FCC submission Product Manual October 21, 2004 Medic4All Ltd. POB 4222 Petach Tikva, Israel 49000 Medic4All TELEMEDICINE SOLUTIONS MiniGate - VMG03 Operation Manual MiniGate is an IP-based USB gateway. Plugging MiniGate into a standard USB port activates its software and displays data generated by Medic4Alls wireless vital signs monitors on the computer screen. With an Internet connection, measurement data can be sent directly and securely to a monitoring center and/or to a web medical file. Ref: OM-111v1 Copyright 2004 by Medic4All AG. All rights reserved Copyright Notice The information in this document is subject to change without prior notice and does not represent a commitment by Medic4All Ltd. This publication may not be reproduced in whole or in part, printed, stored in a retrieval system, distributed in electronic form or otherwise, including photocopying and recording for any purpose other than the personal use of Medic4Alls customer, without the written permission of Medic4All. All other products are trademarks or registered trademarks of their respective holders and should be noted as such. Copyright 2003 Medic4All, Ltd. All Rights Reserved. 0483 Manufacturer: Medic4All Ltd. Hamefalsim 10, P.O.B 4222, Petach Tikva, 49000, Israel. Tel: +972-3-9226610 Fax: +972-3-9226615 EC Authorized Representative: MedNet GmbH Eschstrasse. 19 D-48167 Munster Germany Tel: +49-2506-86440 Fax: +49-2506-864422 Table of Contents Copyright Notice 3 Introduction 6 Scope 6 About this Manual 6 Installation 7 Scope 7 Hardware and software requirements Preparing to install Installation process MiniGate operation 13 7 8 Activating the MiniGate application 13 7 Scope 13 Connecting the MiniGW to the computer 13 MiniGate initial activation and setup 14 MiniGate Daily usage 16 View measurements 16 Updating the Web measurements 18 MiniGate Configuration 19 Configuring measuring devices Changing MiniGate password Associating the MiniGate to Medic4all Web Medical File 21 19 20 List of figures:
Figure 1- Choose language window .............................................................8 Figure 2- welcome to the installation window..............................................9 Figure 3- License agreement window .............................................................9 Figure 4 Destination folder window.............................................................10 Figure 5 Ready to Install window ...............................................................11 Figure 6 - File version conflict window .........................................................11 Figure 7 - Web registration window...............................................................15 Figure 8 - MiniGate authorization window....................................................17 Figure 9 - Offline measurement View............................................................18 Figure 10 - MiniGate setup wizard - Hardware information window............19 Figure 11 - MiniGate system tray Menu ........................................................22 Figure 12 - Web registration window.............................................................22 Introduction Scope Medic4All Telemedicine system is designed for interactive remote medical monitoring. The system installed at the user home includes the MiniGWTM device, which serves as a gateway between the peripheral units (i.e., sensors, medical measuring devices) and the MiniGateTM application. The MiniGateTM is responsible for accepting the measured data, and for sending it to the Medic4All call center medical file. On the local PC, the application provides the user with the ability to view the medical measurements and configure system parameters. Using the Internet, the user or his delegate (e.g., a physician) may view the measurements based on the Medical File viewer. The MiniGWTM device is the mediator between the peripheral units - measuring devices - and the MiniGateTM application. The MiniGWTM device communicates with the MiniGateTM application using a standard USB port, and with a number of Medic4All peripheral units (WristClinicTM, MiniClinicTM, blood pressure monitor, weight scale, and others), via RF communication. About this Manual This manual describes and explains the installation and working environment of the MiniGate application. It provides detailed instructions on how to handle, setup, configure and operate the MiniGate system. Installation Scope The Installation section describes how to install the Medic4All MiniGate application. The MiniGate installation is performed by a setup wizard, which provides step-by-
step instructions on how to install the MiniGate application. Hardware and software requirements Before the installation starts make sure your system supports the following requirements:
Hardware Requirements:
Pentium 3 500MHz Or Similar 64MB RAM 100MB free and available space Available USB port Software Requirements:
Windows XP home Windows XP pro Windows 2000 Windows ME Win 98 SE Microsoft Explorer 5 or higher with SSL 128bit supports Preparing to install In order to install the MiniGate application, you need to have Administrator privileges on your Operating System. Make sure there are no old Medic4All programs installed on your PC. To start the installation, verify that you have the following parts:
Medic4All MiniGate installation CD MiniGW device Installation process To install the Medic4All MiniGate application:
