SEBVMW03VMW03

FCC submission Product Manual October 21, 2004 Medic4All Ltd. POB 4222 Petach Tikva, Israel 49000 Medic4All Telemedicine Solutions Operation Manual MiniClinic™ - VMW03 Pulse, Breathing, ECG and Temperature Monitor Caution: Federal law restricts this device to sale by or on the order of a physician. Overview The MiniClinic™ is a wireless medical monitoring and distress alarm device. It measures, stores and transfers vital signs data to a medical monitoring center using the MedicGate™ or MiniGate™. Please read this booklet carefully in order to achieve best performance of this medical monitoring device MiniClinic™ Features Medical monitoring parameters: • Pulse rate • Heart rhythm regularity • Breathing rate • One lead ECG • Body thermometer Water proof CE standard compliant under the Euro Medical Device Directive Warnings & Precautions Consult your local provider concerning any operational difficulties. Do not attempt to repair the MiniClinic™ on your own. Any modifications made to the equipment void the device warranty and service contract obligations. Keep the MiniClinic™ away from electro-magnetic emitting devices. Do not store the MiniClinic™ in direct sunlight, at a high temperature, or in a location with excessive humidity. Avoid any mechanical shock to the MiniClinic™ such as a harsh drop. Use of this device is not intended as a substitute for consulting with your physician, since additional measurements to those supplied by the MiniClinic™ may be necessary. Disposal of this product and used batteries should be carried out in accordance with the relevant national regulations. Part Identification Wearing the MiniClinic™ Golden Metal Plates Wrist Strap Operation Button Temperature Probe LED Indicator The MiniClinic™ resembles an ordinary wristwatch with wrist strap. Wear it on your wrist similarly to an ordinary wristwatch. Strap the MiniClinic™ around the outer side of your right wrist, as shown in the picture. The strap should be adjusted and tightened gently for personal comfort. Do not apply excessive force as it might restrict the blood flow. Operating the MiniClinic™ - ECG, Heart Rate and Breathing Rate Monitoring To initiate a heart rate and breathing rate monitoring session, please do the following: Sit comfortably on a chair with both feet placed on the floor. Do not cross your legs. Make sure the MiniClinic™ is well strapped onto your wrist. Place your right hand (wearing the MiniClinic™) on top of your abdomen, as shown below. While the MiniClinic™ is placed on middle abdominal line, use your left hand to press the operation button lightly (less than 1 second) – the unit should sound a short beep and the Green LED will start blinking once every second. Quickly place your left hand over the right hand as seen in the picture below. Make sure that the palm of your left hand is in contact with the two golden metal plates of the MiniClinic™. The measurement period lasts about 60 seconds. Please make sure that you sit comfortably, and minimize your movement during the measurement. Moistening the palm of your left hand, which is in contact with the two golden metal plates of the MiniClinic™, with a wet cloth will help to improve the quality of the ECG measurement. Strongly pressing the button interferes with the measurement. Pressing the button for more than 2 seconds initiates the distress function in the MiniClinic™. Make sure not to press the button for more than 2 seconds. While the measurement reading is in progress (approx. 60 seconds) the green LED should blink once every second. At the end of the reading, the MiniClinic™ will beep three times and the green LED will turn off. Once the LED is off, you no longer have to sit still. The MiniClinic™ will transmit the data automatically. Operating the MiniClinic™ - Temperature Measurement To initiate a temperature measurement session, please do the following: Take off the MiniClinic™ from your wrist. Expose the temperature probe from the wrist strap. If desired, place a hygiene thermal sheath over the temperature tip. Put away the protective plastic that covers of the thermal sheath. Press the operation button lightly (less than 1 second) – the unit should sound a short beep and the green LED will blink once every second. Press the operation button again – the unit should sound a short beep and the green LED will blink twice every second. Important! For accurate measurement to take place, sit calmly and try to keep still. Avoid talking or moving until the measurement period is over. Hold the probe about four centimeters from the tip. You can place the thermometer under your armpit or in your mouth. Oral temperature check: Position the tip of the thermometer in one of the two pockets under your tongue. The tip must be in good contact with the tissue. Close your mouth and breath through the nose. Axillary temperature check: Raise your other hand and place the tip at the center of your other hand armpit. Return your other hand to its natural position. Keep still through the whole measurement While measuring the MiniClinic™ green LED will blink twice every second. The measurement lasts about 60 seconds. At the end of the measurement, the MiniClinic will beep three times and the green LED will turn off. Once the LED is off, you no longer have to sit still. The MiniClinic™ will transmit the data automatically. Insert the temperature probe back to the wrist strap. Pressing the button for more than 2 seconds, initiates the distress function in the MiniClinic™. Make sure not to press the button for more than 2 seconds. Medic4All recommends verifying the temperature accuracy by an authorized laboratory every 2 years. Important! For accurate measurement to take place, make sure the temperature tip is in good contact with your armpit. Press the tip slightly against the armpit to gain best results. The performance of the MiniClinic™ may be degraded should the user temperature be below the ambient temperature. The thermometer is suitable excl…

