Arjo Malibu Page 58 Instructions For Use Manual Download | Manualshive

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58

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test

IEC 60601-1-2 test level

Compliance level

Electromagnetic

environment – guidance

Electrostatic
discharge
(ESD)
EN 61000-4-2

±2kV, ±4kV, ±8kV, ±15kV air
±8kV contact

±2kV, ±4kV, ±8kV, ±15kV air
±8kV contact

Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material the
relative humidity level
should be at least 30%

Conducted
disturbances
inducted by RF
fields
EN 61000-4-6

3V in 0,15 MHz to 80 MHz
6V in ISM and amateur radio
bands between 0,15 MHz
and 80 MHz
80% AM at 1 kHz

3V in 0,15 MHz to 80 MHz
6V in ISM and amateur radio
bands between 0,15 MHz
and 80 MHz
80% AM at 1 kHz

Portable and mobile RF
communications
equipment should be used
no closer to any part of the
product, including cables,
than 1.0m, 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:

Radiated RF
electromagnetic
field
EN 61000-4-3

Home Healthcare
environment
10 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz

Home Healthcare
environment
10 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz

Proximity fields
from RF
wireless
communication
s equipment
EN 61000-4-3

385 MHz - 27 V/m
450 MHz - 28 V/m
710, 745, 780 MHz - 9V/m
810, 870, 930 MHz - 28 V/m
1720, 1845, 1970, 2450 MHz
- 28 V/m
5240,5500, 5785 MHz - 9V/
m

385 MHz - 27 V/m
450 MHz - 28 V/m
710, 745, 780 MHz - 9V/m
810, 870, 930 MHz - 28 V/m
1720, 1845, 1970, 2450
MHz - 28 V/m
5240,5500, 5785 MHz - 9V/
m

Electrical fast
transient/burst
EN 61000-4-4

±1kV SIP/SOP ports
±2kV AC port
100kHz repetition frequency

±1kV SIP/SOP ports
±2kV AC port
100kHz repetition frequency

Mains power supply should
be that of a typical
commercial or hospital
environment.

Power
frequency
Magnetic field
EN 61000-4-8

30A/m
50 Hz or 60 Hz

30A/m
50 Hz

Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

Surge
IEC 61000-4-5

±0,5kV ±1kV; ±2 kV, AC
Mains, Line to Ground
±0,5kV ±1kV, AC Mains, Line
to Line

±0,5kV ±1kV; ±2 kV, AC
Mains, Line to Ground
±0,5kV ±1kV, AC Mains,
Line to Line

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Summary of Contents for Malibu

Page 1: ...Malibu Sovereign 2021 Edition INSTRUCTIONS FOR USE 04 AZ6 00_2EN 06 2021 ...

Page 2: ...us 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 WARNING To avoid injury always read this Instructions for Use and accompanied documents before using the product Mandatory to read the Instructions for Use ...

Page 3: ...play 15 Shower 15 Safety Belt 16 Disinfection Unit Optional 18 Transfer Chassis Optional 18 Transfer Chair 19 Air Spa System Operation option 20 Connect the Transfer Chair to Lifting Arm 21 Disconnect the Transfer Chair to Lifting Arm 22 Assisted Bathing with Transfer Chair 24 To the Malibu Sovereign bathtub 24 From the Malibu Sovereign bathtub 28 Home Care Use 30 Space Requirements in mm around t...

Page 4: ...r The contact information appears on the last page of this IFU 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 mem...

Page 5: ...ive The patient s weight must not exceed 130 kg The patient must understand and be able to respond to instructions to stay seated in an upright position The patient s length must be in the range of 140 and 200 cm If the Patient does not meet these criteria an alternative equipment system should be used Installation requirements The equipment must be installed by appropriately trained personnel acc...

Page 6: ...bstacles WARNING To avoid entrapment make sure to keep the patients hair arms and feet close to the body and use designated grab supports during any movement 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 electric shock never use other electrical equipment near this device other than s...

Page 7: ...ostatic mixer has been calibrated according to the Assembly and Installation Instructions by an Arjo technician or qualified personnel 9 Make sure to have a rescue plan ready in case of a patient emergency Actions Before Every Use 4 steps 1 Check that all parts are in place Compare to section Parts Designation on page 8 2 Check Malibu Sovereign bathtub and accessories for damage 3 If any part is m...

Page 8: ... 4 Emergency stop 5 Pop up drain control knob built in surface overflow outlet 6 Shower handle and holder 7 Armrests 8 Lifting arm 9 Transfer chair 10 Safety belt 11 Hand control 12 Disinfection unit door optional 13 Side cover optional 14 Corner cover optional 15 Side cover 16 Back cover optional 17 Front cover 18 Disinfection spray handle bathtub with disinfection 19 Disinfectant bottle bathtub ...

