Depuy Mitek 225024 VAPR VUE Generator User Manual

Depuy Mitek VAPR VUE Generator

UserManual.wiki >

Depuy Mitek >

225024 User Manual HTML Version

User Manual

GYRUS P/N:

192058-BG

P/N: 110009-EN

Rev: J Revised 08/2017

User Manual

This user’s guide will familiarize you with the controls and output functions available from your DePuy Mitek

VAPR VUE® RADIOFREQUENCY (RF) System and instruct you on the proper use of the equipment. Review

this manual thoroughly before installation and use of the VAPR VUE RF System. Please also read, understand

and follow all cautions and warnings in this manual and those included in the Instructions for Use included with the

VAPR System accessories. Additional information, training and product servicing are available from DePuy Mitek.

The information contained in this manual is based upon the most current information available at the time of print-

ing. DePuy Mitek reserves the right to update the equipment and its operation without notice.

The entire content of this manual is the property of DePuy Mitek and is protected by all relevant copyright laws.

Do not reproduce any portion of this manual, in any form, without express written approval of DePuy Mitek.

Worldwide Patents pending.

This manual covers the VAPR VUE System only.

Part Number: 225024

GYRUS P/N:

192058-BG

P/N: 110009-EN

Rev: J Revised 08/2017

TABLE OF CONTENTS

Section 1: INtRodUctIoN

Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Comparison to Conventional Electrosurgery ........................ 1-1

System Description ........................................... 1-2

Principles of Operation ........................................ 1-3

Section 2: INdIcatIoNS foR USe, coNtRaINdIcatIoNS

Indications for Use............................................ 2-1

Contraindications............................................. 2-1

Section 3: SafetY

Operating Personnel .......................................... 3-1

Fire/Explosion Warnings ....................................... 3-1

Electrical Safety Considerations ................................. 3-1

EMC (Electromagnetic Compatibility) Precautions ................... 3-2

Electrosurgical Smoke Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Prior to Surgery .............................................. 3-2

During Surgery............................................... 3-3

After Surgery ................................................ 3-5

Section 4: SYStem deScRIPtIoN

VAPR VUE Radiofrequency Generator ............................ 4-1

Output Modes ............................................... 4-1

Generator Controls and Displays................................. 4-3

Front Panel Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Footswitches ................................................ 4-7

Wireless Footswitch........................................... 4-8

VAPR Electrodes ............................................. 4-9

VAPR Handpiece ............................................ 4-12

Section 5: INStRUctIoNS foR USe

System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

System Setup and Use During Surgery............................ 5-2

Using VAPR Thermal Control (TC) Electrodes ...................... 5-4

Adjusting the Tone Volume ..................................... 5-4

Adjusting the Generator for Footswitch, Hand Control or

Wireless Foot Switch Operation ................................. 5-5

Changing Electrodes During Surgery ............................. 5-5

Use of Suction Electrodes ...................................... 5-6

After Surgery ................................................ 5-6

Section 6: cleaNING aNd SteRIlIzatIoN PRocedUReS

Cleaning the Generator ........................................ 6-1

Cleaning the Footswitch ....................................... 6-1

Cleaning and Sterilizing the VAPR Handpiece and Cable.............. 6-1

Section 7: PeRIodIc maINteNaNce INSPectIoN ............................. 7-1

Section 8: eRRoR aNd faUlt SYmBolS, tRoUBleShootING GUIde

Error & Fault Symbol Interpretation and Recovery ................... 8-1

Error Symbols ............................................... 8-1

Fault Symbols ............................................... 8-1

Recover - Resetting Generator Faults and Errors .................... 8-2

Alarms ..................................................... 8-2

Troubleshooting Guide ........................................ 8-7

aPPeNdIx a: techNIcal SPecIfIcatIoNS .................................... A-1

VAPR VUE Generator Specifications ............................. A-1

VAPR 3 Wired Footswitch Specifications .......................... A-2

VAPR VUE Wireless Footswitch Specifications...................... A-2

Output Waveform and Characteristics............................. A-2

aPPeNdIx B: emc taBleS ............................................... B-1

aPPeNdIx c: WaRRaNtY aNd SeRvIce ...................................... C-1

aPPeNdIx d: acceSSoRIeS ............................................... D-1

INtRodUctIoN

1-1

Section 1

IntroDuCtIon

Caution: Federal law restricts this device to sale by or on the order of a physician.

BACKGROUND

Arthroscopy relates to the use of an arthroscope to visualize the joint space. A variety of

instruments specifically designed for arthroscopic use may be introduced through separate

puncture sites, employing the technique of triangulation, in order to perform various surgical

procedures within the joint space.

The DePuy Mitek VAPR VUE RF System represents a versatile approach to arthroscopy.

Based on an innovative form of bipolar electrosurgery, the VAPR® Radiofrequency System

has been specifically designed to provide a range of arthroscopic surgical modalities including

soft tissue ablation (electro-vaporization), contouring, cutting, coagulation, and temperature

indication. Arthroscopic surgery could include subacromial decompression, acromioplasty,

bursectomy, synovectomy, labral tear resection, excision of scar tissue, chondroplasty,

meniscectomy, lateral release, tendon debridement, ligament debridement, plica removal and/

or fracture debridement. Complementing the VAPR technology, the VAPR VUE system offers

a new approach to tissue management with a COOLPULSE® (CP) RF mode that achieves

enhanced ablation.

COMPARISON TO CONVENTIONAL ELECTROSURGERY

Conventional electrosurgical systems deliver high frequency electrical current through tissue

for the purposes of tissue cutting or hemostasis of blood vessels. Monopolar electrosurgery

utilizes an “active” electrode located on the surgical instrument and a separate “return”

electrode applied to the patient. Current flows from the active electrode through the patient to

the return electrode. Bipolar electrosurgery differs in that both the active and return electrodes

are located on the surgical instrument, thus minimizing the amount of tissue involved in the

electrical circuit.

Problems potentially encountered when using conventional bipolar electrosurgery include

limited power delivery and visualization of the working tip, tissue sticking, and dependence

upon proper electrode-to-tissue orientation. Additionally, conventional bipolar electrodes do not

operate effectively while immersed in conductive irrigating solutions used in arthroscopy, such

as normal saline or Ringer’s lactate.

In contrast, VAPR bipolar electrosurgery electrodes are specifically designed to function in

conductive irrigating solutions. The VAPR “return” electrode is mounted on the shaft of the

instrument and does not have to be oriented to be in contact with tissue during use. This

eliminates the need for a separate patient ground electrode. Additionally, since only the tissue

that is in contact with the active electrode is involved in the electrical circuit, the recognized

safety features of bipolar electrosurgery are preserved.

SYSTEM DESCRIPTION

The VAPR VUE System is designed to provide soft tissue ablation (vaporization), contouring,

cutting and hemostasis of blood vessels during arthroscopic surgical procedures.

The components of the DePuy Mitek VAPR VUE System (Figure 1) are individually described

in Section 4 of this manual:

• VAPR VUE Radiofrequency Generator

• VAPR Handpiece

• VAPR Electrodes

• VAPR Electrodes with integrated handpiece

• VAPR Electrodes with integrated handpiece and hand controls

• VAPR 3 Footswitch

• VAPR VUE Wireless Footswitch

• Power Cord (not provided)

Use only the DePuy Mitek Handpiece and Electrodes with this System.

INtRodUctIoN

1-2

AC POWER INPUT

GENERATOR

20x4 CHARACTER

USER DISPLAY

ON/OFF

SWITCH

CONTROL PANEL

RED FAULT INDICATOR

ONE PIECE

ELECTRODE

(WITH HAND

CONTROL OPTION)

TWO PEDAL + ONE

MODE BUTTON

WIRED FOOTSWITCH

TWO PEDAL + ONE MODE

BUTTON WIRELESS

FOOTSWITCH

fIGURe 1

INtRodUctIoN

1-3

PRINCIPLE OF OPERATION

The VAPR VUE System offers five bipolar modes of operation: Ablation (Vaporization),

Coagulation, CP (COOLPULSE) Ablation, Blended Vaporization, and Coagulation with tem-

perature control.

• In the Ablation mode of operation, high frequency power is delivered from the VAPR

VUE Generator to the Electrode tip. At specific threshold power levels, a vapor pocket,

characterized by an orange glow, is created around the active electrode. Arcs within the

vapor pocket lead to vaporization of tissue entering the vapor pocket.

• The Ablation power threshold for a particular VAPR Electrode is automatically set as

a default by connecting the Electrode to the Generator. The default setting for each

Electrode type is the optimal power required to produce the desired tissue effect. As an

inherent safety feature, the VAPR System is designed to minimize the power required to

sustain the vapor pocket around the active electrode.

• In the Coagulation mode of operation, the VAPR Generator delivers high frequency

power to the active electrode to cause tissue coagulation without sparking or cutting.

The Coagulation power level is also automatically set as a default for each style

of Electrode.

• In the CP (COOLPULSE) Ablation mode of operation, the mode of RF delivery reaches

vaporization mode quicker with short-duration high power pulses. Once the vapor

pocket is formed around the tip, the RF mode reverts to continuous operation (similar to

standard Ablation mode). The COOLPULSE mode is able to sustain the vapor pocket

better than the standard vaporization mode in difficult conditions such as cold or high-

flow saline conditions. The pulses of the CP Ablation mode cause more rapid saline

heating at the active electrode with shorter time for heat dissipation.

• The Blended Ablation mode of operation provides tissue vaporization combined

with hemostasis. Certain Electrode styles will automatically default to Blended

Ablation mode.

• In the Coagulation Mode with temperature control (only available with the VAPR

Temperature Control (TC) electrodes), the tip temperature is set as a default, along with

a power level. The VAPR System will monitor the actual tip temperature while activated,

automatically adjusting the power to maintain the tip temperature at the set temperature.

NOTE

The Temperature Control system will only automatically adjust the power up to the limit of the

coagulate power level as displayed at time of use.

VAPOR

POCKET ELECTRODE

SHAFT

RETURN

ELECTRODE

INSULATOR

fIGURe 2

INdIcatIoNS

foR USe,

coNtRaINdIcatIoNS

2-1

Section 2

InDICAtIons

For use,

ContrAInDICAtIons

INDICATIONS FOR USE

The VAPR VUE Radiofrequency System is intended for resection, ablation, and excision of

soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring

arthroscopic surgery.

NOTE

Refer to VAPR electrode Instructions for Use for specific indication statement.

CONTRAINDICATIONS

The DePuy Mitek VAPR System is contraindicated in any non-arthroscopic surgical procedure

and in procedures where saline or Ringer’s lactate is not used as an irrigant. The System is

also not appropriate for patients for whom an arthroscopic procedure is contraindicated for any

reason. Use of the System is also contraindicated in patients with heart pacemakers or other

electronic device implants.

SafetY

3-1

SafetY

3-1

Section 3

sAFety

OPERATING PERSONNEL

The surgeon using this device should:

• be trained in arthroscopic surgical procedures

• be aware of the risks associated with those procedures

• have current knowledge of technological advances in surgical products and techniques.

WARNING

Hazardous Electrical Output: This equipment is capable of producing a physiological effect and

is for use only by licensed physicians, trained in the use of this device.

WARNING

Read the instructions, cautions, and warnings provided with all VAPR VUE System accessories

before use. This device is an integral system; only use approved accessories with the VAPR VUE

Generator. Your sales representative can advise which accessories are available and approved

for use with the VAPR VUE System.

FIRE/EXPLOSION WARNINGS

• As with all electrosurgical devices, do not use in the presence of flammable anesthetics

or oxidizing gases, such as nitrous oxide, oxygen or endogenous gases which have

accumulated in body cavities. An electrosurgical device has the potential for providing a

source for ignition.

• Nonflammable substances should be used for cleaning and disinfecting. Use of

flammable substances, such as alcohol-based skin prepping agents and tinctures

should also be avoided.

