Medivators Veriscan LT User manual

REPROCESSING SYSTEMS

LT

User Manual

Automated Endoscope

Leak Tester

Veriscan® is a registered trademark of Minntech Corporation.
Fujinon® is a registered trademark of Fujinon Corporation.
OLYMPUS® is a registered trademark of Olympus Corporation.
PENTAX® is a registered trademark of Pentax Precision Instrument Corporation.
Storz® is a registered trademark of Karl Stroz.

50096-988 Rev A

© 2009, MINNTECH CORPORATION

All rights reserved. This publication is protected by copyright. Copying, disclosure to
others, or the use of this publication is prohibited without the expresswritten consent
of Minntech Corporation.

Minntech reserves the right to make changes in the specications shown herein

without notice or obligation. Contact your Medivators representative or Medivators
customer service for more information.

Table of Contents

Introduction ................................................................... 5

Using this Manual ....................................................... 5

Product Description .................................................... 5

Product Specications ............................................... 6

Safety ..............................................................................7

Intended Use .............................................................. 7

Electrical Compliance ................................................. 7

Operator Safety ......................................................... 7

General Cautions ....................................................... 7

Guidelines .................................................................. 8

Cleaning and Disinfection ..................................... 8

System Components ..................................................... 9

System Features .......................................................... 10

System Setup ............................................................... 11

Performing a Leak Test ................................................14

Performing a Screening test ...................................... 17

Testing a Failed Endoscope ....................................... 19

Daily Quality Assurance Test ..................................... 21

Data Access and Management ....................................22

Main Menu ............................................................... 22

Printing and Quick Reports ...................................... 26

ProV-LT Data Management Software ...................... 28

Maintenance, Handling and Care ............................... 30

Troubleshooting .......................................................... 33

Warranty ....................................................................... 34

USERS MANUAL | 3

Introduction

Using this manual

This manual describes the features of the Medivators Veriscan LT Automated Endoscope Leak Tester, including

system, setup, operation, safety, maintenance and troubleshooting procedures. It is important to follow the provided

instructions to keep the device in proper operating condition, to ensure accurate endoscope leak testing, and to

ensure long product life.

This is not a service manual and does not provide detailed instructions for service beyond general maintenance,

handling and care. Contact the manufacturer’s service representative if you have any questions regarding this

product, its use or operation.

Product Description

Flexible endoscopes are highly vulnerable to damage-causing moisture that enters the endoscope’s sensitive

interior through holes, tears, broken seals, cleaning cap leaks and loose contact pins. Prior to Veriscan LT, leak

detection has always been hampered by testing equipment that lacked precision, and required extraordinary skills

of observation beyond the capabilities of even the most experienced cleaning technician. As a result, undetected

leaks allow moisture to enter the endoscope’s interior through no fault of the technician. These leaks invariably

result in extensive endoscope damage, expensive endoscope repairs, and raise the risk of cross-patient infection

due to pathogens passing into subsequent patients through undetected leaks and moisture invasion.

The Veriscan’s automated endoscope leak testing technology transforms leak testing from a frustrating guessing

game into a simple, highly accurate, repeatable process that can be quickly mastered by cleaning technicians

and nurses. Veriscan’s innovative dry leak testing method accurately detects damage-causing endoscope leaks

without the need of immersing an endoscope in water. The endoscope is dry-leak tested through a process of

pressurizing the endoscope, monitoring the internal pressure level, and identifying if an endoscope leak exists

through a loss of pressure. An endoscope does not have to be placed in a uid-bath and visually observed for air

bubble leaks; the Veriscan’s visual display and printout automatically identify if an endoscope leak is detected.

Carefully review the User Manual to familiarize yourself with Veriscan’s features, operation and testing procedures.

We are condent the Veriscan system will quickly become an invaluable tool for enhancing reprocessing room

efciency, reducing endoscope damage and repair expense due to undetected leaks, and reduce the potential risk

of cross-patient infection.

USERS MANUAL | 5

Product Specications

Power Requirement: Universal Power Supply 100-240VAC, 50/60 Hz, .25 Ampere

Fuse Rating: 250V, 1 Ampere, Type S, 3AG style.

