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body-jet® ECO User Manual

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1. A Only use the body jet eco together with components that are specified by Human Med in this This particularly applies to the following parts lt Foot bellows with suitable tubing produced by Herga Electric Ltd item no of the one sided foot bellows 6448 AAAC 0000 item no of the double sided foot bellows 6448 EAAC 0000 1000 ml suction container produced by Serres Oy item no 57308 M 1000 ml suction bag produced by Serres Oy item no 57157 gt Hydrophobic filter set incl vacuum hose with overflow bacteria barrier produced by Medela AG item no 077 0572 plug in coupling connector and vacuum elbow connector for connecting the suction container to the suction port of the device gt Sealing cap for the infiltration pump socket In respect of the allowed medical indications the body jet eco must only be operated using the Biofill applicator REF 580001 and the Biofill cannula REF 580086 manufactured by Human Med The use of an invalid applicator may lead to breakdown of the device The current product list is applicable Any modification to the body jet eco the Biofill applicator the Biofill cannulas and other accessories are not allowed and will result in exemption of Human Med from liability Page 4 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 4 Preparatory activities 4 1 4 Preparations for use Check the device and
2. sccccscccccecceeeccseecssescnsuecsseeessuesssueesseeenseeesaeeesseeesseeesseeesseeesseeenseessseeesssesseessesensesessnsessnsenaages 4 7 as al 8 Ve 82 1401 8 S 6 gal BES P A E A EET eT A O eee eee ee ee ee 5 cam 2D ERE ee ee ere en eer ne eee ee ee ee ee ee ee ee ee ee 5 4 2 1 Test of the overflow bacteria Darr r Lu L LELE LELE LEE K AK EKA Kaka Kaka Kaka aa a aka a kk kk ka k kk kk kk kk k Kr ka a 5 rr a ta all taz SU CHO MU SL SU ee r r ooo 7 d2 VACUUM lle n L M ee Te en n n ll a _e_a_rarrDDD_ _m_m_ _ aan_r _ ___ _ pp am az a a 29 3a3aRD 9 4 2 4 Connection of the Biofill appliCatoOr E L LL EEE EEE EEE EEE EEE EKA KERA RAA a KRA Heka Ha AE Kak KA He RA HK ku HAH HAA H AA HK ku HK AH HAA Hu ka Hu ka kK nk ka 10 4 2 4 1 Installation of the infiltration PUMP u u uk kk kk kk kk ETERN ERNE Kek ka k k k ka ka kk kk a kk a ka a a a a a a a a ka ka a a ka aka kk ka a kk a kk k a a kak ka aka 10 4 2 4 2 Connection of the Biofill applicator to the fluid bag i kk kk kak kk kk k k KK K k k k kk lk K kk kk a kk kk k kk kk a kk kk a kk kk kk k 12 4 2 4 3 Connection of the suction tube of the Biofill appliCator ui kk kak k reen k K k kk K k k kK kk kK kk kk kk K k 14 420 Velo OF ie BIO HIF APPC Ofer eee ee ee eee eee
3. Electromagnetic emissions The body jet eco is intended for use in the electromagnetic environment specified below The user of the body jet eco must assure that it is used in such an environment Emission tests Compliance Electromagnetic environment Guidance RF emissions acc to EN 55011 Group 1 The body jet eco uses RF energy only for its internal function Therefore its RF emissions are very low and are unlikely to cause any interference in nearby electronic equipment RF emissions acc to EN 55011 Class B am The body jet eco is suitable for use in all establishments other than domestic HEINE cara ae NO TES SENE en and those directly connected to the public power supply network that supplies Voltage fluctuations flicker emissions acc to IEC comply buildings used for domestic purposes 61000 3 3 Human Med AG Doc No 900071 Page 8 3 User manual body jet eco Rev Date 0 27 05 2014 Kapitel 8 Technical data human med 8 2 2 Guidance and manufacturer s declaration Electromagnetic immunity The body jet eco is intended for use in the electromagnetic environment specified below The user of the body jet eco must assure that it is used in such an environment Immunity tests IEC 60601 Test level Compliance level Electromagnetic environment Guidance Electrostatic Discharge ESD acc to 6 kV 6 kV Floors should be wood concrete or ceramic tile If IEC 61000 4 2 Contact discharge Contact discharge floor
4. E LELLLEEE ELLES EEE EEE EEE EEE SEKE KE KE KEK EA Ka Ka Ka Ka Ka ka kk ka kk kk kk kk Ka kr 2 9 1 3 Modifications and replacement Of componentS 1 ccscccnseccseccnseecneeessusensuesseeensueessuessueessueesenesaueensuessanessueenauessueessuessauessusenauessasessusenaussansesaas 3 9 1 4 le ALLE T NO HZ HHHH HHHH HEE z mG 3 FE AN REE ET E E E E E en SER 3 2 Ss BEDO E T E aoo_ooex xxggxxxxgxxx22xxxxxbB n E py pp2 M2 4 wa OOT Qn G jArrbb cccaspzn p _w or rh pa pr_ry _r_xx wxxrrxEXTTMTmM TIE E MUM HB zyazZa uZaMD D 4 Human Med AG Doc No 900071 Page 9 1 User manual body jet eco Rev Date 0 27 05 2014 0220o Chapter 9 Maintenance warranty disposal and customer service e human med 9 Maintenance warranty disposal and customer service 9 1 Maintenance 9 1 1 Authorized persons Functionality tests and the inspection of safety relevant features modifications and replacement of components must only be carried out by Human Med or by persons expressly authorized by Human Med In case unauthorized persons carry out modifications or replace device components Human Med doesn t assume any liability and claims under warranty become void 9 1 2 Functionality tests and inspection of safety relevant features Functionality tests and the inspection of safety relevant features represent a preventive maintenance that should be carried out by an authorized technician in regular inte
5. eco 6 Human Med AG Doc No 900071 Page 8 1 User manual body jet eco Rev Date 0 27 05 2014 g Kapitel 8 Technical data human med 8 Technical data 8 1 General data of the body jet eco Dimensions 32 w x 35 d x 30 h cm Weight 11 kg Water jet generation With sterile infiltration pump over an electro mechanical linear drive unit Flow rates of the water jet 60 ml min 20 Suctioning 500 mbar 50 mbar at 0 m above sea level Vacuum at different altitudes 2000 m min 650 mbar 1000 m min 700 mbar 500 m min 800 mbar 0m min 850 mbar Power supply 230 VAC 1 A 50 Hz Applicator sterile Biofill Applicator for single use Sterile or non sterile Biofill cannulae resterilizable Nozzle diameter of the Biofill Applicator 200 um Safety class acc to standard IEC 60601 1 Applied part Type BF Laser class 2 Page 8 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco ede e human med Chapter 8 Technical data Approvals GE 0482 Device class acc to Council Directive 93 42 EEC lla Ambient conditions for transport and storage Temperature 20 C to 50 C Relative humidity 10 to 95 Ambient conditions for operation Temperature 10 C to 40 C Relative humidity 30 to 75 no condensation 8 2 Manufacturer s declaration on electromagnetic compatibility 8 2 1 Guidance and manufacturer s declaration
6. it must be replaced Proceed as follows Deactivate the vacuum buildup by pressing the ON OFF button VAGUUM The LED goes out Human Med AG Doc No 900071 Page 5 5 User manual body jet eco Rev Date 0 27 05 2014 o Chapter 5 Working with the body jet eco 9 human med Pull off the angle connector 7 together with the suction tube E from the port 8 PATIENT of the suction bag Fig 5 3 Close the port PATIENT 8 with the closing cap 9 Fig 5 4 Fig 5 4 Close the suction bag EH Page 5 6 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e Fe e human med Chapter 5 Working with the body jet eco Now remove the filled suction bag from the suction container holding it on the grip 10 Fig 5 5 Insert a new suction bag proceed as described in chapter 4 2 2 Preparation of the suction unit on page 4 6 Fig 5 5 Remove the suction bag Disposal of the filled suction bag A The aspirated liquid may contain germs harmful to health The filled suction bag including the aspirated liquid must be disposed of in strict adherence to the legal hygiene regulations lt must be disposed of in closed containers for infectious waste labeled as hazardous waste Details can be taken from the hygiene plan of the hospital concerned 5 5 After surgery gt Switch the device off gt Close the clamp of the transfer tubing gt Remove the sealing
7. warranty disposal and customer service Maintenance Authorized persons Doc No 900071 User manual body jet eco Rev Date 0 27 05 2014 Table of contents 5 5 5 7 6 2 6 2 6 5 7 2 7 2 7 2 7 2 7 4 7 5 8 2 8 2 8 3 8 4 8 6 9 2 9 2 Page 3 Table of contents human med 9 1 2 Functionality tests and inspection of safety relevant features 9 2 9 1 3 Modifications and replacement of components 9 3 9 1 4 Periodic maintenance 9 3 9 2 Warranty 9 3 9 3 Disposal 9 4 9 4 Customer service 9 4 Page 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e oe e human med Chapter 1 General description of the body jet eco Contents 1 General description of the body jet eco csscsssssssssssessessscessessesessesseseeseesesecsevsesesseesesesseesesasseesesaeseesesaneeesasasseesesascerensansersnsaneerens 2 1 1 Medical INGICATION 0 ccc ccccccccccccccceccccececcacaceceacuceneacuceceaceceneacaueaeaceneaeaseneauaceneaeateneaeauentatsueneaesueneaueneaeaceneaeaueneauauentansuentansneneatens 2 1 2 Contraindications 00 i HHHHHHHHIR HHHH HHHH E Dq AV 2 Human Med AG Doc No 900071 Page 1 1 User manual body jet eco Rev Date 0 27 05 2014 09 20 Chapter 1 General description of the body jet eco e human med 1 General description of the body jet eco The body jet eco is the new model of the body jet series It was specifical
