® Paradigm 522 and 722 Sensor Features Caution - 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 Company Energizer® is a trademark of Eveready Battery Company.
Contents Chapter 1 Introduction .................................................1 Assistance ................................................................................................. 1 Accessories ................................................................................................. 1 User safety ................................................................................................ 2 Indications ...................................................................................
Chapter 3 Starting the sensor ...................................... 15 Introduction .............................................................................................. 15 Inserting the sensor ................................................................................... 15 The transmitter ......................................................................................... 20 Attaching the transmitter ..........................................................................
Chapter 1 Introduction Thank 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.
➠ ➠ ➠ 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.
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.
Sensor Prior 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.
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 interference The Paradigm Link meter and transmitter sends information to the pump using radio frequency.
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Chapter 2 Programming your sensor Introduction 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.
Programming the sensor To 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 Settings 1 Press ACT. EDIT SETTINGS Sensor: Off 2 Select On and press ACT. SENSOR ON/OFF ACT Off On 3 The EDIT SETTINGS screen will appear. Press ACT to program your High Glucose limit.
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. 6 Press ACT to program the High Snooze feature.
Low snooze feature Once 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. 11 Low Snooze will be highlighted, press ACT.
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: 15 Cal Reminder will be highlighted, press ACT. EDIT SETTINGS Alarm Snooze 0:05 Cal Reminder: 0:25 BG Units mg/dL ACT 16 Use the up and down arrow buttons to set the time and press ACT.
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. EDIT SETTINGS BG Units mg/dL Transmtr ID: ------Missed Data 0:30 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. Transmtr ID has been changed.
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. 22 Select Missed Data and press ACT. 23 Use the arrow buttons to set the time, Press ACT. SET MISSED DATA EDIT SETTINGS BG Units mg/dL Transmtr ID: 1111111 Missed Data 0:30 ACT 0:30 ACT 24 When you have completed the sensor setup, press ESC until the HOME screen appears.
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Chapter 3 Starting the sensor Introduction To 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 pump Inserting the sensor The sensor is inserted through the skin with an insertion device called the Sen-serter® and placed in the subcutaneous tissue.
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.
3 Remove the sensor from package by holding base or tape. Do not hold the sensor by the introducer needle handle. 4 Place the sensor in the Sen-serter® until it fits snugly. 5 Place fingers on the back of the white tape and push the carrier down until it clicks into place. 6 Holding the white tape as shown, remove the clear tape using a counterclockwise motion.
7 Turn the lock and remove needle guard from introducer needle. 9 Press the white button to insert the sensor. 10 Make sure the sensor is inserted and flush with your skin. 18 Chapter 3 8 Rest the Sen-serter legs on skin at 45 degree angle, placing two fingers of opposite hand on the Sen-serter legs to maintain angle. 11 While holding the sensor in place, gently slide the Sen-serter away from the sensor. Do not twist, bend or lift the Senserter while removing from the sensor.
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.
The transmitter The 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. Cable Transmitter Sensor Connector Attaching the transmitter 1 Find a comfortable, protected area on the abdomen that is within cable reach to the sensor. 2 Clean the area with isopropyl alcohol and allow to dry.
Connecting the sensor to the transmitter CAUTION: In order to avoid damage, make sure the sensor and the cable are level when attaching. 1 Hold 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. 2 A prepping agent, such as an I.V. Prep may be used to strengthen adhesion before applying sterile dressing. Make sure smooth side is down.
Starting the sensor You 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: 1 Press ACT from the HOME screen. In the MAIN MENU, select Sensor and press ACT. MAIN MENU Bolus Suspend Sensor 2 Select Sensor Start, press ACT. SENSOR MENU Sensor Update Hist. Sensor Alarm History Sensor Start ACT ACT 3 New Sensor will be highlighted, press ACT.
Enter meter BG After 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. 1 In the MAIN MENU, select Sensor and press ACT. MAIN MENU Bolus Suspend Sensor ACT 2 Select Enter Meter BG, press ACT. SENSOR MENU Enter Meter BG Sensor Update Hist.
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Chapter 4 Using your sensor Status 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: 1 From the HOME screen, press the ESC button three times. This takes you to your pump status screen. U100 STATUS Low Battery Basal 1: 0.
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 values Your glucose value will be shown on your graph. Each data point on the graph indicates your sensor glucose.
3 hour graph To 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 Time of BG or alarm. Sensor glucose data points. The first time it will say 3 hour, once you scroll it will say History. 10: 10P 3 Hour 150 Flashing line indicates each sensor glucose or alarm currently being displayed. Displays your sensor glucose data or alarm.
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: 1 In the MAIN MENU, select Sensor and press ACT. MAIN MENU Suspend Sensor Calibration Sensor ACT 2 Select Sensor Alarm History, press ACT. SENSOR MENU Enter Meter BG Sensor Update Hist. Sensor Alarm History ACT 3 The SENSOR ALARM HISTORY screen will appear.
