FCC ID: POMRX92369 Sirona ECG Recorder

Generic / Preliminary Sirona USER MANUAL Caution: FEDERAL LAW RESTRICTS THIS DEVICE FOR SALE TO OR ON THE ORDER OF A PHYSICIAN. Carefully read all instructions prior to use. Observe all warnings and precautions noted in these directions. Failure to do so may result in patient complications. IntriCon Datrix 340 State Place Escondido, CA 92029 Sirona User Manual

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Rev D02 Table of Contents Notices ................................................................................................................................ 3 User Safety Information...................................................................................................... 4 Warnings ............................................................................................................... 4 Cautions ................................................................................................................ 5 Notes: .............................................................................................................................. 5 Section 1: Introduction....................................................................................................... 6 Section 2: Getting Started .................................................................................................. 6 Front Panel.......................................................................................................................... 7 Section 3: Initial Device Setup ........................................................................................... 8 Section 4: Attaching Recorder to Patient............................................................................ 8 Patient Cable ................................................................................................................... 9 Patient Preparation.......................................................................................................... 9 Patient Hookup................................................................................................................ 9 Section 5: Instructions for Patient.................................................................................... 10 RECORD Button .......................................................................................................... 11 SEND Button ................................................................................................................ 11 SIRONA Patient Interface Light Signals...................................................................... 13 Section 6: Device Maintenance ....................................................................................... 14 Inspection and Cleaning................................................................................................ 14 Testing........................................................................................................................... 14 SIRONA DATASHEET ................................................................................................... 17 Service/Technical Support:............................................................................................... 18 Sirona User Manual

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Rev D02 Notices Conventions Used in this Manual WARNING Warning statements describe conditions or actions that can result in personal injury or loss of life. CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of data. Notes contain additional information on usage. NOTE Manufacturers Responsibility IntriCon Datrix considers itself responsible for effects on safety and performance only if:

1. Readjustments, modifications or repairs to the IntriCon Datrix Holter/Event recorders are carried out only by IntriCon Datrix authorized personnel. AND 2. The IntriCon Datrix SIRONA is used as presented in this manual. The warranty is only valid if you use IntriCon Datrix approved replacement parts and accessories. User Responsibility The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification IntriCon Datrix equipment is identified by a serial number on the back of the device. Take care not to deface these numbers. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of IntriCon Datrix. Other Important Information IntriCon Datrix reserves the right to change or amend this manual at anytime without notice. IntriCon Datrix makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. IntriCon Datrix shall not be liable for errors or omissions that may appear in this document. IntriCon Datrix makes no commitment to update or to keep current the information contained in this document. Before using the IntriCon Datrix SIRONA Holter/Event recorder read this manual in its entirety and become thoroughly familiar with the contents. Sirona User Manual

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Rev D02 READ MANUAL FIRST KEEP AWAY FROM MOISTURE User Safety Information Intended Use The SIRONA APETS recorder is a small, portable, digital Holter/Event recorder intended for use by medical professionals to acquire ECG data from a single patient in a clinical, point of care or outpatient setting. ECG data is first recorded to a Secure Digital (SD) card and then transferred to a Holter/Event analysis system for review by a physician or other qualified professional. Explanation of Symbols ELECTRONIC EQUIPMENT DISPOSE OF PROPERLY MANUFACTURER / MANUFACTURE YEAR NON-IONIZING RADIATION TYPE BF DEVICE DC CURRENT IP54 Warnings 1. This device captures and presents data reflecting a patients physiological condition that when reviewed by a trained medical professional can be useful in determining a diagnosis. However, the data should not be used as sole means for determining a patients diagnosis. Sirona User Manual

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Rev D02 2. Use of accessories other than those recommended by IntriCon Datrix may compromise product performance. 3. To maintain designed operator and patient safety, any peripheral equipment and accessories that can come in direct patient contact must be in compliance with IEC 60601-1. 4. Hardware is designed to meet or exceed IEC 60601-1-2, however some environmental electrical interference may cause an artifact in the ECG. The quality of ECG signals may be adversely affected by electromagnetic interference from environmental sources resulting in non-physiological waveforms with the potential for misinterpretation. 5. This device is not intended for use during an MRI. 6. Before performing defibrillation or applying any high frequency surgical equipment to a patient, remove SIRONA leads and electrodes from the chest area. Cable leads or electrodes trapped under defibrillator pads or paddles during defibrillation or electrodes in contact with high frequency electrosurgical equipment can cause patient burns. 7. Once one or more SIRONA patient leads are connected to a patient, do not allow patient leads to meet with any grounded or live parts. Contact could cause unacceptable levels of electrical current to flow to the patient. 8. The equipment is not intended for infants weighing less than 10 kgs. Cautions Formatted: Bullets and Numbering Notes:

