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Performance Characteristics

97 

Figure 5.5 is a representative example of continuous Sensor tracing vs. reference blood glucose reading, 
where Sensor showed poor performance. The open circles (o) on the graph represent the meter 
calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid 
line (—) represents the Sensor glucose value.

 Figure 5.5

Содержание Guardian RT MMT-7900

Страница 1: ...Guardian RT Continuous Glucose Monitoring System REF MMT 7900 User Guide ...

Страница 2: ...ll Healthcare Products Company CaviCide is a registered trademark of the Metrex Research Corporation IV3000 is a registered trademark of Smith Nephew Inc YSI 2300 STAT Plus is a trademark of YSI Incorporated The Guardian RT System is covered by the following Patent Nos 5 390 671 5 391 250 5 568 806 5 586 533 5 586 553 5 777 060 5 779 665 5 786 439 5 851 197 5 882 494 5 954 643 6 093 172 6 248 067 ...

Страница 3: ...nitor 3 Monitor Buttons 3 Monitor Button Functions 4 Monitor User Guide Terms 4 Test Plug 5 Sen serter 5 Availability 5 Help 6 Record Keeping 6 Warranty 6 User Safety 7 Indications for Use 7 Contraindications 7 Warnings 8 Precautions 9 Adverse Reactions 11 Symptoms of Hypoglycemia 11 Symptoms of Hyperglycemia 12 Blood Glucose Meter 12 ...

Страница 4: ...nd Date 24 Clearing the Glucose History 26 Setting the Glucose Unit 29 Setting the Low Glucose Alert 30 Setting the High Glucose Alert 33 Setting the Alert Type 36 Entering the Transmitter ID 37 Inserting the Sensor 39 Sensor Storage and Handling 44 Sen serter Maintenance 44 Affixing the Transmitter 45 Searching for the Transmitter 46 Connecting the Sensor to the Transmitter 47 Sensor Initializati...

Страница 5: ...Insulin Taken 60 Carbohydrate Amount 61 Duration of Exercise 61 Other Events 62 Glucose Alarm History 63 Search 65 Signals 65 The Snooze Option 66 Chapter 4 Troubleshooting and Alarms 67 List of Alarms 68 No ID 68 High 69 Low 70 Check Sensor 71 Low Batt 72 Off No Power 73 Service C60 61 74 Re Init 74 No Sync 75 Cal Err 76 Key Held 77 Enter BG 77 Set Time 78 Replace Sensor 79 System Alarms 80 Test ...

Страница 6: ...er 6 System Maintenance 99 Belt Clip 99 Installation 99 Removal 100 Leather Case 100 Protection from Water 100 Protection from Impact 101 Protection from High and Low Temperatures 101 Cleaning the Monitor 102 Cleaning the Transmitter 102 Cleaning the Sen serter 104 Interference from Electrical Equipment 105 Ordering Supplies 106 Product Specifications 107 FCC Notice for the Monitor 110 FCC Notice ...

Страница 7: ...ce that can store this information for real time review or can download it to a personal computer using a Medtronic MiniMed Com Station MMT 7301 and the Guardian Solutions Software MMT 7315 This information is used by you and your doctor to identify glucose patterns and to improve your diabetes management We know you are ready to start but before you do please read the following user guide to lear...

Страница 8: ...alert is triggered if your Sensor glucose value is greater than or equal to the preset limit Glucose values are calculated and displayed based on the blood glucose reference values entered periodically into the Monitor for calibration NOTE Before taking action based on glucose values or High and Low glucose alerts check your blood glucose using a home glucose meter available from your doctor or ph...

Страница 9: ...ibration is due the word CAL will appear on the Monitor screen This icon will remain on the display until you enter a meter value If you do not enter a meter value within 12 hours of the last entry an ENTER BG alarm is triggered This alarm is also triggered if a calibration has not been done in the last 8 hours since the first calibration For best performance enter a meter value every 6 hours A mi...

Страница 10: ... button to clear alarms alerts ACT The ACT Activate button lets you make changes to programming save information to memory or clear alarms alerts You will hear a beep when you press ACT to confirm the selection Up and Down Arrows The Up and Down arrows are used to change values or settings Press either arrow once to pick the next highest or lowest value Hold down either arrow to scroll through the...

Страница 11: ... Sensor Transmitter or Monitor are working correctly See Chapter 4 Troubleshooting and Alarms for more details Sen serter Figure 1 6 The Sen serter MMT 7500 is a spring loaded reusable device that inserts the Sensor MMT 7002 at an angle under the skin and into the interstitial fluid See Figure 1 6 Availability The Guardian RT and supporting products are available from Medtronic MiniMed and authori...

Страница 12: ...u Record Keeping A serial number is found on the back of the Monitor and on the top of the Transmitter Please enter the serial numbers and purchase date in the table below Warranty Please read the enclosed warranty card carefully as it lists the terms of coverage Department Telephone Number 24 Hour Product Help Line U S and Canada 800 MINIMED 800 646 4633 or 818 576 5555 International Contact your...

Страница 13: ...a home glucose monitor and not on Guardian RT values The Guardian RT provides real time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose It also stores the data so that it can be analyzed to track patterns Glucose data can be further downloaded to PC software for analysis of historical glucose values Contrai...

Страница 14: ...your doctor before using the Sensor Bleeding swelling irritation and or infection at the insertion site are possible risks associated with inserting the Sensor and may result from improper insertion and maintenance of insertion site After insertion wait 2 3 minutes before attaching the Transmitter to watch for bleeding at the insertion site If bleeding occurs apply steady pressure using a sterile ...

