Interacoustics

Air Fx Models AFX1.1 and 2.1 Service Manual Rev 9

Service Manual

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File Name: Interacoustics - Air Fx Models AFX1.1 and 2.1 Service Manual Rev 9.pdf

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Title Page

Service Manual for

Air Caloric Irrigator Models AFX1.1 / AFX2.1

Copyright © 1/5/2016 by Micromedical Technologies. All rights reserved. Information in this document is subject to change without notice. Companies, names, and data used in example herein are fictitious unless otherwise noted. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without express written permission of Micromedical Technologies or its licensees.

VisualEyes™, System 2000™, Balance Quest™, Meta-4™, VORTEQ®, DVA-Test™, InView™, RealEyes™, MobilEyes™, Air Fx, Aqua Stim, Micromedical Technologies, and their logos are trademarks of Micromedical Technologies. Windows®, Windows XP®, and Windows 7® are trademarks of the Microsoft Corporation. FireWire is a registered trademark of the Apple Corporation. Other trademarks are the property of their respective owners.

Micromedical Technologies 10 Kemp Drive Chatham, IL 62629 USA (800) 334.4154 USA, Canada, & Puerto Rico (217) 483.2122 Outside USA (217) 483.4533 Fax www.micromedical.com

Printed in the United States of America

Guymark UK Veronica House, Old Bush Street Brierly Hill, West Midlands DY5 1UB United Kingdom

+44-1384-410-848 PHONE +44-1384-410-898 FAX www.guymark.com

Air Fx Service Manual, Doc. No. 19, Rev 9

Table of Contents

Table of Contents Overview ... 1 Description ... 1 Intended Use ... 1 Intended Users ... 1 System Configuration ... 1 Maintenance ... 1 Packing List ... 2 Examine Packaging and Device ... 2 Packing List (typical) ... 2 Panel Diagrams ... 3 Irrigator Preparation ... 4 Filling the Water Reservoir ... 4 Air Fx Stand-alone Operation ... 5 Using Air Fx with Micromedical VisualEyes VNG... 5 Attaching the Speculum ... 5 Turn On the Irrigator ... 6 Turn Off the Irrigator ... 6 Preventative Maintenance... 7 After Each Patient... 7 Weekly Maintenance ... 7 Annual Maintenance ... 7 Annual Irrigation Temperature Check ... 7 Annual Irrigation Flow Rate Check ... 8 Cabinet Disassembly ... 9 Troubleshooting ... 12 Tools Needed... 12 Irrigator display messages ... 12 Irrigator Inoperative on Power Up ... 13 Irrigator Will Not Achieve Cool Temperature ... 14 Low Airflow Less than 8 LPM ... 15 USB Connection Problems... 15 Air Pump Not Heard When Warm or Cool Is Selected ... 16 Irrigator Display Reads “Air Temp Error” ... 16 Cannot Prime Water Pump Using Fill Procedure ... 17 Irrigator Display Reads “Over Temp Error” ... 17 Appendix ... 18 Draining the Water Reservoir... 18 Change irrigator default temperature and timer settings ... 18 Annual Cleaning Procedure ... 19 General Information ... 20 Domestic and International Warranty and Service Policy... 20 Suitable Use ... 22 EMC Compliance ... 22 Specifications... 25 Environmental Conditions ... 25 Supplies ... 26 © 1/5/2016 by Micromedical Technologies

Air Fx Service Manual, Doc. No. 19, Rev 9

Table of Contents

Component Recycling ... 27

Symbols and Nomenclature [Esc]

Name in brackets of the keyboard key to press An applied part that includes a patient connection that is intended to deliver electrical energy or an electrophysiological signal to or from the patient shall be a Type BF part. An EOG amplifier is considered a Type BF part. An applied part that is not a Type BF part is considered a type B. Observe precautions for handling electrostatic sensitive devices It is against the law to dispose of electronic devices in the trash. The crossed-out wheelie bin symbol shows that the components cannot simply be tossed into the trash but must be recycled or disposed in accordance to local environmental regulations. Chinese RoHS compliance standard where after 10 years of normal use the product could pose an environmental risk. Electrical ground

Important Information about a particular feature or procedure Caution Information regarding methods that can cause loss of patient data, cause significant delays during testing, or can cause damage to the equipment or patient / operator injury. Caution Do not Hi-Pot test using > 1000VDC or for longer than 1 minute or MOV on input will be damaged.