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FCC submission Product Manual October 21, 2004 Medic4All Ltd. POB 4222 Petach Tikva, Israel 49000 Medic4All Telemedicine Solutions Operation Manual MiniClinic™ - VMW03 Pulse, Breathing, ECG and Temperature Monitor Caution: Federal law restricts this device to sale by or on the order of a physician. Overview The MiniClinic™ is a wireless medical monitoring and distress alarm device. It measures, stores and transfers vital signs data to a medical monitoring center using the MedicGate™ or MiniGate™. Please read this booklet carefully in order to achieve best performance of this medical monitoring device MiniClinic™ Features Medical monitoring parameters: • Pulse rate • Heart rhythm regularity • Breathing rate • One lead ECG • Body thermometer Water proof CE standard compliant under the Euro Medical Device Directive Warnings & Precautions Consult your local provider concerning any operational difficulties. Do not attempt to repair the MiniClinic™ on your own. Any modifications made to the equipment void the device warranty and service contract obligations. Keep the MiniClinic™ away from electro-magnetic emitting devices. Do not store the MiniClinic™ in direct sunlight, at a high temperature, or in a location with excessive humidity. Avoid any mechanical shock to the MiniClinic™ such as a harsh drop. Use of this device is not intended as a substitute for consulting with your physician, since additional measurements to those supplied by the MiniClinic™ may be necessary. Disposal of this product and used batteries should be carried out in accordance with the relevant national regulations. Part Identification Wearing the MiniClinic™ Golden Metal Plates Wrist Strap Operation Button Temperature Probe LED Indicator The MiniClinic™ resembles an ordinary wristwatch with wrist strap. Wear it on your wrist similarly to an ordinary wristwatch. Strap the MiniClinic™ around the outer side of your right wrist, as shown in the picture. The strap should be adjusted and tightened gently for personal comfort. Do not apply excessive force as it might restrict the blood flow. Operating the MiniClinic™ - ECG, Heart Rate and Breathing Rate Monitoring To initiate a heart rate and breathing rate monitoring session, please do the following: Sit comfortably on a chair with both feet placed on the floor. Do not cross your legs. Make sure the MiniClinic™ is well strapped onto your wrist. Place your right hand (wearing the MiniClinic™) on top of your abdomen, as shown below. While the MiniClinic™ is placed on middle abdominal line, use your left hand to press the operation button lightly (less than 1 second) – the unit should sound a short beep and the Green LED will start blinking once every second. Quickly place your left hand over the right hand as seen in the picture below. Make sure that the palm of your left hand is in contact with the two golden metal plates of the MiniClinic™. The measurement period lasts about 60 seconds. Please make sure that you sit comfortably, and minimize your movement during the measurement. Moistening the palm of your left hand, which is in contact with the two golden metal plates of the MiniClinic™, with a wet cloth will help to improve the quality of the ECG measurement. Strongly pressing the button interferes with the measurement. Pressing the button for more than 2 seconds initiates the distress function in the MiniClinic™. Make sure not to press the button for more than 2 seconds. While the measurement reading is in progress (approx. 60 seconds) the green LED should blink once every second. At the end of the reading, the MiniClinic™ will beep three times and the green LED will turn off. Once the LED is off, you no longer have to sit still. The MiniClinic™ will transmit the data automatically. Operating the MiniClinic™ - Temperature Measurement To initiate a temperature measurement session, please do the following: Take off the MiniClinic™ from your wrist. Expose the temperature probe from the wrist strap. If desired, place a hygiene thermal sheath over the temperature tip. Put away the protective plastic that covers of the thermal sheath. Press the operation button lightly (less than 1 second) – the unit should sound a short beep and the green LED will blink once every second. Press the operation button again – the unit should sound a short beep and the green LED will blink twice every second. Important! For accurate measurement to take place, sit calmly and try to keep still. Avoid talking or moving until the measurement period is over. Hold the probe about four centimeters from the tip. You can place the thermometer under your armpit or in your mouth. Oral temperature check: Position the tip of the thermometer in one of the two pockets under your tongue. The tip must be in good contact with the tissue. Close your mouth and breath through the nose. Axillary temperature check: Raise your other hand and place the tip at the center of your other hand armpit. Return your other hand to its natural position. Keep still through the whole measurement While measuring the MiniClinic™ green LED will blink twice every second. The measurement lasts about 60 seconds. At the end of the measurement, the MiniClinic will beep three times and the green LED will turn off. Once the LED is off, you no longer have to sit still. The MiniClinic™ will transmit the data automatically. Insert the temperature probe back to the wrist strap. Pressing the button for more than 2 seconds, initiates the distress function in the MiniClinic™. Make sure not to press the button for more than 2 seconds. Medic4All recommends verifying the temperature accuracy by an authorized laboratory every 2 years. Important! For accurate measurement to take place, make sure the temperature tip is in good contact with your armpit. Press the tip slightly against the armpit to gain best results. The performance of the MiniClinic™ may be degraded should the user temperature be below the ambient temperature. The thermometer is suitable excl…

