Filler Collector User Manual
Contents
1. human med FillerCollector User Manual Human Med AG Instruction on use and processing of the FillerCollector Page 1 of 39 Rev Date 0 21 06 2010 FillerCollector User Manual C E o ISO 13485 Instruction on use and processing of the FillerCollector Ref no US660000 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 FillerCollector 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 2010 Human Med AG Instruction on use and processing of the FillerCollector Page 2 von 38 Table of contents Rev Date 0 21 06 2010 Table of contents General description of the FillerCollector 5 ll Safety instructions 5 ll 1 Intended use 5 Il 2 Significance of the safety instructions 5 Il 32. CAUTION V 1 Functional principle of the FillerCollector The FillerCollector is a filtering device for gentle separation of fat cells from a mix of liquid and tissue cells harvested by means of the water assisted liposuction The functional principle of the FillerCollector consists in separating the fat cells from the liquid solely by the physical phenomena of buoyancy and gravity The less dense fat is floating on top of the liquid while the liquid is continuously aspirated from the sepa ration pipe acc to the principle of communicating pipes Owing to the floating filtration without mesh filter fat may get wasted from the Filler Collector into the suction container particularly in case of a strongly stirred aspirate e g caused by fluctuations in pressure wagging of the suction tubing Therefore proceed in a calm and smooth manner during liposuction see also section V 17 2 Gradual pressure reduction 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 by means of the FillerCollector basket The FillerCollector is equipped with a basket serving as a pre filter The incoming aspirate is first running through this basket while 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
3. 1 Remove the aspiration line of the applicator from the PATIENT port of the FillerCollector 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 FillerCollector and body jet harvest jet or any other appropriate suction device in use Human Med AG Doc No 900009 Instruction on use and processing of the FillerCollector Page 35 of 38 Chapter VI Rev Date 1 01 11 2010 2 Remove the connection tubing from SUCTION port on the lid of the FillerCollector a If the value indicated on the vacuum pressure gauge doesnt change there is a jam or a blockage between connection tubing suction contai ner with suction bag and body jet harvest jet or any other appropriate suction device in use b If the value indicated on the vacuum pressure gauge falls below 250 mbar there is a blockage in the FillerCollector In both cases check the system components and their connecting points for leakage or blockage replace them if necessary Imperatively observe the instructions on troubleshooting given in the user manual for the respective suction device in use body jet harvest jet any other appropriate suction device B In spite of proper installation of the device the system the value indicated o
4. Significance of the user manual instruction of medical 6 staff Il 4 General safety instructions 6 Il 5 Compatibility information 7 1 5 1 Interface specification 7 Il 6 Initial startup 7 ll 7 Disposal 7 lil Processing of the FillerCollector 9 lll 1 General information 9 Il 1 1 Processing procedure 9 Il 1 2 Selection of the reprocessing method 10 1 1 3 Control and checking 11 Il 1 4 Recommended cleaning disinfection and sterilization 14 methods lil 2 Workplace safety and health 12 IIl 3 Preparation of reprocessing at the place of use 12 lll 4 Disassembly of the FillerCollector 14 IIl 5 Manual cleaning and disinfection 15 1 5 1 Manual cleaning 15 1 5 2 Manual disinfection 16 1 5 3 Sterilization after manual cleaning 18 Human Med AG Instruction on use and processing of the FillerCollector Page 3 von 38 Table of contents Rev Date 0 21 06 2010 Ill 6 Automatic cleaning and disinfection 11 6 1 Automatic cleaning and disinfection 1 6 2 Sterilization after automatic cleaning lil 7 Information on validation of reprocessing IV Assembly of the FillerCollector prior to clinical use IV 1 Components IV 2 Assembly V Fat cell harvesting with the FillerCollector V 1 Functional principle of the FillerCollector V 1 1 Internal pre filtering by means of the FillerCollector basket V 1 2 Gradual pressure reduction V 1 3 Improvement of the aspirate quality V 1 4 Amount of the co
5. Check whether the overflow protection bacterial filter of the body jet harvest jet or any other appropriate suction device is possibly blocked gt Test and replace acc to the respective instruction in the user manual for the body jet harvest jet or any other appropriate suction device in use Check whether the hose between suction container and body jet harv est jet any other appropriate suction device has been attached correctly gt Correct attachment Device settings filter suction container tubings Check whether the single use suction bag in the suction container has been correctly unfolded whether it is possibly pinched or damaged gt Correct or replace if necessary Human Med AG Doc No 900009 Instruction on use and processing of the FillerCollector Page 37 of 38 Chapter VI Rev Date 1 01 11 2010 Check whether the 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 Check whether the connection tubing between FillerCollector and suc tion container of the body jet harvest jet or any other appropriate suc tion device has been correctly attached at both ends gt Correct attachment Check whether the lid of the FillerCollector has been closed correctly and the sealing ring o ring completely fits into the groove provided Check whether the insufficient vacuum has been
