New Element Medical Equipment Technology Development PFES-1TNB REMOTE & MOBILE BLOOD GLUCOSE MONITORING AND DIABETES PATIENT FOLLOW-UP SYSTEM User Manual
Shenzhen New Element Medical Equipment Technology Development Co., Ltd. REMOTE & MOBILE BLOOD GLUCOSE MONITORING AND DIABETES PATIENT FOLLOW-UP SYSTEM Users Manual
Users Manual
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Table of Contents Components ............................................................................................................. 1 Overview .................................................................................................................. 3 2.1 BG Monitoring Devices ................................................................................................ 3 2.1.1 BG Meter............................................................................................................. 3 2.1.2 Sterile Lancet ..................................................................................................... 12 2.1.3 Lancing Device ................................................................................................... 13 2.1.4 Test Strip ........................................................................................................... 15 2.2 Health Mobile Phone ................................................................................................. 19 Measuring BG Value ............................................................................................... 22 3.1 Preparing for Obtaining a Blood Sample .................................................................... 22 3.2 Preparing the BG Meter ............................................................................................. 23 3.3 Starting Testing .......................................................................................................... 24 Operations on the Phone...................................................................................... 27 4.1 Typing BG Value ......................................................................................................... 29 4.2 Viewing BG Trend ...................................................................................................... 31 4.3 Viewing Follow-Up Scheme ....................................................................................... 32 4.4 Viewing Health Advice ............................................................................................... 33 4.5 Complaint ................................................................................................................... 35 II Precautions ............................................................................................................ 36 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 1 Components Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System collects daily blood glucose (BG) value by BG meter, and transmits the data to the health mobile phone via Bluetooth. Then, the mobile phone sends the data to the server through GPRS. A doctor remotely views the BG variation of a patient, and carries out timely treatment after analysis and diagnosis. The doctor can also interact with the patient through the server. The patient can view doctor advice on the mobile phone as well. The system consists of BG meter and software (software on health mobile phone and server). 2 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 2 Overview 2.1 BG Monitoring Devices The BG monitoring devices can measure BG value anywhere and anytime, and transmit the data to health mobile phone via Bluetooth. The system consists of BG meter, lancing device, test strips and sterile lancet. 2.1.1 BG Meter The BG meter owns functions of data transmission and BG test. The following figure shows the structure of the BG meter, and Table 1 describes functions of each button. 1. Test slot 2. Front Left side Bluetooth indicator 5. Test ejector 3. Display 4. Mode button strip Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Back Right side 6. SET button 7. Battery compartment 8. Bluetooth button Table 1 No. Name Test slot Function Inserting the test strip Bluetooth Indicating data transmission and working status indicator Display Displaying the results, and symbols guiding your test Mode button Turning on/off the meter; browsing and setting modes. Test strip Ejecting the used strip by pushing up this button. ejector SET button Entering and confirming the meter settings. Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Battery Holding the batteries. AAA alkaline batteries only. compartment Bluetooth button Pushing up the button when the meter is off to enable the Bluetooth connection. Data collected by the BG meter are transmitted to the mobile phone when the meter is powered off. The Bluetooth indicator indicates the data transmission status. See Table 2. Table 2 No. Indicator Status Description Off Bluetooth is disabled. Flashing blue Bluetooth is enabled and under connecting. Normally on in Bluetooth connection is set up blue successfully. 2.1.11. Replacing Batteries If the battery symbol appears on the display, it means low battery. Please replace with two new AAA alkaline batteries. If the symbol begins to flash, it means the remaining power is not enough for a test. Replace batteries at No.7 Battery compartment in Figure 3.1. 1.Power off the BG meter. Press and then lift up the fibula to remove the cover. 2.Remove the used batteries, or pat the meter with your palm softly. Do not knock the meter with hard objects. Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 3.Load two new AAA alkaline batteries. Make sure the anodes and cathodes of the batteries respectively point at the "+" and "-" symbols in the compartment. 