ProDerm 1 Plus
Contents
1. EY USER MANUAL AND TECHNICAL DESCRIPTION m E C ProDerm 1 Plus ACTIVE PRESSSURE RELIEVING MATTRESS SYSTEM Version 03 Print date 7 2006 File name Proderm1 07 2006 3 GBL doc vua NET ProDerm 1 Plus Active Pressure Relieving Mattress System Author LINET s r o Petr Jer bek petr jerabek linet cz Emendation LINET s r o Josef Bystriansky josef bystriansky linet cz Related links www linet cz Version 03 Print date 07 2006 File name Proderm1 07 2006 3 GBL doc Copyright LINET s r o 2006 Translation LINET 2006 All rights reserved All trademarks or names are the property of the respective owners LINET s r o reserves the right to change the specifications at any time without warning The information included in this document is presented by LINET in an attempt to accurately and correctly inform the customer However LINET shall not be liable for the consequences arising from the use of this information the infringement of patent or other rights of third parties that arises from the use of this information User Manual ProDerm 1 Plus Version 03 Contents 1 LO CU GEON ee n 4 2 bl ikeen ia asnupi inaina riasan naaa aaea faisaia Eria draia siaaa ada badies au priar aneia 5 3 Safety INStrUCHONS isiksi cases chil cect cee aE eaae aaa eaaa a aS EEEa aaan aiaiai 5 4 Conditions f r USC aciiccsercrptereericten2. Supplier Handover date Serial No confirm that the training of attending staff on the use of the mattress system has been completed Warranty period Date Stamp and signature of Supplier Stamp and signature of Purchaser This handover protocol confirms the start of the warranty period Always quote order number or products in any communication with the supplier User Manual ProDerm 1 Plus Version 03 15 16 Quiver EC CONFORMITY DECLARATION 14 5 2005 Conformity declaration issued by Date of issue Commercial name Registered address Reg No Telephone Fax Linet spol s r o Zelev ice 5 274 01 Slan Czech Republic 00507814 420 312576111 420 312522668 As the importer of the product name brand ProDerm Caremed Supply Inc 7 F No 2 Lane 235 Bao Chiao Rd Xin Tien City Taipei 231 Taiwan ProDerm 1 ProDerm 1 Plus ProDerm 2 ProDerm 2 Plus ProDerm 3 ProDerm 3 Plus ProDerm 4 ProDerm 5 Active anti decubitus mattress system with air pump Class I nonsterile without measuring function Producer Variants of the product Description and function designation Classification of the product as the medical device A Declaration declare that the said product is safe under the conditions of common use in compliance with the instructions and that measures have been taken to ensure the conformity of all the products brought to market with basic requirements of directives re
3. Protection The company LINET spol s r o is aware of the necessity to protect the environment for future generations and therefore devotes great attention to the development innovation planning production and use of such technology and materials that are environmentally friendly This product is constructed from materials that are environmentally friendly The product does not contain dangerous substances based on cadmium mercury asbestos PCB or CFC The operational noise level of the product meets the requirements for the protection of public health against undesirable noise and vibration in protected indoor building premises Wooden parts used in the product are not made from exotic wood such as mahogany jacaranda ebony teak grenadil or santo and do not come from the Amazonian rainforests or other virgin forests All waste packaging left over from when the product is made operational is marked in accordance with the legal regulations on packaging Sort the waste packaging which is left over once the product is made operational by following the graphic symbols and deliver it to a person authorised to further utilise it The product contains recyclable steel plastic and electronic components to optimise recycling once the operation of the product ends separate the individual parts so that the raw materials from which the product is made can be put to further use see CHART Ea AY IN W The product may contain lead accum
4. 0 10 minutes Extraction 2 minutes Cold Rinse Extraction 5 minutes A Control Unit A Tumble rinsing or Tunnel Drying is not recommended The Control Unit should also be cleaned weekly using a damp soft cloth and mild detergent The Control Unit case is manufactured from ABS plastic If the case is soiled the Control Unit can be wiped down with a sodium hypochlorite solution of 1000ppm or any EPA approved hospital disinfectant Do not use phenol based cleaning solutions A User Manual ProDerm 1 Plus Version 03 Switch off the electrical supply to the Control Unit and disconnect the power cord from the main supply before cleaning and inspection Make sure the pump is completely dried before connect the power cord onto the power Use of improper detergents or disinfectants non observance of supplier s instructions regarding dosage and combinations with other agents or faulty care of a mattress system may lead to damage which the supplier cannot be responsible for fyner 8 Maintenance and Troubleshooting A It is recommended to order the inspection by supplier after every 6 months of using This inspection includes the exchange of the Control Unit air filter Failures Possible cause Removal Control Unit is not working Wrong hose connection Blown fuse Control Unit defect Check the connection Exchange the fuse Contact the service dept Control Unit works but the air does not bl
