Olympus ALT-Y0003 User Manual
INSTRUCTIONS
Labels and Symbols 1
Important Information — Please Read Before
Use 3
AUTOMATED ENDOSCOPE LEAK TESTER
ALT-Y0003
Summary of Functions of this Equipment 8
Chapter 1 Checking the Package Contents 9
Chapter 2 Nomenclature and Functions 11
Chapter 3 Installation and Connection 19
Chapter 4 Inspection Before Use 29
Chapter 5 Operation 35
Chapter 6 Routine Maintenance 57
Chapter 7 Other Functions 69
Chapter 8 Troubleshooting 93
Appendix 99
Contents
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 3
Intended use .......................................................................................................................... 3
Instruction manual ................................................................................................................. 3
User qualifications ................................................................................................................. 4
Equipment compatibility ......................................................................................................... 4
Care and storage ................................................................................................................... 5
Maintenance and inspection .................................................................................................. 5
Repair and modification ......................................................................................................... 5
Disposal of this equipment .................................................................................................... 5
Signal words .......................................................................................................................... 5
Warnings and precautions ..................................................................................................... 6
Summary of Functions of this Equipment ...................................................................... 8
Chapter 1 Checking the Package Contents ......................................... 9
1.1 Package list ............................................................................................................... 9
Chapter 2 Nomenclature and Functions ............................................ 11
2.1 Front panel .............................................................................................................. 11
2.2 Control panel .......................................................................................................... 12
2.3 Rear panel ............................................................................................................... 13
2.4 ALT-Y0003 leak test air tube MAJ-2009 ................................................................ 14
2.5 Printer MAJ-1937 (optional) ................................................................................... 15
2.6 ALT-Y0003 interface cable MAJ-2052 (Optional) ................................................. 17
2.7 Portable memory MAJ-1925 (Optional) ................................................................ 18
2.8 ALT-Y0003 wall-mount holder (Optional) ............................................................. 18
Chapter 3 Installation and Connection ............................................... 19
3.1 Installation of this equipment ................................................................................ 19
3.2 Installation of the ALT-Y0003 wall-mount holder on the wall ............................. 21
3.3 Installation of the tube hanger .............................................................................. 24
3.4 Connecting the Power Supply .............................................................................. 26
3.5 Connecting the printer ........................................................................................... 27
ALT-Y0003 INSTRUCTION MANUAL
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Contents
Chapter 4 Inspection Before Use ........................................................ 29
4.1 Installing the ALT-Y0003 leak test air tubes and turning ON the power ............ 29
4.2 Self-check ................................................................................................................ 32
If the error code [E112] is displayed during self-check ........................................................ 33
4.3 Checking the printer paper roll ............................................................................. 34
Chapter 5 Operation ............................................................................. 35
5.1 Precautions for operation ...................................................................................... 35
5.2 Operation workflow ................................................................................................ 37
5.3 Preparation before use ........................................................................................... 38
5.4 Power activation ..................................................................................................... 39
5.5 Recognition of scope ID ........................................................................................ 40
5.6 Connecting ALT-Y0003 leak test air tubes and endoscope ................................ 44
5.7 Recognition of user ID ........................................................................................... 46
5.8 Automated leakage testing .................................................................................... 47
The results in the automated leakage testing are all PASS: ................................................ 50
If the result of leakage testing for at least one endoscope is FAIL ...................................... 51
5.9 Manual leakage testing .......................................................................................... 52
Chapter 6 Routine Maintenance .......................................................... 57
6.1 Summary ................................................................................................................. 57
6.2 Care of ALT-Y0003 leak test air tubes ................................................................... 58
When any debris remains on the surface ............................................................................ 59
When no debris remains on the surface .............................................................................. 60
6.3 Turning power OFF and cleaning outer surface .................................................. 61
6.4 Installing the printer paper roll .............................................................................. 62
6.5 Replacing the fuse .................................................................................................. 65
