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body-jet® User Manual

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1. human med body jet User Manual Human Med AG User Manual body jet Cover sheet Rev Date 10 13 08 2013 A T VRheinland WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 2003 R6 03 AND CAN CSA C22 2 No 601 1 Caution Federal law USA restricts this device to sale by or on the order of a physician C 0422 ISO 13485 under CMDCAS User Manual for body jet Art No 500000 1 All rights to these operating instructions are reserved in particular the rights of repro duction distribution and translation No part of these operating instructions must be reproduced in any form whatsoever photocopy microfilm or any other process or processed reproduced or distributed using electronic systems without the previous written permission of Human Med The information contained in these operating instructions may be amended or sup plemented without previous 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 2013 Human Med AG User Manual body jet Cover sheet Rev Date 10 13 08 2013 Human Med AG Doc No 900018 User manual for body jet Page 1 Rev Date 09 21 05 2012 Table of contents Table of contents Description of the body jet Safety information and measures
2. Fig 30 Each suction container A is to be connected to the suction port G on the respec tive side of the device by means of a vacuum hose with overflow protection bacterial filter D and elbow plug connectors E and F on both ends The vacuum hose with overflow protection bacterial filter and eloow plug connectors is included in the scope of supply Note The suction containers are exclusively intended for use with suction bags Proper suctioning of the body jet can only be guaranteed if 3000 ml suction bags with angle connectors produced by Serres Oy item no 5 187 are used Never connect the suction tube of the WAL Applicator to the suction port G CAUTION The connection port for the suction tube of the WAL Applicator is labeled with PATIENT Never operate the body jet without the overflow protection bacterial filter CAUTION VI 2 2 Insertion of the suction bag Each suction container should hold a suction bag When introducing the suction bag into the suction container proceed as follows 1 Unfold the suction bag and introduce it into the suction container see Fig 31 and 32 on next page Human Med AG Doc No 900018 User manual for body jet Page 6 4 Chapter VI Rev Date 09 21 05 2012 Fig 31 Unfold the suction bag Fig 32 Introduce the suction bag 2 Switch the vacuum pump on by pushing the Vacuum ON OFF key 3 Turn the vacuum change over switch 13
3. ATTENTION The use of an EPA registered hospital disinfectant with label claim of tuberculocidal activity is recommended Human Med tested a disinfectant with quaternary ammo nium compounds with alcohol and only alcohol based disinfectants without alde hyde 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 WARNING For cleaning and disinfection of the surfaces of the body jet and its accessories we recommend wiping them with disinfectant Only use disinfectants that conform to the national standards Dilute the disinfectant in a concentration as specified by the manufacturer Human Med AG Doc No 900018 User manual for body jet Page 7 2 Chapter VII Rev Date 09 21 05 2012 Glean blood contaminated surfaces with warm water before using the disinfectant otherwise it may be less effective When 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 jet 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 disin fectant lf n
4. fol lowed by a number code between 0 and 7 appears on the display The table below provides explanations for these error codes and the actions to be taken STOP 00 Triggered by actuation of the STOP button or by overload of the gear motor gt Check whether the WAL Applicator is blocked or faulty replace if necessary gt Otherwise contact the technical service STOP 01 Triggered by underload of the gear motor gt Check whether the transfer tubing is clamped open clamp if necessary gt Check whether air has been entered into the infiltration pump vent the applicator system if necessary see chapter VI 4 Venting of the WAL Applicator and attachment of the WAL cannulae gt Check whether the infiltration pump is well seated in its socket and cannot be removed after unscrewing the sealing cap solely after pushing the EJECT key repeat the installation pro cedure if necessary see chapter VI 1 Installation of the in filtration pump gt Otherwise contact the technical service STOP 02 Triggered due to non compatibility of a pre defined software parame ter to the actual value gt Contact the technical service Human Med AG Doc No 900018 User manual for body jet Page 8 5 Chapter VIII Rev Date 09 21 05 2012 STOP 03 Triggered due to non compatibility of a pre defined software parame ter to the actual value gt Contact the technical service STOP 04 Triggered due to non compatib
5. lI 1 Se eS he lh 11 10 1 11 Intended use Contraindications Safety notations Warnings Precautions Compliance with safety information Safety of equipment and instruments Contribution of medical staff to safety Significance of the user manual and training of medical Staff Electrical safety and electromagnetic compatibility ll 10 1 Prevention of electric shock Particular safety instructions for use of the body jet Control elements and symbols II 1 II 2 II 3 II 4 II 5 Control elements of the membrane keypad Control elements on the front and on both sides of the device Control elements on the rear side of the device Type label Other symbols WAL Applicator and WAL cannulae IV 1 IV 2 IV 3 Description of the sterile single use WAL Applicator Applied part of BF tvpe Description of the reusable WAL cannulae Reprocessing of the reusable WAL cannulae 1 2 1 1 2 2 1 2 2 1 2 2 1 2 2 1 2 2 1 2 3 1 2 3 1 2 3 1 2 3 1 2 4 1 2 4 1 2 5 1 2 6 3 1 3 1 3 2 3 4 3 5 3 6 4 1 4 1 4 2 4 2 Human Med AG Doc No 900018 User manual for body jet Page 2 Table of contents Rev Date 09 21 05 2012 V Installation of the body jet 5 1 V 1 Ambient conditions 5 1 V 1 1 No operation in explosion hazard zones 5 1 V 1 2 Operating conditions 5 1 V 1 3 Ventilation 5 1 V 1 4 Exposure to liquids 5 1 V 1 5 Power cord and power socket 5 1
6. see Fig 20 Fia 20 Total meas value Human Med AG Doc No 900018 User manual for body jet Page 5 6 Chapter V Rev Date 09 21 05 2012 Keep the MEM button pressed for three seconds to reset the liquid consumption values to zero see Fig 16 V 3 5 Test of the vacuum build up Start the vacuum build up by pushing the key VACUUM ON OFF Number 5 in Fig 2 on page 3 1 The operating noise of the vacuum pump is to be heard In order to adjust the maximum vacuum turn the adjusting knob of the vacuum regu lator Number 12 in Fig 3 on page 3 2 clockwise up to the stop Turn the vacuum change over switch Number 13 in Fig 3 on page 3 2 to the top center in order to close the vacuum outlet The vacuum gauge Number 1 in Fig 1 on page 3 1 now indicates a vacuum of 656 mmHg 0 9 bar 19 mmHg 0 02 Turn the vacuum change over switch to the right or to the left in order to open the vacuum outlet The vacuum gauge indicates a vacuum of at most 225 mmHg 0 3 bar Turn the adjusting knob of the vacuum regulator counterclockwise up to the stop in order to adjust the minimum vacuum The vacuum gauge indicates a vacuum of approx 0 mmHg 0 bar V 3 6 Test of the flow generation unit Switch the linear drive unit to stand by by pushing the ON OFF key on the left keypad panel FLOW see Fig 21 The LED of this key starts blinking When actuating the foot bellows the LED lights con tinuously
7. towards the currently used suction container see Fig 33 4 Introduce the lid of the suction bag under vac uum pressure close the angle connector K with your finger and slightly press on the cen ter point of the suction bag s lid see Fig 34 The lid of the suction bag must seat air tight and flush in the suction container 5 Make sure by closing the angle connector K of the suction bag see Fig 35 that the required vacuum has been built up and the bag is completely unfolded Keep the angle connector K closed with your finger until the final vacuum has been reached Fig 35 Human Med AG Doc No 900018 User manual for body jet Page 6 5 Chapter VI Rev Date 09 21 05 2012 6 Still keeping the angle connector closed ad just the vacuum by turning the rotary knob of the vacuum regulator until the required value is indicated see Fig 36 7 Push the suction tube M of the WAL Applica tor onto the angle connector K of the suction bag see Fig 37 The suction system is now ready for use Fig 37 VI 2 3 Connection of the WAL Applicator to the second suction ba Each suction bag is equipped with an integrated overflow protection that interrupts the suction procedure as soon as the suction bag is full The WAL Applicator there fore should be changed over to the suction bag in the second suction container in time Proceed as follows 1 Pull off the angle connector K
