LipoCollector™ 3 - CAREstream America
Contents
1. amp human med LipoCollector 3 User Manual Human Med AG Instruction on use and processing of the LipoCollector 3 Page 1of 35 Rev Date 0 26 01 2011 LipoCollector 3 User Manual C E oe ISO 13485 Instruction on use and processing of the LipoCollector 3 Ref no 670000 All rights reserved particularly the right to reproduce and distribute as well as trans late this user manual No part of this user manual may be reproduced in any form by photocopying micro film or other procedures or processed copied or distributed using electronic systems without prior written consent of Human Med LipoCollector 3 is a registered trademark owned by Human Med AG Schwerin Germany The technology used in Human Med s products is protected by patents further patents have been filed The information contained in this user manual is subject to change or update without prior notification and Human Med assumes no liability for the contents of the informa tion Printed by Human Med AG Printed in Germany Copyright Human Med AG Wilhelm Hennemann Strafse 9 19061 Schwerin 2011 Human Med AG Instruction on use and processing of the LipoCollector 3 Page 2 von 35 Table of contents Rev Date 0 26 01 2011 Table of contents General description of the LipoCollector 3 5 ll Safety instructions 6 ll 1 Intended use 6 ll 2 Significance of the safety instructions 6 ll 3 Signific2. ATTENTION ATTENTION Infection risk by improper cleaning agents Using improper cleaning agents can provoke an infection control risk Only use cleaners that are approved in accordance with national hy giene related regulations and local guidelines Risk of infection and damage due to residues of cleaning agents After cleaning thoroughly rinse each component with deionized water Aq dest during the last rinse cycle in order to remove all residues Do not use tap water for the last rinse cycle Risk of damage due to residues of disinfectants Disinfectant solutions can contain various aggressive chemical ingre dients e g chlorine that may cause corrosion of the product Therefore thoroughly rinse the product with de ionized water aq dest to remove all residues Do not use tap water for rinsing since it could be chlori nated Risk of damage due to incompatible cleaning agents and disin fectants Incompatible cleaning agents and disinfectant solutions can cause consi derable damages to the LipoCollector 3 Therefore only use cleaners recommended or approved by Human Med for the use with the Lipo Collector 3 Risk of damage by exceeding the concentration and the contact time Strictly adhere to the instructions given by the disinfectant producer re garding the concentration and the contact time of the disinfectant solu tion In order to prevent the device from damages the indicated values must not be
3. rized supplier they must be cleaned disinfected and sterilized before and be accompanied with the relevant documented evi dence lll 5 3 Sterilization after manual cleaning Packaging In accordance with ISO 11607 the dried LipoCollector 3 parts must be packed in sterile packaging suited for steam sterilization as follows suction pipe with connection port together with separation pipe basket together with foot ring lid with port for connection to patient separately collection container separately The packaging must be large enough so that the sealing is not subject to stress Human Med AG Instruction on use and processing of the LipoCollector 3 Page 17 of 35 Chapter III Sterilization Storage Active ingredients Rev Date 26 01 2011 Steam sterilization using a fractionated vacuum process at 121 C 2509F for at least fifteen 15 minutes and at 134 C 273 F for three 3 minutes has been validated Sterilization at 134 C 2739F for max thirty 30 minutes has been tested no adverse effects on the material of the Lipo Collector 3 have been detected Prior to each sterilization procedure always check the batch process record for the respective sterilizer to ensure that the required parameters are being complied with The individual sterile plastic bags have to be stored in a closed cupboard protected from light dust humidity and extreme fluctu ations in temperature The
4. the vacuum pressure gauge is well below 500 mbar liposuction fat har vesting is not possible Proceed as follows 1 Remove the suction tube of the suction instrument cannula from the PATIENT port of the LipoCollector 3 and block it by hand a lf the value indicated on the vacuum pressure gauge increases conside rably a leakage is to be located between suction tube and cannula b If the value indicated on the vacuum pressure gauge is further too low there is a leakage between LipoCollector M 3 and the used suction de vice 2 Remove the connection tubing from the SUCTION port on the lid of the LipoCollector 3 and block it by hand by folding it a lf the value indicated on the vacuum pressure gauge further is too low there is a leakage between connection tubing suction container with suc tion bag and suction device b If the value indicated on the vacuum pressure gauge increases conside rably the leakage is to be located in the LipoCollector 3 Possible n both cases check the named system components and their con solution necting points for leakage or blockage replace them if necessary lmperatively observe the instructions on troubleshooting given in the user manual for the used suction device Human Med AG Doc No 900036 Instruction on use and processing of the LipoCollector 3 Page 34 of 35 Chapter VI Rev Date 0 26 01 2011 VI 2 Localization and elimination of
5. Aufbe reitung von Medizinprodukten recommendation Bundesgesundheitsblatt 44 2001 1115 1126 Local standards and provisions are to be provided by the local respon sible for hospital hygiene Compatibility Human Med distinguishes between 2 types of compatibility _ micro biological compatibility material compatibility Micro biological compatibility The micro biological compatibility signifies that the LipoCollector 3 has been successfully reprocessed and sterilized using the methods described in this in struction Material compatibility The material compatibility indicates that after using the agents prescribed no ad verse effects on the material of the LipoCollector 3 parts have been found to date see also Material durability Material compatibility doesn t signify that a specific degree of germicidal effect can be guaranteed lll 1 2 Selection of the processing method The appropriate processing procedure should be selected according to the national hygiene related provisions and local guidelines of hospital hygiene Automated cleaning and disinfection When selecting the disinfector please check whether it is effectually certified and accredited e g by DGHM or FDA or CE marked acc to DIN EN ISO 15883 it uses an approved program for thermal disinfection at least ten 10 minutes at 93 C 199 4 F or Ao gt 3000 if possible the used program includes a sufficient number of rinse cycles
