Bovie Ids-400 Manuel utilisateur

User’s Guide • Bovie®IDS-400

USER’S GUIDE

ii Bovie Medical Corporation

This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique

and surgical procedure to be performed. It is intended as a guide for using the Bovie®IDS-400 only.

Additional technical information is available in the Bovie®IDS-400 Service Guide.

Equipment Covered in this Manual

Bovie IDS-400:

Reference No.: IDS-400

For Information Contact

Bovie Medical Corporation • 5115 Ulmerton Road, Clewarwater, FL 33760-4004 USA

U.S. Phone 1-800-537-2790 Fax 1-800-323-1640 • International Phone +1-727-384-2323 Fax +1-727-347-9144

www.boviemed.com • info@boviemed.com

permission of Bovie Medical Corporation.

Bovie Part Number MC-55-131-001 Rev. 4

CONVENTIONS USED IN THIS GUIDE

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, may result in minor or moderate injury.

NOTICE:

Indicates an operating tip, a maintenance suggestion, or a hazard that may result in product

damage.

iii

User’s Guide • Bovie®IDS-400

TABLE OF CONTENTS

Equipment Covered in this Manual............................................................................iii

For Information Contact .............................................................................................iii

Conventions Used in this Guide ........................................................................................iii

Introducing the Bovie®IDS-400...........................................................................................1-1

Indications For Use .........................................................................................................1-2

Safety ..............................................................................................................................1-2

Contraindications.....................................................................................................1-5

Key Features...................................................................................................................1-5

Components and Accessories.........................................................................................1-7

Controls, Indicators, and Receptacles................................................................................2-1

Front Panel......................................................................................................................2-2

Symbols on the Front Panel....................................................................................2-3

Preset Controls................................................................................................................2-4

Cut and Blend Controls...................................................................................................2-5

Coag Controls .................................................................................................................2-6

Bipolar Controls...............................................................................................................2-7

Indicators.........................................................................................................................2-8

Power Switch and Receptacles.......................................................................................2-9

Rear Panel ....................................................................................................................2-10

Symbols on the Rear Panel ..................................................................................2-10

Getting Started ......................................................................................................................3-1

Initial Inspection ..............................................................................................................3-2

Installation .......................................................................................................................3-2

Function Checks..............................................................................................................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

Checking Monopolar Mode (with handswitch) ........................................................3-3

Performance Checks.......................................................................................................3-3

Using the Bovie®IDS-400.....................................................................................................4-1

Inspecting the Generator and Accessories .....................................................................4-2

Setup Safety....................................................................................................................4-2

Setting Up .......................................................................................................................4-3

Preparing for Monopolar Surgery....................................................................................4-4

Applying the Return Electrode ................................................................................4-4

Connecting Accessories..........................................................................................4-4

Blend Controls.........................................................................................................4-4

Setting and Recalling Memory Presets...........................................................................4-5

Memory....................................................................................................................4-5

Memory Function Overview.....................................................................................4-5

Setting Your Presets................................................................................................4-6

Memory Feature (Last Selected Preset) .................................................................4-6

Activating the Unit ...........................................................................................................4-7

Activation Safety..............................................................................................................4-7

Maintaining the Bovie®IDS-400...........................................................................................5-1

Cleaning ..........................................................................................................................5-2

Periodic Inspection..........................................................................................................5-2

Fuse Replacement ..........................................................................................................5-2

iv Bovie Medical Corporation

Troubleshooting ....................................................................................................................6-1

Repair Policy and Procedures .............................................................................................7-1

Responsibility of the Manufacturer..................................................................................7-2

Returning the Generator for Service ...............................................................................7-2

Step 1 – Obtain a Returned Goods Authorization Number.....................................7-2

Step 2 – Clean the Generator.................................................................................7-2

Step 3 – Ship the Generator ...................................................................................7-3

Technical Specifications......................................................................................................A-1

Performance Characteristics...........................................................................................A-2

Input Power.............................................................................................................A-2

Duty Cycle...............................................................................................................A-2

Dimensions and Weight..........................................................................................A-2

Operating Parameters.............................................................................................A-2

Transport and Storage ............................................................................................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 60601-1)...........................................................................A-4

