USER GUIDE BEST LIFE Insulin Pump

Transcription

1 USER GUIDE BEST LIFE Insulin Pump 1

2 Table of contents 1. Safety Instruction Understanding BEST LIFE insulin pump... 6 The BEST LIFE insulin pump... 6 Menu structure... 8 Descriptions of Operation Keys... 9 Display Cleaning Starting your pump Battery Setup Setting Date and Time Setting Basal Rate Checking Programmed Basal Priming Basal Delivery Bolus and Temporary Basal Bolus Rate Basic Bolus Square Bolus Dual Bolus Temporary basal SETUP

3 Back Light Alert Pro Mode Self-test Error code Purge Info Suspension & Key lock Trouble Shooting Guide Specifications Initial Setting Description of icons FAQ

4 Read Carefully Before Using the Product These safety instructions must be read before usage to prevent any problem or damages with BEST LIFE 1. Safety Instruction 1) The BEST LIFE insulin pump is intended for continuous infusion of insulin (rapid or short acting insulin). 2) The reservoir is specially designed for BEST LIFE. You should not use any other reservoir of other companies. Infusion sets with luer lock connection can be compatible with BEST LIFE. 3) You should not disassemble or modify the product and the disposables. If you find any problems with the product, take off the battery immediately and contact your local service center or where you purchased BEST LIFE. In addition, if any problems occur to a user of BEST LIFE, please contact a health care professional immediately. 4) It may not work properly if exposed to an electronic magnetic field, especially near X-ray, MRI and CT scanner, etc. Be careful around a power station and substation. If you want to stop using insulin pump for an extended period of time, please remove the battery. 4

5 5) BEST LIFE is not water- proof (IPO). If it gets wet, it may not work properly. Please keep it in the shower pack or the water-proof case when you are around water. If the product gets wet, take off the battery and immediately contact your local service center or where you purchased it. 6) Do not reuse the infusion set and the reservoir. According to health care professionals recommendation, you should not use the infusion set and reservoir more than 72 hours. 7) You should not put any wet reservoir into the product. If the reservoir gets wet, dry it completely before putting it into the pump. 8) In case of running out of battery, it is recommended to carry extra batteries with you when going out. And you may prepare extra syringes for emergency 5

6 2. Understanding BEST LIFE insulin pump The BEST LIFE insulin pump 6

7 1. LCD Window Shows all the operating, programming, memory, menus and alarms. 2. Operation Keys Used to program all the settings and operate the pump. 3. Reservoir Window Allows to check the amount of insulin remaining in the reservoir. 4. Reservoir Cover Protects and hold the reservoir firmly in place. 5. Battery Cover Holds the battery 7

8 Menu structure Home screen BOLUS SET BASAL UTIL PRIME PURGE INFO SUSPEND BASIC SQUARE DUAL SET BOLUS RATE TEMP BASAL BASAL SET BASAL CHECK BASAL SELECT DATE/TIME BACK LIGHT ALERT PRO MODE MAX DOSE OTHER SETUP SELF-TEST TOTAL INFO BOLUS INFO TEMP BASAL INFO WARNING INFO 8

9 Descriptions of Operation Keys 1 Used to move around in menus and to set amount and figures. (Shortcut Key : Press the key for about 5 seconds to directly move to bolus injection menu.) 2 Used to move around in menus and to set amount and figures.( Shortcut Key : Press and hold the key for 5 seconds to lock all the keys. Press and hold again to unlock. 3 Used to move menu screen and to select and confirm each menu and amount, figures, etc. 4 Used to cancel menu and program, operation. (Shortcut Key : Press and hold the key for 5 seconds to suspend and stop the pump. Press and hold again to restart the pump.) 9

10 Display Home Screen Shows Basal insulin is being infused now Current time Residual insulin Residual amount of the battery. Vibration mode. Beep mode Key- lock 10

11 Menu icons Menu icons appear when pressing with the home screen. You can move around in menus by pressing and. 11

12 Remember! On the screen, three menu icons are displayed at a time. If you select one icon, it turns to be in black color. After the last menu icon, the first menu screen will appear again. Remember! If the arrow mark appears on the left or right top as shown on the picture above, it means that there are more menus available. 12

13 Cleaning 1) Take off the battery before cleaning 2) Slightly rub the LCD screen and the outside of the product with a soft piece of fabric 3) Do not use any chemicals (alcohol, benzene, thinner and others) or cleansing materials. Problems may occur. 13

14 3. Starting your pump Battery Setup 1 Remove the battery cover. 2 Insert the battery. 3 Place the battery cover back in place. 14