1. Although the plastic enclosure is designed for a clinical environment and can resist moisture, neither the device nor patient cables should be subjected to autoclaving or steam cleaning. 2. Recommended cleaning procedure is to wipe the exterior surfaces with a cloth dampened with warm water and mild detergent solution and then dry with a clean soft cloth. 3. No serviceable parts are inside. The case cannot be opened without destroying it. 4. Do not pull or stretch patient cables, as this could result in mechanical and/or electrical failures. Store patient cables after use by forming them into a loose loop. 5. Align patient cable connector key and SIRONA key before plugging in patient cable. Forcing misaligned connectors can damage connector pins. 6. Avoid shock or sudden impact. 1. Excessive patient movement could interfere with the operation of the device. 2. Proper patient preparation is important to successful application of ECG electrodes and operation of the device. 3. 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. Changes or modifications not expressly approved by IntriCon for compliance could void the users authority to operate the equipment. 4. 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the wireless transmission off and on,then the user is encouraged to consult the dealer. Sirona User Manual

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Rev D02 Section 1: Introduction This manual is written for clinical professionals. It is assumed that the reader has a working knowledge of medical terminology and procedures as required for monitoring cardiac patients. Purpose of the User Manual The User Manual describes how to safely operate the SIRONA Holter/Event recorder, Smart Dock and linkStream. In the manual, the following are described:

Preparing the device for use Understanding and using the keyboard Acquiring and storing ECG data Transmitting stored ECG data Maintenance System Description The SIRONA Holter/Event recorder is a portable, battery-operated ambulatory ECG recorder used by trained technicians to collect ECG data from patients in a clinical, point-of-care or outpatient setting. SIRONA provides ECG waveform analysis and automated transmission of ECG data for review by a physician or other qualified professional. ECG data is stored on an internal SD card and can be accessed through the Smart Dock interface or by transmitting the data over a telephone line. Smart Dock is an interface between a PC based application called Sirona Viewer and the SD card in Sirona. Smart Dock has two functions 1) Charge the battery in Sirona 2) Access the data stored on the SD card in Sirona linkStream is an accessory which provides the convenience of checking lead hook-up wirelessly. Section 2: Getting Started Batteries The Sirona uses an internal lithium polymer battery that is not accessible in the field. The battery is designed to last for the life of the product. Caution: THE BATTERIES USED IN THIS DEVICE MAY PRESENT A FIRE OR CHEMICAL BURN HAZARD IF MISTREATED. DO NOT DISASSEMBLE, HEAT ABOVE 100 C (212 F) OR INCINERATE. Caution: DISPOSE OF ALL BATTERIES IN ACCORDANCE WITH ALL APPLICABLE LOCAL REGULATIONS KEEP AWAY FROM CHILDREN. Sirona User Manual

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Rev D02 Deleted:

Deleted:

Deleted: IRONA Front Panel LED The Sirona front panel contains two buttons and five LED lights (Light Emitting Diodes) as follows:

Button Record Button Send Button Record Green or Red LED Lead-off Red LED Battery Green or Red LED Sirona User Manual

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Rev D02 Section 3: Initial Device Setup Setting Parameters One of the advantages of this device is that it can easily be configured to work in different modes, and with different operational parameters. In order to enable this, the device has an internal non-

volatile microSD card where it will store configuration parameters. These parameters are retrieved from microSD card upon device start-up. Device ID is set by the manufacturer . The device ID is secured from accidental modification. It is readable but not modifiable by the cardiac technician. A technician can read and modify several parameters before connecting the device to the patient. This configuration is done using the Smart Dock docking station, coupled with the Sirona Viewer PC application. Examples of parameters which can be modified are:

- Recording length

- Pre-trigger time length

- Post-trigger time length

- Recorded Event Threshold for LED and Audible Alarm: number of recordings that will trigger LED to flash periodically to inform the patient that he should send data to the monitoring center.

- Audible Alarm Enable: Enable/disable an audible alarm to the patient when the number of recorded events reaches the preset limit.

