Zmachine Clinician Manual
Contents
1. System Display Waiting for Connection System Buttons MicroSD socket Sensor Charger Port FRONT SIDE Operating Mode Battery Status Information Area SYSTEM DISPLAY 2 Introduction Description of Reusable Components The Zmachine system may include some or all of the reusable items described below Zmachine Zmachine Sensor Cable Zmachine System Charger Rating SVDC 600mA Silicone jacket 1 2m length IN 90 264VAC 0 1A GSC P N 200 160B Blue GSC P N 200 017 47 63Hz OUT SVDC 1 2A GSC P N 200 160G Green GSC P N 200 028 DO e 0 MicroSD Card USB MicroSD Card Reader Zmachine Clinician Key GSC P N 200 051 16G 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 3 Description of Disposable Components The Zmachine system may include some or all of the disposable items described below Z Zmachine Comfort 40 l Sats eee _ O 3 Pym meo s E meos bor semsere dia Pe do BD Alcohol Swabs Fa RM CT E 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 Self Adhesive Hook GSC P N 200 155 Introductio2. Eject Copy Data Insert e rreerrrrrrrrereeea 25 About the Sleep Report amp Statistics Files sas aa nude asiascisao RIAC E MAE nies nines 26 File Score Crou aia sons sadeutbat spaces ida o Oo Ra E Cut eacdvoneed nal aimuaasaseueuas 26 PiE Sta 6 Sa go RR e RR O OD EN RR DR PR RIR DSR ERR te 27 System UES osastoon EAEE E NR RP NR 30 Display Sy SUS Te MTOA ONagro aa aaa a 30 Update Bid WAU dd eA ee a da each le ed 31 petting tie Failed Sensor A ento asas said cb pr Rn Sed a a eesti Aiea Mad dad at sates 32 iI Clinician Instruction and Service Manual Troubleshooting and Specifications ccccccccssssssssssssccccssssssssscsccccsssssssssssccccsssssssssccccsssseeees 33 Wh o0 8 9 Ceo 110 018 0 ara E E E EE Er AOE 33 Z machine Insiehi de Insieht Specifications sasise a E eames tenets 34 CTC al Pertormance secesdisicedectcccesacciusssssdaceveissesccdessdecsssscunesdsscedeveessesccsccddecssassuussdssdecuseessanccdeasens 35 Clinical Peronmnance Sumare e Ra ada ad sa a tek 35 Leg AMINO CES mai dscaca nin osasco vans nanda ani Pocandu Dido cia Palo a oo da dis ais cia dou aii iara esta nus idas 36 Trademark and Intellectual Property Rights cccccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeeeeeees 36 NOS AOS SST pk ae i seats shea al ee A lease foe Ae 36 Software License Agreement Clinician Instruction and Service Manual ili Introduction Description The Zmachine is a high technology slee
3. INCLUDING WITHOUT LIMITATION LOST PROFITS DIRECTLY OR INDIRECTLY ARISING FROM THE SALE INABILITY TO SELL USE OR LOSS OF USE OF ANY PRODUCT EXCEPT AS SET FORTH HEREIN ALL PRODUCTS ARE SUPPLIED AS IS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED 4 All notices and other communications required by this Agreement shall be in writing and shall be delivered either by personal delivery or by mail If delivered by mail notices shall be sent by Legal Notices 3 Express Mail or by certified or registered mail return receipt requested with postage and charges prepaid 5 The Parties agree that every dispute or difference between them arising under this Agreement including a failure to reach a decision as described in this Agreement shall be settled first by a meeting of the parties attempting to confer and resolve the dispute in a good faith manner 6 This Agreement shall be governed in accordance with the laws of the State of Ohio and each party a consents to the exclusive jurisdiction and venue of the federal and state courts located in Ohio b waives any objection it might have to jurisdiction or venue of such forums or that the forum is inconvenient and c agrees not to bring any such action 1n any other jurisdiction or venue to which either party might be entitled by domicile or otherwise 7 No waiver by any party of any breach of the terms and conditions of this Agreement shall constitute a waiver of any subseque
4. 85 206 epochs of data is 0 722 which is well above the 0 6 threshold for good agreement The Kappa score was also computed for each subject individually 99 Kappa scores were obtained The interval estimation with 95 confidence level for the Kappa score is 0 708 0 020 In conclusion the Zmachine Algorithm shows good performance in sleep staging from a single channel of EEG data A copy of the full Technical Report is available upon request Clinical Performance 35 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 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 of Richmond Inc dba 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 1 User agrees that the Zmachine will at all times be used and operated solely in the conduct
