Valleylab SurgiStat II-20 Скачать руководство пользователя страница 55

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Standards and IEC Classifications

chnical S

ecifications

SurgiStat II-20 User’s Guide

•

When the alarm condition is resolved, the green single or split-plate
indicator will illuminate.

•

The system measures the return electrode sensing current according to
IEC 60601-1.

Low Frequency (50–60 Hz) Leakage Current

High Frequency (RF) Leakage Current

Standards and IEC Classifications

The SurgiStat II-20 generator meets all pertinent clauses of the IEC 60601-1
second edition and IEC 60601-2-2 third edition.

Class I Equipment (IEC 60601-1)

Accessible conductive parts cannot become live in the event of a basic insulation
failure because of the way in which they are connected to the protective earth
conductor.

Enclosure source
current, ground open

< 300 µA

Source current, patient
leads, all outputs

Normal polarity, intact ground: < 10 µA

Normal polarity, ground open: < 50 µA

Reverse polarity, ground open: < 50 µA

Sink current at high
line, all inputs

< 50 µA

Bipolar RF leakage
current

< 39 mA

rms

Monopolar RF leakage
current
(additional tolerance)

< 150 mA

rms

Содержание SurgiStat II-20

Страница 1: ...User s Guide SurgiStat II 20 Electrosurgical Generator...

Страница 2: ...trosurgical generator Valleylab Part Number 1003623 Effective Date August 2006 Trademark acknowledgements Valleylab ForceTriad Force FX Force EZ Force Argon LigaSure LigaSmart Smart Cool Tip TissuFect...

Страница 3: ...or maintenance suggestion Warning Indicates a potentially hazardous situation which if not avoided could result in death or serious injury Caution Indicates a hazardous situation which if not avoided...

Страница 4: ...l 2 8 Symbols on the Rear Panel 2 9 Chapter 3 Getting Started Initial Inspection 3 2 Installation 3 2 Function Checks 3 2 Setting Up the Unit 3 2 Checking the Patient Return Electrode Alarm 3 3 Confir...

Страница 5: ...nsions and Weight 8 2 Operating Parameters 8 3 Transport and Storage 8 3 Audio Volume 8 3 Patient Return Electrode Sensing 8 4 Low Frequency 50 60 Hz Leakage Current 8 5 High Frequency RF Leakage Curr...

Страница 6: ...r vs generator settings for Pure Cut mode 8 9 Figure 8 4 Output power vs impedance for Blend mode 8 9 Figure 8 5 Peak voltage vs power setting for Blend mode 8 10 Figure 8 6 Output power vs generator...

Страница 7: ...lowing information Key features Components and accessories Safety Caution Read all warnings cautions and instructions provided with this generator before using Read the instructions warnings and cauti...

Страница 8: ...patient burns at the return electrode site Memory The unit automatically powers up to the most recently used modes and power settings Power adjustment during activation You can change the power settin...

Страница 9: ...o substitute for a properly trained and vigilant medical staff It is important that they read understand and follow the operating instructions supplied with this electrosurgical equipment Physicians h...

Страница 10: ...unded power source with the frequency and voltage characteristics that match those listed on the back of the unit Do not use power plug adapters Electric Shock Hazard Always turn off and unplug the ge...

Страница 11: ...ed coagulation In some circumstances the potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks...

Страница 12: ...in conjunction with the electrosurgical generator place the smoke evacuator at a distance from the generator and set the generator volume control at a level that ensures that the activation tones can...

Страница 13: ...ts When not using active accessories place them in a holster or in a clean dry nonconductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in...

Страница 14: ...1 8 SurgiStat II 20 User s Guide...

Страница 15: ...SurgiStat II 20 User s Guide 2 1 2 2Controls Indicators and Receptacles This section describes the front and rear panels including all controls indicators receptacles the fuse drawer and ports Chapter...

Страница 16: ...Front Panel 2 2 SurgiStat II 20 User s Guide Front Panel Figure 2 1 Layout of controls indicators and receptacles on the front panel...

Страница 17: ...essed selects the Blend mode Blend Indicator Illuminates when Blend mode is selected Cut and Blend Power Display watts Indicates the power set for the Pure Cut or Blend mode Cut and Blend Activation I...

Страница 18: ...he power set for any Coag or Bipolar mode Coag and Bipolar Activation Indicator Illuminates when Desiccate Fulgurate or Bipolar modes are activated Coag and Bipolar Power Control Dial Increases or dec...