• All oxygen connections must be leak free for the duration of the surgical procedure.

Pathways, such as endotracheal tubes, must be leak free and properly sealed to

prevent oxygen leaks.

• Electrosurgical accessories which are activated or hot from use can be a potential fire

hazard if placed near or in contact with flammable materials. Some materials, such as

gauze, cotton or wool, when saturated with flammable liquids, can be ignited by sparks

produced during the normal use of electrosurgical devices.

ELECTRICAL SAFETY CONSIDERATIONS

• Examine all accessories and connections to the VAPR VUE Generator before use.

Ensure that the accessories function as intended. Improper connection may result in

arcing, sparking, or malfunction of the Electrode or Handpiece, any of which can result

in an unintended surgical effect, injury, or product damage.

• Unless specified in the instructions for use accompanying an approved VAPR

accessory, the VAPR VUE System should only be activated with the working tip of the

electrode accessory completely immersed in 0.9% w/v; 150 mmol/l sodium chloride

or Ringer’s lactate solutions. For convenience, these will be referred to within the

remainder of this manual as normal saline or Ringer’s, respectively. Performance will

be suppressed by use of other irrigating solutions such as Glycine, Sorbitol, Dextrose,

Mannitol or other solutions containing a non-physiological concentration of electrolytes.

SafetY

3-2

SafetY

3-2

• No modification to the equipment is allowed.

• To avoid the risk of electric shock this equipment must only be connected to a SUPPLY

MAINS with protective earth.

• Ensure that the generator is positioned so that the ability to disconnect or isolate from

the mains supply is not restricted.

EMC (ELECTROMAGNETIC COMPATIBILITY) PRECAUTIONS

Medical electrical equipment requires special precautions regarding EMC and needs to be

installed and put into service according to the EMC information in Appendix B.

WARNING

Portable and mobile RF communications equipment can affect medical electrical equipment.

WARNING

The use of accessories and cables other than those for which the system was designed can

significantly degrade emissions and immunity performance.

WARNING

Keep the accessory cables away from cables from other electrical equipment. Electrical currents

may be induced in the other equipment causing unintended effects.

WARNING

Do not use a monopolar generator or accessories simultaneously with the VAPR VUE generator.

Activation of a monopolar generator or accessories may cause interference with the VAPR VUE

generator resulting in user message changes on the display. Before proceeding with surgery,

confirm proper power settings are displayed on the generator. Ensure the appropriate output

setting is enabled for the desired surgical outcome.

WARNING

Provide as much distance as possible between the electrosurgical generator and other electronic

equipment (such as monitors) because an activated electrosurgical generator may cause

interference.

ELECTROSURGICAL SMOKE CAUTION

Studies have shown that smoke generated during electrosurgical procedures can be potentially

harmful to surgical personnel. Use appropriate surgical masks or other means of protection.

PRIOR TO SURGERY

CAUTION

Non-function of the generator may cause interruption of surgery. Ensure that all installation

procedures are followed and that all connectors are correctly inserted before use. A backup

generator should be available for use.

Operator Safety Warnings

• Electric Shock Hazard: Do not connect wet accessories to the handpiece or generator.

Ensure that all accessories are securely and properly connected.

• Electric Shock Hazard: Do not remove or tamper with the Generator housing. Contact

DePuy Mitek technical service for assistance.

• The power cord must meet all requirements for safe grounding. Do not use extension

cords, multiple point plugs or 2 to 3 pronged plug adapters.

• Do not reuse or resterilize accessories labeled “SINGLE USE,” as malfunction, injury or

cross-infection may result. These products are for single-use only and have not been

designed to be re-used/re-sterilized.

SafetY

3-3

SafetY

3-3

• Reprocessing may lead to changes in material characteristics such as metallic corrosion

and dulled edges, ceramic and plastic deformation or splitting which may impact the

strength of the device and compromise device performance. Reprocessing of single use

devices can also cause cross-contamination leading to patient infection. These risks

may potentially affect patient safety.

• When bending the FLEX Electrode, do not exceed a 45° angle relative to the plane of

the shaft. Do not change the FLEX Electrode shape more than three times at the same

point on the shaft. More than three angle modifications can result in electrode fracture.

• Use of instruments to bend the electrodes can cause damage to the FLEX Electrode.

Electrodes should only be bent using fingers.

Operator Safety Cautions

• Inspect the insulation of all cords for cracks, nicks and breaks. Inspect all connectors for

damaged or missing parts.

• Use default power levels to test Electrode performance. Confirm proper default power

settings with package insert information before proceeding with surgery.

• Using arthroscopic guidance, ensure that the Electrode tip is completely surrounded by

conductive irrigant solution during use.

• Accessories labeled “REUSABLE” must only be processed according to the recom-

mended procedures provided in this manual.

• Avoid touching the ceramic and active tip of the electrode with your fingers or instruments.

DURING SURGERY

NOTE

For the purposes of safety procedures, and despite the absence of a conventional return pad, the

VAPR System should still be treated as a high power electrosurgical device.

WARNING

Failure of the RF SURGICAL EQUIPMENT could result in an unintended increase of output

power.

Operator Safety Warnings

•

Observe extreme caution when using electrosurgery in close proximity to, or in

direct contact with, any metal objects. The majority of arthroscopes and arthroscopic

instruments are metal. Do not activate the electrode while any portion of the electrode

tip is in contact with metal objects or instruments; avoid ablating tissue that is trapped

between the arthroscope and the electrode. Doing so may result in unintended injury to

the patient or surgical personnel and/or damage to the electrode and/or other equipment.

• Do not wrap Handpiece, Footswitch or Generator power cables around metal objects.

Wrapping cables around metal objects may induce currents that could lead to electric

shock, fire and/or injury to patient or surgical personnel.

• During an electrosurgical procedure, the patient should not be allowed to come into

direct contact with grounded metal objects such as surgical table frame, instrument

table, etc.

• Confirm proper default generator power settings before proceeding with surgery. Always

check that the automatic default settings shown on the display match those indicated on

the package insert of the Electrode being used.

• Caution should be used when overriding the default power settings. Use the lowest

power setting and the minimum tissue contact time necessary to achieve the

appropriate surgical effect.

SafetY

3-4

• Visually inspect the Handpiece and Electrode to ensure that they are clean, dry, and

free of damage prior to inserting the Electrode. Damage to the connectors or the

presence of fluid may cause a hazardous electrical short.

• Ensure that the Electrode is fully seated in the Handpiece prior to use. Improper

connection could result in non-activation of the Electrode and fluid leakage which may

produce an electrical short.

• Ensure that Electrodes with handpiece are properly connected to the generator, and

that the correct default settings are displayed.

• Introducing the Electrode without an instrument cannula may result in tissue injury and/

or product damage.

•

Do not insert, withdraw or touch the active tip of the Electrode when power is being applied.

• All high frequency electrosurgical devices can potentially cause muscle stimulation

during use. The VAPR VUE system has been designed such that this undesirable effect

is minimised, however, muscle stimulation may cause unexpected movement of the

patient within the surgical field.

• When not in use, place the active Electrode in a clean, dry, nonconductive, and highly

visible area not in contact with the patient. Inadvertent activation while in contact with

the patient may result in burns.

• Skin to skin contact (for example between the arms and body of the patient) should be

avoided, for example by insertion of dry gauze.

• Fluids pooled in the body depressions and cavities should be removed before the use of

HF surgical equipment.

• Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase or

decrease in output power, change in output waveform characteristics or absence of

electrosurgical output.

Operator Safety Cautions

• The VAPR VUE system contains an over-current alarm. If this is heard during activation,

the Electrode and Handpiece must be withdrawn and inspected for damage. An

accessory that causes repeated overcurrent alarms (when not in contact with a metal

surface/object) should be discarded.

• Maintain the Generator volume control to a level that will be audible in a normal

operating room environment. The activation tone is heard while the foot pedal or hand

control button is depressed, indicating the Electrode is activated.

• If possible, avoid the use of needle style electrodes for any physiological monitoring

equipment that may be connected to the patient during electrosurgery.

• Where practical, only use monitoring equipment that incorporates high frequency

current limiting devices during electrosurgical procedures.

• The Handpiece or Electrode cable should be positioned so that it avoids contact with

the patient and any other leads.

• Should a power supply interruption occur, the Generator power settings will revert to the

minimum values when power is re-established should the accessory combination still be

connected.

• A backup means should be available for all RF activation modes (i.e., backup Wireless

Footswitch, backup Wired Footswitch, or backup Electrode with hand controls).

SafetY

3-5

• Attempts to bend electrodes can result in electrode fracture or degradation of electrode

performance.

Potential Hazards for Arthroscopic Procedures

As visualization may be impaired during arthroscopy, be particularly alert to these poten-

tial hazards:

• An activated Electrode tip may remain hot enough to cause burns after the electrosurgi-

cal current is deactivated.

• Maintain the active Electrode in the field of view at all times. Injuries to the patient may

result from inadvertent activation or movement of an activated Electrode outside the

field of view.

• Use care when inserting and withdrawing the Electrode from a cannula to avoid the

possibility of damage to the devices and/or injury to the patient.

• Continuous flow of irrigant is strongly recommended. Fluid flow assists in removing

vaporization by-products as well as reducing the temperature of the electrode tip

between activations.

• Ensure that the Electrode tip is completely surrounded by irrigant solution during use.

• Outflow is important, especially in small joint spaces.

• Prolonged or unnecessary activation when not in contact with tissue may result in

unintentional damage to surrounding tissue.

AFTER SURGERY

WARNING

Electric shock hazard: Turn off the Generator and unplug the power cord from the AC source

prior to cleaning Generator.

Equipment Disposal

• The VAPR System Generator contains electronic printed circuit assemblies. At the end

of the useful life of the equipment it should be disposed of in accordance with any appli-

cable national or institutional related policy relating to obsolete electronic equipment.

• Dispose of any system accessories according to normal institution practice relating to

potentially contaminated items.

• Do not reuse or resterilize accessories labeled “SINGLE USE.” These products are for

single-use only and have not been designed to be re-used/re-sterilized. Reprocessing

may lead to changes in material characteristics such as metallic corrosion and dulled

edges, ceramic and plastic deformation or splitting which may impact the strength of the

device and compromise device performance. Reprocessing of single use devices can

also cause cross-contamination leading to patient infection. These risks may potentially

affect patient safety.

SYStem

deScRIPtIoN

4-1

Section 4

system

DesCrIptIon

VAPR VUE RADIOFREQUENCY GENERATOR

The VAPR VUE Generator (FIGURE 3) is an isolated output radiofrequency generator

that provides power for soft tissue vaporization (ablation), cutting and coagulation during

arthroscopic surgical procedures. Technical specifications are detailed in Appendix A.

OUTPUT MODES

The VAPR VUE Generator allows the user to select one of the following functional modes

using generator front panel set-up options: tissue Ablation mode, Coagulation (hemostasis)

mode, CP (COOLPULSE) Ablation mode, Coagulation mode with temperature control, and

Blended Ablation mode that combines Ablation and Coagulation. A brief description of each

mode is provided below:

ABLATE Modes

There are three standard V mode ablation levels V1, V2 and V3. The least aggressive tis-

sue vaporization is created in the V1 mode while the most aggressive tissue vaporization

is created in the V3 mode. Activate using YELLOW foot pedal or hand control button.

Coagulation (COAG) Mode

The Coagulation mode provides hemostasis of blood vessels without tissue vaporization.

Available with all Electrode configurations, the hemostatic effect will be dependent on the

active electrode contact area and power setting. The depth of effect for a given Electrode

configuration and power setting is dependent upon the application time. Activate using

BLUE foot pedal or hand control button.

COOLPULSE (CP) ABLATE Mode

The COOLPULSE Ablation mode provides tissue vaporization with a ‘pulse effect’.