5. DTTP OCUCUION enasi sens tenseusesonsesssacsunsssascdeneebesseceduessegssadsssssiassesslevdsewesteddesess 1 Descrip sigo as ae ee Ee Te a EP RE RE Ae NE Nae Ee l Indications dor USC o S l Toe Zmachinc ata Gaint Osroene r E E E AE a E E 2 Description or Reusable Component S spas Pegada E EAE EE EE CA REEE ET PT 3 Description f Disposable Components eras piada r EE EEEE EEEE ATA EE 4 Description of Documentation and Software Component cccccccccssccccccccceceecceececeeeeceeeeeeeseeeessseeeeeess 5 Glossary ol Symbols ee a E EAE 6 Contraindications Warnings and Cautions sssssecccocoosssssceccccossseseccoossssseeccocossssececessssssseeesso 7 C OM AIN CIC AUIOMS sasea a a a a a a a a GRE 7 WAME Sir a a RE OR RR RD ARE RU areaetatorcs Fi Gt o pisa RREO a ESUP IRES O E SIR A URU O SO RN RR RR DR e SR 8 Care and Maintenance occscceccecesessoiesssselcedtess a aa aaaea 10 NAG ES 6 6 10 oessa one CIE coe a EUS oC IR ROT a er cee AR 10 CVG Aint SU nee SEG A SUS Ud aed a 10 JERES RE KE 1 D S a mere on EE Serer AA ee oe Cen enn ae ore een S E er ene eee Aen ee ee eee 10 Environmental Parameters for Shipping and Storage ccccccccccccccccccccececcccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee es 11 Environmental Parameters for Operation sensitiva casaria a a 11 Disposa lo E gupen a a a a a a 11 Usao OVERVIEW oxsis acedssisecuessesscasstvascvashanscuesasencns sh eusvoecauasceaceassvacsevaseycsisavedaseuas a a aiaa eaaa 12 Understanding SZ tea Cas
6. Input Characteristics Type Fully differential Coupling AC Voltage non distorted 500 uV Voltage maximum 40 V Highpass Filter Cutoff 0 5 Hz Lowpass Filter Cutoff 380 Hz Impedance 10GQ 800pF Analog to Digital Conversion Sampling frequency 2 5 kHz Sampling resolution 16 bit Linearity 1 5 LSB Architecture SAR Battery Nominal Voltage 3 7 VDC Chemistry Cell type Lithium Ton 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 lt 5 Hr standard battery lt 8 Hr extended battery Current Consumption Nominal Running 70 mADC Charging 600 mADC Sleeping lt 0 5 ADC Data Storage Type microSDHC Capacity 16 GB Standard Data capacity 900 Hr Mechanical Length 116 mm Width 68 mm Height 21 mm Weight 102 g standard battery 122 g extended battery Enclosure material ABS Plastic Window material Lexan Standards Electrical Safety IEC UL 60601 1 Electromagnetics IEC UL 60601 1 2 FCC 47 CFR 15 Subpart B 34 Troubleshooting and Specifications 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 r
7. OF BUSINESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION AND THE LIKE ARISING OUT OF THE USE OF OR INABILITY TO USE ANY LICENSED SOFTWARE EVEN IF GSC OR ANY AUTHORIZED GSC REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR ii FOR ANY CLAIM BY ANY OTHER PARTY This License Agreement will be construed under the laws of the State of Ohio If any provision of this License Agreement shall be held by a court of competent jurisdiction to be contrary to law that provision will be enforced to the maximum extent permissible and the remaining provisions of this 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 Legal Notices 39
8. 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
9. related to data requirements O Statistics generated normally 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 Column 15 Deep Sleep hrs Total Deep Sleep reported in hours Column 16 REM hrs Total REM Sleep reported in hours Sleep Report and Statistics Files 29 System Utilities Display System Information To display the Zmachine system information 1 Access the Zmachine System Menu 11 Select Administrative 111 Select About Iv When done press 69 11 01 AM Eh 81 11 01 AM E 81 11 01 AM Sep 26 2012 Admin Sep 26 2012 About Sep 26 2012 Generate Report About S N 99000 Hardware Ver 2 5 0 setup Time amp Date New Patient Firmware Ver 4 5 0 Staging Ver 2 1 0 Setup Actions Update Firmware Feedback Ver 1 2 0 SD Free Hrs 842 0 Odometer 0 00 Administrative 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 30 System Utilities Update Firmware Updates to the Zm
10. 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 8 Contraindications Warnings and Cautions 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 o 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 Contraindications Warnings and Cautions 9 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 the
