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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
communications
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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Содержание Malibu

Страница 1: ... with people in mind 04 AZ 00_14GB 12 2018 Malibu Sovereign Instructions for Use ...

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

Страница 3: ...llow 13 Auto Fill Function 14 Scalding Protection 14 Temperature Display 14 Shower 14 Safety Belt 15 Disinfection Unit 17 Wheel Chassis 17 Transfer Chair 18 Air Spa System Operation option 19 Connect Disconnect the Transfer Chair 20 Assisted Bathing with Transfer Chair 23 Home Care Use 28 Cleaning and Disinfection Instructions 30 Care and Preventive Maintenance 37 Troubleshooting 42 Technical Spec...

Страница 4: ...ce that occur as a result of any unauthorized modification to its products Report Unexpected Operations or Events Contact your local ArjoHuntleigh representative if any unexpected operations or events occur The contact information appear on the last page of this IFU Foreword Service and Support A service routine has to be done on the Malibu Sovereign bathing system to make sure the safety and oper...

Страница 5: ...mend that facilities establish regular assessment routines Caregivers must assess each resident according to the following criteria prior to use The resident must be able to sit in an upright position normally defined as active or semi active The resident s weight must not exceed 130 kg 286 lbs The resident must understand and be able to respond to instructions to stay seated in an upright positio...

Страница 6: ...t always remains in a seated position WARNING To avoid entrapment of the patients or caregivers legs or feet make sure that they are kept clear of all obstacles WARNING To avoid injury make sure that the patient is not left unattended at any time 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 WARN...

Страница 7: ... IFU should be kept and is easily accessible at all times 8 Make sure the thermostatic mixer has been calibrated according to the Assembly and Installation Instructions by a qualified personnel or an ArjoHuntleigh technician 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 Designatio...

Страница 8: ...p up drain control knob with built in surface overflow outlet 6 Shower handle and holder optional 7 Arm rests 8 Lift arm 9 Transfer chair fixed detachable 10 Safety belt 11 Hand control holder 12 Hand control 13 Disinfection unit optional 14 Disinfection spray handle optional 15 Bottle with concentrated disinfectant liquid optional 16 Flowmeter optional 17 Drain pipe 18 Air Spa system nozzles 8 no...

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

Страница 10: ...n when the chair is in the bathtub trying to lift out rotate the chair will stop and the LED for lowering the bathtub on the control panel will light up Patient Lock out Push and hold the patient lock out button A for 3 s and it will disable all panel and remote buttons preventing involuntary activation of functions Patient lock out is indicated by a yellow LED B See Fig 4 Push and hold for anothe...

Страница 11: ...he drainage plug by turning the pop up drain control knob in the bathtub See Fig 2 The pop up drain control knob is also equipped with a built in surface overflow outlet Emergency Stop Function In case of emergency all function can be stopped by pushing the red emergency button See Fig 3 Do not use the emergency stop as ON OFF button as it disables the auto flush function Green LED flash Battery i...

Страница 12: ... with the handle pointing up wards Guide the arm rest slots onto the transfer chair Then fold the arm rest forward See Fig 2 NOTE Do not leave the bathtub with the emergency stop pressed down since it will disable the auto flush function NOTE Make sure the shower handle is placed in the shower handle holder to prevent water from ending up outside the bathtub WARNING To avoid entrapment make sure t...

Страница 13: ... 4 Repeat on the other side Remove 2 steps See Fig 2 1 With both hands detach the seat on each side around the arm rest 2 Repeat on the other side 3 Pull the bottom of the seat straight up Neck Pillow A pillow gives comfort and support during the transfer and bathing See Fig 3 A Preferably used if the patient is short or when the pillow is used and the transfer chair is being detached B Preferably...

