Zephyr Matrx plus User manual

Instructions for Patients

2

Table of Contents

Getting to Know Your System Kit ��3

Understanding Your Tablet Icons ��4

Sensor Setup ��5

Your Study Night ��7

The Morning After Your Study ��8

Intended Use and Cautions ��9

Intended Use �� 9

Product Overview ��9

Contraindications ��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

Radiation Exposure Statement �� 20

3

Getting to Know Your System Kit

Important Features 1. Tablet Power Button

2. Recorder Pair Button

3. Recorder Pause Button

Your Tablet

1

Your Recorder

3

2

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

A. Eort Belt

B. Nasal Cannula

C. Pulse Oximeter

D. MP*

* If Provided. Only used when a

Sleep Theragnostic is ordered.

A

C

B

D

4

Understanding Your Tablet Icons

Tablet Icon Information

These Icons will appear at the top of your

Tablet’s screen

• At a glance you will see the status of your

MATRx plus system�

• The color of the icon will change from white

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�

Your Tablet is connected

to the Recorder (wireless

connection)

Your Eort 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 Recorder is plugged

in and charging

*

Your Recorder is plugged

into power and charging

*

Your Tablet is plugged

into power

*

Your Tablet is unplugged

*

* These icons can be pressed at any time to see the current battery charge

5

Sensor Setup

Note: Use this page as a guide when viewing your Tablet’s how-to videos on Sensor setup.

*If prompted by

Tablet

1. Connect Recorder

and Tablet

Warning:If the range of

motion values are not the

same, stop the test and

contact your Healthcare

Provider.

2. Conrm Range of

Motion

3. Get Connected

Warning:Wear

eort belt over

clothing.

A. Eort Belt

6

B. Nasal Cannula

Note:Remove nail

polish or false nail

from your nger.

C. Pulse Oximeter

Note:Connect if

provided.

D. MP

7

Your Study Night

Prep

For Sleep

Sensors working

1. Check

Tablet plugged in

2. Plug In

Helpful

Tips

Note:Do not

resist tray

movement.

• Press the Pause

button twice on

your Recorder

• This give you 30

minutes to go 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,

Eort Belt or the

MP)

• Press Resume

when you return to

bed

If your hear

an alert

• Check and

correct

• For ow 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

position.

7 Hours

8

The Morning After Your Study

We hope you enjoyed your

experience!

If More Nights Are Needed

1. Plug-in your

Recorder and Tablet

3. Store your System

Kit out-of-reach of

children and 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

9

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 airow, snoring, blood oxygen saturation,

pulse, respiratory eort 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

eectiveness 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, theaters� 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

As a Sleep Theragnostic, the device is not recommended for use in patients who:

• Have loose teeth or advanced periodontal disease

• Have full dentures or dental implants

Notes

• The use of this device is only for the person that is was prescribed for

• Remove Trays and discontinue the study if necessary

10

Cautions

1. Only use with Zephyr approved parts and accessories�

2. Do not blow into the Nasal Cannula connection to avoid causing damage�

3. Avoid electrostatic discharge� The relative humidity should be at least 5%�

4. Avoid impeded blood ow (e�g� blood pressure cu ) as this may aect pulse and saturation

measurements�

5. Do not expose the device to open ames�

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 the Titration Trays from the MP before, during or after your study� Return

the Trays connected to the MP�

11

Warnings

1. 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�

2. Read all manuals and labels prior to use� Ensure that you have been trained prior to use�

3. Use of the device during a Sleep Theragnostic may cause:

• Temporary bite changes

• Gum or tooth discomfort

• Jaw discomfort

• Jaw joint discomfort

• Increased salivation

• Dry mouth

4. Use of the MATRx plus may cause disruption in sleep from the use of the sensors and Mandibular

Positioner�

5. Stop use of the device during a Sleep Theragnostic if you experience any of the following:

• Nausea or vomiting

• Jaw or mouth pain

• Adverse reaction to any system component

6. 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�

7. Do not charge the Recorder while it is connected to you�

8. 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)�

9. Portable and mobile RF communications equipment such as wireless home network devices, mobile

phones, cordless telephones and their base stations, walkie-talkies can aect this device and should

be kept at least a distance 30 cm away from the equipment�

10. The device cannot be used during debrillation�

11. Do not use extension cords or adapters of any type for device charging� The power cord and plug must

be intact and undamaged� Use only the chargers provided�

12. Fire, explosion or severe burn hazard� Do not crush, disassemble, heat above 100C (212F), incinerate

or expose the device to water�

13. Explosion hazard� Do not use the Pulse Oximeter in the presence of ammable anesthetics or other

ammable substances in combination with air, oxygen-enriched environments, or nitrous oxide�

