Arjo Auralis Page 53 Instructions For Use Manual Download

Page: 53 / 68

TECHNICAL SPECIFICATIONS

TRANSPORT AND STORAGE CONDITIONS

Short term (Up to 30 days):

Temperature (Ambient)

-20 °C to 60 °C (-4 °F to 140 °F)

Relative humidity range

0 % to 95 %

Long term (> 30 days):

Temperature (Ambient)

0 °C to 40 °C (32 °F to 104 °F)

Relative humidity range

0 % to 95 % (non-condensing)

CAUTION
To avoid damage to the Auralis system:

• Do not store the

Auralis

system in direct sunlight.

• Store

the

Auralis

pump and

Auralis

mattress in the protective bags supplied.

• Do not store the

Auralis

pump at high temperatures for extended periods. This may cause potential

battery damage.

• Do not store the

Auralis

pump longer than 5 months without recharging the battery.

AURALIS MATTRESSES AND SEAT CUSHION MEASUREMENTS

Part no

Description

Size mm (in)

Weight kg (Ib)
(Including transport bag of weight 0.46kg)

636T01S

Standard 110

2030 x 860 x 115 (80 x 34 x 4.5)

7.9 (17.4)

636T01N

Narrow 110

2030 x 780 x 115 (80 x 30 x 4.5)

7.7 (16.9)

636M05S

Standard 175

2030 x 860 x 175 (80 x 34 x 7)

13.8 (30.4)

636M05N

Narrow 175

2030 x 780 x 175 (80 x 30 x 7)

12.7 (27.9)

636M02S

Standard 200

2030 x 860 x 205 (80 x 34 x 8)

11.3 (24.9)

636M02N

Narrow 200

2030 x 780 x 205 (80 x 30 x 8)

11 (24.2)

636C01S

Seat cushion

470 x 455 x 50 (18.5 x 17.9 x 2)

1.2 (2.6)

636B02

Plus

2140 x 1220 x 205 (84 x 48 x 8)

16 (35.3)

Cover material

Premium fabric

ALLOWED COMBINATIONS

Auralis

• Skin

MCM, Coverlet Only

• Skin

365, Coverlet Only

Auralis Plus

•

Skin IQ

1000, Coverlet Only

EXPECTED SERVICE LIFE

Auralis

pump

7 years

SOUND LEVELS

Sound level during audible alarm

55 dBA at 1.8 m (1 m horizontal, 1.5 m vertical)

Summary of Contents for Auralis

Page 1: ...INSTRUCTIONS FOR USE Auralis 04 AI 00EN_03 10 2020 Alternating pressure system ...

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: ...er cable 20 Skin IQ port 20 Product description Auralis mattresses 21 35 UDSLG GHÀDWLRQ XQLW 21 Detachable cover 21 Cells 21 Loop straps 21 Heelguard cells 21 Cell hooks 21 Tube set 21 Connector 21 Cable management 22 Micro air loss system 22 Auralis 110 mattress overlay 22 Fixing straps Auralis 110 mattress overlay 22 Auralis 175 200 and Plus mattress replacement 22 Securing straps 23 Overlay and...

Page 4: ...UP PRGH 34 Alternating mode default setting 34 Reactive CLP mode 35 Lock out mode 35 Transport mode 36 Turn off and store the Auralis system 38 Turn off the Auralis pump 38 HÀDWH DQG VWRUH WKH XUDOLV PDWWUHVV 38 HÀDWH DQG VWRUH WKH XUDOLV VHDW FXVKLRQ 39 Store the Auralis pump 39 Cleaning and disinfection instructions 40 Cleaning and disinfection 41 Care and preventive maintenance 44 Expected serv...

Page 5: ... Auralis system before every use or every week if for long term use to maintain safety and reliability of the equipment See section Care and preventive maintenance for more information If you require further information please contact Arjo for comprehensive support and maintenance to maximize the long term safety reliability and value of the product Contact your local Arjo representative for spare...

Page 6: ... assessment routines Caregivers should assess each patient according to the following criteria prior to use For the Auralis mattress the patient weight must not exceed 250 kg 550 lb for the standard and narrow mattresses For the Auralis Seat Cushion the patient weight must not exceed 200 kg 440 lb For the Auralis Plus mattress the patient is within the weight range of 100 kg 220 lb to 454 kg 1000 ...

