Medtronic MiniMed 7701 TGMSIII User Manual Mp6025067 011 b

Medtronic MiniMed, Inc. TGMSIII Mp6025067 011 b

manual 7701

Paradigm®522 and 722 Sensor FeaturesCaution - Investigational device. Limited by Federal law to investigational use.
© 2004, Medtronic MiniMed. All rights reserved.This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S. and/or foreign patents may be pending.Bolus Wizard™ is a trademark of Medtronic MiniMed.Dual Wave™ is a trademark of Medtronic MiniMed.Easy Bolus™ is a trademark of Medtronic MiniMed.Square Wave™ is a trademark of Medtronic MiniMed.BD Logic™ is a trademark of Becton, Dickinson and CompanyEnergizer® is a trademark of Eveready Battery Company.Glucagon Emergency Kit® is a trademark of Eli Lilly and Company.Paradigm® is a trademark of Medtronic MiniMed.Paradigm Link™ is a trademark of Medtronic MiniMed.The Link™ is a trademark of Becton, Dickinson and Company (Canada only)Quick-serter® is a trademark of Medtronic MiniMed.Quick-set® is a trademark of Medtronic MiniMed.Silhouette® is a trademark of Medtronic MiniMed.Sof-set® is a trademark of Medtronic MiniMed.IV3000® is a registered trademark of Smith&Nephew, Inc.Sen-serter® is a registered trademark of Medtronic MiniMed.Guardian® is a registered trademark of Medtronic MiniMed.6025067-011 01/05REF MMT-522 MMT-722
Contents 1ContentsChapter 1 Introduction .................................................1Assistance ................................................................................................. 1Accessories ................................................................................................. 1User safety ................................................................................................ 2Indications ............................................................................................. 2Contraindications ..................................................................................... 2Warnings ............................................................................................... 2Reservoir and infusion sets ...................................................................... 2X-rays, MRIs and CT scans ....................................................................... 3Transmitter ........................................................................................ 3Precautions ........................................................................................... 3Avoid extreme temperatures .................................................................... 3Infusion sets and sites ............................................................................ 3Sensor ............................................................................................... 4Adverse reactions ........................................................................................ 4Notice ....................................................................................................... 4Insulin pump and Radio Frequency (RF) accessories ........................................... 4Chapter 2 Programming your sensor ...................................7Introduction ............................................................................................... 7Sensor icons ........................................................................................... 7Programming the sensor ............................................................................. 8High glucose alarm .................................................................................. 8High snooze feature ................................................................................. 9Low glucose alarm ................................................................................... 9Low snooze feature .................................................................................10Alarm snooze ........................................................................................10Cal reminder .........................................................................................11BG units ...............................................................................................11Transmitter ID .......................................................................................12Missed data ..........................................................................................13Review settings ......................................................................................13
2ContentsChapter 3 Starting the sensor ...................................... 15Introduction .............................................................................................. 15Inserting the sensor ................................................................................... 15The transmitter ......................................................................................... 20Attaching the transmitter ..........................................................................20Connecting the sensor to the transmitter .......................................................21Starting the sensor ..................................................................................... 22Enter meter BG ......................................................................................23Chapter 4 Using your sensor ........................................ 25Status screens .......................................................................................... 25Reading your graphs ................................................................................... 26Your glucose values ..............................................................................26Your alarms .......................................................................................263 hour graph ..........................................................................................2724 hour graph ........................................................................................27Sensor alarm history .................................................................................. 28Sensor update history ..............................................................................28Review settings ......................................................................................29Removing transmitter and sensor ................................................................... 30Disconnecting the sensor from the transmitter .............................................30Removing the transmitter .......................................................................30Removing the sensor .............................................................................30Storage and handling ................................................................................30Sen-serter maintenance ............................................................................30Chapter 5 Troubleshooting and alarms .............................. 31Alarms .................................................................................................... 31What to do ...........................................................................................32Sensor alarm conditions .............................................................................. 33Troubleshooting ......................................................................................... 37Reconnect old sensor ................................................................................37Find Lost Sensor ......................................................................................37Icon table ................................................................................................ 38Default settings ......................................................................................... 39
