Getinge ARJOHUNTLEIGH Maxi Air Transfer Instructions For Use Manual

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Maxi Air Transfer
INSTRUCTIONS FOR USE
04.MS.01_5US.CA . June 2012
Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. © Arjo Hospital Equipment AB 2012.
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 Hospital Equipment AB.
Contents
Foreword................................................................................... 4
Intended Use ............................................................................ 5
Safety Instructions .....................................................................6
Preparations...............................................................................7
Product Specifications ...............................................................8
Parts Designation.....................................................................10
Product Description/Functions..................................................12
Correct Placement of the Patient...............................................13
Correct Placement of the Maxi Air Transfer...............................14
Transfer....................................................................................15
Disinfection Instructions............................................................20
Care and Preventive Maintenance............................................22
Check/change the air filter........................................................24
Troubleshooting........................................................................25
Technical Specifications...........................................................26
Labels on Maxi Air Transfer Flites.............................................30
Labels on Maxi Air T ransfer.......................................................32
Approvals and List of Standards................................................34
Electromagnetic Compatibility.................................................. 35
Parts and Accessories.............................................................38
ArjoHuntleigh addresses..............................................Last page
3
Foreword
Thank you for purchasing ArjoHuntleigh equipment.
Your Maxi Air Transfer™ is a part of a series of qual­ity products designed for patient transfer especially for hospital and extended care facilities. Please contact us if you have any questions about the operation or maintenance of your ArjoHuntleigh equipment.
Please read this Instructions for Use thoroughly!
Please read this Instructions for Use (IFU) in its entirety before using your Maxi Air Transfer. Infor- mation in this IFU is crucial to the proper operation and maintenance of the equipment. It will help to protect your product, and make sure that the equip­ment performs to your satisfaction. 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 ArjoHuntleigh equipment can affect its safety. ArjoHuntleigh 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 can result in injury to you or to others.
CAUTION
Means: Failure to follow these instructions can cause damage to all or parts of the system.
NOTE
Means: This is important information for the correct use of this system or equipment.
Service and Support
A service routine must be performed on your Maxi Air Transfer every year by qualified personnel to
ensure the safety and operating procedures of your product. See section, Care and Preventive Mainte-
nance.
If you require further information, please contact ArjoHuntleigh for comprehensive support and ser­vice programs to maximize the long-term safety , reli­ability and value of the product. Contact your local ArjoHuntleigh representative for replacement parts. The telephone numbers appear on the last page of this IFU.
Means: The name and address of the manufacturer .
Means: Read the Instructions for use
4
Intended Use
This equipment should only be used for the purpose specified in this Instructions for Use (IFU). Any other use is prohibited.
The Maxi Air Transfer is intended for lateral transfer or repositioning of hospital and care facility patients. The equipment must be used under the supervision of trained caregivers with adequate knowledge of the care environment, its common practices and proce­dures, and in accordance with the guidelines in this Instructions for Use (IFU).
The equipment must only be used for the purposes stated above, and removable parts must be mounted according to the recommendations given in this IFU.
The system
Maxi Air Transfer together with the Maxi Air Trans- fer Flites™ (patient specific mattress) is an air
assisted lateral patient transfer system for use in lat­eral transfers and repositioning.
Contraindications
This equipment can be unsuitable for patients with tho­racic, cervical or lumbar fractures. The equipment can be unsuitable for patients whose body shape is such that they do not comfortably fit between the boundaries of the mattress.
Always make a clinical assessment to make sure that the patient is suitable for the equipment.
Installation & Service requirements,
Maxi Air Transfer
The expected life of the Maxi Air Transfer is unless otherwise stated five (5) years, if subject to preven­tive maintenance being carried out in accordance with the instruction for Care and Preventive Mainte- nance found in this IFU.
Expected life, Maxi Air Transfer Flites
The expected life of the Maxi Air Transfer Flites is twenty (20) transfers.