6. caused by a leakage of the sealing 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 seal ing rings afterwards make a test 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 provided for this gt Correct the fitting of the sealing ring and or the position of the suction pipe FillerCollector Damages to the collection container of the FillerCollector 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 insufficiency gt Replace the collection container Do not use the collection container any longer if it shows damages strictly adhere to the instruction on processing mamane Prior to sterilization make sure that there are no metal parts in the col lection container The stainless steel parts of the FillerCollector are to be assembled in cold condition only Imperatively observe the instructions given in the user manual for the body jet harvest jet or any other appropriate suction device in use ATTENTION Human Med AG Doc No 900009 Instruction on use and processing of the FillerCollector Page 38 of 38 Chapter VI Rev Date 1 01 11 2010 VI 3 Watery aspirate When the collected a
7. damages the indicated values must not be exceeded Risk of damage due to residues of disinfectants Disinfectant solutions can contain various aggressive chemical ingredients 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 chlorinated lll 5 3 Sterilization after manual cleaning Packaging In accordance with ISO 11607 the dried FillerCollector 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 FillerCollector Page 19 of 38 Chapter III Sterilization Storage Active ingredients Rev Date 1 23 08 2010 Steam sterilization using a fractionated vacuum process at 121 C 250 F for at least fifteen 15 minutes and at 134 C 273 F for three 3 minutes has been validated Sterilization at 134 C 273 F for max thirty 30 minutes has been tested no adverse effects on the material of the Filler Collector have been detected Prior to each sterilization procedure always check the batch proc
8. filter lipocytes and connective tissue from the aspirate collected during water jet assisted 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 M Manual for use and processing of the FillerCollector Page 6 of 38 Chapter and Chapter II Rev Date 0 21 06 2010 ll 1 Intended use The FillerCollector 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 pro duct is a functioning suction equipment e g body jet suitable for WAL and the appropriate application system WAL applicator Human Med does not guarantee the quality of the autologous material collected by means of the FillerCollector and assumes no liability for any surgical procedure performed using the extracted material or their results Il 2 Significance of the safety instructions A This symbol characterizes a hazard that may cause personal injury This symb
9. 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 Finally check all surfaces ports and hollow spaces for visible conta mination Return contaminated parts to the cleaning process Infection control risk by cleaning agents Using unsufficient cleaning agents can provoke an infection control risk Only use cleaners that are approved in accordance with national hygiene related regulations and local guidelines Human Med AG Instruction on use and processing of the FillerCollector Page 17 of 38 Chapter III Rev Date 1 23 08 2010 Risk of damage due to incompatible cleaning agents Incompatible cleaning agents can cause considerable damages to the Filler Collector Therefore only use cleaners approved by Human Med Risk of damage due to residues of cleaning agents In order to remove all residues thoroughly rinse every part with deionized water aq dest in the last rinse cycle Do not use tap water for the last rinse cycle Iil 5 2 Manual disinfection Prescribed a Gigasept Instru AF co Sch lke amp Mayr cleaning concentration contact time 3 15 min 2 30 min agents 1 5 60 min Maximum period of use 7 days In case of strong contamination we recommend renewing the solution earlier b Il Cidex OPA Or
10. 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 We recommend using a 3 8 mm STS cannula stainless steel to ensure that the detached fat particles or cell islets remain as small as possible The infiltration should be done at RANGE 1 or 2 when using a body jet 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 iomiaain various factors as e g used volume of liquid suction velocity and dura tion oil content etc During the floating filtration process in the FillerCollector the amount of collected fat continuously increases top down in relation to the liquid 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 into the suction container waste ATTENTION Human Med AG Instruction on use and processing of the FillerCollector Page 32 of 38 Chapter V Rev Date 01 01 11 2010 After finishing the collection the fat should still be left in the FillerCollector for a short period Dur
