TABLE OF CONTENTS. Physician's Manual. I. Device Description 2. II. Intended Use 5. III. Contraindications 5. IV. Warnings and Precautions 5

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2 TABLE OF CONTENTS SECTION Page I. Device Description 2 II. Intended Use 5 III. Contraindications 5 IV. Warnings and Precautions 5 V. Adverse Events 5 VI. Clinical Trials 5 VII. Patient Information 6 VIII. Information Supplied to the Physician 6 IX. Compliance to Standards 10 X. How the Device is Supplied 10 XI. System Specifications 11 Appendix A. Instructions for Use (Patient's Manual) 12 1

3 I. DEVICE DESCRIPTION NovaSom QSG is a multi-channel ambulatory recording system designed to diagnose Obstructive Sleep Apnea. The system detects apneas and hypopneas, and measures respiration airflow, oxygen saturation, pulse rate, respiration effort and snoring (respiratory) sound intensity. Sleep Solutions, Inc. has developed unique and proprietary audio digital signal processing (DSP) technologies for sensing, analyzing and processing respiratory sounds and converting these sounds to airflow volume. This computer technology utilizes active noise suppression as a method for attenuating ambient noise and to enhance respiration signals. The use of pattern recognition and signal extraction methodologies from noisy backgrounds together with sensor development is the technological foundation of the NovaSom QSG The NovaSom QSG utilizes three sensors: Respiration airflow sensor (nasal and oral airflow plus the ambient noise sensor) Respiration effort sensor Pulse oximeter sensor (blood oxygen saturation level and pulse rate measurement) The Bedside Unit (BU) houses the signal processing and recording circuitry. It resides next to the bed while the portable unit called the Patient Module (PM) is placed on the wrist or arm of the patient. The PM sends the collected sensor information to the BU via a cable as shown in Figure 1. The BU has only two buttons to operate: On/Off and START. Also located on the front of the BU are status lights and bar graphs enabling the user to insure that they have placed the sensor properly. When the patient is ready to sleep, the START button is pressed and the unit begins recording that night s sleep study for up to 8 hours. The study may be temporarily interrupted by unplugging and replugging the connector cable. Throughout the study, sleep breathing information and statistics are stored into the BU memory. The stored information includes time, number, duration and type of apneas and hypopneas, heart rate, oxygen saturation, sound intensity levels, and paused time intervals. The NovaSom QSG has a nonvolatile battery powered RAM memory chip (NVRAM) that can store three 8-hour sleep studies. The NovaSom QSG notes the start of a study (with a time stamp) when the start button is pressed. The System will not start recording data until 10 minutes after the START button has been pressed. This allows the patient time to fall asleep. After operating for 8 hours the system stops collecting data and notes the end of a study with a time stamp. If the study duration is less than 8 hours, the system will stop processing data when the patient removes the sensors or presses the Off button. A proprietary software program, the NovaSom Study Viewer is utilized to retrieve, post-process, display and print the collected data on a personal computer platform. A graphical summary of each night, a numerical summary report of all nights and a detailed event report are provided to view the sleep data. 2

4 Respiration (Breath) Sensor Respiration Effort (Chest) Sensor Connector Cable Bedside Unit (BU) Patient Module (PM) Pulse Oximeter (Finger) Sensor Figure 1 - The NovaSom QSG Components THE SENSORS The NovaSom QSG contains three sensors producing five physiologic data points: The respiration sensor monitors the respiratory airflow volume and snoring (in dba ), the pulse oximeter collects data for monitoring the heart rate and blood oxygen desaturation, and the respiratory effort sensor data is used to measure the respiratory effort. All three sensors are disposable. The Respiration Airflow Sensor Oral and Nasal Respiration The Novasom QSG respiration sensor is a small flexible device that sits above the upper lip. When airflow from the nose or the mouth passes over the device, turbulence is created. This unique design makes it highly sensitive to respiratory airflow. The respiration sensor contains two microphones (see Figure 2). One microphone is dedicated to collecting the respiration airflow and the other is placed outside the air stream area to sense the ambient room noise and the instantaneous sound field for respiratory (snoring) sound intensity level dba. 3