8. 3 After cleaning and disinfection 7 2 Vill Troubleshooting 8 1 VIII 1 Localization and elimination of causes for functional and 8 1 operating faults VIII 2 Error messages and audible signals 8 4 IX Maintenance warranty disposal and customer service 9 1 IX 1 Maintenance 9 1 IX 1 1 Authorized persons 9 1 IX 1 2 Safety inspections 9 1 IX 1 3 Modifications and changes of components 9 2 IX 1 4 Periodic maintenance 9 2 IX 2 Warranty 9 2 IX 3 Disposal 9 2 IX 4 Customer service 9 3 X Technical description of the body jet 10 1 X 1 Technical data 10 1 xo Ambient conditions for transport and storage during 10 2 transportation X 3 Ambient conditions for operation and storage at the 10 2 customer s Human Med AG User manual for body jet Doc No 900018 Page 4 Table of contents Rev Date 09 21 05 2012 XI Storage and transportation of the body jet 11 1 XI 1 Transportation over a threshold 11 2 XI 2 Transportation in lying position 11 3 APPENDIX Current product list Human Med AG Doc No 900018 User manual for body jet Page 1 2 0 Chapter and II Rev Date 09 21 05 2012 Content Description of the body jet 1 ll Safety information and measures ll 1 Indications for use Contraindications Safety notations Warnings Precautions 2 3 4 5 ll 6 Compliance with safety information 7 Safety of equipment and instruments 8 Contribution of medical
9. approved for intra cardiac application The body jet should not be used in patients with severe coagulation disorders ll 3 Safety notations The WARNING safety symbol refers to a risk of personal injury WARNING The CAUTION safety symbol refers to a risk of material damage CAUTION The ATTENTION safety symbol refers to a risk that may cause equip ment to become unserviceable ATTENTION Please pay particular attention to the safety instructions in each chapter lI 4 Warnings 1 This device will not in and of itself produce significant weight reduction 2 This device should be used with extreme caution in patients with chronic medical conditions such as diabetes coagulation disorders heart or lung disease circula tory diseases or obesity 3 The volume of blood loss and endogenous body fluid may adversely affect intra and or postoperative hemodynamic stability and patient safety 4 The capability of providing adequate timely fluid replacement is essential for patient safety Human Med AG Doc No 900018 User manual for body jet Page 1 2 3 Chapter and II Rev Date 09 21 05 2012 ll 5 Precautions 1 This device is designed to contour the body by removing localized deposits of ex cess fat through small incisions in male and female adults 2 Safety and effectiveness in pregnant woman and children have not been estab lished 3 Use of this device is limited to thos
10. are made the unlocking mechanism will automatically be disabled to protect the system from overheating red LED on the EJECT PUMP key will be lit The de activation will be canceled and the LED will go out after five 5 minutes provided that the button is not actuated and the device is switched on The infiltration pump cannot be re Switch the device off and inform the tech moved after multiple attempts with nical service Do not continue trying to re deactivation breaks in between move the infiltration pump Any further attempt to remove the infiltration pump could cause the breakdown of the un locking mechanism Repeated use of the applicators Applicators must not be used for more wear deformation swelling than one intervention If removal according to instructions below fails call technical service B gt o z fu 0 2 nd o c c G Q i g G 2 a 2 lt L S DT Qer O 2 2 c Q z G i 5 U lt j The infiltration pump has been left in The infiltration pump must be removed the device over several days swell immediately after each surgical interven ing tion If the infiltration pump cannot be re moved even with the special procedure specified below contact technical service Other hardware or software fault Call technical service Special procedure for infiltration pump removal In case the infiltration pump cann
11. device Number 24 in Fig 6 on page 3 4 The device is turned on by switching it to I By switching it to 0 the device is turned off Switch the master switch to I The operating noise of the power supply unit can be heard The display on the left indicates the current soft ware version for approx three seconds and then the current flow range RANGE 1 There will be no indication on the right display first but after three seconds the lower display field on the right shows see Fig 17 Fig 17 Initial readout on the display Human Med AG Doc No 900018 User manual for body jet Page 5 5 Chapter V Rev Date 09 21 05 2012 V 3 4 Test of the weighing system Attach a balance weight of max 6 kg in this example a 3 kg weight on the hooks After quickly pressing the MEM key the display on the right indicates the following information The upper display field shows 0000 ml and the lower display field shows 0000 ml see Fig 18 Fig 18 Calibrated state Remove the balance weight from the hooks In the lower display field appears the information 3000 ml 100 ml and the upper display field shows 0000 ml see Fig 19 Fig 19 Current meas value Quickiv push the MEM kev again and the right dis plav shows following information 3000 ml 100 ml is indicated in the upper dis play field and 0000 ml in the lower display field
12. off must be disposed of in strict adherence to the legal hygiene regulations The bags must be disposed of in safe containers for infectious waste labeled as hazardous waste Details can be taken from the hygiene plan of the hospital concerned VI 3 Connection of the WAL Applicator to the liquid bags 1 The liquid bags must be hung on the hooks of the rack The total weight must not exceed 6000 g CAUTION Note In case liquid bottles or canisters are used these must be vented prop erly We recommend using liquid bags only 2 The WAL Applicator is to be connected to the liquid bags over the transfer tubing The transfer tubing must be vented before operation according to the following routine The transfer tubing consists of two transfer tubes A and B with clamps pricking pins and pro tection caps Close one transfer tube A by means of the clamp but before remove the protection cap from its pricking pin see Fig 41 Remove the protection from the pricking pin of the second transfer tube B and prick it into the liquid bag to be used first as shown in Fig 42 the clamp of this transfer tube is open Fig 42 Human Med AG Doc No 900018 User manual for body jet Page 6 8 Chapter VI Rev Date 09 21 05 2012 Now open the tube clamp of the first transfer tube A in order to vent the tubing system As soon as the transfer tube A is completely filled with liquid re clamp it and
13. see chapter XI Storage and transportation of the body jet but it has to be stored upright Human Med AG Doc No 900018 User manual for body jet Page 7 3 Chapter VII Rev Date 09 21 05 2012 3 Apply the brakes to lock the wheels 4 Thoroughly check the device and its components Thoroughly check the device and its components e g including re movable parts such as cords cables and foot bellows for damage before and after each use Do not use a damaged device or damaged components Replace defective equipment In case of damage to the device please contact the responsible technical service 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 900018 User manual for body jet Page 8 0 Chapter VIII Rev Date 09 21 05 2012 Content VIII Troubleshooting 1 VIII 1 Localization and elimination of causes for functional and operating faults 1 VIII 2 Error messages and audible signals 4 900018 8 1 09 21 05 2012 Doc No Human Med AG User manual for body jet Chapter VIII Page Rev Date VIII 1 Localization and elimination of causes for functional and operating faults 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 informa tion to the te
14. the liquid consumption during surgical intervention Master switch is actuated to power the body jet on off Foot bellows holder Put the foot bellows into the bracket holders for transport or after powering off the body jet Foot bellows connection port Foot bellows The foot bellows is actuated to activate the flow generation in the cannula Roller wheels with brakes Human Med AG Doc No 900018 User manual for body jet Page 3 5 Chapter III Rev Date 10 13 08 2013 27 Power connection Power cord The body jet is equipped with a hard wired power cord including power plug in order to electrically isolate all circuits of the body jet from the supply mains Connect the bodv jet to a correctly Len installed and grounded socket outlet ai e RA using only the original power cable Fig 8 Power cord and plug or an equivalent power cable The power cable must bear the na tional test symbol To avoid damage and risk of electri cal shock never pull the cord Grab the plug when isolating the body jet from the supply mains WARNING lll 4 Type label body jet The type label is to be found on the rear side of the device It REF CAT No 500000 1 Serial No US1251 shows the following symbols Caution Federal law USA restricts this device to sale by or on the order of a physician TUVRheinland 120V 60 Hz 6 0 A WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZ
15. together with the suction tube M from the port C of the full suction bag see Fig 38 Human Med AG Doc No 900018 User manual for body jet Page 6 6 Chapter VI Rev Date 09 21 05 2012 2 Close this port with the sealing plug L see Fig 39 Fig 39 3 Now turn the vacuum change over switch Number 13 in Fig 3 on page 3 2 towards the suction container with the empty suction bag inside 4 Push the suction tube M of the WAL Applica tor onto the angle connector K of the new suction bag see Fig 40 Fig 40 VI 2 4 Removal and replacement of the suction bag In case both suction bags are filled during a surgical intervention you have to replace one or both suction bags For this pull the suction tube M with angle connector K from the port C of the full suction bag see Fig 36 on the preceding page Then close this port C with the sealing plug L as shown in Fig 37 on the prece ding page Remove the suction bag from the container A holding it on the grip N Insert a new suction bag according to the procedure described in chapter VI 2 2 Insertion of the suction bag VI 2 5 Disposal of the filled suction bags The liquid suctioned off may contain germs harmful to health WARNING Human Med AG Doc No 900018 User manual for body jet Page 6 7 Chapter VI Rev Date 09 21 05 2012 The filled suction bags including the liquid suctioned
