contact with the eyes,
rinse immediately with plenty of water
and seek medical attention.
Inhalation of the contents can cause
respiratory irritation. Provide fresh air and
medical attention.
•Be careful not to drop the battery.
•Contact the appropriate local authority for advice
when disposing batteries.
Storage of Battery
•The battery is delivered charged but we
recommend you to recharge the battery when
received due to a slow self discharge.
•The battery will slowly self discharge when not
used.
•A battery during storage and transport should be in
a temperature range of -0° C to +30 °C (32 °F to
86 °F), cooler temperatures will extend its service
life.
•For maximum battery performance do not store
the battery above 50 °C (122 °F).
Installation of Charger
See Battery Charger IFU.
How to Charge the Battery
See Battery Charger IFU.
•Check label on the battery.
Low Charge Warning
If the battery needs charging a buzzing tone is heard
when the lift is activated. At this time, there will be
enough battery power to complete the immediate task.
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WARNING
To avoid injury, make sure that the
patient is not left unattended at any time.
Troubleshooting
PROBLEMACTION
The lift continues to raise or descend after the hand
control button is released.
Activate the red emergency Stop button and pull the
battery out - remove the patient from the lift and contact
qualified personnel.
The lift does not raise or descend when the hand control
button is pressed.
•Make sure that the battery is fully engaged in the
battery compartment.
•Make sure that the hand control connection plug is
properly engaged in the socket.
•Make sure that the battery is charged.
•Use the emergency lowering to descend the
patient, see Emergency High/Low on page 12.
Contact qualified personnel as soon as the patient
is removed from the lift.
The lift is hard to manoeuvre during the transfer.•Make sure all brakes are released.
•Make sure all castors role and swivel freely.
•If the problem persists, remove the patient from
the lift and contact qualified personnel.
The lift is making abnormal sounds during lifting or
transfer .
The lift beeps shortly once every minute when not
Remove the patient from the lift and contact qualified
personnel.
Contact qualified personnel.
operated.
It is only possible to lower the lift.The lifting device of this equipment is equipped with a
safety nut. If the safety nut will be activated it will only
be possible to lower the equipment into a safe position.
In case of this scenario stop using the equipment and
contact qualified personnel for repair.
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Care and Preventive Maintenance
The Walker aid is subject to wear and tear, and the following actions must be performed when specified to make sure
the product remains within its original manufacturing specification.
WARNING
To avoid malfunction resulting in injury, make sure to conduct regular inspections and follow
the recommended maintenance schedule. In some cases due to heavy use of the product and
exposure to aggressive environment more frequent inspections should be carried out. Local
regulations and standards may be more stringent than the recommended maintenance
schedule.
NOTE
Product cannot be maintained and serviced while in use with the patient
Preventive Maintenance Schedule: Walker aid
CAREGIVER OBLIGATIONS Action/Check
Cleaning/DisinfectionX
Visually check all exposed parts X
Visually check mechanical attachmentsX
Visually check battery and battery charger (Electrical
version)
Check hand control and cable (Electrical version)X
Check the safety belt and suspension strapsX
Perform functionality testX
Check and clean castorsX
Yearly checks by qualified personnel onlyX
Replace safety belt and suspension strapX
Every
DAY
Every
WEEK
X
Every
YEAR
Every
2nd
YEAR
WARNING
To avoid injury to both the patient and the caregiver, never modify the equipment or use
incompatible parts.
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Caregiver Obligations
Fig. 1
Fig. 2
Fig. 3
Fig. 4
Caregiver obligations shall be carried out by personnel with
sufficient the Walker aid knowledge following the instructions in
this IFU.
Daily
•Disinfect: The Walker aid has to be cleaned immediately
after every use. Arjo disinfectant should be used in
recommended concentrations labelled on the disinfectant
bottle.
CAUTION
Do not use petroleum based solvents,
trichlorethylene etc., since they may damage the
plastic.
Every week
•Visually check all exposed parts: Examine the Walker aid
for damage. Visually check all exposed parts, especially
where personal contact is made by either the patient or
caregiver.
•Make sure no cracks, sharp edges or unhygienic areas that
could cause the patient or user injury.
•Replace damaged parts.
•Visually check mechanical attachments: Visual check
that all screws and nuts are tightened and that there are no
gaps. (See Fig. 1)
•Check the hydraulic system is working smoothly (raising
and lowering).