15 4 If the battery is in place, you will see the company logo on the screen, then the home screen will appear automatically. <Logo Display> <Home screen> When the battery is inserted, the pump will beep. Press any key to stop the beep. The pump starts from the suspension mode. * BEST LIFE insulin pump turns on only when the battery is inserted. No key for power on/off 15

16 Setting Date and Time Please make sure that the date and time are set correctly. It is very important because all the memory and programmed settings are stored on the basis of date and time in the pump. Remember! If you stop using insulin pump for more than 3 days, always make sure that the date and time set are correct before restarting the pump. If not, please adjust the date and time correctly. 1) Move to DATE, TIME in the UTIL menu. 2) Change the date and time in turn. Using and keys, set year, month and date in turn, as well as time format(12 or 24-hour clock), hour and minute. After adjusting each figure, press to save. 16

17 [12-hour-clock mode] [24-hour-clock mode] 17

18 After adjusting each figure, press to save. The previous screen 18

19 Setting Basal Rate BASAL menu is used to set basal rate for 24 hour continuous delivery. BEST LIFE insulin pump delivers insulin every 3 minutes for 24 hours to control your blood glucose. Remember! Consult with your doctor for initial amount of basal insulin. 1) Move the to BASAL PROFILE in the BASAL menu. 19

20 There are 4 basal profiles for different conditions. Choose one profile. 2) Set the Basal rate on 00:00~24:00 hourly basis. You can program different amounts of insulin at different times of the day and night. Set the first period by adjusting ending time using and keys. After changing hour, then press, and change the figure for minute in 30 minute interval. Then press. 20

21 Adjust the amount of basal insulin by pressing and until you reach the right figure for needed amount of insulin. After confirming the front decimal figure, press. Then, change the below a decimal point. Press to complete the first period rate set. (With the setting on the above picture, during 00:00~ 01:00, 8.25IU of basal insulin will be injected.) The TOTAL on the screen bottom means Total basal insulin dose you programmed. 3) Program the next time period the same way explained above. After confirming each period, <INPUT COMPLETE!> appears and the screen automatically goes back to the home screen. 21

22 Remember! If you do not need divided basal rates during 24 hours, you can set the rate in 1 IU control with [BASAL TYPE 2] mode. For detailed information, follow the instructions for [PRO MODE]. Always consult with your diabetes care team for your insulin doses and rates fine-tuning. * For further information, go to the PRO MODE menu. 22

23 Checking Programmed Basal 1) Move to BASAL CHECK in the BASAL menu. If you have programmed all the basal profiles, you can check all the settings you previously programmed. Choose one of the profiles and check the programmed figures and amounts. 2) You can see the programmed values step by step by pressing and. Press to see the screen for 4 profiles. 23

24 24

25 Priming - Preparing reservoir and connecting infusion set. 1) Please wash your hands 2) Move the plunger back and forth to lubricate the reservoir. Pull the plunger as much as the needed amount of insulin. Remove the needle cap of the reservoir. Stick the needle into the vial and put air into the vial. 3) After air is inserted into the insulin vial, pull the plunger down and draw out the desired amount of insulin. 25

26 4) Disconnect the reservoir from the vial, then gently tap on the side to remove the air. 5) Place the needle cap back on the needle. 6) Screw the needle cover and remove the needle. 7) Connect the infusion set to the reservoir. 26

27 8) Go to the PRIME menu. When the message <DO YOU WANT TO PRIME?> is displayed, press. Just wait during <REWINDING> process. When the message < OK IF DONE> appears on the screen and the pump beeps, open the reservoir cover and put the prepared reservoir in place. Then hold the reservoir with silver hook into place firmly. Close the reservoir cover and press 27

28 9) Remove Air With the message <PRIMING>, air is removed from the infusion set and reservoir. Once you see a drop of insulin escaping from the end of infusion set as the picture below, press to stop priming. 10) Residual insulin After priming, residual insulin is displayed on the screen with beep. Press to stop the beep and go to 28

29 the home screen. Remember! If you press when the screen <CHECK RESIDUAL> is on, the insulin is reduced by 2 IU each time you press the button. 11) Abdominal Injection 1. First, wash your hands properly and rub the injection area with a swab. 2. Remove the adhesive tape of the infusion set. Then insert the needle of the infusion set into the injection area. 3. Hold the adhesive down and adjust it on the body so that it does not move. 4. Fix the tubing of the infusion set well to fit your needs. 29

30 Remember! The abdomen is the preferred infusion site as insulin absorption from this area is the safest and more predictable compared to other body sites. The next recommended areas are the upper outer thighs and hips. Please change the infusion site every time you replace the infusion set (You can start from 1 and move to the next number as shown in the picture below.) 30

