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Guidance and Manufacturer’s declaration - Electromagnetic Immunity

The

Maxi Air

system is intended for use in the electromagnetic environment specified below. The customer or the

user of the

Maxi Air

system should ensure that it is used in such an environment.

Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity Test

IEC 60601 Test Level Compliance Level

Electromagnetic Environment

Guidance

Electrostatic Discharge

(ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete

or ceramic tile. If floors are

covered with synthetic material,

the relative humidity should be at

least 30%

Electrical fast

Transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

± 2 kV for power sup-

ply lines

± 1 kV for input-out-

put

± 1 kV line(s) to

line(s)

± 2 kV line(s) to PE

± 2 kV for power supply

lines

± 1 kV for input-output

± 1 kV line(s) to line(s)

± 2 kV line(s) to PE

Mains power quality should be

that of a typical commercial or

hospital environment.

Mains power quality should be

that of a typical commercial or

hospital environment.

Voltage dips, short

interruptions and volt-

age variations on power

supply input lines

IEC 61000-4-11

< 5% UT

(>95% dip in UT)

For 0,5 cycle

40% UT

(60% dip in UT)

70% UT

(30% dip in UT)

< 5% UT

(>95% dip in UT) for

five seconds

< 5% UT

(>95% dip in UT)

For 0,5 cycle

40% UT

(60% dip in UT)

70% UT

(30% dip in UT)

< 5% UT

(>95% dip in UT) for

five seconds

Mains power quality should be

that of a typical commercial or

hospital environment.

If the user of the

Maxi Air

system

requires continued operation

during mains interruptions, it is

recommended that the

Maxi Air

system be powered from an

interruptible power supply or

battery.

Power Frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

3A/m

Power frequency magnetic fields

should be at levels characteristic

of a typical commercial or

hospital environment.

NOTE
UT is the AC mains voltage prior to application of the test level.

Содержание Maxi Air

Страница 1: ... with people in mind 04 MS 01_7GB July 2013 Maxi Air INSTRUCTIONS FOR USE ...

Страница 2: ...s 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 Hospital Equipment AB 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: ... Correct Placement of the Maxi Air air supply 14 Transfer 16 Disinfection Instructions 20 Care and Preventive Maintenance 22 Check and Change the Air Filter 24 Troubleshooting 25 Technical Specifications 26 Labels on Maxi Air mattress 30 Labels on Maxi Air air supply 32 Approvals and List of Standards 34 Electromagnetic Compatibility 35 Parts and Accessories 38 ArjoHuntleigh Addresses 39 ...

Страница 4: ...ld responsible for any accidents incidents or lack of performance that occur as a result of any unauthorized modification to its products Service and Support A service routine must be performed on your Maxi Air every year by qualified personnel to ensure the safety and operating procedures of your product See section Care and Preventive Maintenance If you require further information please contact...

Страница 5: ...ndent unable or not required to participate in the transfer activity The equipment is intended for adult patients The patient safe working load SWL of the Maxi Air mattress is 1200 lbs 544 kg The weight girth and body shape of the patient should be assessed in terms of the potential risk for the caregivers who are to perform the patient transfer using this equipment Maxi Air is intended for use in...

Страница 6: ...ire never use the equipment in oxygen rich environment in presence of heat source or flammable anaesthetic gases WARNING This equipment does not contain any HEPA filter This may cause problems for patients sensitive to contaminated air WARNING To avoid bodily injury to the patient use the Maxi Air in an environment where the temperature is below 32 C 90 F Temperatures above 32 C 90 F can cause the...

Страница 7: ...acement of the patient and Product Specifications 2 Check that all parts of the Maxi Air is in place Compare with the section Parts Designation in this IFU 3 Carry out a thorough inspection for damage 4 If any part is missing or damaged do NOT use the product 5 Enter the patient name and date on the Maxi Air mattress label See section Labels on the Maxi Air Mattress Make sure the Maxi Air air supp...

Страница 8: ...t 11 lbs 5 kg Material Fire Retardant ABS NBR Air Hose Lengths 78 1980 mm 300 7620 mm Optional Power Cord Length 180 4570 mm Maxi Air mattress Widths L 34 860 mm XL 39 990 mm and XXL 50 1270 mm Length 78 1980 mm Material Non woven top nylon back L Green handles XL Blue handles XXL Orange handles ...

Страница 9: ...9 Intentionally left blank ...

Страница 10: ...7 Cover 8 Air filter inside 9 Air hose 10 Socket 11 Snap lock button air hose 12 Nozzle 13 Power cord Mains disconnection device Maxi Air mattress 14 Connection points 15 Velcro lip 16 Snap lock button 17 Safety belts 18 Transfer handles Applied part Type B protection against elec tric shock in accordance with IEC 60601 1 Parts Designation ...