Страница 15: ...ter prior to insertion pain or minor injury may occur Never point loaded Sen serter toward any body part where insertion is not desired Precautions Monitor You should be trained by your healthcare professional on how to program and operate the Monitor and respond to alarm alert conditions before using the system Do not expose the Monitor to water The Monitor should be set aside or placed in a Show...

Страница 16: ...ertion site and use antiseptic to cleanse site Allow area to dry If you also wear an insulin pump make sure that the Sensor insertion site is at least three 3 inches 7 62 cm away from the insulin infusion site If you inject insulin you should give injections at least three 3 inches 7 62 cm away from the Sensor insertion site When replacing Sensor select new insertion site at least two 2 inches 5 0...

Страница 17: ...lease contact your doctor and the Product Help Line at 800 MINIMED 800 646 4633 or 818 576 5555 All other international customers please contact your local sales office Symptoms of Hypoglycemia Hypoglycemia low blood glucose may occur in persons with diabetes who take insulin or certain oral medications There are symptoms linked to low blood glucose that should not be ignored no matter how mild th...

Страница 18: ...od glucose reading and check with your doctor before you treat Blood Glucose Meter Be sure to periodically maintain your home blood glucose meter periodically and check its accuracy when using it for calibration of your Guardian RT system Check with your BG meter s user guide for information on meter coding calibration and testing against solutions and other laboratory instruments Ask your doctor ...

Страница 19: ...ection as a general reference guide But please read the rest of this chapter carefully for the detailed steps needed to Program the Monitor and Set up the Sensor NOTE If the ACT button has not yet been pressed mistakes in programming often can be fixed by simply waiting 10 20 seconds without pressing any buttons Quick Reference Guide PROGRAM MONITOR Set Language Select Time Display Format Set Date...

Страница 20: ...ENSOR START Clean Site Insert Sensor Affix Transmitter to Skin Perform Search Connect Sensor to Transmitter Verify Initialization Place Tape Over Sensor and Connector Enter BG for Calibration at End of Initialization ...

Страница 21: ...in Meals Exercise Others Set High Alarm Snooze as Needed Modify Alarm Limits for Overnight and Daytime Address Alarms and Follow Up Actions Enter BG Values for Calibration in Response to High and Low Alarms Check Sensor Site Periodically Replace Tape and Secure Transmitter As Needed Replace Sensor at 72 Hours Code BG Meter When Changing Test Strip Lots and Run Controls ...

Страница 22: ...ff No Power Monitor Batteries are Used Up Service C60 C61 Transmitter Battery is Low or Used Up Re Init C62 Setup Information Not Received by Monitor No Sync C76 Monitor Lost Communication with Transmitter Cal Err Calibration Error Last BG Entry Differed from Expected Reading Key Held C77 Button Pressed for Too Long Button Stuck Enter BG C78 Enter New BG Value for Calibration Set Time C79 Time Res...

Страница 23: ...ve a new set of batteries ready when replacing the old set In order to properly save and keep stored Monitor information always turn the Monitor off before changing batteries 4 Find the battery compartment on the back side of the Monitor 5 With the screwdriver provided loosen the screw while holding the Monitor s battery compartment lid Do not try to fully remove the screw it is meant to stay atta...

Страница 24: ...old the lid in place Do not overtighten lid NOTE After changing the batteries all programmed settings should be checked and changed if needed NOTE If Monitor display is blank or not responding to button presses U S and Canadian customers please contact the Product Help Line at 800 MINIMED 800 646 4633 or 818 576 5555 All other international customers please contact your local sales office CAUTION ...

Страница 25: ...aved in the Monitor No new information will be collected 1 Press the On Off button 2 The Monitor will beep or vibrate and CONFIRM will blink on the screen 3 Press ACT to confirm If you don t the Monitor will stay on and return to the HOME screen 4 The screen will go blank when successfully turned off Home Screen The HOME Time of Day screen for the Monitor shows the time in the upper left hand corn...

Страница 26: ...before by pressing SEL and then ACT Figure 2 2 describes the screen flow These screens will be explained in detail in Chapter 3 Routine Operation Figure 2 8 SETUP 12 00 AM SIGNALS GLUCOSE SENSOR events GLUCOSE mg dl _ _ _ search SEL SEL SEL SEL 11 57 PM CONFIRM BG DUE SNOOZE 11 57 PM SEL SET UP SUB SCREENS UP ARROW SEL SEL ACT UP ARROW SEL SEL UP ARROW POWER OFF HOME SCREEN GLUCOSE ALARMS meter bg...

Страница 27: ...ll through the subscreens and ACT to enter any given one The subscreens have to be programmed before starting on the Guardian RT This process will be explained in the following pages Figure 2 3 describes the subscreen flow SET UP SUB SCREENS Figure 2 9 NOTE Always set time and date before using the Monitor for the first time clear TRANS ID SET TIME ALERT UNIT SEL SEL SEL SEL DISPLAY language EXIT ...

Страница 28: ...g until selected when the ACT button is pressed a With each press of the Up arrow button this is the language order as it appears on the screen English French Spanish Italian Swedish German Dutch b With each press of the Down arrow button this is the language order as it appears on the screen English Dutch German Swedish Italian Spanish French 6 Press ACT to choose the desired language 7 The displ...

Страница 29: ...Y sub screen appears 4 Press the ACT button once and the upper left hand corner of the screen will be blinking The word SET will appear under the blinking number Use the Up or Down arrow button to choose either 12 AM PM or 24 International which is the time format to be used 5 Press the ACT button to set the time format 6 Press the SEL button and the Monitor will go to the UNIT sub screen Press SE...