•Visually check the battery and the battery charger:
Check the cable condition as well. Withdraw and replace
immediately if damaged. (Electric version) (See Fig. 2)
•Check hand control and cable: Visually check the
condition of the hand control and its cable. If found cut or
damaged, replace. (Electric version) (See Fig. 3)
•Visually check the safety belt and suspension straps:
Check the complete length for fraying, cuts, crack, tears,
that no inner fabric is showing and that no other damage is
visible. If the safety belt or suspension strap is found
damaged, replace it. (See Fig. 4)
•Perform functionality test: Test up/down motion by
pressing up/down. Test emergency High/Low.
Continue with the steps on the next page.
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Fig. 5
•Check and clean the castors: Make sure the castors are
properly fixed and are rolling and swivelling freely (the
function can be affected by soap, hair, dust and chemicals
from floor cleaning). (See Fig. 5)
•If the function is disturbed, clean the castors with water.
•Visual check that the castors are tightened to the chassis.
Yearly Checks by Qualified Personnel Only
The Walker aid must be serviced once a year in accordance with
the Maintenance and Repair Manual.
Contact your local Arjo service repr esentative to sign for a service
agreement.
WARNING
To avoid injury and/or unsafe product, the
maintenance activities must be carried out at the
correct frequency by qualified personnel using
correct tools, parts and knowledge of procedures.
Qualified personnel must have documented
training in maintenance of this device.
NOTE
All Caregiver Obligations are to be checked when
performing the Qualified Personnel Service. For details,
see separate service instructions.
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Technical Specifications
Walker Hydraulic
Safe Working Load (SWL)
(Max patient weight
Maximum weight of lift44 kg (97 lbs.)
Maximum total weight of lift (Lift + Patient)180 kg (397 lbs)
Medical equipmentType
Walker Electric
Lifting capacity136 kg (300 lbs.)
Maximum weight of lift53 kg (117 lbs.)
Battery weight4.4 kg (9.7 lbs.)
Maximum total weight of lift (Lift + Patient)189 kg (417 lbs)
Medical equipmentType
Power Source24V DC
Protection classIP X4
FuseF1 F10AL 250 V
Insulation ClassClass II Equipment
136 kg (300 lbs.)
Operating forces of controls2.7 N
Sound level65 dB
T ransport, Storage and Operation
(Applies to all Walker models except charges)
Temperature range-20 °C to +70 °C (-4 °F to +158 °F) Transport
-20 °C to +70 °C (-4 °F to +158 °F) Storage
+10 °C to +40 °C (+50 °F to +104 °F) Operation
Relative humidity range10% - 80% Transport and Storage
15% - 100% Operation
Atmospheric pressure range500 - 1100 hPa Transport and Storage
800 - 1060 hPa Operation
Mode of operationED maximum 10%;
Maximum 1 minute ON;
Minimum 9 minutes OFF
Start force85 N
Rolling force20 N
Push button force<5 N
Brake force105 N
Lever force20 N
Environmental
Pollution degree2
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Recycling
PackageWood and corrugated cardboard, recyclable
End of Life Disposal
•All batteries in the product must be recycled separately . Batteries are to be disposed in accordance
with national or local regulations.
•Slings including stiffeners/stabilizers, padding material, any other textiles or polymers or plastic
materials etc. should be sorted as combustible waste.
•Lift systems having electrical and electronic components or an electrical cord should be
disassembled and recycled per Waste of Electrical and Electronic Equipment (WEEE) or in
accordance with local or national regulation.
Components that are primarily made up of different kinds of metal (containing more than 90% metal
by weight) for example sling bars, rails, upright supports, etc., should be recycled as metals.
