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Specifications

Operating Conditions

The device can be operated, stored and transported under the following environmental conditions:

Operation

Storage and Transport

5 to 40°C
15 % to 93%, non-condensing
70-106kPa

-25 to 70 ˚C
Up to 93%, non-condensing
70-106kPa

Temperature
Humidity
Pressure

MATRx plus Tablet

8 hours per night (up to 6 nights)
5 V, 2 A
Bluetooth, Wi-Fi, Cellular

Recording Time
Input Power
Communication Protocol

MATRx plus Recorder

7.25 Watt Hour
Bluetooth
12 bit ADC
1

Battery Size
Communication Protocol
Body Position Sensor sensitivity
Body Position Sensor Sampling Rate (Hz)

PULSE OXIMETER

Caution

Operation of the device below this amplitude may cause inaccurate results.

SpO2 and Pulse Rate Accuracy:

Refer to the sensor IFU for details.

Range

0%-100%
25-240

Saturation (%SpO2)
Pulse Rate (bpm)

Resolution

1%
1

Saturation (%SpO2)
Pulse Rate (bpm)

Содержание MATRx plus

Страница 1: ...Healthcare Provider Manual TEST SELECT TREAT...

Страница 2: ...ephyr 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 htm Masimo SET a...

Страница 3: ...Tablet Connection Icons MATRx plus Recorder MATRx plus Sensors Effort Belt Nasal Cannula Pulse Oximeter Mandibular Positioner MP MATRx plus Titration Trays MATRx plus System Installation and Set up P...

Страница 4: ...he Mandibular Positioner MP Preparing for an OA Study Fitting Trays and Taking Impressions Portal Functions for Setting up a Study Create a Patient Start a Study Assign a Specialist Find a Patient Syn...

Страница 5: ...lus Tablet MATRx plus Recorder Pulse Oximeter Effort Belt Nasal Cannula Snoring Data Transfer Mandibular Positioner MATRx plus Titration Trays Impression Material Masimo License Agreement Manufacturer...

Страница 6: ...y Figure 12 Upper Titration Tray Figure 13 Charging the Recorder Figure 14 Charging the Tablet Figure 15 Attaching the Effort Belt Figure 16 Connecting the Sensor Cable to the Recorder Figure 17 Attac...

Страница 7: ...device should be kept within the humidity limit as stated Indicates a Type BF Applied Part Indicates that the component is protected from touch by fingers and objects greater than 12 millimeters and p...

Страница 8: ...le recorder used to conduct an overnight sleep study in a clinical hospital or home environment excluding outdoors vehicles train stations bus stations airports museums theatres This device is not int...

Страница 9: ...tudy and a Static Study The type of study and the specific parameters for each successive night will depend on the data collected and analyzed from the previous study night The progress from one night...

Страница 10: ...harger Effort Belt Nasal Cannula Pulse Oximeter MP and Trays 2 Static Study During this type of study night the system will move the mandible to the target protrusive position at the calculated during...

Страница 11: ...urate in cases of central sleep apnea CSA and severe respiratory disorders Patients fitted with an oral appliance after their MATRx plus Study as prescribed by the interpreting physician should be mon...

Страница 12: ...ay studies Fire explosion or severe burn hazard Do not crush disassemble heat above 100C 212F incinerate or expose the device to water Explosion hazard Do not use the Pulse Oximeter in the presence of...

Страница 13: ...r dyes e g indocyanine green methylene blue Interfering substances Dyes nail polish or any substance containing dyes that change usual blood pigmentation may cause erroneous readings Exposure to exces...

Страница 14: ...ar line Loss of pulse signal can occur in any of the following situations 13 The Pulse Oximeter sensor is too tight There is excessive illumination from light sources such as a surgical lamp a bilirub...

Страница 15: ...used by the HCP to 15 Power Adaptor Connection Port Power Button Volume Button Touch Screen Windows Button MATRx plusTablet The Tablet s primary function is to guide the user in system operation and t...

Страница 16: ...heck Perform the cleaning and disinfection procedures Clear patient data The patient uses the Tablet to Verify their mandibular range of motion View instructions and how to videos on device use and se...

Страница 17: ...elt is connected to the Recorder The Nasal Cannula is connected to Recorder and airflow is detected The Pulse Oximeter is connected to the Recorder and a heart rate is detected The MP is connected to...

