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LIST OF STANDARDS AND CERTIFICATES

List of standards and certi

fi

cates

STANDARD / CERTIFICATE

DESCRIPTION

IEC 60601-1:2005 + AMD1:2012
+ AMD2:2020 (Ed 3.2)

Medical Electrical Equipment – Part 1: general requirements for basic
safety and essential performance.

IEC 60601-1-11:2015 +
AMD1:2020 (Ed 2.1)

Medical Electrical Equipment – Part 1-11: general requirements
for basic safety and essential performance – Collateral Standard:
Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment

IEC 60601-1-2:2020 (ed. 4.1)

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
+ AMD2:2020 (Ed 2.2)

Medical Electrical Equipment Part 1-8 general requirement for basic
safety and electrical performance

- Collateral standard: general requirements, tests and guidance for
alarm systems in medical electrical equipment and medical electrical
systems

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Содержание AtmosAir Velaris

Страница 1: ...INSTRUCTIONS FOR USE AtmosAir Velaris Hybrid mattress system 04 AAV 00EN_02 10 2021 ...

Страница 2: ...ous 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 ...

Страница 3: ...ight 16 Product description Alternating pressure pump 17 Repeater light 17 Hanging brackets 17 Power cable 17 Skin IQ port 18 Audio on oﬀ switch 18 Day Night mode 18 Product description Standard and Plus mattress 19 Covers 19 Mattress connector 19 Connect the pump to the mattress 19 Disconnect the pump from the mattress 20 Handles 21 Non slip base 21 Cable management loops 21 Product description S...

Страница 4: ...rd or Plus mattress 27 Patient position 27 System start up 27 Turn oﬀ and remove the pump 28 Store the pump 28 Homecare use 29 Cleaning and disinfection 30 Clean and disinfect 32 Care and preventive maintenance 34 Troubleshooting and alarms 37 Technical specifications 38 Labels 42 List of standards and certificates 46 Electromagnetic compatibility 47 ...

Страница 5: ...odifications to its products Service and support Routine maintenance before every use or every week in long term care is necessary to maintain the safety and reliability of the product See the Care and preventive maintenance section for more information If you require further information or spare parts see Customer contact information Serious incident If a serious incident occurs in relation to th...

Страница 6: ...nce the system when used in an unpowered reactive mode is indicated for patients that are deemed to be At Risk of a pressure injury If the system is used in conjunction with the pump the patients with a higher risk profile may be considered 2 The above are guidelines only and should not replace clinical judgement The Standard mattress system is for patients within the weight range of 40 kg 90 lb t...

Страница 7: ...ssment and continuous monitoring of the patient is advised Patient assessment Facilities should establish regular assessment routines Caregivers should assess each patient before using the product The patient weight must not exceed 250 kg 550 lb for the Standard mattress 454 kg 1000 lb for the Plus bariatric mattress 250 kg 550 lb for the Stretcher ST mattress 250 kg 550 lb for the Seat cushion If...

Страница 8: ...vel the bed and disconnect the Velaris pump if connected Lower the side rails and initiate CPR as detailed in the facility protocols WARNING To avoid falls and injury make sure that cables and the tube set are positioned correctly Keep cables away from moving bed parts or other possible entrapment areas WARNING To avoid pressure injury the patient must not wear clothing that may cause areas of loc...

Страница 9: ...ally check the package for damage If the package is damaged contact the transport agency Do NOT use the product 2 Read this IFU 3 Check that all parts of the product are supplied Compare to section Parts designation on page 10 If any part is missing or damaged do NOT use the product 4 Recycle the packaging according to local regulations 5 Choose a designated area where this Instructions for Use sh...

Страница 10: ...ight 6 Weight increase button 7 Power fail light 8 Audio alarm pause button and light 9 Low pressure light 10 System fault light 11 Skin IQ connected light Skin IQ AtmosAir Velaris 40 60 80 100 130 170 210 250 350 450 kg 1 5 4 6 9 8 11 10 7 3 2 1 Control panel with lights 2 Repeater light 3 Tube set connector 4 Hanging brackets 5 Skin IQ port 6 Power cable Alternating pressure pump ...

Страница 11: ...tachable top cover 2 Mattress connector 3 Mattress connector cavity 4 Non Slip strips 5 Detachable bottom cover 6 Handles 7 Cover attachment zip with zip flap 8 Cable management loops Standard and Plus mattress 1 7 6 5 2 3 4 8 ...