8. 2 Safety precautions and safety features human med 2 Safety precautions and safety features 2 1 Significance of the safety symbols This symbol characterizes a hazard that may cause personal injury This symbol characterizes a hazard that may cause material damage This symbol characterizes a hazard that may cause a failure or malfunction of the medical device Please pay particular attention to the safety precautions in each chapter 2 2 Adherence to the safety instructions Appropriate application of and compliance with the safety instructions considerably contributes to the safety of the user of the patients and the environment 2 3 Safety of the equipment and instruments The body jet eco complies with all relevant and generally accepted engineering practices as well as with the applicable occu pational protection and accident prevention regulations Page 2 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 2 Safety precautions and safety features 2 4 Safe practice by medical staff Working with medical equipment is basically associated with certain risks to medical staff and patients Risks cannot be entirely eliminated by design features alone Safety does not depend solely on the equipment but to a large extent on factors influenced by its user These factors are dealt with in the safety information of this chapter 2 5 Significance of the user m
9. 27 05 2014 User manual body jet eco Fin dd N i am NEW 4 N WE 9 human med Chapter 4 Preparatory activities The infiltration tube 1 of the Biofill applicator must lead upwards whereas the transfer tubes 2a and 2b for the fluid supply must lead downwards Fig 4 13 Z en ety N j J Now fix the sealing cap hand tight by slightly turning it clockwise Fig 4 14 NOTE The sealing cap must be fixed in a way that it cannot be taken off without turning it slightly counterclockwise Fig 4 14 Fix the sealing cap Human Med AG Doc No 900071 Page 4 11 User manual body jet eco Rev Date 0 27 05 2014 efes Chapter 4 Preparatory activities 9 human med 4 2 4 2 Connection of the Biofill applicator to the fluid bag Before venting the Biofill applicator must be connected to the fluid bag via the transfer tubes The fluid bag is to be attached to the hook on the rack In case fluid bottles or canisters are used these must be vented properly We recommend using fluid The weight of the fluid bag must not exceed 1000 g bags only Each transfer tube is equipped with a clamp a pricking pin and a protective cap Close one transfer tube 2a by means of the clamp Fig 4 15 but before remove the protection cap from its pricking pin The transfer tube may be fixed onto the rack using the retaining clip provided there for this purpose Fig 4 15 Close
10. AG Wilhelm Hennemann StraBe 9 19061 Schwerin Deutschland Phone 49 0 385 39570 0 Fax 49 0 385 3957010 Email into humanmed com Page 9 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco
11. The LED of the logo signals the current operating state of the device Human Med AG Doc No 900071 Page 3 3 User manual body jet eco Rev Date 0 27 05 2014 y f T N amg i Chapter 3 Description of the body jet eco e human med The logo is flashing The Biofill applicator has not been identified by the device control as valid applicator the water jet cannot be activated yet The logo lights up continuously The Biofill applicator has been identified as valid the water jet can be activated now 3 1 3 Functional elements of the suction unit There is one suction container attached to the body jet eco to house the disposable suction bag Fig 3 4 and Fig 3 5 The suction bag is inserted into the suction container and is used for collection of the excessive aspirate 1 Suction bag with lid 2 Suction container 3 Vacuum tube with overflow bacteria barrier and vacuum elbow connector 4 Plug in coupling connector 5 Suction port Fig 3 4 Suction unit Page 3 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco TR e human med Chapter 3 Description of the body jet eco Vacuum elbow connector Angle connector Connection port PATIENT O Oo N Oo Closing cap 10 Grip of the suction bag Fig 3 5 Suction unit The suction container 2 is to be connected to the suction port 5 of the device via a vacuum elbow connector 6 a vacuum tube with overflow
12. bacteria barrier 3 and a plug in coupling connector 4 The vacuum tube with overflow bacteria barrier the plug in coupling connector and the vacuum elbow connector are included in the scope of supply of the device by Serres Oy Art Nr 57157 is used The suction container is intended for exclusive use with a suction bag A trouble free suctioning can only be guaranteed when a 1000 ml suction bag with angle connector made Never connect a suction tube directly to the suction port 5 The connection port 8 for the suction tube of the Biofill applicator is marked PATIENT The vacuum tube with overflow bacteria barrier Fig 3 6 is connected to the suction port 5 of the body jet eco by means of a plug in coupling connector Human Med AG Doc No 900071 Page 3 5 User manual body jet eco Rev Date 0 27 05 2014 oes e Chapter 3 Description of the body jet eco 9 human med This symbol signifies that the following number is the batch code of the product This symbol indicates the maximum date until which the product may be used Fig 3 6 Overflow bacteria barrier Never use the body jet eco without overflow bacteria barrier The proper functioning of the overflow bacteria barrier must be checked on each surgery treatment day see Chapter 4 2 2 Preparation of the suction unit on page 4 6 In case of improper function replace the overflow bacteria barrier A A Page 3 6 Doc No 9000
13. components e g fuses represent corrective maintenance They must not impair the safety of the device and its accessories for the patient user and the environment This requirement is deemed to be met if changes to the structural and functional characteristics are not detrimental to safety 9 1 4 Periodic maintenance Maintenance is specified to be carried out every 12 months If this annual maintenance is missed errors and failures may occur presenting a source of potential hazards The annual maintenance includes the inspection of the safety relevant features of the device 9 2 Warranty The device and components must be checked for defects and transport damage immediately after receipt Damages in this regard can only be claimed if the seller or the carrier is notified without delay damage report must be drawn up Human Med grants their customers a warranty for supplied devices in accordance with the company s General Terms and Conditions starting from the date of delivery and initial instruction A warranty over and above these conditions requires the conclusion of a warranty contract For this contact the seller of the device The warranty covers any work that may be carried out in case of complaints regarding the function of the device provided that it is clearly verified that these have been caused by the manufacturer No warranty will be assumed for any faults resulting from wear and tear in use improper use and unauthorized inte
14. date of manufacture of the device This symbol signifies that the device must be separately disposed of at the end of its service life in accordance with the Council Directive 2002 96 EC of 27 January 2003 on waste of electrical and electronic equipment WEEE The device can also be returned to Human Med for proper disposal Lx E 0482 This symbol signifies that the device is in conformity to the specifications of the Council Directive 93 42 EEC for medical products and the manufacturer works with a quality assurance system monitored by the Notified Body no 0482 n There is another label directly right next to the socket of the infiltration pump This symbol means that the device is equipped with an applied part of type BF Biofill applicator and complies with the requirements of standard IEC 60601 1 relating on protection The device must not be transported outside the OP area with fluid bags still attached The rack and the supporting arm for the FillerCollector must be removed before A Page 3 8 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 3 Description of the body jet eco 3 2 Description of the Biofill applicator and the Biofill cannula The Biofill applicator Fig 3 9 is delivered in sterile condition EO sterilization Faulty Biofill applicators must not be used a resterilization is not allowed The Biofill applicator is an applied part of type
15. eee ee ee ees 15 4 2 6 Connection of the FillerCollecto ee eee cece ee sce ee eee ee eee eee 15 Human Med AG Doc N0 900071 Paged User manual body jet eco Rev Date 0 27 05 2014 0220o Chapter 4 Preparatory activities human med 4 Preparatory activities 4 1 Installation of the body jet eco 4 1 1 Ambient conditions No operation in explosion hazard zones Only use the equipment in rooms used for medical purposes Do not operate the device in explosion hazard zones in which flammable anesthetics combustible skin cleaners or disinfectants are used Operating conditions lechnical Data on page 8 3 Exceeding the indicated tolerances may lead to breakdown of the Only operate the equipment at temperatures and air humidity conditions as specified in chapter 8 installed equipment Ventilation housing The installation in narrow alcoves is not allowed N The equipment must be placed in a way ensuring that air can freely circulate around the system Exposure to liquids The equipment housing is not entirely water tight Therefore be careful not to spill liquids around or on the equipment Do not install the device in direct proximity of hoses or bins containing liquid Page 4 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco Add human med Chapter 4 Preparatory activities Power cord and power outlet The supply voltage must be identical to the volta
