InaVein Trivex User manual

InaVein TRIVEX®System
Operations/Service Manual
Manufactured by
InaVein
InaVein TRIVEX®System Operations/Service Manual 1061421 Rev. F
1
GLOSSARY OF SYMBOLS
Manufacturer
On-Off Push Control
Mode Select Control
Speed Control
Up and Down Buttons
WARNING: HOT
Fluid bag
Lamp
Handpiece
Footswitch
Forward
Reverse
Oscillate
WINDOW LOCK
EU: Not for general waste
CE Mark
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
On (Toggle Switch)
Off (Toggle Switch)
Non-ionizing electromagnetic radiation.
EQUIPMENT CLASSIFICATION—
Type BF applied part
DANGEROUS VOLTAGE: Danger of Electric Shock
Alternating Current
Service Lifetime in Years
Catalog Number
Serial Number
Fuse
UL Classification
Keep Dry
Fragile; handle with care
This Way Up
European Representative
1061421 Rev. F InaVein TRIVEX
System Operations/Service Manual
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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
InaVein TRIVEX®System Operations/Service Manual 1061421 Rev. F
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DEVICE DESCRIPTION
The TRIVEX®System uses a metal halide arc lamp to provide intense, white light via the TRIVEX System Illuminator for transillumination. The illuminator connects with fiber optic cables to the TRIVEX System to provide transillumination during endoscopic resection of superficial varicosities of the lower extremities.
The TRIVEX System uses a pair of peristaltic pumps to provide irrigation and tumescent anesthesia for the Transilluminated Powered Phlebectomy procedure. The left hand pump is dedicated to providing the tumescent anesthesia via the TRIVEX System Illuminator. The right hand pump is dedicated to providing saline to the TRIVEX Resector Handpiece for resector tip irrigation.
INDICATIONS FOR USE
The TRIVEX System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.
CONTRAINDICATIONS
Use of the TRIVEX System is contraindicated in situations where ambulatory phlebectomy is contraindicated.
DEVICE DESCRIPTION/INDICATIONS FOR USE/CONTRAINDICATIONS
1061421 Rev. F InaVein TRIVEX
System Operations/Service Manual
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Please read this manual before using the TRIVEX
System. The brief operating instructions in this guide will make the system easier to use, while the recommended service and maintenance procedures will ensure optimal performance for years of reliable use. As with any surgical instrument, there are important health and safety considerations. These are listed below and reiterated within the text.
Prior to using the TRIVEX System, it is essential that all components of the system be inspected for damage that can negatively impact the equipment performance. The inspection should include all equipment to be used in surgery, including the illuminator, cables, and accessories.
When removing the TRIVEX System and accessories from the shipping container, inspect contents to ensure that all components from the “Unpacking the Components” section are available.
Contact your authorized InaVein Representative if damage is noted.
WARNINGS
• Before using the TRIVEX System for the first time, you should review all available product information. Surgeons should become familiar with this surgical technique and the TRIVEX System. Refer to the TRIVEX Surgical Technique Guide (REF 1030501). You should be experienced in ambulatory phlebectomy surgery using powered instruments. Healthy tissue can be injured by improper use of the TRIVEX System resector. Use every available means to avoid such injury.
• TRIVEX Resector Kits are packaged as a set. They must be used as supplied. Do not interchange resector components.
• Tube sets are provided STERILE and are for single use only. Do not reuse. Do not resterilize. Prior to use, inspect the product package for signs of damage or tampering. Discard any opened and unused product. Do not use after the expiration date.
• The TRIVEX System pumps should not be running while setting up the tubing. Injuries to the operator’s hands can occur.
• Periodic irrigation of the tip of the resector is recommended to provide adequate cooling of the resector and to prevent accumulation of excised materials in the surgical site. Ensure that suction of 128 mmHg minimum is maintained while the instrument is running.
• Work exclusively with sterile substances, sterile fluids, and sterile accessories.
• This system is intended only for use with flexible fluid containers and fluid bags. Glass containers or bottles may break, and there is a risk of implosion.
• Use of bags or containers not approved for this system, or large and/or lopsided loads, may cause the device to tip over.
• If visualization is lost during any point in the procedure stop cutting immediately.
