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ASKLÉ

SANTÉ 

 

- 4 - 

 

D

EFINITION OF SYMBOLS

 

 

Warning - see user manual and (or) instructions for use 

 

Class II device (Double insulation) 

 

In  accordance  with  the  essential  requirements  of  European 
Directive 93/42/EEC, applicable to medical devices (modified 
2007/47/EEC) 

 

Warning  -  electrical  and  electronic  equipment  subject  to 
separate collection of waste 

 

Manufacturer 

 

Series number 

 

BF electrical device (applied to blankets) 

 

Patient weight range 

USE 

C

ONTENTS OF PACKAGING

 

 

1 mattress, rolled up in a transporting bag 

 

1 dirty/clean label 

 

1 identification label 

 

1 AXENSOR® device, located in the blanket cover 

 

1 compressor integrated into a rolled-up mattress 

 

1  electrical  power  cable  with  2  hooks  systems  for  connecting  to  the  sides  of  a 
hospital bed 

 

1 user manual 

O

PERATING PRINCIPLE

 

 

Alternating pressure helps to avoid prolonged vascular compression which is likely to 
lead to tissue hypoxia. 

 

The static low pressure mode allows for the care of people requiring immobilisation 
(fractures,  neurological  injury,  etc.),  reducing  secondary  pain  to  a  minimum, 
promoting  the  patient's  rest  and  carrying  out  a  weaning  process  before  putting  in 
place a static mattress, etc.. 

 

The  "care"  mode  (fixed)  allows  for  the  maintenance  of  certain  acts  of  care  and 
transfers. 

 

Adjustment  of  the  level  of  inflation is automatic  based  on  the  patient's  shape  and 
size  and  the  angle  of  the  backrest,  thanks  to  AXENSOR®  technology.  No  external 
intervention is necessary. 

 

 

Summary of Contents for Automorpho

Page 1: ...User manual PA0010122 MAJ 27 03 2014 UK ...

Page 2: ...ry resuscitation CPR 8 Heel Grounding Valves 8 De installation 9 Storage and transport 9 AXENSOR CONNECT 10 MAINTENANCE DISINFECTION 10 Compressor and AXENSOR system 10 Macro particle filter 10 Mattresses and Covers 11 Diagram of advised maintenance and disinfection 12 ALARMS and TROUBLESHOOTING 13 MAINTENANCE CHECK 14 Frequency of checks 14 Use of the info button 14 DISPOSAL OF THE MEDICAL DEVICE...

Page 3: ...vent bedsores other preventative measures are also essential changing position frequently at least every 2 to 3 hours maintaining skin hygiene and avoiding maceration in cases of incontinence regularly changing protection monitoring or having the skin condition monitored on a daily basis ensuring sufficient and suitable nutrition regularly drinking a sufficient quantity of liquid If one of these m...

Page 4: ...s only compatibility between the systems assembled by the manufacturer ASKLESANTE guarantees safe usage of the AXTAIR AUTOMORPHO AXENSOR motorised air mattress The features and performance of the motorised air support shall only be maintained by using the pump ref VAXT6 PUMP AUTO associated with the mattress ref VAXT6 MA AUTO and VAXT6 MA MAX without any modification and optionally the inflation d...

Page 5: ...as been approved in order to improve the service rendered in terms of therapeutic aid and or prevention of bedsores We have approved this product in order to improve the service offered in the prevention and aid in treatment of bedsores versus the risk of trapping of the bedridden person Keep packaging the transporting bag as well as the mattress out of reach of children in order to avoid any risk...

Page 6: ...rated into a rolled up mattress 1 electrical power cable with 2 hooks systems for connecting to the sides of a hospital bed 1 user manual OPERATING PRINCIPLE Alternating pressure helps to avoid prolonged vascular compression which is likely to lead to tissue hypoxia The static low pressure mode allows for the care of people requiring immobilisation fractures neurological injury etc reducing second...

Page 7: ...l turn on for 1 second and a beep will sound 5 If you have a rapid inflation pump follow these steps If not proceed to step 9 6 Open the CPR valve positioning it to OPEN 7 Connect the rapid inflation pump to the CPR Keep the CPR and the pump on the same line to avoid jamming the CPR with the weight of the pump Improper use may lead to reduced airtightness of the CPR 8 Press down on the rapid infla...

Page 8: ...te until the end of the calculation The end of this calculation requires the presence of a patient on the support In case of the absence of patient the alternate pressure will continue even in static mode At the end of the calculation pressure the compressor will switch into the selected mode WARNING The electrical cable must be installed so as to avoid any crossover with the articulated parts or ...