Dimensions: 13.125 H x 8.25 W x 19.25 L inches

(33.3 H x 21 W x 48.9 L cm)

Weight: 15.8 lbs. (7.18 kg)

PSI range: 3.500 - 3.999 PSI (comparable to current manual leak testers)

Display: Liquid Crystal Display (LCD) with LED backlight

ProV-LT Data Management
Connectivity Ports: USB communications port

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

Storage Temperature Range: +20°C (68°F) to +45°C (113°F)

Humidity: 20% to 80% non-condensing

Electrical Safety Certications: UL Standard 61010-1
CAN/CSA Standard 61010-1

Environmental Rating: Standard

Designed for Use: Indoor Use Only

Warranty Period: One (1) Year

6 | USERS MANUAL

Safety

Intended Use

The Medivators Veriscan system is intended for endoscope leak testing of exible, immersible endoscopes. The

Medivators Veriscan system has been validated by Medivators for use on Olympus, Pentax, Fujinon, and Storz

exible, immersible endoscopes.

Electrical Compliance

The Medivators Veriscan system was tested to stringent electrical certications and safety standards. This device

complies to UL Standard 61010-1 and CAN/CSA Standard 61010-1.

NOTE: This device must always be plugged into an electrical wall outlet that includes an approved Ground
Fault Interrupter (GFI) prior to operation.

Operator Safety

1) Veriscan is to be operated solely by properly trained and qualied personnel, and only used for its intended use.

2) WARNING: To avoid biological contamination and chemical burns, always wear appropriate personal protective
equipment (PPE) including clothing, gloves, and safety glasses when handling used endoscopes.

General Cautions

1) Veriscan users should be properly trained and instructed on the current procedures used to inspect, prepare,

clean, disinfect, rinse, dry, and store endoscopes. Follow recommended standards as referred by ASTM,

ASGE, SGNA and APIC.

2) The Veriscan system is intended to be used in conjunction with the instructions and labeling provided by the

endoscope manufacturer.

3) This is a dry leak test only - Do not place endoscope in water while testing.

4) Veriscan’s leak test parameter settings are pre-set at the factory for highly accurate endoscope leak test

measurements. Parameter settings should not be changed or adjusted, unless specically recommended by

Medivators. Parameter changes should only be performed by trained and qualied personnel.

5) The Veriscan system must be grounded in accordance with applicable electrical and safety regulations.

6) Read all precaution labels on the device before using.

7) Never use the device in a manner not specied or intended by the manufacturer.

8) The Veriscan system uses coin lithium batteries in the internal electronics for retaining memory settings. The

coin lithium batteries contain perchlorate material and if replaced, special handling may apply.

9) The Veriscan’s Quick Connect Tubings are not autoclavable and can only be decontaminated using low

temperature decontamination methods.

10) Inspect Quick Connect Tubings often and replace if damaged or worn.

11) Lubricate Quick Connect Tubing O-ring weekly with silicon oil to ensure a secure connection.

12) Monitor the condition of the desiccant drying crystals on a regular monthly basis. Replace as needed as

determined by comparing the crystals to the Drying Crystals Color Comparison Chart.

13) Monitor the condition of the coalescent lter for oil and particulates on a regular monthly basis. Replace once

yearly, or more if needed.

For service or service-related questions, contact Medivators Technical Support at 1.800.444.4729 or your

authorized Medivators distributor.

USERS MANUAL | 7

Guidelines

Endoscope Leak Testing and Pre-cleaning

An effective endoscope leak test and pre-cleaning process is an essential step in the reprocessing of an

endoscope. Always follow the endoscope manufacturer’s instructions and established professional guidelines to

properly leak test and clean an endoscope. If an endoscope leak is detected, the endoscope should be immediately

taken out of service and sent in for repair.

Endoscopes should always be dry leak tested before submersion in uid to prevent additional uid invasion and

internal endoscope contamination. Leak testing detects endoscope leaks within the interior and exterior of an

endoscope.

Cleaning and Disinfection

Professional Guidelines

The following organizations have published recommended guidelines for cleaning and disinfecting endoscopes.

Society of Gastroenterology
Nurses and Associates, Inc.

401 North Michigan Ave.
Chicago, Ill. 60611-4267 USA
Tel: [phone]
Fax: [phone]
www.sgna.org

American Society for Gastrointestinal Endoscopy
1520 Kensington Rd. Suite 202
Oak Brook, Ill. 60523-2141 USA
Tel: [phone]
Fax: [phone]
www.asge.org

Association of periOperative Registered Nurses, Inc.

2170 S. Parker Rd., Suite 300
Denver, CO 80231-5711 USA
Tel: [phone]
Fax: [phone]
www.aorn.org

British Society of Gastroenterology

3 St. Andrews Place
Regents Park, London, NW1 4LB England
Tel: [phone]
ww.bsg.org.uk

Association of Professionals in Infection
Control and Epidemiology, Inc.