6.6 Storage .................................................................................................................... 67
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ALT-Y0003 INSTRUCTION MANUAL
Contents
Chapter 7 Other Functions .................................................................. 69
7.1 Setting date ............................................................................................................. 69
7.2 Setting time ............................................................................................................. 70
7.3 Performing only self-check ................................................................................... 71
7.4 Setting automated leakage test mode .................................................................. 72
7.5 Setting print mode .................................................................................................. 74
Manual printing .................................................................................................................... 75
Auto Print ............................................................................................................................. 80
When the error code [E094] is displayed during printing ..................................................... 81
7.6 Data display ............................................................................................................ 82
Leak Test Log Display ......................................................................................................... 82
Error Log Display ................................................................................................................. 84
7.7 Download to a portable memory ........................................................................... 85
Downloading data ................................................................................................................ 87
Formatting the portable memory .......................................................................................... 89
7.8 Management of portable memory data in personal computer ........................... 90
Folder structure ................................................................................................................... 91
Chapter 8 Troubleshooting .................................................................. 93
8.1 Troubleshooting guide ........................................................................................... 93
8.2 Return of this equipment for repair ...................................................................... 98
Appendix ................................................................................................. 99
Compatible equipments .................................................................................................. 99
System chart ........................................................................................................................ 99
Specification .................................................................................................................. 101
Environment ...................................................................................................................... 101
Specifications ..................................................................................................................... 101
EMC information ............................................................................................................ 103
ALT-Y0003 INSTRUCTION MANUAL
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Contents
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ALT-Y0003 INSTRUCTION MANUAL
Labels and Symbols
Labels and Symbols
The meaning(s) of the symbol(s) shown on the component packaging, the back cover of this instruction
manual and/or this equipment are as follows:
Symbol Description
Refer to instructions.
Serial number
Manufacturer
Authorized representative in the European Community
ALT-Y0003 INSTRUCTION MANUAL
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Labels and Symbols
Manufacturer name
RFID marking
Fuse rating
Serial number plate
Indicates to see the instruction
manual for the cable to be
connected.
AUTOMATED ENDOSCOPE LEAK TESTER
MODEL ALT-Y0003
POWER INPUT 100–120 V 50/60 Hz 45 VA
Electric rating
CSA/UL marking
Safety-related labels and symbols are attached to this equipment at the locations shown below. If
labels or symbols are missing or illegible, contact Olympus.
Rear panel
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ALT-Y0003 INSTRUCTION MANUAL
Important Information — Please Read Before Use
Important Information — Please Read Before Use
Intended use
This equipment is intended to be used to perform and record leakage testing on Olympus flexible
endoscopes. Do not use this AUTOMATED ENDOSCOPE LEAK TESTER for any purpose other than
its intended use.
Instruction manual
This instruction manual contains essential information on using this AUTOMATED ENDOSCOPE
LEAK TESTER (hereinafter referred to as “this equipment”) safely and effectively. Before use,
thoroughly review this manual and the manuals of all equipment which will be used during the
procedure, and use all equipment as instructed.
Keep this and all related instruction manuals in a safe, accessible location.
If you have any questions or comments about any information in this manual, please contact Olympus.
Terms used in this manual
Leakage Test
A leakage test can detect a pin hole in the external surface of the endoscope and/or
internal working channel wall, and any other leak-related damage.
When the endoscope is immersed in a liquid for cleaning and disinfection, the liquid may
go into the endoscope through a pin hole or other damaged area, resulting in malfunction
of electrical components inside the endoscope. Detecting such a pin hole and damaged
area before liquid immersion of the endoscope can prevent potential damage of the
endoscope caused by the entry of the liquid into the endoscope.
Process
A general term for the leakage testing, self-check, and other operations this Equipment
performs.
Portable Memory
Olympus-designated USB memory: This recording medium is used in combination with
this equipment to save leakage test data stored in the internal memory of this equipment.
Master data
These are unedited leak test log data and error log data copied to personal computers.
ALT-Y0003 INSTRUCTION MANUAL
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Important Information — Please Read Before Use
CSV file format
This is one data format most frequently used by statistical processing software. Each
item of data (record) is accommodated in a single line, in which each item is delimited
by “,” (a comma). This data is useful when executing statistical processing using
commercially available statistical processing software.
