Remed ELPIS-2 User Manual Download Page 13 | Manualshive

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Remed ELPIS-2 User Manual Download Page 13

ELPIS-4 / 3 / 2 User Guide

2017.08.21 Ver M-1.0.0

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tissue, resulting in hemostasis. You can control the degree of blood and incision by
changing the 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 to PubMed (https://www.ncbi.nlm.nih.gov/pubmed)

•

You can refer to various clinical papers and principles by searching for Pulsed

electromagnetic field.

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Summary of Contents for ELPIS-2

Page 1: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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