EN-US English Cochlear™ Osia® 2 Sound Processor User manual 1
This guide is intended for recipients and caregivers using the Cochlear™ Osia® 2 Sound Processor as part of the Cochlear Osia System. Intended use The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. The Osia Sound Processor is intended to be used as part of the Cochlear Osia System to pick up surrounding sound and transfer it to the implant through a digital inductive link.
Contraindications • Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant • Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by good clinical judgement • Abnormally progressive hearing loss • Evidence that hearing loss is bilateral retrocochlear or bilateral central origin • Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgme
Contents Intended use.............................................................................................................. 2 Indications.................................................................................................................. 2 Contraindications..................................................................................................... 3 Symbols used in this guide.................................................................................... 3 Overview.......
Troubleshooting.................................................................................... 24 Cautions..................................................................................................26 Warnings.................................................................................................26 For parents and caregivers..................................................................................26 Processors and parts.............................................................
Overview THIS WAY UP Indicator light Control button Front Microphone ports Cover Back Battery door 6 Attachment holes for Safety line
Use Turn on and off Turn on your sound processor by completely closing the battery door. (A) Turn off your sound processor by gently opening the battery door until you feel the first “click.” (B) A B If enabled, and attached to the implant, audio signals will let you know that the device is starting up. Change programs You can choose between programs to change the way your sound processor deals with sound.
To change programs, press and release the button on your sound processor. If enabled, audio and visual signals will let you know which program you are using. • Program 1: 1 beep, 1 orange flash • Program 2: 2 beeps, 2 orange flashes • Program 3: 3 beeps, 3 orange flashes • Program 4: 4 beeps, 4 orange flashes NOTE You will only hear the audio signal if you are wearing your sound processor. Adjust volume Your hearing care professorial has set the volume level for your sound processor.
Power Batteries The Osia 2 Sound Processor uses a high power 675 (PR44) zinc air disposable battery designed for hearing implant use. CAUTION If a standard 675 battery is used the device will not function. Battery life Batteries should be replaced as needed, just as you would with any other electronic device. Battery life varies according to your implant type, the thickness of skin covering your implant, and which programs you use each day.
Change the battery 1. Hold the sound processor with the front facing you. 2. Open the battery door until it is completely open. (A) 3. Remove the old battery. Dispose of the battery according to local regulations. (B) 4. Remove the sticker on the + side of the new battery and let it stand for a few seconds. 5. Insert the new battery with the + sign facing upwards in the battery door. (C) 6. Gently close the battery door.
Lock and unlock the battery door You can lock the battery door to prevent it from opening accidentally (tamper-proof). This is recommended when the sound processor is being used by a child. To lock the battery door, close the battery door and place the Tamperproof tool into the battery door slot. Slide the locking pin up into place. To unlock the battery door, place the Tamperproof tool into the battery door slot. Slide the locking pin down into place. WARNING Batteries can be harmful if swallowed.
Wear Wear your sound processor Place the processor on your implant with the button/light facing up and battery door facing down. CAUTION It is important to position your processor correctly. Correct positioning enables its best performance. For users with two implants Ask your hearing care professional to mark your sound processors with coloured stickers (red for right, blue for left) to make identifying left and right processors easier.
Attach a Cochlear SoftWear™ Pad The Cochlear SoftWear Pad is optional. If you experience discomfort when wearing your processor, you can attach this adhesive pad to the back of your processor. NOTE You may need a stronger magnet and new feedback calibration measurement after attaching the Cochlear SoftWear Pad. Please contact your hearing care professional if you experience poor sound or magnet retention.
Attach a Safety Line To reduce the risk of losing your processor, you can attach a Safety Line that clips onto your clothing or hair: A B 1. Pinch the loop on the end of the line between your finger and thumb. (A) 2. Pass the loop through the attachment hole in the sound processor from front to back. (B) 3. Pass the clip through the loop and pull the line tight. (B) 4. Attach the clip to your clothing or hair depending on the Safety Line design.
To attach the Safety Line to your hair use the below clip. 1. Press up on the ends to open the clip. (A) 2. With the teeth facing up and against your hair, push the clip up into your hair. (B) 3. Press down on the ends to close the clip. (C) 4. Place your processor on your implant. A B C Wear the headband The Cochlear Headband is an optional accessory that holds the processor in place on your implant. This accessory is useful for children or when performing physical activities.
VELCRO LEFT PROCESSOR POCKET ANTI-SLIP (for forehead) RIGHT VELCRO PROCESSOR POCKET 1. Open the headband and lay it flat on a table with the anti-slip facing up and the pockets facing away from you. 2. Pull the pocket lining out. (A) 3. Insert your processor in the correct pocket. (B) • Place the left processor in the left-side pocket, the right processor in the right-side pocket. • Ensure the top of the processor is at the top of the pocket.
