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Important safety

information

Indications for use

The AiDEX

TM

Continuous Glucose Monitoring System

(CGMS) is indicated for continuous or regular moni-
toring of glucose levels in subcutaneous tissue, and
is used for daily detection and self-management of
blood glucose levels in people 14 years or older. It is
intended for use by patients at home and in healthcare
facilities.
Interpretation of the AiDEX

TM

CGMS results should be

based on the glucose trends and several sequential
readings over time. The AiDEX

TM

CGMS also aids in

the detection of episodes of hyperglycemia and hypo-

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Содержание AiDEX

Страница 1: ...AiDEXTM Continuous Glucose Monitoring System User Guide MicroTech Medical Hangzhou Co Ltd...

Страница 2: ......

Страница 3: ...traindications 3 Precautions 4 Blood glucose test module precautions 6 Product components 8 Component description 9 Using a New Glucose Sensor 14 Applying a sensor 14 Setting the Personal Diabetes Ass...

Страница 4: ...s 33 Using the PDA 34 Pairing with a new transmitter 34 Alarm system description 38 Using the built in Blood Glucose Meter BGM 41 Charing the Personal Diabetes Assistant PDA 50 Caring for your Continu...

Страница 5: ...tissue and is used for daily detection and self management of blood glucose levels in people 14 years or older It is intended for use by patients at home and in healthcare facilities Interpretation o...

Страница 6: ...Tech s Exactive EQ blood glucose test strips It cannot be used for the diagnosis and screening of dia betes nor as a basis for drug therapy decisions Patients This Continuous Glucose Monitoring System...

Страница 7: ...e mental disorders such as depression schizophrenia 2 Are unconscious 3 Are unable to understand or master the usage of the device 4 Have severe hearing or vision impairment 5 User below the age of 14...

Страница 8: ...d changes in blood glucose more than 0 1mmol L per minute glucose levels measured in interstitial fluid by the CGMS may not be the same as blood glucose levels When blood glucose lev els drop rapidly...

Страница 9: ...ibrate the glucose sensor If the problem persists remove and replace the sensor While extensive user testing was done on AiDEXTM CGMS in Type I and Type II diabetic patients the study groups did not i...

Страница 10: ...ult in incorrect test results The blood glucose test function can only be used to determine blood glucose levels using whole blood samples Do not use serum or plasma samples The blood glucose test fun...

Страница 11: ...is only suitable for clinical screening tests or self blood glucose monitoring The test results cannot be considered as validated re sults In order to ensure the accuracy of the results the test resul...

Страница 12: ...includes a Per sonal Diabetes Assistant a Transmitter and a Glucose Sensor Personal Diabetes Assistant will be referred as PDA in the text below The PDA Transmitter system consists of the fol lowing c...

Страница 13: ...the follow ing components Applicator with Built in Sensor Component description Personal Diabetes Assistant The PDA is used to display glucose readings and historical data when paired with an operati...

Страница 14: ...appears Confirm and shutdown the device Display on While in stand by mode press the power button and the display will show the lock screen Display off When the display is on press the power button onc...

Страница 15: ...he brightness of the PDA screen dispaly Enter button The Enter Button can be used to confirm entered information without touching the screen Display 3 2 inch color touchscreen USB port For PDA chargin...

Страница 16: ...The transmitter is used together with the glucose sensor base When the sensor and transmitter are ac tivated on one s body it measures and stores glucose readings as well as transmitting the readings...

Страница 17: ...13 Sensor applicator Sensor base tape Glucose sensor Sterile packaging Sensor components...

Страница 18: ...ide and the back of the upper arm For best performance avoid excessive motion which may weaken the sen sor and its adhesive tape Avoid accidental knocking off the sensor It is strongly rec ommended to...

Страница 19: ...ed by checking its expiration date If the sensor is expired or the steril ized package is damaged please do not use it Note Take out the sensor appli cator by turning it anti clock wise Place the appl...

