DetachaTip III Multi-Use Laparoscopic Instrument Instructions

Dansk

DetachaTip® III: Instrumentpleje-, rengørings- & steriliseringsvejledning

English

Råd: Det anbefales at anvende 3-4343 eller 3-4329 steriliseringsbakker for at opnå den mest optimale beskyttelse af DetachaTip III-instrumenterne. Disse instrumenter er IKKE konstrueret til at blive brugt sammen med DetachaTip 1-1027 eller 1-4327 steriliseringsbakker. Anbefalet klargøring af brugsstedet: Fjern snavs ved at nedsænke instrumentet i koldt vand (<40 °C/104 °F) straks efter brug. Der må ikke anvendes fikseringrengøringsmiddel eller meget varmt vand (>40 °C/104 °F), da det kan fiksere eventuelle rester, hvilket vil påvirke resultatet af rengøringsprocessen. Transport: Anvend sikker opbevaring og transport til rengøringsområdet for at undgå skader og kontaminering af miljøet. Dekontamineringsforberedelser: Instrumentskafterne skal skilles ad fra håndtaget inden rengøring. Luerporthætten og instrumentskafternes distale ende skal være åbne inden rengøring. Dekontaminering må kun udføres med drikkevand fra hanen. Der skal anvendes deioniseret vand til den automatiserede rengøringsmaskine fra Medisafe SISA.

Vandpistol

Vask ydersiden af instrumenterne under rindende vand med en blød nylonbørste, indtil alle synlige rester er vasket af.

20 cc sprøjte

Manuel rengøring: Vælg én

Forvask

5 minutter Læg instrumenterne i blød i 0,5 % enzymvaskemiddel ved 40 °C/104 °F.

Vask ydersiden af instrumenterne under rindende vand med en blød nylonbørste, indtil alle synlige rester er vasket af.

15 minutter Fyld instrumenterne og ultralydsrenseren op med 0,5 % enzymvaskemiddel ved 40 °C/104 °F inden ultralydsrensning.

Skyl den indvendige lumen med en vandpistol eller sprøjte via luerporten med vand fra hanen og maskinen i pulstilstand. Gentag denne proces, indtil der løber klar væske ud.

Gå videre til punkt 2: Manuel eller automatisk rengøring.

10 sekunder Skyl den indvendige lumen via luerporten med vand fra hanen med ultralydsrenseren i pulstilstand. Gentag denne proces, indtil der løber klar væske ud.

Skyl ydersiden på instrumentet med vand fra hanen for at fjerne al rengøringsopløsning.

Skyl den indvendige lumen via luerporten fem gange med vand fra hanen. Gentag denne proces, indtil der løber klar væske ud. 15 sekunder Skyl med vand fra hanen.

15 sekunder Skyl med vand fra hanen.

2 minutter Forvask med vand fra hanen inden vask TØM

5 minutter Vask ved 55 °C/131 °F med vand fra hanen og 0,5 % Mediclean Forte rengøringsmiddel TØM

3 minutter Skyl med deioniseret vand. TØM

Medisafe SISA

3 minutter Skyl med deioniseret vand inden vask TØM

Fyld op med deioniseret vand. Tilsæt 0,5 % 3E-zyme rengøringsmiddel. Fyld op med deioniseret vand.

5 minutter Afgas ved 37 °C-42 °C/ 99 °F-108 °F

25 minutter Vask ved 42 °C-51 °C/ 108 °F-124 °F

Medisafe PCF

3 minutter Skyl med vand fra hanen inden vask TØM

10 minutter Vask ved 45 °C /113 °F med 0,5 % 3E-zyme rengøringsmiddel. Skift mellem 45 sekunders ultralydsrensning og 15 sekunders skyl. TØM

2 minutter Skyl med vand fra hanen TØM

1 minut Skyl med vand fra hanen

Miele G7735 CD

Skyl den indvendige lumen via luerporten fem gange med vand fra hanen. Gentag denne proces, indtil der løber klar væske ud.

Vask ydersiden af instrumenterne under rindende vand med en blød nylonbørste, indtil alle synlige rester er vasket af.

