Introduction
NXT Owner’s Manual NXT-UM01, MAN2010
17
Re-use, reprocessing, or resterilization of disposables can lead to device failure and create
a risk of cross-infection and/or cross transmission of infectious disease(s) from one
patient to another.
NXT System Accessories are not intended to be defibrillation-proof.
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 equipment is restricted to one patient at a time.
Do not use the NXT System in the presence of a magnetic resonance imaging 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.
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 each other.
Only connect devices specified and approved by LABORIE to the NXT System multiple
socket outlets. Connecting any device not approved by LABORIE to the Medical Electrical
(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.
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 medical electrical systems,
encompassed in the IEC/EN 60601 series.
Batteries are not operator replaceable (except for in the Remote Control NXT). Do not
attempt to remove the battery. All servicing of the NXT System, modules, or attachments
must be completed by LABORIE authorized personnel.
NOTE:
Local laws take priority over the above-mentioned requirements and warnings;
if in doubt, consult your local LABORIE representative or the technical service department.