Страница 19: ...inates when bipolar foot control is selected Power Indicator Illuminates when the unit is on Single Plate Patient Return Electrode Indicator Illuminates when the system detects a single plate Monopola...

Страница 20: ...ts standard three pin handpieces Connect handswitching accessories Bipolar Receptacle Accepts standard cables for Bipolar handpieces Power On Off Switch Turns the unit on or off Monopolar Footswitchin...

Страница 21: ...ctivation To increase volume rotate the knob clockwise Footswitch Receptacle Accepts the E6008 or E6008B monopolar footswitch Use the monopolar footswitch for both monopolar and bipolar activation Use...

Страница 22: ...atient return electrode Split plate patient return electrode Monopolar footswitch control Footswitch on the selector button Bipolar footswitch control Power Switch and Handpiece Connectors Read instru...

Страница 23: ...tacles SurgiStat II 20 User s Guide 2 9 Symbols on the Rear Panel Symbols Description Equipotential ground stud Nonionizing radiation Volume control Danger Explosion risk if used with flammable anesth...

Страница 24: ...2 10 SurgiStat II 20 User s Guide...

Страница 25: ...SurgiStat II 20 User s Guide 3 1 3 3Getting Started This section includes the following information Initial inspection Installing the unit Checking unit functions Testing unit performance Chapter...

Страница 26: ...s in the previous chapter for the location of connectors and controls Setting Up the Unit 1 Verify that the Power Switch is in the Off O position and that no accessories are connected to the unit 2 Co...

Страница 27: ...nges to bipolar footswitching when the bipolar mode is selected 2 Verify that the Bipolar Mode Indicator illuminates and that the system generates the Coag tone when you press the Coag pedal Blue or t...

Страница 28: ...the Monopolar Handswitching receptacle 2 Activate one at a time the Cut and Coag handswitching controls 3 Verify that each control causes the correct indicator to illuminate and tone to sound Performa...

Страница 29: ...etting up Preparing for monopolar surgery Preparing for bipolar surgery Activation safety Activating the unit Caution Read all warnings cautions and instructions provided with this generator before us...

Страница 30: ...f the self test has been completed as described Otherwise inaccurate power outputs may result The instrument receptacles on this generator are designed to accept only one instrument at a time Do not a...

Страница 31: ...ncreases if the return electrode is compromised Valleylab recommends the use of split plate patient return electrodes and Valleylab generators with a contact quality monitoring system Caution Do not s...

Страница 32: ...fy the following A Cut mode is selected and a Coag or Bipolar mode is selected Each display shows a power setting The unit automatically powers up to the most recently used power settings The Patient...

Страница 33: ...monitor the resistance of the single plate electrode or the resistance at the contact between the split plate electrode and the patient Connecting Accessories 1 Connect a monopolar active electrode t...

Страница 34: ...ing electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed Use the lowes...

Страница 35: ...to either the patient or the physician do not allow the patient to come in contact with a grounded metal object during activation When activating the unit do not allow direct skin contact between the...

Страница 36: ...tances the application of additional patient return electrodes may help mitigate the increased risk When you turn on your unit remember these features SurgiStat II will power up to the most recently u...

Страница 37: ...watts The setting for Desiccate increases to 40 watts but the Blend power output remains at 50 watts 1 Monopolar Cut Select the desired Cut power settings by rotating the Cut and Blend Power Control...

Страница 38: ...4 10 SurgiStat II 20 User s Guide...

Страница 39: ...SurgiStat II 20 User s Guide 5 1 5 5Maintaining the SurgiStat II This section covers the following topics Cleaning Periodic inspection Fuse replacement Chapter...

Страница 40: ...the procedures approved by your institution or use a validated infection control procedure Periodic Inspection Every six months visually inspect the SurgiStat II for signs of wear or damage In particu...

Страница 41: ...outlet 2 Remove the power cord from the Power Cable Receptacle on the rear panel 3 To release the fuse drawer insert a small flathead screwdriver into the slot on the drawer below the power cord recep...

Страница 42: ...5 4 SurgiStat II 20 User s Guide...

Страница 43: ...SurgiStat II 20 User s Guide 6 1 6 6Troubleshooting This section includes error code descriptions and actions to take to resolve them Chapter...

Страница 44: ...uck 1 Turn off then turn on the generator Do not press buttons or accessory activation devices during the self test 2 If the alarm number reappears disconnect all accessories Turn off then turn on the...

