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Medtronic Signia Stapler, Руководство по эксплуатации товара

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Sterilizing

The adapters, manual retraction tool, and the reusable 
insertion guide are provided non-sterile. They may be 
sterilized by steam autoclave.  

WARNING 

Do not use hydrogen peroxide gas plasma technology 
(such as STERRAD

™*

 systems), ethylene oxide, or gamma 

sterilization. The adapters and accessories are approved for 
steam autoclave sterilization. 

The following information is the sterilization method 
recommended and qualified for the linear adapter. Do not 
expose the device to temperatures in excess of 279 F  
(137 C), as this may shorten device service life and/or lead to 
device failure. 

 

∙

Place the adapter on its side during sterilization.

 

∙

Allow a 20-minute cool down period at room temperature 
post sterilization. Do not leave the instrument in the 
autoclave for cool down; remove it immediately after the 
sterilization cycle is complete. 

 

∙

Do not use flash steam sterilization. Use of flash steam 
sterilization will damage the device, and may lead to 
malfunction.

Steam Autoclave Sterilization

132 C pre-vacuum (Hi Vac) steam cycle

 

∙

Exposure temperature: 270 F (132 C) 

 

∙

Exposure time: 4 minutes

 

∙

Vacuum dry time: 20-40 minutes

134 C pre-vacuum (Hi Vac) steam cycle

 

∙

Exposure temperature: 273 F (134 C)

 

∙

Exposure time: 3 minutes

 

∙

Vacuum dry time: 20-40 minutes 

Outside USA (OUS)

Minimum recommended WHO

†

Cycle

Pre-Vacuum Steam Cycle

Cycle

Cycle

Cycle

Exposure Temperature (C)

132

134

134

134

Exposure Time (minutes)

4

3

5

18

Vacuum Dry Time (minutes) 20-40

20-40

20-40 20-40

†World Health Organization

NOTE

When sterilizing multiple instruments in one autoclave 
cycle, ensure the sterilizer manufacturer’s stated maximum 
load is not exceeded.

Storage

Store at room temperature.

Transport humidity

limitation

 

90%

    

Transport atmospheric

pressure

 

54.9 kPa

101.3 kPa

   

20.2°F

-29°C

140°F

60°C

Transport temperature

limitations

  

Disposal

Discard or recycle as per local, state, and governmental 
regulations.

STERILIZATION  

INSTRUCTIONS

Содержание Signia Stapler

Страница 1: ...THE FUTURE OF STAPLING IS IN YOUR HANDS TODAY The world s first smart stapler Signia Stapler Product Information Guide ...

Страница 2: ...NTENTS PRODUCT OVERVIEW 03 Introduction Technology Overview Features Benefits PRODUCT COMPARISON 09 MATERIALS MANAGEMENT 10 510 K Clearance Instructions For Use Cleaning Sterilization Storage Ordering Information ...

Страница 3: ...ides greater precision and maneuverability compared to manual staplers1 4 Push button powered firing that decreases the strain of operation when stapling compared to firing manually4 Compatibility with our existing reload portfolio featuring the proven performance of Tri Staple technology Enhanced performance when paired with Tri Staple 2 0 reloads and Signia loading units with Tri Staple 2 0 cart...

Страница 4: ...in real time on an easy to understand display screen1 right on the stapler How it works The smart features of the Signia stapler are only available when it s paired with Tri Staple 2 0 reloads and Signia loading units with Tri Staple 2 0 cartridges That s because our new loading units have a chip which allow them to communicate meaningful information to the stapler during your procedure 1 All the ...

Страница 5: ... 2 Indicates the stapler will require a higher firing force due to thicker or variable tissue and the device will slow its speed to deliver optimal staple formation6 Zone 3 Indicates the stapler will require the highest firing force due to very thick or variable tissue and the device will adjust to its slowest speed to deliver optimal staple formation6 Note Display feedback provided when using the...

Страница 6: ...d ergonomics create a well balanced feel in the hand during use1 Easy to reach controls accommodate a range of hand sizes1 Easy to understand display screen1 The Tri Staple technology advantage Benefits you and your patients can count on The Signia stapler delivers them with the unparalleled performance of Tri Staple technology which 6 Generates less stress on tissue during compression and clampin...

Страница 7: ...stem is comprised of Signia power handle Signia power shell Signia adapters Various accessories And it s compatible with Tri Staple 2 0 reloads Signia loading units with Tri Staple 2 0 cartridges Endo GIA reloads Endo GIA reloads with Tri staple technology System accessories include a single bay battery charging station reusable insertion guide and a manual retraction tool 7 ...

Страница 8: ...e assembled Signia power shell and power handle to enable functionality of compatible Medtronic stapling reloads The adapters are composed of motormating connectors sensor gauges and device communications interfaces to provide communications between Signia loading units with Tri Staple 2 0 cartridges Tri Staple 2 0 reloads and the power handle It is provided nonsterile and must be sterilized befor...

Страница 9: ...ion 14 8 V 2150 mAh 4 single use batteries per handle single use disposable Reusability Reusable reposable system comprised of disposable and reusable components Single use disposable Single use disposable Points of articulation with the 45 degree maximum range Unlimited 3 on each side left right 3 on each side left right Articulation Powered Manual second instrument or lateral pressure against bo...

Страница 10: ...visions of the Act include requirements for annual registration listing of devices good manufacturing practice labeling and prohibitions against misbranding and adulteration Please note CDRH does not evaluate information related to contract liability warranties We remind you however that device labeling must be truthful and not misleading If your device is classified see above into either class II...

