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ACKERMANN 16-2000-700, Instructions For Use Manual

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USER MANUAL 16-2000-700/701/702/703 

Rev. 05/2018

Contents

1. Areas of use for the HF 16-2000-700 system.........................................................5

1.1 HF 16-2000-700 operating modes...................................................................5

2. Electrosurgery basics..........................................................................................6

2.1 Monopolar operation......................................................................................7
2.2 Bipolar operation..........................................................................................7

3. Symbol..............................................................................................................8
4. Device appearance and construction.....................................................................9

4.1 Front panel..................................................................................................9
4.2 Back panel.................................................................................................12
4.3 Main panel.................................................................................................13
4.4 Active panel – detailed view for a given output...............................................15

5. HF 16-2000-700 technical specifications..............................................................16
6. HF 16-2000-700 accessories list.........................................................................19
7. Preparing the system for work............................................................................20

7.1 Connecting power cables..............................................................................20
7.2 Pneumatic ducts connection..........................................................................23
7.3 Connecting accessories for electrosurgical procedures......................................25

7.3.1 Neutral electrode cable.......................................................................25
7.3.2 Instrument cable for universal ASD sockets...........................................26
7.3.3 Monopolar electrode cable with 3-pin plug.............................................26
7.3.4 Bipolar instrument cable for 2-pin sockets.............................................26
7.3.5 Argon duct........................................................................................27

7.4 Instrument detection...................................................................................27
7.5 Wireless footswitch receiver..........................................................................29

7.5.1 Operation with 3-button footswitch.......................................................30

7.6 Settings.....................................................................................................30

7.6.1 Working parameter adjustment............................................................32
7.6.2 Effect adjustment...............................................................................33
7.6.3 Argon flow settings.............................................................................34

7.6.3.1 Cautions for using argon-enhanced coagulation...............................36
7.6.3.2 Suggested settings......................................................................37

8. System operation and surgical procedures...........................................................39

8.1 Turning the system on.................................................................................39
8.2 Neutral electrode monitoring – the NEM SYSTEM.............................................39

8.2.1 Monitoring of application of split disposable neutral electrodes.................39
8.2.2 Split disposable electrodes..................................................................42
8.2.3 Non-split reusable electrodes...............................................................42
8.2.4 Neutral electrode application principles.................................................44

8.3 Operating mode selection.............................................................................46
8.4 HF 16-2000-700 system activation methods...................................................50

8.4.1 Activation from handle........................................................................50
8.4.2 Activation from footswitch:..................................................................50

Page: 3 of 134

Summary of Contents for 16-2000-700

Page 1: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 16 2000 700 701 702 703 ELECTROSURGICAL UNIT INSTRUCTIONS FOR USE ...

Page 2: ...the approval of the manufacturer The manufacturer will appreciate any errors or anything unclear in this operating manual being pointed out to us by users of our products Due to the continuing progress and development of our products we reserve all rights for technical alterations Rev 05 2018 SERVICE ADDRESS Ackermann Instrumente GmbH Eisenbahnstrase 65 67 78604 Rietheim Weilheim Germany SYMBOLS U...

Page 3: ...Monopolar electrode cable with 3 pin plug 26 7 3 4 Bipolar instrument cable for 2 pin sockets 26 7 3 5 Argon duct 27 7 4 Instrument detection 27 7 5 Wireless footswitch receiver 29 7 5 1 Operation with 3 button footswitch 30 7 6 Settings 30 7 6 1 Working parameter adjustment 32 7 6 2 Effect adjustment 33 7 6 3 Argon flow settings 34 7 6 3 1 Cautions for using argon enhanced coagulation 36 7 6 3 2 ...

Page 4: ...guage 77 8 13 3 Style change 78 8 13 4 Volume adjustment 78 8 13 5 Screen brightness change 79 8 13 6 Service 80 8 13 7 Restoring the suggested settings 80 8 13 8 Inspection due date 81 8 13 9 Contact 81 8 13 10 Maximum activation time 82 8 14 Turning the system off 82 9 Errors and messages 83 9 1 The most common errors during system operation 83 9 2 List of errors and messages 83 10 Protection me...

Page 5: ...e for sealing large blood vessels and for preparing tissues using special instruments 1 1 HF 16 2000 700 operating modes HF 16 2000 700 system may be equipped with the following operating modes MONO CUT standard monopolar cutting PRECISE CUT precise monopolar cutting MIXED CUT drying monopolar cutting MUCO CUT monopolar cutting for mucosectomy procedures POLIPO CUT endoscopic monopolar cutting pol...

Page 6: ...r sealing large blood vessels IMPORTANT NOTICE The availability of particular modes depends on the configuration of the unit 2 Electrosurgery basics Currently electrosurgery is a technique used in virtually all kinds of surgical procedures In order to use electrosurgery effectively it is necessary to learn and understand it and to apply the safety rules designed for maximum protection of both the ...