Страница 20: ...y Note Applying a sensor may cause bruising or bleeding If bleeding does not stop remove the sensor and apply a new sensor to a different location Align the transmitter to the sensor base and press th...

Страница 21: ...ly The recyclable applicator is meant for single use only Dispose the used sensor package and sensor appli cator according to your local regulations Follow the steps described above carefully and be s...

Страница 22: ...t up Press and hold the power but ton the PDA will vibrate indicating that the PDA is powered on After about 30 seconds the Setup Wiz ard will appear and guide you through entering basic settings When...

Страница 23: ...19...

Страница 24: ...20 Sensor start up After the sensor is successfully applied to your body and connected to the transmitter the paired PDA will display New sensor detected please confirm Press the Confirm to continue...

Страница 25: ...21 Now the PDA will display Sensor initializing Sensor initialization typically takes about 1 hour to complete...

Страница 26: ...22 When the sensor initialization is complete the PDA will begin to display the current blood sugar value...

Страница 27: ...zation and starts displaying your current blood glucose val ue immediately If you press Confirm the sensor will start initializing again At this point the PDA skips initialization and starts displayin...

Страница 28: ...s rapidly changing may cause the CGMS to be less accurate Please calibrate the system only using reliable blood glucose test values Use certified BG meter and test strips that are within expiration da...

Страница 29: ...alibration menu on the PDA s home screen The PDA will prompt Please calibrate with BG strip Insert a new blood glucose testing strip into the PDA s testing strip port to activate the blood glucose tes...

Страница 30: ...26 Please follow the instructions in the Using the built in blood glucose meter section When your test result is displayed click Calibrate to complete the sensor calibration process...

Страница 31: ...he blood glucose meter and do not want to calibrate the CGMS press Record after the test result is displayed Your blood glucose reading will be recorded to history but not used to calibrate the real t...

Страница 32: ...the measurement from a different blood glucose meter for calibration press Manual Calibration when the PDA shows Please insert blood glucose test strip Enter the value manually and press Calibrate to...

Страница 33: ...recommended to calibrate the sensor as soon as possible after it is initialized to confirm the sensor s performance If you doubt that the glucose level displayed by the CGMS is correct you can use the...

Страница 34: ...m the edge and slowly uncover it until the entire sensor is removed You can use warm soapy water to remove any remaining sticky residue Press the two locking arms on one side of the sensor base pull t...

Страница 35: ...low glucose alerts are triggered Before setting the target glucose range please make sure that the transmitter is connected to the sensor base and that the PDA and transmitter have a good wireless co...

Страница 36: ...low sensor glucose threshold The threshold range is 2 2 5 0 mmol L 39 6 mg dL 90 mg dL default value is 3 5 mmol L Add Press OK to confirm After entering the preferred threshold values the PDA will u...

Страница 37: ...range the PDA will show settings change failed Make sure that the PDA and transmit ter are within communication range and try again Date and time settings Press Settings on the PDA s home screen to en...

Страница 38: ...an only be paired with one transmitter at a time Before pairing please find your transmitter serial number on the transmitter box Make sure the new transmitter is assembled to the sensor base Press Se...

Страница 39: ...aired to it Unpair the old transmitter Press OK to unpair the old transmitter and pair a new one Note When unpairing an expired transmitter make sure that the PDA and transmitter are within commu nica...

Страница 40: ...36 Enter the transmitter s serial number when prompted...

Страница 41: ...37 Click Confirm The PDA will search for a connection and show Pairing successful when the connection has been made...

Страница 42: ...nd low priority alarms no high priority alarms as defined by ISO standards The low priority prompt message may be a physio logical status alarm message hyperglycemia alert or a technical alarm message...

Страница 43: ...larm priority levels Alarm level Visual signal Audio signal Sound pres sure dB Medium priority Flashing yellow light Three consecutive beeps 60 90 Low priority Steady yellow light Two consec utive bee...

Страница 44: ...ood glucose please take medicine or inject appropriate amount of insulin according to doctor s prescription Sensor Expired Low Remove the current glucose sensor and replace it with a new sensor Sensor...