Страница 12: ...12 PARTS DESIGNATION 1 5 4 3 2 1 Detachable top cover 2 Non Slip strips 3 Detachable bottom cover 4 Cover attachment zip with zip flap 5 Handles Stretcher ST mattress ...

Страница 13: ...13 PARTS DESIGNATION 1 Detachable top cover 2 Cover attachment zip with zip flap 3 Non Slip strip 4 Detachable bottom cover 5 Handle Seat cushion 1 5 4 2 3 ...

Страница 14: ... the control panel press and hold the Lock button for 2 seconds When locked the light turns on To unlock all control panel buttons press and hold the Lock button for two seconds When unlocked the light turns oﬀ The control panel buttons automatically lock after 60 seconds if no control panel button is pressed Audio oﬀ light See Figure 3 The Audio oﬀ light turns on when the Audio notifications and ...

Страница 15: ...s the weight reduces increases by one step The selected weight is indicated by a green light The Plus mattress weight settings 350 kg and 450 kg are indicated by a blue light when selected Always round up the patient s weight to the next higher value Audio alarm pause button and light See Figure 5 Press the Audio alarm pause button to silence the audible alarm for 15 minutes The light turns on Pre...

Страница 16: ...ST or during therapy the system fault light turns on and an alarm sounds Low pressure light See Figure 8 If the mattress fails to achieve the target pressure the low pressure light turns on and an alarm sounds Skin IQ light See Figure 9 The Skin IQ light turns on when a Skin IQ coverlet is connected to the Skin IQ power outlet port See Figure 13 Figure 6 NOTE To turn the pump oﬀ and cancel the ala...

Страница 17: ... Figure 11 Use the hanging brackets to mount the pump at the foot end of the bed The pump can also be placed on a flat surface near the bed and the mattress connector Power cable See Figure 12 Position the power cable in the cable management loops on the left side of the mattress See Figure 22 on page 21 Figure 10 Skin IQ AtmosAir Velaris 40 60 80 100 130 170 210 250 350 454 kg Figure 11 Figure 12...

Страница 18: ...it when it has been determined that audio output could be disturbing for the patient The Audio on oﬀ switch is located underneath the side panel cover The cover can only be removed by a service technician Set the switch to position A to disable all audio output Set the switch to position B to enable all audio output Day Night mode A light sensor automatically reduces the brightness of the pump lig...

Страница 19: ...nect the pump to the mattress 1 Locate the connector at the foot end of the mattress and pull it out of the pocket slightly See Figure 16 2 Hold the mattress connector in your left hand and press the connectors together Make sure that the pump tube set connector clicks into place on both sides double click See Figure 17 3 Push the connectors back into the cavity and reposition the zip flap See Fig...

Страница 20: ...side the connector cavity near the foot end of the mattress See Figure 19 2 Firmly squeeze the two buttons on the top and bottom of the pump connector and pull it away from the mattress connector See Figure 20 3 Push the mattress connector back into the connector cavity See Figure 21 Figure 19 Figure 20 Figure 21 ...

Страница 21: ... bed frame Cable management loops See Figure 24 1 Place the power cable in the cable management loops on the left side of the bottom mattress cover 2 Secure the cable using the six cable loops with locking clips 3 Fold down the zip flap over the power cable and loops Figure 22 WARNING To avoid bodily injury never use the mattress or ST mattress as a patient movement device Figure 23 Skin IQ AtmosA...

Страница 22: ...e mattress use the four handles on the bottom mattress cover Non slip base See Figure 26 Non slip strips integrated in the bottom cover prevent the mattress from slipping on the trolley frame Figure 25 WARNING To avoid bodily injury never use the mattress or ST mattress as a patient movement device Figure 26 Product description Stretcher ST mattress ...

Страница 23: ...overs are co joined by a zip Handle See Figure 27 To move the seat cushion use the handle on the back Non slip base See Figure 28 The non slip strip integrated in the bottom cover prevents the cushion from slipping on the chair Figure 27 Figure 28 Product description Seat cushion ...

Страница 24: ...r body For mattress sizes see section Measurements and compatibility on page 40 4 For Standard or Plus mattress Position the mattress on the bed frame Make sure that the mattress is orientated correctly with the mattress connector at the foot end of the bed frame See Figure 29 For ST mattress Position the mattress on the trolley frame Make sure that the mattress is orientated correctly with the cu...

