USER INSTRUCTIONS THE CLEAR™440 SERIES C4-m/C4-m-CB model Behind-the-ear
YOUR WIDEX CLEAR™440 HEARING AID (To be filled out by the hearing care professional) Date: _____________________________ Battery size: _____________________________ 2
CONTENTS SYMBOLS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 THE HEARING AID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Right/left identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 The battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Inserting the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Removing the battery . . . . . . . . . . . . . . . . . . . . . . .
SYMBOLS The following symbols will be used throughout the manual: WARNING Messages with this heading indicate serious adverse reactions, potential safety hazards and inadequate performance of device. CAUTION Messages with this heading indicate/include information regarding any special care to be exercised. Non-ionizing radiation Not for general waste.
THE HEARING AID The illustration below shows the hearing aid without an ear-set. The choice of ear-set solution depends on your specific needs. Please refer to the separate ear-set user manual. 1. Microphone openings 2. On/off function 3. Nail grip 4.
NOTE In addition to these user instructions, a separate user manual is provided describing the various ear-set solutions available for your hearing aid: “Ear-sets for Widex BTE hearing aids” WARNING This booklet and the manual “Ear-sets for Widex BTE hearing aids” contain important information and instructions. Read these booklets carefully before you start using the hearing aid. NOTE Your hearing aid, ear-set and accessories may not look exactly as illustrated in this booklet.
They are to be programmed by licensed hearing healthcare professionals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing (re) habilitation as well as tinnitus management. Description of device Your CLEARTM hearing aid is used with an ear-set which consists of an earwire and an earpiece, in which the receiver is placed.
Right/left identification The arrow shows the position of the identification mark (red mark = right and blue mark = left). Acoustic indicators The hearing aid may be set to produce a signal to indicate the use of certain functions. The signal may be a spoken message or tones adjusted by the hearing care professional in consultation with you. The signal can also be deactivated.
The battery We recommend zinc-air batteries. Use a size 10 battery for the hearing aid. To obtain replacement batteries, please consult your hearing care professional. It is important to take note of the expiration date and the recommendations on the battery pack regarding disposal of used batteries. Otherwise there is a risk that the battery life may be reduced. Inserting the battery Before inserting a new battery into the hearing aid, remember to remove the adhesive tab.
Use the nail grip to gently swing the battery drawer open. Do not press the drawer beyond the open position. Place the battery in the drawer as illustrated, so that the plus (+) sign on the battery is facing towards you when you hold the hearing aid as shown. You can use the battery magnet provided to steer the battery into place. + If the battery drawer does not close easily, the battery is incorrectly inserted. When changing battery, it is a good idea to hold the hearing aid over a table.
Removing the battery 1. Open the battery drawer as previously described. Place the hearing aid on the provided cloth on a clean, plane surface and turn it as illustrated. 2. Supporting the drawer with your finger, use the battery magnet provided to push the battery out of the battery drawer from the minus side.
Battery drawer without a nail grip The hearing aid may be provided with a battery drawer without a nail grip, which means that you need a tool to open the battery drawer. This type of drawer can be a good choice if the hearing aid is worn by a child. A special tool for opening the drawer will be included with this drawer. The battery drawer is opened as illustrated.
Low battery indication An acoustic indicator will sound when the battery is nearly exhausted, unless this function has been disabled (see page 8). We recommend that you always have a spare battery with you. WARNING Never leave an exhausted battery in the hearing aid. Exhausted batteries may leak, damaging the hearing aid. WARNING Your hearing aid may stop functioning, for instance if the battery is exhausted.
Turning the hearing aid on and off The battery drawer of the hearing aid also functions as the on/off switch. Close the battery drawer to turn on the hearing aid. An acoustic indicator will indicate that the hearing aid has been switched on unless this function has been disabled. Open the battery drawer to turn off the hearing aid. Please remember to turn off the hearing aid when it is not in use. Remove the battery if the hearing aid will not be used for several days.
