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Zephyr MATRx Plus, Инструкция по эксплуатации

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General Information

 © 2019 Zephyr Sleep Technologies Inc.

Zephyr Sleep Technologies

#102, 701 64th Ave� S�E�

Calgary, Alberta, Canada T2H 2C3

Toll Free:

 1�877�341�8814

Technical Support:

 1�877�227�9832

Email:

 info@zephyrsleep�com

www.zephyrsleep.com

Manufacturer’s Information

MATRx plus™ is a trademark of Zephyr 

Sleep Technologies Inc� All other 

trademarks are property of their 

respective holders� This device is covered 

under one or more patents as set forth at  

www�zephyrsleep�com/patents

Trademarks and Patents

Masimo, SET ®,    , and LNCS are trademarks 

of Masimo� The Masimo SET ® and Masimo 

components included within this product 

are covered under one or more patents as 

set forth at www�masimo�com/patents

This information applies to the Masimo SET® components that are used within the 

MATRx plus System�

Possession or purchase of this device does not convey any express or implied license to use 

the device with unauthorized sensors or cables which would, alone or in combination with 

this device, fall within the scope of one or more of the patents relating to this device.

Masimo License Agreement

Содержание MATRx Plus

Страница 1: ...Instructions for Patients ...

Страница 2: ...cations 9 Notes 9 Cautions 10 Warnings 11 Frequently Asked Questions 13 System Troubleshooting 14 Patient Tablet Error Messages 14 General Information 17 Manufacturer s Information 17 Trademarks and Patents 17 Masimo License Agreement 17 Manufacturer Declaration for Emissions 18 Federal Communications Commission Notices 20 Manufacturer Declaration for Emissions 20 Industry Canada Statement 20 Radi...

Страница 3: ...harge your Tablet and Recorder when you arrive home and after each study night Before and after use inspect the trays for damage to the impression material If the trays are damaged stop the study and return to your Healthcare Provider Your Sensors A Effort Belt B Nasal Cannula C Pulse Oximeter D MP If Provided Only used when a Sleep Theragnostic is ordered A C B D ...

Страница 4: ... Tablet is connected to the Recorder wireless connection Your Effort Belt is connected to the Recorder Your Nasal Cannula is connected to the Recorder and breathing is detected Your Pulse Oximeter is connected to the Recorder and your pulse is detected Your MP is connected to the Recorder Your Recorder is fully Charged Your recorder needs charging Note an 85 charge is needed to start a study Your ...

Страница 5: ...to videos on Sensor setup If prompted by Tablet 1 Connect Recorder andTablet Warning If the range of motion values are not the same stop the test and contact your Healthcare Provider 2 Confirm Range of Motion 3 Get Connected Warning Wear effort belt over clothing A Effort Belt ...

Страница 6: ...6 B Nasal Cannula Note Remove nail polish or false nail from your finger C Pulse Oximeter Note Connect if provided D MP ...

Страница 7: ... to sleep If you feel the MP move If you need to get up Press Pause on your Tablet Do not remove or unplug any sensors Nasal Cannula Pulse Oximeter Effort Belt or the MP Press Resume when you return to bed If your hear an alert Check and correct For flow alerts check for kinks in tubing Good night 3 Start Sweet dreams 4 Sleep Good morning 5 End Ready for Sleep Note Sleep in your normal body positi...

Страница 8: ...d pets until your next study night Note Tray use is not to exceed 3 nights of sleep total 24 hours 2 If Provided rinse Trays under cold water Caution Do not wet any other parts of the system If Study is Complete 1 Pack your System Kit 2 Return it to your Provider Note Remember to notify your Provider if the trays were loose or came out during your study Check your study progress ...

Страница 9: ... be suitable for oral appliance therapy and to recommend a target mandibular position The use of the device does not replace the need for follow up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines Product Overview MATRx plus is a portable recorder used to conduct an overnight sleep study in a clinical hospital or home environm...

