Getting to Know Your System Kit

Transcription

1 FOR PATIENTS Getting to Know Your System Kit Your Tablet Your Recorder IMPORTANT FEATURES TABLET POWER BUTTON 2 RECORDER PAIR BUTTON 3 RECORDER PAUSE BUTTON IMPORTANT: CHARGE 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 When connecting the power adaptor to the Recorder, line up the red dots and push the connector in without twisting. When disconnecting, hold the connector sleeve and pull the connector straight out without twisting. SENSORS A B C * D If Provided A EFFORT BELT * D MP (If Provided) B C NASAL CANNULA PULSE OXIMETER * Only used when an OA Study is ordered 1

2 Understanding Your Tablet Icons Tablet Icon Overview THESE ICONS WILL APPEAR AT THE TOP OF YOUR TABLET S SCREEN At a glance you will see the status of your MATRx system The color of the icon will change from grey to green when each component is properly connected and ready for use During the study the color of the icon will change from green to red, with an alert, if you need to check a connection Tablet Icon Information These icons can be pressed at any time to see the current battery charge The Tablet is connected to the Recorder (wireless connection) The Recorder is fully charged The Recorder needs charging An 85% charge is needed to start a study. The Recorder is plugged in and charging The Recorder is plugged into power and fully charged These icons can be pressed at any time to see the current battery charge 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 Tablet is plugged into power Your Tablet is unplugged. The battery shows the current charge. 2

3 Sensor Setup : Use this page as a guide when viewing your Tablet s how-to videos on Sensor setup 1 PAIR RECORDER & TABLET * If prompted by Tablet 2 CONFIRM RANGE OF MOTION Warning If the range of motion values are not the same, stop the test and contact your Healthcare Provider. 3 GET CONNECTED A Effort Belt Warning Wear effort belt over clothing. Position Recorder in front of navel. B Nasal Cannula C Pulse Oximeter Remove nail polish from your finger. D MP Connect if provided: Line up red dots, push into place, do not twist. 3

4 Your Study Night 1 CHECK 2 PLUG-IN 3 START 4 SLEEP 5 END PREP FOR SLEEP READY FOR SLEEP Sleep in your normal body position. Sensors working Tablet plugged in Good Night! Sweet Dreams! Good Morning! 7 HOURS IF YOU FEEL THE MP MOVE IF YOU NEED TO GET UP IF YOU HEAR AN ALERT HELPFUL TIPS Do not resist tray movement. Press the Pause button twice on your Recorder This will give you minutes to go to sleep 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 Check and correct For flow alerts, check for kinks in tubing 4

5 The Morning After Your Study IF MORE NIGHTS ARE NEEDED Check Your Study Progress Plug-in your Recorder and Tablet Caution If provided, rinse Trays under cold water. Do not wet any other parts of the system. Store Trays and MP in bag provided. Warning Store your System Kit out-ofreach of children and pets until your next study night. Tray use is not to exceed 3 nights of sleep (total 24 hours). 1 2 IF YOUR STUDY IS COMPLETE Pack up your System Kit Return it to your Provider Remember to notify your Provider if the trays were loose or came out during your study. We hope you enjoyed your MATRx plus experience! 5

6 Intended Use and Cautions Intended Use The MATRx plus is indicated for use by a lay person in a home and hospital environment under the direction of a Healthcare Professional (HCP). MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients. The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient s respiratory status related to repositioning of the mandible during an overnight study. MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may 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 environment, excluding: outdoors, vehicles, train stations, bus stations, airports, museums, theatres. The device is not intended for use near surgical equipment or magnetic resonance imaging equipment. Contraindications This device is not to be used as an apnea monitor or in a life supporting or life sustaining situation This device is not to be used by patients under the age of 18 The MATRx plus device is MR unsafe In an OA Study mode,, the device is not recommended for use in patients who: Have loose teeth or advanced periodontal disease Have full dentures or dental implants s The use of this device is only for the person that is was prescribed for If the light from the Tablet disturbs you during the study, turn the device over. Audible alerts will let you know if any actions are required during the study. Remove Trays and discontinue the study if necessary Cautions Only use with Zephyr approved parts and accessories. Do not blow into the Nasal Cannula connection to avoid causing damage. Avoid electrostatic discharge. The relative humidity should be at least 5%. Avoid impeded blood flow (e.g. blood pressure cuff ) as this may affect pulse and saturation measurements. Do not expose the device to open flames. Do not immerse the device or sensors in water, solvents or cleaning solutions. Do not use a Pulse Oximeter sensor with exposed optical components. Do not attempt to disconnect the Titration Trays from the MP before, during or after your study. Return the Trays connected to the MP. 6

