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4.6 General Warnings

• 

The system is to be installed and put into service in accordance with the 

information provided in these instructions for use.

• 

The system is typically not suitable for child use, if it is to be used for 

child occupancy ensure a risk assessment has been undertaken taking 

into account the proportions of the child and dimensions of the system.

• 

Misused electrical equipment can be hazardous.

• 

Exposure of the control unit to any liquid while it is plugged in could 

result in a severe electrical hazard. 

• 

The control unit is a precision electronic product. Use care when 

handling or transporting it. Dropping or other sudden impacts may result 

in damage to the unit. 

• 

Do not open the control unit – Risk of electrical shock.

• 

Repairs and service are to be conducted by suitably trained personnel. 

If the control unit is not functioning properly, or has been damaged, 

unplug the unit and take it out of service immediately. 

• 

Modification of the mattress or control box is not allowed without the 

permission of Drive DeVilbiss Healthcare Ltd. – A hazard could be 

introduced.

• 

Occupants and users of this equipment must never smoke in close 

proximity to the control unit, mattress, cushion or bedding being used 

with it - Risk of fire. 

• 

Accessories that have not been approved or designed for use with the 

system are not be used.

• 

Control unit shall not be used in the presence of flammable gasses or 

used in oxygen rich environments – Risk of explosion/fire.

• 

Control unit functions must be locked out when a patient is left 

unattended.

• 

If children, adults who lack capacity or even pets pose a potential 

risk of intentional or unintentional tampering with the control unit its 

suitability for use is to be considered during the initial patient/product 

risk assessment.

• 

The support surface is for single occupancy use. Additional weight 

could damage the mattress or affect the performance of the mattress 

system.

• 

Minimise articles (e.g. bedding) between the support surface and 

patient, and secure bed sheets loosely so as not to affect product 

functionality. 

• 

Perform regular patient skin checks – Any tissue deterioration may 

require equipment reallocation and/or a re-assessment of the care 

being provided.

• 

Incompatible support platforms (eg. bed frame or mattress) can create 

safety/stability hazards.

Warning

Содержание DeVilbiss Healthcare Theia

Страница 1: ...Dynamic System Instructions for use...

Страница 2: ...o normal use QUICK REFERENCE GUIDE P1 of 2 FIG 1 FIG 2 FIG 3 FIG 4 Connect the mattress cushion to the control unit FIG 5 ensuring the feed pipes do not kink or become trapped between bed chair parts...

Страница 3: ...and cushion MUTE STATIC POWER FAILURE LOW PRESSURE WEIGHT RANGE 1 MIN MAX MID 4 8 No Symbol Description 3 MUTE STATIC POWER FAILURE LOW PRESSURE WEIGHT RANGE 1 MIN MAX MID 4 8 Static Mode Press to set...

Страница 4: ...1 Preparing for Use 8 2 Control Interface 8 3 CPR Function 8 4 Low Pressure Warning 8 5 Power Failure Warning 9 DECONTAMINATION CLEANING 9 1 Control Unit 9 2 Mattress and Cushion 9 3 Alternative Cove...

Страница 5: ...ilbiss Healthcare Ltd service engineers or qualified personnel 1 INTRODUCTION 2 CONTACT INFORMATION Drive DeVilbiss Healthcare Ltd Sidhil Business Park Holmfield Halifax HX2 9TN United Kingdom For Ser...

Страница 6: ...as it depends on the physical size of the patient in relation to the proportions of the mattress and bed frame 3 3 Intended Use The intended use of the support surface is for sleeping resting sitting...

Страница 7: ...tures 3 5 Indications To assist as part of an overall programme of care when active load distribution through mechanical means is required Bed frames used with the system can vary greatly depending on...

Страница 8: ...dema when using alternating mode only Other contraindications may be relevant which are specific to the patient or care environment 4 4 Training If these instructions for use are not deemed sufficient...