Страница 11: ...11 14 17 11 10 16 18 9 15 12 13 1 2 3 4 5 6 7 8 ...

Страница 12: ... power cord from the Maxi Air air supply to an electrical outlet 2 The LED will light up to indicate that the mains is turned on 3 To inflate the Maxi Air mattress press the push button on the Maxi Air air supply 4 To deflate the Maxi Air mattress press the push button again Mains disconnection device If for any reason the Maxi Air air supply does not respond to the push button stop inflating by p...

Страница 13: ... 6 150 mm from the top of the Maxi Air mattress Make sure the patient rests conveniently against the pillow during the transfer See Fig 3 WARNING Always make sure the patient has the correct size of the Maxi Air mattress If the Maxi Air mattress is too narrow the Maxi Air mattress can tip over during transfer causing serious injury to the patient and the caregivers WARNING To avoid bodily injury m...

Страница 14: ...The extended hose enables a lateral transfer of a patient to the MR equipment with the Maxi Air air supply at a safe distance Make sure to place the Maxi Air air supply outside the MR environment A See Fig 2 WARNING Before every transfer always make sure the Maxi Air air supply is secured from movement and from falling not in the way of the electrical outlet in use not placed on the floor Incorrec...

Страница 15: ...15 Intentionally left blank ...

Страница 16: ...ly placed on the Maxi Air mattress Attach the safety belts loosely If the belts are attached too tight they can cause discomfort during the inflation Tighten them after the inflation See Fig 2 7 Adjust the receiving surface to an ergonomic height 8 Place the receiving surface as close as possible to the sending surface continue with the steps on the next page 3 WARNING To avoid the patient from fa...

Страница 17: ...ly and inflate the Maxi Air mattress continue with the steps on the next page 10 WARNING To avoid bodily injury during the transfer always make sure to apply the brakes on both the sending and receiving surface raise and lock the bed rail on the receiving surface NOTE If the receiving surface does not have any bed rail the caregiver on the receiving side is responsible to make sure the patient doe...

Страница 18: ...ss firmly towards the receiving surface See Fig 5 continue with the steps on the next page 15 WARNING To avoid bodily injury make sure the Maxi Air mattress is completely inflated before starting the transfer A partly inflated Maxi Air mattress can cause the patient to hit the underlying surface causing bodily injury The pull force will increase with a partial inflated mattress and this can cause ...

Страница 19: ... hold the handles until the Maxi Air mattress is completely deflated See Fig 9 20 After the transfer is completed unbuckle the safety belts lock all side rails if possible remove the Maxi Air mattress and remove and disinfect the Maxi Air air supply see section Disinfection Instructions 18 WARNING To avoid bodily injury make sure that the Maxi Air mattress is centred on the receiving surface befor...

Страница 20: ...G To avoid eye or skin irritation never disin fect in the presence of a patient For the best results only use ArjoHuntleigh branded disinfectant If you have any questions regarding disinfecting the equipment or wish to order disinfection fluid see section Parts and Accessories contact your local ArjoHuntleigh representative Accessories for disinfecting the Maxi Air Protective glasses Protective gl...

Страница 21: ...cleaning fluid Scrub the hose with a brush 9 Rinse the air hose with water approx 25 C to remove cleaning fluid 10 If cleaning fluid cannot be removed in step 7 and step 9 spray water on the affected part and wipe off with disposable towels cloth Repeat until all of the cleaning fluid has been removed Step 11 20 Disinfection 11 Spray cleaning fluid on the Maxi Air air supply 12 Allow a disinfectio...

Страница 22: ...mended maintenance schedule WARNING To avoid injury to both patient and caregiver never modify the equipment or use incompatible parts CAREGIVER OBLIGATIONS Action Check Before EveryNew Patient Every Transfer Every Week Every Month Disinfect only the Maxi Air air supply X Visually check all exposed parts X Perform functionality test X Check change the air filter X WARNING To avoid injury and or un...

Страница 23: ... for damages tears and unhygienic signs Check especially the Maxi Air mattress since it has been in contact with both the patient and the caregivers Every Week Perform functionality test Check the on off function of the Maxi Air air supply air hose connection at the Maxi Air air supply and Maxi Air mattress and air hose for damage Every month Check change the air filter for dirt If needed replace ...

Страница 24: ...air filter D for dirt See Fig 3 5 If the air filter is dirty replace it Do not use the Maxi Air air supply until the air filter has been changed 6 Attach the cover C and the rubber ring B See Fig 2 If the product does not work as intended immediately contact your local ArjoHuntleigh representative for support Fig 1 A Fig 2 C B Fig 3 D Check and Change the Air Filter ...