Type CF Equipment (IEC 60601-1) / Defibrillator Proof .........................................A-4

Drip Proof (IEC 60601-2-2).....................................................................................A-4

Electromagnetic Interference ..................................................................................A-4

Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)......................A-4

Voltage Transients (Emergency Generator Mains Transfer) ..................................A-4

Output Characteristics ....................................................................................................A-5

Maximum Output for Monopolar and Bipolar Modes..............................................A-5

EMC Compliance............................................................................................................A-5

Output Power Curves .....................................................................................................A-9

Warranty ................................................................................................................................B-1

User’s Guide • Bovie®IDS-400

LIST OF FIGURES

Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel..................2-2

Figure 2 – 2 Controls for setting and recalling presets........................................................2-4

Figure 2 – 3 Controls for the Cut and Blend modes............................................................2-5

Figure 2 – 4 Controls for the Coag mode ............................................................................2-6

Figure 2 – 5 Controls for the Bipolar mode .........................................................................2-7

Figure 2 – 6 Indicators for power, return electrodes, and footswitch control.......................2-8

Figure 2 – 7 Location of 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 modes ....................................................A-9

Figure A – 2 Output power vs impedance for Cut I mode ................................................A-10

Figure A – 3 Output power vs impedance for Cut II mode ...............................................A-10

Figure A – 4 Output power versus impedance for Blend mode.........................................A-11

Figure A – 4 Output power versus impedance for Pinpoint mode.....................................A-11

Figure A – 6 Output power vs impedance for Spray mode ...............................................A-12

Figure A – 7 Output power vs impedance for Bipolar mode .............................................A-12

vi Bovie Medical Corporation

1-1

User’s Guide • Bovie®IDS-400

INTRODUCING THE BOVIE®IDS-400

This section includes the following information:

●●Indications For Use

●●Safety

●●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 instructions, warnings, and cautions provided with electrosurgical accessories before

using. Specific instructions are not included in this manual.

INDICATIONS FOR USE

The Bovie®IDS-400 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and

coagulate different kinds of tissue.

SAFETY

The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the operator. There is no

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 have used electrosurgical equipment safely in numerous procedures.Before starting any surgical procedure, the surgeon

should be familiar with the medical literature, complications, and hazards of using electrosurgery in that procedure.

To promote the safe use of the Bovie®IDS-400, this section presents the warnings and cautions that appear throughout this user’s

guide. It is important that you read, understand, and follow the instructions in these warnings and cautions so that you can operate

this equipment with maximum safety. It is also important that you read, understand, and follow the instructions for use in this

user’s guide.

WARNINGS:

Hazardous Electrical Output - This equipment is for use only by trained, licensed physicians.

Danger: Fire / Explosion Hazard - Do not use the Bovie®IDS-400 in the presence of flammable

materials.

Fire / Explosion Hazard - The following substances will contribute to increased fire and explosion

hazards in the operating room:

• Flammable substances (such as alcohol based skin prepping agents and tinctures)

• Naturally occurring flammable gases which may accumulate in body cavities such as

the 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 precautions at all times. When using 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.

Connect the power cord to a properly polarized and grounded power source with the frequency

and voltage characteristics that match those listed on the back of the unit.

Electric Shock Hazard - Connect the generator power cord to a properly grounded receptacle.

Do not use power plug adapters.

Electric Shock Hazard - Always turn off and unplug the generator before cleaning.

Fire Hazard - Do not use extension cords.

Patient Safety - Use the generator only if the self-test has been completed as described.

Otherwise, inaccurate power outputs may result.

Failure of the high frequency electrosurgical equipment could result in an unintended increase of

output power.

The instrument receptacles on this generator are designed to accept only one instrument at a

time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing

so will cause simultaneous activation of the instruments.

Use the lowest output setting necessary to achieve the desired surgical effect. Use the active

electrode only for the minimum time necessary in order to lessen the possibility of unintended

burn injury. Pediatric applications and/or procedures performed on small anatomic structures may

require reduced power settings. The higher the current flow, and the longer the current is applied,

the greater the possibility of unintended thermal damage to tissue, especially during use on small

structures.

1-2 Bovie Medical Corporation

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

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