TEST. SELECT. TREAT. Titration Tray Manual

Transcription

1 TEST. SELECT. TREAT. Titration Tray Manual

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

3 Symbols SYMBOL NAME DESCRIPTION Warning Caution Rx Only Warning Caution Prescription only Consult Instructions Non-Sterile Do Not Reuse Keep Dry Temperature Limitation Humidity Limitation Device Manufacturer Indicates the possibility of injury to people. Indicates the possibility of damage to equipment or inability to successfully perform the study. Emphasizes a characteristic or important consideration. Indicates the device can be only used for prescribed purposes. Indicates information that may require further instructions. Indicates that the accessory supplied is non-sterile. Indicates the accessories that are single patient use for one study only. The device should be kept dry. The device should be kept within the temperature limit as stated. The device should be kept within the humidity limit as stated. Indicates the device manufacturer. Date of Manufacture Batch code Indicates the date of manufacture. Indicates the manufacturer s batch code. Catalogue number Indicates the catalog number of the device. Serial Number Indicates the serial number of the component. Type BF Indicates a Type BF Applied Part. 3

4 Introduction 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 therapy with an oral appliance 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. This device is not intended for use near surgical equipment or magnetic resonance imaging equipment. The device is deployed by a healthcare professional (e.g. sleep technician, dental technician, physician, nurse, etc.). MATRx plus records breathing through nasal airflow, oxygen saturation and abdominal effort while the patient sleeps. The device can be used in a Oral Appliance (OA) Study to determine in which patients with obstructive sleep apnea (OSA) mandibular advancement by an oral appliance will reduce obstruction of airflow, thereby identifying patients suitable for oral appliance therapy (OAT). This is accomplished by a temporary appliance fit to the patient s teeth that automatically incrementally and reversibly advances the patient s mandible forward in response to respiratory information detected. The data collected from the OA Study is automatically analysed and an assessment of whether the patient is expected to achieve successful therapy from the oral appliance is provided. The device selects patients as suitable for oral appliance therapy and recommends a target mandibular position based on a success criterion of an oxygen desaturation index (ODI) of less than 10 events per hour with a 4% desaturation criterion. User Profile The device is used by the following individuals: Healthcare Providers who are responsible for dispensing the device, instructing the patient, assessing suitability and prescribing treatment Patients who will be using the device for a home sleep study 4

5 Contraindications The device is used by the following individuals: 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 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 the patient has received training prior to dispensing. The HCP (e.g. sleep technicians, dental office staff, sleep physicians and dentists) should consider the medical history of the patient, including history of asthma, breathing, respiratory disorders, neurologic diseases or other relevant health problems, and refer the patient to the appropriate HCP before prescribing the device. This device should not be prescribed for patients that are unable to understand and comply with instructions, including removal of the Titration Trays unassisted. Instruct the patient to avoid the use of drugs and alcohol prior to a study. Patients fitted with an oral appliance 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 treatment is achieved. 9. Stop use of the device during an OA Study if the patient experiences any of the following: Nausea or vomiting Jaw or mouth pain Adverse reaction to any system component 10. Instruct the patient to keep the system out of reach of children and pets. 11. 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. Inspect the Titration Trays and tray material carefully prior to each use. Stop the study and return the system to the Healthcare Provider if: Cautions 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 Only use with Zephyr approved parts and accessories. Failure to use Zephyr approved parts and accessories will void the warranty. Do not prescribe this test for patients who are unable to breathe comfortably through their nose while supine. 5

6 Titration Trays - Description The Titration Trays are customized to the patient s bite by means of a quick-set impression material which ensures adequate retention for the study period. The Titration Trays are used to measure the patient s mandibular range of motion; these values will be used to limit the movement of the Mandibular Positioner (MP) during the OA Study. MATRx plus Titration Trays are available in medium and large sizes and each set of trays consists of an Upper and Lower Tray. Each tray set is packaged with the following: A set of Tray Attachment Pins used to connect the trays to the Mandibular Positioner (MP) A Patient Information Card used to record the patient s scale readings, and A storage bag used to store the trays and MP for the study A TD Clip Trim Lines Size and Orientation Label Indicator Line Incisal Groove Indicator Line Guide Rails Orientation Label Figure 1 - Lower Titration Tray Trim Lines Size and Orientation Label Incisal Groove Scale Scale Orientation Label Figure 2 Upper Titration Tray On each tray, two labels can be found that denote the size and orientation of the tray. One label is located close to the Trim Lines and the other, only denoting orientation, is located on the attachment point of the mounting bracket. 6

