CAUTION: FEDERAL (U.S.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

Transcription

1 IPC USER S GUIDE

2 CAUTION: FEDERAL (U.S.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN READ ALL DIRECTIONS IN THIS GUIDE BEFORE USING THE MAXUM SYSTEM. CONTACT YOUR HEARING CARE PROFESSIONAL IF YOU HAVE ANY QUESTIONS OR CONCERNS ABOUT YOUR MAXUM SYSTEM. CONTACTS FOR INFORMATION AND ASSISTANCE: Doctor: Tel: Center: Tel: Other: Tel:

3 TABLE OF CONTENTS INDICATIONS/CONTRAINDICATIONS... 4 WARNINGS AND PRECAUTIONS... 5 HOW DOES THE MAXUM SYSTEM WORK?... 9 HOW DOES THE MAXUM SYSTEM DIFFER FROM MY ACOUSTIC HEARING AID? WHAT ARE THE PARTS OF THE MAXUM SYSTEM? WHAT HAPPENS AFTER SURGERY? USE AND CARE OF THE MAXUM SYSTEM INSERTION AND REMOVAL OF THE IPC COMFORT AND WEARING SCHEDULE DIRECTIONS FOR USE SERVICE AND MAINTENANCE FREQUENTLY ASKED QUESTIONS TROUBLE SHOOTING GUIDE SAFETY TECHNICAL SPECIFICATIONS

4 INDICATIONS/CONTRAINDICATIONS Indications The MAXUM Systems are indicated for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids. Your doctor or audiologist/hearing instrument specialist will perform several audiometric tests and a medical examination to determine whether you are a candidate for the MAXUM. Contraindications The MAXUM is contraindicated for subjects who have: Conductive hearing loss Retrocochlear or central auditory disorder (brain stem disorder) Active middle ear infections Tympanic membrane (ear drum) perforations associated with recurrent middle ear infections Disabling tinnitus (ringing in the ear) Magnetic Resonance Imaging (MRI) examinations are contraindicated for patients implanted with the MAXUM. Patients implanted with a MAXUM System should not undergo an MRI examination, enter a room where MRI exams are performed, or get close to other strong magnetic fields. If you have a medical or occupational need to be exposed to strong magnetic fields such as a need for MRI examinations or working with MRI equipment, inform your hearing health care professional, your physician or contact Ototronix at Nickel Sensitivity: MAXUM Implant Assembly, Split Coil versions (P/N M220L and M220R) are contraindicated for patients with foreign body sensitivity to metals containing nickel. Where material sensitivity is suspected, appropriate tests should be conducted prior to implantation. (MAXUM Implant Assembly, Full Coil versions (P/N M210L and M210R) do not contain nickel and this contraindication does not apply.)

5 WARNINGS AND PRECAUTIONS The MAXUM System is proven safe and effective if used and cared for responsibly. The MAXUM IPC System is based on the same implant technology as the previous MAXUM BTE System and showed similar results in a limited confirmatory study conducted on a subset of 10 subjects, 9 of which were from the original (BTE) study, with similar results. The following warnings and precautions should be noted to avoid potential harm to yourself and damage to the device. Warnings Inform your physician that you are implanted with a MAXUM System before having the following medical or surgical procedures: MAGNETIC RESONANCE IMAGING (MRI) EXAMINATIONS MRI is contraindicated for patients implanted with the MAXUM. Patients implanted with a MAXUM System should not undergo an MRI examination, enter a room where MRI exams are performed, or get close to other strong magnetic fields. The effects of these exams on the implant are unknown. If an MRI is necessary, the implant should be removed and re-implanted after the exam. ELECTROCONVULSIVE THERAPY Electroconvulsive therapy is contraindicated for patients implanted with the MAXUM. Electroconvulsive therapy must never be used on a patient with a MAXUM System implant because it may damage the implant or the patient s hearing. DIATHERMY Diathermy is contraindicated for patients implanted with the MAXUM. Diathermy must never be applied over the implant because the high currents induced into the implant may damage the implant or the patient s hearing. ELECTROSURGERY Electrosurgical instruments are capable of producing electromagnetic fields that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents may damage the implant or the patient s hearing. 5