4.Insert the two hinges of the compartment cover into the slots and press softly until they fit the fibula. Caution: Use AAA alkaline batteries only. Do not use rechargeable batteries. 2.1.12. Settings After loading batteries correctly, press the Mode button to start the meter. See the following figure and Table 3 for system interface and description of each button. Set the meter as follows: 1.Press the SET button. Item to be set is flashing. 2.Press the Mode button to set values for the flashing items. Press once to enter fine adjustment (the flashing value increases by +1 after each pressing of Mode button). Press and hold the Mode button to enter quick change. 3.After finishing the preceding setting, press the Mode button again to proceed. Item to be set is flashing. 10 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Table 3 Code Measurement unit Blood drop symbol 10 Memory symbol Test strip symbol 11 Measurement mode Low battery symbol 12 Control solution mode Test result 13 Reminder alarm Error warning 14 Day average Ketone warning 15 Time Face/Low/High symbol 16 Date 11 2.1.2 Sterile Lancet It is used to prick your finger to obtain blood samples. The sterile lancet consists of protective cap, lancet and base. Pull off the cap before use. The appearance is shown in the following figure. Protective cap Lancet Base Caution: Never share a sterile lancet. The sterile lancet is for single use only. Always 12 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System use a new sterile lancet each time when doing a test. 2.1.3 Lancing Device The lancing device is used together with the lancet to obtain blood samples. The following figure shows the appearance of the lancing device, and Table 4 describes the functions. 13 Table 4 No. Name Adjustable cap Depth indicator Function Turning the cap to adjust the penetration depth. The longer the depth indicator is, the deeper the penetration is, and vice versa. 14 Arrow Lancet holder Securing the lancet by inserting it into the lancet holder. Release button Pressing the button to prick your finger. Cocking control Pull the cocking control to get ready for prick. Identifying the depth of penetration. Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 2.1.4 Test Strip 1. Absorbent hole The BG meter can measure the BG value of whole blood by obtaining blood samples with the test strip. The absorbent hole is close to the blood sample, and will absorb the 2. Confirmation window 3. Test handle strip sample into the test strip when the blood sample is applied. The figure on the right shows the 4. Contact bars 15 front of the test strip, and the following table describes the functions. Table 5 No. Name Absorbent hole Function Close to the sample, and absorbing the sample into test strip. Confirmation window Checking whether the sample is sufficient through the confirmation window. 16 Test strip handle Contact bars Handling the test strip Inserting the end into the test slot on the BG meter. Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Store the test strips in their original vial, which contains desiccant inside, and keeps the test strips from moisture. Code number and optional color chart are printed on the test strip vial. Table 6 describes the functions. Table 6 No. Name Function Code Used for calibrating the BG meter. number 17 After reading the test result, you can directly compare the color on the test strip with the color chart on the test strip Optional color chart vial. The chart presents blue colors in two depths, respectively standing for glycopenia (2.8 mmol/L) and hyperglycemia (19.4 mmol/L). White shadow stands for unused test strips. 18 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 2.2 Health Mobile Phone The figure on the right shows the appearance of the health mobile phone; Table 7 describes the function and usage of the health mobile phone keys. 19 Table 7 No. Name Function Power Powering on/off the mobile phone; Pressing the button to awake button the phone when it is standby. Talk key Dialing numbers Navigation Navigation and confirmation. key e+Health Pressing the key to start the system and display the interface when key 20 End key the interface is hidden. Press the key to end a call or hide the interface. Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System No. Name Function e+Health shortcut See e+Health key icon 21 3 Measuring BG Value Before measuring, prepare a clean, dry table and all necessary items (including BG meter, lancing device, sterile lancet, test strips, alcohol and cotton swabs). 3.1 Preparing for Obtaining a Blood Sample 1.Pull off the cap of the lancing device. Insert the lancet into the lancet holder of the lancing device. Push down the lancet until it is secured in the lancet holder. 2.Twist the protective disk off the lancet, and then replace the cap of the lancing device. Note: You can adjust the depth of penetration as needed. 3.Pull the cocking control back until it clicks. 22 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 4.Wash your hands with soap and warm water. Clean your hands and sterilize the puncture site with cotton swab and alcohol. Note: Rub your hand from the wrist to fingertip two or three times to stimulate blood perfusion. 3.2 Preparing the BG Meter 1.Insert the test strip facing up into the test slot. The BG meter automatically starts. Note: Make sure no test strip is inserted in the BG meter before operation. 2.The BG meter automatically displays code number. You can start measuring when the displayed code number is the same as that on the test strip vial. 23 3.3 Starting Testing 1.Press the lacing device's tip firmly against the lower side of your fingertip. Choose a different spot each time you test to prevent soreness and calluses. 