Страница 25: ... connector to the mattress connector Make sure that the pump tube set connector clicks into place on both sides double click See Figure 32 5 Place the power cable in the cable management loops on the left side of the bottom mattress cover Secure the cable using the six cable loops with locking clips See Figure 33 6 Fold down the zip flap over the power cable and loops Skin IQ AtmosAir Velaris 40 6...

Страница 26: ...e seat cushion in the correct orientation CAUTION To avoid puncturing the seat cushion check that there are no sharp objects on the chair Figure 34 Reactive therapy Make sure that the mattress is correctly installed on the bed trolley frame before delivery of reactive therapy See Assemble the hybrid mattress system on page 24 See Figure 35 Patient position Place the patient on the mattress Make su...

Страница 27: ...head is placed on the head end of the mattress Caregiver position The caregiver should be positioned in front of the pump during Active therapy See Figure 37 System start up 1 Connect the pump power cable to a power source The pump makes a start up tone and runs a self diagnostic check for about 10 seconds 2 When the check is completed the pump immediately starts to deliver active alternating ther...

Страница 28: ...ress connector See Figure 38 Store the pump 1 Clean and disinfect the pump See section Cleaning and disinfection on page 30 2 Wrap the pump tube set around the hanging brackets anticlockwise See Figure 39 3 Wrap the power cable around the hanging brackets clockwise See Figure 40 4 Store the pump in a designated area For the storage requirements see Transport and storage on page 39 Figure 38 NOTE T...

Страница 29: ...dren Before using the AtmosAir Velaris hybrid mattress system in a home environment make sure that all caregivers including relatives have read and understood the instructions in this IFU When the hybrid mattress system is in use make sure that It is kept away from sources of heat and moisture and protected from dust lint and dirt The pump is not covered The operational environment meets the requi...

Страница 30: ...If eyes or skin become irritated contact a physician Always read the material safety data sheet of the disinfectant WARNING To avoid electrical shock always disconnect the pump from the power source before cleaning and inspecting WARNING To prevent cross contamination always follow the disinfection instructions in this IFU WARNING To avoid eye or skin irritation never disinfect in the presence of ...

Страница 31: ...OT USE WIPES containing Sodium Hydroxide NaOH Fully rinse with clean water to remove residual chemicals Quaternary ammonium solution 3 15 Acceptable for use at pH 7 10 only Always check the label first DO NOT USE WIPES containing Sodium Hydroxide NaOH Fully rinse with clean water to remove residual chemicals Hydrogen peroxide solution 3 10 Acceptable for use at pH 5 9 only Low and high pH s will D...

Страница 32: ...s 4 Spray the cleaning solution on a clean cloth 5 Wipe all areas of the pump to remove any deposits or visible dirt 6 Clean all areas with residual dirt with the cloth as needed 7 Use a new cloth soaked in water to wipe oﬀ all traces of cleaning solution 8 Use a dry cloth to remove any excess moisture from the pump Disinfect the pump 9 Spray disinfectant solution on a clean cloth and wipe all are...

Страница 33: ...ipe the mattress connector and the connector cavity thoroughly 19 Allow time for disinfection according to the instructions provided by the disinfectant manufacturer 20 Use a new cloth soaked in water to wipe oﬀ all traces of disinfectant solution from the mattress seat cushion 21 Use a dry cloth to remove any excess moisture 22 Allow the mattress seat cushion top and bottom covers to air dry Wash...

Страница 34: ...p tube set and connector Visually check the top and bottom covers Clean and disinfect Visually check all labels Visually check all zips WARNING To avoid malfunction resulting in injury inspection your device regularly Always follow the recommended maintenance schedule WARNING To avoid injury and or an unsafe product the pump s case must only be removed by qualified service personnel There are no u...

Страница 35: ...the pump Run Standby and front panel repeater lights turn on The hybrid mattress system starts delivering active alternating therapy with a default weight setting of 100kg 220 lb 4 If the functionality test fails contact qualified service personnel Visually check the control panel Check that the control panel is firmly aﬃxed Check that the control panel is undamaged Check that the control panel is...

Страница 36: ...or signs of wear tears or strike through stained firesock Inspect the bottom cover for signs of wear and tears Caregiver obligations after each patient Clean and disinfect The hybrid mattress system has to be cleaned and disinfected For further instructions see section Cleaning and disinfection on page 30 Visually check all labels Check that all labels are attached on the hybrid mattress system ac...