Review settings To review your sensor settings: 1 In the MAIN MENU, select Sensor and press ACT. MAIN MENU Suspend Sensor Calibration Sensor ACT 2 Select Sensor Setup, press ACT. SENSOR MENU Sensor Alarm History Sensor Start Sensor Setup ACT 3 Select Review Settings, press ACT.
Removing transmitter and sensor Disconnecting the sensor from the transmitter Hold 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 transmitter Remove by pulling gently on the transmitter. Do not pull off by the sensor connector wire. Removing the sensor Remove the outer tape from over the sensor.
Chapter 5 Troubleshooting and alarms Alarms 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.
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: 1 View the alarm: From the HOME screen, press any button to see the alarm message. (any button) 2 Read all of the alarm text. There are instructions on how to fix the alarm condition. (Press to read more text, if available.
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 9:42A 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.
Bad transmtr The transmitter battery is depleted. Replace transmitter. 8:35A BAD TRANSMTR Replace transmitter now ESC, ACT to clear Bad sensor The transmitter has detected a bad sensor. Replace Sensor. 10:05A BAD SENSOR Replace Sensor See user guide ESC, ACT to clear 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.
Meter BG now A meter BG is needed right away to update sensor and to keep receiving sensor glucose data. 8:35A METER BG NOW Sensor reading invalid Enter meter BG now ESC, ACT to clear 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. _:_ METER BG BY 7:23 p This is a reminder to enter meter BG soon ESC, ACT to clear Low mg/dl The glucose value is lower than or equal to the low glucose limit set.
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.
Troubleshooting Reconnect old sensor You should only use this feature if you have disconnected the sensor and transmitter and have to reconnect. For example, when flying on an aircraft. 1 Select Sensor Start, press ACT. SENSOR MENU Sensor Update Hist. Sensor Alarm History Sensor Start ACT 2 Select Reconnect Old Sensor , press ACT. SENSOR START MENU New Sensor Reconnect Old Sensorr Find Lost Sensor ACT 3 Reconnect Old Sensor screen will appear. Follow instructions and press ACT.
Icon table Do not reuse: Attention: See Instructions for Use Method of sterilization using ethylene oxide: w r Date of manufacture (year - month): Batch code: LOT Use by: (year - month) Catalogue number: REF Device serial number: SN Storage temperature range: Fragile product: Type BF equipment: (Protection from electrical shock) Pump: Conforms to IEC60601-1 sub-clause 44.6 and IEC60529 standard. IPX7 Transmitter: Protected Against the Effects of Continuous Immersion in Water.
Radio communication: Default settings Menu Sensor Menu: Item Default Setting Sensor: High Glucose: Low Glucose: Alarm Snooze: BG Units: Cal Reminder Missed Data Low Snooze High Snooze Off Off Off Off mg/dL Off 0:20 0:20 1:00 Limits Low-400* 40-Hi* 0:05-1:00 0:05-4:00 0:05-0:40 0:05-1:00 0:05-3:00 *Depending on your settings for High and Low Glucose, your limit ranges will vary.
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Glossary A Alarm 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. B BG 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. C Cal Reminder - The pump will trigger a Meter BG Now alarm automatically every 12 hours, signaling that the current calibration value is no longer valid.
S Sensor - 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. T Transmtr 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.
Index Numerics 24-Hour Product contacting 1 Help Line, A Accessories 1 ComLink 2 meter 1 sensor 2 transmitter 2 Adverse reactions 4 Aircraft flying with pump FCC radio frequency rules 4 Alarm history viewing for sensor 28 Alarm Snooze setting 10 Alarms bad sensor 34 bad transmtr 34 cal err 34 conditions for receiving 33 high mg/dL 35 how to respond 32 lost sensor 33 low mg/dL 35 low transmtr 33 meter BG by 35 meter BG now 35 sensor end 34 sensor error 36 understanding 31 weak signal 33 Assistance 24-Hou
L turning Sensor feature on 7 Pump icons sensor communicating Sensor on how to know 7 sensor on 7 Lost sensor alarm 33 Lost sensor data Missed Data feature 13 Low 33 Low Glucose alarm setting 9 Low mg/dL alarm 35 Low snooze alarm setting 10 Low transmtr alarm 33 R Radio frequency FCC rules and compliance 4 Review Settings viewing for sensor 29 RF features, Paradigm Link meter 1 M Meter 1 Meter BG by alarm 35 Meter BG now alarm 35 Missed Data feature setting 13 S N Notice radio frequency compliance 4
sites to avoid 16 Status screens pump 25 sensor 25 storage temperature, pump 38 supplies, ordering 2 T Transmitter ID setting 12 U Update history viewing sensor calibration values 28 User Safety adverse reactions 4 contraindications 2 indications 2 precautions 3 UserSafety warnings 2 W Warnings reservoir and infusion sets 2 transmitter 3 X-rays, MRIs and CT scans 3 Weak signal alarm 33 Index 3
4 Index