16. its components e g including removable parts such as cord and foot bellows thoroughly for damage before use Do not use a damaged device or damaged components Check the guarantee seal between the housing cover and the device housing as well as the type label on the rear side of the device The device must not be used if any of the identification labels is damaged Connect the device to a properly installed grounded outlet Chapter 2 7 Prevention of electrical shock on page 2 4 Connect the foot bellows to the foot bellows port Switch the body jet eco on I O The master switch for switching on and off is situated at the rear of the device No 2 in Fig 3 2 in Chapter 3 1 1 Functional elements on page 3 3 4 2 OP preparations 4 2 1 Test of the overflow bacteria barrier Before using the suction unit of the body jet eco first check the functions of the overflow bacteria A barrier Human Med AG Doc No 900071 Page 4 5 User manual body jet eco Rev Date 0 27 05 2014 0220o Chapter 4 Preparatory activities 9 human med Attach the overflow bacteria barrier to the device The vacuum elbow connector 6 must have been attached to the suction container 2 the plug in coupling connector 4 must have been connected to the suction port 5 Activate the vacuum buildup by pushing the ON OFF button VACUUM The green lighting LED signifies that the vacuum generation is active Fig 4 2 Activ
17. sure that you are using the right cannula and that it is undamaged Do not use damaged cannulae Do not bend the Biofill cannula tube by more than 5 otherwise it might break A bent cannula must not be re straightened as this might cause the cannula tube to break Never use the Biofill applicator without Biofill cannula NOTE lf the Biofill applicator is replaced the quality of the spray jet must be tested again Page 5 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 09 20 e human med Chapter 5 Working with the body jet eco 5 4 During surgery After a prick incision the Biofill cannula is introduced into the adipose tissue through the skin opening By actuating the foot bellows the infiltration flow is started The generated water jet helps to gently detach the fat cells from the tissue The required suctioning is done by opening and closing the bypass hole in the handle of the Biofill cannula once the vacuum buildup has been activated Replacement of the fluid bag The fluid bag should never be emptied completely A When changing over the transfer tube to the new fluid bag take care that no air enters the tubing system in order to prevent a failure Otherwise repeat the venting procedure Chapter 4 2 5 Venting of the Biofill applicator on page 4 15 Removal and replacement of the suction bag In the event that a suction bag is completely filled during the surgery
18. 71 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco o e human med Chapter 3 Description of the body jet eco 3 1 4 Device label meaning of device label symbols and other symbols Fig 3 7 Device label Fig 3 8 Fuse label The device label Fig 3 7 is to be found on the rear side of the device It carries technical information and symbols that must not be ignored by any user of the device The fuse label Fig 3 8 is placed directly on the device plug where the fuses are installed The label indicates the fuse parameters The meaning of the symbols is explained in the following This symbol signifies that the device is equipped with a laser system that emits potentially hazardous radiation This label indicates that the integrated laser system is a laser equipment of class 2 This means that the available laser radiation is still within the visible spectrum 400 nm to 700 nm and not dangerous to the eyes provided that the time of exposure to radiation does not exceed 0 25 s eyelid reflex Nevertheless avoid looking directly into the laser beam O This symbol signifies that the user manual and other relevant instructions must be read and followed Human Med AG Doc No 900071 Page 3 7 User manual body jet eco Rev Date 0 27 05 2014 Chapter 3 Description of the body jet eco 9 human med This symbol signifies that sitting on the device is forbidden This symbol refers to the
19. 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz d 1 2 VP d 1 2 VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 27 100 12 12 23 For transmitters rated at a minimum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Page 8 6 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e human med Chapter 9 Maintenance warranty disposal and customer service Gontents 9 Maintenance warranty disposal and customer SEPVICE 1ccceccceesceeseeeeeeeeseeeseeeneeeneeeeseeeaseoeseeeaseeaseonseeeaeeonseoeseoeaesenseoeseneaeees 2 gt a aa gt gt u r rc aea abooaoaoaoDoMDaoaa gt b5555P55kkkx22x p pp ppp o gt p op op owrwrwory r n gt eb beo bbbbbbbbbbbbbbbkbkbb b b w prk 2 9 1 1 bazaar llllllrererererb rrr rer oeoe _ _o v gt Bexg eyer pe hoaZmWMP gt D N NDIM2 2 9 1 2 Functionality tests and inspection of safety relevant features
20. 850 mbar be replaced 500 m min 800 mbar Fig 4 11 Maximum vacuum depending on altitude Human Med AG Doc No 900071 Page 4 9 User manual body jet eco Rev Date 0 27 05 2014 0220o Chapter 4 Preparatory activities 9 human med 4 2 4 Connection of the Biofill applicator 4 2 4 1 Installation of the infiltration pump Take the Biofill applicator from the sterile packaging Use only Biofill applicators from undamaged packaging Take care to leave the hand piece of the Biofill applicator in the sterile area and hand the connection parts over to the operator of the device This medical product is exclusively intended for single use Remove the sealing cap from the infiltration pump socket by turning it counterclockwise Push the infiltration pump into the socket Fig 4 12 As soon as the used applicator has been identified by the barcode scanner as valid Biofill applicator the water jet generation is active The logo LED stops flashing and changes to a continuous illumination lf the logo LED continues flashing refer to chapter 6 2 Applicator coding on page 6 5 NOTE Fig 4 12 Push the infiltration pump into the socket The period in which the water jet generation is active is limited to two hours Never look directly into the infiltration pump socket The barcode scanner remains active until the Biofill applicator has been identified Page 4 10 Doc No 900071 Human Med AG Rev Date 0
21. A DUNI WOO te ET aa Ren 5 z rd ae eSeosXXD rrr ggoo meee e epey zrarTr aiozoa2oxxxnna 7 Human Med AG Doc No 900071 Page 5 1 User manual body jet eco Rev Date 0 27 05 2014 Chapter 5 Working with the body jet eco 9 human med 5 Working with the body jet eco 5 1 Activation of the water jet By pushing the ON OFF button FLOW the water jet will be set ready for operation The blinking LED of the ON OFF button indicates that the water jet is ready for operation By pushing this button again the water jet is no longer ready for operation The water jet is activated by actuation of the foot bellows When actuating the foot bellows the LED of the ON OFF button FLOW is green 5 2 Activation of the vacuum buildup The vacuum required for suctioning is preset to the value of 500 mbar By pushing the ON OFF button VACUUM the vacuum buildup is activated The blinking LED of the ON OFF button confirms the activation By pushing this button again the vacuum buildup will be deactivated 5 2 1 Display of the actual vacuum level The actual vacuum level is displayed as a LED light bar 200 mbar LED 1 300 mbar LEDs 1 to 2 400 mbar LEDs 1 to 3 500 mbar LEDs 1 to 4 Page 5 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco oe Fe e human med Chapter 5 Working with the body jet eco FOR 600 mbar LEDs 1 to 5 The orange lighting LED indicates that an vac
22. BF and intended for single use only Please observe the information given in the package leaflet 3 2 1 Elements of the sterile single use Biofill applicator A Hand piece with nozzle capillary tube is used for introduction of the infiltration fluid into the body area concerned and for transport of adipose tissue B Pricking pin with protection cap is used for connection of the transfer tubing set to the fluid bag C Tube clamp of the transfer tubing set is used interrupting the fluid supply into the Biofill applicator by closing if required D Transfer tubing set with two transfer tubes is used for transport of the infiltration fluid from the fluid bag to the infiltration pump E Tube socket Is used for attachment of the suction tube F to the suction bag or to the FillerCollector Fig 3 9 Biofill applicator F Suction tube Is used for connection of the hand piece with the suction bag or the FillerCollector and for transport of the aspirate either into the suction container or into the collection container of the FillerCollector Human Med AG Doc No 900071 Page 3 9 User manual body jet eco Rev Date 0 27 05 2014 Chapter 3 Description of the body jet eco 9 human med G Infiltration pump with piston Is used for generation of the water jet pressure needed H Infiltration tube Is used for transport of the pressurized infiltration fluid from the infiltration pump G to the hand piece A of the