Glossary Service Technician Someone who is qualified by training and experience to perform technical repairs or maintenance to the equipment. Biofilm Organic growth caused by bacteria or algae Mineral Deposits Inorganic material caused by hard water or oxidation of interior metallic components

Air Fx Service Manual, Doc. No. 19, Rev 9

Overview

Overview Description The Air Fx caloric irrigator is used for clinical testing of the head-motion sensors in the ear using warm or cool air delivered into the external ear canals.

Intended Use This irrigator is recommended for use on an adult, ambulatory patient population. Patients who are candidates for caloric testing often have dizziness or imbalance caused by reduced or absent vestibular function in the inner ear. Typically four caloric irrigations are performed, including a cool and a warm irrigation of each ear. Eye nystagmus responses to the irrigations are measured and compared to each other.

Intended Users Proper use requires specialized training in the operation of the irrigator and knowledge of correct irrigation techniques. An audiologist or a medical doctor should be the ones that order a caloric test and they should also interpret the results. The Air Fx is a medical device and improper application of the device due to lack knowledge or misuse can impose a risk to the patient and or incorrect test results. This service manual is intended to be used by qualified service technicians with a biomedical, mechanical, or electronics background to perform more intensive maintenance and troubleshooting tasks for servicing the Air Fx. If additional diagrams or parts lists are required, please contact Micromedical Technologies for assistance. Caution All personnel who operate the Air Fx should familiarize themselves with the contents of this manual prior to using the irrigator with a patient. Additional training can be requested via Micromedical Technologies or one of its representatives.

System Configuration The Air Fx can be used as a standalone device or in conjunction with the Micromedical VisualEyes™ VNG system during caloric testing. The irrigator uses a USB HID driver provided with Windows® for communicating with Micromedical VisualEyes™ VNG software.

Maintenance The Air Fx requires periodic maintenance. Basic troubleshooting information is provided in this manual. Additional troubleshooting information appropriate for biomedical technicians is available in the service manual. If service is required, please contact Micromedical Technologies or your local Micromedical Technologies distributor. Do not attempt to repair the unit yourself.

Air Fx Service Manual, Doc. No. 19, Rev 9

Packing List

Packing List Examine Packaging and Device In the case of shipping damage, immediately advise the carrier of the damages and keep the packaging as proof. Important Save all packaging in the event of shipping the Air Fx back to Micromedical. Open the package and examine the contents. In the event of any device damage or missing components, please contact Micromedical Technologies.

Packing List (typical) Qty

Designation

Air Fx

60cc syringe and tube

Power cord IEC 10 Amperes

USB Cable, 3m (9.8ft)

1 pack

Speculum Ø 2.75 mm

Software CD (standalone unit)

1 pack

Speculum Ø 4.25 mm

User’s Manual

Qty

Designation

Air Fx Service Manual, Doc. No. 19, Rev 9

Panel Diagrams

Figure 1 Front Panel Diagram

A B C D E F G

Specifies Warm Irrigation to be performed / returns to standby state Specifies Cool Irrigation to be performed / returns to standby state Adjust temperature set point up 1°C Adjust temperature set point down 1°C Handle support Hose connection LCD output screen

