Cautions - General Sleep Zmachine Insight+ DT-200 Service Manual

•
The Zmachine has been designed so that it cannot be connected to the wall charger and
connected to a patient simultaneously. Please do not attempt to defeat this intentional
safety feature.

Cautions

•
Federal Law (USA) restricts this device to sale by, or on the order of, a physician or other
qualified healthcare practitioner licensed by the law of the state in which he or she
practices to use or order the use of this device.
•
Read and understand this entire manual before using the Zmachine.
•
Clinicians are advised to instruct patients on the proper use of the Zmachine system.
•
The Zmachine includes an internal Lithium Ion battery and must not be disposed of in a
fire.
•
The Zmachine contains an internal Lithium Ion battery; this battery is not user replaceable.
Following a full charge, if the Zmachine fails to operate for at least 12 hours, then the
battery has reached end-of-life. Please contact General Sleep for battery replacement.
•
Only use General Sleep approved parts and accessories, including but not limited to,
sensors, sensor cables, chargers and microSD cards.
•
The Zmachine employs high sensitivity amplifiers to acquire and analyze very low
amplitude EEG signals. As such, it is possible that there may be some unavoidable
interference from radio frequency magnetic fields, electrostatic discharges and low
frequency magnetic fields. This interference may alter the results from the Zmachine
system. Transmitters, power transformers, motors and similar equipment that generate
strong electromagnetic fields should not be used in close proximity to the Zmachine.
•
Electric blankets should not be used with the Zmachine as this may interfere with the
sensitive EEG amplifiers.
•
Do not allow the conductive parts of the Zmachine sensors and connectors to contact other
conductive parts, including earth ground.
•
The Zmachine may not work adequately for some patients, such as those with highly
fragmented sleep, or an abnormal EEG signal. Some medications that affect the EEG
signal could affect Zmachine performance.
•
In order for the Zmachine to product accurate results, the patient must have achieved some
sleep.
•
The Zmachine is not protected against ingress of water or particulate matter. Care should
be exercised to avoid exposing the Zmachine to liquids or particulate matter.
•
Do not immerse the Zmachine in liquid to clean.
8 Contraindications, Warnings and Cautions