General Sleep Zmachine Insight+ DT-200 User manual

Copyright © 2018 by General Sleep Corporation
All rights reserved
Zmachine
®
Insight & Insight+
Model: DT-200
Clinician Instruction and Service Manual
Rev. 1.7

Clinician Instruction and Service Manual i
About this Manual
You are advised to read and understand this manual before using the Zmachine.
This manual contains all of the information that is needed to set up and operate the Zmachine, and
does not assume prior knowledge or experience with operator-programmable medical electronics
devices. Retain this manual for future reference.
The information in this manual has been carefully checked and is believed to be accurate.
However, in the interest of continued product development, General Sleep Corporation ("GSC")
reserves the right to make changes and improvements to this manual and to the product(s) that it
describes, at any time, and without notice or obligation.
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 law 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
Euclid, OH 44132, USA
Telephone [phone]
Web Site www.GeneralSleep.com
Note: This manual is applicable to the Zmachine Insight & Insight+ with firmware
version 4.10.0 and later.

ii Clinician Instruction and Service Manual
Table of Contents
Introduction ................................................................................................................................... 1
Description ................................................................................................................................................ 1
Indications for Use ..................................................................................................................................... 1
The Zmachine at a Glance ......................................................................................................................... 2
Description of Reusable Components ........................................................................................................ 3
Description of Disposable Components .................................................................................................... 4
Description of Documentation and Software Components ........................................................................ 5
Glossary of Symbols .................................................................................................................................. 6
Contraindications, Warnings and Cautions ................................................................................ 7
Contraindications ....................................................................................................................................... 7
Warnings.................................................................................................................................................... 7
Cautions ..................................................................................................................................................... 8
Care and Maintenance ................................................................................................................ 10
Inspection ................................................................................................................................................ 10
Cleaning ................................................................................................................................................... 10
Interference .............................................................................................................................................. 10
Environmental Parameters for Shipping and Storage .............................................................................. 11
Environmental Parameters for Operation ................................................................................................ 11
Disposal of Equipment ............................................................................................................................ 11
Attaching the Hanging Cover .................................................................................................................. 11
Usage Overview ........................................................................................................................... 12
Understanding the Zmachine ................................................................................................................... 12
Zmachine New Patient Setup ................................................................................................................... 13
Pack Supplies for Patient to Take Home ................................................................................................. 13
Familiarize Patient with the Zmachine .................................................................................................... 13
Generate a sleep report and review .......................................................................................................... 13
Adjust System Setup & Discuss .............................................................................................................. 14
Re-Fill Zmachine Travel Case and Provide to Patient ............................................................................. 14
General System Setup and Operation ...................................................................................... 15
Charging the Zmachine ........................................................................................................................... 15
Booting the Zmachine ............................................................................................................................. 16
Accessing the Zmachine System Menu ................................................................................................... 17
Setting the Time and Date ....................................................................................................................... 18
Prepare the Zmachine for a New Patient ................................................................................................. 19
Setting the Alerts to Get-Out-Of-Bed (Insight+ only) ............................................................................. 20
Setting the Statistics to Display (Insight+ only) ...................................................................................... 21
Setting the Day Break Time .................................................................................................................... 22
Sleep Report and Statistics Files ................................................................................................ 23
Generate Sleep Report and Statistics ....................................................................................................... 23
MicroSD Card Operations (Eject, Copy Data, Insert) ............................................................................. 24
About the Sleep Report & Statistics Files ............................................................................................... 25
File: score.csv .......................................................................................................................................... 25
File: Stats.csv ........................................................................................................................................... 26
System Utilities ............................................................................................................................ 29
Display System Information .................................................................................................................... 29
Update Firmware ..................................................................................................................................... 30
Setting the Failed Sensor Alert ................................................................................................................ 31

Clinician Instruction and Service Manual iii
Troubleshooting and Specifications ........................................................................................... 32
Troubleshooting ....................................................................................................................................... 32
Zmachine Insight & Insight+ Specifications ........................................................................................... 33
Clinical Performance .................................................................................................................. 34
Clinical Performance Summary ............................................................................................................... 34
Legal Notices ................................................................................................................................ 35
Trademark and Intellectual Property Rights ............................................................................................ 35

