Indications For Use; Device Description - Medtronic Skeeter Ultra-Lite Oto-Tool 3055601 Instrucciones De Uso

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INDICATIONS FOR USE

The Skeeter Ultra-Lite Oto-Tool System is a slender, lightweight drill handpiece with burs, specifically used in middle ear
surgical procedures, including stapes footplate surgery.

DEVICE DESCRIPTION

The Skeeter handpiece and burs may be used with the XPS Model 3000 via direct connection with the Skeeter handpiece
connector. The lightweight Skeeter Ultra-Lite Oto-Tool Handpiece weighs 57 grams. The drill shaft diameter is approximately
2mm and is angled approximately 15 degrees from the plane of the handpiece. The shaft angulation and small diameter
maximize visualization of the surgical field during drill use.
The Skeeter Ultra-lite Oto-Tool Handpiece can be powered by three (3) 9 volt batteries housed in the Accelerator Foot Control.
However, when used with the XPS Model 3000 console, the handpiece plugs directly into the console and is operated using
the XPS single function or multifunction footswitch. The footswitch allows variable speed operation of the handpieces ranging
from very slow to high speed in excess of 12,000 rpm.
The Skeeter is used with the Oto-Flex bur. The Oto-Flex bur designed for use with the Skeeter are composed of a flexible
stainless steel shaft with a bur and a PTFE bearing at one end and the handpiece engagement at the other. The inside of the
PTFE bearing is lightly coated with silicone spray to reduce operating friction.
Color Coding
For ease of identification of size, all Oto-Flex Burs are color coded. Diamond Burs are further differentiated from Carbide
Burs by a white band on the shaft of each Diamond Bur. A Color Code Chart is conveniently provided in the base of the Oto-
Tool System Sterilization Case. The bur size identification color code is as follows:
Violet: 0.5 mm Yellow:
Blue: 0.6 mm Orange: 1.0 mm
Green: 0.7 mm Gray:
THE SKEETER ULTRA-LITE OTO-TOOL SYSTEM CONSISTS OF THE FOLLOWING MAIN COMPONENTS:
• XPS Model 3000 Console (One pump; # 1897101 or two pumps; #1897102 and #1897102BF)
• Skeeter Ultra-Lite Oto-Tool Handpiece (#3055601)
• Skeeter Footswitch (#3055607)
• XPS Footswitch (#1895400, #1895410, #1895420)
• Oto-Flex burs (Set of 6 burs: #3155610)
Other components include:
• Ultralite Sterilization Case (#3155615)
• Otologic Metric Scale (#3052460)
• 9 V Batteries - Pack of 12 (#3158201)
• Handpiece Extension Cable (#3155606)
• Pole Basket for Footswitch (#1897510)
• Cleaning Solution (#3112600)
• Silicone Spray (#3152480)
CONTRAINDICATIONS
None are known.
WARNINGS
• Verify reusable device was sterilized prior to use. If not sterilized, do not use.
• Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
• Do not operate the XPS 3000 System in the presence of flammable anesthetics. Avoid potential ignition or explosion of
gases.
• Achieve electrical grounding reliability with proper connections. Connect the XPS 3000 Console to hospital grade
receptacles only.
• Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without irrigation may cause
an inordinate amount of heat buildup resulting in thermal injury to tissue.
• When not operating handpiece, ensure that handpiece rests on a non-conductive surface that provides containment for
handpiece and blade/bur. Avoid unintended thermal injury by an uncontained handpiece.
• When not operating handpiece, eliminate accidental foot control activation. Control energy to and through handpiece
to prevent unintended tissue, bone or nerve resection.
• This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and
test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or
highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary
to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for
anesthetized patient.
• DO NOT attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to ensure effective
cutting and control of the drill.
• Carefully inspect burs both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or
other defects. Replace any suspicious bur with a new one prior to use.
• Should a bur fracture in use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and
removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.
• Excessive noise from the bur when drilling close to the cochlea or ossicular chain may cause hearing damage.
0.8 mm Brown: 1.8 mm
Red: 2.3 mm
1.4 mm Black: Specialty
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