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Clinician Instruction and Service Manual

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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

(888) 330-4424

Web Site

www.GeneralSleep.com

Note: This manual is applicable to the Zmachine Insight & with firmware
version 4.10.0 and later.

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Содержание Zmachine Insight+ DT-200

Страница 1: ...Copyright 2018 by General Sleep Corporation All rights reserved Zmachine Insight Insight Model DT 200 Clinician Instruction and Service Manual Rev 1 7 ...

Страница 2: ......

Страница 3: ...inued 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 ...

Страница 4: ...ient 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 ...

Страница 5: ...ce 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 ...

Страница 6: ......

Страница 7: ...l 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 qua...

Страница 8: ...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 ...

Страница 9: ...e 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 Sl...

Страница 10: ...tem 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 ...

Страница 11: ... 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 ...

Страница 12: ...sician 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 Canadi...

Страница 13: ...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 cabl...

Страница 14: ...s 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 moto...

Страница 15: ...ed 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 Advi...

Страница 16: ...static 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 Zma...

Страница 17: ...lacing 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 ...

Страница 18: ... 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 allo...

Страница 19: ... 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 atte...

Страница 20: ...k 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 ...

Страница 21: ...the free end of the Zmachine System Charger into the Zmachine Sensor Charger Port iii Charging will start and stop automatically Plug the Zmachine System Charger into a wall outlet Insert the free end into the Zmachine Sensor Charger Port Charging Zmachine Note The charge cable connector is keyed and can only be fully inserted when properly oriented Note Ensure that the Zmachine is fully charged b...

Страница 22: ...ate of charge preparing for a new patient etc To boot the Zmachine i Press and release the button ii If the system battery has sufficient power it will boot immediately Otherwise refer to the Charging section of this document In order to save battery power the Zmachine automatically dims the LCD backlight after 20 seconds turns off the LCD backlight after 40 more seconds and shuts down the system ...

Страница 23: ...s 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 i Boot the Zmachine ii Insert the Zmachine Clinician Key into the Sensor Charger Port iii The System Menu will be displayed when the Clinician Key is inserted and will disappear when the key is removed ...

Страница 24: ...lds a button will advance to the next field b button will cycle through values in a field c will select selection of Save or Cancel iv Select Save and press to commit changes and reboot the system Select Cancel and press to discard all changes Note Whenever the time or date are manually updated and saved the seconds are automatically zeroed at the moment is depressed thereby enabling sub second ti...

Страница 25: ...enu ii Select Administrative a will scroll through the menu choices b Pressing will confirm the selection iii Select New Patient iv A confirmation screen will appear v Selecting will permanently erase all data sleep report statistics etc and will prepare the Zmachine for a new patient vi Select OK bottom of system display and press to run the operation and reboot the system Select Cancel bottom of...

Страница 26: ...lly but woke and was unable to fall back to sleep within the prescribed interval called a Sleep Maintenance alert To change the alerting i Access the Zmachine System Menu ii Select Setup Actions iii Select Patient Alerts iv Select Sleep Onset and press to toggle enabled disabled a A check mark indicates that the function is enabled v Select Sleep Maint and press to toggle enabled disabled a A chec...

Страница 27: ...ct Set Actions iii Select Stats to Display iv Select TST and press to toggle displayed hidden v Select SE and press to toggle displayed hidden vi Select LPS and press to toggle displayed hidden vii Select WASO and press to toggle displayed hidden Note A check mark indicates that the statistic will be displayed when the sensor cable is disconnected Note All statistics are calculated and displayed i...

Страница 28: ...t nocturnal sleepers If the patient sleeps through this time then the resulting report will show their sleep as spanning two days i e both sides of 4PM To change the Day Break Time i Access the Zmachine System Menu ii Select Set Actions iii Select Day Break Time iv Change the Hour and AM or PM v Select Save or Cancel and press Note All statistics are calculated and displayed in the clinician repor...

Страница 29: ...atistics To generate the sleep report and summary statistics file i Access the Zmachine System Menu ii 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 ...

Страница 30: ...leasing If the card was depressed sufficiently upon release the card will protrude from the card slot sufficiently so as to allow it to be withdrawn Push Card Edge to Unlock Withdraw Card from Slot Removing the microSD card ii Insert microSD card into the supplied USB microSD Card Reader iii Import data into your Zmachine Data Viewer software or copy paste files to your computer manually USB to Mi...

Страница 31: ... csv Column definition 1 2 3 4 5 6 7 8 Date Time Score Session Day Events Temporary Signature Arousal Column 1 Date This is the date of the start of the current 30 second epoch mm dd yyyy format Column 2 Time This is the start time of the current 30 second epoch hh mm ss format Column 3 Score This is the wake sleep score of each 30 second epoch 0 Awake 2 Light Sleep N1 N2 3 Deep Sleep Slow Wave Sl...

