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ZEUS-100/80                                                                                                          ZO-OM-008 

 

REV : 08                                                                  31

                                                                     

ZERONE 

 

12. Appendix 

12.1 Electromagnetic Compatibility (EMC) Information 

 
 
 
 
 

  Medical electrical equipment needs special precautions regarding Electromagnetic 

        Compatibility (EMC). Observe the EMC instructions in this appendix during   

installation and operation. 

 
   

  The use of portable and mobile RF equipment may have an impact on this and other 

          pieces of medical equipment. 
 

NOTE: The tables and guidelines that are included in this Appendix provide information   

to the customer or user that is essential in determining the suitability of th equipment   
or system for the electromagnetic environment of use, and in managing the   
electromagnetic environment of use to permit the equipment or system to perform its   
intended use without disturbing other equipment and systems or non-medical 
electrical equipment. If this equipment does cause harmful interference with other   
devices, 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 equipment 
- connect the equipment into an outlet on a circuit different from that to which the   

other device(s) is connected. 

 
 

 
 
 
 
 

Table 201 

Guidance and manufacturer

s declaration 

  electromagnetic emissions

 

ZEUS-100/80 model is intended for use in the electromagnetic environment specified below. 

The customer or user of the ZEUS-100/80 model should ensure that it is used in such an 

environment. 

Emissions test

 

Compliance

 

Electromagnetic environment - guidance

 

RF emissions 

CISPR 11

 

Group 1

 

 

RF emissions 

CISPR 11

 

Class A

 

The ZEUS-100/80 model is suitable for usage in 

all establishments (e.g. hospitals and doctors

 

offices) except domestic establishments those 

directly connected to the public low-voltage power 

supply network that supplies buildings used for 

domestic purposes. 

Harmonic emissions 

IEC 61000-3-2

 

Class A

 

Voltage fluctuations/flicker 

emissions 

IEC 61000-3-3

 

Complies 

Check the followings before using this product. 

Warning 

Содержание ZEUS-100/80

Страница 1: ...ZERONE Electrosurgical Unit ZEUS 100 80 OPERATION MANUAL ZERONE CO LTD...

Страница 2: ...ZEUS 100 80 ZO OM 008 ZEUS 100 80 Operation manual ZERONE CO LTD...

Страница 3: ...N OF EACH PART 16 5 6 USING METHOD AND PROCEDURE 21 5 7 ACCESSORY DIAGRAM 22 6 PERIODIC INSPECTION 24 7 TECHNICAL FACTORS 24 7 1 SPECIFICATION 24 7 2 OUTPUT 25 8 STANDARD OUTPUT TABLE BY SURGERY PART...

Страница 4: ...es 810 LS Ro 13 Gunpo si Gyeonggi do Korea zip 435 831 Tel 82 31 427 2772 Fax 82 31 427 2332 For Repair Service Tel 82 31 427 2772 Technical For technical inquiries contact us with the following Assis...

Страница 5: ...repairs and replacement complies for Guidelines for Consumer Protection quoted by the Korean Economic Planning Board If the product fails to operate during this period our service center will provide...

Страница 6: ...refully and be fully aware of them before you start operating the equipment Serious physical injury death or property damage might occur to patients if this not observed Warning Slight physical injury...

Страница 7: ...r to the manual 4 Non ionizing Radiation This equipment intentionally supplies non ionizing RF energy for physiological effect 5 High Voltage Warning 6 Caution 7 Protective Earth 8 EU Representatives...

Страница 8: ...humidity ranges T 10 40 H 20 95 Near to electronic heaters Areas with high humidity or ill ventilation Excessive shock or vibration Areas contaminated chemical materials or leaked gas Dust or metals...

Страница 9: ...shock and fire inflicting an injury on patients or operators Before using accessories always check if reusable accessories and codes are not broken cracked scratched etc If this is not done patients...

Страница 10: ...life follow the local laws and regulations of Disposal The improper disposal of waste electronic equipment from consumer may be subject to fines For more information on repair please refer to the serv...

Страница 11: ...can have negative effects on other medical units that are using other electricity Check the linkage condition of equipment ground Impressed voltage AC120V AC230V should be used in accordance with the...

Страница 12: ...and O2 Electrosurgical Unit using high frequency can generate a flame at an always operating electrode by contacting the anesthetics Therefore the materials should be completely evaporated for cleanli...

Страница 13: ...al area the use of BIPOLAR techniques may be desirable in order to avoid unwanted tissue damage About Patient Return Plate Plate Electrode should be near to an operation part of human body and adhere...

Страница 14: ...regarding effect of microbe Clean its external appearance with non ignitable non explosive materials Don t use corrosive easily grinding materials that can damage it such as lacquer thinner ethylene...

Страница 15: ...fferent sound which enables you to easily distinguish an operation type If the area between a patient and the pad is not appropriate REM Return Electrode Monitoring gives the alarm with a warning soun...

Страница 16: ...es specified in the instruction for use Maximum N A Experience Minimum A person who received sufficient training in electrosurgical procedures Maximum N A Permissible impairments N A Intended Patient...

