Arjo Walker User guide

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INSTRUCTIONS FOR USE
Walker
04.GC.01_17EN • 03/2020
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WARNING
To avoid injury, always read this Instruction for Use and accompanying documents before using the product.
Mandatory to read the Instructions for Use
Design Policy and Copyright ® and ™ are trademarks belonging to the Arjo group of companies. © Arjo 2020. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. The content of this publication may not be copied either whole or in part without the consent of Arjo.
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Contents
Foreword ................................................................................... 4
Intended Use .............................................................................5
Safety Instructions ....................................................................6
Preparations ..............................................................................7
Parts Designation ......................................................................8
Product Description/Functions ................................................10
Using the Walker .....................................................................13
Cleaning and Disinfection Instructions ....................................15
Battery Instructions .................................................................17
Troubleshooting ......................................................................18
Care and Preventive Maintenance ..........................................19
Technical Specifications .........................................................22
List of Standards and Certificates ...........................................23
Overall Dimensions .................................................................24
Labels .....................................................................................26
Electromagnetic Compatibility .................................................28
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)
1 Visually check the package for damage. 2 The package should be recycled according to
local regulations.
3 Check 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!
4 Unpack the battery charger. Select and attach the
adapter correctly suited to your power outlet. See Battery Charger IFU.
5 Charge the battery until indicator indicates full
charge.
6 Disinfect the product according to Cleaning and
Disinfection Instructions on page 15.
7 Prepare an area, dry with good ventilation for
storage of the lift.
6 If 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).
8 Choose a designated area where the IFU should
be kept, accessible at all times for the users.
9 If 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)
1 Check that all parts of the lift are in place. 2 Carry out a thorough inspection of the sling for
damage.
3 If any part is missing or damaged - do NOT use
the lift!
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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.
5 Make 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.
1 Castor with brake (all four castors) 2 Pillar (Electrical) 3 Hand control (Electrical) 4 Battery (Electrical) 5 Hand grip 6 Support table 7 Safety belt 8 Suspension straps 9 Spade 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)
1 The support table is raised by using the hand pump. Pump
evenly, using the full range of movement. (See Fig. 1)
2 The support table is lowered by pressing the Lowering
button. (See Fig. 2)
Electric Raising and Lowering
(2 steps)
1 Unhook the hand control from its holder. (See Fig. 3) 2 T 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)
1 Apply brakes on the castors by pressing the lock tabs (A)
with your foot. (See Fig. 4)
B
A
B
2 The 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.
1 Press 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.
1 Loosen the locking lever (A) and adjust the hand grips (B)
in both position and angle. Fasten the locking lever.
(See Fig. 6)
2 Place 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.
1 The safety belt is attached to the knob on the front of the
support table (A). (See Fig. 1 & Fig. 2)
2 Pass the safety belt over the support table, behind the
patient’s back and over the support table again.
3 Attach to the other knob on the front of the support
table (B).
4 Make 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)
1 Attach 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.
2 Pass it under the patient and attach it to the knob in
front (D).
3 Repeat on the other side of the Walker aid.
Suspension Straps, Female Patient (3 steps)
1 Attach 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.
2 Pass it under the patient and attach it to the knob on the other
side (D).
3 Repeat on the other side of the Walker aid.
Spade Seat
(3 steps)
The spade seat is used when lifting the patient. 1 Attach 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
2 Before lifting the patient, make sure the spade is securely
supported and locked by the quick coupling. (See Fig. 6)
3 Loosen 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 .
1 Unplug the hand control. (See Fig. 2) 2 Control 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.
3 Press it into the hole next to the “up arrow” in order to raise
the Walker aid.
4 Press 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)
1 Attach 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)
2 Brake the wheels on the wheelchair/bed. 3 Make sure the patient is sitting safely in the wheelchair or
on the bedside.
4 Move the Walker aid so the spade seat is next to the
wheelchair seat/bedside.