Страница 18: ...s primary function is to collect data from each of the sensors control the MP and relay this data to the Tablet The body mounted sensors are connected to the Recorder and designed to record the follow...

Страница 19: ...or use NASAL CANNULA The Nasal Cannula measures nasal airflow and snoring The Nasal Cannula is an applied part It features a dual lumen cannula with air filters This ensures the airflow from each nost...

Страница 20: ...he Masimo pulse oximeter s directions for use Figure 10 Mandibular Positioner MP MANDIBULAR POSITIONER MP The MP connects to the patient s Titration Trays via the Upper and Lower Tray Attachment Rods...

Страница 21: ...ment results Note For further information on the Titration Trays refer to the MATRx plus Titration Tray Manual The Titration Trays are customized to the patient s bite by means of a quick set impressi...

Страница 22: ...ware Installation The Data Viewer software can be downloaded from the Portal Warning Use an appropriate antivirus software on your computer Note Computer back up procedures should be in place prior to...

Страница 23: ...MATRx plus software If it does not select the Sleep Study icon i e heart symbol on the Login screen to launch the software The Tablet can be configured to connect to the office Wi Fi if there is poor...

Страница 24: ...ssible following patient use Ensure these supplies are available To prepare for the cleaning and disinfection procedure perform the following 1 2 3 4 5 Accelerated hydrogen peroxide AHP spray bottle a...

Страница 25: ...any additional on screen instructions Extend the MP s Upper Rod by pressing the Full Extension button a b c d e f Disconnect the Power Adaptors from the Recorder and Tablet Remove the MP from the Reco...

Страница 26: ...nt free cloth Inspect all surfaces to confirm they are visibly clean Place the components aside for disinfection 5 6 7 CLEANING PROCEDURE RECORDER TABLET AND POWER ADAPTORS Caution Do not soak or imme...

Страница 27: ...by pressing the Full Extension button Using the bottle of AHP spray the MP and MP Cable until all surfaces and hard to reach areas have been covered Caution Do not spray the Recorder or MP Cable conne...

Страница 28: ...reas of the Recorder MP Cable connector Tablet and Power Adaptors i e seams base of connector ports prongs of Power Adaptors Caution Do not soak or immerse the Tablet Recorder Power Adaptors or sensor...

Страница 29: ...g to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines The device selects patients as suitable for oral appliance therapy and recommends a t...

Страница 30: ...lost and the Night Study Manager will automatically reinitiate the study on a subsequent night CONNECTING THE RECORDER S POWER ADAPTOR 1 2 Line up the red dot on the Power Adaptor s connector to the r...

Страница 31: ...to the front again Snap the two blue cable connectors of the Sensor Cable to the buttons on either side of the buckle Insert the other end of the Sensor Cable into the Recorder s Effort Belt port The...

Страница 32: ...rity and correct positioning and adhesion of the sensor Note Remove any nail polish on the finger that will be used for the Pulse Oximeter Use only Masimo sensors for Pulse Oximeter measurements see P...

Страница 33: ...ay s connection to the MP s rods use the Tray Attachment Pins provided Figure 21 Tray Attachment Pins Note The two piece Tray Attachment Pin has a push pull rivet design When the internal pin is inser...

Страница 34: ...stem and are not to be used for any other purpose Oral health examination and MATRx plus Titration Tray fitting is to be performed by a licensed dentist or dental healthcare professional Detailed inst...

Страница 35: ...ient will be entered into the database 1 2 3 4 5 Login to the Portal Select the patient Click on the patient s name on the top of the Patient Information screen Press Start New Study at the bottom of...

Страница 36: ...m Protrusion and Habitual Bite are required fields ASSIGN A SPECIALIST More than one HCP i e Specialist can have access to a patient s study data on the Portal This facilitates a team approach for rev...

Страница 37: ...he patient information and study details have been entered in the Portal this data must be relayed to the Tablet in preparation for the patient s study night Note If unable to press Select Patient Cle...

Страница 38: ...tions for the expected service life of the Effort Belt and Pulse Oximeter FUNCTIONAL CHECK LEDs on the Recorder illuminate Speaker on the Tablet emits sound A Functional Check should be performed prio...