Insert the Medic4All CD into the CD ROM and run the file: Medic4All MiniGate Setup.exe. The MiniGate setup screen opens; on top of this screen, the Choose language window appears. 1. Figure 1- Choose language window
In the language selection window, select a language and click Next. Note: The language chosen determines both the language used in the installation screens and the language used in the MiniGate graphical user interface. The MiniGate Welcome to the installation wizard window appears. 2. Figure 2- welcome to the installation window
Follow the instructions that appear in the Welcome to the installation wizard window and click Next. The License agreement window appears. 3. Figure 3- License agreement window
Read the license agreement. If you wish to exit the installation, click Cancel. If you wish to continue with the installation of the MiniGate, mark in the and click Next. The Destination folder window appears. 4. Figure 4 Destination folder window
You can change the default destination folder that is presented in the window or you can use the default folder. To change the destination folder, select the folder in which you wish to install the MiniGate application and click Next. Note: It is recommended to install the MiniGate in the default destination folder that appears in the destination field. The Ready to install program window appears.
In the Ready to install program window, click Next. 5. Figure 5 Ready to Install window The system installs the application components. Important: During installation, the system might encounter files with version conflicts. As a result, the system will open the File version conflict window and will consult the user whether to keep the old components. In this case, click Yes to keep the old components and continue with the installation (see Figure 1). 6. Figure 6 - File version conflict window The system finishes installing the MiniGate and opens the Installation complete window. The Installation complete window contains a start Medic4All MiniGate check box that is checked by default. In order to continue and configure the MiniGate, check the Start Medic4All MiniGate checkbox and click Finish. The MiniGate application will start running (see MiniGate initial activation and setup). In order to terminate the installation without starting the MiniGate application, uncheck the Start Medic4All MiniGate checkbox and click Finish. Note: If you choose to continue and open the MiniGate application, refer to the activating the MiniGate application section. Important: In case the installation did not succeed, contact your Medic4all representative for further instructions. MiniGate operation Activating the MiniGate application Scope The MiniGW device operates as a necessary identification key for the MiniGate system. Important: In order to work with the MiniGate application the MiniGW must be plugged into the computer. Important: Make sure that only one MiniGW is plugged into the computer at any given time, otherwise the system might malfunction The MiniGate system supports multiple measuring devices and communicates with the users call center medical file using the Web. These advanced features require setting and configuration. The MiniGate can be manually configured. The user may add, update, or delete measuring device IDs. The user may change the MiniGate local password and define or update medical file settings. Every Medic4all MiniGate is initially set at the factory to work with its dedicated measuring device and is set with a default password. Therefore, at initialization, the user has to configure only user-specific WEB parameters for establishing the link to the patient medical file. In this section all the features and manual functions shall be described. Connecting the MiniGW to the computer In order to start working with the system, the MiniGW must be plugged in and recognized by the operating system. To do so, restart the computer (if it wasnt restarted since the installation), close all working applications, plug the MiniGW into an empty USB port, and wait for the system to recognize it. After a few seconds the system recognizes the MiniGW as an HID device. Note: In case the PC does not recognize the MiniGW, try reentering the MiniGW. In case the problem is not solved, start the Windows Add New Hardware wizard or contact your Medic4all representative for further instructions. MiniGate initial activation and setup When first activating MiniGate, the user is required to associate, through he Internet, the MiniGate system to his call center medical file. Important: In case the MiniGate is not configured with a measurement device, on activation the Minigate setup wizard -hardware information window will pop up. If this happens please refer to the Configuring measuring devices section. Note: Perform this configuration only if you already have an appropriate web viewer account connected to your personal medical file at the call center. To associate the MiniGate system to your call center medical file:
If the MiniGate application is not yet running, open it now by selecting Start =>
Programs => M4A MiniGate => MiniGate. When the MiniGate is activated and a new MiniGW is plugged into the computer, the MiniGate system recognizes the MiniGW entry as first entry to this MiniGate system and displays the following message: Your M4A MiniGate is configured correctly. Click OK to associate your MiniGate to your M4A Medical File.