6. body jet harvest jet used suction device but always to the suction container waste Likewise observe the user manuals for the body jet harvest jet or any other appropriate suction device used ATTENTION Attach the suction tubing of the suction instrument cannula to the reduction con nector PATIENT on the top side of the lid of the LipoCollector 3 When attaching the connection and suction tubing take care that both hoses are pull relieved For this purpose fasten each hose to the in strument table near the LipoCollector 3 using towel forceps with tub ing clip or holding and drape clamps in order to ensure the stable posi tion of the LipoCollector 3 ATTENTION Human Med AG Instruction on use and processing of the LipoCollector 3 Page 27 of 35 Chapter V Rev Date 0 26 01 2011 Content V Fat harvesting with the LipoCollector 3 V 1 Functional principle of the LipoCollector 3 V 1 1 Internal pre filtering through the basket of the LipoCollector 3 V 1 2 Gradual pressure reduction V 1 3 Improvement of the aspirate guality V 1 4 Amount of the collected aspirate and its liguid content V 1 5 Fat extraction from the collection container of the LipoCollector 3 29 28 28 29 29 29 Human Med AG Instruction on use and processing of the LipoCollector 3 Page 28 of 35 Chapter V Rev Date 0 26 01 2011 Lipocytes are sensitive to temperatures The amb
7. connec tor large diameter provided for this on the inside of the lid E Fasten the basket C by turning it slightly until it latches step 4 Attach the separation pipe F to the bayonet nut connector small diameter provided for this on the inside of the lid E Fasten the separation pipe F by turning it slightly until it latches Human Med AG Instruction on use and processing of the LipoCollector 3 Page 25 of 35 Rev Date 0 26 01 2011 Step 5 Select a suction pipe F according to the desired amount to be collected and put the compatible sealing ring J into the groove of the connection port H on the upper end of the selected suction pipe F Take care that the sealing ring perfectly fits into the groove Do not stretch the sealing ring J too much this could impair its elasticity and lead to leakage of the Filler Collector and reduction of the suction power In case of a damaged sealing ring J silicone particles may fall into the collected aspirate For this reason avoid any damage otep 6 a WvoCotector3 Push the suction pipe F through the orifice FATIENT SUCTION F EF ten SUCTION provided for this in the lid E of the omara SRA LipoCollector 3 q iiaa O MM ee step 7 LipoCollector3 Put the sealing plug I into the orifice EXTRACT Bae provided in the lid E of the LipoCollector 3 step 8 Finally insert the lid E assembled
8. only sterile or low germ max ten 10 germs ml and low endotoxin max 0 25 endotoxin units ml water is used the drying air is filtered the disinfection machine is maintained and inspected regularly When selecting the cleaning agent please make sure that itis principally suited for cleaning medical products the used chemicals are compatible with the product parts see also Material Durability Strictly adhere to the concentrations indicated by the producer of the cleaning agent Human Med AG Instruction on use and processing of the LipoCollector 3 Page 10 of 35 Chapter III Rev Date 26 01 2011 Manual cleaning and disinfection When selecting the cleaning agent and disinfectant please make sure that they are principally suited for cleaning medical products a disinfectant is used which efficacy has been approved DGHM listed CE approval FDA approval for USA the used chemicals are compatible with the system components see also Material Durability Strictly adhere to the concentrations and reaction times indicated by the producer of the cleaning agents and disinfectants Only use fresh solutions sterile or low germ max ten 10 germs ml and low endotoxin max 0 25 endotoxin units ml water Only use filtered air for drying lll 1 3 Control and checking All disinfection and sterilization procedures must be reviewed regularly Biological indicators for monitoring the disinfection
9. shelf life is determined by the product specifications of the sterile packaging used Gigasept Instru AF Cocospropylendiaminguanidiniumdiacetat quaternary ammonium compound benzyl C12 16 alkyldimethyl chloride ethanol tride cylethoxylat propan 2 ol N dodecylpropan 1 3 diamine this information is based on the producer s specification CIDEX OPA Phthaldialdehyd synonym benzol 1 2 dicarbaldehyd this information is based on the producer s specification lll 6 Automated cleaning and disinfection Prescribed cleaning agents Note The following cleaning agents are approved by the producer a deconex TWIN BASIC TWIN ZYME and neutralizer deconex 64 NEUTRADRY co Borer Chemie AG b CIDEZYME GI ENZOL enzymatic detergent co ADVANCED STERILIZATION PRODUCTS Division of Ethicon Inc Only use cleaners that are approved by the producer for cleaning PSU plastics Do not use cleaners containing phenol since these could dam age the plastic parts of the LipoCollector 3 Never use rinse agents They cause stress cracks in the collec tion container and can shorten its service life If possible the instruments are to be transported from the place of use to the reprocessing facilities in dry condition in order to avoid that protein can deposit due to the cleaning agent used Human Med AG Instruction on use and processing of the LipoCollector 3 Page 18 of 35 Chapter III Rev Date 26 01 2011
10. this basket where larger tissue strands of the aspirate are caught in the basket grid This reduces the risk of blockage of the cannulae during fat extraction from the container and subsequent reinjection moreover it conduces to gentle fat treatment prevention of pressure peaks Human Med AG Instruction on use and processing of the LipoCollector 3 Page 29 of 35 Chapter V Rev Date 0 26 01 2011 V 1 2 Gradual pressure reduction Owing to the floating filtration without mesh filter fat may get wasted from the Lipo Collector 3 into the suction container particularly in case of a strongly stirred aspi rate e g caused by fluctuations in pressure wagging of the suction tubing There fore proceed in a calm and smooth manner during liposuction While working with the LipoCollector 3 the pressure in the system should not be dropped abruptly In case the system should be opened from the patient side a large pressure gradient would be generated due to the ambient air pressure causing the suction tubing to wag and the aspirate to eject intensely which may impair the filtra tion For this reason please consider the following advices e Release the bypass hole of the cannula slowly by rolling the thumb e Do not pull the cannula abruptly from the incision when vacuum pressure has been built up V 1 3 Improvement of the aspirate quality The vacuum should only be as high as required for a good suction result We
