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

  I Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Table of Contents 1 Components ............................................................................................................. 1 2 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 3 Measuring BG Value ............................................................................................... 22 3.1 Preparing for Obtaining a Blood Sample .................................................................... 22
                                            II 3.2 Preparing the BG Meter ............................................................................................. 23 3.3 Starting Testing .......................................................................................................... 24 4  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 5 Precautions ............................................................................................................ 36
  1 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).
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  3 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.
                                            4      Front                 Left side             1. Test slot 2.  Bluetooth indicator 3. Display 4. Mode button 5.  Test  strip ejector
  5 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System               Back             Right side                             6. SET button 7.  Battery compartment 8.  Bluetooth button
                                            6 Table 1 No. Name Function 1 Test slot Inserting the test strip 2 Bluetooth indicator Indicating data transmission and working status 3 Display Displaying the results, and symbols guiding your test 4 Mode button Turning on/off the meter; browsing and setting modes. 5 Test strip ejector Ejecting the used strip by pushing up this button. 6 SET button Entering and confirming the meter settings.
  7 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System 7 Battery compartment Holding the batteries. AAA alkaline batteries only. 8 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 1 Off Bluetooth is disabled. 2 Flashing blue Bluetooth is enabled and
                                            8 under connecting. 3 Normally on in blue Bluetooth connection is set up 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.
  9 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:
                                            10 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.
  11 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System Table 3 1 Code 9 Measurement unit 2 Blood drop symbol 10 Memory symbol 3 Test strip symbol 11 Measurement mode 4 Low battery symbol 12 Control solution mode 5 Test result 13 Reminder alarm 6 Error warning 14 Day average 7 Ketone warning 15 Time 8 Face/Low/High symbol 16 Date
                                            12 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.       Caution: Never share a sterile lancet. The sterile lancet is for single use only. Always Protective cap Lancet   Base
  13 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.       1 2 5 6 3 4
                                            14 Table 4 No. Name Function 1 Adjustable cap Turning the cap to adjust the penetration depth. 2 Depth indicator The  longer  the  depth  indicator  is,  the  deeper  the penetration is, and vice versa. 3 Arrow Identifying the depth of penetration. 4 Lancet holder Securing the lancet by inserting it into the lancet holder. 5 Release button Pressing the button to prick your finger. 6 Cocking control Pull the cocking control to get ready for prick.
  15 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System  2.1.4 Test Strip 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 sample  into  the  test  strip  when  the blood sample is applied. The  figure  on  the  right  shows  the 2. Confirmation   window 1.  Absorbent hole 3.  Test  strip handle 4.  Contact bars
                                            16 front of the test strip, and the following table describes the functions. Table 5 No. Name Function 1 Absorbent hole Close to the sample, and absorbing the sample into test strip. 2 Confirmation window Checking whether the sample is sufficient through the confirmation window. 3 Test strip handle Handling the test strip 4 Contact bars Inserting the end into the test slot on the BG meter.
  17 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 1 Code number Used for calibrating the BG meter.
                                            18 2 Optional   color chart After reading the test result, you can directly compare the color on the test strip with the color chart on the test strip 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.
  19 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.      6 5 4 2 3 1
                                            20 Table 7 No. Name Function 1 Power button Powering on/off the mobile phone; Pressing the button to awake the phone when it is standby. 2 Talk key Dialing numbers 3 Navigation key Navigation and confirmation. 4 e+Health key Pressing the key to start the system and display the interface when the interface is hidden. 5 End key Press the key to end a call or hide the interface.
  21 Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System No. Name Function 6 e+Health shortcut icon See e+Health key
                                            22 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.
  23 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.
                                            24 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.
  25 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.
                                            26 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.
  27 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:
    28  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.
  29 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
    30 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.
  31 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.
    32 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
  33 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.
    34 Click   to  download  the  latest  advice.  Reminders  are displayed periodically if you do not download the advice. Click   to update or delete the health advice.
  35 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.
    36 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.    If  the  follow-up  interface  is  hidden  or  covered  by  other  software  interfaces,  press
  37 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 operatethe equipment.

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