IOPI® User Manual
Contents
1. Phone 1 425 549 0139 E 9 PN 800 2301 02 2014 05 3 Indications for Use Tongue and lip strength and endurance measurement in patients with oral motor problems including dysphagia and dysarthria Contraindications Do not use with children under the age of 3 Do not put the Tongue Bulb in a patient s mouth if there is a risk of the patient having a seizure Do not use the Tongue Bulb with a patient who has any current or past problem with pain disorders involving the jaw muscles or joint of the mandible TMJ Disorder Myofacial Pain Disorder NWARNINGS The medical professional should ensure the patient is healthy enough to perform a maximal motor task recognizing that it may produce a generalized effort response The medical professional should hold on to the Tongue Bulb tube any time it is in a patient s mouth The Tongue Bulbs as supplied by IOPI Medical LLC are not sterile and are not intended for sterilization The Tongue Bulbs as supplied by IOPI Medical LLC are intended for single patient use only Please read the IOPI Tongue Bulb Directions for Use for cleaning instructions between uses with the same patient Keep Tongue Bulbs out of the reach of children The medical professional should inform any patient who is to perform the tongue endurance measurement at 5096 or more of the Peak pressure that they may experience the sensati2. See imqge to the right Insert the metal male end of the Connecting Tube only 2 3 mm into the opened end of the Tongue Bulb tube Remove the Tongue Bulb from its package to use it with a patient taking care not to touch the parts of the Tongue Bulb that go into the patient s mouth Turn the IOPI device on by pressing the Power button Oi The display will show 0 1 kPa Tongue Measuring Tongue Strength 1 With the IOPI turned on push the Peak Mode button In this mode the LCD displays the highest pressure applied to the IOPI continuous mode NOTE When the 1 1 is first turned on the LCD display shows pressure 92 4 WARNING Hold onto the stem of the Tongue Bulb Press the Peak Reset button 2 The LCD display will read 0 Position the Tongue Bulb against the patient s hard palate see image to the below Tell the patient Press the Tongue Bulb with your tongue as hard as you can for about 2 seconds e Visual and verbal encouragement during the test is acceptable and helps some people The 2 second hold time is not important it just avoids the question How long should I hold it when you tell them to squeeze the bulb www IOPIMedical com 5 After the patient has made his or her maximum response and relaxed record the value you see on the IOPI LCD display and then push the Peak Reset button gt Q lt 6 Let the pati
3. 05 17 Phone 1 425 549 0139 18 Troubleshooting Symptom Tongue Bulb stays flattened or dimpled after compression Possible Cause An air leak can occur anywhere in the system Tongue Bulb Connecting Tube or inside in the IOPI device itself Actions 1 Determine if the Tongue bulb leaks by trying another Tongue Bulb 2 Determine if there is a leak where the Connecting Tube connects to the Pressure Port Put some soap bubbles around the seam between the Pressure Port and the end of the attached Connecting Tube Apply a squeeze to a Tongue Bulb and look for soap bubbles that get larger or move around 3 While leaks inside the IOPI device are unlikely if steps 1 and 2 have been tried and the cause of the leak has not been detected then please contact IOPI Medical LLC or your local distributor as soon as possible Abnormally short endurance values A small air leak See steps above to determine the source of the air leak The LCD display reads A change in Contact IOPI Medical LLC or gt 2 kPa when there is accuracy your local distributor as soon no bulb attached to as possible the IOPI device Peak pressure A change of Perform an Accuracy Check measurements that accuracy see page 16 If the pressure seem too high or too low based on experience with the IOPI device and the patient reading is not within specifications contact IOPI Medical LLC or your local distributor as
4. Values An estimated normal probability distribution of a group of 171 normal U S persons aged 18 89 is shown below Although there were no consistent age differences there was a pronounced gender difference Male Female Probability 0 10 20 30 40 50 60 70 Max Pressure kPa Gender Mean SD Number of Subjects Male 35 10 3 88 Female 28 7 7 83 Data are taken from Clark et al 2012 No significant differences were found when comparing the right and left lip strengths so these data have been pooled See www OPImedical com for the complete reference of this study and details of numerical procedures References Please refer to www IlOPImedical com for a list of up to date references that may be useful for understanding normal values applications of the IOPI and protocols that have been published by researchers www IOPIMedical com IOPT Maintenance Replacing the Battery Replace the battery if the display shows a low battery icon LO BAT the display is dim or if the display does not illuminate when the Power button has been pressed 2 replace the battery slide the battery cover on the back of the IOPI to its fully open position 3 Install a new 9V alkaline non rechargeable block battery and connect it to the battery connector being sure to correctly match the polarity 4 Slide the battery cover to its fully closed position NOTE Contact your local waste disp