Patient assessment
It is recommended that facilities establish regular assessment routines. Caregivers should assess each patient according to the following criteria prior to use:
This equipment is intended for patients who are dependent, 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 Transfer Flites 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 Tr ansfer and the Maxi Air Transfer Flites are intended for use in hospital and extended care facilities.
If the patient does not meet these criteria an alterna­tive equipment/system shall be used.
5
Safety Instructions
WARNING
Do NOT use the is equipment for any type of lifting of patients.
WARNING
Do NOT use the equipment if the power cord is damaged. Damaged power cord may cause serious injury to the patient and the caregivers.
WARNING
To avoid explosion or fire, 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
T o avoid bodily injury to the patient, use the Maxi Air Transfer in an environment where the temperature is below 34 °C (93 °F). Temperatures above 34 °C (93 °F) can cause the Maxi Air Transfer Flites surface to reach a temperature of 44°C (111°F).
6
Preparations
Head end
Foot end
Left
Right
Actions before first use (when delivered)
1 Visually inspect the Maxi Air Transfer and the
Maxi Air Tr ansfer Flites for damage.
2 Check that all parts are supplied. Compare with
section Parts Designation in this IFU. If any part is missing or damaged - do NOT use the product!
3 Read the IFU. 4 Disinfect the Maxi Air Transfer.
See section Disinfection Instructions.
5 Perform a functionality test.
See section Care and Preventive Maintenance.
6 Find a good ventilated dry area for storing the
Maxi Air Tr ansfer and the Maxi Air Transfer Flites.
7 Choose a designated area where the IFU should
be kept, accessible at all times.
8 Make sure to have a rescue plan ready in case of a
patient emergency.
9 If you have any questions, please contact your
local ArjoHuntleigh representative for support and service. The contact information (Arjo-
Huntleigh addresses) is listed at the end of this IFU.
Below is the direction of the Maxi Air Transfer Flites:
Actions before every new patient
1 Select a suitable Maxi Air Transfer Flites size
according to sections Correct placement of the patient and Product Specifications.
2 Check that all parts of the Maxi Air Transfer and
the Maxi Air Transfer Flites are 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
Transfer Flites label. See section Labels on the
Maxi Air Transfer Flites.
6
WARNING
To prevent cross-contamination, always follow the disinfection instructions in this Instructions for Use.
Make sure the Maxi Air Transfer is disinfected
according to section Disinfection Instructions. 7 If you have any questions, please contact your
local ArjoHuntleigh representative for support
and service. The contact information (Arjo-
Huntleigh addresses) is listed at the end of this
IFU.
Actions before every transfer (with same patient)
1 Check that all parts are in place. Compare with the
Parts Designation in this IFU. 2 Carry out a thorough inspection for damage.
3 If any part is missing or damaged - do NOT use
the product!
7
Product Specifications
L (Green handles)
XL (Blue handles)
XXL (Orange handles)
Maxi Air Transfer
Dimensions: 12,5 x 7 x 7”(317,5 x 178 x 178 mm) Weight: 11 lbs. (5 kg) Material: Fire Retardant ABS, NBR Air Hose Length: 78” (1980 mm) Pow e r C o r d L e n g t h : 180” ( 4570 mm)
Maxi Air Transfer Flites
Widths: L 34” (860 mm), XL 39” (990 mm) and XXL 50” (1270 mm) Length: 78” (1980 mm) Material: Non-woven top, nylon back
8
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9
Applied part:Type B. protection against elec­tric shock in accordance with IEC 60601-1
Parts Designation
Maxi Air Transfer
1 Carrying handle 2 Attachment hooks 3 Socket inlet 4 Push button (On/Off) 5 LED mains power indicator 6 Rubber bumper 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 Transfer Flites
14 Connection points 15 Velcro lip 16 Snap lock button 17 Safety belts 18 Transfer handles
10
18
1
2
3
17
16
15
4
5
6
7
8
14
9
13
11
12
10
11
Fig. 1
Fig. 2
Fig. 3
Product Description/Functions
Maxi Air Transfer and Maxi Air Transfer Flites con­nection
1 Connect the air hose from the Maxi Air Transfer, to either
the left or right foot end connection point of the Maxi Air Transfer Flites. (See Fig. 1)
2 Attach the snap lock button on the Maxi Air T ransfer Flites
to the air hose snap lock button. (See Fig. 2)
3 Use the velcro lip to secure the air hose in place. (See Fig. 3)
Operation and controls
1 Plug in the power cord from the Maxi Air Transfer to an
electrical outlet. 2 The LED will light up to indicate that the mains is turned on. 3 T o inflate the Maxi Air Transfer Flites, press the push button
on the Maxi Air Transfer. 4 To deflate the Maxi Air Transfer Flites, press the push but-
ton again.