Page 9: ...9 3 18 20 19 24 Malibu bathtub 22 23 4 Sovereign bathtub 4 A M D E F L K B C H I J Basic Assisted G 2 3 6 7 8 9 25 26 5 21 11 10 1 1 1 1 1 1 1 1 13 27 28 16 15 12 14 17 ...

Page 10: ... with the chair in the bathtub before trying to lift out rotate the chair If not in the lowest position the LED for lowering the bathtub on the control panel will light up Control Panel Lower Raise the Malibu Sovereign bathtub Push and hold the lower Malibu Sovereign bathtub button A to lower the bathtub See Fig 4 Push and hold the upper Malibu Sovereign bathtub button B to raise the bathtub NOTE ...

Page 11: ...the transfer chair out of the bathtub If the battery fails to work during a power failure no LED indication contact your Arjo technician The battery must be checked and replaced through a yearly check by authorized personnel according to section Care and Preventive Maintenance on page 43 LED Indications See Fig 2 Mains power status No LED Mains off Green LED Mains on Battery Charging Status mains ...

Page 12: ... easier cleaning access To attach the armrest to the transfer chair first hold the armrest with the handle pointing upwards Guide the armrest slots onto the transfer chair Then fold the armrest forward See Fig 4 NOTE To reset the emergency stop function turn the red emergency button clockwise until it pops up NOTE Do not leave the Malibu Sovereign bathtub with the emergency stop pressed down since...

Page 13: ... the front frame 2 Push down the bent part of the seat 3 Push one side around the armrest and make sure it snaps into place 4 Repeat on the other side Remove 2 steps See Fig 2 1 With both hands detach the seat on each side around the armrest 2 Repeat on the other side 3 Pull the bottom of the seat straight up Fig 1 Fig 2 ...

Page 14: ...d then every 24 hours if the bathtub is not used Auto Fill Function The Malibu Sovereign bathtub is equipped with an auto fill function which is preset to a water level height in the bathtub 285 mm for Malibu 1700 240 mm for Malibu 1600 and Sovereign Activate it by 1 Pushing the bathtub filling button 2 Once the filling level is reached it stops by itself Push the bathtub filling button again and ...

Page 15: ...er temperature Temperature Display The Malibu Sovereign bathtub has two temperature displays See Fig 1 The top display gives the current temperature of the water in the tub A The lower display gives the active filling or shower water temperature B Shower The shower water temperature is adjusted by turning the temperature setting knob See Fig 2 NOTE Temperature readings occur on sequence why they s...

Page 16: ...s at the top and bottom of the buckle clips A and at the same time pulling the buckle clips apart from each other See Fig 4 Adjust 5 steps 1 Pull the fastening clips A and B apart by twisting the smaller fastening clip A slightly upwards See Fig 5 Continue with the steps on the next page WARNING To prevent the patient from falling make sure the safety belts are undamaged If damaged do NOT use the ...

Page 17: ...lip B See Fig 7 4 Make sure the safety belt is firmly attached to the patient s body 5 Lock the buckle clips by inserting the smaller buckle clip A into the larger buckle clip B See Fig 8 When not in use Make sure that the safety belt is buckled over the seat when the transfer chair is not in use See Fig 9 Remove Remove the safety belt by pulling it away from the knobs at the back of the chair See...

Page 18: ...ntrol The bottle has a low level warning The green LED on the disinfection button flashes and makes a buzzer sound Transfer Chassis Optional The transfer chassis is used in combination with the detachable transfer chair See Fig 3 Apply the brakes on the castors press the lower part of the castor lock tab with your foot See Fig 4 Release the castor brakes press the upper part of the castor lock tab...

Page 19: ...o avoid entrapment make sure to keep the patients hair arms and feet close to the body and use designated grab supports during any movement WARNING To avoid the patient from falling out of the device make sure that all catches are in a locked position See Fig 1 WARNING To avoid entrapment or pinching of genitals make sure there is enough clearance during movement over the tub edge toilet bedpan or...

Page 20: ...inutes The Air Spa system has two different intensity settings How to use the Air Spa System 3 steps 1 Push the Air Spa system ON OFF button on the control panel and the air blower will start at minimum speed 2 The intensity of the air stream will increase by pushing the button again 3 Push the button again to stop NOTE Operating the Air Spa system with soapy water can cause excessive foaming Fig ...