11. moreover it conduces to gentle fat treatment prevention of pressure peaks Human Med AG Instruction on use and processing of the FillerCollector Page 31 of 38 Chapter V Rev Date 01 01 11 2010 V 1 2 Gradual pressure reduction While working with the FillerCollector 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 points 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 rec ommend 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
12. on use and processing of the FillerCollector Page 36 of 38 Chapter VI Rev Date 1 01 11 2010 VI 2 Localization and elimination of 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 can nula in the tissue is symptomatic for a blocked cannula gt Wipe off flush Check whether the aspiration line of the body jet harvest jet applicator has been correctly connected to the FillerCollector gt Correct the connection Applicator Check whether the body jet harvest jet or the suction pump of any other appropriate suction device has been switched on indicator lamp pump noise gt Switch on acc to the respective instruction in the user manual for the body jet harvest jet or any other appropriate suction device in use Check whether the vacuum rotary switch of the body jet has been turned to the correct suction container side gt Correct this setting acc to the respective instruction in the user manual for the body jet 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 body jet harvest jet or any other appropriate suction device in use
13. that this constitutes a frequent source of operating errors It takes about ten 10 seconds to build up the full vacuum pressure in the collection container of the FillerCollector ATTENTION 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 pump e g body jet harvest jet General Blocked suction cannula leaks within the system frequently error causes IN the FillerCollector damage to the collection container caused by faulty processing or operating errors incorrect or pinched hose connections incorrect settings Fault localization The total system applicator with cannula FillerCollector connection tubing suc tion container with suction bag and body jet harvest jet or any other appropriate suction device is properly connected switched on and set to the maximum vacuum 500 mbar The aspiration cannula is in the adipose 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 installed and the value indicated on the vacuum pressure gauge 500 mbar is correct lipo suction fat harvesting is not possible Proceed as follows
14. 0 C 68 F warm water for five 5 minutes each pre rinse cycle Cleaning with 55 C 131 F hot water mixed with cleaning solu 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 With 10 C 50 F cold water for three 3 minutes With 20 C 68 F warm fully deionized water for three 3 minutes The cleaned parts are to be blown out at a temperature of 80 C 176 F and a hold time of one 1 minute Thermal rinsing with fully deionized water at a temperature of 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 At 70 C 158 F for at least fifteen 15 minutes The products cool down at 30 C 86 F Human Med AG Instruction on use and processing of the FillerCollector Page 21 of 38 Chapter III Rev Date 1 23 08 2010 Maintenance The individual parts of the FillerCollector 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 b
15. Collector step 7 Put the sealing plug I into the orifice EXTRACT SUCTION ge A provided in the lid E of the FillerCollector PATIENT Step 8 Finally insert the lid E assembled as described in step 1 to 7 into the collection container A of the Filler Collector The FillerCollector is now ready for connection of the suction tubing coming from the aspiration cannula to the hose connector PATIENT Human Med AG Instruction on use and processing of the FillerCollector Page 28 of 37 Chapter IV Rev Date 2 01 11 2010 IV 3 Attachment of the suction tube and the connection tubing 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 body jet harvest jet or any other appro priate suction device in use Do not attach the connection tubing directly to the body jet harvest jet but always to the suction container waste Likewise observe the user manuals for the body jet harvest jet or any other appropriate suction device in use Attach the suction tubing of the WAL harvest jet Applicator to the hose connector PATIENT on the top side of the lid When attaching the connection and suction tubing take care that both hoses are pull relieved For this purpose fasten each hose to the instrument table near the FillerCollecto