D E F G H I Figure 2 Rear Panel Diagram

A B C D E

Exhaust fan Air Inlet Filter USB B Connector Power Switch Fill / Drain Valve

F G H I

Fuses Ground Screw AC Input Fill / Drain Water Outlet

Air Fx Service Manual, Doc. No. 19, Rev 9

Preventative Maintenance

Irrigator Preparation Filling the Water Reservoir Do not turn on the irrigator or attach the power cord. The Air Fx will be shipped from the Micromedical factory without any distilled water in the reservoir. Caution The Air Fx cannot be used without adequate distilled water present in the water reservoir. The distilled water must be added and the pump primed before applying power. Failure to maintain the proper level of distilled water can result in an inability to attain the preset cool temperature and a resultant error message on the display. Running the unit with insufficient water in the reservoir may also damage the coolant pump. Misuse is not covered under warranty. Be careful that the power is turned off and that you do not spill the water on the IP0 cabinet when you refill the irrigator reservoir. Caution The irrigator electronics may be damaged and an electrical risk will be present if water enters the irrigator cabinet. Always turn off AC power to the irrigator and remove the power cord from the back of the irrigator before attaching the water tubes to the back panel. Dry any drops of water that are present on the irrigator cabinet. If water enters the irrigator cabinet, do not turn on the AC power. Contact Micromedical service. Step by Step Fill Instructions: 1. Check that the irrigator is powered OFF. 2. Unscrew the cap to the water reservoir on the top of the irrigator by turning counter-clockwise with one hand. Do not force the cap or use mechanical tools to remove the cap. 3. Fill the reservoir with distilled water up to 1cm from the bottom of the threads. Take care not to spill any water into the unit except into the water reservoir to prevent damage to the circuitry and prevent any electrical shock to the user. If any water is spilled, wipe it up immediately. 4. Purge air from the hoses, pump and handle by connecting the included 60cc syringe & tube to the Fill / Drain Water Outlet (see Figure 2). Fully push the tube into the Fill / Drain Water push-in connector (about 1” (2cm) of tubing). Gently pull on the tubing to confirm the tube is secure. 5. Switch the Fill / Drain Valve to the Fill / Drain position. 6. Draw back the syringe to draw the air out of the internal tubing and draw distilled water into the syringe. 7. Set the Fill / Drain Valve to the Run position. 8. Disconnect the syringe from the tube and squirt any distilled water drawn back into the reservoir. 9. Reconnect the syringe to the tube. 10. Repeat steps 5 to 8 to draw the air out again. Repeat this drawing process until all of the air is removed from the internal lines, leaving only distilled water drawn into the syringe. Draw at least 2 full syringes of distilled water and squirt the water back into the reservoir. 11. Set the Fill / Drain Valve to the Run position. 12. Disconnect the syringe. The tube can be removed by pushing on the sides of the tubing connector’s gray collar around the tubing while simultaneously pulling on the tubing. 13. Screw the cap back on the water reservoir. 14. Attach the AC power cord to the back of the irrigator and switch on the Air Fx using the power switch next to the power cord. Water will automatically be pumped through the hoses into the handle and returned to the reservoir. .

Air Fx Service Manual, Doc. No. 19, Rev 9

Preventative Maintenance

15. Test system by running irrigator to 50 °C and then back down to 20°. If the irrigator is able to do this then it is ready to use. If the irrigator is unable to get to 50°C and 20°C repeat steps 3 through 11 and call Micromedical if there is any issue.

Air Fx Stand-alone Operation The Air Fx irrigator can operate as a stand-alone unit without connection to a VNG system. You will select the irrigation temperature from the irrigator front panel and when the irrigation temperature has been reached you can start the irrigation timer and start the VNG recording using two separate start controls.

Using Air Fx with Micromedical VisualEyes VNG Power on and connect the Air Fx to the Micromedical VisualEyes™ VNG via the supplied USB cable. The Micromedical VisualEyes™ VNG software will need to be configured to communicate with the Air Fx irrigator. Refer to the Micromedical VisualEyes™ VNG user’s manual for instructions. Caution For protection against electrical shock: Do not place the AC power cord on the floor where it may be damaged by rolling wheels or pinched. Protect the power cord by placing the cord behind the irrigator and away from harm. Plus, always use a grounded AC power cord with a grounded AC power outlet. Never use a 2-wire power extension cord.

Attaching the Speculum Caution Each speculum is single use only and must be replaced for each new patient. In order to use the Air Fx, you have to use a speculum on the tip of the otoscope head. Micromedical recommends the use of 2.75mm diameter specula to better deliver the air to the tympanic membrane. The 4.25mm speculum can be used to view the ear canal and tympanic membrane when looking for any ear wax build-up and to identify the course of the ear canal. To assemble a speculum on the ear tip of the handle, you have to insert it on the tip of the otoscope and turn it clockwise approximately 45°. A small plastic tip will be locked in the metal part of the head and will fix the speculum on the handle. Pull gently on the speculum to verify it is secure.