23. Biofill applicator 3 2 2 Instructions for the use of the Biofill cannula The Biofill cannulae Fig 3 are normally delivered unsterile and must be thoroughly cleaned and sterilized before use according to the accompanying processing instructions Detailed instructions on cleaning disinfection and sterilization of the Biofill cannulae can be found in the leaflets included in the packaging The Biofill cannulae are used for infiltration of the tumescent fluid as well as for aspiration of the adipose tissue The Biofill cannulae have several suction openings and one bypass hole in their handle By closing this bypass hole the suctioning is started by opening it the suctioning is stopped Biofill cannula K Bypass hole Fig 3 10 Biofill cannula for use with the Biofill applicator Page 3 10 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 4 Preparatory activities Contents 4 ni ya ya ie LD Drrr gt gt eerrr e rr rrrrrrrrree mmmmmr e rea 2 4 1 Installation of the body jet eco iidkk aka keke kak k ak renerne KK KK KK KK KAR 2 A AMDO COMO IONS tree rept sera _ _cB mYDODBBBiIiI mE KER a ete eee mere nema mnn mnn nnn mne 2 4 1 2 Installation of the body je CCO ccecccsecsesecsessesessessesessessacesseesacessavaccessusacsessusacsesusansasusaseeseusassaseesassiseusaeseseutissitestissisentnsesentes 3 4 1 3 Components device combination
24. and operating elements of the body jet eco 3 1 1 Functional elements 1 Rack with hook for the fluid bag 2 Control panel for device operation 3 Supporting arm for FillerCollector optional to secure the collection container against tipping over and to keep a defined distance towards the device 4 Suction container including suction bag with angle connector 5 Connection port for foot bellows used to activate the water jet 6 Eject button to unlock the infiltration pump for removal 7 Sealing cap to keep the infiltration pump in the socket and seal the socket Fig 3 1 body jet eco front view Page 3 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 3 Description of the body jet eco 1 Rack holder 2 Master switch including fuse to switch the device on and off e 0 The device is switched off e The device is switched on 3 Potential equalizing plug 4 Power connection with integrated mains fuse for power plug and cord to supply the device with electrical power Fig 3 2 body jet eco rear view 3 1 2 Control elements for device operation 1 Display of the operational state of the device human med logo 2 LED light bar indicates the actual vacuum 3 ON OFF button VACUUM to activate deactivate the vacuum buildup 4 ON OFF button FLOW to activate deactivate the water jet Fig 3 3 Control elements of the body jet eco
25. anual and training of medical staff The user manual represents an important element in the safety design concept of the body jet eco Therefore every medical professional who Is concerned with gt preparation setup operation disassembly cleaning and disinfection of the device and instruments must read the user manual and the instructions for use of the instruments This user manual is an inherent part of the device Every user must be familiar with the instructions included herein Keep these instructions in the manual Keep this manual in a safe but easily accessible place so that it is available to users at all times The users operators normally qualified medical staff must have experience in clinical use of this device and its accessories and must acquire sufficient knowledge of the device by means of literature or test runs prior to use Only qualified medical staff who has been properly trained in operation and handling of this equipment is allowed to use the body jet eco in strict adherence to the present user manual The training must be performed only by personnel who are suitable on the basis of their knowledge and practical experience Human Med assumes no liability for any damage resulting from using the device without instruction or through improper use In case of any uncertainty or question please contact Human Med We will be glad to give you further assistance and to receive your suggestions concerning this use
26. aratory activities 9 human med A supporting arm Fig 4 21 to which the FillerCollector is attached ensures that the collection container is stable and cannot tip over Furthermore it helps to keep a defined distance between the sterile collection container and the device Fig 4 21 Holding arm for the FillerCollector The supporting arm is just pushed into the fixture provided for this on the device housing Fig 4 22 Fig 4 22 Holding arm for FillerCollector Page 4 16 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e human med Chapter 5 Working with the body jet eco Contents 5 Working with the body jet eco ssesererererer eneret Ek ER EL ELEL ERR REEL ERE anak AKAR AK AK AK AK HK AK AK AK HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA HA 2 Sale ACN ORO INS D SO tt Z r er rarararararararararararraararerarer rrr KM Mn 2 5 2 Activation of the VACUUM buildup iu kak kK kek kK k KAK K KA k KA KA kk KK k KK KK AK kK KK KK kk K kk KK kk k kK kk KK kk KK kK KK KK A 2 5 2 1 Display of the actual vacuum level u uu L uL ELLE anak EEE EEE AKA aka KA KE a Kak aka Ka Haa a kak aka aka a ka a aka ka ka a ka kk kk ka a kk kk kk ke 2 S20 Dlsan al l EP wille N N Waer Dazono nmr_ _cnbnbnrn _ _ a 7 r mm 3 I
27. ated ON OFF button VACUUM If two LEDs of the light bar are illuminated the overflow bacteria barrier may be blocked Replace the filter produced by Medela AG Ref No 077 0572 or the hydrophobic filter set REF No 101947 see current product Fig 4 3 LED light bar for display of the vacuum level list Page 4 6 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 9 human med Chapter 4 Preparatory activities 4 2 2 Preparation of the suction unit Unfold the suction bag Fig 4 5 Fig 4 4 Unfold the suction bag Insert the suction bag into the suction container and firmly push down the lid of the suction container so that it fits tightly for proper sealing Connect the vacuum tube with overflow bacteria barrier to the suction container by means of the vacuum elbow connector Fig 4 6 Suction container incl suction bag and vacuum tube with overflow bacteria barrier Human Med AG Doc No 900071 Page 4 7 User manual body jet eco Rev Date 0 27 05 2014 Chapter 4 Preparatory activities 9 human med Attach the suction container to the device Connect the vacuum tubing with overflow bacteria barrier to the suction port Fig 4 7 Now the suction bag must be completely unfolded under vacuum pressure For this close the angle connector 7 with your finger Fig 4 8 If the suction bag is not unfolded yet at once take your finger off from the angle conn
28. ation of the infiltration pump on page 4 11 gt The sealing cap must not be removable without turning it counterclockwise The fluid bag has not been connected gt Prick the pricking pin of the transfer tubing into the fluid bag Chapter 4 2 4 2 Connection of the Biofill applicator to the fluid bag on page 4 12 The clamp of the transfer tubing is not gt Check the clamp and open if necessary open gt Check the transfer tube leading to the fluid bag The transfer tubing has not been gt Check the connection routine for the Biofill applicator vented properly Chapter 4 2 4 2 Connection of the Biofill applicator to the fluid bag on page 4 12 et sqq The Biofill applicator is faulty Although all above mentioned items have been checked The infiltration pump is broken thoroughly there is no fluid coming out of the Biofill Other causes applicator after actuating the foot bellows for 60 sec gt Replace the Biofill applicator Chapter 5 5 OP end on page 5 7 et sqo Incorrect spot jet The Biofill applicator is blocked or gt After removal of the cannula check first whether the appli faulty cator produces a continuous straight spot jet Chapter 5 3 Attachment of a Biofill cannula and water jet test on page 5 3 Page 6 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e e 9 human med Chapter 6 Troubleshootin Possible cause of fault Possible cause of
29. cap from the socket of the infiltration pump Human Med AG Doc No 900071 Page 5 7 User manual body jet eco Rev Date 0 27 05 2014 09 20 Chapter 5 Working with the body jet eco 9 human med gt Push the EJECT button until the stop Keep it pressed and at the same time remove the infiltration pump from the socket Fig 5 6 p Fig 5 6 Removal of the infiltration pump gt Pull the transfer tube from the fluid bag gt Pull the suction tube from the suction bag gt Close the port PATIENT 8 with the closing cap 9 Fig 5 4 gt Remove the reusable Biofill cannula from the hand piece of the Biofill applicator and forward it to immediate reprocessing Follow the reprocessing instructions for WAL cannulae they are provided with each cannula delivered M Dispose of the Biofill applicator together with the suction tube gt Now remove the filled suction bag from the suction container holding it on the grip dispose of it A The Biofill applicator system may contain germs harmful to health The used Biofill applicator and the used suction bags must be disposed of in strict adherence to the legal hygiene regulations Used products must be disposed of in closed containers for infectious waste labelled as hazardous waste Details can be taken from the hygiene plan of the hospital concerned Page 5 8 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 09 20 e