5 Adjust the spade seat height so it is in level with the
wheelchair seat /bedside.
6 If possible, move the spade seat gently in over the
wheelchair/ bed. 7 Apply brakes on all castors of the Walker aid. 8 Let the patient grip the hand grips. If necessary , adjust these. 9 Move 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.
9 If 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)
1 Clean 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)
2 Spray disinfectant on the Walker aid and its
removed parts.
3 Use a brush or a cloth if needed for cleaning to
remove any deposits.
4 Use a new wet cloth to wipe off all traces of
disinfectant or if more suitable by spraying water and wipe with a clean cloth.
5 Repeat previous step until all of the disinfectant
has been removed.
Disinfection (Step 6 to 11 of 11)
6 Spray disinfectant on the Walker aid and its
removed parts.
7 Allow appropriate contact time of the disinfectant
according to the instructions on the bottle.
8 Use 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
PROBLEM ACTION
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/Disinfection X Visually check all exposed parts X Visually check mechanical attachments X Visually check battery and battery charger (Electrical
version) Check hand control and cable (Electrical version) X Check the safety belt and suspension straps X Perform functionality test X Check and clean castors X Yearly checks by qualified personnel only X Replace safety belt and suspension strap X
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 lift 44 kg (97 lbs.) Maximum total weight of lift (Lift + Patient) 180 kg (397 lbs) Medical equipment Type
Walker Electric
Lifting capacity 136 kg (300 lbs.) Maximum weight of lift 53 kg (117 lbs.) Battery weight 4.4 kg (9.7 lbs.) Maximum total weight of lift (Lift + Patient) 189 kg (417 lbs) Medical equipment Type
Power Source 24V DC Protection class IP X4 Fuse F1 F10AL 250 V Insulation Class Class II Equipment
136 kg (300 lbs.)
Operating forces of controls 2.7 N Sound level 65 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 range 10% - 80% Transport and Storage
15% - 100% Operation
Atmospheric pressure range 500 - 1100 hPa Transport and Storage
800 - 1060 hPa Operation
Mode of operation ED maximum 10%;
Maximum 1 minute ON;
Minimum 9 minutes OFF Start force 85 N Rolling force 20 N Push button force <5 N Brake force 105 N Lever force 20 N
Environmental
Pollution degree 2
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Recycling
Package Wood 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
Allowed Combinations Power Model
Battery 24 V NDA0100-03 Battery charger NDA1200-EU, NDA2200-EU, NDA4200-US,
NDA6200-AU and NDA8200-INT
List of Standards and Certificates
ST ANDARD/CERTIFICATE DESCRIPTION
EN/IEC 60601-1:2005 AMD1:2012
ANSI/AAMI ES60601-1 (2005) AMD 1 (2012)
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. 60601-1:14 Medical Electrical Equipment - Part 1: General Requirements
for Basic Safety and Essential Performance
ISO 10535:2006 Hoists 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 Label States safety and environmental
information for the battery .
Identification Label
States the product identification; serial number, year and month of manufacturing.
Data Label States 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
SWL Safe Working Load (max total
load)
24V DC Supply voltage
MAX: 150 V A Maximum power
IP X4 Degree 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-XX Product 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 est Compliance Guidance
This equipment uses RF energy only for its internal functions.
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class 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.
