Model ZUTR10003 Operation Manual Rev H

Automatic Endoscope Leak Tester Model# ZUTR10003

Table of Contents Page 2

Introduction 1. Intended Use 2. Labels, Symbols and Signal Words 3. Environmental Conditions 4. Supply Ratings

Page 3

Important Safety Information

Page 4

Mounting Configurations and Cleaning Procedure

Page 5

Getting to know the Automatic Endoscope Leak Tester

Page 6

Instructions For Use

Zutron Medical, LLC 9816 Pflumm Road Lenexa, Kansas 66215 Phone 877-343-5873 Fax 913-967-5944

Automatic Endoscope Leak Tester Model# ZUTR10003

Introduction Intended Use The Automatic Leak Tester is used as an early detection tool in wet leak testing to detect small holes in the exterior of an endoscope. Early detection of leaks can prevent issues with cross contamination and costly repairs do to fluid invasion. Do not use this product for any other purpose. Compatible with ACMI, Fujifilm, Fuse, Olympus, Pentax, Richard Wolf & Storz endoscopes.

Labels, Symbols & Signal Words The meanings of the labels, symbols and signal words that appear on the packaging, manual and/or instrument are as follows: The following signal words are used throughout this manual:

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

NOTE

Indicates additional helpful information.

Environmental Conditions ● ●

For indoor use only Temperature range: 10°C/50°F to 40°C/104°F

Supply Ratings Voltage:

DC 12V, 3.3A NOTE

Use only the AC/DC power supply included with the unit.

Page 2

Automatic Endoscope Leak Tester Model# ZUTR10003

Important Safety Information WARNING

Plug power cord into a GFI protected receptacle.

WARNING

Do not immerse the unit in water.

WARNING

Do not operate the unit if the cord is damaged or has been exposed to water.

WARNING

Install in accordance with electrical codes.

WARNING

Do not open the air pump unit (electrical hazard).

CAUTION

Read this entire manual before operating unit.

CAUTION

Always leak test an endoscope in accordance with manufacturer's instructions.

CAUTION

Always wear protective personal equipment when handling a dirty endoscope.

CAUTION

Ensure that the air hose connector is securely attached to the air pump unit and that the endoscope leak test connector is fastened securely to the endoscope. Ensure that the unit has been running for at least 30 seconds before placing endoscope in water.

CAUTION

Do not ever power the toggle switch off while the endoscope is submerged in water.

CAUTION

Always wait 10 seconds after powering toggle switch off to release the air from inside the endoscope before disconnecting the leak test connector.

Page 3

Automatic Endoscope Leak Tester Model# ZUTR10003

Mounting Configurations Standard / Counter-Top The standard Automatic Leak Tester has rubber bumpers on the bottom of the unit and is intended to be p laced on a flat surface.

Wall-Mount The Automatic Leak Tester has the option to be converted to a wall mount unit. A bracket that is sold separately bracket may be installed by a trained service personnel. Please contact Zutron Medical for more information.

CAUTION

Permanent wall-mounted installation should be performed by trained service personnel. Improper mounting could result in injury or damage to the Automatic Leak Tester.

NOTE

Consult with responsible personnel for proper location and bracing of the mounting plate in your specific facility.

Cleaning Procedure 1. Lightly moisten a lint-free cloth with a working solution of a low foaming, neutral pH, medical grade detergent that has been prepared in accordance with the detergent manufacturer’s instructions for use. 2. Use the moistened cloth to wipe the exterior surfaces of the Automatic Leak Tester. 3. Allow the detergent solution to remain on the exterior surfaces of the Automatic Leak Tester for the time recommended by the detergent manufacturer. 4. Lightly moisten a lint-free cloth with clean water and remove residual detergent from the surfaces of the Automatic Leak Tester. 5. Thoroughly dry the surfaces of the Automatic Leak Tester with a dry lint-free cloth. 6. Lightly moisten a lint free cloth with 70% ethyl or isopropyl alcohol. 7. Use the moistened cloth to wipe the exterior surfaces of the Automatic Leak Tester. 8. Allow the exterior surfaces of the Automatic Leak Tester to air dry.

Page 4

Automatic Endoscope Leak Tester Model# ZUTR10003

Getting to know the Automatic Endoscope Leak Tester Air Pump Unit Air Hose Connection Power Supply Power Light On / Off Toggle Air Hose Endoscope Adapter

ACMI Adapter - ZUTR10001AA Fujifilm Adapter - ZUTR10001FA Olympus - ZUTR10001OA Pentax Adapter - ZUTR10001PA Richard Wolf Adapter - ZUTR10001RWA Calibration Gauge - ZUTR10003TG

Storz Adapter - ZUTR10001SA

Calibration of Leak Tester Calibrate the unit daily by connecting the Leak Tester Calibration Gauge to the unit. This unit is calibrated to produce air pressure between 120–196 mmHg. Order # ZUTR10003TG.

Page 5

Automatic Leak Tester Model # ZUTR10003

Instructions For Use

1. Plug in the power supply to the unit and attach the air hose connector to the front of the unit.

2. Toggle Automatic Leak Tester “ON” to ensure no fluid is inside the tubing or adapter. After a few seconds toggle “OFF”.

3. Before placing endoscope in water, attach the leak test adapter to the endoscope and press toggle “ON”. Wait at least 30 seconds before placing endoscope in water.

4. Submerge endoscope in water and look for air bubbles that indicate a leak coming from the endoscope, while deflecting the bending section.

5. After testing, remove the endoscope from water and toggle the Automatic Leak Tester “OFF”.

6. Always wait 10 seconds after powering the toggle switch off to release the air from inside the endoscope before disconnecting the leak test connector.

Zutron Medical, LLC 9816 Pflumm Road Lenexa, Kansas 66215 Phone 877-343-5873 Fax 913-967-5944

Page 6