TEST. SELECT. TREAT. Titration Tray Manual
|
|
- Tiffany Wilkins
- 5 years ago
- Views:
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
Before & After your MATRx Study
Before & After your MATRx Study A MATRx study is a highly accurate sleep test ordered by a sleep physician. This overnight study is done in a local sleep lab to find out if your obstructive sleep apnea
More informationProSomnus MicrO 2 Sleep and Snore Device
ProSomnus MicrO 2 Sleep and Snore Device AND ProSomnus [IA] Sleep and Snore Device PATIENT INSTRUCTIONS FOR USE 1 ProSomnus Sleep Devices include the ProSomnus MicrO 2 Sleep and Snore Device and the ProSomnus
More informationProSomnus MicrO 2 Sleep and Snore Device
ProSomnus MicrO 2 Sleep and Snore Device AND ProSomnus [IA] Sleep and Snore Device PATIENT INSTRUCTIONS FOR USE 1 ProSomnus Sleep Devices include the ProSomnus MicrO 2 Sleep and Snore Device and the ProSomnus
More informationPatient Instruction Booklet. TAP Elite ThermAcryl. TAP Elite TL. TAP 3 Elite. Revision E, 2013 PRTD29. * Medicare requires Double Lingual Bar Design
Patient Instruction Booklet TAP Elite ThermAcryl TAP Elite TL TAP 3 Elite * Medicare requires Double Lingual Bar Design Revision E, 2013 PRTD29 Table of Contents 2 Important Safeguards... 3 Introduction...
More informationADJUSTABLE HERBST APPLIANCE - OASYS HINGE ACRYLIC
P SYSTEMS FOLLOW-UP/MAINTENANCE VISITS: See your dentist at the following intervals after receiving your appliance: ADJUSTMENTS MADE BY DENTISTS OR PATIENT Turning the hex driver clockwise to advance the
More informationPatient Instruction Booklet
Patient Instruction Booklet TAP 3 ThermAcryl TAP 3 TL TAP 3 Revision E, 2014 PRTD17 Table of Contents Important Safeguards Important Safeguards... 3 SAVE THESE INSTRUCTIONS 2 Introduction... Warnings...
More informationADJUSTABLE HERBST APPLIANCE - OASYS HINGE ACRYLIC
P SYSTEMS The delivery visit should confirm the fit and comfort of the appliance, as well as the patients ability to insert and remove the appliance properly and without difficulty. It may be necessary
More informationProSomnus Sleep and Snore Devices PATIENT INSTRUCTIONS FOR USE
ProSomnus Sleep and Snore Devices PATIENT INSTRUCTIONS FOR USE 1 table of contents Introduction... 4 Warnings...7-8 Possible Side Effects... 9-10 Series Package Components: MicrO 2 & [IA]...11-12 Parts
More informationINSTRUCTIONS FOR USE AUSTRALIA O 2 VENT OPTIMA ORAL APPLIANCE FOR SLEEP APNOEA THERAPY
INSTRUCTIONS FOR USE AUSTRALIA O 2 VENT OPTIMA ORAL APPLIANCE FOR SLEEP APNOEA THERAPY Name of User Name of Sleep Physician Name of Dentist Serial No. of Device Date of first fitting/purchase Connector
More informationVENT MONO INSTRUCTIONS FOR USE THE O 2 INTENDED USE
THE O 2 VENT MONO INSTRUCTIONS FOR USE INTENDED USE The Oventus O 2 Vent Mono is a removable medical device that is fitted in the patient s mouth and is intended to reduce or alleviate snoring and obstructive
More informationInstructions for use for the medical professional English
English Page 2 of 32 TABLE OF CONTENTS TABLE OF CONTENTS 1 The OPTISLEEP therapeutic appliance... 4 1.1 Indications for use... 5 1.2 Contraindications... 5 2 OPTISLEEP Workflow... 6 3 Determining the treatment
More informationSingle Use Curlew TM Multiple Biopsy Forceps
Single Use Curlew TM Multiple Biopsy Forceps 13 SPECIMEN WITH METAL STORAGE CYLINDER With In Situ Fixation, Batch or Single Specimen Collection US Patents 5,782,747; 5,980,468; 6,071,248; foreign patents
More informationThe Herbst. Used in the Treatment of Snoring and Obstructive Sleep Apnea. Appliance. Herbst with Standard Hardware
The Herbst Appliance Used in the Treatment of Snoring and Obstructive Sleep Apnea Herbst with Standard Hardware Herbst with Telescopic Advancement Hardware The Herbst for Snoring and Obstructive Sleep
More informationInstructions for Use SomnoDent Signature and Standard Line Fusion, Flex, Classic, Herbst Advance, Herbst Telescopic, Herbst Shim, AIR & AIR+ Devices
Instructions for Use SomnoDent Signature and Standard Line Fusion, Flex, Classic, Herbst Advance, Herbst Telescopic, Herbst Shim, AIR & AIR+ Devices Shim www.somnomed.com 1 Introduction The SomnoDent is
More informationConnect your Scanner to SomnoMed Canada. SOMGauge Protrusive Bite Recording - Manual. Scanning Impressions - Lower and Upper