Page 7: ...WARNING To avoid suffocation always attach the Auralis mattress cover and Auralis seat cushion cover when in use WARNING To avoid severe burn injury do not use the Auralis pump in the presence of XQFRQWDLQHG ÀDPPDEOH OLTXLGV RU JDVHV WARNING To avoid falling and injury make sure that cables and the tube set are positioned correctly and are clear of moving bed mechanisms or other possible entrapmen...

Page 8: ...nt includes small parts that may present a choking hazard to small children vulnerable persons and pets if inhaled or swallowed CAUTION To avoid equipment damage never use the Auralis pump close to heat sources CAUTION To avoid equipment damage never use sharp objects or electrically heated under blankets on or under the Auralis system CAUTION To avoid equipment damage do not expose the Auralis sy...

Page 9: ...e 53 within this IFU for dimensions of all Auralis mattresses FWLRQV EHIRUH UVW XVH 5 steps 1 Check the package for damage If the product looks damaged during transport contact the transport agency Do NOT use the product 2 Check that the items are complete Auralis pump with power cable and hanging brackets Auralis 110 mattress overlay Auralis 175 200 or Plus mattress replacement or Auralis seat cu...

Page 10: ...LQWHQDQFH 6FKHGXOH RQ SDJH 2 If any item is damaged do NOT use the product After each patient OHDQ DQG GLVLQIHFW WKH SURGXFW DIWHU HDFK SDWLHQW DFFRUGLQJ WR VHFWLRQ OHDQLQJ DQG GLVLQIHFWLRQ LQVWUXFWLRQV RQ SDJH The position of the caregiver The caregiver should be positioned in front of the pump during operation See Figure 1 ...

Page 11: ...HOME CARE 11 Intentionally left blank ...

Page 12: ...tandby button and indicator 2 Wait indicator 3 XWR UP PRGH EXWWRQ 4 Alternating mode button 5 Reactive CLP mode button 6 Comfort control buttons indicators Lock out buttons indicators Control panel buttons and indicators 7 Low battery indicator 8 Battery charge indicators 9 Mains power failure indicator 10 Low pressure indicator 11 Service indicator 12 Alarm mute button and indicator 1 2 3 5 4 6 8...

Page 13: ...ment zip 4 Cells quantity Head cells 3 Torso cells 12 Heelguard cells 5 5 Loop straps 6 Heelguard cell straps 7 Cell hooks 8 Overlay base cover including micro air loss system 9 Fixing straps 10 Tube set 11 Connector 12 Cable management 2 4 3 1 5 8 10 12 Parts designation Auralis 110 mattress overlay 11 7 6 9 ...

Page 14: ... 8 Non slip base with Foam underlay mattress 175 LU OOHG RQHG VXE PDWWUHVV PDWWUHVV 9 Securing straps four on each side 10 Overlay base including micro air loss system 11 Overlay zip 12 Tube set 13 Connector 14 Cable management PARTS DESIGNATION AURALIS 175 AND 200 MATTRESS REPLACEMENT 14 2 3 12 14 Parts designation Auralis 175 and 200 mattress replacement 13 1 4 5 6 8 7 10 9 11 ...

Page 15: ...LU OOHG RQHG VXE mattress 9 Securing straps four on each side and three at head end 10 Tube set 11 Connector 12 Cable management 13 Bolster x2 14 Bolster sleeve x2 15 Air channel 16 Foot extension sleeve 17 Bolster Valve under valve symbol x2 18 CPR Tag PARTS DESIGNATION AURALIS PLUS MATTRESS REPLACEMENT 15 2 3 1 4 5 6 7 9 Parts designation Auralis Plus mattress replacement 8 10 11 12 13 14 15 16 ...

Page 16: ...over 2 Cover attachment zip 3 Alternating cells 4 Tube set 5 Connector 6 HÀDWLRQ YDOYHV 7 Fixing straps 8 Non slip base PARTS DESIGNATION AURALIS SEAT CUSHION 16 1 2 4 7 8 6 3 5 Parts designation Auralis seat cushion ...