Introduction 1 Chapter 1IntroductionThank you for choosing Medtronic MiniMed as your partner in helping you gain better control of your diabetes. The Paradigm® 522 and 722 pump combines the technology of the Guardian® Continuous Glucose Monitoring system as well as the Paradigm Link™ Blood Glucose Monitor powered by BD Logic™ Technology to provide not only insulin delivery but real-time glucose sensor values as well.This user guide is designed to help you understand the sensor features of your pump. We strongly recommend that you work closely with your healthcare professional for a safe and complete pump start. Assistance Medtronic MiniMed provides a 24-hour Product Help Line for assistance. The Help Line is staffed with technicians who are trained in the set-up and operation of the pump and are able to answer pump-related questions. When calling the Help Line or your local Medtronic MiniMed office, please have your pump and serial number available. The phone number for the 24-hour Product Help Line is also on the back of your pump. Accessories➠Meter: Your pump can be used with the optional Paradigm Link™ Blood Glucose Monitor powered by BD Logic™ Technology. You can program your pump to automatically receive your blood glucose (BG) readings from this meter. When a BG reading is taken, the value is automatically transferred to the pump and stored in its memory as a calibration point. The calibration point is used to calculate the real-time sensor glucose values that are displayed. The data may then be downloaded to a computer.Department Telephone number24-hour Product Help Line (calls within the United States)800.646.4633(800.Mini M ed)24-hour Product Help Line (calls outside the United States)818.576.5555
2 Chapter 1 ➠Transmitter: The transmitter (MMT-7701) is a small oval disk that connects to the sensor and is adhered to the skin with a medical dressing. It contains a battery, sensor electronics and a radio frequency transmitter. When a sensor is attached to the transmitter, it automatically initializes the sensor and begins to periodically transmit glucose data to the pump using a radio signal. ➠Sensor: The glucose sensor (MMT-7002) is a device that continuously measures glucose from your subcutaneous tissue as an electronic signal, the strength of which is proportional to the amount of glucose present. An introducer needle allows for subcutaneous insertion of the sensor.➠ComLink: The Medtronic MiniMed ComLink (MMT-7304), if available, is used to download the pump data to the diabetes management software installed in your computer via a serial communications interface cable.User safety IndicationsThe Paradigm 522/722 pump system is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes. The pump displays real-time glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. Pump history can be downloaded to a computer for analysis of historical glucose values.The real-time glucose values provided by the Paradigm 522 and 722 pump are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that a confirmation fingerstick measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not based on the value displayed by the Paradigm 522 and 722 pump.ContraindicationsPump therapy is not recommended for people who are unwilling or unable to perform a minimum of four (4) blood glucose tests per day and to maintain contact with their healthcare professional. Successful insulin pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms.WarningsReservoir and infusion setsUse only the Paradigm reservoir and Paradigm infusion sets with your pump. The reservoir and infusion sets are specifically designed for use with the pump. Use of non Medtronic MiniMed Paradigm
Introduction 3 reservoirs and/or infusion sets may reduce pump accuracy and hinder occlusion detection. Do not modify your Paradigm reservoir or Paradigm infusion set. Do not put any other drugs/medications inside your reservoir to use with this pump. Only insulin that has been prescribed by your physician can be used in this pump. X-rays, MRIs and CT scans If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, TAKE OFF YOUR PUMP, METER, TRANSMITTER, and SENSOR, and remove them from the area.NOTE - The Paradigm pump and transmitter are designed to withstand common electromagnetic interference, including airport security systems.TransmitterThe Transmitter should be removed if irritation or reaction to the Transmitter tape develops.The Transmitter should be disconnected from the sensor while traveling on an aircraft, or if it interferes with another transmitting device.Precautions Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost its potency. It is essential, therefore, that you test your blood glucose levels at least four times per day. If your BG is out of range, check the pump and the infusion set to ensure that the necessary amount of insulin is being delivered.Avoid extreme temperatures1Avoid exposure of your pump and remote control to temperatures above 108°F (42°C) or below 34°F (1°C).2Insulin solutions freeze near 32°F (0°C) and degrade at high temperatures. If you are outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your pump and insulin cool.3Do not steam, sterilize or autoclave your pump, transmitter, or sensor.Infusion sets and sitesAvoid using an infusion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise.
4 Chapter 1 SensorPrior to exercising, make sure the sensor is firmly attached.Adverse reactions Operation of the sensor feature requires the insertion of a glucose sensor into the skin. Bleeding, swelling, bruising, or infection at the sensor insertion site are possible risks of sensor use. The sensor should be removed if redness, pain, tenderness or swelling develop at the insertion site. The transmitter should be removed if irritation or a reaction to the transmitter tape develops. Contact your doctor and the Medtronic MiniMed 24-Hour Product Help Line in the event of any adverse reaction.Notice Insulin pump and Radio Frequency (RF) accessories The pump, Paradigm Link meter, transmitter and remote control comply with the United States Federal Communications Commission and international standards for Electromagnetic Compatibility.Do not use the RF meter or the transmitter to send your BG reading to the pump while on an aircraft. Manually enter your BG. The transmitter should be disconnected from the sensor while traveling on an aircraft, or if it interferes with another transmitting device.These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesirable operation. It does not interfere with any radio frequency signals transmitted from outside sources.These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. Operation is subject to the following two conditions: 1This device has been tested and found to comply with the regulations governing such devices in your area. For the specific regulation and test results for your area, please contact the Medtronic MiniMed 24-hour Product Help Line.2This device generates, uses, and can radiate radio frequency energy and, if installed and used in accordance with the instruction, may cause interference to radio communications. If the device CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic MiniMed could void your ability to operate the equipment.
Introduction 5 does cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures:➠Reorient or relocate the insulin pump/remote control/Paradigm Link meter/transmitter➠Increase the separation between the insulin pump/remote control/Paradigm Link meter/transmitter and the device that is receiving/emitting interferenceThe Paradigm Link meter and transmitter sends information to the pump using radio frequency. If other devices that use radio frequency are in use, such as cell phones, cordless phones and wireless networks, they may prevent communication between the pump and the meter and/or the pump and transmitter. This interference will not cause any incorrect data to be sent and will not cause any harm to your pump, transmitter or meter. Moving away from or turning off these other devices may allow communication. Refer to, “Troubleshooting and alarms” in the pump user guide to correct interference problems you may have.Wireless transmission between the pump and transmitter within the six-feet operating range may be interrupted due to the transmitter cable orientation. Move the pump closer to the transmitter or to another position. If a Lost Sensor alarm has occurred retry: Sensor Start > Find Lost Sensor. If you have questions, please contact the Medtronic MiniMed 24-hour Product Help Line.
