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User Guide

Blood Glucose
Monitoring System (Cloudia)

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Summary of Contents for Cloudia

Page 1: ...User Guide Blood Glucose Monitoring System Cloudia...

Page 2: ...Data Transmission 33 Memory Recall 35 Replacing the battery 36 How to Clean and Disinfect 38 Storage and Handling 46 Display Messages and Problem Solving Guide 47 Performance Evaluations System Specif...

Page 3: ...plays the result as a blood glucose level The GoodLife Blood Glucose Monitoring System Cloudia GoodLife System is designed to provide blood glucose measurements with easy and comfort able testing The...

Page 4: ...ount of reducing substances such as triglycerides 1000mg dL ascorbic acid 2 25mg dL uric acid 15mg dL and xylose 50mg dL 1 2 3 4 A red blood cell count hematocrit that is either very high over 55 or v...

Page 5: ...contact at 1 855 692 3511 Mon Fri 9 00 am 4 30 pm Pacific Time NOTE Please make sure that all products listed on the contents of the box are contained in the package before using this system If you f...

Page 6: ...For Self testing Battery AAA 6V HMD BioMedical Inc Hsinchu Taiwan serial no XXXXX 0000001 SIM 8901204043780370392 For In Vitro Diagnostic Use Only FCC ID AYY0000001 3L 02 XXXXXX V1 SIM AAA AAA AAA AA...

Page 7: ...be adjusted and stored into 3 types of test modes Before Meal Test After Meal Test and Control Solution Test Alarm Symbol Appears when alarm is set Symbol Appears when data transmission Test Result Ti...

Page 8: ...lary whole blood or GoodLife Glucose Control 1 2 Solution Results will not be accurate if used with plasma or serum samples Do not use test strips beyond the expiration date indicated on the strip via...

Page 9: ...check if the GoodLife Blood Glucose Monitoring System Cloudia and Test Strip are working correctly as a system Users should perform a control solution test when a new vial of test strip is opened a m...

Page 10: ...losed at temperatures between 50 F 10 C and 86 F 30 C Please carefully read the label before use For purchase of control solution please contact your local distributor or customer support at 1 855 692...

Page 11: ...strip to exit Meter will auto matically turn off NOTE If you do not get OK reading but appear other error message turn off the meter by remove check strip from the meter Then check the battery and rep...

Page 12: ...below to set the date and time manually Celsius and Fahrenheit can be set according to your preference Then press the Set button to choose between C for Celsius and F for Fahrenheit When Temperature U...

Page 13: ...ter will display OK before turning off 7 8 Press and hold the Set button for 2 seconds to turn on the meter when ON show up it means auto transmission Press the Set button to choose between ON auto an...

Page 14: ...sure to tightly replace vial cap after removing test strips Insert test strip immedi ately into strip slot as illustrated The meter turns on automatically Check if the code number on the meter matche...

Page 15: ...in individuals experiencing a hyperglyce mic hyperosmolar state with or without ketosis and criti cally ill patients should not be tested with the meter Important Safety Information The meter is for...

Page 16: ...glucose result seems unusually high or low or inconsistent with your previous results check the following 1 Does the code number on the test strip vial match the code number on the meter 2 p i r t s t...

Page 17: ...tion Setting Auto Data Transmis sion the test result will be transmitted to the database through GSM system after every time you test When the meter is set as manual transmission press es and holds th...

Page 18: ...g devices with micro processor control such as infusion pumps hemodialysis machines breath ing assistor anesthesia machines infant incubators etc t t t t t t The test records in the meter will not be...

Page 19: ...t replace the batter ies immediately Remove the old batteries and insert 4 new AAA batteries into the battery compartment Be sure to align the plus and minus signs correctly 4 Close the battery compar...

Page 20: ...ser To mitigate the risk of bloodborne pathogen trans mission eg viral hepatitis the meter must be prop erly cleaned and disinfected The life of the meter is 5 years for 18 250 cleaning and disinfecti...

Page 21: ...f premoistened wipe out of canister Remember to recap the canister 4 Wipe entire device until visibly clean Set Mem 5 Throw away the used wipe Please do not reuse the wipe CAUTION 1 The meter should a...

Page 22: ...d into the test strip slot 5 Throw away the used wipes Please do not reuse the wipe Warning 1 Please use disinfectant with caution 2 For your own safety please do not mix disinfectant with other liqui...

Page 23: ...infection or need more information please contact your distributor or customer support at 1 855 692 3511 References 1 FDA Public Health Notification Use of Fingerstick Devices on More than one Person...

Page 24: ...ng battery Please follow all the instructions on the User Guide while operating GoodLife Blood Glucose Meter HMD BioMedical Inc will not be responsible for any impairment occurred from NOT following t...

Page 25: ...ill ap pears call your doctor immediately Tempera ture is above or below the operating range of test strips The result you have obtained may not be accurate Move to an area with temperature between 50...

Page 26: ...cient 2 Meter is defective You have to 1 Repeat test with suf ficient sample 2 Perform Meter Check by inserting check strip Error message Err1 Data communi cation module is malfunction Err2 Failure to...

Page 27: ...g Temp Range 50 F 104 F 10 C 40 C 8 Operating Relative Humidity 20 80 RH 9 Memory Capacity 999 test results with time and date 10 Result Setting Before meal After meal and Control solution test settin...

Page 28: ...ncentration 75 mg dL Within 5 Within 10 Within 15 Within 20 35 87 40 67 87 77 78 87 90 85 87 98 Tests were conducted by trained technicians in the laboratory setting The venous whole blood from one su...

Page 29: ...ides an integrated table including test results of blood glucose measurements and quality controls The system does not recommend any medical treat ment or dosing recommendations Hardware requirement P...

Page 30: ...window on your computer and go to www iglucose net 1 Click on the login button from the iglucose homepage 2 Enter the meter serial number in Email or Serial and Password and click the login button 3 I...

Page 31: ...60 61 The welcome page will appear Click on the View Readings button 4 Your Time zone page will appear choose your time zone and click on Update Time zone button 5...

Page 32: ...any of the following tabular or graphic report formats to view your reading Trend Report Pie Chart logbooks or Summary 6 Trend Report Displays high and low glucose read ings within a customized date a...

Page 33: ...nd post meal glucose readings that fall in and out of target ranges logbooks Displays daily and historical glucose readings with date and time stamp Glucose read ings are also displayed before and aft...

Page 34: ...ion 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 t 3FPSJFOU PS SFMPDBUF UIF...

Page 35: ...irement The FCC has granted an Equipment Authorization for this device with all reported SAR levels evaluated as in compliance with the FCCRF exposure guidelines SAR information on this device is on f...

Page 36: ...ree of defects in material and workmanship for 5 years from the date of original purchase During the stated 5 year period HMD shall at no charge replace a unit found to be defective with an equivalent...

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