INSTRUCTIONS AUTOMATED ENDOSCOPE LEAK TESTER Labels and Symbols 1 Important Information — Please Read Before Use 3 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 ALT-Y0003 Appendix 99
Contents Contents Labels and Symbols .......................................................................................................... 1 Important Information — Please Read Before Use ......................................................... 3 Intended use .......................................................................................................................... Instruction manual .......................................................................................................
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 ................................
Contents Chapter 7 Other Functions .................................................................. 69 7.1 Setting date ............................................................................................................. 69 7.2 Setting time ............................................................................................................. 70 7.3 Performing only self-check ................................................................................... 71 7.
Contents iv 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.
Labels and Symbols 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 CSA/UL marking Indicates to see the instruction manual for the cable to be connected.
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.
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.
Important Information — Please Read Before Use 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.
Important Information — Please Read Before Use 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. WARNING • 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.
Important Information — Please Read Before Use PRECAUTION • Certain endoscopes cannot be leak-tested automatically in this equipment. Refer to the “List of Compatible Endoscopes ” 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).
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.
1.1 Package list Chapter 1 1.1 Checking the Package Contents 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 Stay (×1) Hanger parts (×1) ALT-Y0003 INSTRUCTION MANUAL One-touch rivets (×4) 9 Ch.
1.1 Package list Accessories ALT-Y0003 leak test air tubes (×2) (MAJ-2009) Power cord Scope ID master card Card holders (×2) Instruction manual List of Compatible Endoscopes Ch.
2.1 Front panel Chapter 2 2.1 Nomenclature and Functions Front panel 2 1 Ch.2 10 9 8 7 No. 3 5 Name 6 4 Description 1 RFID reader Reads user IDs and scope IDs into this equipment 2 CONTROL PANEL Used to control and set up this equipment. 3 Tube connector 2 Accepts the ALT-Y0003 leak test air tube 4 Tube connector 2 indicator Blinks when the scope ID has been recognized and then lights when the scope has been connected to the ALT-Y0003 leak test air tube.
2.2 Control panel 2.2 Control panel 3 4 5 2 6 7 1 Ch.2 8 10 No. Name 9 Description 1 User ID indicator Lights up when the user ID is recognized. 2 Endoscope ID indicator Lights up when the scope ID is recognized. 3 LCD monitor Displays the test process and results. 4 MENU button In the standby state, the function menus can be displayed on the LCD monitor by pressing the button.
2.3 Rear panel 2.3 Rear panel 2 1 3 Ch.2 7 6 No. Name 4 5 Description 1 LAN Connector This terminal is provided for future function extension and cannot be used currently. 2 Option terminal Not used. (A terminal only for service persons.) 3 Printer terminal Use the ALT-Y0003 interface cable to connect the printer to this equipment. 4 AC Inlet Accepts AC power supply 5 Fuse box Contains a fuse for this equipment.
2.4 ALT-Y0003 leak test air tube MAJ-2009 2.4 ALT-Y0003 leak test air tube MAJ-2009 1 2 3 Ch.2 4 No. Name Description 1 Endoscope side connector Connected to the venting connector of Olympus endoscope or water-resistant cap. 2 O-ring (Black) Rubber to keep the ALT-Y0003 leak test air tube airtight. 3 Connecting grip Held to connect the ALT-Y0003 leak test air tube to this equipment. 4 Removing grip Held to remove the ALT-Y0003 leak test air tube from this equipment.
2.5 Printer MAJ-1937 (optional) 2.5 Printer MAJ-1937 (optional) Front Panel 3 4 2 1 5 Ch.2 6 9 7 8 No. Name Description 1 ERROR LED Indicates printer errors 2 POWER LED Indicates Power On and Off 3 Paper cover Stores paper under this cover 4 Transparent window to check the printer paper roll Check through this transparent window whether the paper is set or how much it remains 5 Paper cutter Pull the paper toward you to cut paper.
2.5 Printer MAJ-1937 (optional) Rear panel 2 1 Ch.2 No. Name Description 1 IF Connector Accepts the ALT-Y0003 interface cable 2 AC Power Inlet Accepts the exclusive power cord.
