Microline Surgical ReNew 3900 Serie Manual Del Usuario página 2

Phase
Pre-Wash
Wash 1
Rinse 1
PURW Rinse
Dry
And separately, for German market and referencing the VARIO TD program:
Phase
Pre-Wash
Wash 1
Rinse 1
Final Rinse
Disinfect: "The A concept (ref. DIN EN ISO 15883) and its national requirements must be taken into consideration in the on-site process
0
validation, carried out by the user."
7. Visually Inspect to ensure all soil is removed.
STERILIZATION
1. Prior to sterilization, the device must be thoroughly cleaned.
2. Wrap the device in 2 layers of 1-ply polypropylene wrap using sequential envelope folding techniques.
Microline Surgical recommends using the following validated steam sterilization cycles as guidelines:
Sterilization Cycle Exposure Time
Gravity Cycle 30 minutes at 270°F (132°C)
Pre-Vacuum Cycle 4 minutes at 270°F (132°C)
STERILIZATION PARAMETERS FOR EUROPEAN COUNTRIES
Microline Surgical recommends the following parameters as sterilization cycle parameters for Europe, except for France and Switzerland:
Sterilization Cycle Exposure Time at 134°C
Pre-Vacuum Cycle 3 minutes
For France and Switzerland, the following sterilization cycle parameters are recommended:
Sterilization Cycle Exposure Time at 134°C
Pre-Vacuum Cycle 18 minutes
PRECAUTIONS
1. Do not use handpiece if the O-ring located on the distal end of the shaft appears worn, damaged or missing.
2. If the blades/jaws are not completely closed when screwed onto the handpiece, they may not cut or grasp completely at the distal tip.
3. CAUTION: Prior to use, assure that the plastic hub of tip is fully in contact with the insulation tube of handpiece and that no gap exists
between the two parts at that contact point.
WARNINGS
• No modification of this equipment is allowed.
• The ReNew Handpiece has a white O-ring at the distal end of the shaft, which is an integral part of the system. Prior to each use, it is
very important to verify that the white O-ring is in place and it is not damaged. If the white O-ring is missing or damaged, do not use
the instrument.
ELECTROCAUTERY
First, connect the electrosurgical cord (not furnished with the instrument) to the handpiece by placing the female end of the cord on the male
adapter pin on the handpiece. Plug the other end of the cord into the monopolar receptacle of the generator.
ELECTRICAL RATINGS
To reduce the risk of electrical burn or shock, handpieces and tips are not to be used beyond their maximum recurring peak voltage ratings (Vp):
RATING MODE
800 Vp Cut mode (Cut, Cut Pure)
1.25 KVp Coag Burst mode (Blend, Desiccate)
2.65 KVp Coag Spray mode (Fulgurate, Spray)
ELECTRICAL PRECAUTIONS
1. A complete understanding of the principle of monopolar electrocautery surgical procedures is necessary to avoid accidental shocks,
burns, or potential gas embolism to the patient.
2. Be sure that a return electrode grounding pad has been properly attached to the patient and the generator.
3. Do not activate the generator until the metallic end of the tip is in contact with the tissue or is in a position to deliver high frequency energy
to the tissue.
4. Keep the power as low as possible to achieve the desired effect.
5. Use only with safety certified HF generators (IEC 60601-2-2).
6. Refer to the HF generator IFU for operating instructions and warnings.
7. Refer to the HF generator IFU for selection of HF cable and neutral pad electrode consistent with handpiece ratings.
8. CAUTION: To reduce risk of electrical burn or shock, do not rest fingers or hands near metal parts during use, particularly near cautery
cap connector or between handles.
REUSE LIFE
Due to the product design, the raw materials used and the intended purpose, it is not possible to determine a precise limit with regard to the
maximum possible number of reprocessing cycles. The serviceable life of the instruments is determined by their function as well as by careful
handling.
The device has undergone reprocessing cycle validation to 90 uses. The functional inspection must be completed before each use.
In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing conditions.
ENVIRONMENTAL PROTECTION
To reduce contamination risks, the ReNew Handpiece and tips shall be disposed of in compliance with all applicable local, state and federal laws
and regulations.
WARRANTY
Microline Surgical warrants that its instruments are free from any defects in both material and workmanship. Microline Surgical shall not be held
liable for any incidental or consequential damages of any kind. Work performed on an instrument will void this warranty. Gross abuse or neglect
of a Microline Surgical instrument will void this warranty.
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.
SYMBOL DEFINITIONS
Following are the graphical symbols and their descriptions used in the labeling of the ReNew Handpieces:
Rx Federal (USA) law restricts this device
ONLY
to sale by or on the order of a physician
Consult instructions for use
Manufacturer
Refer to instruction manual/booklet
Not made with natural rubber latex.
Medical Device Safety Service GmbH
Schiffgraben 41
D-30175 Hannover
Germany
Time (minutes) Temperature
2:00 Cold Tap Water
2:00 65.5°C
00:15 Hot Tap Water
1:00 90°C
6:00 98.8°C
Time (minutes) Temperature
2:00 min Cold Tap Water
Drain
5:00 min 55°C
Drain
3:00 min <50°C Hot Tap Water
Drain
2:00 min <50°C DI Water
Drain
Detergent
N/A
Alkaline Detergent
N/A
N/A
N/A
Detergent
N/A
Alkaline Detergent
N/A
N/A
Drying Time
40 minutes
30 minutes
Drying Time
30 minutes
Drying Time
30 minutes
GENERATOR CREST FACTOR (CF)
CF< or = 2
2<CF<or = 6
CF>6
Catalog Number
Lot Number
Serial Number
Non Sterile