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Summary of Contents for General Sleep Zmachine Insight+ DT-200
- Page 1 ® Zmachine Insight & Insight+ Model: DT-200 Clinician Instruction and Service Manual Rev. 1.7 Copyright © 2018 by General Sleep Corporation All rights reserved...
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Page 3: About This Manual
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. -
Page 4: Table Of Contents
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 .......................... - Page 5 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 Clinician Instruction and Service Manual...
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Page 7: Introduction
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... -
Page 8: The Zmachine At A Glance
The Zmachine at a Glance System Display MicroSD System Buttons Socket Sensor/Charger Port FRONT SIDE Operating Mode Battery Status Information Area SYSTEM DISPLAY Introduction... -
Page 9: Description Of Reusable Components
GSC P/N 200-070 GSC P/N 200-034 Zmachine Travel Case Zmachine Hanging Cover GSC P/N 200-120 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. Introduction... -
Page 10: Description Of Disposable Components
The Zmachine system may include some or all of the disposable items described below. Zmachine Patient Sensors Alcohol Swabs GSC P/N 200140-1 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... -
Page 11: Description Of Documentation And Software Components
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) Clinician Instruction and Zmachine Data Viewer Service Manual (pdf) (Windows Software) -
Page 12: Glossary Of Symbols
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. -
Page 13: Contraindications, Warnings And Cautions
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. Contraindications, Warnings and Cautions... -
Page 14: Cautions
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. •... - Page 15 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.
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Page 16: Care And Maintenance
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. -
Page 17: Environmental Parameters For Shipping And Storage
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... -
Page 18: Usage Overview
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. -
Page 19: Zmachine New Patient Setup
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. -
Page 20: Adjust System Setup & Discuss
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. -
Page 21: General System Setup And Operation
General System Setup and Operation Charging the Zmachine The Zmachine internal battery, when fully charged and operating within design parameters, can operate the Zmachine for at least 12 hours. It takes approximately three hours to obtain a full charge. To charge the Zmachine: Plug the Zmachine System Charger into a wall outlet. -
Page 22: Booting The Zmachine
Booting the Zmachine Although the Zmachine will automatically boot and begin operation when the Zmachine Patient Cable is inserted, there may be times when you want to manually boot the Zmachine for operations such as checking/setting time and date, verifying the battery state of charge, preparing for a new patient, etc. -
Page 23: Accessing The Zmachine System Menu
Accessing the Zmachine System Menu To change any system setting requires access to the Zmachine System Menu. Access to the System Menu has been designed to be inaccessible to patients through the use of the Zmachine Clinician Key. To access the Zmachine System Menu: Boot the Zmachine. -
Page 24: Setting The Time And Date
Setting the Time and Date To set the time and date: Access the Zmachine System Menu. Select Setup Time & Date and press iii) Use the System Buttons to adjust the time and date fields. button will advance to the next field button will cycle through values in a field will select selection of Save or Cancel Select Save and press... -
Page 25: Prepare The Zmachine For A New Patient
Prepare the Zmachine for a New Patient The Zmachine system uses a sophisticated learning algorithm to maximize accuracy. Therefore, the Zmachine must be cleared of all information before being used on each different patient. To prepare the Zmachine for a new patient: Access the Zmachine System Menu. -
Page 26: Setting The Alerts To Get-Out-Of-Bed (Insight+ Only)
Setting the Alerts to Get-Out-Of-Bed (Insight+ only) The Zmachine can be set to generate alerts to get-out-of-bed when the patient has not fallen asleep within the prescribed time interval (called a Sleep Onset alert), or when the patient has fallen asleep successfully, but woke and was unable to fall back to sleep within the prescribed interval (called a Sleep Maintenance alert). -
Page 27: Setting The Statistics To Display (Insight+ Only)
Setting the Statistics to Display (Insight+ only) The Zmachine can be set to display statistics to the patient each time the sensor cable is disconnected. To set which statistics will be displayed: Access the Zmachine System Menu. Select Set Actions iii) Select Stats to Display Select TST and press... -
Page 28: Setting The Day Break Time
Setting the Day Break Time The Day Break Time is the hour at which the system transitions from one day to the next. This is used by the statistics computation and reports. The default, 4:00 PM, is appropriate for most nocturnal sleepers. -
Page 29: Sleep Report And Statistics Files