16. 11 12 13 Human Med AG User manual for body jet Chapter VI Doc No 900018 Page 6 1 Rev Date 09 21 05 2012 eger pappen unf om nal rz u nan A ummulla die mn W A A I A WW B FRI ia U E G R ECE Ne WW EGES GE Before starting work with the body jet the device must be installed properly In structions on installation are to be found in chapter V Installation of the body jet of this user manual The body jet must be connected to the power supply using the power cord supplied with the device and is to be powered on by pushing the master switch on the rear side When switching the device on the display on the left indicates the current soft ware version for approx three seconds and then the current flow range RANGE 1 When switching the device on no LED must emit light and no error message must be shown on the display VI 1 Installation of the infiltration pump Take the WAL Applicator from the sterile package Only use WAL Applicators from undamaged packages ATTENTION Fig 24 Inserted infiltration pump Fig 25 Unlock the infiltration pump Remove the sealing cap from the socket of the in filtration pump by turning it counterclockwise Push the infiltration pump into the socket The infiltration tube 1 of the WAL Appli cator must point upwards whereas the transfer tubes 2 must point downwards CAUTION The infiltration pump is pushed in
17. 250 W Vacuum adjust 0 656 mmHg 19 mmHg able from to 0 87 5 kPa 2 5 kPa Flow rate suction unit high flow 60 l min sterile single use WAL Applicator closed system Non sterile resterilizable WAL cannulae Nozzle diameter 300 um BF CE 0482 UL File E212412 Human Med AG Doc No 900018 User manual for body jet Page 10 2 Chapter X Rev Date 09 21 05 2012 X 2 Ambient conditions for transport and storage during transportation The body jet may be transported in upright or lying position see chapter XI Storage and transportation of the body jet but it must be stored in upright position Temperature from to 20 C 50 C 4 F 122 F Relative humidity from to 10 95 WAL Applicator gt Temperature from to 8 C 35 C 40 F 68 F X 3 Ambient conditions for operation and storage at the customer s Temperature from to 10 C 40 50 F 104 F Relative humidity from to 30 75 no condensation For further information please contact our supplier human med inc 1860 Crown Drive Suite 1408 Dallas Texas 75234 Phone 214 3256763 or the manufacturer Human Med AG Wilhelm Hennemann Str 9 19061 Schwerin Germany Phone 49 0 385 39570 0 Fax 49 0 385 39570 29 Email info humanmed com Human Med AG Doc No 900018 User manual for body jet Page 10 3 Chapter X Rev Date 09 21 05 2012 Huma
18. ARDS ONLY IN ACCORDANCE WITH UL 60601 1 2003 R6 03 AND CAN CSA C22 2 No 601 1 GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN EQUIPMENT IS CONNECTED TO EQUIVALENT RECEPTACLE MARKED HOSPITAL ONLY OR HOSPITAL GRADE Date of Manufacture 2013 08 C 0482 Manufactured by Human Med AG Wilhelm Hennemann Strafje 9 Germany 19061 Schwerin e human med Rev 01 2013 08 08 Fig 9 Type label This symbol signifies that the user manual and other relevant Instructions must be read and followed This symbol indicates that pushing at the sides of the device is prohibited Human Med AG Doc No 900018 User manual for body jet Page 3 6 Chapter III Rev Date 10 13 08 2013 This symbol is followed by the date of manufacture of the device This symbol indicates that the product conforms to the specifi cations of TUV Rheinland of North America OSHA requirements for the United States of America and Canada This symbol signifies that the product is in conformity to the speci fications 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 This symbol signifies that the device at the end of its service life shall not be disposed of in the domestic waste as to the correct disposal see chapter IX II 5 Other symbols Fig 10 Hooks for attachment of the liquid bags Symb
19. Fig 21 Human Med AG Doc No 900018 User manual for body jet Page 5 7 Chapter V Rev Date 09 21 05 2012 Look into the socket of the infiltration pump for checking whether the linear drive unit is moving see Fig 22 The moving speed of the linear drive unit deceler ates or accelerates by pushing the keys and The respective range 1 to 5 is indicated in the lower display field on the left side Fig 22 Pressure container socket Human Med AG Doc No 900018 User manual for body jet Page 6 0 Chapter VI Rev Date 09 21 05 2012 Content VI Working with the body jet VI 1 Installation of the infiltration pump VI 2 Insertion of the suction bag and connection of the suction tube VI 2 1 Connection of the suction containers VI 2 2 Insertion of the suction bag VI 2 3 Connection of the WAL Applicator to the second suction bag VI 2 4 Removal and replacement of the suction bag VI 2 5 Disposal of the filled suction bags VI 3 Connection of the WAL Applicator to the liquid bags VI 4 Venting of the WAL Applicator and attachment of the WAL cannula VI 5 Startup of the flow generation and the suction unit VI 5 1 Test of the suction unit VI 5 2 Test of the overflow protection bacterial filter VI 5 3 Preparation of the device for surgical intervention VI 6 Operation VI 7 End of operation ml o N OD Q91 N KN 10 10
20. G Doc No 900018 User manual for body jet Page 4 2 Chapter IV Rev Date 09 21 05 2012 IV 2 Description of the reusable WAL cannulae The WAL cannulae are delivered unsterile and must be thoroughly cleaned and sterilized before use according to the processing instructions At the beginning of the liposuction an infiltration cannula is used for fluid infiltration The infiltration cannula has only one hole through which the physiological saline is infused into the adipose tissue Irrigation aspiration cannulae have several suction holes and one bypass hole in their hand piece for starting and stopping the suctioning by either closing or opening the hole I Irrigation and aspiration cannula is available in various designs see current product list K Bypass hole By closing and opening the bypass hole the suctioning is started and stopped Fig 15 WAL irrigation and aspiration cannula IV 3 Reprocessing of the reusable WAL cannulae The infiltration and irrigation aspiration cannulae are supplied unsterile They must be thoroughly cleaned and sterilized before every occasion of use Detailed instructions on cleansing disinfection and sterilization of the infiltration and irrigation aspiration cannulae are outlined in the Reprocessing instructions for WAL cannulae as package insert attached to each cannulae delivery These instructions have been validated by the manufacturer as being suitable f
21. User manual for body jet Page 9 1 Chapter IX Rev Date 10 13 08 2013 IX 1 Maintenance IX 1 1 Authorized persons Safety inspections modifications and replacement of components must only be carried out by Human Med or by persons expressly authorized by Human Med In case un authorized persons carry out modifications or replace device components Human Med doesn t assume any liability and claims under warranty become void IX 1 2 Safety inspections The safety inspection represents a preventive maintenance in which an authorized technician checks whether the safety and serviceability of the device and its accesso ries are in accordance with technical specification safety inspection must be made every 12 months In the event that the safety inspection is not carried out by an authorized technician within the period prescribed any claims under warranty become void The following safety checks are specified for this equipment e Device and accessories are free of external damage e User manual is available e All labels and inscriptions are in right place and legible e Ground wire test according to standard IEC 60601 1 e Leakage current measurement according to standard IEC 60601 1 e Functioning test of master switch display suctioning vacuum pressure genera tion and foot bellows easy removal of the infiltration pump e General condition of the drive unit and the unlocking mechanism e Replacemen
22. V 1 6 Installation of the body jet 5 2 V 2 Components device combination 5 2 V 3 Preparations for use 5 3 V 3 1 Visual inspection 5 3 V 3 2 Connection of the body jet 5 3 V 3 3 Device test after switch on 5 4 V 3 4 Test of the weighing system 5 5 V 3 5 Test of the vacuum build up 5 6 V 3 6 Test of the flow generation unit 9 6 VI Working with the body jet 6 1 Vi 1 Installation of the infiltration pump 6 1 VI 2 Insertion of the suction bag and connection of the 6 2 suction tube VI 2 1 Connection of the suction containers 6 2 VI 2 2 Insertion of the suction bag 6 3 VI 2 3 la of the WAL Applicator to the second 6 5 VI 2 4 Removal and replacement of the suction bag 6 6 VI 2 5 Disposalof the filled suction bags 6 6 VI 3 Connection of the WAL Applicator to the liquid bags 6 7 VI 4 Venting of the WAL Applicator and attachment of the 6 8 WAL cannula Human Med AG Doc No 900018 User manual for body jet Page 3 Table of contents Rev Date 09 21 05 2012 VI 5 Startup of the flow generation and the suction unit 6 10 VI 5 1 Test of the suction unit 6 10 VI 5 2 Test of the overflow protection bacterial filter 6 10 VI 5 3 Preparation of the device for surgical intervention 6 11 VI 6 Operation 6 12 VI 7 End of operation 6 13 VII Cleaning disinfection and storage after operation 7 1 VII 1 Before cleaning and disinfection 7 1 VII 2 Cleaning and disinfection 7 1 VII
