Related Manuals for IOPI MEDICAL PRO
Summary of Contents for IOPI MEDICAL PRO
- Page 1 Iowa Oral Performance Instrument MODEL 3.1 ENGLISH IOPI ® User Manual IOPI® Medical LLC 18500 156th Ave NE, STE 104 Woodinville, WA 98072 U.S.A. www.IOPImedical.com PHONE: +1 (425) 549-0139...
- Page 2 ® IOPI Icons SYMBOL TITLE DESCRIPTION REFERENCE Catalogue Indicates the manufacturer’s reference number so ISO 15223-1, Number that the medical device can be identified Clause 5.1.6 Serial Indicates the manufacturer’s serial number so that a ISO 15223-1, Number specific medical device can be identified Clause 5.1.7 Date of Indicates the date when the medical device was...
- Page 3 ® IOPI Shipping Icons SYMBOL TITLE DESCRIPTION REFERENCE Fragile, Handle Indicates a medical device that can be broken ISO 15223-1, with Care or damaged if not handled carefully Clause 5.3.1 Indicates a medical device that needs to be ISO 15223-1, Keep dry protected from moisture Clause 5.3.4...
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Page 4: Table Of Contents
Table of Contents Indications for Use .................. Warnings ......................Safety and Care ..................Instructional Icons ..................Definitions ...................... Control Buttons ..................Components ....................How Does the IOPI Work? ..............Modes ......................Set Up ......................TONGUE Measuring Tongue Strength ............. Anterior Tongue Strength Normal Values ........ -
Page 5: Indications For Use
Indications for Use The IOPI Pro (Model 3.1) is used by healthcare professionals to measure, ® evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. -
Page 6: Safety And Care
IOPI Pro before and after use with each patient. Remove the ® silicone cover from the Pro, wipe both items and let dry, then replace the cover on the Pro. • The bulbs, as supplied by IOPI Medical LLC, can be reused by the same patient ®... -
Page 7: Instructional Icons
• Do not open the IOPI® Pro 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® Pro and its components, accessories, and service items in accordance with the associated Instructions for Use and with local or national disposal or recycling laws. - Page 8 IOPI Medical LLC ® APPROVED ACCESSORIES: APPROVED COMPONENTS: 5-8101 IOPI Report Generator ® 5-6010 Box of 10 Tongue Bulbs 5-6105 Box of 5 Trainer Bulbs APPROVED SERVICE ITEMS: 5-0001 Connecting Tube 5-0102 Accuracy Check Kit 5-0005 Mini-USB to USB Cable IOPI Medical LLC ®...
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Page 9: Control Buttons
This number is used to Power identify the stored data that will be collected in Peak and/or (ON/OFF) Target Mode. The IOPI Pro will turn itself off after 15 minutes of inactivity. ® Data Out Mini-USB port for use with IOPI software. ®... -
Page 10: Components
IOPI Pro Components ® Included in the IOPI Pro Kit Deluxe (PN 1-3100-DL) and Standard (PN 1-3100-SD): ® Deluxe Standard Item Description Device, which includes a surrounding silicone Iowa Oral cover, that measures and displays pressure from Performance 8-3101 an air-filled bulb. The Pressure In port is a short... -
Page 11: How Does The Iopi Work
® For patients with dysphagia or dysarthria, oral motor fatigability may be of interest. The IOPI Pro 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. -
Page 12: Modes
Modes Program Mode Program Mode is used to clear the stored data from memory and reset the index number to 100. For memory clearing instructions, see page 22. Continuous Mode Continuous Mode can be used for IOPI Medical to troubleshoot the device ®... -
Page 13: Set Up
Tongue Bulb that will go into the patient’s mouth. A Trainer Bulb may be used with the IOPI® Pro in place of the Tongue Bulb and Connecting Tube. Information on connecting a Trainer Bulb to the Pro can be found in the IOPI®Trainer Bulb Instructions for Use. -
Page 14: Tongue
Tongue Measuring Tongue Strength 1. With the IOPI Pro device turned on, push the Peak Mode button [ ® followed by the Reset button [ ]. The display will show “0”. 2. Place the Tongue Bulb in the position of interest:... - Page 15 4. Tell the patient: “Press the Tongue Bulb with your tongue 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?”...