Click OK in the information message window. The MiniGate system opens the Web Registration window (see Figure 2). 7. Figure 7 - Web registration window
In the web registration window, fill in your Web user ID and WEB password in the designated fields and click OK. If you do not have a web medical file, click Cancel. Note: Remember, the Web user password is not the same as the MiniGate password and it is case sensitive. The system associates the MiniGate to the users medical file and displays the following message: Your equipment information has been saved successfully to the Personal Medical File Web Service.
Click OK. The MiniGate system starts working and is ready to receive measurements. Note: When the system is working and ready to receive measurements, the following icon appears in the system
. tray:
When the MiniGW is disconnected or deactivated the following icon appears in the system tray:
. MiniGate Daily usage When activated, the MiniGate system application runs in the background without interfering with other PC programs. Usually you do not have to activate the system, except after installation, since it is automatically started when the computer is turned on. However, if the MiniGate application was not activated or was stopped, the MiniGate system will not work. The MiniGate symbol in the systems tray indicates if the MiniGate is operational or not; if the MiniGate icon is missing, you have to start the application. To start the MiniGate system:
Click the M4A MiniGate station shortcut on your desktop or select Start => Programs => M4A MiniGate => MiniGate. The MiniGate system is ready to receive measurements. Note: When the system is working and ready to receive measurements, the following icon appears in the system tray:
When the MiniGW is disconnected or deactivated,
. the following icon appears in the system tray:
. View measurements In order to enter the View measurements screens:
Click the Measurements view shortcut on your desktop or select Start
=> Programs => M4A MiniGate => Measurement View. The MiniGate application opens the Authorization window (see Figure 3). 8. Figure 8 - MiniGate authorization window
Enter the MiniGate password and Click Next. Important: The MiniGW initial password is: m4a123 Note: Remember the MiniGate password is case sensitive. The MiniGate measurement viewer appears (see Figure 4). 9. Figure 9 - Offline measurement View Updating the Web measurements While there is an active Internet connection, the measurements received by the MiniGate are transmitted automatically, once every 30 seconds, to the users medical file. If the Internet connection is down, the system stores the measurement in the local repository (see also View measurement) and waits for Internet connection to be established. When the Internet connection is reestablished, the MiniGate automatically sends all the new measurements (the measurements which were not yet sent to the Internet) to the users medical file. In order to accelerate the arrival of new measurements to the patient medical file
(without waiting for the automatic update), open the MiniGate menu and select Web Medical File Measurements Update. All the measurements not yet sent will be transmitted immediately to the Web medical file. MiniGate Configuration Configuring measuring devices To configure new sensors to the MiniGate:
Verify the MiniGate is working (view the MiniGate icon in the system tray - see Activating the MiniGate application).
Open the MiniGate menu by right-clicking the MiniGate icon in the system tray.
Select the M4A MiniGate configuration option. The system opens the MiniGate Setup Wizard Hardware Information window
(see Figure 5). 10. Figure 10 - MiniGate setup wizard - Hardware information window
Click Add. The system opens the Add sensor window.
In the Add sensor window, enter the ID number of the sensor you wish configure and Click Add. Note: The sensor ID is an 8 character ID and usually appears on a sticker on the back of the sensor. The sensor ID identifies the sensor to the MiniGW and enables the MiniGW to communicate with the sensor. The sensor ID entered appears in the configured sensors field. Important: Verify that the sensor ID that appears in the configured sensors field is the same ID as appears on your sensor.
