OFP IRRIGATION TUBE Instructions for Use

Steam Sterilization (Autoclaving) Use biological indicators as recommended by your hospital's policy and follow the sterilizer manufacturer's instructions, plus any relevant national and local hospital guidelines and policies. Such guidelines include AAMI TIR12:1994 and ANSI/AAMI ST79:2006 (USA), EN 285:2006 and HTM 2010:1994 (Europe). Olympus has validated the efficacy of steam sterilization (autoclaving) in a pre-vacuum sterilizer at the temperatures and durations in the table below. Always leave space between the packages in the autoclave. If packages are placed too close together, effective sterilization may be compromised. Allow the packages to dry within the autoclave using the autoclave's drying cycle (if applicable) or by opening the door of the autoclave and allowing the packages to air dry. Handling a wet package can compromise its sterility. For details on operation of the autoclave, refer to the instruction manual for the autoclave. Typical parameters for pre-vacuum autoclaves for wrapped instruments, according to national guidelines/standards: Minimum Hold Temperature 121-124°C 126-129°C 132°C 134-137°C

Exposure Time 15 mins 10 mins 4 mins 3 mins

Guideline/Standard Reference EN 285: 2006, HTM 2010:1994 EN 285: 2006, HTM 2010:1994 ANSI/AAMI ST79:2006 ANSI/AAMI ST79:2006, EN 285:2006, HTM 2010:1994

Do not exceed a temperature of 137°C during autoclaving, otherwise equipment damage or accelerated deterioration may result. The items included with the OFP that are designated as 'autoclavable' may be sterilized using 'flash' steam sterilization cycles utilized for sterilizing unwrapped instruments in emergency situations. Olympus recommends gradual air cooling after a flash cycle - use of liquids for rapid cooling could result in equipment damage or accelerated deterioration. The US Association of Operating Room Nurses (AORN) and the US Association for the Advancement of Medical Instrumentation (AAMI) caution that flash-sterilized items must be used immediately, since sterility assurance of unwrapped items cannot be maintained.

Operating Precautions The irrigation tube and filter MUST be autoclaved before use and MUST be discarded at the end of the day of use. Failure to do so may lead to patient infection and a reduction in equipment performance. A colour change in the irrigation tubing is normal after autoclaving, this will not affect performance and will recover if left to rest. Check the “use by” date of the tubing as indicated on the packaging label. Do not use any tubes beyond the specified “use by” date. Only use the Olympus connecting tube MAJ-855 and irrigation tube supplied to connect the OFP to the endoscope, otherwise patient safety may be compromised or damage to the pump may occur. Note that the luer lock connector on the MAJ-855 which attaches to the OFP filter includes a oneway valve to prevent backflow - do NOT use the MAJ-855 without this connector in place, or pump contamination and damage may result. Ensure the OFP is disconnected from the power supply before installation or removal of the irrigation tube. Ensure the tube is threaded correctly in the pump head to prevent pinching and damaging the tube. Always ensure the filter is fitted in-line to maintain pump performance and safety. Disconnecting the irrigation tube below the level of the fluid container may result in fluid siphoning from the container. When the irrigation tube has been correctly installed and the pump operated, do not disturb the position of the irrigation tube eg: by opening the pump head, otherwise the irrigation tube must be replaced. Failure to do so may lead to a reduction in equipment performance. Should the OFP be operated with a blocked endoscope or filter, damage to the irrigation tube may occur. In this event, care must be taken when disconnecting the fluid path as the system may be pressurised. To depressurise the system, the pump head should be opened to allow fluid back into the bottle, this must only be carried out with the endoscope removed from the patient. The irrigation tube must be replaced before the unit is reused. If the filter becomes blocked or the irrigation tube from the pump to the fluid container is blocked or kinked, the flow rate will be noticeably reduced. Check the tube for kinks or blockages and the filter for contamination, replace if necessary. Use only in conjunction with Olympus Exera series endoscopes and MAJ-855. Use only sterile water in conjunction with the OFP during operation. Use of irrigation fluid other than sterile water may cause an infection risk to the patient.

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Issue 14 May 2010

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