Positioning the hearing aid Insert the earpiece in the ear canal while holding the lower part of the tube. It may help to pull the outer ear backwards and upwards with the opposite hand. Place the hearing aid behind the ear, so that the hearing aid and tube rest comfortably on the ear, close to your head. The illustrations show an open ear-tip. For further information on ear-tip/earmold types, anchors and procedures, see the separate ear-set user manual provided.
Removing the hearing aid Remove the hearing aid from its position behind the ear. Carefully pull the earpiece out of the ear canal, while holding the lower part of the earwire. If the earpiece is provided with an extraction cord, take hold of this and carefully pull the ear-tip out of the ear canal.
Volume adjustment The hearing aid volume is adjusted automatically in accordance with your sound environment. If you have a remote control, you can also adjust the volume manually or mute your hearing aid. Any adjustment of the volume setting will be cancelled when your hearing aid is turned off, or when you change program. In the default setting, any volume adjustment via the remote control will affect both hearing aids.
Lost partner alarm (Note: Only applicable if this feature has been activated by your hearing care professional). If one of your hearing aids falls off your ear, and/or the battery is exhausted, a tone signal and a spoken message will sound two times in the other hearing aid, and a diode will flash on both hearing aids. When the lost hearing aid is repositioned, and/or the battery is exchanged, the diodes stop flashing.
Listening programs By default, your hearing aid has one listening program. If you have a remote control, your hearing aid may be provided with five of the following programs, plus the special Zen program called Zen+. Please also refer to the user instructions for your remote control.
If your needs change over time, the combination of listening programs can be altered. Zen program Your hearing aid may be provided with a unique optional listening program called Zen. It makes musical tones (and sometimes a rushing noise) in the background using the latest in Fractal technology. These sounds are shaped according to your hearing loss so you can listen to them at any time and at any place with a simple push of the program button.
CAUTION If you perceive decrease in loudness, tolerance of sounds, speech not as clear, or worsening tinnitus, contact your hearing care professional. The duration of the Zen play time can be set by your hearing care professional according to your needs. Benefits The Zen program may provide a relaxing listening background for some people. When the Zen program is used in a tinnitus management program, its wearer may experience some relief from tinnitus.
Directions for use The Zen program can be activated with a simple push of the program button on the hearing aid (or on the remote control). Depending on how your Hearing Healthcare Professional has set up the program, you can access the Zen program by a “short-press” of the program button or a “long-press” of the program button. • “Short-Press” option – the program button is pressed for less than a second. At most two listening programs can be programmed for Zen.
Precautions To ensure the safety and effectiveness of the Zen program when used as a sound therapy tool for tinnitus, the tinnitus management program must be designed and conducted by Hearing Healthcare Professionals who are trained in tinnitus management. A tinnitus management program should include a complete audiological evaluation, tinnitus diagnosis, counseling, use of proper amplification and/or sound therapy tools.
Risks There are no known risks or side effects associated with the use of the Zen program.
Switching between the listening programs Each time you change program via the remote control, an acoustic indicator will sound unless this function has been disabled. Program 1: Program 2: Program 3: Program 4: Program 5: Zen+: Message or one short beep Message or two short beeps Message or three short beeps Message or one long and one short beep Message or one long and two short beeps Message or tone In the default setting, both your hearing aids will be affected when you change programs.
Using a telephone When using a telephone, we recommend that you hold the telephone against your head at an angle above your ear, rather than directly against the ear. If the sound is not optimal, try moving the telephone earpiece to a slightly different position.
CLEANING The following cleaning accessories are available for the hearing aid and ear-set *. For cleaning the ear-set, see the user manual “Ear-sets for Widex BTE hearing aids”. 1. Cloth 2. Wax removing tool 3. Cleaning thread Contact your hearing care professional if you need additional supplies of cleaning accessories.