5 Nasal Airflow Ambient Microphone Airflow Microphone Ambient Sound The ambient microphone collects snoring and ambient sound intensity dba. It is placed outside the air stream in order to avoid the turbulence and vibrations generated by direct exposure to airflow. The sensor is a proximity microphone predominantly receiving snoring sounds and ambient noise. The assembly is mechanically isolated from the airflow sound sensor assembly in order to minimize acoustical coupling. Proprietary active noise cancellation technology uses these signals to isolate the respiratory sounds from other sound energy in the room. The Pulse Oximeter Sensor The pulse oximeter channel specifications are listed in Section XI. The pulse oximeter circuitry is located in the Patient Module and processes the signals collected by the disposable finger sensor. Both the oximeter and the pulse sensor are made by Nonin Medical, Inc. The input signals are digitized and sent to the BU for recording. The Respiratory Effort Sensor Oral Airflow The respiratory effort sensor measures chest motion during breathing. Chest motion is correlated with changes in the volume of the thoracic cavity. The chest sensor enables the detection of obstructive apneas which is indicted by chest effort with no airflow. The respiratory effort sensor is made of Tygon tubing, which ends in a pressure sensor located in the Patient Module. Changes in the tubing diameter during respiration alter the air pressure in the tubing. The air pressure data is analyzed in the BU. The respiratory effort sensor has been designed so that it is simple, accurate and convenient to use. The sensor readings have been validated against conventional piezo-electric-based abdominal and thoracic effort sensors. 4

6 II. INTENDED USE The NovaSom QSG is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The NovaSom QSG System can score obstructive apneas, which includes mixed apneas. III. CONTRAINDICATIONS There are no contraindications for use of the NovaSom QSG. IV. WARNINGS AND PRECAUTIONS NovaSom QSG is not intended for use with infants or children NovaSom QSG is not an apnea monitor and only records breathing sounds, blood oxygen and respiratory effort NovaSom QSG has no alarms and should not be used as an apnea monitor NovaSom QSG should not be used in a noisy environment NovaSom QSG Finger Sensor cannot be used with any dark color fingernail polish (i.e. blue, black, purple, deep red) NovaSom QSG should not be used by someone with long fingernails V. ADVERSE EVENTS No adverse events have been reported to date. VI. CLINICAL TRIALS An independent investigator (David Claman, M.D., UCSF/Mt. Zion Sleep Disorders Center, San Francisco) conducted a clinical trial using the NovaSom QSG in a sleep laboratory, Comparing the accuracy of the Novasom QSG to the conventional polysomnography (PSG System 4100) in recording apnea and hypopnea events 1 Forty-two volunteer subjects were enrolled from a symptomatic patient population already scheduled for a formal sleep study at UCSF/Mt. Zion Sleep Disorders Center. Novasom QSG data was collected simultaneously with the formal sleep study using the PSG. The data was compared on an event-by-event basis. The Apnea-Hypopnea Index (AHI) was determined and compared with the AHI from the PSG using the Pearson s correlation coefficient. Using an AHI cutoff of 15 for the detection of obstruction sleep apnea, specificity was 95% and sensitivity was 86%. The correlation coefficient between the PSG and the NovaSom QSG System was Claman, et al. Clinical Validation of the Bedbugg in detection of obstructive sleep apnea. Journal of Otolaryngology - Head and Neck Surgery, Volume 125 No. 3 pp

7 VII. PATIENT INFORMATION There are only two buttons on the Bedside Unit for the patient to operate (On/Off and START). The NovaSom QSG is a voice-guided system. Patients should be informed that they might be awakened during the night by the voice prompts from the system if a sensor becomes misplaced. The patient should be reminded that the operation of the device depends on sound so it is important to operate it in a quiet environment. VIII. INFORMATION SUPPLIED TO THE PHYSICIAN Reading the Sleep Summary The Sleep Study Summary consists of three sections Graphical summary page, one per night Numerical summary page, one per study Detailed event report, optional (available via website, or per request) If a sleep study is performed for three nights, the report starts with three graphical summary pages, followed by one numerical three-night summary page, followed by the optional detailed event report. The graphical summary page provides the physician a visual summary of a study night. In order to provide the physician with a detailed view, the SpO2 and snoring dba curves are divided into two four hour segments as indicated by [1] and [2] in Figure 3. The upper graph [3] contains SpO2 and snoring dba curves whereas the lower graph [4] shows apnea and hypopnea events. The apnea events are denoted by a red bar whose length is proportional to the duration of the event, while a blue bar is used for the hypopnea events. Obstructive apneas are denoted by a on top of the red bar and an unclassified apnea is denoted by a on top of the red bar. The statistical information is tabulated at the lower part of this page. The numerical summary page lists all the data for each night as well as cumulative/average data (See Figure 4). Each night s statistics are given in a separate column. The study duration and number of times a patient unplugs the PM from the BU are shown, as well as invalid sensor information. Two AHI's are given using two different criteria (< 2% and < 4% 0 2 desaturation) for defining hypopneas (rows [5] and [6]). This information is followed by the heart rate and snoring intensity [7]. The duration of the snoring level greater than 50 dba corresponds to audible levels heard by the bed partner. The detailed event report (optional) provides complete descriptions of each apnea or hypopnea event (See Figure 5). Time, duration, SpO2 value and amount of drop from the baseline are indicated in [8]. Time of the night [9], SpO2 level [10], and heart rate [11] are displayed at one minute intervals. The physician uses the data in the Sleep Study Summary to generate a physician interpretation (report). 6