11. Further reprocessing beyond this number or other reprocessing procedures are in the user s responsibility Human Med AG Instruction on use and processing of the LipoCollector 3 Page 13 of 35 Chapter III Rev Date 26 01 2011 lll 4 Disassembly of the LipoCollector 3 A Remove the suction pipe with connection port 1 from the lid 2 equipped with port for connection to patient 2a B Pull the sealing plug 3 from the lid and dispose of it C Remove the white sealing rings 4 from the lid and the connection port of the suction pipe and dis pose of them D Carefully remove the basket 5 and the separation pipe 6 from the lid E Take the collection container 7 out of the foot ring 8 Advice for easy removal of the sealing rings Lightly push the sealing rings out of the grooves and remove them see Fig 1 and 2 Fig 1 Fig 2 The sealing rings and the sealing plug are single use products and must not be reprocessed and sterilized Their reuse may lead to loss of material elasticity and to contamination of the aspirate by silicone par ticles That may cause foreign body reactions of the patient and there fore reuse is explicitly prohibited Human Med AG Instruction on use and processing of the LipoCollector 3 Page 14 of 35 Chapter III Rev Date 26 01 2011 lll 5 Manual cleaning and disinfection WARNING WARNING ATTENTION
12. The water inflow into the washing machines must start at lower temperatures approx 20 C 68 0 F to prevent thermal coagula tion of proteins All individual parts intended for reuse as suction pipe with connection port lid with port for connec tion to patient basket separation pipe collection contain er and foot ring must be put into the washing and disinfection machine When cleaning the lumen of the suction pipe this is to be con nected to the hose connectors of the washing and disinfection ma iiia chine preferably on the drawer cart of the machine The same is to be done when cleaning the port for connection to the patient on the lid We recommend using silicone hoses for the connectors of the washing and disinfection machine lll 6 1 Automated cleaning and disinfection The following working steps are to be carried out when using a washing and disin fection machine The procedure described below reflects the reprocessing as vali dated by Human Med Automated Pre rinse twice with 20 C 68 F warm water for five 5 pre cleaning minutes each pre rinse cycle Automated Cleaning with 55 C 131 F hot water mixed with cleaning solu cleaning tion as specified by the cleaning agent producer we recom mend using deconex TWIN BASIC together with TWIN ZYME and at a temperature hold time of at least fifteen 15 minutes First With 10 C 50 F cold water for three 3 minutes rinse cycle Second W
13. ance of the user manual instruction of medical 6 staff Il 4 General safety instructions 7 ll 5 Initial use 7 ll 6 Disposal 7 lil Processing of the LipoCollector 3 8 lll 1 General information 8 lll 1 1 Processing procedure 8 lll 1 2 Selection of the reprocessing method 9 11 1 3 Control and checking 10 I 1 4 Recommended cleaning disinfection and sterilization 10 methods lll 2 Workplace safety and health 11 lll 3 Preparation of reprocessing at the place of use 12 lll 4 Disassembly of the LipoCollector 3 13 lll 5 Manual cleaning and disinfection 14 1 5 1 Manual cleaning 14 1 5 2 Manual disinfection 15 1 5 3 Sterilization after manual cleaning 16 lll 6 Automated cleaning and disinfection 17 11 6 1 Automated cleaning and disinfection 18 1 6 2 Sterilization after automated cleaning 19 lll 7 Information on validation of reprocessing 19 Human Med AG Instruction on use and processing of the LipoCollector 3 Page 3 von 35 Table of contents Rev Date 0 26 01 2011 IV Assembly of the LipoCollector 3 prior to clinical use IV 1 Components of the LipoCollector 3 IV 2 Assembly of the LipoCollector 3 IV 3 Attachment of the suction tube and the connection tubing V Fat cell harvesting with the LipoCollector 3 V 1 Functional principle of the LipoCollector 3 V 1 1 Internal pre filtering through the basket of the LipoCollector 3 V 1 2 Gradual pressure reduction V 1 3 Impro
14. as described in step 1 to 7 into the collection container A of the Lipo Collector 3 The LipoCollector 3 is now ready for connection of the suction tubing coming from the aspiration cannula to the reduction connector PATIENT Human Med AG Instruction on use and processing of the LipoCollector 3 Page 26 of 35 Chapter IV Rev Date 0 26 01 2011 IV 3 Attachment of the suction tube and the connection tubing Each tubing used must be able to withstand the amount of negative pressure created by the suction device without collapsing All connecting components between the LipoCollector 3 and the patient must be suitably biocompatible for the subsequent use of the aspirate Various types of tubing are used within the system 1 The suction instrument cannula is connected with the LipoCollector 3 by means of the suction tube This suction tube must be a 7 x 11 mm sized hose with a socket CH 32 2 The aspirated irrigation liquid is conveyed through the connection tubing from the LipoCollector 3 into the suction container that is attached to the suction device The connection tubing must be a 7 x 10 mm sized hose with a socket CH 30 Attach one end of the connection tubing to the connection port H of the suction pipe on the top side of the lid SUCTION The other tubing end socket is to be attached to the suction container of the used suction device A Do not attach the connection tubing directly to the
15. ated parts are to be transported in con tainers in order to prevent the environment and personnel from poten tial contamination When transporting dry please ensure that no soilings can dry on the instruments Do not use fixating agents or hot water gt 40 C 104 F since these promote the protein coagulation impairing the cleaning result Close the container The subsequent cleaning must begin within three 3 hours after use lf this time limit is exceeded special measures are to be taken to achieve a proper cleaning effect We recommend starting with repro cessing of the LipoCollector 3 parts immediately after use When transporting the instruments immersed in fluid the cleaning must begin within one 1 hour after use Saline is not suited for immersion Risk of damage to the instruments Reprocess the instruments immediately after use The above indicated time limits for transport must not be exceeded Never leave a used instrument overnight be fore reprocessing If an instrument is left in dry condition for a longer period heavy soilings may dry on leading to encrustations that may be difficult to remove Provided that the product is used as intended by the producer the end of its service life is determined by normal wear and tear All parts of the LipoCollector 3 have been successfully tested for a thirty time 30 reprocessing using the validated manual and automated reprocessing procedures including sterilization
16. be drained off from the syringe before the fat will be transferred into smaller syringes for further application Human Med AG Instruction on use and processing of the LipoCollector 3 Page 1 of 1 Appendix Rev Date 0 26 01 2011 Appendix Current product list Europe