Page 17: ...ess the Run Standby button for four seconds Wait indicator The Wait indicator see Figure 3 is shown when the XUDOLV PDWWUHVV RU VHDW FXVKLRQ LV EHLQJ LQÀDWHG 7KH indicator remains on for approximately 15 minutes until the Auralis mattress or Auralis seat cushion LV IXOO LQÀDWHG DQG UHDG IRU XVH 7KH XUDOLV 3OXV mattress takes approximately 17 minutes to reach full LQÀDWLRQ XWR UP PRGH EXWWRQ 7KH XW...

Page 18: ...the default is set to the middle comfort setting Press the button to increase pressure in the cells WR PDNH WKH PDWWUHVV UPHU Press the button to reduce pressure in the cells to make the mattress softer Lock out mode The Lock out mode sets the pump in a locked state to prevent unintentional changing of settings When the pump is in Lock out mode pushing any button will result in a negative tone and...

Page 19: ...Low battery indicator The single top indicator see Figure 12 is shown and an audible alarm sounds when there is a minimum of 1 hour battery life left The alarm can be muted see Mute alarm button When there is less than 15 minutes of battery life left the Auralis pump enters the Reactive CLP mode At this point the audible alarm cannot be muted Battery charge indicators The three indicators blue see...

Page 20: ...e Auralis pump The alarm indicators shown on the front of the pump are green when the pump is operating normally and yellow when there is an alarm condition See Figure 15 Hanging brackets The hanging brackets are used to hang the Auralis pump at the foot end of the bed See Figure 16 Power cable The power cable must be positioned in the cable management on the left side of the Auralis mattress 6HH ...

Page 21: ...tic support to the patient depending on selected therapy mode 3 head cells static only 12 torso cells alternating CLP 5 foot cells with Heelguard alternating CLP Auralis 6 foot cells with Heelguard alternating CLP Auralis Plus Loop straps The loop straps keep the cells aligned and in place Heelguard cells The Heelguard cells help to keep the pressure in the heel area lower for longer Cell hooks Th...

Page 22: ... VHSDUDWH IURP WKH FHOO LQÀDWLRQ WR HQDEOH both micro air loss and patient transport modes to be incorporated into the mattress Auralis 110 mattress overlay The Auralis 110 mattress is an overlay and is placed on top of an existing bed mattress Fixing straps Auralis 110 mattress overlay 7KH IRXU LQJ VWUDSV DUH WR EH SODFHG XQGHU WKH four corners of an existing bed mattress and prevent the Auralis ...

Page 23: ...Use the overlay zip to remove the base See Figure 21 The overlay can then placed on top of an existing bed mattress Bolsters Auralis Plus mattress only The bolsters are located on either side of the core RI WKH PDWWUHVV LQ RUGHU WR W WKH EHG LQ LWV ZLGHVW SRVLWLRQ 7KH FDQ EH LQÀDWHG GHÀDWHG XVLQJ WKH valves at the foot end Foot extension Auralis Plus mattress only This consists of both an extra He...

Page 24: ...W WKH XUDOLV VHDW FXVKLRQ from falling off a chair with an open construction or removable seat cushion Non slip base The non slip base prevents the Auralis seat cushion IURPVOLSSLQJ ZKHQ WKH LQJ VWUDSV FDQQRW EH XVHG HÀDWLRQ YDOYHV 7KH GHÀDWLRQ YDOYHV DUH ORFDWHG XQGHUQHDWK WKH Auralis seat cushion See Figure 22 Tube set The tube set is anti kink and not removable from the seat cushion Connector T...

Page 25: ...UDSLG GHÀDWLRQ XQLW VWHSV 1 3UHVV ERWK WKH 35 UDSLG GHÀDWLRQ XQLW UHOHDVH buttons simultaneously See Figure 25 2 0DNH VXUH WKH IURQW SDUW RI WKH 35 UDSLG GHÀDWLRQ unit is open See Figure 26 7KH 35 UDSLG GHÀDWLRQ XQLW HYDFXDWHV WKH DLU IURP the main body of the mattress in 15 seconds HDFWLYDWH WKH 35 UDSLG GHÀDWLRQ unit 3UHVV GRZQ WKH RSHQ SDUW RI WKH 35 UDSLG GHÀDWLRQ unit until it clicks into pla...