- Tachycardia threshold

- Bradycardia threshold

- Cardiac Pause threshold Configuration The device is designed to use several cables configurations as listed below in Error! Reference source not found.. The device detects the type of cable attached and configure itself accordingly. Deleted: used Sirona User Manual

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Rev D02 Section 4: Connecting Devices 4.1 Attaching Recorder to Patient Patient Cable The Patient cable connects to the Walta connector on the side of the SIRONA recorder. The cable is keyed for proper alignment. Be sure to align the key. Do not force a cable into position. Use only IntriCon Datrix cable part numbers listed in table 1. Patient Preparation Note: Proper patient preparation and electrode placement are important for acquiring a high quality ECG. 1. Prepare the electrode site by removing oils and lotion from the skin. If necessary, shave the area where electrodes will be placed. 2. Clean the skin at the placement site with an alcohol prep pad. 3. Dry the area with a lint-free cloth. 4. Use Silver Chloride disposable electrodes designed for 24 hour Holter/Event monitoring. Do not use 12-lead ECG or Stress Test Electrodes. Patient Hookup In order to obtain a high-quality ECG signal it is necessary to maintain good electrical contact between the electrodes, patient cables and the patients skin. A suggested electrode placement is shown in the diagram below. However, it is up to the physician to make the final placement determination. Warning: CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS. Deleted: Attaching Recorder to Patient Deleted: circular Deleted: The recorders ECG display screen can be used to verify a proper patient hookup. Sirona User Manual

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Rev D02 3-Lead 1-Channel Electrode Placement Read and follow instructions included with the electrodes. 1. Check the patient cable for damage or wear. Replace if necessary. Use Silver Chloride disposable electrodes designed for 24 hour Holter/Event monitoring. 2. Place the electrodes onto the ECG leads. 3. Remove the backing from the pre-gelled disposable electrode. 4. Firmly place an electrode on each of the prepared skin surface sites. Dispose of any electrode that does not properly adhere to the skin. Warning: ECG REPORTS MUST BE READ BY A PHYSICIAN WHO IS TRAINED TO INTERPRET AN ECG STUDY. 4.2 Connecting Smart Dock to a PC or to a wall socket using a wall adapter The Smart Dock is connected to a PC through a mini-USB to USB cable. The mini-

USB end plugs into the Smart Dock and the USB end plugs into the PC or to a wall adapter ( only when the Smart Dock is being used to charge the Sirona ) Sirona User Manual

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Rev D02 Deleted:

Deleted: Patient Page Break Deleted:

Formatted: Bullets and Numbering Deleted: . The Green Record LED will flash a number of times corresponding to the number of recordings saved in memory Deleted: mouthpiece and 4.3 Connecting the linkStream to a PC The linkStream is connected to a PC through a mini-USB to USB cable. The mini-USB end plugs into the linkStream and the USB end plugs into the PC Section 5: Instructions for Use 5.1 Instructions for Patient Before the patient leaves the office inform the patient about:

a) Proper use of the Record button and patient diary. b) Transmitting ECG by TTM. c) Light message displays 5.2 Instructions for Technician Before putting the Sirona on the Smart Dock make sure the Sirona is in docking mode. Sirona can be put in docking mode by pressing the Send and Record button simultaneously for 5 seconds. Start Up Upon the connection of a cable, the SIRONA performs a system check and briefly flashes each LED. It will then sound three tones using the speaker. RECORD Button The event button is the large round Record button on the device with a raised ring around it. Press the Record button to store ECG data before and after the button press to the SD card. The event time, when used in conjunction with a patient diary, provides a physician with the ability to correlate patient symptoms with the ECG data. SEND Button The recorder will sound an audible alert when the number of events stored is equal to or greater than the number previously set in the event threshold option. The patient must contact the call center using a traditional land line. After the technician answers, the patient will be instructed to hold the Sironas speaker up to the phones mouthpiece and then press and hold the Send button for 5 seconds. This will transmit the stored events to the doctor or service via Trans-Telephonic Monitoring (TTM). The unit should be held up to the phone until the sound stops. When the sound stops the patient should get back on the phone to talk to the technician. The technician will then inform the patient of a successful transmission or instruct the patient to repeat the process in the case of an incomplete transmission. Heart Rate and Pause Calculation The method used by the Sirona device to detect beats and derive heart rates for preprocessing uses digital filtering and peak detection to create event vectors. The event vectors are further processed using decision rules based on MIT/BIH database testing. Once an ECG complex has been identified, a corresponding time is logged in milliseconds. The distance between each ECG complex is used to calculate heart rate. Pauses are classified when the interval of any beat is longer than the user specified threshold for pause and is less than 30000 milliseconds. Sirona User Manual