1275 K. Street NW, Suite 1000
Washington, DC 20005-4006 USA
Tel: [phone]
Fax: [phone]
www.apic.org

American Society for Testing and Materials

100 Barr Harbor Drive
West Conshohocken, PA 19428-2959 USA
Tel: [phone]
Fax: [phone]
www.astm.org

Canadian Society of Gastroenterology
Nurses and Associates

27 Nicholson Dr.
Lakeside, NS B3T 1B3 Canada
Fax: [phone]
www.csgna.com

Societe Francaise d’Hygiene Hospialiere S.F.H.H.

Hopital de la Croix-Rousse
Unite h’Hygiene Hospitaliere-Epidemiologie
93 Grande Rue de la Croix-Rousse
69317 Lyon Cdx04 France
Tel: [phone]
Fax: [phone]
www.sfhh.net

8 | USERS MANUAL

System Components

Veriscan Box

This box contains the following components:

• One (1) Veriscan-LT System

• One (1) Power cord

• One (1) Crystal desiccant bag

• One (1) Silicon Oil

• One (1) ProV-LT Link Database Software

• One (1) Quick Start Guide

• One (1) Veriscan Users Manual

If any of the components are missing, contact Medivators

Customer Support at 1-800-444-4729

or your authorized distributor.

Installation Kit (endoscope specic)

This box contains the following components:

• One (1) Quick connect tubing

• Five (5) printer paper rolls

• One (1) Crystal desiccant bag

• One (1) USB cable

USERS MANUAL | 9

System Features

LT

1. Display Screen

Displays information and test results

2. Control Keypad

Touchpad used to operate Veriscan System

3. Printer

Provides printout of test results

4. Quick Connect Port

Veriscan connector for Quick Connect Tubing
to endoscope

5. Power Switch

Used to turn Veriscan system ON/OFF

6. Power Cord Outlet

Receptacle for AC power cord

7. Power Cord

Provides electrical connection for Veriscan to
AC wall outlet

8. RS232 Port

Not currently used

9. USB Port

Port to connect Veriscan to separate computer
via USB cable

10. Drying Crystals Bulb

Receptacle for desiccant crystals

11. Metal Bulb Receptacle

Removable metal receptacle for securing
drying crystals bulb

12. Receptacle Release Button

Button to release metal bulb receptacle to
provide access to drying crystals bulb

13. Bulb Housing Structure

Housing for securing and linking drying
crystals bulb and metal bulb receptacle to
the device

14. Coalescent Filter Housing

Housing for securing and linking the oil and

particle lter to the device

15. Coalescent Filter

Oil and particle lter removes foreign

substances from air that enters and exits the
endoscope during testing

1

4

9

6

5

7

8

2

3

10 | USERS MANUAL

System Setup

Installation

• Position Veriscan system on a at, level surface and within six (6) feet/

two (2) meters of the electrical AC wall outlet.

• Veriscan’s electrical requirements can be found under the “Introduction,
Product Specications” section.

Attaching the Power Cord

• WARNING: Exercise caution when plugging in this electrical
device. Risk of electric shock.

• Connect power cord to power cord outlet located on rear of unit. Gently
push cord in until fully inserted. (see gure 1)

• Plug the other end of the power cord into a standard AC wall outlet.

• NOTE: This device must always be plugged into an electrical wall

outlet that includes an approved Ground Fault Interrupter (GFI)

prior to operation.

Powering the Veriscan System “ON”

• Press the power switch located on the back of the unit to turn system
power ‘on’. (see gure 2)

Figure 1

• When Veriscan is turned on, it will automatically perform an initialization
process which includes a series of diagnostic self-tests. When this
process is complete, the display will indicate that the unit is ready for
testing as displayed below:

mm/dd/yy hh:mm
Connect Scope
Press “Start”

Setting the Time and Date

The Veriscan’s internal clock will record the time of all leak test
procedures. To set the clock:

• Press the MENU button on the display keyboard

• Press the arrow down key until Set Date/Time selection is reached

• Press the CONTINUE key to select the Set Date/Time option

• To enter the month, press CONTINUE and then enter the correct month
in the “month = “ area: 1 = January, 2 = February, etc.. If an incorrect

entry is made, press CANCEL to start the process over. Press
CONTINUE when nished.

• To enter the date, press the down arrow key from the “month” row until
the “date” row is reached. Press CONTINUE to reach the date set

area. Enter the date. For single digit numbers, it is not necessary to

enter a “0” before the number (e.g. enter 3 for the 3

CONTINUE when nished.

rd

). Press

Figure 2

Figure 3

• To enter the year, press the down arrow key from the “date” row until
the “year” row is reached. Press CONTINUE to reach the year set
area. Enter the year as a single digit where 6 = 2006, 70 = 2007, etc.

Press CONTINUE when nished.

USERS MANUAL | 11