Figure 3 Place Speculum on Otoscope Head

Figure 4 Turn Speculum Clockwise to Lock, Pull Gently on Speculum to Verify It’s Secure

Specula are latex free and silicone free. Be aware not to put too much torque on the speculum or you will break the plastic nub on the inside of the speculum, preventing the speculum from securing to the handle. Once this tip is broken, the speculum cannot be secured again on the handle. The speculum is removed from the handle by first turning the speculum counterclockwise to unlock. The speculum must be tight to prevent air leaks. © 1/5/2016 by Micromedical Technologies

Air Fx Service Manual, Doc. No. 19, Rev 9

Preventative Maintenance

Turn On the Irrigator If the Air Fx irrigator is used in conjunction with the Micromedical VisualEyes™ VNG then connect the USB cable to the VNG computer, otherwise leave the USB cable disconnected. Turn on the power switch on the back panel. The Air Fx irrigator will initialize, show the firmware version, and then go into the standby state.

Select Cool / Warm Air Fx v1.4 Turn Off the Irrigator The Air Fx irrigator will go into standby mode after ten minutes has elapsed or the irrigation temperature selection button is pressed twice. If the Air Fx irrigator is used in conjunction with the Micromedical VisualEyes™ VNG then the software will send the Air Fx into standby mode at the end of the test. When the Air Fx is in the standby mode, it is safe to turn off the power switch on the back panel.

Air Fx Service Manual, Doc. No. 19, Rev 9

Preventative Maintenance

Preventative Maintenance Caution Do not use a tool to clean out the otoscope air outlet because a fragile temperature sensor is in the tip. Contact the factory if a blockage is detected.

After Each Patient Wipe the outside of the otoscope head and replace the single use speculum after each patient.

Weekly Maintenance Inspect and clean the cabinet, hose and otoscope with a non-alcohol based anti-bacterial cleaning solution.

Annual Maintenance Filter Cleaning Check the exhaust fan filter for debris or dust. The filter can be removed and cleaned after turning off power to the irrigator and detaching the plastic retaining bracket on the exhaust fan. Check the air inlet filter for debris or dust. Remove the grommet and tubing using a pair of needle-nosed pliers. Blow out debris with a can of compressed air. Contact Micromedical Technologies for replacement air filters.

Irrigator Cleaning Annually the Air Fx irrigator should be cleaned to remove any biofilm and mineral deposits. The Annual Cleaning Procedure outlined in the Appendix must be performed by a qualified service technician.

Annual Irrigation Temperature Check Important An RTD temperature meter Is needed to check the temperature of the output air. To verify accuracy of irrigation air temperature, place the small RTD temperature sensor in center of air stream at speculum exit. Set irrigator to cool and when irrigator display reads READY, record temperature of air stream. Repeat by setting irrigator to warm and when READY read air stream temperature. Caution If air stream temperature is not within 1C of displayed temperature, then return unit to Micromedical Technologies for calibration.

Air Fx Service Manual, Doc. No. 19, Rev 9

Preventative Maintenance

Annual Irrigation Flow Rate Check Important An Air Flow Meter is needed to check the flow rate of the output air. Contact Micromedical for a flow meter. To verify air flow rate, insert otoscope speculum into flow meter orifice. Air flow rate should be between 8 and 12 l/m and remain steady. If air flow is outside this range or fluctuates more than +/- 1 l/m, check for air leaks around speculum or flow meter orifice. Caution If air flow rate is not within specifications, then return unit to Micromedical Technologies for calibration.

Air Fx Service Manual, Doc. No. 19, Rev 9

Cabinet Disassembly

Cabinet Disassembly Make sure the water reservoir cap is on and the power cable is disconnected from the back of the irrigator. Turn the irrigator on a side. Remove the four Phillips screws circled in red.

Turn the irrigator over back on its feet. On the back panel remove the five Phillips pan head screws circled in red. Do not remove the screw in the bottom center.

Air Fx Service Manual, Doc. No. 19, Rev 9

Cabinet Disassembly

On the front panel remove the four Phillips screws.

Tip the front panel forward.

Remove the four Phillips flat head screws circled in red. Slide the blue bezel over the front panel and hose assembly. Use a little bit of soapy water or lens cleaner around the seal of the reservoir in order to lift the cabinet off the base without removing the screw lid of the reservoir. After removing the cabinet cover, replace the water reservoir lid to prevent accidental spilling of the distilled water. Reverse this process to reassemble the cabinet.

