5.10 Maintenance
Inspection.
• Visually inspect all parts. If necessary, clean them again. Instruments should be treated with lubricants in every reprocessing cycle to maintain their function and to protect them from corrosion and aging.
Lubricants.
• Different sterilization processes require different kinds of lubricants. If required, contact the manufacturer of the sterilization device.
Olympus distributes two lubricants:
-Grease for stopcock (O0170)
-Oil for metal parts and sealings (A0273)
CAUTION!
Decrease of Image Quality.
Apply all lubricants sparingly. Make sure that the telescopes’ objective or ocular windows are not smudged with lubricant. Lubricants on objective or ocular windows considerably decrease viewability and image quality.
Moving Metal Parts.
Lubricate moving metal parts in joints or attachment devices.
• Apply a drop of oil to all parts to be lubricated.
• Use a cotton pad to remove excess oil.
Stopcocks.
Olympus instruments are equipped with two different stopcocks:
1) Dismantable stopcocks (featuring a knurled nut)
2) Maintenance-free stopcocks (not featuring a knurled nut)
Dismantable Stopcocks.
Each time after using an instrument with dismantable stopcock, do the following:
• Detach the knurled nut on the cock plug.
• Remove the cock plug.
• Thoroughly clean all components.
• Lightly grease the cock plug with stopcock grease (cat. no. O0170).
• Reinsert the cock plug.
• Fasten the knurled nut.
• Reprocess and store assembled dismantable stopcocks in opened condition.
Maintenance-Free Stopcocks.
Do not disassemble maintenance-free stopcocks.
Do not grease maintenance-free stopcocks. Reprocess and store maintenance-free stopcocks in opened condition.
5.11 Steam Sterilization
If possible, Olympus recommends using fractionated prevacuum steam sterilization. Steam sterilization with prevacuum has been validated for its germicidal effectiveness with most of the Olympus endoscopes and accessories. Refer to the product-specific instruction manual for compatibility with steam sterilization.
Prior Cleaning.
Endoscopic instrumentation must be meticulously cleaned prior to sterilization. Thorough cleaning removes both microorganisms and organic material. Failure to remove organic material decreases effectiveness of the sterilization process. After cleaning, make sure that the instrument is carefully dried.
Steam Sterilization Procedure.
• Disassemble the instrumentation. Refer to the product-specific instruction manual for instruments which can be assembled before steam sterilization. For some products, reprocessing cards are available that also provide information on disassembly.
• Openallstopcocks.
• Place the instruments in appropriate instrument trays or pouches (for Olympus instrument trays, see the “Storage and Handling” section). Wrap or seal them adequately. Do not seal the instruments in close contact with each other as this might impair sterilization.
• Refer to the autoclave’s instruction manual.
• Use only prevacuum autoclave cycles to ensure that steam fills all lumens.
• After steam sterilization, let the instrument cool down gradually to room temperature without additional cooling. Sudden changes in temperature may damage the Instruments.Never rinse the instruments with cold water for cooling. Be careful when unloading the autoclave, the contents may be hot.
• Make sure that the sterile package of the instruments is not damaged. If the package has been perforated, if the sealing has been opened, if the packaging is wet or if the packaging is damaged in any other way, resterilize the instruments.
Steam Sterilization Conditions.
Olympus recommends to autoclave the instruments as follows:
Cycle................Temperature..............Exposure Time
Fractionated prevacuum .......134 .C....................... 5 min.
Other autoclaving parameters are:
Cycle................Temperature..............Exposure Time
Pre-vacuum......132 .C (270 .F)........ 4 minutes
Pre-vacuum......135 .C (275 .F)........ 3 minutes
Autoclavable Olympus products are designed for steam sterilization according to the following standards (in their respective latest approved version):
-US standard ANSI/AMMI ST46
-British standard BS 3970 and HTM-2010
-European standard EN 285
CAUTION!
Risk of Instrument Damage.
Do not exceed a temperature of 138 .C. Otherwise, instrument damage may occur.