Wall mains outlet:
A three-pin outlet having an exclusive terminal for grounding.
Error Code
A code consisting of [E] and a three-digit number is displayed on the LCD monitor, if there
is a problem with this equipment. When an error code is displayed, check the error code
list to find out what corrective measures to take.
User qualifications
The operator of this equipment must be sufficiently trained in reprocessing of endoscopes. The
medical literature reports cases of infections due to inappropriate cleaning, disinfection, and /or
sterilization. Thoroughly review and understand the following items before use:
Cleaning, disinfection, and sterilization procedures described in the instruction manuals for
the endoscope and ancillary equipment
Professional health and safety standards
Applicable guidelines on cleaning, disinfection, and sterilization of endoscopy equipment.
Structure and handling of endoscopic equipment
Personal protective equipment requirements to minimize exposure to chemicals and
infectious materials.
This manual does not explain or discuss details of cleaning, disinfection, and sterilization.
Equipment compatibility
Use this equipment in combination with ancillary equipment listed in System Chart in Appendix. Using
incompatible equipment can result in patient or operator injury and equipment damage and/or
malfunction. Refer to the “List of Compatible Endoscopes <ALT-Y0003>” for compatible types of
endoscope.
Do not use this equipment in combination with non-Olympus endoscopes; Olympus has not tested the
efficacy of detecting leakage with this equipment other than those combinations designated.
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ALT-Y0003 INSTRUCTION MANUAL
Important Information — Please Read Before Use
WARNING
PRECAUTION
NOTE
Care and storage
After use, reprocess and store this equipment referring to the instructions in Chapter 6, “Routine
Maintenance” in this manual. Inappropriate care and storage could present an infection control risk
and/or cause equipment damage or malfunction.
Maintenance and inspection
The ALT-Y0003 requires routine maintenance and inspection. In addition to checks before use, the
person in charge of maintenance and administration of the medical equipment at the hospital should
periodically check all of the items described in this manual. If any irregularity is observed, do not use
this equipment and follow the procedure as described in Section 8.1, “Troubleshooting guide”. If the
irregularity still presents, this equipment needs repairing. Contact Olympus.
Repair and modification
Do not disassemble, modify or attempt to repair this equipment and its accessories. Doing so could
result in operator or patient injury and/or equipment damage or malfunction. Some problems that
appear to be malfunctions may be corrected by referring to Section 8.1, “Troubleshooting guide”. If the
problem persists, do not use this equipment and contact Olympus.
Disposal of this equipment
Follow all applicable national and local guidelines in disposing of this equipment.
Signal words
The following signal words are used throughout this manual:
Describes serious adverse reactions and potential safety hazards, limitations
in use imposed by them, and steps that should be taken if they occur.
Includes information regarding any special care to be exercised by the
practitioner and/or patient for the safe and effective use of the device.
Indicates additional helpful information.
ALT-Y0003 INSTRUCTION MANUAL
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Important Information — Please Read Before Use
WARNING
Warnings and precautions
Follow the warnings and precautions given below when handling this equipment. This information is
supplemented by the warnings given in each chapter.
• Strictly observe the following precautions. Failure to do so may place the patient
and medical personnel in danger of an electric shock.
Keep fluids away from all electrical equipments. If fluids are spilled on or into
this equipment, stop operation immediately and contact Olympus.
Do not prepare, inspect, or use this equipment with wet hand
• Do not install this equipment in any place where any of the following are present.
High oxygen concentration.
Oxidizing substance such as Nitrous Oxide (N
Flammable anesthetic gas
Flammable liquid
This equipment is not explosion-proof and may explode or cause fire under these
conditions.
• Do not insert an EndoTherapy accessory or other object through an opening
including the air vents of this equipment. Also, do not allow any liquid including
water or disinfectant solution to flow into the opening. Contact with an electrical part
inside this equipment could cause an electric shock and/or malfunction of this
equipment.
• This equipment may interfere with other medical electronic equipment used in
combination with it. Before use, refer to the Appendix to confirm the compatibility of
this equipment with all equipment to be used.