7 Preparing for an OA Study: Fitting Trays and Taking Impressions Warning The Titration Trays, Tray Attachment Pins and the Titration Tray Storage Bag should be discarded after single patient use. Re-use may result in injury to the patient and inaccurate assessment results. Discontinue the study if the Titration Trays and/or retention material show damage. Use of the Titration Trays is not to exceed 3 nights of sleep (total 24 hours). The Titration Trays are not to be used after the completion of the study. Titration Trays are specialized impression trays for use with the MATRx plus System 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. Before fitting a patient with trays, check their dental health history (including diseased or loose teeth, dental work, etc.) and their oral health history (including nasal congestion) to ensure that the patient can tolerate the tray fitting and study. Tray Cleaning: Prior to Use Trays are provided nonsterile and should be cleaned before use Rinse the trays under cold tap water for 30 seconds. Inspect the trays after rinsing and discard any tray that appears damaged or is not visibly clean. Tray Fitting Prior to taking impressions, the patient s tray size must be determined and adjustments made in both tray length, and width, if needed. Tray size should be based on the smallest tray that fits well around the teeth, without binding or fitting loosely, without impinging the gingival tissue, and minimizes encroachment within the lingual space. Also, the molar ends of the tray should not extend beyond the mesial half of the most posterior teeth. If the tray is too long, trimming will be required prior to taking impressions. In cases were the tray is too wide or narrow to fit the patient s dental arch, the width of each tray can be easily adjusted. A heat torch can be used to soften the tray material around the retention grooves. This will allow for easy bending and adjustment. 7

8 Upper Tray Lower Tray Medium Tray MU ML Large Tray LU LL Table 1 Titration Tray Sizing and Orientation Trimming the Trays Prior to taking impressions, trim the molar end of any tray that extends beyond the mesial half of the most posterior tooth. Tray trimming should be done with a sharp pair of scissors (e.g. crown and bridge scissors). Trim the trays, using the trim lines as a guide, while maintaining the tray s shape and structure, and polish the trimmed areas to remove any sharp surfaces. Trimming the trays will optimize tray comfort and allow for full range of motion during the patient s OA Study. Once your tray adjustments are complete, place the trays back in the patient s mouth to confirm that the tray fits well and is comfortable, before taking impressions. Prior to filling the trimmed trays with impression material, ensure any sharp edges have been removed and all trimmed surfaces are smooth and free of debris. Taking Impressions Trays have been designed specifically for use only with Henry Schein Blu-Bite HP Fast Set impression material. For directions and guidance on making impressions with Henry Schein Blu-Bite HP Fast Set please see manufacturer s guidelines The Upper Tray impression should be taken first. Fill the tray with a generous amount of impression material. Insert the tray ensuring both the patient and tray midlines are aligned. The scale of the tray should be facing upwards. With gentle but firm pressure, push the tray against the upper teeth and hold the tray in place until the impression material sets (i.e. 30 seconds). Once the impression material has set, slowly remove the tray and inspect the impression to ensure everything has been captured. Trim excess impression material from the Upper Tray (see Trimming the Impressions). 8

9 After the impression is trimmed, place the trimmed Upper Tray back into the patient s mouth to confirm tray fit, retention and comfort. This should be done with the Lower Tray connected to ensure both trays are positioned correctly. With the trays in place, ensure the patient can slide their mandible back and forth easily, and that the mandible is not shifted to the left or right. Remove the trays, verifying adequate retention. Fill the Lower Tray with a generous amount of impression material. Insert the trays and instruct the patient to firmly close their mouth and bite into the Incisal Groove of the Lower Tray. Ensure the mandible is not shifted to the left or right and that the patient is comfortable. Hold the trays in place until the impression material sets. Gently remove the trays, verifying adequate retention and inspect the lower impression to ensure everything has been captured. Trim excess impression material from the Lower Tray (see Trimming the Impressions). Signs of a good impression and proper tray size: Maximum bite depth into each tray Minimal areas of show through Minimum amount of impression material left in each tray Patient and tray midlines are aligned Confirming tray fit and comfort: After both trays have been properly trimmed, place them back into the patient s mouth to check tray fit, comfort, and ease of tray movement Retract the tissue on both sides of the patient s mouth to ensure there is no tissue impingement Ask the patient to confirm that the trays fit comfortably To check tray retention, ask the patient to try opening their mouth. There should be some resistance; the patient should not be able to open their mouth easily. Check for ease of tray movement. It is very important that the patient can comfortably protrude and retrude their mandible. Ask the patient if there is any pinching or discomfort The impression procedure is now complete. Trimming the Impressions Use of the Titration Trays is not to exceed 3 nights of sleep (total 24 hours). The Titration Trays are not to be used after the completion of the study. The trays will be used in an OA Study; the duration of the complete study period may be up to 6 nights. Excess impression material should be trimmed from the trays to ensure the trays will move back and forth easily during the study, and to optimize tray fit and comfort. 9