2.6 ALT-Y0003 interface cable MAJ-2052 (Optional) 2.6 ALT-Y0003 interface cable MAJ-2052 (Optional) 1 2 Ch.2 No. Name Description 1 Printer side connector Accepts the IF connector of the printer. 2 Equipment side connector Accepts the printer terminal of this equipment. * The ALT-Y0003 interface cable is 1.5 m long.
2.7 Portable memory MAJ-1925 (Optional) 2.7 Portable memory MAJ-1925 (Optional) 2 1 Ch.2 No. Name Description 1 Connector Insert the connector into the Portable memory port. 2 LED The LED is blinking while the endoscopic images, patient data, and setting information are saved or read. 2.8 ALT-Y0003 wall-mount holder (Optional) 1 2 No. Name Description 1 Mounting holes Holes for screws to fix the ALT-Y0003 wall mount holder to a wall. 2 Foot base Accepts the feet of ALT-Y0003.
3.1 Installation of this equipment Chapter 3 3.1 Installation and Connection Installation of this equipment This equipment is not water-proof. Install this equipment referring to the following instillation conditions. Use of the ALT-Y0003 wall-mount holder (MAJ-2020) (Optional) enables you to install this equipment on the wall. To mount this equipment on the wall, refer to Section 3.2, “Installation of the ALT-Y0003 wall-mount holder on the wall” in this instruction manual.
3.1 Installation of this equipment Installation location conditions To ensure safe use of this equipment, be sure to observe the following conditions which are requisite for installation of this equipment. • Place this equipment on a flat location. • The power cord (3 m/9.8 ft) should be able to reach the power outlet. • This equipment should not be exposed to direct sunlight. • The location should be clean and free of dirt or dust. • The ambient temperature should not exceed 40C (104F).
3.2 Installation of the ALT-Y0003 wall-mount holder on the wall 3.2 Installation of the ALT-Y0003 wall-mount holder on the wall For installation of the ALT-Y0003 wall-mount holder on the wall, ask a qualified installation specialist to carry out the installation. Olympus is not liable for any injury or damage which occurs as a result of improper installation or mishandling.
3.2 Installation of the ALT-Y0003 wall-mount holder on the wall PRECAUTION • Do not install the ALT-Y0003 wall-mount holder upside down. This equipment may fall off. • After installing the ALT-Y0003 wall-mount holder on the wall, install this equipment, taking care not to step on the power cord or cables. The power cord or cables may be damaged.
3.2 Installation of the ALT-Y0003 wall-mount holder on the wall 2 Referring to the drawings of Figure 3.1 showing the dimensions and weight of the ALT-Y0003 wall-mount holder, make sure the strength of the wall surface of the four installation positions. If the strength is insufficient, add reinforcement. 304 mm (12.0 in) 152 mm (6.0 in) 38 mm (1.5 in) 204 mm (8.0 in) 10 mm (0.4 in) 26 mm (1.0 in) 119 mm (4.7 in) Screw/bolt holes Diameter: ø 8.0 (4 positions) Ch.3 Weight of the ALT-Y0003: Approx.6.
3.3 Installation of the tube hanger 3.3 Installation of the tube hanger Installing the tube hanger on this equipment enables you to hook the endoscope side connector of the ALT-Y0003 leak test air tube when they are not in use. PRECAUTION Avoid placing anything other than the endoscope side connector of the ALT-Y0003 leak test air tubes on the tube hanger. Otherwise the tube hunger may get damaged. 1 Ch.
3.3 Installation of the tube hanger 2 Align the holes of the stay and the hanger part and insert the one-touch rivets into the holes from the hanger part side (see Figure 3.3). Insert the new one-touch rivets until they hit the surface of hanger part, and secure the stay to the hanger part. (See Figure 3.4) One-touch rivets Figure 3.3 Ch.3 Figure 3.4 3 Align the pins on the rear panel of this equipment with the grooves of the stay.
3.4 Connecting the Power Supply 3.4 Connecting the Power Supply WARNING • Be sure to connect the power plug of the power cord directly to a grounded, hospital grade, wall mains outlet. If this equipment is not grounded properly, it can cause an electric shock and/or fire. • Do not connect the power plug to the 2-pole power circuit with a 3-pole to 2-pole adapter. It can prevent proper grounding and cause an electric shock. • Do not allow the power plug to get wet.