Available with specific Electrode configurations only, the vaporization effect is dependent

upon the application but will typically be more aggressive than the standard V3 mode.

Activate using YELLOW foot pedal or hand control button.

COAG with Temperature Control

When in coagulation mode, this allows the display of electrode tip temperature, and control

against a set temperature. Activate using BLUE foot pedal or hand control button.

Blended ABLATION (BV) Modes

There are two Blended Ablation modes: BV1 and BV2. The Blended Vaporization output

modes combine tissue ablation with hemostasis and are useful when cutting or de-bulking

more vascular tissue structures.

• BV1 mode automatically switches between the V2 ablation mode and coagulation

(hemostasis) mode.

• BV2 mode switches between the V3 ablation mode and coagulation (hemostasis) mode.

Activate using YELLOW foot pedal or hand control button.

SYStem

deScRIPtIoN

4-2

AC ON/OFF

Switch

Volume

Adjustment

Ablate Output

Display

Coagulate

Power

Setting

Coagulate

Power

Adjustment

Ablate Power

Adjustment &

Output Mode

Select

AC ON/OFF

Indication

Ablate

Power

Setting

Mode Function/

Wireless

Footswitch

Pairing

Fault

Indicator

Instrument

Type

Footswitch

Connection

Equipotential

Terminal

Usb Interface

(Service Use Only)

Serial Interface

(Service Use Only)

AC Power

Input

Fuse Holder

Wired Footswitch Enable

Wireless Footswitch Enable

Handswitching Enable

Instrument

Connection

Coagulate

Output Display

fIGURe 3

SYStem

deScRIPtIoN

4-3

GENERATOR CONTROLS AND DISPLAYS

Power Switch

The power switch turns AC power on and off. It is

advisable to switch off the Generator whenever

it is not in use to avoid any possibility of inadver-

tent activation.

Fault Indication Light

This light will illuminate to indicate a Generator

critical failure or a VAPR accessory malfunction.

NOTE

The light will illuminate briefly during the self-test

routine. This is normal and does not indicate a failure.

Mode Button

Depressing the mode button once will enable

selection of the Output Mode using the BLUE

Power Up and Down buttons. Once the display

shows the desired V, CP or BV output mode,

holding the Mode Button down will return the

Generator to a Ready condition.

Depressing the mode button twice will enable

selection of User Mode, ADVANCED (output power displayed in Watts) or BASIC (output

displayed as relative number from 1 to 10). The equivalent values for ADVANCED and BASIC

mode vary by Electrode type. Refer to the Electrode Instructions for Use to confirm the BASIC-

ADVANCED Equivalency Table for the specific Electrode type.

NOTE

When an instrument is attached, switching between ADVANCED and BASIC User Mode after

adjusting the power output settings will reset the power output values to the default settings for

the specific electrode type. The Mode button must be pressed to confirm use.

Power Up/Down

The Power Up and Down buttons are used

to override the default power settings. The

Yellow Arrow buttons control the Ablation (V),

COOLPULSE (CP) Ablation and Blended

Ablation (BV) outputs in standard electrodes and

set tip temperature with TC electrodes. The Blue

Arrow buttons control the Coagulate (COAG)

output. Press the appropriate button once for a

power increment or decrement. Holding down

the button accelerates the incrementing or

decrementing.

NOTE

Power can only be adjusted after an Electrode is properly connected to the Generator. Each

VAPR Electrode type will determine its own default output power and set temperature.

SYStem

deScRIPtIoN

4-4

Power Indicator

Illuminates when the unit is switched on.

Wired Footswitch Select

Press to select. Illuminates when the unit is in

wired footswitch mode.

Wireless Footswitch Select/Pair

Press to select. Illuminates when the unit is in

wireless footswitch mode.

Pressing and holding for 2 seconds will initiate

wireless footswitch pairing procedure.

Hand Control Select

(inactive for unsupported instruments)

Press to select. Illuminates when the unit is in

hand control mode.

Power/Temperature Setting Display

The left side displays the nominal output power

(in Watts or as relative number) for the select-

ed Ablation, COOLPULSE Ablation or Blended

Ablation modes or set temperature for TC elec-

trodes. The right side displays the nominal output

power (in Watts or as relative number) for the

Coagulate output. When an output is activated,

the power display for the selected output flashes

and an audible tone sounds. For a VAPR TC elec-

trode the actual measured ‘TIP’ temperature is

displayed.

FRONT PANEL DISPLAY SYMBOLS

P a i r i n g i n P r o g r e s s

F a i l - R e f e r t o

U s e r M a n u a l

P r e s s M O D E t o U s e

When the generator is powered on, the wireless footswitch module may enter a pairing process which

may result in mispairing with other foot pedals and generators within close proximity. If this occurs,

repairing will be necessary.

SYStem

deScRIPtIoN

4-5

NOTE

Letters in grey are flashing.

A t t a c h I n s t r u m e n t

Indicates that the Generator is waiting for either the Handpiece or Electrode with integrated handpiece to

be attached to the front panel receptacle.

A t t a c h E l e c t r o d e

Indicates that the Generator is waiting for an Electrode to be inserted into the Handpiece. Not displayed

when using Electrodes with integrated Handpiece.

NOTE

Mode selection can only be performed after an Electrode and Handpiece or a One-piece Electrode is

connected to the Generator. If the Mode button is quickly pressed and released the next user set-up option

appears.

O U T P U T S H O R T E D

R E - A P P L Y P E D A L

May appear if the active tip shorts against nearby metal objects. A warning tone will also be issued.

Operation will resume automatically when the short is removed (provided foot-pedal or hand control

button remains depressed). For TC electrodes only, press the mode button on the front panel or footswitch

to resume operation.

S e l e c t L a n g u a g e

⇑

F r a n c a i s

⇓

Indicates the current language and enables (via the blue UP and DOWN buttons on generator) the

selection of alternate languages.

The following languages are supported:

a. English

b. French

c. German

d. Italian

e. Spanish

f. Finnish

g. Dutch

h. Swedish

i. Danish

j. Norwegian

k. Portuguese

SYStem

deScRIPtIoN

4-6

S e l e c t M o d e

⇑

V 1

⇓

Indicates the current output mode and enables (via the blue UP and DOWN buttons on generator) the

selection of alternative output modes, where available. Accessible only when an instrument is connected

to the generator.

NOTE

Above display is an example only. The “V 1” is one of the output modes.

S e l e c t U s e r M o d e

⇑

A d v a n c e d

⇓

Indicates the current user mode and enables (via the blue UP and DOWN buttons on generator) the

selection of user mode, BASIC or ADVANCED. If the user mode is changed (either from BASIC to

ADVANCED or from ADVANCED to BASIC), then the following will be displayed:

E l e c t r o d e R E S E T

t o D E F A U L T v a l u e s

P r e s s M O D E t o u s e

SYStem

deScRIPtIoN

4-7

FOOTSWITCHES

Wired Footswitch

The VAPR 3 Footswitch (FIGURE 4) connects to the VAPR VUE Generator. The yellow and

blue pedals are used for output activation. The black mode pedal is used for fault clearance or

remote adjustment of the ABLATE output setting.

The adjacent light will illuminate on selection.

• Depressing the yellow pedal activates the selected Ablation (V), COOLPULSE Ablation

(CP) or Blended Ablation (BV) outputs.

• Depressing the blue pedal activates the Coagulate (DES) output to produce hemostasis

or thermal modification of tissue.

• Depressing the black mode pedal can reset the Generator from a fault condition.

• Depressing the black mode pedal for 2 seconds under normal conditions allows the

generator ABLATE power to be adjusted from the VAPR3 footswitch. Each press of the

yellow pedal will increment the power level up one level (to the maximum power level

for the particular electrode in use). Each press of the blue pedal will decrement the

power level down one level.

NOTE

The mode control pedal on the Footswitch can only change ablation power. Coagulation power

can be adjusted only using the buttons on the Generator.

Mode Button

Ablate/power

up adjust

Coagulate/power

down adjust

fIGURe 4

SYStem

deScRIPtIoN

4-8

WIRELESS FOOTSWITCH

The VAPR VUE Wireless Footswitch (FIGURE 5) interfaces wirelessly to the VAPR VUE

Generator. The yellow and blue pedals are used for output activation. The black mode pedal

is used for fault clearance or remote adjustment of the ABLATE power settings (if enabled as

shown below).

fIGURe 5

Wireless footswitch pairing process.

To establish a wireless link between the generator and wireless footswitch:

• Prior to the attachment of an Electrode, press and hold the Wireless Footswitch

Select/Pair button for 2 seconds. Follow the on screen instructions:

• The display will show “Hold Footswitch Face Up”. Hold the Footswitch in a horizontal

position with the pedals facing upward in close proximity (2 feet or less) in front of the

generator for several seconds. Observe the progress bar on the bottom of the display.

• As the progress bar gets close to filling the bottom line of the display, prepare to turn the

footswitch upside down.

• The display will change to show “Hold Footswitch Face Down”. Promptly turn and then

hold the Footswitch in a horizontal position with the pedals facing downward in close

proximity (2 feet or less) in front of the generator for several seconds. Observe the

progress bar on the bottom of the display.

• Successful pairing is confirmed via audible beep and a displayed message.

• Repeat the pairing process if unsuccessful pairing at the first time.

NOTE

Once a Footswitch is paired to a Generator it will remain so, even after the main power to the

Generator is cycled or the wireless Footswitch batteries are changed. If the main power to the

generator is cycled, wireless footswitch use must be confirmed by pressing the black mode pedal

on the footswitch (re-pairing is not necessary).

Front panel display during footswitch pairing process.

H o l d F o o t s w i t c h

F a c e U p

❚❚❚❚❚❚❚❚❚❚❚❚❚❚❚❚

SYStem

deScRIPtIoN

4-9

H o l d F o o t s w i t c h

F a c e D o w n

❚❚❚❚❚❚❚❚❚❚❚❚

P a s s - F o o t s w i t c h i s

n o w r e a d y t o u s e

If the pairing process is unsuccessful, the following will appear:

P a i r i n g i n P r o g r e s s

F a i l - R e f e r t o

U s e r M a n u a l

Repeat the pairing process if unsuccessful pairing at the first time.

Once successful pairing has occurred, the following will be displayed upon powering on

the Generator:

P r e s s M O D E p e d a l

t o C o n f i r m S e t t i n g

VAPR ELECTRODES

The family of VAPR Electrodes has been designed to facilitate access and control the

delivery of energy to the joint space. The Electrodes interface to the Generator via a discrete

Handpiece, or they may be equipped as a one-piece Electrode (an integrated handpiece,

cable and plug assembly) allowing their direct connection to the Generator. Each Electrode

contains an internal classification code which automatically adjusts the VAPR Generator to the

optimal output power setting for the specific Electrode. The VAPR Electrode has an integrated

“return” electrode on its shaft, eliminating the need for a conventional patient ground pad.

Angled Electrode styles are also available to facilitate tissue access and positioning during use.

Flexible (FLEX) electrodes are also available. These electrodes can be bent, as specified in

product-specific Instructions for Use.

Articulating suction electrodes are also available to facilitate access to constrained anatomy.

These electrodes include a mechanical actuator on the handle assembly which can be used to

achieve angular displacement of the distal portion of the electrode from 0 to approximately 110

degrees.

SYStem

deScRIPtIoN

4-10

The current product group consists of the following types of electrodes:

Type Functions

Ablation Tissue ablation / vaporization and coagulation

Thermal Tissue coagulation only for collagen shrinkage

Suction Tissue ablation/ vaporization and coagulation with ability to apply

suction to remove bubbles and debris.

Articulating Suction

Electrodes

Tissue ablation/coagulation to allow for ablation/coagulation for

constrained anatomy with ability to apply suction to remove bubbles

and debris.