16. FillerCollector 15 lll 5 Manual cleaning and disinfection 16 Il 5 1 Manual cleaning 16 II 5 2 Manual disinfection 17 Il 5 3 Sterilization after manual cleaning 18 lil 6 Automatic cleaning and disinfection 19 Ill 6 1 Automatic cleaning and disinfection 20 Il 6 2 Sterilization after automatic cleaning 21 lil 7 Information on validation of reprocessing 21 Human Med AG Instruction on use and processing of the FillerCollector Page 10 of 38 Chapter III Rev Date 1 23 08 2010 lil 1 General information lll 1 1 Processing procedure The FillerCollector 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 equipment 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 accordance with the RKI guideline we assess the FillerCollector as reprocessa ble without any particular requireme
17. FillerCollector Disposable Set aerie 1 pu 5 sets single US660023 FillerCollector Disposable Set packed 1 pu 10 sets single use Connection Tubing to Suction Container US653300 Length 3 meter 1 pu 25 pcs E 660023 653300 BEAULI 660000 BEAULI Disposables pu US655010 Extraction Cannula LipoCollector US665010 Extraction Cannula 300mm ee a aa FillerCollector single packed single use US655020 BEAULI Infiltration Cannula 1 pu 10 pcs US655090 Luer to Luer Connector female female 1 pu 10 pcs 665010 o O _ 655010 655090 655020 Articles can be ordered in complete pu package units only human med AG 2010 page 4 of 4
18. atic repro cessing procedures including sterilization Further reprocessing beyond this number or other reprocessing procedures are in the user s responsibility Ultra sonic cleaning bath rinsing bath cleaning bath and brushes Human Med AG Instruction on use and processing of the FillerCollector Page 15 of 38 Rev Date 1 23 08 2010 lll 4 Disassembly of the FillerCollector 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 ot it C Remove the white sealing rings 4 from the lid and the connection port of the suction pipe and dispose 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 The sealing rings and the sealing plug are single use products and must not be reprocessed and sterilized heir reuse may lead to iiia loss of material elasticity and to contamination of the aspirate by silicone particles That may cause allergic reactions of the patient and therefore is explicitly prohibited Human Med AG Instruction on use and processing of the FillerCollector Chapter III Page 16 of 38 Rev Date 1 23 08 2010 III 5 Manual cleaning and disinfection lll 5 1 Manual cleaning Prescribed cleaning agents ATTENTION Immersion of
19. cuum S Start the suctioning by closing the bypass hole of the Water straw ke _ 5 Stop or finish the suctioning by opening the bypass hole again 6 After finishing the suctioning switch the suction unit off The harvested fat can be extracted immediately after the excessive liquid has been removed The fat cells are extracted through the orifice EXTRACT pro vided in the lid of the FillerCollector by means of sterile single use syringes and a sterile extraction cannula ref no US665010 For this purpose the silicone plug sealing this orifice is to be removed before A Luer to Luer connector female female ref no US665090 is available for transfer from syringe to syringe Human Med AG Doc No 900009 Instruction on use and processing of the FillerCollector Page 33 of 38 Chapter VI Rev Date 1 01 11 2010 Content VI Troubleshooting 34 VI 1 Lack of suction power owing to insufficient vacuum 34 VI 2 Localization and elimination of failures of system components 36 VI 3 Watery aspirate 38 Human Med AG Doc No 900009 Instruction on use and processing of the FillerCollector Page 34 of 38 Chapter VI Rev Date 1 01 11 2010 VI 1 Lack of suction power owing to insufficient vacuum Since the FillerCollector is integrated into the suction system all required connec tions must be pressure stable i e no leak air must enter the system However ex perience shows
20. d processing of the FillerCollector Page 11 of 38 Chapter III Rev Date 1 23 08 2010 Compatibility Human Med distinguishes between 2 types of compatibility micro biological compatibility material compatibility Micro biological compatibility The micro biological compatibility signifies that the FillerCollector 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 FillerCollector 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 Automatic cleaning and disinfection When selecting the disinfecting entity 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 only sterile or low germ max ten 10 germs ml and low endotoxin max 0 25 endotoxin u
21. e accompanied with the relevant documented evidence lll 6 2 Sterilization after automatic cleaning see section Ill 5 3 Sterilization after manual cleaning Ill 7 Information on validation of reprocessing The following test instructions materials and machinery have been used for valida tion of the cleaning process gt Agent for automatic cleaning deconex TWIN BASIC TWIN ZYME co Borer Chemie AG gt Neutralizator for automatic cleaning Deconex 64 NEUTRARADRY Borer Chemie AG gt Agent for manual cleaning Gigasept Instru AF SCHULKE amp MAYR gt Disinfectant for manual disinfection Gigasept Instru AF SCHULKE amp MAYR gt 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 lf the above described chemicals and machines are not available it is the user s responsibility to ensure validation of the reprocessing method used lt is the reprocessors responsibility to ensure that the reprocessing actually per formed with equipment materials and personnel in the reprocessing facility achieves the desired result This requires validation and routine monitoring of the process Likewise any deviation from the instructions provided must be properly evaluated by the reprocessor for effectiveness and potential adverse consequences Human Med AG Instruc