Mains disconnection device
If for any reason, the Maxi Air Transfer does not respond to the push button, stop inflating by pulling out the power cord from the electrical outlet. Do not place anything in front of the electrical outlet. Make sure the outlet is easily accessible.
Contact qualified personnel if a malfunction occurs.
12
Correct placement of the p atient
Fig. 1
Fig. 2
Fig. 3
WARNING
Always make sure the patient has the correct size of the Maxi Air Transfer Flites. If the Maxi Air Transfer Flites is too narrow, the Maxi Ai r T ransfer Flites can tip over during transfer caus- ing serious injury to the patient and the caregivers.
WARNING
To avoid bodily injury make sure the patient is correctly positioned on the Maxi Air Transfer Flites. If the patient is incorrectly positioned, the Maxi Air Transfer Flites can tip over during the transfer.
Placement of the patient
Make sure the patient is placed in the middle of the Maxi Air Transfer Flites. (See Fig. 1)
Make sure the patient’s body does NOT reach outside the boundaries of the Maxi Air Transfer Flites.
If the feet reach outside the foot end, make sure there is enough space for the transfer. (See Fig. 2)
The patient’s head should be placed approximately 6” (150 mm) from the top of the M axi Air Transfer Flites.
Make sure the patient rests conveniently against the pillow during the transfer. (See Fig. 3)
13
Correct placement of the Maxi Air Transfer
Fig. 1
WARNING
Before every transfer , always make sure the Maxi Air Transfer is:
secured from movement and from falling
not in the way of the electrical outlet in use
not placed on the floor Incorrectly placed Maxi Air Transfer can cause hazards e.g. interrupted inflation. This can
cause serious injury to the patient and the caregivers.
WARNING
To avoid tripping hazards, make sure that the power cord on the floor is rolled up before the transfer.
Placement of the Maxi Air Transfer
• Hang the Maxi Air T ransfer on the receiving surface by the attachment hooks. Make sure it is secured from movement and from falling down. (See Fig. 1)
• Make sure the Maxi Air T ransfer is not placed in front of the electrical outlet that is being used.
• Make sure the power cord on the floor is rolled up.
14
Transfer
Fig. 1
Fig. 2
Transfer between surfaces (21 steps)
Sending surface/side = surface the patient lays on Receiving surface/side = surface the patient is transferred to
1 Apply the brakes on the sending surface. 2 Make sure the patient is in a horizontal position.
3
WARNING
To avoid the patient from falling or caregiver from being injured, ensure that there are two or more caregivers present during the transfer.
Position one caregiver on each side of the patient.
(See Fig. 1)
4Place the Maxi Air T ransfer Flites with the labels upwards,
underneath the patient. Follow local routines.
5 Make sure the patient is correctly placed on the Maxi Air
Transfer Flites.
6
WARNING
To prevent patient from rolling off the Maxi Air Transfer Flites, the safety belts must be used during the entire movement.
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 send-
ing surface.
continue with the steps on the next page
15
9 Adjust the sending surface height slightly higher than the
Fig. 3
Receiving
Sending
surface
surface
receiving surface. (See Fig. 3)
10
WARNING
T o 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
Apply the brakes, raise and lock the outer 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 does not reach outside the boundaries of the receiving surface.