Page 7: ...and no unintended thermal effect occurs at the site of the neutral electrode application From the neutral electrode the HF current returns to the unit 2 2 Bipolar operation When the device operates in the bipolar mode HF current flows between two jaws of a bipolar instrument and concentrates exclusively on the small area located between them In the bipolar mode the dangerous flow of current throug...

Page 8: ...2 EEC Consult instructions for use The product may not be disposed of as normal domestic waste Follow the Instructions for Use Batch code Date of manufacture Fragile handle with care Do not use if package is damaged Ackermann electrosurgical devices are manufactured in protection class I CF It is the highest class of patient protection against electric shock from electromedical devices Type CF app...

Page 9: ...three universal ASD outputs with instrument detection Fig 1 items 1 3 and 4 and one monopolar output item 2 Fig 1 HF 16 2000 700 frontside view Version I The front panel of the HF 16 2000 700 system Version I contains the following items Fig 1 stand by button 7 main view button 8 touch panel screen 9 universal ASD output with instrument detection socket one 1 monopolar output socket two 2 universa...

Page 10: ...wing items Fig 2 universal ASD output with instrument detection socket one 1 universal ASD output with instrument detection socket two 2 universal ASD output with instrument detection socket three 3 universal ASD output with instrument detection socket four 4 argon output 5 neutral electrode socket 6 stand by button 7 main view button 8 Version III of the HF 16 2000 700 system is also available wi...

Page 11: ... 2018 Fig 3 Equipment connection sockets universal ASD output with instrument detection 1 monopolar output 2 universal ASD output with instrument detection 3 bipolar output 4 argon output gas outflow 5 neutral electrode socket 6 Page 11 of 134 ...

Page 12: ...l footswitch socket for all outputs 1 footswitch socket for one of the inputs by default it is assigned to the third ASD output 2 RS service port 3 USB port 4 wireless footswitch receiver module 5 speaker 6 additional grounding pin 7 argon supply input I 8 argon supply input II 9 power cable input 10 fuse socket 11 main power switch 12 manufacturer s rating plate 13 Page 12 of 134 ...

Page 13: ...ocket has an assigned control panel Fig 5 items 1 2 3 4 Fig 5 The main panel The main panel in the basic configuration of the HF 16 2000 700 system Fig 5 output I control panel 1 output II control panel 2 output III control panel 3 output IV control panel 4 neutral electrode indicator NEM 5 argon indicators and argon flow settings panel 6 Menu button 7 MultiSwitch indicator 8 icon of wireless foot...

Page 14: ...ed panel Fig 6 Control panel for output 1 Fig 6 shows the control panel for output 1 where output 1 window 1 footswitch control selection button 2 cutting mode icon 3 power limit for the selected cutting mode 4 effect level for the selected cutting mode 5 coagulation mode icon 6 power limit for the selected coagulation mode 7 effect level for the selected coagulation mode 8 detection status of the...

Page 15: ... a given output Fig 7 contains output selection button for footswitch control 1 2 3 4 cutting mode icon 5 restoring the suggested settings for a selected cutting mode 6 coagulation mode icon 7 restoring the suggested settings for a selected coagulation mode 8 exit from the detailed view for a given output 9 argon flow settings button 10 wireless footswitch icon 11 power monitor 12 Page 15 of 134 ...

Page 16: ...ting with adjustable degree of haemostasis The mode is available in monopolar and ASD outputs 9 effects Up to 350 W PRECISE CUT Precise cutting with adjustable degree of haemostasis The mode is available in monopolar and ASD outputs 9 effects Up to 50 W MIXED CUT Drying cutting with adjustable degree of haemostasis in the cutting phase with adjustable cutting time and coagulation time 0 05 0 25 s ...

Page 17: ... intensity The mode is available in monopolar and ASD outputs 9 effects Up to 200 W FORCED COAG Forced coagulation with adjustable coagulation intensity The mode is available in monopolar and ASD outputs 9 effects Up to 200 W HYBRID COAG Universal coagulation with adjustable coagulation intensity The mode is available in monopolar and ASD outputs 9 effects Up to 200 W SPRAY COAG Spray non contact ...

Page 18: ...4S 349 04S tools connected 9 levels ARTRO BI CUT Arthroscopic cutting in conductive liquids The mode is available in ASD outputs with 58S xxx 351 05S 351 13S 351 15S tools connected 9 levels SOFT BI COAG Bipolar coagulation The mode is available in bipolar and ASD outputs 9 effects Up to 120 W FORCED BI COAG Forced bipolar coagulation The mode is available in bipolar and ASD outputs 9 effects Up t...

Page 19: ... MPa on argon cylinder OTHER Device dimensions 495 x 415 x 225 mm with display Weight 12 2 kg WORKING LIFE 10 YEARS IMPORTANT NOTICE The technical specifications listed in the table may change as our products develop 6 HF 16 2000 700 accessories list Table 2 Standard equipment of the HF 16 2000 700 system No ITEM DESCRIPTION QUANTITY 1 Power cable 4 m 1 2 Instructions for use 1 3 Electrosurgical e...