31 Basal Delivery Basal selection is the menu for you to be able to select the profile you want of the already set Basal profile and inject Basal insulin immediately. 1) Move to BASAL PROFILE in the BASAL menu. 31

32 Select one profile according to your condition, then the programmed basal will be injected immediately. The TOTAL basal amount of each profile is displayed on the screen. 32

33 4. Bolus and Temporary Basal Bolus Rate Bolus rate means the time period to inject 1 IU of bolus insulin. For example, with 20sec. bolus rate, it takes 20 sec. to inject 1 IU. 1 Move to SET BOLUS RATE in the BOLUS SET menu. Adjust the rate with and keys, then press the. You can change the figure from 10sec. to 40sec. in 5 sec. interval. 33

34 The user can adjust the BOLUS RATE according to the reaction of the human body that absorbs insulin. Those users feeling pain and making skin trouble due to fast infusion of insulin have only to set the slow bolus injection rate. 34

35 Basic Bolus Delivers a specific dose of insulin over a short period of time Commonly used for every meals and snacks Used to correct a high blood glucose 1) Go to BASIC in the BOLUS SET menu. 2) You can adjust the amount of insulin needed by pressing and, then press to confirm. Then the screen of bolus injection appears automatically. 35

36 (On the screen, TOTAL means the amount of bolus insulin injected during the day.) 3) The Screen of Injection Breakfast time Lunch time Dinner time 2 Injected insulin amount When injection is over, you will see the message <INJECTION COMPLETE!>, then the screen moves to the home screen automatically. 36

37 4) How to stop insulin injection halfway To stop injection halfway, press, then press. The screen will move to the home screen automatically. 37

38 (As the below picture A, if you press, you can go back to previous injection process. And, as the below picture B, if you do not press any key, you can go back to previous injection process after 20 seconds. ) [Picture A] [Picture B] èè 20 sec. èè The way to stop injection process for Square and Dual is the same as this way. 38

39 Square Bolus Insulin delivery over a period of time; 30min. ~ 8 hours Especially for meal which takes longer to digest Suggestion for using this feature include - Eating a long meal such as holiday or buffet dinner. - Extended snacking - Delayed digestion due to gastro paresis - To cover foods with large amount of fat or protein 1) Move to SQUARE in the BOLUS SET menu. 2) Set the amount for Square bolus by using and. 39

40 Then adjust TERM (time period) from 30min. to 8 hours. You can change the period in 10 min intervals. And press. 3) The screen of injection displayed Injected insulin amount 2 Basal profile no. injected now. 3 Current time 40

41 If injection is over, you will see the message <INJECTION COMPLETE!>, and the screen moves to the home screen automatically. 41

42 Dual Bolus Combines an immediate basic delivery followed by a square bolus delivery It is useful when eating foods that are absorbed quickly mixed with other foods that take longer to absorb. i.e when having fruit salad and pizza together 1) Move to DUAL in the BOLUS SET menu. 2) Set the amount for DUAL bolus 1. Set the amount for Basic bolus by using and, 42

43 then press. 2. Set the amount for Square bolus and TERM(time period) by using and, then press. Dual bolus injection process starts right away. 43

44 3) The Screen of Injection èè [Basic Bolus] [Square Bolus] Injection for Basic bolus starts first, then injection for Square bolus starts after Basic bolus injection is finished. If injection is over, you will see the message <INJECTION COMPLETE!>, and the screen moves to the home screen automatically. 44

45 Temporary basal Used to temporarily increase or decrease basal insulin amount. For the changes, please consult with your diabetes care team. 1) Moves to TEMP BASAL in the BASAL menu. 2) Set date, time and rate You can set date, then set the time period (starting and ending time) in 30 minute interval by using and keys. Set the rate (%) to increase or decrease basal insulin. The range 45

46 is from -90 % to +90%. After programming all the settings for Temporary basal, the screen will show the home screen and Temporary basal program starts immediately. 46

47 5. SETUP Back Light You can adjust brightness and definition in this menu. (With High level of brightness and definition, more power is consumed from battery.) 1) Move to BACKLIGHT in the UTIL menu. 2) Adjust brightness and definition by pressing and, then press. Menu screen appears automatically. 47

48 Alert You can set Beep or vibration mode for alarm signals. Also, the sound when you press keys can be turned on or off. 1) Move to ALERT in the UTIL menu. 2) Alarm signals and key tone 48