The working tips of the Electrodes can be divided into the following main functional types

according to the geometry of the active electrode and insulation support.

Side-facing Electrode

The side-facing electrode is designed to maximize tissue contact area

and produce rapid tissue debulking. The active, tissue contact electrode

is mounted on the side of the working tip with the return electrode

extending over the insulator on the opposite side of the active electrode.

This configuration is particularly useful in engaging tissue which is

approached at an acute angle. Additionally, the insulator and return

electrode assist in protecting adjacent structures from inadvertent injury

during activation. The larger contact area of the electrode means that

these electrodes also produce effective hemostasis of blood vessels.

The 2.3 mm configuration is particularly useful in engaging tissue that

cannot be approached using the 3.5 mm electrode.

End-facing Electrode

The forward-facing electrode is designed to facilitate controlled, precise

tissue effects. Additionally, side extensions of the insulator minimize

undesired collateral tissue contact.

The 2.3 mm configuration is particularly useful in engaging tissue that

cannot be approached using the 3.5 mm electrode.

Temperature Control End Effect Electrode

This electrode is a soft tissue coagulation device. Utilization with a

VAPR system allows tip temperature of the electrode to be controlled

and indicated on the generator display.

SYStem

deScRIPtIoN

4-11

Wedge Electrode

The 45° angled active tip is designed to facilitate controlled, precise

tissue effects. Additionally the side extension of the insulator will

minimize undesired collateral tissue contact.

Hook Electrode

The hook electrode is designed to provide tissue cutting. Use of the

hook as a probe should be avoided.

Angled Suction Electrode

The forward facing active tip is designed to facilitate controlled, precise

tissue effects. The RF probe, with angled shaft is intended to be used

for removal of soft tissue during arthroscopic procedures in smaller,

more difficult to access areas of the anatomy such as the knee (e.g.,

posterior horn of meniscus). The integral Suction Port allows bubbles

and vaporization products to be removed. The design provides a large

area suction path which attracts difficult to access frond tissue to the tip

and helps minimize clogging.

90 Degree Suction Electrode

The side facing electrode is designed to maximize the tip tissue contact

area and provide rapid tissue debulking. The electrode has a large tip-

to-shaft offset which maximizes tactile feedback and facilitates removal

of difficult to reach tissue. The integral Suction Port allows bubbles

and vaporization products to be removed. The design provides a large

area suction path which attracts difficult to access frond tissue to the

tip and helps minimize clogging. Additionally, the forward facing end

of the manifold may be useful in protecting adjacent structures from

inadvertent injury during activation.

SYStem

deScRIPtIoN

4-12

Articulating Suction Electrodes

Articulating suction electrodes are designed to provide access to

constrained anatomy and allow bubbles and vaporization products to be

removed.

These electrodes include a mechanical actuator on the handle

assembly which can be used to achieve angular displacement of the

distal portion of the electrode from 0 to approximately 110 degrees.

WARNING

The VAPR Electrodes are single use, sterile, disposable soft tissue ablation and coagulation

devices intended for use with the VAPR System. These products are for single-use only and have

not been designed to be re-used/re-sterilized. Reprocessing may lead to changes in material

characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation

or splitting which may impact the strength of the device and compromise device performance.

Reprocessing of single use devices can also cause cross-contamination leading to patient

infection. These risks may potentially affect patient safety.

WARNING

Read the instructions, cautions, and warnings provided with all VAPR VUE System accessories

before use. This device is an integral system; only use approved accessories with the VAPR VUE

Generator. Your sales representative can advise which accessories are available and approved

for use with the VAPR VUE System.

VAPR HANDPIECE

The VAPR Handpiece with Electrode (FIGURE 6) is ergonomically designed to facilitate

user comfort and control during use. The Handpiece connects the disposable Electrode with

the VAPR VUE Generator. The Handpiece and Cable are supplied non-sterile and must be

sterilized prior to each use. Refer to Handpiece Instructions for Use for specific sterilization

instruction. It is intended to be re-used up to twenty times.

Electrode

Handpiece

fIGURe 6

VAPR Handpiece with 2-piece Electrode.

SYStem

deScRIPtIoN

4-13

One-piece Electrodes (FIGURE 7) are equipped with an integrated cable and plug, eliminating

the need for the Handpiece. These Electrodes are single-use only.

Working Tip

Electode Shaft

Cables and Plug Handle

fIGURe 7

VAPR One-piece Electrode.

VAPR Hand Control Electrodes (FIGURE 8) have three integral buttons: ablation (yellow

button), coagulation (blue button), and mode (black button) buttons. These Electrodes are

single-use only.

Connector Plug

Working

Tip

Electrode Shaft

Buttons for

Hand Operated

Activation

Handle

Electrode

and Cables

fIGURe 8

VAPR Electrode with integrated handpiece and hand controls

SYStem

deScRIPtIoN

4-14

Cut

Coag Mode

fIGURe 8a.

Details of hand controls

fIGURe 9

VAPR Articulating Suction Electrode

INStRUctIoNS

foR USe

5-1

Section 5

InstruCtIons

For use

NOTE

The Manufacturer is responsible for safety, reliability, and performance of equipment only if:

• Installation procedures in this manual are followed.

• Assembly operations, extensions, readjustments, modifications or repairs are carried out by

persons authorized by the manufacturer and the electrical installation of the relevant operating

room complies with the local codes and regulatory requirements governing such facilities.

• The equipment is used in accordance with these instructions.

WARNING

The DePuy Mitek VAPR VUE System and accessories have been designed specifically as a

system to maximize safety and effectiveness. To avoid incompatibility and unsafe operation, only

DePuy Mitek cables and accessories should be used. DePuy Mitek accessories are rated for at

least the maximum peak output voltage of the system.

CAUTION

EMC CONSIDERATIONS

• Provide as much separation as possible between the Generator and other electronic equipment

(such as monitors). When activating the Generator, unintended electromagnetic coupling may

cause interference with the other equipment.

• Should any unintentional effects appear upon other equipment when using the Generator,

repositioning the Generator, the connecting leads or other equipment may alleviate the

problem. It may also help to use different mains supply sockets for any affected equipment.

• The generator should not be used adjacent to or stacked with other electrical equipment.

If adjacent or stacked use is necessary both the Generator and other equipment should be

observed to verify normal operation in the configuration in which it will be used.

• The EMC classification of the VAPR VUE system (class A) is suitable for use on dedicated

supply systems not connected to the public mains network, such as hospitals.

NOTE

Although class A limits have been derived for industrial and commercial establishments,

administrations may allow, with whatever additional measures necessary, the installation and

use of class A ISM equipment in a domestic establishment or establishment connected directly to

domestic electricity power supplies.

Refer to VAPR VUE Wireless Footswitch User Manual for EMC consideration for the Wireless

Footswitch.

SYSTEM INSTALLATION

1. Place the Generator on a table, cart racking system or other stable platform that can be

positioned as close as possible to the operative site during use.

2. Provide at least four inches (10 centimeters) of space from the rear of the Generator.

Never cover the Generator or stack other equipment on top of it other than in a standard

cart system. Ensure adequate ventilation, as it is normal for the Generator to become

warm during use.

INStRUctIoNS

foR USe

5-2

3. Insert the power cord into the Power Cord Receptacle on the back of the Generator. A

standard hospital grade power cord is necessary for proper connection of the Generator

to the power source. To ensure user safety, the Generator must be properly grounded

through the power cord and power outlet.

4. Connect the power cord from the Generator directly to an AC source. The Generator is

designed to operate as shipped with full regulation between 90-132 VAC or 207-253

VAC at 50-60 Hz. This allows the Generator output to remain constant in case of brown-

outs or power surges.

WARNING

The power cord must meet all requirements for safe grounding. Its purpose should not be

defeated by using extension cords, multiple plug points or three pronged to two pronged

adapters. Power cords should always be grasped by the plug. Do not pull the cord itself.

5. Connect the Wired Footswitch (if required) to the receptacle on the front of the Generator.

6. Press the Generator power switch to the ON position. When the Generator is first

switched on prior to Electrode connection a system self-check sequence will be initiated.

Verify that all indicator lights are on and off at least once during this sequence. During

the self check sequence the alarm system is verified by checking for three alarm tones

of increasing pitch. The first tone is minimum volume, the second maximum volume,

the third being the user preset volume. A fourth higher pitch tone may be emitted if an

Electrode is connected to the Generator.

7. Verify that “ATTACH INSTRUMENT” is flashing on the display prompt on the front of

the Generator. This completes the Generator installation procedure. Turn the generator

power switch OFF when not in use.

SYSTEM SETUP AND USE DURING SURGERY

Minimum System Component Requirements:

• A properly installed VAPR VUE Generator

• VAPR 3 Footswitch or VAPR VUE Wireless Footswitch (if VAPR Electrode does not

incorporate hand controls).

• A Sterile VAPR Handpiece and Electrode, or a VAPR Electrode with integrated hand-

piece, or a VAPR Electrode with hand controls appropriate to the procedure being

undertaken.

NOTE

The VAPR Handpieces are supplied NON-STERILE. Refer to Section 6 of this manual for

sterilization instructions prior to use.

1. Press the Generator power switch to the ON position. Verify that the system self-check

sequence is initiated.

2. Verify that “ATTACH INSTRUMENT” is flashing on the Generator display, indicating that

the Generator is in idle mode.

3. Set up for the desired activation method:

a. Wired Footswitch: Attach the wired footswitch connector to the front panel foot switch

socket and press the WIRED FOOTSWITCH SELECT button on the front panel.

b. Wireless Footswitch: Press the WIRELESS FOOTSWITCH SELECT/PAIR button on

the front panel. See “Wireless footswitch pairing process” if pairing is required.

INStRUctIoNS

foR USe

5-3

c. Hand Control: Only available on certain electrodes, if one of these is connected to

the generator it will default to this activation method. Alternatively, press the HAND

CONTROL SELECT button on the front panel if switching from wired or wireless

footswitch back to hand control activation method.

4. The ABLATE and COAG output displays can be shown as maximum power in Watts

(ADVANCED) or a relative number from 1 to 10 (BASIC). Refer to Appendix A for

equivalencies between ADVANCED and BASIC output displays. Set up for the desired

output display style:

a. Press MODE button twice. The first press will allow the required Output Mode (CP, V3,

V2, V1, BV1, BV2 and COAG as indicated by instrument allowed operating modes)

to be selected. The second press of the mode button will allow the ADVANCED or

BASIC User Mode to be selected by pressing the BLUE up-down arrows.

b. Press MODE button to confirm the selection.

5. Inside the sterile field, pass the plug end of the sterile Handpiece or One-piece electrode

out of the sterile field, and connect it to the front of the Generator.

6. (Only when using VAPR Handpiece) Verify that “ATTACH ELECTRODE” is flashing on

the Generator display, indicating the Handpiece is properly connected to the Generator.

7. (Only when using VAPR Handpiece) Connect the VAPR Electrode to the Handpiece as

shown in FIGURE 10. Once connected, the “ATTACH ELECTRODE” symbol flashing on

the Generator display will change to the default settings for that Electrode style.

fIGURe 10

Handpiece connection

NOTE

The Default Power settings used for the intended arthroscopic procedures vary with the size and/

or configuration of the active electrode. Increasing or decreasing the Default Power settings

will determine the level of performance. If the power to the generator is switched ON with an

electrode plugged in, the MODE button on the front panel must be pressed to accept the default

settings.

If power settings have been overridden to non-default values, the adjusted values will be

retained when unplugging and replugging the same electrode, when connecting a new electrode

of the same type, or when connecting a different electrode model with the same default values.

If the generator is switched off and then on, a newly attached electrode will always revert to its

default values. Always confirm proper, desired power settings before proceeding with surgery.

