Medtronic MiniMed 7701 TGMSIII User Manual Mp6025067 011 b
Medtronic MiniMed, Inc. TGMSIII Mp6025067 011 b
manual 7701
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| Document Description | manual 7701 |
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| Date Submitted | 2005-02-15 00:00:00 |
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® 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. 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. REF MMT-522 MMT-722 6025067-011 01/05 Contents Chapter 1 Introduction .................................................1 Assistance ................................................................................................. 1 Accessories ................................................................................................. 1 User safety ................................................................................................ 2 Indications ............................................................................................. 2 Contraindications ..................................................................................... 2 Warnings ............................................................................................... 2 Reservoir and infusion sets ...................................................................... 2 X-rays, MRIs and CT scans ....................................................................... 3 Transmitter ........................................................................................ 3 Precautions ........................................................................................... 3 Avoid extreme temperatures .................................................................... 3 Infusion sets and sites ............................................................................ 3 Sensor ............................................................................................... 4 Adverse reactions ........................................................................................ 4 Notice ....................................................................................................... 4 Insulin pump and Radio Frequency (RF) accessories ........................................... 4 Chapter 2 Programming your sensor ...................................7 Introduction ............................................................................................... 7 Sensor icons ........................................................................................... 7 Programming the sensor ............................................................................. 8 High glucose alarm .................................................................................. 8 High snooze feature ................................................................................. 9 Low glucose alarm ................................................................................... 9 Low snooze feature .................................................................................10 Alarm snooze ........................................................................................10 Cal reminder .........................................................................................11 BG units ...............................................................................................11 Transmitter ID .......................................................................................12 Missed data ..........................................................................................13 Review settings ......................................................................................13 Contents Chapter 3 Starting the sensor ...................................... 15 Introduction .............................................................................................. 15 Inserting the sensor ................................................................................... 15 The transmitter ......................................................................................... 20 Attaching the transmitter ..........................................................................20 Connecting the sensor to the transmitter .......................................................21 Starting the sensor ..................................................................................... 22 Enter meter BG ......................................................................................23 Chapter 4 Using your sensor ........................................ 25 Status screens .......................................................................................... 25 Reading your graphs ................................................................................... 26 Your glucose values ..............................................................................26 Your alarms .......................................................................................26 3 hour graph ..........................................................................................27 24 hour graph ........................................................................................27 Sensor alarm history .................................................................................. 28 Sensor update history ..............................................................................28 Review settings ......................................................................................29 Removing transmitter and sensor ................................................................... 