11 Hang the Maxi Air Transfer on the receiving surface.
12 Plug the power cord into an electrical outlet. 13
WARNING
To avoid sudden deflation make sure the air hose is properly connected before transfer. Sudden deflation can cause bodily injuries to both the patient and caregivers.
Receiving side: connect the air hose to the Maxi Air T rans- fer Flites.
14 Sending side: firmly hold the transfer handles during the
inflation of the Maxi Air Transfer Flites. Receiving side: turn on the Maxi Air Transfer and inflate the Maxi Air Transfer Flites.
continue with the steps on the next page
16
15
Fig. 4
Fig. 5
Fig. 6
WARNING
To avoid bodily injury, make sure the Maxi Air Transfer Flites is completely inflated before starting the transfer. A partly inflated Maxi Air Transfer Flites 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 bodily injury to the caregiver as well.
Sending side: feel underneath the Maxi Air T ransfer Flites to make sure that the patient can’t be felt through it.
(See Fig. 4)
If any part of the patient can be felt, the Maxi Air Transfer Flites is partly inflated. To correct this problem:
• abort the inflation,
• reposition the patient and
• inflate again.
16 Sending side: tighten the safety belts and push the Maxi Air
Transfer Flites firmly towards the receiving surface.
(See Fig. 5)
NOTE Use the transfer handles that are closest to the
widest parts of the patient’s body. (See Fig. 6)
continue with the steps on the next page
17
17 Receiving side: meet up the air mattress when it is halfway
Fig. 7
Fig. 8
Fig. 9
over the receiving surface. (See Fig. 7)
18
WARNING
To avoid bodily injury, make sure that the Maxi Air Transfer Flites is centred on the receiving surface, before the Maxi Air Transfer Flites is deflated. If not centred, the patient can fall down.
Receiving side: make sure the Maxi Air Transfer Flites is centred. (See Fig. 8)
19 Sending side: turn off the Maxi Air T ransfer and detach the
hose from the Maxi Air Transfer Flites.
Receiving side: firmly hold the handles until the Maxi Air Transfer Flites 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 Transfer Flites and
• remove and disinfect the Maxi Air Transfer, see section
Disinfection Instructions.
18
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19
Disinfection Instructions
WARNING
Do NOT wash the Maxi Air Transfer Flites! The Maxi Air Transfer Flites is a p atient spe­cific product and is not intended for use between patients. If the Maxi Air Transfer Flites is washed, the paper coating will disappear, revealing a DO NOT REUSE sign.
WARNING
T o prevent cross-cont amination, always fol­low the disinfection instructions in this
Instructions for Use.
CAUTION Do not lower down the Maxi Air Transfer in
disinfectant solution. This could damage the electrical components and cause inter­nal corrosion.
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 Transfer
Protective gloves
Protective glasses
Spray bottle
Disinfectant fluid
WARNING
Always use protective gloves and protec­tive eye wear when dealing with concen­trated disinfectant. Avoid getting it on your skin or in your eyes. If contact occurs, rinse with large amounts of water. If skin or eyes become irritated, consult a physician.
WARNING
To avoid eye or skin irritation, never disin­fect in the presence of a patient.
CAUTION To avoid damage on the equipment only
use ArjoHuntleigh branded disinfectant s.
Cleaning brush
Wash cloth Disposable paper towels
The following procedure should be carried out between patients.
20
Disinfection of the Maxi Air Transfer
Fig. 1
A
Fig. 2
(16 steps)
1 Use protective gloves and glasses. (See Fig. 1) 2 Prepare the solution for submerging the air hose.
Make sure it is mixed according to the instructions on the disinfectant bottle label.
3 Remove the air hose from the Maxi Air Transfer
by turning the hose socket (A) counter clock-wise and pull the air hose out. (See Fig. 2)
Air hose:
4 Rinse the outside of the air hose with warm water
for 10 sec.
5 Use a spray bottle containing disinfection fluid
mixed according to the instructions on the disin­fection bottle label. Spray the outside of air hose with disinfectant.