Страница 30: ...TIME sub screen appears Setting the Current Hour 1 Press the ACT button once and the word HOURS will appear The first two digits will be blinking and the word SET will appear 2 Use the Up or Down arrow button to choose the correct hour If using the 12 hour format make sure the screen shows the correct AM or PM text For example AM is displayed and you need PM press the Up or Down arrow to scroll th...

Страница 31: ...e last two digits of the current year For example 00 is entered for the year 2000 and 04 is entered for the year 2004 etc 3 Press the ACT button once and the word MONTH will appear Setting the Current Month 1 The word MONTH will now appear with the number 01 blinking in the upper right hand corner of the screen Use the Up or Down arrow button to choose the digits for the current month For example ...

Страница 32: ...the Monitor that you want to save download the data using the Com Station and Guardian Solutions Software before clearing the history NOTE You only need to clear the Monitor glucose history prior to first time use between different users or at the end of any training or demo sessions prior to first time use Glucose history data in the Monitor overwrites itself automatically so you do not need to c...

Страница 33: ...ep and the word NO will appear on the screen blinking 5 Use the Up or Down arrow button to choose between YES and NO Select YES to clear the Monitor memory 6 With YES displayed on the screen press the ACT button once The Monitor will display YES with CONFIRM blinking GLUCOSE HIST CLEAR NO GLUCOSE HIST CLEAR GLUCOSE HIST CONFIRM YES ...

Страница 34: ...will then go to the LANGUAGE screen The memory will now be cleared Press SEL to go to the EXIT screen followed by ACT to go back to the HOME screen 9 If NO is selected the Monitor memory will NOT be cleared and the Monitor will go to the LANGUAGE screen Press SEL to go to the EXIT screen followed by ACT to go back to the HOME screen CLEARING ...

Страница 35: ...UP screen appears 2 Press the ACT button once to go to the SETUP sub screens 3 Press the SEL button 5 times until the UNIT sub screen appears 4 Press the ACT button once and use the Up or Down arrow button to choose either mg dl or mmol l 5 Press the ACT button again to save the chosen units and the Monitor will go to the ID sub screen Press SEL 3 times to go to EXIT and press ACT one to go back t...

Страница 36: ...et a low glucose alert Typically the number entered is above the value that causes you to have symptoms of low blood glucose Confirm the alert limit with your doctor For this feature to work you must select ON a value and CONFIRM to save the value in memory Always treat low blood glucose per the advice of your doctor and the readings of your blood glucose meter From the HOME screen 1 Press the SEL...

Страница 37: ...ce it takes time for the Guardian RT to collect and measure glucose values there is a delay in triggering the alert Ask your doctor which low glucose limit is right for you 9 Press the ACT button to confirm the chosen value The screen will go to the HIGH sub screen If you would like program the HIGH Limit as well If not press SEL 8 times to go to EXIT Press ACT once to go back to the HOME screen 1...

Страница 38: ...or Down arrow button to select the desired interval in 10 minute increments from 20 minutes to 60 minutes 1 hour Press the ACT button The CONFIRM screen will be displayed Press the ACT button to set NOTE Ask your doctor to which Repeat time interval is right for you NOTE If after setting a REPEAT interval you change either the REPEAT setting and or the Low Alert limit setting the system will reset...

Страница 39: ...r doctor From the HOME Screen 1 Press the SEL button 7 times until the SETUP screen appears 2 Press the ACT button once to go to the SETUP sub screens 3 Press the SEL button once until the HIGH Limit sub screen appears The previously set high glucose limit or the default value of 200 mg dl 11 1 mmol l will appear in the upper right hand of the display 4 Press the ACT button and the following scree...

Страница 40: ... glucose values there is a delay in triggering the alert Ask your doctor which glucose limit is right for you 9 Press the ACT button to confirm the chosen value The screen will go to the ALERT sub screen Press SEL 7 times to go to EXIT Press ACT once to go back to the HOME screen 10 If you do not want to use this feature repeat steps 1 4 and then use the Up or Down arrow button to select OFF and p...

Страница 41: ... Up or Down arrow to select the desired interval in 30 minute increments from 60 minutes to 180 minutes 3 hours Press the ACT button The CONFIRM screen will be displayed Press the ACT button to set NOTE Ask your doctor which Repeat time interval is right for you NOTE If after setting a REPEAT interval you change either the REPEAT setting and or the High Alert limit setting the system will reset an...

Страница 42: ...P screen appears 2 Press the ACT button once to get to the SETUP sub screens 3 Press the SEL button 2 times until the ALERT sub screen appears 4 Press the ACT button once and the word BEEP default setting will appear blinking Use the Up or Down arrow button to choose BEEP VIBRATE or BOTH 5 Press the ACT button again to save your choice in the Monitor memory If the VIBRATE alert has been chosen the...

Страница 43: ...9999 which is the serial number shown on the Transmitter device label This number including leading zeros must be entered into the Monitor before glucose data sent from the Transmitter can be received and stored in the Monitor This will limit the Monitor to only receive data from the Transmitter with that ID number If a different Transmitter is used the new Transmitter ID must be entered From the ...

Страница 44: ...he third digit 8 Keep using the Up or Down arrow to choose numbers for each of the digits left Then press the ACT button to go to the next digit The example below uses 7596 NOTE If the ID number is less than 7 digits make sure leading zeros are entered 9 Press the ACT button after the 7th digit has been entered to save the ID in the Monitor Press SEL 2 times to go to the EXIT screen followed by AC...

Страница 45: ... closer than 3 inches 7 62 cm from pump infusion site or manual injection site Belt or waistline Within 2 inch 5 08 cm area around navel or less than 3 inches 7 62 cm from pump infusion site or manual injection site Site where clothing will rub or press against the Sensor Scarred or atrophied tissue Areas experiencing a lot of movement NOTE Clean site with alcohol making sure site is dry before in...