Continue inserting as many sensors as you like. When finished, Click Next. The system generates a configuration-succeeded message.
Click Finish to end the configuration process. The configuration process is complete and the new sensors are now configured to the system. Changing MiniGate password As mentioned in the View measurement section, in order to open the Measurement view screen, the user must enter the MiniGate password. The MiniGate password is a unique password per MiniGW device and it is stored, in a secure way, on the MiniGW device. The MiniGate password is a case sensitive password consisting of 6-8 characters (digits and letters). To change the MiniGate password:
Verify the MiniGate is working (view the MiniGate icon in the system tray - see Activating the MiniGate application).
Open the MiniGate menu by right-clicking the MiniGate icon in the system tray.
Select the M4A MiniGate configuration option. The system opens the MiniGate Setup Wizard Hardware Information window
(see Figure 5).
Fill in the Gateway password field with the new password. Note: The MiniGate password must be at least 6 characters and contain both digits and letters.
Re-enter the new password in the confirm password field and click Next. The system opens the following confirmation window: "Your M4A MiniGate password has changed. To accept the new password, please enter your old M4A MiniGate password as confirmation:"
Enter the old MiniGate password and Click Next. The password is changed and the system generates change password confirmation. Associating the MiniGate to Medic4all Web Medical File To associate your MiniGate to your medical file, so measurements from your MiniGate will show on your Medical File:
Verify that the MiniGate is working (view the MiniGate icon in the system tray - see Activating the MiniGate application)
Open the MiniGate menu by right-clicking the MiniGate icon in the system tray (see Figure 6). 11. Figure 11 - MiniGate system tray Menu
Select the Web Medical File Equipment Update option. The system opens the Web Registration window (see Figure 7). 12. Figure 12 - Web registration window
In the web registration window, enter your Web user ID and Web password ID in the designated fields and click OK. Note: Remember that the Web user password is case sensitive.
Click Next. The system updates the Web server and generates a confirmation message. Specifications Environment Operating condition Storage condition Dimensions Weight
+10C to +40C / 30% RH to 85% RH
-10C to +55C / 30% RH to 85% RH Approx. 95[W] x 15[H] x 25 [D] mm Approx. 7g Power Supply/bat Power Radio Frequency communication Frequency Max transmission power Bandwidth Transmission range Data transfer rate Protocol 5V up to 100mA powered from the USB interface 433.92 MHz (EU) 866.3 MHz (EU) 915 MHz (USA) 10 dbm (EIRP) at 433.92 MHz and 866.3 MHz.
-1 dbm (EIRP) at 915 MHz 60 kHz max. 200 m (free space) 12Mbps USB 2.0 / HID Contents:
1. Operation Manual 2. MiniGate FCC Part 15 Information This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the Federal Communication Commission
(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 equipment off and on, the user is encouraged to try to correct the inference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. MiniGate VMG03 Tested To Comply With FCC standards FOR HOME OR OFFICE USE Warranty This product is warranted against defects in material and workmanship beginning from the date of shipment for a period of one year (the Term). Under the Term, the obligation of Telcomed Advanced Industries Ltd (the Company) will be limited to repair or replacement of the product (not including batteries, cables and spendable parts), according to the Companys discretion. Such repair or replacement will be made only after the Companys examination determines that said product is defective in material and/or workmanship. This product warranty is void if the product has been repaired or altered in any way as to affect its use and operation as determined by the Company. This warranty is also void if the product has been subjected to abuse, misuse, negligence or accident. No warranties, whether expressed or implied, shall exist beyond the Term. Under no circumstances shall the Company be responsible for any loss of data or income or any special, incidental, consequential or indirect damages, arising from the product or its operation, howsoever caused. Under no circumstances the Company will be liable for any claim arising from the product or its operation in excess of the total price paid for this product. The Company reserves the right to make changes and improvements to the product without prior notice.