10 Trim the excess impression material from the lingual aspect of the tray. This will maximize the space available for the patient s tongue. Remove any sharp edges, being careful not to remove material from inside the retention grooves located along the sides of the tray. Trim all the impression material from the bottom of the tray. This will allow the Upper and Lower Tray to slide against one another easily. Trim excess impression material from the molar ends of each tray. This will prevent tissue impingement and allow the patient to fully protrude and retrude their mandible comfortably. On the buccal aspect of the tray, trim all excess impression material, again being careful not to remove impression material from inside the retention grooves. To optimize comfort, ensure that all sharp edges are removed and surfaces are smooth. Do not over-trim the impressions as this could cause loss of tray retention. After trimming is complete, check the upper and lower midlines to ensure they are representative of the patient s bite. After the impressions have been properly trimmed, place them back into the patient s mouth and ensure the patient can breathe comfortably. After impressions have been trimmed, check for signs of cracks or loose pieces of impression material that could become dislodged with use. If found, redo the impressions. Proper tray trimming will result in: Maximum space for the tongue Easy back and forth movement of the trays Optimal tray comfort No tissue impingement If the trays do not fit properly or the patient complains of discomfort, check for the following: Excess impression material on the trays: this may prevent a tight or comfortable fit therefore remove any material that may be creating problems Sharp tray surfaces from tray trimming: remove material that may be creating discomfort and ensure all trimmed surfaces are smooth Teeth undercuts that may be in the way: if necessary remove undercuts but ensure adequate retention before proceeding In most cases, the impression material in the vestibular area will not require trimming. This will aid in both tray retention and comfort. Taking Scale Readings Ensure the Lower Tray s Guide Rails and surface of the Upper Tray s Scale are completely clear of impression material and slide smoothly back and forth parallel to each other before determining the patient s scale readings. Caution Do not prescribe this test for patients who are unable to breathe comfortably through the nose while supine. 10

11 The tray scale is located on the Upper Tray. The red line, known as the scale indicator, is located on the Lower Tray. The patient s scale readings are determined by identifying where the Lower Tray s red line crosses the Upper Tray s scale. Each mandibular position should be recorded to the nearest 0.1mm. The zero reading on the scale is the incisal edge-to-edge position. This enables transfer of the MATRx plus target protrusive position to a bite registration device, in preparation for appliance fabrication. Scale readings are required for the following mandibular positions: Habitual Bite Maximum Protrusion Maximum Retrusion Before taking the scale readings, it is recommended that the patient relax their muscles by performing mandibular range of motion exercises. With the trays in place, ask the patient to move their mandible to each position at least 3 times in order to confirm reproducibility of the scale readings. Figure 3 Titration Tray Scale Reading MEASUREMENT 1A: HABITUAL BITE With the trays in place, ask the patient to establish their most comfortable bite and record the position in millimeters. MEASUREMENT 1B: ALTERNATE HABITUAL BITE With the trays removed, measure the patient s dental overjet in millimeters. The alternate Habitual Bite will be recorded at 0 minus the measured overjet (i.e. an overjet of 2mm = an Alternate Habitual Bite of -2mm). 11

