Microline Surgical ReNew 3900 Serie Manual Del Usuario

ReNew Family of Laparoscopic Handpieces 3900 Series Ratcheted and Non-Ratcheted- Instructions For Use
INDICATIONS FOR USE
The ReNew Handpieces and tips are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical
procedures.
CONTRAINDICATIONS
None known.
COMPONENTS OF A RENEW HANDPIECE
PRODUCT
ReNew IV Handpieces
ReNew Scissor Tips
ReNew Grasper & Dissector Tips
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 above).
2. Ensure that the device received is the ReNew handpiece and matches the supplied IFU.
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.
HANDPIECE/TIP ASSEMBLY
1. Gently close the blades/jaws with your index finger and your thumb to ensure complete closure (See Fig. 2).
2. With blades/jaws of tip and handles of handpiece in their closed position, insert the tip into the shaft.
3. Hold the jaws and turn the handpiece rotation knob clockwise until tip is screwed tight.
4. Open the tip to full aperture. If this is not possible, repeat steps 1-3.
5. Single use tips must have the band removed from the jaws before attempting steps 1-4.
6. The device is ready for use.
OPERATING INSTRUCTIONS FOR RATCHETED HANDPIECES
1. Push switch (see Fig. 3) forward in order to engage the ratchet mechanism.
2. Close the handles to the desired grasping position and let go. The instrument is locked on the tissue.
3. To release the grasper jaws, press down on the locking lever.
4. In order to use the instrument in non-ratcheted mode, pull the switch toward the back of the instrument. The instrument will open and
close freely.
NOTE
Non-Ratcheted mode is necessary to screw a tip onto the handpiece.
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. Rinse articles with running tap water for 30 seconds to remove gross soil, actuating moving parts while rinsing.
2. Presoak the components of the instrument and or limited use tip in enzymatic solution detergent per the Manufacturer's Instructions.
3. Remove (unscrew) the cautery plug to flush any lumen-like channels with detergent.
4. Insert a 60mL luer type syringe filled with prepared detergent solution where the cautery plug was removed and flush with a minimum of
60 mL of detergent solution. Repeat filling the syringe and flushing the shaft and tip for a total of three (3) times and 180 mL. Alternatively,
the device may be attached to an automated flush device to allow a minimum of 180mL of prepared detergent solution to flow through the
device in a similar manner.
5. Fully immerse the test articles into the prepared detergent solution and allow the articles to soak for a minimum of five (5) minutes.
6. While immersed, use a soft bristled brush to remove all visible soil from the articles. Pay attention to any challenge areas and actuate any
movable parts while brushing for a minimum of one (1) minute.
7. While immersed, use a lumen brush to brush the interior lumen for a minimum of one (1) minute.
8. Remove the articles and rinse under lukewarm running tap water for a minimum of one (1) minute while actuating movable parts.
9. Insert a 60mL luer type syringe filled with lukewarm tap water where the cautery plug was removed and flush with a minimum of 60 mL.
Repeat filling the syringe and flushing the shaft for a total of three (3) times and 180mL. Ensure that clear water exits the other side while
flushing. Alternatively, the device may be attached to an automated flush device to allow a minimum of 180mL of lukewarm tap water to
flow through the device in a similar manner.
(CAUTION: Water temperatures >45˚C may cause scalding).
10. Rinse the articles in Reverse Osmosis/ deionized (RO/DI) water. Repeat two (2) additional times for a total of three (3) RO/DI rinses.
While rinsing, actuate movable parts.
11. Insert a 60mL luer type (or equivalent) syringe filled with warm* deionized (RO/DI) water where the cautery plug was removed and rinse
with 60 mL of deionized water. Repeat filling the syringe and flushing the shaft and tip three (3) times for a total of 180mL. Alternatively,
the device may be attached to an automated flush device to allow a minimum of 180mL of warm* deionized (RO/DI) water to flow through
the device in a similar manner.
12. Dry the articles completely using clean lint-free cloth.
13. Visually inspect the device and device components in a well-lit area to ensure all surfaces are clean. Repeat cleaning steps if visible soil
is still observed.
14. Inspect the instrument for functionality and package appropriately for sterilization.
AUTOMATED CLEANING
Microline Surgical recommends that tips and non-latex rings be detached from handpiece before cleaning and sterilization. The minimum
automated cleaning requirements are as follows:
1. Rinse with running tap water while actuating moving parts to remove gross soil.
2. Through the luer connection, flush the device with lukewarm tap water while fully immersed in a bath of lukewarm tap water (CAUTION:
Water temperatures >45˚C may cause scalding).
3. Use a lumen brush to clean hard to reach areas.
4. Load device(s) into automated washer. Load device(s) in the open position.
5. Automated wash cycle parameters as follows:
6. Instrument Cycle: High
ReNew Family of Laparoscopic Handpieces
Instructions For Use
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: [email protected]
09-39-36-ART Rev N 02/2019 ECN 7232
ENGLISH
CATALOG NUMBERS
3900 Series
3100 Series
3200 Series
3300 Series
3400 Series
3600 Series
3800 Series
Figure 1
Figure 2
Figure 3