Страница 14: ...etected The LED between the displays lights up if a temperature above or equal to 45 C 113 F after 10 s is detected Temperature Display The Malibu Sovereign bath has two temperature displays See Fig 1 The top display gives the current bath water temperature A The lower display gives the active filling or shower temperature B Shower The shower temperature is adjusted by turning the temperature sett...

Страница 15: ...at the top and bottom of the buckle clips B and at the same time pulling the buckle clips B 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 ...

Страница 16: ...s firmly attached to the patient s body 5 Lock the fastening clips by inserting the smaller fastening clip A into the larger fastening clip B See Fig 8 When not in use 1 step 1 Make sure that the safety belt is buckled over the seat when the transfer chair is not in use See Fig 9 Remove 2 steps 1 Remove the safety belt by pulling it away from the knobs at the back of the chair See Fig 10 2 It is a...

Страница 17: ...assis The wheel chassis is used in combination with the detachable transfer chair Apply the brakes on the castors by pressing the lower part of the castor lock tab with your foot See Fig 3 Release the castor brakes by pressing the upper part of the castor lock tab with your foot See Fig 3 For attaching the wheel chassis to the transfer chair slide the wheel chassis under the transfer chair from ei...

Страница 18: ...ssis may also be used over a toilet not applicable when using the comfort seat See Fig 3 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 the patient from falling out of the device make sure that all catches are in a locked position WARNING To avoid entrapment or pinching of genital...

Страница 19: ...r 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 1 Air Spa sys...

Страница 20: ...g down the Lift in button on the hand control so that the transfer chair is secured on the lift arm and the wheel chassis is clear of the floor See Fig 2 7 Pull out the spring loaded catch to release the wheel chassis from the transfer chair and at the same time slide out the wheel chassis sideways from the chair See Fig 3 and 4 3 WARNING To avoid the patient from falling out of the device make su...

Страница 21: ...thtub See Fig 1 3 Lower the chair but leave enough space for the wheel chassis to be lifted up and slid under the chair 4 Make sure the wheel chassis is unlocked 5 Lift the wheel chassis up and slide it into the two rails located underneath the chair See Fig 2 6 Make sure the spring load catch in the back of the chair clicks into place Listen for the click sound when inserting the wheel chassis Se...

Страница 22: ...the wheel chassis touches the floor 11 Once castors on the wheel chassis touches the floor lift up the safety catch on the lift arm open and then continuing lowering by pushing the Lift out button 12 Make sure the chair is completely unhooked from the lift arm See Fig 5 9 WARNING To avoid falling the wheeled chassis castors must be unlocked when detaching the transfer chair from the lift arm Fig 4...

Страница 23: ... by wheelchair See Fig 4 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 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 th...

Страница 24: ... transfer chair is secured on the lift arm and the wheel chassis is clear of the floor Continue with the steps on the next page 7 WARNING To avoid entrapment of the patients or caregivers legs or feet make sure that they are kept clear of all obstacles 8 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...

Страница 25: ...Lift out button The chair will only be raised since the rotation of the chair out of the 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 10 19 Push down the Lift in button to lower the transfer chair back again 14 WARNING To avoid entrapment or pinching of genitals make sure there ...

Страница 26: ... for the wheel chassis to be lifted up and slid under the chair 6 Make sure the wheel chassis are unlocked 7 Lift the wheel chassis up and slide it into the two rails located underneath the 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 fastened and tightened WARNIN...

Страница 27: ...ouches the floor lift up the safety catch on the lift arm open and then continuing lowering by pushing the Lift out button See Fig 5 14 Make sure the chair is completely unhooked from the lift arm before transport 15 Transport the patient on the transfer chair with wheel chassis or transfer the patient to a standing and raising aid or wheelchair See Fig 6 16 Make sure to disinfect and clean the ba...

Страница 28: ...s understood the cleaning and disinfection instructions Perform a functionality test according to section Care and Preventive Maintenance on page 37 The environment fulfils all the requirements described in this IFU WARNING To prevent scalding make sure that the water mixer has been calibrated Confirm that responsible organization has established calibration routines Use the Malibu Sovereign bath ...

