SEBVMG02VMG02

FCC submission Product Manual October 21, 2004 Medic4All Ltd. POB 4222 Petach Tikva, Israel 49000 Medic4All TELEMEDICINE SOLUTIONS MedicGate™ - VMG 02 Vital Signs Monitoring PSTN Gateway Operation Manual Overview The MedicGate™ is the home gateway for the Medic4All telemedicine system. The MedicGate™ collects and stores the measurement data from Medic4All’s medical monitoring products via wireless communication and transfers the data to a medical monitoring center via telephone lines. Establishing a telephone call can be done via the medical monitoring center; by the user pressing the MedicGate™ call button; generating a distress alarm from the MiniClinic™ or distress device. During the call, the medical monitoring center operator can switch the call into data mode, read the measurements from the MedicGate™ and switch the call back to voice mode. The MedicGate™ also enables the user to talk with the medical monitoring center operator via a built-in hands-free speakerphone or via the telephone connected to the unit. Please read this booklet carefully in order to achieve best performance of this device Warnings & Precautions ♦ Consult your local provider concerning any operational difficulties. Do not attempt to repair the MedicGate™ on your own. Any modifications made to the equipment void the device warranty and service contract obligations. ♦ Keep the MedicGate™ away from electro-magnetic emitting devices. ♦ Do not store the MedicGate™ in direct sunlight, at a high temperature, or in a location with excessive humidity. ♦ Avoid any mechanical shock to the MedicGate™ such as a harsh drop. Parts Identification Telephone Call Originated From the Monitoring Center The medical monitoring center operator originates the call to the user home. ♦ Answer the telephone call from any telephone at home like any other telephone call. ♦ The medical monitoring center operator will instruct you to pick up the telephone connected to the MedicGate™ and hang up the other telephone ♦ The medical monitoring center will then activate the MedicGate™. The MedicGate™ blinking green LED will become solid green. Place the handset on its cradle in case you want to activate the hands-free speakerphone. Pick up the telephone in case you choose to talk through the handset. ♦ The medical monitoring center operator may instruct you to take one or more measurements ♦ The medical monitoring center operator can switch the call to data mode to read the measurements accumulated in the MedicGate™. The call is then switched back to voice mode to continue the conversation. The measurements are immediately analyzed by the medical monitoring center operator and stored in your medical file. ♦ The medical monitoring center operator normally ends the call. In case you want to terminate the call from your end, simply press the black End-Call button. The MedicGate™ green LED will blink slowly. End-Of-Call-Button LED Indicator Call Button Speakerphone Microphone Telephone Call Originated From the User In case you want to place a call to the medical monitoring center. ♦ Press the red Call button on the MedicGate™ or generate a distress alarm from the MiniClinic™. ♦ The MedicGate™ dials the medical monitoring center. The unit speakerphone will be activated and you will hear the progress of the telephone call. The MedicGate™ green LED will blink rapidly. ♦ In case the medical monitoring center is busy or does not answer the call at a given moment, the MedicGate™ will dial the medical monitoring telephone numbers several times, as configured by the medical monitoring center. ♦ When the call is answered you can talk with the medical monitoring center operator. The MedicGate™ LED will become solid green ♦ The call continues as described previously. Auto-Answering Incoming Call If during a distress call the call was disconnected, the MedicGate™ will automatically answer the call after 6 rings in the next 15 minutes and activate the hands-free speakerphone. Installing (or Replacing) the Batteries ♦ Unscrew the battery compartment cover on the underside of the MedicGate™, as show below. ♦ Place four new batteries with the positive (+) and negative (-) properly aligned with the corresponding symbols in the battery compartment. ♦ Screw back the battery compartment cover on the underside of the MedicGate™. ♦ Please note that the batteries take 48 to fully recharge. Improper installation of the batteries may cause battery leakage. Do not mix used and new batteries, it may result in damage to the device or shorten battery life. Use only batteries that match the requirements specified in the Specifications section. Please take the batteries out if the device is not used for a long period (app. 2 months or more) Disposal of this product and used batteries should be carried out in accordance with the relevant national regulations. Connecting the MedicGate™ In order for the gateway to become operational the following steps must be taken: ♦ Make sure the “short – circuit” cable is connected at the back of the gateway between the V.Line plug and the V.Phone plug. ♦ Connect a crossed telephone cable (RJ11 – BT Connector) from the wall jack into the Gateway Line plug. ♦ Connect a crossed external telephone cable (RJ11 - RJ11) from the telephone device line plug to the Gateway Phone plug. ♦ Connect the MedicGate™ to the power supply. Handling Fault Conditions ♦ If configured to do so by the medical monitoring center the MedicGate™ can detect that the telephone line is not connected, the LED becomes red and the MedicGate™ beeps twice every 120 seconds. Please call the monitoring center and report this condition. ♦ If configured to do so by the medical monitoring center the MedicGate™ can beep after receiving a medical measurement. ♦ When the MedicGate™ is not connected to the power, for example during electricity outage, the MedicGate™ LED becomes blinking red to indicate this condition. Verify that the power adapter is connected properly. ♦ When the MedicGate…