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Guidance and manufacturer’s declaration – electromagnetic immunity Immunity test IEC 60601-1-2 test level Compliance 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
450 MHz - 28 V/m 710, 745, 780 MHz - 9V/m 810, 870, 930 MHz - 28 V/m
450 MHz - 28 V/m
710, 745, 780 MHz - 9V/m
810, 870, 930 MHz - 28 V/m
Electromagnetic environment – guidance
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
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AUSTRALIA Arjo Australia Building B, Level 3 11 Talavera Road Macquarie Park, NSW, 2113, Australia Phone: 1800 072 040
BELGIQUE / BELGIË Arjo Belgium nv Evenbroekveld 16 9420 Erpe-Mere Belgium T: +32 (0) 53 60 73 80 F: +32 (0) 53 60 73 81 E-mail: info.belgium@arjo.com
BRASIL Arjo Brasil Equipamentos Médicos Ltda Rua Marina Ciufuli Zanfelice, 329 PB02 Galpão
- Lapa São Paulo – SP – Brasil CEP: 05040-000 Phone: 55-11-3588-5088 E-mail: vendas.latam@arjo.com E-mail: servicios.latam@arjo.com
CANADA Arjo Canada Inc. 90 Matheson Boulevard West Suite 300 CA-MISSISSAUGA, ON, L5R 3R3 Tel/Tél: +1 905 238 7880 Free: +1 800 665 4831 Institutional Free: +1 800 868 0441 Home Care Fax: +1 905 238 7881 E-mail: info.canada@arjo.com
ýESKÁ REPUBLIKA Arjo Czech Republic s.r.o. Na Strzi 1702/65 140 00 Praha Czech Republic Phone No: +420225092307 e-mail: info.cz@arjo.com
DANMARK Arjo A/S Vassingerødvej 52 DK-3540 LYNGE Tel: +45 49 13 84 86 Fax: +45 49 13 84 87 E-mail: dk_kundeservice@arjo.com
DEUTSCHLAND Arjo GmbH Peter-Sander-Strasse 10 DE-55252 MAINZ-KASTEL Tel: +49 (0) 6134 186 0 Fax: +49 (0) 6134 186 160 E-mail: info-de@arjo.com
ESPAÑA Arjo Ibérica S.L. Parque Empresarial Rivas Futura, C/Marie Curie 5 Edi cio Alfa Planta 6 o cina 6.1-.62 ES-28521 Rivas Vacia, MADRID Tel: +34 93 583 11 20 Fax: +34 93 583 11 22 E-mail: info.es@arjo.com
FRANCE Arjo SAS 2 Avenue Alcide de Gasperi CS 70133 FR-59436 RONCQ CEDEX Tél: +33 (0) 3 20 28 13 13 Fax: +33 (0) 3 20 28 13 14 E-mail: info.france@arjo.com
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
NEW ZEALAND Arjo Ltd 34 Vestey Drive Mount Wellington NZ-AUCKLAND 1060 Tel: +64 (0) 9 573 5344 Free Call: 0800 000 151 Fax: +64 (0) 9 573 5384 E-mail: nz.info@Arjo.com
NORGE Arjo Norway AS Olaf Helsets vei 5 N-0694 OSLO Tel: +47 22 08 00 50 Faks: +47 22 08 00 51 E-mail: no.kundeservice@arjo.com
ÖSTERREICH Arjo GmbH Lemböckgasse 49 / Stiege A / 4.OG A-1230 Wien Tel: +43 1 8 66 56 Fax: +43 1 866 56 7000
POLSKA Arjo Polska Sp. z o.o. ul. Ks Piotra Wawrzyniaka 2 PL-62-052 KOMORNIKI (PoznaĔ) Tel: +48 61 662 15 50 Fax: +48 61 662 15 90 E-mail: arjo@arjo.com
PORTUGAL Arjo em Portugal MAQUET Portugal, Lda. (Distribudor Exclusivo) Rua Poeta Bocage n.º 2 - 2G PT-1600-233 Lisboa Tel: +351 214 189 815 Fax: +351 214 177 413 E-mail: Portugal@arjo.com
SUISSE / SCHWEIZ Arjo AG Fabrikstrasse 8 Postfach CH-4614 HÄGENDORF Tél/Tel: +41 (0) 61 337 97 77 Fax: +41 (0) 61 311 97 42
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
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Address page - REV 25: 01/2020
www.arjo.com
Page 32
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
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ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden
www.arjo.com
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