Symbol Definitions - Microline Surgical 3500 Serie Instrucciones De Uso

TAKE APART HANDPIECE / TIP ASSEMBLY
Gently close the blades/jaws with your index finger and your thumb to ensure complete closure (See Fig. 5). With blades/jaws of tip and handles
of handpiece in their closed position insert the tip into the shaft. Hold the jaws and turn the handpiece rotation knob clockwise until tip is screwed
tight. The instrument is ready for use.
DISASSEMBLY OF A TAKE APART HANDPIECE
Refer to Cleaning section for information on disassembly of the device.
RE-PROCESS INSTRUCTIONS
1. Immediately after surgical use remove the outer shaft. Immerse instruments in a tray, basin, or appropriate container in sterile distilled
water. When the handpiece and its outer tube are being transferred to Central Sterile Processing, they should be wrapped in a
moistened towel of distilled water. The non-latex rings in the handle should be removed prior to cleaning and sterilization.
2. Thoroughly clean device according to instructions provided in Cleaning section.
3. Sterilize device according to instructions provided in Sterilization section.
4. Conduct a visual inspection for damaged components. If any component appears to be damaged do not use device.
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 (applicable to non-Ratcheted Handpiece only)
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 (applicable to non-Ratcheted Handpiece only)
To reduce the risk of electrical burn or shock, handpieces and tips are not to be used beyond their maximum recurring peak voltage ratings:
RATING
800 Vp
1.25 KVp
2.65 KVp
ELECTRICAL PRECAUTIONS (applicable to non-Ratcheted Handpiece only)
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.
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.
DISPOSAL OF DEVICE
To reduce contamination risks, the ReNew Take Apart Handpiece and tips shall be disposed of in compliance with all applicable local, state and
federal laws and regulations.

SYMBOL DEFINITIONS

Following are the graphical symbols and their descriptions used in the labeling of the ReNew Take Apart Handpieces:
Federal (USA) law restricts this device to sale
Rx ONLY
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
Figure 5. (Only Non-Ratcheted Handpiece is shown in this figure)
MODE
Cut mode (Cut, Cut Pure)
Coag Burst mode (Blend, Desiccate)
Coag Spray mode (Fulgurate, Spray)
GENERATOR CREST FACTOR
CF< or = 6
2<CF<or = 6
CF>6
Catalog Number
Lot Number
Serial Number
Non Sterile
09-39-00096-00-ART Rev E