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Rev D02 Smart Dock Operation When Sirona is placed on the dock Smart Dock will charge battery. The charging status is indicated by the battery LED on Sirona. The table in charging section below explains the battery LED behavior. To extract data from the SD card in the Sirona. Put the Sirona in dock mode by pressing Send+Record together for 5 seconds. Place the Sirona on the Smart Dock. Open the Sirona Viewer application on the PC and hit the Save Holter Data tab to save the data as a bin file. linkStream Operation After connecting the linkStream to the PC, open the Sirona Viewer application on the PC. Press Send button on the Sirona for more than 5 seconds to start wireless transmission mode. On the Sirona Viewer hit the Scan for device button. And then press Start ECG to see the signal that is being wirelessly transmitted by the Sirona. Press Stop ECG button to stop wireless ECG transmission. Sirona User Manual

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Rev D02 SIRON A Patient Interface Light Signals There are several messages that could appear to alert you that action may be required, or simply to alert you that an error has occurred. These messages include:

LIGHT MESSAGE ACTION Battery LED solid Red when device is on the Smart Dock Battery is charging Leave the device on the Smart Dock until the Battery light turns off Deleted: flashes green every 0.5 seconds Deleted: becomes solid green Battery LED off when device is on the Smart Dock Battery is fully charged Remove the device from the Smart Dock Deleted: solid green Battery LED flashes green every 10 seconds Device is functioning normally None Battery LED flashes red every 2 seconds Low Battery Charge the Sirona by placing it on the Smart Dock Battery LED flashing red every 500ms when on the Smart Dock Faulty Battery Contact technician/service Lead-off LED flashes red every 2 seconds Indicated lead disconnected or poor patient connection Check lead / electrode Record LED lights up green for 5 seconds Record button has been pressed None Record LED flashes red continuously Recording error Contact technician / service Deleted: System Deleted: Record LED flashes green

... [1]

Sirona User Manual

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Rev D02 Section 6: Device Maintenance Inspection and Cleaning Routine inspection will help maintain the safety and performance of your SIRONA Holter/Event recorder, Smart Dock and linkStream. Before operating the device perform a visual inspection to identify any damage or excessive wear. The outside surfaces can be cleaned with a cloth dampened with a mild soap and water solution. Do not dispose of the unit in trash. Dispose of as the Waste Electrical and Electronic Equipment

(WEEE) regulations for your area require. Caution: DO NOT IMMERSE THE DEVICE IN LIQUID!

Caution: DO NOT CLEAN THE PATIENT CABLES WITH ALCOHOL. DO NOT AUTOCLAVE THEM, OR USE ULTRASONIC CLEANERS. Caution: DO NOT USE ANY HARSH CHEMICALS SUCH AS ACETONE, AMMONIA OR IODINE TO CLEAN THE SIRONA. Testing The SIRONA executes a self-diagnostic check at these three times:

Deleted: unit a. At power-up b. At the insertion of any cable c. Upon removing the PWM device from the Smart Dock d. Any errors in the units subsystems will be reported with an appropriate error message. If error messages persist contact your IntriCon Datrix service representative. There are no user serviceable parts in the SIRONA. The unit must be returned to IntriCon Datrix for service. The SIRONA may also be tested by attaching the patient leads to a commercially available ECG simulator and verifying each lead has amplitude and morphology as described in the simulators manual. Excessive artifact usually indicates the patient cable needs replacing. Use only replacement cables purchased from IntriCon Datrix. Sirona User Manual

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Rev D02 Charging The Sirona should only be charged with equipment supplied by Intricon Datrix (Model Number RX 92446-0009 and Model Number RX92598) intended for that purpose. The charging cable is attached to either a PC or a wall adapter through USB on one end and through a Walta connector to the Sirona on the other end, The Smart Dock(Model Number RX92446-0009) and Charging cable (Model Number RX92598) should only be used with the wall adapter(Model Number RX83103) when they are connected to the wall adapter through the USB cable. The lights on the Patient Worn Module will inform the user of the state of the charge of the battery as described below:

Condition PWM on the Smart Dock PWM on the Smart Dock PWM on the Smart Dock PWM attached to a patient Meaning Charging Battery is fully charged Charger is not charging Normal Operation Solid Green Battery is fully charged Battery Voltage is LOW Charging PWM attached to a patient PWM attached to charging cable PWM attached to charging cable Storage The Sirona, Smart Dock and linkStream should be stored between 10oC and 70oC and 10% to 95% relative humidity (non-condensing). Transport The Sirona, Smart Dock and linkStream should be transported between 10oC and 70oC and 10%

to 95% relative humidity (non-condensing). Battery LED Solid Red Off Flashing Red Green flash every 10 seconds Flashing Red Flashing Green Caution: DO NOT IMMERSE IN WATER. KEEP AWAY FROM CHILDREN. Sirona User Manual

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Rev D02 Deleted: Flashing Green Deleted: Solid Green Comment [NP2]: Only true for holter?