Page 21: ...ting arm by pushing the Lift in button on the hand control so that the transfer chair is secured on the lifting arm and the transfer chassis is clear of the floor See Fig 2 5 Pull out the spring loaded catch to release the transfer chassis from the transfer chair and at the same time slide out the transfer chassis sideways from the chair See Fig 3 and 4 3 WARNING To avoid the patient from falling ...

Page 22: ... the Malibu Sovereign bathtub See Fig 1 3 Lower the chair but leave enough space underneath for the transfer chassis to be lifted up and to be able to slide it under the chair 4 Make sure the castor brakes on transfer chassis are unlocked 5 Lift the transfer chassis up and slide it into the two rails located underneath the chair See Fig 2 6 Make sure the spring loaded catch in the back of the chai...

Page 23: ...er chassis touches the floor 10 Once castors on the transfer chassis touch the floor lift up the safety catch on the lifting arm and then continuing lowering the chair by pushing the Lift out button See Fig 5 11 Make sure the chair is completely unhooked from the lifting arm 9 WARNING To avoid falling the transfer chassis castors must be unlocked when detaching the transfer chair from the lifting ...

Page 24: ...attached transfer chair using a standing and raising aid or wheelchair then see its corresponding IFU If a patient is being positioned on an already attached transfer chair then continue on step 11 Continue with the steps on the next page WARNING To avoid falling make sure that the patient is positioned correctly and that the safety belt is being used properly fastened and tightened and that the a...

Page 25: ...e transfer chair is secured on the lifting arm and the transfer chassis is clear of the floor Continue with the steps on the next page 5 WARNING To avoid entrapment of the patients or caregivers legs or feet make sure that they are kept clear of all obstacles 6 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 l...

Page 26: ...y pushing the Lift out button The chair will only be raised since the rotation of the chair out of the Malibu Sovereign bathtub will only work when the bathtub is at lowest position This makes it easier to clean parts of the patient s body which would otherwise be out of reach See Fig 9 15 Push the Lift in button to lower the transfer chair back again 11 WARNING To avoid entrapment or pinching of ...

Page 27: ...27 Intentionally left blank ...

Page 28: ...the transfer chassis to be lifted up and slide under the transfer chair 5 Make sure the transfer chassis are unlocked 6 Lift the transfer chassis up and slide it into the two rails located underneath the transfer chair See Fig 2 Continue with the steps on the next page WARNING To avoid falling make sure that the patient is positioned correctly and that the safety belt is being used properly fasten...

Page 29: ...lifting arm open and then continuing lowering by pushing the Lift out button See Fig 5 12 Make sure the chair is completely unhooked from the lifting arm before transport 13 Transport the patient on the transfer chair connected to transfer chassis See Fig 6 If a patient is being positioned from the transfer chair to a standing and raising aid or wheelchair see its corresponding IFU See Fig 7 14 Ma...

Page 30: ...ts described in this IFU WARNING To prevent scalding make sure that the thermostatic mixer has been calibrated Confirm that responsible organization has established calibration routines Use the Malibu Sovereign bathtub Before using the Malibu Sovereign bathtub in home environment make sure that All caregivers including relatives have read and understood the instructions in this IFU All carpets and...

Page 31: ...s for personnel and patient Wall Position measurements depending on Malibu Sovereign bathtub model Contact Arjo to order side back corner cover if Short side is equal or larger measurements than 60 mm Long side is equal or larger measurements than 80 mm NOTE Space for furniture and other personal items are not included in these measurements 55 80 1602 1702 770 Fig 1 Fig 2 55 80 1602 1702 770 30 60...

Page 32: ... Malibu Sovereign bathtub model Contact Arjo to order side back corner cover if Short side is equal or larger measurements than 60 mm Long side is equal or larger measurements than 80 mm Fig 3 55 80 1602 1702 770 30 60 55 80 1602 1702 770 Fig 4 ...

Page 33: ...s depending on Malibu Sovereign bathtub model Contact Arjo to order side back corner cover if Short side is equal or larger measurements than 60 mm Long side is equal or larger measurements than 80 mm Fig 5 30 60 1602 1702 770 Fig 6 ...

Page 34: ...34 Intentionally left blank ...

Page 35: ...htub not included in Malibu Sovereign bathtub delivery Protective glasses Protective gloves Spray bottle with disinfectant or disinfection spray handle with disinfectant Not needed for a Malibu Sovereign bathtub with integrated disinfection Spray bottle with water shower handle with water Cloths Wet and Dry Disposable towels Soft bristled brush Long handled soft bristled brush Allowed Disinfectant...