Page 20: ...pply socket is located on the back panel of the casing Fig 4 item 10 The system does not require connecting any additional grounding cable It is used for grounding if power supply without grounding is used or in places where the electric shock protection system requires it The footswitch is connected to the universal socket Main footswitch in the back panel of the device casing it allows to contro...

Page 21: ...tton footswitch MultiSwitch wireless 2 button footswitch MultiSwitch wired 2 button footswitch wireless 3 button footswitch MultiSwitch For information about connecting a wireless footswitch see section 7 5 How to connect accessories to the universal outputs Fig 1 items 1 3 with the Smart Device instrument detection system is explained in Fig 9 The method of connecting accessories to the monopolar...

Page 22: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 Fig 9 How to connect accessories to outputs 1 and 3 ASD in the HF 16 2000 700 system Version I Page 22 of 134 ...

Page 23: ... under pressure is connected The gas is drawn from the inlet where an argon cylinder is connected or from inlet 1 if two cylinders are connected If the regulator is equipped with cylinder pressure measurement the gas will first be drawn from the lower pressure cylinder If two argon cylinders are connected when the gas is depleted in one cylinder the device will automatically switch to the other cy...

Page 24: ...00 701 702 703 Rev 05 2018 Fig 11 How to connect the argon ducts to the HF 16 2000 700 system Fig 12 How to connect argon to the HF 16 2000 700 system For more information about argon ducts see section 7 6 3 Page 24 of 134 ...

Page 25: ...ich allow performing various procedures in the fields of general and vascular surgery gynaecology oncology and many others The following accessories can be connected to the sockets on the front panel of the system 7 3 1 Neutral electrode cable The connection output of the neutral electrode output is made in compliance with the USA standard Fig 1 item 6 Disposable Neutral electrode plug Reusable Ne...

Page 26: ... Fig 1 item 2 Active monopolar electrode handle plug The active electrode plug handle is compatible with standard monopolar cables and electrode handles with the following diameters 4 mm with handles of 4 mm in diameter 2 4 mm with handles of 2 4 mm and 4 mm in diameter with an adapter for 2 4 mm electrodes 7 3 4 Bipolar instrument cable for 2 pin sockets The socket of the bipolar output is made i...

Page 27: ...ect and identify the connected instrument IMPORTANT NOTICE Instrument detection applies only in the case of instruments with ASD plug The instrument detection system identifies the connected accessories and automatically adjusts the operating mode and settings It also remembers the last used settings for each instrument and remembers the last settings when using the instrument again After connecti...

Page 28: ...imum usable power for those instruments that need it It is impossible to exceed the upper limit of the assigned power This increases the safety of work and reduces the risk of damaging an instrument by using too high power settings Fig 14 shows data on the instrument connected to the system To display these data touch the instrument detection status window panel Fig 5 item 9 They contain instrumen...

Page 29: ...t of cabling in the operating room is reduced IMPORTANT NOTICE Two footswitches can be connected simultaneously to the HF 16 2000 700 system It is possible to freely configure the wired and wireless footswitches The wireless footswitch for the HF 16 2000 700 system is adapted with a dongle The dongle should be connected to the footswitch socked in the back panel of the system Fig 4 item 1 or 2 It ...

Page 30: ...panel output OUT 3 MultiSwitch button can be used to remote change of either the program or effect power Section 7 6 2 7 6 Settings The settings are made independently for each output and for each program The types of available settings assigned to each mode are presented in the Table 3 It is possible to change the settings using the footswitch Section 8 11 2 The MultiSwitch function The list of a...

Page 31: ... flow l min DUAL CUT Effect Power W BI CUT Effect Power W URO BI CUT Effect HYSTERO BI CUT Effect ARTRO BI CUT Effect SOFT COAG Effect Power W FORCED COAG Effect Power W HYBRID COAG Effect Power W SPRAY COAG Power W ENDO SPRAY Power W URO COAG Effect ARTRO COAG Effect HYSTERO COAG Effect DUAL COAG Effect Power W STANDARD ARGON Power W Argon flow l min ENDO ARGON Power W Argon flow l min PULSE ARGO...

Page 32: ...power depending on the operating conditions A processor measures all operating parameters in real time and adjusts the output power on an ongoing basis so as to obtain the selected effect The power level set by the user and visible on the screen in the upper power limit for a given mode The power limit and the effect are set independently for cutting and coagulation modes They are set independentl...

Page 33: ...ssible also by handle and by MultiSwitch button on the footswitch a adjustment by the handle To activate this function simultaneously press buttons yellow and blue on the handle Window with adjusted parameter will appear on the screen Yellow button increases the effect power blue button decreases the effect To exit the adjustment mode wait for a moment without pressing any buttons b adjustment by ...