Страница 46: ...out Sensor from package by holding base or tape Do not hold Sensor by introducer needle handle Place the Sensor in the Sen serter until it fits snugly 2 Hold Sen serter as shown 3 Secure white tape of Sensor and take off clear tape using counterclockwise motion ...

Страница 47: ...easure when the Sen serter is in the loaded position you can set the lock at the top of the device until you are ready to insert a To Lock Rotate the white knobs 90o away from the arrows on the side of the Sen serter b To Unlock Rotate the white knobs 90o so that they align with the arrows on the side of the Sen serter ...

Страница 48: ...t is optional for patients 7 Rest Sen serter legs against skin at 45 degree angle placing two fingers of opposite hand on Sen serter legs to keep this angle NOTE Sensor may not penetrate skin if insertion angle is less than 45 degrees 8 Press white button to insert Sensor checking to see that Sensor is inserted and flush with skin ...

Страница 49: ...e and gently take out introducer needle at 45 degree angle Do NOT rotate introducer needle when taking it out Throw away needle in sharps container Check site for redness bleeding irritation pain tenderness or swelling NOTE The expected life of the Sensor is at least 24 hours and is good for up to 72 hours of use Replace Sensor at 72 hours or earlier in the event of a REPLACE SENSOR C80 alarm If t...

Страница 50: ...sed within 1 week to ensure Sensor sensitivity Throw away Sensor after Use Before expiration date on label or if the package is damaged or the seal broken Do not use Sensor if High temperature limit indicator is black not clear Sen serter Maintenance Occasionally clean Sen serter with soapy water using liquid detergent or other household soaps Allow to dry Disinfect Sen serter by wiping with 10 bl...

Страница 51: ...labeled 1 4 Stick the adhesive pad to the smooth flat unlabeled side of the Transmitter 5 Take off the paper from the skin side of the adhesive pad side labeled 2 Press firmly to prepped skin 6 Transmitter should now be affixed to skin with serial number facing outward NOTE An adhesive remover such as Detachol can be used to take off the adhesive pad or any adhesive residue left on the skin after ...

Страница 52: ...e and CONFIRM will be blinking on the screen 3 Press the ACT button again to begin a SEARCH The screen will display WAITING and a countdown clock starting at 8 minutes and 00 seconds The countdown will be in 10 second intervals Connect Sensor to Transmitter at start of countdown It may take up to 8 minutes to finish the SEARCH 4 If you want to cancel the SEARCH press SEL The Monitor will beep or v...

Страница 53: ...er to the Sensor You should hear a click when fully connected See Figure 2 5 Figure 2 11 2 The Monitor will search for signals sent by the Transmitter If the Transmitter is not identified by the Monitor an alarm code will appear See Chapter 4 Troubleshooting and Alarms for detailed information on Alarm codes 3 When the Transmitter is identified by the Monitor the screen will briefly display SUCCES...

Страница 54: ...T will not record or display any glucose values and the High and Low glucose alerts will not work until calibration is done Calibration is needed to make sure the Guardian RT can turn the electronic signals from the Sensor into glucose values Make sure to enter a BG value right after taking a fingerstick glucose reading Calibration will happen within 10 to 15 minutes of the Meter BG entry NOTE Use...

Страница 55: ... to 15 minutes from the time of entering the fingerstick glucose reading 5 The HOME screen will appear NOTE The Monitor will not use values between 20 39 mg dl 1 1 2 2 mmol l and 401 600 mg dl 22 2 33 3 mmol l for calibration These values will be displayed and saved for informational purposes only BE SURE TO TREAT LOW AND HIGH CONDITIONS PER THE ADVICE OF YOUR DOCTOR Also when a value in the 40 40...

Страница 56: ...te the screen below will be displayed The example 90 mg dl 5 0 mmol l is the recently entered Meter BG value No Sync If the Sensor is not in INIT Initialize mode and still working and the Guardian RT is not synchronized then the screen below will be displayed This means that the Monitor is not getting Sensor data from the Transmitter at this point in time PENDING 90 mg dl GLUCOSE No SYNC 12 00AM ...

Страница 57: ...nsor is not working and the system is no longer sending Sensor glucose values Change out the Sensor immediately to continue using the Guardian RT system Removing the Sensor Remove dressing Pinch snap arms on sides of Glucose Sensor and gently disconnect Transmitter Sensor Connector from Glucose Sensor Slowly remove Glucose Sensor by pulling it parallel to the skin Throw away Sensor in Sharps or ot...

Страница 58: ...52 Chapter 2 ...

Страница 59: ...ll display the last 8 hours of glucose values The oldest value will be displayed if the Up arrow button is pressed or the newest most recent if the Down arrow button is pressed for a total of 96 available entries The history can be viewed in 5 or 30 minute increments From the HOME Screen 1 Press the SEL button once until the GLUCOSE HISTORY screen appears In the example below the most current gluc...

Страница 60: ...n 30 minute increments In the example below the glucose value was 96 mg dl 5 33 mmol l 4 hours and 35 minutes ago Press the ACT button to go back to scrolling in 5 minute increments The asterisk will no longer be displayed 4 If the glucose value is lower or higher than operational range of 40 400 mg dl 2 2 22 2 mmol l the screen will display LO or HI where the glucose value is normally found See e...

Страница 61: ...ill thus appear on the display If no BG reading was entered before dashes will appear on the screen 2 Press the ACT button and the number display will go to dashes Enter the desired meter blood glucose value in increments of 1 mg dl 0 1 mmol l by using the UP or Down arrow button Remember the number value will start at 100 mg dl See Chapter 2 Getting Started Sensor Calibration NOTE If you scroll b...