Deleted: 65 Deleted:

Sirona Accessory List Description Part Number 3 Wire 1-Channel Event Cable 20"

5 Wire 2-Channel Holter Cable 20"

5 Wire 5-Channel Event Cable 20"

7 Wire 3-Channel Holter Cable 20"

3 Wire 1-Channel Event Cable 39"

5 Wire 2-Channel Holter Cable 39"

5 Wire 2-Channel Event Cable 39"

7 Wire 3-Channel Holter Cable 39"

5 Wire 3-Channel Holter Cable 20"

5 Wire 3-Channel Holter Cable 39"

2 Wire 1-Channel Event Cable 20"

2 Wire 1-Channel Event Cable 39"

3 Wire 2-Channel Event Cable 20"

3 Wire 2-Channel Event Cable 39"

Belt Clip USB Cable Wall Charger Smart Dock Charging Cable RX92368-001 RX92368-003 RX92368-004 RX92368-005 RX92368-006 RX92368-008 RX92368-009 RX92368-010 RX92368-011 RX92368-012 RX92368-013 RX92368-014 RX92368-015 RX92368-016 RX82765-000 RX82929-000 RX83103-000 RX92518-000 RX92598-000 Sirona User Manual

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Rev D02 SIRONA DATASHEET General Specifications:

Input impedance: 10 M CMRR: > 60 dB AC signal range: 5mV DC signal range: 300mV Bandwidth: 0.05 40 Hz. Sampling rate: 250 samples/sec. Resolution: 10 bits Battery: Lithium-Polymer rechargeable Memory type: Flash Waterproof rating: IP54 and brief immersion to 6 (when patient cable attached) Lead status: Automatic lead-off detection User alerts: LED indicators and audible alerts. Wireless link option: 2.4Ghz PhysioLink internal transceiver Operating temperature range: 0 60 C Operating humidity range: 10 90% r.h. (non-condensing) Weight: 42 gr. (1.5 Oz.) excluding cable. Holter Monitor Specifications:

2 or 3 channel recording depending on cable 24, 48 and 192 hour recording length Typical battery life: 192 hours minimum between charges Upload to PC via smart-dock USB 2.0 accessory Event Recorder Specifications:

1 or 2 channels depending on cable Pre-trigger length: 30, 45, 60, 90, or 300 seconds*

Post-trigger length: 30, 60, 90, 120 and 180 seconds Maximum number of events: 2048 Automatic arrhythmia detection: brady, tachy, pause and AF Pacemaker pulse detection TTM event data transmission Typical battery life: 15 days between charges*

The Sirona is compliant with IEC 60601-1 as a Type BF, internally powered device designed for short time operation. The equipment is not suitable for AP or APG category environments. The Sirona complies with Part 15 of the FCC rules. Comment [NP3]: Ingress Protection Rating: IP54 and brief immersion to 6(when patient cable attached) Deleted: X Deleted: > 1000 Deleted: 30 Deleted: SIRONA Sirona User Manual

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Rev D02 Service/Technical Support:

IntriCon Datrix 340 State Place Escondido, CA 92029 Tel: 760-480-8874 Fax:

760-480-9474 Warning: THE SIRONA SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF ADJACENT OR STACKED USE IS NECESSARY, THE SIRONA SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED. Guidance and manufacturer's declaration - electromagnetic emissions The Sirona is intended for use in the electromagnetic environment specified below. The customer or user of the Sirona should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance Deleted:

Deleted:

The Sirona 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 Sirona is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 N/A N/A Guidance and manufacturer's declaration - electromagnetic immunity The Sirona is intended for use in the electromagnetic environment specified below. The customer or user of the Sirona should assure that it is used in such an environment. Sirona User Manual