Page 26: ...facing up See Figure 28 3 Secure the Auralis mattress overlay by placing DQG WLJKWHQLQJ WKH IRXU LQJ VWUDSV XQGHU WKH corners of an existing mattress See Figure 29 4 Place the detachable cover over the Auralis mattress overlay with the Arjo logo visible and located at the foot end of the Auralis mattress Continue with steps on the next page WARNING To avoid death or serious injury by entrapment al...

Page 27: ...a patient s head or body For mattress VL HV VHH VHFWLRQ XUDOLV PDWWUHVVHV DQG VHDW FXVKLRQ PHDVXUHPHQWV RQ SDJH 4 Position the Auralis mattress replacement on the bed frame Make sure that WKH 35 UDSLG GHÀDWLRQ XQLW LV ORFDWHG DW WKH head end check that the tube set is positioned correctly the mattress cells are facing up See Figure 31 5 Secure the Auralis mattress replacement by attaching the eigh...

Page 28: ...ure that the bolster valves are positioned in the extended part of either side of the bed Auralis Plus mattress only See Figure 34 Auralis pump 7 steps 1 Hang the Auralis pump at the foot end of the bed See Figure 35 Make sure the pump is not near a heat source in the sun covered up 2 Check that the tube set is not twisted 3 Connect the tube set to the Auralis pump Make sure the tube set clicks in...

Page 29: ...the patient s condition specialist advice should be sought 1 Select the correct size mattress extension for the width of bed extension 2 Remove all packaging 3 0DNH VXUH WKDW WKH PDWWUHVV H WHQVLRQ LV WWHG with its cover 4 Place the mattress extension with the zip nearest the bottom into the space between the mattress and the footboard see Figure 38 Make sure that there are no sharp edges which ma...

Page 30: ...are facing up the tube set appears from the front right corner of the cushion the cells in the seat cushion are in a horizontal position across the chair with the V shape pointing towards the front See Figure 40 2 Secure the Auralis seat cushion to the chair as described below Open sided chair WWDFK WKH LQJ VWUDSV DURXQG WKH IUDPH RI the chair See Figure 41 Closed chair with removable seat cushion...

Page 31: ...over the Auralis seat cushion Make sure the Arjo logo is visible at the front part of the seat 4 Zip the cover onto the Auralis seat cushion Do not trap any material in the zip Make sure the zip is fully closed 5 Place the Auralis pump RQ WKH ÀRRU QH W WR WKH chair Make sure the cable is under the chair the tube set is placed along the side of the chair See Figure 43 6 Check that the tube set is n...

Page 32: ...on on the control panel for 2 seconds The following indicators are shown Run Standby Wait indicator Alternating mode button Comfort control indicator Battery charge indicator Green indicators on the front of the pump See Figure 45 7KH XUDOLV PDWWUHVV LV IXOO LQÀDWHG ZKHQ WKH DLW indicator is off after approximately 15 minutes The Auralis Plus mattress takes approximately 17 PLQXWHV WR UHDFK IXOO L...

Page 33: ...t comfort setting is in the middle The pressure can be adjusted by two increments higher or lower than the default setting See Figure 47 WARNING To avoid discomfort or injury for the patient ALWAYS set the comfort level at maximum for patients weighing over 360 kg 793 lb Auralis Plus only If there is a power failure the Auralis pump enters Battery mode If the Auralis pump is fully charged the Aura...

Page 34: ...PRGH FDQ EH extended Extend 1 step 3UHVV WKH XWR UP EXWWRQ WR H WHQG WKH XWR UP mode by 5 minutes 7KH XWR UP FDQ EH H WHQGHG XS WR D PD LPXP RI times For further extension repeat step 1 If not extended the Auralis pump goes back to the previous mode by default Deactivate 7R GHDFWLYDWH WKH XWR UP PRGH SUHVV DQG KROG GRZQ WKH XWR UP EXWWRQ IRU VHFRQGV RU VHOHFW DQ of the other modes Alternating mode...

