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CLEANING & STERILISATION GUIDE Signia™ Stapler
Cleaning Instructions During use:
Power Handle
Remove excess soil on the reusable instruments with disposable wipes.
WARNING & PRECAUTION
After use: Reprocess the instruments as soon as possible following use. If reprocessing cannot be performed immediately, cover the instruments with a moist towel.
The power handle is made from metal, electronics and plastic. NOTE
Do not use instrument lubricant on the power handle or the adapter.
The power handle is a reusable device and will deactivate after reaching the end of its service life. The device will not deactivate during use. The number of uses remaining indication is provided on the power handle OLED display.
Power Shell
1. The power handle is provided non-sterile. Clean after each use. DO NOT STERILISE.
PRECAUTION
WARNING The power shell is single‑use only. DISCARD AFTER USE. DO NOT STERILISE. Re-sterilised or reprocessed sterile power shells will not function.
2. Do not rinse under running water or submerge. Avoid moisture on the gold electrical contacts on the bottom and front face. 3. Do not use alcohol, quaternary ammonium or bleach based wipes as they may cause physical deterioration of the handle housing such as discolouration, embrittlement or cracking. Only use the cleaning methods described in this manual to maximise the physical characteristics of the handle housing. 4. Do not use instrument lubricant on the power handle.
To clean the power handle
down all exposed surfaces with a slightly water ∙∙Wipe dampened lint-free cloth to completely remove any gross debris from the device.
additional cleaning is required, use a hydrogen peroxide ∙∙Ifbased wipe. the power handle is completely dry prior to inserting ∙∙Ensure it into a sterile power shell or charger. WARNING The power handle is non-sterile and cannot be sterilised. Do not immerse. The power handle will be damaged if sterilisation is attempted.
Adapters WARNING The adapter is supplied non-sterile. It must be cleaned and sterilised prior to use. Clean the adapter immediately after use to prevent blood and other biological materials from drying on the surface of the device. Do not use abrasive agents. Remove and dispose of the single-use reload (if attached) from the adapter prior to cleaning and sterilising.
After use The adapter should be cleaned thoroughly after every use to remove all traces of blood and debris. Reprocess as soon as possible following use. If reprocessing cannot be performed immediately, cover the adapter with a moist towel. NOTE The adapter is a reusable instrument and will deactivate after reaching the end of its service life. The number of uses remaining is indicated on the power handle display. These indications are described in the Signia™ stapling system’s user manual.
Manual cleaning 1. Remove the adapter from the stapler according to the instructions for use provided with the Signia™ stapling system’s user manual. 2. Wipe down the adapter with a separate lint-free cloth soaked in a 32-40 C (90-104 F) pH-neutral detergent solution diluted per the manufacturer’s specifications. 3. Under 32-40 C (90-104 F) running water, scrub all reachable exterior surfaces with a general instrument soft nylon bristle brush for 1-2 minutes to remove surgical debris. Hold the distal end of the adapter under running water and flush for 1-2 minutes. Do not insert the brush into the distal end shaft. While brushing, pay particular attention to the grooves on the pin. Also pay particular attention to the grooves and sides of the reload unload button. 4a. For enzymatic detergents (Validated with Steris Prolystica™* 2X Concentrate): Hold the adapter at a slight angle to allow the detergent solution to flow into the shaft from the bottom and air bubbles to release from the top. Once all air bubbles are released, immerse the adapter in a 32-40 C (90-104 F) enzymatic bath diluted as specified by the manufacturer’s Instructions for Use and soak for 10‑20 minutes. 4b. For alkaline detergents (non-enzymatic pH greater than 9.5 but less than 10.8) (Validated with neodisher MediClean forte™*): Hold the adapter at a slight angle to allow the detergent solution to flow into the shaft from the bottom and air bubbles to release from the top. Once all air bubbles are released, immerse the adapter in a 90-104 F (32-40 C) alkaline bath diluted as specified by the manufacturer’s Instructions for Use and soak for 10‑20 minutes. 5. Manually agitate the adapter in the bath for 1-2 minutes. 6. Invert the adapter until all fluid has completely drained. 7. In a clean 90-104 F (32-40 C) water bath, hold the adapter at a slight angle to allow the water to flow into the shaft from the bottom and air bubbles to release from the top. Once all air bubbles are released, immerse the adapter and soak for 2-3 minutes. 8. Manually agitate the adapter in the bath for 1-2 minutes. 9. Invert the adapter until all fluid has completely drained.