6 Brush the surface of the air hose with the cleaning
brush until all visible dirt is removed.
7 Roll up the air hose and lower it down into the disin-
fectant solution.
8 Leave the air hose in the solution for a minimum
of five minutes and a maximum of ten minutes.
9 Rinse the air hose with cold water until there are
no visible traces of the disinfectant.
10 Wipe the air hose dry with disposable towels.
Maxi Air Transfer:
11 Use a damp wash cloth (warm water) to wipe off all
surfaces on the Maxi Air Transfer.
12 Use a spray bottle containing disinfection fluid
mixed according to the instructions on the disin­fection bottle label. Spray the Maxi Air Transfer with the disinfectant and allow a disinfection time according to the instructions on the disinfectant bottle label.
13 Make sure all surfaces are disinfected and rub
them with the wash cloth.
14 Use a new damp wash cloth (cold water) to wipe off
all surfaces on the Maxi Air Transfer until there are no visible traces of the disinfectant.
15 Wipe the Maxi Air Transfer dry with disposable
towels.
16 Insert the air hose socket to the Maxi Air T ransfer
socket inlet. Make sure it clicks into place.
21
Care and Preventive Maintenance
The Maxi Air T ransfer and the Maxi Air Transfer Flites are subject to wear and tear, and the following actions must be performed to make sure that 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.
WARNING
T o avoid injury to both p atient and caregiver , never modify the equipment or use incomp atible parts.
Preventive maintenance schedule for Maxi Air Transfer and the Maxi Air Transfer Flites.
CAREGIVER OBLIGA TIONS Action/Check
Disinfect X Visually check all exposed parts X Perform functionality test X Check/change the air filter X
Between
PATIENTS
Every
TRANSFER
Every
WEEK
Every
MONTH
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 proce­dure. Qualified personnel must have documented training in maintenance of this device.
QUALIFIED PERSONNEL Action/Check
Every YEAR
Change the air filter X Perform functionality test X
NOTE All Caregiver Obligations are to be checked when performing the Qualified Personnel Service.
22
Caregiver Obligations
Caregiver obligations shall be carried out by personnel with sufficient Maxi Air Transfer and the Maxi Air Transfer Flites knowledge following the instructions in this IFU.
Between Patients
Disinfect the Maxi Air Transfer. Make sure the Maxi Air Transfer is disinfected between patients according to section
Disinfection Instructions.
Every transfer
Visually check all exposed parts for;
- damages,
- tears and
- unhygienic signs. Check especially the Maxi Air Trans fer Flites 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 Transfer,
- air hose connection at the Maxi Air Transfer and Maxi Air Transfer Flites and
- air hose for damage.
Every month
Check/change the air filter. Check the air filter for dirt. If needed, replace it. See section Check/change the air filter.
Yearly
Maxi Air Transfer has to be serviced according to the section Care and Preventive Maintenance schedule by qualified per-
sonnel.
23
Check/change the air filter
Fig. 1
A
Fig. 2
C
B
Fig. 3
D
Check/change the air filter (6 Steps)
1 Fold in the attachment hooks (A). (See Fig. 1)
2 Pull up the rubber ring (B). (See Fig. 2)
3 Pull down the cover (C). (See Fig. 2)
4 Check the air filter (D) for dirt. (See Fig. 3)
5 If the air filter is dirty, replace it. Do not use the Maxi Air
Transfer 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.
24
Troubleshooting
Troubleshooting for Maxi Air Transfer and the Maxi Air Transfer Flites
PROBLEM ACTION
Check power supply.
Check power cord connections on the Maxi Air
No air flow.
Transfer and the electrical outlet.
Check air hose connections between the Maxi Air Transfer and the Maxi Air Transfer Flites.
Check the air hose for damage.
Low pressure in the Maxi Air Transfer Flites.
NOTE
If the problem cannot be solved with the written troubleshooting actions, please contact qualified personnel.
Check the Maxi Air Transfer Flites for damage.
Make sure the air filter is clean.