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FCC submission Product Manual October 21, 2004 Medic4All Ltd. POB 4222 Petach Tikva, Israel 49000 Medic4All TELEMEDICINE SOLUTIONS MedicGate™ - VMG 02 Vital Signs Monitoring PSTN Gateway Operation Manual Overview The MedicGate™ is the home gateway for the Medic4All telemedicine system. The MedicGate™ collects and stores the measurement data from Medic4All’s medical monitoring products via wireless communication and transfers the data to a medical monitoring center via telephone lines. Establishing a telephone call can be done via the medical monitoring center; by the user pressing the MedicGate™ call button; generating a distress alarm from the MiniClinic™ or distress device. During the call, the medical monitoring center operator can switch the call into data mode, read the measurements from the MedicGate™ and switch the call back to voice mode. The MedicGate™ also enables the user to talk with the medical monitoring center operator via a built-in hands-free speakerphone or via the telephone connected to the unit. Please read this booklet carefully in order to achieve best performance of this device Warnings & Precautions ♦ Consult your local provider concerning any operational difficulties. Do not attempt to repair the MedicGate™ on your own. Any modifications made to the equipment void the device warranty and service contract obligations. ♦ Keep the MedicGate™ away from electro-magnetic emitting devices. ♦ Do not store the MedicGate™ in direct sunlight, at a high temperature, or in a location with excessive humidity. ♦ Avoid any mechanical shock to the MedicGate™ such as a harsh drop. Parts Identification Telephone Call Originated From the Monitoring Center The medical monitoring center operator originates the call to the user home. ♦ Answer the telephone call from any telephone at home like any other telephone call. ♦ The medical monitoring center operator will instruct you to pick up the telephone connected to the MedicGate™ and hang up the other telephone ♦ The medical monitoring center will then activate the MedicGate™. The MedicGate™ blinking green LED will become solid green. Place the handset on its cradle in case you want to activate the hands-free speakerphone. Pick up the telephone in case you choose to talk through the handset. ♦ The medical monitoring center operator may instruct you to take one or more measurements ♦ The medical monitoring center operator can switch the call to data mode to read the measurements accumulated in the MedicGate™. The call is then switched back to voice mode to continue the conversation. The measurements are immediately analyzed by the medical monitoring center operator and stored in your medical file. ♦ The medical monitoring center operator normally ends the call. In case you want to terminate the call from your end, simply press the black End-Call button. The MedicGate™ green LED will blink slowly. End-Of-Call-Button LED Indicator Call Button Speakerphone Microphone Telephone Call Originated From the User In case you want to place a call to the medical monitoring center. ♦ Press the red Call button on the MedicGate™ or generate a distress alarm from the MiniClinic™. ♦ The MedicGate™ dials the medical monitoring center. The unit speakerphone will be activated and you will hear the progress of the telephone call. The MedicGate™ green LED will blink rapidly. ♦ In case the medical monitoring center is busy or does not answer the call at a given moment, the MedicGate™ will dial the medical monitoring telephone numbers several times, as configured by the medical monitoring center. ♦ When the call is answered you can talk with the medical monitoring center operator. The MedicGate™ LED will become solid green ♦ The call continues as described previously. Auto-Answering Incoming Call If during a distress call the call was disconnected, the MedicGate™ will automatically answer the call after 6 rings in the next 15 minutes and activate the hands-free speakerphone. Installing (or Replacing) the Batteries ♦ Unscrew the battery compartment cover on the underside of the MedicGate™, as show below. ♦ Place four new batteries with the positive (+) and negative (-) properly aligned with the corresponding symbols in the battery compartment. ♦ Screw back the battery compartment cover on the underside of the MedicGate™. ♦ Please note that the batteries take 48 to fully recharge. Improper installation of the batteries may cause battery leakage. Do not mix used and new batteries, it may result in damage to the device or shorten battery life. Use only batteries that match the requirements specified in the Specifications section. Please take the batteries out if the device is not used for a long period (app. 2 months or more) Disposal of this product and used batteries should be carried out in accordance with the relevant national regulations. Connecting the MedicGate™ In order for the gateway to become operational the following steps must be taken: ♦ Make sure the “short – circuit” cable is connected at the back of the gateway between the V.Line plug and the V.Phone plug. ♦ Connect a crossed telephone cable (RJ11 – BT Connector) from the wall jack into the Gateway Line plug. ♦ Connect a crossed external telephone cable (RJ11 - RJ11) from the telephone device line plug to the Gateway Phone plug. ♦ Connect the MedicGate™ to the power supply. Handling Fault Conditions ♦ If configured to do so by the medical monitoring center the MedicGate™ can detect that the telephone line is not connected, the LED becomes red and the MedicGate™ beeps twice every 120 seconds. Please call the monitoring center and report this condition. ♦ If configured to do so by the medical monitoring center the MedicGate™ can beep after receiving a medical measurement. ♦ When the MedicGate™ is not connected to the power, for example during electricity outage, the MedicGate™ LED becomes blinking red to indicate this condition. Verify that the power adapter is connected properly. ♦ When the MedicGate…