Change the cover To remove the cover: 1. Open the battery door. (A) 2. Press and lift to remove the cover. (B) A B To attach the cover: 1. Place the cover over the front part of the sound processor base unit. The button should be aligned with the cover opening. 2. Press down on the cover around the button until you feel a “click” on both sides of the button. (A) 3. Press down on the cover between microphone ports until you feel a “click”. (B) 4. Close the battery door.
A B C D Flight mode When boarding a flight, wireless functionality must be deactivated because radio signals must not be transmitted during flights. To activate flight mode: 1. Turn off your sound processor by opening the battery door. 2. Press the button and close the battery door at the same time. 3. If enabled, audio and visual signals will confirm that flight mode is activated (see Audio and visual indicators, page 21).
Wireless accessories You can use Cochlear Wireless accessories to enhance your listening experience. To learn more about the options available, ask your hearing care professional or visit www.cochlear.com. To pair your sound processor to a wireless accessory: 1. Press the pairing button on your wireless accessory. 2. Turn off your sound processor by opening the battery door. 3. Turn on your sound processor by closing the battery door. 4.
Care Regular care CAUTIONS Do not use cleaning agents or alcohol to clean your processor. Turn your processor off before cleaning or performing maintenance. Your sound processor is a delicate electronic device. Follow these guidelines to keep it in proper working order: • Turn off and store the sound processor away from dust and dirt. • Avoid exposing your sound processor to extreme temperatures.
• If the sound processor gets wet or is exposed to a very humid environment, dry it with a soft cloth, remove the battery and let the processor dry out before inserting a new one. • If sand or dirt enters the processor, try to remove it carefully. Do not brush or wipe in the indents or holes of the casing. Audio and visual indicators Audio signals Your hearing care professional can set up your processor so you can hear the following audio signals.
Wireless signals Beeps and melodies What it means Wireless Accessory pairing confirmation. Ripple tone in upward melody Wireless streaming activated. Ripple tone upward melody 2 × ripple tone downward melody End wireless streaming due to low battery voltage and return to program. MFi pairing confirmation.
Visual signals Your hearing care professional can set up your processor to show the following light indications. General signals Light What it means Green flashes No implant or wrong implant detected When connection to implant is successfull steady green light will be seen for 5 s. Steady green Start up in Flight Mode. 4 x dual flashes Change program. Number of flashes indicates the number of the current program. 1-4 flashes Volume level increased/ decreased by one step.
Troubleshooting Contact your hearing care professional if you have any concerns regarding the operation or safety of your sound processor. Processor will not turn on 1. Try turning the processor on again. See Turn on and off, page 7. 2. R eplace the battery. See Change the battery, page 10. 3. I f you have two implants, check that you are wearing the correct sound processor on each implant, see page 12. 4. If the problem continues, contact your hearing care professional. The processor switches off 1.
You do not hear sound or sound is intermittent 1. Try a different program. See Change programs, page 7. 2. R eplace the battery. See Change the battery, page 10. 3. M ake sure the sound processor is properly oriented on your head, see Wear your sound processor, page 12. 4. If the problem continues, contact your hearing care professional. Sound is too loud or uncomfortable 1. If turning down the volume does not work, contact you hearing care professional. Sound is too quiet or muffled 1.
Cautions Young children who are developing motor skills are at greater risk of an impact to the head from a hard object (e.g. table or chair). Impact to the sound processor may cause damage to the processor or its parts. Impact to the head in the area of the implant could damage the implant and result in its failure. Warnings For parents and caregivers • Removable parts of the system (batteries, magnets, battery door, safety line) can be lost or may be a choking or strangulation hazard.
Processors and parts • Each processor is programmed specifically for each implant. Never wear another person’s processor or lend yours to another person. • Use your Osia System only with approved devices and accessories. • If you experience a significant change in performance, remove your processor and contact your hearing care professional. • Your processor and other parts of the system contain complex electronic parts. These parts are durable but must be treated with care.
• Your device contains magnets that should be kept away from life supporting devices (e.g. cardiac pacemakers and ICDs (implantable cardioverter defibrillators) and magnetic ventricular shunts), as the magnets may affect the function of these devices. Keep your processor at least 15 cm (6 in) from such devices. Contact the manufacturer of the specific device to find out more. • Your sound processor radiates electromagnetic energy that may interfere with life supporting devices (e.g.
• Magnetic fields that are very close to an Osia implant can affect the operation of the implant. These magnetic fields can be created by magnets that are stronger than the Osia Sound Processor coil magnets.If you stop hearing and suspect that you have a strong magnetic field close to the location of the Osia implant, move away from the source of the magnetic field. Hearing will then return. If the problem continues, contact your clinician or a Cochlear representative.
Medical treatments MR Magnetic Resonance Imaging (MRI) • The Osia 2 Sound Processor, remote and related accessories are MR Unsafe. • The Osia implant is MRI conditional. For full MRI safety information refer to the information supplied with the system, or contact your regional Cochlear office (contact numbers available at the end of this document). • If the patient is implanted with other implants, consult the manufacturer’s instructions before performing MRI.