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10. Repeat step 3.
Treatment
Time (min:sec)
Temperature
Chemicals
11. Rinse under 32-40 C (90-104 F) running tap water for 1-2 minutes.
Pre-Wash
00:45
Cold tap water
N/A
Wash
04:00
Hot tap water
Enzymatic1 or Alkaline2 Detergent3
Rinse
00:15
Hot tap water
N/A
Wash
03:00
Hot tap water
Enzymatic1 or Alkaline2 Detergent3
Rinse
00:15
12. Perform a final rinse under purified water for 1-2 minutes. 13. Dry with a clean, soft, lint-free cloth. 14. Inspect the adapter. If not visibly clean, repeat the above steps. PRECAUTION Do not use instrument lubricant on the power handle or the adapter.
Automatic cleaning 1. Remove the adapter from the stapler according to the instructions for use provided with the Signia™ stapling system’s user manual. 2. Wipe down the adapter with a lint-free cloth soaked in 32-40 C (90-104 F) pH-neutral detergent solution diluted per manufacturer’s instructions. 3. Under 32-40 C (90-104 F) running water, scrub all reachable surfaces with a general instrument soft nylon bristle brush for 1-2 minutes to remove surgical debris. Hold the distal end of the adapter under running water and flush for 1-2 minutes. Do not insert the brush into the distal end shaft. While brushing, pay particular attention to the grooves on the pin. Also pay particular attention to the grooves and sides of the reload unload button. 4. Rinse under 32-40 C (90-104 F) running tap water for 1-2 minutes. 5. Perform the automatic cleaning cycle, following the recommendations in the table on the next page.
Hot tap water
N/A
Thermal Rinse 05:00
Hot purified water heated to 95 C (203 F)
N/A
Dry
High setting 95 C (203 F)
N/A
06:00
1. Validated with Steris Prolystica™* 2x concentrate 2. Validated with neodisher MediClean forte™* 3. Dilute detergents per the manufacturer’s specifications
6.
Dry with a clean, soft, lint-free cloth.
7.
Inspect the adapter. If not visibly clean, repeat the above steps.
PRECAUTION Do not use instrument lubricant on the power handle or the adapter. NOTE The adapter has been tested for material compatibility with cleaners that have pH ranges from neutral to 10.8. Refer to the cleaner’s manufacturer for information on the microbiological effectiveness of the cleaner.
NOTE
Reusable Insertion Guide
The Signia™ adapter should be placed in such a manner to avoid contact with other devices to prevent damage from occuring as a result of movement during the wash cycle. It is recommended that the adapter be placed with reload unload button facing downward to assist drainage.
Warnings Detergents and solutions should have a pH between neutral and 10.8. The reusable insertion guide is supplied non-sterile. Prior to use it must be cleaned and sterilised.
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After Use
Automatic Cleaning
The reusable insertion guide should be cleaned thoroughly after every use to remove all traces of blood and debris. Reprocess as soon as possible following use. If reprocessing cannot be performed immediately, cover the device with a moist towel.
NOTE
Manual Cleaning 1. Wipe down the device with a lint-free cloth soaked in 32-40 C (90-104 F) pH-neutral detergent solution diluted per manufacturer’s instructions. 2. Under 32-40 C (90-104 F) running water, scrub all reachable surfaces with an 11.9mm soft nylon bristle brush for 1-2 minutes to remove surgical debris. Pay particular attention to the grooves on the extended handle and indentations on the underside of the tool. 3a. For enzymatic detergents (validated with Steris Prolystica™* 2x Concentrate): immerse the device in a 32-40 C (90-104 F) enzymatic bath diluted as specified by the manufacturer’s Instructions for Use and soak for 5-10 minutes. 3b. For alkaline detergents (non-enzymatic pH greater than 9.5 but less tha n 10.8) (validated with neodisher MediClean forte™*): immerse the device in 32-40 C (90-104 F) alkaline bath diluted as specified by the manufacturer’s Instructions for Use and soak for 5-10 minutes.