• Excessive pressure of the TRIVEX resector against the vessel or prolonged activation of the TRIVEX resector in a stationary position may result in perforation of the resector through the limb surface.
• Do not hold the light source shutter open without a fiber optic cable in place. Failure to observe this precaution may result in eye injury.
• During procedure, avoid prolonged contact of the Illuminator tip to patient tissue or flammable materials. The Illuminator tip may reach high temperatures due to high-intensity light transmission.
• DANGER: Risk of explosion if used in the presence of flammable anesthetics.
• When the light source is turned on, do not look directly at the metal halide arc lamp without protective goggles.
• To prevent electrical shock, do not remove the TRIVEX System console cover. There are no user-serviceable components inside. Dismantling the equipment will void the warranty. Refer servicing to an authorized InaVein representative.
• To prevent electrical shock, connect the power cord to a properly-wired grounding receptacle only.
• To prevent electrical shock, unplug the unit from the electrical outlet before attempting to replace the fuses.
• Use extreme caution: The high internal pressure of the lamp may cause an explosion, regardless of whether the lamp is cold or hot. Always wear protective clothing and a face mask when handling the lamp.
• Hazardous high voltage and energy are present at the output and in the internal circuitry of this unit.
• If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1-1.
WARNINGS
InaVein TRIVEX®System Operations/Service Manual 1061421 Rev. F
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• If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 60601-1/IEC 60601-1 approved isolation transformer and retest the system.
• In some cases, high voltage may persist after the power has been removed. Only personnel qualified to service electronic equipment should operate or troubleshoot an “uncased” power supply.
• Dangerous voltages are present during leakage current testing. DO NOT TOUCH the TRIVEX System while power is applied.
• HIGH VOLTAGE (1500 VAC) is present during dielectric strength and Hi-Pot testing. Exercise extreme caution while operating the dielectric strength tester or the Hi-Pot tester to prevent personal injury from electrical shock or damage to the equipment. Ensure that only authorized personnel are in the test area during the tests.
• To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating.
• The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
– Use of the accessory in the patient vicinity.
– Evidence that the safety certification of the
accessory has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1.
PRECAUTIONS
U.S. Federal law restricts this device to sale by or on the order of a physician.
• Prior to use, examine the device(s) for possible
damage to assure proper functioning. If damaged, do not use.
• Verify that the resector handpiece and its cable
are sterile.
• Verify that the illuminator and the fiber optic
cable are sterile.
• Check to ensure that the resector(s) required
for the procedure are available.
• Verify that the Preoperative Setup has been
successfully completed.
• Only InaVein Disposable TRIVEX Resector Kits can be used with the TRIVEX System. Resectors used with the TRIVEX System are for single use only. Do not resterilize or lubricate the resectors. Dispose of the resectors after use.
• Use of reprocessed, single-use resectors may permanently damage, impede performance, or cause failure of your InaVein TRIVEX System. Use of such products may render any warranties null and void.
• Make sure the wheels on the TRIVEX System roller base are locked to prevent the system from rolling during setup and use.
• As in conventional ambulatory phlebectomy procedures, bruising, hematoma, and hemosiderin deposits have been observed in clinical studies utilizing the TRIVEX System.
• Disconnect power cord before cleaning the unit.
• Do not sterilize or immerse the TRIVEX System console in disinfectant.
• To prevent moisture from entering the handpiece cable during sterilization ensure that the protective cap is screwed on completely. Moisture can damage the cable or handpiece connectors.
• Do not allow the rotating portion of any resector to touch any metallic object such as the illuminator. Damage to both instruments is likely. Damage to the resector can range from a slight distortion or dulling of the resector edge to actual fracture of the tip in vivo. If such contact does occur, inspect the tip. If you find cracks, fractures or dulling, or if you have any other reason to suspect a resector is damaged, replace it immediately.
• Excessive leverage on the resector does not improve cutting performance and, in extreme cases, may result in wear and degradation of the inner assembly.
• Do not cool the resector handpiece by immersing it in cold water.
• Do not operate the resector in the open air for an extended period, as the lack of irrigation may cause the resector to overheat and seize.