Page 35: ... pump Lock out mode Locking Push and hold Comfort control Positive and Comfort control Negative buttons at the same time for at least 2 seconds The top and bottom Comfort control indicators will ÀDVK VLPXOWDQHRXVO 6HH LJXUH 3XPS LV QRZ LQ Lock out mode and will not accept any more inputs until unlocked Unlocking from Lock out mode Push and hold Comfort control Positive and Comfort control Negative...

Page 36: ...ress supports the SDWLHQW IRU KRXUV ZLWKRXW GHÀDWLQJ See Figure 53 WARNING To avoid injury disconnect the power cable from the power source before moving the bed CAUTION To avoid entanglement when the Auralis pump is in Transport mode make sure that the tube set connector is stowed appropriately NOTE There is no Transport mode on the Auralis seat cushion Deactivate To deactivate the Transport mode...

Page 37: ...lster if required 4 HDYH WR GHÀDWH IRU PLQXWHV NOTE ROVWHUV VKRXOG EH GHÀDWHG EHIRUH UHGXFLQJ WKH bed frame into its narrowest form ROVWHU LQÀDWLRQ XUDOLV 3OXV RQO VWHSV 1 WARNING To avoid discomfort or injury for the patient deactivate transport mode before inflating the bolsters Locate the valve symbol on the bottom of the mattress See Figure 55 2 Turn the valve under the valve symbol on the ERO...

Page 38: ...5 UDSLG GHÀDWLRQ XQLW WR GHÀDWH WKH Auralis mattress 3 Place the tube set over the Auralis mattress parallel to the foot end See Figure 58 4 Roll the Auralis mattress tightly allowing it to GHÀDWH VR LW WV LQWR WKH EDJ 6HH LJXUH Start from the foot end and continue up to the 35 UDSLG GHÀDWLRQ XQLW DW WKH KHDG HQG RU XUDOLV 3OXV RQO GHÀDWH EROVWHUV EHIRUH UROOLQJ 5 Place the Auralis mattress in the...

Page 39: ... in the protective bag The inside of storage bag should be dry clean and free from contamination and sharp objects 5 Store the Auralis seat cushion in a designated area in line with storage requirements see 7UDQVSRUW DQG VWRUDJH FRQGLWLRQV RQ SDJH Store the Auralis pump 3 steps 1 Clean and disinfect the Auralis pump according to VHFWLRQ OHDQLQJ DQG GLVLQIHFWLRQ LQVWUXFWLRQV RQ page 40 2 Wrap the p...

Page 40: ...r use and the safety data sheet of the disinfectant WARNING To avoid electrical shock always disconnect the Auralis pump from the power source before cleaning and inspecting WARNING To prevent cross contamination always follow the disinfection instructions in this Instructions for Use WARNING To avoid eye or skin irritation never disinfect in the presence of a patient CAUTION To avoid equipment da...

Page 41: ...been left should be cleaned again with the cleaning solution before continuing with the cleaning and disinfectant process 5 Use water and a new cloth to wipe off all traces of cleaning solution followed by a dry cloth to remove any excess moisture from the Auralis pump Disinfect the Auralis pump 6 Spray disinfectant solution on to a dry cloth and spread the solution onto all areas of the Auralis p...

Page 42: ...s mattress seat cushion 17 Spray disinfectant solution on to a dry cloth and spread the solution onto all external areas of the Auralis mattress Auralis seat cushion top covers 18 Allow time for disinfection according to the instructions provided by the disinfectant manufacturer 19 After disinfecting the top cover use water and a new cloth to wipe off all traces of disinfectant solution from the t...

Page 43: ...er with a dry cloth 27 Allow the internal components to air dry before reattaching the top cover of the mattress 28 If required the straps and base of the Auralis mattress seat cushion can also be cleaned using the same method as above Unclip the straps before cleaning for ease of access ...

Page 44: ...s inside the Auralis pump Auralis mattress or Auralis seat cushion The Auralis pump s case must only EH UHPRYHG E TXDOL HG VHUYLFH SHUVRQQHO 1R PRGL FDWLRQ RI WKLV HTXLSPHQW LV DOORZHG WARNING To avoid injury and or unsafe product the maintenance activities must be carried out at the FRUUHFW IUHTXHQF E TXDOL HG VHUYLFH SHUVRQQHO XVLQJ FRUUHFW WRROV SDUWV DQG NQRZOHGJH RI SURFHGXUHV 4XDOL HG VHUYLF...

