IFU-01, Rev. A Page 13 of 20
The following marking information will be placed on the package:
Description:
VitalConnect Sensor Patch, (Patch
Model No.: 545-00006-00, Sensor
Model No.: 600-00001-00)
CAUTION:
- Do not place device on broken
skin. If irritation develops,
discontinue use
- For individual use only
- Do not use if package has been
opened
- Do not use if you have an
implanted device such as a
pacemaker
For detail information, see Instructions
for use
Manufactured by:
Vital Connect, Inc.
2105 S. Bascom Ave
Campbell, CA 95008
408-963-4600
www.vitalconnect.com
Underwriters Laboratories
MEDICAL — PATIENT MONITORING EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005), "Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance;
CAN/CSA-C22.2 No. 60601-1:08; ANSI/AAMI/IEC 60601-2-25,
"Medical Electrical Equipment - Part 2-25: Particular Requirements for the
Basic Safety and Essential Performance of Electrocardiographs" E358758
Recommended shipping and storage temperature range: 0 – 50 deg C
Recommended shipping and storage relative humidity range: 10 – 95% RH
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