5. mouth as described for tongue strength measurement 8 Instruct the patient to Squeeze the Tongue Bulb until the top green light comes on and keep it on for as long as possible 9 When the top green light comes on press the Start Timer button 10 If if a red light turns for more than a second remind the patient to squeeze hard enough to keep the green light on It is acceptable to encourage the patient to keep going as long as possible 11 If the patient cannot illuminate the green light within about 2 seconds press the Stop Timer button QI and tell the patient to relax 12 Record the time shown in the LCD display NOTE Usually this test is done only once per session with each patient Tongue Endurance Normal Values The data is as yet insufficient to assume the statistical normality of the endurance distributions in the normal population so an estimate of a normal probability function is not yet warranted However the U S studies published so far suggest an average endurance of about 30 35 seconds for the tongue Endurance times of 10 seconds or less would be an indication that a patient probably has low endurance it may be useful to consider that fatigability is a contributing factor to this patient s oral motor problems IOPI Medical LLC Lip Measuring Lip Strength NOTE In the following method of measuring lip strength the bulb is not placed directly between the lips The describe
6. soon as possible The IOPI device will not turn on Battery is dead Follow the Replace Battery procedure in the Maintenance section as described on page 15 If the device still does not turn on contact IOPI Medical LLC or your local distributor as soon as possible IOPI Medical LLC Technical Specifications APPLICATION Measuring method Pressure in an air filled bulb in kPa Indications for use Tongue and lip strength and endurance measurement in patients with oral motor problems including dysphagia and dysarthria APPLIED STANDARDS EN 60601 1 2nd Ed EN 60601 1 2 2007 EN 60601 1 6 2007 ISO 14971 2012 DIMENSIONS OF IOPI DEVICE Height x Width x Depth 18 cm x 10 cm x 2 5 cm Weight 258g MEASURING RANGE Pressure to 100 kPa ACCURACY Pressure 2 kPa POWER Power supply CLASSIFICATIONS Protection against electric shock 9V alkaline battery According to IEC 60601 1 Type B Protection against ingress of water None Mode of operation Continuous duty FDA US HC Canada MDD TGA Australia Device Classification OPERATING ENVIRONMENT Temperature 16 C to 27 C 60 F to 80 F Humidity 10 to 83 relative humidity STORAGE TRANSPORT ENVIRONMENT Temperature 20 C to 49 C 4 F to 120 F 10 to 83 relative humidity Humidity MANUFACTURER IOPI Medical LLC 11920 198t
7. All rights reserved
8. Iowa Oral Performance Instrument MODEL 2 3 MEDICAL IOPT User CIOPI gt Manual x IOPI Medical LLC 11920 198th Ave NE Redmond WA 98053 PHONE 1 425 549 0139 FAX 1 425 558 4596 wwwW lOPImedical com IOPI Icons Symbol Identity Catalogue Number Serial Number Manufacturing Date Consult Instructions Before Use EJ pe AR A Caution patient applied part according to IEC 60601 1 amA 9V alkaline 9 Volt Alkaline Battery Do Not Dispose of in Household Refuse EU Authorized Representative Manufactured By Conformity European Medical LLC is certified to ISO 13485 2003 under the Canadian Medical Device Regulation www IOPIMedical com Table of Contents Indications for Use Warnings ipi eicere an en erred pe k di Components nen sin Control Buttons Safety and How Does the IOPI Work Tongue Measuring Tongue Strength Tongue Strength Normal Values Measuring Tongue Endurance Tongue Endurance Normal Values Lip Measuring Lip Strength Lip Strength Normal Values References ien nep p Maintenance Troubleshootng en Technical Specifications Limited
9. consistent gender difference Peak tongue strength values corresponding to various percentiles from the estimated normal distributions are shown below It is common to consider values below the 5th percentile to be abnormal shaded table cells Tongue Strength kPa 54 63 34 43 47 53 55 63 25 34 39 44 48 56 Young Middle Old Phone 1 425 549 0139 PN 800 2301 02 2014 05 11 Measuring Tongue Endurance 1 Measure and record the patient s Peak pressure as described on page 11 2 Press the Lights Mode button gt and note that the bottom light of the light array will turn on and the LCD will display the value 50 kPa 3 Use the SET MAX arrows A W to adjust the value in the LCD display to 50 of the patient s Peak pressure NOTE The top green light of the light array will now illuminate when the patient compresses the Tongue Bulb to 50 of their Peak pressure 4 Place the IOPI so that the light array can be seen easily by the patient 5 Prepare to use the Timer Mode on the IOPI to measure the length of time that the patient can illuminate the top green light NOTE A stopwatch may be used in place of the IOPI s timer feature 6 Tousethe Timer Mode press the Timer Mode button O and notice that the LCD display will show 0 seconds If the display does not show 0 press the Timer Reset button gt 0 7 Position the Tongue Bulb in the patient s
