XOH-PIIXMobile Patient Management System

© Corventis 2010 Page 1 of 5 For US distribution (01/10) P00873-001 Rev. B AVIVO™ Mobile Patient Management System INSTRUCTIONS FOR USE Rx only Indications for Use The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO Mobile Patient Management System also monitors, derives and displays: • ECG • Heart Rate (including HR variability) • Activity • Posture • Body Temperature • Respiration rate (including RR variability) • Body fluid status Description of the Device The AVIVO Mobile Patient Management System includes: a) PiiX™ - an adherent patient-worn device containing multiple sensors used to track a suite of physiological parameters. PiiX can collect up to 72 ECG episodes. However, PiiX must be replaced after 7 days of use or when the end of life indicator appears. An end of life indicator as shown below, will light up when the PiiX needs to be replaced. b) zLink TM - a device that receives data from the PiiX and transmits to the Server. c) zLink Base – a charging station for the zLink. d) zLink Holster – a wearable holder for the zLink. e) Prep wipes – wipes used for cleaning the skin prior to applying the PiiX. The AVIVO System enables remote monitoring of physiological parameters in ambulatory patients to: a) facilitate patient and medical management, and b) assist physicians/health practitioners in the diagnosis and identification of various clinical conditions/events/trends. Contraindications 1. PiiX should not be used on patients with known allergies or hypersensitivities to adhesives or hydrogel. Precautions 1. PiiX should not be used on patients with implantable devices with active minute ventilation sensors. 2. PiiX may cause mild discomfort, skin irritation, redness, itching, rash, contact dermatitis in some individuals. The device should be removed if any pain or discomfort occurs. If skin irritation or redness persists after the device has been removed, a topical anti-inflammatory cream may be applied to the area (in consultation with your health care provider). 3. PiiX is intended for single patient use. 4. PiiX should be removed prior to external defibrillation or an MRI scan. 5. PiiX should not be applied to broken, damaged or irritated skin. 6. PiiX is water resistant but not waterproof. It should not be submerged in water (showering is acceptable, but swimming and submersion bathing are prohibited). 7. PiiX should not be disassembled. 8. Replace the PiiX if it peels off; do not reapply the PiiX. 9. Replace the PiiX if it appears damaged. 10. No creams or lotions should be applied immediately prior to use of PiiX. 11. This product is recommended for adult use. The AVIVO Patient Management System is not intended to replace direct communication with your healthcare provider. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis. Additionally, it will not summon emergency response personnel in the event you need help. Talk to your healthcare provider immediately if you have any concerns, or if your condition changes. The AVIVO System is not an emergency response service. Seek medical advice if you experience any symptoms that concern you. © Corventis 2010 Page 2 of 5 For US distribution (01/10) Step-by-step Operating Instructions – AVIVO Mobile Patient Management System No specific training is needed for the use of this system. zLink should be set-up first prior to PiiX application. zLink Set-up 1. Plug the zLink into a standard electrical outlet. 2. Dock zLink into the Base. The lights will automatically come on, confirming zLink is ON. Power Light: BLUE Light ON: Full charge confirmed AMBER Light ON: Low charge warning AMBER Light Flashing: Battery capacity less than 10%. Full charge may take up to 4 hours Cell Light: BLUE: Adequate cell coverage AMBER: No cell coverage. Move zLink to another location Other lights on the zLink are utilized only if troubleshooting is necessary. Refer to these lights only if asked by a Corventis Customer Service representative. zLink may also be turned ON and OFF manually. To turn zLink ON when zLink is not docked in the Base, press the round Power button located below the lights. All lights will come on, confirming zLink is ON. To turn zLink OFF, press the round Power button for several seconds until all the lights turn off. 3. To initiate use, charge the zLink for a minimum of 4 hours before removing it from the zLink Base Keep your zLink in the Base overnight, every night. With a full charge, the zLink will remain charged for up to 12 hours. Preferably, the zLink should be kept within 30 feet (9 meters) of the patient as much as possible to ensure data transmission. PiiX Application PiiX First device: 1. Trim (rather than shave) hair in intended location. Avoid moles and pimples. 2. Use alcohol wipe provided with PiiX to clean the skin where the device is intended to be applied. Allow the skin to dry. 3. Remove the PiiX from the foil pouch by tearing at the notch and apply immediately. 4. Remove the covers from the underside of the PiiX. © Corventis 2010 Page 3 of 5 For US distribution (01/10) 5. Handle the PiiX on the edges until the PiiX is placed on the skin. 6. Place the PiiX in a diagonal position only, oriented with Corventis at the top. Noting the picture below, place the device in the chest region, to the left of the sternum and starting at the clavicle (or collarbone) referred to as the ‘left quadrant’. 7. The PiiX must be in direct contact with the skin. Once applied, press the edges firmly against the skin. Look for these indicators to appear on the PiiX display: PiiX Removal: 1. Peel back the edge of the PiiX. Slowly and gently push the skin away from the PiiX as it is removed. Rapid removal can cause skin irritation. 2. If the PiiX does not peel easi…