Page 34: ...e icon labelled Argon Fig 7 item 10 The argon flow adjustment option for a given mode and the argon duct priming icon will appear on the screen To change the argon flow settings touch the appropriate arrows on the argon flow scale Before starting work fill up the argon ducts with the gas by pressing the PURGE icon In argon enhanced endoscopic coagulation modes the argon flow can be adjusted in a l...

Page 35: ...of argon enhanced coagulation 7 argon flow adjustment for coagulation 8 argon flow setting value for cutting 9 argon flow setting value for coagulation 10 exit 11 IMPORTANT NOTICE The argon enhanced modes are only available for outputs 1 and 2 Fig 1 items 1 2 When two argon cylinders are connected they are switched automatically When the gas in cylinder no 1 is depleted the system switches itself ...

Page 36: ...RNING PERFORMING ARGON ENHANCED LAPAROSCOPIC PROCEDURES IS ONLY ALLOWED WITH INSUFFLATORS HAVING A PRESSURE NIVELATION FUNCTION In case of doubt consult the insufflator supplier to confirm that the insufflator has such function IMPORTANT NOTICE To prevent sudden increase in insufflation pressure during argon application the trocar valve should be open If the pressure reaches the critical level sto...

Page 37: ...s for each procedure The settings can differ depending on the needs Ackermann made every effort to determine the optimum suggested settings Open surgery Argon enhanced coagulation STANDARD ARGON mode gas flow 5 0 l min coagulation power 35 W Argon enhanced cutting ARGON CUT mode gas flow 5 0 l min cutting power 250 W effect 3 Laparoscopy and endoscopy SUGGESTED SETTINGS gas flow 1 5 l min coagulat...

Page 38: ... result on the tissue Power is adjusted automatically to achieve the chosen effect and the value shown on screen is the upper limit of power generated by the HF unit The device has a power monitoring tool that shows the actual generated power on the output Power Monitor Fig 17 Power Monitor The illustration below shows the power measurement graph Last 60 seconds of activation is displayed includin...

Page 39: ...in screen in divided into four panels which correspond to the respective connection sockets of the system Following safety rules accessories may also be connected while the system is on In this case pay attention to prevent the possible activation of the system by accidental pressing of the handle button or the footswitch 8 2 Neutral electrode monitoring the NEM SYSTEM 8 2 1 Monitoring of applicat...

Page 40: ...t the power to max 150W while using 16 2000 1212SMFL electrode Neutral electrodes other than those mentioned above may not function properly with the NEM neutral electrode safety system The manufacturer is not responsible for the use of Ackermann electrosurgical devices with neutral electrodes other than those mentioned above or for any incidents resulting from such use Before starting the procedu...

Page 41: ...ing the operation of the generator If system activation is attempted in case of inadequate application of the divided neutral electrode an error message will be displayed on the screen Then neutral electrode connection should be checked The figure below informs about neutral electrode error Fig 20 Incorrectly connected neutral electrode IMPORTANT NOTICE The neutral electrode monitoring system does...

Page 42: ...e the conductive substance dries out and does not ensure sufficient conduction Disposable electrodes should be applied carefully When applying the neutral electrode make sure that its longer side faces the operative field This requirement does not apply to ACK Safe electrodes which have a special construction and can be applied in any position If it is necessary to attach the electrode at a differ...

Page 43: ...m is monitored CAUTION The neutral electrode should never be wet or wrapped with anything Do not spread additional conductive gels on the surface of the neutral electrode When disconnecting the neutral electrode never do so by pulling the cable Do not under any circumstances try to repair the neutral electrode yourself RECOMMENDATION Examine the condition of the electrode and the connection cable ...

Page 44: ...t apply the electrode on excessively hairy skin shave the application area if necessary Do not use at sites with excessive fatty tissue e g the abdomen or buttocks Do not apply the neutral electrode over implants When disconnecting the neutral electrode never do so by pulling the cable The neutral electrode cannot touch any conductive elements e g metal parts of the table RECOMMENDATION The neutra...

Page 45: ...EL ELECTRODE APPLICATION SITES incorrectly correctly Correct sites of neutral electrode application in patients with a cardiac pacemaker Correct sites of neutral electrode application in adult patients Correct sites of neutral electrode application in a child Page 45 of 134 ...

Page 46: ...ction bar indicating the instrument connected to output 3 Fig 21 Operating mode selection step 1 If an ASD instrument is connected to an output with the instrument detection system Fig 1 items 1 3 4 the device will automatically limit the list of available modes see section 7 4 and will set the suggested mode for the connected instrument STEP 2 Expand the list of available modes by touching any cu...

Page 47: ...the operating mode which is appropriate for the procedure by clicking on the bar with the selected mode name To confirm the selected mode double click the bar with the mode name or click the exit window or the exit button exit window operating mode selection exit button Fig 23 Operating mode selection step 3 Page 47 of 134 ...