22. e transported either dry or immersed in fluid Contaminated 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 f 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 FillerCollector 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 FillerCollector have been successfully tested for a thirty time 30 reprocessing using the validated manual and autom
23. ess record for the respective sterilizer to ensure that the re quired parameters are being complied with The individual sterile plastic bags have to be stored in a closed cupboard protected from dust and humidity and extreme fluctua tions in temperature The shelf life is determined by the product specifi cations 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 Automatic cleaning and disinfection Prescribed cleaning agents Note The following cleaning agents are approved by the producer a deconex TWIN BASIC TWIN ZYME and neutralizer deco nex 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 damage the plastic parts of the FillerCollector 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
24. he FillerCollector Page 8 of 38 Chapter I and Chapter II Rev Date 0 21 06 2010 2 The tubing that transfers the waste solution from the FillerCollector via the SUCTION port on the lid of the FillerCollector to the waste container of the suction device must have an internal diameter of 4 8 mm and a length of 3 m ll 6 Initial startup The FillerCollector 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 must be cleaned and sterilized before their first use according to the processing instructions included in this user manual ll 7 Disposal The FillerCollector can be disposed of at the end of its service life according to the national regulations related to the disposal of medical waste Human Med AG Instruction on use and processing of the FillerCollector Page 9 of 38 Chapter III Rev Date 1 23 08 2010 Content lll Processing of the FillerCollector 10 lil 1 General information 10 Ill 1 1 Processing procedure 10 Ill 1 2 Selection of the processing method 11 Il 1 3 Control and checking 12 Il 1 4 Recommended cleaning disinfection and sterilization methods 12 lil 2 Workplace safety and health 13 lil 3 Preparation of reprocessing at the place of use 13 lll 4 Disassembly of the
25. illerCollector Page 18 of 38 Chapter III Rev Date 1 23 08 2010 Drying Dry all parts internally and externally using sterile compressed air Maintenance The individual parts are not intendend for maintenance Check and Visually check the parts for damage and wear Inspection Check the ports on the lid for deformation the collection con tainer 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 autho rized supplier they must be cleaned disinfected and sterilized before and be accompanied with the relevant documented evi dence Risk of unsufficient effectiveness of disinfection in small lumen parts When disinfecting small lumen parts there is the risk that the inner lumen is not suffi ciently in contact with the disinfectant solution Therefore the disinfectant solution must be injected into narrow lumina by means of a syringe Risk of damage due to incompatible disinfectants Incompatible disinfectants can cause considerable damages to medical devices Therefore only use disinfectant solutions which Human Med has approved and re leased for use with the FillerCollector Risk of damage by exceeding the concentration and the contact time Strictly adhere to the instructions given by the disinfectant producer regarding the concen tration and the contact time of the disinfectant solution In order to prevent the device from
26. impair its elasticity and lead to leakage of the Filler Collector 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 connector 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 FillerCollector Page 27 of 37 Chapter IV Rev Date 2 01 11 2010 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 Step 6 Push the suction pipe F through the orifice SUCTION provided for this in the lid E of the Filler
27. ing 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 FillerCollector Prior to fat extraction the excessive liquid if existing should be suctioned from the bottom of the FillerCollector This helps to reduce the risk of unintentional aspira tion of liquid into the syringes what might entail a longer sedimentation time d We recommend using the Water straw ref no US660040 S for removal of the excessive liquid The Water straw is made Z of a stainless steel tube with a hose connector at one end and a bypass opening in the upper tube section S In order to remove the excessive liquid from the Filler 4 Collector 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 through this orifice into the FillerCollector 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 liquid is suctioned but not fat cells we recommend not setting the maximum va