23. ags have to be replaced during operation Fig 58 VI 7 End of operation 1 Switch the flow generation unit off by pushing the ON OFF key of the left keypad panel Flow see Fig 59 Fig 59 Human Med AG User manual for body jet Doc No 900018 Page 6 14 Chapter VI 3 Fiq 61 Fig 62 Fiq 63 Rev Date 09 21 05 2012 2 Remove the sealing cap see Fig 60 Press the EJECT PUMP key see Fig 61 The unit will beep for five seconds indicating that the infiltration pump can be removed At the same time the word REMOVE appears in the left display see Fig 6Fig 62 Remove the infiltration pump from the socket while the unit is beeping see Fig 63 Human Med AG Doc No 900018 User manual for body jet Page 6 15 Chapter VI Rev Date 09 21 05 2012 lf you were unable to remove the infiltra tion pump on your first attempt the unlocking operation can be repeated one 1 more time If additional attempts are made the unlocking mechanism will automatically be disabled to protect the system from overheating The red LED on the EJECT PUMP key will be lit see Fig Fig 64 GFig 64 ATTENTION The deactivation will be canceled and the LED will go out after five 5 minutes if in that period the EJECT PUMP key has not been pressed and the device is switched on 6 Clamp the transfer tubes Cut the tubing system above the infiltration
24. al filter of the tubing set or the overflow pro tection of the suction bag Connect the power plug Press the master switch to power on the body jet Connect the foot bellows Human Med AG User manual for body jet Doc No Page 900018 8 2 Chapter VIII ss No flow generation no fluid comes out of the nozzle LED GT 5S gt c goy Sot c Liquid 4 The device has been correctiv con nected and switched on but the dis plav is blank The ON OFF key has not been pushed The foot bellows has not been actuated The infiltration pump has not been correctiv inserted into the socket The sealing cap has not been screwed properly The liquid bag has not been con nected 10 One clamp of the transfer tubing is not open 11 The transfer tubing set has not been vented properly 12 The WAL Applicator is blocked or faulty The infiltration pump is broken Other causes The WAL Applicator is blocked or faulty The WAL Applicator is blocked or faulty Rev Date 09 21 05 2012 Possible cause of fault cause of fault Instruction for elimination for elimination A fuse may have blown Call technical service Push the ON OFF key The small LED shall light green Actuate the foot bellows Repeat the installation routine described in chapter VI 1 Installation of the infil tration pump of this user manual Screw the sealing cap following the de scr
25. ay accuracy 25 mbar Note The numbers on the outer circle 0 to 1 are valid for a vacuum pressure in bar The vacuum can be read in mmHg by means of the numbers on the inner circle 0 to 750 2 Display top right The total liquid consumption is indicated on this display Fig 1 gauge E 3 Display down right The current liquid consumption is indicated on this display eee 4 MEM human med By pushing this key the weighing system is operated 5 VACUUM ON OFF Using this key the suction unit is switched on or off 6 STOP In case of failures or emergencies this button is to be pressed to stop the device 7 Display on the left After switching the body jet on the software version and then the current flow range rig Membran Key pa RANGE 1 to 5 are indicated on this display 8 and Using these keys the flow range can be changed over 9 ON OFF By pressing this key the flow generation unit is switched over to stand by or off 10 EJECT PUMP Using this key the infiltration pump is unlocked and can be pulled out from its socket see chapter VI 7 End of operation Human Med AG Doc No 900018 User manual for body jet Page 3 2 Chapter III Rev Date 10 13 08 2013 lll 2 Control elements on the front and on both sides of the device 11 Socket for the infiltration pump 12 Adjusting knob of the vacuum regulator The vacuum is to be adjusted t
26. bellows 6448 AAAC 0000 item no of the double sided foot bellows 6448 EAAC 0000 e 3000 ml suction container waste produced by Serres Oy item no 57348 e 3000 ml suction bag produced by Serres Oy item no 57187 e Hydrophobic filter set incl vacuum hose with overflow protection bacterial filter produced by Medela AG item no 077 0572 elbow plug connectors to connect the suction container to the suction port of the device e Sealing cap of the infiltration pump socket The body jet must only be operated using disposable WAL Applicators and reusable WAL cannulae produced by Human Med The current product list is applicable Human Med AG Doc No 900018 User manual for body jet Page 5 3 Chapter V Rev Date 09 21 05 2012 Any modification to the bodv jet device the WAL Applicator the WAL cannulae or other accessories are not allowed and will result in exemption of Human Med from liability WARNING The suction tube of the WAL Applicator is allowed to be connected to any other appropriate suction device Other combinations of equipment are not allowed and will result in exemption of Human Med from liability The bodv jet must only be operated using liquid bags with sterile 0 9 normal saline according to United States Pharmacopeia with a maximum volume of 3 liter per bag WARNING V 3 Preparations for use After properly installing the body jet according to this user manual and before
27. chnical service of Human Med Possible cause of fault Instruction for elimination No flow generation no fluid comes out of Lack of vacuum No only weak suction with cannula the nozzle Incorrect vacuum pressure level The suction bag has not been inserted correctly or the suction tube has not been attached correctly The selected suction port suction con tainer is not correct The suction bag has not been inserted correctly or the suction tube has not been attached correctly The aspiration cannula is blocked Overflow protection bacterial filter of the tubing set and or overflow protection of the suction bag is are blocked The power plug has not been con nected The master switch of the device is not ON The foot bellows have not been con nected Turn the vacuum adjusting knob to the required vacuum pressure level Gheck the suction bag and the suction tube Gheck the seals for cracks perishing and leakage Check which suction port has been se lected If necessary rectify it using the vacuum change over switch Check the suction bag and the suction tube correct if necessary Replace the aspiration cannula Check the functioning of the overflow pro tection bacterial filter of the tubing set and or overflow protection of the suction bag in case of contact with liquids these parts block immediately and don t let air pass anymore Replace the overflow protection bacteri
28. cutting devices priority is to be given to the safety regulations related to these devices II 10 1 Prevention of electrical shock Leakage current The device complies with the requirements of the applicable version of standard IEC 60601 1 related to devices of protection class and devices with applied parts of type BF Power cord and power socket To avoid risk of electrical shock this equipment must only be con nected to supply mains with protective earth WARNING The supply voltage must be identical to the voltage stated on the type label on the rear side of the body jet WARNING Connect the device to a properly installed and grounded outlet Only use the power cord supplied with the device Equipment check Check the device and its accessories e g cords cables foot bellows for damage prior to each use Do not use a damaged device a damaged instrument trolley or damaged accessories WARNING Replace defective accessories For spare parts or servicing please contact our customer service For your own safety and that of your patients never attempt to repair by yourself Any modification to the equipment will exempt Human Med from liability WARNING Human Med AG Doc No 900018 User manual for body jet Page 1 2 6 Chapter and II Rev Date 09 21 05 2012 II 11 Particular safety instructions for use of the body jet The following instructions must be strictly observ
29. d 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 Manufacturer Human Med AG Wilhelm Hennemann Stra e 9 19061 Schwerin Germany Phone 49 0 385 3957011 Fax 49 0 385 3957010 Email info humanmed com Human Med AG Doc No 900018 User manual for body jet Page 10 0 Chapter X Rev Date 09 21 05 2012 Content X Technical description of the body jet 1 X 1 Technical data 1 X 2 Ambient conditions for transport and storage during transportation 2 X 3 Ambient conditions for operation and storage at the customer s 2 Human Med AG User manual for body jet Chapter X X 1 Technical data Dimensions in cm Weight in kg Power supply Flow generation Flow rate in ml min Suction unit Transfer tubing set applicator applied part Cannulae Safety class acc to IEC 60601 1 OP applicator safety class Approval certificate Device class Doc No 900018 Page 10 1 Rev Date 09 21 05 2012 54 L x 60 W x 178 H 44 120 VAC 6 A 60 Hz Ref 500000 1 Sterile infiltration pump with electro mechanical drive unit 90 to 190 ml min 15 Adjustable in five ranges RANGE 1 to 5 90 110 130 160 190 ml min Presetting over the keypad Activation of flow generation by foot bellows Integrated vacuum pump manually adjustable Rated power