25
Technical Specifications
Technical Data
Maxi Air Transfer
Weight 11 lbs. (5 kg) Expected life 5 years from manufacturing date Protection class Not protected against ingress of water Pollution degree 2 Operating force: Push button 30.0 N Maximum duty cycle For continuous use Sound Level 74 db (A) MRI classification MR unsafe Motor power 120 V 1100 W (USA)
230 V 1200 W (Rest of the world)
Maxi Air Transfer Flites
Safe working load (SWL) (Maximum patient weight)
Weight 2 lbs. (1 kg)
Expected life 20 transfers Shelf life Estimated shelf life (2 years) starts from the
Medical equipment type MRI classification MR Safe Radiolucency classification Radiolucent Latex content Latex free
1200 Ibs. (544 kg)
manufacturing date stated on LOT label on the outer package.
WARNING
To avoid electric shock, make sure that the equipment is connected to:
• Continuously powered supply mains with protective earth.
• Separate fuse and ground fault circuit interrupter (GFCI)
• A mains disconnection device
• Equipotential bonding point All installations must be in accordance with local codes and regulations.
26
Allowed Combinations
Products Compatible with Model
Maxi Air Transfer ArjoHuntleigh Maxi Air Transfer Flites L, XL, XXL
Maxi Air Transfer Flites L, XL, XXL
No other combinations are allowed.
Environmental Conditions
Operating
Temperature +10°C to + 34°C (+50 to +93°F) Humidity 10-70% at +20°C (+68°F)
ArjoHuntleigh Maxi Air Transfer
Hovertech AIR200G
(only compatible with Maxi Air Transfer Flites size L) Manufactured before 20120101
Hovertech AIR400G
Manufactured before 20120101
Hovertech HT AIR1200
Manufactured before 20120101
AirPal PA-1200
Manufactured before 2011
Atmospheric pressure 700 hPa to 1060 hPa
Transport and Storage
Temperature -40°C to +80°C (-40°F to +176°F) Maxi Air T ransfer
-17°C to +43°C (+0°F to +110°F) Maxi Air Transfer Flites Humidity 10-70% at +20°C (+68°F) Atmospheric pressure 500 hPa to 1060 hPa
27
Recycling
The device should be recycled according to national regulations. Package Wood and corrugated cardboard
recyclable
Maxi Air Transfer Electric, metal and plastic parts shall be separated and
recycled according to (WEEE) and according to mark­ings on the unit.
Disposal (Environmental Protection)
Maxi Air Transfer The device is marked with the WEEE symbol to indicate
that it is electronic equipment covered 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 return your device and accessories to Arjo­Huntleigh. You can also contact your local authorities for advice on disposal.
Maxi Air Transf er Flites The hospitals should follow local routine for disposal of
contaminated material.
28
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29
Labels on Maxi Air Transfer Flites
TEX
REF
T ype B, Applied part: pro­tection against electrical shock in accordance with IEC 60601-1.
Follow Instructions for Use
Read the Instruction for Use before use
LOT number
MR-Safe
Foot end of mattress
Manufacturing date The shelf life (2 years) of the Maxi Air Transfer Flites starts from the manufactur­ing date on the LOT label on the outer package
LALAEX
Latex free product
Model number
Do not wash
Do not reuse Appears if the Maxi Air Transfer Flites is washed
The name and address of the manufacturer.
30
Maxi Air Transfer Flites
MAS014000-WW
LOT
Patient Name:
Date:
L
Data label
31
Labels on Maxi Air Transfer
A
B
C
Fig. 1
A1
A2
D
IP2X Protection class: The
product must only be used in a dry location.
Class I Insulation class
V ~ Hz Voltage and AC frequency
W Motor power
Separate electrical and electronic components for recycling in accordance with the European Direc­tive 2002/96/EC (WEEE)
Follow Instructions for Use
The equipment has been EMC-tested and fulfils all requirements according to IEC-60601-1-2.
Identification label
The identification label is found under the top lid. It states the product number, the serial number and the manufacturing date.
