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WARNINGS:

Use electrosurgery with caution in the presence of internal or external devices such as pacemak-
ers or pulse generators. Interference produced by the use of electrosurgical devices can cause
devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect
entirely. Consult the device manufacturer or hospital Cardiology Department for further information
when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other
implantable devices

.

If the patient has an Implantable Cardioverter Defibrillator (ICD), contact the ICD manufacturer for
instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple
activation of ICDs.

Do not use electrosurgical equipment unless properly trained to use it in the specific procedure
being undertaken. Use by physicians without such training has resulted in serious, unintended
patient injury, including bowel perforation and unintended, irreversible tissue necrosis.

For surgical procedures where the high frequency current could flow through parts of the body
having a relatively small cross-sectional area, the use of bipolar techniques may be desirable to
avoid unwanted coagulation.

For all Monopolar modes, any associated equipment and active electrodes must be rated to with
stand the combination of output voltage, Vpeak and crest factor as stated in the table on 
page A-5.

The generator is equipped with a return electrode sensing and contact quality monitoring system
(NEM), which monitors the quality of the patient return electrode connection. When a correctly
functioning single plate return electrode is connected to the generator, the NEM verifies the con-
nections between the generator and the single return electrode. It DOES NOT verify that a single
return electrode is in contact with the patient. When using a split return electrode, the NEM con-
firms the total resistance is within the preset safety range. Proper application and visual inspection
of the patient return electrode is required for safe operation.

In some circumstances, 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 a path
to the return electrode that includes the skin-to-skin contact point. Current passing through small
skin-to-skin contact points is concentrated and may cause a burn. This is true for grounded,
ground referenced, and isolated output generators.

To reduce the potential for alternate site burns, do one or more of the following:

• Avoid skin-to-skin contact points, such as fingers touching leg, when positioning the patient.
• Place 5 to 8 cm (2 to 3 in.) of dry gauze between contact points to ensure that contact does 

not occur.

• Position the return electrode to provide a direct current route between the surgical site and 

the return electrode which avoids skin-to-skin contact areas.

• In addition, place patient return electrodes according to the manufacturer’s instructions.

Potential for alternate site burns increases if the return electrode is compromised. Bovie recom-
mends the use of split return electrodes and Bovie generators with a contact quality 
monitoring system.

The entire area of the neutral electrode should be reliably attached to the patient’s body and as
close to the operating field as possible.

The cables to surgical electrodes should be positioned in such a way that contact with the patient
or other leads is avoided. Temporarily unused active electrodes should be stored so that they are
isolated from the patient.

Do not wrap the accessory cords or return electrode cords around metal objects. This may induce
currents that could lead to shocks, fires, or injury to the patient or surgical team.

The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen

should be avoided if a surgical procedure is carried out in the region of the thorax or the head,
unless these agents are sucked away.

1-3

User ’s Guide • Bovie

®

IDS-400

Содержание ids-400

Страница 1: ......

Страница 2: ...i User s Guide Bovie IDS 400 USER S GUIDE...

Страница 3: ...ii Bovie Medical Corporation...

Страница 4: ...7 2790 Fax 1 800 323 1640 International Phone 1 727 384 2323 Fax 1 727 347 9144 www boviemed com info boviemed com 2014 Bovie Medical Corporation All rights reserved Contents of this publication may n...

Страница 5: ...cks 3 2 Setting Up the Unit 3 2 Checking the Return Electrode Alarm 3 2 Confirming Modes 3 3 Checking Bipolar Mode with bipolar footswitch 3 3 Checking Monopolar Mode with monopolar footswitch 3 3 Che...

Страница 6: ...age A 2 Audio Volume A 3 Return Electrode Sensing A 3 Low Frequency 50 60 Hz Leakage Current A 3 High Frequency RF Leakage Current A 4 Standards and IEC Classifications A 4 Class I Equipment IEC 60601...

Страница 7: ...the unit power switch and front panel receptacles 2 9 Figure 2 8 Layout of connectors and controls on the rear panel 2 10 Figure 5 1 Fuse holder 5 2 Figure A 1 Output power versus voltage for all mod...

Страница 8: ...y Warnings and Cautions Key Features Components and Accessories Additional Accessories CAUTIONS Read all warnings cautions and instructions provided with this generator before using Read the instructi...

Страница 9: ...he bowel Oxygen enriched atmospheres Oxidizing agents such as nitrous oxide N20 atmospheres The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precauti...