Page 36: ...lity Maintain a high water temperature all the way from the hot water dispenser to the different distribution pipes Mix hot and cold water as close as possible to the point of use Use Make sure that the water circulates in the Malibu Sovereign bath and the shower on a daily basis even if the bathtub is not used and particular to make sure to remove any water that may be left behind in the hose Let...

Page 37: ...fectant bottle inside the disinfection compartment See Fig 1 8 Set the temperature control as low as possible 9 Grab the disinfection spray handle 10 Spray disinfection fluid while keeping an eye on the flow meter 1 Check the liquid value so it is in accordance with the recommended mix ratio See Fig 2 If necessary adjust the bottle suction cap to get the right mix ratio See Fig 3 1 Put the disinfe...

Page 38: ...isible residue Turn accessories and loose parts and rinse again Clean step 8 18 8 Put on protective gloves and protective glasses See Fig 2 9 Spray disinfectant in drain Use a long handled brush to scrub drain 10 Close the drainage plug 11 Spray disinfectant on all internal Malibu Sovereign bathtub surfaces the lifting arm and the transfer chair and the loose parts and other accessories at the bot...

Page 39: ...ention to parts and knobs attached to the Malibu Sovereign bathtub surface such as drain control knob surface overflow outlet See Fig 5 22 Soak a cloth in disinfectant 23 Wipe all other contact areas such as the outside of the Malibu Sovereign bathtub particularly behind the head metal sensory knobs hand control and the transfer chassis if any with the cloth 24 Allow an appropriate contact time of...

Page 40: ...Start from the top and move downwards 7 Shower and rinse the loose parts and the accessories in the bottom of the bathtub with water to remove visible residue Turn accessories and loose parts and rinse again Clean step 8 25 8 Put on protective gloves and glasses See Fig 2 9 Open the disinfection cover and lift out the disinfection spray handle See Fig 3 10 Check the level of disinfectant 11 Press ...

Page 41: ...ssories with a soft bristle brush or cloth to remove any deposits e g skin flakes Scrub thoroughly especially on handles See Fig 8 19 Soak a cloth in disinfectant 20 Wipe all other contact areas such as the outside of the Malibu Sovereign bathtub particularly behind the head metal sensory knobs hand control and the transfer chassis optional with the cloth 21 For bathtubs with Air Spa system Disinf...

Page 42: ...the outside of the Malibu Sovereign bathtub particularly behind the head metal sensory knobs hand control and transfer chassis optional with the cloth 32 Allow an appropriate contact time of the disinfectant according to the disinfectant IFU 33 For bathtubs with Air Spa system Disinfection cycle will turn off automatically For bathtubs without Air Spa system Press the Disinfection button on the co...

Page 43: ...hedule CAREGIVER OBLIGATIONS Action Check Between Patients Every Week Every Month Every Year Every 2 nd Year Every 5 th Year Clean and Disinfect X Visually check all exposed parts X Visually check mechanical attachments X Visually check hoses pipes and connections X Check hand control and cable X Check castors and brakes on transfer chassis X Perform functionality test X Check neck pillow X Visual...

Page 44: ... or caregiver 2 Make sure that no cracks or sharp edges could cause injury or become unhygienic Visually check mechanical attachments 1 Check that all screws and nuts are tightened and that there are no gaps 2 Check safety catch and transfer chair attachment for ease of movement and intact parts See Fig 1 3 Check the lifting hook attachment with transfer chair unhooked by trying to rotate the hook...

Page 45: ...nd control functions disinfection options and the lifting functions 2 With water turned on check shower hose handle and holder for damage 3 Sovereign bathtub lifting arm Check lifting arm for correct movement by checking that the transfer chair slides on the seat guides in the bathtub See Fig 6 Check neck pillow Make sure there are no cracks or tears that would allow water to get into the filling ...

Page 46: ...Sovereign bathtub is in its highest position 2 The shut off valve can be reached under the Malibu Sovereign bathtub The filter in both valves should be rinsed as follows 1 Close the valves A The handles red for hot water and blue for cold should be in a cross position See Fig 2 2 Remove the cap B with a wrench 3 Pull out the filter C and clean it carefully in water 4 Reassemble B and C 5 Open the ...

Page 47: ...piring date for seat Look at the label located on the back of the seat to find the expiration date See Fig 1 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 Caregiv...