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VMW03 block diagram. Enable SPI bus Temperatur e Sensor Touch detector ECG & Activation Leads Analog input SPI bus Piezzo sensor 3 x Silver Oxide batteries Reference input Enable Analog input MSP430F149 Chipcon CC1020 RF transceiver Activation button Wire antenna LEDs Amplifier / filter 3.6V regulator Serial FLASH Amplifier / filter Activation comparator Temperature Amplifier Analog in put

Medic4All Ltd. Hamefalsim 10, P.O.B 4222, Petach Tikva, 49000, Israel. Tel: 972-3-9226610 Fax: 972-3-9226615 To: FCC Equipment Authorization Branch Attn: Ms. Linda Elliot [email protected] From: Rami Shmueli [email protected] Medic4All Applicant: Medic4All FCC ID: SEBVMW03 Date: 15 December, 2004 Correspondence Reference Number: 28085 Subject: Confidentiality request Letter Dear Linda Elliot, 1. We request to keep the exhibit of the Schematics confidential. 2. The schematics are of no interest for the public and can be used by potential competitors for copying our products. 3. This request is made under the provisions of Section 0.457(d) of the Commission's Rules, and Section 552(b)(4) of the Freedom of Information Act. 4. I, the undersigned, am listed on Form 731 of the application. Sincerely yours, Rami Shmueli Medic4All VP R&D

External photo VMW03 overall view.

VMW03 Label

Internal photo VMW03 internal view.