11. GENERAL Zmachine Insight Zmachine Insight amp Insight Model DT 200 Clinician Instruction and Service Manual Rev 1 3 Copyright 2015 by General Sleep Corporation All rights reserved 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 amp Insight with firmware version 4 5 0 and later Clinician Instruction and Service Manual Table of Contents
12. Persistent Sleep is the elapsed time reported in minutes until the beginning of the period in which 10 of 12 minutes are scored as sleep start of Sleep Maintenance This statistic includes time spent out of bed Column 8 WASO min Wake After Sleep Onset is the total awake time reported 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 1s 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 bed Column 11 SE2 Sleep Efficiency is 100x TST SPT and reported as a percentage This statistic excludes time spent out of bed Column 12 LPS2 min Latency to Persistent Sleep is the elapsed time reported in minutes until the beginning of the period in which 10 of 12 minutes are scored as sleep start of Sleep Maintenance This is also known as Latency to Persistent Sleep This statistic excludes time spent out of bed Column 13 WASO2 min Wake After Sleep Onset is the total awake time reported in minutes following LPS Awake must be 3 or more contiguous epochs in order to be counted This statistic excludes time spent out of bed 28 Sleep Report and Statistics Files Column 14 Temporary Signature This column is
13. able data for the purposes of generating the report Assuming that some wake and some sleep were present within the data no loss of accuracy should be expected remember the signature interval was only defined to ensure that some wake and sleep were recorded Usage Overview 13 Zmachine New Patient Setup Boot the Zmachine p 17 Check time and date change if needed p 19 Prepare Zmachine for New Patient p 20 Insight only Change alert to get out of bed settings p 21 Insight only Change statistics to display settings p 22 Check day break time change if needed p 23 Charge the Zmachine p 16 ae Oe o Pack Supplies for Patient to Take Home Pack Zmachine Travel Case with the following supplies p 3 Zmachine DT 200 fully charged Sensor cable Sensors one package for each day plus a few extras Alcohol swabs two swabs for each day plus several extras System Charger Patient Guide a ee ie 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 ret
14. achine system firmware may be released by General Sleep Corporation GSC from time to time To install a firmware update on your Zmachine system Hint With the Zmachine off eject the microSD card Using the microSD card reader and PC copy the firmware update file to the microSD card do not change the name of this file Properly eject the microSD card reader from the PC Return the microSD card containing the firmware update file to the Zmachine Press 9 to boot the Zmachine Access the Zmachine System Menu Select Administrative Select Update Firmware If the firmware update was successful the Zmachine will reboot when the operation has completed Otherwise an error screen will be displayed 11 01 AM p 81 11 01 AM p 81 11 01 AM Sep 26 2012 Admin Sep 26 2012 Firmware Sep 26 2012 Loading New Firmware System will reboot in approximately 15 seconds Following a firmware update it is always a good idea to access the Zmachine System Menu Administrative About to verify that the correct firmware update was installed System Utilities 31 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 w
15. aged skin The self adhesive sensors could damage fragile skin Warnings Do not use the Zmachine in an oxygen rich or explosive atmosphere o Do not use the Zmachine in conjunction with high frequency surgical equipment Do not connect the Zmachine to a patient undergoing cardiac defibrillation o 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 Contraindications Warnings and Cautions 7 e 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
16. d 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 Warranted Product or part thereof to GSC GSC shall determine whether to repair or replace Products and parts covered by this warranty and 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 or part thereof If GSC reasonably determines that a repair or replacement is covered by the warranty GSC shall bear the costs of shipping the repaired or replacement 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 products or part thereof that have been subject to misuse n