5. attress system is delivered in pasteboard packaging the Control Unit is separated from Overlay The whole consignment must be checked for completeness on delivery in accordance with the delivery note The shipper and the supplier should be advised immediately of any defect or damage in writing Safety Instructions Prior to using the mattress system the carer should be familiarise themselves with the operation of the bed as detailed in this User Manual All operations of the mattress system should be done in accordance with this Manual Do not use the mattress system if any fault is found especially faults which might cause injury to a patient staff or any third person or damage to the mattress bed or other surrounding equipment Only fully trained and experienced Carers should be allowed to operate this mattress system Prior to use the user should check that all functions are in order and bed has no faults The mattress system can be used in background parameters stated in Conditions for use only It is prohibited to use mattress system in patients with weight overlapping the limit stated in User Manual Before cleaning or undertaking any maintenance always unplug the mains cable The mattress system should not be used in an explosion hazard environment or in a presence of inflammable anaesthetics Only approved Manufacturers spares should be used If other suppliers parts are used the manufacturer supplier cannot be held responsible for an
6. e mattress system is designed in accordance with EN 60601 1 2 Standard A Medical electrical equipment Part 1 2 General requirements for safety Electromagnetic compatibility sensitive medical devices could be influenced by the electromagnetic emission of the mattress Main Unit It is necessary to deactivate the Control Unit for a duration of the measuring with these devices Indication patients with low risk of pressure sore development that means patients with 16 20 points on extended Norton Pressure Sores Severity Scale patients with existing pressure sores up to Grade l Il Stirling Scale Contraindications patients with higher risk of pressure sores development than the system is designed for patients with unstable cervical fractures patients with unconsolidated vertebral fractures patients with weight overlapping maximum weight stated in Technical Parameters of the mattress system 6 Mattress Syst m Installation and Setting Up In agreement with Delivery Note check the completeness of the delivery and check if there is any visible damage incurred by transport Eventual inadequacies point out to Delivery Note and pass on to supplier Carefully read the User Manual Lay out the overlay directly onto the existing common mattress and ensure that the supply hoses are at the foot end of the bed Secure the overlay to the mattress through the securing straps on the mattress Hang
7. iaenie meio Pee R 6 5 Technical Parameters svccscciccccctscsicccccczcnsesccuestsnccnusaseacsesbseresteskscskaxctseskxesbctecnenceseeed 6 6 Mattress Syst m Installation and Setting Up eese 7 7 Cleaning and Infection Control cccccccsssssseeeeeeeeeeeeeeseeeeeneeeeeeeeeseeeseeneeeeeeeesenees 9 8 Maintenance and Troubleshooting eeceeeeeeeeeeeeeeeeeeeeeeeeneeeeeneneeeeeeeeeneees 10 9 cli 10 10 Environmental Protection LLeeeeeeeeeeeeeeeeeee esee eene enne nennen nnns 11 11 Warranty and Serviee iocis eris dtnche ur E CER neu kpuRERDGRIRARKR RESA RE RE KERRRRRERA MER NER UERRARR 12 12 Used Marke and Symbols iei i enit anaia anaiai aaaea ia aia 13 13 Boae a ERR NE K n 13 A Appendix Record of service checks and routine maintenance 14 B Appendix Il ProDerm 1 Plus Mattress System Handover Protocol 15 User Manual ProDerm 1 Plus Version 03 3 16 fyner 1 Introduction Active Pressure Relieving Mattress System ProDerm 1 Plus original title Pearl IV operated by LNT 19RO0 Control Unit is a specialized Air Therapy Support Systems for prevention of pressure sores The ProDerm 1 Plus Overlay is designated for use in combination with common hospital mattress It is an alternating system that employs durable shaped air t
8. lated thereto stated in paragraph B B Fulfilled technical requirements This product s characteristics comply with the technical parameters related to it and stated in MDD 93 42 EEC which stipulates the technical parameters for healthcare products and in directive 89 336 EEC which stipulates the technical parameters of products concerning their electromagnetic compatibility C Means of assessing conformity Conformity was assessed by the procedure stated MDD 93 42 EEC Annex VII D Used standards The said product fulfills the requirements of these harmonized technical standards which were used for assessing of conformity EN 60601 1 EN 60601 1 2 EN 12182 and EN 1441 Risk Analysis NU dd Ing Zbyn k Frol k managing director User Manual ProDerm 1 Plus Version 03