Page 45: ... socket x Auralis mattresses and seat cushion Visually check the tube set and connector x Visually check the top cover x Visually check all zips x 9LVXDOO FKHFN WKH LQJ DQG VHFXULQJ VWUDSV x Visually check all loop straps and Heelguard cell straps x Visually check all cell hooks x Auralis system Visually check all labels x Perform a full functionality test on the Auralis system x KHFNV E TXDOL HG ...

Page 46: ... and a self diagnostic check runs for 10 seconds Once the check is completed the Auralis pump beeps twice and is ready for use 3 Press the Run standby button to start the Auralis pump 4 To check the alarm functionality disconnect the tube set from the pump while the system is switched on After 30 seconds two green alarm panel indicators on the front of the pump turn yellow the Low pressure indicat...

Page 47: ...tresses Auralis seat cushion and Auralis mattress extensions accessory only Labels on Auralis mattresses Auralis seat cushion and Auralis mattress extensions on page 58 If any label is missing contact Arjo Customer Service After 24 months use check by TXDOL HG SHUVRQQHO RQO The Auralis system must be serviced after 24 months use in accordance with the Maintenance and Repair Manual ...

Page 48: ... should be heard when correctly connected Maximum 20 minutes for mattress Maximum 5 minutes for seat cushion LOW PRESSURE 1 The tube set is not connected properly 2 7KH 35 UDSLG GHÀDWLRQ unit on the Auralis mattress is not closed 3 The valves on the Auralis seat cushion are not closed 4 There is a leak in the system 5 System below optimum SUHVVXUH ZKLOVW UH LQÀDWLQJ bolsters Auralis Plus only 1 Ch...

Page 49: ... quoting the serial number 7R QG WKH VHULDO QXPEHUV IRU the Auralis pump mattress or seat cushion see sections DEHOV RQ SDJH DQG DEHOV RQ XUDOLV PDWWUHVVHV Auralis seat cushion and Auralis PDWWUHVV H WHQVLRQV RQ SDJH 58 Immediate upon expiry of service timer INTERNAL FAULT and Front panel alarms show yellow The Auralis pump has detected an internal fault Switch the Auralis pump off and restart it ...

Page 50: ...TURE The Auralis pump is operating outside its temperature range and has entered the transport mode There is an audible alarm and the indicators turn yellow before the Auralis pump shuts down 1 Turn off the Auralis pump 2 Disconnect the power cable 3 Check the position of the Auralis pump is it near a heat source is it in the sun is it covered up 4 If any of above apply move or uncover the Auralis...

Page 51: ...TROUBLESHOOTING AND ALARMS 51 Intentionally left blank ...

Page 52: ...re than 12 5 mm diameter and water droplets falling vertically Mode of operation Continuous Alternating Mode Cycle Time 10 minutes Alternate 10 minutes XWR UP PLQXWHV 3 FRQWLQXRXV BATTERY Battery type Li ion non removable Voltage 14 4 V Capacity 2200 mAh Battery life 300 cycles minimum ELECTRICAL Supply voltage 100 230 V Supply frequency 50 60 Hz Power input 4 58 VA OPERATING CONDITIONS Temperatur...

Page 53: ...ND SEAT CUSHION MEASUREMENTS Part no Description Size mm in Weight kg Ib Including transport bag of weight 0 46kg 636T01S Standard 110 2030 x 860 x 115 80 x 34 x 4 5 7 9 17 4 636T01N Narrow 110 2030 x 780 x 115 80 x 30 x 4 5 7 7 16 9 636M05S Standard 175 2030 x 860 x 175 80 x 34 x 7 13 8 30 4 636M05N Narrow 175 2030 x 780 x 175 80 x 30 x 7 12 7 27 9 636M02S Standard 200 2030 x 860 x 205 80 x 34 x ...