WARNINGS
(Continued)
/ PRECAUTIONS
1061421 Rev. F InaVein TRIVEX
System Operations/Service Manual
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• Use only the TRIVEX Light Source Adaptor (REF 7210375) with this system. Use of any other light source port adaptor may cause reduced light emission from the fiber optic cable.
• The power switch must be turned off, and the power cord disconnected from the power source, before attempting to replace the lamp.
• Replace the lamp and lamp life indicator only with an appropriate InaVein lamp and lamp life indicator (REF 7210115) as specified for the TRIVEX System. Use of any other lamp or lamp life indicator will void the warranty.
• Lamp may be very hot. Use protective eyewear when handling lamp.
• Do not leave the operating light cord on a patient or on patient drapes. Failure to observe this precaution may result in burns to the patient and/or to the surrounding drapes.
• This unit complies with IEC 60601-1-2. However, the user must be aware that this does not necessarily ensure protection of the unit against interference from other devices.
• Do not operate at line voltage other than those stipulated on the back of the unit.
• Ensure that the available mains voltage matches the data listed on the label attached to the back of the control unit. Incorrect voltage can cause errors or malfunction, and may destroy the equipment.
• Handle the unit with care. If the unit is dropped or damaged in any way, it must be returned immediately for service.
• Electrical safety testing should be performed by a biomedical engineer or other qualified person.
• This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment.
• This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment it may be corrected by one or more of the following measures:
– Reorient or relocate this equipment, the
other equipment, or both.
– Increase the separation between the pieces
of equipment.
– Connect the pieces of equipment into
different outlets or circuits.
– Consult a biomedical engineer.
• Equipment should be disposed of in accordance with local and/or federal codes and requirements.
PRECAUTIONS (Continued)
InaVein TRIVEX®System Operations/Service Manual 1061421 Rev. F
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SYSTEM COMPONENTS
Figure 1. Component Identification
Fluid bag holder hooks (x2)
Saline solution bag
Tumescent solution bag
Irrigation mast
Control unit
Control unit console
Connection ports
TRIVEX System stand with Roller base
TRIVEX System Illuminator
TRIVEX System Resector
Footswitches (x2)
The TRIVEX®System consists of a variety of components:
The TRIVEX System control unit provides controls for the mode and speed of the TRIVEX Resector, for activation and flow of the tumescent and saline pumps, and for operation of the light source for the TRIVEX System Illuminator.
The console includes a display for resector speed and LED indicators for pump flow rate.
The four control buttons (tumescent pump, lamp, resector mode, and saline pump) have lighted indicators above and below each push button. These indicate the status of each component by illuminating steady green, flashing green, steady orange, or flashing orange.
The front of the control unit has ports for connecting the illuminator, two footswitches, and resector.
The TRIVEX System stand provides a mobile base for the TRIVEX System control unit and an irrigation mast for the saline and tumescent solution irrigation bags.
The 60 watt metal halide arc lamp provides intense, white light via the TRIVEX System Illuminator.
The TRIVEX Resector Handpiece drives the InaVein 4.5 mm TRIVEX Resector (REF 7209514) and 5.5 mm TRIVEX Resector (REF 7209515), and features push-button controls for resector operation.
RESECTOR HANDPIECE
The TRIVEX Resector Handpiece is a hand-held motor drive that is electrically connected to the control unit via a 10 foot (3 meter) cable. The resector handpiece drives the disposable resectors.
The resector handpiece and its cable are autoclavable (see “CLEANING AND STERILIZATION”). The resector handpiece cable is user replaceable (see “SERVICE”).
TRIVEX SYSTEM ILLUMINATOR
The TRIVEX System Illuminator (REF 7210351) is an accessory, and is used to instill tumescent solution and to transilluminate the targeted varicosities. Please see the TRIVEX System Illuminator Instructions for Use (REF 1061419) for additional information.
Component Identification
0
9
8
1
7
1061421 Rev. F InaVein TRIVEX
System Operations/Service Manual
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SYSTEM COMPONENTS (continued)
ASSEMBLING THE COMPONENTS
ASSEMBLE CONTROL UNIT TO STAND
1. Place the stand with roller base on a smooth level surface with the rear panel facing you.
2. Remove the 3/16" Allen wrench from the base of the irrigation mast. Using the Allen wrench, remove the four bolts securing the rear panel to the roller base.