IOS Instructions How to create and submit the best scans to SomnoMed Canada for the creation of a custom SomnoDent Sleep Apnea Appliance Its a simple process: STEP 1 Connect your Scanner to SomnoMed Canada
More informationGetting to Know Your System Kit
FOR PATIENTS Getting to Know Your System Kit Your Tablet Your Recorder IMPORTANT FEATURES 1 2 3 1 TABLET POWER BUTTON 2 RECORDER PAIR BUTTON 3 RECORDER PAUSE BUTTON IMPORTANT: CHARGE YOUR TABLET AND RECORDER
More informationCAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE INDICATIONS FOR USE The LATERA Absorbable Nasal Implant is indicated for supporting upper and lower lateral nasal cartilage. CAUTION: Federal law restricts
More informationThe fitting process of SomnoGuard AP. Hints to complement the user instructions
The fitting process of SomnoGuard AP Hints to complement the user instructions Essential equipment and instruments Spray disinfectant for all instruments Boling water bath Water boiler Disposable gloves
More informationTHE SnoreFree SYSTEM. No Impressions No Models No Costly Lab Bills No Long Time-Consuming Appointments No Adjustments With Handpieces
THE SnoreFree SYSTEM Recently a wealth of information has been presented through the print, radio and broadcast media about different methods to treat snoring. As the public has been made aware that dental
More informationSomnoDent Sleep Apnea Device. Instructions for use and care. SomnoDent Flex. SomnoDent Edent
TM SomnoDent Sleep Apnea Device Instructions for use and care SomnoDent Flex SomnoDent Classic SomnoDent Edent Contents Treatment with SomnoDent Contents 2 How the SomnoDent oral sleep device works 3 Instructions
More informationIMPRESSION PROCEDURES TRAINING MANUAL
IMPRESSION PROCEDURES TRAINING MANUAL 01 01 A.B. DENTAL A.B. Dental is proud to present this impression taking procedure protocol. This manual explains, step by step, the procedure while using A.B. Dental
More informationThe fitting process of SomnoGuard
The fitting process of SomnoGuard Hints to complement the actual user instructions AP Tomed Dr. Toussaint GmbH, 31.07.2010 Needed accessories Spray disinfectant for all working tools Boling water bath
More informationSLEEP APNEA DEVICES CATALOG
SLEEP APNEA DEVICES CATALOG Engineered For Excellence Featured Inside! Custom Milled Devices Phone: 800.489.4020 Web: www.dynaflex.com Engineered For Excellence CAD/CAM Milled Devices 3 Year Warranty DynaFlex
More informationClinician Fitting Instructions. TAP 3 ThermAcryl TAP 3 TL TAP 3
Clinician Fitting Instructions TAP 3 ThermAcryl TAP 3 TL TAP 3 Revision B, 2010 Table of Contents Important Safeguards... 3 Introduction... 4 Warnings... 7 Possible Side Effects... 8 Fitting the TAP 3
More informationSelecting the Right Patients for Oral Appliance Therapy
Selecting the Right Patients for Oral Appliance Therapy AN OVERVIEW OF THE IN-LAB MATRx TITRATION SYSTEM Oral Appliance Titration Made Simple Confidently Prescribe Oral Appliance Therapy The ONLY validated
More informationMM01-Facebow And Bite Registration Procedure Checklist
MM01-Facebow And Bite Registration Procedure Checklist Bite fork Registration OK Redo 1. Estimate the shape of the patient s arch 2. Place the bite tabs on the bite fork 3. Warm the compound in hot water
More informationClinician Fitting Instructions
Clinician Fitting Instructions TAP I ThermAcryl TAP I TL TAP I Revision D, 2012 PRTD12 Table of Contents Important Safeguards... 3 Introduction... 4 Warnings... 7 Possible Side Effects... 8 Fitting the
More informationTruGuard Custom Tongue and Jaw Positioner Instructions for Use
TruGuard Custom Tongue and Jaw Positioner Instructions for Use Caution: Federal Law restricts this device to sale by or on the order of a licensed Physician or Radiation Therapist. DEVICE DESCRIPTION Bionix
More informationDevice Preparation (all steps to be performed per standard interventional technique)
sertera Biopsy Device Instructions for Use Please read all information carefully. Failure to properly follow the instructions may lead to unintended consequences. Important: This package insert is designed
More informationUSER MANUAL Rev. 1.15
QUANTUM QSP 7 TM BEACH CHAIR SHOULDER POSITIONER (BCP) USER MANUAL Rev. 1.15 Please read all the following instructions carefully to ensure proper functionality and to avoid injury or damage to your device.
