Product Manual

1-6 SEER
®
Light 2040604-012D
Manual Information
WARNING
CARDIAC APPLICATION This device cannot be used
for direct cardiac application.
WARNING
LEAKAGE CURRENT — Electrical shock to patient
could result from component failure and lack of power
isolation.
In the event this system is used in the patient vicinity/
environment, it must be configured in such a way that it
and all of its electrically-connected peripheral devices are
isolated from mains power to prevent excessive leakage
current to the patient. Use of isolated mains power, or a
medical grade isolation transformer (in compliance with
UL 60601, CAN/CSA C22.2 No. 601.1, EN/IEC 60601-1)
with this system will support compliance with EN/IEC
60601-1-1. All nonmedical peripheral devices shall
comply with applicable EN/IEC/ISO and UL safety
standards that are relevant to that equipment (i.e., EN/
IEC 60950, UL 60950). The overall system (device and all
of its connected peripheral devices) must comply with EN/
IEC 60601-1.
Use of SEER Light Connect device in the patient vicinity
requires that these measures are observed.
Patient vicinity/environment defined as:
Any volume in which intentional or unintentional
contact can occur between patient and parts of the
system or between patient and other persons touching
parts of the system (IEC 60601-1-1).
A space (volume), within a location intended for the
examination and treatment of patients, extending 6 ft
(1.83 m) beyond the normal location of the bed, chair,
table, treadmill, or other device that supports the
patient during examination and treatment and
extending vertically to 8 ft 2.4 in. (2.5 m) above the
floor.
Areas where healthcare staff members monitor
patients remotely and perform charting and
administrative tasks are not considered to be Patient
Vicinity/environment areas.