8 Figure 3: Graphical Summary 7

9 5 6 7 Figure 4: Numerical Sleep Study Summary 8

10 Figure 5: Detailed Event Report 9

11 IX. COMPLIANCE TO STANDARDS The design of the NovaSom QSG meets the following standards for medical device performance: EN , "Medical And Electrical Equipment, Part 1: General Requirements For Safety, 2. Collateral Standard: Electromagnetic Compatibility Requirements And Tests", dated May 1993 EC-68-2 "Basic Environmental Test Procedures" ISO "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" NovaSom QSG is UL Listed (96ZJ) X. HOW THE DEVICE IS SUPPLIED Ordering the NovaSom QSG for a Sleep Study Sleep Solutions has simplified the entire sleep study process for both the patient and the physician. After an order has been placed via telephone, fax, or the Internet, the NovaSom QSG will be shipped directly to the patient s home. This service approach relieves the physician of any involvement with purchasing or maintaining equipment and obviates any need for additional office staff or space. The NovaSom QSG is packed in a molded-foam shipping box. The box contains the following items: Bedside Unit Patient Module with Wrist Strap Connector Cable Power Supply Breath Sensor Chest Sensor Finger Sensor Medical Tape Instructions for Use & Quick Guide Instructional Video Return Instructions with a Return Waybill Questionnaire Packet All items are packed into compartments in the molded foam. The breath, finger and chest sensors are supplied in individual bags. The system contains several disposable items: the three body sensors and the patient module wrist strap. A pre-printed, return airwaybill is included in the shipping box for the patient to use for the return of the system. We ask the patient to complete a questionnaire packet that will provide the physician with additional patient reported health information. There are four specific questionnaires: the Epworth Sleepiness Scale, the Functional Outcomes of Sleep (FOSQ), and the NovaSom QSG Morning Follow-up and Easeof-Use Questionnaires. The results will be faxed or mailed to the physician. Sleep Solutions will conduct a six-month follow-up of patients. The questionnaire packet is an important aid in sleep-associated diagnosis and therapy and supports complete disease state management. After three nights of study, the patient returns the system to Sleep Solutions in the provided shipping box. Sleep Solutions then uploads the data and immediately reports the results to the physician. The sleep study summary is posted electronically at a firewall-protected web location accessible only by the physician. 10

12 XI. SYSTEM SPECIFICATIONS Available Signals: Airflow Respiratory Sounds Snoring Level Oximeter Heart Rate Memory Capacity: More than 3 X 8 hours Snoring Level: Frequency Response: 20 to 2600 Hz Detection Range: 40 to 90 dba - scale; ±1 db Calibration: Adjusted to reflect measurements made 2 feet from the source. SpO2 Channel: Oxygen Saturation Range 50 to 100% Pulse Rate Range 18 to 300 pulses per minute Measurement Wavelengths Red Nanometers Infrared Nanometers Accuracy (±1 Standard Deviation) % ±3 digits for adults using Flex or Reflectance Sensors Rate ±3% ±1 digit Patient Isolation Greater than 12 mega ohms Leakage Current Not applicable Shielding: An RF shield is included over the analog components Temperature: Operating 0 C to +50 C Non Operating -20 C to +50 C Humidity: Operating 10 to 90% Non-Condensing Non-Operating 10 to 95% Non-Condensing Dimensions: Bedside Unit: 8.55 X 7.30 X 2.78 inches Patient Module: 3.95 X 2.83 X 1.16 inches Weight: Bedside Unit: 2 pounds 2 oz Patient Module: 4.1 oz Power: AC power, V, 47-63Hz. 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. 11

13 2450 El Camino Real, Suite 101, Palo Alto, CA toll free phone: p f Sleep Solutions and NovaSom QSG are trademarks of Sleep Solutions, Inc M 3/02