1061421 Rev. F InaVein TRIVEX
®
System Operations/Service Manual
2
TABLE OF CONTENTS
PREFACE
This manual contains information you need to operate and maintain the InaVein TRIVEX®System. It is
essential that you read and understand all the information in this manual before using or maintaining
the system.
TABLE OF CONTENTS
GLOSSARY OF SYMBOLS . . . . . . .1
PREFACE . . . . . . . . . . . . . . . . . . . . .2
DEVICE DESCRIPTION . . . . . . . . . .3
INDICATIONS FOR USE . . . . . . . . . .3
CONTRAINDICATIONS . . . . . . . . . . .3
WARNINGS . . . . . . . . . . . . . . . . . .4–5
PRECAUTIONS . . . . . . . . . . . . . . .5–6
SYSTEM COMPONENTS . . . . . .7–12
Resector Handpiece . . . . . . . . . . . .7
TRIVEX System Illuminator . . . . . .7
Component Identification . . . . . . . .7
Unpacking the Components . . . . . .8
Assembling the Components . . . . .8
Assemble Control Unit to Stand .8
Assemble Handle to Mast . . . . . .8
Control Unit Front Panel . . . . . .9–11
Front Panel Connectors . . . . . . .9
Console Controls
and Functions . . . . . . . . . . .10–11
Control Unit Rear Panel . . . . . . . .12
Power Switch . . . . . . . . . . . . . .12
Fuse Panel . . . . . . . . . . . . . . . .12
PREOPERATIVE SETUP . . . . .13–16
Setup . . . . . . . . . . . . . . . . . . . . . .13
Power Up . . . . . . . . . . . . . . . . .13
Tumescent Supply Setup . . . . .13
Resector Handpiece Saline
Supply Setup . . . . . . . . . . . . . . .14
Connecting the TRIVEX
Resector Handpiece
and Resector . . . . . . . . . . . . . . .15
Connecting the TRIVEX
System Illuminator . . . . . . . . . .16
OPERATIONS . . . . . . . . . . . . . .17–19
Resector Control . . . . . . . . . . . .17
Resector Handpiece
Suction Control . . . . . . . . . . . . .18
Resector Handpiece Irrigation
Control . . . . . . . . . . . . . . . . . . .18
Resector Speed . . . . . . . . . . . .19
Cutting . . . . . . . . . . . . . . . . . . . .19
Window Lock . . . . . . . . . . . . . . .19
Illuminator Irrigation . . . . . . . . .19
Illuminator Control . . . . . . . . . . .19
CLEANING AND STERILIZATION . . . . . .20
Resector Handpiece . . . . . . . . . . .20
Control Unit and Footswitches . . .20
Fiber Optic Cable . . . . . . . . . . . . .20
Illuminator . . . . . . . . . . . . . . . . . . .20
MAINTENANCE . . . . . . . . . . . . .21–23
Electrical Interference . . . . . . . . . . .21
Environmental Protection . . . . . . . . .21
Preventative Maintenance . . . . . . . .21
Hi-Pot Current Leakage Test . . . . . .21
Electrical Safety Checks . . . . . . . . .21
Dielectric Strength Test . . . . . . . . .22
Ground Test . . . . . . . . . . . . . . . . .22
Leakage Current Test
115 VAC with Power On . . . . . . . .23
Leakage Current Test
230 VAC with Power On . . . . . . . .23
SERVICE . . . . . . . . . . . . . . . . . .24–25
Service Philosophy . . . . . . . . . . . .24
Replacing the Lamp and Lamp
Life Indicator . . . . . . . . . . . . . . . . .24
TRIVEX System Fuses . . . .24–25
Resector Handpiece Cable . . . . . .25
Replacing the Handpiece
Cable . . . . . . . . . . . . . . . . . . . . .25
Returning the TRIVEX System
Control Unit . . . . . . . . . . . . . . . . . .25
TROUBLESHOOTING . . . . . . . .26–27
TECHNICAL SPECIFICATIONS . . .28
ORDERING INFORMATION . . . . . .29
GUIDANCE AND
MANUFACTURER’S DECLARATION ELECTROMAGNETIC
EMISSIONS . . . . . . . . . . . . . . . . . . .30
GUIDANCE AND
MANUFACTURER’S DECLARATION ELECTROMAGNETIC
IMMUNITY . . . . . . . . . . . . . . . . .31–32
GUIDANCE FOR SEPARATION
DISTANCES . . . . . . . . . . . . . . . . . . .33
WARRANTIES . . . . . . .BACK COVER
SERVICE REPLACEMENT
PROGRAM . . . . . . . . .BACK COVER
REPAIR SERVICE
PROGRAM . . . . . . . . .BACK COVER
FIGURES
1 Component Identification . . . . . . .7
2 Assemble control unit to stand . . .8
3 Control Unit Front Panel . . . . . . . .9
4 Control Unit Console . . . . . . . . .10
5 Control Unit Rear Panel . . . . . . .12
6 Tubing Connections . . . . . . . . . .14
7 Fiber Optic Cable Inspection . . .16
8 Resector Handpiece Controls . . .17
9 Fully Opened Resector
Handpiece Suction Lever . . . . . .18
10 Fully Closed Resector
Handpiece Suction Lever . . . . . .18
11 Lamp and Lamp Life Indicator . .24
TABLES
1 115 VAC 60 Hz
Leakage Current Test . . . . . . . . .23
2 230 VAC 50/60 Hz
Leakage Current Test . . . . . . . . .23