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USER MANUAL 16-2000-120

 Rev. 02/2016

CONTENTS

 

       

 

                                                                                                                                          PAGE

1.

INTENDED USE                                       

 

                                                                                                  

 

 

5

2.

ELECTROSURGERY BASICS                                                                                                                  

 

 

6

2.1.

MONOPOLAR

 

    OPERATION                                                                                                             

 

6

2.2.

BIPOLAR OPERATION                                                                                                                     

 

 

6

3.

 TECHNICAL SPECIFICATIONS                                                                                                                

 

 

7

4.

 SYMBOLS IN THE INSTRUCTION FOR USE AND ON THE

 

    UNIT                                                          

 

 

9

5.

ACCESSORIES FOR

 

    ELECTROSURGICAL

 

        PROCEDURES                                                                  

 

 

9

5.1.

NEUTRAL

 

    ELECTRODE CABLE                                                                                                   

 

   

  

1

  

0

5.2.

INSTRUMENT CABLE                 

 

 

                                                           

 

 

                                         

 

 

1

  

0

5.3.

ACKERMANN SMART DETECTION

 

                                                              

 

                                 

 

 

................................

 

  

  

10

5.4.

FOOTSWITCH                                                                                                                               

 

  

  

.

  

 

  

11

6.

LIST

 

    OF ACCESSORIES                                                                                                              

 

    .            

 

 

12

7.

UNIT APPEARANCE AND

 

    CONSTRUCTION                                                                                        

 

  

  12

7.1.

FRONT

 

        PANEL                                                                                                                              

 

  

  

.

  

 

  

12

7.2.

BACK

 

    PANEL                                                                                                                                 

 

   

  

13

8.

PREPARING THE UNIT

 

        FOR OPERATION                                                                                           

 

   

  13

8.1.

PLACING THE UNIT ON A TROLLEY (AS

 

        AN OPTION)                                                

 

                

 

 

...............

 

 

 

  13

8.2.

CONNECTING THE

 

    POWER CABLE                                                                             

 

                 

 

 

................

 

 

14

8.3.

CONNECTING

 

    ACCESSORIES                                                                                     

 

                  

 

 

.................

 

 

14

8.4.

LEVEL

 

        SETTINGS                                                                                                          

 

               

 

 

..............

 

 

  

  

15

9.

UNIT OPERATION AND

 

        ELECTROSURGICAL

 

        PROCEDURES                                                           

 

  

  

.

  15

9.1.

SWITCHING ON THE

 

        UNIT                                                                                            

 

                 

 

 

................

 

 

15

9.2.

VOLUME ADJUSTMENT                                                                                                 

 

                 

 

 

................

 

 

16

9.3.

NEUTRAL

 

        ELECTRODE

 

    MONITORING                                                                         

 

                 

 

 

................

 

 

16

9.3.1.

DISPOSABLE

 

   

  ELECTRODES                                                                      

 

                        

 

 

.......................

 

 

17

9.3.2.

REUSABLE 

 

    ELECTRODES                                                               

 

                     

 

 

....................

 

               

 

 

18

9.3.3.

NEUTRAL ELECTRODE

 

        APPLICATION

 

  

      PRINCIPLES                                         

 

               

 

 

..............

 

  

  

19

9.4.

UNIT

 

    OVERLOAD

 

    CONTROL                                                                                  

 

    

   

. .

                        

 

 

20

9.5.

MONOPOLAR

 

    CUTTING                                                                            

 

                

 

 

...............

 

                      

 

 

21

9.6.

MONOPOLAR

 

    COAGULATION                                                                  

 

                

 

 

...............

 

                     

 

 

 

  22

9.7.

BIPOLAR COAGULATION                                                                          

 

                

 

 

...............

 

                      

 

 

23

9.8.

SWITCHING OFF THE

 

        UNIT

 

                                                                          

 

               

 

 

..............

 

                    

 

 

  

  

24

10.

   PROTECTION MEASURES AND

 

        WARNINGS                                                    

 

                                  

 

 

25

11.

TECHNICAL 

 

 INSPECTION, WARRANTY

 

        AND

 

    SERVICE                                   

 

                                  

 

 

27

12.

UNIT AND

 

    ACCESSORIES

 

    MAINTENANCE                                                       

 

    .                                  

 

 

34

PAGE 3

 OF 39

Summary of Contents for 16-2000-120

Page 1: ...USER MANUAL 16 2000 120 HIGH FREQUENCY UNIT WITH 110V 220V for cutting and coagulation in surgical procedures ...