6 Chapter 1
Programming your sensor 7 Chapter 2Programming your sensorIntroduction This chapter describes how to program your pump to get it ready to accept sensor data. To understand how to navigate through these screens refer to your Pump User Guide. For your reference the sensor icons are described below.Sensor icons Using your pump - refer to the Pump User Guide (Paradigm 522/722 Infusion Pump User Guide) to learn how to navigate through the pump screens.There are various icons that appear at the top of your pump screen, like the time, battery and reservoir icons which are described in your pump user guide. The icons described here appear if you are using the sensor. Alert and Alarm icons have the same meaning as described in your pump user guide.The sensor icon appears once the Sensor feature is turned on. The sensor icon changes when the sensor is connected to the transmitter and communicating with the pump.
8 Chapter 2 Programming the sensorTo set up the sensor feature, from the Home screen, press ACT, and do the following steps:NOTE - The sensor features are programmed in the order described in this chapter.Main Menu > Sensor> Sensor Setup > Edit SettingsHigh glucose alarm Your pump will alarm if your BG reaches or goes above what you set here. If you do not turn on the High Glucose Alarm your pump will not alarm when your BG goes high.1Press ACT.2Select On and press ACT. 3The EDIT SETTINGS screen will appear. Press ACT to program your High Glucose limit.4Select On and press ACT.5In the SET HIGH GLUCOSE screen, use the up and down arrow buttons to set your limit. Press ACT. EDIT SETTINGSSensor: Off ACTSENSOR ON/OFFOffOnACT EDIT SETTINGSSensor: OnHigh Glucose: OffLow Glucose: OffACTHIGH GLUCOSEOffOnACTOn(flashing) set, then press ACT.SET HIGH GLUCOSE200mg/dLACT
Programming your sensor 9 High snooze feature Once you get a High Glucose Alarm, the pump alarms about every 5 minutes while the high glucose condition exists, unless you set the High Snooze feature. This allows your glucose to return to normal after you take some insulin without having the pump alarm about every 5 minutes. You can set the time period for between 5 minutes to 3 hours. Low glucose alarm Your pump will alarm if your BG reaches or goes below what you set here. If you do not turn on the Low Glucose Alarm, your pump will not alarm when your BG goes low.6Press ACT to program the High Snooze feature.7Use the up and down arrow buttons to select your High Snooze alarm time and press ACT. 8Press ACT to program your Low Glucose limit. 9Select ON and press ACT.10 In the SET LOW GLUCOSE screen, use the up and down arrow buttons to set your low glucose limit and press ACT.-EDIT SETTINGSSensor: OnHigh Glucose: 200High Snooze: 1:00ACT(flashing) set, then press ACTSET HIGH SNOOZE1:00 ACTEDIT SETTINGSHigh Snooze 1:00Low Glucose: OffAlarm Snooze: 0:05ACTLOW GLUCOSEOffOnACT(flashing) set, then press ACT.SET LOW GLUCOSE50mg/dLACT
10 Chapter 2 Low snooze featureOnce you get a Low glucose alarm, the pump alarms about every 5 minutes while the low glucose condition exists, unless you set the Low Snooze feature. This option can be turned on during a specific period of time when you are expecting your glucose level to fall below the set low limit. You can set the time period for between 5 minutes to 1 hour.Alarm snooze This option allows you to set an alarm snooze for the Meter BG Now alarm(see Chapter 5, Troubleshooting and Alarms for more information). So, instead of alarming every 5 minutes, they will alarm at the time interval you set here. For example, if you set an Alarm Snooze of 20 minutes for the Meter BG Now alarm, the alarm will only repeat every 20 minutes until you enter a Meter BG.11 Low Snooze will be highlighted, press ACT.12 In the SET LOW SNOOZE screen, use the up and down arrow buttons to set the time for your Low Snooze alarm. Press ACT.13 Alarm Snooze will be highlighted, press ACT.14 Use the up and down arrow buttons to set the Alarm Snooze. Press ACT.EDIT SETTINGSLow Glucose: 50Low Snooze: 0:20Alarm Snooze: 0:05ACT(flashing) set, then press ACT.SET LOW SNOOZE0:20EDIT SETTINGSLow Snooze 0:20Alarm Snooze: 0:05Cal Reminder 0:25ACT(flashing) set, then press ACTALARM SNOOZE0:05
Programming your sensor 11 Cal reminder To help you remember to enter your meter BG readings for sensor calibration you can set the Cal Reminder feature. To set your Cal Reminder:BG units You can select mg/dL or mmol/L as your Blood Glucose Unit (measurement type).NOTE - This menu option will not appear if the Bolus Wizard feature is on.15 Cal Reminder will be highlighted, press ACT.16 Use the up and down arrow buttons to set the time and press ACT.17 BG Units will be highlighted, press ACT.18 Select mg/dL or mmol/L and press ACT.EDIT SETTINGSAlarm Snooze 0:05Cal Reminder: 0:25BG Units mg/dLACT(flashing) set, then press ACTCAL REMINDER SET CAL REMINDER0:25OffOnACT ACTEDIT SETTINGSBG Units mg/dLTransmtr ID: ------Missed Data 0:30ACTBLOOD GLUCOSE UNITSmg/dLmmol/LACT