More informationClinician Fitting Instructions
Clinician Fitting Instructions TAP 3 ThermAcryl TAP 3 TL TAP 3 Revision E,2014 PRTD16 TAP_3_Clinican_Booklet2010.indd 1 Table of Contents Important Safeguards... Introduction... Warnings... Possible Side
More informationCustomer Service (800) Quick Start Guide to Success. Watch the demonstration video online at
Customer Service (800) 875-3370 Quick Start Guide to Success A message from ZYPPAH s Founder and CEO I m Dr. Jonathan Greenburg, the inventor of the ZYPPAH Hybrid Oral Appliance for snoring. My passion
More informationEnglish. Fealite Nasal Pillows System. User Manual
Fealite Nasal Pillows System User Manual 0123 Table of Contents Fealite Nasal Pillows System 1 Intended Use 1 Medical Information 1 Parts of the Fealite 3 Fitting the Fealite 5 Using Tube Retainer (Optional)
More informationLet s explore and find what works!
Since there are so many different types of snoring solutions out on the market today, we understand things can get confusing. So we reviewed and evaluated the leading types of devices on the market today
More informationStratis INSTRUCTIONS FOR USE. Needle-free Injection System. 0.5mL volume (+/-5%)
Stratis Needle-free Injection System INSTRUCTIONS FOR USE 0.5mL volume (+/-5%) Stratis English Symbols Glossary (Note: All symbols are derived from ISO 15223-1, Medical Devices - Symbols to be used with
More informationPH-04A: Clinical Photography Production Checklist With A Small Camera
PH-04A: Clinical Photography Production Checklist With A Small Camera Operator Name Total 0-49, Passing 39 Your Score Patient Name Date of Series Instructions: Evaluate your Series of photographs first.
More informationClinician Fitting Instructions
Clinician Fitting Instructions TAP 3 Elite ThermAcryl TAP 3 Elite TL TAP 3 Elite Revision C, 2012 PRTD28 Table of Contents Important Safeguards... Introduction... Warnings... Possible Side Effects... Fitting
More informationSelectTech 3.1 Bench Assembly / Owner s Manual
SelectTech 3.1 Bench Assembly / Owner s Manual This product is compliant with the applicable CE requirements. Congratulations on your commitment to fitness and your purchase of the Bowflex SelectTech 3.1
More informationTHE ROLE OF THE MATRx IN PREDICTING WHICH PATIENTS CAN BE TREATED SUCCESSFULLY WITH ORAL APPLIANCES
THE ROLE OF THE MATRx IN PREDICTING WHICH PATIENTS CAN BE TREATED SUCCESSFULLY WITH ORAL APPLIANCES Brock Rondeau, D.D.S. I.B.O., D.A.B.C.P., D-A.C.S.D.D., D.A.B.D.S.M., D.A.B.C.D.S.M. Oral appliance therapy
More informationPATIENT INSTRUCTIONS Jaw Dynasplint System
PATIENT INSTRUCTIONS Jaw Dynasplint System Corporate Headquarters: 800.638.6771 toll-free 800.380.3784 fax Canada: 800.668.9139 toll-free 905.851.3494 fax Europe: 31.45.523.0418 phone 31.45.523.1303 fax
More informationHow to provide intraoral scans to SomnoMed for the production of SomnoDent device.