17. d processing of the LipoCollector 3 Page 16 of 35 Chapter III ATTENTION Rinsing WARNING Drying Maintenance Check and inspection Note Rev Date 26 01 2011 Procedure and concentration when using Cidex OPA Immerse the LipoCollector 3 parts in the concentrated undiluted Cidex OPA solution for five 5 minutes There must not be any air bubbles on the parts of the LipoCollector 3 In order to avoid damages only use gripping pliers with rubber jaws when handling the instruments in the disinfectant solution After disinfection completely rinse all parts in a large volume rinse bath at least 8 liters for at least one 1 minute Afterwards flush all lumina of the lid as well as the suction pipe and the separation pipe by hand again Dispose of the rinse water Thoroughly rinse all parts with sterilized deionized water aq dest to remove all toxic residues of the disinfectant The rinsing of the parts as described is to be repeated twice The sterile deionized water must be replaced after each rinse cycle Dry all parts internally and externally using sterile compressed air The individual parts are not intendend for maintenance Visually check the parts for damage and wear Check the ports on the lid for deformation the collection con tainer for cracks all stainless steel parts for corrosion Reject any damaged part If damaged parts shall be returned to Human Med or to an autho
18. exceeded lll 5 1 Manual cleaning Prescribed When disinfecting with Gigasept Instru AF also use Gigasept Instru cleaning AF for cleaning agents ATTENTION When disinfecting with Cidex OPA use a low foaming encymatic detergent of a neutral ph value 6 8 for cleaning We recommend using CIDEZYME Gl or the enzymatic detergent ENZOL We advice against using strong acid or alkaline cleaning agents Human Med AG Instruction on use and processing of the LipoCollector 3 Page 15 of 35 Chapter III Rev Date 26 01 2011 Immersion of All individual parts intended for reuse as the parts for suction pipe with connection port lid with port for con dua nection to patient basket separation pipe collection con pre rinsing tainer and foot ring must be immersed in the cleaning and disinfectant solution mixed with lukewarm water deionised if possible for at least ten 10 minutes or longer in case of stubborn or dried on soilings The concentration is to be selected according to the producer s speci fication Manual All individual parts must be pre cleaned in the cleaning solution using pre cleaning brushes This work must be repeated until the brushes and the sur faces and hollow spaces to be cleaned are free of visible contamina tion After cleaning rinse all parts with potable water Manual Afterwards all parts must be completely immersed in an ultrasound cleaning bath with cleanin
19. failures of system components In order to localize further possible error sources and to eliminate them if necessary observe the following instructions Check whether the aspiration cannula is blocked most frequent error cause during liposuction Suddenly less resistance when moving the cannula in the tissue is symptomatic for a blocked cannula gt Wipe off flush Applicator Check whether the suction tube of the cannula has been correctly connected to the LipoCollector 3 gt Correct the connection Check whether the suction pump of the used suction device has been switched on indicator lamp pump noise gt Switch on acc to the respective instruction in the user manual for the used suction device Check whether the vacuum power has been set high enough max 0 5 bar gt Correct this setting acc to the respective instruction in the user manual for the used suction device Check whether the overflow protection bacterial filter if existing of the used suction device is possibly blocked gt Test and replace acc to the respective instruction in the user manual for the used suction device Check whether the hose between suction container and suction device has been attached correctly gt Correct attachment Check whether the single use suction bag in the suction container has been cor rectly unfolded whether it is possibly pinched or damaged gt Correct or replace if necessary Check whether t
20. for valida tion of the cleaning process gt Agents for automated cleaning deconex TWIN BASIC TWIN ZYME Borer Chemie AG CIDEZYME GI ENZOL Advanced Sterilization Products gt Neutralizator for automated cleaning Deconex 64 NEUTRARADRY Borer Chemie AG Agents for manual cleaning Gigasept Instru AF SCHULKE amp MAYR CIDEZYME GI ENZOL Advanced Sterilization Products gt Disinfectants for manual disinfection Gigasept Instru AF SCHULKE amp MAYR CIDEX OPA Advanced Sterilization Products Washing and disinfection machine LS 2000 co Hamo with drawer cart laparoscopy cart with ports for lumina Program NEUTRAL WASHING Please contact Human Med for additional information on the validations If the above described chemicals and machines are not available it is the user s responsibility to ensure validation of the reprocessing method used It is the reprocessor s responsibility to ensure that the reprocessing actually per formed with eguipment materials and personnel in the reprocessing facility achieves the desired result This reguires validation and routine monitoring of the process Human Med AG Instruction on use and processing of the LipoCollector 3 Page 20 of 35 Chapter III Rev Date 26 01 2011 Likewise any deviation from the instructions provided must be properly evaluated by the reprocessor for effectiveness and potential adverse consequences List of tested cleaners and dis
21. g and disinfectant solution mixed with lukewarm water deionized if possible They must stay in the ultrasound bath for at least five 5 minutes As an option they can also be cleaned in an immersion bath with the same lukewarm cleaning solution for fifteen 15 minutes The concentration is to be selected according to the producer s speci fication Do not mix with other cleaners After cleaning rinse all parts with deionized water aq dest Cleaning Finally check all surfaces ports and hollow spaces for visible conta check mination Return contaminated parts to the cleaning process lll 5 2 Manual disinfection Prescribed a Gigasept Instru AF co Schiilke amp Mayr cleaning concentration contact time 3 15 min 2 96 30 min agents 1 5 96 60 min Maximum period of use 7 days In case of strong contamination we recommend renewing the solution earlier b ll Cidex OPA Ortho phthalaldehyde HL disinfectant solution Contact time at least 5 min undiluted Maximum period of use 14 days In case of strong contamination we recommend renewing the solution earlier _ Manual Procedure and concentration when using Gigasept Instru AF disinfection immerse the LipoCollector 3 parts in the prepared solution concentration acc to the producer s specification for fifteen 15 minutes There must not be any air bubbles on the parts of the LipoCollector 3 Human Med AG Instruction on use an
