Table of Contents
Summary of Contents for IOPI MEDICAL 3.2
- Page 1 Iowa Oral Performance Instrument MODEL 3.2 IOPI Trainer ® User Manual For the Medical Professional IOPI® Medical LLC 18500 156th Ave NE, STE 104 Woodinville, WA 98072 U.S.A. PHONE: +1 (425) 549-0139 www.IOPImedical.com FAX: +1 (425) 558-4596...
- Page 2 IOPI Shipping Icons Icons ® Symbol Identity Symbol Identity Catalogue Number Fragile Serial Number Protect from rain Manufacturing Date This side up Consult Instructions Storage and Transport Before Use Temperature Storage and Transport Caution Atmospheric Pressure Type BF patient applied Storage and Transport part according to Humidity...
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Page 3: Table Of Contents
Table of Contents Indications for Use ..................Warnings ......................Safety and Care ....................Instructional Icons ..................Definitions ...................... Components ....................Control Buttons ....................Introduction ....................Modes ......................Biofeedback ....................Target Values ....................Clinic Use ...................... Home Use ..................... Trainer Bulb Positions for Exercise .............. -
Page 4: Indications For Use
Indications for Use The IOPI Trainer (Model 3.2) is used to increase the strength and endurance ® of the tongue and lip in pati ents with oral motor disorders, including dysphagia and dysarthria. The IOPI Trainer is intended for clinical or home use by pati ents under the ®... -
Page 5: Safety And Care
Safety & Care Instructions Safety Precautions Please observe the following safety precautions when setting up and using the IOPI Trainer: ® • This device is only intended for use with oral motor structures. • This device is sold to medical professionals who are assisting patients with oral motor problems, including dysphagia and dysarthria, or to the patient on the order of the supervising medical professional. The medical professional is in charge of directing a patient’s use of the IOPI Trainer in ® order to ensure that it is only used as intended. • To avoid user errors, carefully read this manual before using the IOPI Trainer. -
Page 6: Instructional Icons
Instructional Icons IOPI Report Generator is an opti onal soft ware accessory for use with the IOPI ® ® Trainer. While the user can record the target value and successful repeti ti on count by hand, the IOPI Report Generator soft ware generates a report of all ® event data collected by the device. The following icons are used in the manual to assist the user with specifi c instructi ons for each opti on: Indicates instructi ons for users who plan to download stored event data using IOPI Report Generator. -
Page 7: Components
Trainer Kit (PN 1-3200): ® Item Descripti on Device, which includes a surrounding silicone cover, that displays pressure indicated by LEDs from an Iowa Oral Performance Instrument Trainer 8-3201 air-fi lled bulb relati ve to a target value. The Pressure (Model 3.2) In port is a short stainless steel tube to which the Trainer Bulb is att ached (B). Sensors squeezed by the tongue or lip to provide 5-6105 Box of Trainer Bulbs biofeedback for oral motor exercise. Padded case for storing and transporti ng Trainer Carrying Case 5-0004 the IOPI Trainer. -
Page 8: Control Buttons
IOPI Medical LLC APPROVED SOFTWARE: ® APPROVED ACCESSORIES: 5-8101 IOPI Report Generator ® 5-6105 Box of 5 Trainer Bulbs APPROVED SERVICE ITEMS: 5-0005 Mini-USB to USB Cable 5-0102 Accuracy Check Kit IOPI Medical LLC ®... - Page 9 IOPI Trainer Control Buttons & Symbols ® Symbol Identi ty Descripti on In Run Mode, this butt on displays the target pressure. Target Holding this butt on down while pressing the Power butt on [ ] Mode acti vates Program Mode. In Run Mode, this butt on is inacti ve. Set Target: In Program Mode, this butt on increases the target pressure cor- Up Arrow responding to the top (green) light of the biofeedback light array. The highest target value setti ng is 60 kPa. In Run Mode, this butt on is inacti ve.