9. ow Defect on the air pump diaphragm Disconnected hoses Defect on inductor inside of the Control Unit Contact the service dept Plug in the hoses Contact the service dept The Overlay Mattress is not inflated after one hour of master unit operating The air escapes from cells Crashed or wrongly fixed incoming hoses CPR Valve is opened Check the cells Check the hoses contact the service dept Close the CPR Valve N 9 Storage In case of any major failure do not try to repair the Control Unit Do not open the Control Unit case Contact the service dept of Linet Before Storage check all parts of Mattress System and their functionality Control Unit W Check the power cord and plug for abrasions or excessive wear W Plug in the unit and verify that air flows from the units hose connection ports W Place in plastic bag for storage and protect against liquid penetration Mattress W Check the air manifold for kinks or breaks User Manual ProDerm 1 Plus Version 03 Quine W Disconnect the air feed tubes All the air will now be expelled Starting at the head end the mattress can be rolled W Place in plastic bag of storage Conditions for storage environment are the same as for the operational environment If any major fault or deficiency is found the mattress system must not be used and the manufacturer service contractor must be contacted immediately 10 Environmental
10. report immediately after delivery to the supplier of mattress system Maximum weight of patient is 120 kg patient is used Maximal recommended tilt of the backrest is 30 while the active mattress is used inappropriately strained lining preclusive the preventive function of mattress system Bed sheet should be put freely onto the overlay Anti decubitus effect of mattress system is lowered when any other than supine position of User Manual ProDerm 1 Plus Version 03 Quiver 7 Cleaning and Infection Control Overlay Mattress The Overlay Mattress should be cleaned on the bed weekly using a damp soft cloth and mild detergent Overlay Mattress can be wiped over with a solution of sodium hypochlorite 1000ppm or any other non phenolic germicidal solution While using disinfection and cleaning solutions take notice of following directions W Avoid highly alkaline or acid chemicals using value should not exceed pH 6 up to 8 W Do not use abrasive cleaning agents W Do not use any chemicals containing any substance which could change the structure and adherence of plastics thinners like acetone toluene gasoline etc The cover can be washed in washing machines by the following specifications Industrial Break wash cold 10 minutes Main wash 60 6 minutes Main wash 70 10 minutes Extraction 2 minutes 3 Cold Rinses Extraction 5 minutes Domestic Pre wash cold 10 minutes Main Wash 7
11. the Control Unit to the foot board of the bed frame Attach the air tubes connectors to socket on the left side panel of the Control Unit Ensure that the air hoses are not wrapped or kinked under the mattress Carefully plug the power cord into a properly grounded power source Turn on the master switch on the front panel Low pressure Manual pressure signalisation adjustment Operating Pressure Level signalisation Main power switch User Manual ProDerm 1 Plus Version 03 The Control Unit should start to inflates the mattress Now should start to light the orange light signalising the low pressure This light will go out after Operating pressure attainment which takes max 22 minutes Than you can put the lining freely onto the mattress Adjust the Operating Pressure Level by manual regulator to adapt the optimal pressure level for concrete patient PROPOSED PRESSURE LEVEL ADJUSTMENT IN ACCORDANCE TO WEIGHT OF PATIENT ProDerm 1 Plus LNT 19RO 1201 kg 4 50 110 Pi gt 60 i PATIENT i WEIGHT 100 70 OG Tain vo Alternating Function The Control Unit starts to alternate the pressure in Overlay cells in the 10 minutes time interval Ecologically liquidate the packaging Carefully save the User Manual CPR Valve For quick Overlay Mattress deflating open turn round the red CPR valve located in head end of mattress The Overlay Mattress will deflate during approx 30 seconds Eventual inadequacies