7 Warnings Federal Law restricts this device to sale by or on the order of a licensed practitioner. Prescription use only. To be used only for prescribed purposes. Read all manuals and labels prior to use. Ensure that you have been trained prior to use. Use of the device during an OA Study may cause: Temporary bite changes Jaw joint discomfort Gum or tooth discomfort Increased salivation Jaw discomfort Dry mouth Use of the MATRx plus may cause disruption in sleep from the use of the sensors and Mandibular Positioner. Stop use of the device during an OA Study if you experience any of the following: Nausea or vomiting Adverse reaction to any system component Jaw or mouth pain Electric shock hazard. Do not remove or disassemble any covers, enclosures or parts of system components. The system is not user serviceable. Do not use the device near liquids. Contact Zephyr for service or repair inquiries. Do not charge the Recorder while it is connected to you. This device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided (see Manufacturer Declaration for Emissions). 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 cm away from the equipment. The device cannot be used during defibrillation. Do not use extension cords or adaptors of any type for device charging. The power cord and plug must be intact and undamaged. Use only the chargers provided. 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 flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide. Do not connect to an electrical outlet controlled by a wall switch or dimmer. Do not place the device or external power supply in any position that might cause it to fall on you. Do not lift the device by the power supply cord or patient cable; use only the body of the device. Avoid the use of drugs and alcohol prior to your night study. Choking hazard: Keep the system out of reach of children and pets. Discontinue the study if any parts of the MATRx plus Recorder, Tablet, sensors, Titration Trays and/or retention material show damage. The Nasal Cannula, Titration Trays, Titration Tray Storage Bag and Tray Attachment Pins should be discarded after single patient use. The MATRx plus Recorder and Effort Belt should be worn over clothing. Route or tape cabling to reduce the possibility of entanglement or strangulation. 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. Before going to sleep for the night, you must confirm that each sensor is setup correctly and sending a signal to the Recorder. Inspect the Titration Trays and tray material carefully prior to each use. Stop the study and return the system to the Healthcare Provider if: The tray material has degraded The tray material has come off the Titration Trays during the study. If this occurs, remove any pieces from the mouth. The Titration Trays are uncomfortable due to the tray material 7

8 FAQs What should I do if I have to get up during the study? Do not remove any sensors Pause the study by using the button on the Recorder or Tablet When you are ready to go back to sleep, press the same button on the Recorder or the Resume button on the Tablet What should I do if I can t sleep? Pause and resume the study by using the button on the Recorder. This will give you another half an hour to fall asleep. What should I do if I feel the MP moving? Pause and resume the study by using the button on the Recorder. This will stop the trays from moving for the next half hour so that you can fall asleep. What should I do if I can t move past the pairing 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, therefore the study cannot be completed. Contact your Healthcare Provider. What should I do if I can t move past the Recorder charging screen on the Tablet? Charge the Recorder After charging is complete, confirm that the Recorder is paired with the Tablet by pressing the Pair button the on the Recorder If the Recorder and Tablet are paired, check the Recorder s battery status by pressing the Recorder charge icon located on the top of the Tablet screen. The battery charge must be above 85% to continue. 8

9 System Troubleshooting Patient Tablet Error Messages ERROR TITLE ERROR MESSAGE CAUSE / ACTIONS Incorrect Date of Birth Re-enter your date of birth and try again Incorrect date of birth Re-enter your date of birth If error continues, contact your Healthcare Provider Positioner Error Not Enough Data Collected An error in your range of motion values has been detected. The study cannot continue. Remove your sensors and contact your Provider. Another XXX minutes is required to complete the study. Press Continue and go back to sleep. If you end the study now, there may not be enough data. Range of motion values provided are not the same as those entered in the system. The study cannot continue. Remove your sensors Contact your Healthcare Provider At least 4 hours of sleep time is required to complete a study night otherwise study night may need to be repeated. Press Continue to go back to sleep Study Paused Press Resume when ready to continue Your study has been 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, then press the Pair button on the Recorder. If there is no flashing green light on the Recorder, charge the Recorder before pairing again. Recorder is out of range of Tablet and/or Recorder is not charged. Confirm the Recorder is within 3 feet of the Tablet, then press the Pair button on the Recorder to re-pair If there is no flashing green light on the Recorder, charge the Recorder before re-pairing If error continues, contact your Healthcare Provider MP Not Connected Confirm the MP is connected to the Recorder. The study will resume automatically after fixing the error. MP is disconnected from Recorder, not connected properly or damaged. Disconnect/Reconnect MP to Recorder If error continues, stop the study and contact your Healthcare Provider 9