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Page 10: Introduction
Introduction The IOPI Trainer ® The IOPI Trainer is a device that must be used in parallel with the IOPI ® ® Pro (Model 3.1) or a Series 2 IOPI (Models 2.1, 2.2, or 2.3). As described ® in the biofeedback secti on (page 12), the maximum pressure value (P is needed to create an eff ecti ve therapy plan. P can only be measured using the IOPI Pro or a Series 2 IOPI device. ® ® The main purpose of the IOPI Trainer is to allow for the conti nuati on ® of therapy at home. This allows the pati ent to be more independent aft er initi al instructi on from the medical professional. -
Page 11: Modes
Modes Program Mode Program Mode is used to set the target pressure for the patient and clear the device memory. For instructions see Set Up section on page 14. Run Mode Run Mode is used to provide biofeedback for oral motor exercises of the tongue and lips. Run Mode is automatically entered when the device is turned on by pressing and holding the Power button [ ] until the display turns on. In this mode, the display shows the successful repetition count. To start a new set of exercises, reset the displayed count to 0 by pressing the Reset button [ ]. The light array will illuminate in proportion to the bulb pressure relative to the target value. Every time a successful repetition is performed, the displayed successful repetition count will increase by +1. Phone: +1 (425) 549-0139 PN 800-3201-05 2021.05... -
Page 12: Biofeedback
Biofeedback How is the IOPI used for exercise therapy? ® In Program Mode, the pressure required to illuminate the green light at the top of the biofeedback light array can be adjusted to a specifi c value. This target value provides feedback to the pati ent regarding his or her level of eff ort. The medical professional determines what target value is appropriate for exercise therapy purposes and provides specifi c instructi ons to the pati ent for a parti cular exercise protocol. A typical exercise protocol would include the following parameters: (1) Intensity (the target value) a. Based on 2 factors: the maximum pressure (P ) and the eff ort level T = P T= Target value, P = Maximum pressure, E = Eff... -
Page 13: Target Values
TARGET VALUES (kPA) Based on Maximum Pressure (P ) x Eff ort Level (%) Eff ort Level (%) Pmax (kPa) The medical professional may wish to use IOPI Pati ent Progress ® Datasheets to record protocol details and track pati ent progress over the course of exercise therapy. -
Page 14: Clinic Use
Clinic Use Set Up 1. Remove the IOPI Trainer device from the carrying case and place it on ® a fl at surface. 2. Enter Program Mode by starti ng with the device off . Press and hold the Target butt on [ ]. While sti ll holding the Target butt on [ ], press and hold the Power butt on [ ] unti l PROG [ ] is displayed in the bott om left corner of the screen. Let go of the butt ons. a. Adjust the Target Value: Press the Set Target arrow butt ons [ ] unti l the screen shows the desired pressure value. -
Page 15: Home Use
6. Connect the Trainer Bulb to the Pressure In port [ ] on the bott om of the IOPI Trainer (see Page 8) by sliding the att achment grip over the metal port ® as far as it will go. 7. Remove the Trainer Bulb from its package, taking care to not touch the parts of the Trainer Bulb that go into the pati ent’s mouth. 8. Turn the IOPI Trainer on by pressing and holding the Power butt on [ ] unti l ® the display turns on. The device will enter Run Mode and the display will show a repeti ti on count of 0. 9. Positi on the Trainer Bulb in the mouth based on the exercise protocol design. Typical positi ons for the Trainer Bulb are shown on pages 16-17. Home Use The IOPI Trainer Kit comes with a set of IOPI... -
Page 16: Trainer Bulb Positions For Exercise
Trainer Bulb Positions for Exercise Tongue - Anterior INITIAL POSITION ACTION Position the Trainer Bulb against The patient lifts the anterior the patient’s hard palate, just tongue to compress the Trainer behind the alveolar ridge. The Bulb against the hard palate. The blue bulb seal should be behind mandible should be intrinsically the incisors, the bulb should be stabilized during the task (i.e. flat on the blade of the tongue, the jaw should not be opening and the tubing should rest gently and closing, but rather remain between the incisors. - Page 17 INITIAL POSITION ACTION Position the Trainer Bulb under The patient squeezes the Trainer the orbicularis oris (just inside Bulb against the teeth. the corner of the patient’s lips, lateral to the central incisor). WARNING: The medical professional or patient should always hold on to the safety grip of the Trainer Bulb when it is in the patient’s mouth. Fax: +1 (425) 558-4596 PN 800-3201-05 2021.05...
