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AtriCure ASU2-115, Руководство пользователя

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USER’S MANUAL

 

 

 

 

Page 4 of 39 

 

P000463.F 

1.1.

 

    System Description 

As shown in Figure 1, the system is comprised of the following: 

•

 

AtriCure Bipolar Handpiece with integral cable (not shown)  

•

 

AtriCure Ablation and Sensing Unit (ASU) 

•

 

Footswitch 

•

 

Power cord.  

Accessory devices are described in paragraph 10. 

 

 

Figure 1 – ASU, Footswitch, and Power Cord  

 

1.2.

 

   Unpacking 

Lift the ASU, Footswitch, and Power Cord from the box and remove the protective wrapping.  It is 
recommended that the original shipping box and protective wrapping be saved for future storing 
and/or transporting of the device.  

1.3.

 

   Warnings and Precautions 

 

The safe and effective use of RF energy is highly dependent upon factors under the control 
of the operator.  There is no substitute for a properly trained operating room staff.  It is 
important that the operating instructions supplied with the ASU be read, understood and 
followed before use. 

 

 

Содержание ASU2-115

Страница 1: ...ON AND SENSING UNIT ASU USER S MANUAL Model ASU2 115 Model ASU3 230 AtriCure Incorporated 7555 Innovation Way Mason Ohio 45040 USA Customer Service 1 866 349 2342 toll free 1 513 755 4100 phone P000463 Rev F ...

Страница 2: ......

Страница 3: ...USER S MANUAL European Representative Herbert Köntges Köntges SPRL Avenue Hellevelt 35 B 1180 Brussels Belgium Tel 32 2 375 51 63 FAX 32 2 375 89 06 email herbert kontges skynet be ...

Страница 4: ...r Use 16 3 4 Power Cord 16 3 5 Connecting and Disconnecting the Handpiece 17 3 6 Installing the Footswitch 17 4 INSTRUCTIONS FOR USE 19 4 1 Powering Up the ASU 19 4 2 Operating Modes 20 4 3 Audio Tones 21 4 4 Delivering RF Energy 22 5 TROUBLESHOOTING 25 5 1 No RF Power Output 25 5 2 Error Codes 25 5 3 Electromagnetic or Other Interference 26 6 SYMBOLS USED 28 7 TECHNICAL SPECIFICATIONS 29 7 1 RF O...

Страница 5: ...MANUAL Page 2 of 39 P000463 F 8 2 Cleaning and Disinfecting 34 9 DISPOSAL 35 10 ACCESSORIES 35 10 1 ASB1 Source Switch Accessory 35 10 2 ASB3 Switch Matrix Accessory 37 11 ADDITIONAL ACCESSORIES AND CABLES 39 ...

Страница 6: ...Rail linear pen devices depending on the mode of operation The AtriCure ASU is capable of producing a maximum output power of 32 5 Watts under a 100 Ohm load although no current AtriCure Bipolar Handpiece uses power above 30 Watts The operating mode is a function of the handpieces or pen and is set by the ASU The AtriCure ASU is designed to operate only with an AtriCure Bipolar Handpiece AtriCure ...

Страница 7: ...ng Lift the ASU Footswitch and Power Cord from the box and remove the protective wrapping It is recommended that the original shipping box and protective wrapping be saved for future storing and or transporting of the device 1 3 Warnings and Precautions The safe and effective use of RF energy is highly dependent upon factors under the control of the operator There is no substitute for a properly t...

Страница 8: ...taples etc can result in unintended burn injuries When not using the Handpiece place it in a clean dry nonconductive and highly visible area not in contact with the patient Inadvertent contact by an active Handpiece with the patient may result in burns When the ASU is activated the conducted and radiated electrical fields may interfere with other electrical medical equipment Refer to Section 5 for...

Страница 9: ...s a potential for electrical shock Refer to authorized personnel for service Use only the Footswitch provided with the ASU The Power Cord of the ASU must be connected to a properly grounded receptacle Extension cords and or adapter plugs must not be used Do not wrap instrument cable around metal objects Wrapping cables around metal objects may induce hazardous currents To avoid shock do not allow ...

Страница 10: ... to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the ASU and the other devices Connect the ASU into an outlet on a circuit different from that to which the other device s are connected Contact the AtriCure service representative for help 1 4 2 Electromagnetic Emissions Guidance and manufacturer s ...

Страница 11: ...vironment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on 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 ...

Страница 12: ...distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b 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 Electromagneti...

Страница 13: ... 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the ...

Страница 14: ... no current AtriCure Bipolar Handpiece uses power above 30 Watts The operating mode is a function of the handpiece and is set by the ASU The AtriCure ASU is designed to operate with the AtriCure Handpiece The ASU and Handpiece are designed for use without a neutral electrode The Footswitch is the input device used to activate RF energy delivery 2 2 ASU Front Panel Illustration and Nomenclature An ...