VMW03 operational description The VMW03 is a medical wrist unit which performs the following measurements: panic button, ECG, heart rate, breathing rate, heart rhythm regularity and body temperature. The VMW03 communicates with the MedicGate (VMG02) and with the MiniGate (VMG03) via RF protocol. The VMW03 dimensions: 26 cm x 4.5 cm x 2 cm, approx. The VMW03 is powered from three 1.5V type 389 silver-oxide batteries. The VMW03 current consumption is up to 40 mA. The VMW03 block diagram and RF transceiver block diagram are shown in Figures 1 and 2, respectively. The VMW03 transceiver is based on chipset Chipcon CC1020. The transceiver uses one channel. Integral antenna – wire, about 8 cm length The antenna cannot be de-attached or changed by the user. RF communication frequency: 915 MHz. Output transmission power: -1 dBm (EIRP) Baud rate: 9.6 Kbps Modulation type: FSK Bandwidth: 50 kHz The VMW03 field strength is less than 50 mV/m at 3 meters and meets the requirements of paragraph (a) of section 15.249. Figure 1. VMW03 block diagram Enable SPI bus Temperatu re Sensor Touch detector ECG & Activation Leads Analog input SPI bus Piezzo sensor 3 x Silver Oxide batteries Reference input Enable Analog input MSP430F149 Chipcon CC1020 RF transceiver Activation button Wire antenna LEDs Amplifier / filter 3.6V regulator Serial FLASH Amplifier / filter Activation comparator Temperature Amplifier Analog in put The following are the main components shown in the block diagram: ∗ TI MSP430F149 micro controller has the following features: • 60K byte FLASH memory • 2048 byte RAM • 16 bit architecture • Up to 8 MIPS (8 MHz) • 12 bit A/D converter • 2 timers • UART/SPI • Watch dog • 48 digital I/O control lines ∗ The MSP430F149 is the CPU of the VMW03 and performs the following tasks: • Communicates with the Chipcon CC1020 RF transceiver. • Detects when the battery voltage drops below 2.9V, disables the RF transceiver. • Measures the regulated voltage value during RF transmission for providing an indication when the batteries need to be replaced. • Three analog inputs: regulator output as the reference voltage, pressure sensor (Piezo) output from the pre-amplifier and ECG analog output from the ECG amplifier/filter. • Green LED output • Red LED output • Real Time Clock – maintains the time and date. The RTC is used for generating time stamp for the measurements and for scheduling software events. • ECG touch detect input – detects when the patient is touching the ECG electrodes • Activation button input (interrupt) ∗ The Chipcon CC1020 is an RF transceiver supporting up to 153.6Kbps. In the VMW03 project it operates at 9.6Kbps at 915MHz. ∗ Piezo-electric sensor – mounted on a metal plate, the Piezo translates mechanical displacement due to breathing into voltage changes. The Piezo also serves as a buzzer and is connected to the MSP430F149 using a capacitor. The capacitor reduces the load from the Piezo when the buzzer is not activated. The metal plate of the Piezo also serves as the third ECG lead. ∗ Input amplifier / filter – high impedance amplifier, followed by a 20 Hz low-pass filter (anti-aliasing filter). The module is powered by the regulator output. ∗ ECG sensor – 2 copper with gold-coated leads mounted on the wristwatch upper surface and additional lead located at the lower side of the wristwatch. (The lower side lead is the same metal plate, which is connected to the Piezo sensor). The ECG amplifier measures the voltage potential between two hands, filter it between 0.05Hz to 40 Hz and amplify by 310. The analog output signal is transferred to the MSP430F149 A/D input, for sampling, decimation and transmitting by the CC1020. The ECG circuit is powered by the regulator output. ∗ Temperature sensor – thermistor, located at the edge of the wristband. ∗ Temperature amplifier – high impedance amplifier, followed by a 1 Hz low-pass filter. The module is powered by the regulator output. ∗ Serial FLASH – 128Kbyte up to 1 Mbyte (assembly option) serial FLASH ∗ 3.3V regulator – a low drop regulator that regulates the battery into stable 3.3V. The regulator is activated or put into standby mode by the MSP430F149. The regulator feeds the CC1020, Serial FLASH and analog circuits. ∗ A dedicated circuit feeds the MSP430F149 from two batteries (through a diode) during sleep mode and from the regulator output through a FET during operation. This enables to reduce the power consumption during sleep mode. ∗ 3 Silver-Oxide batteries, generating a voltage between 4.1V and 4.6V at 85 mAh. The batteries are attached to the board using battery clips and can be replaced without soldering. ∗ Activation button – wakes the MSP430F149 from sleep mode to perform the measurement. Figure 2. Tx-Rx block diagram