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Page 16: Anterior Tongue Strength Normal Values
New research indicates there may be international 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 www.IOPImedical.com. Estimated normal probability distributions of maximum anterior tongue pressure of three age groups of normal U.S. -
Page 17: Measuring Tongue Endurance
Measuring Tongue Endurance 1. Measure and record the patient’s maximum tongue pressure (P ) as described on pages 14-15. 2. Press the Target Mode button [ ]. Use the Set Target arrow buttons ] to adjust the target value to 50% of the patient’s P 3. -
Page 18: Lip
(the circumferential muscle complex that surrounds the mouth). It is tension in this muscle that allows the lips to be compressed against one another. 1. With the IOPI Pro on, push ® the Peak Mode button [ In this mode, the display will show the highest pressure applied to the attached bulb. -
Page 19: Lip Strength Normal Values
Lip Strength Normal Values An estimated normal probability distribution of a group of 171 normal US people, aged 18–89, is shown below. Although there were no consistent age differences, there was a pronounced gender difference. Male Female Max Pressure (kPa) No significant differences were Gender Mean... -
Page 20: Biofeedback
Biofeedback How is the IOPI used for exercise therapy? ® In Target Mode, the pressure required to illuminate the green light at the top of the biofeedback light array can be adjusted to a specific value. This target value provides feedback to the patient regarding his or her level of effort. The healthcare professional determines what target value is appropriate for exercise therapy purposes and provides specific instructions to the patient for a particular exercise protocol. -
Page 21: Target Values
IOPI Pro. This reference list also includes normal values of other populations ® and protocols that have been published by researchers. Phone: +1 (425) 549-0139... -
Page 22: Err" Message
“Err” Message When there is 20% or less available device memory, the “Err” message flashes three times when the device is turned on. When the memory is full, the “Err” message remains solid and your device cannot perform any functions until the memory is cleared. -
Page 23: Data Output
Data Output The IOPI® Pro records all Peak and Target Mode event data. Every time the device is turned on, an index number is displayed for three seconds in order to uniquely identify the data to be collected. If the user wishes to associate indexed data with a particular patient, bulb location, and data collection session, it is recommended that they make note of the index number(s). -
Page 24: Maintenance
The exact starting and ending positions are important. 1. Connect the female end of the Connecting Tube to the Pressure In port [ ] on the IOPI Pro. ® 2. Turn on the device and press the Peak button. Figure 3. - Page 25 Figure 5. 1200 1600 Syringe Altitude (Meters) Plunger Figure 6. Syringe Tubing 1000 2000 3000 4000 5000 6000 Altitude (Feet) Phone: +1 (425) 549-0139 PN 800-3101-09_EN 2025.02...
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Page 26: Replacing The Batteries
4. Replace the battery and silicone covers. The IOPI® Pro also contains one non-replaceable lithium coin cell battery (CR2032 lithium 3V) within its enclosure. This coin cell battery should NOT be accessed or removed by the user or patient. If a coin cell battery is ingested, call a local poison control center immediately for treatment information. -
Page 27: References
References 1 Adams , V., Mathisen, B., Baines, S., Lazarus, C., & Callister, R. (2014). Reliability of Measurements of Tongue and Hand Strength and Endurance Using the Iowa Oral Performance Instrument with Healthy Adults. Dysphagia, 29(1), 83-95. 2 Vanderwegen, J., Guns, C., Van Nuffelen, G., Elen, R., & De Bodt, M. (2013). The Influence of Age, Sex, Bulb Position, Visual Feedback, and the Order of Testing on Maximum Anterior and Posterior Tongue Strength and Endurance in Healthy Belgian Adults. -
Page 28: Troubleshooting
Medical LLC or your local seem too high or ® distributor as soon as possible. too low based on experience with the IOPI Pro device and ® the patient. Follow the Replacing the Batteries procedure in The IOPI Pro device Batteries are ®... -
Page 29: Technical Specifications
Pressure in an air-filled bulb (in kPa). Indications for use The IOPI Pro is used by healthcare professionals to measure, evaluate, ® and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. -
Page 30: Limited Warranty
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. - Page 31 Notes Phone: +1 (425) 549-0139 PN 800-3101-09_EN 2025.02...
- Page 32 IOPI® Medical LLC 18500 156th Ave NE, STE 104 Woodinville, WA 98072 U.S.A. PHONE: +1 (425) 549-0139 www.IOPImedical.com © Copyright 2017/2025 IOPI Medical, LLC. All rights reserved. ®...
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