Introduction
Laborie NXT Pro Owner’s Manual LBL-00146 [C], MAN2010 17
Improper processing of reusable items prior to initial use or reuse can result in cross-
infection and/or cross-transmission of infectious disease from one patient to another.
Risks associated with catheterization increase immediately after urethral or bladder
surgery. The performance of urodynamic studies with post-operative patients is at the
discretion of the physician.
Medical care professionals performing urodynamic studies should be prepared to
recognize and treat symptoms associated with ureteral catheterization, vasovagal
syncope (fainting), and Autonomic Dysreflexia.
To avoid potential patient injury, never clean or service any module or component of the
NXT system while in use with a patient.
The use of the Medical Electrical (ME) equipment is restricted to one patient at a time.
Do not use the NXT system in the presence of a magnetic resonance imaging (MRI)
system, as the NXT system may contain ferromagnetic objects that pose a risk to the
patient in the presence of a magnetic core.
To avoid risk of electric shock, do not touch the pogo pins located inside the NXT docking
station, Urocap NXT charging hub, or Urocap NXT wall charger.
To avoid the risk of electric shock, only connect this equipment to a mains power supply
with protective earth. All devices must be powered by the Line Isolation Transformer or
the wall charger specified in the Instructions for Use.
Do not connect any additional multiple-socket outlets or extension cords to the NXT
system or any of its components.
This device is intended for use in a clinical environment with controlled EMC standards to
limit potential interference. The NXT system may be adversely affected by Bluetooth,
cellular, or EMC interference. Minimize interference from other Bluetooth devices by
setting up all modules of the system in proximity to one another.
Electromagnetic interference in the form of electrostatic discharge or radiated emissions
can cause the NXT system components to temporarily disconnect. Components may
require a power cycle before operation can resume after exposure to these
electromagnetic interferences.
Only connect devices specified and approved by Laborie to the NXT system multiple-
socket outlets. Connecting any device not approved by Laborie to the ME system alters
the functional integrity of the product, creating a safety risk.
Always position the NXT system to facilitate ease of access to all electrical connections
and plugs. The device operator must be able to disconnect the device quickly and safely
in case of an emergency.
Avoid use of this equipment adjacent to or stacked with other equipment, as it could
result in improper operation. If such use is necessary, observe this equipment and the
other equipment to verify that they are operating normally.
Do not alter or add to the NXT medical electrical system. Any alteration to the NXT
system by an unauthorized party transfers responsibility for meeting ME system
requirements from Laborie to the altering party. Anyone connecting supplementary
equipment to ME equipment configures a medical system and is therefore responsible for
ensuring that the system complies with the requirements for ME systems, encompassed
in the IEC/EN 60601 series.
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