12 Chapter 2 Transmitter ID The transmitter ID is found on the back of your transmitter. You need to enter your transmitter ID so the transmitter and pump can communicate with each other.19 Select Transmtr ID and press ACT.20 Use the up and down arrow buttons to select each of the seven ID numbers. Press ACT after each entry. Press ESC when you are done. 21 The EDIT SETTINGS screen will appear. Your Transmitter ID will be highlighted. EDIT SETTINGSBG Units mg/dLTransmtr ID: -------Missed Data 0:30ACT- - -(flashing) set, then press ACTSET TRANSMITTER ID_ _ _ _ _ _ _SET TRANSMITTER ID1111111Tip - To remember your transmitter ID, write it down here ___________.ACTACTTransmtr IDhas been changed.Please restart Sensor ACT
Programming your sensor 13 Missed data The Missed Data feature allows you to set the period of time the pump will wait to alert you to failed reception of sensor data from the transmitter to the pump.Review settingsMain Menu > Sensor > Sensor Setup > Review SettingsThe Review Settings feature allows you to review your settings to verify that they have been set as you intended. Select Review Settings now and verify that your settings are correct.22 Select Missed Data and press ACT.23 Use the arrow buttons to set the time, Press ACT. 24 When you have completed the sensor setup, press ESC until the HOME screen appears.EDIT SETTINGSBG Units mg/dLTransmtr ID: 1111111Missed Data 0:30ACT- - -(flashing) set, then press ACTSET MISSED DATA0:30 ACTREVIEW SETTINGSSensor: OnHigh Glucose 200 High Snooze 1:00 Low Glucose: 50Low Snooze 0:20Alarm Snooze 0:05Cal Reminder 0:25BG Units: mg/dLTransmtr ID: 1111111Missed Data 0:30
14 Chapter 2
Starting the sensor 15 Chapter 3Starting the sensorIntroductionTo start the sensor working you must complete the following steps in order. ➠Insert the sensor➠Apply the transmitter➠Connect the sensor to the transmitter➠Perform “Sensor Start” on the pumpInserting the sensor The sensor is inserted through the skin with an insertion device called the Sen-serter® and placed in the subcutaneous tissue. The sensor produces a signal that is proportional to the concentration of glucose in the interstitial fluid at the insertion site. This signal is sent to the transmitter, which is then sent to the pump. The pump translates the signal and displays a sensor reading on your pump screen.Choose a site with adequate subcutaneous fat for sensor insertion. Shown below are the body areas (shaded) that are best for sensor insertion.CAUTION: Never insert the sensor within 2 inches from the pump infusion site or within 3 inches from the manual injection site.
16 Chapter 3 Areas to avoid: ➠Frequently used injection or pump/sensor sites➠Belt or waistline➠2-inch area around navel➠Site where clothing will rub or constrict➠Scarred or atrophied tissue➠Areas subjected to rigorous movement➠Never insert the sensor within 2 inches from the pump infusion site or within 3 inches from the manual injection site. NOTE - Clean site with alcohol, making sure site is dry before inserting the sensor. Do NOT use skin-preparation solutions prior to insertion. However, I.V. Prep may be used after insertion and before applying a sterile dressing. Lift back of tape slightly to apply I.V. Prep.Always refer to the instructions that shipped with your glucose sensor.1Wash your hands. 2Clean and dry the sensor site.
Starting the sensor 17 3Remove the sensor from package by holding base or tape. Do not hold the sensor by the introducer needle handle. 4Place the sensor in the Sen-serter® until it fits snugly.5Place fingers on the back of the white tape and push the carrier down until it clicks into place.6Holding the white tape as shown, remove the clear tape using a counterclockwise motion.
18 Chapter 3 7Turn the lock and remove needle guard from introducer needle.8Rest the Sen-serter legs on skin at 45 degree angle, placing two fingers of opposite hand on the Sen-serter legs to maintain angle.9Press the white button to insert the sensor. 10 Make sure the sensor is inserted and flush with your skin.11 While holding the sensor in place, gently slide the Sen-serter away from the sensor. Do not twist, bend or lift the Sen-serter while removing from the sensor.
Starting the sensor 19 12 Holding the sensor base, remove the white paper from the adhesive pad. Press adhesive against your skin.13 Hold the sensor with two fingers on the base, and gently remove the introducer needle at 45-degree angle. Do NOT rotate introducer needle when removing. Dispose of needle in sharps container.NOTE - Bleeding will not affect the sensor’s performance. 14 Check the site for redness, bleeding, irritation, pain, tenderness or inflammation.
