Advanced Bionics CI-1605 Gerätebeschreibung Seite 3

The symbols used on the labeling and their meanings are as
follows:
CAUTION: Federal law restricts this device to sale, distribution, and use
by or on the order of a physician.
European Community Mark of Conformity. Authorized to affix
CE Marking in 2017
0123
XXXX-XX-XX
XXXX-XX-XX
+50˚C
0˚C
150 kPa
70 kPa
Warnings
• The HiFocus™ SlimJ Electrode Depth Gauge (hereafter
referred to as the Depth Gauge) should not be resterilized or
reused. Do not use if the sterile packaging is damaged.
• The Depth Gauge should not be used as a stent in the patient.
• The safety of performing MRI with the Depth Gauge in the
patient has not been established. Do not perform MRI with the
Depth Gauge in the patient.
Model number
Date of
manufacture
Use By Date
See instructions
for use
Temperature product should be stored at
Sterile Lot
Number
Suitable for atmospheric range between 70 kPa and
150 kPa, which is equivalent to altitude 3000 m above
sea level and 5 m depth underwater.
Serial number
Manufacturer
Fragile
Single-use only, do
not resterilze product
Ethylene oxide
sterilized
1