Test Report No.8412305151 For Medic4All (Israel) Ltd. Equipment Under Test: MiniClinic Model: VMW03 (915 MHz) From The Standards Institution Of Israel Industry Division Telematics Laboratory EMC Section Certificate No. 1487-01 Test Report No.: 8412305151 Page 1 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) Order placed by: Medic4All (Israel) Ltd. Address: 10 Hamefalsim Str., P.O. Box 4222, Petach-Tikva 49000, Israel Sample for test selected by: The customer The date of test: 31/03, 10, 12, 15/05/2004 Description of Equipment Under Test (EUT): MiniClinic Model: VMW03 (915 MHz) Manufactured by: Medic4All (Israel) Ltd. Reference Documents:
CFR 47 FCC: Rules and Regulations; Part 15. “Radio frequency devices”; Subpart B. “Unintentional Radiators”. Section 15.109. “Radiated emission limits”. Subpart C: “Intentional radiators” (2002), Section 15.205. “Restricted bands of operations”, Section 15.209. “Radiated emission limits, general requirements”. “Radiated Emission Limits, Additional Provisions”; Section 15.249. “Operation within the bands 902 - 928 MHz, 2400 - 2483.5 MHz, 5725 - 5875 MHz, and 24.0 - 24.25 GHz”. Test Results: The EUT meets the following requirements of CFR 47 FCC Part 15: Subpart B: Section 15.109. Radiated emission Class B Subpart C : Section 15.209. Radiated emission Section 15.429 (a), Section 15.205. This Test Report contains 24 pages and may be used only in full. This Test Report applies only to the specimen tested and may not be applied to other specimens of the same product. Test Report No.: 8412305151 Page 2 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) Table of Contents 1. EUT Description and operation 3 1.1. General description: 3 1.2. Potential emission sources: 8 1.3. EUT setup and operation: 8 2. Measurements, examinations and derived results 9 2.1. Location of the Test Site: 9 2.2. Test condition: 9 2.3. Initial visual check and functional test: 9 2.4. Radiated emission test: 10 2.5. Test of field strength of emission from intentional radiators 12 3. Test summary 19 4. Appendix 1. Test equipment used 20 5. Appendix 2: Antenna Factor and Cable Loss 21 Test Report No.: 8412305151 Page 3 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) 1. EUT Description and operation 1.1. General description: * Note: All information in below clause was supplied by the customer. Description of Equipment Under Test (EUT): MiniClinic Model: VMW03 (915 MHz) Manufactured by: Medic4All (Israel) Ltd. The VMW03 is a medical wrist unit which performs the following measurements: panic button, ECG, heart rate, breathing rate, heart rhythm regularity and body temperature. The VMW03 communicates with the MedicGate (VMG02) and with the MiniGate (VMG03) via RF protocol. Tested model has carrier frequency 915 MHz. The EUT is Transceiver based on chipset Chipcon CC1020. The transceiver uses one channel. Integral antenna – wire, about 8 cm length. Output transmission power: -1 dBm (EIRP) Bandwidth: 50 kHz Modulation type: FSK. The EUT”s dimensions: 26 cm x 4.5 cm x 2 cm, approx. The EUT’s powered from three 1.5V type 389 silver-oxide batteries. The EUT’s current consumption is up to 40 mA. The EUT’s block diagram and Tx-Rx block diagram are shown in Figures 1 and 2, respectively. VMW03 external and internal views are presented in Photos 1-2. Test Report No.: 8412305151 Page 4 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) Figure 1. EUT’s block diagram Enable SPI bus Temperatu re Sensor Touch detector ECG & Activation Leads Analog input SPI bus Piezzo sensor 3 x Silver Oxide batteries Reference input Enable Analog input MSP430F149 Chipcon CC1020 RF transceiver Activation button Wire antenna LEDs Amplifier / filter 3.6V regulator Serial FLASH Amplifier / filter Activation comparator Temperature Amplifier Analog in put Test Report No.: 8412305151 Page 5 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) Figure 2. Tx-Rx block diagram Test Report No.: 8412305151 Page 6 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) Photo 1. EUT’s overall view Test Report No.: 8412305151 Page 7 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) Photo 2. EUT’s internal views Test Report No.: 8412305151 Page 8 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) * Information in clauses below is provided by the manufacturer. 1.2. Potential emission sources: The potential emission sources are detailed in Table 1. Table 1. Potential emission sources Frequency Location 14.7456 MHz crystal VMW03 32.768 kHz crystal VMW03 915 MHz RF signal VMW03 1.3. EUT setup and operation: Respective tests were performed in Transmission (Tx) and Receiving (Rx) modes. Test Report No.: 8412305151 Page 9 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) 2. Measurements, examinations and derived results 2.1. Location of the Test Site: Preliminary radiated test and immunity tests were conducted at the EMC laboratory of the Standards Institution of Israel in Tel-Aviv. All other tests were conducted in an Open Area Test Site located at Kibbutz Native Halamed Hai in Emek HaEla, Israel. 2.2. Test condition: Temperature: 22 °C. Humidity: 56 %. Atmospheric pressure: 1010 mbar. 2.3. Initial visual check and functional test: Initial visual check and brief built- in- test of the EUT was performed before testing. - No external damages were found. - The test on the EUT passed successfully. Test Report No.: 8412305151 Page 10 of 24 Pages Title: Test on MiniClinic Model: VMW03 (915 MHz) 2.4. Radiated emission test: 2.4.1. General: Per FCC Part 15 Subpart B Section 15.109 / Subpart C Section 15.209.
Initial scans were made using a peak detector but still using the appropriate CISPR 16 (Quasi-Peak) detector IF bandwidth.
A tolerance limit was set 10 dB below the specification limit. Levels above the tolerance limit were retested using the Quasi-Peak detector.
If the result with a Quasi-Peak detector exceeds the specification limit, it is marked wi…

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VMW03 VMW03 radiated emission test setup on Open site. Front view Radiated emission test setup on Open site. Rear view Conducted emission test setup.