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XL 1MHz FBUS Flash 1MHz FBUS Bluetooth LMX9830 2.402 – 2.480 GHz 12Bit ADC 1MHz FBUS Microchip Pic32 32KHz Ext Crystal 8MHz Internal VBATT Temperature ECG BIOZ LPF HPF Instrumentation Amplifier SPI BUS SPI 10 B I T A D C V+ V- The components are described as follows PIC32 PIC32MX340 is used as the central processor. It is a 32-bit, low power RISC processor with the enhanced MIPS32® Release 2 Instruction Set Architecture. Several internal modules from the PIC are used to interface to the external components in the adherent device. oA2D (ADC) The microcontroller has an internal 10 bit analog to digital converter which receives analog ECG signal, the temperature output and ½ battery voltage. oUART UART2 is used as a communication link by the bluetooth module oSPI Serial Peripheral Interface (SPI) bus is used to handle the link between flash, external ADC and accelerometer. It operates at 1 MHz External ADC A 12-bit external ADC is interfaced to the PIC32 chip using the SPI bus. It’s input is analog BIOC signal. Flash The on-board flash can store 4 MBytes of data Bluetooth Serial transmission between the adherent device and the gateway is carried out over a Bluetooth link. LMX 9830 Bluetooth Serial Port module is the RF transceiver used for this communication. ECG and BioConductance The electrical signal received is amplified by an Instrumentation amplifier. The amplified signal is passed through both a high pass (HPF) and a low pass filter (LPF). The HPF output gives the BioConductance signal which is digitized by the external ADC, while LPF gives the ECG signal which is given to the internal ADC. XL The accelerometer is used to detect change in physical position.

Piix – External Photo Figure 1: External Photo of PiiX – Top View Figure 2: External Photo of PiiX – Bottom View

PiiX Internal Photo Figure 1: Internal photo of PiiX – PCB Component Side TX Antenna Figure 2: Internal photo of PiiX – PCB Soldered Side Figure 3: Internal photo of PiiX – Battery

