LABORIE Urocap IV Owner’s Manual UC4-UM01
9
1.3
CAUTIONS AND WARNINGS
READ CAREFULLY BEFORE USE
CAUTION
United States Federal Law restricts this device to sale or use by, or on the order of, a licensed physician.
GENERAL SYSTEM WARNINGS:
•
Only technicians and physicians trained in Urodynamics should operate this device. The operator must read
the Owner’s manual entirely and refer to any additional training materials before using the device. Optional
In-Service is available from LABORIE.
•
The Urocap™ IV system and associated devices are intended for indoor use only and under the following
standard operating conditions:
o
Temperature: +10ºC to +40ºC
o
Humidity: 30% to 75% relative humidity
o
Pressure: 700 to 1060 hPa (up to 2000m)
•
Physicians and technicians MUST inform patient of any potential risks of the procedure including potential
discomfort, dysuria and hematuria.
•
DO NOT USE in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
•
Do not use if device packaging has been opened, or damaged, or if it presents any fault due to improper
transport, storage, or handling that could in any way hamper its use.
•
DO NOT STAND anywhere on the system or its devices. The devices are not designed to support the weight
of a person.
•
DO NOT immerse the Urocap™ IV equipment or any components in water or any other liquids.
•
DO NOT USE the Urocap™ IV in the presence of a magnetic resonance imaging system as it may contain
ferromagnetic objects that pose a risk to the patient in the presence of a magnetic core. The strong
magnetic field produced by the MRI may cause disruption of the system.
•
DO NOT ATTEMPT TO OPEN OR REPAIR the Urocap™ IV system components by yourself or by an
unauthorized party. ONLY Laborie-trained technicians may service the Urocap™ IV system components.
•
LABORIE equipment and accessories are licensed by Governments and approved by Safety Agencies to
work with each other ONLY.
•
LABORIE equipment and accessories are warranted to work with each other ONLY.
•
No modification of this equipment is allowed.
•
DO NOT STERILIZE the Urocap™ IV system components.
•
Use Input and Output Cables and Cords provided by LABORIE only.
•
Exposure to ESD may cause the system to RESET.
•
To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth
to prevent damage or injury.