How to provide intraoral scans to SomnoMed for the production of SomnoDent device. KEY QUESTIONS: 1. Where do I send my Case? Send intra-oral scan files (maxilla and mandible in protrusive bite) and an
More informationMultipower. User Guide E S S E N T I A L S T R E N G T H
E L E M E N T E S S E N T I A L S T R E N G T H User Guide The identification plate of and manufacturer, affixed to the frame behind the barbell rack, gives the following details: A B C D E Name and address
More information4766 Research Dr. San Antonio, TX insightdentalsystems.com
OVERVIEW OF THE INSIGHT DENTAL IMPLANT DELIVERY SYSTEM The IDS system comes in a unit dose implant system where its advantage provides sterile instrumentation in one single-use kit. It is organized to
More informationASK US. A Study for Obstructive Sleep Apnea Patients Using a New At-Home Sleep Test ARE YOU ABOUT THE STUDY #
#15420040.0 A Study for Obstructive Sleep Apnea Patients Using a New At-Home Sleep Test STUDY DENTIST Dr. Michael Simmons DMD, MSc ARE YOU Struggling with or given up on CPAP and don t know what to do?
More informationMass Fusion Splicing of Optical Fiber Ribbon Cables
Application Notes Mass Fusion Splicing of Optical Fiber Ribbon Cables Author Prasanna Pardeshi and Sudipta Bhaumik Issued January 2014 Abstract To build a fiber optic network, one may eventually join two
More informationTherapy options. snoring & obstructive sleep apnea. Mandibular advancement devices Nasal dilators Supine position preventers
Therapy options for the treatment of snoring & obstructive sleep apnea Therapy options Mandibular advancement devices Nasal dilators Supine position preventers Snoring and obstructive sleep apnea A portion
More information8 Performing Medical Procedures
8 The Terason usmart3200t Ultrasound System can aid in performing medical procedures such as biopsies. Depending on whether you purchased the additional equipment required for these procedures, you may
More informationMemRx Orthodontic Appliances
MemRx Orthodontic Appliances Uses and Instructions The MemRx Fundamentals As the need for faster, more efficient treatment of non-compliant patients increases, orthodontic!technology and materials has
More informationUDELL DENTAL LABORATORY Instructions for Use PREAT Precision Attachments
Indications Instructions The Locator Root Attachment is designed for use with overdentures or partial dentures, retained in whole or in part by endodontically treated roots in the mandibular or maxilla.
More informationSt. Jude Medical 8-Channel Adapter. Clinician's Manual
St. Jude Medical 8-Channel Adapter Clinician's Manual CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. For U.S. California Only: Proposition 65, a State of California
More informationVIP Partner Laboratory (PL) Process Flow
VIP Partner Laboratory (PL) Process Flow 1. VIP Software 2. CT Scan Appliance 3. CT Scan Clinician purchases VIP for PL fabricates CT Scan Appliance Patient submitted for scans treatment planning purposes
More informationTWIST STEPPER NO. 045
TWIST STEPPER NO. 045 IMPORTANT: Read all instructions carefully before using this product. Retain owner s manual for future reference. For customer service, please contact: support@sunnyhealthfitness.com
More informationSLEEP IMPROVING WRISTBAND. Item No Owner s Guide
SLEEP IMPROVING WRISTBAND Item No. 205350 Owner s Guide Thank you for purchasing the Sharper Image Sleep Improving Wristband. Based on ancient Chinese acupuncture principles, this biofeedback device uses
More informationIMPORTANT SAFETY NOTICE:
Dear Customer, Please read this instruction very carefully before using this item. You will find important information regarding safety of your magnetic bike. IMPORTANT SAFETY NOTICE: Note the following
More informationPATIENT BROCHURE EVERYTHING YOU NEED TO KNOW. Please read this brochure before. starting Provent Sleep Apnea Therapy
EVERYTHING YOU NEED TO KNOW Please read this brochure before starting Provent Sleep Apnea Therapy PATIENT BROCHURE Welcome to Provent Therapy The freedom to sleep how you like. SIMPLE, EFFECTIVE, MASK-FREE.