Страница 15: ...near pen During the ablation cycle the ASU displays a graph of power Current Voltage versus Time The y axis is Power and the x axis is Time When the Footswitch is disconnected or reconnected the display of the power graph is not affected Refer to Section 4 4 3 Temperature Display This 3 digit LED display shows the temperature at the thermocouple located near the outer edge of the upper jaw 1 3 mm ...

Страница 16: ...ected and the ASU is ready for use RF ON Indicator A Blue LED indicates that RF power is being output to the Handpiece The RF power output is initiated by pressing the Footswitch TRANSMURALITY Indicator A Blue flashing LED indicates that the Transmurality Algorithm has been satisfied indicating that the user may terminate the ablation cycle Front Panel Receptacle Receptacle Description HANDPIECE o...

Страница 17: ...d Nomenclature An illustration of the ASU rear panel is shown in Figure 3 below Figure 3 ASU Rear Panel 1 Data Port 5 Equipotential Ground Stud 2 Speaker Volume Control 6 Input Voltage Selector Switch 3 Power Entry Module 7 Footswitch Receptacle 4 Fuse Box 8 Service Access ...

Страница 18: ...echnical Specifications in Section 7 of this manual Input Voltage Selector Switch The input voltage selector switch is pre set at the factory to either 110V or 220V and should not be adjusted by the operator This setting should only be adjusted by the manufacturer or by an authorized service representative Speaker Volume Control The audible volume level is adjustable via a rotary dial The ASU incl...

Страница 19: ...the viewing angle of the ASU Conductance Graph Display adjust the handle position using the directions in Section 3 1 above 3 3 Preparing the ASU For Use The ASU may be placed on a mounting cart or on any sturdy table or platform It is recommended that carts have conductive wheels Refer to hospital procedures or local codes for detailed information Provide at least four to six inches of space arou...

Страница 20: ... and remove it from the ASU receptacle NOTE Refer to the Handpiece instruction sheet for more detailed information about connecting the Handpiece to the ASU in a sterile environment 3 6 Installing the Footswitch 3 6 1 Inspect the Footswitch Inspect the Footswitch for any signs of physical damage to the cable and connector If physical damage is found or the Footswitch does not perform within specif...

Страница 21: ...otswitch for Use The Footswitch should be placed on a flat floor It is recommended that the area near the Footswitch be kept dry to reduce the risk of slippage Appropriate precautions should be taken to ensure that the cable connecting the Footswitch to the ASU does not create a hazard in the operating room ...

Страница 22: ...switch located on the power entry module on the rear panel When power is turned on the system performs the System Self Tests See Figure 5 If all Self Tests pass the system transitions to the STANDBY mode If any Self Test fails the system transitions to the FAULT mode The Self Test generates two quick beeps at startup The operator must verify that the beeps are generated NOTE Refer to Section 4 2 b...

Страница 23: ... Footswitch has been depressed and released The LCD display message indicates the system is in the READY Mode RF ON Mode This Mode is entered when the Footswitch is depressed while in the READY Mode The system transitions from the RF ON Mode to the READY Mode upon 40 second time expiration or if the Footswitch is released ERROR Mode This Mode is entered upon detection of any recoverable error cond...

Страница 24: ...one in 10 second intervals is generated when RF energy is being delivered to the Isolator Transpolar pen This tone has a higher pitch than the Error tone Transmurality Tone Intermittent medium pitched tone This tone is generated in the RF ON mode when Transmurality is achieved The Transmurality tone will continue and RF energy will continue to be applied until the Footswitch is released or until 4...

Страница 25: ...e connections are made The display screen and Ready Indicator of the ASU should indicate that the RF generator is in the READY mode See Figure 7 Figure 7 Tissue Conductance Display Graph Indicating READY Mode for Isolator Handpieces above and Power Display Graph for Isolator Transpolar pen and Coolrail linear pen device below NOTE When the READY mode is entered from the RF ON mode the previous plo...

Страница 26: ...nce the ASU will determine when a transmurality condition has been achieved When this condition has been achieved the Blue Transmurality indicator will flash and the audible tone emitted from the ASU will change from constant to intermittent thus signaling to you that transmurality has been achieved If you do not release the Footswitch within 40 seconds the system will automatically time out and s...

Страница 27: ...oolrail linear pen In such cases the Graph will wrap to a second screen which will display a continuation of the conductance for a maximum of 20 additional seconds Figure 10 below shows an example of this wrapping feature for an ablation requiring more than 20 seconds Similarly for the Isolator Transpolar pen and Coolrail linear pen the power graph will wrap to a second screen for ablations lastin...

Страница 28: ...panel will display an error code If an Error Code of E07 through E09 PO1 through P11 or F01 through F14 appears try turning power off then on If the problem persists contact AtriCure Customer Service Use the table below to attempt to resolve the following recoverable application errors LCD DISPLAY MESSAGE DESCRIPTION SOLUTION Replace Handpiece H01 Invalid Handpiece Version Replace Handpiece Replac...