20 Chapter 3 The transmitterThe Medtronic MiniMed Transmitter (MMT-7701) is a device that takes electronic signals generated by the glucose sensor and sends them by radio frequency to the pump. The transmitter is attached to the sensor by a sensor connector.Attaching the transmitter1Find a comfortable, protected area on the abdomen that is within cable reach to the sensor. 2Clean the area with isopropyl alcohol and allow to dry.3Peel the paper from the Transmitter side of the adhesive pad.4Stick the adhesive pad to the back of the Transmitter.5Peel the paper from the skin side of the adhesive pad. Apply to skin by pressing firmly.Tra n s mi t t erCableSensor Connector
Starting the sensor 21 Connecting the sensor to the transmitterCAUTION: In order to avoid damage, make sure the sensor and the cable are level when attaching.1Hold the sensor base while connecting the cable. Do not squeeze clips. You should hear a click when the cable and sensor connect. You will also hear a short beep from the transmitter.2A prepping agent, such as an I.V. Prep may be used to strengthen adhesion before applying sterile dressing. Make sure smooth side is down. The cable may be looped under tape for strain relief. Apply a sterile, transparent dressing such as an IV3000® tape, over site.
22 Chapter 3 Starting the sensorYou are now ready to start your sensor so the sensor and the pump can communicate with each other. To do this, follow the steps below:NOTE - If screen times out, start again, DO NOT disconnect sensor.1Press ACT from the HOME screen. In the MAIN MENU, select Sensor and press ACT.2Select Sensor Start, press ACT.3New Sensor will be highlighted, press ACT.4Connect your sensor now if you have not already done so. Press ACT.5Press ACT.MAIN MENUBolusSuspendSensorACTSENSOR MENUSensor Update Hist.Sensor Alarm HistorySensor StartACTReconnect Old SensorFind Lost SensorSENSOR START MENUNew Sensor ACTNEW SENSORConnect new sensor,then press ACT, orESC to abortACTSENSOR READY 2 HRSAlert will sound when meter BG is required.Press any key to cont.
Starting the sensor 23 Enter meter BGAfter the two hour initialization period you must enter a BG reading into the pump to calibrate the sensor. If you are using the Paradigm Link this will be done automatically with each fingerstick. To enter a value manually perform the following steps.1In the MAIN MENU, select Sensor and press ACT.2Select Enter Meter BG, press ACT.3Use the up and down arrow buttons to enter your BG, press ACT.MAIN MENUBolusSuspendSensorACT SENSOR MENUEnter Meter BGSensor Update Hist.Sensor Alarm HistoryACT(flashing) set, then press ACTENTER BG140mg/dLACT
24 Chapter 3
Using your sensor 25 Chapter 4Using your sensorStatus screens Your STATUS screens tell you what is going on in your pump. In the SENSOR STATUS screen you can check the status of sensor information including when your next calibration will be needed, your sensor’s age, and the state of your transmitter battery. To get to your status screens:The Sensor Status screen will only be available if the sensor feature has been turned on.1From the HOME screen, press the ESC button three times. This takes you to your pump status screen.2To see the Sensor Status screen, press ESC one more time.STATUS U100Low BatteryBasal 1: 0.00 U/HReservoir Started:Battery: LowFri 24 SEP 2004S/N# 2222222Paradigm 5221.13 X.XX X.X 03SEP, 8:25AUnits Left: 173.1UTime Left: > 24 hoursSENSOR STATUSNext Cal: 8:30ASensor Age: 2d 3hSensor Isig: 123.45Transmtr Batt: GoodTransmtr Ver: 1.1Transmtr ID: 1111111Pump S/N#: 2222222
26 Chapter 4 Reading your graphs Once the sensor is calibrated you can view your sensor glucose values in real-time. To view your current glucose and the most recent three hours of data press ESC once from the home screen, to view the most recent 24 hours of data press ESC twice from the home screen.Your glucose valuesYour glucose value will be shown on your graph. Each data point on the graph indicates your sensor glucose. If an arrow is next to your sensor glucose:➠An up arrow next to your glucose indicates that your glucose is rising at a rate of 1 to 2mg/dL per minute for the last 20 minutes. Your glucose has changed by 20-40 mg/dL in the last 20 minutes.➠A down arrow next to your glucose indicates that your glucose is dropping at a rate of 1 to 2mg/dL per minute for the last 20 minutes. Your glucose has changed by 20-40 mg/dL in the last 20 minutes.➠Two up arrows next to your glucose indicates that your glucose is rising at a rate of more than 40 mg/dL over the last 20 minutes.➠Two down arrows next to your glucose indicates that your glucose has been dropping at a rate of more than 40 mg/dL over the last 20 minutes.Your alarmsThe graph will also show any alarms that you received along with the time of the alarm. The alarms you will see in your graph screens are:For further information on these alarms, go to Chapter 5, Troubleshooting and Alarms.➠Meter BG➠Cal Error➠Sensor End➠Bad Sensor➠Sensor Error➠Weak Signal➠Lost Sensor