10. d method is valid however because the pressure developed in the bulb depends upon the strength of the circumferential muscle complex that surrounds the mouth It is tension in these muscles that allows the lips to be compressed against one another With the IOPI on push the Peak Mode button L b In this mode the LCD will display the highest pressure applied to the IOPI Press the Peak Reset button gt The LCD display will read 0 Position an IOPI Tongue Bulb inside the patient s cheek just lateral to the corner of the mouth WARNING Hold onto the stem of the Tongue Bulb 4 Tell the patient Press the Tongue Bulb against your teeth by pursing your lips as hard as you can for about 2 seconds Visual and verbal encouragement during the test is acceptable and helps some people The 2 second hold time is not important it just avoids the question How long should I hold it when you tell them to squeeze the bulb After the patient has made his or her maximum response and relaxed record the value you see on the IOPI LCD display and then push the Peak Reset button Tafel Let the patient rest for 30 60 seconds and then repeat Steps 3 5 two more times The Peak lip strength is the highest of the three recorded values If the values consistently decrease over the three trials the rest period may not be long enough Fax 1 425 558 4596 PN 800 2301 02 2014 05 13 14 Lip Strength Normal
11. ent rest for 30 60 seconds and then repeat Steps 3 5 two more times 7 The Peak tongue strength is the highest of the three recorded values If the values consistently decrease over the three trials the rest period may not be long enough Tongue Strength Normal Values These normal values are derived from 10 studies conducted on the US population New research indicates there may be national variation in these normal values perhaps dependent on the language spoken by the subjects patients For the latest studies that IOPI Medical is aware of please visit our website Estimated normal probability distributions ZEN d IL Se of maximum tongue Middle pressure of three age 3 groups of normal U S 2 subjects are shown to the right 0 10 20 30 40 50 60 70 80 90 100 110 These data were Max Pressure kPa derived from the SD Age years Number of Subjects weighted average Young 63 13 6 20 39 276 of the means and Middle 63 12 5 40 60 219 standard deviations Old 56 13 5 gt 60 198 of tongue strength of normal subjects reported in 10 publications Consult Normal Values in www lOPImedical com for references and details of the numerical procedures Most groups contained approximately equal numbers of males and females In some studies males were somewhat stronger than females by about 5 10 kPa but only for young subjects For middle aged and old subjects there was no
12. h Ave NE Redmond WA 98053 U S A Tel 1 425 549 0139 FAX 1 425 558 4596 EU AUTHORIZED REPRESENTATIVE AUSTRALIAN SPONSOR EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands EMERGO AUSTRALIA Level 20 Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia Fax 1 425 558 4596 PN 800 2301 02 2014 05 19 20 Limited Warranty WARRANTY IOPI Medical LLC warrants your product to be free from defects in material and workmanship for a period of two years from the original date of purchase If you discover a defect in a product covered by this warranty we will repair it using new or refurbished components or if repair is not possible replace the item EXCLUSIONS This warranty covers defects in manufacturing discovered while using the product as recommended by the manufacturer The warranty does not cover loss or theft nor does coverage extend to damage caused by misuse abuse unauthorized modification improper storage conditions and other failures to use or maintain in accord with the manufacturer s instructions The warranty does not cover parts that are subject to normal wear and tear LIMITS OF LIABILITY Should the product s fail your sole recourse shall be repair or replacement as described in the preceding paragraphs IOPI Medical LLC will not be held liable to you or any other party for any damages that result from the failure of this product Damages exc
13. ideal position or if the depression time was too slow or too fast If there is variability in the readings this is due to variability in your method Repeat until your reading stabilizes 1 kPa 9 Using the altitude at your location compare this pressure reading to Figure 3 for altitude in meters or Figure 4 for altitude in feet 10 If the pressure reading does not fall within the shaded region of Figure 3 or 4 contact IOPI Medical or your local distributor Figure 1 Figure 2 E 1 15 let 15 SE 2 E 20 H _ 25 2 H E za 30ml o2 3 www IOPIMedical com Figure 3 Syringe BEEN UO 9 5 beum m m m hu m m m ju m m m jeu ee m m ku k x a m x x b m x m hu x m x nj DEET EEN e o _ o o E o Sy RR 1 1 AR Su no jo S 1222 WE DEE _______ 5 lt _ _______ _ __ __ lt o N m m m e o a i r Yl ss td ZS ee a eg za oO S ZS g v9 ao gege oS DADA 0 c c c 88 o A o 00 Sulpeay aunssaid 8uipeay eJnssaJd Tubing PN 800 2301 02 2014