6 COBALT TREATMENT, PET SCANS, TRANSCRANIAL DIAGNOSTIC ULTRASOUND, OR LINEAR ACCELERATION TECHNIQUES The effect of cobalt treatment, PET scans, transcranial diagnostic ultrasound, and linear acceleration techniques on the implant are unknown. Before undergoing any of these procedures, MAXUM System users should consult their physicians about the potential risks. MAGNETIC SURGICAL INSTRUMENTS If other surgeries are to be performed in the middle ear space of the implanted ear, avoid using magnetic (ferric) instruments. Such instruments will attract the implant, and may damage the implant or the patient s hearing. ELECTROMAGNETIC COMPATIBILITY The MAXUM Systems have been found to comply with the test requirements of EN , Electromagnetic Compatibility for Medical Devices. Compliance indicates the systems are reasonably protected from harmful interference in a typical medical installation. However, these devices may be affected by systems that produce, utilize, or radiate radio frequency energy. If your MAXUM System appears to be affected, try the following solutions to resolve the problem: Reorient and/or relocate the interfering device. Increase the separation between the MAXUM System and the interfering device. If these solutions do not resolve the problem, please inform your hearing health care professional, your physician or contact Ototronix at ANTI-THEFT DETECTORS AND AIRPORT SECURITY DEVICES Anti-theft detectors found in retail stores, public libraries, etc., and airport security devices produce electromagnetic fields. Some MAXUM System users may hear distorted sounds when passing through or near one of these devices. Testing with the MAXUM has indicated that the device is not damaged by these systems. Do not stand near or lean against anti-theft devices in doorways of department stores and libraries. Anti-theft devices in stores and libraries are safe, providing you walk through them at a normal pace. When passing through an anti-theft system, walk though the center of the gates. If only one gate is present stay as far away as possible from it. If scanning with a hand held metal detector is necessary at airport security stations, warn the security personnel that you have an implanted medical device. Ask them not to hold the metal detector to the device any longer than absolutely necessary. You may wish to ask for an alternate form of personal search. 6

7 RADIO FREQUENCY IDENTIFICATION (RFID) SYSTEMS RFID is a technology that uses radio waves to exchange data between a reader and an electronic tag attached to an object. RFID Systems are used currently in keyless entry systems, passports and identification, retail sales and asset management, toll roads and many others. The MAXUM Systems are reasonably protected from harmful interference from RFID Systems. Some MAXUM System users may hear distorted sounds when passing through or near one of these devices. Testing with the MAXUM has indicated that the device is not damaged by these systems. It is recommended that you keep a separation distance of 6 inches (15 cm) between your MAXUM and items thought to contain RFID systems. CELL PHONE COMPATIBILITY Some hearing device users have reported buzzing sounds when they are using cell phones, indicating that the cell phone and hearing device may not be compatible. According to the ANSI C63.19 standard (ANSI C American National Standard Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids), the compatibility of a particular hearing device and cell phone can be predicted by adding the rating for the hearing device immunity to the rating for the cell phone emissions. For example, the sum of a hearing device rating of 2 (M2) and a telephone rating of 3 (M3) would result in a combined rating of 5. Any combined rating that equals at least 5 would provide normal use ; a combined rating of 6 or greater would indicate excellent performance. The immunity of the MAXUM has been found to be M4. While this rating system was created for acoustic hearing aids, the equipment performance measurements, categories and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied. NOTE: The performance of individual hearing aids may vary with individual cell phones. Therefore, if you are purchasing a new phone, be sure to try it with your MAXUM prior to purchase. For additional guidance, please ask your cell phone provider for the booklet entitled Hearing Aid Compatibility with Digital Wireless Cell Phones. If you have questions regarding these Warnings please inform your hearing health professional, your physician or contact Ototronix at