Air Fx Service Manual, Doc. No. 19, Rev 9

Cabinet Disassembly

Figure 5 Internal components of the Air Fx Air Irrigator

Once the irrigator has been opened, the power cable can be restored to the back of the irrigator for testing the components.

Air Fx Service Manual, Doc. No. 19, Rev 9

Troubleshooting

Troubleshooting Caution If you see water leaking from inside the irrigator case or from the quick disconnect couplings on the back– do not operate the irrigator. Power off the unit and push in on all tube connections first. If that doesn’t stop the leak open the irrigator cabinet and check internal tube connections.

Tools Needed Basic Troubleshooting: Air temperature RTD probe (reading from 20C to 50C accuracy 0.1C) Disposable 60cc syringe with tube Two 1/8” flat head screw drivers Digital Volt-Ohm meter Flow meter Advanced Troubleshooting by qualified biomedical electronic technicians Allen wrenches: 1/16” Sharp scissors Phillips screw drivers: Sizes 0, 1, and 2 Heat shrink gun

Irrigator display messages The following table shows the irrigator display messages requiring user attention (v1.4 Firmware) Irrigator Display Select Cool/Warm Air Fx v1.4 Select Cool/Warm

Reason Initial power up display

Select Cool/Warm Irrig. Timeout Call TechSupport Over Temp Error

Standby display, after irrigator timeout error during Cool or Warm irrigation loops (typical 10 min). Safety temperature sensor in the irrigator handle (water side) is reading out of range during Cool/Warm irrigation loops. Check Symptom list below for further troubleshooting. Main air temperature sensor in the irrigator handle is reading out of range during Cool/Warm irrigation loops. Check Symptom list below for further troubleshooting. Irrigator did not reach desired set point within the programmed “Time to Temp” setting (typical 3 min). Both main temperature sensor and over temp sensor are reading temperature over 55°C. Either the sensors are defective or the irrigator is operating outside temperature range. Both main temperature sensor and over temp sensor are reading temperature below 10°C. Either the sensors are defective or the irrigator is operating outside temperature range.

Call TechSupport Air Temp Error Call TechSupport Time Limit Error Select Cool/Warm Device Too Warm Select Cool/Warm Device Too Cold

Standby display, waiting for user action

Air Fx Service Manual, Doc. No. 19, Rev 9

Troubleshooting

Irrigator Inoperative on Power Up The LCD Display does not display any text, and the blue LEDs for the front panel buttons do not come on. There is no beep made when the irrigator powers up.

Basic Troubleshooting  Check the switch on the Back panel. Make sure that the power cord is plugged in all the way both at the irrigator and the wall outlet. Turn on power switch at power entry. Check that there is AC voltage at wall outlet by plugging in another device. If AC Mains power is available, check the two fuses in the irrigator power entry. Use the two small flat tip screw drivers to push in on the tabs on each side of the fuse holder. Once tabs are pushed in pull out on the fuse holder drawer. If fuses are blown replace them (might need the digital volt meter to ohm out the fuse to see if they are good). Check the back panel label for correct fuse size and rating.  Before powering up check for cause of the fuse blowout – any shorts, internal damage etc.

Advanced Troubleshooting If the fuse blows again, remove the power cord, open the irrigator cabinet. Disconnect the air pump and PS1 power supply to determine if these devices are causing the excessive current. Using an ohm meter, check AC Hi to AC Lo to make sure there is no short circuit. Plug in Power supply AC side and apply AC power to circuit. Check if irrigator LCD display or blue LEDs light in pushbuttons come on. If no, then check +12vdc at power supply output. If dc voltage is present, follow dc power to other devices. Fan at rear of cabinet is powered by 12vdc. Plug in air pump. Pump will not run until cool or warm is selected. To bypass solid state relay in order to check air pump, move BLK wire on AC HI side of solid state relay to the AC LO BLK terminal and apply AC power. Move BLK wire back to original location.

Check dc voltages on front circuit board.

Air Fx Service Manual, Doc. No. 19, Rev 9

Troubleshooting

Irrigator Will Not Achieve Cool Temperature The irrigator will not achieve the cool temperature and will not display READY or may give an “OverTemp Error” message. Warm temperature can be achieved.