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EUT’s (VMG02) block diagram External Speaker Reset LED Panic button Status Hook state indicator Relay 1 Phone V-Phone V-Line Busy Tone DTMF Detectors UART Power Amplifier Si2400 Built-in Microphone Built-in Speaker Phone Line PIC18F452 RF Transceiver Module SRAM Rechargeable battery and char ger RTC Gain Reset button Pulse / Tone MUX I2C bus RS-232 LEDs RS-232 U4090B Full / half duplex control

Medic4All Ltd. Hamefalsim 10, P.O.B 4222, Petach Tikva, 49000, Israel. Tel: 972-3-9226610 Fax: 972-3-9226615 30-November-2004 To: FCC Equipment Authorization Branch Attn: Diane Poole Copy: Mr. Yuri Rozenberg – The Standards Institute of Israel Subject: Confidentiality request Letter Applicant: Medic4All FCC ID: SEBVMG02 Correspondence Reference Number: 28117 731 Confirmation Number: EA759351 Dear Diane Poole, 1. We would like to have 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. I, the undersigned, am listed on Form 731 of the application. Sincerely, Rami Shmueli V.P. R&D Medic4All

Medic4All Ltd. Hamefalsim 10, P.O.B 4222, Petach Tikva, 49000, Israel. Tel: 972-3-9226610 Fax: 972-3-9226615 30-November-2004 To: FCC Equipment Authorization Branch Attn: Diane Poole Copy: Mr. Yuri Rozenberg – The Standards Institute of Israel Subject: Confidentiality request Letter Applicant: Medic4All FCC ID: SEBVMG02 Correspondence Reference Number: 28117 731 Confirmation Number: EA759351 Dear Diane Poole, 1. We would like to have 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. I, the undersigned, am listed on Form 731 of the application. Sincerely, Rami Shmueli V.P. R&D Medic4All

Medic4All Ltd. Hamefalsim 10, P.O.B 4222, Petach Tikva, 49000, Israel. Tel: 972-3-9226610 Fax: 972-3-9226615 30-November-2004 To: FCC Equipment Authorization Branch Attn: Diane Poole Copy: Mr. Yuri Rozenberg – The Standards Institute of Israel Subject: Confidentiality request Letter Applicant: Medic4All FCC ID: SEBVMG02 Correspondence Reference Number: 28117 731 Confirmation Number: EA759351 Dear Diane Poole, 1. We would like to have 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. I, the undersigned, am listed on Form 731 of the application. Sincerely, Rami Shmueli V.P. R&D Medic4All

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. Diana Poole ([email protected] ) From: Rami Shmueli [email protected] Medic4All Applicant: Medic4All FCC ID: SEBVMG02 Correspondence Reference Number: 28206 Date: 6 January, 2005 Subject: Confidentiality request Letter Dear Diane Poole, 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

VMG02 external photos. Power. Tele phone Line

VMG02 Label MedicGate™ Model: VMG02 Power: 9V / 400 mA from regulated DC power supply Backup power: 4 x 1.2V 1800 mAH NiMH rechargeable batteries Manufactured by Medic4All Ltd, P.O.B 4222 Petach-Tikva, Israel SN: 00000000 FCC ID: SEBVMG02 0483 2004 FCC ID: SEBVMG02 Complies with Part 68 FCC rules Registration No: US: ????????? Ringer Equivalent: 0.0B

VMG02 internal photo.