Страница 25: ... electrical outlet Low pressure in the Maxi Air mattress Check air hose connections between the Maxi Air air supply and the Maxi Air mattress Check the air hose for damage Check the Maxi Air mattress for damage Make sure the air filter is clean NOTE If the problem cannot be solved with the written troubleshooting actions please contact qualified per sonnel ...

Страница 26: ...g load SWL Maximum patient weight 1200 Ibs 544 kg Weight 2 lbs 1 kg Expected life 20 transfers Shelf life Estimated shelf life 2 years starts from the manufacturing date stated on LOT label on the outer package Medical equipment type MRI classification MR Safe Radiolucency classification Radiolucent Latex content Latex free WARNING To avoid electric shock make sure that the equipment is connected ...

Страница 27: ...101 Hovertech AIR400G Manufactured before 20120101 Hovertech HTAIR1200 Manufactured before 20120101 AirPal PA 1200 Manufactured before 2011 No other combinations are allowed Operating Temperature 10 C to 32 C 50 to 90 F Humidity 10 70 at 20 C 68 F Atmospheric pressure 700 hPa to 1060 hPa Transport and Storage Temperature 40 C to 80 C 40 F to 176 F Maxi Air air supply 17 C to 43 C 0 F to 110 F Maxi...

Страница 28: ...by the Directive 2002 96 EC on waste electrical and electronic equipment In European countries the crossed out wheeled bin WEEE symbol reminds you that all the electrical and electronic products batteries and accumulators must be taken to separate collection at end of their working life This requirement applies in the European Union Do not dispose these products as unsorted municipal waste You can...

Страница 29: ...29 Intentionally left blank ...

Страница 30: ...Appears if the Maxi Air mattress is washed LA LATEX TEX REF Foot end of mattress The name and address of the manufacturer Manufacturing date The shelf life 2 years of the Maxi Air mattress starts from the manufacturing date on the LOT label on the outer package CE marking in accordance with the Medical Devices Directive 93 42 EEC The equipment has been EMC tested and fulfils all requirements accor...

Страница 31: ...31 Data label LATEX REF Maxi Air MAS014000 WW LOT Patient Name Date L ...

Страница 32: ...name and address of the manufacturer Identification Label The identification label states the product number the serial number and the manufacturing date The identification label is located under the top lid Access the identification label See Fig 1 1 Turn the screws A to an unlocked A1 position 2 Remove the attachment hooks and handle B by pulling the handle upward and side to side at the same ti...

Страница 33: ...weden Product no Serial no XXX XXXX XX XXXXXXXXXX Made by Arjo in Eslov Sweden YYMMDD Identification Label Data label 120V Company Logo Product Name MR unsafe Push button Maxi Air Model MASXXXXXX AU ArjoHuntleigh AB Verkstadsvägen 5 241 38 Eslöv SWEDEN Made in Sweden 5 3 Data label 230V Maxi Air ...

Страница 34: ... Approvals and List of Standards CERTIFICATE STANDARDS UL EN IEC 60601 1 2005 Medical electrical equipment General requirements for safety UL CAN CSA C22 2 No 601 1 Medical equipment Certified for Canada ...

Страница 35: ...t may cause radio interference or may disrupt the operation of nearby equip ment It may be necessary to take action such as reorienting relocating the equipment or shielding the location Guidance and manufacturer s declaration electromagnetic emissions Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Maxi Air system uses RF energy only for its intern...

Страница 36: ...put 1 kV line s to line s 2 kV line s to PE Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and volt age variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT For 0 5 cycle 40 UT 60 dip in UT 70 UT 30 dip in UT 5 UT 95 dip in UT fo...

Страница 37: ...ency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less tha...

Страница 38: ...38 Parts and Accessories Power cord US 8563082 AU 6364344 Air hose 8662971 Extended air hose 8664411 Air filter 6305180 For disinfectant contact your local representative Maxi Air mattress L XL XXL ...

Страница 39: ...m ITALIA ArjoHuntleigh S p A Via di Tor Vergata 432 00133 ROMA ITALIA Tel 39 0 6 87426211 Fax 39 0 6 87426222 E mail Italy promo arjohuntleigh com NEDERLAND ArjoHuntleigh Nederland 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 arjohuntleigh com NEW ZEALAND ArjoHuntleigh Ltd 41 Vestey Drive Mount Wellington AUCKLAND 1060 Tel 64 0 9...

Страница 40: ...ArjoHuntleigh GETINGE and MAQUET ArjoHuntleigh focuses on patient mobility and wound management solutions GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences MAQUET specializes in solutions therapies and products for surgical interventions and intensive care www ArjoHuntleigh com ArjoHuntleigh AB Verkstadsvägen 5 241 38 Eslöv SWEDEN ...

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