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.
→

Patient Guide
7
Step 2: Apply Sensor Pads
Apply the sensor pads as shown:
←
Bony area
behind left
earlobe
←
Center of
neck
(approx.)
Peel and
discard the
clear backing
←
Bony area
behind right
earlobe
Place sensor pads
Warning! The clear backings are a choking hazard and
should be kept away from children and pets.
Hint: A mirror can be helpful in positioning the sensor pads behind
your ears. The location of the neck sensor pad needs only be
approximate.
Hint: Do not fold your earlobe out of the way when applying the ear
sensor pads as this could place the sensor in the fold of your ear
which may be uncomfortable.
→

8
Patient Guide
Step 3: Secure the Sensor Pads
Never press the center portion of the sensor pad. Rub the outer edge of
each sensor pad with your fingertip to secure the adhesive.
NO!
YES
Note: If you are not satisfied with the placement of a sensor pad, simply
remove, discard, and repeat the steps above using a fresh sensor
pad. Never re-use a sensor pad.
Now, wait 30 minutes before continuing onto Step 4.
This will allow time for the sensor pads to adhere
properly to your skin.

Patient Guide
9
Step 4: Attach the Patient Cable
When ready for bed, snap the individual patient cable wires onto the sensor
pads as shown.
BLACK wire to the NECK sensor pad
WHITE wires to the EAR sensor pads
CORRECT
Note: The BLACK wire should ONLY be attached to NECK sensor.
Note: Either white wire can be connected to either ear sensor.
Hint: You can arrange the wires to fall in front or behind you,
whichever is more comfortable.

10
Patient Guide
Step 5: Connect the Patient Cable
When you are in bed and ready to attempt sleep (not reading or doing any
other activity), plug the free end of the patient cable into the Zmachine.
The Zmachine will turn on automatically.
→
Connecting the Patient cable to the Zmachine
After starting, the Zmachine will automatically check the connection
between the sensor pads and your skin. If a sensor needs to be replaced,
and at least 30 minutes has passed since the sensor pads were applied,
simply remove, discard, and repeat the steps above using a fresh sensor
pad. Never re-use a sensor pad.
All Pass Replace white wire with
2 raised bumps
Note: One of the white sensor wires has two raised bumps on the snap
connector which can be felt with your finger tip, and the other is
smooth. These bumps are used to distinguish the wires during the
sensor check.
Hint: The Zmachine display will automatically dim and then turn off
while running. Pressing any button will wake the display for a
few seconds. The system continues to run while the display is off.

Patient Guide
11
Step 6: Zmachine Sleep Functions
When the Zmachine is collecting your sleep information, it will display the
Recording screen.
Recording Screen
Insight+ Only:After about two nights of use, the Zmachine will
automatically switch from Recording to Recording+. At this time, the
Zmachine may display additional information about your sleep (updated
and displayed each time you unplug the patient cable), and/or may produce
an alert for you to leave bed (beeping sound while displaying an empty
bed).
Recording+
Sleep Statistics
Leave Bed Alert
Note: Your healthcare provider may, or may not, have enabled the
functions described above.

12
Patient Guide
Step 7: Disconnect the Patient Cable
When leaving bed for any reason or when you are no longer trying to
sleep, unplug the patient cable from the Zmachine while lifting slightly on
the connector to disengage the locking tab.
→
Disconnecting the Patient cable from the Zmachine
Note: The Zmachine will automatically stop monitoring and finish
processing (this may take several seconds). The system display
will automatically dim and then turn off. The Zmachine will shut
down completely within two minutes.
Hint: If planning to return to bed, place the Zmachine on your pillow as
a reminder to re-connect when you return to bed. If you are done
sleeping, then proceed to the next steps.

Patient Guide
13
Step 8: Remove the Sensor Pads
When you are finished trying to sleep and the patient cable has been
disconnected from the Zmachine:
1. Unsnap the patient cable wires from the sensor pads.
2. Carefully peel the sensor pads from you skin and discard.
3. Remove any remaining gel and/or adhesive from your skin using
soap and water or an alcohol swab.
→
Unsnap patient cable
wires
Remove sensor pads &
clean skin
Warning! The used sensor pads are a choking hazard
and should be kept away from children and pets.

14
Patient Guide
Step 9: Charge
The Zmachine has enough battery power to run for one full night and
should be charged during the day in preparation for the next night of use.
1. Plug the free end of the charger cable into the Zmachine.
2. Plug the charger into a wall outlet. The Zmachine will start and
stop charging automatically and can safely remain connected to the
charger until ready for the next use.
Connect charger to
Zmachine
Plug charge into wall outlet
Note: Always fully charge the Zmachine before each use. It can take at
least three hours to obtain a full charge.