Page 2: ...y or in part without 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 02 2016 SERVICE ADRESS Ackermann Instrumente GmbH Eisenbahnstraße 65 67 78604 Rietheim Weilhe...

Page 3: ... THE UNIT FOR OPERATION 13 8 1 PLACING THE UNIT ON A TROLLEY AS AN OPTION 13 8 2 CONNECTING THE POWER CABLE 14 8 3 CONNECTING ACCESSORIES 14 8 4 LEVEL SETTINGS 15 9 UNIT OPERATION AND ELECTROSURGICAL PROCEDURES 15 9 1 SWITCHING ON THE UNIT 15 9 2 VOLUME ADJUSTMENT 16 9 3 NEUTRAL ELECTRODE MONITORING 16 9 3 1 DISPOSABLE ELECTRODES 17 9 3 2 REUSABLE ELECTRODES 18 9 3 3 NEUTRAL ELECTRODE APPLICATION ...

Page 4: ...1 1 MANUAL WASHING 34 12 1 2 MECHANICAL WASHING 35 12 1 3 AUTOCLAVE STERILIZATION 35 12 1 4 FORMALDEHYDE STERILISATION 35 13 ENVIRONMENTAL REQUIREMENTS 36 14 ELECTROMAGNETIC EMISSIONS 36 15 ENVIRONMENTAL PROTECTION GUIDELINES 39 SYMBOLS IN THIS INSTRUCTION FOR USE IMPORTANT INFORMATION WHAT TO DO WHAT NOT TO DO WARNING PAGE 4 OF 39 ...

Page 5: ... intended for cutting and coagulation in surgical procedures The 16 2000 120 unit enables the following operation modes pure cutting cutting with hemostasis soft coagulation forced coagulation bipolar coagulation The unit is equipped with a CF floating output so that it can be used on the central nervous system and the heart PAGE 5 OF 39 ...

Page 6: ... or coagulation effect results from the concentration of the high density HF current on the small surface of the active electrode This causes an increase of temperature and water evaporation from the tissue in the direct vicinity of the active electrode and eventually results in haemostasis and arrest of bleeding or cutting of the tissue Subsequently the HF current flows to the neutral electrode w...

Page 7: ...kHz Defibrillation impulse resistance according to EN 60601 1 NEM system Neutral electrode monitoring Maximum resistance at which the unit will operate 160 Ohm AUTOTEST Automatic test of the unit and accessories after power supply is connected Display of service codes OVERLOAD Overload protection CUTTING PURE CUT Pure monopolar cutting 9 levels 120 W for 300 Ω max 700 Vp BLEND CUT Monopolar cuttin...

Page 8: ...polar coagulation 9 levels 120 W for 50 Ω max 225 Vp WEIGHT AND DIMENSIONS Length 330 mm Width 285 mm Height 105 mm Weight 3 5 kg WORKING LIFE 10 years The technical specifications listed in the table may change as our products develop PAGE 8 OF 39 ...

Page 9: ...use Non Ionizing Radiation Serial number Catalogue number Equipotentiality Conforms to Directive 93 42 EEC The product may not be disposed of as normal household garbage Ackermann HF units are manufactured in protection class CF I It is the highest class of patient protection against electric shock from electromedical devices Type CF applied parts can be used in contact with any part of the patien...

Page 10: ...l and other procedures The maximum voltage of active accessories should be checked before they are connected to the unit The operating voltage of the accessories should not be lower than the maximum output voltage of the unit 5 1 NEUTRAL ELECTRODE CABLE disposable neutral electrode plug reusable neutral electrode plug The connection sockets of the neutral electrode output Fig 4 item 3 For more inf...

Page 11: ...00 16 2003 160 16 2000 110 16 2003 121 16 2003 122 Bipolar 16 2003 138 162000 1310ASD The list of supported instruments can change as the unit software is modified During activation the diodes over the active footswitch socket selection button change their function and signal the mode cutting and coagulation and the socket OUT1 or OUT2 in which the unit has been activated e g for cutting at socket...

Page 12: ...utting with hemostasis K5 forced coagulation button K6 soft coagulation button K4 K3 cutting level adjustment button enhancement K4 and reduction K3 K8 K7 monopolar coagulation level adjustment button enhancement K8 and reduction K7 K10 K9 bipolar coagulation level adjustment button enhancement K10 and reduction K9 K11 footswitch control buttons monopolar or bipolar outputs D1 monopolar cutting le...