10 System Troubleshooting ERROR TITLE ERROR MESSAGE CAUSE / ACTIONS Tablet Unplugged 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 not connected properly or electrical outlet is not functioning. Confirm power adaptor is correctly plugged into the Tablet and an electrical outlet Confirm the electrical outlet is functioning Leave the Tablet plugged in for the rest of the night to ensure your study continues No Air Flow Reading Confirm the Nasal Cannula is connected to the Recorder and correctly positioned in your nose. Blowing your nose may help. The study will resume automatically after fixing the error. Nasal Cannula 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 No Pulse Oximeter Reading Confirm the Pulse Oximeter is connected to the Recorder and correctly positioned on your finger. The study will resume automatically after fixing the error. Pulse Oximeter is not connected to Recorder, or not positioned properly on your finger. Disconnect/Reconnect Pulse Oximeter to Recorder Ensure sensor is properly positioned on your finger If error continues, stop the study and contact your Healthcare Provider No Effort Belt Reading Confirm the Effort Belt is connected to the Recorder and correctly positioned on your abdomen. The study will resume automatically after fixing the error. Effort Belt is not connected to Recorder, or not positioned correctly on your abdomen. Disconnect/Reconnect Effort Belt to Recorder Disconnect/reconnect Effort Belt cable to Effort Belt Ensure Effort Belt is properly positioned on your abdomen (i.e. in front of your belly button) If error continues, stop the study and contact your Healthcare Provider 10

11 System Troubleshooting ERROR TITLE ERROR MESSAGE CAUSE / ACTIONS Positioner Error The MP s 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 minutes and allow you to fall asleep. Press Continue and this will pause tray movement for 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. Recorder Plugged In Confirm the Recorder s power adapter is not plugged into the Recorder. The study will resume automatically after fixing the error. The Recorder should not be plugged in during the study. Disconnect the power adapter from the Recorder to continue the study. No Further Studies Return MATRx plus to your Healthcare Provider There have been 6 unsuccessful study nights and there are no more studies ordered. Return MATRx plus to your Healthcare Provider No Further Studies Study is complete. Return MATRx plus to your Healthcare Provider. The study has been completed successfully and is ready for evaluation. Return MATRx plus to your Healthcare Provider Error Device error. Return MATRx plus to your Healthcare Provider. Maintenance by manufacturer is required. Return MATRx plus to your Healthcare Provider 11

12 General Information Manufacturer s Information Trademarks and Patents Zephyr Sleep Technologies #102, th Ave. S.E. Calgary, Alberta, Canada T2H 2C3 Toll Free: Technical Support: info@zephyrsleep.com 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 Masimo, SET,, and M-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 Zephyr Sleep Technologies Inc. 12

13 General Information Masimo License Agreement 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. Manufacturer Declaration for Emissions Essential Performance The prevention of excessive mandibular motion is considered Essential Performance of the MATRx plus device. Excessive mandibular motion is mitigated by design. EMC Standards and Testing TABLE 1: EMC TEST LIMITS Phenomenon Basic EMC Standard Immunity Test Level Electrostatic Discharge Radiated RF EM fields Proximity fields from RF wireless communications equipment EFT/Bursts Surges Line-Line Surges Line-Ground Rated power frequency magnetic fields Conducted disturbances induced by RF fields Voltage Dips Voltage Interruptions Radiated Disturbance Conducted Disturbance RF Emissions IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC FCC 47 CFR Part 15, Subpart B, CISPR 11, Group 1, Class B CISPR 11, Group 1, Class B IEC Harmonics, IEC Flicker +/-8kV contact, +/ 2,4,6,8, 15kV air 10V/m, 80MHz-2.7GHz, 80% AM at 1kHz As per Clause 8.10 of IEC , see Table 2: Proximity Field Parameters +/-2kV, AC mains, +/-1kV, I/O ports ± 0.5 kv, ±1 kv ± 0.5 kv, ±1 kv, ±2 kv A/m, 50 and 60Hz 6V in ISM + Amateur bands, 3V ( MHz) 0 % UT; 0.5 0, 45, 90, 135, 180, 225, 270 and 315 Interrupt >95% drop, 5s 13

14 General Information Table 2: Proximity Field Parameters Frequency Range (MHz) Dwell Time (s) Test Level (V/m) Modulation Frequency

15 General Information Federal Communications Commission Notices This product complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. Caution Changes or modifications to this equipment that have not been approved by Zephyr Sleep Technologies may void the user s authority to operate this equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference 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 to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment 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 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, obstructs or repeatedly interrupts a radiocommunications service operating in accordance with FCC rules. Industry Canada Statement Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved 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.) is not more than that necessary for successful communication. This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: This device may not cause interference, and This device must accept any interference, including interference that may cause undesired operation of the device. Radiation Exposure Statement The radiated energy from the MATRx plus conforms to the FCC limit of the SAR (Specific Absorption Rate) requirement set forth in 47 CFR Part 2 section The radiated energy from the Zephyr Wireless MATRx plus antennas conforms to the IC limit of the RF exposure requirement regarding IC RSS-102, Issue 2 clause