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Rev D02 Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Conducted RF 3 Vrms N/A IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m IEC 6100-4-3 80 MHz to 2.5 GHz 80 MHz to 2.5 3V/m GHz d d P 17.1 Portable and mobile RF communications equipment should be used no closer to any part of the Sirona, including cables, than the recommended separation distance calculated for the equation applicable to the frequency of the transmitter. Recommended separation distance. 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 on each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

MHz MHz GHz MHz 17.1 33.2 2.5 800 800 to 80 to P P d 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 access 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 Sirona is used exceeds the applicable RF compliance level above, the Sirona should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Sirona. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. Sirona User Manual

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Rev D02 Guidance and manufacturer's declaration - electromagnetic immunity The Sirona is intended for use in the electromagnetic environment specified below. The customer or user of the Sirona should assure that it is used in such an environment. IEC 60601 test Electromagnetic environment -

Compliance level guidance level Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 6100-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

+/- 6 kV contact

+/- 6 kV contact

+/- 8 kV air

+/- 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. N/A N/A N/A N/A N/A N/A

+/- 2 kV for power supply

+/- 1 kV for input/output

+/- 1kV line(s) to lines(s)

+/- 2kV line(s) to earth lines lines

<5 % UT

(>95% dip in UT) for 0,5 cycle 40% UT

(60% dip in UT) for 5 cycles 70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95% dip in UT) for 5 sec Power frequency

(50/60 Hz) IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic if a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level Recommended separation distances between portable and mobile RF communications equipment and the Sirona Sirona User Manual

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Rev D02 The Sirona is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sirona can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the Sirona as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 17.1 P 80 MHz to 800 MHz d 17.1 P 800 MHz to 5 GHz d 33.2 P 0.01 0.1 1 10 100 0.12 0.37 1.17 3.69 11.67 0.12 0.37 1.17 3.69 11.67 0.23 0.77 2.33 7.37 23.3 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. Sirona User Manual

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Rev D02 Page 13: [1] Deleted Nidhi Panday 7/24/2012 12:38:00 PM Record LED flashes green Number of flashes corresponds to the number of stored recordings[NP1]

None

8 7 6 4 3 2 ]

REVISION HISTORY PART # REV REV DESCRIPTION DRAFTER / DATE ENG. APPD / DATE Q.A. APPD / DATE ECO RX82820-001 Cc A |RELEASED TO ALPHA CONTROL G.CLARK 06/07/12 S.CZECK 06/07/12 R.HEFFERAN 06/07/12 38676 RX82820-002 Cc B_ |UPDATED FCC ID NUMBER G.CLARK 07/31/12 C.CONGER 08/06/12 { FFERAN 08/01/12 39198 C |UPDATED FCC ID# ON BOTH LABELS G.CLARK 09/06/12 39350

/\, READ MANUAL FIRST WARNING!

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| order of a physician,

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[REF] Model No, RX92369

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RX82820-001 RX82820-002 intriCon The Body-Worn Device Company ee EEN ETARY CORON OE TOL. UNLESS OTHERWISE SPECIFIED INTRICON CORPORATION, NOT TO BE USED XXX 4.005 FOR ANY PURPOSE UNAUTHORIZED BY UXXXX + 0005 INTRICON CORPORATION" ANGLE: + 1 Tm . nn a B LABEL ARTWORK - HAMMER PWM Sa MATERIAL FINISH Dwe~ ee REV THIRD ANGLE PROJECTION SEE BOM N/A RX82820 ecwmeeercti Cc . 3D MODEL / REV: / ROUEN: NA DO NOT SCALE DRAWING = SCALE: 1:1 SHEET 1 OF 1 8 Zi 6 5 : 4 3 2 t i

Attention:

Application Examiner Re: Request for confidentiality Applicant: IntriCon Corporation FCC ID: POMRX92369 To whom it may concern, Permanent Confidentiality Request is hereby submitted by IntriCon Corporation to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:

e Schematics e Detailed Block diagrams e Detailed Operational/Functional Description Rationale for request for confidentiality:

IntriCon Corporation has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. If you have questions or need further information, please contact the undersigned. Sincerely,

Letter of Agency I appoint Intertek Testing Services NA Inc. to act on our behalf in front of the Federal Communications Commission with respect to all matters relating to certification of equipment under the FCC rules until further notice. I further certify that no party (as defined in 1.2002 of CFR 47, 1995) to this application, including myself, is subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C.,853A. Equipment:

Sirona Dated this 28th day of June_,2012 _. Signature Name Product Development Engineer Title IntriCon Corporation Company 6516049534 Telephone