LABORIE NXT Go Owner's Manual page 11

Do not reuse single-use accessories. After use, dispose of single-use accessories in accordance with local
regulations.
Reuse, 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.
Healthcare 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 the risk of electric shock, only connect this equipment to a mains power supply with protective
earth.
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 Go system. Connecting any device not
approved by Laborie to the ME system alters the functional integrity of the product, creating a safety risk.
Only connect devices specified and approved by Laborie to the NXT system. Connecting other electrical
equipment to the multiple-socket outlets effectively leads to creating a ME system and the result can be
a reduced level of safety. Do not connect any additional multiple-socket outlets or extension cords to the
NXT system or any of its components.
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 ME 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.
Chapter 1 Introduction 5