28. llected aspirate and its liquid content V 1 5 Fat extraction from the collection container of the FillerCollector 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 2010 USA 19 19 20 20 23 24 25 29 29 29 30 30 30 31 33 33 35 37 Human Med AG Manual for use and processing of the FillerCollector Page 4 of 38 Chapter I and Chapter II Rev Date 0 21 06 2010 Contents Il 1 Intended use Significance of the safety instructions 2 ll 3 Significance of the user manual instruction of medical staff 4 General safety instructions 5 Compatibility Information N N N O O Il 5 1 Interface specification ll 6 Initial startup co ll 7 Disposal Human Med AG Manual for use and processing of the FillerCollector Page 5 of 38 Chapter I and Chapter II Rev Date 0 21 06 2010 The FillerCollector shall harvest the cell liquid mixture suctioned off during water jet assisted lipoplasty WAL and shall separate the preferably complete fat cells from the remaining liquid for laboratory purposes or autologous fat transfer The amounts harvested by the FillerCollector under sterile conditions in a gentle and time saving way are comparatively small between 100 and 200 ml The FillerCollector serves to
29. n the vacuum pressure gauge is well below 500 mbar liposuction fat harvesting is not possible Proceed as follows 1 Remove the aspiration line of the applicator from the PATIENT port of the FillerCollector and block it by hand a Ifthe value indicated on the vacuum pressure gauge increases conside rably a leakage is to be located between aspiration line of the applicator and the cannula b If the value indicated on the vacuum pressure gauge is further too low there is a leakage between FillerCollector and body jet harvest jet or any other appropriate suction device 2 Remove the connection tubing from the SUCTION port on the lid of the FillerCollector and block it by hand a If the value indicated on the vacuum pressure gauge is further too low there is a leakage between connection tubing suction container with suc tion bag and body jet harvest jet or any other appropriate suction de vice in use b Ifthe value indicated on the vacuum pressure gauge increases consider ably the leakage is to be located in the FillerCollector In both cases check the named system components and their con necting points for leakage or blockage replace them if necessary Imperatively observe the instructions on troubleshooting given in the user manual for the respective suction device in use body jet harvest jet any other appropriate suction device Human Med AG Doc No 900009 Instruction
30. nits 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 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 Human Med AG Instruction on use and processing of the FillerCollector Page 12 of 38 Chapter III Rev Date 1 23 08 2010 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 process are not available Nevertheless test Strips can be used for testing the concent
31. nts After thorough cleaning this product and its individual parts must be sterilized by steam sterilization prior to their application on the patient The automatic cleaning and disinfection is to be preferred Factory new unsterile parts of the FillerCollector are to be treated like used prod ucts They must necessarily be cleaned before disinfection and sterilization Manual or automatic cleaning Both manual and automatic 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 Automatic cleaning methods minimize this risk and moreover have the advantage of standardized and validated procedures Recommendation Automatic 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 automatic cleaning in a specific situation 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 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 Human Med AG Instruction on use an
32. ol characterizes a hazard that may cause material damage CAUTION This symbol characterizes a hazard that may cause 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 and disinfect the device must read the user manual and the instructions for use of the instruments Only medical staff who has been trained in this procedure is allowed to use the FillerCollector in strict adherence to the present instruc tions for use Human Med AG Manual for use and processing of the FillerCollector Page 7 of 38 Chapter I and Chapter II Rev Date 0 21 06 2010 Human Med assumes no liability for any damage resulting from im proper use In case of uncertainties questions or suggestions please contact our customer service ll 4 General safety instructions The FillerCollector 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 FillerCollector may cause Injuries Always handle with the greatest care and minimize the height of d