Proposed water and steam quality acc. to EN 285 .............................................. Condensate..........Feed-water Coke residues......................................................... 10 mg/l
SiO.......................................... 0.1 mg/kg................ 1 mg/l
Fe...........................................0.1 mg/kg............. 0.2 mg/l
Cd ....................................... 0.005 mg/kg......... 0.005 mg/l
Pb.......................................... 0.05 mg/kg........... 0.05 mg/l
Traces of heavy metals (except Fe, Cd, Pb) ................. 0.1 mg/kg............. 0.1 mg/l
Cl. ........................................... 0.1 mg/kg................ 2 mg/l
P.O. ........................................ 0.1 mg/kg............. 0.5 mg/l
Conductivity (at 25 .C) ............ . 3 .S/cm........... . 5 .S/cm
pH ...................................................... 5–7...................5–7.5
Appearance.............................. colourless............colourless clear....................clear without residues..
without residues Water hardness (total alkaline earth ions)...... 0.02 mmol/l...... . 0.02 mmol/l
Example for fractionated prevacuum steam sterilization
1. Evacuation
2. Steaming and evacuation 2x
3. Heating
4. Sterilization
5. Evacuation
6. Drying
7. Aeration
NOTE!
Use of Instrument Trays.
-Do not stack the instrument trays or load them on their side edges during steam sterilization.
-For steam sterilization, Olympus recommends a drying time of at least 15–30 minutes. Choose an appropriate drying time, depending on the specific steam sterilization unit in your facility.
-Users may want to consider the use of appropriate, lint-free absorbing cloth.
5.12 Gas Sterilization
Prior Cleaning.
Endoscopic instrumentation must be meticulously cleaned prior to sterilization. Thorough cleaning removes both microorganisms and organic material. Failure to remove organic material decreases the effectiveness of the sterilization procedure. The information given in this section describes the instrument’s material compatibility. It does not describe the efficacy of the procedure on the instruments.
Gas Sterilization Procedure.
• Disassemble the instruments according to the instructions provided in the product-specific instruction manual and the Olympus Endoscopy System Guide (this manual).
• Open all stopcocks.
• Place the instruments in appropriate instrument trays or pouches (for Olympus instrument trays, see “Storage and Handling” section).
• Refer to the sterilizer’s instruction manual.
• Aerate the instruments sufficiently.
Conditions for Ethylene Oxide Gas Sterilization.
Refer to ANSI/AAMI ST41 or DIN 58 948 for
recommendations and standards.
Do not exceed the parameters outlined in the chart below.
Gas concentration........................................ 600–700 mg/l
Temperature.............................................. 55 .C (130 .F)
Pressure....................................0.1–0.17 MPa (16–24 psi)
Humidity.....................................................................55 %
Exposure time............................................................> 2 h
Aeration cycle at room temperature ...........................................7 days in an aeration chamber.....................12 h at 50–60 .C (122–135 .F) Conditions for Low Temperature Steam and Formaldehyde Gas Sterilization (LTSF). Refer to EN 14180 or DIN 58 948-16.
Do not exceed the parameters outlined in the chart below.
Gas concentration....................................................2–6 %
Temperature.............................................. 60 .C (135 .F)
Pressure........................................max. 0.17 MPa (24 psi)
Humidity..................................................................> 70 %
Exposure time..........................................................> 1 hr.
WARNING!
Gas Sterilization is Toxic.
Ethylene oxide and formaldehyde are toxic and may present health hazards. Follow domestic health care regulations for compatibility of the processes. After sterilizing the instruments, aerate them to remove toxic residues.
WARNING!
Infection Control Risk.
Thoroughly clean and dry the instruments before gas sterilization. Residual water may inhibit sterilization.
5.13 Other Sterilization Processes
Prior Cleaning.
Endoscopic instrumentation must be meticulously cleaned prior to sterilization. Thorough cleaning removes both microorganisms and organic material. Failure to remove organic material decreases the effectiveness of the sterilization process. The information given in this section describes the instrument’s material compatibility. It does not describe the efficacy of the specified process.
STERRAD. Low Temperature Plasma Sterilization Process.
• For sterilization, disassemble the instrumentation according to the instructions provided in the product-specific instruction manual and the Olympus Endoscopy
System Guide (this manual).
• Open all stopcocks.
• Certain instruments with long narrow lumen might require boosters during sterilization. The use of boosters is not allowed in every country. For details, refer to the sterilizer’s instruction manual.
• Place the instruments in sterilizing pouches or containers (any container/pouches must be certified by its manufacturer for STERRAD. use).
• Refer to the sterilizer’s instruction manual.
NOTE!