Страница 39: ...ecorder CHARGING THE RECORDER If the battery on the Recorder requires charging you will be instructed to plug the Recorder into power To see the current charge of the battery press the Recorder icon P...

Страница 40: ...readings are entered as expected the test will pass otherwise you will be informed of a test fail 1 2 3 4 40 Note A successful study relies on accurate MP function The Functional Check verifies that t...

Страница 41: ...e any nail polish on the finger that will be used for the Oximeter Review the following warning and cautions with the patient prior to dispensing the system Warning The patient should avoid the use of...

Страница 42: ...the MATRx plus System Carry Case Recorder and Power Adaptor Tablet and Power Adaptor Effort Belt sized to the patient Nasal Cannula MP and Titration Trays attached to the Recorder for an OA Study MP...

Страница 43: ...or the patient Choose the study you want to review and click the link Open Study in Data Viewer Each Study Event will be categorized by type date time stamp details and download availability A complet...

Страница 44: ...pen Study enter your Professional ID Professional Password and the specific Patient Study ID For Open File use the standard Windows browser Point the browser to the location of the downloaded file a b...

Страница 45: ...Sensor Status is displayed as a color bar graph at the top of the signal display Active sensors on study running Green Inactive sensors on study will resume Orange Paused sensors on awaiting user inpu...

Страница 46: ...dow 8 Body Position is displayed as a color bar graph on the bottom of the signal display Prone Dark Blue Supine Thick Purple Lateral Light Blue Lateral Right Light Green Upright Black Upside Down Whi...

Страница 47: ...etween time into study Relative and time of day Absolute Turn on the Marker Line Add a line that trails the marker by 10 seconds Highlight 10 seconds of time trailing the marker line Measures the diff...

Страница 48: ...exclude periods of time from automatic scoring Note This function can only be used when reviewing a Baseline Study Click and drag to zoom Copies screen shot to clipboard Click to activate the marker l...

Страница 49: ...be easily viewed Adjust Channel Gain in the right click menu Gain Adjust in the Channel Menu of the toolbar Keyboard Shortcuts Some of the key actions are Open file Save custom layers file Activate ma...

Страница 50: ...Add Remove Excluded Period window 2 In the Toolbar open the Edit Menu and select Add Remove Excluded Period Press the Choose Start Time button and then click the start time in the Data Viewer press C...

Страница 51: ...ata on the oximetry panel using either one of the following criteria When the OD method is used to score events oxygen desaturations are marked green The excluded period will be highlighted with dark...

Страница 52: ...m Layer name and user name 1 2 Note An empty layer can be created to manually re score a study using an alternate method by selecting the Create Empty checkbox Press OK 3 52 Adding Removing Events Add...

Страница 53: ...vent details Event list Verify layer Add new events by time or selection Saving and Opening a Layer Custom layers can be created for editing events and saved to allow editing at a later time To save t...

Страница 54: ...liance after their MATRx plus Study as prescribed by the interpreting physician should be monitored and undergo further sleep testing with their therapeutic appliance in place to ensure adequate treat...

Страница 55: ...active MP Parameters Frequency of Changes per Hour Frequency of MP motor changes per hour calculated from study active time Frequency of Motor Position Changes Number of times the MP motor made a dis...

Страница 56: ...cored Events When creating a Baseline Study report the displayed the Desaturation layer is used All parameters will be displayed Study Information Respiratory Disturbances Oxygen Desaturations Oxygena...

Страница 57: ...r is a patient that can be expected to achieve a therapeutic outcome of less than 10 oxygen desaturation events per hour with a custom oral appliance Study Information Study Summary Statistics Oral Ap...

Страница 58: ...night During this study the mandibular protrusion increases with detected respiratory events Study Information Oxygenation Cardiovascular Parameters with Distribution Study Histogram Layer Informatio...

Страница 59: ...e second OA Study night Up to two Static Study nights can be performed Part III and IV Static Study Night Report Study Information Oxygenation Cardiovascular Parameters with Distribution Study Histogr...

Страница 60: ...rder s LED light below the Play Pause button flashes orange quickly the Recorder and Tablet are no longer paired therefore the study cannot be completed Follow the instructions in Appendix 1 Re Pairin...

Страница 61: ...or Tablet Password parameters are invalid missing empty or null Enter Admin Menu to complete Tablet Set up Set up Incomplete A patient has not been selected on the Tablet Login to Admin Menu Press Sel...

