Note: Be aware that using a longer Backlight time causes your pump to use more battery power. When your pump battery is low, the timeout for the backlight on your pump screen is automatically reduced. Where is my pump status screen? 1. Press and select Status to go to the Status screen. The Status screen appears. 2. From the Status screen, you can select the type of status information you want to view. For example, to see a quick status of your pump and recent insulin deliveries, go to Quick Status.
After you enter your pump settings, you have the option of entering the following Bolus Wizard settings: • Carb ratio • Insulin sensitivity factor • BG target To enter your pump settings: ■ Select your language, and then select Next to go to each new screen. 2. When the Select Time Format screen appears, select a 12 Hour or a 24 Hour time format. 3. When the Enter Time screen appears, adjust the setting to the current time. If you are using a 12-hour clock, be sure to specify AM or PM. 4.
2. When the Carb Ratio screen appears, enter your carb ratio by entering the End time and the ratio. You can adjust your carb ratio at any time. For details, see Changing your carb ratio, on page 94. 3. When the Sensitivity screen appears, enter your insulin sensitivity factor by entering the End time and the mg/dL per unit. You can adjust your insulin sensitivity factor at any time.
If your pump does not find the sensor signal within 15 minutes after you selected OK, the Check connection alert appears. 3. Ensure the transmitter and sensor connection is secure, and then select OK. The "Check sensor insertion" message appears. If your sensor is fully inserted, select Yes and skip to step 7. 5. If your sensor is not fully inserted, select No. A Change sensor alert appears. 6. Select OK and change your sensor. 7.
• No sensor glucose (SG) values are available. SG values may be unavailable because: • Sensor calibration is required. For details on when and how to calibrate your sensor, see Calibrating your sensor, on page 204. • Your pump has lost connection to the sensor. Move your pump closer to the sensor. For more details, see My pump cannot find the sensor signal, on page 288. • The SG value received was outside the expected range and was not displayed. Select OK to clear the alert.
Maintenance
■ Maintenance Maintenance Cleaning your pump CAUTION: Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your pump. Never use lubricants with your pump. When you clean your pump, be sure to keep the reservoir compartment dry and away from moisture. When you clean your pump with organic solvents, it can cause the pump to malfunction and result in minor injury.
Cleaning your transmitter Always refer to your transmitter user guide for instructions on cleaning the transmitter. Storing your pump Storage mode lets you safely place your pump in storage while not in use. Note: If you place your pump in storage mode, it is important to insert a new AA battery for 8 to 12 hours every six months to ensure that the internal battery does not discharge to a deep discharge. A battery that is deeply discharged may experience decreased performance.
To wake your pump from storage mode: 1. Insert a new AA battery into your pump. For details, see Inserting the battery, on page 38. A Pump Error message appears. 2. Select OK. Your pump displays a Power Loss alarm. ■ 3. Select OK. Maintenance The Time & Date screen appears. 4. Enter the current Time, Time Format, and Date. 5. Select Save. Your pump displays an Active Insulin Cleared alert. 6. Select OK. Make sure that all of your settings, such as basal rate, are set as desired.
296 Chapter 15
Product specifications and safety information
Product specifications Alarm and alert escalation The following alerts may escalate to a siren if not cleared: • Alert before high • Lost sensor signal • Alert before low • No calibration occurred • Alert on high • Possible signal interference • Alert on low • High SG • Basal delivery resumed • Rise Alert • BG not received • Sensor expired • Calibration not accepted • Sensor signal not found • Calibrate now • Low SG XX mg/dL (XX represents 50 mg/dL or below) • Change sensor • Sensor updatin
Minutes Audio Audio and vibration Vibration 0 Audio Audio and vibrate Vibrate 1 Audio Audio and vibrate Vibrate 2 Audio Audio and vibrate Vibrate 3 Audio Audio and vibrate Vibrate 4 Audio Audio and vibrate Vibrate 5 Audio Audio and vibrate Vibrate 6 Audio and vibrate Audio and vibrate Audio and vibrate 7 Audio and vibrate Audio and vibrate Audio and vibrate 8 Audio and vibrate Audio and vibrate Audio and vibrate 9 Audio and vibrate Audio and vibrate Audio and vibra
Alarm 1655 Hz followed by 3310 Hz Alternate Alarm 1850 Hz Siren (escalated alarm) 1655 Hz, followed by 3310 Hz Alert 934 Hz High Sensor Glucose 1312 Hz, followed by 1410 Hz, 1500 Hz, 1619 Hz, 1722 Hz Low SG 1722 Hz, 1619 Hz, 1500 Hz, 1410 Hz, 1312 Hz Lost SG 1485 Hz, followed by 1395 Hz, 1320 Hz, 1395 Hz Message tone 1655 Hz Reminder tone 934 Hz Fill tubing tone 1850 Hz Bolus delivery cancellation tone 1485 Hz, followed by 1655 Hz and 1485 Hz Loading complete tone 934 Hz Reservoir lo
Basal delivery Delivery rate range 0 to 35 units per hour or the Max Basal Rate amount, whichever is lower. Max Basal Rate default 2 units per hour Basal patterns Maximum of 8 patterns. Each pattern covers a 24hour period and can have up to 48 rates. Rates are set in 30-minute increments. Basal pattern names Fixed names: Basal 1, Basal 2, Basal 3, Basal 4, Basal 5, Workday, Day Off, Sick Day Increments • 0.025 units per hour for basal amounts in the range 0 to 0.975 units • 0.