3.5 Connecting the printer 3.5 Connecting the printer Connecting a printer (Optional) to this equipment enables you to print the results of leakage testing of the endoscope. WARNING • Use the ALT-Y0003 interface cable (optional) for this equipment. Using a different interface cable may result in malfunction of this equipment or damage to the interface cable. • Do not wet the ALT-Y0003 interface cable. A wet ALT-Y0003 interface cable may cause an electric shock.
3.5 Connecting the printer 3 Connect the ALT-Y0003 interface cable to the IF connector of the printer. IF connector Printer side connector Figure 3.8 4 Ch.3 Connect the ALT-Y0003 interface cable to the printer terminal of this equipment, and rotate the screws to fix the cable. Printer terminal Equipment side connector Figure 3.
4.1 Installing the ALT-Y0003 leak test air tubes and turning ON the power Chapter 4 Inspection Before Use WARNING Before each use, inspect this equipment as instructed below. Otherwise, this equipment may not work properly. Should the slightest irregularity be observed, do not use this equipment and contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage. 4.
4.1 Installing the ALT-Y0003 leak test air tubes and turning ON the power NOTE • To inform users of the time to replace the internal pump, “Caution Contact Olympus for New Pump” will be lit up on the LCD monitor upon power activation. When this indication is lit up, it is time to replace the pump. Turn OFF the power and contact Olympus. • Disconnect the water-resistant cap from the ALT-Y0003 leak test air tube if connected. Otherwise, a self-check error may occur. Ch.
4.1 Installing the ALT-Y0003 leak test air tubes and turning ON the power 6 7 8 When using the printer, turn ON the power switch of the printer. Turn ON the power switch of this equipment. The power indicator will turn ON. The startup screen and the connection status of the printer will be displayed on the LCD monitor. (See Table 4.1) Indicator 1.;/275 #.6 ; #WVQ 2TKPV &KUCDNGF 1.;/275 #.6 ; #WVQ 2TKPV #EVKXCVGF 2TKPVGT 10 1.;/275 #.
4.2 Self-check 4.2 Self-check The self-check is performed to inspect for leakage within the channel and examine whether the pump or valves works properly. This self-check is automatically performed when the power is turned ON, but it can be also manually performed when necessary. For the manual self-check, refer to Section 7.3, “Performing only self-check”. PRECAUTION • Do not apply excessive force on the ALT-Y0003 leak test air tubes by forcibly bending them or placing anything on it.
4.2 Self-check 3 When using this equipment for the first time, set the date and time according to Section 7.1, “Setting date” and Section 7.2, “Setting time”. 4 Turn OFF this equipment. If the error code [E112] is displayed during self-check If the error code [E112] is displayed in the self-check, make sure the connection between this equipment and this equipment side connector of the ALT-Y0003 leak test air tube is proper.
4.3 Checking the printer paper roll 4.3 Checking the printer paper roll PRECAUTION Do not start printing if the printer paper roll is incorrectly installed. Otherwise, the printer paper roll may jam and/or printing may fail. Make sure that the printer paper roll has been installed in this equipment. If not, replace the printer paper roll according to Section 6.4, “Installing the printer paper roll”. Transparent window to check the printer paper roll Ch.4 Figure 4.
5.1 Precautions for operation Chapter 5 Operation This chapter explains how to perform a leakage test of the endoscope with this equipment. 5.1 Precautions for operation WARNING • Be sure to wear protective equipment such as protective eye wear, face mask, moisture-resistant gloves that fit properly and are long enough so that your skin is not exposed. Otherwise, dangerous chemicals and/or potentially infectious material such as blood and/or mucus of the patient may cause an infection.
5.1 Precautions for operation NOTE • To perform a leakage test in this equipment, an endoscope must be of a type with a built-in Scope ID or have a Scope ID tag. In addition, a USER ID card is required. • This equipment can be stopped at any time during operation by pressing the STOP/BACK button. When a process is interrupted, be sure to execute it again from the beginning. Ch.