Introduction 1
1
Introduction
Description
The Zmachine is a high technology sleep monitor, developed by General Sleep Corporation,
which uses state-of-the-art electroencephalography (EEG) hardware in combination with
advanced signal processing algorithms to detect sleep stages, including Wake, Light Sleep, Deep
Sleep and REM. The Zmachine was designed for use in the clinical or home environment. The
Zmachine gathers high quality, objective, epoch-by-epoch, sleep state information and summary
sleep statistics, all of which can be reviewed by a clinician either independently, or in the
presence of their patient.
The Zmachine acquires the EEG signal necessary for sleep monitoring using three high quality,
self-stick, single-use, disposable EEG sensors. The three sensors are designed for easy, self-
application by the patient with minimal skin preparation (alcohol wipe and dry). The sensors are
located completely outside of the hairline on the mastoids (signal) and the back of the neck
(ground). Integrated impedance measurement technology verifies the quality of the sensor
connections immediately prior to the start of monitoring and at periodic intervals during use.
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.

2 Introduction
The Zmachine at a Glance
FRONT SIDE
SYSTEM DISPLAY
System Display
System Buttons
Sensor/Charger
Port
MicroSD
Socket
Battery Status
Operating Mode
Information Area

Introduction 3
Description of Reusable Components
The Zmachine system may include some or all of the reusable items described below.
Zmachine
Rating: 5VDC ~ 600mA
GSC P/N 200-160B (Blue)
GSC P/N 200-160G (Green)
Zmachine Sensor Cable
Silicone jacket / 1.2m length
GSC P/N 200-017
Zmachine System Charger
IN: 90-264VAC ~ 0.1A,
47-63Hz || OUT: 5VDC ~ 1.2A
GSC P/N 200-028
MicroSD Card
GSC P/N 200-051-4G
USB-MicroSD Card Reader
GSC P/N 200-070
Zmachine Clinician Key
GSC P/N 200-034
Zmachine Travel Case
GSC P/N 200-120
Zmachine Hanging Cover
GSC P/N 200-154
Note: Due to differences in brand and model numbers, part appearances may vary.
Only use General Sleep approved parts and accessories.

4 Introduction
Description of Disposable Components
The Zmachine system may include some or all of the disposable items described below.
Zmachine Patient Sensors
GSC P/N 200140-1
Alcohol Swabs
GSC P/N 200-060
Note: Due to differences in brand and model numbers, part appearances may vary.
Only use General Sleep approved parts and accessories.

Introduction 5
Description of Documentation and Software Components
The Zmachine system may include some or all of the documentation and software items
described below. Documentation and software are also available for download from the General
Sleep website.
Patient Guide (printed)
GSC P/N 200-170
Clinician Instruction and
Service Manual (pdf)
GSC P/N 200-171
Zmachine Data Viewer
(Windows Software)
GSC P/N 200-103

6 Introduction
Glossary of Symbols
SYMBOL DEFINITION OF SYMBOL
IEC 60601-1 Type BF applied parts.
Attention. Check the accompanying documentation.
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.
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 both United States and Canadian safety
standards.

Contraindications, Warnings and Cautions 7
2
Contraindications, Warnings
and Cautions
Contraindications
• Do not use the Zmachine on newborns, infants, or children. The Zmachine has only been
tested on adults.
• Do not use the Zmachine on patients with a pacemaker, cardiac defibrillator, or other
medical electronic device.
• Do not use the Zmachine on patients with fragile or damaged skin. The self-adhesive
sensors could damage fragile skin.
Warnings
• Do not use the Zmachine in an oxygen rich or explosive atmosphere.
• Do not use the Zmachine in conjunction with high frequency surgical equipment.
• Do not connect the Zmachine to a patient undergoing cardiac defibrillation.
• Do not use the Zmachine in an MRI environment.
• Do not use the Zmachine on a patient that may not be capable of freeing themselves in the
event of entanglement with the sensor cable.
• Advise patient to take care in arranging the sensor cable to avoid entanglement.
• Do not dispose of the Zmachine improperly as the internal Lithium Ion battery may leak or
explode.
• Do not open the Zmachine enclosure for any reason. The Zmachine contains no user
serviceable parts and service or repairs must be performed only by General Sleep
Corporation.