WARNING
To avoid injury, always follow the allowed combinations listen in this IFU. No other
combinations are allowed
Medical Electrical Equipment - Part 1: General Requirements
for Basic Safety and Essential Performance
Medical Electrical Equipment - Part 1: General Requirements
for Basic Safety and Essential Performance
CAN/CSA-C22.2 No. 60601-1:14Medical Electrical Equipment - Part 1: General Requirements
for Basic Safety and Essential Performance
ISO 10535:2006Hoists for the transfer of disabled persons -- Requirements and
test methods
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Overall Dimensions
Ø 125 (4 7/8”)
B
410 (16 1/8”)
A
165 (6 1/2)
1040 (41”)
944 (37 1/8”)
Ø 125 (4 7/8”)
117 (4 7/8”)
610 (24)
694 (27 3/8”)
826 (32 1/2”)
843 (33 1/4”)
677 (26 5/8”)
691 (27 1/4”)
944 (37 1/8”)
1320 (52”)
mm (inches)
A minimum 400 (15 3/4”) gives
B minimum 1165 (45 7/8”)
A maximum 965 (38”) gives
B maximum 1730 (68 1/8”)
Stroke maximum 565 (22 1/4”)
Walker Electric
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Walker Hydraulic
B
Ø 125 (4 7/8”)
410 (16 1/8”)
A
165 (6 1/2)
944 (37 1/8”)
1040 (41”)
117 (4 7/8”)
Ø 125 (4 7/8”)
610 (24)
694 (27 3/8”)
826 (32 1/2”)
843 (33 1/4”)
691 (27 1/4”)
944 (37 1/8”)
1320 (52”)
677 (26 5/8”)
mm (inches)
A minimum. 350 (14 1/8”) gives
B minimum 1140 (44 7/8”)
A maximum 850 (33 7/8”) gives
B maximum 1640 (64 5/8”)
Stroke maximum 500 (19 5/8”)
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Labels
+
=
kg / lb
SWL
Pb
Label Explanation
Battery LabelStates safety and environmental
information for the battery .
Identification
Label
States the product identification;
serial number, year and month of
manufacturing.
Data LabelStates technical performance and
requirements, e.g. the Input Power,
Input Voltage and maximum
Patient W eight etc.
Tested with
Weight Label
States the date and the weight that
was used when validating the
product.
Symbol Explanation
SWLSafe Working Load (max total
load)
24V DCSupply voltage
MAX: 150 V AMaximum power
IP X4Degree of protection
T otal mass of equipment including
its safe working load.
Lifting stroke
Supply voltage
Fuse F A - F10AL 250V
(i.e. the product is protected
against splashing water)
Separate electrical and electronic
components for recycling in
accordance with the European
Directive 2012/19/EU (WEEE)
A battery is the power source of
this equipment.
Environmental danger - contains
lead.
Not for disposal.
Recyclable
CE marking indicating conformity
with European Community
harmonised legislation
Indicates the product is a Medical
Device according to EU Medical
Device Regulation 2017/745
Classified by Underwriters
Laboratories Inc. with respect to
electrical shock, fire, mechanical,
hazards and other specified
hazards only in accordance with
the Approvals and List of
Standards
Name and address of the
manufacturer
Manufacturing date
NDA0100-XXProduct no. of the battery
ED max 10%Mode of operation for Hi/Lo
function:
ED maximum 10%;
Maximum 1 minute ON;
Minimum 9 minutes OFF
T ype B, applied part: protection
against electrical shock in
accordance with IEC 60601-1.
Read the IFU before use.
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Identification
Label
Data Label
CE Label
Battery
Label
IFU Label
Applied part
Tested with Weight Label
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Electromagnetic Compatibility (EMC)
Product has been tested for compliance with current regulatory standards regarding its capacity to block EMI
(electromagnetic interference) from external sources.
Some procedures can help reduce electromagnetic interferences:
•Use only Arjo cables and spare parts to avoid increased emissions or decreased immunity which can
compromise the correct functioning of the equipment.
•Ensure that other devices in patient-monitoring and/or life-support areas comply to accepted emissions
standards.
WARNING
Wireless communications equipment such as wireless computer network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies, etc. can affect this
equipment and should be kept at least 1.5 m away from the equipment.
Intended Environment: Professional Healthcare Facility Environment
Exceptions: HF Surgical Equipment and the RF Shielded room of an ME SYSTEM for magnetic resonance imaging
WARNING
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
Guidance and manufacturer’s declaration – electromagnetic emission
Emission T estComplianceGuidance
This equipment uses RF energy only for its internal functions.
RF emissions CISPR 11Group 1
RF emissions CISPR 11Class B
Therefore its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
This equipment is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low voltage power supply network that
supplies buildings used for domestic purposes.
