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ELPIS-4 / 3 / 2 User Guide

 

2017.08.21 Ver M-1.0.0 

37/45 

 

 

10. 

EMC emissions and immunity 

 

Guidance and manufacturer’s Declaration – Electromagnetic Emissions

 

The ELPIS-4, 3, 2 System is intended for use in the electromagnetic environment specified below. 
The customer or the user of the equipment should assure that it is used in such an environment 

Emission Test 

Compliance 

Electromagnetic environment 

– guidance` 

RF emissions 
EN55011 

Group 1 

The ELPIS-4, 3, 2 System is intentionally generated 
and / or used conductively coupled radio-frequency 
energy which is necessary for the internal 
functioning of the equipment itself. 

RF emissions 
EN55011 

Class A 

The ELPIS-4, 3, 2 System is suitable for use in all 
establishments other than domestic and 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 

 

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 

The ELPIS-4, 3, 2 System is intended for use in the electromagnetic environment specified below. 
The customer or the user of the equipment should assure that it is used in such an environment. 

Immunity Test 

IEC 60601 

IEC 60601 

Test Level 

Compliance Level 

Electromagnetic 

environment - guidance 

Electrostatic 
discharge (ESD) 
IEC 61000-4-2 

± 6 Contact 
± 8 Air 

± 6 Contact 
± 8 Air 

Floors should be wood, 
concrete or ceramic tile. 
If floors are covered with 
synthetic material, the relative 
humidity should be at least 
30% 

Electrical fast 
Transient / burst 
IEC 61000-4-4 

± 2

 for power 

supply lines 

± 2

 for power 

supply lines 

Mains power quality should be 
that of a typical commercial or 
hospital environment. 

Surge 
IEC 61000-4-5 

± 1

 differential 

mode 

± 2

 common 

mode 

± 1

 differential 

mode 

± 2

 common 

mode 

Anti-surge protection needs to 
be incorporated into the main 
supply to the equipment if 
surge protection is to be 
guaranteed. 

Содержание ELPIS-2

Страница 1: ......

Страница 2: ...ctions refer to the related medical publications As the User Guide has been arranged in independent chapters some of the descriptions have been duplicated If you encounter any problems during operatio...

Страница 3: ...eference 13 3 Installation 14 3 1 Standard configuration Optional 14 3 2 Electrical installation condition 15 3 3 Environmental condition 15 3 3 1 Application environment 15 3 3 2 Storage environment...

Страница 4: ...ectrosurgery history principles and current and future uses 34 8 2 Electrosurgery 34 9 Technical specfications 35 9 1 Size and weight 35 9 2 Power 35 9 3 Bipolar Mode outputs 35 9 4 Monopolar Mode out...

Страница 5: ...6 Front view 17 Figure 07 Rear view 17 Figure 08 Device control section 18 Figure 09 ELPIS 4 3 2 Segment displays 21 Figure 10 ELPIS 4 3 2 Power standbys 21 Figure 11 Bipolar Forceps connection Handsw...

Страница 6: ...d maintenance of the equipment 1 2 Requirements for safety 1 2 1 Precautions for electrical safety The rated power for this equipment is AC 220 V Confirm that all the connecting sections power line or...

Страница 7: ...ct the doctor in charge 1 2 2 Classifications Protection type and level for electric shock Class I BFtype Electromagnetic compatibility EMC test standard Type 2 class A 1 3 Precautions during operatio...

Страница 8: ...pplying high frequency surgery and some materials such as cotton or gauze may become saturated due to oxygen sparks due to normal use of the high frequency surgical device The patient should not touch...

Страница 9: ...not recommended Electrosurgical units should use power only as needed It is recommended that the use time be minimized to avoid injury to other parts of the body It is safe to use lower power than ped...

Страница 10: ...ccordance with the User Guide In the User Guide the method for the correct use of the equipment is described Read the User Guide carefully The equipment shall be operated under the supervision of a pe...

Страница 11: ...e and this condition is the cutting off When the energy applied to the whole electrode is small the current density is relatively low so cell heating is slow cell rupture and tissue cleavage do not oc...

Страница 12: ...cell fluid and cleaves the tissue by dividing the cell tissue by pressure increase and pressure The reason for using powerful high frequencies is to concentrate the heat because the tissue must not on...

Страница 13: ...he duty cycle Figure 03 Electrosurgical waveform 2 2 Objectives This device is an electrosurgical unit It is prohibited to use it for purposes other than the intended use 2 3 References Please refer t...

Страница 14: ...ional Main system Power cable User manual Electrode Tips Monopolar Handswitching Pencil Monopolar Footswitching Pencil Bipolar Forceps Bipolar Cable Disposable Patient Plate Single Foot Switch Double...

Страница 15: ...flat surface Confirm that the power is connected Install the equipment in a location with appropriate ambient temperature and humidity and do not install in a location where it will be exposed to dus...

Страница 16: ...f electrical shock connection shall be made to a protected and grounded power supply Caution Please do not connect the power cable without any power switch off as this may cause a fault Before moving...

Страница 17: ...ELPIS 4 3 2 User Guide 2017 08 21 Ver M 1 0 0 17 45 4 Product description 4 1 External view 4 1 1 Front view Figure 06 Front view 4 1 2 Rear view Figure 07 Rear view...

Страница 18: ...tion level display Displayed Mono function level 12 Mono Cut function level display Displayed Mono function level 13 Mono Coag function operation display Light on when the selected function operates 1...

Страница 19: ...ection noise 5 3 Waring before use An extra electrosurgical unit is needed to prepare for sudden malfunction of the electrosurgical unit during surgery Check the speaker volume before using the unit I...