30. e body jet CO 2 2 Er 2 3 1 Functions and operating elements of the Dody jet amp C0 2cs cs muuuuenenenenenene nen nen rr keke ka keka kaka rr kk k kK k kk kk renere nere 2 3 1 1 Functional elements ces saae eneenene ennen ennen keen enken e reen enken ken aa a a ka a ka a ka a ka aka ka ka ka aka k ka a kak kk kk ka ka a aa a k kk kk k kk ka a 2 D PR CONIFOFEeMenTs for GOV Ce oe OI aes cs eas E es DX DDDDK r r r lr rr br Nserzpann 3 3 1 3 Functional elements of the SUCTION Unit LELE KA EA keen KEK EA Kak aka kla aka Haa ka a ak a kak lk a ka a ka ka ka ka kk kk kk ka a 4 3 1 4 Device label meaning of device label symbols and other symbolS u LuuL ELLE EEE Eka KEK KAKE KA KAKA KAK KA KAKA K ka 7 3 2 Description of the Biofill applicator and the Biofill cannula ssssssssnenneeen kk tek t REE EE RENEE REE KK K k KAK KK KA KK KK kK KK kk 9 3 2 1 Elements of the sterile single use Biofill appliCatoOr ces LEL LELE ASA KE KE KEK a KA Kak aka aa aa ka a kak lk kk a kal aa 9 G22 INSWUGHONS TOL ING TUSE OF DION CANN zzo_ wWw_ y_w w w99 gt 22D2D22D gma 10 Human Med AG Hx Doc N0 900071 00000000 Page 3 1 User manual body jet eco Rev Date 0 27 05 2014 o Chapter 3 Description of the body jet eco 9 human med 3 Description of the body jet eco 3 1 Functions
31. ector for a moment and then close it again Repeat this procedure until the suction bag has been completely unfolded and lies against the inner surface of the suction container m i a Fig 4 8 Insertion of the suction bag Prior to use the suction container und the suction bag must always be checked for cracks and other damage Either a damaged container or a damaged bag must not be used Page 4 8 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 9 human med Chapter 4 Preparatory activities 4 2 3 Vacuum check Make sure by closing the angle connector 7 of the suction bag with your finger that the required vacuum has been built up and the bag is completely unfolded Fig 4 9 Fig 4 9 Close the angle connector of the suction bag Keep the angle connector K closed with your finger until the final vacuum level has been reached When the final vacuum level has been reached four LEDs of the light bar should be illuminated Fig 4 10 Fig 4 10 LED light bar for display of the vacuum level If this level is not reached read in chapter 6 1 Faults of suctioning and water jet generation on page 6 2 Please take also account of 800 m min Z mbar the altitude when checking the final vacuum level Fig 4 11 2000 m min 650 mbar When the angle connector 7 is open no more than two LEDs of the light bar should be illuminated otherwise the suction bag must 0 m min
32. ed to the hook Fig 7 1 Prior to transport the rack must be removed There must be no filled suction bag in the suction container Fig 7 1 Warning label for transport NOTE Information on the ambient conditions for transport and storage are included in chapter 8 Technical data on page 8 3 Human Med AG Doc No 900071 Page 7 5 User manual body jet eco Rev Date 0 27 05 2014 f T N deh Chapter 7 Cleaning disinfection transport and storage after OP eo Human med Page 7 6 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e e human med Chapter 8 Technical data Gontents 8 ij nal td DH NM DD EEC 2 8 1 General data of the body jet CO kk kk keke kk eka kek k LEE e keka r k kek k k kalak ekr kk ERE LER KK rk kk lk rk Ka kek ek rk rk kk EEEE EEEE arnas 2 8 2 Manufacturer s declaration on electromagnetic compatibility L Lu uk k k K k KEK KK k KK KK k k KK K A KK KK KK KA 3 8 2 1 Guidance and manufacturer s declaration Electromagnetic emi SS ONnS u LELLE ELE LELE EEE EEE EEE EEE KEKE KA KEK KAK KAK KAK KAK kK ka kk a kK ka a kk a ka 3 8 2 2 Guidance and manufacturer s declaration Electromagnetic immunity 2 LELE LELE Eka EEE EEE KAKA KAKA KA KA a KAK kK ka Ka a kk a ka a kk a ka 4 8 2 3 Recommended separation distances between portable and mobile RF communications equipment and the body jet
33. eebody jet eco User Manual ln this world there is nothing softer and thinner than water But to compel the hard and unyielding it has no equal Laozi e human med 0220o human med C o ISO 13485 User manual for body jet eco Item no 500000 8 All rights to these operating instructions are reserved in particular the rights of reproduction distribution and translation No part of these operating instructions may be reproduced in any form whatsoever photocopy microfilm or any other process or processed reproduced or distributed using electronic systems without the prior written permission of Human Med The information included in these operating instructions may be amended or supplemented without prior notification and does not represent any obligation on the part of Human Med Printed by Human Med AG Printed in Germany Copyright Human Med AG Wilhelm Hennemann StraBe 9 19061 Schwerin Germany 2014 Human Med AG Doc No 900071 User manual body jet eco Rev Date 0 27 05 2014 human med Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e human med 1 1 1 1 2 2 2 1 PAR 2 3 2 4 259 2 6 Cd 2 8 3 3 1 3 1 17 3 1 2 3 7 3 3 1 4 3 2 3 2 17 3 2 2 Human Med AG General description of the body jet eco Medical indication Contraindications Safety precautions and safety features Signif
34. et uses kK KK KK Kl KK KK kk KK kK kK KK KK A kK KK KK 2 2 2 Adherence to the safety iINStrUCtIONS sists wesirexerw sxe vewwannweveniseneerne werd kk kak ak KK KK Ak K k K KK kK A REEL KK KK kK kk kk KK kK A kK KK k kk KK kK kk kK KK kk 2 2 3 Safety of the equipment and instruments i kk kK KEK K kK k KK K KAK KA KK KAKA KEK KK KA k KK kK KK k KK kK KK kK KK KK A KK 2 24 Sal pracice Dy medical Staff se runestene keyay keleya k ye bek k ye a yeke keka keka yatayekeyekayek TANEN keysa r Eare kelayek keka yek ye bayek keka vats k la y ke kelka yek ke Nay ek 3 2 5 Significance of the user manual and training of medical staff ec eccceeeceeeeeeeeeeeseeeeseeeeseeeesaeeeseeeeseeeeaeeeseeeeseeesseeeeseeeeaeeesseeeeas 3 2 6 Electrical safety and electromagnetic compatibility cc ecccceececeeeeseeeeneeeeseeeeeeeeeseeeeseeeeseeeeseeeesaeeeseeeeseeeseeeeseeesaeeesseeeseeeesaeeeeas 4 2 71 Prevention of electrical ShOCK rer cretacasnnw ance snaneanniaevexnssuatosamaanwacenanstnammunanavannssuemaantganusunesuanaeatd snwaneren esa KK KK A kk KK kk KK kK A kk kk kK kK A kK KK kk KK kK kk 4 2 8 Particular safety instructions for use of the body jet CO lkkakk ener eke keka kaka kak renen k kaka k kk kk kk kk kk KA 5 Human Med AG Doc No 900071 Page 2 1 User manual body jet eco Rev Date 0 27 05 2014 Chapter
35. fault of fault Instruction forfaultclearance for fault clearance gt Replace the Biofill applicator if the water jet is incorrect Chapter 5 5 OP end on page 5 7 et sqq Spray jet is not The Biofill applicator is faulty gt Replace the Biofill applicator Chapter 5 5 OP end on fan shaped page 5 7 et sqq Liquid underneath The Biofill applicator is faulty gt Replace the Biofill applicator Chapter 5 5 OP end on the device page 5 7 et sqq 6 2 Applicator coding The infiltration pump of the Biofill applicator for the body jet eco is equipped with a barcode label This will to a great extent prevent the use of unauthorized products and the reuse of Biofill applicators designed as disposables The Biofill applicator can be used for infiltration over the next two hours after scanning of the barcode label and release of the device for operation Afterwards the water jet generation will be disabled the suctioning continues to be active In the event that the used Biofill applicator is not identified by the device control as valid Biofill applicator the water jet cannot be activated In such a case replace the Biofill applicator After a short break of the power supply max 5 minutes you can continue using the Biofill applicator In the event that no red laser beam is visible in the socket of the infiltration pump after starting the device Do not look directly into the laser beam please contact the res
36. fore starting with cleaning and disinfection by pulling the power plug Dispose of the used Biofill applicator and the suction bag A The Biofill Applicator system may contain germs harmful to health The used Biofill applicator and suction bags must be disposed of in strict adherence to the legal hygiene regulations Used products must be disposed of in closed containers for infectious waste labeled as hazardous waste Details can be taken from the hygiene plan of the hospital concerned 7 1 2 Cleaning and disinfection The body jet eco and the associated components must be thoroughly cleaned before reuse Do not use cleaning agents containing solvents for cleaning and disinfection Moisture must not penetrate the equipment Let any liquid entered immediately drain off The device is only to be used again when the liquid has evaporated completely Page 7 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 7 Cleaning disinfection transport and storage after OP For cleaning and disinfection of the surfaces of the device we recommend wiping it with disinfectant Only use disinfectants that conform to the national standards Dilute the disinfectant in a concentration as specified by the manufacturer We recommend using the Bacillol Plus solution trade name Bacillol AF Clean blood contaminated surfaces with warm water before using the disinfectant otherwise it may be les
