DrillSaw Sports 400™ System
User’s Guide
DFU-0253-4r0_fmt_en-US
Page 3 of
46
1.
DO NOT
– under any condition, or for any reason – open the handpiece, any
system component, or any other system accessory.
2.
This device has passed testing for EMI/RFI radiation and susceptibility, and
EMC compatibility. This device may cause interference with other devices in the
near vicinity if not set up,and used as instructed by Arthrex.
3.
Do not attach accessories to the handpiece unless the handpiece is in the safe
mode.
4.
Only use
batteries approved by Arthrex.
5.
Do NOT
clean the device with abrasive cleaning or disinfectant compounds,
solvents, or other materials that could scratch or damage the device.
6.
The aseptic battery packs are
NOT
to be cleaned and disinfected in a thermo
washer disinfector.
7.
NEVER
place the handpiece or accessories in Cidex or other aldehyde
disinfectant solutions.
8.
After sterilization in the autoclave, let the accessory device cool down slowly.
NEVER
use cold water to cool the handpieces. This will damage the electronic
components and seals.
9.
Liquid on the battery and handpiece contacts may damage the device. Before
connecting the battery, ensure the receptacles are clean and dry.
10.
Always comply with the instructions issued by the manufacturer of the cleaning
disinfectant regarding concentration, exposure times, temperature, and material
compatibility.
11.
Remove all accessories, including attachments and battery before sterilizing a
handpiece.
12.
Caution: Federal law restricts this device to sale by or on the order of a
physician.
13.
This device is intended to be used by a trained medical professional
14.
Biohazard waste, such as explanted devices, needles and contaminated
surgical equipment, should be safely disposed of in accordance with the
institutions policy.
15.
Serious incidents should be reported to Arthrex Inc., or an in-country
representative, and to the health authority where the incident occurred.
•
Surgeons are advised to review the product-specific surgical technique prior to performing
any surgery. Arthrex provides detailed surgical techniques in print, video, and electronic
formats. The Arthrex website also provides detailed surgical technique information and
demonstrations. Or, contact your Arthrex representative for an onsite demonstration.
•
In CE accepting Countries:
Procedures carried out using these devices may be used on
the general population.
•
In CE accepting Countries:
The clinical benefits associated with the use of these devices
outweigh the known clinical risks.
•
In CE accepting Countries:
There are no unacceptable residual risks or uncertainties
associated with the clinical use of these devices.