22. g the supplied sterile single use parts extraction cannula sealing rings for lid and connection port of the suction pipe sealing plug After sterilization all parts of the LipoCollector 3 must sufficiently cool down below body temperature before they can be used Human Med AG Instruction on use and processing of the LipoCollector 3 Page 23 of 35 Chapter IV Rev Date 0 26 01 2011 IV 1 Components of the LipoCollector 3 Legend Collection container Foot ring Basket Sealing ring for lid Lid of the collection container Separation pipe Suction pipe Connection port of the suction pipe Sealing plug Sealing ring for the connection port of the suction pipe Q TanmmnmMmIoe0das gt Human Med AG Instruction on use and processing of the LipoCollector 3 Page 24 of 35 Chapter IV Rev Date 0 26 01 2011 IV 2 Assembly of the LipoCollector 3 step 1 Put the collection container A into the foot ring B step 2 Put a new sealing ring D into the groove of the lid E Take care that the sealing ring perfectly fits into the groove Do not stretch the sealing ring D too much this could impair its elasticity and lead to leakage of the LipoCollector 3 and reduction of the suction power In case of a damaged sealing ring D silicone particles may fall into the collected aspirate For this reason avoid any damage Step 3 Attach the basket C to the bayonet nut
23. guipment before leaving the processing facilities Toxic chemical fumes As protection against toxic chemical fumes the disinfection and sterilization room must be ventilated sufficiently Material durability Note n order to clean the collection container only use cleaning agents re commended for cleaning of PSU plastics Please contact the producer of the cleaning agent and disinfectant in this regard Do not use cleaning agents and or disinfectants containing phenol since these could damage the plastic parts of the Lipo Collector 3 Never use rinse agents They cause stress cracks in the collection container and can shorten its service life Human Med AG Instruction on use and processing of the LipoCollector 3 Page 12 of 35 Chapter III Rev Date 26 01 2011 lll 3 Preparation of reprocessing at the place of use The reusable parts of the LipoCollector 3 are to be prepared for the subsequent re processing immediately after they have been used still in the operating room When reprocessing medical products take care in working carefully according to the local safety regulations Preparation and transport WARNING CAUTION Limitation of reprocessing Remove the rough surface soiling using a disposable cloth paper towel Transport reusable product components from the place of use to the reprocessing facilities The parts can be transported either dry or immersed in fluid Contamin
24. have been carried out using the disinfector LS 2000 co Hamo with drawer cart and laparoscopy cart equipped with connection ports for lumina programmed for NEUTRAL WASHING and the cleaning agents gt deconex TWIN BASIC TWIN ZYME with neutralizer deconex 64 NEUTRA RADRY Borer Chemie AG Human Med AG Instruction on use and processing of the LipoCollector 3 Page 11 of 35 Chapter III Rev Date 26 01 2011 The parameters used are described in the section ll 6 1 Automated cleaning and disinfection Steam sterilization on the basis of the fractionated vacuum method The sterilization is to be done at a sterilization temperature of min 132 C 269 6 F max 138 C 280 4 F and at a sterilization temperature holding time of min three 3 minutes max thirty 30 minutes in a steam sterilizer validated according to ANSI AAMI ISO 11134 lll 2 Workplace safety and health Prevention of infections and chemical burns Bodily particles of the patients and decontamination chemicals represent a hazard Protective eguipment is reguired for protection against dangerous chemicals and potentially infectious materials During cleaning disinfection or sterilization wear pro tective equipment comprising eye protection and face shield moisture resistant clothes as well as tight fitting chemical resistant gloves that have to be sufficiently long so that no skin areas remain uncovered Always remove contaminated protec tive e
25. he hydrophobic filter in the suction bag is jammed caused by contact with liquid e g after pouring out the aspirate in case of reuse gt Replace suction bag Device settings filter suction container tubings Check whether the connection tubing between LipoCollector 3 and suction con tainer of the used suction device has been correctly attached at both ends gt Correct attachment Check whether the lid of the LipoCollector 3 has been closed correctly and the sealing ring O ring completely fits into the groove provided Check whether the insufficient vacuum has been caused by a leakage of the seal ing ring or of the lid gt When the vacuum has been built up press the lid down on the collection container for ten 10 seconds and or replace the sealing rings after wards make a test Human Med AG Doc No 900036 Instruction on use and processing of the LipoCollector 3 Page 35 of 35 Chapter VI Rev Date 0O 26 01 2011 Check whether the sealing ring perfectly fits on the connection port of the suction pipe and the suction pipe has been correctly introduced into the lid orifice pro vided for this gt Correct the fitting of the sealing ring and or the position of the suction pipe Damages to the collection container of the LipoCollector 3 caused by faulty processing to be recognized by cracks in the container or deformations indentations on the lid edge also can result in an vacuum insufficie
26. ient temperature for the collected adipose tissue must be at least 209C but not higher than 379C Note f pre warmed not warmer than body temperature infiltration and irrigation solution has not been used yet it should definitely be consi dered to be used for surgical interventions including lipocyte ex traction A In order to minimize damages to the adipose tissue being collected the suction vacuum must not exceed 0 5 bars WARNING Note The composition of the anesthetic irrigation solution may affect the vitality of the harvested cells V 1 Functional principle of the LipoCollector 3 The LipoCollector 3 is a filtering device for the gentle separation of fat cells from a mix of liquid and tissue cells harvested during liposuction e g water assisted lipo suction WAL The functional principle of the LipoCollector M 3 consists in separating the fat cells from the liquid solely by the physical phenomena of buoyancy and gravi ty The less dense fat is floating on top of the liquid while the liquid is continuously aspirated from the separation pipe acc to the principle of communicating pipes The suction flow is routed away from the aspirate so that the mechanical strain on the collected fat tissue is reduced V 1 1 Internal pre filtering through the basket of the LipoCollector 3 The LipoCollector 3 is equipped with a basket serving as a pre filter The incoming aspirate is first running through