Page 48: ...mode selection step 4 IMPORTANT NOTICE There are always two active modes on the panel one cutting mode and one coagulation mode If the user intends to use only one operating mode cutting or coagulation it is recommended to set the inactive status for the other mode for safety reasons The inactive status mode prevents from accidental use To set the inactive status to a mode select the inactive wind...

Page 49: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 inactive modeFigure f modes Fig 25 List o with an inactive mode Panel appearance with an inactive mode Fig 26 Panel with an inactive mode Page 49 of 134 ...

Page 50: ...tting and the blue button is used to activate coagulation 8 4 2 Activation from footswitch a universal socket for footswitch which is supporting all outputs Fig 4 item 1 when using the switch connected to this socket it is possible to activate the cutting and coagulation modes in all four outputs of the system The output indicated using the footswitch controlled output selection button is activate...

Page 51: ...when using the AutoStop function For more details see 8 8 1 The AutoStart and AutoStop functions in bipolar coagulation 8 5 Monopolar cutting Depending on software version the HF 16 2000 700 system is equipped with the following monopolar cutting modes MONO CUT Monopolar cutting with various haemostasis effects Effect 1 is mainly used to cut the tissues when no additional bleeding control is neces...

Page 52: ...t enables safe and effective dissection of tissues Instrument endoscopic mucosectomy knife POLIPO CUT Monopolar cutting for endoscopic procedures Necessary for polyp removal Alternating cutting and coagulation allow to obtain optimum coagulation and reduce the risk of bleeding This mode is described in detail in section 8 5 2 Instrument loops for polypectomy PAPILLO CUT Monopolar cutting for endos...

Page 53: ...des are available only from output I and output II DUAL CUT Monopolar cut in simultaneous mode Cutting with 9 different effects of haemostasis Enables the activation of two monopolar handles simultaneously therefore two operators can perform action at the same time Specialistic mode applied i e in cardiac surgery Instrument monopolar electrodes e g knife loop needle Cutting is usual performed usin...

Page 54: ...ting and soft coagulation It is used for very strong coagulation during procedures involving severe bleeding where tissue drying is necessary To enable this mode select the appropriate cutting type button Power and effect settings For this mode cutting power and effect can be adjusted The settings are made on the panels corresponding to cutting for the selected output additional settings field cut...

Page 55: ...me in a cycle Suggested settings for the MIXED CUT mode Effects 4 Power 120 W Cutting time 0 06 s Coagulation time 0 15 s 8 5 2 Polypectomy and Papillotomy Intended use Special cutting modes for endoscopic procedures In this mode the coagulation and cutting are performed alternately enabling tissue coagulation and cutting with an endoscopic instrument The typical applications include polypectomy a...

Page 56: ...n endoscopic procedures Level 9 indicates the highest safe cutting and coagulation level in endoscopic procedures The power settings in this mode are selected automatically for each level to obtain a repeatable endoscopic cutting effect regardless of tissue parameters Percentage settings Before starting the procedure set the correct cutting level and percentage CUTTING on the panel corresponding t...

Page 57: ... one cycle click the additional settings icon To change the cycle time settings touch the keys on the scale indicated by arrows loop closing detection adjustment of cutting adjustment of cutting percentage in a cycle adjustment of cutting adjustment of coagulation time time Page 57 of 134 ...

Page 58: ...n This function is disabled by default You can turn it on by touching the Endo Detect button To disable the detection touch this button again WARNING Enabling this function reduces the risk of operator s error It prevents accidental activation of a loop which is not closed on the tissue thus reducing the risk of perforation CAUTION NOTE do not use the Endo Detect function when removing polyps smal...

Page 59: ...l spatula lancet FORCED COAG Monopolar contact coagulation The traditional type of coagulation which allows for quick and efficient coagulation of local bleeding Instrument monopolar electrodes e g ball spatula lancet HYBRID COAG Monopolar coagulation for contact and non contact applications with high voltage Instrument monopolar electrodes e g ball spatula lancet SPRAY COAG Non contact monopolar ...

Page 60: ... monopoloar histeroscope loop or ball electrodes URO COAG Urological monopolar coagulation coagulation TURP TURBT in non conductive liquids e g purisol or glucose Instrument monopolar resectoscope loop or ball electrodes DUAL COAG Monopolar coagulation in simultaneous mode Monopolar contact coagulation with 9 different effects enables fast and effective coagulation of bleeding area Enables the act...

Page 61: ... flexible argon probes NOTE Argon modes are available only from output I ASD and output II monopolar or ASD depending on the configuration PULSE ARGON Argon enhanced pulse monopolar coagulation It is used in gastroenterology for bleeding control It enables precise dosing exactly at the bleeding site Instrument flexible argon probes see section 7 6 3 NOTE Argon modes are available only from output ...