Страница 45: ...ndow A transient electrical current is generated and this current is mea sured to determine the blood glucose level reading Blood sampling Before testing first become familiar with how to collect bloo...

Страница 46: ...ood glucose test If the PDA s screen is on the PDA will automatically go to the blood glucose test screen when insert a test strip into the test strip port An animation will prompt you to apply blood...

Страница 47: ...tory results Your PDA s blood glucose meter and laboratory equipment both report glucose concentrations in the serum or plasma component of your blood However variations between the two are normal and...

Страница 48: ...5 minutes Wash and dry your hands before obtaining a blood sample Make sure you closely follow the instructions in this manual Test results may show small deviations this may due to the following reas...

Страница 49: ...ed first and control solution 2 is used when a second level test is required MicroTech offers a separately available control solution package that contains both Control Solution 1 and Control Solution...

Страница 50: ...solution drop Shake the control solution bottle gently squeeze out the control solution discard the first drop and drop the second drop onto a clean nonabsorbent surface Now touch the second drop to t...

Страница 51: ...ed to the CTRL1 range printed on the test strip vial or foil pouch Check the expiration date of the test strip and control solution Make sure that the packages have not been opened for more than 6 mon...

Страница 52: ...ct your dealer Control Solution 1 is sufficient for most self testing needs If you think your meter or strips may not be working correctly you may also want to do a level 2 test The ranges for both CT...

Страница 53: ...rt with message window Retest with a new strip Make sure there is enough blood to fill the test window Temperature exceeds operation range Audio and vibration alert with message window Move to a place...

Страница 54: ...e PDA charging cable into the PDA charger Plug the other end of the charging cable into the PDA s charging port Insert the PDA charger into a 220V power outlet A battery charging animation will be dis...

Страница 55: ...ch Medical Use of unapproved compo nents can result in injury Caring for your Continuous Glucose Monitoring System CGMS Cleaning the PDA and transmitter Clean the outer surface of the PDA using a mild...

Страница 56: ...blood chemicals water or other substances on the PDA s test strip and charging ports Disposal Dispose PDA transmitters and sensors that you do not use any more in compliance with local regulations for...

Страница 57: ...ot using the PDA transmitter or sensor system store the components in a cool dry clean and well ventilated area If you decide not to use the PDA for a prolonged period the battery should be stored sep...

Страница 58: ...ion pressure 700hpa 1060hpa Ingress protection level IPX7 IPX0 Use life 4 Years G7 S01 14 days G7 S01A 10 days G7 S01B 7 days Shelf life 1 year 4 Years Detection range 2 0mmol L 25 0 mmol L Measuremen...

Страница 59: ...he device is used in such an environment Portable and mobile RF communication interference may have an impact on the device Please use the cables and accessories provided The cable information is as f...

Страница 60: ...uld be observed to verify normal operation in the configuration in which it will be used The basic performance is described in the table below Performance Description Measurement accuracy When the glu...

Страница 61: ...internal function Therefore its RF emissions are very low and are not likely to cause any interference in near by electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in...

Страница 62: ...line to GND 2KV line to GND 1KV line to GND 2KV line to GND Mains power quality should be that of a typical commer cial or hospital environment Voltage dips short interruptions and voltage variations...

Страница 63: ...band 10V m Portable and mobile RF communica tions equipment should be used no closer to any part of the device includ ing cables than the recommended separation distance calculated from the equation a...

Страница 64: ...Separation distance according to frequency of transmitter m 150kHz 80MHz d 1 2 P 80MHz 800MHz d 1 2 P 800MHz 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 1...

Страница 65: ...use only Type BF applied part Storage temperature Sterilized by radiation Refer to instruction manual booklet Biohazard In vitro diagnostic device Non ionizing radiation See instructions for use Water...

Страница 66: ...1016 PMTL 251 V02 EC REP Lotus NL B V Koningin Julianaplein 10 1e Verd 2595AA The Hague Netherlands...

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