Manual Surgical Drill Instructions for Use

HANDLING The drill should be inspected to insure proper functionality prior to each use with particular attention paid to all moving parts. If debris emanates from the instrument, is identified in any of the device concavities, or if the device is not Available Models functioning smoothly, other alternatives should Part No. Part Name be employed for operating the desired drill bit. CFD-899-4000 Manual Surgical Drill™ If any damage or malfunction is detected, the Drill should not be used and should be sent to INTRODUCTION This document presents the “Instructions for Use” MicroAire or an authorized service center for repair. Failure to make a complete inspection (IFU) for the MicroAire Manual Surgical Drill™. may result in unsatisfactory performance. These instructions outline the proper operation, care, and maintenance for this surgical instrument. Use of the Drill for a task other than that to which it is intended may result in damage, Following this IFU will insure long life, patient unsatisfactory performance, or patient risk. In safety, and proper instrument performance. order to maintain warranty, drill REPAIR MUST BE PERFORMED BY MICROAIRE SURGICAL DESCRIPTION INSTRUMENTS or an authorized service center. The MicroAire Manual Surgical Drill™ (Drill) is a reusable drill and Chuck Key designed for manual INSTRUCTIONS FOR USE drilling of bone. Operating the Manual Surgical Drill™ consists of the following steps. Caution: Always perform drill inspection per “Handling” instructions above prior to use. Drill Bit Stationary Grip Twisting Grip Chuck 1. Insert the desired drill bit into the Drill Bit Chuck Chuck using the Chuck Key located in the Key Twisting Grip.

ENGLISH

Manual Surgical Drill™

CAUTION Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). STORAGE AND OPERATING CONDITIONS Operation 104°F/ 40°C

> < ?

Temperature

50°F/10°C

Relative Humidity Limits

0

Atmospheric Pressure Limits

86

91% 106

Storage and Transportation 120°F/ 49°C

> < ?

0°F/-20°C

91%

0

106

86

INDICATIONS FOR USE The MicroAire Surgical Drill™ is indicated for general use in drilling bone holes. OPERATION OF DRILL The Manual Surgical Drill™ should be handled and operated by personnel completely familiar with its use and care.

NOTE: Compatible Drill Bit diameters specified on Drill Bit Chuck 2. Grasp the Stationary Grip with one hand. 3. Position the drill bit in the desired location for drilling. 4. Rotate the twisting grip with other hand. CARE OF DRILL Prior to each surgical procedure, the Drill and Chuck Key should be cleaned and sterilized as instructed below. As with any reusable medical device, personnel should follow accepted guidelines such as ANSI/AAMI ST46:2002 Steam Sterilization and Sterility Assurance in Health Care Facilities and AORN Standards, Recommended Practices, and Guidelines. It is important to rinse instruments that have been exposed to blood and saline solution before these substances dry. Blood and saline solutions are corrosive. In addition, blood will also cause a stain that is difficult to remove. The Drill and Chuck Key should, therefore, be kept moist immediately following use, by covering it with a moist towel prior to cleaning. DO NOT SOAK OR IMMERSE.

CLEANING Remove the Chuck Key from the Chuck Key bay. Using a hand-held, soft bristle brush, clean the Drill Bit Chuck, Chuck Key, and Drill body using warm running water and a neutral pH detergent designed for cleaning surgical instruments. Make sure to clean the Chuck Key bay located in the end of the Twisting Grip. Pay close attention to crevices or other areas that could retain contaminates such as fluids or blood. During cleaning, never use steel wool, wire brushes, or highly abrasive detergent cleaners as they will damage the surface finish of the hand drill. CLEANING: AUTOMATED Automated cleaning for this device is not recommended. This device must be cleaned manually to minimize corrosion of internal components, and to ensure proper removal of biological matter from the front, which can interfere with optimum performance. RINSING Rinse the Drill using warm running water and wipe dry with a clean, soft cloth. Do not immerse the Drill in cleaning solutions, basins, or ultrasonic cleaning devices. For best results and to avoid residue build up, rinse the Drill with distilled or demineralized water. Be sure to thoroughly rinse the inside of the Chuck Key bay. INSPECTION Visually inspect the Drill for cleanliness paying special attention to crevices, recesses, and the Chuck Key bay. DRYING Prior to sterilization and storage, the Drill must be thoroughly dry. Remaining moisture may be removed from hard to reach areas by using compressed air. CHUCK MAINTENANCE To maintain your MicroAire Manual Drill in optimal working order, MicroAire recommends lubricating the 3-Jaw Chuck of the drill prior to sterilization. This added lubrication step will assure that your drill chuck operates smoothly at all times, allowing a quick and easy exchange of drill bits. MicroAire recommends the use of a standard surgical instrument lubricant such as MILTEX Spray Lube, 8 oz. (0.24 liter) bottles, Catalog No. 3-700, or a similar variety designed specifically for lubrication of surgical instruments prior to steam sterilization.