49 Pro Mode Move to PRO MODE in the UTIL menu. 1) Max dose You can set max dose for Daily bolus (Total bolus amount for a day), Daily basal (Total basal amount for a day) and Single bolus (Amount for each bolus) 49

50 Set the maximum does of insulin injection of [DAILY BOLUS], by using the button and press to move to the next [DAILY BASAL]. Set in the same way as above the each maximum dose of [DAILY BASAL] and [SINGLE BOLUS] in turn. - Maximum 300 IU for bolus and basal - Maximum 100 IU for single bolus 50

51 After adjusting each figure, press to save. The previous screen will appear automatically. 2) Other Setup Bolus Info Type This menu is used to choose how to display Bolus dose history. 51

52 Press the to select the [BOLUSINFORYPE] 1 or 2 and press to move next [BASAL TYPE]. Set in the same way as above the each function [BASAL TYPE], [BOLUSHOT-KEY] in turn. BOLUS INFO TYPE 1 BOLUS INFO TYPE 2 When you choose [BOLUS INFO TYPE 1], the total amount of insulin injected during a day is displayed. When you choose [BOLUS INFO TYPE 2], every single dose of bolus is displayed with start and complete time. (Last 90 days) 52

53 1 Basal Type You can choose the way to program basal. BASAL TYPE 1 BASAL TYPE 2 With [BASAL TYPE 1] mode, you can set time and amount With [BASAL TYPE 2] mode, only total amount for a day can be adjusted. If your basal insulin rate is in scale for 24 hours, you can choose this simple mode. 2 Bolus Hot-Key : Short-cut key for bolus injection When Bolus Hot-key is on, you can directly start bolus injection by just pressing continuously for 5 seconds. To activate [BOLUS HOT-KEY], choose [ON] by pressing 53

54 buttons. 3 Bolus Set Type You can choose the way to adjust amount of bolus insulin. Bolus Set Type 1 54

55 Bolus Set Type 2 With Bolus Set Type 1, you can change the figure on the front part and below part of a decimal point separately. With Bolus Set type 2, the whole part of figure is changed together. 4 Display time Display time for menu screen can be set from 5 to 900 seconds. 5 Infusion sensing There are three levels of occlusion sensitivity ; Low, Middle and High. When occlusion is detected, no delivery alarm will occur. The occlusion alarm is trigger by unit of missed insulin. The table shows occlusion detection for 3 different levels. 55

56 This function can be selected according to each user s preference. H Recommended for people who has high demand on tight control, especially Type1 diabetics M - Moderate L - Recommend for people with Type 2 diabetes 56

57 Self-test This menu is used to check that the insulin pump functions properly. Move to SELF-TEST in the UTIL menu. è è If there is no problem found through the self test, the screen will 57

58 move to menu screen automatically. è è If you see Error codes like below picture, please contact your local service center or where you purchased your insulin pump. 58

59 Error code Please contact your distributor or where you purchase your insulin pump if you see the Error with number as above picture. 59

60 6. Purge When you use detachable infusion set, [Purge] function helps you to remove air before reconnecting infusion set. It does not save as a bolus delivery information. Go into PURGE menu, and set needed amount to fill catheter. Then press. 60

61 7. Info. BEST LIFE insulin pump displays history of doses, alarms and errors that occurred for the last 90 days. 1) Total Info Move to the TOTAL INFO in the INFO menu. TOTAL INFO shows the total amount of all doses, basal, bolus and square bolus on a daily basis. To move to other dates, press and. 61

62 2) Bolus Info Move to the BOLUS INFO in the INFO menu. Bolus info type 1 Bolus info type 2 Bolus info type 1 shows the total amount of bolus Bolus info type 2 shows the single bolus on daily basis with start and complete time. Press and to move next step. 62

63 3) Temporary Basal Info Move to TEMP BASAL INFO in the INFO menu. TEMP BASAL INFO shows information of temporary basal rate and time period. 4) Warning Info You can check all the last alarms and warnings in this menu. Move to the WARNING INFO in the INFO menu. In order to see more alarm occurrences, use and. 63

64 8. Suspension & Key lock Suspension Insulin pump should be put on [stop]mode in the following case ; - When you change the infusion set and the reservoir - When you change the battery - When you stop using pump for an extended period of time 1) Move to SUSPEND, and press to stop the pump. The screen for stop mode will appear automatically. 64

65 2) Move to SUSPEND, and press to cancel the stop mode. Home screen will show operation mode automatically. Remember! The shortcut key for suspension If you press and hold for a few seconds, the screen will 65