8 Precautions 8 Do not allow others to tamper with or wear any part of your MAXUM System. Each system is individually prescribed and use by others could result in bodily injury or damage to the device. Do not swallow any part of your MAXUM System or use in any manner other than that described in this manual. Doing so can result in illness, injury, or damage to the device. Do not wear the IPC when engaging in contact sports of any kind. This could result in damage to the ear canal and/or ear drum, as well as damage the device. Do not get your MAXUM System wet. Doing so could cause intermittent performance or damage the device beyond repair. In the event that the device does get wet, remove the battery and store the device in the dehumidifier overnight, leaving the battery door open. If the device still malfunctions, notify your hearing care professional. Do not allow any part of the device to be exposed to excessive heat, such as direct sunlight, blow dryer, or flame, or leave on the dashboard inside of a vehicle. Contact with a hot device may cause minor skin irritation or burns. Heat may also damage the device beyond repair. Do not apply hair care products, such as hairspray or gel, while wearing your MAXUM System. This may damage the device. Do not attempt to wear a damaged device. Damage may be caused by heavy impact such as dropping onto a hard surface. Inspect the entire device for damage before continuing to wear the device. Do not attempt to open the IPC except to remove the battery. Exposing or tampering with the internal controls could seriously alter the device performance and output. Only hearing care professionals should make adjustments to the internal controls. Notify your hearing care professional if you experience any bothersome interference. It is possible that there may be electromagnetic interference, resulting in humming or buzzing sounds, when close to appliances such as televisions, computers, or other electronic appliances. This is not uncommon, and your hearing care professional will help you with the problem. Do not ingest batteries; batteries are harmful if swallowed. The button cell batteries used to power your MAXUM System are small and could be easily swallowed. Keep them away from children, pets, or anyone who might not understand the dangers associated with swallowing batteries. In case a battery is swallowed, immediately contact the National Button Battery Hotline at 1(202) or your local physician. If you experience any medical problems, such as pain or discomfort, which you believe are related to the use of your MAXUM System, or if there are any problems with the functions of your MAXUM System, immediately contact your hearing care professional. See page 2 of this guide for the phone number.

9 HOW DOES THE MAXUM SYSTEM WORK? MAXUM Systems work with a magnetic implant attached to the ossicular bones in your middle ear. The two bones used in the process are called the incus and the stapes. Ear Canal Ossicles Implant Auditory Nerve After the implant surgery is performed you will receive the Integrated Processor and Coil (IPC). This external component completes your MAXUM IPC System. IPC The IPC houses both the sound processor and the electromagnetic coil. The sound processor in the IPC receives sound, amplifies it, and sends electrical signals to the coil at the tip of the device. This coil changes the sounds to electromagnetic signals, which cause the implant to vibrate. These vibrations travel through the cochlea, stimulating the hair cells and nerves that send impulses to the brain that are interpreted as speech or sounds. Ear Drum The MAXUM System consists of a small rare earth magnet implant and an Integrated Processor and Coil (IPC). Cochlea 9

10 HOW DOES THE MAXUM SYSTEM DIFFER FROM MY ACOUSTIC HEARING AID? The MAXUM System delivers sound differently than hearing aids. Rather than trapping amplified sound in the ear canal, the MAXUM delivers sound directly to the inner ear. Ototronix, LLC designs devices and systems that may be used as alternatives to conventional acoustic hearing aids. Data was collected from 95 people participating in a clinical trial to illustrate the safety and effectiveness of the Ototronix MAXUM BTE System with an analog processor. The MAXUM IPC System is based on the same implant technology as the MAXUM BTE System, and may provide the same benefits seen in the MAXUM BTE System study. A limited confirmatory study of the MAXUM IPC with an analog processor was performed on a subset of 10 of the 95 MAXUM BTE System subjects and showed similar results. In addition, a limited confirmatory study of the MAXUM IPC with a digital processor was performed on a subset of 10 of the 95 MAXUM System subjects and showed similar results. Individual results may vary. Acoustic Hearing Aid MAXUM System 10

11 Benefits of the MAXUM System Include: HEARING OF SOUND Compared to your well fit acoustic hearing aid, you may perceive a higher fidelity sound. You may also hear more sounds in the speech range, which are mid to high frequency sounds. In other words, you may follow a conversation more easily and it may sound more natural to you. ACOUSTICAL FEEDBACK You may experience whistling or squealing when you increase the volume on your acoustic hearing aid. However, many patients who used the MAXUM System reported no feedback and almost all patients preferred the MAXUM System as having the least amount of feedback SOUND QUALITY Sounds may be clearer, and more natural, including the sound of your own voice. Most patients preferred the MAXUM System in the area of sound quality compared to their hearing aid. SURGICAL IMPLANT The procedure used to implant the internal portion of the MAXUM System is minimally invasive, and is similar to other surgeries performed through the ear canal (stapedectomy, tympanoplasty). OCCLUSION EFFECT When you speak with your acoustic hearing aid on, you may experience the feeling that you are talking into a barrel or tunnel. This is called the occlusion effect. The MAXUM System has been found to produce reduced occlusion compared to a hearing aid. 11