Страница 29: ...overeign bath must always be installed according to recommended space requirements this to provide optimal working conditions for personnel and patient NOTE SSDFH IRU IXUQLWXUH DQG RWKHU SHUVRQDO LWHPV DUH QRW LQFOXGHG LQ WKHVH PHDVXUHPHQWV Fig 1 Fig 2 ...

Страница 30: ...Data Sheets MSDS available for the disinfectant being used Accessories for Disinfecting the Malibu Sovereign bath Protective glasses Protective gloves Spray bottle with disinfectant or disinfection spray handle with disinfectant Spray bottle with water shower handle with water Cloths Wet and Dry Disposable towels Soft bristled brush Long handled soft bristled brush WARNING To avoid eye and skin da...

Страница 31: ...e sure to close the disinfection cover after use to prevent the patient getting their feet hurt during lowering of the chair Installation precautions In order to limit the growth of bacterial flora it is necessary to take action at four levels Avoid stagnating water and make sure proper water circulation Take precautions against the formation of scale and corrosion based on the water quality Maint...

Страница 32: ...e gloves and eye wear See Fig 2 9 Spray shower disinfectant in drain Use a long handled brush to scrub drain 10 Close the drain 11 Spray disinfectant on all internal bathtub surfaces the lift arm and the transfer chair and the loose parts and other accessories at the bottom of the bathtub Turn the loose parts and the accessories and spray on other side Pay attention to parts and knobs and sensors ...

Страница 33: ...ol knob surface overflow outlet See Fig 5 22 Allow an appropriate contact time of the disinfectant according to the instructions on the disinfectant bottle 23 Open the drain 24 Rinse all parts clean with plenty of water having a temperature of approximately 25 C 77 F using the shower handle to remove disinfectant 25 Soak a cloth in disinfectant 26 Wipe all other contact areas such as the outside o...

Страница 34: ...d 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 24 of 40 8 Put on protective gloves and eye wear 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 Push down the disinfection button A on the control panel for 5 s The LED w...

Страница 35: ...the surface of overflow outlet See Fig 5 19 Scrub the surfaces of bathtub loose parts and accessories with a soft bristle brush or cloth to remove any deposits e g skin flakes Scrub thoroughly especially on handles and hand control See Fig 6 20 Open the drain 21 Rinse all parts clean with plenty of water having a temperature of approximately 25 C 77 F using the shower handle to remove disinfectant...

Страница 36: ...trol panel to end the disinfection cycle 32 If the bathtub has an Air Spa system Push the disinfection button and it will shorten the sequence for the automatic disinfection cycle Reduced time is up to 35 s The LED will start flashing A sequence of rinsing and drying of the Air Spa system will now start and when complete the automatic disinfection stops and the LED goes out 33 Place the disinfecti...

Страница 37: ...cannot be maintained and serviced while in use with the patient CAREGIVER OBLIGATIONS Action Check Between Patients Every Week Every Month Every Year Every 2 nd 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 on wheel chassis X Perform functionality test X...

Страница 38: ...patient 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 t...

Страница 39: ...ction options and the lifting functions 2 With water turned on check shower hose handle and holder for damage 3 Sovereign bath lift arm Check lift 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 If there is such damage replace the p...

Страница 40: ...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 5 Open the valves Check expiring date for seat replace before expired Look at the label located on the back of the seat to find the expiration date See Fig 3 WARNING Pressurised ...

Страница 41: ...ce 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...

Страница 42: ...d in out of the bathtub does not work Check hand control and cables replace if necessary Lift arm in out of the bathtub does not work 1 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 bathtub filling and shower 1 Check incoming water flow 2 Check clean filters No water flow or bad water flow during ...