27. infectants particularly suited for cleaning and disinfection of the collection container Tradename Producer Remarks Thermosept RKN zym Enzymatic detergent Thermosept alca clean Alkaline cleaner containing tensides possible ph value oe Mediclean DR WEIGERT 5 10 orte CIDEZYME GI EN ADVANCED STERILI enzymatic deter ZATION PRODUCTS Enzymatic detergent Manual cleaning Gigasept Instru AF SCHULKE amp MAYR Aldehyde free CIDEZYME GI EN zol wynn deer ARNON EROTS Gigasept Instru AF Neodisher Septo 3000 DR WEIGERT ZATION PRODUCTS semi critical medical devices TWIN BASIC Neutral enzymatic and mild TWIN ZYME Borer Chemie AG alkaline Human Med AG Instruction on use and processing of the LipoCollector 3 Page 21 of 35 Chapter IV Rev Date 0 26 01 2011 Content IV Assembly of the LipoCollector 3 prior to clinical use IV 1 Components of the LipoCollector 3 IV 2 Assembly of the LipoCollector 3 IV 3 Attachment of the suction tube and the connection tubing 22 23 24 26 Human Med AG Instruction on use and processing of the LipoCollector 3 Page 22 of 35 Chapter IV WARNING WARNING WARNING Rev Date 0 26 01 2011 Visually check all parts of the LipoCollector 3 for damage wear and possible fouling Do not assembly if any individual part shows damages The complete LipoCollector 3 is to be assembled under aseptic conditions usin
28. ith 20 C 68 F warm fully deionized water for three 3 rinse cycle minutes Blowing The cleaned parts are to be blown out at a temperature of 80 C 176 F and a hold time of one 1 minute Automated Thermal rinsing with fully deionized water at a temperature of disinfection 93 C 199 4 F and a temperature hold time of ten 10 minutes by adding the neutralizer deconex 64 NEUTRADRY co Borer Chemie AG concentration 1 ml L Automated At 70 C 158 for at least fifteen 15 minutes drying Human Med AG Instruction on use and processing of the LipoCollector 3 Page 19 of 35 Chapter III Rev Date 26 01 2011 Cooling The products cool down at 30 C 86 F Maintenance The individual parts of the LipoCollector 3 are not intended for maintenance Check and Visually check the parts for damage and wear Check the inspection ports on the lid for deformation the collection container for cracks all stainless steel parts for corrosion Reject any damaged part Note If damaged parts shall be returned to Human Med or to an authorized supplier they must be cleaned disinfected and steri lized before and be accompanied with the relevant documented evidence lll 6 2 Sterilization after automated cleaning see section lll 5 3 Sterilization after manual cleaning lll 7 Information on validation of reprocessing The following test instructions materials and machinery have been used
29. nce with the RKI guideline we assess the LipoCollector 3 as reprocess able without any particular reguirements After thorough cleaning this product and its individual parts must be sterilized by steam sterilization prior to their application on the patient The Automated cleaning and disinfection is to be preferred Factory new unsterile parts of the LipoCollector 3 are to be treated like used pro ducts They must necessarily be cleaned before disinfection and sterilization Manual or automated cleaning Both manual and automated cleaning of the system components basically lead to satisfactory results However manual cleaning methods bear a certain risk of infec tion for the cleaning personnel Automated cleaning methods minimize this risk and moreover have the advantage of standardized and validated procedures Recommendation Automated cleaning is always preferred to manual cleaning be cause the processes are always consistent The local responsible for hospital hygiene is to be consulted when deciding on manual or automated cleaning in a specific situation Human Med AG Instruction on use and processing of the LipoCollector 3 Page 9 of 35 Chapter III Rev Date 26 01 2011 Standards Human Med recommends respecting the US standard ANSI AAMI ST35 Good Hospital Practice Handling and Biological Decontamination of Reusable Medical Devices as well as the RKI instructions Anforderung an die Hygiene bei der
30. ncy gt Replace the collection container LipoCollector 3 Do not use the collection container any longer if it shows damages Strictly adhere to the instruction on processing WARNING The LipoCollector 3 only is to be sterilized after it has been dis assembled Prior to sterilization make sure that there are no metal parts in the collection container Imperatively observe the instructions given in the user manual for the suction device used ATTENTION VI 3 Watery aspirate When the collected aspirate is too watery this frequently results from incorrect ex traction If the extraction cannula is introduced too deeply into the collection container of the LipoCollector 3 or in case no original cannulae are used some of the irriga tion fluid can also be aspirated watering down the collected aspirate Prior to fat extraction the liquid should basically be suctioned off from the bottom of the LipoCollector 3 see Chapter V 1 5 Fat extraction from the collection con tainer of the LipoCollector 3 This helps to reduce the unintentional aspiration of liguid into the syringe what might entail a longer sedimentation time Furthermore the extraction syringe used should be put into a holding rack with the piston facing upwards and should be left there for about ten 10 minutes During this time the fat continues separating from the liguid due to its natural buoyancy After wards the excessive liguid can
31. nto the suction container waste ATTENTION Human Med AG Instruction on use and processing of the LipoCollector 3 Page 30 of 35 Chapter V Rev Date 0 26 01 2011 After finishing the collection the fat should still be left in the LipoCollector 3 for a short period During this time the sedimentation of the collected aspirate continues i e more and more liquid is separated and the floating fat becomes more and more compact A test centrifugation of a small amount is recommended in order to exactly determine the water content of the fat V 1 5 Fat extraction from the collection container of the LipoCollector 3 Prior to fat extraction the excessive liguid if existing should be suctioned from the bottom of the LipoCollector 3 This helps to reduce the risk of unintentional aspira tion of liguid into the syringes what might entail a longer sedimentation time We recommend using the Water straw Ref no 675020 for removal of the excessive liguid The Water straw is made of a stainless steel tube with a hose connector at one end and a bypass opening in the upper tube section In order to remove the excessive liquid from the Lipo Collector 3 by means of the Water straw proceed as follows 1 Pull the connection tubing off the connection port SUCTION and attach it to the hose connector of the Water straw 2 Pull the suction pipe out through the orifice SUCTION Instead push the Water straw thr