Страница 17: ...tion Electrosurgical Unit 1EA single Foot Switch 1EA Disposable Twin Button Handle 1EA Power Cord 1EA Knife Electrode 2 4 70mm 1EA Needle Electrode 2 4 70mm 1EA Needle Electrode Angled 2 4 70mm 1EA Ba...

Страница 18: ...e Connection for Main Power Connection for Grounding Connection for Cutting Coagulation Foot switch Power Switch Cutting Mode Coagulation Mode Connection to Patient Plate Connection for Bipolar Forcep...

Страница 19: ...the lamp turns on Cutting Output Set Up Indicator It displays Cutting and Blend Output as Watt Cutting Output Increase This button increases the output of selected mode When this button is pressed on...

Страница 20: ...rrest of bleeding If it is selected the lamp above the button turns on Coagulation Output Increase This button increases the output of selected mode When this button is pressed one time the output get...

Страница 21: ...ulation Applied part Connection Terminal for Twin Button Handle Connection 2 for Cutting and Coagulation Applied part Connection Terminal for Monopolar Handle Connection for Main Power Connects with M...

Страница 22: ...tion 3pin Plug Cable 3m Rated Voltage 3000Vpp Expiration date of Disposable Twin Button Handle Check the packaging for Disposable Twin Button Handle Power Cord Connect it to Main Power Connection on t...

Страница 23: ...Cable Clamp Alarm lamp stops flickering and the standby state starts Attach Pad to a patient s body Double Patient Return Plate Connect Double Patient Return Plate to Patient Return plate Cable Clamp...

Страница 24: ...Use it by step on Foot Switch Power off Turn the electrosurgical unit OFF and disconnect the power cord from the Receptacle wall mains outlet Make sure that the electrosurgical unit and foot switch ar...

Страница 25: ...ZEUS 100 80 ZO OM 008 REV 08 23 ZERONE Diagram of Foot Switches Foot Switch Diagram of Bipolar Forceps and Cable Bipolar Forceps...

Страница 26: ...1 Specification Name of Product Electrosurgical Unit Model Name ZEUS 100 ZEUS 80 Rated Voltage AC120V AC230V Rated Frequency 50Hz 60Hz Power Consumption 300VA 10 Fuse T4 0AL when AC120V T2 0AL when A...

Страница 27: ...on 60W at 300ohm 1 6MHz 2 5 30 Bipolar coagulation 80W at 100ohm 1 6MHz 1 6 100 These parameters can be changed without notice ZEUS 80 Tolerance 20 Mode output power Carrier Crest Duty Freq Factors Ra...

Страница 28: ...Stomach Intestine resection Blend 20 and Up Hemostasis Pure Coagulation 10 50 3 22 Neuro Surgery Blend Loop 20 70 Pure Coagulation Ball 10 25 1 8 Massive Coagulation Prostatic Resection Pure or Blend...

Страница 29: ...n Handle Monopolar Handle and Foot Switch are connected 4 Change the accessories such as Twin Button Handle Monopolar Handle and Foot Switch and others 5 Check if the output is set low 6 If the troubl...

Страница 30: ...ZEUS 100 80 ZO OM 008 REV 08 28 ZERONE 10 Load Regulation 10 1 Pure Cutting 10 2 Blend 10 3 Contact Coagulation...

Страница 31: ...ZEUS 100 80 ZO OM 008 REV 08 29 ZERONE 10 4 Bipolar Coagulation 11 Voltage Output Graphic 11 1 Pure Cutting Load 300 Max Peak Output Voltage 270Vp 11 2 Blend Load 300 Max Peak Output Voltage 375Vp...

Страница 32: ...ZEUS 100 80 ZO OM 008 REV 08 30 ZERONE 11 3 Contact Coagulation Load 300 Max Peak Output Voltage 320Vp 11 4 Bipolar Coagulation Load 100 Max Peak Output Voltage 135Vp...

Страница 33: ...ser 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 equipment connect the equipm...

Страница 34: ...IEC 61000 4 5 0 5 kV 1 kV 1 kV Mains power quality should be that of a typical commercial or hospital environment Surge Line to ground IEC 61000 4 5 0 5 kV 1 kV 2 kV 2 kV Voltage dips IEC 61000 4 11...

Страница 35: ...on in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in t...

Страница 36: ...CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217Hz 2 0 3 28 5240 5100 5800...

Страница 37: ...date of purchase Customer Detail Name of hospital Address Name Phone Name of Distributor Name of manufacture ZERONE Co Ltd Shinil IT UTO Bldg Dangjeong dong 810 LS Ro 13 Gunpo si Gyeonggi do Korea Pho...

Страница 38: ...al issued 01 2009 06 12 Add 100 MODEL 02 2012 04 25 Change address and add section 11 03 2013 10 10 Applied to 60601 1 3rd Edition 04 2016 06 16 Add Caution 05 2016 10 12 Change of address European ag...

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