Page 13: ...al grounding pin 12 fuse socket 13 power cable socket 8 PREPARING THE UNIT FOR OPERATION In order to make the unit ready to operate connect the power cable and accessories 8 1 PLACING THE UNIT ON A TROLLEY 16 2000 120 can be placed on a trolley 16 2000 1500 The steel coated trolley is equipped with a movable base with a locking mechanism on the rubber rolls It has stabilising pins to protect the u...

Page 14: ...3 In order to avoid the risk of electric shock the unit must be connected to the mains with protective grounding The unit does not need to be connected to an additional protective earth contact Fig 5 item 11 An additional protective earth contact serves to ground the unit when an ungrounded power socket is used or at places where a shock protection system requires the connection of an additional e...

Page 15: ...nto the surrounding tissue Therefore the setting should be selected according to the operator s experience by referring to the appropriate clinical recommendations or the results of an appropriate practice The settings are changed using the keys with arrows effect enhancement effect reduction Before the unit is applied for the first time it is recommended to explore the levels of different setting...

Page 16: ...e monopolar operating mode the unit requires a neutral electrode to be connected Ackermann units are equipped with a neutral electrode application monitoring system The NEM system installed in Ackermann HF units is designed for use with Ackermann disposable neutral electrodes with the catalogue number 16 2000 1212DFL Only these neutral electrodes are compatible with our system The manufacturer onl...

Page 17: ...s that the monitoring is performed on a continuous basis also during the operation of the unit The neutral control monitoring system does not affect the operation in the bipolar mode Figure 9 The message that the neutral electrode is not connected correctly 9 3 1 DISPOSABLE NEUTRAL ELECTRODES The neutral electrode must not be modified in any way Once applied the electrode should not be transferred...

Page 18: ...nt s body Only a correct electrode connection to the unit is monitored The neutral electrode must not be wetted or wrapped with anything Do not spread any additional conductive gel on the surface of the neutral electrode When disconnecting the neutral electrode never do it by pulling the cable Under no circumstances try to repair the neutral electrode by yourself Examine the condition of the neutr...

Page 19: ...h any conductive elements e g metal parts of the table The neutral electrode should be so applied as to ensure that it adheres to the patient s body with its entire surface The neutral electrode should always be applied on clean and degreased skin The neutral electrode should be applied in smooth well vascularised areas without skin breakdown or pits for instance on the upper arm or thigh The neut...

Page 20: ... limiting its operation time to prevent it from overheating OVERLOAD The limitation depends on the level settings and the type of procedure carried out When unit overload occurs it is signalled by a modulated pulsed acoustic signal and a message OVE LOA The unit forces an interruption in the procedure until the message disappears and the acoustic signal stops about 30 s Figure 10 The message about...

Page 21: ...s a rule cutting is performed using a knife or loop electrode The manner of connecting electrodes is explained in Fig 6 Before starting the cutting select the operating mode pure cutting or with hemostasis The mode is selected with buttons K1 and K2 Pure cutting K1 cutting with a minimum hemostasis margin which damages the tissue to the least extent It is used where there is no need for additional...

Page 22: ...onopolar coagulation is available at both sockets OUT1 and OUT2 after the appropriate monopolar instrument is connected As a rule coagulation is performed using a ball or spatula electrode The manner of connecting electrodes is explained in Fig 6 Before starting the procedure select the coagulation mode soft or forced coagulation The mode is selected using buttons K5 and K6 Forced coagulation K5 T...

Page 23: ...do so set the footswitch in the monopolar coagulation activation mode using button K11 it is signalled by a blue diode situated left of button K11 Selection of the function activated by a footswitch cutting monopolar coagulation bipolar coagulation K11 9 7 BIPOLAR COAGULATION Bipolar coagulation is available at both sockets OUT1 and OUT2 after the appropriate bipolar instrument is connected Bipola...

Page 24: ...tivated using a footswitch In the bipolar coagulation mode the unit is activated using the blue or grey button of the footswitch 9 8 SWITCHING OFF THE UNIT After a procedure has been completed switch the unit off using the standby button holding it down for about 3 seconds Fig 4 item 1 and then using the power switch Fig 5 item 7 and take out the plug from the power cable socket After switching th...

Page 25: ...re a complete and ready to use substitute electrosurgical unit 10 3 When performing procedures on patients connected to monitoring devices ECG remember to place the monitoring electrodes as far as possible from the electrosurgical electrode application site Furthermore it is recommended that monitoring devices equipped with protective systems against high frequency currents should be used Do not u...