Different STERRAD systems with diffe
5.10 Maintenance
Inspection.
• Visually inspect all parts. If necessary, clean them again. Instruments should be treated with lubricants in every reprocessing cycle to maintain their function and to protect them from corrosion and aging.
Lubricants.
• Different sterilization processes require different kinds of lubricants. If required, contact the manufacturer of the sterilization device.
Olympus distributes two lubricants:
-Grease for stopcock (O0170)
-Oil for metal parts and sealings (A0273)
CAUTION!
Decrease of Image Quality.
Apply all lubricants sparingly. Make sure that the telescopes’ objective or ocular windows are not smudged with lubricant. Lubricants on objective or ocular windows considerably decrease viewability and image quality.
Moving Metal Parts.
Lubricate moving metal parts in joints or attachment devices.
• Apply a drop of oil to all parts to be lubricated.
• Use a cotton pad to remove excess oil.
Stopcocks.
Olympus instruments are equipped with two different stopcocks:
1) Dismantable stopcocks (featuring a knurled nut)
2) Maintenance-free stopcocks (not featuring a knurled nut)
Dismantable Stopcocks.
Each time after using an instrument with dismantable stopcock, do the following:
• Detach the knurled nut on the cock plug.
• Remove the cock plug.
• Thoroughly clean all components.
• Lightly grease the cock plug with stopcock grease (cat. no. O0170).
• Reinsert the cock plug.
• Fasten the knurled nut.
• Reprocess and store assembled dismantable stopcocks in opened condition.
Maintenance-Free Stopcocks.
Do not disassemble maintenance-free stopcocks.
Do not grease maintenance-free stopcocks. Reprocess and store maintenance-free stopcocks in opened condition.
5.11 Steam Sterilization
If possible, Olympus recommends using fractionated prevacuum steam sterilization. Steam sterilization with prevacuum has been validated for its germicidal effectiveness with most of the Olympus endoscopes and accessories. Refer to the product-specific instruction manual for compatibility with steam sterilization.
Prior Cleaning.
Endoscopic instrumentation must be meticulously cleaned prior to sterilization. Thorough cleaning removes both microorganisms and organic material. Failure to remove organic material decreases effectiveness of the sterilization process. After cleaning, make sure that the instrument is carefully dried.
Steam Sterilization Procedure.
• Disassemble the instrumentation. Refer to the product-specific instruction manual for instruments which can be assembled before steam sterilization. For some products, reprocessing cards are available that also provide information on disassembly.
• Openallstopcocks.
• Place the instruments in appropriate instrument trays or pouches (for Olympus instrument trays, see the “Storage and Handling” section). Wrap or seal them adequately. Do not seal the instruments in close contact with each other as this might impair sterilization.
• Refer to the autoclave’s instruction manual.
• Use only prevacuum autoclave cycles to ensure that steam fills all lumens.
• After steam sterilization, let the instrument cool down gradually to room temperature without additional cooling. Sudden changes in temperature may damage the Instruments.Never rinse the instruments with cold water for cooling. Be careful when unloading the autoclave, the contents may be hot.
• Make sure that the sterile package of the instruments is not damaged. If the package has been perforated, if the sealing has been opened, if the packaging is wet or if the packaging is damaged in any other way, resterilize the instruments.
Steam Sterilization Conditions.
Olympus recommends to autoclave the instruments as follows:
Cycle................Temperature..............Exposure Time
Fractionated prevacuum .......134 .C....................... 5 min.
Other autoclaving parameters are:
Cycle................Temperature..............Exposure Time
Pre-vacuum......132 .C (270 .F)........ 4 minutes
Pre-vacuum......135 .C (275 .F)........ 3 minutes
Autoclavable Olympus products are designed for steam sterilization according to the following standards (in their respective latest approved version):
-US standard ANSI/AMMI ST46
-British standard BS 3970 and HTM-2010
-European standard EN 285
CAUTION!
Risk of Instrument Damage.
Do not exceed a temperature of 138 .C. Otherwise, instrument damage may occur.