The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. Report Number: 30950536.001 Page 1 of 73 EUT: Adherent Device of GEN 1 AVIVO Mobile Patient Management System Model: PiiX EMC / Rev 11/9/2009 FCCID: XOH-PIIX Emissions Test Report EUT Name: Adherent Device of GEN 1 AVIVO Mobile Patient Management System Model No.: PiiX CFR 47 Part 15.247 2008 and RSS 210: 2007 Prepared for: Ashish Bhargava Corventis, Inc. 1410 Energy Park Drive, Suite #1 St. Paul, MN 55108 Tel: (651)-925-3758 Fax: (615) 389-3251 Prepared by: TUV Rheinland of North America, Inc. 1279 Quarry Lane Pleasanton, CA 94566 Tel: (925) 249-9123 Fax: (925) 249-9124 http://www.tuv.com/ Report/Issue Date: 6 April 2009 Report Number: 30950536.001 Statement of Compliance The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. Report Number: 30950536.001 Page 2 of 73 EUT: Adherent Device of GEN 1 AVIVO Mobile Patient Management System Model: PiiX EMC / Rev 11/9/2009 FCCID: XOH-PIIX Manufacturer: Corventis, Inc. 1410 Energy Park Drive, Suite #1 St. Paul, MN 55108 (651)-925-3758 Requester / Applicant: Ashish Bhargava Name of Equipment: Adherent Device of GEN 1 AVIVO Mobile Patient Management System Model No. PiiX Type of Equipment: Intentional Radiator Application of Regulations: CFR 47 Part 15.247 2008 and RSS 210: 2007 Test Dates: 24 March 2009 to November 6 2009 Guidance Documents: Emissions: AN C63.4: 2003 Test Methods: Emissions: AN C63.4: 2003 The electromagnetic compatibility test and documented data described in this report has been performed and recorded by TUV Rheinland, in accordance with the standards and procedures listed herein. As the responsible authorized agent of the EMC laboratory, I hereby declare that the equipment described above has been shown to be compliant with the EMC requirements of the stated regulations and standards based on these results. If any special accessories and/or modifications were required for compliance, they are listed in the Executive Summary of this report. This report must not be used to claim product endorsement by NVLAP or any agency of the U.S. Government. This report contains data that are not covered by NVLAP accreditation. This report shall not be reproduced except in full, without the written authorization of TUV Rheinland of North America. Jeremy Luong November 6 2009 Sarbjit Shelopal November 6 2009 Test Engineer Date NVLAP Signatory Date Industry Canada NVLAP CODE 500011-0 US5251 2932D-1 Table of Contents The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. Report Number: 30950536.001 Page 3 of 73 EUT: Adherent Device of GEN 1 AVIVO Mobile Patient Management System Model: PiiX EMC / Rev 11/9/2009 FCCID: XOH-PIIX 1 Executive Summary _______________________________________________________ 7 1.1 Scope______________________________________________________________________ 7 1.2 Purpose____________________________________________________________________ 7 1.3 Summary of Test Results _____________________________________________________ 7 1.4 Special Accessories __________________________________________________________ 8 1.5 Equipment Modifications _____________________________________________________ 8 2 Laboratory Information ____________________________________________________ 9 2.1 Accreditations & Endorsements _______________________________________________ 9 2.1.1 US Federal Communications Commission _______________________________________________9 2.1.2 NIST / NVLAP ____________________________________________________________________9 2.1.3 Canada – Industry Canada ___________________________________________________________9 2.1.4 Japan – VCCI _____________________________________________________________________9 2.1.5 Acceptance by Mutual Recognition Arrangement _________________________________________9 2.2 Test Facilities ______________________________________________________________ 10 2.2.1 Emission Test Facility_____________________________________________________________10 2.2.2 Immunity Test Facility_____________________________________________________________10 2.3 Measurement Uncertainty ___________________________________________________ 10 2.4 Calibration Traceability _____________________________________________________ 11 3 Product Information______________________________________________________ 12 3.1 Product Description ________________________________________________________ 12 3.2 Equipment Configuration ___________________________________________________ 12 3.3 Operating Mode ___________________________________________________________ 12 3…

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Test Setup Photo Figure 1: Photo of Test Setup for PiiX, 30 MHz to 1000MHz (Front View) Figure 2: Photo of Test Setup for PiiX, 30 to 1000 MHz (Rear View) Figure 3: Photo of Test Setup for PiiX, 1GHz to 18GHz (Front View) Figure 4: Photo of Test Setup forPiiX, 1GHz to 18GHz (Rear View) Figure 5: Photo of Test Setup for PiiX, 18 GHz to 26GHz (Front View) Figure 6: Photo of Test Setup for PiiX, 18 GHz to 26GHz (Rear View)