Страница 10: ...tal resistance is within the preset safety range Proper application and visual inspection of the patient return electrode is required for safe operation In some circumstances potential exists for alte...

Страница 11: ...etic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the sur...

Страница 12: ...ces National Institute for Occupational Safety and Health NIOSH Control of Smoke from Laser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 Contraindications There ar...

Страница 13: ...ediately adjusts the power to varying impedance during the electrosurgical procedure The unit s digital technology senses and responds to changes in tissue and density Unlike analog this feature reduc...

Страница 14: ...for connecting footswitching pencil A905EL adaptor for 1 6 electrode into 3 32 collet BV 1253B footswitch for Monopolar procedures BV 1254B footswitch for Bipolar and vessel sealing procedures A827 fo...

Страница 15: ...1 8 Bovie Medical Corporation...

Страница 16: ...2 1 User s Guide Bovie IDS 400 CONTROLS INDICATORS AND RECEPTACLES This section describes The Front and Rear Panels Controls Indicators Receptacles and Ports...

Страница 17: ...FRONT PANEL Figure 2 1 Layout of controls indicators and receptacles on the front panel 2 2 Bovie Medical Corporation...

Страница 18: ...pray Mode Bipolar Controls Bipolar Mode Indicators Split Return Electrode Solid Return Electrode Regulatory Symbology Read instructions before use Defibrillator Proof Type CF Equipment RF Isolated pat...

Страница 19: ...the 10 user defined presets Press and hold the Set button for three seconds to save the settings Recall Button Toggles through the 10 presets Stop at the desired number 0 9 illuminated in the Preset...

Страница 20: ...tween Cut I Cut II and Blend modes Blend Amount Indicator Indicates the amount of blend added in the Blend mode More bars illuminated indicates more blend divided into 10 steps Blend Amount Control Bu...

Страница 21: ...ns Increases or decreases the Pinpoint or Spray Coag power output in increments of 1 to 10 watts Coag Activation Indicator Illuminates when Coag mode is activated Pinpoint and Spray Mode Selector Togg...

Страница 22: ...lar Power Display watts Indicates the power set for the Bipolar mode Displays error code in the event of an error Bipolar Power Control Buttons Increases or decreases the Bipolar power output in incre...

Страница 23: ...en when the system detects a single plate Notices Solid pad indicator only detects that a pad is connected to the unit The unit does not moni tor pad placement on the patient Split Return Electrode In...

Страница 24: ...Footswitching Receptacle Accepts cables or adapters equipped with standard active plugs Connect footswitching accessories Bipolar Receptacle Accepts standard cables for bipolar handpieces Connect bipo...

Страница 25: ...ces must be disposed of as medical biohazard waste and 2 10 Bovie Medical Corporation SYMBOLS DESCRIPTION Equipotential Ground Stud Non ionizing Radiation Volume Control Danger Explosion Risk If Used...

Страница 26: ...3 1 User s Guide Bovie IDS 400 GETTING STARTED This section includes the following information Initial Inspection Installation Function Checks Performance Checks...

Страница 27: ...connectors and controls WARNING At no time should you touch the active electrode or bipolar forceps A burn could result Setting Up the Unit 1 Verify that the Power Switch is in the Off O position and...

Страница 28: ...erates the Cut activation tone 4 While activating the Cut mode rotate the volume control over the full range to verify that the sound is audible throughout the range 5 Press the Coag pedal blue on the...

Страница 29: ...3 4 Bovie Medical Corporation...

Страница 30: ...ng for Monopolar Surgery Preparing for Bipolar Surgery Setting and Recalling Memory Presets Activating the Unit Activation Safety CAUTIONS Read all warnings cautions and instructions provided with thi...

Страница 31: ...serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body...

Страница 32: ...heels are recommended For details refer to the procedures for your institution or to local codes Provide at least 10 to 15 cm 4 to 6 in of space from the sides and top of the generator for cooling Nor...

Страница 33: ...tor the resistance at the contact between the electrode and the patient 2 Adjust the Blend setting to the desired amount of hemostasis Level 1 10 Adjustment is preformed by pressing the up or down but...

Страница 34: ...ing activation Recall and Set membrane switches are disabled during activation During activation the activated mode can be adjusted up and or down a maximum of four steps Refer to the following table...

Страница 35: ...allows the unit to display the last selected power preset when the generator is turned on NOTICE To have a setting selection available at startup or to be one of the 10 user defined presets the adjus...