14. Do not connect to an electrical outlet controlled by a wall switch or dimmer�

15. 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�

12

16. Avoid the use of drugs and alcohol prior to your night study�

17. Choking hazard: Keep the system out of reach of children and pets�

18. Discontinue the study if any parts of the MATRx plus Recorder, Tablet, sensors, Titration Trays and/or

retention material show damage�

19. The Nasal Cannula, Titration Trays, Titration Tray Storage Bag and Tray Attachment Pins should be

discarded after single patient use�

20. The MATRx plus Recorder and Eort Belt should be worn over clothing�

21. Route or tape cabling to reduce the possibility of entanglement or strangulation�

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 conrm that each sensor is setup correctly and sending

a signal to the Recorder�

24. 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 o 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

13

Frequently Asked Questions

1. 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

2. 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�

3. 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�

4. What should 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 ashing green, charge the Recorder’s battery and

press the pair button�

• If the Recorder’s LED light below the Play/Pause button ashes orange quickly, the Recorder and

Tablet are no longer paired

• Follow the on screen instructions to re-pair the Tablet and Recorder�

5. What should I do if I can’t move past the Recorder charging screen on the Tablet?

• Charge the Recorder

• After charging is complete, conrm 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�

14

System Troubleshooting

Patient Tablet Error Messages

ERROR TITLE ERROR MESSAGE CAUSE / ACTIONS

Incorrect Date of Birth Check the entered birth data and

try again�

Incorrect date of birth

• Re-enter your date of birth

• If error continues, contact your

Healthcare provider

Not Enough Data

Collected

Another XXX minutes are required

to complete the study� If you end

the study now, there may not be

enough data� Press continue to go

back to sleep�

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

Conrm the recorder is within 3

feet of the tablet and press the

connect button on the Recorder�

If there is no ashing green light

on the recorder, charge it before

trying again�

Recorder is out of range of Tablet and/or

Recorder is not charged�

• Conrm the Recorder is within 3 feet of

the Tablet, then press the Pair button on

the Recorder to re-pair

• If there is no ashing green light on the

Recorder, charge the Recorder before

re-pairing

• If error continues, contact your

Healthcare Provider

MP Not Connected Conrm the MP is connected�

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

15

ERROR TITLE ERROR MESSAGE CAUSE / ACTIONS

Tablet Not Plugged in Conrm the Tablet is plugged in�

Tablet is not plugged into power, power

adapter is not connected properly or

electrical outlet is not functioning�

• Conrm power adapter is correctly

plugged into the Tablet and an

electrical outlet

• Conrm the electrical outlet is

functioning

• Leave the Tablet plugged in for the

rest of the night to ensure your study

continues

Nasal Cannula Not

Connected

Conrm the Nasal Cannula is

connected�

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

Oximeter Not

Connected

Conrm the Oximeter is

connected

Pulse Oximeter is not connected to

Recorder, or not positioned properly on

your nger�

• Disconnect/Reconnect Pulse Oximeter

to Recorder

• Ensure sensor is properly positioned on

your nger

• If error continues, stop the study and

contact your Healthcare Provider

16

ERROR TITLE ERROR MESSAGE CAUSE / ACTIONS

MP Error

The MP 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 you may feel the trays move

to the correct position� The

study will resume automatically

after xing 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

Conrm the recorder is

unplugged�

• The Recorder should not be plugged in

during the study� Disconnect the power

adapter from the Recorder to continue

the study�

17

General Information

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

18

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

Manufacturer Declaration for Emissions

Phenomenon Basic EMC Standard Immunity Test Level

Electrostatic Discharge IEC 61000-4-2 +/-8kV contact, +/ 2,4,6,8, 15kV air

Radiated RF EM elds IEC 61000-4-3 10V/m, 80MHz-2.7GHz, 80% AM at 1kHz

Proximity elds from RF

wireless communications

equipment

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 elds IEC 61000-4-8 30A/m, 50 and 60Hz

Conducted disturbances

induced by RF elds IEC 61000-4-6 6V in ISM + Amateur bands, 3V (0.1580MHz)

Voltage Dips IEC 61000-4-11 0 % UT; 0.5 cycle, @ 0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

Voltage Interruptions IEC 61000-4-11 Interrupt >95% drop, 5s

Radiated Disturbance FCC 47 CFR Part 15, Subpart

B, CISPR 11, Group 1, Class B

Conducted Disturbance CISPR 11, Group 1, Class B

RF Emissions IEC 61000-3-2 Harmonics,

IEC 61000-3-3 Flicker

19

TABLE 1: EMC TEST LIMITS

Frequency Range Dwell 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

20

Federal Communications Commission Notices

This product complies with Part 15 of the FCC Rules� Operation is subject to the following two conditions:

1. This device may not cause harmful interference�

2. This device must accept any interference received, including interference that may cause undesired

operation�

Caution

Changes or modications to this equipment that have not been approved by Zephyr Sleep Technologies may

void the user’s authority to operate this equipment�

Note

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 articular installation�

If this equipment does cause harmful interference to radio or television reception, which can be determined

by turning the equipment o 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 dierent 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 dened 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 radio-communications 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 license-exempt RSS standard(s)�

Operation is subject to the following two conditions:

1. This device may not cause interference, and

2. 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 (Specic Absorption Rate)

requirement set forth in 47 CFR Part 2 section 1093� 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 4�2�

Zephyr MATRx Plus User manual

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