Page 62: ...wer The settings are made on the panels corresponding to coagulation for the selected output To adjust argon flow settings touch the Argon icon see section 7 6 3 When working in this mode pulse time can be adjusted To adjust the pulse time select the advanced settings icon advanced settings To adjust the pulse time use the arrows on the touch panel pulse time adjustment This time can be adjusted f...

Page 63: ...nction is available in two modes DUAL CUT and DUAL COAG DUAL CUT MONO CUT 9 effects max output power 350 W DUAL COAG FORCED COAG 9 effects max output power 200 W DUAL CUT and DUAL COAG modes are available on 1st and 2nd socket of unit i e OUT1 ASD and OUT2 ASD or 3 pin monopolar To make the simultaneous work modes appear in the menu it is neccessary to activate the OUT1 ASD socket must be connecte...

Page 64: ...oose a different mode than the first operator the HF 16 2000 700 informs user that desired mode is unavailable at the moment This action doesn t affect or disturb the work of first operator AUTOMATIC POWER LEVEL ADJUSTMENT When using simultaneous modes the power level is set automatically for both instruments to obtain the desired effect The power output parameter shown on the screen is the upper ...

Page 65: ...for TURP and TURB procedures Instrument bipolar urological resectoscope HYSTERO BI CUT Bipolar cut for gynaecological procedures hysteroscopy in conductive liquids saline solution or Ringer s solution Instrument bipolar histeroscope resectoscope loop electrode ARTRO BI CUT Bipolar cutting for arthroscopic procedures This mode is used in wet environment It requires the use of conductive fluids e g ...

Page 66: ...ctrode is required The typical use is for closing medium sized blood vessels Instruments bipolar forceps bipolar needle electrodes bipolar laparoscopic instruments ARTRO BI COAG Arthroscopic bipolar coagulation in conductive liquids e g saline solution Instruments bipolar arthroscopic electrodes SCISS BI COAG Universal soft bipolar coagulation for cutting with bipolar scissors Instruments bipolar ...

Page 67: ...e automatic activation after grasping the tissue is possible After grasping the tissue and the set delay the generator is turned on It is stopped when the forceps are opened or after a specified time when using the AutoStop function 8 9 1 The AutoStart and AutoStop functions in bipolar coagulation The AutoStart and AutoStop functions are available for low voltage bipolar coagulation SOFT BI COAG m...

Page 68: ...ed This function can be enabled in the bipolar coagulation settings It allows for bipolar work without using a footswitch The delay between tissue grasping and generator activation can be set in the range from 0 05 to 3 s default 0 5 s using the time adjustment buttons The AutoStart function is turned off by default after each system start up The AutoStop function limits the time of bipolar coagul...

Page 69: ... coagulation appears on the instrument Suggested settings Effect 3 Power 80 W for laparoscopic procedures Power 150 200 W for open surgery In the VesSeal mode the set power means the maximum power However when using laparoscopic instruments we suggest to limit the power to 80 W Nevertheless please take into account the fact that despite common opinion setting too low power causes excessive heating...

Page 70: ...the settings to obtain a stronger coagulation effect Figure 29 Message The allowed VesSeal time has been exceeded It is recommended to check if the power and effect settings are close to those suggested If the clamp is applied incorrectly the following message will appear on the screen Figure 30 Message The allowed VesSeal time has been exceeded The above message means that the coagulation process...

Page 71: ...eration This means the system cannot be covered with anything during operation If the system rests on a shelf ensure that there is at least 2 cm of clearance above the device A failure to ensure the appropriate cooling conditions will cause overheating to occur earlier and to last longer Do not put any objects on the device Due to the risk of flooding the system should be installed above and at a ...

Page 72: ...cording method To define your own programs select the program management bar on the touch panel program management bar Figure 32 Program management bar A window for program management will appear on the screen Figure 33 Program management window Page 72 of 134 ...

Page 73: ...ter the new name and confirm with the enter button Double click on the Shift button enables the CapsLock function To exit program management select the exit button exit button confirmation of the entered name Figure 34 Giving names to programs and groups The MultiSwitch button at the program name Fig 33 item 3 is used to add remove the MultiSwitch function to from the list of programs for the curr...

Page 74: ... 2 The MultiSwitch function The MultiSwitch function allows to switch the programs rapidly using a three button footswitch To switch the programs currently added to the MultiSwitch list press the middle button of the footswitch The number of programs in the list is indicated on the button Fig 33 item 5 The number of the currently selected program is next to the program name Fig 33 item 1 The Multi...

Page 75: ...ure 36 Effect adjustment using the footswitch The MultiSwitch button may also be used to change the program Press the button shortly to make the change which is indicated on the screen Figure 37 Program change using the MultiSwitch button Page 75 of 134 ...

Page 76: ...Menu button on the main panel allows to use the following tools Catalogue Language Style Volume Screen brightness Recommended settings Service Contact Inspection due date Maximum activation time To enter a tool click one of the following icons Figure 38 Menu content Page 76 of 134 ...