12 WHAT ARE THE PARTS OF THE MAXUM SYSTEM? Implant The implant is surgically implanted by your physician. The IPC is placed in your ear whenever you want to use the MAXUM IPC System. The IPC houses the sound processor and the electromagnetic coil. See the following pages for illustrations and details on the components of each. IPC Implant The MAXUM IPC System consists of two components: Implant Integrated Processor and Coil (IPC) The implant consists of a small rare earth magnet sealed in a titanium metal canister. A wire-form ring composed of titanium alloy wire holds the magnet to the incudo-stapedial joint in the middle ear. The implant receives electromagnetic energy from the electromagnetic coil, causing direct stimulation and vibration of the middle ear ossicles. These vibrations travel through the cochlea, stimulating the hair cells and nerves that send impulses to the brain that are interpreted as speech or sounds. 12

13 Integrated Processor and Coil (IPC) The IPC is a custom earmold shell composed of acrylic polymer with an electromagnetic coil at the tip. It also houses the sound processor component of your device. It is custom designed from an impression of your ear canal. The IPC has the following controls: Battery Compartment Toggle switch to change programs The sound processor within the IPC receives and amplifies the sound vibrations and transforms them to electrical signals. The signals are received by the electromagnetic coil at the tip of the IPC. This coil transforms the electrical signals into electromagnetic energy. Toggle Switch Microphone Battery Compartment Removal Cord 13

14 WHAT HAPPENS AFTER SURGERY? It is likely that you will be discharged the day of surgery, and your first follow-up appointment should be scheduled with your surgeon at that time. If your ear has healed completely from the surgery, you will be fitted for the external components of your device during a ten-week follow-up appointment. Are There Post-Operative Complications? A few hours after surgery you may notice a loss of hearing. This is a normal and temporary reaction to the surgery. It should begin to improve shortly thereafter, and you will notice continued improvement for many weeks following your surgery. It is common to experience some ear pain and swelling after surgery. This is temporary, and will subside with time. It is also possible that a hematoma (blood blister) or tympanic membrane perforation may occur, both of which may resolve themselves or can be resolved with medicine or surgery. In order to minimize these complications, many types of movement and activities will be restricted temporarily. You will also need to take special care of your ear while it is healing. The post-operative precautions and care should be followed to avoid excessive pain and damage to your ear, hearing, and the implant. 14

15 Post-Operative Precautions Do not exercise or move your head quickly for the first two weeks after surgery. Do not engage in vigorous exercise or contact sports, such as basketball, football, soccer, hockey, etc. for three months Do not wear external components of the device in the ear canal when engaging in contact sports at any time. Do not blow your nose for three weeks. Any accumulation in the nose may be drawn back and expectorated through the mouth. Keep your nose and mouth open while sneezing. Do not blow on musical instruments for three weeks. No swimming for two months. Avoid diving until advised. Flying is permissible after one week, but only on commercial airlines for the first month. Later, when you are using your MAXUM device, report to your doctor any swelling or pain you experience in the external ear canal. Post-Operative Care Change cotton in ear daily for one week. Use only sterile cotton. Wash your hands for two to three minutes with soap and water before touching your ear. If necessary, the external ear may be cleansed with cotton dampened with rubbing alcohol. Do not wash your hair or get water in the ear for one week after surgery and keep water out of the ear canal for three weeks. A cotton plug placed in the canal and covered with Vaseline will prevent water entering the ear while washing the face or taking a shower. Do not use Q-Tips to clean your ear. It is very normal for hearing to regress a few hours after surgery. It will be very distorted and poor for some time. Do not be discouraged over this. Often the hearing will be poor initially but will continue to improve for many weeks after surgery. Call your physician if you develop a cold or have an elevation in temperature above normal. Please call your physician if you should have excessive pain or dizziness during the first few weeks following surgery. Call your physician if there is excessive pain or drainage. A small amount of bloody drainage on the cotton the first few days after surgery is not unusual. 15