Страница 62: ...Re enter patient details in database On the Tablet s Admin Menu screen the Select Patient button is disabled Previous patient study data has not been cleared Select Clear Patient Data Once cleared the...

Страница 63: ...functioning Study will resume automatically when error is corrected No Air Flow Reading Nasal Cannula is not connected to Recorder or prongs of Nasal Cannula are not positioned correctly in the nostr...

Страница 64: ...ore studies ordered Confirm Tablet is connected to wireless connection e g data plan Wi Fi Allow more time for data to upload Return MATRx plus to your Healthcare Provider No Further Studies The study...

Страница 65: ...rror General system error System cannot be used Contact Zephyr Technical Support App Storage Space Error There is only 600 MB available to the app Tablet does not have enough memory to set up a new pa...

Страница 66: ...again Incorrect date of birth Re enter your date of birth If error continues contact your Healthcare Provider Positioner Error An error in your range of motion values has been detected The study canno...

Страница 67: ...Confirm Tablet s power adaptor is correctly plugged into the Tablet and an electrical outlet Study will resume automatically when error is corrected Tablet is not plugged into power power adaptor is n...

Страница 68: ...motor has stalled this may be caused by pushing against the trays while they are moving in your mouth To correct this error press Continue and this will pause tray movement for 30 minutes and allow y...

Страница 69: ...tudy or automatically upon presentation of the expected signal Accessories List Component Catalog Number Carry Case Tablet including Case and Charger Tablet Cover Tablet Charger Recorder including Cha...

Страница 70: ...to 6 nights 5 V 2 A Bluetooth Wi Fi Cellular Recording Time Input Power Communication Protocol 70 MATRx plus Recorder 7 25 Watt Hour Bluetooth 12 bit ADC 1 Battery Size Communication Protocol Body Pos...

Страница 71: ...tion with the Masimo packaging Saturation SpO2 During no Motion Accuracy Adults Saturation SpO2 During Motion 70 100 2 digits 70 100 2 digits 70 100 2 digits 70 100 3 digits 70 100 3 digits Not applic...

Страница 72: ...pled to 25 Hz for display Range inches H20 Accuracy inches H20 Sampling Rate Hz Bluetooth Communication Data transfer from the Tablet to the Portal is done through RF communication The specifications...

Страница 73: ...s instructions for use and product specifications Masimo License Agreement This information applies to the Masimo SET components that are used within the MATRx plus System Possession or purchase of th...

Страница 74: ...t IEC 61000 4 3 As per Clause 8 10 of IEC 60601 1 2 see Table 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 Gr...

Страница 75: ...ce in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference t...

Страница 76: ...for the transmitter by Industry Canada To reduce potential radio interference to other users the antenna type and its gain should be so chosen that the equivalent isotropically radiated power e i r p...

Страница 77: ...hcare Device will appear identified with the heart symbol select the Healthcare Device and press pair After a few seconds the Recorder will start re pairing to the Tablet After re pairing is completed...

Страница 78: ...Press the Set up icon i e gear symbol to continue to the Set up login screen On the bottom left hand side of the login screen press the bar icon to view the available Wi Fi connections Choose your off...

Страница 79: ...position and monitors recurrence of these transient respiratory disturbances The continued occurrence of respiratory events despite mandibular protrusion is a reflection of the patient s ability to r...

Страница 80: ...piratory events to the control system Each event is classified with respect to the magnitude of decrease in airflow and the depth of desaturation and their rate of occurrence frequency The result of t...

Страница 81: ...of a protrusive intervention is first assessed only after an initial 2 hours have elapsed after reaching the preliminary target position and a protrusive movement occurs only if the cumulative count...

Страница 82: ...te the study by hitting the button displayed on the Tablet During the paused mode the data is gathered and is available for review by the HCP however the data is clearly marked and is not included in...

Страница 83: ...come cannot be predicted by the HCP s review of the data set either the dynamic or static study night Instead the prediction is made using a wide variety of variables that might correlate with outcome...

Страница 84: ...102 701 64th Ave S E Calgary Alberta Canada T2H 2C3 Phone 1 877 341 8814 www zephyrsleep com 2018 Zephyr SleepTechnologies Inc LBL 00264 01 Healthcare Provider Manual...

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