Position of Identification label
Remove the attachment hooks, handle and lid (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 time.
3 Remove the lid (C) to find the Identification
label (D).
XXXXXXXXXX Serial Number
(located inside) Push button
MR unsafe
Classified by Underwriters Laboratories Inc. with respect to electrical shocks, fire and mechani­cal, hazards and other specified hazards only in accordance with the Approvals and List of Standards. See Approv-
als and List of Standards
Attach the attachment hooks, handle and lid (See Fig. 1)
1 Attach the lid (C). 2 Push down the attachment hooks (B) and handle.
Make sure they click into place.
3 Turn the screws (A) to a locked (A2) position.
4ML5 Certificate control number
for UL.
The name and address of the manufacturer.
32
Product no
XXX XXXX-
Serial no
XX
XXXXXXXXXX
Made by Arjo in Eslov, Sweden YYMMDD
Identification Label
Push button
Maxi Air Transfer
Product Name
MR unsafe
Company Logo
Maxi Air Transfer, Model: MASXXXXXX-US
ArjoHuntleigh AB,Verkstadsvägen 5, 241 38 Eslöv (SWEDEN). Made in Sweden
Data label
33
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
34
Electromagnetic comp atibility
Medical electrical equipment needs special precautions regarding EMC (Electromagnetic compatibility) and needs to be used according to the EMC information below . The Maxi Air Transfer is intended for use in the electromagnetic environment specified below . The customer or the user of the Maxi Air Transfer should make sure that it is used in such an environment.
WARNING
Stacking or placing other electrical equipment next to this device is not recommended, it can interfere with the equipment’s operation and safety. Portable and mobile radio-frequency (RF) communications equipment can interfere with this equipment operation and safety.
WARNING
The equipment may cause radio interference or may disrupt the operation of nearby equip­ment. 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
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC-61000-3-3
Group 1 The Maxi Air Transfer uses RF energy only for its internal func-
tion. Therefor, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emis­sions.
Class B
Class B
Complies
The Maxi Air Transfer is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
35
Guidance and Manufacturer’s declaration - Electromagnetic Immunity
The Maxi Air T ransfer is intended for use in the electromagnetic environment specified below. The customer or the user of the Maxi Air Transfer 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
Electrical fast Transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and volt­age variations on power supply input lines
IEC 61000-4-11
± 6 kV contact
± 8 kV air
± 2 kV for power sup­ply lines ± 1 kV for input-out­put
± 1 kV line(s) to line(s) ± 2 kV line(s) to PE
< 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
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines ± 1 kV for input-output
± 1 kV line(s) to line(s) ± 2 kV line(s) to PE
< 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
Floors should be wood, concrete or ceramic tile. If floors are cov­ered with synthetic material, the relative humidity should be at least 30%
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.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the Maxi Air Trans- fer requires continued operation during mains interruptions, it is recommended that the Maxi Air Transfer be powered from an interruptible power supply or bat­tery.
Power Frequency (50/60 Hz) magnetic field
IEC 61000-4-8
NOTE UT is the AC mains voltage prior to application of the test level.
3A/m 3A/m Power frequency magnetic fields
36
should be at levels characteristic of a typical commercial or hospi­tal environment.
Guidance and Manufacturer’s declaration - Electromagnetic Immunity
Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guid-
ance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 Vrms 80 kHz to 2,5 GHz
3V
3 Vm
Portable and mobile RF communica­tions equipment should be used no closer to any part of the Maxi Air Transfer including cables, than the recommended separation distance calculated from the equation appli­cable to the frequency of the trans­mitter.
Recommended separation distance d=1,2√P d=1,2P 80 MHz to 800 MHz
d=2,3P 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 than the compliance level in each frequency range. b) Interfer­ence may occur in the vicinity of equipment marked with following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects and people.
37
Parts and Accessories
Power cord
US 8563082
Cover
86 62963
Air hose
8662971
For disinfectant, contact
your local representative.
Air filter
6305180
Maxi Air Transfer Flites
L, XL, XXL
38
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