32. of reprocessing at the place of use lll 4 Disassembly of the LipoCollector 3 lil 5 Manual cleaning and disinfection Ill 5 1 Manual cleaning Ill 5 2 Manual disinfection lll 5 3 Sterilization after manual cleaning lll 6 Automated cleaning and disinfection lll 6 1 Automated cleaning and disinfection lll 6 2 Sterilization after automated cleaning lll 7 Information on validation of reprocessing o o o o eo co 11 12 13 14 14 15 16 17 18 19 19 Human Med AG Instruction on use and processing of the LipoCollector 3 Page 8 of 35 Chapter III Rev Date 26 01 2011 lil 1 General information lll 1 1 Processing procedure The LipoCollector M 3 produced by Human Med is intended for being reprocessed after use The admissible reprocessing methods are described in this chapter In order to prevent the patient from infections all components suited for processing must be reprocessed each time before use The design and the material of the eguipment only allow applying specific methods for reprocessing instruments Disinfection or sterilization The Robert Koch Institute RKI and the American Centers for Disease Control and Prevention CDC as well assess those reusable medical products as critical that penetrate the skin or mucosa and thus come in contact with blood inner tissues or organs Among them there are also products through which body fluids are con veyed In accorda
33. ough this orifice into the LipoCollector 3 until the container bottom 3 Switch the suction unit on By adjusting the vacuum settings you can control the suction speed To ensure that only the excessive liguid is suctioned but not fat cells we recommend not setting the maximum vacuum S start the suctioning by closing the bypass hole of the Water straw U 5 Stop or finish the suctioning by opening the bypass hole again 6 U After finishing the suctioning switch the suction unit off The harvested fat can be extracted immediately after the excessive liguid has been removed The fat cells are extracted through the orifice EXTRACT pro vided in the lid of the LipoCollector 3 by means of sterile single use syringes and a sterile extraction cannula Ref no 665010 For this purpose the silicone plug sealing this orifice is to be removed before A Luer to Luer connector female female Ref no 665090 is available for transfer from syringe to syringe Human Med AG Doc No 900036 Instruction on use and processing of the LipoCollector 3 Page 31 of 35 Chapter VI Rev Date 0 26 01 2011 Content VI Troubleshooting 32 VI 1 Lack of suction power owing to insufficient vacuum 32 VI 2 Localization and elimination of failures of system components 34 VI 3 Watery aspirate 35 Human Med AG Doc No 900036 Instruction on use and processing of the LipoCollector 3 Page 32 of 35 Chapte
34. process are not available Nevertheless test strips can be used for testing the concentration of the disinfectant The concentration must be tested daily to prevent the solution from being diluted until it loses its effec tiveness In order to control the sterilization all sterilization procedures are to be regularly checked using an appropriate biological indicator Cleaning and sterilization must only be carried out by trained staff in rooms specifically designated for this purpose lll 1 4 Recommended cleaning disinfection and sterilization methods The cleaning disinfection and sterilization methods recommended herein have been thoroughly tested with the individual parts of the LipoCollector 3 Manual cleaning and disinfection We recommend using the disinfectants Gigasept Instru AF and Cidex OPA The effectiveness and compatibility of both disinfectants have been approved by an in dependent accredited testing laboratory Imperatively observe the instructions given by the disinfectant producer The procedures described below are based on the standard DIN EN ISO 17664 Sterilization of medical devices Information to be pro vided by the producer for processing resterilzable medical devices Automated cleaning and disinfection The basic suitability of all LipoCollector 3 parts for an effective automated cleaning and disinfection has been approved by an independent accredited testing laboratory The approval tests
35. r VI Rev Date 0 26 01 2011 VI 1 Lack of suction power owing to insufficient vacuum Since the LipoCollector 3 is integrated into the suction system all required con nections must be pressure stable i e no leak air must enter the system However experience shows that this constitutes a frequent source of operating errors Note It takes about ten 10 seconds to build up the full vacuum pressure in the collection container of the LipoCollector 3 Possible indications No or only a small amount of aspirate in the container slow for insufficient flow in the suction tubing low vacuum pressure indicated on vacuum _ the pressure gauge of the suction device General Blocked suction cannula leaks within the system damage to error causes the collection container caused by faulty processing or oper ating errors incorrect or pinched hose connections incorrect settings Fault localization The total system applicator with cannula LipoCollector 3 connection tubing suc tion container with suction bag and suction device is properly connected switched on and set to the maximum vacuum 500 mbar The aspiration cannula is in the adi pose tissue suction holes and by pass hole are closed First check the value displayed on the vacuum pressure gauge in order to locate the possible error cause as described in A or B by following the procedure given be low A Although the device the system has been properly ins
36. re commend a vacuum pressure of max 0 5 bars Thus the mechanical strain on the fat cells is reduced which is also favorable for the quality of the lipocyte concentrate Operating with smooth cannula movements helps to ensure trouble free collection and optimal harvesting of the fat content from the aspirate The surgeon should rather leave it to the water to do the work and should not try to extract the fat by dissection with pressure through the suction port of the cannula The fat should be flushed free by means of the water s gentle force Proceeding in this way exces sively large connective tissue pieces in the aspirate can be prevented as much as possible V 1 4 Amount of the collected aspirate and its liquid content The volume indicated on the suction pipe is an approximate value only The actual content of usable fat cells within the aspirate varies due to en various factors as e g used volume of liquid suction velocity and dura tion oil content etc During the floating filtration process in the LipoCollector 3 the amount of collected fat continuously increases top down in relation to the liguid amount the fat is grow ing downwards until the bottom is reached and the fat flows into the separation pipe The collection process finishes at the latest when the fat runs over into the suc tion pipe Pay attention to the fat s fill level in the container in order not to unin tentionally aspirate fat i