The Signia™ reusable insertion guide should be placed in the washer-disinfector with the logo facing up to avoid water collecting in the crevices on the underside of the tool. The Signia™ reusable insertion guide should be placed in the washer-disinfector in such a manner to avoid contact with other devices (damage may occur as a result of movement during the wash cycle). 1. Wipe down the reusable insertion guide with a lint-free cloth soaked in 32-40 C (90-104 F) pH-neutral detergent solution diluted per manufacturer’s instructions. 2. Under 32-40 C (90-104 F) running water, scrub all reachable surfaces with an 11.9 mm soft nylon bristle brush for 1-2 minutes to remove surgical debris. Pay particular attention to the grooves on the extended handle and indentations on the underside of the tool. 3. Rinse under running tap water (32-40 C/90-104 F) for at least 1 minute. 4. Perform the automatic cleaning cycle, following the parameters in the table below: Treatment
Time (min:sec)
Temperature
Chemicals
Pre-Wash
00:45
Cold tap water
N/A
Wash
04:00
Hot tap water
4. Manually agitate the device in the bath for at least 1 minute.
Enzymatic1 or Alkaline2 Detergent3
Rinse
00:15
Hot tap water
N/A
5. Repeat step 2.
Wash
03:00
Hot tap water
6. Rinse under warm running tap water (32-40 C/90-104 F) for at least 1 minute.
Enzymatic1 or Alkaline2 Detergent3
Rinse
00:15
7. Perform a final rinse under purified water for a minimum of 1 minute. 8. Dry with a clean, soft, lint-free cloth 9. Inspect the device. If not visibly clean, repeat the above steps.
Hot tap water
N/A
Thermal Rinse 05:00
Hot purified water heated to 95 C (203 F)
N/A
Dry
High setting 95 C (203 F)
N/A
06:00
1. Validated with Steris Prolystica™* 2x concentrate 2. Validated with neodisher MediClean forte™* 3. Dilute detergents per the manufacturer’s specifications
5. Dry with a clean, soft, lint-free cloth. 6. Inspect the device. If not visibly clean, repeat the above steps.
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NOTE The reusable insertion guide has been tested for material compatibility with cleaners that have pH ranges from neutral to 10.8. Refer to the cleaner’s manufacturer for information on the microbiological effectiveness of the cleaner.
Manual Retraction Tool Warnings Detergents and solutions should have a pH between neutral and 10.8. The manual retraction tool is supplied non-sterile. Prior to use it must be cleaned and sterilised.
After Use The manual retraction tool should be cleaned thoroughly after every use to remove all traces of blood and debris. Reprocess as soon as possible following use. If reprocessing cannot be performed immediately, cover the instrument with a moist towel.
3b. For alkaline detergents (non-enzymatic pH greater than 9.5 but less than 10.8) (validated with neodisher MediClean forte™*): immerse the device in a 32-40 C (90-104 F) alkaline bath diluted as specified by the manufacturer’s Instructions for Use and soak for 5-10 minutes. 4. Manually agitate the device in the bath for at least 1 minute. 5. Repeat step 2. 6. Rinse under warm running tap water (32-40 C/90-104 F) for at least 1 minute. 7. Perform a final rinse under purified water for a minimum of 1 minute. 8. Dry with a clean, soft, lint-free cloth 9. Inspect the device. If not visibly clean, repeat the above steps.
Automatic Cleaning NOTE
NOTE
The Signia™ manual retraction tool should be cleaned in the open position; with external and internal handles in either an open V shape (45 degree angle relative to the shaft) or T shape (90 degree angle relative to the shaft).
The Signia™ manual retraction tool should be cleaned in the open position; with external and internal handles in either an open V shape (45 degree angle relative to the shaft) or T shape (90 degree angle relative to the shaft).
The Signia™ manual retraction tool should be placed in the washer-disinfector lying flat to assist drainage and in such a manner to avoid contact with other devices (damage may occur as a result of movement during wash cycle).
1. Wipe down the device with a lint-free cloth soaked in 32-40 C (90-104 F) pH-neutral detergent solution diluted per manufacturer’s instructions.
1. Wipe down the manual retraction tool with a lint-free cloth soaked in 32-40 C (90-104 F) pH-neutral detergent solution diluted per manufacturer’s instructions.
2. Under 32-40 C (90-104 F) running water, scrub all reachable surfaces with an 11.9mm soft nylon bristle brush for 1-2 minutes to remove surgical debris. Pay particular attention to the indentations on the interior of the handles.
2. Under 32-40 C (90-104 F) running water, scrub all reachable surfaces with an 11.9mm soft nylon bristle brush for 1-2 minutes to remove surgical debris. Pay particular attention to the indentations on the interior of the handles.