Страница 62: ...once or the Up arrow 2 times will return you to the HOME screen In the example below the last calibration was done at 12 45 A M Therefore the next BG value is due before 12 45 P M because the last BG entered was 12 hours before Depending on the condition and calibration status of the Sensor there are four other screens that may be displayed instead of BG DUE by pressing the Up arrow once from the ...

Страница 63: ...s pressed from the HOME screen Calibration Pending If a BG value has been recently entered but the Up arrow is pressed within 15 minutes of the entry not giving the Sensor enough time to calibrate the screen below will be displayed The example 90 mg dl 5 0 mmol l is the recently entered Meter BG value ENTEr bg 12 45 PM PENDING 90 mg dl GLUCOSE ...

Страница 64: ... the word REPLACE is displayed on the screen along with a time that is not the current time i e the time displayed is a future time the Sensor must be changed before the next calibration is due The time displayed is the end of Sensor life If REPLACE and the current time are displayed on the screen then the Sensor is not working and the system is no longer sending Sensor glucose values Change out t...

Страница 65: ...ware using the Com Station cradle Event information is helpful in evaluating glucose trends and patterns displayed in the software reports There are four types of events that can be recorded into the Monitor Insulin Carb Amount Exercise Other From the HOME screen 1 Press the SEL button 3 times and the EVENTS screen will appear 2 From the EVENTS screen press the ACT button The screen will display I...

Страница 66: ...e NOTE If you are an insulin pump user the dose refers to your bolus not basal insulin If your bolus amounts are in the hundredth of a unit 2 places after the decimal point round to the nearest tenth of a unit one place after the decimal point or whole number of units 3 Press the ACT button 4 Press the Up or Down arrow button to enter units of insulin taken from 0 1 to 99 units 5 Press the ACT but...

Страница 67: ...rbohydrate The unit range is from 1 to 300 Enter the Carb Amount in units grams or exchanges If you do not know how to figure out amount of carbohydrate eaten ask your doctor to learn how 3 Press the ACT button again to save the carbohydrate amount in the Monitor memory Return to the HOME screen Duration of Exercise From the HOME screen 1 Press the SEL button 3 times and the EVENTS screen will app...

Страница 68: ...trual cycle etc can be entered using the OTHER screen From the HOME screen 1 Press the SEL button 3 times and the EVENTS screen will appear 2 Press the ACT button once The screen will display SET with INSULIN blinking 3 Press the Down arrow and the screen will display SET and OTHER will be blinking 4 Press the ACT button again to enter the OTHER event and go back to the HOME screen NOTE No values ...

Страница 69: ...re are no alarms in the history the following screen will appear 4 If there are alarms in the history the newest one will be displayed first The alarm will be displayed with the time and date they were triggered and the corresponding value 5 In the example below an alarm was triggered at 13 04 1 04 PM on August 3 2002 when the glucose value reached 140 mg dl 7 77 mmol l This value is at or above t...

Страница 70: ...play either of these two screens 7 Use the Up or Down arrow button to go through the rest of the Glucose Alarm History Pressing the DOWN arrow will display the previous next most recent alarm Pressing the UP arrow will display the oldest alarm Press SEL to return to the HOME screen 13 04 GLUCOSE LO 03AUG02 13 04 GLUCOSE HI 03AUG02 ...

Страница 71: ...hen doing the Test Plug Procedure See Chapter 4 Troubleshooting and Alarms This procedure lets you know if the Monitor Transmitter or Sensor are working properly From the TIME AND ALARM Screen 1 Press the SEL button 6 times until the SIGNALS screen appears Press the ACT button to view the ISIG Press the ACT button once more and the SETUP screen will be displayed 2 If the Up or Down arrow button is...

Страница 72: ...ant the HIGH alert to interrupt you during a given time interval e g during a business meeting The Snooze option will thus deactivate the HIGH alert for a specified period from 1 to 12 hours In order to get to and set this feature the Glucose HIGH limit setting must be ON At the end of the set SNOOZE time period the high glucose alarm feature will be turned on once more You can view the SNOOZE scr...

Страница 73: ...ggered is stored in the Monitor memory for later download to the Guardian Solutions Software NOTE Always take care of alarms right away The first button press after an alarm is triggered turns on the display backlight The backlight will stay on for about 10 to 20 seconds after the last button press NOTE A calibration must be done after taking care of certain alarms by entering a new METER BG value...

Страница 74: ...nsmitter ID Cause A Transmitter ID has not been entered in the Monitor Action Press the SEL button and then the ACT button to clear the alarm Enter the Transmitter ID serial number into the Monitor s TRANS ID setup screen See Chapter 2 Getting Started NO ID 12 00 AM C52 ...

Страница 75: ...glucose limit Action 5 Press the SEL button and then the ACT button to clear the alarm The alarm will turn off and the HOME screen will reappear The alarm will repeat about every hour or longer if the Repeat interval has been customized until the condition has been corrected 6 Take a blood glucose meter reading If the value indicates a high blood glucose level treat per your doctor s instructions ...

Страница 76: ...w glucose limit set Action 1 Press the SEL button and then the ACT button to clear the alarm The alarm will turn off and the HOME screen will reappear The alarm will repeat about every 20 minutes or longer if the Repeat interval has been customized until the condition has been corrected 2 Take a blood glucose meter reading If the value indicates low blood glucose level treat per your doctor s inst...

Страница 77: ...til the condition is corrected 2 Make sure the insertion site appears normal and the Sensor is still connected DO NOT REMOVE CONNECTOR 3 If the alarm is triggered two or more times take out the Sensor Before putting in a new Sensor do the Test Plug procedure at the end of this chapter to check system function 4 If the Transmitter is not working correctly a new Transmitter must be used If it is wor...