37. sisted lipoplasty The aspirate is firstly collected in the container Owing to its physical buoyancy the cell material is floating on the liquid surface while the irrigation fluid is lead into the waste container A special basket holds strands of connective tissue in the sterile collection container even if the suction power gets stronger Compared to conventional procedures this method of lipocyte harvesting represents a refinement and an ease of work Human Med AG Manual for use and processing of the LipoCollector 3 Page 6 of 35 Chapter I and II Rev Date 0 26 01 2011 Il 1 Intended use The LipoCollector 3 is intended to be used for harvesting filtering and transferring of autologous fat tissue during water jet assisted lipoplasty The device can be used in outpatient as well as inpatient surgeries The prerequisite for optimal use of the product is a functioning suction equipment suitable for WAL and the appropriate ap plication system WAL applicator Human Med does not guarantee the quality of the autologous material collected by means of the LipoCollector 3 and assumes no liability for any surgical procedure performed using the extracted material or their results ll 2 Significance of the safety instructions A This symbol characterizes a hazard that may cause personal injury This symbol characterizes a hazard that may cause material damage CAUTION This symbol characterizes a hazard that may ca
38. talled and the value in dicated on the vacuum pressure gauge 500 mbar is correct liposuction fat harvesting is not possible Proceed as follows 1 Remove the suction tube of the suction instrument cannula from the PATIENT port of the LipoCollector 3 a If the value indicated on the vacuum pressure gauge falls below 300 mbar there is a jam or blockage between applicator and cannula b Ifthe value indicated on the vacuum pressure gauge doesnt change the jam or blockage is to be located between LipoCollector 3 and suction device Human Med AG Doc No 900036 Instruction on use and processing of the LipoCollector 3 Page 33 of 35 Chapter VI Rev Date 0 26 01 2011 2 Remove the connection tubing from the SUCTION port on the lid of the LipoCollector 3 a If the value indicated on the vacuum pressure gauge doesn t change there is a jam or a blockage between connection tubing suction con tainer with suction bag and suction device b If the value indicated on the vacuum pressure gauge falls below 250 mbar there is a blockage in the LipoCollector 3 Possible n both cases check the system components and their connecting solution Points for leakage or blockage replace them if necessary Imperatively observe the instructions on troubleshooting given in the user manual for the used suction device B In spite of proper installation of the device the system the value indicated on
39. te can be discarded since the surgeon s technigue may also affect the fat extraction and there fore may have to be adapted to optimize future results Dropping or other vigorous application of force may damage the components of the LipoCollector M 3 which may potentially impair the functioning of the system Always handle with care Only original parts and accessories must be used ll 5 Initial use The LipoCollector 3 is supplied as a set made up of several individual components After checking that the packaging is undamaged and the content is complete the disposable components labeled as sterile are separated from the rest and stored All reusable items that have been delivered unsterile must be cleaned and sterilized before their first use according to the processing instructions included in this user manual ll 6 Disposal The LipoCollector 3 can be disposed of at the end of its service life according to the EU Directives related to the disposal of medical waste Human Med AG Instruction on use and processing of the LipoCollector 3 Page 7 of 35 Chapter III Rev Date 26 01 2011 Content lll Processing of the LipoCollector 3 lil 1 General information lll 1 1 Processing procedure lll 1 2 Selection of the processing method lll 1 3 Control and checking lll 1 4 Recommended cleaning disinfection and sterilization methods lll 2 Workplace safety and health lll 3 Preparation
40. use a failure or mal function of the medical device ATTENTION Please pay particular attention to the safety information in each chapter ll 3 Significance of the user manual instruction of medical staff Who needs to read the user manual The user manual represents an important part of the product safety concept There fore all those who will e prepare e set up e operate e dismantle e clean disinfect pack and store the device must read the user manual and the instructions for use of the instruments Human Med AG Manual for use and processing of the LipoCollector 3 Page 7 of 35 Chapter I and II Rev Date O 26 01 2011 Only medical staff who has been trained in this procedure is allowed to use the LipoCollector 3 in strict adherence to the present instruc tions for use Human Med assumes no liability for any damage resulting from improper use In case of uncertainties guestions or suggestions please contact our customer service ll 4 General safety instructions The LipoCollector 3 and its accessories are only to be used under ambient conditions which guarantee the strict adherence to the surgical hygiene management Dropping the lid or other heavy parts of the LipoCollector M 3 may cause injuries Always handle with the greatest care and minimize the height of drop Prior to first intended use a test run is necessarily to be made in a normal liposuction in which the aspira
41. vement of the aspirate quality V 1 4 Amount of the collected aspirate and its liquid content V 1 5 Fat extraction from the collection container of the LipoCollector 3 VI Troubleshooting VI 1 Lack of suction power owing to insufficient vacuum VI 2 Localization and elimination of failures of system components VI 3 Watery aspirate APPENDIX Product list USA 22 23 24 26 28 28 28 29 29 29 30 32 32 34 35 Human Med AG Manual for use and processing of the LipoCollector 3 Page 4 of 35 Chapter I and II Rev Date 0 26 01 2011 Contents ll 1 Intended use 6 ll 2 Significance of the safety instructions 6 ll 3 Significance of the user manual instruction of medical staff 6 ll 4 General safety instructions 7 ll 5 Initial use 7 ll 6 Disposal 7 Human Med AG Manual for use and processing of the LipoCollector 3 Page 5 of 35 Chapter I and Il Rev Date 0 26 01 2011 The LipoCollector 3 shall harvest the cell liguid mixture suctioned off during water jet assisted lipoplasty WAL and shall separate the preferably complete fat cells from the remaining liguid for laboratory purposes or autologous fat transfer The amount that can be harvested by means of the LipoCollector 3 under sterile conditions in a gentle and time saving way is up to 700 ml The LipoCollector 3 serves to filter lipocytes and connective tissue from the aspi rate collected during water jet as
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