General Sleep Zmachine Insight User manual

Patient Guide
Zmachine®Insight & Insight+
30 minutes before bedtime,
begin the instructions on page 6

Patient Guide
i
About this Guide
You are advised to read and understand this entire guide before using
the Zmachine.
The information in this guide has been carefully checked and is believed to
be accurate. However, in the interest of continued product development,
General Sleep Corporation reserves the right to make changes and
improvements to this guide and to the product(s) that it describes, at any
time, and without notice or obligation. If you do not understand the
instructions contained in this guide, or require assistance in setting up,
using, or maintaining this equipment, please contact your healthcare
provider or General Sleep Corporation.
Caution:
Federal Law (USA) restricts this device to sale by, or on the order of, a
physician or other qualified healthcare practitioner licensed by the laws of
the state in which he or she practices to use or order the use of this device.
Mailing and Shipping Address
General Sleep Corporation
26250 Euclid Avenue, Suite 709
Cleveland, OH 44132, USA
Telephone
[phone]
Web Site
www.GeneralSleep.com
Guide Revision: 1.6
Copyright © 2019 by General Sleep Corporation
All rights reserved

ii
Patient Guide
Table of Contents
About this Guide i
Table of Contents ii
Introduction 1
Indications for Use 1
Symbol Descriptions 1
Description of Components 2
The Zmachine Indicators & Elements 3
Warnings and Cautions 3
Disposal 4
Cleaning 4
Interference 4
Positioning the Zmachine 5
Step 1: Clean/Prepare Skin 6
Step 2: Apply Sensor Pads 7
Step 3: Secure the Sensor Pads 8
Step 4: Attach the Patient Cable 9
Step 5: Connect the Patient Cable 10
Step 6: Zmachine Sleep Functions 11
Step 7: Disconnect the Patient Cable 12
Step 8: Remove the Sensor Pads 13
Step 9: Charge 14
Frequently Asked Questions 15
Legal 16

Patient Guide
1
Introduction
The Zmachine®Insight and Insight+ are high technology sleep systems
that use state-of-the-art brainwave monitoring technology to determine
your unique sleep patterns. The Zmachine is typically used in the home to
assist your healthcare provider in understanding and improving your sleep.
Indications for Use
The Zmachine is a single-channel, EEG acquisition and analysis system,
designed for use in the home or clinical environments. This device is
intended to be used by qualified healthcare practitioners to monitor the
wake and sleep states of adult patients and as an adjunct to their diagnosis
of sleep disorders.
Symbol Descriptions
Symbol Definition of Symbol
Read and understand the instructions before using this
system.
This system is not rated for use in wet conditions. Keep
dry.
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.
IEC 60601-1 Type BF applied parts.
Built according to RoHS (Restriction of Use of
Hazardous Substances) regulations that limit or ban
specific substances in new electronic and electric
equipment.
Product tested and certified by SGS North America,
Inc. to meet worldwide safety standards.

2
Patient Guide
Description of Components
The Zmachine system may include some or all of the following items:
Zmachine
Patient Cable
Charger
Sensor Pads
Alcohol Swabs
Patient Guide
(this document)
Hanging Cover
Travel Case
Note: Due to differences in brand and model numbers, part
appearances may vary. Only use General Sleep approved parts
and accessories.

Patient Guide
3
The Zmachine Indicators & Elements
Warnings and Cautions
If you have any questions or concerns, you should contact your Healthcare
Provider before using the Zmachine.
Warnings and Cautions
Do not use the Zmachine on newborns, infants, or children. The
Zmachine has only been tested on adults.
Do not use the Zmachine if you have a pacemaker, cardiac defibrillator,
or other medical electronic device.
Do not use the Zmachine in an oxygen rich or explosive atmosphere.
Do not use the Zmachine if you have fragile or damaged skin.
Do not use the Zmachine if you feel that you may not be capable of
freeing yourself in the event that you become tangled with the patient
cable.
Keep all parts and accessories out of reach of children and pets. The
small parts and accessories (such as sensor pads and their clear
backings) could present a choking hazard to small children and pets.
Some patients may experience skin irritation, hypersensitivity, or
allergic reaction to the self-stick sensors. If this occurs, discontinue use
of the Zmachine and contact your healthcare provider for further
instructions.
Take care to arrange the patient cable in such a manner as to avoid
entanglement.
Do not open the Zmachine enclosure for any reason.
Electric blankets should not be used with the Zmachine as this may
interfere with the sensitive amplifiers.
Sensor/Charger
Port
System Buttons
MicroSD
Socket
System Display

4
Patient Guide
Warnings and Cautions
The Zmachine should be kept away from transmitters, power
transformers, motors and similar equipment that generate strong
electromagnetic fields.
Do not allow the conductive parts of the Zmachine sensor pads and
connectors to contact other conductive parts, including earth ground.
Do not immerse the Zmachine in liquid. Care should be exercised to
avoid exposing the Zmachine to liquids or small particles.
The Zmachine is designed for indoor use only. If exposed to cold
temperatures during transportation, allow the Zmachine system to reach
room temperature before using.
If, at any time, function or safety of the Zmachine is thought to be
impaired, the Zmachine device should be taken out of operation, secured
against unintended use, and returned to your system provider. Do not
attempt to service the Zmachine.
The Zmachine includes an internal Lithium Ion battery and must not be
disposed of in a fire.
Disposal
Dispose of any used sensor pads and alcohol swabs, but do not dispose of
the Zmachine system or accessories. These should be returned to your
system provider.
Cleaning
The outer surfaces of the Zmachine may be cleaned as needed. To remove
fingerprints and dirt, use a small amount of water or isopropyl alcohol to
dampen a soft cloth and wipe the surface clean. Do not immerse the
Zmachine or allow any liquid to enter the enclosure.
Interference
The Zmachine acquires and analyzes very low level brainwave signals. As
such, equipment that generates strong electromagnetic fields (such as
electric blankets) should not be used with the Zmachine.

Patient Guide
5
Positioning the Zmachine
If you received your Zmachine with a hanging cover and a 3M Command®
Medium Utility Hook (pictured), your system can be positioned to hang
behind your head during sleep. This allows you to orient the patient cable
toward the top of your head, thereby allowing the maximum freedom of
movement during sleep.
Apply the 3M Command Hook in accordance with manufacturer
instructions. Locate the hook at the head of your bed, either on the wall or
headboard, just to the side of where you normally sleep, and approximately
two (2) feet above your bed (see red boxes for sample locations).
Locate the hook such that the Zmachine will not hit
your head if it were to fall.
3M Command Hook
(medium size)
Hanging Cover (white)

6
Patient Guide
Step 1: Clean/Prepare Skin
At least 30 minutes before going to bed, prepare skin for the sensor pads as
shown:
Using an alcohol swab, clean the three circled areas on your skin. One
swab is enough for all three areas.
Bony
area
behind
left
earlobe
Center of
neck
(approx.)
Use alcohol
swab to clean
these areas
Bony
area
behind
right
earlobe
Clean these areas
Hint: A mirror can be helpful for this and the next step.
Note: Let skin air dry for about 30 seconds, or pat dry with a tissue,
before applying the sensor pads.
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