16 USE AND CARE OF THE MAXUM SYSTEM Now you are ready to begin using your new MAXUM System. The following information will help you get the best results and the maximum amount of wear from your MAXUM System. Battery Insertion The MAXUM System uses a size 312 battery. Any brand of 312 batteries should work with your IPC except for the high power 312 battery. To install a battery, open the battery compartment by using the lip on the battery door. Place the battery into the ring or ledge with the + side of the battery up. If the battery is placed incorrectly, the battery compartment door will not shut easily and the IPC could be damaged. The battery will usually last 1-2 weeks, depending on the settings and the number of hours the hearing device is worn each day. 16

17 INSERTION AND REMOVAL OF THE IPC INSERTING THE IPC Your IPC is custom made for your ear. Do not force the IPC into your ear. The IPC is a custom device and can only fit your ear. 1. Lubricate the tip of the IPC with polysporin ointment, mineral oil, or another lubricant prescribed by your physician. 2. Hold the IPC with your index finger on the top portion of the IPC and your thumb on the bottom ridge with the tip aimed towards your ear. Turn the top portion of the IPC forward a quarter turn (towards your face). Insert the IPC starting with this angle and gently twist the IPC forwards and backwards slightly to work the IPC as far into the ear canal as you can comfortably place it. 3. Adjust the final seating of the IPC with your index finger and thumb gripping the removal cord while gently moving it to get the best hearing and most physical comfort. REMOVING THE IPC Grasp the removal cord and carefully pull the IPC from your ear. There is a small ball at the end of the removal cord to help you. 17

18 COMFORT AND WEARING SCHEDULE The deep fit of the IPC may cause some initial discomfort. You may need to wear your IPC for a limited amount of time and slowly increase wearing time as you become accustomed to it. Please follow the instructions given by your hearing care professional. You will be provided with a wearing schedule similar to the sample below to assist you in getting used to the device. SAMPLE IPC WEARING SCHEDULE Day 1 and 2 Day 3 and 4 Day 5 and 6 Day 7 and 8 Day 9 and 10 A one-hour period two times during the day A two-hour period two times during the day A four-hour period once during the day A four-hour period two times during the day An eight-hour period once during the day After Day 10, you should be able to wear the device for the amount of time you desire. If the IPC is not comfortable after 2 weeks of wearing it, contact your hearing care professional. NOTICE: If your ear becomes sore, stop using the IPC for five days. Then, try the Wearing Schedule again. If your ear becomes sore again or if any draining or bleeding occurs, stop using the IPC and contact your hearing care professional. 18

19 DIRECTIONS FOR USE TOGGLE SWITCH Up to four programs may be placed into your IPC. Volume or sound shaping may vary in the different programs. You can cycle through your programs to change programs as needed by pressing down or up on the toggle switch. You should hear one beep for Program 1, two beeps for Program 2, three beeps for Program 3 and four beeps for Program 4. The toggle switch can be pushed either up or down. Both directions have the same effect and cycle the program forward. If you notice discomfort while pushing the toggle switch, attempt to push it in the opposite direction. If using the toggle switch causes lasting pain or discomfort, contact your hearing care professional. BATTERY COMPARTMENT The door to the Battery Compartment swings out of the IPC to allow access to the battery for easy insertion and removal. When you are not using the IPC, be sure to open the Battery Compartment. This saves battery energy, and allows moisture that might have accumulated in the battery case to evaporate. Toggle Switch Battery Compartment MY PROGRAMS Program 1: Program 2: Program 3: Program 4: 19