Страница 10: ...id impeded blood flow e g blood pressure cuff as this may affect pulse and saturation measurements 5 Do not expose the device to open flames 6 Do not immerse the device or sensors in water solvents or cleaning solutions 7 Do not use a Pulse Oximeter sensor with exposed optical components 8 Do not attempt to disconnect theTitrationTrays from the MP before during or after your study Return the Trays...

Страница 11: ...ecautions regarding EMC and needs to be installed and put into service according to the EMC information provided see Manufacturer Declaration for Emissions 9 Portable and mobile RF communications equipment such as wireless home network devices mobile phones cordless telephones and their base stations walkie talkies can affect this device and should be kept at least a distance 30 cm away from the e...

Страница 12: ... 22 Tissue damage can be caused by incorrect application or use of the Oximeter sensor for example by wrapping the sensor too tightly Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor 23 Before going to sleep for the night you must confirm that each sensor is setup correctly and sending a signal to the R...

Страница 13: ...uld I do if I can t move past the connect recorder screen on the Tablet Press the Pair button again If the Recorder s LED lights are not Illuminating or flashing green charge the Recorder s battery and press the pair button If the Recorder s LED light below the Play Pause button flashes orange quickly the Recorder and Tablet are no longer paired Follow the on screen instructions to re pair the Tab...

Страница 14: ...een paused by pressing the Pause button on the Tablet or Recorder Press Resume when ready to continue and go to sleep Recorder Not Connected Confirm the recorder is within 3 feet of the tablet and press the connect button on the Recorder If there is no flashing green light on the recorder charge it before trying again Recorder is out of range of Tablet and or Recorder is not charged Confirm the Re...

Страница 15: ...nula is not connected to Recorder or prongs of Nasal Cannula are not positioned correctly in your nose or your nose is plugged congested Disconnect Reconnect Nasal Cannula to Recorder Ensure prongs of Nasal Cannula are properly positioned in each nostril Check the length of the Nasal Cannula for kinks Blow your nose If error continues stop the study and contact your Healthcare Provider Oximeter No...

Страница 16: ...The study will resume automatically after fixing the error Press Continue and this will pause tray movement for 30 minutes and allow you to fall asleep If this error continues the MP may not be functioning properly Stop the study and contact your Healthcare Provider Unplug the recorder from power Confirm the recorder is unplugged The Recorder should not be plugged in during the study Disconnect th...

Страница 17: ...set forth at www zephyrsleep com patents Trademarks and Patents Masimo SET and LNCS are trademarks of Masimo The Masimo SET and Masimo components included within this product are covered under one or more patents as set forth at www masimo com patents This information applies to the Masimo SET components that are used within the MATRx plus System Possession or purchase of this device does not conv...

Страница 18: ...ent IEC 61000 4 3 As per Clause 8 10 of IEC 60601 1 2 seeTable 2 Proximity Field Parameters EFT Bursts IEC 61000 4 4 2kV AC mains 1kV I O ports Surges Line Line IEC 61000 4 5 0 5 kV 1 kV Surges Line Ground IEC 61000 4 5 0 5 kV 1 kV 2 kV Rated power frequency magnetic fields IEC 61000 4 8 30A m 50 and 60Hz Conducted disturbances induced by RF fields IEC 61000 4 6 6V in ISM Amateur bands 3V 0 1580MH...

Страница 19: ... Time s Test Level V m Modulation Frequency 385 30 27 18 450 30 28 18 710 30 9 217 745 30 9 217 780 30 9 217 810 30 28 18 870 30 28 18 930 30 28 18 1720 30 28 217 1845 30 28 217 1970 30 28 217 2450 30 28 217 5240 30 9 217 5500 30 9 217 5785 30 9 217 ...

Страница 20: ...ipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help Manufacturer Declaration for Emissions Note Harmful interference is defined by the FCC as follows Any emission radiation or induction that endangers the functioning of a radio navigation service or of other safety services or seriously degrades...

Страница 21: ...Zephyr Sleep Technologies 102 701 64th Ave S E Calgary Alberta T2H 2C3 Canada 1 877 341 8814 www zephyrsleep com LBL 00287 02 ...

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