30 Disconnecting the sensor from the transmitter .............................................30 Removing the transmitter .......................................................................30 Removing the sensor .............................................................................30 Storage and handling ................................................................................30 Sen-serter maintenance ............................................................................30 Chapter 5 Troubleshooting and alarms .............................. 31 Alarms .................................................................................................... 31 What to do ...........................................................................................32 Sensor alarm conditions .............................................................................. 33 Troubleshooting ......................................................................................... 37 Reconnect old sensor ................................................................................37 Find Lost Sensor ......................................................................................37 Icon table ................................................................................................ 38 Default settings ......................................................................................... 39 Contents 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. 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. Department Telephone number 24-hour Product Help Line (calls within the United States) 800.646.4633 (800.M i n i M e d ) 24-hour Product Help Line (calls outside the United States) 818.576.5555 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. Introduction ➠ ➠ ➠ 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 Indications The 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. Contraindications Pump 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. Warnings Reservoir and infusion sets Use 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 Chapter 1 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. Transmitter The 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 temperatures 1 Avoid exposure of your pump and remote control to temperatures above 108°F (42°C) or below 34°F (1°C). 2 Insulin 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. 3 Do not steam, sterilize or autoclave your pump, transmitter, or sensor. Infusion sets and sites Avoid using an infusion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise. Introduction 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. Contact your doctor and the Medtronic MiniMed 24-Hour Product Help Line in the event of any adverse reaction. Notice CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic MiniMed could void your ability to operate the equipment. 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: 1 This 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. 2 This 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 Chapter 1 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. 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. Introduction 6 Chapter 1 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.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 The sensor with the pump. icon appears once the Sensor feature is turned on. icon changes when the sensor is connected to the transmitter and communicating Programming your sensor 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. ACT EDIT SETTINGS Sensor: On High Glucose: Off Low Glucose: Off ACT High 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. 4 Select On and press ACT. HIGH GLUCOSE Off On ACT 5 In the SET HIGH GLUCOSE screen, use the up and down arrow buttons to set your limit. Press ACT. SET HIGH GLUCOSE On 200 ACT mg/dL (flashing) set, then press ACT. Chapter 2 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. EDIT SETTINGS Sensor: High Glucose: High Snooze: On - 200 1:00 ACT 8 Press ACT to program your Low Glucose limit. 7 Use the up and down arrow buttons to select your High Snooze alarm time and press ACT. SET HIGH SNOOZE 1:00 EDIT SETTINGS High Snooze 1:00 Low Glucose: Off Alarm Snooze: 0:05 ACT ACT (flashing) set, then press ACT 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. 9 Select ON and press ACT. LOW GLUCOSE Off On ACT 10 In the SET LOW GLUCOSE screen, use the up and down arrow buttons to set your low glucose limit and press ACT. SET LOW GLUCOSE 50 ACT mg/dL (flashing) set, then press ACT. Programming your sensor 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. EDIT SETTINGS Low Glucose: 50 Low Snooze: 0:20 Alarm Snooze: 0:05 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. ACT SET LOW SNOOZE 0:20 (flashing) set, then press ACT. 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. 13 Alarm Snooze will be highlighted, press ACT. EDIT SETTINGS Low Snooze 0:20 Alarm Snooze: 0:05 Cal Reminder 0:25 ACT 14 Use the up and down arrow buttons to set the Alarm Snooze. Press ACT. ALARM SNOOZE 0:05 (flashing) set, then press ACT 10 Chapter 2 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. CAL REMINDER Off On ACT SET CAL REMINDER 0:25 ACT (flashing) set, then press ACT 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. 