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LABORIE Urocap™ IV Owner’s Manual UC4-UM01
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Connecting electrical equipment to a multiple socket outlet effectively leads to creating a medical electrical
system and can result in a reduced level of safety.
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The Urocap™ IV system must be positioned in such a way to provide unobstructed access to the power cord
connector in the event of a required emergency stop.
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Do not place the printer in the patient environment unless it is powered via the Laborie provided Line
Isolation Transformer (Separating transformer).
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Only connect items that have been approved by Laborie to the system. Any additional connections become
the responsibility of the operator and shall tested to meet the IEC 60601-1, ME SYSTEMS requirements.
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There is the risk of electrical shock if the operator plugs in Non-ME Equipment (i.e. printer or laptop) directly
into the MAINS supply that is intended to be powered by a Line Isolation Transformer (Separating
transformer)
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Do not touch the printer/laptop and the patient simultaneously.
General System Important Information
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Before the procedure, verify that the Urocap™ IV system components and software are functioning properly.
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LABORIE is not responsible for loss of patient files or test data. It is strongly recommended to back up patient
data on a regular basis.
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To avoid the potential of incorrect data reporting, always verify all remote events are downloaded with data.
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Avoid accidental contact between connected but unused applied parts and other conductive parts including
those connected to protective earth to prevent damage or injury.
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Do not plug or unplug devices, or pair or unpair Bluetooth devices, while the Urocap™ IV system is in use.
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Calibration should be checked at least every six (6) months or whenever there is a suspicion that the
calibration is incorrect. ONLY calibrate the transducers if necessary.
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To ensure proper system use, follow the equipment setup instructions in the Equipment Setup section in this
manual.
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To avoid disruption, ensure the Urocap™ IV uroflowmeter is plugged in to a power outlet during test
procedures.
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It is important that the beaker is well centered on the Urocap uroflowmeter and does not touch the funnel.
DO NOT TOUCH the beaker during voiding and ensure the patient does not touch or move the beaker
during a procedure.
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In case of device connection/Bluetooth connection interruption, reconnect the devices as outlined in this
manual
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To avoid the risk of device connection interruption, reduce the distance between the device and the
computer. The maximum distance between the processor and the computer can be up to 10 meters (33 feet).
Also, remove any physical barriers like walls, posts, doors, or people.
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To reduce the risk of equipment connection failure, the software contains built-in algorithms that add
checksum (CRC) protocols to data transmissions. In the event the data received is not correct, an alert
message is displayed to the user.
Generals System Safety Compliance
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The Urocap™ IV uroflowmeter enclosure is classified IP54 according to degree of protection against ingress
of water and particulate matter as per the test requirements of IEC 60529.
