H-1100 - Smiths Medical

SECTION 4
Important Safety Information
This section covers information for prescribers and guidelines for safe use
of the Level 1 ® NORMOFLO ® H-1100 Irrigation Fluid Warmer (Fluid
Warmer).
WARNINGS
Death or serious injury may occur to the patient or user if these
warnings are not followed:
S E C T I O N 4 • I m p o r t a n t S a f e t y I n f o r m a t i o n
• Read and follow all instructions, labeling, and accompanying
documents supplied with this medical device. Failure to follow
instructions, including all warnings and cautions, could result in
death or serious injury to the patient or user.
• Do not use the Fluid Warmer in high-energy fields such as: MRI,
X-RAY, portable and mobile RF communications equipment, and
other such devices. The Fluid Warmer may act as a projectile in
a strong magnetic field, cause image artifacts, or not function
as intended.
• Do not bend the heat exchanger. Bending may damage the
heat exchanger allowing communication between the
recirculating solution and irrigation fluid path, resulting in the
delivery of inappropriate fluids.
• Exposed conductor on MAINS power cord can cause an
electrocution hazard. Remove device from service if MAINS
power cord has exposed wires.
• Activation of the Over Temperature warning signal indicates
that warming has stopped and immediate operator intervention
is required. Failure to clear the over temperature condition or to
take the device out of service may result in death or serious
injury to the patient.
Continued
4 Level 1 ® NORMOFLO ® H-1100 Irrigation Fluid Warmer | Operator’s Manual