More informationPrecision Sleep Medicine
Precision Sleep Medicine Picking Winners Improves Outcomes and Avoids Side-Effects North American Dental Sleep Medicine Conference February 17-18, 2017 Clearwater Beach, FL John E. Remmers, MD Conflict
More informationHome Sleep Test. User Manual. One Night Test. For help at any time, call Also, please visit to watch our video.
Home Sleep Test User Manual For help at any time, call 1-877-753-3776. Also, please visit www.novasom.com to watch our video. One Night Test Before You Begin Before You Begin The AccuSom unit: cannot be
More informationSTANDARDS & GUIDELINES
STANDARDS & GUIDELINES 3.1.1. Complete Dentures 2 APPENDIX A FOR 3.1.1 Complete Dentures.. 3 Patient History and Treatment Plan Impressions Centric and Protrusive Denture Try In Insertion 3.1.2. Partial
More informationObstructive Sleep Apnea Syndrome. Common sleep disorder causes high blood pressure and heart attacks
Obstructive Sleep Apnea Syndrome Common sleep disorder causes high blood pressure and heart attacks Message: Sleep apnea is very common. It is estimated that 158 million people worldwide suffer from sleep
More informationweight.detach/bench ITEM NO: 76310
weight.detach/bench ITEM NO: 76310 OWNER S MANUAL IMPORTANT: Read all instructions carefully before using this product. Retain this owner s manual for future reference. The specifications of this product
More informationTWISTING STAIR STEPPER WITH BANDS
TWISTING STAIR STEPPER WITH BANDS NO. 068 USER MANUAL IMPORTANT! Please retain owner s manual for maintenance and adjustment instructions. Your satisfaction is very important to us, PLEASE DO NOT RETURN
More informationSignature Personalized Patient Care
Surgical Technique Acetabular Guide System Contents One Surgeon. One Patient. Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical
More informationCustomized Cranial and Craniofacial Implants. Instructions For Use. 7000revD_Instructions_For_Use. Page 1 of 8
Customized Cranial and Craniofacial Implants Instructions For Use Page 1 of 8 Table of Contents INDICATIONS... 3 DESCRIPTION OF DEVICE... 3 CONDITIONS OF USE... 3 CONTRAINDICATIONS... 3 KELYNIAM GLOBAL
More information,,~ 30! Premarket Notification - SomnoMed MAS Flex "S"
510(K) SUMMARY This summary of 510(k) safety and effectiveness infornation is being submitted in accordance with the requirements of 21 CFR 807.92. Submitter Information: SomnoMed Inc Date Summary Prepared:
More informationEVER Pharma D-mine Pen Pen injector for Apomorphine 10 mg/ml
EVER Pharma D-mine Pen Pen injector for Apomorphine 10 mg/ml Instructions for Use with Dacepton 3 ml Cartridges Apomorphine hydrochloride hemihydrate solution for injection Subcutaneous Use TABLE OF CONTENTS
More informationTWISTING STAIR STEPPER WITH BANDS NO. 068 USER MANUAL
TWISTING STAIR STEPPER WITH BANDS NO. 068 USER MANUAL IMPORTANT: Read all instructions carefully before using this product. Retain owner s manual for future reference. For customer service, please contact:
More informationCorrection System. Surgical Technique
Nextra Hammertoe Correction System Surgical Technique Maximized Bone Purchase* Stable and Secure Phalanx Optimized Screw Design Adjustable Bone-to-Bone Apposition Progressive Ratchet Tightening Mechanism
More informationUnique Dental Supply. Catalog We Bring World Quality Products to Enhance your Business QUALITY PRODUCTS SINCE 1974
Panadent Articulating System FINAL:UDS-NL-2013 14-09-22 2:04 PM Page 3 UDS Unique Dental Supply We Bring World Quality Products to Enhance your Business R QUALITY PRODUCTS SINCE 1974 Catalog 2014 Panadent
More informationUsing the Eraser Tool for Occlusal Reduction
Insight Insight The following set of cards has been crafted to help you get the most from your Align itero system. From the most efficient ways to use the eraser tool, effective scanning for implants to
More information3000 Series Articulator System
3000 Series Articulator System Models 3040 and 3140 Instruction Manual Whip Mix Corporation 361 Farmington Ave. P.O. Box 17183 Louisville, KY 40217-0183 USA 502-637-1451 800-626-5651 Fax 502-634-4512 www.whipmix.com
More informationWhat is Oral Appliance Therapy?