17 BG Units will be highlighted, press ACT. EDIT SETTINGS BG Units mg/dL Transmtr ID: -----Missed Data 0:30 ACT 18 Select mg/dL or mmol/L and press ACT. BLOOD GLUCOSE UNITS mg/dL mmol/L ACT Programming your sensor 11 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. Please restart Sensor SET TRANSMITTER ID _- -_- _ _ _ _ _ ACT (flashing) set, then press ACT SET TRANSMITTER ID ACT 1111111 Tip - To remember your transmitter ID, write it down here ___________. 12 Chapter 2 21 The EDIT SETTINGS screen will appear. Your Transmitter ID will be highlighted. ACT 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. --- (flashing) set, then press ACT Review settings Main Menu > Sensor > Sensor Setup > Review Settings The 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. REVIEW SETTINGS Sensor: On High Glucose 200 High Snooze 1:00 Low Glucose: 50 Low Snooze 0:20 Alarm Snooze 0:05 Cal Reminder 0:25 BG Units: mg/dL Transmtr ID: 1111111 Missed Data 0:30 Programming your sensor 13 14 Chapter 2 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. 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. Starting the sensor 15 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. 1 Wash your hands. 16 Chapter 3 2 Clean and dry the sensor site. 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. Starting the sensor 17 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. Starting the sensor 19 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. 3 Peel the paper from the Transmitter side of the adhesive pad. 4 Stick the adhesive pad to the back of the Transmitter. 5 Peel the paper from the skin side of the adhesive pad. Apply to skin by pressing firmly. 20 Chapter 3 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. The cable may be looped under tape for strain relief. Apply a sterile, transparent dressing such as an IV3000® tape, over site. Starting the sensor 21 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. SENSOR START MENU New Sensor Reconnect Old Sensor Find Lost Sensor NOTE - If screen times out, start again, DO NOT disconnect sensor. 4 Connect your sensor now if you have not already done so. Press ACT. NEW SENSOR Connect new sensor, then press ACT, or ESC to abort 22 Chapter 3 ACT 5 Press ACT. SENSOR READY 2 HRS Alert will sound when meter BG is required. Press any key to cont. 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. Sensor Alarm History ACT 3 Use the up and down arrow buttons to enter your BG, press ACT. ACT ENTER BG 140 mg/dL (flashing) set, then press ACT Starting the sensor 23 24 Chapter 3 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: 0.00 U/H Reservoir Started: 03SEP, 8:25A Units Left: 173.1U Time Left: > 24 hours Battery: Low Fri 24 SEP 2004 S/N# 2222222 Paradigm 522 1.13 X.XX X.X 2 To see the Sensor Status screen, press ESC one more time. SENSOR STATUS Next Cal: 8:30A Sensor Age: 2d 3h Sensor Isig: 123.45 Transmtr Batt: Good Transmtr Ver: 1.1 Transmtr ID: 1111111 Pump S/N#: 2222222 The Sensor Status screen will only be available if the sensor feature has been turned on. Using your sensor 25 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. 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 alarms The 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: Meter BG ➠ Cal Error ➠ Sensor End ➠ Bad Sensor ➠ Sensor Error ➠ Weak Signal ➠ ➠ Lost Sensor For further information on these alarms, go to Chapter 5, Troubleshooting and Alarms. 26 Chapter 4 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. Each time you bolus a marker will appear on your graph 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: Sensor glucose data points Flashing line indicates each sensor glucose or alarm. Time of BG or alarm. 2:55P 24 Hour 150 The first time it will say 24 hour, once you scroll it will say History. Displays your sensor glucose data or alarm. The darkened area is the 12 hours from 6:00pm to 6:00am. Using your sensor 27 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. SENSOR ALARM HISTORY 20OCT 6:53A Hi 250 19OCT 10:45A Lo 70 19OCT 2:30P Hi 258 Sensor update history Lists all your calibration values entered into the pump. To view your Sensor Update History: 1 In the MAIN MENU, select Sensor and press ACT. MAIN MENU Suspend Sensor Calibration Sensor 28 Chapter 4 ACT 2 Select Sensor Update Hist., press ACT. SENSOR MENU Enter Meter BG Sensor Update Hist. Sensor Alarm History ACT 3 The SENSOR UPDATE HISTORY screen will appear. SENSOR UPDATE HISTORY 20 OCT 11:41A 100 19OCT 5:45P 98 19OCT 2:30P 98 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. SENSOR SETUP Edit Settings Review Settings ACT REVIEW SETTINGS Sensor: On High Glucose: 200 High Snooze: 1:00 Low Glucose: 50 Low Snooze: 0:20 Alarm Snooze: 0:05 Cal Reminder: 0:25 BG Units: mg/dL Transmtr ID: 1111111 Missed Data: 0:30 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. Using your sensor 29 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. Gently pull the sensor from your body. When removed place in a sharps container. Storage and handling Store 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 maintenance Cleanse 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. 30 Chapter 4 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. ➠ 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. Troubleshooting and alarms 31 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.) ALARM MESSAGE 3 Clear the alarm: Press ESC then ACT after you read the alarm instructions. 4 The HOME screen appears. 5 Follow the instructions that appeared with the alarm to fix the alarm condition. 6 Check your settings (i.e., time/date, basal, etc.) to make sure they are correct. 