General Sleep Zmachine Synergy User manual

Patient Guide
Zmachine®Synergy
20 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 Synergy.
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: 1.12
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
Indication for Use 1
Symbol Descriptions 1
Description of Components 2
The Zmachine Synergy Indicators & Elements 3
Warnings and Cautions 4
Disposal 5
Cleaning 5
Interference 5
Using the System 5
Step 1: Clean/Prepare Skin 6
Step 2: Apply Sensor Pads 7
Step 3: Setup Effort Belt 8
Step 4: Connect Cable and Sensors 9
Step 5: Connect the Cannula 10
Step 6: Connect the Finger Probe 11
Step 7: Review (not really a step) 12
Starting the Test 13
Stopping the Test 14
Frequently Asked Questions 15
Legal 16

Patient Guide
1
Introduction
The Zmachine®Synergy is a high technology sleep monitor developed by
General Sleep Corporation. The system records signals related to your
brainwave patterns, breathing, and body position during sleep. The system
was designed for easy in-home use.
Indication for Use
The Zmachine®Synergy is an EEG and respiratory signal recorder. The
device is intended for use by adult patients in the home or clinical
environment, under the direction of a qualified healthcare practitioner, to
aid in the 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 Synergy system may include some or all of the following
items:
Zmachine Synergy
EEG Cable
Nasal Cannula
Effort Belt
Effort Belt Cables
Finger Probe
Sensor Pads
Alcohol Swabs
Paper Tape
Belt Clip
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 Synergy Indicators & Elements
Ref. Description Ref. Description
1
Main system status
4
Effort belt status
2
Sensor pads status
5
Cannula status
3
Effort belt status
6
Finger probe status
Ref. Description
7
Power Button: Turns the system on & off
8
Effort Belt: Senses chest movements while breathing
9
Effort Belt Cable: Connects effort belt to system
10
Effort Belt Buckle: Holds effort belt
11
Pulse Oximeter: Senses heart rate and oxygen levels
12
Nasal Cannula: Senses airflow and snoring
13
EEG Cable: Senses sleep patterns
1
3
2
6
5
4
7
9
10
12
11
13
8

4
Patient Guide
Warnings and Cautions
If you have any questions or concerns, you should contact your Healthcare
Provider before using the Zmachine Synergy.
Contraindications, Warnings and Cautions
Do not use the Zmachine on newborns, infants, or children. The
Zmachine has only been tested on adults.
Keep all parts and accessories out of reach of children and pets. The
small parts and accessories (such as EEG sensors and their clear
backings) could present a choking hazard to small children and pets.
Do not use the Zmachine in an oxygen rich or explosive atmosphere.
The Zmachine could ignite flammable gases.
Do not use the Zmachine if you cannot free yourself if tangled with the
system cables. This could present a strangulation hazard.
Take care in arranging the system cables to avoid becoming tangled
during the night.
Do not use the Zmachine if you have fragile or damaged skin. The self-
adhesive EEG sensors or paper tape could damage fragile skin.
Do not open the Zmachine enclosure or attempt to service for any
reason. Otherwise, the safety and/or performance of the system could be
compromised.
Do not expose the Zmachine to excessive heat, as the internal Lithium
Ion battery may leak or explode.
Only use General Sleep approved parts and accessories described in this
guide. Other parts may not function correctly with the Zmachine and
could pose a safety hazard or lead to poor performance.
The Zmachine records very small electrical signals. Do not use
transmitters, power transformers, motors and similar equipment that
generate strong electromagnetic fields near the Zmachine. This could
interfere with the recorded signals.
Electric blankets should not be used with the Zmachine. They could
interfere with the recorded signals.
Avoid exposing the Zmachine to any liquids or small particulates as this
could damage the system.
Do not immerse the Zmachine in liquid for any reason as this could
damage the system.
The Zmachine is designed for indoor use only. Allow the Zmachine
system to reach room temperature before using.
The Zmachine could become damaged if it has been subjected to
unfavorable conditions or mishandling.

Patient Guide
5
Contraindications, Warnings and Cautions
If, at any time, the Zmachine or accessories are thought to be damaged
or malfunctioning, stop using the Zmachine and contact your healthcare
provider for further instructions.
Some patients may experience skin irritation, hypersensitivity, or
allergic reaction to the self-stick sensors or adhesive tape. If this occurs,
stop using and contact your healthcare provider for further instructions.
Do not connect the Zmachine to any equipment except as described in
this guide.
Do not modify the Zmachine and/or open Zmachine enclosure for any
reason. The Zmachine contains no user serviceable parts.
The cannula and other sensor wires can leave temporary marks and/or
indentations on your face and skin.
Disposal
Dispose of any used sensor pads, alcohol swabs and cannulas. Return all
other parts and accessories to your Healthcare Provider.
Cleaning
The outer surfaces of the Zmachine Synergy will be cleaned by your
healthcare provider. If you need to remove fingerprints or 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 case.
Interference
The Zmachine acquires and analyzes very small electrical signals from
your body and brain. Because of this, equipment that generates strong
electrical fields (such as electric blankets) should not be used with the
Zmachine.
Using the System
Closely perform the steps beginning on the next page to help ensure a
comfortable night and a great recording.