30. d outlet Only use the Human Med power cord supplied with the device For safety reasons do not use any extension leads or power distri bution units Human Med AG Doc No 900018 User manual for body jet Page 5 2 Chapter V Rev Date 09 21 05 2012 Run the power cord from the device to the outlet in a way that haz ardous situations e g tripping are eliminated WARNING 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 pro WANIN fessional manner V 1 6 Installation of the body jet e Place the body jet on a stable horizontal and vibration free surface to ensure its stability e For thermal reasons and adequate display legibility the device must not be exposed to direct sunlight e The rear side of the body jet must be directed away from the operating field e Always keep a safety distance of at least 1 m between the device and the sterile areas particularly the tables for instruments operating tables and staff wearing sterile garment Apply the brakes of all four roller wheels when placing the device V 2 Components device combination Only use components together with the body jet that are specified by Human Med in this user manual ATTENTION This particularly applies to the following parts e Foot bellows with suitable cables produced by Herga Electric Ltd item no of the one sided foot
31. e physicians who by means of residency train ing or sanctioned continuing medical education have demonstrated proficiency in suction lipoplasty 4 Results of this procedure will vary depending upon patient age surgical site and experience of the surgeon 5 Results of this procedure may or may not be permanent 6 The amount of fat removed should be limited to that necessary to achieve the de sired cosmetic effect 7 All reusable components of the device must be sterilized and all disposable com ponents replaced before using the device on another patient 8 If the vacuum regulator does not regulate the vacuum pressure properly or if the suction cannula and tip are not of appropriate size shape and rigidity this might result in tissue damage II 6 Compliance with safety information Appropriate application of and compliance with the safety information considerably contributes to the safety of the user of the patients and the environment ll 7 Safety of equipment and instruments The body jet complies with all relevant and generally accepted engineering practices as well as with the applicable occupational protection and accident prevention regula tions lI 8 Contribution of medical staff to safety 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
32. ear side of the device 2 Fig 52 Switch the flow generation unit to stand by by pushing the ON OFF key on the left keypad panel FLOW see Fig 50 The green LED is blinking Start the flow generation by actuating the foot bellows The green LED is lighting continu ously Select the flow range using the and keys RANGE 1 to 5 see Fig 51 The set flow range is shown on the left display field Switch the suction unit on off by pushing the VACUUM ON OFF key see Fig 52 Human Med AG Doc No 900018 User manual for body jet Page 6 12 Chapter VI Rev Date 09 21 05 2012 5 Set the requested vacuum in the range from 0 to 850 mbar by turning the adjusting knob of the vacuum regulator 1 see Fig 53 rm HIGH VACUUMI HIGH FLOW 6 The current vacuum is indicated on the vac uum gauge see Fig 54 The final vacuum depends on the pump type used and on the height of the position above sea level 2000 m min 65 kPa 1000 m min 75 kPa 500 m min 80 kPa 0 m min 85 kPa Fig 54 Fig 54a Vacuum at different heigths above sea level The bodv jet is ready now for surgical intervention In emergencies or in case of failures the suction unit and the flow generation can be put out of operation by pressing the STOP key ATTENTION After the body jet has been stopped by pressing the STOP key it can only be put into operation again using the mas
33. ecessary also use a soft brush soaked in disinfectant Fix the sealing cap to the socket again Foot bellows foot bellows tubing and power cord Wipe the foot bellows the foot bellows tubing 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 185 F in a washer disinfector and sterilized at a temperature of 121 C 250 F 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 can cause stress cracks in the suction container and can shorten its service life The suction container has been successfully tested for a thirty time 30 reproces sing using the above described automated reprocessing procedures including sterili zation Further reprocessing 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 Otherwise the container can be damaged ATTENTION Never use a damaged container it can impede the vacuum build up VII 3 After cleaning and disinfection 1 Hang the power cord and the foot bellows in the bracket holders provided 2 Park the body jet at the place provided for storage The body jet may be transported in upright or lying position
34. ed Every person operating the device must previously be instructed and familiar with operational parameters The foot bellows must not be operated before use of the device The infiltration line must not be kinked The WAL Applicator and the used WAL cannula must not be directed towards the eyes When working with the device the foot bellows have to be secured against unintentional actuation WARNING When attaching the hand piece take care that the water jet is only directed towards the operating field Operational safety The use of this device is limited to those physicians who by means of residency training or sanctioned continuing medical education have demonstrated proficiency in suction lipoplasty The device must be installed and initially put into operation only by qualified staff who has been trained by Human Med or their authorized representatives The device may only be used after delivery and installation of the device by the service team of Human Med or their authorized representatives Implementing all safety measures as described in this user manual mastering functional procedures and operation of the device in case of a mal function Every person operating 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 device each use
35. ed AG Doc No 900018 User manual for body jet Page 5 1 Chapter V Rev Date 09 21 05 2012 V 1 Ambient conditions V 1 1 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 anaesthetics combustible skin cleaners or disinfectants are used WARNING V 1 2 Operating conditions Only operate the equipment at temperatures and air humidity con ditions as specified in chapter X Technical description of the body je Exceeding the indicated tolerances may lead to break down of the installed equipment ATTENTION A When operating the device at an ambient temperature of more than 35 C do not touch the device surfaces for longer than 10 sec WARNING V 1 3 Ventilation The equipment must be placed in a way ensuring that air can freely circulate around the system housing The installation in narrow alcoves is not allowed ATTENTION V 1 4 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 ATTENTION V 1 5 Power cord and power socket The supply voltage must be identical to the voltage indicated on the type label on the rear side of the body jet WARNING Connect the device to a grounde
36. eneral 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 interventions 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 Safety inspections 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 IX 3 Disposal The equipment shall be disposed of at the end of its service life as normal electronic waste according to the local national regulations Human Med AG Doc No 900018 User manual for body jet Page 9 3 Chapter IX Rev Date 10 13 08 2013 IX 4 Customer service Should you be interested in a maintenance contract please contact Human Med or an authorize
37. etely over by using the handle see Fig 69 Fig 68 Fig 69 Human Med AG Doc No 900018 User manual for body jet Page 11 3 Chapter XI Rev Date 09 21 05 2012 Apply the brakes of the wheels when placing the device for use as well as for storage of the body jet ATTENTION XI 2 Transportation in lying position Before transporting in lying position the transportation lock is to be mounted to the body jet in order to prevent it from damage 1 Transportation lock 2 Borehole of the transportation lock 3 Wing screw Fig 70 The borehole of the transportation lock 2 is put onto the tube of the air guide plate 4 The transportation lock is fastened to the air guide plate 4 using the wing screw 3 Fig 71 Before using the body jet remove the transportation lock 1 again otherwise the device can be damaged ATTENTION Demount the transportation lock by unfastening the wing screw 3 Human Med AG User manual for body jet Chapter XI ATTENTION Fig 73 Doc No 900018 Page 11 4 Rev Date 09 21 05 2012 When transporting the weighing system of the body jet it must be particularly pro tected against damage e g by dropping hitting Human Med AG Doc No 900018 User manual for body jet Page 11 5 Chapter XI Rev Date 09 21 05 2012