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Page 18: Follow-Up Appointments
Follow-Up Appointments In order to supervise pati ent use of the IOPI Trainer, it is criti cal to schedule ® regular follow-up appointments. These appointments provide the medical professional with an opportunity to re-evaluate the pati ent’s strength and endurance measurements using an IOPI Pro or IOPI Series 2 device, review ® ® home compliance in terms of both usage and technique, and adjust the exercise protocol parameters if needed. There are two opti ons for reviewing pati ent usage data during follow-up appointments: The medical professional can press and hold the Total butt on [ ] to observe and record the number of successful repeti ti ons displayed on the screen. -
Page 19: Maintenance
Maintenance Accuracy Check Perform the following accuracy check monthly. This procedure can be performed by the medical professional. It is a check only and requires an IOPI Pro device ® (or IOPI 2.1, 2.2 or 2.3). If you would like IOPI Medical to check the calibrati on ® ® rigorously¸ contact IOPI Medical or your local distributor for instructi ons. ® NOTE: Practi ce this process a few ti mes unti l the ti ming is smooth before you record your readings. -
Page 20: References
Replacing the Batteries 1. Replace the batt eries if the display shows a low batt ery icon [ ], if the display is dim, or if the display does not illuminate when the Power butt on [ ] has been pressed. 2. To replace the batt eries, remove the blue silicone cover and press and slide the batt ery cover on the back of the IOPI Trainer off . ® 3. Install two new AA alkaline non-rechargeable batt eries, being sure to correctly match the polarity. 4. Replace the batt ery and silicone covers. NOTE: Contact your local waste disposal authority for instructi ons on how to dispose of used alkaline batt eries. -
Page 21: Troubleshooting
Troubleshooting Symptom Possible Cause Actions 1. Determine if the Trainer Bulb Trainer Bulb stays An air leak is leaking by trying another flattened or dimpled can occur Trainer Bulb. after compression. anywhere in the system (Trainer 2. While leaks inside the IOPI Trainer ®... -
Page 22: Technical Specifications
Technical Specifications APPLICATION Measuring method Pressure in an air-filled bulb (in kPa). Indications for use The IOPI Trainer (Model 3.2) is used to increase the strength and ® endurance of the tongue and lip in patients with oral motor disorders, including dysphagia and dysarthria. The IOPI Trainer is intended for clinical or home use by patients under ® the direction of a medical professional. APPLIED STANDARDS IEC 60601-1:2005 (Third Edition) + CORR. IEC 60601-1-11:2015 1:2006 + CORR. 2:2007 + A1:2012 IEC/EN 62304:2006 IEC 60601-1-2:2014 + EN 60601-1-2:2015 EN ISO 10993-1:2009 IEC 60601-1-6:2010 (Third Edition) + A1:2013 ISO 14971:2012 IEC 62366:2007 (First Edition) + A1:2014 BS EN ISO 15223-1:2016 DIMENSIONS OF IOPI DEVICE ® Height x Width x Depth 17.7 cm x 8.8 cm x 3.0 cm Weight... -
Page 23: 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. 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 excluded 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 IOPI 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. ®... - Page 24 IOPI® Medical LLC 18500 156th Ave NE, STE 104 Woodinville, WA 98072 U.S.A. PHONE: +1 (425) 549-0139 FAX: +1 (425) 558-4596 www.IOPImedical.com © Copyright 2017/2021 IOPI Medical, LLC. All rights reserved. ®...