17. e Licensed Software is proprietary you may not decompile reverse engineer disassemble or otherwise reduce the Licensed Software to a human perceivable form If you transfer the System you have the right to transfer the Licensed Software provided that the transferee agrees to be bound by the terms and conditions of this License Agreement This License remains effective until terminated This License 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 38 Legal Notices 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 FITNESS FOR ANY PARTICULAR PURPOSE GSC DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE LICENSED SOFTWARE WILL MEET YOUR REQUIREMENTS OR THAT THE OPERATION OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR FREE OR THAT SUCH ERRORS IN THE LICENSED SOFTWARE WILL BE CORRECTED GSC S ENTIRE LIABILITY TO YOU FOR ACTUAL DAMAGES FOR ANY CAUSE WHATSOEVER AND REGARDLESS OF THE FORM OF THE ACTION AND YOUR EXCLUSIVE REMEDY SHALL BE LIMITED TO THE MONEY PAID FOR THE SYSTEM WHICH INCLUDED THE LICENSED SOFTWARE IN NO EVENT SHALL GSC BE LIABLE TO YOU i FOR ANY INCIDENTAL CONSEQUENTIAL OR INDIRECT DAMAGES INCLUDING DAMAGES FOR LOSS
18. e after 5 hours of charging or the LCD indicates Charge Fault Zmachine display indicates microSD card full Sensor check indicates that one or more sensors need to be replaced Zmachine system and or cable are damaged Sleep report does not match the patient report Solution The battery has reached end of life Contact General Sleep to arrange for battery replacement The wall charger may be faulty or the battery may have reached end of life Contact General Sleep to arrange for battery or charger replacement 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 Replace the failed sensors according to the Patient Guide If the problem persists then a faulty sensor cable may be the cause Contact General Sleep to arrange for replacement Discontinue use immediately and return to General Sleep for repair or replacement Patient self reporting is highly subjective and may or may not be accurate However if you suspect a problem with the Zmachine system then discontinue use and contact General Sleep Troubleshooting and Specifications 33 Zmachine Insight amp Insight Specifications The Zmachine is a Class II type BF internally powered medical device and is rated for continuous operation
19. eave bed Column 7 Temporary Signature This column is related to data requirements 0 Report generated normally with the data requirement satisfied default 2 days amp 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 Temporary Signature E ao Er DD Column 1 Day This is the recording day number 0 1 2 format Statistics are generated for each day Column 2 Start Date This is the date of the start of each 30 second epoch mm dd yyyy format Column 3 Start Time This is the start time of each 30 second epoch hh mm ss 24 hour format Sleep Report and Statistics Files 2 Column 4 SPT hrs Sleep Period Time 1s 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 This statistic includes time spent out of bed Column 6 SE Sleep Efficiency is 100x TST SPT and reported as a percentage This statistic includes time spent out of bed Column 7 LPS min Latency to
20. ecord 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 amp Kales R amp K 1968 visual sleep scoring rules The performance of the Zmachine was evaluated by comparing the Zmachine algorithm to the consensus of human scorers Analysis demonstrates substantial agreement between the Zmachine and the consensus of polysomnographic technologists The P1 the probability that Zmachine will correctly assign an epoch when the PSG Consensus assigns the epoch to a particular stage and P2 when the 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 LightSleep Deep Sleep REM 0 928 0 825 0 783 0 723 PR 0 838 0 855 0 743 0 749 The P1 and P2 values were also computed for each subject individually 99 P1 and 99 P2 values were obtained for each stage The mean and interval estimation 95 confidence level is summarized the following table Wake LightSleep Deep Sleep 0 933 0 012 0 822 0 016 0 730 0 063 0 719 0 037 0 814 0 027 0 854 0 017 0 722 0 072 0 751 0 033 The overall Kappa agreement between the Zmachine Algorithm and the PSG Consensus for
21. eglect or accident that have been damaged by causes external to the warranted product including but not limited to failure of or faulty electrical power that have been used in violation of GSC s instructions that have been affixed to any nonstandard accessory attachment on which the serial number has been removed or made illegible that have been modified by anyone other than GSC or that have been disassembled serviced or reassembled 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 1n 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 THE SOLE AND EXCLUSIVE WARRANTY FOR GSC S PRODUCTS EXTENDS ONLY TO THE USER 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 RECEIVED BY GSC IN CONNECTION THEREWITH GSC SHALL NOT BE LIABLE FOR ANY INCIDENTAL SPECIAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE
22. eport Set Time and Date Setup Time amp Date Date is MM DD YYYY Setup Actions E 00 AM 09 26 2012 Administrative 091 261 2012 Cancel Note Whenever the time or date are manually updated and saved the seconds are automatically zeroed at the moment 9 is depressed thereby enabling sub second time synchronization General System Setup and Operation 19 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 1 Access the Zmachine System Menu 11 Select Administrative a CG will scroll through the menu choices b Pressing amp Y will confirm the selection 111 Select New Patient 1V A confirmation screen will appear v Selecting amp 9 will permanently erase all data sleep report statistics etc and will prepare the Zmachine for a new patient V1 Select OK bottom of system display and press amp to run the operation and reboot the system Select Cancel bottom of system display and press to cancel this operation 11 01 AM 81 11 01 AM EE 81 11 01 AM Sep 26 2012 Admin Sep 26 2012 New Pat Sep 26 2012 Generate Report About WARNING setup Time amp Date New Patient Will erase ALL data Setup Actions Update Firmware Select OK to Proceed Administrat
23. equipment is switched off or moved from the proximity of the Zmachine 10 Care and Maintenance 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 1t should be disposed of in accordance with local waste regu
24. hich sensor s need to be replaced Regardless which setting 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 1 Access the Zmachine System Menu 11 Select Setup Actions ili Select Sensor Action iv Select ON or OFF and press 69 11 01 AM p 81 11 01 AM Sep 26 2012 Actions Sep 26 2012 Patient Alerts Stats to Display Day Break Time Sensor Action p 81 11 01 AM Sensor Sep 26 2012 Alert the patient if a sensor fails during recording OFF typical J Cancel Note The default time interval between measurements pass fail inpedance limits and many other advanced settings can be viewed and changed using the Zmachine Data Viewer software 32 System Utilities Troubleshooting 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 The Zmachine can no longer run for at least 12 hours on a full charge The Zmachine does not indicate a full charg
25. i ath ata Sk Sa ca a 12 Zmachine New Prticnt SEUD sad a a clare o eta e bee oes hs Aaa a 14 Pack Supplies for Patient to Take Home a dO DS Maske ees 14 Famiharize Patient with the Zia itn he sa La 14 Generate asleep report aNd TOVICM isa a DO De 14 Adjust System oc UPA DISCUSS ess as o Desses nerd nas abel ad asia aii e a DD EaD 15 ReFill Zmachine Travel Case and Provide to Patent ssi ccicas caxtasscacsitoncatst Gisiohs i note Gig es 15 General System Setup and Operation siscsssccasetssisvsdescessionssivrscvsvesxesssveersiecdessistssicbevncdeseousseraaves 16 Chirino Ne ZAC hine a ies cael aes cate ld e ad ene as 16 Bootino he ZAC NB gs aa a erate E ven nina Ly Accessing the Zmachine System Menu cccc ccccciscctescsscnccocennsessecssneseccsoncssecsenedeceseacssecssnesecceeseserandveseerss 18 Seting the Timeand Dale ss dns clo ds we Ser ste aco eso e teal oo om Gea 19 Prepare the Zmachme for a New Parent cco oc ccna Lia TS a i a a a 20 Setting the Alerts to Get Out Of Bed Insight only cccccccccseseseeeeeeeeeeeeesseseeeeeeseeseeeeseeseeeeeeees 21 Setting the Statistics to Display Insight only cccccccscssssssessseeeseeeeeeeeeeeessseseseesesseseeseeeeeeeeeees 22 petinosthe Day Bicak DC serena nene CORRA N A N RSS a Dei PRC RA RES DEN Dad 23 Sleep Report and Statistics Files css sessenta costeira ani diana da Da Ud Di dada a Di 24 Generate Sleep Report and Statisti CS ss Rn E E DEUS 24 MicroSD Card Operations
26. ive OK Cancel Note The Zmachine must be prepared in this manner before providing to a new 20 patient General System Setup and Operation 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 To change the alerting 1 Access the Zmachine System Menu 11 Select Setup Actions 111 Select Patient Alerts Iv Select Sleep Onset and press amp to toggle enabled disabled a A check mark indicates that the function is enabled v Select Sleep Maint and press amp 9 to toggle enabled disabled a A check mark indicates that the function is enabled 11 01 AM p 81 11 01 AM p 81 11 01 AM Sep 26 2012 Actions Sep 26 2012 Profile Sep 26 2012 Generate Report Patient Alerts i Select Patient Alerts Setup Time amp Date Stats to Display Setup Actions Day Break Time Sleep Onset V Sleep Maint V Administrative Sensor Action Cancel Note A check mark indicates that the alert is enabled General System Setup and Operation 21 Setting the Statistics to Display Insight only The Zmachine can be set to display statistics to the patient each time the sensor cable is disco