Страница 32: ...ent satisfied default 2 days 12 hours This requirement can be changed using the Zmachine Data Viewer 1 Report generated with less data Column 8 Arousal This column is related to the detection of an EEG arousal when the epoch is scored as sleep 0 No arousal detected 1 Arousal detected File Stats csv This is an example of Stats csv as viewed in a spreadsheet 1 2 3 4 5 6 7 Day Start Date Start Time S...

Страница 33: ...d in minutes following LPS Awake must be 3 or more contiguous epochs in order to be counted This statistic includes time spent out of bed Column 9 SPT2 hrs Sleep Period Time is the total recording time reported in hours excluding out of bed gaps for each day Column 10 TST2 hrs Total Sleep Time is the accumulation of all epochs determined to represent sleep This statistic excludes time spent out of...

Страница 34: ...the beginning of sustained Deep Sleep reported in minutes Column 16 Deep Sleep hrs Total Deep Sleep reported in hours Column 17 REM Latency min Time to the beginning of sustained REM Sleep reported in minutes Column 18 REM hrs Total REM Sleep reported in hours Column 19 Deep Sleep Latency2 min Time to the beginning of sustained Deep Sleep reported in minutes This statistic excludes time spent out ...

Страница 35: ... 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 Feedback Ver Version of the alert to get out of bed and statistics algorithms Insight only SD Free Hrs Recording space remaining on the microSD card in hours Odometer Accumulated EEG acquisition time in hours ...

Страница 36: ...le iii Properly eject the microSD card reader from the PC iv Return the microSD card containing the firmware update file to the Zmachine v Press to boot the Zmachine vi Access the Zmachine System Menu vii Select Administrative viii Select Update Firmware ix If the firmware update was successful the Zmachine will reboot when the operation has completed Otherwise an error screen will be displayed Hi...

Страница 37: ...tting is selected the detection of a failed sensor will always be noted in the report Note If Sensor Action is enabled i e ON then a failed sensor will cause the Zmachine to produce an immediate audible alert that will potentially wake your patient This may not be desirable in some clinical applications To change the impedance alert behavior i Access the Zmachine System Menu ii Select Setup Action...

Страница 38: ...nge for battery or charger replacement Zmachine display indicates microSD card full Prepare the Zmachine for a New Patient System Menu Administrative New Patient This operation will clear all data from the microSD If this does not resolve the problem the microSD card may be defective Contact General Sleep to arrange for microSD card replacement Sensor check indicates that one or more sensors need ...

Страница 39: ...e SAR Battery Nominal Voltage 3 7 VDC Chemistry Cell type Lithium Ion Secondary Capacity 900 mAh C 5 Rate 23 degC standard 1800mAh C 5 Rate 23 degC extended Runtime 12 18 5 hrs standard battery 24 29 5 hrs extended battery Charge time 5 Hr standard battery 8 Hr extended battery Current Consumption Nominal Running 70 mADC Charging 600 mADC Sleeping 0 5 µADC Data Storage Type microSDHC Capacity 4 GB...

Страница 40: ...Zmachine assigns an epoch to a particular stage the probability of such assignment is correct values for the detection of Wake Light Sleep Deep Sleep and REM for the Zmachine algorithm staging version 2 1 are summarized in the following table Wake Light Sleep Deep Sleep REM P1 0 928 0 825 0 783 0 723 P2 0 838 0 855 0 743 0 749 The P1 and P2 values were also computed for each subject individually 9...

Страница 41: ...uct 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...

Страница 42: ...AT 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 OR FITNESS FOR A PARTICULAR PURPOSE GSC S MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE PRODUCTS OR THEIR USE WHETHER BASED ON WARRANTY CONTRACT TORT OR OTHERWISE SHALL NOT EXCEED THE ACTUAL PAYMENTS RE...

Страница 43: ...ense will terminate automatically without notice from GSC if you fail to comply with any term or provision of this License Upon termination of this License you may not make any further use of the Licensed Software THE LICENSED SOFTWARE IS PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTY WITH RESPECT TO ITS MERCHANTABILITY OR ITS FITNES...

Страница 44: ...mbers health plan beneficiary numbers account numbers certificate license numbers vehicle identifiers and serial numbers including license plate numbers device identifiers and serial numbers web universal resource locators URLs internet protocol IP address numbers biometric identifiers including finger and voice prints full face photographic images and any comparable images Protected Health Inform...

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