33. or Page 24 of 37 Chapter IV ATTENTION WARNING WARNING Rev Date 2 01 11 2010 Visually check the FillerCollector parts for damage and wear Do not assembly if any individual part shows damages The complete FillerCollector is to be assembled under aseptic conditions using the supplied sterile single use parts extraction cannula sealing rings for lid and connection port of the suction pipe sealing plug After sterilization all FillerCollector parts must cool down sufficiently below body temperature before they can be used Human Med AG Instruction on use and processing of the FillerCollector Page 25 of 37 Chapter IV Rev Date 2 01 11 2010 M IV 1 Components A E 7 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 TaAanrmMmIoeowaDA DP Human Med AG Instruction on use and processing of the FillerCollector Chapter IV IV 2 Assembly M Page 26 of 37 Rev Date 2 01 11 2010 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
34. oscopy 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 as well as gt CIDEZYME GI ENZOL enzymatic detergent ADVANCED STERILIZATION PRODUCTS Division of Ethicon Inc The parameters used are described in the section III 6 1 Automatic cleaning and disinfection Human Med AG Instruction on use and processing of the FillerCollector Page 13 of 38 Chapter III Rev Date 1 23 08 2010 Steam sterilization according to 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 III 2 Workplace safety and health Prevention of infections and chemical burns Bodily particles of the patients and decontamination chemicals represent a hazard Protective equipment is required 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 un covered Always rem
35. ove contaminated protec tive equipment 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 Filler Collector Never use rinse agents They cause stress cracks in the collection container and can shorten its service life lll 3 Preparation of reprocessing at the place of use The reusable parts of the FillerCollector 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 Human Med AG Instruction on use and processing of the FillerCollector Page 14 of 38 Chapter III Preparation and transport CAUTION Limitation of reprocessing Required auxiliary means Rev Date 1 23 08 2010 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 b
36. r using towel forceps with tubing clip or holding and drape clamps in order to ensure the Stable position of the FillerCollector Human Med AG Instruction on use and processing of the FillerCollector Page 29 of 38 Chapter V Rev Date 01 01 11 2010 Content V Fat harvesting with the FillerCollector V 1 Functional principle of the FillerCollector V 1 1 Internal pre filtering by means of the FillerCollector basket V 1 2 Gradual pressure reduction V 1 3 Improvement 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 FillerCollector 30 30 30 31 31 31 32 Human Med AG Instruction on use and processing of the FillerCollector Page 30 of 38 Chapter V Rev Date 01 01 11 2010 Lipocytes are sensitive to low temperatures The ambient tempera ture for the collected adipose tissue must be at least 20 C 68 F but not higher than 37 C 98 6 F lf pre warmed not warmer than body temperature infiltration and irrigation solution has not been used yet it should definitely be consi arem dered to be used for surgical interventions including lipocyte extrac tion In order to minimize damages to the adipose tissue being collected the suction vacuum must not exceed 0 5 bars The composition of the anesthetic irrigation solution may affect the vitality of the harvested cells
37. ration 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 specially 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 FillerCollector 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 Automatic cleaning and disinfection The basic suitability of all FillerCollector parts for an effective automatic cleaning and dis infection has been approved by an independent accredited testing laboratory The approval tests have been carried out using the disinfector LS 2000 co Hamo with drawer cart and lapar
38. rop Prior to first intended use a test run is necessarily to be made ina normal liposuction in which the aspirate can be discarded since the surgeon s technique 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 FillerCollector which may potentially impair the caution functioning of the system Always handle with care Only original parts and accessories must be used ATTENTION ll 5 Compatibility Information lf the FillerCollector is not used in combination with the body jet harvest jet or any other suction lipoplasty system manufactured by Human Med an FDA cleared suction lipoplasty system including appropriate liposuction cannulae and connection tubing FDA Product Code MUU Regulation Number 21 CFR 878 5040 should be applied The use of FDA cleared syringes e g 50 cc syringes Luer Lock and Luer to Luer connectors is also recommended ll 5 1 Interface specification The tubing must be able to withstand the amount of negative pressure created by the pump without collapsing Two kinds of connecting tubing are required 1 The tubing that connects the liposuction cannula with the FillerCollector via the PATIENT connection port on the lid of the FillerCollector must have an inter nal diameter of 7 mm Human Med AG Manual for use and processing of t