27. lations Care and Maintenance 11 Usage Overview Understanding the Zmachine This description is based on the Zmachine DT 200 running sleep staging algorithm version 2 1 0 To see what version your Zmachine is running refer to page 30 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 use of 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 These internal parameters are called a sleep signature Individualization of the sleep signature is the key to realizing the accuracy of the Zmachine While this is a revolutionary concept in automated sleep staging individualization is routinely performed when polysomnographic PSG records are visually scored When an experienced sleep technologist begi
28. mn definition T Date Time Score Session E Events emporaty Arousal Signature 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 amp N2 3 Deep Sleep Slow Wave Sleep 5 REM Sleep 5 Not Scored sensor problem Column 4 Session This is the recording session number 0 1 2 format The session number will be automatically incremented each time the sensor cable is disconnected and reconnected Column 5 Day This is the recording day number 0 1 2 format The day number is incremented when the current time passes the Day Break Time i e 4 p m 26 Sleep Report and Statistics Files Column 6 Events These are events related to patient alerting Insight only O 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 Alerts will now be suspended for the next 10 minutes this can happen no more than once per session 3 Patient achieved 10 minutes of sleep within a 12 minute sliding window This suspends the sleep onset rule and arms the sleep maintenance rule 4 Alert generated audible and LCD message for patient to l
29. n 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 Z Download Patient Guide printed Clinician Instruction and Zmachine Data Viewer GSC P N 200 170 Service Manual pdf Windows Software GSC P N 200 171 GSC P N 200 103 Introduction Glossary of Symbols 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 Introduction Contraindications Warnings and Cautions Contraindications e 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 dam
30. n 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
31. nnected To set which statistics will be displayed 1 Access the Zmachine System Menu 11 Select Set Actions 111 Select Stats to Display Iv Select TST and press CY to toggle displayed hidden v Select SE and press 9 to toggle displayed hidden vi Select LPS and press to toggle displayed hidden vii Select WASO and press to toggle displayed hidden 11 01 AM p 81 11 01 AM p 81 11 01 AM Sep 26 2012 Actions Sep 26 2012 Profile Sep 26 2012 Select Stats to Display Generate Report Patient Alerts setup Time amp Date Stats to Display setup Actions Day Break Time Administrative Sensor Action Cancel Note A check mark indicates that the statistic will be displayed when the sensor cable is disconnected Note All statistics are calculated and displayed in the clinician report regardless of the status of these display settings 22 General System Setup and Operation 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 If the patient sleeps through this time then the resulting report will show their sleep as spanning two days 1 e both sides of 4PM To change the Day Break Time 1 Access the Zmachine System Menu 11 Select Set Actions 111 Select Day Break Time Iv Change the Hour and AM or PM
32. ns 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 human brain to see the unique patterns for that particular patient Rarely would an experienced technologist immediately score the record from start to finish in a linear fashion They often page forward and back and sometimes return to change a previous score as more is learned about the unique morphology of the sleep record Is the patient a good alpha producer or a weak producer Does the patient exhibit alpha throughout the record or only prior to sleep onset Does the EMG activity behave as expected or does it persist throughout the night What about the signal levels are they strong and classically defined or weak and odd looking 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 and this is called the signature interval To generate the most accurate sleep signature the signature interval needs to contain both wake and sleep Other than simply using the Zmachine the patient need not do anything special during the signature interval nor tell the Zmachine when they were awake or asleep the algorithm will figure this out it