28
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Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity testIEC 60601-1-2 test levelCompliance level
Electrostatic
±2kV, ±4kV, ±8kV, ±15kV air
±2kV, ±4kV, ±8kV, ±15kV air
discharge (ESD)
EN 61000-4-2
Conducted
±8kV contact
3V in 0,15 MHz to 80 MHz
±8kV contact
3V in 0,15 MHz to 80 MHz
disturbances
inducted by
RF fields
EN 61000-4-6
Radiated RF
electromagnetic
field
EN 61000-4-3
Proximity fields
6V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz
80% AM at 1 kHz
Professional Healthcare
environment
3 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz
385 MHz - 27 V/m
6V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz
80% AM at 1 kHz
Professional Healthcare
environment
3 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz
385 MHz - 27 V/m
from RF
wireless
communications
equipment
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Portable and mobile RF
communications equipment
should be used no closer to
any part of the product,
including cables, than 1.0 m,
if the transmitter’s output
power rating exceeds 1W
a
Field strengths from fixed
RF transmitters, as
determined by an
electromagnetic site survey ,
should be less than the
compliance level in each
frequency range
b
.
Interference may occur in the
vicinity of equipment
marked with this symbol:
EN 61000-4-3
Electrical fast
1720, 1845, 1970, 2450 MHz 28 V/m
5240,5500, 5785 MHz - 9V/m
±1kV SIP/SOP ports
1720, 1845, 1970, 2450 MHz -
28 V/m
5240,5500, 5785 MHz - 9V/m
±1kV SIP/SOP ports
transient/burst
EN 61000-4-4
Power frequency
Magnetic field
EN 61000-4-8
100 kHz repetition frequency
30 A/m
50 Hz or 60 Hz
100 kHz repetition frequency
30 A/m
50 Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
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 ca nnot 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 product is used exceeds the
applicable RF compliance level above, the product should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary .
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
29
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Parts and Accessories
Battery Charger
NDAX000–XX
Extra battery
NDA 0100
For disinfectant contact
your local representative
GCA0010–031
Safety belt, padding and
suspension straps
30
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AUSTRALIA
Arjo Australia
Building B, Level 3
11 Talavera Road
Macquarie Park, NSW, 2113,
Australia
Phone: 1800 072 040
HONG KONG
Arjo Hong Kong Limited
Room 411-414, 4/F, Manhattan Centre,
8 Kwai Cheong Road, Kwai Chung, N.T.,
HONG KONG
Tel: +852 2960 7600
Fax: +852 2960 1711
ITALIA
Arjo Italia S.p.A.
Via Giacomo Peroni 400-402
IT-00131 ROMA
Tel: +39 (0) 6 87426211
Fax: +39 (0) 6 87426222
E-mail: Italy.promo@arjo.com
MIDDLE EAST
Arjo Middle East FZ-LLC
Of ce 908, 9th Floor,
HQ Building,North Tower,
Dubai Science Park,
Al Barsha South
P.O Box 11488, Dubai,
United Arab Emirates
Direct +971 487 48053
Fax +971 487 48072
Email: Info.ME@arjo.com
NEDERLAND
Arjo BV
Biezenwei 21
4004 MB TIEL
Postbus 6116
4000 HC TIEL
Tel: +31 (0) 344 64 08 00
Fax: +31 (0) 344 64 08 85
E-mail: info.nl@arjo.com
SUOMI
Arjo Scandinavia AB
Riihitontuntie 7 C
02200 Espoo
Finland
Puh: +358 9 6824 1260
E-mail: Asiakaspalvelu. nland@arjo.com
SVERIGE
Arjo International HQ
Hans Michelsensgatan 10
SE-211 20 MALMÖ
Tel: +46 (0) 10 494 7760
Fax: +46 (0) 10 494 7761
E-mail: kundservice@arjo.com
UNITED KINGDOM
Arjo UK and Ireland
Houghton Hall Park
Houghton Regis
UK-DUNSTABLE LU5 5XF
Tel: +44 (0) 1582 745 700
Fax: +44 (0) 1582 745 745
E-mail: sales.admin@arjo.com
USA
Arjo Inc.
2349 W Lake Street Suite 250
US-Addison, IL 60101
Tel: +1 630 307 2756
Free: +1 80 0 323 1245 Institutional
Free: +1 800 868 0441 Home Care
Fax: +1 630 307 6195
E-mail: us.info@arjo.com
At Arjo, we are committed to improving the everyday lives of people affected by reduced mobility and age-related health challenges.
With products and solutions that ensure ergonomic patient handling, personal hygiene, disinfection, diagnostics, and the effective
prevention of pressure ulcers and venous thromboembolism, we help professionals across care environments to continually raise