20 SERVICE AND MAINTENANCE IPC STORAGE When not in use you should store it in the dehumidifier with the battery door open or use the carrying case. DEHUMIDIFIER USE Moisture can cause problems with the function of your IPC. In order to reduce moisture and improve performance of the device, the IPC should be placed in a dehumidifying kit for a minimum of 4 hours once a week, or immediately after exposure to high humidity (85%) or perspiration. If the device is consistently exposed to high humidity or perspiration, use the dehumidifier each night. The battery does not need to be removed from your device before putting it in the dehumidifier. CLEANING THE IPC Use a brush or soft cloth to clean the canal tip or vent openings. A UV light (contained in some dehumidifiers) can be used to sanitize your IPC. Liquid sanitizing solutions may be used on the tip of the IPC if applied to a soft cloth first. Do not soak the IPC. BATTERY DISPOSAL Batteries must be disposed in accordance with federal, state, and local regulations. DEVICE DISPOSAL If you wish to dispose of your IPC for any reason, return it to your hearing care professional. For any further cleaning, maintenance or repair, contact your hearing care professional. 20

21 FREQUENTLY ASKED QUESTIONS WILL THE IMPLANT WORK WITHOUT THE EXTERNAL DEVICE? All parts of your MAXUM device work together as a system the implant will not improve your hearing without the IPC. If for some unforeseeable reason you choose not to have those components fitted, or if these external portions of the system cannot be fitted, the systems will not be able to amplify sounds for you. It is anticipated that users will have nearly the same hearing (-4.2 db average) as before the implant as proven in MAXUM BTE System clinical trial data. However, individual results may vary. CAN I WEAR MY HEARING AID IN MY IMPLANTED EAR? CAN THE IMPLANT BE REMOVED? The implant can be removed through a similar surgical procedure with similar risks. It may also be re-implanted once the structures of the middle ear have been allowed to heal and can withstand surgery. WILL I NEED FUTURE SURGERY IN ORDER TO UPGRADE MY DEVICE? Future upgrades of the external parts of your device will not require a change to your implant. However, as future technologies become available, it will be possible to upgrade the implant through similar surgery. The implant does not interfere with your hearing aid. Allow two weeks after your implant surgery for healing, and you may then resume use of your hearing aid in the implanted ear if desired. 21

22 HOW LONG WILL MY MAXUM SYSTEM LAST? Scientific literature shows that this magnet in the implant retains its properties for a length of time that exceeds the average human life-span. Data from an ongoing study shows that the life expectancy of the external IPC of the MAXUM System is shown to be a minimum of four years when exposed to an average frequency of 1000 Hz and used an average of eight hours per day. At that point, wearers have the option to repair or replace the IPC. CAN I USE THE TELEPHONE WHILE WEARING THE SYSTEM? Your MAXUM System allows you to use the telephone by placing the receiver over the microphone on the top of the IPC. The receiver should be parallel with your head and centered over the top of the IPC where the microphone is located. CAN I BATHE WHILE WEARING THE SYSTEM? The IPC should be removed before you bathe. Bathing with the device or accidentally getting it wet may result in device malfunction. If this occurs, do not dry it with a hair dryer. First remove the battery, and then dry the device with a cloth. Place it in the dehumidifier overnight and then check performance. In the event of malfunction, notify your hearing care professional. NOTE: The implanted components are not affected by bathing, showering or swimming. CAN I SLEEP WHILE WEARING THE SYSTEM? The IPC should be removed before you go to bed. Open the battery compartment when the device is not in use in order to preserve battery life and allow moisture to evaporate. 22

23 TROUBLE SHOOTING GUIDE Problem Possible Cause Remedy No sound IPC not turned on Battery low or dead Processor needs repair Check that you are in the correct program with the toggle switch Replace battery Contact your hearing care professional Weak or distorted sound Battery low Device needs programming adjustments Replace battery Contact hearing care professional for adjustment Loud-sounds uncomfortable Intermittent performance/ sound breaking up Volume too high Device needs programming adjustments Battery low Moisture in device Device needs internal adjustments Device was dropped or mishandled Switch to different program with the toggle switch Contact hearing care professional for adjustment Replace battery Put device in dehumidifier for 4 hours or more Contact hearing care professional for adjustment or repair Damage to the outside of the device Device was dropped or mishandled Device broken Contact hearing care professional for repair For clinical study information, please refer to the Patient Information Guide. 23