Page 26: ...avoided unless those agents are sucked away 10 12 Use non flammable disinfectants Otherwise they should be left to evaporate before the procedure There is also a risk of pouring those agents under the body or into a body cavity Should this happen such flooded areas should be dried A flammable agent can be set on fire by a spark occurring during normal unit operation 10 13 Sparks at the active elec...

Page 27: ...ce itself is not a significantly emitting element When not activated generators do not emit high frequency power As the field distribution depends on the specific workplace unit placement and wiring the measurements must be performed individually Your local OSH authority can determine the detailed distribution of the emission zones for you 11 TECHNICAL INSPECTION WARRANTY AND SERVICE After each pr...

Page 28: ...ity is transferred to the user In order to ensure the correct operation of the device the installation 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 units These procedures are obligatory More information on the authorised services may be obtained fr...

Page 29: ...USER MANUAL 16 2000 120 Rev 02 2016 PURE CUT PURE CUT PAGE 29 OF 39 Effect 1 Effect 5 Effect 9 Resistance Ω Power W Peak voltage V Resistance Ω Effect 1 Effect 5 Effect 9 ...

Page 30: ...WAVEFORM SINE WAVE WITH MODULATION DUTY CYCLE FROM 40 TO 80 MAXIMUM REPETITIVE PEAK TO PEAK VOLTAGE 2100 V MAXIMUM POWER TRANSFER FOR MATCHING RESISTANCE 120 W 20 BLEND CUT BLEND CUT PAGE 30 OF 39 Power W Effect 1 Effect 5 Effect 9 Effect 1 Effect 5 Effect 9 Resistance Ω Resistance Ω Peak voltage V ...

Page 31: ...AVEFORM SINE WAVE WITH MODULATION DUTY CYCLE FROM 25 TO 45 MAXIMUM REPETITIVE PEAK TO PEAK VOLTAGE 2100 V MAXIMUM POWER TRANSFER FOR MATCHING RESISTANCE 120 W 20 FORCED COAG FORCED COAG PAGE 31 OF 39 Power W Effect 1 Effect 5 Effect 9 Resistance Ω Effect 1 Effect 5 Effect 9 Peak voltage V Resistance Ω ...

Page 32: ...HING RESISTANCE 50 Ω WAVEFORM SINE WAVE MAXIMUM REPETITIVE PEAK TO PEAK VOLTAGE 400 V MAXIMUM POWER TRANSFER FOR MATCHING RESISTANCE 120 W 20 SOFT COAG SOFT COAG PAGE 32 OF 39 Power W Effect 1 Effect 5 Effect 9 Resistance Ω Effect 1 Effect 5 Effect 9 Peak voltage V Resistance Ω ...

Page 33: ...CHING RESISTANCE 50 Ω WAVEFORM SINE WAVE MAXIMUM REPETITIVE PEAK TO PEAK VOLTAGE 400 V MAXIMUM POWER TRANSFER FOR MATCHING RESISTANCE 120 W 20 BICOAG BICOAG PAGE 33 OF 39 Power W Effect 1 Effect 5 Effect 9 Resistance Ω Effect 1 Effect 5 Effect 9 Peak voltage V Resistance Ω ...

Page 34: ...re they can be used Unless otherwise marked the offered electrosurgical accessories may be steam sterilized at up to 134 C and a pressure of 2 Bar When using different accessories please observe the manufacturer s recommendations 12 1 RECOMMENDED CLEANING AND STERILIZATION AGENTS FOR REUSABLE ELECTROSURGICAL ACCESSORIES Consult the manufacturer s sterilisation instructions before cleaning and ster...

Page 35: ...eodisher FE Washing Neodisher Septo DN Disinfection In order to avoid mechanical damage do not dry electrode handles in compressed air under a pressure higher than 3 bar 12 1 3 MECHANICAL WASHING Unless specified otherwise non disposable products should be sterilised in an autoclave in accordance with DIN 58946 temperature 134 C max time up to 20 minutes pressure 2 bar 12 1 4 FORMALDEHYDE STERILIZ...

Page 36: ...OMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 2 The unit must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment nay be affected When the unit is not activated its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The unit is suitable for use...

Page 37: ...ne s to line s 2kV line s to earth 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations an power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for ...

Page 38: ... RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and refle...

Page 39: ...m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorptio...

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