Page 77: ...ommercial visit 8 13 2 Change of text and message language The HF 16 2000 700 system offers an option of selecting the language for texts and messages that appear on the touch panel of the system To change the language click the field with the selected language version Depending on system version the language versions may differ However there are always two basic versions i e Polish and English Fi...

Page 78: ... select the Appearance icon then indicate the style which is the most appropriate for the user s current needs Sunset 3D Night Sunset Figure 41 Style change 8 13 4 Volume adjustment The volume of the acoustic signals of the interface can be adjusted by the user To reduce increase the volume touch the respective button on the volume scale It is possible to enable or disable voice messages by touchi...

Page 79: ...e alarm sounds always remain at the same volume level regardless of volume adjustments 8 13 5 Screen brightness change The HF 16 2000 700 system offers an option to adjust screen brightness To adjust brightness touch the Screen brightness icon and increase or decrease screen brightness as required using the arrows brighter darker Figure 43 Screen brightness adjustment Page 79 of 134 ...

Page 80: ...is required Figure 44 Access to service settings 8 13 7 Restoring the suggested settings The Suggested settings icon allows to return to the factory suggested settings All settings of the programs and groups in the system are deleted restoring the suggested settings cancelling the suggested settings restore function Figure 45 Restoring the suggested settings Page 80 of 134 ...

Page 81: ...date The Inspection due date icon allows to check inspection validity There you can find informations about earlier inspections Figure 46 Inspection due date 8 13 9 Contact This icon contains contact details for the manufacturer s address Figure 47 Contact Page 81 of 134 ...

Page 82: ...vation time 8 14 Turning the system off When the procedure is completed turn the system off using the stand by button press and hold it for about 1 second Fig 1 item 7 then using the power switch Fig 4 item 12 and disconnect the power cord from the power outlet After switching the system off disconnect the electrodes and forceps from the cables then disconnect the electrode cables from the system ...

Page 83: ...r message is displayed when the system is turned on example message Act according to instructions on the screen 3 I cannot find the operating mode of interest The instrument detection status window signals a connected instrument The mode is not listed Use a different instrument compatible with the desired operating mode 4 Why can t I set higher power The connected instrument limits the maximum all...

Page 84: ... has locked for safety reasons Contact the service ACCESSORY ERROR Shorted switch on the handle Please release the handle button If the button is released and the system continues to display the message the accessory is damaged Connect a functioning accessory Page 84 of 134 ...

Page 85: ...e informing about the lack of argon Refill the argon FOOTSWITCH ERROR Shorted button on the footswitch Please release the footswitch button If the message is still displayed the cutting button on the footswitch is damaged Connect a functioning footswitch Page 85 of 134 ...

Page 86: ...EM COOLING The system is cooled to protect it from overheating see section 8 9 The system forces an interruption in the procedure until the indicator turns off about 30 seconds AUTOSTOP The message informs that AutoStop has stopped working Page 86 of 134 ...

Page 87: ...ecting the appropriate checkbox on the touch panel cancels the set modes in the programs and groups and returns to the factory settings in the entire system NEUTRAL ELECTRODE APPLICATION Check the neutral electrode connection For additional information see sections 8 2 1 Page 87 of 134 ...

Page 88: ...e informing that a non closed loop has been detected Please check loop application CLAMP APPLIED INCORRECT The VesSeal clamp has not been applied correctly Please check if the correct output is activated if the forceps are clean and if they are assigned to the correct output Page 88 of 134 ...

Page 89: ...700 701 702 703 Rev 05 2018 EXCEEDING THE ALLOWED VesSeal TIME The vessel has not been closed Please re apply the clamp VesSeal AUTOSTOP A message informing about the correct termination of the VesSeal work Page 89 of 134 ...

Page 90: ...L 16 2000 700 701 702 703 Rev 05 2018 BIPOLAR ACCESSORY ERROR The bipolar instrument is shorted Please open the instrument branches INSPECTION OVERDUE Inspection overdue Please contact our service Page 90 of 134 ...

Page 91: ...stop After reactivation the time is calculated from the start SIMULTANEOUS WORK When second of two operators choose a different mode than the mode already activated by the first operator the HF 16 2000 700 will inform user that desired mode is unavailable at the moment This action doesn t affect or disturb the work of first operator Page 91 of 134 ...

Page 92: ... the hand touching the thigh h the neutral electrode should be applied as close as possible to the procedure site but not closer than 20 cm from the operating field 10 2 When planning surgeries that cannot be safely completed in the case of basic electrosurgical system failure a complete and ready to use substitute electrosurgical system should be prepared 10 3 When performing procedures on patien...