Страница 20: ...tient Plate connection use indicator and the REM indicator on the touch screen change from red blinking to green 2 When you press the foot pedal of the Monopolar Footswitch Monopolar 1 Use indicator l...

Страница 21: ...it Turn on the power switch located on the back of the unit As shown in the figure below the orange power button will blink the Remed logo will appear and disappear and the orange power button will li...

Страница 22: ...the patient s body when using bipolar When attached the current may flow to areas other than the tissue to which the bipolar electrode is in contact resulting in unintended consequences 1 Handswitchin...

Страница 23: ...Plate to the patient s body when using bipolar When attached the current may flow to areas other than the tissue to which the bipolar electrode is in contact resulting in unintended consequences 1 Han...

Страница 24: ...e well ventilated muscular area remove hair before attachment clean and dry Avoid areas where bones protrude and the femur lower legs buttocks or dorsal side are good parts The Patient Plate should no...

Страница 25: ...o the REM indicator and the Patient Plate mode indicator will flash Bipolar has two different types of Coag functions with Handswitching and Footswitching Soft Forced By lowering the voltage it does n...

Страница 26: ...When changing the output intensity make sure that the output value set on the screen has changed Use proper output strength for the surgical site The output intensity should be kept to a minimum to av...

Страница 27: ...ration sound 6 3 2 Monopolar mode When the unit is in standby mode press and hold the power button for 2 to 3 seconds the unit will turn on and the power indicator will change from the orange standby...

Страница 28: ...ch a way that solidification takes place when the electrode is in contact with the tissue site It is a non contact solidification type with low heat penetration strength and is suitable for areas wher...

Страница 29: ...ngth from the lowest output strength 1 The output range of each function is as follows Pure W Blend 1 W Blend 2 W Blend 3 W ELPIS 4 1 400 1 250 1 200 1 150 ELPIS 3 1 300 1 230 1 180 1 120 ELPIS 2 1 20...

Страница 30: ...reen has changed Use proper output strength for the surgical site The output intensity should be kept to a minimum to avoid the risk of burns When you start the unit by pressing the operation button o...

Страница 31: ...S 2 1 200 1 150 1 120 1 100 When you start the unit by pressing the Cut Pedal of the Monopolar Footswitch the CUT indicator lights up along with the operation tone and the operation of the unit starts...

Страница 32: ...0 Caution When changing the output intensity make sure that the output value set on the screen has changed Use proper output strength for the surgical site The output intensity should be kept to a min...

Страница 33: ...d in the following cases If the patient is not properly connected to the Patient Plate attached to the patient If placing the Patient Plate on the Monopolar Handswitching Pencil connection not the Pat...

Страница 34: ...nits have endured the test of time and are accepted as a welcome part of modern surgery and its history 2 Electrosurgery Curr Surg 2006 Nov Dec 63 6 458 63 Jones CM1 Pierre KB Nicoud IB Stain SC Melvi...

Страница 35: ...Input power 220 VAC 60 Hz Power consumption ELPIS 4 max 1 000 VA ELPIS 3 max 950 VA ELPIS 2 max 800 VA 9 2 Bipolar Mode outputs ELPIS 4 Hand 100 W Foot 100 W ELPIS 3 Hand 80 W Foot 80 W ELPIS 2 Hand...

Страница 36: ...20 W Contact Coag 100 W Spray Coag 80 W ELPIS 2 Pure Cut 200 W Blend 1 Cut 150 W Blend 2 Cut 120 W Blend 3 Cut 100 W Contact Coag 100 W Spray Coag 80 W 9 5 Environmental condition 9 5 1 Application en...

Страница 37: ...ic Emissions IEC 61000 3 2 Class A Voltage Fluctuations Flicker Emissions IEC 61000 3 3 Complies Guidance and Manufacturer s Declaration Electromagnetic Immunity The ELPIS 4 3 2 System is intended for...

Страница 38: ...d RF Immunity EN 61000 4 3 80MHz 2 5GHz 2Hz 80 amplitude modulation Equipment should only be used in the vicinity of other equipment compliant with EN 60601 1 2 Conducted RF Immunity EN 61000 4 6 0 15...

Страница 39: ...omagnetic propagation is affected by absorption and reflection structures object and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and l...

Страница 40: ...Separation distance according to frequency of transmitter 150 kHz 80 MHz 3 5 1 Where V1 3 80 MHz 800 MHz 3 5 1 Where E1 3 800 MHz 2 5 GHz 7 1 Where E1 3 0 01 0 117 0 117 0 233 0 1 0 369 0 369 0 738 1...

Страница 41: ...ed to enter the equipment or accessories When the operation for one patient is completed clean the surface of the transducer with alcohol and smooth cloth 11 2 Routine inspection of equipment The cove...

Страница 42: ...pply or if the following remedies do not help turn off the power to the equipment and contact the REMED Customer Service Center Symptom What to do References in the User Guide Equipment does not turn...

Страница 43: ...ion from the person who has been given authorization from the company once per year 11 6 Warranty This product is manufactured through an intensive quality control and inspection process Compensation...

Страница 44: ...ou are unsure of the answer you can leave the item blank Number Inspection item Evaluation result Remarks 1 Is use of the equipment impossible due to the current failure Yes No 2 When the power switch...

Страница 45: ...ampyeong dong A block No 401 Silocon park 35 No 255 street Pangyo ro Bundang gu Seongnam si Gyeonggi do Telephone 031 696 4891 Fax 031 696 4877 Customer support Address No 301 303 Migeon Techno World...

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