32 Chapter 5 Alarm description and instructions show here. ESC, ACT 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. WEAK SIGNAL Sensor too far Select Patterns away from pump See user guide ESC, ACT to clear 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 Sensor 11:17A LOST SENSOR Pump no longer getting Sensor data. See user guide ESC, ACT to clear Low transmtr Occurs when the transmitter battery is low. Replace transmitter. Need to order new transmitter. 12:00A LOW TRANSMTR Replace transmitter now ESC, ACT to clear Troubleshooting and alarms 33 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. 8:35A SENSOR END Replace Sensor See user guide ESC, ACT to clear 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. 3:36P CAL ERROR Invalid sensor data or invalid BG value See user guide ESC, ACT to clear 34 Chapter 5 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. If you do not set a Low BG then you will not get a Low BG alarm. 12:05A LOW 40 MG/DL Glucose is lower than user specified limit ESC, ACT to clear 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. 11:17A HIGH 200 MG/DL Glucose is higher than user specified limit ESC, ACT to clear Troubleshooting and alarms 35 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. 36 Chapter 5 _:_ SENSOR ERROR Sensor failed selftest See user guide ESC, ACT to clear 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. RECONNECT OLD SENSOR Reconnect old sensor then press ACT, or ESC to abort ACT SENSOR READY 2 HOURS Alert will sound when meter BG is required. Press any key to cont. Find Lost Sensor If you receive a Lost Sensor alarm: 1 Select Sensor Start, press ACT. SENSOR MENU Sensor Update Hist. Sensor Alarm History Sensor Start 2 Select Find Lost Sensor, press ACT. 3 Your sensor will be ready in 15 minutes. ACT SENSOR START MENU New Sensor Reconnect Old Sensor Find Lost Sensor ACT SENSOR READY 15 MIN Alert will sound when meter BG is required. Press any key to cont. Troubleshooting and alarms 37 Icon table Do not reuse: Attention: See Instructions for Use Method of sterilization using ethylene oxide: 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. IPX8 Country: Language of Instructions for Use: Recycle: 38 Chapter 5 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. Troubleshooting and alarms 39 40 Chapter 5 Glossary 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. 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. 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. 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. High 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. Low 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. Missed Data - The pump will alarm if it has not received data from the sensor for an amount of time that you set. Pump S/N - Pump S/N is the serial number of the pump currently in use. Glossary 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. 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. Transmtr Ver - The software version of the transmitter currently in use. ii Glossary Index Numerics 24-Hour Product contacting 1 Help Line, 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-Hour Product Help Line 1 Avoiding an insertion site 16 Bad sensor alarm 34 Bad transmtr alarm 34 BG 24 hour graphs 27 3-hour graphs 27 values in graphs 26 BG units 9 Cal 34 Cal err alarm 34 Calibration reminder setting a Cal Reminder 11 Choosing an insertion site 15 Contraindications 2 FCC compliance Part 15 of FCC Rules 4 Flying on an aircraft FCC radio frequency rules 4 Graphs 24 hour 27 3 hour 27 sensor 26 Help Line, contacting 1 High Glucose alarm setting 8 High mg/dL alarm 35 High snooze alarm setting 9 History review settings 29 sensor alarm, viewing 28 sensor updates, viewing 28 Icons on the pump sensor communicating 7 sensor on 7 Indications 2 Inserting the sensor 15 choosing a site 15 Sen-serter 15 sites to avoid 16 Index 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 Radio frequency FCC rules and compliance 4 Review Settings viewing for sensor 29 RF features, Paradigm Link meter 1 Meter 1 Meter BG by alarm 35 Meter BG now alarm 35 Missed Data feature setting 13 Notice radio frequency compliance 4 and FCC Precautions extreme temperatures 3 infusions sets and sites 3 sensor 3 Pump alarms how to responds 32 setting up Sensor feature 7 status screens 25 Index Sen-serter 15 Sensor 24 hour graphs 27 3 hour graphs 27 Alarm History, viewing 28 Alarm Snooze 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 calibration reminder setting Cal Reminder 11 graphs 26 High Glucose alarm 8 High snooze alarm 9 icons sensor communicating 7 sensor on 7 Low Glucose alarm 9 Low snooze alarm 10 Missed Data feature loss of sensor data 13 Review Settings 29 setting up feature on pump 7 startup procedure list 15 inserting the sensor 15 choosing a site 15 Sen-serter 15 sites to avoid 16 status screens 25 Transmitter ID 12 turning feature on 7 Update History, viewing calibration values 28 Sensor communicating how to know 7 Sensor End alarm 34 Sensor error alarm 36 Site avoiding insertion in 16 choosing for insertion 15 Snooze alarms setting 10 Start sensor procedure list 15 inserting the sensor 15 choosing a site 15 Senserter 15 sites to avoid 16 Status screens pump 25 sensor 25 storage temperature, pump 38 supplies, ordering 2 Transmitter ID setting 12 Update history viewing sensor calibration values 28 User Safety adverse reactions 4 contraindications 2 indications 2 precautions 3 UserSafety warnings 2 Warnings reservoir and infusion sets 2 transmitter 3 X-rays, MRIs and CT scans 3 Weak signal alarm 33 Index 4 Index
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