8. With the arthroscope inserted into the joint cavity, carefully insert the Electrode through

the instrument portal under direct vision. Avoid the use of excessive force. Wherever

possible, use an instrument cannula for the access portal. Maintain the active Electrode

in the field of view at all times.

INStRUctIoNS

foR USe

5-4

9. Press either the yellow or blue pedal of the Footswitch or yellow or blue button of the

hand control, as appropriate, to activate the Electrode:

YELLOW Pedal or Button: Activates the Ablation, COOLPULSE Ablation and the

Blended Ablation (BV) modes depending on output mode selection. Activation is accom-

panied by flashing of the Ablation or Blended Ablation power display and a high pitched

audible tone.

BLUE Pedal or Button: Activates the Coagulate (COAG) mode only. Activation is

accompanied by flashing of the Coagulate power display and an audible tone.

10. Power and mode adjustment can only be made when the Generator is not activated.

The permissible range of power adjustment is determined by the Electrode style. All

settings may be altered from the front panel buttons. The mode control button on the

Footswitch or Hand Control can only change ablation power, as described in section 4.

The coagulation power can be adjusted on the Generator, as described in section 4.

USING VAPR THERMAL CONTROL (TC) ELECTRODES

• When attaching the VAPR TC electrode the Generator will automatically configure itself

in temperature control mode. The display will indicate the default SET temperature and

coagulation power. The ablation output is inhibited; pressing the yellow pedal will have

no effect.

• The SET temperature may be adjusted from its default using the yellow Up/Down

buttons. Similarly the Coagulation power may be adjusted using the blue Up/Down

buttons on the generator.

• Power, SET and mode adjustment can only be made when the generator is not

activated.

• During activation, the display will change from the SET temperature to the actual

measured TIP temperature.

• The system will only deliver power up to the limit indicated on the display. The desired

SET temperature may not be reached such as during high flow conditions in the joint. If

this occurs, increase the power from its default setting in small increments until correct

temperature control is possible.

• For user convenience an over-temperature indicator is operational in temperature

control mode. An audible tone will sound if the measured TIP temperature reaches more

than 8ºC over the SET temperature.

NOTE

Certain conditions may momentarily cause temperature overshoot and trigger the over-

temperature indicator. Once triggered the tone will sound for a minimum of one second. Possible

causes are:

1. Excessive power used with low/no flow environment.

2. Insufficient saline around tip.

3. Unstable surgical environment, excessive changes in saline flow rate and/or volume.

Incorrect irrigation solution used.

ADJUSTING THE TONE VOLUME

The activation tone volume can be adjusted by using the dedicated volume UP/DOWN controls

on the front panel of the generator (refer to section 4).

NOTE

Familiarize yourself with the two audible output tones to verify output selection as it is often

difficult to visualize the activation pedals (footswitch) or buttons (hand controls) during

arthroscopic surgery.

INStRUctIoNS

foR USe

5-5

ADJUSTING THE GENERATOR FOR FOOTSWITCH,

HAND CONTROL OR WIRELESS FOOTSWITCH OPERATION

To configure the generator for use with Wired Footswitch, Hand Controls or Wireless

Footswitch, select the preferred control method by pressing the associated button on the front

panel (refer to section 4).

NOTE

•On selection of the desired control method, other means of control will become inactive.

•If a wireless footswitch was the last operational mode selected, turning the AC power to the

generator off and then on will revert back to wireless footswitch mode. The mode button on the

wireless footswitch must be pressed to acknowledge wireless footswitch operation.

•If a wired footswitch was the last operational mode selected, turning the AC power to the

generator off and then on will revert back to wired footswitch mode.

•If an electrode with hand controls is connected, the generator will default to hand control

operation. Wired or wireless footswitch operation, if available, may be selected.

CHANGING ELECTRODES DURING SURGERY

When using the VAPR Handpiece, an Electrode can be removed from the Handpiece by

unlocking the connector assembly and then pulling the Electrode and Handpiece apart.

Once the Electrode is disconnected, the Generator will automatically enter idle mode with the

display showing the “ATTACH ELECTRODE” symbol.

Fit a new sterile Electrode as previously described. If the new Electrode has different default

settings than the previous Electrode, check that the Generator display matches the Electrode

default settings specified on the package insert.

When Using VAPR Electrodes with integrated handpiece, insert the plug at the end of the

electrode into the connector on the front panel of the generator. Ensure correct orientation of

the plug to the connector. At the end of surgery, disconnect the Electrode by pulling on the plug.

NOTE

When switching to or from a VAPR Electrode with integrated handpiece, the generator will

display “ATTACH INSTRUMENT”.

If the new Electrode has identical default settings to the previous Electrode, the Generator will

retain the settings displayed prior to changing the Electrode, even if power settings have been

overridden to non-default values.

Switching the Generator power off will clear all output adjustments.

WARNING

Do not insert or withdraw Electrodes while activated. Injury and/or product damage may result.

NOTE

In the event of a power failure, or if the Generator is turned off while an Electrode is connected

to the Generator, the Generator will revert to the default settings for the attached Electrode

when the mains power is reestablished. The user will be prompted to accept these settings before

proceeding. (The display reads “PRESS MODE TO USE”).

Recommendations

• Unless circumstances dictate otherwise, use the Electrode default power and mode

settings to enhance patient and user safety.

• Remove any tissue buildup from Electrodes to maximize surgical effect.

INStRUctIoNS

foR USe

5-6

• Avoid any unnecessary and prolonged Electrode activation to prevent overheating.

• When de-bulking or vaporizing tissue, apply firm pressure using a progressive surface

brushing technique. Avoid burying the electrode in the tissue as this could increase

debris formation.

• The speed of tissue de-bulking will be determined by the output mode selection, size

and style of the Electrode, and application technique.

• When rapidly de-bulking or vaporizing tissue some browning of the tissue can be

anticipated. This can either be brushed away with a non-activated electrode or ablated

using gentle application pressure during activation.

• If more than one style of Electrode is used during a procedure, the Generator will revert

to the default settings defined by each Electrode style.

• Bubbles are produced during tissue vaporization which may interrupt surgery by

temporarily interfering with vision. A fluid management system is recommended to

prevent accumulation and to remove bubbles, as well as any particulate products

of vaporization, from the operative field. Use of Electrodes with built-in suction will

minimize these effects.

WARNING

Avoid bubble accumulation in the joint space during use. The accumulation of bubbles around

the working tip of the Electrode will diminish performance and may produce overheating

sufficient to damage adjacent structures.

USE OF SUCTION ELECTRODES

Suction electrodes are designed to provide improved visibility at the operative site whilst

facilitating removal of degradation products. To avoid premature clogging of the suction

pathways in these devices:

• Close the pinch/roller clamp before insertion of the device into patient.

• Open the pinch/roller clamp immediately prior to activation (ablation).

• Close the pinch/roller clamp immediately after device activation (ablation).

• The pinch/roller clamp should not be opened for tissue modification or the sealing of

blood vessels (blue pedal use) as the suction flow may suck unintended tissue into the

device and cause clogging.

AFTER SURGERY

After surgery, you need to perform the following:

• Withdraw the Electrode.

• Disassemble the Electrode and Handpiece.

• Dispose of the SINGLE-USE VAPR Electrodes.

• Prepare the Handpiece and Cable for steam autoclave processing.

IMPORTANT

Disconnecting the Electrode/Handpiece will automatically result in the “ATTACH

INSTRUMENT” idle mode. The Generator can be left in this mode between cases but at the end

of the operating session must be switched off from the power supply.

cleaNING aNd

SteRIlIzatIoN

PRocedUReS

6-1

Section 6

CleAnIng AnD

sterIlIzAtIon

proCeDures

CLEANING THE GENERATOR

The VAPR VUE Generator cannot be sterilized. The Generator surfaces can be cleaned with a

non-abrasive cleaning agent. Do not allow fluids to enter the Generator connectors.

CLEANING THE FOOTSWITCH

The VAPR 3 footswitch and VAPR VUE Wireless Footswitches cannot be sterilized. Refer to

the Instructions for Use for the particular footswitch you are using.

NOTE

The use of strong alkali detergents or cleaners must be avoided as these may damage the device.

CLEANING AND STERILIZING THE VAPR HANDPIECE AND CABLE

Refer to the Instructions for Use for the VAPR Handpiece for cleaning and sterilization.

PeRIodIc

maINteNaNce

INSPectIoN

7-1

Section 7

perIoDIC mAIntenAnCe

InspeCtIon

The manufacturer recommends that the VAPR VUE Generator be regularly inspected to ensure

continued safety of operation throughout its service life. The following safety checks should

be performed at least every 12 months by a qualified person who has adequate training,

knowledge and practical experience to perform such tests.

• Inspect the Generator and the Footswitch for obvious signs of mechanical damage

or wear. Ensure that the Generator case shows no sign of tampering. There are no

user serviceable items within the Generator or Wired Footswitch. There are no user

serviceable items within the Wireless Footswitch except the batteries and battery cover

gasket.

• Check that the Generator back panel label is present and decipherable and that the

front panel markings and symbols are still legible.

• Retract the fuse drawer of the main inlet connector and verify that both fuses are intact

and match the rated current and breaking characteristics as per the back panel label.

• Verify that the resistance between the earth terminal of the mains inlet connector and

the Generator enclosure is within the limits defined in IEC 60601-1 or the corresponding

national standard as applicable.

• Switch on the Generator ensuring that the initial internal self-test completes normally

as reported on the front panel display. Check that the audio alarm, front panel

warning indicator and vacuum fluorescent display are functioning normally via the user

verification sequence which follows initialization.

• Check that the enclosure earth leakage current is within the limits for Class I equipment

as prescribed with IEC 60601-1 or the corresponding national standard as appropriate.

• Measure the patient earth leakage currents and ensure it is within the limits of CF type

equipment as defined within IEC 60601-1 or a corresponding national standard.

• Details of these tests should be recorded in an equipment log with the date of test

for future reference. Contact DePuy Mitek customer service should a unit fault be

suspected.

• Inspect the front keypad membrane for any damage.

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-1

Section 8

error AnD

FAult symBols,

trouBleshootIng guIDe

ERROR & FAULT SYMBOL INTERPRETATION AND RECOVERY

Most technical problems are indicated by either an Error or a Fault symbol that appears in the

Generator display window. The VAPR VUE system constantly performs self-checking to ensure

its correct operation. Fault codes are reported to the user based on time and weighting of those

self checks.

• An Error symbol indicates an accessory malfunction or a Generator component failure

that requires servicing of the equipment. These symbols include a code number to be

used by DePuy Mitek technical service to diagnose why the system failed.

• A Fault symbol indicates a transient non-hazardous event and can be corrected by

resetting the system.

ERROR SYMBOLS

An Error symbol is displayed as follows:

I N T E R N A L F A I L U R E

E r r o r c o d e

x x x R e f x x

FAULT SYMBOLS

A Fault symbol is displayed as follows:

T E X T U A L M E S S A G E

F a u l t c o d e

x x x R e f x x

where TEXTUAL MESSAGE relates to the type of fault.

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-2

WARNING

An Error symbol indicates an equipment malfunction which may be hazardous. Disconnect all

accessories and switch the Generator off. Switch the Generator back on and if the self-test is

completed satisfactorily as evidenced by the “ATTACH INSTRUMENT” message on the display,

the failure occurred in the accessories which should be discarded and replaced. If the self-test

fails, then all functions will be inhibited and no attempt should be made to use the Generator.

Contact DePuy Mitek customer service for assistance.

RECOVERY – RESETTING GENERATOR FAULTS AND ERRORS

NOTE

Remember to take note of the fault/error code for reporting to customer service before

completing the reset.

Reset the generator by either:

PRESSING MODE BUTTON

Depress and release the MODE button once,

DISCONNECTING THE INSTRUMENT AND CYCLING THE POWER

Press the mains on/off switch twice to cycle the power.