8 Contraindications, Warnings and Cautions
• 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.

Contraindications, Warnings and Cautions 9
• Do not sterilize the Zmachine or accessories.
• The Zmachine is designed for indoor use only. After shipping or transportation, allow the
Zmachine system to reach room temperature before using.
• The function or safety of the equipment could be impaired if it has been subjected to
unfavorable conditions or mishandling. If, at any time, function or safety is thought to be
impaired, or any damage to the Zmachine or accessories has been observed, the Zmachine
device should be taken out of operation and secured against unintended use. Contact
General Sleep for service.
• Some patients may experience skin irritation or hypersensitivity from the sensors. Advise
patient that if this occurs, to discontinue use and consult their healthcare provider.

10 Care and Maintenance
3
Care and Maintenance
Inspection
The Zmachine should be inspected regularly for damage to the system and accessories. If, at any
time, function or safety is thought to be impaired or any damage to the Zmachine or accessories
has been observed, then the Zmachine device should be taken out of operation and secured
against unintended use. Contact General Sleep for information regarding service and technical
support.
Cleaning
The outer surfaces of the Zmachine may be cleaned as needed. Use a small amount of water or
isopropyl alcohol to dampen a soft cloth to remove fingerprints and dirt. Do not allow any liquid
to enter the case of the Zmachine.
Interference
The Zmachine will continue to operate in the presence of radio frequency magnetic fields (RF)
and during electrostatic discharges according to the requirements specified in IEC/UL 60601-1-2.
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. Mobile phones, transmitters, power
transformers, motors and similar equipment that generate strong electromagnetic fields should not
be used in close proximity of the Zmachine. Electric blankets should not be used with the
Zmachine.
Although the Zmachine meets the standards for electromagnetic compatibility (IEC/UL 60601-1-
2), the device may cause interference when used in close proximity with sensitive electrical
equipment. It is advised that if interference on sensitive electrical equipment is observed that the
equipment is switched off or moved from the proximity of the Zmachine.

Care and Maintenance 11
Environmental Parameters for Shipping and Storage
The Zmachine and its accessories can be stored, shipped and operated within the following
environmental limits. Conditions outside these ranges could affect performance and reliability.
Temperature: 0°C to 40°C (32°F to 104°F)
Humidity: 15% to 93% (non-condensing)
Pressure: 800mm-360mm Hg (1500 feet below sea level to 20,000 feet above sea level)
Protect the Zmachine from sudden temperature changes that can lead to condensation within the
device. To minimize condensation, avoid moving the system between heated buildings and
outside storage. Once moved inside, allow the Zmachine to stabilize in the unopened shipping
container at the inside ambient temperature before unpacking and placing into service. Before
operation, wipe down all visible condensation and allow the system to reach equilibrium at room
temperature.
Environmental Parameters for Operation
The Zmachine is designed to operate safely under the following conditions. Conditions outside
these ranges could affect reliability.
Temperature: 10°C to 40°C (50°F to 104°F)
Humidity: 15% to 93% (non-condensing)
Pressure: 800mm-360mm Hg (1500 feet below sea level to 20,000 feet above sea level)
Disposal of Equipment
When the Zmachine has reached the end of its operating life, it should be disposed of in
accordance with local waste regulations.
Attaching the Hanging Cover
The hanging cover can be used in conjunction with a 3M Command® Medium Utility Hook (3M
part number 17001ES), available from most retailers, to allow your patient the ability to hang the
Zmachine on the wall or headboard during sleep. To use the hanging cover, simply insert the
Zmachine into the hanging cover as show.
+ →