37. ge indicated on the type label on the rear side of the body jet eco Connect the device to a grounded outlet Only use the power cord supplied with the device Run the power cord from the device to the outlet in a way that hazardous situations e g tripping are eliminated For safety reasons do not use any extension leads or power distribution units Do not connect the device to the power supply neither use it if it is in defective conditions that cannot be properly remedied in a professional manner 4 1 2 Installation of the body jet eco To ensure its stability place the body jet eco on a suitable equipment table approved for surgeries For thermal reasons and adequate display legibility the device must not be exposed to direct sunlight Always keep a safety distance of at least 1 m between the device and the sterile areas particularly the instrument tables operating tables and staff in sterile garment In order to place the FillerCollector in a stable and safe manner and to keep a defined distance between the sterile collection container and the device we recommend using the supporting arm Never mount the FillerCollector directly onto the device only by means of the supporting arm Do not lean on the supporting arm Human Med AG Doc No 900071 Page 4 3 User manual body jet eco Rev Date 0 27 05 2014 0220o Chapter 4 Preparatory activities 9 human med 4 1 3 Components device combination user manual
38. human med Chapter 6 Troubleshooting Contents DD ERE ON ES EE A E eee 2 6 1 Faults of suctioning and water jet generation W ssssssssssekee eee kk k k NERE REEL E ERE REE REE ERE kK kK REE kK KK A kk KK KK kK ERR ES 2 02 APILA CONO eee E 6 SE 5 Human Med AG Doc No 900071 Page 6 1 User manual body jet eco Rev Date 0 27 05 2014 Chapter 6 Troubleshootin 9 human med 6 Troubleshooting The list below is provided to help users in localizing and if possible eliminating causes of functional faults as well as to enable them to give more detailed information to the technical service of Human Med 6 1 Faults of suctioning and water jet generation Possible cause of fault Instruction for fault clearance Lack of vacuum The ON OFF button VACUUM has not gt Push the ON OFF button VACUUM the LED of the button been pushed must light up green The suction bag has not been inserted gt Check the suction bag and the suction tube correctly or the suction tube has not gt Check the seals for cracks perishing and leakage been attached correctly Chapter 4 2 2 Preparation of the suction unit on page 4 6 No only weak The Biofill cannula is blocked gt Detach the Biofill cannula and loose the aspirate blockage suctioning with The light bar indicates a vacuum cannula The suction bag has not been inserted gt Check the suction bag and the suction tube correct if correctly or the suction t
39. icance of the safety symbols Adherence to the safety instructions Safety of the equipment and instruments Safe practice by medical staff significance of the user manual and training of medical staff Electrical safety and electromagnetic compatibility Prevention of electrical shock Particular safety instructions for use of the body jet eco Description of the body jet eco Functions and operating elements of the body jet eco Functional elements Control elements for device operation Functional elements of the suction unit Device label meaning of device label symbols and other symbols Description of the Biofill applicator and the Biofill cannula Elements of the sterile single use Biofill applicator Instructions for the use of the Biofill cannula Doc No 900071 User manual body jet eco Rev Date 0 27 05 2014 Table of contents 1 2 1 2 1 2 2 2 2 2 2 2 2 2 2 3 2 3 2 4 2 4 2 5 3 2 3 2 3 2 3 3 3 4 4 1 4 1 1 4 1 2 4 1 3 4 1 4 4 2 4 2 1 4 2 2 4 2 3 4 2 4 4 2 4 1 4 2 4 2 4 2 4 3 4 2 5 4 2 6 ST 9 2 5 2 1 9 3 Table of contents Preparatory activities Installation of the body jet eco Ambient conditions Installation of the body je eco Components device combination Preparations for use OP preparations Test of the overflow bacteria barrier Preparation of the suction unit Vacuum check Connection of the Biofill applicator Installation of the infiltratio
40. ly designed for reconstructive surgery applications in hospitals as well as in dermatology clinics e g for autologous fat harvesting for soft tissue corrections and wrinkle smoothing The body jet eco generates a gentle pulsating water jet that helps to detach the fat cells from the surrounding tissue and aspirates the detached fat cells With this method the fat cells are not damaged so that the harvested fat can be used for autologous fat grafting in aesthetic plastic surgery applications As protection for the patient the body jet eco features a system function precluding the reuse of the Biofill applicators and the use of Biofill applicator copies 1 1 Medical indication The body jet eco is intended to be used for harvesting natural body fat for autologous fat grafting and lipofilling 1 2 Contraindications The body jet eco and the instruments to be connected are not approved for intra cardiac application The body jet eco must not be used in patients with severe coagulation disorders Page 1 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco e human med Chapter 2 Safety precautions and safety features Contents 2 Safety precautions and safety features cccceseceeseeeeseeeeseeeeneeeeneeeeneeeeseeoeseeoenseoeseeoeseeoeseeoegseoesseoesseoeseeoesseoeseeoesseoesesoesseeassoesees 2 2 1 Significance of the safety syMDOIS wigs cet au cige cat uk kK k KK K KK K KK AK KK K c
41. mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the body jet eco is used exceeds the applicable RF compliance level above the body jet should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the body jet eco P Over the frequency range 150 KHz to 80 MHz field strengths should be less than U1 V m a Human Med AG Doc No 900071 Page 8 5 User manual body jet eco Rev Date 0 27 05 2014 Kapitel 8 Technical data human med 8 2 3 Recommended separation distances between portable and mobile RF communications equipment and the body jet eco The body jet eco is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the body jet eco can help to prevent electromagnetic interference PY maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the body jet eco as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz
42. n pump Connection of the Biofill applicator to the fluid bag Connection of the suction tube of the Biofill applicator Venting of the Biofill applicator Connection of the FillerCollector Working with the body jet eco Activation of the water jet Activation of the vacuum buildup Display of the actual vacuum level Attachment of a Biofill cannula and water jet test Doc No 900071 Rev Date 0 27 05 2014 human med 4 2 4 2 4 2 4 3 4 4 4 5 4 5 4 5 4 7 4 9 4 10 4 10 4 12 4 14 4 15 4 15 5 2 5 2 5 2 5 2 5 3 Human Med AG User manual body jet eco e human med 5 4 9 0 6 6 1 6 2 r 7 1 7 1 1 W DA 7 1 3 7 2 8 1 8 2 8 2 1 8 2 2 8 2 3 9 9 1 9 1 1 Human Med AG During surgery After surgery Troubleshooting Faults of suctioning and water jet generation Applicator coding Cleaning disinfection transport and storage after OP Cleaning and disinfection after OP Before cleaning and disinfection Cleaning and disinfection After cleaning and disinfection Storage and transport Technische Daten General data of the body jet eco Manufacturer s declaration on electromagnetic compatibility Guidance and manufacturer s declaration Electromagnetic emissions Guidance and manufacturer s declaration Electromagnetic immunity Recommended separation distances between portable and mobile RF communications equipment and the body je eco Maintenance
43. n safety and that of your patients never attempt to repair by yourself Any modification to the equipment will exempt Human Med from liability gt gt gt Page 2 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 09 20 e human med Chapter 2 Safety precautions and safety features 2 8 Particular safety instructions for use of the body jet eco The following instructions must be strictly observed gt The direct water jet may be dangerous due to a possible cutting effect depending on the pressure settings and eyes and skin might be injured 2 Every medical professional operating the device must previously be instructed and acquainted with operational parameters gt The Biofill Applicator and the used Biofill cannula must not be directed towards the eyes When working with the device the foot bellows have to be secured against unintentional actuation When attaching the cannula handle take care that the water jet is only directed towards the operating field Operational safety The device must be installed and initially put into operation only by qualified staff that has been trained by Human Med or their authorized representatives on how to put into operation and install the necessary components as well as how to connect the accessories required for medical application The device is only to be used after gt delivery and ready to operate installation of the device by the service