Страница 78: ...TE Make sure to put in new batteries within 10 minutes of taking out the old ones to avoid automatic resetting of date and time This will also avoid the triggering of a Replace Sensor alarm 3 Do a manual Search procedure a From the HOME Screen press the SEL button 5 times until the SEARCH screen appears b Press the ACT button and the Monitor will beep or vibrate CONFIRM will be blinking on the scr...

Страница 79: ...LOSS OF DATA STORED IN MEMORY Follow steps in Chapter 2 Getting Started 3 Perform the manual Search procedure a From the HOME Screen press the SEL button 5 times until the SEARCH screen appears b Press the ACT button and the Monitor will beep or vibrate CONFIRM will be blinking on the screen c Press the ACT button again to begin a SEARCH The screen will display SEARCH and the number 8 minutes A co...

Страница 80: ...insert a new Sensor to connect to the new Transmitter After the Transmitter is changed the Monitor must be reprogrammed with the new Transmitter ID number See Chapter 2 Getting Started Re Init Error Message C62 RE INIT Re Initialize Sensor Cause The Monitor did not get the needed setup information from the Transmitter Action Press the SEL button and then the ACT button to clear the alarm Disconnec...

Страница 81: ... will beep or vibrate CONFIRM will be blinking on the screen c Press the ACT button again to start a SEARCH The screen will display SEARCH and the number 8 A countdown will begin It may take up to 8 minutes to finish the SEARCH 3 If not correct reenter the Transmitter ID number and do the Sensor Initialization procedure See Chapter 2 Getting Started 4 Reposition the Monitor and Transmitter within ...

Страница 82: ...or more than 2 hours Action 1 Press the SEL button and then the ACT button to clear the alarm The alarm will turn off and the HOME screen will appear An alarm to recalibrate will repeat until a new calibration is done 2 Check to make sure that the antenna icon is displayed If it is not displayed the communication link between the Transmitter and the Monitor has not been set Restore communication b...

Страница 83: ...s alarm is triggered if calibration has not been done in the last 12 hours or following a CAL ERR alarm or if a calibration has not been done in the last 8 hours since the first calibration Action Press the SEL button and then the ACT button to clear the alarm Take a fingerstick reading using a meter Press the SEL button until the METER BG screen appears Press the ACT button and the dashes will bl...

Страница 84: ...ly the batteries were taken out and not placed back for more than 10 minutes and the clock does not have the right time Action Press the SEL button and then the ACT button to take care of the alarm Reprogram your Monitor and change Sensor if prompted following the instructions in Chapter 2 Getting Started SET TIME 12 00 AM C79 ...

Страница 85: ...is alarm will repeat every 20 minutes until the Sensor is changed and initialized Action 1 Press the SEL and then the ACT button to turn off the alarm 2 Turn the Monitor Off 3 Turn the Monitor On 4 Remove the Sensor and insert a new Sensor Follow the Inserting the Sensor section in Chapter 2 Getting Started Initialize the Sensor by following the Sensor Initialization section also in Chapter 2 NOTE...

Страница 86: ...Solutions Software to help with troubleshooting the device 3 To report the alarm U S and Canadian customers please contact the Product Help Line at 800 MINIMED 800 646 4633 or 818 576 5555 All other international customers please contact your local sales office 4 Clear the alarm by pressing the SEL button and the ACT button The Monitor programming will change to factory settings except for glucose...

Страница 87: ...ct the Sensor Connector end of the Transmitter to the Transmitter Connector end of the Test plug see Figure 4 1 Press the parts together until the snap arms on the Cable Connector come together with a click Figure 4 1 4 If the Monitor recognizes the Transmitter the Monitor will enter the Initialization mode The Monitor will display INIT and 2 20 h 5 The Monitor will count the minutes down from 2 2...

Страница 88: ...NOTE If you miss the first transmission of data and the second transmission has been sent the ISIG reading will typically be above 29 to 34 nA and can go very high This value should be ignored All following transmissions will return to the 24 to 29 nA range 8 If the ISIG value is outside the range of 24 to 29 nA the Transmitter Monitor or both may have a problem U S and Canadian customers please c...

Страница 89: ...ns to characterize performance of the Guardian RT are given below there is no commonly accepted statistical approach for capturing the performance of continuous glucose monitors such as the Guardian RT Performance may be best characterized by viewing graphs called time elapsed plots In these plots the values from Guardian RT for one subject over time are overlaid with values at the same time from ...

Страница 90: ...often occur which are most challenging to test systems measuring glucose in interstitial fluid i e higher glucose levels more rapid changes in glucose concentrations and often more hypoglycemic episodes Subjects saw on average between 4 and 5 fingerstick values per day This enables subjects to better manage their diabetes when compared to those who perform less fingersticks per day Agreement betwe...

Страница 91: ...all difference between the Guardian RT glucose values and the YSI values The paired glucose measurements are summarized in Table 5 1 Table 5 1 The accuracy of the Guardian RT was also evaluated by calculating the percentage of Guardian RT readings within 20 and within 30 of the YSI reading or within 20 mg dl 1 1 mmol l in the low glucose range Results are shown in Table 5 2 Table 5 2 For the Low g...

Страница 92: ...y acceptable while results in zones C D and E are potentially dangerous and therefore clinically significant errors The Clarke Error Grid zones are labeled on the correlation plot Table 5 3 Zone Description A Clinically accurate would lead to correct treatment decisions B Would lead to benign decisions or no treatment C Would lead to overcorrection of normal glucose levels D Would lead to failure ...

