OPERATION MANUAL. Automatic Endoscope Leak Tester. Model# ZUTR-10003

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Automatic Endoscope Leak Tester OPERATION MANUAL ZUT-Lab-004-10003 REV. F

Table of Contents Page 2 Introduction 1. Intended Use 2. Labels, Symbols and Signal Words 3. Environmental Conditions 4. Supply Ratings Page 3 Page 4 Page 5 Page 6 Safety Warnings and Cautions Mounting Confgurations and Cleaning Procedure Getting to know the Automatic Endoscope Leak Tester Instructions For Use

Table of Contents Intended Use The Automatic Endoscope 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 fuid invasion. Do not use this product for any other purpose. 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: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. 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. The Automatic Endoscope Leak Tester (ZUTR-10003) was tested by Intertek, a Nationally Recognized Testing Laboratory (NRTL), and was certifed to UL 61010-1 and CSA C22.2 No 61010-1 safety standards. Report # 100658629ATL-001A. Page 2

Important Safety Information Plug power cord into a GFI protected receptacle. Do not immerse the unit in water. Do not operate the unit if the cord is damaged or has been exposed to water. Install in accordance with electrical codes. Do not open the air pump unit (electrical hazard). Read this entire manual before operating unit. Always leak test an endoscope in accordance with manufacturer's instructions. Always wear protective personal equipment when handling a dirty endoscope. Ensure that the air hose connector is securely attached to the air pump unit and that the scope leak test connector is fastened securely to the endoscope, and that the toggle switch has been powered on for at least 5 seconds, prior to submerging the endoscope in water. Do not ever power the toggle switch off while the endoscope is submerged in water. Always wait 10 seconds after powering the toggle switch off to release the air from inside the scope before disconnecting the scope leak test connector. Page 3

Mounting Confgurations The following describes the mounting confgurations available for the Automatic Leak Tester. Permanent wall-mounted installation should be performed by trained service personnel. Improper mounting could result in injury or damage to the leak tester. Wall Mount The wall-mount Endoscope Leak Tester will come with a mounting bracket attached to the back of the unit. This bracket may be attached to an appropriate wall as determined by the responsible personnel of the facility. NOTE Consult with responsible personnel for proper location and bracing of the mounting plate in your specific facility. Standard / Table-top The standard Endoscope Leak Tester has rubber bumpers on the bottom of the unit and is intended to be placed on a fat surface. 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 leak tester. 3. Allow the detergent solution to remain on the exterior surfaces of the LT 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 leak tester. 5. Thoroughly dry the surfaces of the LT 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 leak tester. 8. Allow the exterior surfaces of the LT to air dry. Page 4

Automatic Endoscope Leak Tester Getting to know the Automatic Endoscope Leak Tester Air Pump Unit Air Hose Connection Power Supply Power Light On / Off Switch Air Hose Scope Connector Fujinon Scope Connector Olympus Scope Connector Pentax Scope Connector Storz Scope Connector Calibration of Leak Tester This unit is calibrated to produce air pressure between 2.3 to 2.9 PSI or 120 150 mmhg. It is recommended that you send the unit into Zutron Medical annually to be calibrated. Page 5

Automatic Leak Tester Model# ZUTR10003 For wet leak testing Fujinon, Pentax, Olympus, Storz and Wolf flexible endoscopes. 2. 1. Toggle Automatic Leak Tester ON briefly to ensure no fluid is inside the tubing or adapter. After a few seconds toggle OFF. Attach the air hose connector to the air pump unit. 4. 3. Submerge endoscope in water and look for air bubbles that indicate a leak coming from the scope while deflecting the bending section. Attach the scope leak test connector to the endoscope out of the water and then toggle the Automatic Leak Tester ON and wait at least 30 seconds 5. 6. After testing, remove the endoscope from the water and toggle the Automatic Leak Tester to OFF. After toggling off, wait 10 seconds for Automatic Leak Tester to depressurize the endoscope and then detach the scope leak test connector. Zutron Medical's Multi-Enzymatic Cleanser is ideal for use during wet leak testing. The non-foaming, low suds formula reduces the risk of false positive leak tests that can be caused by low foaming enzymatic cleansers. (Order # ZUTR28601) Page 6