Device Identification

READ AND BECOME FAMILIAR WITH ALL INSTRUCTIONS, WARNINGS, AND PRECAUTIONS PRIOR TO USING THIS PRODUCT. Description DetachaTip® III Multi-Use Laparoscopic Instruments are provided sterile in a variety of shaft configurations; scissors, graspers, dissectors. The outer shaft of these instruments is manufactured with a non-conductive material to allow for the use of these instruments during monopolar electrosurgical usage. These instruments comply with IEC 60601-1. Both a Multi-Use DetachaTip III Handle and a DetachaTip III Shaft with Luer Lock Port are required for use. Indications: The DetachaTip III Multi-Use instruments are intended for use in a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue. Contraindications: • These instruments are not intended for contraceptive coagulation of the fallopian tubes, but may be used to achieve hemostasis following transection of the fallopian tubes. • These instruments are not indicated for use by any person other than surgeons trained in laparoscopic procedures.

WARNINGS:

2.

3.

5.

6. 7. 8. 9. 10. 11.

Smøring: Når instrumenterne er rengjorte, men inden de steriliseres, skal alle håndtagets bevægelige dele smøres med et vandopløseligt smøremiddel, såsom ”smøremælk” til instrumenter. Efter instrumentet er blevet smurt, skal det klargøres til sterilisering. BEMÆRK: Selv skafter, der ikke blev anvendt under et indgreb, bør smøres før resterilisering.

12. 13.

1. 2. 3.

Funktionstest, vedligeholdelse: Udfør funktionstest i overensstemmelse med monteringsvejledningen i denne brugsanvisning og se efter, om udstyret er rent. Om nødvendigt udføres rengøringstrinene igen, indtil instrumentet er rent. Se luerporthætten efter for at kontrollere, at den sidder forsvarligt fast på instrumentet, og at luerporten er åben.

4.

Temperatur

Trykcyklus

(132 °C/270 °F)

(132 °C/270 °F)

Damp-/holdetid

4 minutter

15 minutter

Tørretid

20 minutter

20 minutter

(137 °C/278 °F)

(137 °C/278 °F)

Temperaturen må ikke overskrides

Damp-/holdetid

3 minutter

Tørretid

20 minutter

Directions for Use

Prævakuum cyklus Temperatur

Temperaturen må ikke overskrides

(134 °C/273 °F)

(137 °C/278 °F)

DetachaTip III laparoskopiinstrumenter er valideret i tredive (30) dampsteriliseringscyklusser. Et kirurgisk instruments produktlevetid afhænger i høj grad af instrumentets pleje og behandling. For at opnå optimal produktlevetid skal DetachaTip III-instrumenterne beskyttes mod kontakt med andre instrumenter under rengøring og resterilisering. Lad instrumenterne afkøle og tørre inden brug. Hvis der anvendes DetachaTip III-instrumentbakker, følges steriliseringsparametrene fra disses brugsanvisning. Steriliserede instrumenter skal opbevares i tørre, rene og støvfri omgivelser ved moderate temperaturer fra (10 °C/50 °F) til (32 °C/90 °F). Udstyr og materialer, der blev anvendt til validering: De følgende tester, materialer og maskiner er blevet brugt i denne valideringsrapport: Desinficerings-/vaskemaskine

Rensemiddel

Instrumenthylde

Miele G7735 CD

0,5 % Mediclean Forte

Miele E 450-1

Medisafe SISA

0,5 % 3E-zyme

Medisafe SISA stativ

Medisafe PCF

0,5 % 3E-zyme

Medisafe PCF stativ

These devices are provided sterile for multiple use. Instruments are to be resterilized using steam sterilization (See Instrument Care, Cleaning & Sterilization Instructions). Federal (USA) law restricts this device to sale by or on the order of a physician. This instrument should be used with IEC 60601-1 approved recognized monopolar electrosurgical generators with the capability of being activated with a foot switch. Before using the instrument, make sure the Luer Lock Cap is securely in place to prevent pneumoperitoneum leakage.

Handling of Insulated Instruments DetachaTip III Instruments are precision surgical laparoscopic instruments. To ensure lasting quality of the instruments, please follow the handling instructions described below: 1. Always support the instrument by firmly grasping the handle, or proximal end of the instrument. Never handle the instrument by the distal end alone. Never place heavy items on top of the instruments. 2. Avoid overstressing mechanisms of instruments by properly gripping and maneuvering during surgery. If excessive force is applied, the mechanism can be easily overstressed resulting in damage or breakage. 3. The DetachaTip III instruments are designed for use with the DetachaTip III Instrument Tray (3-4329) and DetachaTip III Plus Instrument Tray (3-4343).