Using your sensor 27 3 hour graphTo scroll through your sensor glucose data points and any alarms that you may have received press the down button. Below is an example along with explanations of a screen you may see 24 hour graph To view the current glucose and a graph of the most recent 24 hours of data, from the HOME screen, press ESC twice:Time of BG or alarm.Displays your sensor glucose data or alarm.1 0 : 1 0 P 3 Hour Sensor glucose data points.Flashing line indicates each sensor glucose or alarm currently being displayed.150The first time it will say 3 hour, once you scroll it will say History.Each time you bolus a marker will appear on your graph2 : 5 5 P 24 Hour Time of BG or alarm.The first time it will say 24 hour, once you scroll it will say History.Displays your sensor glucose data or alarm.Sensor glucose data pointsFlashing line indicates each sensor glucose or alarm.The darkened area is the 12 hours from 6:00pm to 6:00am.150
28 Chapter 4 Sensor alarm history Lists all of the sensor alarms that have occurred and will display up to 36 alarms. To view your Sensor Alarm History:Sensor update history Lists all your calibration values entered into the pump. To view your Sensor Update History:1In the MAIN MENU, select Sensor and press ACT.2Select Sensor Alarm History, press ACT.3The SENSOR ALARM HISTORY screen will appear.1In the MAIN MENU, select Sensor and press ACT.2Select Sensor Update Hist., press ACT.3The SENSOR UPDATE HISTORY screen will appear.MAIN MENUSuspendSensor CalibrationSensorACT SENSOR MENUEnter Meter BGSensor Update Hist.Sensor Alarm HistoryACT SENSOR ALARM HISTORY19OCT 10:45A Lo 7019OCT 2:30P Hi 25820OCT 6:53A Hi 250MAIN MENUSuspendSensor CalibrationSensorACT SENSOR MENUEnter Meter BGSensor Update Hist.Sensor Alarm HistoryACT SENSOR UPDATE HISTORY20 OCT 11:41A 10019OCT 5:45P 9819OCT 2:30P 98
Using your sensor 29 Review settings To review your sensor settings:NOTE - If you do not turn on the High Glucose or the Low Glucose alarms then you will not see High Snooze or Low Snooze listed under Review Settings.1In the MAIN MENU, select Sensor and press ACT.2Select Sensor Setup, press ACT.3Select Review Settings, press ACT.MAIN MENUSuspendSensor CalibrationSensorACT SENSOR MENUSensor Alarm HistorySensor StartSensor SetupACT SENSOR SETUPREVIEW SETTINGSEdit SettingsReview SettingsACTSensor: OnHigh Glucose: 200High Snooze: 1:00Low Glucose: 50Low Snooze: 0:20Alarm Snooze: 0:05Cal Reminder: 0:25BG Units: mg/dLTransmtr ID: 1111111Missed Data: 0:30
30 Chapter 4 Removing transmitter and sensorDisconnecting the sensor from the transmitterHold the glucose sensor assembly in one hand and the sensor connector in the other hand. While pinching the snap arms on the sides of the glucose sensor assembly together, gently pull the glucose sensor assembly away from the sensor connector.Removing the transmitterRemove by pulling gently on the transmitter. Do not pull off by the sensor connector wire. Removing the sensorRemove the outer tape from over the sensor. Gently pull the sensor from your body. When removed place in a sharps container.Storage and handlingStore sensors in refrigerator at +2 to 10°C (+36 to +50° F). Do not freeze.Prior to opening, allow the sensor package to reach room temperature and 5% to 95% humidity to prevent condensation.Sen-serter maintenanceCleanse Sen-serter with soapy water, using liquid detergent or other household soaps. Allow to dry.Disinfect Sen-serter by wiping with 10% bleach solution or 70% isopropyl alcohol.Store Sen-serter in the released position to maintain optimum product performance and life.
Troubleshooting and alarms 31 Chapter 5Troubleshooting and alarmsAlarms Your pump has a sophisticated network of safety checks and systems. If the safety network detects anything unusual, your pump notifies you of conditions that require your immediate attention. The backlight illuminates the pump screen, and the alarm message displays on the screen. Alarms put the pump in “Attention” mode.NOTE - The STATUS screen shows any alarms that are active.➠Why are alarms important?Your pump monitors activities and notifies you if there is an unusual pump status or your attention is required.An alarm gradually becomes higher in volume until you turn it off. If the vibrate mode is on, all alarms start as vibrations and then change to beeps. For your safety, if there is no response within ten (10) minutes, the beeps change to a siren. The pump will alarm with a siren and/or a vibration every minute until the alarm is cleared. when a solid circle appears, follow the instructions on the screen.
32 Chapter 5 What to do When an alarm is triggered, the pump goes into Attention mode, and an alarm message shows on the screen. The pump then defaults to the HOME screen. Do these steps when you get an alarm:1View the alarm:From the HOME screen, press any button to see the alarm message.2Read all of the alarm text. There are instructions on how to fix the alarm condition. (Press to read more text, if available.) 3Clear the alarm: Press ESC then ACT after you read the alarm instructions. 4The HOME screen appears.5Follow the instructions that appeared with the alarm to fix the alarm condition.6Check your settings (i.e., time/date, basal, etc.) to make sure they are correct.(any button)/ALARMMESSAGEESC, ACTAlarm description and instructions show here.