If this does not resolve the problem, contact DePuy Mitek customer service.

ALARMS

Alarms are prioritized in the order listed below.

Fault Type Description Alarm Type

[F] Fatal error. User can reset the generator Latching

[AF] Automatic Fatal error. The generator will automatically reset

when the condition causing the error is cleared.

Non - Latching

[R] Recoverable error. User can reset the generator and enter a

Ready mode if permitted.

Latching

[SOFT] Soft error. The unit will automatically recover and continue

to operate as normal when the condition causing the error is

cleared. For certain faults, the user may be required to confirm

the fault before proceeding.

Non - Latching

NOTE

•A LATCHING alarm signal continues to be generated until stopped by a deliberate operator

action.

•A NON-LATCHING alarm signal automatically stops when the event causing the alarm no

longer exists.

Error codes are grouped as shown below:

Error code Description

100-199 Program crash, memory fault

200-299 Hardware failure (internal)

300-399 Dosage error, over-temperature

400-499 User error or equipment failure

500-599 Reserved for manufacture/engineer diagnostic

• All visual alarm conditions produced by the VAPR VUE system are LOW Priority

technical alarms as per IEC60601-1-8 table 1.

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-3

• There are no user defined alarms used in the VAPR VUE system.

• There are no distributed alarms used in the VAPR VUE system.

• There is no facility for disabling or silencing alarms used in the VAPR VUE system.

• Audio alarms comply with the requirements of IEC 60601-2-2:2009.

Alarm tones for the 4 types of faults are as follows:

Fault Type Alarm Description

[F] 2kHz tone for 200ms repeated every 500ms indefinitely.

[AF] 2kHz tone for 200ms repeated every 500ms four times.

[R] 2kHz tone for 200ms repeated every 500ms indefinitely.

[SOFT] 2kHz tone for 200ms repeated every 500ms three times.

The list of error codes is presented in the following table:

Error

Code Ref Vfd Text String Type Description

100 10 SYSTEM RESET [R] Software execution failure (watchdog reset)

100 11 INTERNAL FAILURE [F] ROM checksum failure

100 12 SETTINGS CORRUPT [R] Non volatile memory corrupt or not

initialised

100 13-16 Reserved — —

100 17 SYSTEM RESET R] Software execution failure

100 18 INTERNAL FAILURE [F] Continuous test timing

100 19 INTERNAL FAILURE [F] Background loop timing

100 20 INTERNAL FAILURE [F] Status_event_q overrun

100 21 INTERNAL FAILURE [F] User_event_q overrun

100 22 INTERNAL FAILURE [F] Vfd_event_q overrun

100 23 INTERNAL FAILURE [F] Waveform_generator_event_q overrun

100 24 Reserved — —

100 25 INTERNAL FAILURE [F] RS232 monitor Rx Queue overflow

100 26 INTERNAL FAILURE [F] RS232 monitor Tx Queue overflow

100 27 INTERNAL FAILURE [F] ID board communications fault

100 28 INTERNAL FAILURE [F] CPU Core failure – indicates a failure

with the CPU core or one of its on-chip

peripherals.

200 10 INTERNAL FAILURE [F] PWM signal : shorted high

200 11 INTERNAL FAILURE [F] PWM signal : shorted low

200 12-13 Not used — —

200 14 INTERNAL FAILURE [F] Energy stuck high

200 15-19 Reserved — —

200 20 INTERNAL FAILURE [F] CLAMP signal error (DAC output)

200 21 INTERNAL FAILURE [F] BOOST signal error (DAC output)

200 22-24 Reserved — —

200 25 INTERNAL FAILURE [F] OVERDOSE signal error : permanently ON

200 26 INTERNAL FAILURE [F] ENERGY signal error : stuck low

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-4

Error

Code Ref Vfd Text String Type Description

200 27 Reserved — Reserved for audio fault detection

200 28 Warming up [SOFT] Generator too cold

200 29 reserved — Reserved for audio fault detection

200 30 Reserved — —

200 31-32 Reserved — —

200 33 INTERNAL FAILURE [F] BUSVOLTS signal error (analogue input )

200 34 INTERNAL FAILURE [F] Incorrect PK RF board installed

200 35-36 Reserved — —

200 37 INTERNAL FAILURE [F] SPRF active stuck on

200 38 Reserved — —

200 39 CHECK MAINS SUPPLY [R] Mains input supply out of limits

200 40 — — —

200 41 Not used — —

200 42 INTERNAL FAILURE [F] CPU POST Thermistor failure

200 43 INTERNAL FAILURE [F] CPU POST failure

200 44 RAM [R] RAM test failure [POST check]

200 45 INTERNAL FAILURE [F] Crystal failure [POST check]

200 46 Reserved — —

200 47 INTERNAL FAILURE [F] Analogue reference failure [POST check]

200 48 INTERNAL FAILURE [F] CLAMP_SET failure [POST check]

200 49 INTERNAL FAILURE [F] BOOST_SET failure [POST check]

200 50 INTERNAL FAILURE [F] CURRLIM_SET failure [POST check]

200 51 Reserved — —

200 52 INTERNAL FAILURE [F] COAG_CUT failure [POST check]

200 53-55 Reserved — —

200 56 INTERNAL FAILURE [F] NO_RF failure [POST check]

200 57-64 Reserved — —

200 65 INTERNAL FAILURE [R] RFBUS_VOLTS failure [POST check]

200 66 Reserved — —

200 67 INTERNAL FAILURE [F] PSU_STATUS failure [POST check]

200 68 INTERNAL FAILURE [R] Mains input failure [POST check]

200 69 INTERNAL FAILURE [F] OVERDOSE failure [POST check]

200 70 INTERNAL FAILURE [F] PWM low failure [POST check]

200 71 INTERNAL FAILURE [F] ID CAL circuit failure [POST check]

200 72 Reserved — Reserved

200 73 INTERNAL FAILURE [F] CURRLIM failure [POST check]

200 74 INTERNAL FAILURE [F] VOLTLIM failure [POST check]

200 75 INTERNAL FAILURE [F] SPRF_ACTIVE failure [POST check]

200 76 INTERNAL FAILURE [F] VCC_ANA_DIV_2 failure [POST check]

200 77 INTERNAL FAILURE [F] 12V failure [POST check]

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-5

Error

Code Ref Vfd Text String Type Description

200 78 Reserved — n/a

200 79 INTERNAL FAILURE [F] PK-RF Thermistor failure [POST check

200 80-81 Reserved — n/a

200 82 INTERNAL FAILURE [F] ANALOGUE_REF failure

200 83 INTERNAL FAILURE [F] VCC_ANA_DIV_2 failure

200 84 INTERNAL FAILURE [F] 12V failure

200 85-86 Reserved — Reserved

200 87 INTERNAL FAILURE [F] PSU_STATUS failure

200 88-89 Reserved — Reserved

200 90 INTERNAL FAILURE [F] CURRLIM_SET failure

200 91-92 Reserved — N/a

200 93 INTERNAL FAILURE [F] External Watchdog unable to reset CPU

200 94 INTERNAL FAILURE [F] Internal Watchdog unable to reset CPU

300 10 THERMAL SHUTDOWN [R] Internal overheating

300 11 Reserved — Reserved

300 12 INTERNAL FAILURE [F] PK-RF board overheating

300 13 EXCESSIVE TIP TEMP [SOFT] Tip temperature exceeding 8°C above

set temperature during thermal control

algorithm.

300 14 <Instrument

dependent – see

shorted errors in table

R10.1.X.20>

[SOFT] Accessory error : excessive RF

output current

Output shorted – the error text and user

interaction are dependent on the instrument.

300 15-20 Reserved — N/a

300 21 <Instrument

dependent – see

shorted errors in table

R10.1.X.20>

[SOFT] SP Accessory error : excessive RF

output current

Output shorted – the error text and user

interaction are dependent on the instrument.

300 23 INSTRUMENT ERROR [R] Instrument thermistor is open circuit

300 24 INSTRUMENT ERROR [R] Instrument thermistor is short circuit

400 10 INTERNAL FAILURE [F] Coag activation signal stuck

400 11 INTERNAL FAILURE [F] Cut activation signal stuck

400 12 INTERNAL FAILURE [F] Mode activation signal stuck

400 14 INTERNAL FAILURE [F] Electrode identification circuit fault

400 15 BUTTON STUCK [R] Front panel : CUT (left) UP button stuck

400 16 BUTTON STUCK [R] Front panel : CUT (left) DOWN button stuck

400 17 BUTTON STUCK [R] Front panel : blue (Right) UP button stuck

400 18 BUTTON STUCK [R] Front panel :

blue (Right) DOWN button stuck

400 19 BUTTON STUCK [R] Front panel : MODE button stuck

400 20 Reserved — —

400 21-24 Reserved — —

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-6

Error

Code Ref Vfd Text String Type Description

400 25 Test Time Expired

Remove Power Lead

[SOFT] BioMed Time Credit expired. Notifies the

user that the allocated time credit has

expired. No RF can be generated until the

generator is power-cycled by mains power.

400 26 BUTTON STUCK [R] Front panel : Volume UP stuck

400 27 BUTTON STUCK [R] Front panel : Volume DOWN stuck

400 28 BUTTON STUCK [R] Front panel :

Wireless Footswitch activation button stuck

400 29 BUTTON STUCK [R] Front panel :

Footswitch activation button stuck

400 30 BUTTON STUCK [R] Front panel :

Handswitch activation button stuck

500 10 Reserved — N/a

600 20 FOOTPEDAL STUCK [AF] Footswitch cut stuck

600 21 FOOTPEDAL STUCK [AF] Footswitch coag stuck

600 22 FOOTPEDAL STUCK [AF] Footswitch mode stuck

600 23 HANDSWITCH STUCK [AF] Handswitch cut stuck

600 24 HANDSWITCH STUCK [AF] Handswitch coag stuck

600 25 HANDSWITCH STUCK [AF] Handswitch mode stuck

600 26 FOOTPEDAL STUCK [AF] Wireless footpedal cut stuck

600 27 FOOTPEDAL STUCK [AF] Wireless footpedal coag stuck

600 28 FOOTPEDAL STUCK [AF] Wireless footpedal mode stuck

600 29 “Wireless Footswitch

Attention Low Battery”,

with “Press Mode to

use” / “Refer to User

Manual” alternating

every 1s

[SOFT] Wireless footswitch is indicating low

battery. This fault is only to be reported

if not already acknowledged by the user

(since 1st power-up).

600 30 “Wireless Footswitch

Attention Low

Reception”, with

“Press Mode to use” /

“Refer to User Manual”

alternating every 1s

[SOFT] Wireless footswitch is indicating low signal

reception. This fault is only to be reported

if not already acknowledged by the user

(since 1st power-up).

600 31 “CUT/COAG STUCK” [SOFT] Activation input signal stuck.

Handswitch or footswitch/wireless

footswitch cut or coag button/pedal stuck.

Refer to table 9.1 for list of scenarios that

will cause this fault.

The above faults will be detected and reported within 1 second of occurring with the exception

of the 400-14 alarm which takes up to 1 minute. This fault code reports a fault in the electrode

identification circuit. This is also checked on power-up, at which time a fault would be detected

and reported immediately (200-71).

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-7

TROUBLESHOOTING GUIDE

The following troubleshooting guide describes potential problem causes and suggested

operator solutions. If the suggested actions do not resolve the problem, please contact

technical service.

Problem Suggestions/Solutions

No output power Check Handpiece Cable connections.

Check Electrode connection.

Contact technical service.

Generator resets during

activation (Fault Symbol 100.10)

Ensure no contact was made with other equipment

during activation.

Check grounding of Generator.

Check integrity of Electrode.

Fault indicator illuminates Check error code list for associated fault.

Unable to activate the Generator Check footswitch for damage.

Ensure correct footswitch is connected.