VMG02 operational description The VMG02 is a medical gateway, which communicates with the medical center (voice and data) via the telephone line and communicates with Medic4All peripheral devices via RF protocol. The VMG02 dimensions: 18cm x 14.5cm x 5cm. The VMG02 power source: 120 VAC/ 9 VDC Power Adapter, mfr MW comp, Model PSU15A-2. The VMG02 block diagram and RF transceiver block diagram are shown in Figures 1 and 2, respectively. The VMG02 transceiver is based on chipset Chipcon CC1020. The transceiver uses one channel. Antenna type – whip antenna 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 VMG02 field strength is less than 50 mV/m at 3 meters and meets the requirements of paragraph (a) of section 15.249. Figure 1. VMG02 block diagram External Speaker Reset LED Panic button Status Hook state indicato r Relay 1 Phone V-Phone V-Line Busy Tone DTMF Detectors UART Power Amplifier Si2400 Built-in Microphon Built-in Speaker Phone Line PIC18F452 RF Transceiver Module SRAM Rechargeabl e battery and char ger RTC Gain Reset button Pulse / Tone MUX I2C bus RS-232 LEDs RS-232 U4090B Full / half duplex control The Si2400 is a low-speed data modem with the following features: • 300-2400 baud • DTMF generation and detection • Call progress tone detection • Relay driver • Audio (speech) input and output • Intrusion detection during on-hook and off hook • Caller ID detection • On-hook monitoring of DTMF tones, call progress tones and hook state • Compliance with international standards including CTR21 (for Europe) and FCC part 68 (for the USA) Due to the limitation of I/O ports in the PIC18, some of the I/O ports will be connected through the Si2400. Microchip PIC18F452 micro controller has the following features: • 32K byte FLASH memory • 1536 byte RAM • 16 bit architecture with 8 bit multiplier • 10 MIPS (40 MHz) • 10 bit A/D converter • 3 timers • UART • I2C The PIC18 is the CPU of the M4A Gateway and performs the following tasks: • Controls the Si2400 via a UART interface • Communicates with Chipcon RF transceiver • Controls the speaker gain. • Mutes the speaker output or the microphone input • Connects to the Panic / Reset buttons • Reads the DTMF and busy tone detectors • Controls the relay connection to the external telephone DTMF and busy tone detector module based on the Zarlink MT3271 chip. U4090B – speakerphone chip. Relay 1 is a telecom type mechanical relay that disconnects the external telephone while the system performs data transfer. Relay 2 (optional) connects a 300 ohm load in parallel between the Tip and Ring lines in order to maintain the call in off-hook state while the Si2400 goes momentarily on-hook. This relay can be used to switch back the videoconferencing equipment from video mode to voice mode. Relay 2 is a solid-state relay. This option is not used. The line (supply) power detector measures and reports the line power condition to the micro controller in order to detect input power loss. The Chipcon CC1020 is a programmable RF transceiver operating at 9.6Kbps at 915MHz. Speaker amplifier with 2-level programmable gain control FRAM – 32K byte serial RAM with I2C interface RTC – real time clock with I2C interface. Rechargeable batteries and charger Buttons: Panic (Red), Reset (Green) DC input connector (DC connector) External telephone interface (RJ11 connector) Telephone line interface (RJ11 connector) Videoconferencing telephone interface (RJ11 connector) Videoconferencing line interface (RJ11 connector) RCA receptacle connects to the TV audio input Multiplexer (optional) connects the PIC18 UART interface to the Si2400 modem or to one of the two optional RS232 interfaces. Two RS232 interfaces connected to the optional multiplexer Figure 2. Tx-Rx block diagram