14. ies the buttons for adjusting the target 2 SET MAX Pressure pressure that corresponds to the top green light of the light array in Lights Mode Adjust Maximum Increases the target pressure corresponding 3 U to the top green light of the light array in P Lights Mode Adjust Maximum Decreases the target pressure corresponding 4 Dere to the top green light of the light array in Lights Mode When pressed the LCD display shows the elapsed time in seconds between pressing 3 O Timer Mode the Start Timer E03 and Stop Timer 67 buttons This button will start the Timer 6 gt Start Timer This button will stop the Timer 7 Q Stop Timer 8 Timer Reset This button will reset the Timer to zero 0 Activates peak finding function Displays 9 the maximum pressure achieved when attached bulb is compressed 10 Peak Reset This button will reset the peak finding function to zero 0 Toggles the battery power between On 11 Power and Off The IOPI will turn itself off after 15 minutes without a button push or pressure response Short stainless steel tube that connects to 12 Pressured female end of Connecting Tube e Patient Isolation 13 R Type B Type B patient applied part according to IEC 60601 1 www IOPIMedical com Phone 1 425 549 0139 PN 800 2301 02 2014 05 7 Safety amp Care Instructions Safety precautions Please observe the following safety precautio
15. k dust temperature changes or humidity These environmental conditions may result in malfunction a shorter electronic life span or damage to the device Do not open up the IOPI and tamper with the internal components doing so will terminate the product warranty and may cause damage At the end of its useful life dispose of the IOPI device and its accessories in accordance with local or national disposal or recycling laws IOPI Medical LLC How Does the IOPI Work How does the IOPI measure strength The IOPI measures the Peak pressure a patient can produce in an IOPI Tongue Bulb by pressing the bulb against the roof of the mouth with the tongue Peak pressure is a measure of strength expressed in units of pressure the kiloPascal kPa How does the IOPI measure endurance For patients with dysphagia or dysarthria oral motor fatigability may be of interest The IOPI can be used to assess tongue fatigability by measuring its endurance which is inversely proportional to fatigability Low endurance values are an indicator of a high fatigability Endurance is measured with the IOPI by quantifying the length of time that a patient can maintain 5096 of his or her Peak pressure This procedure is conducted by setting the maximum pressure in the Lights Mode to 5096 of the patient s Peak pressure and timing how long the patient can hold the top green light on How is the IOPI used for exercise therapy In Lights Mode the pressure
16. luded include but are not limited to the following lost profits lost savings loss of or injury to data damage to person or property and incidental or consequential damages arising from the use or inability to use this product In no event will IOP Medical LLC be liable for more than the amount of your purchase price not to exceed the current list price of the product and excluding tax shipping and handling charges IOPI Medical LLC disclaims any and all other warranties express or implied By using the product the user accepts all terms described herein HOW TO OBTAIN SERVICE UNDER THIS WARRANTY Before sending the unit for repair contact IOPI Medical LLC 1 425 549 0139 sales iopimedical com REQUIREMENTS The cost of shipping to the manufacturer and payment of any customs clearance fees or duties are the responsibility of the user These costs may be credited to the user s account if the product is determined to be under warranty Return shipping costs for products repaired or replaced under this warranty will be paid for by IOPI Medical LLC www IOPIMedical com Notes Phone 1 425 549 0139 PN 800 2301 02 2014 05 21 22 Notes www IOPIMedical com Phone 1 425 549 0139 PN 800 2301 02 2014 05 23 MEDICAL IOPI Medical LLC 11920 198th Ave NE Redmond WA 98053 U S A PHONE 1 425 549 0139 FAX 1 425 558 4596 www lOPImedical com Copyright 2013 IOPI Medical LLC