39. spirate is too watery this frequently results from incorrect ex traction If the extraction cannula is introduced too deeply into the collection container of the FillerCollector 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 FillerCollector see Chapter V 1 5 Fat extraction from the collection con tainer of the Filler Collector This helps to reduce the unintentional aspiration of liquid into the syringe what might entail a longer sedimentation time Furthermore the extraction syringe used should be put into a holder with the piston facing upwards and should be left there for about ten 10 minutes During this time the fat separates from the liquid due to its natural buoyancy Afterwards the exces sive liquid can 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 FillerCollector Page 1 of 1 Appendix Rev Date 0 21 06 2010 Appendix Product list 2010 USA Product List 07 2010 human med FillerCollector FillerCollector complete set pu US660000 includes 1set 660023 1pc 653300 1pc 665010 1 set FillerCollector Disposables pu US660023 5
40. the parts for manual pre rinsing Manual pre cleaning Manual cleaning Cleaning check When disinfecting with Gigasept Instru AF also use Gigasept Instru AF for cleaning 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 All individual parts intended for reuse as suction pipe with connection port lid with port for con nection to patient basket separation pipe collection con 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 All individual parts must be pre cleaned in the cleaning solution using 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 Afterwards all parts must be completely immersed in an ultrasound bath with cleaning 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
41. tho 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 mmerse the FillerCollector parts in the prepared solution con centration acc to the producers specification for fifteen 15 minutes There must not be any air bubbles on the parts of the FillerCollector Procedure and concentration when using Cidex OPA Immerse the FillerCollector parts in the concentrated undiluted Cidex OPA solution for five 5 minutes There must not be any air bubbles on the parts of the FillerCollector In order to avoid damages only use gripping pliers with rubber jaws when handling the instruments in the disinfectant solution ATTENTION Rinsing 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 iia The rinsing of the parts is to be repeated twice as described The sterile deionized water must be replaced after each rinse cycle Human Med AG Instruction on use and processing of the F
42. tion on use and processing of the FillerCollector Page 22 of 38 Chapter III Rev Date 1 23 08 2010 List of tested cleaners and disinfectants particularly suited for cleaning and disinfection of the collection container Tradename Producer Remas Thermosept RKN zym Enzymatic detergent Thermosept alca clean Alkaline cleaner containing tensides possible ph value aa Mediclean DR WEIGERT 10 orte CIDEZYME GI EN ADVANCED STERILI he enzymatic deter ZATION PRODUCTS Enzymatic detergent Manual cleaning Gigasept Instru AF SCHULKE amp MAYR Aldehyde free CIDEZYME GI EN ADVANCED STERILI ae enzymatic deter ZATION PRODUCTS Enzymatic detergent Manual disinfection Gigasept Instru AF SCHULKE amp MAYR Aldehyde free Neodisher Septo 3000 DR WEIGERT E t CSOCS d ADVANCED STERILI High level disinfectant for ZATION PRODUCTS semi critical medical devices Two component cleaning system for automatic cleaning TWIN BASIC Neutral enzymatic and mild TWIN ZYME Borer Chemie AG alkaline CIDEX OPA Human Med AG Instruction on use and processing of the FillerCollector Page 23 of 37 Chapter IV Rev Date 2 01 11 2010 Content IV Assembly of the FillerCollector prior to clinical use IV 1 Components IV 2 Assembly IV 3 Attachment of the suction tube and the connection tubing 24 25 26 27 Human Med AG Instruction on use and processing of the FillerCollect
43. use to the reprocessing facilities in dry condition in order to avoid that protein can deposit due to the cleaning agent used The water inflow into the washing machines must start at lower tem peratures approx 20 C 68 0 F to prevent thermal coagulation of proteins Human Med AG Instruction on use and processing of the FillerCollector Chapter III Recommen dation Page 20 of 38 Rev Date 1 23 08 2010 All individual parts intended for reuse as suction pipe with connection port lid with port for con nection to patient basket separation pipe collection container 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 machine 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 Ill 6 1 Automatic cleaning and disinfection The following working steps are to be carried out when using a washing and disin fection machine dated by Human Automatic pre cleaning Automatic cleaning First rinse cycle Second rinse cycle Blowing Automatic disinfection Automatic drying Cooling The procedure described below reflects the reprocessing as vali Med Pre rinse twice with 2
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