Microline Surgical ReNew 3900 Serie Instrucciones De Uso

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.
Note: Additional IFUs may be obtained free of charge by contacting Microline Customer service, or by visiting
https://www.microlinesurgical.com/resources/ifus/
CONTRAINDICATIONS
All contraindications specific for endoscopic (inclusive of laparoscopic) surgical procedures are applicable to this device.
SHIPPING AND STORAGE CONDITIONS
No specific shipping or storage conditions. Store according to standard hospital storage procedures.
COMPONENTS OF A RENEW HANDPIECE
PRODUCT
ReNew Handpieces
ReNew Scissor Tips
ReNew Grasper & Dissector Tips
PRE-CHECK INSTRUCTIONS
Carefully inspect the shipping carton and its contents for any sign of damage. If damage is visible, do not use the
1.
instrument.
This instrument is delivered without a tip. Tips are available in various configurations (see above).
Ensure that the device received is the ReNew handpiece and matches the supplied IFU.
2.
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 with, the small,
medium, or no ring sets may be used during a procedure.
HANDPIECE/TIP ASSEMBLY
Remove white band from the blades/jaws of tips. Ensure the blades/jaws are completely closed with your index finger and
1.
your thumb (See Fig. 2).
With blades/jaws of tip and handles of handpiece in their closed position, insert the tip into the shaft.
2.
Hold the jaws and turn the handpiece rotation knob clockwise until tip is screwed tight.
3.
Open the tip to full aperture. If this is not possible, repeat steps 1-3.
4.
Single use tips must have the band removed from the jaws before attempting steps 1-4.
5.
The device is ready for use.
6.
OPERATING INSTRUCTIONS FOR RATCHETED HANDPIECES
Push switch (see Fig. 3) forward in order to engage the ratchet mechanism.
1.
Close the handles to the desired grasping position and let go. The instrument is locked on the tissue.
2.
To release the grasper jaws, press down on the distal end of locking lever.
3.
In order to use the instrument in non-ratcheted mode, pull the switch toward the back of the instrument. The instrument will
4.
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.
Always rinse from proximal to distal using the luer connector.
Whenever possible, affix a flush mechanism to the luer fitting when cleaning.
Do not flush from distal to proximal.
Do not flush by clamping around the device shaft to obtain a seal.
MANUAL CLEANING
Detach tips and non-latex rings before cleaning and sterilization.
Single patient use disposable tips are to be discarded before cleaning and sterilizing the handpiece. Reusable 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.
Validated Equipment and Materials Used:
• Soft bristled brush Medline
• Lumen brush Medline MDSBR40002B or equivalent
• Luer-type syringe, 60 ml
• Enzymatic solution, Enzol
® ®
Amsco Steris 444 Washer-Disinfector, WD1-106NC9 or equivalent
•
Rinse articles with running tap water for 30 seconds to remove gross soil, actuating moving parts while rinsing.
1.
Presoak the components of the instrument and or reusable tip in enzymatic solution detergent per the Manufacturer's
2.
Instructions.
Remove (unscrew) the cautery plug to flush any lumen-like channels with detergent.
3.
Insert a 60 ml luer type syringe filled with prepared detergent solution where the cautery plug was removed and flush with a
4.
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 180 ml of prepared detergent
solution to flow through the device in a similar manner.
a. Note, do not flush from the distal end of the device.
b. Note, in all instances of manual flushing, 180ml flushing was validated. Additional flushing may be used if desired.
Fully immerse the test articles into the prepared detergent solution and allow the articles to soak five (5) minutes.
5.
ReNew Family of Laparoscopic
Handpieces Instructions For Use
Microline Surgical, Inc. 迈克兰器械有限公司
50 Dunham Road, Suite 1500
Beverly, MA 01915 U.S.A.
Tel 电话: +1(978) 922-9810 | Fax 传真: +1(978) 922-9209
Web 网站: www.microlinesurgical.com
Email 电子邮件: info@microlinesurgical.com
ENGLISH
CATALOG NUMBERS
3904, ReNew Handpiece, 34cm
3905, ReNew Handpiece, 42cm
3914, ReNew Ratcheted Handpiece, 34cm
3915, ReNew Ratcheted Handpiece, 42cm
3918, ReNew Ratcheted Handpiece, 25cm
3924, ReNew Rigid Shaft Handpiece, 34cm
3925, ReNew Rigid Shaft Handpiece, 42cm
3934, ReNew Ratcheted Rigid Shaft Handpiece, 34cm
3935, ReNew Ratcheted Rigid Shaft Handpiece, 42cm
3100 Series
3200, 3300, 3400, 3600, 3800 Series
Small Non-Latex Rings
Switch
®
MDS88 BRUSH or equivalent
® or equivalent
09-39-36-ART Rev W
Medium Non-Latex Rings
Figure 1
Figure 2
Figure 3
1
Locking Lever