You may have been diagnosed by your physician as required treatment for sleep-disordered breathing (snoring and/or obstructive sleep apnea). This condition may pose serious health risks since it disrupts
More informationBOCL-01: Bonding Materials Checklist
Task 19: Gather materials to bond partner using toothpaste as etchant Take a photo of gathered materials and submit with this completed checklist BOCL-01: Bonding Materials Checklist Date: Patient: Operator:
More informationSICAT AIR & OPTISLEEP. The appliance-based 3D solution for the treatment of obstructive sleep apnea
SICAT AIR & OPTISLEEP The appliance-based 3D solution for the treatment of obstructive sleep apnea DIGITAL & INTUITIVE with OPTISLEEP, the most advanced oral appliance straight from the dentist. THE DIGITAL
More informationSnoring And Sleep Apnea in the U.S. Definitions Apnea: Cessation of ventilation for > 10 seconds. Defining Severity of OSA
Snoring and Obstructive Sleep Apnea: Oral Appliance Therapy Management Midwest Society of Orthodontists October 16-17, 2009 Anthony J DiAngelis DMD, MPH Chief, Department of Dentistry, HCMC Professor,
More informationDid you know more than a million Australians suffer from severe sleep apnoea?
Did you know more than a million Australians suffer from severe sleep apnoea? Your comprehensive guide to curing sleep apnoea www.futuredental.com.au 1 Contents What is Obstructive Sleep Apnoea? 2 What
More informationTURN CLASS II INTO SIMPLE CLASS I PATIENTS.
TURN CLASS II INTO SIMPLE CLASS I PATIENTS. THE CARRIERE MOTION TM APPLIANCE fast gentle natural The Carriere Philosophy. Fast. Shortens overall treatment time by up to four months as it treats Class II
More informationTechnique Guide. Orthodontic Bone Anchor (OBA) System. Skeletal implants for the orthodontic movement of the teeth.
Technique Guide Orthodontic Bone Anchor (OBA) System. Skeletal implants for the orthodontic movement of the teeth. Table of Contents Introduction Orthodontic Bone Anchor (OBA) System 2 Indications and
More informationorthodontic Bone anchor (oba) SYStem
orthodontic Bone anchor (oba) SYStem Skeletal implants for the orthodontic movement of teeth SurgIcal technique Table of Contents Introduction Orthodontic Bone Anchor (OBA) System 2 Indications and Contraindications
More informationANJON BREMER LIGHT VEST
PATENTED TECHNOLOGY, TARGETED TO YOUR NEEDS ANJON BREMER APPLICATION, REMOVAL, AND CPR INSTRUCTIONS WWW.GENERIXMEDICAL.COM INTRODUCTORY INFORMATION FOR THE ANJON BREMER MRI Safety Information: Non-clinical
More informationAIR WALKER TRAINER USER MANUAL SF-E902
AIR WALKER TRAINER USER MANUAL SF-E902 IMPORTANT: Read all of the instructions carefully before using this product. Retain the owner s manual for future reference. For customer service, please contact:
More informationThe LOCATOR concept. Simplicity and versatility for prosthesis fixation
The concept Simplicity and versatility for prosthesis fixation The concept Experience the freedom in prosthesis fixation Simple and secure fixation of implant-supported prostheses is essential for successful
More informationIncreased Tongue Space. Option 1: Short Hook Single Point Midline Adjustment. turns the dsm world upside down! DDS TO MD COMMUNICATION
Insider MAGAZINE DENTAL SLEEP MEDICINE MARCH 2016 Issue 10 the new dreamtap Greater Adjustment Range Increased Tongue Space Custom-formed Soft Liners Superior Retention Option 1: Short Hook Single Point
More informationThe first 3D solution for obstructive sleep apnea therapy. MATRx plus with SICAT Air and OPTISLEEP
The first 3D solution for obstructive sleep apnea therapy MATRx plus with SICAT Air and OPTISLEEP The first fully digital workflow for a more restful sleep Digital workflow with MATRx plus, SICAT Air,
More informationSunny Magnetic Exercise SF-B910
Sunny Magnetic Exercise SF-B910 Bike IMPORTANT: PLEASE READ THIS MANUAL CAREFULLY BEFORE USING THE BIKE For Customer Service, please contact: support@sunnyhealthfitness.com Important Safety Information
More informationOWNER S MANUAL. Quick Insertion Guide: INSERT EARTIP into ear canal and rotate earpiece backwards & into position CHECK FOR SEAL
OWNER S MANUAL Quick Insertion Guide: 1 2 3 4 IDENTIFY EARPIECES marked (R) for right and (L) for left ALIGN EARPIECES at the ear canal, with cord facing forward & slightly downward INSERT EARTIP into
More informationCongratulations on purchasing your new Total Gym
TOTAL GYM ELITE OWNER S MANUAL Congratulations on purchasing your new Total Gym With this product in your home, you have everything you need to start your own workout program, to tone and strengthen the
More informationMX SELECT OWNER S MANUAL. Revolutionising Strength Training REGISTER YOUR PRODUCT AT MXSelect. MX_Select.