6
Patient Guide
Step 1: Clean/Prepare Skin
Use an alcohol swab to clean the bony areas behind
the left and right earlobes, and also the back of the
neck as shown.
Hint: A mirror can be helpful for this and the next step.
Note: Let skin air dry for about 20 or 30 seconds after cleaning
before proceeding onto Step 2.

Patient Guide
7
Step 2: Apply Sensor Pads
Remove clear backing from sensor pad.
Apply a sensor pad to each of the three cleaned areas as shown.
Secure each sensor pad with finger by rubbing the outer edge only.
Avoid pressing the center as gel will spread onto the adhesive.
Hint: If you positioned a sensor pad incorrectly, simply repeat the
steps above using a new sensor pad (never reuse a sensor pad).
Wait 20 minutes before continuing onto Step 3.
This will let the sensor pads adhere properly to your skin.

8
Patient Guide
Step 3: Setup Effort Belt
Attach effort belt to Synergy and adjust length to fit your body. Always
wear the Synergy over a shirt.
Click belt onto tabs and position high under the armpits with the system
above the pectoral muscles/breasts. Adjust belt length for a snug but
comfortable fit that hugs your chest and moves with your breathing.
Insert belt cables into Synergy and snap free ends onto belt.
It should look like this when
finished (high and centered).
TIGHTEN
LOOSEN

Patient Guide
9
Step 4: Connect Cable and Sensors
Insert free end of EEG Cable into Synergy.
Snap BLACK wire to NECK sensor.
Connect the black wire to the
neck sensor (not the ears).
Snap the two WHITE wires to the two EAR sensors. Either white wire
can be connected to either ear sensor.

10
Patient Guide
Step 5: Connect the Cannula
Place cannula in nostrils, drape over ears, & remove some slack.
Adjust slider just a little to remove some slack. Do not tighten.
Apply small two pieces of tape as shown.
The slider should not be tight; a tight
cannula can be uncomfortable. The
tape will keep the cannula in the
correct position all night. Loosen the
slider now if needed.
Note: If you have sensitive skin, the
tape can leave temporary marks on
your face.
Gently twist cannula onto the fitting until it just stops (about ½ turn).
Do not overtighten
Tightening beyond snug
may damage the device.

Patient Guide
11
Step 6: Connect the Finger Probe
Position the finger probe with the cord exiting over the top of your hand
as shown. Apply a small piece of tape to secure the cord (be sure to
leave a little slack in the cord for comfort).
Nail polish and false nails will
interfere with the test and should
be removed prior to use.
Clip the cord onto either side of the effort belt.
Hint: If you notice the finger probe becoming uncomfortable during
the test, you may move it to another finger at any time.

12
Patient Guide
Step 7: Review (not really a step)
The complete setup should look similar to this...

Patient Guide
13
Starting the Test
Press the button for about 1-2 seconds until the lights turn on, then
release. Do not hold for too long or the system will shut off again.
Note: The Synergy will automatically check your sensors. A yellow
light indicates that the corresponding sensor is not yet connected or
needs further attention (green means good). Refer to the previous
instructions and correct any problems. If you are unsuccessful in
correcting a yellow indicator, simply continue with the test.
Go to bed when ready. Sleep in any position that is comfortable. It is
perfectly acceptable to lie on the wires or any other part of the system.
Hint: The lights will auto-dim to minimize interference with your sleep.
The system is still running while dim. A momentary button press will
briefly show the current status of all sensors and then auto-dim again.

14
Patient Guide
Stopping the Test
Press the button for about 3-4 seconds until the system beeps, then
release. All lights will glow orange, then turn off.
Unhook yourself from the system.
•Remove finger probe and tape
•Remove nasal cannula and tape
•Remove sensor pads
•Unsnap effort belt cable
•Unbuckle effort belt
•Remove any gel and/or adhesive remaining on your skin from
the tape and sensor pads using soap & water or an alcohol swab
•Place all parts and accessories into the travel case (except
Cannula and Sensors Pads)
Return all equipment as instructed.

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 Synergy?
Yes. However, use caution around water to prevent water from entering
the system.
Can I lie directly on the Zmachine Synergy system and cords?
Yes, lying on the system and cords is absolutely fine and will not influence
the recording. Sleep in any position that is comfortable and representative
of your normal sleep.
I feel that my skin was a little irritated when I removed 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 and should disappear within about a half hour
following removal of the sensor pads. If your skin is dry, you may use a
dab of hand or face lotion over the affected area(s) 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 Synergy if using for a second
night?
No. When you receive the Zmachine Synergy it will be fully charged and
can run for at least 24 hours, so no need to recharge before a second night.
What should I do if I find that a sensor has become dislodged or
disconnected during the night?
Simply re-position / re-attach the affected sensors as soon as this has been
discovered and continue using the system as before.
Why did the Zmachine Synergy turned itself off before I started
using it?
The Zmachine may shut itself off after 20 minutes if it never detected a
good signal at any point in time following power on. So, don’t power on
the Synergy too far in advance of applying the sensors.

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, Euclid, 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 Patent: 2201694, 2516093, 2783015
European Patent: 1124611, 2512573
Japanese Patent: 4532739, 4721451, 5684828
Other patents pending
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, Euclid, 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