Patient Guide
15
Frequently Asked Questions
Can I get out of bed for a drink, to use the bathroom, etc. when connected
to the Zmachine?
Yes, simply unplug the patient cable from your Zmachine and place the
Zmachine on your pillow. The patient cable can stay connected to your
sensor pads when you are out of bed. When you return to bed, simply re-
connect to the Zmachine to continue.
Can I lie on the patient cable?
Yes, lying on the patient cable and wires is absolutely fine and will not
influence the recording.
I feel that my skin is a little irritated when I first remove the sensor pads in
the morning. Is this normal?
Yes, the sensor pads can cause minor skin irritation or drying for some
people. This is normal with daily use and should disappear within about a
half hour following removal of the sensor pads and cleaning of any
residual gel and/or adhesive. If your skin is dry, you may use a dab of
hand lotion or face lotion over the affected areas in the morning. If you
have any concerns, discontinue use and contact your healthcare provider
for further instructions.
Do I need to charge the Zmachine every morning?
Yes, the Zmachine needs to be re-charged every morning in preparation for
the next night of use. To ensure a full charge, the Zmachine can remain
connected to the charger until ready for the next use.

16
Patient Guide
Legal
Trademark and Intellectual Property Rights
The Z logo, Zmachine, and General Sleep are registered trademarks of General Sleep Corporation.
The Zmachine has been designed and developed by General Sleep Corporation, Cleveland, Ohio, USA.
At the time this manual was printed, the Zmachine was protected by the following patents:
United States Patents: 5813993, 7654948, 8089283, 8512221
Canadian Patents: 2201694, 2516093, 2783015
European Patents: 1124611, 2512573
Japanese Patents: 4532739, 4721451, 5684828
User Agreement
This User Agreement (“Agreement”) sets forth the terms of use by and between Consolidated
Research, Inc. d/b/a General Sleep Corporation (“GSC”), an Ohio corporation, whose address is 26250
Euclid Avenue, Suite 709, Cleveland, OH 44132, and the user of the subject equipment known as the
Zmachine (“User”). User agrees that the Zmachine will at all times be used and operated solely in the
conduct of User’s business for the purpose for which it was designed and intended and under and in
compliance with applicable laws and all lawful acts, rules, regulations and orders of any governmental
bodies or officers having power to regulate or supervise the use of such property. User further agrees
to ensure that third parties to which it gives access to the Zmachine will at all times be used and
operated solely in the conduct of User’s business for the purpose for which it was designed and
intended and under and in compliance with applicable laws and all lawful acts, rules, regulations and
orders of any governmental bodies or officers having power to regulate or supervise the use of such
property. The Zmachine contains certain pre-loaded computer software which is licensed but not sold
or otherwise transferred to User and is subject to the Software License Agreement terms contained in
this Manual. GSC warrants that the Zmachine will be free from defects in workmanship or materials,
when given normal, proper, and intended usage for a period of two (2) years (“Warranty Period”) from
the date of its shipment to User. Excluded from this warranty are expendable components and supply
items such as, but not limited to, sensors and sensor cables. GSC’s obligations under this warranty are
to repair or replace any warranted product (or part thereof) that GSC reasonably determines to be
covered by this warranty and to be defective in workmanship or materials provided that the User has
given notice of such warranty claim within the Warranty Period and the warranted product is returned
to the GSC with freight prepaid. Repair or replacement of products under this warranty does not
extend the Warranty Period. To request repair or replacement under this warranty, User should contact
GSC directly. GSC will provide User with a Return Material Authorization (RMA) number to return
the Zmachine (or part thereof) (“Warranted Product”) to GSC. GSC shall determine whether to repair
or replace the Warranted Product; all products or parts replaced shall become GSC’s property. In the
course of warranty service, GSC may, but shall not be required to, make engineering improvements to
the Warranted Product. If GSC reasonably determines that a repair or replacement is covered by the
warranty, GSC shall bear the costs of shipping the repaired or replaced product to User. All other
shipping costs shall be paid by User. Risk of loss or damage during shipments under this warranty
shall be borne by the party shipping the product. Products shipped by User under this warranty shall be
packaged in the original shipping container or equivalent packaging to protect the product. If User
ships a product to GSC in unsuitable packaging, any physical damage present in the Product on receipt
by GSC (and not previously reported) will be presumed to have occurred in transit and will be the
responsibility of User. This warranty does not extend to any Warranted Product that has been subject
to misuse, neglect, or accident; that has been damaged by external causes such as failure of or faulty
electrical power; use in violation of GSC’s instructions; nonstandard accessory attachment; on which
the serial number has been removed or made illegible; modification by anyone other than GSC;
disassembly, service, or reassembly by anyone other than GSC, unless authorized by GSC. GSC shall
have no obligation to make repairs, replacements, or corrections which result, in whole or in part, from
normal wear and tear. GSC makes no warranty (a) with respect to any products that are not Warranted
Products, (b) with respect to any products purchased from a person other than GSC or a GSC-
authorized distributor or (c) with respect to any product sold under a brand name other than GSC. This
warranty is void if the User resells the Zmachine to a third party. THIS WARRANTY IS THE SOLE
AND EXCLUSIVE WARRANTY FOR GSC’S PRODUCTS, EXTENDS ONLY TO THE USER
THAT HAS PURCHASED THE ZMACHINE FROM GSC OR AN AUTHORIZED DEALER,
AND IS EXPRESSLY IN LIEU OF ANY OTHER EXPRESS OR IMPLIED WARRANTIES
INCLUDING WITHOUT LIMITATION ANY WARRANTY AS TO MERCHANTABILITY