ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 1 of 12 Instructions for Use Confidant Connector 3.0 GSM/Serial Converter Description The Confidant Connector (a GSM/Serial Converter), referred to as the Connector, obtains data from personal medical monitoring devices over a serial port and then transmits that data via the Internet over an established GSM/GPRS wireless Network to the Confidant Data Center. Display The display provides the user with the status of the Connector, user choices and displays the results of the process of collecting and storing the readings. The Battery Indicator displays the state of the battery and amount of power to operate the Connector. The Radio Indicator provides an indication of the presence of the GSM network and the relative power 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 1 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 2 of 12 of the radio signal being received. The Process Indicator is used to inform the user that the Connector is communicating and processing the data with the Data Center. The User Information is broken into four types of information:
Initial state and the ability to choose the type of connected personal medical monitoring device. The results of the processing of the data, such as Date/Time with the Blood Glucose reading. The ability to associate additional information with the readings based on the type of device. The display of any error messages. Buttons There are three buttons on the front of the Connector that provide the user interaction with the Connector. POWER Turns the Connector On and Off A Toggles information being presented to the user. Such as during the initial use the choices B Starts the process of the selected action, such as sending the desired device type to the Data of the types of Devices Center 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 2 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 3 of 12 Installing the Battery The battery chamber is accessed by opening the battery door on the back of the device. Gently slide the door to one side, as indicated by the Open arrow and lift upwards. The inside of the battery compartment is marked for correct battery orientation. The battery must be installed in the correct orientation for the device to operate. The device requires one Li-ion battery (Nokia BL-5C or equivalent). Recharging the Battery The battery is recharged by using the provided 120v AC Charging unit. Plug the USB cable into the charging unit and into the Connector. Charger USB cable 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 3 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 4 of 12 Plugging in the Data Cable Two Data Cables with different sized Plugs are provided; one small (2.5mm) and one large (3.5mm). This is to accommodate a range of monitoring devices with different Socket sizes. Note that either cable can be connected to the Connector using the corresponding Socket. Questions to determine which cable to be used contact Technical support for assistance. 3.5 mm Connector 2.5 mm Connector To monitoring device To monitoring device Starting the Connector The Connector is started by pressing and releasing the POWER button. The display will light all items, clear the screen and then will display the Battery and Radio Indicators. The personal medical monitoring device selection will be displayed and await the user selecting the default device or toggling through the devices. If the device is idle for 45 seconds it automatically shuts off to conserve battery life. 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 4 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 5 of 12 Note: The Connector will shut off after 45 seconds of its initial start up unless communications are initiated. Pushing the POWER button repeatedly will turn the Connector ON and OFF and will not improve the performance. Restarting the Connector In the event that problems develop with communication, the Connector can be restarted by pressing the POWER button, to turn the device off and pressing the button a second time to power it on. This restarts the Connector. Process Indicator The Process Indicator cycles through the arrows of the display while communications and processing is taking place. Once processing is completed, the arrows turn off, and the results of the processing and communications are displayed in the User Information area. Error Messages Error Messages are displayed in the User Information area, when they occur. Err01 Indicates that there was a problem with the Internet connection to the Data Center or the Data Center could not process the information. Corrective action is to retry the process again. Err02 Indicates that the Connector could not communicate with the personal medical monitoring device. Ensure that the cable is connected properly and is seated securely to the device and the Connector. Retry the process, with the correct device type. Err03 Indicates there is a problem with the radio signal or the carrier. Contact Technical support for assistance. 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 5 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 6 of 12 Err04 Indicates that the battery charger is not charging the battery. Contact Technical support for assistance. Err05 Indicates that the battery does not have enough of a charge to power the radio successfully. Plug in the charger and charge the battery for two hours. If the problem continues, contact Technical support for assistance. Button A (Choice) The Choice button will toggle the display of the information being presented to you for selection. Depending on the state of the connector, there may be one or more choices to display. Once initialized and connected to the network, the button presses will toggle between the following displays:
GLU - representing a Blood Glucose Meter BP representing a Blood Pressure Meter LB representing a Weight Scale 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 6 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 7 of 12 OP representing a specialized optional device registered for this Connector Display State Once the readings have been processed by the data center, the results will be sent to the Connector for display and appropriate action. Blood Glucose Meter Readings The display will be a rotating display (1 second) of:
Date Time 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 7 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 8 of 12 Value Type (Meal Information) The type display will be based on a toggle of the choices available:
FAS representing Fasting PRE representing Pre-Meal POS representing Post-Meal UUU representing Unclassified 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 8 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 9 of 12 Blood Pressure Meter Readings The display will be a rotating display (1 second) of:
Date Time SYS-DIA values Pulse value There are no values to toggle for these readings at this time. 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 9 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 10 of 12 Weight Scale Readings The display will be a rotating display (1 second) of:
Date Time Weight value (in pounds) There are no values to toggle for these readings at this time. Optional Device Readings The display will be a rotating display (1 second) of:
Date Time Value There are no values to toggle for these readings at this time 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 10 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 11 of 12 Completed Upon successful registration of the Connector or Submission of data. Troubleshooting If you experience any problems with the Connector device try restarting it. It is ready to communicate when Battery and Radio Indicators are lighted. If you continue to have difficulty, double check the battery to make sure it is correctly installed. Replace/recharge the battery when it becomes weak. In the event there is no communications or the device does not process the personal medical monitoring device information correctly, contact Technical Support. For Technical Support, Contact:
Confidant Hawaii, LLC Mililani Street, Suite 600 Honolulu, HI 96813 Phone: (808) 628-7396 Email: support@confidantinc.com WARNINGS Do not immerse the Confidant Connector device in water or other liquids. Do not expose the Confidant Connector device to excessive heat or cold. The information contained in this manual is subject to change without notice. Confidant Hawaii, LLC reserves the right to make changes to equipment design or program components, as progress in engineering, manufacturing methods, or other circumstances may warrant. No responsibility is assumed for the use of equipment or software that is not supplied by Confidant Hawaii, LLC. 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 11 ATTACHMENT 2 Users Manual Issued by: QA Effective Date: 02/23/2011 Revision: A Page: 12 of 12 Federal Communications Commission (FCC) Statement You are cautioned that changes or modifications not expressly approved by Confidant International LLC could void the users authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the 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 interference 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 into 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. Operation is subject to the following two conditions:
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. 820 Mililani Street Suite 600 Honolulu, HI 96813
(W) 808.741.1688 (F) 808.628.6885 www.confidantinc.com 12