Page 3 - HR500 User Guide - 2016-USA Version Hensler_Neat

1. INTENDED USE:
The Cenna Bone Mill model HR500 is intended to mill cortical, cancellous, or cortical-cancellous
bone for surgical procedures.

2. IMPORTANCE:
For safety issues, potential hazards, effectiveness, and proper use of this device, it is important that
the operator of this device be familiar with this guide.

3. WORDS:
In this manual “Warning” refers to the potential hazards; “Precautions” points to special care and
effectiveness, and “Important” emphasizes instructions.

4. UNPACKING AND INSPECTION:
a) Before unpacking, inspect the exterior of the packages and make note of any visible
damage. Please notify carrier if any.
b) Unpack and inspect every part for any noticeable damage. Make notes of damage.
c) If contents are incomplete after removing product from packaging, notify Cenna Medical
Technologies’ (Cenna Med) Customer Service Department. If any damages are found,
please notify the carrier and Customer Service.
d) Keep the shipping containers and packing material for future inspections.
e) Within 48 hours, install the battery charger and place the battery pack in the cradle of the
charger.

5. WARNINGS:
a) Do not operate this device without eye protection.
b) Do not reprocess the Single-use blades. These blades are not designed and validated for
multiple-case uses.
c) Do not reprocess the multiple-use blade beyond its specifications.
d) Do not operate this device near equipment sensitive to EMR, such as a magnetic resonance
imaging device.
e) Do not bypass the interlocking safety switch located in front of the device to operate this
device. bypassing the safety interlocking switch could potentially cause serious injuries.
f) Do not operate this device without the Safety Cap installed and secured.
g) Do not attempt to remove safety cap when motor is powered (orange light).
h) Do not use this device if the “O” seal of the motor base is damaged.
i) Do not use this device if any of the front seal is damaged.
j) Do not use this device if the failsafe interlocking safety switch is stuck or damaged.
k) Do not use this device if any of the components are found to be defective.
l) Do not use any component other than Cenna Medical’s.
m) Do not process bone chips larger than 16mm cubic dimensions in the M16 and S16 rotors.
n) Do not process bone chips larger than 20mm cubic dimensions in the S20 rotor.
o) Do not use this device for milling any material other than cortical, cortical-cancellous, or
cancellous bone.
p) After each procedure place battery pack back in the battery charger cradle.

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