Basic Troubleshooting Draw out air bubbles per the fill and drain instructions. If the irrigator still will not cool after drawing out air bubbles, check to see if the water pump is running. Turn power to the irrigator off. Insert a piece of plastic tubing in the fill/drain connector on the back panel. Take the lid off the top water reservoir. Make sure there is water in the reservoir. Turn the fill/drain valve on the back panel down. Hold the plastic tubing so water from the pump will flow through the tubing into the reservoir. Turn on the irrigator AC power. Watch for water flowing from the tube into the reservoir indicating that the water pump is working and that the tubing is not clogged. The flow of water should never be described as a drip. If the water is dripping out of the tube there is a clog in the water system.

Advanced Troubleshooting Check the Water Line Filter for clogs by removing the irrigator Front panel as shown in the Cabinet Disassembly instructions. If the filter needs to be replaced you will need to open the entire cabinet. Contact Micromedical Technologies for replacement parts.

Figure 6 Water Line Filter

If there is no water coming out of the tube, then water pump might not be running/working. If the pump is not running check the 12vdc power connection to the pump at P3. If the power is there and the water pump is not running then contact Micromedical Technologies about replacing the water pump.

Air Fx Service Manual, Doc. No. 19, Rev 9

Troubleshooting

Low Airflow Less than 8 LPM Basic Troubleshooting To verify air flow rate, insert otoscope speculum into flow meter orifice. Air flow rate should read 8-12 l/m and remain steady. If air flow is not within this range or steady, check for air leaks around speculum or flow meter orifice.

Advanced Troubleshooting Tighten both screws on the lens of the otoscope lens. Measure the flow rate again. If the results are still low, disconnect the clear air intake tube on the front right barb fitting of the air pump. Caution Do not run the irrigator for very long without the air pump attached, this might cause over heating in the Otoscope handle. Use clear tubing with the white barb fitting on one end. Connect the clear tube to the front right barb fitting of the Air Supply Port (air pump output). Connect the other end of the tube to the flow meter. The air pump is working if the reading is 14 LPM or greater. If the reading is less, then contact Micromedical to send the irrigator in for a replacement air pump and recalibration.

Connect a small piece of clear tubing between this barb fitting and air flow meter to check air flow output.

Figure 7 Air Supply Port

USB Connection Problems Basic Troubleshooting Disconnect the USB cable from the irrigator. Listen for the ding dong sound. Make sure that the volume on your computer is turned on and turn up. Use another USB cable (such as the USB printer cable) to check if the irrigator USB cable is at fault. Connect the USB cable to another USB port and listen for the ding dong sound indicating successful connection.

Advanced Troubleshooting Disconnect the USB cable from the PCB Board and plug the external USB cable to the USB connector on the PCB Board directly. If the irrigator makes a connection to the computer, then contact Micromedical for a replacement USB cable for the irrigator. If there is still a connection error, please contact Micromedical for further diagnosis. The irrigator can be reset due to static discharge, so make sure the irrigator’s operating environment is ESD free. Figure 8 Control PCB USB Cable

Air Fx Service Manual, Doc. No. 19, Rev 9

Troubleshooting

Air Pump Not Heard When Warm or Cool Is Selected Advanced Troubleshooting Check the white AC Power connector on the top of the air pump. Make sure the connection is tight (many models have the power connector cable-tied). Check the AC voltage at the white connector (probes should be able to squeeze into the back of the power connector without having to break the cable tie). If there is 120 or 240 VAC at the connector but the pump is not running, then the air pump will have to be replaced. Contact Micromedical to send the irrigator in for a replacement air pump and recalibration.

Figure 9 Air Pump Power

Irrigator Display Reads “Air Temp Error” Basic Troubleshooting Make sure the handle or the hose assembly is not damaged.

Advanced Troubleshooting Check for +12V voltage on the RTD Puck (pin2). Check resistance of RTD signal wires. The nominal RTD signal at 30C is 1.5V (P6-1, RTD puck pin1)

Figure 10 RTD Puck Pins (L to R - 6 5 4)

Figure 11 RTD Puck Pins (L to R - 1 2 3)

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