Proposed water and steam quality acc. to EN 285 .............................................. Condensate..........Feed-water Coke residues......................................................... 10 mg/l
SiO.......................................... 0.1 mg/kg................ 1 mg/l
Fe...........................................0.1 mg/kg............. 0.2 mg/l
Cd ....................................... 0.005 mg/kg......... 0.005 mg/l
Pb.......................................... 0.05 mg/kg........... 0.05 mg/l
Traces of heavy metals (except Fe, Cd, Pb) ................. 0.1 mg/kg............. 0.1 mg/l
Cl. ........................................... 0.1 mg/kg................ 2 mg/l
P.O. ........................................ 0.1 mg/kg............. 0.5 mg/l
Conductivity (at 25 .C) ............ . 3 .S/cm........... . 5 .S/cm
pH ...................................................... 5–7...................5–7.5
Appearance.............................. colourless............colourless clear....................clear without residues..
without residues Water hardness (total alkaline earth ions)...... 0.02 mmol/l...... . 0.02 mmol/l
Example for fractionated prevacuum steam sterilization
1. Evacuation
2. Steaming and evacuation 2x
3. Heating
4. Sterilization
5. Evacuation
6. Drying
7. Aeration
NOTE!
Use of Instrument Trays.
-Do not stack the instrument trays or load them on their side edges during steam sterilization.
-For steam sterilization, Olympus recommends a drying time of at least 15–30 minutes. Choose an appropriate drying time, depending on the specific steam sterilization unit in your facility.
-Users may want to consider the use of appropriate, lint-free absorbing cloth.
5.12 Gas Sterilization
Prior Cleaning.
Endoscopic instrumentation must be meticulously cleaned prior to sterilization. Thorough cleaning removes both microorganisms and organic material. Failure to remove organic material decreases the effectiveness of the sterilization procedure. The information given in this section describes the instrument’s material compatibility. It does not describe the efficacy of the procedure on the instruments.
Gas Sterilization Procedure.
• Disassemble the instruments according to the instructions provided in the product-specific instruction manual and the Olympus Endoscopy System Guide (this manual).
• Open all stopcocks.
• Place the instruments in appropriate instrument trays or pouches (for Olympus instrument trays, see “Storage and Handling” section).
• Refer to the sterilizer’s instruction manual.
• Aerate the instruments sufficiently.
Conditions for Ethylene Oxide Gas Sterilization.
Refer to ANSI/AAMI ST41 or DIN 58 948 for
recommendations and standards.
Do not exceed the parameters outlined in the chart below.
Gas concentration........................................ 600–700 mg/l
Temperature.............................................. 55 .C (130 .F)
Pressure....................................0.1–0.17 MPa (16–24 psi)
Humidity.....................................................................55 %
Exposure time............................................................> 2 h
Aeration cycle at room temperature ...........................................7 days in an aeration chamber.....................12 h at 50–60 .C (122–135 .F) Conditions for Low Temperature Steam and Formaldehyde Gas Sterilization (LTSF). Refer to EN 14180 or DIN 58 948-16.
Do not exceed the parameters outlined in the chart below.
Gas concentration....................................................2–6 %
Temperature.............................................. 60 .C (135 .F)
Pressure........................................max. 0.17 MPa (24 psi)
Humidity..................................................................> 70 %
Exposure time..........................................................> 1 hr.
WARNING!
Gas Sterilization is Toxic.
Ethylene oxide and formaldehyde are toxic and may present health hazards. Follow domestic health care regulations for compatibility of the processes. After sterilizing the instruments, aerate them to remove toxic residues.
WARNING!
Infection Control Risk.
Thoroughly clean and dry the instruments before gas sterilization. Residual water may inhibit sterilization.
5.13 Other Sterilization Processes
Prior Cleaning.
Endoscopic instrumentation must be meticulously cleaned prior to sterilization. Thorough cleaning removes both microorganisms and organic material. Failure to remove organic material decreases the effectiveness of the sterilization process. The information given in this section describes the instrument’s material compatibility. It does not describe the efficacy of the specified process.
STERRAD. Low Temperature Plasma Sterilization Process.
• For sterilization, disassemble the instrumentation according to the instructions provided in the product-specific instruction manual and the Olympus Endoscopy
System Guide (this manual).
• Open all stopcocks.
• Certain instruments with long narrow lumen might require boosters during sterilization. The use of boosters is not allowed in every country. For details, refer to the sterilizer’s instruction manual.
• Place the instruments in sterilizing pouches or containers (any container/pouches must be certified by its manufacturer for STERRAD. use).
• Refer to the sterilizer’s instruction manual.
NOTE!
Different STERRAD systems with diffe
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