2.Press the release button of the lancing device. If needed, you can rub your finger softly from the pad of finger to fingertip to stimulate blood perfusion. 3.Make sure a new test strip is inserted into the BG meter. Use the absorbent hole of test strip to touch the blood sample. Blood will be drawn in. You can check whether the sample is sufficient through the confirmation window. If the blood is deficient, the blood drop symbol flashes. 4.When the BG meter is reading the result, the clock symbol flashes on the display. 24 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System The result is displayed in approximately 5 seconds. 5.The test result is stored in the memory. 6.Push up the test strip ejector. The test strip is ejected, and the BG meter automatically switches itself off. If no push-up operation is performed, the BG meter switches off automatically three minutes after displaying the test result. 7.Enable the software on the health mobile phone. 8.Pushing up the Bluetooth button when the meter is turned off to enable the Bluetooth connection. The connection of mobile phone and BG meter succeeds when the Bluetooth indicator keeps on. You can upload data then. Note: Discard the used test strip into a disposal container. 25 9.Pull off the cap of the lancing device. Take off the lancet from the lancet holder. 10.Discard the lancet into a disposal container for sharp items. Note: Follow the instructions of dismantling and discarding the used lancet strictly to prevent accidental puncture. 26 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 4 Operations on the Phone Press the e+Health key or click the shortcut icon on the phone screen. The interface of healthcare monitoring platform is displayed. See the figure on the right: 27 Click Diabetes Follow-Up on the interface. The main interface of diabetes patient follow-up is displayed. See the figure on the right. Diabetes follow-up includes BG monitoring, follow-up scheme, health advice, complaint, device management, settings and update. 28 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 4.1 Typing BG Value Select on the main interface of BG monitoring. The BG monitoring interface is displayed. See the figure on the right: You can enter BG monitoring data, view BG trend and analysis report here. Two methods are available for BG value input: BG meter transmission and manual input. You can 29 change the input method by selecting different options. 1.BG Meter Transmission The BG meter transmits data to the health mobile phone after automatically connecting to the latter. If the health mobile phone enables GPRS, it automatically sends data to the server. 2.Manual Input The patient enters data on the mobile phone after measuring the BG value with BG meter. Historical data: viewing stored BG data. Upload: uploading stored but not uploaded data to the server. 30 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Storage: storing the BG value after the user inputs the data. 4.2 Viewing BG Trend Select on the main interface of BG monitoring. The BG monitoring interface is displayed. See the figure on the right: Click BG Trend. Then select the start time and end time. The BG trend chart during the required period is displayed. 31 4.3 Viewing Follow-Up Scheme Select on the main interface of BG monitoring. The follow-up scheme interface is displayed. See the figure on the right: The patient can download, enter, view and upload follow-up scheme here. The patient checks each parameter according to the follow-up scheme downloaded from the server, and then records the values to the follow-up information. After saving the 32 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System information, the patient can upload it to the server. 4.4 Viewing Health Advice Select on the main interface of BG monitoring. The interface of health advice is displayed. See the figure on the right: The doctor can send health advice through the server; the patient can view health advice on the mobile phone. 33 Click to download the latest advice. Reminders are displayed periodically if you do not download the advice. Click delete the health advice. 34 to update or Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 4.5 Complaint Click on the main interface of diabetes patient follow-up. The interface of complaint is displayed. See the figure on the right: The patient can send the feedback to the server when not feeling well by clicking Complaint. The doctor can also view the complaint through the server. 35 Click Upload after filling in relevant information to save it to the phone, and then upload it to the server. 5 Precautions The power indicator flashing red slowly indicates low battery. Please replace the AAA alkaline batteries with two new ones. Do not use rechargeable batteries. Make sure the distance between the BG meter and mobile phone is between 5 cm and 10 m when uploading BG data. When entering data, press the power button on the top of the health mobile phone to enable it if it is in power-saving state. 36 If the follow-up interface is hidden or covered by other software interfaces, press Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System on the lower right to return to the follow-up interface. Additional Information: Figures and descriptions in the operation guide are only for demonstration. Please adhere to actual products in case of any discrepancy. Please contact relevant hospital personnel for any questions during operation. FCC NOTE: 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. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user's authority to operate the equipment. 37
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