Troubleshooting and alarms 33 Sensor alarm conditions Listed below are the alarms that you may encounter while using the sensor feature of your pump, along with how to resolve the alarm condition.Weak signal Alerts you when the pump does not receive valid data for a period of time, as set in Missed Data. Move the pump to a new location on your body.Lost sensor The pump has not received a signal from the transmitter for more than 40 minutes. Make sure the transmitter and sensor are connected. If you hear a beep you will have to recalibrate. Do NOT disconnect. To find your sensor use the Find Lost Sensor function:Main Menu > Sensor> Sensor Start > Find Lost SensorLow transmtr Occurs when the transmitter battery is low. Replace transmitter. Need to order new transmitter. 9:42ASelect PatternsWEAKSIGNALSensor too far away from pump See user guide ESC, ACT to clear11:17ALOSTSENSORPump no longer getting Sensor data. See user guide ESC, ACT to clear12:00A LOWTRANSMTRReplace transmitter now ESC, ACT to clear
34 Chapter 5 Bad transmtr The transmitter battery is depleted. Replace transmitter.Bad sensor The transmitter has detected a bad sensor. Replace Sensor.Sensor End The sensor has reached the end of its life. Replace sensor. The sensor has a life of about 72 hours which is about 3 days.Cal error Enter a new meter BG and try again. If error repeats, wait 10-15 minutes and try again. If error repeats replace sensor.Replace transmitter now ESC, ACT to clearBADTRANSMTR8:35A10:05ABADSENSORReplace Sensor See user guide ESC, ACT to clear 8:35ASENSORENDReplace Sensor See user guide ESC, ACT to clear3:36P CALERRORInvalid sensor data or invalid BG value See user guide ESC, ACT to clear
Troubleshooting and alarms 35 Meter BG now A meter BG is needed right away to update sensor and to keep receiving sensor glucose data.Meter BG by A meter BG entry is required by the time that is shown to update sensor and to keep receiving sensor glucose data.Low mg/dl The glucose value is lower than or equal to the low glucose limit set. If you do not set a Low BG then you will not get a Low BG alarm.High mg/dl The glucose value is higher than or equal to the high glucose limit set. If you do not set a High BG then you will not get a High BG alarm. 8:35A METERBG NOWSensor reading invalid Enter meter BG now ESC, ACT to clearMETERBG BY 7:23 pThis is a reminder to enter meter BG soon ESC, ACT to clear_:_12:05A LOW40 MG/DLGlucose is lower than user specified limit ESC, ACT to clear11:17A HIGH200 MG/DLGlucose is higher than user specified limit ESC, ACT to clear
36 Chapter 5 Sensor error Sensor failed self-test. Press ESC then ACT to clear. You do not need to change the Sensor. If the sensor fails self-test a second time you will get a Bad Sensor alarm. If that occurs you will need to replace the sensor.SENSORERRORSensor failed self-test See user guide ESC, ACT to clear_:_
Troubleshooting and alarms 37 TroubleshootingReconnect old sensorYou should only use this feature if you have disconnected the sensor and transmitter and have to reconnect. For example, when flying on an aircraft.Find Lost SensorIf you receive a Lost Sensor alarm:1Select Sensor Start, press ACT.2Select Reconnect Old Sensor , press ACT.3Reconnect Old Sensor screen will appear. Follow instructions and press ACT.1Select Sensor Start, press ACT.2Select Find Lost Sensor, press ACT.3Your sensor will be ready in 15 minutes.ACTSENSOR MENUSensor Update Hist.Sensor Alarm HistorySensor StartSENSOR START MENUFind Lost SensorACTNew SensorReconnect Old SensorrRECONNECT OLD SENSORReconnect old sensor then press ACT, orESC to abortSENSOR READY 2 HOURSAlert will sound whenmeter BG is required.Press any key to cont.ACTACTSENSOR MENUSensor Update Hist.Sensor Alarm HistorySensor StartSENSOR START MENUReconnect Old SensorACTNew SensorFind Lost SensorSENSOR READY 15 MINAlert will sound when meter BG is required.Press any key to cont.
38 Chapter 5 Icon table Do not reuse:Attention: See Instructions for UseMethod of sterilization using ethylene oxide:Date of manufacture (year - month):Batch code: Use by: (year - month)Catalogue number: REFDevice serial number: SNStorage temperature range:Fragile product:Type BF equipment: (Protection from electrical shock)Pump: Conforms to IEC60601-1 sub-clause 44.6 and IEC60529 standard. IPX7Transmitter: Protected Against the Effects of Continuous Immersion in Water. IPX8Country:Language of Instructions for Use:Recycle:wrLOT
Troubleshooting and alarms 39 Default settings*Depending on your settings for High and Low Glucose, your limit ranges will vary.Radio communication:Menu Item Default SettingLimitsSensor Menu: Sensor: OffHigh Glucose: Off Low-400*Low Glucose: Off 40-Hi*Alarm Snooze: Off 0:05-1:00BG Units: mg/dLCal Reminder Off 0:05-4:00Missed Data 0:20 0:05-0:40Low Snooze 0:20 0:05-1:00High Snooze 1:00 0:05-3:00
40 Chapter 5
Glossary i GlossaryAAlarm Snooze - Once a sensor alarm occurs the pump will not repeat the alarm until after this period of time. This is the setting for the Meter BG Now alarm.BBG Units - Blood glucose units used by the pump (mg/dL or mmol/L). The BG units can only be set from the sensor “Edit Settings” screen if the Bolus Wizard is turned off.CCal Reminder - The pump will trigger a Meter BG Now alarm automatically every 12 hours, signaling that the current calibration value is no longer valid. The value of the Cal Reminder is the amount of time before the current calibration value expires when the user wants to be reminded to calibrate by having the pump issue a Meter BG Now alarm. For example, if the Cal Reminder is set to 2 hours, the Meter BG Now alarm will occur 2 hours before the calibration is required.HHigh Glucose - The pump will alarm if the sensor indicates that the user’s blood glucose is at or above this value. You have the option to turn this feature on or off.High Snooze - Allows the user to set the delay between the first High Glucose Alarm and any subsequent alarms. This will allow the user to avoid an alarm every five minutes until the condition is corrected. LLow Glucose - The pump will alarm if the sensor indicates that the user’s blood glucose is at or below this value. You have the option to turn this feature on or off.Low Snooze - Allows the user to set the delay between the first Low Glucose Alarm and any subsequent Low Glucose Alarms. This will allow the user to avoid an alarm every five minutes until the condition is corrected.MMissed Data - The pump will alarm if it has not received data from the sensor for an amount of time that you set.PPump S/N - Pump S/N is the serial number of the pump currently in use.