Страница 37: ...tart up 1 Internal hardware fault replace pump 2 Select Standby remove power source Re power and if pump fails BIST replace pump 10 Seconds after power up At any time during normal operation LOCK MODE The pump has been put into Lock mode Press and hold the lock button for more than 2 seconds The lock button light is oﬀ and all buttons are unlocked AUDIO ALARM PAUSE The pump audio alarm has been pa...

Страница 38: ...st liquid ingress IP22 Protected from touch by fingers and objects greater than 12 millimetres Protected from water spray less than 15 degrees from vertical Mode of operation Continuous Alternating Mode Cycle Time 10 minutes ELECTRICAL Supply voltage 100 230 V Supply frequency 50 60 Hz Power input 3 46 VA OPERATING CONDITIONS Temperature Ambient 5 C to 40 C 41 F to 104 F Relative humidity range 15...

Страница 39: ... pump 7 years END OF LIFE DISPOSAL Package Corrugated cardboard recyclable Product Fabric material used on the mattresses or any other textiles polymers or plastic materials etc should be sorted as combustible waste Mattresses at the end of life should be disposed of as waste according to the national or local requirements which may be landfill or combustion Pump units have electrical and electron...

Страница 40: ...x 2000 x 180 42 x 79 x 7 Reliant 17 5 39 633030 Premium Plus mattress Part no Size mm in Top cover material Weight kg lb Arjo bed frames 633025 1220 x 2140 x 180 48 x 84 x 7 Reliant 24 53 Citadel Plus 633031 Premium ST mattress Part no Size mm in Top cover material Weight kg lb Arjo Trolley 633042 670 x 1950 x 130 26 x 77 x 5 Reliant 10 22 Lifeguard Trolley 633043 Premium 633044 660 x 1910 x 130 2...

Страница 41: ...before storage Alcohol does not require rinsing with water Further following disinfecting agents are also considered to be acceptable by the TOP COVER material manufacturer Quaternary Ammonium solution 3 15 at pH range 7 10 see Allowed disinfectants on page 31 for recommendations Hydrogen Peroxide solution 3 10 at pH 5 9 see Allowed disinfectants on page 31 for recommendations Always allow time fo...

Страница 42: ...bels on the Pump LABEL EXPLANATION Product label States technical performance and requirements e g input power and input voltage Serial number label States the item identification 1 2 1 Product label 2 Serial number label ...

Страница 43: ...rial 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 d...

Страница 44: ...um patient weight Surface ID Label States the product identification and product weight Law tag States certification of flammability test Example of mattress 1 Silkscreens 2 Top cover label inside the top cover 3 Surface ID label inside the bottom cover 4 US law tag inside the bottom cover 5 Canadian law tag inside the bottom cover ...

Страница 45: ...r Manufacturing date kg lb Safe working load defines the maximum total load of the patient kg lb mattresses kg lb Safe working load defines the maximum total load of the patient kg Ib seat cushion kg lb Product weight surface 80 Recommended wash temperature 15 min at 80 C 176 F Tumble dry at 80 C 176 F Do not iron Wipe surfaces with cleaning solution then wipe with a cloth moistened with water and...

Страница 46: ...teral Standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601 1 2 2020 ed 4 1 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 AMD2 2020 Ed 2 2 Medical Electrical Equipment Part 1 8 general...

Страница 47: ...AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSION The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The pump uses RF energy only for its internal function Therefore its RF emissions are very...

Страница 48: ...omagnetic 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 Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 7 gHz 10 V m 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 propag...

Страница 49: ... Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 gHz d 2 3 P 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 frequency...

Страница 50: ... 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 μT 95 dip in μT for 0 5 cycle 40 μT 60 dip in μT for 5 cycle 70 μT 30 dip in μT for 25 cycles 5 μT 95 dip in μT for 5 s 5 μT 95 dip in μT for 0 5 cy...

Страница 51: ...ing 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 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 arjo com NEW ZEALAND Arjo Ltd 34 Vestey Drive Mount Wellington NZ AUCKLAND 1060 Tel 64 0 9 573 5344 Free Ca...

Страница 52: ...e ergonomic patient handling personal hygiene disinfection diagnostics and the eﬀective prevention of pressure ulcers and venous thromboembolism we help professionals across care environments to continually raise the standard of safe and dignified care Everything we do we do with people in mind ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö Sweden www arjo com ...

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