Carilex DualFlex Instructions For Use Manual Download Page 7

 

 

1

 

 

 

 

1.2.2  Handing over the device 

Device approval

 

 

 

1.2.3 Maintenance and installation

 

 

 

1.2.4 Information  and Test obligation of the user 

Obligations of the user

 

 

 

1.3  Notes for the users 

 

 

1.3.1 Handing over the device 

Procedures for accident prevention

 

 

 

  The device must be thoroughly cleaned and disinfected before the first use.

The initial start-up of the device, as well as the hand over to the user must be

carried out by an authorised personnel assigned by the operator.

After completion, the training it must be documented that the user has understood

the operation and use of the device for special therapy or care purposes.

  

  

 

    

 
 

 
 
 
 
 
 
 
 
 
 
 
 

 

6

 

 

 

 

 

Important notes for safe use

The device may only be used, if the operator has released it for therapeutic or care

use and if the hand over was carried out properly and under the supervision of

authorised personnel.

After the hand over the users are fully responsible for the safe and dedicated use of 

the device.

The maintenance and/or repair of the equipment or parts may only be carried out by

an authorised service agent.

Read these Instructions for use carefully before the first use of the device. This will

allow you to experience all the benefits that the device offers and avoid possible

personal injury and property damage.
A review of the functions has to be carried out and the proper condition of the device

has to be confirmed by the user before each use or transfer for use by patients.

In case of specific issues, which are not covered in enough in detail in these 

Instructions for use please contact the supplier or operator for further guidance.

The hybrid alternating pressure mattress replacement system DualFlex is made

according to the current state of the art and is reliable. However, hazards may arise

during the use of  this device if it is operated by untrained personnel or it is not operated

as described in these instructions for use.

In order to comply with the regulations of accident prevention and to prevent

accidental damage, the following procedural guidelines are to be followed when

handing over the device:

Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

Summary of Contents for DualFlex

Page 1: ...ons for Use DualFlex Hybrid Alternating Pressure Mattress Replacement System for Dual Stage Nursing U 2S2602 30631 G V1 2 DualFlex Hybrid Alternating Pressure Mattress Replacement System for Dual Stag...

Page 2: ...tress replacement system DualFlex It is part of the device documentation Do not pass this device to a third party without these Instructions for use For the confirmation of the up to date status of th...

Page 3: ...Sales and Service In the event of a complaint or if you have any questions about the use of the device or a need for spare parts please contact the supplier that delivered the device to you or your p...

Page 4: ...the Instructions for use 9 1 6 1 Identification of risks of injury 9 1 6 2 Identification of material damage 9 1 6 3 Identification of additional information 9 1 6 4 Additional symbols to the safety...

Page 5: ...isinfection 21 6 Care and maintenance 22 6 1 Inspection 22 6 2 Maintenance 22 7 Troubleshooting 23 7 1 Error causes and remedies measures 23 8 Technical data 24 9 EMC declaration 25 26 4 Instructions...

Page 6: ...ns who have been trained in the operation and the intended use of the device 1 2 1 Instruction Training on the device The training of users on how to use the device must be carried out by the qualifie...

Page 7: ...quipment or parts may only be carried out by an authorised service agent Read these Instructions for use carefully before the first use of the device This will allow you to experience all the benefits...

Page 8: ...ment System intended to treat and or prevent decubitus ulcers otherwise known as bed sores pressure sores and pressure ulcers Always consult a physician or health professional before using this device...

Page 9: ...oning of the DualFlex only under the following conditions The device is used for the intended use and maintained only in accordance with the information provided by these Instructions for use Only ori...

Page 10: ...E Means application tips and useful information Additional symbols to the safety information Additional symbols to the safety information are those listed below signs Machine wash warm Max 70 C Do not...

Page 11: ...wer Mute 10 Class II Double insulation 1 7 Adjust Instructions for Use Hybrid alternating pressure mattress replacement system DualFlex Functional Earth FE Non AP APG IP21 This medical equipment is No...

Page 12: ...aged in particular in the case of damage caused by moisture or water you should promptly inform the carrier as well as the supplier 2 3 Recommended environmental conditions for Storage and Transport A...

Page 13: ...eptacle for an air fillter 4 on the rear Panel two pipe connections 5 for the pressure hoses a power cable 6 with a plug to connect the device into a power socket Hybrid Mattress Replacement 6 Instruc...

Page 14: ...the device is monitoring the mattress internal pressure while the compressor is inflating Low Pressure Indicator 7 Both continuous flashing of orange LED and audible indicator will be triggered to no...

Page 15: ...ert the compressed air hose 4 into the connecting piece 3 To disconnect a compressed air hose from the connecting piece Press the release 1 Turning on the power unit WARNING Electric shock Touching li...

Page 16: ...bs and disconnect both quick plugs from the connections on the power unit 2 3 4 15 connected to close the tubing circuitry 1 Check the pressure in the air cells to ensure there is enough air to suppor...

Page 17: ...a risk that they may be injured if placed in an unstable position Always use the DualFlex coverlet Without the coverlet there is a high risk of cross contamination The hybrid alternating pressure matt...

Page 18: ...essed air hoses to the power unit Make sure that the compressed air hoses are routed without bending kinks or pressure points 4 1 1 Application of the Hybrid Alternating Pressure Mattress Replacement...

Page 19: ...ination e g leftovers please immediately change the bed linen and wipe the coverlet with mild soap water and dry thoroughly Use moisture proof incontinence materials Ventilate the coverlet frequently...

Page 20: ...ring the cleaning and disinfection Wear personal protective equipment Safety glasses Protective gloves Mouth and nose protective Incompatible cleaning agents The parts of the pressure mattress replace...

Page 21: ...pe cleaned areas with soft dry cloth 3 If heavily soiled the coverlet can be washed in the machine using commercially available usual detergent 4 Washing temperature to be a maximum of 70 C if possibl...

Page 22: ...is carried out in three steps Pre disinfection Cleaning Final disinfection Disinfection procedure Pre disinfection 1 Wipe the surfaces with disinfectant 2 Allow the disinfectant to take effect accordi...

Page 23: ...of the power unit with pressure control and control markings Condition of the compressed air hoses and connections Condition of the air cells 6 2 Maintenance The air filter element should be replaced...

Page 24: ...ower unit Compressed air hoses are not free there are bending and pressing points in the compressed air hoses Contact the supplying medical distributor or the technical service of your distributor Ope...

Page 25: ..._V3 1 IEC 60601 1 2005 A1 2012_V3 1 IEC 60601 1 2 2014 EN60601 1 2 2015 Operating Conditions Temperature range 5 C 40 C Relative humidity range 15 93 Atmosphere range 700hPa 1060hPa Rechargeable batte...

Page 26: ...Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 5 3 V P 80 MHz to 800 MHz d 1 5 3 E P 800 MHz to 2 5 GHz d 1 7 E P 2 0 1...

Page 27: ...immunity The Air Pump system is intended for use in the electromagnetic environment specified below The customer or the user of the Air Pump system should assure that it is used in such an environment...

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