24 SAFETY This manual contains information and warnings, which must be followed to ensure safe performance of the MAXUM System. Local government rules and regulations, if applicable, should also be followed at all times. Glossary of Symbols Symbol Description Symbol Description Serial number Non-ionizing radiation Reference number (Model) Store at temperatures between -10 C and +55 C (14 F and 131 F) Do Not Throw Away Caution: Federal Law restricts this device to sale by or on the order of a physician Consult Instructions for Use Single Use Only Do Not Resterilize Sterilized using Ethylene Oxide Manufacturer Date of Manufacture Lot number Use By (Expiration Date) Type BF, EN Keep Dry Do Not Use if Package is Damaged Store at Relative Air Humidity of 95% or Less 24

25 Warning Notes The MAXUM IPC is a battery operated, stand-alone device. Do not connect or combine the MAXUM System with any other system. For more information on electrical safety while connecting the MAXUM System refer to the Clinician s Guide ( ). Note 1: If non-system equipment is connected, it is the operator s responsibility to ensure that the assembled system complies with IEC Note 2: Do not use the device in the presence of flammable anesthetics (gases) or oxygen rich environments. Note 3: The system is not intended to be defibrillation-proof. If possible, remove the IPC from the patient environment before defibrillation. 25

26 TECHNICAL SPECIFICATIONS Component List MAXUM IPC: MAXUM IPC (M310) User s Guide ( ) Operating Environment Temperature: -10 C to +55 C (14 F to 131 F) Rel. Humidity: <95%, non-condensing Air Pressure: 500 hpa to 1060 hpa Connections The MAXUM IPC has one CS64 4-Pin flex communication port for programming. This port should only be accessed by the Clinician. Power Supply The MAXUM IPC is internally powered by a size 312, zinc air battery. Nominal Voltage: 1.4V Maximum Current Consumption: < 10mA Storing and Handling Temperature: -10 C to +55 C (14 F to 131 F) Rel. Humidity: <95%, non-condensing Standards Safety: EN , Type BF Electromagnetic compatibility: EN Systems: EN Cellular telephone compatibility: EN

27 Electromagnetic Compatibility Guidance and Manufacturer s Declaration Electromagnetic Emissions The MAXUM System is intended for use in the electromagnetic environment specified below. The customer or the user of the MAXUM System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Not applicable Not applicable The MAXUM System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The MAXUM System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 27

28 Guidance and Manufacturer s Declaration Electromagnetic Immunity The MAXUM System is intended for use in the electromagnetic environment specified below. The customer or the user of the MAXUM System should assure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic Discharge (ESD) IEC ±8 kv Air ±6 kv Air ±8 kv Air ±6 kv Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity should be at least 30%. Electrical fast transient/burst IEC ±2 kv for power supply lines ±1 kv for input/output lines N/A (Device is battery powered) Mains power quality should be that of a typical commercial or hospital environment. Surge IEC ±1 kv differential mode ±2 kv common mode N/A (Device is battery powered) Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC <5 % U T (>95 % dip in U T ) For 0.5 cycle 40 % U T (60 % dip in U T ) For 5 cycles <5 % U T (>95 % dip in U T ) For 5 sec N/A (Device is battery powered) Mains power quality should be that of a typical commercial or hospital environment. If the user of the MAXUM System requires continued operation during power mains interruptions, it is recommended that the MAXUM System be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field IEC A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE U T is the a.c. mains voltage prior to application of the test level. 28

29 Guidance and Manufacturer s Declaration Electromagnetic Immunity The MAXUM System is intended for use in the electromagnetic environment specified below. The customer or the user of the MAXUM System should assure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance Conducted RF IEC Radiated RF IEC Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 V 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the MAXUM System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 80 MHz to 800 MHz 800 MHz to 2,5 GHz 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 meters (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 Interference may occur in the vicinity of equipment marked with the following symbol: 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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MAXUM System is used exceeds the applicable RF compliance level above, the MAXUM System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MAXUM System. B Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 29

30 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the MAXUM System The MAXUM System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MAXUM System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MAXUM System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output of transmitter W Separation distance according to frequency of transmitter m 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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. 30

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32 Patient Support: (877) 410-HEAR or (281) Ototronix, LLC I-45 North Houston, Texas USA CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a physician Ototronix, LLC. All rights reserved. MAXUM is a trademark of Ototronix, LLC. P/N EN Rev. D