Страница 43: ...eeping sound is heard Only the lift arm out of bathtub can be operated This means that mains is off and battery is almost empty 1 Finish bath at once 2 Wait for mains to return before starting new bath 3 With mains on check battery level LED for green indication When the battery level with green LED light is steady the battery is charged Battery level LED flashing green with mains on 1 Battery is ...

Страница 44: ...lbs Bathtub weight excluding package 190 kg 5 kg 419 lbs 11 lbs Maximum floor load 576 kg 1 0 m2 Maximum floor pressure 4 5 N mm2 Maximum ambient temperature 40 C 104 F Operating force Push buttons on hand control 3 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...

Страница 45: ...A Fuses 230 V 10 A Power supply cord Only replaced by qualified personnel Lifting stroke bathtub 300 mm 11 3 4 Bathtub raising time full load 33 5 s Bathtub lowering time full load 25 5 s Lifting stroke lift arm Malibu Sovereign bath 530 mm 20 7 8 580 mm 23 Cyclic time for lift arm movement up turn down full load 65 5 s Maximum duty cycle Lift actuator 1 minute ON 9 minutes OFF Maximum duty cycle ...

Страница 46: ...er bars but Large and Stretchers Maxi Twin Range All hanger bars but Large Sara 3000 Sara Plus Sara Lite and Stedy No other combinations are allowed Recycling Battery Recyclable Not for disposal Environment danger Package Wood and corrugated cardboard recyclable The product Electric steel and plastic parts shall be separated and recycled according to WEEE Disposal of Malibu Sovereign bath Bathtub ...

Страница 47: ...47 Intentionally left blank ...

Страница 48: ...e Supply voltage Supply voltage Voltage Feed 800 VA Power maximum IPX4 Protection class i e the product is protected against splashing water Class I Connected to protective earth Mode of operation Time span of operation being turned ON and OFF Read the IFU before use Separate electrical and electronic components for recycling in accordance with the European Directive 2012 19 EU WEEE Expiration dat...

Страница 49: ...on Label Data Label for Wheel Chassis Data Label for Bathtub Lift EU Approval Label Data Label Bathtub Lift US Data Label for Seat Data Label for Arm Rest Attention Label Applied Part Data Label for Wheel Chassis Identification Label ...

Страница 50: ...used in the home healthcare environment ANSI Z124 1 1995 Standards for Plastic Bathtub Units ANSI ASME A112 19 8 1987 Suction Fittings ANSI ASSE 1014 1989 Handheld Shower ANSI ASSE 1016 2005 Individual Thermostatic Pressure Balancing and Combination Pressure Balancing and Thermostatic Control Valves for Individual Fixtures EN 1717 2001 Protection against pollution of portable water in water instal...

Страница 51: ...51 Intentionally left blank ...

Страница 52: ...and 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 ...

Страница 53: ...geb Interference may occur in the vicinity of equipment marked with this symbol Radiated RF electromagnetic field EN 61000 4 3 HomeHealthcareenvironment 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 communications 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 ...

Страница 54: ...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...

Страница 55: ...55 Parts and Accessories For disinfectant contact local ArjoHuntleigh representative Chair seat commode and comfort Safety belt 8664559 Neck support ArjoHuntleigh Arjo Clean ...

Страница 56: ...Intentionally left blank ...

Страница 57: ...Intentionally left blank ...

Страница 58: ...Intentionally left blank ...

Страница 59: ...y promo arjo com MIDDLE EAST Huntleigh Middle East Of ce G005 Nucleotide Complex Biotechnology Research Park P O Box 214742 Dubai United Arab Emirates Tel 971 0 4 447 0942 E mail 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 ...

Страница 60: ...ective everyday care early mobilisation safe patient handling venous thromboembolism prevention pressure injury prevention hygiene routines bariatric care and diagnostics With extensive know ledge and experience we strive to improve efficiency and ensure a safer and dignified environment for caregivers and their patients ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö Sweden www arjohuntleig...

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