The hearing aid Clean the hearing aid with the soft cloth after use. WARNING Never use water or cleaning solutions to clean the hearing aid, as this may cause it to malfunction. The microphone openings Clean the microphone openings by passing the wax removing tool straight through the openings. If you feel resistance, withdraw the tool and try again. Use only the wax removing tool provided.
ACCESSORIES RC-DEX A compact hearing aid remote control making it easy to adjust volume and change programs. For help in determining whether you could benefit from a remote control, please consult your hearing care professional.
IN CASE OF MALFUNCTION The following pages contain some quick advice on what to do if your hearing aid stops working or performs unsatisfactorily. If the problems persist, contact your hearing care professional for assistance. The advice relates only to the hearing aid. Also see the user manual “Ear-sets for Widex BTE hearing aids”.
Problem Possible cause Solution The hearing a. The RC-DEX is a. Move the RC-DEX aids do not used beyond the closer to the CLEAR respond with transmission hearing aids a correspondrange (> 1 m) ing change in b. Strong electrob. Move away from volume or magnetic interferknown source of EM program to ence in the vicininterference the RC-DEX ity c. The RC-DEX and c.
CARING FOR YOUR HEARING AID The hearing aid is a valuable object and should be treated with care. Here are some things you can do to prolong the life of your hearing aid: CAUTION • Turn off your hearing aid when it is not in use. Remove the battery if the hearing aid will not be used for several days. • When the hearing aid is not in use, keep it in its case in a cool, dry location out of reach of children and pets. • Do not expose the hearing aid to extreme temperatures or high humidity.
WARNINGS WARNING Hearing aids and batteries can be dangerous if swallowed or used improperly. Swallowing or improper use can result in severe injury or even fatalities. In case of ingestion, contact a physician immediately and the 24 Hour National Button Battery Ingestion Hotline at (202) 625-3333. • Keep hearing aids and their parts, accessories and batteries out of reach of children and anyone else who might swallow such items or otherwise cause injury to themselves.
WARNING • Risk of explosion if battery is replaced by an incorrect type or recharged. Dispose of used batteries according to the instructions. • Never allow others to wear your hearing aid, as this could cause permanent damage to their hearing. • When selecting a listening program, please remember that there are situations in which it is particularly important to be able to hear the surrounding sounds (e.g. traffic, warning signals). • The hearing aid is made of modern non-allergenic materials.
WARNING • Be aware that the use of any type of hearing aid may involve a slightly increased risk of infection in the ear canal. An infection can arise as a result of inadequate ventilation of the ear. We therefore recommend that you remove the hearing aid and ear-set from your ear at night to allow the ear canal to be ventilated. Make sure that you clean and inspect your hearing aid and ear-set as required.
CAUTION • Your hearing aid has been tested for interference according to international standards. Nevertheless, it is possible that unforeseen interference may occur in the hearing aid due to electromagnetic radiation from other products such as alarm systems, room surveillance equipment and mobile phones.
ADVICE NOTE • The hearing aid will not restore normal hearing and will not prevent or improve a hearing loss resulting from organic conditions. However, the hearing aid can help you to make the best possible use of your remaining hearing ability. You should also bear in mind that it can take time to get used to a new hearing aid and new sounds. • In most cases, using the hearing aid infrequently will not permit you to gain full benefit from it.
REGULATORY INFORMATION The following Table summarizes the technical details of the WidexLink technology as it is implemented in the CLEAR™ hearing aids. Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Antenna type Inductive antenna Inductive antenna Inductive antenna Embedded ceramic antenna Antenna dimensions Ø1.8 mm, Ø8 mm, Ø6 mm, L - 4.
Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Channel Single channel radio Single channel radio Single channel radio 5 logical channels Bandwidth 660 kHz (-15 dB) 660kHz (-15 dB) 660kHz (-15 dB) 1 MHz Data-rate 212 kbit/ second (raw channel capacity) 212 kbit/ second (raw channel capacity) 212 kbit/ 2.