Ensure correctly paired wireless footswitch is being used.

Check connection of hand control probe.

Ensure correct activation device is selected.

Alarm tone too loud or too quiet Readjust volume.

Generator will remember the last volume setting used.

No display on the Generator Request assistance from qualified service engineer if

fault persists.

Check inlet fuses, replace with correct type.

See Appendix A for fuse specifications.

Contact customer service if problem persists.

Generator displays “ATTACH

INSTRUMENT” symbol when

Handpiece Cable is inserted

Remove connector and inspect pins for damage.

Check that connector is fully inserted.

Check for damage to Cable.

Generator displays “ATTACH

ELECTRODE” symbol after

Electrode is inserted

Ensure the connector contacts are clean and dry and have

not been damaged. Check Electrode integrity. Ensure that

only DePuy Mitek approved Electrodes are being used.

Generator overheats (Fault

Symbol 300.10)

Ensure ambient temperature is within operating limits. Allow

Generator to cool down before re-use. Check sufficient

ventilation provided around Generator.

Accessory Fault

(Fault Symbol 300.14 or 300. 21)

Contact may have been made with other equipment during

activation such as the scope or other instrumentation. Note,

this may also occur when activation occurs in close proxim-

ity to such instruments. Remove the electrode from the joint

and inspect the accessories for damage. Check the acces-

sories by activating the electrode immersed in sterile irrigat-

ing fluid contained in a bowl, or similar, remote from patient

contact before proceeding with surgery. If the fault recurs,

first replace the electrode and check as above. If the fault

remains, replace the handpiece and check as above. If the

fault continues, contact DePuy Mitek Customer Service.

eRRoR aNd

faUlt SYmBolS,

tRoUBleShootING

GUIde

8-8

Problem Suggestions/Solutions

Output Shorted When working in a joint cavity the electrode tip may make

contact with metallic instrumentation close to the operative

site. As a safety measure, the generator will immediately

terminate activation and show a warning message with a

short alarm tone.

In the case of any short, remove the electrode from the joint

and inspect the accessories for damage. If the foot pedal

remains depressed activation will automatically restart

following a short period.

For TC electrodes, the ‘Output Shorted’ fault may be

cleared by releasing the BLUE pedal, in this instance acti-

vation will not automatically restart if the foot pedal remains

depressed. Check the accessories by activating the elec-

trode immersed in sterile irrigating fluid contained in a bowl,

or similar, remote from patient contact before proceeding

with surgery. If the fault recurs, first replace the electrode

and check as above. If the fault remains, replace the hand

piece and check as above. Do not use any accessory that

persistently faults. If the fault continues, contact DePuy

Mitek Customer Service, and discontinue use of accessory.

Unable to access temperature The Temperature Control mode is only enabled when an

appropriate TC electrode is connected.

Wired Footswitch inoperative Check the activation source has not been set to HAND

CONTROL or WIRELESS FOOTSWITCH.

Hand Control inoperative Check the activation source has not been set to WIRED or

WIRELESS FOOTSWITCH.

Wireless Footswitch inoperative Check the activation source has not been set to HAND

CONTROL or WIRED FOOTSWITCH.

Verify that the wireless footswitch has been correctly paired

with the generator.

techNIcal

SPecIfIcatIoNS

A-1

Appendix A

teChnICAl

speCIFICAtIons

In this section, “typical” refers to a specification that is within ± 20% of a stated value at room

temperature (25°C/ 77°F).

VAPR VUE GENERATOR SPECIFICATIONS

Dimensions (H x W x D): 5 in x 16 in x 16 in (13.5 cm x 41 cm x 41 cm)

Weight: 18 lb. (8kg) approximately

Transport and Storage Conditions

Ambient Temperature Range: 32 to 104°F (0 to 40°C)

Relative Humidity: 10% to 90%, non-condensing

Atmospheric Pressure: 500 to 1060 millibars

Operating Conditions

Ambient Temperature Range: 50 to 104°F (10 to 40°C)

Relative Humidity: 30% to 75%, non-condensing

Atmospheric Pressure: 700 to 1060 millibars

Power Supply

Regulation Voltage: 90 -132 Volts RMS, 207- 253 Volts RMS

Operating Range: nominal 100-120/230 V RMS 50/60Hz

Input Rating 1000 VA

Inlet Fuses: Time lag 10.0A (T10AH 250V)

Leakage Currents: Within limits of Class CF equipment as per IEC

Power Cord Applicable to the USA and Canada markets:

UL listed type SJT, SJE, SJO, SJTO minimum 18AWG

3 conductor rated minimum 60DEGC terminating in

molded-on or Hospital Grade attachment plug having 125V

minimum 15A configuration.

Alarm Volume: Adjustable between 40dBA (at minimum volume)

and greater than 65dBA (at maximum volume) at 1m.

NOTE

The audible signals present during RF activation follow the

specific requirements of IEC60601-2-2 and do not represent

alarm conditions. All other audible signals are not technical

alarm tones and do not follow IEC60601-1-8. The fault indicator

on the front panel indicates a Low Priority alarm condition.

Classification: Class 1 ordinary equipment as per IEC 60601-1.

Electrical: EMC: Group 1 Class A as per IEC 60601-1-2.

Defibrillator Proof, Type CF equipment with isolated

(CF) applied part. Each of the electrode terminals of

the Generator can withstand the effects of defibrillator

discharge.

techNIcal

SPecIfIcatIoNS

A-2

Liquid Spillage: Liquid Spillage as per IEC 60601-2-2. The Generator

enclosure will prevent reasonable amounts of liquid from

inter fering with the Generator’s safe and satisfactory

operation.

Intermittent Operation

The Generator is cooled by natural convection. Under maximum power setting and rated load

conditions the Generator is suitable for a 10 seconds on, 30 seconds off duty cycle for 1 hour.

Temperature Control Mode

Control range 45 - 95ºC

Display range 10 - 99ºC

Over temp indicator >8ºC above SET temperature

VAPR 3 WIRED FOOTSWITCH SPECIFICATIONS

CAT. NO. 225023

Rating IPX8

VAPR VUE WIRELESS FOOTSWITCH SPECIFICATIONS

CAT. NO. 227214

Rating IP68

OUTPUT WAVEFORM AND CHARACTERISTICS

Waveform

The RF output in V1/V2/V3 and COAG modes is a variable amplitude sinusoid

waveform varying between approximately 300kHz and 450kHz, corresponding

to minimum and maximum load impedance respectively. The RF output in CP

mode is a fixed amplitude sinusoidal waveform of approximately 360kHz.

Crest Factor V1, V2, V3, CP, BV1, BV2 and COAG

A nominal crest factor of 1.4 for all outputs. (NOTE: Crest factor for CP is for

pulse envelope during ON time).

Power V output (V1, V2, V3, BV1, BV2) maximum power 260W into 330 Ohms.

V output (COAG) maximum power 200W into 28 Ohms.

CP output for 228146, 228147 and 225028, maximum power 400W into 68 Ohms.

CP output for 225029, maximum power 260W into 68 Ohms.

CP output for 225030, maximum power 200W into 68 Ohms.

Maximum Voltages:

Mode

Maximum

(typical into 1K + 20%)

Maximum

(typical into open circuit + 20%)

V1 305V RMS 431V PK 340V RMS 480V PK

V2 368V RMS 520V PK 410V RMS 580V PK

V3 408V RMS 577V PK 453V RMS 640V PK

CP (part numbers 228146,

228147 and 225028)

408V RMS 577V PK 423V RMS 598V PK

CP (part numbers 225029

and 225030)

367V RMS 564V PK 372V RMS 570V PK

BV1 As V2 As V2

BV2 As V3 As V3

Coagulate 144V RMS 204V PK 159V RMS 225V PK

VAPR TC Coagulate 124V RMS 175V PK 131V RMS 184V PK

techNIcal

SPecIfIcatIoNS

A-3

NOTE

The following load curves apply to the fundamental power delivery capability of the generator alone.

They do not imply a given power output for any given electrode and cable configuration when used

with the generator. Each accessory will self-impose an upper set power limit for the generator, the

value of which will be equal to or below the maximum power delivery capability of the generator.

NOTE

In the following curves, “DES” refers to COAG mode. BV1 power output (a composite

waveform of V2 and COAG) will be equal or less than V2 output depending on load. BV2 power

output (a composite waveform of V3 and COAG) will be equal or less than V3 output depending

on load. BV1 and BV2 are blended outputs which are a composite waveform based upon 50%

duty cycle for ABLATE and 50% duty cycle for COAG, alternating at 30 Hz.

Figure A-1. Typical Output Peak Open Circuit Voltage (230VAC 50Hz)

CAUTION

The measurements indicated above are the averaged measurements from a number of generators

and are subject to +/- 20% tolerance. Please refer to the graph below and the table on Page A -2

for the maximum voltage values.

Figure A-2. Maximum Output Peak Open Circuit Voltage (230VAC 50Hz)

228146, 228147 and 225028 Max

225029 and 225030 Max

V3 Max

V2 Max

V1 Max

Des Max

techNIcal

SPecIfIcatIoNS

A-4

Figure A-3. Output Linearity in to rated load 68R

Figure A-4. Typical Output Peak Open Circuit Voltage

Figure A-5. Full Power V3, V2 and V1@ 260W; DES@ 200W 240V

100

150

200

250

300

10 100 1000 10000

Full Power V3, V2 & V1 @ 260W; DES @ 200W

240V

Resistance (R)

Full Power V3, V2 & V1 @ 260W; DES @ 200W

240V V3

DES

Resistance (R)

Power (W)

techNIcal

SPecIfIcatIoNS

A-5

BASIC-ADVANCED Equivalency Tables

NOTE

The equivalent values for ADVANCED and BASIC mode vary by Electrode type. Refer to the

Electrode Instructions for Use to confirm the BASIC-ADVANCED Equivalency Table for the

specific Electrode type.

Ablation CP Ablation Coagulation

BASIC ADVANCED BASIC ADVANCED BASIC ADVANCED

Value Lower Upper Value Lower Upper Value Lower Upper

1 10 10 1 10 10 1 10 10

2 20 45 2 100 140 2 20 45

3 50 60 3 150 190 3 50 80

4 80 110 4 200 220 4 90 110

5 120 140 5 240 260 5 120 150

6 160 180 6 280 280 6 160 180

7 200 240 7 300 300 7 190 200

8 260 260 8 320 320

9 340 340

10 360 400

NOTE

In ADVANCED mode, output power can be adjusted in finer increments than in BASIC mode.

NOTE

When an instrument is attached, switching between ADVANCED and BASIC User Mode after

adjusting the power output settings will reset the power output values to the default settings for

the specific electrode type. The Mode button must be pressed to confirm use.

The power values for load resistances below 20 Ohms are shown for the Biomed test instru-

ment (Biomedical Engineering and Service use only). For all other instruments the generator

will display “OUTPUT SHORTED.”

Figure A-6. Half Power V3, V2, V1 @ 130W; DES @ 100W 240V

0.00

20.00

40.00

60.00

80.00

100.00

120.00

140.00

10 100 1000 10000

Half Power V3, V2 & V1 @ 260W; DES @ 200W

240V

Resistance (R)

Half Power V3, V2 & V1 @ 130W; DES @ 100W

240V

DES

Resistance (R)

Power (W)

techNIcal

SPecIfIcatIoNS

A-6

Figure A-7. CP Output (230VAC 50Hz)

techNIcal

SPecIfIcatIoNS

A-7

Equipment fault

Refer to instruction manual/booklet

Non-ionizing radiation. This equipment intentionally emits RF

energy during activation.

Defibrillator-proof type CF equipment.

This equipment provides a degree of protection against electric

shock to TYPE CF as defined in IEC 60601-1. This equipment has

an F type applied part capable of withstanding the effects of defi-

brillator discharge.

techNIcal

SPecIfIcatIoNS

A-8

This symbol indicates the conductor that may be used to provide

potential equalization between the equipment and the installations

bus bar.

