Safety Checks
Warning:
Inspect the Oximeter, cables, Sensors, and other accessories for damage prior
to operation. There is a risk that damaged parts could reduce the performance
of the Oximeter or present a safety hazard. If any damage is noted, or if the
Oximeter fails to respond, the Oximeter or accessory should not be used
until it has been inspected and serviced or replaced by CASMED-authorized
personnel.
Warning:
The operator must not perform any servicing on the Oximeter except as
specifically stated in Chapter 6,
Cleaning and Maintaining the Oximeter
on
page 63.
The parts of the Oximeter include the Oximeter, Preamp cable(s), Battery,
AC power Cord and Sensor(s). The accessories for the Oximeter include, but
are not limited to: USB flash drive, StO
2
Simulator and mounting hardware.
See Appendix F, Parts on page 93 for a listing of approved parts and
accessories.
Warning:
Liquids must not be allowed to enter the device. There is a risk of electric
shock or device malfunction if liquids enter a device. If the Oximeter or Preamp
is accidentally wetted, take it out of operation. It must be thoroughly dried
(minimum 1 hour) and checked by a CASMED-authorized service technician
before it is used again.
Parts and Warranty
CAS Medical Systems, Inc., (CASMED) is responsible for the effects on safety, reliability, and
performance of the product only if:
•
Assembly, operations, extensions, readjustments, modifications, or repairs are carried out
by persons authorized by CASMED.
•
The electrical installation of the relevant room complies with the requirements of the
appropriate regulations.
•
The device is used in accordance with the instructions for use.
•
All publications conform to the product specifications and applicable IEC publications on
safety and essential performance of electro-medical equipment as well as with applicable
UL requirements and AHA recommendations valid at the time of printing.
The CASMED quality management system complies with the international standards ISO 13485
and the Council Directive on Medical Devices 93/42/EEC.
Warning:
Only use CASMED-supplied accessories with this Oximeter. CASMED-
supplied accessories ensure patient safety and preserve the integrity, accuracy,
and electromagnetic compatibility of the Oximeter.
The warranty does not cover damages resulting from the use of accessories and consumables
from other manufacturers. For complete warranty information, refer to Appendix G,
Warranty
Policy
, on page 95.
PN 21-22-3000 Rev 07
xvii
FORE-SIGHT ELITE User Manual
