6 DePuy Synthes User Manual Small Battery Drive II
Introduction
General Information
2
Do not reuse
Products intended for single use must not be
reused.
Reuse or reprocessing (e.g. cleaning and
resterilization) may compromise the structural
integrity of the device and / or lead to device
failure, which may result in patient injury, illness
or death.
Furthermore, reuse or reprocessing of single use
devices may create a risk of contamination e.g.
due to the transmission of infectious material
from one patient to another. This could result in
the injury or death of the patient or user.
Depuy Synthes does not recommend
reprocessing contaminated products. Any
Depuy Synthes product that has been
contaminated by blood, tissue and / or bodily
fluids / matter should never be used again and
should be handled according to hospital
protocol.
Even though they may appear undamaged, the
products may have small defects and internal
stress patterns that may cause material fatigue.
Temperature
Relative humidity
Atmospheric pressure
S9
Duty cycle type according to IEC60034-1
IPX4
Ingress protection rating according to
IEC 60529
Explanation of the general symbols used
The following symbols are applied to the device or
individual components. Information on additional
symbols is given in the relevant sections of this
document.
Caution
Consult the Instructions for Use before
operating the device.
The device is classified as type BF against
electrical shock and leakage current. The device
is suitable for use on patients according to the
standards defined by IEC 60601-1
SM_109761
Do not immerse device in liquids.
10PB
Product is UL classified to the requirements
of both the United States and Canada
The device meets the requirements of the
Medical Device Regulation (EU) 2017/745.
Li-Ion
This device contains Lithium-Ion batteries that
should be disposed of in an environmentally
friendly manner. The European Battery Directive
2006/66/EC applies to this device.
Cd
MH
The European directive 2012/19/EC on waste
electrical and electronic equipment (WEEE)
applies to this device. This device contains
materials that should be disposed of in
accordance with environment protection
requirements. Observe national and local
regulations.
Indicates Environment Friendly Use Period of
5 years in China.
Indicates Environment Friendly Use Period of
10 years in China.
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