Page 54: ...r Resistant Repellent Yes Polyurethane coating includes an antimicrobial agent to control microbial deterioration of fabric Yes Fire Retardant1 BS 7175 0 1 5 2 Way Stretch Yes Recommended Wash Temperatures 60 C 140 F 15 minutes Maximum Wash Temperatures Max 95 C 203 F 15 minutes Recommended Drying Temperatures 60 C 140 F or air dry Maximum Drying Temperatures Max 80 C 176 F Wipedown Chemicals2 Chl...

Page 55: ...Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601 1 2 2014 4th EMC Edition Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances IEC 60601 1 8 2006 AMD1 2012 Medical Electrical Equipment Part 1 8 General requirement for basic ...

Page 56: ... and input voltage Serial number label 6WDWHV WKH SURGXFW LGHQWL FDWLRQ Labels on the Auralis Pump A u r a l i s Product label Serial number label LABEL EXPLANATION Product label States technical performance and requirements e g input power and input voltage Serial number label 6WDWHV WKH SURGXFW LGHQWL FDWLRQ ...

Page 57: ... number REF Reference number Name and address of the manufacturer Manufacturing date Separate electrical and electronic components for recycling in accordance with the European Directive 2012 19 EU WEEE Type BF Applied part protection against electrical shock in accordance with IEC 60601 1 Double Insulated o C o C Temperature limitation To indicate the temperature limitations for the product durin...

Page 58: ...s the washing conditions Law tag US and Canada only 6WDWHV FHUWL FDWLRQ RI ÀDPPDELOLW WHVW Labels on Auralis mattresses Auralis seat cushion and Auralis mattress extensions Care and cleaning label inside the top cover and on base cover Top cover label inside the top cover Serial number label inside the base cover Law tag if applicable on base cover of Auralis 175 mattress and Auralis Long and Shor...

Page 59: ...V WKH PD LPXP WRWDO ORDG RI WKH SDWLHQW NJ E mattresses kg lb 6DIH ZRUNLQJ ORDG GH QHV WKH PD LPXP WRWDO ORDG RI WKH SDWLHQW NJ E seat cushion kg lb Product weight Auralis mattresses kg lb Product weight Auralis seat cushion Recommended wash temperature 15 min at 60 C 140 F Max wash temperature 15 min at 95 C 203 F Tumble dry at 80 C 176 F Maximum drying temperature 80 C 176 F Do not iron Wipe sur...

Page 60: ...the equipment affecting its performance Portable and mobile radio frequency RF communications equipment e g mobile cell phones can affect medical electrical equipment If this equipment needs to be used adjacent to other electrical equipment normal operation must be checked before use For detailed EMC information contact Arjo service personnel WARNING Stacking or placing other electrical equipment ...

Page 61: ...nment guidance RF emissions Group 1 The Auralis pump uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B This pump is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies bui...

Page 62: ...IURP HG 5 WUDQVPLWWHUV 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 the following symbol Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is ...

Page 63: ...wer of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz G 3 80 MHz to 800 MHz G 3 800 MHz to 2 7 GHz G 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 2 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the f...

Page 64: ...ge IEC 61000 4 5 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical domestic commercial or hospital environment Voltage dips short interruptions and voltage 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 for 5 cycle 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 ...

Page 65: ...PARTS AND ACCESSORIES 65 Parts and accessories Auralis Plus Long mattress extension Accessory 636614 Auralis Plus Short mattress extension Accessory 636615 Coiled Skin IQ power cable 636377 ...

Page 66: ...PARTS AND ACCESSORIES 66 Intentionally left blank ...

Page 67: ...omo arjo com MIDDLE EAST Arjo Middle East FZ LLC Of ce 908 9th Floor HQ Building North Tower Dubai Science Park Al Barsha South P O Box 11488 Dubai United Arab Emirates Direct 971 487 48053 Fax 971 487 48072 Email Info ME arjo com NEDERLAND Arjo BV Biezenwei 21 4004 MB TIEL Postbus 6116 4000 HC TIEL Tel 31 0 344 64 08 00 Fax 31 0 344 64 08 85 E mail info nl arjo com NEW ZEALAND Arjo Ltd 34 Vestey ...

Page 68: ...re 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 WKH VWDQGDUG RI VDIH DQG GLJQL HG FDUH YHU WKLQJ ZH GR ZH GR ZLWK SHRSOH LQ PLQG ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö Sweden www arjo com ...

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