38. ility of a pre defined software parame ter to the actual value gt Contact the technical service STOP 05 Triggered due to non compatibility of a pre defined software parame ter to the actual value gt Contact the technical service STOP 06 Triggered by exceeding of the voltage limit value gt Contact the technical service STOP 07 Triggered by exceeding of the amperage limit value gt Check whether the WAL Applicator is blocked or defective replace if necessary gt Otherwise contact the technical service Note When a STOP fault message appears on the display the bodv jet must be powered off and then powered on again by actuating the master switch on the rear side of the device In case error causes cannot be localized or eliminated please contact the respon sible technical service Inform the manufacturer Human Med AG Wilhelm Hennemann StraBe 9 19061 Schwerin Germany Phone 49 0 385 39570 0 Fax 49 0 385 39570 29 Email info humanmed com Human Med AG Doc No 900018 User manual for body jet Page 9 0 Chapter IX Rev Date 10 13 08 2013 Content IX Maintenance warranty disposal and customer service IX 1 Maintenance IX 1 1 Authorized persons IX 1 2 Safety inspections IX 1 3 Modifications and replacement of components IX 1 4 Periodic maintenance IX 2 Warranty IX 3 Disposal IX 4 Customer service d N N N N Human Med AG Doc No 900018
39. ion aspiration cannulae The bacterial filters tubing suction bags and cannulae are to be changed for each patient The body jet must be used together with a sterile single use tubing set with a small infiltration pump WAL Applicator transporting the saline for the infiltration into the tis sue area and a vacuum pump transporting the aspirate from the cannula into the suction containers The WAL Applicator is classified as an applied part of BF type A gentle pulsating fan shaped saline spray is introduced into the adipose tissue through the WAL Applicator and the infiltration or irrigation aspiration cannulae in order to infiltrate and to loosen and separate the fat cells Saline solution for loosening adi pose tissue and for intralobular and intracellular infiltration can be applied continuously during the whole aspiration process The irrigation aspiration cannulae are used for the aspiration of the loosened fat cells and the continuous infiltration of saline fluid Human Med AG Doc No 900018 User manual for body jet Page 1 2 2 Chapter and II Rev Date 09 21 05 2012 lI 1 Indications for use The body jet is indicated for aesthetic body contouring The body jet must only be used together with a WAL Applicator system and WAL cannulae produced by Human Med The WAL applicator is classified as an applied part of BF type ll 2 Contraindications The body jet and the instruments to be connected are not
40. iption in chapter VI 1 Installation of the infiltration pump The cap must not be removable without turning it slightly counterclockwise Prick the pricking pin of the transfer tubing into the liquid bag see chapter VI 3 Connection of the WAL Applicator to the liquid bags Check the clamps and open if necessary Check the transfer tube leading to the liquid bag Check the connection routine for the WAL Applicator described in chapter VI 4 Venting of the WAL Applicator and at tachment of the WAL cannulae Although all above mentioned items have been checked thoroughly there is no liq uid coming out of the WAL Applicator after actuating the foot bellows for 60 sec Replace the WAL Applicator Replace the WAL Applicator Replace the WAL Applicator Human Med AG Doc No 900018 User manual for body jet Page 8 3 Chapter VIII Rev Date 09 21 05 2012 Possible cause of fault Instruction for elimination 1 The flow generation has not been Push the ON OFF key to deactivate the deactivated by pushing the ON OFF flow generation key The infiltration pump was not removed Push the EJECT PUMP key and remove within the time period indicated by the the infiltration pump from the socket within audible signal five seconds the period during which the audible signal can be heard Note The unlocking operation can be repeated one 1 more time If additional attempts
41. is symbol signifies that the following number is the batch code of the pro duct This symbol indicates the maximum date until which the product may be Fig 5 Overflow protection bacterial filter used Prior to any surgical intervention the proper functioning of the overflow pro tection bacterial filter must be checked see chapter VI 5 2 Test of the over flow protection bacterial filter In case of improper function replace the overflow protection bacterial filter ATTENTION Human Med AG User manual for body jet Chapter III Doc No 900018 Page 3 4 Rev Date 10 13 08 2013 lll 3 Control elements on the rear side of the device Fig 6a Fig 7 Rear view down 20 21 22 23 24 25 26 28 29 Weighing system The current weight of the liquid bags is deter mined by means of the weighing system Hooks for attachment of the liquid bags one bag to each hook The maximum volume of the bags that can be held by the hooks is 6000 ml totally ATTENTION Removable rack Before removing the rack the con nector 23 for the weighing system Is to be screwed off CAUTION Ensure that the weighing system is pointing away from the membrane keypad when attaching the rack see Fig 14 on page 5 4 ATTENTION Connector for the weighing system is used for connecting the control PCB and the weighing system 20 that registers
42. n Note The spray pattern is to be checked again when a new WAL cannula is attached Human Med AG Doc No 900018 User manual for body jet Page 6 10 Chapter VI Rev Date 09 21 05 2012 VI 5 Startup of the flow generation and the suction unit VI 5 1 Test of the suction unit gt Switch the suction unit on by pressing the key VACUUM ON OFF gt Turn the adjusting knob of the vacuum regulator 12 clockwise up to the stop HIGH VACUUM HIGH FLOW Fig 47 gt Close the angle connector K with your finger and wait until the vacuum has been built up see Fig 48 gt Check whether the vacuum gauge indicates a value of at least 825 mbar if not see chapter Vill Troubleshooting Fig 48 VI 5 2 Test of the overflow protection bacterial filter gt Adjust the vacuum pressure to the maximum level gt Disconnect the elbow plug connector B gt Check the value shown on the vacuum gauge it must not exceed 300 mbar In case of exceedance replace the overflow protection bacterial filter produced by Medela item no 077 0572 REF No US101931 or the Fig 49 complete hydro phobic filter set REF no US 101947 see product list Human Med AG User manual for body jet Chapter VI Doc No 900018 Page 6 11 Rev Date 09 21 05 2012 VI 5 3 Preparation of the device for surgical intervention 1 Turn on the body jet by pressing the master switch on the r
43. n Med AG Doc No 900018 User manual for body jet Page 11 0 Chapter XI Rev Date 09 21 05 2012 Content XI Storage and transportation of the body jet 1 XI 1 Transportation over a threshold 2 XI 2 Transportation in lying position 3 Human Med AG Doc No 900018 User manual for body jet Page 11 1 Chapter XI Rev Date 09 21 05 2012 The body jet may be transported in upright or lying position but it must be stored upright only The device must not be transported outside the OP area with liquid bags attached ATTENTION While transporting the device there is the risk to bump against the weighing system see Fig 65 ATTENTION Fig 65 Recommendation Remove the rack when the device will be transported over thresholds uneven surfaces or in a Car Human Med AG Doc No 900018 User manual for body jet Page 11 2 Chapter XI Rev Date 09 21 05 2012 XI 1 Transportation over a threshold When the body jet must be transported over a threshold proceed as follows Release the brakes on the wheels Number 1 in Fig 6Fehler Verweisquelle konnte nicht gefun den werden 6 before transporting the device Turn the device so that the rear wheels run over the threshold first see Fig 67 Fig 67 s shown below in Fig 68 lift the device slightly with both hands on the handle and at the same time pull it over the threshold Then pull the device compl
44. o the required level by turning this rotary knob 13 Vacuum change over switch is turned to select the suction container to be used 14 Suction bag with angle connector Fig 3 Socket for insertion of the is to be inserted into the suction container in infiltration pump order to collect the waste aspirate l F 15 Suction container is used to hold the suction bag 16 Sealing cap Is used to hold the infiltration pump in position and to close its socket Fig 4b Suction bag This symbol indicates that the infiltration pump of the WAL Applicator must be inserted into the socket 11 The WAL Applicator is an applied part of BF type Human Med AG Doc No 900018 User manual for body jet Page 3 3 Chapter III Rev Date 10 13 08 2013 17 Vacuum hose with overflow protection bacterial filter is used together with two 2 elbow plug con nectors for connecting the suction container to the suction unit of the body jet 18 Suction port is used to connect the plug connector of the vacuum hose with overflow protection bacte rial filter to the suction unit Fig 4c Side view This symbol indicates that the user manual of Chapter the device must be read before components VI 5 2 are connected to the suction port 19 Overflow protection bacterial filter Never operate the body jet without using the overflow protection bacterial filter CAUTION Th
