Microline Surgical 3500 Serie Instrucciones De Uso

Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly, MA 01915 U.S.A.
Tel: +1(978) 922-9810 | Fax: +1(978) 922-9209
Web: www.microlinesurgical.com
Email: info@microlinesurgical.com
ReNew Take Apart Handpiece 3500 Series - Instructions For Use
(Includes instructions for Ratcheted and Non-Ratcheted Handpieces)
INDICATIONS FOR USE
The ReNew Take Apart Handpieces are indicated for endoscopic (inclusive of laparoscopic) surgical procedures.
CONTRAINDICATIONS
None known
COMPONENTS OF A TAKE APART HANDPIECE
PRODUCT
ReNew Take Apart Handpiece Kits
ReNew Take Apart Handpiece Components
INNER SHAFT
CATALOG NO.
OUTER SHAFT
CATALOG NO.
PRE-CHECK INSTRUCTIONS
1. Carefully inspect the shipping carton and its contents for any sign of damage. If damage is visible, do not use the instrument.
This instrument is delivered without a tip. Tips are available in various configurations (see catalog).
2. Ensure that the device received is the ReNew Take Apart instrument and matches the supplied IFU.
3. Ensure all components are present upon receiving device. Carton should contain ReNew Take Apart instrument, IFU, small and
medium handle inserts.
4. Check instrument to ensure all components are working. If components are not working properly, do not use the instrument.
• Outer tube and inner shaft should separate from each other, and the handle, easily.
• Ratchet switch should engage and disengage ratchet arm successfully.
• Thumb trigger should articulate freely with the ratchet disengaged.
• Rotation knob should rotate smoothly.
• Do not use handpiece if the white O-ring located on the distal end of the shaft appears worn, damaged or missing.
ERGONOMICS
This instrument is delivered with two sets of separately packaged reusable non-latex rings (small & medium sizes). These rings are designed
to be mounted around the inside of both handle finger holes and they are intended to maximize surgeon comfort by adjusting the inside size of
the handpiece finger rings. Depending on what the surgeon feels most comfortable, the small, medium, or no ring sets may be used during a
procedure.
ASSEMBLY OF A TAKE APART HANDPIECE
CLOSE
Figure 2
1. Open the variable handle to its limit as shown in Figure 2.
2. Locate the arrow on the face of the index knob of the handle. If it is not easily visible, rotate the knob until the arrow is visible.
3. Orient the arrow on the flat of the inner shaft to the arrow on the index knob as shown in Figure 3.
4. The inner shaft may have to be rotated a small amount to achieve the precise alignment required to insert the shaft.
5. Insert the inner shaft completely until it is captured by the variable handle.
6. Secure the inner shaft by closing the handle.
7. With the handle closed, confirm the two are connected by attempting to pull them apart. If they come apart repeat steps 1-6.
8. With the handle closed, load the outer shaft over the inner shaft as shown in Figure 4.
9. Rotate the outer shaft until the outer shaft is aligned to be received by the handle.
10. Insert the outer shaft until the knob can begin to be threaded.
11. Thread the knob until it is tight to secure the shaft.
PRE-PROCESS INSTRUCTIONS
Prior to use, follow the guidelines below for proper cleaning and sterilization.
MANUAL CLEANING
Microline Surgical recommends that tips and non-latex rings be detached from handpiece before cleaning and sterilization.
Single patient use disposable tips are to be discarded before cleaning and sterilizing the handpiece. Limited use tips are to be cleaned and
sterilized following the instructions per the ReNew Reusable tip IFU (09-39-00124-00-ART), yet must be removed from the handpiece before
cleaning and sterilization.
1. Unthread any tip that is on the handpiece.
2. While holding the index knob, unthread the outer tube knob and gently pull the outer shaft from the handpiece.
3. Hold the handpiece by the fixed handle and gently pull the inner shaft out of the handle. The variable handle will rise until it releases
the inner shaft.
4. Remove (unscrew) the flush port cap/cautery post.
5. Presoak the components of the instrument and or limited use tip in enzymatic solution containing 60 mL of ENZOL
Detergent per 4 L of water @ 22-40°C.
6. Brush the distal (working end) of the instrument and or limited use tip under water, to avoid airborne contaminants.
7. Brush the lumen of the outer shaft assembly under water, to avoid airborne contaminants.
8. Make sure that all visible bioburden has been removed under water.
9. Soak the instrument and or limited use tip in deionized water.
10. Inspect the instrument for any damage and package appropriately for sterilization.
11. Other equivalent neutral pH cleaning solutions that are suitable for the product may be used. Always follow the manufacturer's
instructions regarding the concentration of the cleaning solution, temperature and exposure time.
STERILIZATION
Handpiece should be taken apart into its three components (handle, inner shaft, and outer shaft) prior to sterilization.
1. Prior to sterilization, the instrument must be thoroughly cleaned.
2. Wrap the instrument.
Microline Surgical recommends using the following validated steam sterilization cycles as guidelines:
Sterilization Cycle
Gravity Cycle
Pre-Vacuum Cycle
CATALOG NUMBERS
3504TA
3505TA
3514TA
3515TA
3500H
3510H
3504A
3504B
3505A
3505B
3504A
3505A
3504B
3505B
OPEN
ORIENT ARROWS
Exposure Time at 270°F (132°C)
15 minutes
15 minutes
CATALOG NO. 3500H
Figure 1
Figure 3
ENGLISH
LENGTH /DESCRIPTION
Non-Ratcheted 34 cm
Non-Ratcheted 42 cm
Ratcheted 34 cm
Ratcheted 42 cm
Non-Ratcheted Handle
Ratcheted Handle
34 cm Inner Shaft
34 cm Outer Shaft
42 cm Inner Shaft
42 cm Outer Shaft
HANDLES
CATALOG NO. 3510H
Figure 4
Enzymatic
®
Drying Times
20 minutes
20 minutes