This lubricant can be purchased through a variety of medical equipment distributors. To properly lubricate the chuck, apply several drops or sprays of lubricant to the front of the chuck and rotate the locking collar back and forth to distribute the lubrication to the insides. Only the chuck should be lubricated, as no addition lubrication is required for the body of the drill. Once lubricated, sterilize the drill as normal. By taking this step prior to sterilization, you can be assured of optimal performance on every procedure. PACKAGING FOR STERILIZATION Prior to sterilization, the Chuck Key should be removed from the Chuck Key bay. The Drill is now ready for sterilization per ANSI/AAMI ST46:2002 Steam Sterilization and Sterility Assurance in Health Care Facilities. Single Instruments – A standard medical grade steam sterilization wrap may be used. Ensure that the wrap is large enough to contain the instrument without stressing the packaging (ANSI/AAMI ST46-1993). Sets of Instruments – sets of instruments may be loaded into dedicated instrument trays or general purpose sterilization trays for sterilization. If applicable, use standard medical grade steam sterilization wrap following the AAMI double wrap method (ANSI/AAMI ST461993). STERILIZATION Independent laboratory testing has validated steam sterilization as an effective sterilization process for the Manual Surgical Drill™. As recommended by the aforementioned standards the sterilizer manufacturer’s written instructions for cycle parameters should be followed in order to achieve adequate instrument exposure. The following table outlines the minimum cycle temperature and exposure time for sterilization per ANSI/AAMI ST46:2002 Steam Sterilization and Sterility Assurance in Health Care Facilities. Steam Sterilization Method

Temperature

Exposure Time1

Dry Time

Vacuum Displacement 270°F/132°C 4 minutes 30 minutes Gravity 250°F/121°C 30 minutes 45 minutes Displacement

MAINTENANCE OF DRILL THE MANUAL SURGICAL DRILL™ IS GUARANTEED FOR ONE YEAR. Always inspect the Drill prior to use per “Operation of Drill” section above. If any damage or malfunction is detected, the Drill should not be used and should be sent to MicroAire Surgical Instruments or an authorized service center for repair. PROTECT INSTRUMENTS The use of neutral pH detergents is vital to the care of surgical instruments. Contact with acidic or alkaline solutions will remove the instruments’ protective barrier and lead to staining or corrosion; The Manual Surgical Drill™ should never be exposed to: Aqua Regia, Iodine, Hydrochloric Acid, Ferric Chloride, or Sulfuric Acid. The following substances should be avoided whenever possible: Aluminum Chloride, Barium Chloride, Bichloride of Mercury, Calcium Chloride, Chlorinated Lime, Carbolic Acid, Dakin’s Solution, Mercury Chloride, Potassium Permanganate, Potassium Thiocyanate, Saline, Sodium Hypochlorite, or Stannous Chloride. STORAGE Sterile, packaged instruments should be stored in a designed, limited-access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature/humidity extremes. END OF LIFE At End of Life, the device should be disposed of as medical waste as required by your local regulations. The device does not require specific recycling or other hazardous disposal. 1”Exposure time: The period during which items are exposed to saturated steam at the specified temperature.” (ANSI, AAMI ST46:2002)

DANSK

Manual Surgical Drill™ Tilgængelige modeller Komponentnr. Komponentnavn CFD-899-4000 Manual Surgical Drill™ INDLEDNING Dette dokument udgør “brugsanvisningen” til MicroAire Manual Surgical Drill™. Disse anvisninger forklarer den korrekte betjening, pleje og vedligeholdelse af dette kirurgiske instrument. Når man følger denne brugsanvisning, vil man sikre en lang levetid for instrumentet, patientsikkerhed og korrekt funktion af instrumentet. BESKRIVELSE MicroAire Manual Surgical Drill™ (boret) er et genanvendeligt bor og patronnøgle udformet til manuel boring i knogle. Borepatron

Stationært greb

Drejegreb Patronnøgle

FORSIGTIG Ifølge amerikansk lovgivning må dette instrument kun sælges af en læge eller ifølge en læges ordination (eller praktiserende læge). OPBEVARINGS- OG DRIFTSBETINGELSER Drift

Opbevaring og transport

40 °C/ (104 °F)

> <

Temperatur

10 °C (50 °F)

Relative fugtighedsgrænser

0

Atmosfæriske trykbegrænsninger

86

91 %

106

?

49 °C/ (120 °F)

> <

-20 °C (0 °F)

91 %

0

106

?

86

INDIKATIONER FOR BRUG MicroAire Surgical Drill™ er indiceret til generel brug til boring af huller i knogle.

MediMark Europe 11, rue Emile Zola - BP 2332 F-38033 Grenoble Cedex 2 France

MicroAire Surgical Instruments 3590 Grand Forks Boulevard Charlottesville, VA 22911 800.722.0822 Toll-free 434.975.8000 Main www.microaire.com LBL-899-7301 Rev G