Страница 93: ...7 Figure 5 1 is a correlation plot of Guardian RT readings versus readings from the reference method the YSI 2300 Glucose Analyzer It is overlaid with the Clarke Error Grid The total number of paired data points is 3941 Figure 5 1 ...

Страница 94: ...Grid Analysis N A means that the Clarke Error Grid does not consider the possibility of these zones in that concentration range Glucose Range mg dl Number and of Data Points Evaluated A B A B C D E 40 80 356 9 271 76 1 214 60 1 57 16 0 2 0 6 80 22 5 3 0 8 81 120 769 20 768 99 9 463 60 2 305 39 7 1 0 1 N A N A 121 240 2362 60 2352 99 6 1476 62 5 876 37 1 4 0 2 N A 6 0 2 240 454 11 394 86 8 277 61 0...

Страница 95: ... RT unit worn by one subject during a one day period Figure 5 2 In Figure 5 2 Guardian RT device 1 is represented by a solid line and the Guardian RT device 2 by a light gray line Low and High Alerts The ability of the Guardian RT to detect high and low glucose levels was measured in the same clinical study Since it is important to set the alert levels in a conservative fashion the Low Glucose Ale...

Страница 96: ...han 85 mg dl 4 7 mmol l This percentage may be exaggerated because blood glucose may be dropping when the Guardian RT alerts Table 5 5 shows the percent of Low Glucose readings correctly identified by the Guardian RT for specific settings Table 5 5 True Alert Rates are the of times when the glucose level was at or below the alert setting and the alert sounded False Alerts Rates are the of times wh...

Страница 97: ... than 225 mg dl 12 5 mmol l This percentage may be exaggerated because blood glucose may be rising when the Guardian RT alerts Table 5 6 shows the percent of High Glucose readings correctly identified by the Guardian RT for specific settings Table 5 6 True Alert Rates are the of times when the glucose level was at or above the alert setting and the alert sounded False Alerts Rates are the of times...

Страница 98: ...atified Clarke Error Grid analysis above Table 5 4 agreement between Guardian RT values and YSI values tends to be poorer at low and high glucose concentrations when compared to other concentration ranges Guardian RT performance in the hypoglycemic range as a function of Sensor insertion time is characterized below Results from the two different data sets are presented The two populations were sep...

Страница 99: ...nd 30 mg dl of YSI readings from 40 80 mg dl Table 5 9 and the percentage of readings within 20 and 30 of YSI readings from 81 120 mg dl Table 5 10 was analyzed according to time after Sensor insertion and according to the glucose concentration range as determined by the YSI analyzer Table 5 9 Hours From Insertion Mean ARE Std Dev 0 12 hrs 24 84 20 04 12 24 hrs 19 66 16 17 24 36 hrs 16 43 15 62 36...

Страница 100: ... less often to those calibrated more often the following alarm performance was observed Specificity increased 2 4 in the hypoglycemic range and decreased 0 2 in the hyperglycemic range Sensitivity increased between 5 9 across the hyperglycemic range and decreased 7 16 when the alarm was set to 80 mg dl or below and decreased 3 7 when set between 85 and 100 mg dl Stratified error grid analysis also...

Страница 101: ...ous Sensor tracing vs reference blood glucose reading where Sensor showed excellent performance The open circles o on the graph represent the meter calibration readings The closed circles represent the reference blood glucose readings and the solid line represents the Sensor glucose value Figure 5 3 ...

Страница 102: ... reference blood glucose reading where Sensor showed average typical performance The open circles o on the graph represent the meter calibration readings The closed circles represent the reference blood glucose readings and the solid line represents the Sensor glucose value Figure 5 4 ...

Страница 103: ...sor tracing vs reference blood glucose reading where Sensor showed poor performance The open circles o on the graph represent the meter calibration readings The closed circles represent the reference blood glucose readings and the solid line represents the Sensor glucose value Figure 5 5 ...

Страница 104: ...98 Chapter 5 ...

Страница 105: ...Monitor to a belt or to clothing Installation The Belt Clip is attached to the back of the Monitor by sliding the triangular shaped ridge on the back of the clip into a groove on the back of the Monitor Push the clip until it stops and clicks into place See Figure 6 1 Figure 6 1 ...

Страница 106: ... with water or other liquids should be avoided The Monitor should never be placed under water The Monitor should always be set in a dry place before showering bathing or swimming Any moisture that comes in contact with the Monitor should be dried with a soft towel It is possible to shower bathe and swim with the Sensor and Transmitter However please ensure that The occlusive dressing covering the ...

Страница 107: ... from sharp objects during everyday use During exercise if an alarm is triggered you should stop exercising Follow the directions in Chapter 4 Troubleshooting and Alarms Protection from High and Low Temperatures The Monitor was designed to operate in a temperature range of 0 to 50 degrees Celsius 32 to 122 degrees Fahrenheit If outside during freezing weather the Monitor should be kept underneath ...

Страница 108: ...l wipe Cleaning the Transmitter For single patient use 1 Wash your hands thoroughly 2 Dampen a clean cloth with mild liquid soap and warm water and wipe the outside of the Transmitter cable and connector Do not wet the inside of the connector CAUTION Do not place the Transmitter into the liquid soap solution 3 Hold by the Transmitter end and rinse the Transmitter under warm tap water Be careful no...

Страница 109: ...ransmitter with 70 Isopropyl alcohol being careful not to get the inside of the connector wet 7 Place the Transmitter on a clean dry non shedding cloth and allow to air dry 8 Once the Transmitter is dry place it in a sealed bag labeled with the cleaning date See the example below 9 If there is any blood inside the connector the Transmitter must be disposed of Cut off the connector portion and disc...