This symbol indicates that the product contains less than the

maximum concentration value of all six hazardous substances.

This symbol identifies that products contain certain toxic or

hazard ous substances or elements, and can be used safely during

its environmental protection use period. The number in the middle

of the logo indicates the environmental protection use period (# of

years) for the electronic information product. The logo also

signifies that the product should be recycled immediately after its

environ mental protection use period has expired.

MEDICAL - APPLIED CURRENT/ENERGY

EQUIPMENT AS TO ELECTRICAL SHOCK,

FIRE AND MECHANICAL HAZARDS ONLY

ES60601-1 (2005) + AMD 1 (2012),

CAN/CSA-C22.2 No. 60601-1 (2014),

IEC 60601-2-2 (2009),

IEC 60601-1-8 (2006, A1: 2012),

IEC 60601-1-6 (2010, A1: 2013)

21FA

emc taBle

B-1

Appendix B

emC tABles

Guidance and Manufacturer’s Declaration –

Electromagnetic Emissions

The VAPR VUE GENERATOR is intended for use in the electromagnetic environment specified

below. The customer or the user of the VAPR VUE GENERATOR should assure that it is used

in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF Emissions CISPR 11 Group 1 The VAPR VUE GENERATOR uses RF energy

only for its internal function. Therefore, its RF

emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

RF Emissions CISPR 11 Class A The VAPR VUE GENERATOR 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

emc taBle

B-2

Guidance and Manufacturer’s Declaration –

Electromagnetic Immunity

The VAPR VUE GENERATOR is intended for use in the electromagnetic environment specified

below. The customer or the user of the VAPR VUE GENERATOR should assure that it is used

in such an environment.

Immunity Test

IEC 60601

Test Level

Compliance

Level

Electromagnetic

Environment – Guidance

Electrostatic

Discharge (ESD)

IEC 61000-4-2

±6 kV Contact

±8 kV Air

±6 kV Contact

±8 kV 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 kV for Power

Supply Lines

±1 kV for Input /

Output Lines

±2 kV for Power

Supply Lines

±1 kV for Input /

Output Lines

Mains power quality

should be that of a typical

commercial or hospital

environment.

Surge

IEC 61000-4-5

±1 kV Differential

Mode

±2 kV Common

Mode

±1 kV Differential

Mode

±2 kV Common

Mode

Mains power quality

should be that of a typical

commercial or hospital

environment.

Voltage Dips,

short interrup-

tions and Voltage

Variations on

Power Supply

Input Lines

IEC 61000-4-11

<5 % UT (>95% Dip

in UT) for 0.5 Cycle

40% UT

(60% Dip in UT)

for 5 Cycle

70% UT

(30% Dip in UT)

for 25 Cycle

<5% UT

(>95% Dip in UT)

for 5 sec

<5 % UT (>95%

Dip in UT) for

0.5 Cycle

40% UT

(60% Dip in UT)

for 5 Cycle

70% UT

(30% Dip in UT)

for 25 Cycle

<5% UT

(>95% Dip in UT)

for 5 sec

Mains power quality

should be that of a typical

commercial or hospital

environment.

If the user of the VAPR VUE

GENERATOR requires

continued operation during

power mains interruptions,

it is recommended that the

VAPR VUE GENERATOR

be powered from an unin-

terruptible power supply or

a battery.

NOTE

UT is the AC mains voltage prior to application of the test level.

emc taBle

B-3

Guidance and Manufacturer’s Declaration –

Electromagnetic Immunity

The VAPR VUE GENERATOR is intended for use in the electromagnetic environment specified

below. The customer or the user of the VAPR VUE GENERATOR should assure that it is used

in such an environment.

Immunity Test

IEC 60601

Test Level

Compliance

Level

Electromagnetic Environment –

Guidance

Power Frequency

(50/60 Hz)

Magnetic Field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should

be at levels characteristic of a typical

location in a typical commercial or

hospital environment.

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to

80 MHz

3 V Portable and mobile RF communications

equipment should be used no closer to

any part of the VAPR GENERATOR,

including cables, than the recommended

separation distance calculated from the

equation applicable to the frequency

of the transmitter. Recommended

Separation Distance.

d = [1.17]√P

d = [1.17]√P 80 MHz to 800 MHz

d = [2.33]√P 800 MHz to 2.5 GHz

Where P is the maximum output

power rating of the transmitter in

watts (W) according to the transmitter

manufacturer and d is the recommended

separation distance in meters (m).

Field strengths from fixed RF transmitters,

as determined by an electromagnetic site

survey (a) should be less than the com-

pliance level in each frequency range (b).

Interference may occur in the vicinity

of equipment marked with the

following symbol:

Radiated RF

IEC 61000-4-3

3 Vrms

80 MHz to

2.5 GHz

3 V/m

NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV

broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic

environment due to fixed RF transmitters, an electromagnetic site survey should be considered.

If the measured field strength in the location in which the VAPR VUE GENERATOR is used

exceeds the applicable RF compliance level above, the VAPR VUE GENERATOR should be

observed to verify normal operation. If abnormal performance is observed, additional measures

may be necessary, such as reorienting or relocating the VAPR VUE GENERATOR.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

emc taBle

B-4

Recommended Separation Distances between Portable

and Mobile RF Communications Equipment and the

VAPR VUE GENERATOR

The VAPR VUE GENERATOR is intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. The customer or the user of the VAPR VUE

GENERATOR can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the

VAPR VUE GENERATOR as recommended below, according to the maximum output power of

the communications equipment.

Rated Maximum

Output Power of

Transmitter (W)

Separation Distance According to Frequency of Transmitter (m)

150 kHz to 80 MHz

d = [3.5/V1]√P

80 MHz to 800 MHz

d = [3.5/E1]√P

800 MHz to 2.5 GHz

d = [7/E1]√P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in meters (m) can be estimated using the equation applicable to the

frequency 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 the higher frequency range applies.

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

FCC warning statement:

• This device complies with Part 15 of the FCC Rules.

Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) This device must accept any interference received, including interference that may

cause undesired operation.

• This equipment complies with FCC radiation exposure limits set forth for an uncontrolled

environment. End users must follow the specific operating instructions for satisfying

RF exposure compliance. This transmitter must not be co-located or operating in

conjunction with any other antenna or transmitter.

• Changes or modifications not expressly approved by the party responsible for

compliance could void the user’s authority to operate the equipment.

WaRRaNtY aNd

SeRvIce

C-1

Appendix C

WArrAnty AnD servICe

DePuy Mitek products are guaranteed to be free from defects in material and workmanship

for the warranty period of a particular product, beginning from date of invoice.

Contact your DePuy Mitek representative for specific product warranty information.

DePuy Mitek offers an expedited service replacement program for its products to

minimize downtime in your operating room. For a return authorization number or for

additional information on this program, call DePuy Mitek Customer Service at +1 (800)

382-4682 and choose Option 5 in the United States or contact your DePuy Mitek

representative.

acceSSoRIeS

D-1

Appendix D

ACCessorIes

NOTE

Not all electrodes are available in all countries. Consult your local sales representative for availability.

The following Electrodes and accessories are compatible with the VAPR VUE system:

Part Number Product Description

225002 VAPR® Handpiece

REUSABLE

225023 VAPR® 3 Footswitch

REUSABLE

227214 VAPR® VUE™ Wireless Footswitch

REUSABLE

225303 VAPR® End Effect Electrode

3.5 mm x 160 mm

225301 VAPR® Side Effect Electrode

3.5 mm x 160 mm

225305 VAPR® 90 Degree Hook Electrode

3.5 mm x 160 mm

225304 VAPR® Angled End Effect Electrode

3.5 mm x 160 mm

225302 VAPR® Angled Side Effect Electrode

3.5mm x 160 mm

225201 VAPR® 2.3 Side Effect Electrode

140 mm

225202 VAPR® 2.3 End Effect Electrode

140 mm

225211 VAPR® 2.3 Side Effect Electrode (Short)

85 mm

225213 VAPR® 2.3 Wedge Electrode (Short)

85 mm

225203 VAPR® 2.3 Wedge Electrode

140 mm

225312 VAPR® Flexible Side Effect Electrode

3.5 mm x 160 mm

225314 VAPR® Flexible End Effect Electrode

3.5 mm x 160 mm

227301 VAPR® Side Effect Electrode

3.5 mm Side Effect with Integrated Handpiece

227305 VAPR® Hook Electrode

3.5 mm Hook with Integrated Handpiece

227302 VAPR® Angled Side Effect Electrode

with Integrated Handpiece, 3.5 mm x 160 mm

227312 VAPR® Flexible Side Effect Electrode

with Integrated Handpiece, 3.5 mm x 160 mm

227203 VAPR® 2.3 Wedge Electrode

with Integrated Handpiece, 140 mm

227213 VAPR® 2.3 Wedge Electrode (Short)

with Integrated Handpiece, 85 mm

227211 VAPR® 2.3 Side Effect Electrode (Short)

with Integrated Handpiece, 85 mm

acceSSoRIeS

D-2

227202 VAPR® 2.3 End Effect Electrode (Short)

with Integrated Handpiece, 140 mm

225360 VAPR® LD Suction Electrode

4.0 mm x 160 mm

225361 VAPR® LP Suction Electrode

4.0 mm x 160 mm

225370 VAPR® S90 Electrode

4.0 mm, 90° Suction with Integrated Handpiece

227355 VAPR® S50 Electrode

50° Suction with Integrated Handpiece

227504 VAPR® Premiere50 Electrode

50° Suction with Integrated Handpiece

227204 VAPR® Premiere90 Electrode

90° Suction with Integrated Handpiece

227252 VAPR® Temperature Control End Effect Electrode

with Integrated Handpiece, 2.3 mm x 140 mm

225252 VAPR® Temperature Control End Effect Electrode

2.3 mm x 140 mm

228147 VAPR® COOLPULSE® 90 Electrode with Hand Controls

90° Suction with Integrated Handpiece

228146 VAPR® COOLPULSE® 90 Electrode

90° Suction with Integrated Handpiece

228203 VAPR® 2.3 Wedge Electrode with Hand Controls

2.3mm with Integrated Handpiece

228300 VAPR® Side Effect Electrode with Hand Controls

3.5mm Side Effect with Integrated Handpiece

228305 VAPR® Hook Electrode with Hand Controls

3.5mm Hook Electrode with Integrated Handpiece

228370 VAPR® S90 Electrode with Hand Controls

4.0mm, 90° Suction with Integrated Handpiece

228504 VAPR® Premiere50 Electrode with hand Controls

3.0mm, 50° Suction with Integrated Handpiece

225028 VAPR® TRIPOLAR 90° Suction Electrode with Integrated Handpiece

225029 VAPR® ARCTIC™ Suction Electrode with Dome Tip

225030 VAPR® ARCTIC™ Suction Electrode with Chisel Tip

DePuy Mitek, Inc. Medos International SARL

325 Paramount Drive Chemin-Blanc 38

Raynham, MA 02767, USA 2400 Le Locle, Switzerland

1-800-356-4835

* For recognized manufacturer, refer to product label.

US Representative DePuy International Ltd.

DePuy Mitek, Inc. St Anthony’s Road

325 Paramount Drive Leeds LS11 8DT England

Raynham, MA 02767, USA Tel: +44 113 270 0461

1-800-356-4835 Fax: +44 113 272 4101

Manufactured for DePuy Mitek by:

Gyrus Medical Ltd,

Fortran Road, St Mellons,

Cardiff, CF30LT, UK

P/N: 110009-EN Rev: J

Depuy Mitek 225024 VAPR VUE Generator User Manual

Depuy Mitek VAPR VUE Generator

User Manual

Navigation menu

Namespaces

Views

Navigation