33. nt breach of the same or any other terms or conditions of this Agreement 8 This Agreement shall be binding upon and it shall inure to the benefit of the parties hereto and their respective heirs agents representatives successors and assigns 9 The invalidity or unenforceability of any particular provision of this Agreement shall not affect the other provisions hereof and this Agreement shall be construed 1n all respects as if such invalid or unenforceable provision were omitted Software License Agreement The computer software Licensed Software loaded on the Zmachine the System is licensed not sold to you for use only under the terms of this license Consolidated Research of Richmond Inc dba General Sleep Corporation GSC reserves any rights not expressly granted to you While you may possess the System but GSC retains all ownership rights and title to the Licensed Software itself You are hereby granted the non exclusive right to use the Licensed Software solely with the specific System on which the Licensed Software was provided to you You shall not transfer the Licensed Software in any manner from the System to any other computer or system without the prior written consent of GSC You shall not distribute copies of the Licensed Software or its related documentation to others You shall not modify or translate the Licensed Software or its related documentation without the prior written consent of GSC Th
34. 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 that User and all others using the Zmachine shall abide by and conform to all laws and governmental orders rules and regulations including any future amendments thereto controlling or in any manner affecting operation or use or of the Zmachine 2 The Zmachine contains certain pre loaded computer software which 1s licensed but not sold or otherwise transferred to User and is subject to the Software License Agreement terms contained in this Manual 3 GSC warrants to the initial User that the Zmachine will be free from defects in workmanship or materials when given normal proper and intended usage for a period of one year Warranty Period from the date of its initial shipment to User Excluded from this warranty are 36 Legal Notices 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 warrante
35. ower the Zmachine automatically dims the LCD backlight after 20 seconds turns off the LCD backlight after 40 more seconds and shuts down the system after an additional 60 seconds of inactivity Hint Pressing any button will restart the sequence described above General System Setup and Operation 17 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 1 Boot the Zmachine 11 Insert the Zmachine Clinician Key into the Sensor Charger Port 111 The System Menu will be displayed when the Clinician Key is inserted and will disappear when the key is removed 11 00 AM Sep 26 2012 Generate Report setup Time amp Date Setup Actions Administrative 18 General System Setup and Operation Setting the Time and Date To set the time and date 1 Access the Zmachine System Menu 11 Select Setup Time amp Date and press 68 111 Use the System Buttons to adjust the time and date fields a D 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 9 to commit changes and reboot the system Select Cancel and press amp 9 to discard all changes 11 00 AM 81 11 00 AM Sep 26 2012 Time Sep 26 2012 Generate R
36. p 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 Introduction 1 The Zmachine at a Glance
37. port generation Otherwise loss of data can result 1 Eject the microSD card by pressing inward on the edge of the card with your fingertip fingernail and releasing 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 11 Insert microSD card into the supplied USB microSD Card Reader 111 Import data into your Zmachine Data Viewer software or copy paste files to your computer manually USB to MicroSD Card Reader Iv Reverse the above steps to insert the microSD card into the Zmachine gold contacts facing down Press the card into the card slot with your fingertip fingernail and release If the card was depressed sufficiently it will lock in place when released Sleep Report and Statistics Files 25 About the Sleep Report amp 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 SCOTE CSV Stats cSV These are ASCII files in comma separated variable csv format that can be read by any text editor such as Microsoft Notepad Wordpad or Word or directly imported into a spreadsheet such as Microsoft Excel File score csv Colu