Страница 110: ...multiple patient use 1 Dampen a clean cloth with mild liquid soap and warm water and wipe the Sen serter 2 Rinse with warm tap water 3 Apply 3 4 drops of quaternary ammonium compound disinfectant e g CaviCide on a clean dry cloth Wipe down the sen serter 4 Using 70 percent isopropyl alcohol or isopropyl alcohol wipes wipe down the sen serter 5 Place the sen serter on a clean dry cloth and allow to...

Страница 111: ...t place the Monitor in direct contact with X rays or other medical or industrial imaging equipment If a user is scheduled to have an X ray CT or MRI scan take off Sensor Transmitter and Monitor Put in new Sensor after procedure The Monitor is designed to withstand interference from airport X rays or metal detectors and store anti theft security devices Nevertheless always check the Monitor after i...

Страница 112: ...nal customers please contact your local sales office Orders can be placed online at www minimed com Table 6 1 Products Table 6 2 Accessories Product Model Number Glucose Sensor MMT 7002 Monitor MMT 7901 Transmitter MMT 7700 Guardian Solutions Software MMT 7315 Accessory Model Number Com Station MMT 7301 Sen serter MMT 7500 Belt Clip MMT 7402 Test Plug MMT 7400 Leather Case MMT 7401 I V Prep MMT 17...

Страница 113: ...rs Display Liquid crystal display LCD Display Window Length 1 40 inches 3 56 centimeters Height 0 70 inches 1 78 centimeters Dimensions Length 3 56 inches 9 04 centimeters Height 2 77 inches 7 04 centimeters Width 0 86 inches 2 18 centimeters Weight 4 ounces 114 grams Limited Warranty 1 year System Memory Stores up to 21 days of data Alarms Audible 50 decibels 1 meter Vibrate similar to the vibrat...

Страница 114: ...22 degrees Fahrenheit Relative Humidity 10 to 95 with no condensation Storage Conditions Temperature 20 to 55 degrees Celsius 4 to 131 degrees Fahrenheit Relative Humidity 10 to 100 with condensation Approved Cleaners A mild household liquid detergent diluted with water a quaternary ammonia solution or isopropyl alcohol on a wipe Approved Disinfectants 10 bleach solution 3 hydrogen peroxide soluti...

Страница 115: ...rnary ammonia solution or isopropyl alcohol on a wipe DO NOT place liquids into either connector Approved Disinfectants Tap water 10 bleach solution 3 hydrogen peroxide solution 70 isopropyl alcohol Table 6 5 Transmitter Component Performance Specifications Biocompatibility Complies with ISO 10993 1 for long term body contact Operating Conditions Temperature 0 to 50 degrees Celsius 32 to 122 degre...

Страница 116: ...iving sending interference U S and Canadian customers please contact the Product Help Line at 800 MINIMED 800 646 4633 or 818 576 5555 All other international customers please contact your local sales office Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment FCC Notice for the Transmitter This dev...

Страница 117: ...System Maintenance 111 2 This device must accept any interference received including interference that may cause undesired operation ...

Страница 118: ...rdian RT and system components to sale by or on the order of a physician SN Serial Number Storage Temperature Range Type BF Device Protection from electrical shock On Off Backlight Batch Number REF Catalogue Number Fragile Product Protect Against Moisture Open Here Recycling Symbol Sterilized Using Irradiation Do Not Re Use Single use only ...

Страница 119: ... a Medical Device CE Mark With a Radio Transmitter Under The R TTE1999 5 EC Directives IPX1 Monitor Protected Against the Effects of Vertically Falling Water Drops IPX8 Transmitter and Sensor Protected Against the Effects of Continuous Immersion in Water Table 6 6 Icons 0459 0459 0976 ...

Страница 120: ...LUCOSE HIST Displayed on screens used for viewing or clearing glucose history values Not used on the NOW screen GLUCOSE LIMIT Displayed on screens showing hypoglycemia or hyperglycemia alarm limits GLUCOSE SENSOR Displayed on screens showing raw glucose Sensor values or status SET Displayed during parameter value selection SET GLUCOSE Displayed when setting glucose measurement unit mg dl or mmol l...

Страница 121: ...used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Guardian RT Monitor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The Guardian RT is suitable for use in all establishments inclu...

Страница 122: ...mmercial hospital or home environment Synthetic materials may be present The relative humidity may be as low as 10 Electrical Fast Transient Burst IEC 61000 4 4 Not Applicable Not Applicable Not Applicable Surge IEC 61000 4 5 Not Applicable Not Applicable Not Applicable Voltage Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 Not Applicable Not Applicable ...

Страница 123: ...hould be used no closer to any part of the Guardian RT than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Not Applicable d 1 2 x square root P 80 800 MHz d 2 3 x square root P 800 MHz 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufact...

Страница 124: ... radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Guardian RT is used exceeds the applicable RF compliance level above the Guardian RT should be observed to verify normal operation If a...

Страница 125: ...tter W Separation Distance According to Frequency of Transmitter m 80 MHz 800 MHz d 1 2 x square root P 800 MHz 2 5 GHz d 2 3 x square root P 0 01 0 12 0 23 0 1 0 38 0 73 1 1 2 2 3 10 3 8 7 3 100 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter...

Страница 126: ...120 ...

Страница 127: ...ce for living organisms Glucose Sensor A device that can monitor glucose levels in the body by sending out electronic signals proportional to those levels Guardian RT Monitor A medical device developed by Medtronic MiniMed that continuously monitors glucose levels and sends out high and low glucose alerts Hyperglycemia Abnormally high levels of glucose in the blood Hypoglycemia Abnormally low leve...

Страница 128: ...122 ...

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