Page 93: ...frequency current Place where the high frequency current cumulates Risk of burns 10 7 The output power setting should not be greater than necessary for performing a given procedure 10 8 An error of an electrosurgical device may result in undesirable increase in output power and inadvertent damaging of patient s tissues A yearly technical inspection of the device in an authorized manufacturer s ser...

Page 94: ...nt for a short time at short time intervals Before using electrosurgery consult an authorised representative for the heart pacemaker and a cardiac surgeon Check the pacemaker thoroughly after the procedure Use of electrosurgery systems on patients with heart pacemakers is not permitted under outpatient clinic conditions 10 16 High frequency leakage currents can cause burns at a distance from the e...

Page 95: ...splayed see section 9 with an alarm sound MECHANICAL FAILURES In the event of damage to the sockets switches casing or film keyboard or if the device is dropped the contact an authorised service before further use The manufacturer s authorised service can perform a more detailed technical inspection SERVICE Electrosurgical unit is a device classified in the highest used risk class of a medical dev...

Page 96: ...stallation and staff training should be performed by an authorised representative of Ackermann Each participant of such training receives a certificate which entitles him her to use Ackermann electrosurgical unit These procedures are mandatory More information on the authorised services may be obtained from the manufacturer Service Ackermann Instrumente GmbH Eisenbahnstr 65 67 78604 Rietheim Weilh...

Page 97: ...00 Vp BI CUT 1000 Vp URO BI CUT 500 Vp HYSTERO BI CUT 500 Vp ARTRO BI CUT 450 Vp SOFT COAG 225 Vp FORCED COAG 1 5 kVp HYBRID COAG 1 7 kVp SPRAY COAG 5 7 kVp ENDO SPRAY 2 6 Vkp URO COAG 1 5 kVp ARTRO COAG 1 5 kVp HYSTERO COAG 1 5 kVp DUAL COAG 1 5 kVp STANDARD ARGON 5 7 kVp ENDO ARGON 5 7 kVp PULSE ARGON 5 7 kVp SOFT BI COAG 225 Vp FORCED BI COAG 1 kVp URO BI COAG 175 Vp HYSTERO BI COAG 175 Vp ARTR...

Page 98: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 OUTPUT GRAPHS IMPORTANT NOTICE The presented graphs could change with the development of our products Page 98 of 134 ...

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Page 101: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 Page 101 of 134 0 500 1000 1500 2000 2500 0 50 100 150 200 250 300 350 400 450 MUCO CUT level 5 level 9 Resistance Ω Power W ...

Page 102: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 Page 102 of 134 Object 2 1 2 3 4 5 6 7 8 9 0 50 100 150 200 250 300 350 400 450 MUCO CUT R 135 ohm P W Level Power W ...

Page 103: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 Page 103 of 134 0 500 1000 1500 2000 2500 0 50 100 150 200 250 300 PAPILLO CUT Resistance ohm Power W ...

Page 104: ...USER MANUAL 16 2000 700 701 702 703 Rev 05 2018 PAPILLO CUT Page 104 of 134 1 2 3 4 5 6 7 8 9 700 720 740 760 780 800 820 840 860 880 900 Vppcut Level Power cut V ...

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Page 129: ...vice STERILISATION OF ACCESSORIES IMPORTANT NOTICE Sterilization should be adapted to the supplier s recommendations for a specific accessory The supplied accessories unless otherwise noted are not sterile and require sterilisation before they can be used Unless marked otherwise the electrosurgical accessories offered may be steam sterilised at up to 134 C and a pressure of 0 2 MPa 2 Bar When usin...

Page 130: ...EX Schuelke Mayr Gigasept FF Lysetol FF Anios Aniosyme PLA Salvanios PH10 The following agents are recommended for disinfecting neutral silicone electrodes Manufacturer Product Henkel Hygiene Incidin perfekt Minutil Incidur F 12 1 2 Mechanical washing Manufacturer Product Henkel Hygiene Sekumatic FR Washing Sekumatic FRE Washing Sekumatic FD Disinfection Schuelke Mayr Thermosept RKF Washing Thermo...

Page 131: ...etic environment specified below The customer or the user of the HF 16 2000 700 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 2 The HF 16 2000 700 must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected When HF 16 2000 700 is not activated...

Page 132: ...5 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycle 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 cycles Mains power quality should be that of a typical commercial or hospital environment If it is necessary to continue the operation during mains power interruptions it is recommended that the HF 16 2000 700 is powered from an uninterruptible power supply or a battery Power frequency...

Page 133: ... as re orienting or relocating the HF 16 2000 700 b Over the frequency range 150 kHz to 80 MHz fields strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and HF 16 2000 700 HF 16 2000 700 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of HF 16 20...

Page 134: ...ith domestic waste The user is obliged to dispose of a broken or redundant electrical or electronic device at a dedicated collection point place it in a special container or possibly return it to the seller The details are set forth in the relevant national laws This obligation is indicated on the product packaging or in the manual in the form of a crossed out waste bin By sorting waste for recycl...

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