Manual Cleaning
3a. For enzymatic detergents (validated with Steris Prolystica™* 2x Concentrate): immerse the device in a 32-40 C (90-104 F) enzymatic bath diluted as specified by the manufacturer’s Instructions for Use and soak for 5-10 minutes.
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3. Rinse under running tap water (32-40 C/90-104 F) for at least 1 minute. 4. Perform the automatic cleaning cycle, following the parameters in the table below: Treatment
Time (min:sec)
Temperature
Chemicals
Pre-Wash
00:45
Cold tap water
N/A
Wash
04:00
Hot tap water
Enzymatic1 or Alkaline2 Detergent3
Rinse
00:15
Hot tap water
N/A
Wash
03:00
Hot tap water
Enzymatic1 or Alkaline2 Detergent3
Rinse
00:15
Hot tap water
N/A
Thermal Rinse 05:00
Hot purified water heated to 95 C (203 F)
N/A
Dry
High setting 95 C (203 F)
N/A
06:00
1. Validated with Steris Prolystica™* 2x concentrate 2. Validated with neodisher MediClean forte™* 3. Dilute detergents per the manufacturer’s specifications
5. Dry with a clean, soft, lint-free cloth. 6. Inspect the device. If not visibly clean, repeat the above steps. NOTE The manual retraction tool has been tested for material compatibility with cleaners that have pH ranges from neutral to 10.8. Refer to the cleaner’s manufacturer for information on the microbiological effectiveness of the cleaner.
Disinfection See the automatic cleaning sections.
Sterilisation Instructions Sterilising
The adapters, manual retraction tool and the reusable insertion guide are provided non-sterile. They may be sterilised by steam autoclave. WARNING Do not use hydrogen peroxide gas plasma technology (such as STERRAD™* systems), ethylene oxide, or gamma sterilisation. The adapters and accessories are approved for steam autoclave sterilisation. The following information is the sterilisation method recommended and qualified for the linear adapter. Do not expose the device to temperatures in excess of 137 C (279 F), as this may shorten device service life and/or lead to device failure.
∙∙Place the adapter on its side during sterilisation. a 20 minute cool down period at room temperature ∙∙Allow post sterilisation. Do not leave the instrument in the autoclave for cool down; remove it immediately after the sterilisation cycle is complete.
not use flash steam sterilisation. Use of flash steam ∙∙Do sterilisation will damage the device, and may lead to malfunction. Steam Autoclave Sterilisation 132 C pre-vacuum (Hi Vac) steam cycle Exposure temperature: 132 C (270 F) Exposure time: 4 minutes Vacuum dry time: 20-40 minutes
∙∙ ∙∙ ∙∙
134 C pre-vacuum (Hi Vac) steam cycle Exposure temperature: 134 C (273 F) Exposure time: 3 minutes Vacuum dry time: 20-40 minutes
∙∙ ∙∙ ∙∙
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Storage
AUSTRALIA AND NZ Pre-vacuum Steam Cycle
Minimum Recommended Cycle
Cycle
Cycle
WHO1 Cycle
Exposure temperature (C)
132
134
134
134
Exposure time (minutes)
4
3
5
18
Vacuum time (minutes)
20-40
20-40
20-40 20-40
Store at room temperature. 90%
101.3 kPa
54.9 kPa
Transport humidity limitation
Transport atmospheric pressure
60°C 140°F ‑29°C 20.2°F
Transport temperature limitations
1. World Health Organisation (WHO) steam sterilisation cycle
NOTE
Disposal
When sterilising multiple instruments in one autoclave cycle, ensure the steriliser manufacturer’s stated maximum load is not exceeded.
Discard or recycle as per local, state and governmental regulations.
Always refer to the Instructions For use included with the product for complete indications, instructions, warnings, precautions, and contraindications
Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park NSW 2113 Australia Tel: +61 2 9857 9000 Fax: +61 2 9889 5167 Toll Free: 1800 668 670
Medtronic New Zealand Ltd Level 3 - Building 5, Central Park Corporate Centre 666 Great South Road, Penrose, Auckland 1051 New Zealand Fax: +64 9 918 3742 Toll Free: 0800 377 807
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© Medtronic. 2018 All Rights Reserved. EM 899-08-17 # 4393-092017