66 show the message <STOP : SEL>, then Press. To get you pump back in operation mode, press and hold key. The screen will show the message <CLEAR : SEL>, then press. Key Lock Key- lock function prevents the insulin pump from being operated unwillingly especially during sleeping. To lock the keys, press and hold for a few seconds until you see the icon [ ] on the screen. To unlock the keys, press and hold for a few seconds until the icon [ ] disappears. The key-locking function is set. 66

67 9. Trouble Shooting Guide This guide helps you when there are problems that may occur while using your bolus pump. If alarms (warnings & notes) occur, the injection process is stopped automatically. 1) Occlusion [OCCLUSION] means blockage or clogging in infusion set. Troubleshooting Replace the infusion set with new one. (If you press, the warning message disappears.) 2) Low battery [LOW BATTERY] means there is a shortage of battery. 67

68 Troubleshooting Change the battery. If you do not change the battery, the pump will be turned off showing the message [POWER OFF]. 3) Low residual volume When there is less than 10IU of insulin left in the reservoir, you will see the message [RESIDUAL : BELOW 10 IU]. (If you press, the message will disappear, and it will appear after a while.) Troubleshooting Check the volume of insulin inside the reservoir, then replaced with a new one filled with enough insulin. 4) Empty reservoir When there is no insulin left in the reservoir, you will see the message [RESIDUAL : 0 IU]. (If you press, the message will disappear.) Troubleshooting Change the reservoir, otherwise the message will continue to show whenever 68

69 you try to deliver insulin. 5) Over-injection When the delivered insulin exceeds the programmed [Max Dose], alarm signals as above pictures will appear. Troubleshooting - Please check the programmed max dose for basal. If needed, increase the amount. If error code appears on the LCD screen please contact the distributor or pump trainer immediately. 69

70 10. Specifications Product Name Manufacturer Manufacturing BEST LIFE-1 Diamesco Co., Ltd KFDA No License No. Product License No. Size Weight Power Supply The Insulin Storage No mm(W) X 21.2mm(D) X 46mm(H) 62g (except for battery) DC 3.6V Lithium Battery 300 IU (3cc) Volume Motor Type Injection Mode DC Motor Basal, Temporary basal, Bolus (Basic, Square, Double) Basal increments Basal profile 0.05 IU 4 profiles Basal rate 48 Bolus increments Max dose 0.05 IU Maximum 300 IU for Basal and Bolus Maximum 100 IU for single bolus Memory Warning Signal 90 day history for last doses and alarms Beep or vibration Alarms - Low reservoir(below 10 IU and 70

71 0IU) - Empty reservoir - Occlusion of infusion set - Low battery - Over-injection ; Basal, Daily bolus, Single bolus Storage conditions Temperature: -10 ~ 40 Humidity: 10 ~ 90% RH Atmospheric Pressure: 660 ~ 1060 mbar Operating conditions Temperature: 0 ~ 40 Humidity: 20 ~ 70% RH Atmospheric Pressure: 660 ~ 1060 mbar 71

72 11. Initial Setting Item Initial Set Value Remarks Daily allowable bolus 150 IU (Pro Mode) Allowable one bolus 50 IU (Pro Mode) Basal Daily allowable basal insulin The basal setting time 0 IU 150 IU (Pro Mode) 0 ~ 24 hours Temporary basal 0% Lighting Step 1 Clarity Step 2 Warning Sound Key Sound Sound ON Bolus injection rate 10 seconds (Pro Mode) Basal setting 1 (Pro Mode) Bolus Hot-key OFF (Pro Mode) Bolus setting 1 (Pro Mode) Display time 20 seconds (Pro Mode) Infusion sensing H (Pro Mode) Key-locking function Clear 72

73 12. Description of icons Do not reuse them. Infusion set and reservoir are sterilized by EO gas The date of manufacture The period of circulation Lot number (serial number) Use after prescription by the physician No PVC Non pyrogenic Non toxic Should be careful with humidity. Do not use hook to carry Fragile 73

74 13. FAQ Q1) what to do when the pump is dropped into water? Quickly remove the battery and contact your local service center or your distributor for inquiry. Q2) What to do when the pump is dropped on the ground? Check if there is any damage on the outer side of your pump and if it works properly. Run [Self-test]. If the pump does not work or any error/warning occurs, contact your local service center or where you purchased your pump. 74

75 Manufactured by : Diamesco Co., Ltd. Head office 3F Dia B/D , Seongsu1-Ga 2-Dong Seongdong-Gu, Seoul, Korea (C.P ) Tel Fax Factory 2F Dae-Kwan B/D , Seongsu1-Ga 2Dong Seongdong-Gu, Seoul, Korea (C.P ) Tel Fax