Test Report No.8412305158 For Medic4All (Israel) Ltd. Equipment Under Test: MedicGate Model: VMG02 (915 MHz) From The Standards Institution Of Israel Industry Division Telematics Laboratory EMC Section Certificate No. 1487-01 Test Report No.: 8412305158 Page 1 of 32 Pages Title: Test on MedicGate Model: VMG02 (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: 13,14/04, 5, 12/05/2004 Description of Equipment Under Test (EUT): MedicGate Model: VMG02 (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 15.107. “Conducted limits”. Section 15.109. “Radiated emission limits”. Subpart C: “Intentional radiators” (2002), Section 15.205. “Restricted bands of operations”, Section 15.207. “Conducted limits”. 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 15.107. Conducted emission Class B, Section 15.109. Radiated emission Class B. Subpart C Section 15.207. Conducted Emission Section 15.209. Radiated emission Section 15.249 (a), Section 15.205. This Test Report contains 32 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.: 8412305158 Page 2 of 32 Pages Title: Test on MedicGate Model: VMG02 (915 MHz) Table of Contents 1. EUT Description and operation 3 1.1. General description: 3 1.2. EUT connector list: 9 1.3. Potential emission sources: 9 1.4. EUT setup and operation: 9 2. Measurements, examinations and derived results 10 2.1. Location of the Test Site: 10 2.2. Test condition: 10 2.3. Initial visual check and functional test: 10 2.4. Emission tests: 10 2.5. Conducted emission test: 11 2.6. Radiated emission test: 14 2.7. Test of field strength of emission from intentional radiators 16 3. Test summary 26 4. Appendix 1. Test equipment used 27 5. Appendix 2: Antenna Factor and Cable Loss 28 6. Appendix 3: Test configuration illustrations 32 Test Report No.: 8412305158 Page 3 of 32 Pages Title: Test on MedicGate Model: VMG02 (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): MedicGate Model: VMG02 (915 MHz) Manufactured by: Medic4All (Israel) Ltd. The VMG02 is a medical gateway which communicates with the medical center (voice and data) via the telephone line and communicates with Medic4All peripheral devices via RF protocol. Tested model has carrier frequency 915 MHz. The EUT is Transceiver based on chipset Chipcon CC1020. The transceiver uses one channel. Antenna type – whip antenna. Output transmission power: -1 dBm (EIRP) Bandwidth: 50 kHz Modulation type: FSK. The EUT”s dimensions: 18cm x 14.5cm x 5cm. The EUT’s power source: 120 VAC/ 9 VDC Power Adapter, mfr MW comp., Model PSU15A-2. The EUT’s block diagram and Tx-RX block diagram are shown in Figures 1 and 2, respectively. The EUT’s general views are presented in Photos 2-5. Test Report No.: 8412305158 Page 4 of 32 Pages Title: Test on MedicGate Model: VMG02 (915 MHz) Figure 1. EUT’s block diagram External Speaker Reset LED Panic button Status Hook state indicato r Relay 1 Phone V-Phone V-Line Busy Tone DTMF Detectors UART Power Amplifier Si2400 Built-in Microphon Built-in Speaker Phone Line PIC18F452 RF Transceiver Module SRAM Rechargeabl e battery and char ger RTC Gain Reset button Pulse / Tone MUX I2C bus RS-232 LEDs RS-232 U4090B Full / half duplex control Test Report No.: 8412305158 Page 5 of 32 Pages Title: Test on MedicGate Model: VMG02 (915 MHz) Figure 2. Tx-Rx block diagram Test Report No.: 8412305158 Page 6 of 32 Pages Title: Test on MedicGate Model: VMG02 (915 MHz) Photo 1. EUT’s overall view Photo 2. EUT’s rear panel view Power. Telephone Line Test Report No.: 8412305158 Page 7 of 32 Pages Title: Test on MedicGate Model: VMG02 (915 MHz) Photo 3. EUT’s internal view Test Report No.: 8412305158 Page 8 of 32 Pages Title: Test on MedicGate Model: VMG02 (915 MHz) Photo 4. Tx-Rx module print side Photo 5. Tx-Rx module component side Test Report No.: 8412305158 Page 9 of 32 Pages Title: Test on MedicGate Model: VMG02 (915 MHz) * Information in clauses below is provided by the manufacturer. 1.2. EUT connector list: A list of the EUT's connectors is detailed in Table 1. Table 1. Connector list No. Connector's name Connector's type Type of Cable No. of identical connectors 1 DC DC Unshielded 1 2 Audio out RCA Shielded 1 3 Telephone RJ-11 unshielded 4 4 RS232 RJ-45 unshielded 2 1.3. Potential emission sources: The potential emission sources are detailed in Table 2. Table 2. Potential emission sources Frequency Location 14.7456 MHz (crystal) VMG02 8.000 MHz (crystal) VMG02 4.9152 MHz VMG02 4.194304 MHz VMG02 915 MHz( RF signal) VMG02 1.4. EUT setup and operation: EUT was [placed on a table, supplied from 120 VAC /9 VDC Adapter. Respective tests were performed in Transmission (Tx) and Receiving (Rx) modes. Test Report No.: 8412305158 Page 10 of 32 Pages Title: Test on MedicGate Model: VMG02 (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 tes…

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Radiated emission test setup on Open site. Front/ Side / Overall view Radiated emission test setup.