17. ns when setting up and using your IOPI This device is only intended for measuring oral motor structures This device is sold only to medical professionals assisting patients with oral motor problems including dysphagia and dysarthria The medical professional is in charge of supervising a patient s use of the IOPI in order to ensure that it is only used as intended To avoid measurement errors carefully read this manual before using the IOPI Prior to using IOPI accessories such as the IOPI Tongue Bulb with the IOPI device carefully read the Directions for Use for the accessory Caring for your IOPI To ensure that you receive the maximum benefit from using this device please abide by the following care guidelines When not in use store the IOPI device in the carrying case provided with the device Do not immerse the IOPI device in water If the surface of the device comes into contact with water dry it immediately with a soft cloth To clean the exterior of the IOPI device wipe it with a soft slightly moistened cloth Use of mild soaps or disinfectants is suitable Do not use abrasive or corrosive cleaning agents as these may damage the unit Remove the 9V battery whenever you plan to store the IOPI device for a long period of time When replacing the battery only use a new 9V alkaline battery Do not use a rechargeable battery Do not expose the IOPI device to strong electromagnetic fields excessive force shoc
18. on of throat soreness following the measurement This condition may persist for as long as 24 hours IOPI Medical LLC IOPI Components Included in The IOPI System PN 1 2300 Component Item PN Description A lowa Oral Performance 8 2301 Device measures and displays Instrument IOPI pressure from an air filled bulb Model 2 3 Pressure In port is a short stainless steel tube to which the Connecting Tube is attached C B Box of Tongue Bulbs 5 6010 Squeezed by the tongue to measure tongue strength and endurance C Connecting Tube 5 0001 Connects the Tongue Bulb to the Pressure In port D Carrying Case 5 0002 Padded case for storing and transporting the IOPI device E Accuracy Check Syringe 5 0101 Syringe used in the Accuracy Check procedure IOPI Medical LLC approved accessories 5 6010 Box of Tongue Bulbs 5 0001 Connecting Tube 5 0101 Accuracy Check Syringe NOTE Only use IOPI Medical LLC approved accessories with The IOPI System Fax 1 425 558 4596 PN 800 2301 02 2014 05 IOPI Control Buttons Identity Description Toggles the column of lights On and Off The LCD display shows the target pressure 5 required to illuminate the top green light of 1 Lights Mode the light array When entering Lights Mode the LCD displays the default target pressure of fifty 50 and one light will be illuminated Set Maxim m Identif
19. osal authority for instructions on how to dispose of used alkaline batteries In Europe used batteries should be recycled in accordance with council directive 2006 66 EC as transposed into national laws Do not dispose of in clinic trash Phone 1 425 549 0139 PN 800 2301 02 2014 05 15 16 Accuracy Check Perform the following accuracy check monthly Note that this procedure is a check only If you would like IOPI Medical or an authorized electronics shop to check the calibration rigorously contact IOPI Medical or your local distributor for instructions NOTE Practice this process a few times until the timing is smooth before you record your readings The exact starting and ending positions are important 1 Connect the Connecting Tube to the Pressure Port on the IOPI Turn on the IOPI and press the Peak button Set the front edge of the plunger of the syringe just touching the back edge of the 30 ml mark see Figure 1 4 Leave the plunger in this position and connect the syringe tubing to the metal end of the Connecting Tube 5 Over a period of about 5 seconds depress the plunger so that its front edge ends up just touching the back edge of the 15 ml mark see Figure 2 Note the peak pressure reading on the IOPI Disconnect the syringe tubing from the Connecting Tube and push the Reset button on the Peak function 8 Repeat Steps 3 7 several times Discard readings if you know you pushed the plunger past the
20. required to illuminate the green light at the top of the light array can be adjusted using the Set Max arrow buttons This green light is used as a target for the patient The medical professional determines what target value is appropriate for exercise therapy purposes and provides specific instructions to the patient for a particular exercise protocol A protocol should include the number of times to illuminate the green light and for each repetition how long the green light should be illuminated before releasing pressure on the bulb Please visit our website www OPimedical com for a list of articles providing information about exercise therapy for oral motor structures E T P nax X 100 T Target value P Peak tongue pressure E Effort 96 Fax 1 425 558 4596 PN 800 2301 02 2014 05 9 10 S 2 9 et Up Remove the IOPI device from the carrying case and place on a flat surface Remove the Connecting Tube from the package and notice that it has two ends a female end plastic tubing and a male end metal Connect the female end plastic tubing to the Pressure Port lt on the IOPI device by sliding the tubing over the metal port as far as it will go Look at the Tongue Bulb and notice that one end is a blue bulb and the other end is tubing Use scissors to cut the seal off the end of the tubing by cutting em across the package while the K Tongue Bulb is still in its package
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