45. ol for handling of the device during transport The device must not be transported outside the OP area with liquid bags attached ATTENTION While transporting the device there is the risk to bump against the weighing system ATTENTION Fig 11 Foot bellows connection ports on the rear side of the device Human Med AG Doc No 900018 User manual for body jet Page 3 7 Chapter III Rev Date 10 13 08 2013 Symbol for foot bellows connection This symbol signifies that solely a foot bellows is to be connected to the port labelled with this symbol ATTENTION Note Only use and connect the air pressure foot bellows supplied by Human Med together with the device There are two different types of foot bellows included in the scope of supply one pair of one sided foot bellows manufactured by Herga Electric Ltd item no 6448 AAAC 0000 see Fig 12 and another pair of double sided foot bellows manufactured by Herga Electric Ltd item no 6448 EAAC 0000 see Fig 13 The inner diameter of the cable for the foot bellows shall not be more than 3 2 mm The outer diameter of the cable must not exceed 6 4 mm Please use that type of foot bellows that you consider to be most convenient to operate ran Fig 12 one sided foot bellows Fig 13 double sided foot bellows Human Med AG Doc No 900018 User manual for body jet Page 4 0 Chapter IV Rev Date 09 21 05 2012 C
46. ontent IV WAL Applicator and WAL cannulae 1 IV 1 Description of the sterile single use WAL Applicator 1 Applied part of BF type IV 2 Description of the reusable WAL cannulae 2 IV 3 Reprocessing of the reusable WAL cannulae 2 Human Med AG Doc No 900018 User manual for body jet Page 4 1 Chapter IV Rev Date 09 21 05 2012 IV WAL Applicator and WAL cannulae IV 1 Description of the sterile single use WAL Applicator Applied part of BF type Fig 14 WAL Applicator system A Hand piece with jet capillary tube Is used to introduce the irrigation fluid into the body area concerned and to transport adipose tissue B Pricking pin with protection cap Is used to connect the transfer tubing set with the liquid bags C Tube clamp of the transfer tubing set By closing the tube clamp the fluid supply into the WAL applicator system can be interrupted if required D Transfer tubing with two transfer tubes Is used to connect two liquid bags at the same time E Tube socket By means of this socket the suction tube F is attached to the suction bag F Suction tube with socket E Is used to connect the hand piece A with the suction bag G Infiltration pump with a piston Is used to produce the set flow for detachment of the fat cells H P tubing Is used for transporting the pressurized fluid to the jet capillary from the infiltra tion pump G to the hand piece A Human Med A
47. or any damage resulting from using the device with out proper training or 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 user manual lI 10 Electrical safety and electromagnetic compatibility The device must be connected to an earthed mains supply in accordance with the ap plicable version of standard IEC 60601 1 2 The body jet has been tested for immunity to interference and for electromagnetic compatibility by an accredited laboratory The test results are within the limit values for medical electrical equipment as defined in the applicable version of 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 Human Med AG Doc No 900018 User manual for body jet Page 1 2 5 Chapter I and II Rev Date 09 21 05 2012 An exception to this is the interaction with HF surgical devices since these do not always comply with the limit values of the applicable version of standard IEC 60601 1 2 When using the body jet together with HF surgical appliances a safety distance of at least two meters must be maintained between the body jet and the HF surgical unit as well as the HF surgical cables When using the body jet together with HF surgical appliances or laser
48. or the preparation of the infiltration and irrigation aspiration cannulae for reuse The person responsible for cleansing is obliged to ensure that the cleansing actually carried out with the equipment materials and staff deployed in the cleansing facility attains the desired results As a guarantee of the latter validation and routine monitoring of the procedure are normally necessary It is equally important that any departure from the instructions provided must be carefully evaluated by the person responsible for cleansing with regard to their effectiveness and possible disadvantageous consequences Human Med AG Doc No 900018 User manual for body jet Page 4 3 Chapter IV Rev Date 09 21 05 2012 Human Med AG Doc No User manual for body jet Page Chapter V Rev Date 900018 5 0 09 21 05 2012 Content V Installation of the body jet V 1 Ambient conditions V 1 1 No operation in explosion hazard zones V 1 2 Operating conditions V 1 3 Ventilation V 1 4 Exposure to liquids V 1 5 Power cord and power socket V 1 6 Installation of the body jet V 2 Components device combination V 3 Preparations for use V 3 1 Visual inspection V 3 2 Connection of the body jet V 3 3 Device test after switch on V 3 4 Test of the weighing system V 3 5 Test of the vacuum build up V 3 6 Test of the flow generation unit 9 OOA N N lt a rd rd st Human M
49. ot be pulled out of its socket owing to any of the causes listed in the table above proceed as follows 1 Prepare the device for standard operation and generate a water jet for approx ten seconds 2 Do not actuate the foot bellows 3 Remove the sealing cap from the socket of the infiltration pump 4 Now actuate the foot bellows in order to release the infiltration pump from its socket b Deactivate the flow generation by pushing the ON OFF key on the left key pad panel FLOW Human Med AG Doc No 900018 User manual for body jet Page 8 4 Chapter VIII Rev Date 09 21 05 2012 6 Push the EJECT PUMP key and pull the infiltration pump out of the socket within the five second period indicated by the beeping sound If the infiltration pump cannot be removed with this special procedure please inform the technical service of Human Med Human Med does not assume any liability for damage to the device caused by other unauthorized attempts to remove a jammed infiltration pump Vill 2 Error messages and audible signals In the event of malfunctions the operation of the device must be immediately terminated by pushing the STOP key Error messages In case of a stoppage by pushing the STOP key the flow generation and vacuum built up are deactivated automatically The unlocking mechanism and the weighing system however keep functioning A signal is to be heard and the word STOP
50. pump 7 Remove the reusable WAL cannula from the hand piece of the WAL Applicator and let it be reprocessed immediately 8 Switch the body jet off Cut the device from power supply by pulling the power plug Human Med AG Doc No 900018 User manual for body jet Page 7 0 Chapter VII Rev Date 09 21 05 2012 Content VII Cleaning disinfection and storage after operation 1 VII 1 Before cleaning and disinfection 1 VII 2 Cleaning and disinfection 1 VII 3 After cleaning and disinfection 2 Human Med AG Doc No 900018 User manual for body jet Page 7 1 Chapter VII Rev Date 09 21 05 2012 VII 1 Before cleaning and disinfection Make sure that the device has been cut from power supply before starting with cleaning and disinfection by pulling the power plug WARNING Dispose of the single use WAL Applicator and the suction bag The system may contain germs harmful to health CAUTION The used WAL 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 con cerned VII 2 Cleaning and disinfection The body jet and the associated components must be thoroughly cleaned before reuse Do not use cleaning agents containing solvents for cleaning and dis infection
51. put the protection cap on the pricking pin again see Fig 43 Fig 43 The transfer tube A may now be pricked into the second liquid bag if available but before remove the protection cap from the pricking pin By opening and closing the tube clamps you select the liquid bag requested for surgical intervention The transfer tube A may also be fixed onto the rack by means of a tube clamp When infiltration solution saline is spilled onto the device or its compo nents wipe it off immediately and thoroughly with a soft cloth and warm waler ATTENTION VI 4 Venting of the WAL Applicator and attachment of the WAL cannula Before the cannula is attached the WAL Applicator must be vented as follows 1 Power on the body jet by actuating the master switch on the rear side of the device 2 Switch the flow generation to stand by by pushing the ON OFF button on the membrane keypad FLOW The stand by mode of the flow generation is con firmed by the blinking LED Set the flow range to RANGE 3 Activate the flow generation by actuating the foot bellows the green LED will be lit Now the applicator system is being vented and after a few seconds a straight pencil jet of fluid will be produced If no pencil jet of fluid is produced the WAL Applicator is defective and must be replaced V Take care to direct the water jet into a suitable container when venting the applicator system Never direct the water jet towa
52. r must acquaint himself with the appropriate flow rate settings for each application in literature studies _ and or trial tests Safety features Safe and reliable operation of the body jet is ensured by a series of built in safety features The flow build up is only possible after an audible click indicating that the infil tration pump has been inserted correctly The device has been designed in a way that gross operational errors are ex cluded The design of the disposable WAL Applicator doesn t allow its resterilization Human Med AG Doc No 900018 User manual for body jet Page 1 2 7 Chapter I and ll Rev Date 09 21 05 2012 The liquid flow will be stopped by a non return valve in case the foot bellows is not actuated Human Med AG Doc No 900018 User manual for body jet Page 3 0 Chapter III Rev Date 10 13 08 2013 Content lil Control elements and symbols lll 1 Control elements of the membrane keypad lll 2 Control elements on the front and on both sides of the device II 3 Control elements on the rear side of the device lll 4 Type label lll 5 Other symbols oOo ae A N Human Med AG Doc No 900018 User manual for body jet Page 3 1 Chapter III Rev Date 10 13 08 2013 il lt ALI n n le II Control elements and symbols II 1 Control elements of the membrane keypad 1 Vacuum gauge shows the current vacuum displ