12. the European Union You can apply to your authorities or the equipment seller for detailed information about the correct way of removing separated OEEZ WEEE electric and electronic equipment and lead accumulators Protect your health and the environment Thank you 11 Warranty and Service There is a 24 months warranty granted for this mattress system commencing on the delivery date if there is no other stipulation in a sale agreement The warranty and after warranty service is done by the supplier or authorised service on a base of written authorisation confirming qualification for such activities Respective authorisation is issued by a manufacturer User Manual ProDerm 1 Plus Version 03 12 Used Marks and Symbols N Warning in User Manual A Protection against Electrical shock Device type BF 0 Switched out l Switched on CE CE mark 13 Contacts Your queries address to Tel 420 312 57 61 11 Fax 4420 3127 52 26 68 Address LINET spol s r o Zelev ice 5 274 01 Slan Czech Republic http www linet cz E mail info linet cz User Manual ProDerm 1 Plus Version 03 fyner A Appendix Record of service checks and routine maintenance PURPOSE AND DESCRIPTION OF WORK DATE TECHNICIAN User Manual ProDerm 1 Plus Version 03 B X Appendix ll ProDerm 1 Plus Mattress System Handover Protocol Order No Purchaser Model No
13. ubes and control unit which is designed for the purpose to achieve a good massage effect and blood circulation in the body tissue The mattress system is designed and manufactured in conformity with international standards EN 60601 1 2 EN 60601 1 EN ISO 10993 The product also meets all the requirements of Directive 93 42 EEC standard technical requirements for medical devices and 89 336 EEC including EMC The manufacturer operates under quality management systems certified in accordance with EN ISO 9001 2000 and EN ISO 13485 2000 Standards Prior to using this mattress system it is important to familiarise yourselves with this manual All operation and user servicing should be carried out in accordance with this manual Any other operation being in discrepancy with the user manual or the purpose of the bed is carried out at the user s risk and the supplier shall not be liable for any possible damage or injury It is important to ensure the manual is available to the user throughout service life of the mattress system Warning m The supplier cannot be responsible for damages injuries accidents or casualties generated by virtue of incautious neglectful or incorrect handling W The basic briefing of mattress handling will be guided by supplier or trained person m The Safety Instructions for mattress system operation and handling directions must be strictly observed User Manual ProDerm 1 Plus Version 03 2 3 Delivery M
14. ulators AKB marked with this graphic symbol Once the service life of these accumulators ends deliver them to a person authorised for recollection you will not have to pay a recollection charge AN The product is not designed for removal as part of communal waste User Manual ProDerm 1 Plus Version 03 fyner Information for the users of electric and electronic equipment see CHART This symbol on the product or accompanying documentation means that the electric or electronic components used waste from electric and electronic equipment OEEZ WEEE may not be disposed of destroyed together with communal waste In order to correctly eliminate the entire product deliver OEEZ WEEE to the workplaces of firms specialised in this task where they will be accepted free of charge By removing this product appropriately you will help preserve valuable natural resources and help prevent potential negative effects on the environment and human health which could result from the incorrect destruction of waste You can request further details from authorised environmental protection authorities or the closest collection point for separated waste collection A N Fines may be imposed under national regulations if an incorrect procedure for waste removal is used Information for users about the removal of electric and electronic equipment in other countries outside the European Union The symbol shown above is valid only in the countries of
15. y damage or injury The Control Unit and mattress has to be protected against liquid penetration or open flame Prevent the contact of mattress and sharp object or objects which can cause damage of mattress Do not place the heat source near to mattress system Always connect the Main Unit to the prescribed and safe electric current source User Manual ProDerm 1 Plus Version 03 Gruner 4 Conditions for Use The mattress system should only be used in an internal the ambient temperature ranges from 10T to environment where 40 the relative humidity ranges from 30 to 75 the atm pressure ranges from 700 to 1060 hPa 1l Any use outside these conditions must be discussed with the supplier 5 Technical Parameters Control Unit ProDerm 1 Plus Model no LNT 19RO FOR PRODERM 1 PLUS Dimensions 25 7 x 11 5 x 9 4 cm Weight 1 8 kg Supply 230 V AC 50 Hz Power Input Max 5A Water and dust preventing IPXO Classification Class Device of the BF type Fuses parameters T1AH250V AC Operating cycle Continuous Pressure alternating interval 10 minutes Overlay ProDerm 1 Plus Model no Dimensions 198 x 89 x 12 cm Weight 12 kg Material of cover Nylon covered by PU Material of base Nylon covered by PVC Maximal weight of patient 120 kgs CPR deflating rate 20s User Manual ProDerm 1 Plus Version 03 Quiver In spite of th
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