0703-001-700 Rev-C
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9
4.4 Electrical Safety
WARNINGS:
ELECTROMAGNETIC INTERFERENCE HAZARD
▪ Use only Stryker-approved electronic components
and accessories. Failure to comply may result in
increased electromagnetic emissions or decreased
electromagnetic immunity of the system.
▪ Take special precautions regarding electromagnetic
compatibility (EMC) when using this medical electrical
equipment. Install and place this medical electrical
equipment into service according to the EMC
information contained in this manual. See
Section 15
Electromagnetic Compatibility
. Portable and mobile
radio frequency (RF) communications equipment
can affect the function of this medical electrical
equipment.
ELECTRICAL SHOCK HAZARD
▪ ALWAYS connect this equipment to a hospital-
grade, facility power receptacle with protective earth
(ground).
▪ DO NOT touch or make contact with the rover and
patient simultaneously.
Failure to comply may cause electrical shock and result in
patient or healthcare staff injury.
4.5 Environmental/Biological Safety
WARNINGS:
FIRE HAZARD:
DO NOT use this equipment in areas in
which flammable anesthetics or flammable agents are
mixed with air, oxygen or nitrous oxide. Failure to comply
may cause a fire and result in burn injury or property
damage. See
BS EN ISO 10079-1: 2009, clause 9.4
.
BLOODBORNE PATHOGEN HAZARD
▪ The Bloodborne Pathogens Standard provided by
the United States Occupational Safety and Health
Administration (US OSHA 29 CFR 1910.1030) requires
those employers with employees having occupational
exposure to potentially infectious materials to establish
a written Exposure Control Plan. The Exposure Control
Plan is designed to eliminate or minimize employee
exposure through use of personal protective equipment
(PPE), appropriate vaccinations (for example, hepatitis
B), and other control measures.
▪ ALWAYS wear PPE when operating or handling this
equipment.
▪ ALWAYS follow local regulations regarding proper
handling and disposal of biohazard waste.
Failure to comply may cause infection and result in
healthcare staff injury.
CONTAMINATION HAZARD
▪ DO NOT collect fluids from patients being treated with
radioisotopes or hazardous chemical agents.
▪ ALWAYS follow local regulations for safe handling,
recycling, and disposal of biohazard fluid waste and
equipment. See
Section 12 Disposal/Recycle
.
Failure to comply may cause environmental contamination
and result in injury.
INFECTION HAZARD
▪ ALWAYS clean and disinfect the equipment as
indicated upon initial receipt and before each use.
▪ DO NOT place the rover within the sterile field.
▪ DO NOT reuse, reprocess, or repackage a manifold
that is intended for single use only.
– A single use device may not withstand chemical,
chemical vapor, or high temperature sterilization
reprocessing.
– Design features may make cleaning and
disinfection difficult.
– Reuse may create a contamination risk or
compromise structural integrity resulting in
operational failure.
– Critical product information may be lost during
repackaging.
Failure to comply may lead to infection or cross infection
and result in patient and/or healthcare staff injury.
FLUID WASTE LEAKAGE HAZARD:
ALWAYS make sure
rover power is ON when collecting fluid waste. The rover
can only detect full canisters if the rover power is ON. If
rover power is OFF, fluid waste leakage can occur.
0000160552, Rev. C Effective Date: Nov 25, 2015 1:43:15 PM
Print Date: Nov 25, 2015 02:19:13 PM