53. rds persons WARNING The supplied cannulae are unsterile They must be thoroughly cleaned and sterilized before use Follow the reprocessing instructions for WAL cannulae provided with the cannulae WARNING Human Med AG Doc No 900018 User manual for body jet Page 6 9 Chapter VI Rev Date 09 21 05 2012 Before attaching the cannula to the hand piece of the WAL Applicator check to ensure that you are using the right cannula and that it is un damaged Do not use damaged cannulae WARNING Do not use a WAL cannula if the cannula tube is bent by more than 10 Cannula tubes that are bent by more than 10 could break Bent cannulae should not be re straightened as this could cause the can nula tube to break all bent cannulae should be taken out of use Note The venting procedure is to be repeated when replacing the WAL Applicator 5 Then attach the desired WAL cannula A to the hand piece of the WAL Applicator B as shown in Fig 44 The jet of fluid should now be flat and fan shaped and should come out of the nozzle at an angle see Fig 45 Fiq 44 Recommendation Treat the inside of the cannula handle A with surgical sill cone spray before attaching the cannula to the hand piece of the single use WAL Applicator B Note f the wrong cannula is used as shown in Fig 46 the test spray jet will not be fan shaped Fig 45 Correct spray pattern Fig 46 Incorrect spray patter
54. staff to safety 9 Significance of the user manual and training of medical staff II 10 Electrical safety and electromagnetic compatibility ll 10 1 Prevention of electrical shock oOo on A B O OO O WwW N N N N N ll 11 Particular safety instructions for use of the body jet Human Med AG Doc No 900018 User manual for body jet Page 1 2 1 Chapter I and ll Rev Date 09 21 05 2012 Water assisted lipoplasty WAL with the body jete In the water assisted lipoplasty method with the body jet a gentle pulsating fan shaped spray is used to apply saline during lipoplasty The water spray is introduced into adipose tissue to loosen the tissue structure and to release adipocytes During WAL with the body jet a flow generation system pipes the infiltration solution saline through a sterile closed tubing system into an infiltration cannula or irrigation aspiration cannula that can vary in diameter and arrangement of openings similar to other liposuction cannulae The settings for the flow generation can be adjusted in five levels RANGE 1 2 3 4 and 5 The body jet consists of a powered vacuum pump with a double piston a vacuum gauge for adjusting the vacuum pressure a safety trap an overflow protection bacte rial filter in the tube between the vacuum pump and the suction bag suction bags with integrated overflow protection bacterial filters two suction containers a connecting tube and infiltration and irrigat
55. t of the overflow protection bacterial filter The results of these safety checks must be recorded in the medical product book In case deficiencies are found during the safety checks which might endanger patients personnel or third parties the equipment must not be used until these deficiencies have been properly remedied by technical staff WARNING Human Med AG Doc No 900018 User manual for body jet Page 9 2 Chapter IX Rev Date 10 13 08 2013 IX 1 3 Modifications and replacement of components Modifications and the replacement of 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 met when changes to the struc tural and functional characteristics are not detrimental to safety IX 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 a safety inspection IX 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 A damage report must be drawn up Human Med grants their customers a warranty for supplied devices in accordance with the company s G
56. ter switch on the rear side of the device VI 6 Operation After a prick incision the aspiration irrigation cannula is inserted into the adipose tissue through the skin opening By operating one of the two foot bellows the flow generation unit is started and the water spray necessary to detach the fat cells is generated The required suctioning is done by opening and closing the bypass hole in the cannula handle The amount of liquid consumed during operation is displayed down on the right keypad panel Volume see Fig 55 Fig 55 Human Med AG Doc No 900018 User manual for body jet Page 6 13 Chapter VI Rev Date 09 21 05 2012 In order to activate this display the MEM key must be pressed before starting the operation see Fig 56 Fig 56 If the liquid consumption shall be indicated again the displayed values can be reset by one quick push on the MEM key The previous liquid con sumption is stored as memory value and indicated at the top of the display on the right keypad panel see Fig 57 This procedure may be repeated as often as re quired The total consumption is always shown at Fig 57 the top the amount of liquid consumed during the current operation is always shown down on the display of the right keypad panel Volume By pressing the MEM key for three seconds all dis played consumption values are reset to zero see Fig 58 The consumption values should be reset when liquid b
57. to a large extent on factors influenced by its user These factors are dealt with in the safety information of this chapter Human Med AG Doc No 900018 User manual for body jet Page 1 2 4 Chapter and II Rev Date 09 21 05 2012 lI 9 Significance of the user manual and training of medical staff Who should read this user manual The user manual represents an important part of the product safety concept There fore everyone who is concerned with e preparation e setup e operation e disassembly e cleaning and disinfection of the device including accessories must read the user manual and the instructions for use of the instruments This user manual is an inherent part of the body jet All users 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 all users may consult it at any time Before using the device each user must acquaint himself with the appropriate flow rate settings for each application in literature studies and or trial tests Training Only medical staff who has been properly trained in operation and handling of this equipment is allowed to use the body jet in strict ad herence to the present user manual WARNING The training is to be carried out only by personnel who are qualified on the basis of their knowledge and practical experience Human Med assumes no liability f
58. to place by ap plying slight pressure with the ball of the thumb see Fig 25 Human Med AG Doc No 900018 User manual for body jet Page 6 2 Chapter VI Rev Date 09 21 05 2012 It is snapped into place by asserting little more pres sure with the thumb itself see Fig 26 Note If the infiltration pump is not correctly inserted and snapped into place no flow can be generated Fig 26 Now fix the sealing cap hand tight by slightly turning it clockwise ja x a MES tie avda oa AA nn i i ie dn Fig 27 Attach the sealing cap Fig 27a Turn the sealing cap Fig 28 Fixed sealing cap clockwise VI 2 Insertion of the suction bag and connection of the suction tube VI 2 1 Connection of the suction containers Two suction containers of identical design are provided on the left and right side of the body jet for holding the single use suction bags The suction bags include a bac terial filter in the lid Prior to use always check the suction containers for cracks and other damages Do not use damaged containers A Suction container B Lid of the suction bag C Port for angle connector K L Sealing plug Fig 29 Human Med AG Doc No 900018 User manual for body jet Page 6 3 Chapter VI Rev Date 09 21 05 2012 D Vacuum hose with overflow protection bacterial filter E F Elbow plug connectors G Suction port K Angle connector
59. using the device a trial operation of all important functions must be performed V 3 1 Visual inspection e Thoroughly check the device and its components e g including removable parts such as cords cables and foot bellows for damage before use Do not use a damaged device or damaged components e Check the guarantee seal between the housing cover and the device housing and the type label on the rear side of the device The device must not be used when the labels are damaged V 3 2 Connection of the body jet e Connect the device to a properly installed grounded outlet see also chapter V 1 5 Power cord and power socket e Connect the foot bellows to the ports Number 26 in Fig 7 on page 3 4 see also Fig 11 on page 3 6 e Attach the rack with the weighing system to the body jet Human Med AG Doc No 900018 User manual for body jet Page 5 4 Chapter V Rev Date 09 21 05 2012 Ensure that the weighing system is pointing away from the membrane key pad when attaching the rack see Fig 16 ATTENTION Fiq 16 Correctly attached rack e Plug the connector of the weighing system in the respective socket Number 23 in Fig 6 on page 3 4 e Install the suction containers with the connecting tubing and the overflow pro tection bacterial filter on the right and on the left side of the device V 3 3 Device test after switch on The master switch is located on the rear side of the

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