(Benefits) The use of wireless transmission allows convenient and synchronized control of hearing aid functions. The CLEAR wireless hearing aids share input information between the two partner hearing aids. In so doing, the wearers would experience the following additional user benefits (only when wearing binaural CLEAR hearing aids). Synchronization of volume control settings between hearing aids – The volume in both hearing aids will change when the VC is adjusted on one ear.
(Contraindications): • Congenital or traumatic deformity of the ear • Active drainage from the ear within 90 days • History of rapid progressive hearing loss within previous 90 days • Acute or chronic dizziness • Sudden unilateral hearing loss in previous 90 days CAUTION (Risks) The use of the CLEAR/DEX should not interfere with other devices such as a pacemaker.
RADIO TRANSMITTER / CABLES / TRANSDUCERS The CLEAR™ series hearing aid contains a radio transmitter / receiver with the following Radio transmitter parameters: • Frequency (range): 10.6 MHz (10.2 – 11.
QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY IN THE WIDEXLINK SYSTEM WidexLink wireless technology enables communication between two partners of a binaural pair of CLEAR hearing aids and with their matched external devices. The requirements for the quality of service (QoS) vary among the various components and their intended user scenarios.
Wireless Security Measures Security of the wireless signals is assured through device system design that includes: • Individual MAC address for each unit which is checked during each transmission. • A built-in pairing table which specifies valid and legitimate pairing among units • A proprietary Widex communication protocol which checks the package numbers during each transmission. • A Cyclic Redundancy Check (CRC) to check data validity and correct errors.
GUIDANCE AND MANUFACTURER’S DECLARATION Electromagnetic emissions The CLEAR™ series hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of a CLEAR™ series hearing aid should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 2 The CLEAR™ hearing aid must emit electromagnetic energy in order to perform its intended function.
Electromagnetic immunity The CLEAR™ series hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of a CLEAR™ series hearing aid should assure that it is used in such an environment. Immunity Test IEC 60601 Test level Compliance level Electromagnetic environment – guidance Electrostatic ± 6 kV condischarge tact (ESD) ± 8 kV air IEC 61000-4-2 ± 6 kV contact Floors should be ± 8 kV air wood, concrete or ceramic tile.
Immunity Test IEC 60601 Test level Compliance level Electromagnetic environment – guidance Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.
Electromagnetic immunity – cont. The CLEAR™ series hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of a CLEAR™ series hearing aid should assure that it is used in such an environment.
Immunity Test IEC 60601 CompliElectromagnetic environTest level ance level ment – guidance Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b.
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. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 1.2 √P 80 MHz to 800 MHz d = 1.2 √P 800 MHz to 2.5 GHz d = 2.3 √P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.
(EMI/EMC Compliance). The CLEAR™ hearing aid complies with the following EMC/EMI standards: Standard Test type Note 47 CFR Part 15, subpart C RF emissions USA Federal Communications Commission (FCC) requirements for intentional radiators. EN 303 330-2 RF emissions V1.3.1 incl. Spurious emission EMC and radio spectrum matters for Short Range Devices in the frequency range 9 kHz – 25 MHz IEC 60601-12:2007 *adapted protocol EMC emission Immunity, RF and ESD Medical electrical equipment.
IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists, or otorhinolaryngologists.
Children with hearing loss In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.
FCC ID: TTY-C4M FCC ID: TTY-C4MCB IC: 5676B-C4M IC: 5676B-C4MCB Federal Communications Commission Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
NOTE: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Changes or modifications to the equipment not expressly approved by Widex could void the user’s authority to operate the equipment.
Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour l’émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à l’intention des autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.
Hereby, Widex A/S declares that this C4-m and C4-m-CB are in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. A copy of the Declaration of Conformity can be found at: http://www.widex.
Hearing aids, accessories and batteries should not be disposed of with normal household waste. Please consult your national Widex distributor for advice on how to dispose of these items.
Manufacturer CIB203/0511 ¡9 514 0133 041*¤ ¡#01v¤ Printed by HTO / 2011-05 9 514 0133 041 #02