Sterilisering: Steriliser instrumenterne ved at bruge en fraktioneret prævakuumproces i overensstemmelse med det relevante lands krav. Sørg for, at luerhætten er åben under sterilisering. Det er IKKE tilladt at bruge flashsterilisering (til øjeblikkelig brug) på lumeninstrumenter. INTERNATIONALE PARAMETRE AMERIKANSKE PARAMETRE Prævakuum cyklus

Do not use the DetachaTip III Shaft for the purposes of suction/irrigation or any other purpose for which it is not intended to be used. Injury to patient and/or user may result. Actuation of electrosurgical unit simultaneously with suction irrigation mode may increase the capacitive coupling through the shaft area of the insulated instrument and cause arcing at the distal end of the instrument. Laparoscopic procedures should be performed only by physicians with adequate training and knowledge of these procedures. In addition, medical literature should be consulted regarding techniques, hazards, contraindications, and complications prior to the performance of these procedures. When electrosurgical instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure and ensure that electrical insulation is not compromised. Use only with electrosurgical units that comply with IEC 60601-1 Standards. Do not exceed the maximum electrical capacity of the device. Maximum Rated Voltage is 2000 Vp. Keep the voltage power as low as possible to achieve the desired end effect. Refer to use instructions provided by the electrosurgical generator manufacturer to ensure that all safety precautions are followed. Ensure the electrosurgical cord is fully mated with the device prior to electrosurgical use. Using a metal cannula in conjunction with a plastic site stability device creates a potential hazard when using electrosurgical instruments. Inspect the connecting insulation at the distal end of the shaft which intersects with the jaws for any broken, cracked, or torn surfaces or parts. If any of these conditions appear, do not use the instrument. After prolonged electrosurgical use, residual heat in the instrument tip can cause tissue damage. Care must be exercised during electrosurgery to avoid use in areas of explosive gas concentrations. The risk associated with surgical smoke toxicity may be mitigated by the use of an appropriate smoke evacuation system. Follow hospital procedures for venting of the pneumoperitoneum. Do not activate the electrosurgical function of the device until the tip of the instrument is touching the target tissue. It is strongly recommended that the surgeon use high quality surgical gloves that have good insulation properties, thereby minimizing the risk of puncture and burn. The functional tip and shaft of the device are the applied parts.

Precautions:

Desinficering: Automatisk varmedesinficering kan udføres i en desinficerings-/vaskemaskine i overensstemmelse med nationale krav vedrørende A0-værdier (se EN ISO 15883). Denne desinficeringserklæring vedrører KUN europæiske standarder.

Indpakning: Brug passende indpakning til sterilisering. Anordningen skal steriliseres med anvendelse af de anførte steriliseringsmaterialer i en eller flere af følgende steriliseringscyklusser.

1. 2. 3. 4. 5. 6. 7.

Steriliseringsmaterialer Poser: SPS Medical selvforseglende poser, SPS Medical poser på rulle

Rx ONLY

DetachaTip III Multi-Use Laparoscopic Instrument with Luer Port

4.

BEMÆRK: Det er brugerens pligt at sikre sig, at rengørings- og steriliseringsprocessen, inklusive ressourcer, materialer og personale, kan opnå det påkrævede resultat. Regionale og nationale love kræver ofte, at disse processer, inklusive ressourcer, bliver korrekt valideret og vedligeholdt. Producentens særlige instruktioner til automatiske vaskemaskiner skal følges. Lad instrumenterne afkøle og tørre inden brug.

EO

®

1.

15 minutter Fyld instrumenterne og ultralydsrenseren op med 0,5 % enzymvaskemiddel ved 40 °C/104 °F inden ultralydsrensning.

10 minutter Læg instrumenterne i blød i koldt vand fra hanen.

Automatisk rengøring

Punkt 2: Manuel eller automatisk rengøring

Punkt 1:

ADVARSEL: Instrumenterne må ikke hvile på bunden af ultralydsrenseren under rengøring, da det kan resultere i skader eller mangelfuld rengøring.

PVC

STERILE

8. 9. 10.