38. self If either 12 Usage Overview wake or sleep are missing from the signature interval then the sleep signature and the resulting sleep staging output would be less accurate In order to ensure that examples of both wake and sleep are captured in the signature interval a minimum period of time and data are specified upon which the sleep signature will be calculated By default the Zmachine will generate a sleep signature after two days and at least twelve hours of data have been acquired This signature interval is a settable parameter and can be increased or decreased as desired depending upon the environment in which the Zmachine is being used It was only chosen 1n order to ensure with a high probability that some sleep data was captured during the signature interval i e it is highly likely that the patient achieved some sleep during two days of use 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 examples of wake and sleep within the data For example with a sleep signature already generated the Zmachine can be used on pure waking data with no loss of accuracy expected It is perfectly appropriate to run a sleep report before a sleep signature is generated e g after a single night of sleep The Zmachine will simply generate a temporary sleep signature based on all avail
39. ting 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 1 Plug the Zmachine System Charger into a wall outlet 11 Insert the free end of the Zmachine System Charger into the Zmachine Sensor Charger Port 111 Charging will start and stop automatically Plug the Zmachine System Insert the free end into the Charger into a wall outlet 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 before providing to a patient for use Advise patients to charge the Zmachine after each night of use Note The Zmachine can safely remain connected to the charger until ready for use 16 General System Setup and Operation 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 To boot the Zmachine 1 Press and release the 9 button 11 If the system battery has sufficient power 1t will boot immediately Otherwise refer to the Charging section of this document Ready for Connection In order to save battery p
40. urns with their Zmachine Generate a sleep report p 24 Remove the microSD card from the Zmachine p 25 Insert card into USB microSD Card Reader and connect to a personal computer p 25 Use the Zmachine Data Viewer software to review the data Return the microSD card to the Zmachine p 25 Sane a 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 amp Discuss If you feel one or more of the Zmachine system settings should be changed then make the adjustments as follows Boot the Zmachine p 17 Insight only Adjust the alert to get out of bed settings p 21 Insight only Adjust the statistics to display settings p 22 Adjust day break time setting p 23 Review any changes to the system settings with your patient so that they know what to expect from the Zmachine SS ee 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 Usage Overview 15 General System Setup and Operation Charging the Zmachine The Zmachine internal battery when fully charged and opera
41. v Select Save or Cancel and press 69 11 01 AM Eh 81 11 01 AM Eh 81 11 01 AM Sep 26 2012 Actions Sep 26 2012 Day Start sep 26 2012 Generate Report Patient Alerts E Set Day Break Time Setup Time amp Date Stats to Display 4 PM Is typical _ setup Actions Day Break Time Administrative sensor Action Cancel Note All statistics are calculated and displayed in the clinician report regardless of the status of these display settings General System Setup and Operation 23 Sleep Report and Statistics Files Generate Sleep Report and Statistics To generate the sleep report and summary statistics file 1 Access the Zmachine System Menu 11 Select Generate Report 11 00 AM p 81 11 00 AM 11 00 AM Sep 26 2012 Calculating Sep 26 2012 Sep 26 2012 Generate Report Processing Report Report Generated Please Wait setup Time amp Date F Setup Actions MI Safe To Eject Administrative SD Card Now Cancel 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 24 Sleep Report and Statistics Files 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 re
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