Страница 29: ...nce to other devices which can be determined by turning the ASU off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the ASU and the other devices Connect the ASU into an outlet on a circuit different from that to which the other device s are connected Contact the Atri...

Страница 30: ...und wires in the operating room are electrically consistent All ground wires should go to the same grounded metal with wires that are as short as possible 4 If the above steps do not remedy the situation qualified service personnel should check the ASU 5 3 2 Neuromuscular Stimulation 1 Stop the surgery 2 Check all connections to the ASU and active electrodes to look for a possible metal to metal s...

Страница 31: ...ed Alternating Current Attention consult accompanying documents Dangerous Voltage Type CF Defibrillation Proof Applied Part Type CF Applied Part READY RF ON Transmurality Equipotential Footswitch Fuses Non Ionizing Radiation Power OFF Power ON Speaker ...

Страница 32: ...inear pen D 25 6 W at 127 57 0 Vrms Isolator clamp E 22 8 W at 143 57 0 Vrms Isolator clamp F 28 5 W at 114 57 0 Vrms Isolator clamp G 28 5 W at 114 57 0 Vrms Isolator clamp H 28 5 W at 114 57 0 Vrms Isolator clamp J 12 0 W from 20 to 500 77 5 Vrms Isolator Transpolar pen K 25 0 W from 39 to 240 77 5 Vrms Isolator Transpolar pen or Coolrail linear pen L 30 0 W from 47 to 200 77 5 Vrms Isolator Tra...

Страница 33: ...ble depending on the system operating mode See Section 7 1 The maximum power output of 30 0 W for the Coolrail linear pen is available between 47 to 200 load for device operating under device code L Lower maximum output powers are available depending on the system operating mode See Section 7 1 The maximum power output of 20 0 W for the Isolator linear pen is available between 31 to 300 load for d...

Страница 34: ...P000463 F Page 31 of 39 Figure 11 Power vs Load clamp algorithm ...

Страница 35: ... ASU2 ASU3 POWER OUTPUT 0 5 10 15 20 25 30 35 0 100 200 300 400 500 600 700 800 900 1000 1100 1200 Load Impedance Ohms Power Watts Device Code L Device Code K Device Code B Device Code C Device Code J Figure 12 Power vs Load pen algorithm ...

Страница 36: ...ty to latch or rotate Rubber feet damage cracking or inability for the ASU to remain stabile on a flat surface Footswitch cord fraying or damage Footswitch connector damage cracking or inability to insert and latch footswitch plug Footswitch pedal damage check activation by pressing and releasing the pedal Other medical equipment that may be used simultaneously with the ASU should also be inspecte...

Страница 37: ...r body fluids they shall be cleaned before the contamination can dry within two hours of contamination 3 The outer surfaces of the unit and or accessories shall be cleaned with 70 90 Isopropyl alcohol IPA wipes for a minimum of two minutes Do not allow fluids to enter the chassis 4 Pay attention to all areas where fluids or soil may gather such as under around the handles or any tight crevices gro...

Страница 38: ...te EN60601 1 and or EN60601 1 1 harmonized national standard Supply mains operated equipment may introduce dangerous leakage currents into the heart An auxiliary device other than those listed in paragraph 10 1 2 may have an adverse effect on nearby radio or TV or medical equipment There may also be cases when nearby electrical appliances adversely influence the auxiliary device causing data error...

Страница 39: ...USER S MANUAL Page 36 of 39 P000463 F Source Switch set up is shown in the following figures Figure 13 Figure 14 ...

Страница 40: ...sted in paragraph 10 2 2 may have an adverse effect on nearby radio or TV or medical equipment There may also be cases when nearby electrical appliances adversely influence the auxiliary device causing data errors or malfunction Auxiliary devices compatible for use with the Switch Matrix include Any AtriCure IsolatorTM Handpiece Any AtriCure TranspolarTM Pen Any AtriCure CoolrailTM linear pen OSCO...

Страница 41: ...USER S MANUAL Page 38 of 39 P000463 F ASB3 Switch Matrix Unit is shown below with the ASU ...

Страница 42: ...age 39 of 39 Switch Matrix set up is shown in the following figures 11 Additional Accessories and Cables ASU ASB Power Cord ASU ASB Interface Cable Auxiliary Cable ASU Footswitch ASU ASB Footswitch Interface Cable ...

Страница 43: ... of its products after sale lease or transfer and has no control of the selection of Customer s patients AtriCure s products are warranted for the following periods after shipment to the original purchaser AtriCure Ablation and Sensing Unit One 1 Year AtriCure Switch Matrix One 1 Year AtriCure Source Switch One 1 Year AtriCure Footswitch One 1 Year Grounded Electrical Cord One 1 Year THIS WARRANTY...

Страница 44: ......

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