Inspect the package and product for damage. Do not use if packaging is breached or product is damaged. This instrument is delivered sterile. No modification of this device is allowed. The blue foam must be removed and discarded per hospital protocol. This device is designed for introduction and use through a port of appropriate size. The jaw tips must be closed prior to insertion into or removal from the cannula. The jaw tips open and close to cut, dissect and/or grasp tissue by actuating the ring handles. The device is equipped with a standard 4mm male plug connector. To operate the monopolar electrosurgical feature, follow instructions provided by the electrosurgical generator manufacturer. Shaft must be assembled to handle prior to use, refer to Assembly Instructions. The device shaft is equipped with a standard Luer Lock Connector located on the rotation knob of the shaft. The Luer Lock facilitates cleaning the interior of the instrument shaft, using either the manual or the automated cleaning methods (See Instrument Care Cleaning and Sterilization Instructions). Inspect the Luer Port Cap after each sterilization to ensure the cap fits tightly over the Luer Port. If the Luer port cap does not fit tightly, replace the Luer port cap. Ensure the Luer Port Cap is securely in place prior to and during use. After use, this product may be a potential biohazard. Clean and re-sterilize as detailed in this IFU or dispose in accordance with accepted hospital or facility medical practice and following applicable local, state and federal laws and regulations. This product is designed for non-continuous operation, with a duty cycle of 10 seconds ON, and 30 seconds OFF.

8 4

1

6

7

9 10

REF 3-XXXX

XXXXXXX

2 1. Distal End Scissors/Grasper/ Dissector 2. Shaft Lot Code 3. Non-Conductive Composite Shaft 4. Luer Port Cap 5. Rotation Knob 6. Proximal End Inserts Into Handle 7. Shaft Release Button 8. 4 mm Standard Monopolar Post

3

5

9. Thumb Bump for 15 Palming 10. Ratchet Lever 11. Thumb Ring 12. Scallop for Palming 13. Pinky Finger Bump 14. Handle Lot Code 15. Index Finger Bump

Assembly Instructions 1. Use with DetachaTip III Handle (REF 3-1010) 1.1 Connecting the Shaft to the Handle Using sterile techniques, hold the shaft and front finger ring of the handle as shown in Illustration 1. Ensure that the thumb-ring has free movement, and the ratchet is in the “OFF” position before inserting the instrument shaft. Firmly insert the shaft into the handle. The thumb-ring will swing down as the shaft locks in place. Rotate the shaft 360° in the handle to make sure it locks in place. Check function of handle and working tip to confirm proper assembly.

REF 3-1010 XXXXXXX

11

14

12

13

Illustration 1. Allow thumb ring free range of motion during insertion and removal

1.2 The universal handle is designed to be held around the inside of both handle finger holes, the front finger ring and the thumb-ring. They are intended to maximize surgeon comfort and flexibility. Palming the instrument is also designed into the handle features using the thumb-bump, or the thumb-scallop. DetachaTip III Handle allows for use with or without the locking ratchet. Ratchet OFF allows for use of any shaft without ratchet function. With the exception of the scissors, ratchet ON allows for ratcheting function regardless of the ratchet lever position. Slight downward movement of the ratchet lever (in the ON position) towards the front ring handle, releases the ratchet momentarily. Upon release of the ratchet lever, ratchet automatically returns to the ON position. NOTE: The ratchet will only function with a Grasper/Dissector shaft. 1.3 Detaching the Shaft from the Handle Illustration 2 Allow thumb ring free range of Make sure the ratchet lever is in the “OFF” motion during insertion and removal position. Push downward on the blue shaft lock release button while holding the top of the handle, as shown in Illustration 2. While holding the button down, pull the shaft and handle apart. The thumb-ring will swing up as the shaft detaches from the handle.

DetachaTip III Laparoscopic instrument functionality has been validated after thirty (30) steam sterilization cycles at 134°C/273°F with 18 minute hold time. The useful life span of a surgical instrument is largely dependent on the care and handling of the instrument. For optimal product life, protect the DetachaTip III instruments from contact with other instruments during decontamination and re-sterilization. Allow instruments to cool and dry prior to handling. USE OF CHLORINATED CLEANING OR DISINFECTING AGENTS IS CONTRAINDICATED AND MAY CAUSE DEGRADATION OF INSTRUMENT MATERIAL AND MAY CONTRIBUTE TO INSTRUMENT BREAKAGE.

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For International orders or inquiries, please contact CONMED International Sales +1 (315) 797-8375 • FAX +1 (315) 735-6235 www.conmed.com P/N 14152 REV E 12/2020