• Always use the Power cord provided with this equipment. Otherwise, equipment
failure or Power cord burnout could result. Also, remember that the provided Power
cord is for exclusive use with this equipment and should not be used with other
equipment.
• Do not bend, pull or twist the power cord. Electric shock, equipment damage, or fire
can result.
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O).
6
• This equipment can be set up to use the RFID (Radio Frequency Identification)
function. Please be aware that the radio waves emitted from the RFID antenna of
this equipment may cause medical equipments such as pacemakers to
malfunction. If any interference with this equipment is observed, immediately move
away from the RFID antenna or set the power switch to OFF. Call your doctor if you
do not begin to feel better.
ALT-Y0003 INSTRUCTION MANUAL
Important Information — Please Read Before Use
PRECAUTION
• Certain endoscopes cannot be leak-tested automatically in this equipment. Refer to
the “List of Compatible Endoscopes <ALT-Y0003>” provided with this equipment.
• Do not use this equipment in any place where it may be subject to strong
electromagnetic radiation (for example, in the vicinity of a microwave therapeutic
equipment, short wave medical treatment equipment, MRI, and cellular/portable
phone, etc). Doing so may result in malfunction of this equipment.
• Do not press the buttons on the front panel of this equipment with a sharp or hard
object. Doing so may damage the buttons.
• Avoid applying excessive force to the connectors, as this may damage this
equipment.
• Do not use this equipment in a dusty environment. Otherwise, damage and/or
malfunction can occur.
• Be sure that this equipment is not used adjacent to other equipments (other than
the components of this equipment or system) to avoid electromagnetic
interference.
• Be sure that this equipment is not used adjacent to or stacked with other
equipment. An external force applied to this equipment may result in damage and
deformation.
• This equipment emits RF (Radio Frequency) energy to perform intended functions.
Therefore, it may cause electromagnetic interference in nearby electronic
equipment, and is labeled with the following symbol. If electromagnetic interference
occurs, mitigation measures may be necessary, such as moving the electronic
equipment away, reorienting or relocating this instrument, or shielding the location.
ALT-Y0003 INSTRUCTION MANUAL
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Summary of Functions of this Equipment
Summary of Functions of this Equipment
Automated Leakage Testing (ALT)
This equipment feeds air into the endoscope and computes changed air pressure to check
automatically for a pin hole of the endoscope. The Automated Leakage Testing is performed in
air, not in water.
See Section 5.8, “Automated leakage testing”.
Manual Leakage Testing (MLT)
This equipment feeds air into the endoscope to visually check for any bubble emerging from the
endoscope in water.
See Section 5.9, “Manual leakage testing”.
Self-check
This equipment has a self-check function to verify that it is working properly.
See Section 4.2, “Self-check”.
Printing
The results of leakage tests and self-checks and the records of errors can be printed from a
connected printer.
See Section 7.5, “Setting print mode”.
Data download
The results of leakage tests and self-checks and the records of errors can be downloaded to a
portable memory.
See Section 7.7, “Download to a portable memory”.
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ALT-Y0003 INSTRUCTION MANUAL
1.1 Package list
Chapter 1 Checking the Package
Contents
1.1 Package list
Match all items in the package with the components shown below. Inspect each item for damage. If this
equipment is damaged, a component is missing, or you have any questions, do not use this
equipment; immediately contact Olympus.
AUTOMATED ENDOSCOPE LEAK TESTER
AUTOMATED ENDOSCOPE LEAK TESTER (ALT-Y0003)
Tube hanger
Ch.1
Stay (×1) Hanger parts (×1) One-touch rivets (×4)
ALT-Y0003 INSTRUCTION MANUAL
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1.1 Package list
Accessories
Ch.1
ALT-Y0003 leak test air tubes (×2)
(MAJ-2009)
Scope ID master card Card holders (×2)
Instruction manual List of Compatible Endoscopes
Power cord User ID master card
<for ALT-Y0003>
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ALT-Y0003 INSTRUCTION MANUAL
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