3. Align the base of the control unit with the top of the roller base and lower the control unit straight down onto the roller base (figure 2).
4. For each of the four drawer latches located in the interior of the roller base: lift and engage the latch, then turn the latch key one half turn clockwise. Fold the latch key flat.
5. Replace the rear panel and reinsert the four bolts.
ASSEMBLE HANDLE TO MAST
6. Remove the four irrigation mast mounting bolts from the rear of the control unit.
7. Assemble the handle to the mast by: removing the two 1/4-20 x 5/8" socket head screws and washers from the handle using the 3/16" Allen wrench and then place the handle inside the box section of the mast weldment. Orient the handle so the threaded inserts align with the hole openings in the box section of the weldment. Secure the handle with the two, 1/4-20 x 5/8" socket head screws and washers.
8. Fit the irrigation mast with handle onto the rear of the control unit and secure it with the four irrigation mast mounting bolts.
Caution: Make sure the wheels on the TRIVEX System roller base are locked to prevent the system from rolling during setup and use.
UNPACKING THE COMPONENTS
Carefully unpack and inspect all components shipped with your InaVein TRIVEX System. If any parts are missing or damaged, contact your authorized InaVein representative. Save the carton and packing materials in the event a component must be returned for repair. You should have received the following:
Carton 1 of 2
1 ea. TRIVEX System Stand with Roller Base 1 ea. Irrigation Mast includes a 3/16" Allen wrench
attached at the base of the irrigation mast
1 ea. Irrigation Mast Handle
Carton 2 of 2
1 ea. REF 7210386 TRIVEX System Control Unit 1 ea. REF 1061421 Operations/Service Manual 2 ea. REF 7209791 TRIVEX System Footswitch 1 ea. REF 8005600 U.S. Power Cord 1 ea. REF 8013378 U.K. Power Cord 1 ea. REF 8013380 International Power Cord
Figure 2. Assemble control unit to stand
Drawer latch with key
InaVein TRIVEX®System Operations/Service Manual 1061421 Rev. F
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SYSTEM COMPONENTS (continued)
TRIVEX®SYSTEM CONTROL UNIT FRONT PANEL
Figure 3. TRIVEX®System control unit front panel
CONTROL UNIT FRONT PANEL
1. Tumescent Pump Door – covers the tumescent pump hardware.
2. Saline Pump Door – covers the saline pump hardware.
3. TRIVEX System Console – contains the push buttons and displays for system operation.
FRONT PANEL CONNECTORS
There are four connectors on the front panel:
4. Fiber Optic Cable Connection Port – self-closing port designed to accept the TRIVEX Light Source Adaptor (REF
7210375).
Caution: Use of any other light source port adaptor may cause reduced light emission from the fiber optic cable.
5. Footswitch Tubing Connection Ports – accept tubing for the TRIVEX System footswitches.
6. Resector Handpiece Cable Connection Port – accepts the Resector Handpiece cable.
3
1
4
5
6
2
1061421 Rev. F InaVein TRIVEX
System Operations/Service Manual
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SYSTEM COMPONENTS (continued)
CONTROL FUNCTION
7. Tumescent Pump ON/OFF Button
Turns the tumescent pump ON or OFF.
8. Tumescent Pump Flow LED Indicators
Indicates the flow rate setting of the tumescent solution.
9. Tumescent Pump Flow Increase / Decrease Buttons
Increase or decrease the flow rate of the Tumescent pump. Each press of a button results in the flow rate increasing or decreasing by one level.
10. Lamp ON / OFF Button Turns the lamp ON or OFF.
11. Window Lock Control Holding down both Resector Speed Control increase/decrease
buttons simultaneously engages the Window Lock function.
12. Resector Speed Increase/ Decrease Buttons
Increase or decrease resector speed by 100 rpm with each button press.
13. Resector Speed Display (rpm)
Displays the current speed of the resector incrementally in 100 rpm steps over a range of 100 rpm to 1500 rpm.
Figure 4. TRIVEX®System control unit console
CONSOLE CONTROLS AND FUNCTIONS
13
8
9
11
7
19
10
16
17
12
14
18
15
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