Materials • Sound processor enclosure: PA12 (Polyamide 12) • Magnet housing: ABS (Acrylonitrile butadiene styrene) • Magnets: Gold coated Environmental conditions Condition Minimum Maximum Storage & transport temperature -10°C (14°F) +55°C (131°F) Storage & transport humidity 0% RH 90% RH Operating temperature +5°C (41°F) +40°C (104°F) Operating relative humidity 0% RH 90% RH Operating pressure 700 hPa 1060 hPa Product dimensions (Typical values) Component Length Width Depth Osia 2 pr
Operating characteristics Characteristic Value/Range Sound input frequency range 100 Hz to 8 kHz Sound output frequency range 250 Hz to 6 kHz Wireless technology Proprietary low power bidirectional wireless link (wireless accessories) Published commercial wireless protocol (Bluetooth Low Energy) Operating frequency communication to implant 5 MHz Operating frequency RF (radio frequency) transmission 2.4 GHz Max. RF output power -3.85 dBm Operating voltage 1.05 V to 1.
Wireless communication link The wireless communication link operates in the 2.4 GHz ISM band using GFSK (Gaussian frequency-shift keying), and a proprietary bidirectional communication protocol. It continuously switches between channels to avoid interference on any specific channel. Bluetooth Low Energy also operates in the 2.4 GHz ISM band, using frequency hopping over 37 channels to combat interference.
Electromagnetic compatiblity (EMC) Guidance and manufacturer’s declaration – electromagnetic emissions The Osia Sound Processor is intended for use in the electromagnetic environment specified below. The customer or the user of the Osia Sound Processor should assure that it is used in such an environment. Emission test Compliance Group 1 The Osia Sound Processor uses RF energy only for its internal function.
Guidance and manufacturer’s declaration – electromagnetic immunity The Osia Sound Processor is intended for use in the electromagnetic environment specified below. The customer or the user of the Osia Sound Processor should assure that it is used in such an environment Immunity test Compliance level Electromagnetic environment – Guidance Electrostatic discharge (ESD) +/- 8 kV contact IEC 61000-4-2 +/-15 kV air Floors should be wood, concrete or ceramic tile.
Electromagnetic environment – Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Osia Sound Processor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. IMMUNITY TEST: Conducted RF IEC 61000-4-6 COMPLIANCE LEVEL: 3 Vrms 0.15 to 80 MHz; 6 Vrms in ISM 0.15 to 80 MHz Recommended separation distance d=1.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 3: If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Osia Sound Processor. Radio Frequency Identification (RFID) RFID uses electromagnetic fields to automatically identify and track tags attached to objects.
Operation is subject to the following two conditions: • This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by Cochlear Limited may void the FCC authorization to operate this equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
FCC ID: QZ3OSIA2 IC: 8039C-OSIA2 CAN ICES-3 (B)/NMB-3(B) HVIN: OSIA2 PMN: Cochlear Osia 2 Sound Processor The model is a radio transmitter and receiver. It is designed not to exceed the emission limits for exposure to radio frequency (RF) energy set by the FCC and ISED.
Product order overview The below items are available as accessories and spare parts for the Osia 2 Sound Processor. NOTE Items that are named Nucleus® or Baha® are also compatible with the Osia 2 Sound Processor.
Product Code Product Battery B454122 Power One Implant Plus P675, Mercury Free - 6 Pcs Cochlear SoftWear Pad P793406 SoftWear Pads - 20 Pads Cochlear Wireless accessories P770843 Cochlear Wireless Mini Microphone 2, AUS P770842 Cochlear Wireless Mini Microphone 2, EU P770841 Cochlear Wireless Mini Microphone 2, GB P770844 Cochlear Wireless Mini Microphone 2, US P770847 Cochlear Wireless Mini Microphone 2+, AUS P770846 Cochlear Wireless Mini Microphone 2+, EU P770845 Cochlear Wireless Mini M
Key to symbols The following symbols may appear on your processor or remote components and/or packaging: Refer to instruction manual Date of manufacture Manufacturer Temperature limits Catalogue number Serial number IP52 MR MRI unsafe Authorised representative in the European Community This device restricted to sale by or on the order of a physician.
Radio symbols FCC ID: QZ3OSIA2 USA product label requirements IC: 8039C-OSIA2 Canada product label requirements Australia/New Zealand label requirements 43
Cochlear Ltd (ABN 96 002 618 073) 1 University Avenue, Macquarie University, NSW 2109, Australia Tel: +61 2 9428 6555 Fax: +61 2 9428 6352 Cochlear Ltd (ABN 96 002 618 073) 14 Mars Road, Lane Cove, NSW 2066, Australia Tel: +61 2 9428 6555 Fax: +61 2 9428 6352 Cochlear Deutschland GmbH & Co.