5.2 Operation workflow 5.2 Operation workflow The chart below shows the leakage test work flow. Review and understand each step before use to obtain an accurate leakage test result. 1 Prepare equipment before use 2 Turn the power ON 3 Have the scope ID recognized 4 Connect the ALT-Y0003 leak test air tube with the endoscope 5 Have the user ID recognized 6 Section 5.3 on page 38 Section 5.4 on page 39 Section 5.5 on page 40 Section 5.6 on page 44 Ch.5 Section 5.
5.3 Preparation before use 5.3 Preparation before use PRECAUTION Use a basin deep enough to allow complete immersion of the endoscope and large enough for the insertion section of the endoscope and the universal cord to be coiled into a diameter of 17 cm or over. If the insertion section or universal cord is coiled into a smaller diameter, the leakage testing may not be conducted properly. Prepare equipment as shown below.
5.4 Power activation 5.4 Power activation NOTE • When the printer is used, turn ON the printer before turning ON this equipment. • For indicators on the printer after power activation, refer to Table 4.1 in Section 4.1, “Installing the ALT-Y0003 leak test air tubes and turning ON the power”. 1 Confirm that ALT-Y0003 leak test air tubes are surely connected to Tube connector 1 and 2 of this equipment.
5.5 Recognition of scope ID 5.5 Recognition of scope ID To keep an endoscopic leak test log, have this equipment recognize the individual scope ID that identifies the endoscope to be tested. PRECAUTION • Have this equipment recognize the scope ID of the endoscopes to be leak-tested. Otherwise, the leakage testing can not be recorded properly. • Do not bang the scope ID tag or scope connector onto the RFID reader during scope ID recognition.
5.5 Recognition of scope ID 1 Confirm that ALT-Y0003 leak test air tubes are surely connected to Tube connector 1 and 2 of this equipment. Also confirm that an endoscope or no water resistance caps are connected to the endoscope connectors of ALT-Y0003 leak test air tubes.
5.5 Recognition of scope ID 4 Check that the Tube connector 1 indicator is blinking. Connect an endoscope to the ALT-Y0003 leak test air tube connected to Tube connector 1 according to the instruction described in Section 5.6, “Connecting ALT-Y0003 leak test air tubes and endoscope”. NOTE The error code [E122] is displayed when, in the step 4 above, an endoscope is connected to the ALT-Y0003 leak test air tube that has been connected to Tube connector 2.
5.5 Recognition of scope ID The LCD monitor indicators change as shown in Figure 5.6 below when the ID is entered or when the endoscope is connected. 5ECP 5EQRG +& ޓޓޓޓ1T 7UGT +& =/'07?)Q VQ /GPW (a) Standby screen (Waiting for ID entry) Recognition of Scope ID (of a first endoscope) %QPPGEV 5EQRG )+( ::: Endoscope Code No./Serial No.
5.6 Connecting ALT-Y0003 leak test air tubes and endoscope 5.6 Connecting ALT-Y0003 leak test air tubes and endoscope Set the endoscope for automated leak testing and connect it to the ALT-Y0003 leak test air tube. PRECAUTION • Be sure to confirm that the basin does not contain any water or a disinfectant solution before filling the basin with water. If there is any pin hole in the endoscope, the fluid may enter the endoscope, resulting in malfunction of the endoscope.
5.6 Connecting ALT-Y0003 leak test air tubes and endoscope 1 2 Confirm that the basin does not contain any water or disinfectant solution. 3 Visually check that there is no water drop, dust, dirt, nor stain inside the endoscope connector of the ALT-Y0003 leak test air tube and outside the venting connector of either endoscope or water-resistant cap. 4 Turn the endoscope connector of the ALT-Y0003 leak test air tube clockwise until it stops, pushing it to the venting connector as shown in Figure 5.7.
5.7 Recognition of user ID 5.7 Recognition of user ID To keep an endoscope leak test log, have this equipment recognize the individual User ID that identifies the reprocessing operator. NOTE • The START button on the main control panel does not function unless the User ID has been recognized. • For addition or re-issue of the user ID card, contact Olympus.
5.8 Automated leakage testing 5.8 Automated leakage testing This equipment features the following functions for the automated leakage testing: • This equipment can perform a leakage test in air in an ALT; you do not need to store water in the basin. • This equipment performs automatic leakage testing of the endoscope. • This equipment can store the records of leakage testing.