Page 9: ... is limited to 30 minutes Securing care mode flickering of the care mode light indicates that the mode is almost finished It is triggered 5 minutes before the end A sound signal is emitted when triggered At the end of the 30 minutes the compressor automatically switches into the mode previously used Low pressure static mode inflates all cells in the mattress at a constant pressure depending on the...

Page 10: ...be carried out HEEL GROUNDING VALVES The range of mattresses is equipped with 4 independent heel grounders at the levels of the cells at the foot of the mattress In position A The cell with the air vented deflates In position B The cell is re inflated WARNING Do not simultaneously deflate more than 2 out of 4 cells in order to guarantee the comfort and safety of the patient Do not leave a heel gro...

Page 11: ...GE AND TRANSPORT A model identification label allows you to identify which product from the Axtair range is in the bag This label must be visible during storage The following storage and transport conditions must be respected Temperature between 25 C and 70 C Humidity levels between 30 and 93 Atmospheric pressure between 50kPa and 106 kPa WARNING Keep the device away from sources of humidity direc...

Page 12: ... power must be off Do not use high pressure jets to clean an Axtair AUTOMORPHO AXENSOR compressor Do not put the compressor on the floor Hang it at a distance of 60 cm from a water source Do not use corrosive cleaning products such as industrial cleaning agents acetone solvents ether or colouring products alcohol iodine potassium permaganate silver nitrate etc Do not use abrasive materials such as...

Page 13: ...ded for use by the manufacturer Adhere to the recommended time periods CE certification obligatory under Directive 94 42 EEC for products to be used on the surfaces of Medical Devices For the covers and the base the following maintenance recommendations must be respected Washed at a maximum water temperature of 90 C reduced mechanical action rinsing at decreasing temperature reduced spin dry White...

Page 14: ...Pre Treatment of surface Decontamination Spread over surface by µfibres Alcohol based solution Recommended hygiene mask gloves apron Physical cleanliness Unacceptable Bio cleaning surface maintenance Method 3 operations Product Detergent Disinfectant Recommended gloves apron Machine wash cover at 90 C Detergent Replacement cover identical to the original protection Conformance of Mattress and Comp...

Page 15: ... is properly closed 3 Remove the patient from the support 4 Contact your maintenance service The compressor is measuring zero pressure when it pumps 1 min The compressor is measuring too much pressure 1 min Inflation impossible 10 min Fixed light alarm sound signal Low First inflation impossible 40 min 1 Check that the mattress is properly connected to the compressor 2 Check that state of the AXEN...

Page 16: ...ong the compressor and mattress have been in use To see this information you require specific equipment contact your distributor for more information WARNING Checks can only be carried out by designated people contact your distributor USE OF THE INFO BUTTON Continuously pressing this button allows you to get information on the last recorded alarm and the need for a check Alarm key Signal Meaning F...

Page 17: ...est waste sorting centre at the end of its life cycle The device must be placed in the mixed small appliances receptacle You can contact the shop or service provider from which the product was bought to find out where your nearest collection points for used equipment are Before any disposal the device must be cleaned following the instructions in the MAINTENANCE DISINFECTION chapter to avoid any r...

Page 18: ... kg 30 180 kg Weight of support 8 Kg 10 kg Size of support 195 x 87 x 17 cm 195 x 87 x 20 5 cm Therapeutic air cells Number 18 Height 12 cm Material Ether polyurethane Number 18 Height 15 5 cm Material Ether polyurethane Head cells 3 static cells Rapid inflation CPR valve less than 15 secs Foam mattress Polyether foam detachable Height 5cm Upper cover Detachable Waterproof and permeable to water v...

Page 19: ...ompressor Box materials Fire resistant plastic material Warranty 2 years against any manufacturing flaw Life cycle 6 years Regulations IEC 60601 1 Ed 3 IEC 60601 1 2 ELECTROMAGNETIC COMPATIBILITY The Axtair AUTOMORPHO AXENSOR is in accordance with the relevant electromagnetic compatibility regulations EMC The Axtair AUTOMORPHO AXENSOR requires special precautions in terms of electromagnetic compat...

Page 20: ...ASKLÉSANTÉ Groupe Winncare 200 rue Charles Tellier Actiparc de Grézan 30 034 Nîmes Cedex 1 France Tel 33 0 4 66 02 15 15 Fax 33 0 4 66 02 15 00 Email contact askle com www winncare fr DISTRIBUTED BY ...

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