Sleep Report and Statistics Files Generate Sleep Report and Statistics To generate the sleep report and summary statistics file: Access the Zmachine System Menu. Select Generate Report → → Note: Following report generation, the microSD card can be ejected safely. If you do not wish to eject the microSD card at this time, simply press OK to return to the previous menu. -
Page 30: Microsd Card Operations (Eject, Copy Data, Insert)
MicroSD Card Operations (Eject, Copy Data, Insert) The microSD card can only be ejected safely when the Zmachine is off, at the Main Screen (displaying either the sleeping puppy or sleep statistics) with the operating mode in the upper left corner indicating ‘Ready’, or following report generation. -
Page 31: About The Sleep Report & Statistics Files
About the Sleep Report & Statistics Files When generating a sleep report (which includes the summary statistics file), any previous reports on the microSD card will be overwritten. The sleep report and statistics files will appear in the root directory of the microSD card with the following file names: score.csv stats.csv These are ASCII files in comma-separated-variable (csv) format that can be read by any text... -
Page 32: File: Stats.csv
Column 6: Events These are events related to patient alerting (Insight+ only). 0 = Patient alerting is not enabled. 1 = Patient alerting is enabled. 2 = Patient woke from at least 5 minutes of sleep within a 6 minute sliding window, but not enough sleep to achieve sleep maintenance. - Page 33 Column 4: SPT (hrs) Sleep Period Time is the total recording time, reported in hours, including out of bed gaps, for each day. Periods of time when the impedance check shows failed sensor(s) are not included in this number. Column 5: TST (hrs) Total Sleep Time is the accumulation of all epochs determined to represent sleep.
- Page 34 Column 14: Temporary Signature? This column is related to data requirements. 0 = Statistics generated normally. 1 = Statistics generation was forced by the clinician when insufficient data was available for the report (a warning screen was displayed). A temporary patient signature is generated for the purposes of generating the report.
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Page 35: System Utilities
System Utilities Display System Information To display the Zmachine system information: Access the Zmachine System Menu. Select Administrative iii) Select About When done, press → → S/N = System serial number. Hardware Ver = Version of the system hardware. Firmware Ver = Version of the system firmware. Staging Ver = Version of the sleep staging algorithm. -
Page 36: Update Firmware
Update Firmware Updates to the Zmachine system firmware may be released by General Sleep Corporation (GSC) from time to time. To install a firmware update on your Zmachine system: With the Zmachine off, eject the microSD card. Using the microSD card reader and PC, copy the firmware update file to the microSD... -
Page 37: Setting The Failed Sensor Alert
Setting the Failed Sensor Alert Throughout the recording session, the Zmachine can periodically measure and limit test the sensor impedance values (default is every 15 minutes). If the Zmachine detects a failed sensor, it can either stay silent (default), or can produce an immediate alert to the patient with instructions presented on the system display indicating which sensor(s) need to be replaced. -
Page 38: Troubleshooting And Specifications
Troubleshooting solutions for some problems you may encounter with the Zmachine system are listed below. If none of the corrective actions provided solve your problem or if your problem is not listed, then discontinue use immediately and contact General Sleep. Problem... -
Page 39: Zmachine Insight & Insight+ Specifications
Zmachine Insight & Insight+ Specifications The Zmachine is a Class II, type BF, internally powered, medical device and is rated for continuous operation. Input Characteristics Type Fully differential Coupling Voltage (non-distorted) ±500 μV Voltage (maximum) ±40 V Highpass Filter Cutoff 0.5 Hz Lowpass Filter Cutoff 380 Hz... -
Page 40: Clinical Performance
Clinical Performance Clinical Performance Summary A ninety-nine subject (99) clinical study was conducted in which polysomnographic (PSG) data was acquired and analyzed by polysomnographic technologists, and simultaneously data from the differential mastoids were acquired and processed by the Zmachine algorithm. Each PSG record was scored independently by at least two (2) certified polysomnographic technologists (3 records scored by 2 technologists, 16 records scored by 3 technologists, and 80 records scored by 4 technologists) using the Rechtschaffen &... -
Page 41: Legal Notices
Legal Notices 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... - Page 42 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.
- Page 43 Agreement will remain in full force and effect. Should you have any questions concerning this License Agreement, you may contact GSC by writing to General Sleep Corporation, at 26250 Euclid Avenue, Suite 709, Euclid, Ohio 44132.
- Page 44 Privacy Policy For purposes of this Agreement (“Agreement”), the following terms have the following meanings: “User” means anyone using the Zmachine Synergy (described in this manual), or any associated systems or software. “De-identified Information” shall mean Information that has been de-identified in accordance with the requirements for de-identification of protected health information under 45 CFR §164.514(b).
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