44. no closer to any part of the body jet eco including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Page 8 4 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco eW e human med Chapter 8 Technical data Immunity tests IEC 60601 Test level Compliance level Electromagnetic environment Guidance Radiated RF interferences acc to IEC 3 V m 3 V m Recommended separation distance 61000 4 3 80 MHz 2 5 GHz d 1 2 VP d 1 2 VP for 80 MHz to 800 MHz d 2 3 VP for 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C Note 1 Ur is the AC mains voltage prior to application of the test level Note 2 At 80 MHz and 800 MHz the higher frequency range applies Note 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land
45. ponsible technical service Human Med AG Doc No 900071 Page 6 5 User manual body jet eco Rev Date 0 27 05 2014 g 0220o Chapter 6 Troubleshooting e human med Page 6 6 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 0 human med Chapter 7 Cleaning disinfection transport and storage after OP Contents 7 Cleaning disinfection transport and storage after OP sesiscsciccsessnscrnesscsnascnacaveauxsnnnensnsaineneraqinensnscanasenneavenuntntnenensainavavacscvavencacnsnes 2 1 1 Giganing and disiniecion aner OP Laya s ee mien sn omer k leke y k l say K kk mse k leka ka Wek uk kb en k U ba b la bev k l KEN k ERE k eka K We ene bee w ee 2 Tote BPE GICANING Ada le K yy eres eee cere eee eee cee 2 V RN NC dena eke la ee aerzrzrzwo n el rv ao rj mm pp yz xx 2 dd HN nage nak welel la zelle zX gt DD gt x xkkj j jj h hhhhWwbkbb WT WT r r T r rTr Tr Dr rrrrD r rb bMb T r TM WMT T 4 Tes SOFAS ANG TANS tNDaeoe bb re me eset ase eee esos ese ae eee 5 Human Med AG Doc No 900071 Page 7 1 User manual body jet eco Rev Date 0 27 05 2014 Chapter 7 Cleaning disinfection transport and storage after OP human med 7 Cleaning disinfection transport and storage after OP 7 1 Cleaning and disinfection after OP 7 1 1 Before cleaning and disinfection Make sure that the device has been cut from power supply be
46. r manual Human Med AG Doc No 900071 Page 2 3 User manual body jet eco Rev Date 0 27 05 2014 09 20 Chapter 2 Safety precautions and safety features e human med 2 6 Electrical safety and electromagnetic compatibility The device must be connected to a grounded mains supply in accordance with the applicable national standards The body jet eco has been tested by an accredited laboratory for immunity to interference and for electromagnetic compatibility The test results are within the limits for medical electrical equipment as defined in standard IEC 60601 1 2 That means that this device is adequately immune to interference and cannot interfere with other devices provided that it has correctly been installed and works properly 2 7 Prevention of electrical shock The device complies with the requirements of standard IEC 60601 1 related to devices of protection class and devices with applied parts of type BF The supply voltage must be identical to the voltage stated on the type label on the rear side of the device Connect the device to a properly installed and grounded outlet Only use the power cord supplied with the device Check the device and the delivered accessories e g foot bellows cables suction container for damage prior to each use Do not use a damaged device a damaged cable or damaged accessories Replace defective accessories For spare parts or servicing please contact our customer service For your ow
47. rvals to ensure that the device is in technically and operationally safe condition We recommend carrying out an inspection of the safety relevant features every 12 months within the scope of maintenance In particular the following is checked and or tested Device and accessories are free of external damage User manual is available all labels and inscriptions are in right place and legible Protective earth conductor test according to standard IEC 60601 1 Leakage current test according to standard IEC 60601 1 Functional test of master switch control elements suctioning infiltration foot bellows barcode identification General condition of the drive unit and the unlocking mechanism Replacement of the overflow protection bacteria barrier The results of the above listed checks and tests are documented in a maintenance record that is handed out to the user after completion of the maintenance Page 9 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 09 20 l e human med Chapter 9 Maintenance warranty disposal and customer service endanger patients personnel or third parties the equipment must not be used until these deficiencies have been In case deficiencies are found during the functionality tests and inspection of safety relevant features that might properly remedied by technical staff 9 1 3 Modifications and replacement of components Modifications and the replacement of
48. rventions in the equipment as well as damage caused intentionally or by gross negligence Further claims particularly claims for damages are excluded Periodic maintenance must be performed to sustain the warranty We recommend concluding a maintenance contract Human Med AG Doc No 900071 Page 9 3 User manual body jet eco Rev Date 0 27 05 2014 Chapter 9 Maintenance warranty disposal and customer service human med Functionality tests and inspections of the safety relevant features modifications and the replacement of components must only be carried out by Human Med or by persons expressly authorized by Human Med In case unauthorized persons carry out modifications or replace device components claims under warranty become void 9 3 Disposal In all EC Member States the body jet eco must be separately disposed of at the end of its service life in accordance with the Council Directive 2002 96 EC of 27 January 2003 on waste electrical and electronic equipment WEEE In all other countries the device is to be disposed of according to the local national regulations It can also be returned to Human Med for proper disposal 9 4 Customer service Should you be interested in a maintenance contract please contact Human Med or an authorized distributor Do you have any questions concerning the equipment or instructions for use If so contact Human Med We will be glad to provide further assistance Postal address Human Med
49. s are covered with synthetic material the relative 8 kV 8 kV humidity should be at least 30 Air discharge Air discharge Electrical fast transient burst acc to IEC 2 KV for power 2 kV for power supply Mains power quality should be that of a typical 61000 4 4 supply lines lines commercial or hospital environment Surges acc to IEC 61000 4 5 1 kV output line to 1 kV output line to Mains power quality should be that of a typical output line output line commercial or hospital environment 2 kV output line to earth 2 kV output line to earth Voltage dips short interruptions and voltage lt 5 Uz for 1 2 cycle 00 U for 10 ms Mains power quality should be that of a typical variations on power supply input lines acc to commercial or hospital environment If the user of the IEC 61000 4 11 Wo re U Jer GIS WO Jes er hen ns body jet eco requires continued operation during power 70 Ur for 25 cycles 70 Ur for 500 ms mains interruptions it is recommended that the body jet eco be powered from an uninterruptible power lt 5 U for 5s 00 Ur for 5 s supply or a battery Magnetic fields at the supply frequency 3 A m 3 A m Power frequency magnetic fields should be at levels 50 60 Hz acc to IEC 61000 4 8 characteristic of a typical location in a typical commer cial or hospital environment Conducted RF interferences acc to IEC o Van 3V Portable and mobile RF communications equipment 61000 4 6 150 kHz 80 MHz should be used
50. s effective If infiltration solution saline is spilled onto the device or its components wipe it off immediately and thoroughly with a soft cloth and warm water Wipe the surfaces make sure that they are treated all over Observe the contact time of the disinfectant specified by the manufacturer body je eco Wipe the device with a soft cloth soaked in disinfectant Sealing cap of the infiltration pump socket Wipe the sealing cap of the infiltration pump socket with a soft cloth soaked in disinfectant If necessary also use a soft brush soaked in disinfectant Then fix the sealing cap to the socket again Foot bellows foot bellows tube and power cord Wipe the foot bellows the foot bellows tube and the power cord with a soft cloth soaked in disinfectant Suction container The suction container can be cleaned and disinfected by hand Optionally it can be washed at a temperature of 85 C in a washer disinfector and sterilized at a temperature of 121 C and a hold time of at least 15 minutes Only use cleaners that are approved by the producer for cleaning PC plastics Never use rinse agents because they cause stress cracks in the suction container and may shorten its service life Human Med AG Doc No 900071 Page 7 3 User manual body jet eco Rev Date 0 27 05 2014 Chapter 7 Cleaning disinfection transport and storage after OP human med The suction container has been successfully tested for a thirty time 30 reproces