12 MEASUREMENT 2: MAXIMAL PROTRUSION With the trays in place, ask the patient to protrude their mandible as far as possible and record the position in millimeters.. Repeat this procedure 3 times and record the largest number. MEASUREMENT 3: MAXIMUM RETRUSION With the trays in place, ask the patient to relax their mandible. Using gentle pressure on the chin and mandible, manually retrude the mandible until Full (anatomical) Retrusion has been achieved and record the position in millimeters.. Repeat this procedure 3 times and record the smallest number. The patient s range of motion (Maximum Protrusion - Maximum Retrusion) should be roughly the same as the range of motion measured with a bite registration device. If there is a difference, it is likely that the trays have not been trimmed adequately and the extra material is interfering with the patient s ability to maximally protrude and/or retrude. Therefore, check the trays, refit and repeat the patient s measurements. Recording Bite Data Once you have verified the accuracy of the patient s scale readings, record these measurements in the patient s record and on the Patient Information Card. Instruct the patient how to read the card in order to verify their range of motion on the night of their OA Study. After recording the patient s bite data, the OA Study parameters can be entered in the Patient Information Portal. The tray scale, graduated in millimeters, ranges from -7 to +13. If the patient s range of motion is outside of either of these measurements, these minimum and maximum values should be recorded on the Patient Information Card and entered in the Portal. Tray Cleaning: After Impressions Ensure the patient can insert and remove the trays by themselves. Following the impression procedure, rinse each tray under cold tap water for 30 seconds. Instruct the patient to rinse their trays under cold tap water after each study night. 12

13 Connecting the Trays to the Mandibular Positioner The patient s Titration Trays should be attached to the MP before dispensing the system to the patient (see MATRx plus Provider Manual) Slide the Upper Tray s Mounting Bracket into the Lower Tray s Guide Rails. Ensure both trays slide back and forth easily. Hold the MP with the cable facing down. Hold the set of trays with the scale facing up. Push the trays onto the rods of the MP. Each rod and the corresponding tray s attachment point are uniquely shaped to ensure correct orientation during connection (i.e. the Upper Tray will only attach to the upper rod and the Lower Tray will only attach to the lower rod). 6. To connect the trays to the MP, use the Tray Attachment Pins provided. The two-piece Tray Attachment Pin has a push/pull rivet design. When the internal pin is inserted into the outer pin sleeve, the rivets of the pin sleeve expand outward producing a secure grip within the hole. a. b. c. d. Ensure the attachment holes on the trays are lined up with the attachment holes on the rods of the MP. Pull the internal pins out from their pin sleeves. Insert each of the pin sleeves through the attachment holes until the ends of the sleeves are flush against the Mounting Brackets on the Upper and Lower Trays. Push each of the internal pins through each of the pin sleeves until the pin head is flush and the end of the sleeve is flared. You may hear a snap when the pin is inserted correctly. 7. Place the MP and the attached trays in the storage bag provided. Prior to dispensing the MATRx plus System to a patient, ensure the trays are connected to the MP. Figure 4 Tray Attachment Pins Figure 5 Securing the Titration Trays to the MP with the Tray Attachment Pins 13

14 Taking a 3D X-ray Scan in a Protruded Position This section applies when the TD Clip has been included with Titration Trays. After a MATRx plus study, the Transitional Device (TD) Clip can be used to hold the patient s Titration Trays at the desired target protrusive position when taking a 3D X-ray scan with a 3D CBCT. Figure 6 TD Clip Assembly Insert a Tray Attachment Pin through the Lower Tray s attachment hole. Attach the Lower Clip by sliding the Lower Clip Notch over the Tray Attachment Pin. Figure 7 Attach the Lower Clip Place the Upper Clip on top of the Lower Clip. Hold the Titration Trays at the target protrusive position and slide the front end of the Upper Clip into the mounting bracket of the Upper Tray until it is flush against the end of the tray. Figure 8 Position the Upper Clip Secure the target protrusive position with a Tray Attachment Pin Insert the Titration Trays, set at the target protrusive position with the attached TD Clip, into the patient s mouth. Complete the 3D X-ray scan in the protruded position. Discard the Titration Trays and the TD Clip after the procedure is complete. Figure 9 Secure the protrusive position 14

15 Accessories List Component Titration Trays - Medium Titration Trays - Large Catalog Number CAT CAT Use Single patient use Single patient use Titration Tray Specifications Dimensions Large Tray Medium Tray Upper Tray: L x W x H (mm) 79 x 74 x x 65 x 11 Lower Tray: L x W x H (mm) 76 x 65 x x 56 x 13 Product Operation, Transport and Storage Temperature Humidity Pressure Operation 5 to 40 C 15 % to 93%, non-condensing kPa Storage and Transport -25 to 70 C Up to 93%, non-condensing kPa IMPRESSION MATERIAL Titration Trays are only to be used with Henry Schein Blu-Bite HP Fast Set with vinyl polysiloxane (P/N ). See manufacturer s instructions for use and product specifications. 15

16 Titration Tray Manual 610A 70th Ave. S.E. Calgary, Alberta, Canada. T2H 2J6 Phone: Zephyr Sleep Technologies Inc. LBL