Страница 45: ...on restarting the unit record the number and call the Valleylab Service Center E6 Internal pulse width measurement conflicts with calibrated value 1 Turn unit off 2 If error code occurred directly aft...

Страница 46: ...6 4 SurgiStat II 20 User s Guide...

Страница 47: ...User s Guide 7 1 7 7Repair Policy and Procedures Refer to this section for information on The manufacturer s responsibility Returning the generator for service Returning circuit boards Finding service...

Страница 48: ...accordance with the Valleylab instructions for use For warranty information refer to Chapter 9 Warranty Returning the Generator for Service Before you return the generator call your Valleylab represen...

Страница 49: ...ion Number B Be sure the generator is completely dry before you pack it for shipment Package it in its original shipping container If the original shipping container is not available request one when...

Страница 50: ...7 4 SurgiStat II 20 User s Guide...

Страница 51: ...8Technical Specifications All specifications are nominal and subject to change without notice A specification referred to as typical is within 20 of a stated value at room temperature 25 C 77 F and a...

Страница 52: ...Cut 120 watt 500 load the generator is suitable for activation times of 10 seconds on 30 seconds off for one hour Dimensions and Weight 110 120 Volt Nominal input power voltage for calibration 120 V...

Страница 53: ...ture range 10 to 40 C 50 to 104 F Relative humidity 15 to 75 noncondensing Atmospheric pressure 700 to 1060 millibars Warm up time If transported or stored at temperatures outside the operating temper...

Страница 54: ...kHz for 1 second then 1 kHz for 1 second Duration 4 seconds Single Plate Measurement current 100 A Measurement frequency 62 5 kHz 2 5 kHz Set resistance 0 to 5 3 Continuous measurement Once the syste...

Страница 55: ...ll pertinent clauses of the IEC 60601 1 second edition and IEC 60601 2 2 third edition Class I Equipment IEC 60601 1 Accessible conductive parts cannot become live in the event of a basic insulation f...

Страница 56: ...rgiStat II generator operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The Sur...

Страница 57: ...nput power voltage used for calibration An indication of a waveform s ability to coagulate bleeders without a cutting effect Mode Output Power Output Frequency Repetition Rate Vp p max Crest Factor Ra...

Страница 58: ...on Monopolar Cut Curves These measurements were taken using short 0 5 meter leads For each output power vs impedance curve the upper curve represents readings taken at full power the lower curve readi...

Страница 59: ...ower vs generator settings for Pure Cut mode Figure 8 4 Output power vs impedance for Blend mode 0 10 20 30 40 50 60 70 80 90 100 110 120 130 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95...

Страница 60: ...vs power setting for Blend mode Figure 8 6 Output power vs generator settings for Blend mode Output Power Setting watts Open Circuit Peak Voltage volts 0 10 20 30 40 50 60 70 80 90 100 0 5 10 15 20 2...

Страница 61: ...r Coag Curves These measurements were taken using short 0 5 meter leads Figure 8 7 Output power vs impedance for Desiccate mode Figure 8 8 Peak voltage vs power setting for Desiccate mode Load Resista...

Страница 62: ...Output power vs generator settings for Desiccate mode Figure 8 10 Output power vs impedance for Fulgurate mode 0 10 20 30 40 50 60 70 80 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 Output Power...

Страница 63: ...13 Figure 8 11 Peak voltage vs power setting for Fulgurate mode Figure 8 12 Output power vs generator settings for Fulgurate mode Output Power Setting watts Open Circuit Peak Voltage volts 0 5 10 15 2...

Страница 64: ...User s Guide Bipolar Curves Figure 8 13 Output power vs impedance for Bipolar mode Figure 8 14 Peak voltage vs power setting for Bipolar mode Load Resistance ohms Output Power watts Output Power Setti...

Страница 65: ...wer Curves Technical Specifications SurgiStat II 20 User s Guide 8 15 Figure 8 15 Output power vs generator settings for Bipolar mode 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Output Power watts Generator...

Страница 66: ...8 16 SurgiStat II 20 User s Guide...

Страница 67: ...b s factory in a way so as in Valleylab s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty periods for Valleylab products are as f...

Страница 68: ...the aggregate purchase price for the goods sold by Valleylab to the customer There are no warranties which extend beyond the terms hereof Valleylab disclaims any liability hereunder or elsewhere in co...

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