Страница 9: ...A hazard could be introduced Occupants and users of this equipment must never smoke in close proximity to the control unit mattress cushion or bedding being used with it Risk of fire Accessories that...

Страница 10: ...could be incurred Do not store whilst inflated damage could be incurred Do not store objects such as side rails on top of the mattress or cushion damage could be incurred Warning Caution 5 2 Transport...

Страница 11: ...e of potential product damage Manufacturer Date of manufacture Lot number Class II electrical device Theuser occupantisprotectedbyatleasttwolayersofinsulationbetweenthecurrent carrying parts e g contr...

Страница 12: ...ts Type BF Applied parts which are electrically isolated from earth and other parts of the medical equipment Complying with specific requirements for protection against electric shock to EN 60601 1 95...

Страница 13: ...electrical cables can create a risk of electrocution and or fire A CE marked extension cable must only be used when it is not possible to reach a wall socket with the equipment mains cable Contact Dr...

Страница 14: ...imum of 2 hours prior to plugging into the mains supply Risk of electrical system damage if operated outside of the recommended temperatures Caution Open all packaging with care Once removed from the...

Страница 15: ...control unit ensuring the air hose does not kink or become trapped between parts of the bed frame Plug the mains cable into a suitable mains supply and switch on the control unit The system will star...

Страница 16: ...ay It s recommended to adjust comfort control to the max when inflating before adjusting the pressure to the patient s needs Before changing the comfort control a clinical judgement is required from f...

Страница 17: ...connections are secure and correctly installed according to the relevant instructions If the pressure is consistently low open the zipper and confirm that all of the hoses are properly connected Chec...

Страница 18: ...of the below washing instructions are not followed the product warranty will be invalidated Do not use solvents neat bleach phenolic based cleaning solutions or abrasive products to clean the casing...

Страница 19: ...ter and a clean cloth and allow to fully dry before use Ensure the internal foam and air cells are orientated correctly to the mattress covers when reassembling 9 3 Alternative Cover Cleaning Instruct...

Страница 20: ...ble and visual indicators work appropriately when plugged in and unplugged from mains supply Check that the battery is still functional and operates in the event of a power loss Check that the mattres...

Страница 21: ...used with your system is not to be disposed of in general municipal waste as it is to be considered as Waste Electrical and Electronic Equipment WEEE Some of the electrical components could be harmfu...

Страница 22: ...Cushion Weight 2kg Maximum Patient Weight 120kg 18 stone No of Cells 6 cells Alternating Therapy AB pattern Cycle Time 12 mins Pressure Range 20 55mmHg Control Unit Dimensions L 270mm x W 155mm x H 10...

Страница 23: ...Mattress Weight 9 7kg Maximum Patient Weight 180kg 28 stone No of Cells 17 cells Alternating Therapy AB pattern Cycle Time 12 mins Pressure Range 20 55mmHg Control Unit Dimensions L 270mm x W 155mm x...

Страница 24: ...Weight 180kg 28 stone No of Cells 17 cells Alternating Therapy AB pattern Cycle Time 12 mins Pressure Range 20 55mmHg Control Unit Dimensions L 270mm x W 155mm x H 100mm Control Unit Weight 1 6kg Cove...

Страница 25: ...ed for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacture s declaration electromagnetic immunity Immunity...

Страница 26: ...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 of the transmitter...

Страница 27: ...urer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in ea...

Страница 28: ...ow instructions or g otherwise used in a manner inconsistent with any instructions provided by Drive DeVilbiss Healthcare Ltd The warranty explicitly exempts consumable items Thiswarrantycontainstheen...

Страница 29: ...29...

Страница 30: ...Airflo xiamen Medical Co Ltd 1F 3F 4F No 6 East Haijing Road Haicang Xiamen Fujian China Y Sung Handelsvertretung Duesselihaler Str 24 40211 Duesseldorf Germany Drive DeVilbiss Healthcare Ltd Sidhil...

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