Страница 11: ...f adverse events under the MDR regulation 21 CFR Part 803 please go to http www fda gov MedicalDevices Safety ReportaProblem default htm for the CDRH s Office of Surveillance and Biometrics Division of Postmarket Surveillance You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll free number 800 638 2041 or 3...

Страница 12: ...510 K CLEARANCE 12 K160176 ...

Страница 13: ...ing of the power handle housings STORAGE Return the power handle to a battery charger for charging and storage Store at room temperatures 50 F 104 F or 10 C 40 C and relative humidity 30 75 Avoid prolonged exposure to elevated temperatures DISPOSAL NOTE Contact Covidien customer service prior to recycling and disposing of to confirm contracted recycling and disposal agreements Contact customer ser...

Страница 14: ...ible Einweg Klammerlade mit gekrümmter Spitze radiale Ladevorrichtungen und Klammersystems INDIKATIONEN Wenn das Signia Klammerinstrument bestehend aus Elektrogehäuse und dem Signia wiederverwendbaren Ladevorrichtungen Ladevorrichtungen und Magazinen pädiatrischen und thorakalen chirurgischenVerfahren z Sie können zurTranssektion und Resektion von Lebersu Transsektion und Resektion der Bauchspeich...

Страница 15: ...warnings and precautions WARNINGS AND PRECAUTIONS 1 The power shell is provided STERILE and is intended for use in a SINGLE procedure only 2 Visually inspect the power shell packaging for damage or wear prior to use Do not use the power shell if the packaging or device appears damaged 3 Do not exceed limitations of the hinge when opening the power shell 4 Do not overly deflect side clips Replace i...

Страница 16: ...munications between compatible stapling reloads and the power handle For system configuration information and Instructions for Use see the Signia stapling system s user manual Refer to each system component s Instructions for Use for detailed product descriptions and associated indications instructions contraindications warnings precautions The product is to be used by medical professionals qualif...

Страница 17: ...hey are used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3Vrms 150 kHz to 80 MHz 3V m 80 MHz to 2 5 GHz 3V 3V m Portable and mobile RF communications equipment should be used no closer to any part of the power handle adapter and power shell including cables than the recommended ...

Страница 18: ...rnings and precautions The product is to be used by medical professionals qualified in the transportation preparation and use of surgical devices The Signia stapling system is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated INDICATIONS FOR USE The Signia stapler composed of the Signia reusable power handle Signia single use power...

Страница 19: ... 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 manual retraction tool with a lint free cloth soaked in 32 40 C pH neutral detergent solution diluted per manufacturer s instructions 2 Under 32 40 C running water scrub all reachable surfa...

Страница 20: ...s 4 3 5 18 Vacuum dry time minutes 20 40 20 40 20 40 20 40 1 World Health Organization WHO steam sterilization cycle NOTE When sterilizing multiple instruments in one autoclave cycle ensure the sterilizer manufacturer s stated maximum load is not exceeded WARNINGS AND PRECAUTIONS 1 For steam autoclave sterilization the Manual RetractionTool has been tested to a maximum exposure temperature of 137 ...

Страница 21: ...hysical characteristics of the handle housing 4 Do not use instrument lubricant on the power handle To clean the power handle Wipe down all exposed surfaces with a slightly water dampened lint free cloth to completely remove any gross debris from the device If additional cleaning is required use a hydrogen peroxide based wipe such as Oxivir Tb per the manufacturer s instructions Ensure the power h...

Страница 22: ...the adapter until all fluid has completely drained 10 Repeat step 3 11 Rinse under 90 104 F 32 40 C running tap water for 1 2 minutes 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...

Страница 23: ...urified 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 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 t...

Страница 24: ...an soft lint free cloth 9 Inspect the device If not visibly clean repeat the above steps Automatic Cleaning 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 placed in the washer d...

Страница 25: ...t use flash steam sterilization Use of flash steam sterilization will damage the device and may lead to malfunction Steam Autoclave Sterilization 132 C pre vacuum Hi Vac steam cycle Exposure temperature 270 F 132 C Exposure time 4 minutes Vacuum dry time 20 40 minutes 134 C pre vacuum Hi Vac steam cycle Exposure temperature 273 F 134 C Exposure time 3 minutes Vacuum dry time 20 40 minutes Outside ...

Страница 26: ...irings including 10 hours of dwell time A lockout feature will activate if a minimum of two firings are not possible And the user will be notified via audible indicator and a yellow signal on the OLED screen 9 Storage Return the power handle to a battery charger bay for safe storage Always store the device at room temperature 50 104 F or 10 40 C and relative humidity between 30 75 And avoid prolon...

Страница 27: ...SHORT coming soon Signia Linear Adapter Short SIGSBCHGR Signia Single Bay Charger SIGRIG Signia Reusable Insertion Guide SIGMRET Signia Manual Retraction Tool SIGTRAY Signia Sterilization Tray SIGPCORD1 Signia Power Cord 1 US SIGPCORD6 Signia Power Cord 6 JA To try the Signia stapler in your next procedure contact your local Medtronic sales representative or call 800 722 8772 More information is o...

Страница 28: ...Force Limit Evaluation 2015 4 Based on internal test report RE00022065 UCONN Biodynamics final report on results focusing on biomechanical exposure related to laparoscopic stapler use 2012 5 Based on claim No 1 of software requirements specification SRS and 510k testing 6 Based on PT00002451 Signia Stapler User Manual Page 13 7 Based on internal test report PCG 007 When compared to Echelon Flex gr...

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