12 Usage Overview
4
Usage Overview
Understanding the Zmachine
This description is based on the Zmachine DT-200, running sleep staging algorithm version 2.1.0
or later. To see what version your Zmachine is running, refer to page 29.
Patients should be advised to apply the sensors at least 30 minutes before bedtime. This will
allow sufficient time for the sensor gel to soak into the skin and lower the sensor impedances
without the use of an abrasive skin preparation. When the patients are ready to go to bed and try
to sleep, they should snap the sensor cable onto the sensors. When in bed, the sensor cable
should be plugged into the Zmachine. Upon connection of the sensor cable, the Zmachine will
turn on, check the sensor impedances, and begin recording.
Every patient will have unique EEG patterns that are related to their age, skull thickness, medical
history, medication use, etc. Rather than making assumptions about the exact nature of these
differences, the Zmachine relies on a self-tuning algorithm which automatically adjusts its
internal parameters to the unique EEG patterns of each patient. The set of parameters is called a
sleep signature, and this individualization is the key to the accuracy of the Zmachine.
While individualization is a new concept in automated sleep staging, it is routinely performed
when polysomnographic (PSG) records are visually scored. When an experienced sleep
technologist begins the process of scoring a night of sleep, they will often page through the record
to familiarize themselves with the “look” of the signals. This allows the technologist to learn the
unique patterns for that particular patient. Rarely would an experienced technologist immediately
score the record, from start to finish, in a linear fashion. This pre-scanning of the records by the
sleep technologist is very similar to the process of creating a sleep signature.
When the Zmachine first begins recording a new patient, a sleep signature will not yet exist for
that patient, so the first data collected by the Zmachine will be used to generate a sleep signature.
To generate an accurate sleep signature, the signature interval should contain both wake and
sleep. However, even a small amount of sleep achieved during the signature interval is sufficient
for an accurate sleep signature to be generated. Once the sleep signature has been generated,
there is no further need to have both wake and sleep within the data and the Zmachine can be
used on pure waking or pure sleep data with no loss of accuracy expected.

Usage Overview 13
Zmachine New Patient Setup
1. Boot the Zmachine (p.16)
2. Check time and date - change if needed (p. 18)
3. Prepare Zmachine for New Patient (p. 19)
4. (Insight+ only) Change alert to get-out-of-bed settings (p. 20)
5. (Insight+ only) Change statistics to display settings (p. 21)
6. Check day break time - change if needed (p. 22)
7. Charge the Zmachine (p. 15)
Pack Supplies for Patient to Take Home
Pack Zmachine Travel Case with the following supplies (p. 3):
1. Zmachine DT-200 (fully charged)
2. Sensor cable
3. Sensors (one package for each day, plus a few extras)
4. Alcohol swabs (two swabs for each day, plus several extras)
5. System Charger
6. Patient Guide
Note: Be sure to provide your patient with a few extra packages of sensors and alcohol
swabs to allow them to remove, clean, and re-apply sensors if needed.
Familiarize Patient with the Zmachine
Review the instructions contained in the Patient Guide with your patient. Special attention should
be given to applying the sensors and instructing the patient to connect their sensor cable to the
Zmachine only when lying in bed and ready to attempt sleep.
Generate a sleep report and review
When your patient returns with their Zmachine:
1. Generate a sleep report (p. 23)
2. Remove the microSD card from the Zmachine (p. 24)
3. Insert card into USB-microSD Card Reader and connect to a personal computer (p. 24)
4. Use the Zmachine Data Viewer software to review the data
5. Return the microSD card to the Zmachine (p. 24)
If you are finished using the Zmachine with this patient, then stop here. Otherwise, continue with
the next steps.

14 Usage Overview
Adjust System Setup & Discuss
If you feel one or more of the Zmachine system settings should be changed, then make the
adjustments as follows:
1. Boot the Zmachine (p.16)
2. (Insight+ only) Adjust the alert to get-out-of-bed settings (p. 20)
3. (Insight+ only) Adjust the statistics to display settings (p. 21)
4. Adjust day break time setting (p. 22)
5. Review any changes to the system settings with your patient so that they know what to
expect from the Zmachine.
Re-Fill Zmachine Travel Case and Provide to Patient
Re-fill the Zmachine Travel Case with the equipment and supplies listed previously and provide
to patient for continued use. See steps above.
Note: If returning the Zmachine to a patient to continue their use, there is no need to
erase data from the microSD or to prepare for a New Patient. Simply allow them
to continue using the Zmachine system.