51. se a new Biofill applicator further information in chapter 6 2 Applicator coding on page 6 5 The ON OFF button FLOW has been gt In all probability the fuse of the drive motor has been pushed and the foot bellows has been trioped because an incorrect applicator has been used actuated the LED of the ON OFF gt Contact the technical service button FLOW lights up continuously but there is no motor noise No water jet comes The foot bellows has not been out of the nozzle actuated No water jet comes out of the nozzle The foot bellows has not been connected gt Actuate the foot bellows the LED of the ON OFF button Flow must light up green gt Connect the foot bellows The ON OFF button FLOW has not gt Press the ON OFF button FLOW the LED must blink been pressed Chapter 4 2 5 Venting of the Biofill applicator on page 4 15 Human Med AG Doc No 900071 Page 6 3 User manual body jet eco Rev Date 0 27 05 2014 09 20 Chapter 6 Troubleshooting human med 9 human med Possible cause of fault Possible cause of fault of fault Instruction for fault clearance The infiltration pump has not been correctly inserted into the socket gt Repeat the installation routine Chapter 4 2 4 1 Installation of the infiltration pump on page 4 9 et sqq The sealing cap has not been properly gt Screw the sealing cap on as described in chapter 4 2 4 1 screwed on Install
52. sing using the above described automated reprocessing procedures including sterilization Further reprocessing cycles beyond this number or other reprocessing procedures are in the user s responsibility Do not use cleaning agents and disinfectants containing phenol for manual or automated cleaning A otherwise the container may be damaged Never use a damaged container it may impede the vacuum buildup 7 1 3 After cleaning and disinfection Roll up the power cord and the foot bellows tube and keep them close to the device Park the body jet eco at the place provided for storage Thoroughly check the device and its components e g removable parts such as power cord and foot bellows for damage before and after each use Replace defective equipment In case of damage to the device please contact the responsible technical service A Do not use a damaged device or damaged components For your own safety and that of your patients never attempt to repair by yourself Any modification will exempt Human Med from liability Human Med AG Doc No 900071 User manual body jet eco Page 7 4 Rev Date 0 27 05 2014 9 human med Chapter 7 Cleaning disinfection transport and storage after OP 7 2 Storage and transport The body jet eco must be transported by holding it on the recessed grips provided It must be stored standing on its feet The device must not be transported outside the OP area with fluid bags attach
53. team of Human Med or their authorized representatives gt completion of all safety measures outlined in this user manual 2 the user is fully conversant with mastering functional procedures and operation of the device in case of malfunctions Human Med AG Doc No 900071 Page 2 5 User manual body jet eco Rev Date 0 27 05 2014 Chapter 2 Safety precautions and safety features human med Every medical professional who operates the device is fully responsible for implementing all safety measures required to ensure that the patient the surgeon and all other attendees are not exposed to danger during operation of the device Before using the body jet eco each user must become fully conversant with the use of the water jet and the vacuum needed for suctioning by studying related literature or carrying out test runs Safety features Safe and reliable operation of the body jet eco is ensured by a series of built in safety features gt The device has been designed in a way that serious operating errors are excluded gt The vacuum level and the infiltration flow are limited owing to the design of the device and the Biofill applicator gt A barcode system helps to prevent the reuse of the Biofill applicators designed as single use products Page 2 6 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 3 Description of the body jet eco Contents 3 Description of th
54. the ON OFF button FLOW on the membrane keypad the water jet will be ready for operation The readiness for operation is indicated by the flashing LED Activate the water jet by actuating the foot bellows the LED lights up continuously The Biofill applicator is vented now and after a few seconds a straight spot jet should come out of the nozzle capillary Fig 4 20 Activated ON OFF button FLOW RD lf there is no straight spot jet coming out of the capillary the Biofill applicator doesn t work properly and must be replaced the water jet towards people A Take care to direct the water jet into a suitable container when venting the Biofill applicator Never direct 4 2 6 Connection of the FillerCollector We recommend using the FillerCollector Ref No 660000 for harvesting in an easy safe and efficient manner small adipose tissue volumes of up to 250 ml that may be used for autologous fat grafting immediately after liposuction with the body jet eco The FillerCollector is delivered as a set of several individual components This set consists of sterile single use and reusable components The reusable parts have to be cleaned and sterilized prior to use The cleaning sterilization procedure and the assembly are described in the current user manual and reprocessing instruction for the FillerCollector Human Med AG Doc No 900071 Page 4 15 User manual body jet eco Rev Date 0 27 05 2014 ofe Chapter 4 Prep
55. the transfer tube Page 4 12 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco human med Chapter 4 Preparatory activities Remove the protection cap from the pricking pin of the second transfer tube 2b and prick it into the fluid bag Fig 4 16 The clamp of this transfer tube 2b remains open Now open the tube clamp of the first transfer tube 2a in order to vent the tubing system Fig 4 17 As soon as the transfer tube 2a is completely filled with fluid reclamp it and put the protective cap on the pricking pin again Fig 4 17 Venting of the transfer tubing Human Med AG Doc No 900071 Page 4 13 User manual body jet eco Rev Date 0 27 05 2014 09 20 Chapter 4 Preparatory activities e human med If infiltration fluid is spilled onto the device or its components wipe it off immediately and thoroughly with a soft cloth and warm water 4 2 4 3 Connection of the suction tube of the Biofill applicator Push the socket of the suction tube E firmly onto the angle connector 7 of the suction bag Fig 4 18 Push the other end of the suction tube onto the hand piece of the Biofill applicator Fig 4 19 Fig 4 19 Attach the suction tube to the hand piece Page 4 14 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 0220o 9 human med Chapter 4 Preparatory activities 4 2 5 Venting of the Biofill applicator By pushing
56. ube has not necessary Chapter 4 2 2 Preparation of the suction unit been attached correctly on page 4 6 or Chapter 4 2 4 3 Connection of the suction The light bar indicates no vacuum tube of the Biofill applicator on page 4 14 Overflow bacteria barrier and hydro gt Check the proper functioning of the overflow protection phobic filter of the suction bag are bacteria barrier and the hydrophobic filter of the suction bag blocked Chapter 4 2 2 Preparation of the suction unit on page 4 The light bar indicates a vacuum level 6 Page 6 2 Doc No 900071 Human Med AG Rev Date 0 27 05 2014 User manual body jet eco 0220o 9 human med Chapter 6 Troubleshootin Possible cause of fault Instruction for fault clearance In the event these parts have contact with liquids they block immediately and don t let air pass anymore gt Replace the overflow protection bacteria barrier or the suction bag The water jet cannot The human med logo is blinking gt Install a new Biofill applicator Chapter 4 2 4 Connection of be activated The LED of the ON OFF button FLOW the Biofill applicator on page 4 9 is not illuminated gt Two hours after scanning the barcode label for identification The installed Biofill applicator has not of the Biofill applicator the water jet generation is been identified as valid applicator deactivated and is not operable any longer The suctioning continues to work gt U
57. uum buildup error has occurred The final vacuum level depends on the type of vacuum pump and the elevation above sea level chapter 8 Technical data on page 8 2 5 3 Attachment of a Biofill cannula and water jet test Before attaching the Biofill cannula check whether the Biofill applicator generates a continuous straight spot jet If the generated water jet doesn t show the described pattern the applicator must be replaced Never direct the water jet towards people AN Take care to direct the water jet into a suitable container when checking the Biofill applicator Then attach the selected Biofill cannula to the hand piece of the Biofill applicator Fig 5 1 RECOMMENDATION Treat the inside of the Biofill cannula handle with surgical silicone spray before pushing the cannula onto the hand piece of the Biofill applicator Fig 5 1 Attach the Biofill cannula to the hand piece of the Biofill applicator Human Med AG Doc No 900071 Page 5 3 User manual body jet eco Rev Date 0 27 05 2014 09 20 Chapter 5 Working with the body jet eco 9 human med The water jet coming out of the nozzle now should be flat and fan shaped Fig 5 2 NOTE The Biofill applicator must be used together with a Biofill cannula You cannot infiltrate when using a cannula from other product lines 4 Fig 5 2 Correct fan shaped spray jet Before attaching the cannula to the hand piece of the Biofill applicator make

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