PARCUS MEDICAL
X-Twist Reusable Instrumentation Instructions for Use
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X-Twist Reusable Instrumentation Important Product Information Instructions for Use
Indications: Anika offers a variety of reusable instrumentation intended for use in the surgical environment. This includes various types of inserters, taps, awls, drill bits and reamers, drill guides, trays, and other general orthopedic instruments. In addition to these instructions, Anika also provides surgical technique guidebooks and animations of simulated use on the Anika website, as indicated on the package label. Warnings: A. Caution: Federal Law restricts this device to sale by or on the order of a physician. B. This product must be inspected prior to each use and before sterilization. C. Never place a cannulated device over a bent or damaged guide pin. D. Loading this instrument or any instrument used with this device in an off-axis manner may result in breakage or bending of the instrument, drill guide or obturator. E. Never use a dull, bent, or damaged instrument. F. This product is not intended to be left in the body. G. Be sure to remove any debris from the cannulation of the device, as applicable, during the cleaning process. H. Always confirm compatibility of devices such as cannulated drill bits and reamers prior to introducing into the patient. Material: These products are manufactured from stainless-steel, aluminum, and medical grade polymers. Stainless-steel and aluminum are radio-opaque and can, therefore, be detected with conventional X-Ray or fluoroscopy. Polymers are typically radio-lucent, so ultrasound can be used for detection. Inspection: Inspect the device for damage at all stages of handling. If damage to the device, label, or packaging is detected, consult the manufacturer for guidance. Inspect device markings and ensure all are clearly visible. Device Lifetime: This device is intended for multiple use. End of device life has occurred when the device fails visual and/or functional criteria. Cleaning: Immediate rinsing and cleaning after use with an enzymatic detergent will effectively remove and prevent drying of adherent blood, tissue, etc.
Scrub device with a soft brush, paying special attention to the cannulation and other areas where debris might accumulate. Always avoid any harsh materials that can scratch or mar the surface of the device. Rinse the device thoroughly with water following the cleaning process. Sterilization: This product is a non-sterile item that must be cleaned and sterilized prior to use. The following table provides the recommended minimum sterilization parameters that have been validated by Anika to provide a 10-6 sterility assurance level (SAL): Cycle Type Pre-vacuum
Minimum Temperature
Minimum Exposure Time (Wrapped)
Minimum Dry Time
132°C / 270°F
4 minutes
30 minutes1
134°C / 273°F
3 minutes
30 minutes1
1 Drying times vary according to load size and should be increased for larger loads
Symbol Glossary: Symbol
Definition Legal Manufacturer
Standard Used ISO 15223-1
Authorized representative in the European Community Use-by-date
ISO 15223-1
Ref # 5.1.1 5.1.11 5.1.3 5.1.2
ISO 15223-1
5.1.4
Batch code
ISO 15223-1
5.1.5
Catalog number
ISO 15223-1
5.1.6
Sterilized using ethylene oxide
ISO 15223-1
5.2.3
Do not resterilize
ISO 15223-1
5.2.6
Non-sterile
ISO 15223-1
5.2.7
Do not use if package is damaged
ISO 15223-1
5.2.8
Single sterile barrier system
ISO 15223-1
5.2.11
Double sterile barrier system
ISO 15223-1
5.2.12
Keep away from sunlight
ISO 15223-1
5.3.2
Keep dry
ISO 15223-1
5.3.4
Upper limit of temperature
ISO 15233-1
5.3.6
Do not re-use
ISO 15223-1
5.4.2
Consult instructions for use
ISO 15223-1
5.4.3
Consult electronic instructions for use (eIFU)
ISO 15223-1
5.4.3
Patient identification
ISO 15223-1
5.7.3
Patient information website
ISO 15223-1
5.7.4
Healthcare center or doctor
ISO 15223-1
5.7.5
Date
ISO 15223-1
5.7.6
Medical device
ISO 15223-1
5.7.7
Unique device identifier
ISO 15223-1
5.7.10
Quantity
NA
NA
www.anikaifu.com
Caution: U.S. Federal law 21 CFR 801 restricts this device to sale by or on the order of a physician MR Conditional ASTM F2503
801.109 Table 2
MR Safe
ASTM F2503
Table 2
MR Unsafe
ASTM F2503
Table 2