Страница 36: ...will be displayed and available when the unit is activated The number 2 Preset will now be the last saved Preset settings for Preset 2 ACTIVATING THE UNIT NOTICE Review Activation Safety on page 6 of...

Страница 37: ...y current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient p...

Страница 38: ...5 1 User s Guide Bovie IDS 400 MAINTAINING THE BOVIE IDS 400 This section covers the following topics Cleaning Periodic Inspection Fuse Replacement...

Страница 39: ...uids to enter the chassis Do not sterilize the generator PERIODIC INSPECTION Every six months visually inspect the Bovie IDS 400 for signs of wear or damage In particular look for any of the following...

Страница 40: ...6 1 User s Guide Bovie IDS 400 TROUBLESHOOTING This section includes Error Code Descriptions and actions to take to resolve them...

Страница 41: ...tswitch pedal may be stuck F6 Simultaneous activation error The unit does not allow simultaneous activation of the cut and coagulation modes The activation mode is first come first serve This means th...

Страница 42: ...7 1 User s Guide Bovie IDS 400 REPAIR POLICY AND PROCEDURES Refer to this section for information on Responsibility of the Manufacturer Returning the Generator for Service...

Страница 43: ...x and ship directly to Bovie Medical Corporation Step 1 Obtain a Returned Goods Authorization Number Call the Bovie Medical Corporation Customer Service Center 727 384 2323 to obtain a Returned Goods...

Страница 44: ...umber and the information hospital phone number etc listed in Step 1 Obtain a Returned Goods Authorization Number B Be sure the unit is completely dry before you pack it for shipment Although the pref...

Страница 45: ...7 4 Bovie Medical Corporation...

Страница 46: ...0 TECHNICAL 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 47: ...e device should be stored and used in a room temperature of approximately 770 F 250 C A 2 Bovie Medical Corporation Ambient temperature range 40 to 70 C Relative humidity 10 to 100 including condensat...

Страница 48: ...not adjustable 70 dB 5 dB Frequency 2 kHz 1 2 seconds 1 kHz 1 2 seconds Duration 2 seconds Solid Trip resistance 0 to 5 3 Continuous measurement Once the system establishes the solid return electrode...

Страница 49: ...wet electrical insulation or other components which when wet are likely to affect adversely the safety of the generator Electromagnetic Interference When other equipment is placed on or beneath a Bovi...

Страница 50: ...IDS 400 The IDS 400 and its accessories are not suitable for interconnection with other equipment Portable and mobile RF communications equipment can affect Medical Electrical Equipment The IDS 400 sh...

Страница 51: ...quency 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 separation distance for th...

Страница 52: ...V differential mode 2 kV common mode 1 kV differential mode 2 kV common Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage...

Страница 53: ...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 separation distance for the higher...

Страница 54: ...ustrate specific output power delivered to a range of load resistances for each mode Figures A 9 through A 14 illustrate outpput power curves that depict the changes for each mode at specific power se...

Страница 55: ...Bovie Medical Corporation A 10 Figure A 3 Output power versus impedance for Cut II mode Figure A 4 Output power versus impedance for Blend Min mode...

Страница 56: ...User s Guide Bovie IDS 400 A 11 Figure A 5 Output power vs impedance for Blend Max mode Figure A 6 Output power vs impedance for Pinpoint mode...

Страница 57: ...Figure A 7 Output power vs impedance for Spray mode Figure A 8 Output power vs impedance for Bipolar mode A 12 Bovie Medical Corporation...

Страница 58: ...Figure A 9 Power setting versus output power for Cut I mode Figure A 10 Power setting versus output power for Cut II mode A 13 User s Guide Bovie IDS 400...

Страница 59: ...Figure A 11 Power setting versus output power for Blend Min and Max mode Figure A 12 Power setting versus output power for Pinpoint mode A 14 Bovie Medical Corporation...

Страница 60: ...Figure A 13 Power setting versus output power for Spray mode Figure A 14 Power setting versus output power for Bipolar mode A 15 User s Guide Bovie IDS 400...

Страница 61: ...A 16 Bovie Medical Corporation...

Страница 62: ...ch has been repaired or altered outside Bovie s factory in a way so as in Bovie s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty...

Страница 63: ...any liability hereunder or elsewhere in connection with the sale of this product for indirect or consequential damages This warranty and the rights and obligations hereunder shall be construed under a...

Страница 64: ......

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