ii GlossarySSensor - Indicates whether the sensor feature is On or Off.Sensor Age - Sensor age is the amount of time, in days and hours, since the sensor was first inserted.Sen-serter - The Sen-serter is indicated as an aid for insertion of the Medtronic MiniMed glucose sensor.TTransmtr Batt - The status of the transmitter battery. Possible values are “Good,” “Low,” or “Bad.”Transmtr ID - The serial number of the transmitter currently in use.Transmtr Ver - The software version of the transmitter currently in use.
Index 1 IndexNumerics24-Hour Product Help Line,contacting 1AAccessories 1ComLink 2meter 1sensor 2transmitter 2Adverse reactions 4Aircraftflying with pumpFCC radio frequency rules 4Alarm historyviewing for sensor 28Alarm Snoozesetting 10Alarmsbad sensor 34bad transmtr 34cal err 34conditions for receiving 33high mg/dL 35how to respond 32lost sensor 33low mg/dL 35low transmtr 33meter BG by 35meter BG now 35sensor end 34sensor error 36understanding 31weak signal 33Assistance24-Hour Product Help Line 1Avoiding an insertion site 16BBad sensor alarm 34Bad transmtr alarm 34BG24 hour graphs 273-hour graphs 27values in graphs 26BG units 9CCal 34Cal err alarm 34Calibration remindersetting a Cal Reminder 11Choosing an insertion site 15Contraindications 2FFCC compliancePart 15 of FCC Rules 4Flying on an aircraftFCC radio frequency rules 4GGraphs24 hour 273 hour 27sensor 26HHelp Line, contacting 1High Glucose alarmsetting 8High mg/dL alarm 35High snooze alarmsetting 9Historyreview settings 29sensor alarm, viewing 28sensor updates, viewing 28IIcons on the pumpsensor communicating 7sensor on 7Indications 2Inserting the sensor 15choosing a site 15Sen-serter 15sites to avoid 16
2Index LLost sensor alarm 33Lost sensor dataMissed Data feature 13Low 33Low Glucose alarmsetting 9Low mg/dL alarm 35Low snooze alarmsetting 10Low transmtr alarm 33MMeter 1Meter BG by alarm 35Meter BG now alarm 35Missed Data featuresetting 13NNoticeradio frequency and FCCcompliance 4PPrecautionsextreme temperatures 3infusions sets and sites 3sensor 3Pumpalarmshow to responds 32setting up Sensor feature 7status screens 25turning Sensor feature on 7Pump iconssensor communicatingSensor onhow to know 7sensor on 7RRadio frequencyFCC rules and compliance 4Review Settingsviewing for sensor 29RF features,Paradigm Link meter 1SSen-serter 15Sensor24 hour graphs 273 hour graphs 27Alarm History, viewing 28Alarm Snooze 10alarmsbad sensor 34bad transmtr 34cal err 34conditions for receiving 33high mg/dL 35how to respond 32lost sensor 33low mg/dL 35low transmtr 33meter BG by 35meter BG now 35sensor end 34sensor error 36understanding 31weak signal 33calibration remindersetting Cal Reminder 11graphs 26High Glucose alarm 8High snooze alarm 9iconssensor communicating 7sensor on 7Low Glucose alarm 9Low snooze alarm 10Missed Data featureloss of sensor data 13Review Settings 29setting up feature on pump 7startup procedure list 15inserting the sensor 15choosing a site 15Sen-serter 15sites to avoid 16status screens 25Transmitter ID 12turning feature on 7Update History, viewingcalibration values 28Sensor communicatinghow to know 7Sensor End alarm 34Sensor error alarm 36Siteavoiding insertion in 16choosing for insertion 15Snooze alarmssetting 10Start sensorprocedure list 15inserting the sensor 15choosing a site 15Senserter 15
Index 3 sites to avoid 16Status screenspump 25sensor 25storage temperature, pump 38supplies, ordering 2TTransmitter IDsetting 12UUpdate historyviewing sensor calibrationvalues 28User Safetyadverse reactions 4contraindications 2indications 2precautions 3UserSafetywarnings 2WWarningsreservoir and infusion sets 2transmitter 3X-rays, MRIs and CT scans 3Weak signal alarm 33
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