Page 48: ...y Lifting arm in out of the Malibu Sovereign bathtub does not work 1 Malibu Sovereign bathtub is not in the lowest position Lower the bathtub 2 Check hand control and cables replace if necessary No water flow or bad water flow during Malibu Sovereign bathtub filling and shower 1 Check incoming water flow 2 Check clean filters No water flow or bad spray pattern during shower only No water flow Turn...

Page 49: ...reign bathtub 3 With mains on check battery level LED for a green light indication When the battery level with green LED light is steady the battery is charged Battery level LED flashing green with mains on and battery connected 1 Battery is charging the battery is fully charged when green LED light becomes steady 2 If the battery level LED never becomes steady the battery needs to be replaced dur...

Page 50: ...172 kg Maximum floor load 576 kg 1 m2 Maximum floor pressure 4 5 N mm2 Maximum ambient temperature 40 C Operating force Push buttons on hand control and panel Emergency stop 3 1 N 10 1 N Degree of protection Class Lift Hi Lo IPX4 IP Ingress Protection X The protection against contact and ingress of objects is not specified for this product 4 Water splashing against the product from any direction d...

Page 51: ...2 s outside 22 2 s inside 20 2 s outside 25 2 s inside 21 2 s outside Cyclic time for lifting arm movement up turn down full load Malibu 1600 with patient lift Malibu 1700 with patient lift Sovereign with patient lift 61 2 s 60 2 s 61 2 s Maximum duty cycle Lift actuator chair and Malibu Sov ereign bathtub 1 minute ON 9 minutes OFF Maximum duty cycle Air Spa system 15 minutes ON 15 minutes OFF WAR...

Page 52: ...ient voltage 4 kV Creepage distance 3 mm Air clearance 1 8 mm Direction of movement Up and down right and left clockwise and counterclockwise If local regulations are higher they must be met Water Connections Cold hot water connection G 3 4 male customers connection Maximum static pressure 6 bar 600 kPa 87 psi Minimum operating pressure 1 bar 100 kPa 15 psi Minimum drainage capacity 100 l minute T...

Page 53: ...shall be separated and recycled according to marking on the unit Disposal of Malibu Sovereign bathtub Malibu Sovereign Bathtub End of Life Disposal Equipment that has electrical and electronic components should be disassembled and recycled per Waste of Electrical and Electronic Equipment WEEE or in accordance with local or national regulation Disinfection liquids if you have extra liquid it s safe...

Page 54: ...N and OFF Read the IFU before use The manufacturer s catalogue number The manufacturer s serial number The legal manufacturer of a product REF SN The date when the medical device was manufactured Separate electrical and electronic components for recycling in accordance with the European Directive 2012 19 EU WEEE Expiration date for the seat year and month SWL Safe working load Max Patient Weight M...

Page 55: ...tention Label Data Label for transfer Chassis Data Label for Malibu Sovereign Bathtub Lift EU Approval Label Data Label for Chair seat Data Label for armrest Attention Label Applied Part Data Label for lift ...

Page 56: ...ting for the National Health Service IEC 60601 1 6 2010 A1 2013 Medical electrical equipment Part 1 6 Collateral standard Usability IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General requirements for safety EN 60601 1 2 2015 Electromagnetic compliance IEC 60601 1 11 2015 General requirements for basic safety and essential performance Collateral Standard Requirements for medical e...

Page 57: ...their base stations walkie talkies etc can affect this equipment and should be kept at least 1 5 m away from the equipment 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 ...

Page 58: ...b Interference may occur in the vicinity of equipment marked with this symbol Radiated RF electromagnetic field EN 61000 4 3 Home Healthcare environment 10 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz Home Healthcare environment 10 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz Proximity fields from RF wireless communication s equipment EN 61000 4 3 385 MHz 27 V m 450 MHz 28 V m 710 745 780 MHz 9V m 810 870 930 MHz...

Page 59: ...e prior to application of the test level 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 cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If th...

Page 60: ...45 041 Transfer chassis S8557492 Safety belt S8664559 03 Neck Pillow 8350897 031 Battery Kit AH1012091 Side cover AH1008797 Back cover Malibu 1600 AH1011993 Back Cover Malibu 1700 Sovereign AH1011770 Corner cover AH1006584 Wall Bracket kit 8547054 Bedpan CDA 1500 07 bedpan holder AJA 1105 09 ...

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Page 62: ...62 Intentionally left blank ...

Page 63: ... ORRU 4 XLOGLQJ 1RUWK 7RZHU 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 Nederland BV LH HQZHL 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 1 8 1 Tel 64 0 9 573 5344 Free Call ...

Page 64: ...e 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 the standard of safe and digni ed care Everything we do we do with people in mind ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö Sweden www arjo com ...

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