MX SELECT OWNER S MANUAL Revolutionising Strength Training REGISTER YOUR PRODUCT AT WWW.MXSELECT.COM MXSelect MX_Select MX-Select MX SELECT WELCOME TO THE MX SELECT FAMILY Congratulations on your purchase
More informationFibrlok II 2529 Universal Optical Fiber Splice
Fibrlok II 2529 Universal Optical Fiber Splice Instructions January 2007 78-8128-0163-3-E Contents: 1.0 General... 3 2.0 Splicing Set-up... 4 3.0 Fiber Preparation... 5 4.0 Splice Assembly... 6 5.0 For
More informationINSTRUCTIONS FOR USE AND CARE
DIAMONDS INSTRUCTIONS FOR USE AND CARE DIAMONDS, MULTI-USE, FRICTION GRIP Quala Diamonds are a rotary cutting device made of stainless steel and coated with diamond particles on the working end. It is
More informationLava. Chairside Oral Scanner C.O.S. The Future in Motion
Lava Chairside Oral Scanner C.O.S. The Future in Motion A Brilliant Impression of the Future. What if you could instantaneously view impressions in awe-inspiring detail and turn an unpleasant procedure
More informationPure 312 Nx, Pure 13 Nx
Pure 312 Nx, Pure 13 Nx User Guide Hearing Systems Content Welcome 4 Your hearing instruments 5 Instrument type 5 Getting to know your hearing instruments 6 Components and names 7 Controls 10 Hearing programs
More informationPotential Complications
Potential Complications The risk of complications associated with wisdom teeth removal is less than 0.5 percent when performed by an experienced oral surgeons who uses contemporary techniques and surgical
More informationListing of Standards By Task
Listing of Standards By Task PARTIAL DENTURES 1. Disinfect the impression and/or model 2. Evaluate the prescription for completeness 3. Document changes to the prescription 4. Evaluate the impression or
More informationThis patient just got his braces put on along with an expansion device in the roof of his mouth
Czajka 1 Dr. Cline Date: 3/16/2015 Time at Office: 9:30 11:30 Number of Patients: 5 Patient 1 (images 1 3): This patient just got his braces put on along with an expansion device in the roof of his mouth
More informationTranscutaneous Electrical Nerve Stimulation Device GF-3 / GF-3T
Transcutaneous Electrical Nerve Stimulation Device GF-3 / GF-3T Operation Manual Read Before Using GF-3-INS-LAB-RevA08 TABLE OF CONTENTS INTRODUCTION TO TENS INDICATIONS AND CONTRAINDICATIONS WARNINGS
More informationInstructions for CT Scanning
16 Argon Dental USA 1000 Corporate Drive Marshfield, WI 54449 Instructions for CT Scanning Questions? Please contact: Joel A. Gonzales Director of Sales & Service West Argon Dental USA (480) 440-3927 joelg@argondentalusa.com
More informationEndorectal Balloon (ERB) Endorectal Balloon (ERB) Instructions for Use
Endorectal Balloon (ERB) Instructions for Use GRF-0004-00 Rev. 08 Page 1 of 9 Contents Instructions for Use... 3 Indications for Use... 3 Contraindications... 3 Storage... 4 Warnings... 4 Accessories Provided...
More informationUsing the Lucia Jig to take an accurate & reliable centric relation bite registration
Trimming Instructions Trimming the silicone bite records is an important step to ensure an accurate fit on the model. Trimming eliminates all the interferences so there is no movement once the models are
More information