Bolus delivery Bolus Speed options • Standard: 1.5 units/minute • Quick: 15 units/minute Bolus programming increments • 0.025 units • 0.05 units • 0.1 units ■ Fluid delivered/stroke • 0.25 μL (microliter) for 0.025 unit pump stroke Product specifications and safety information • 0.5 μL for 0.05 unit pump stroke • 2.0 μL for 0.2 unit pump stroke Bolus Wizard feature default settings Item Default Limits Increments Carb units grams - - Insulin to carb ratio None 1–200 g/u 0.1 g/u for 1–9.
(food estimate) total bolus estimate = A B (correction estimate) C-D E + - active insulin where: A = food (grams) B = carb ratio C = current BG D = High BG Target E = insulin sensitivity Food estimate: Carb grams ÷ Carb ratio = Units of insulin Correction estimate: (Current BG - High BG Target) ÷ Insulin sensitivity - Active insulin = Units of insulin Total bolus estimate: Food estimate + Correction estimate = Units of insulin 2.
3. If your current BG is within your High or Low BG Target, the total bolus estimate is based only on the food estimate. (food estimate) total bolus estimate = food (grams) carb ratio ■ Food estimate: Note: When the current BG is below the Low BG Target, an active insulin amount is not considered in the Bolus Wizard feature calculations. Total bolus estimate = Food estimate 4. If you do not enter a BG, the total bolus estimate is based only on the food estimate.
Active Insulin Curve 100% 90% 8 Hour 80% 7 Hour 6 Hour 5 Hour % Insulin Remaining 70% 4 Hour 3 Hour 2 Hour 60% 50% 40% 30% 20% 10% 0% 0 1 2 3 4 5 6 7 8 9 Time (hours) Graph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22, Number 9, Sept. 1999, page 1501. Carb ratios Maximum ratio settings 8 Range 1 to 200 grams/unit Delivery accuracy • For a basal rate of 1.0 U/h, the delivery accuracy is ±5%. For a basal rate of 0.025 U/h, the delivery accuracy is ±10%.
• The following image is a representative delivery accuracy curve. The Trumpet Curve represents the maximum percentage change from the expected insulin dosage for a given time interval, known as the observation window, during the infusion of insulin. The upper curve corresponds to positive changes, and the lower curve corresponds to negative changes.
Vibrate mode range 0 to 20 increments or Max Bolus limit, whichever comes first Default step size 0.1 unit Adjustable step size 0.1 to 2 units per increment up to Max Bolus limit Environmental conditions The MiniMed 770G insulin pump system is designed to withstand most conditions encountered in your daily life. For more details about environmental conditions, such as exposure to magnetic fields and radiation, waterproof capabilities, and extreme temperatures, see User safety, on page 7.
The quick fill rate is 15 units per minute. • When filling the tubing, a warning occurs at 30 units. A second warning occurs at 40 units instructing you to rewind the pump. • Insulin used to fill the infusion set is recorded in the Daily History. Infusion pressure ■ The maximum infusion pressure and occlusion pressure are 25 psi (172.4 kPa).
Basal settings Item Default setting Limits Increments Max Basal Rate 2 U/h 0–35 U/h 0.025 U for 0.025–0.975 U/h 0.05 U for 1.00–9.95 U/h 0.1 U for rates of 10.0 U/h or more Basal Rate 0.000 U/h 0.000 U/h to Max Basal Rate setting 0.025 U for 0.025–0.975 U/h 0.05 U for 1.00–9.95 U/h 0.1 U for rates of 10.0 U/h or more Temp Basal Type Percent Percent, Rate N/A Temp Basal Percent 100% 0–200% 5% Temp Basal Rate Current basal rate 0.0 U/hr to Max Basal Rate 0.025 U for 0.025–0.975 U/h 0.
Alert range Increment Default value First reminder occurs at 5 to 50 units. Second reminder occurs at 50 percent of the remaining specified amount. 1 unit 20 units The second reminder is automatic and cannot be changed by the user. ■ Max Bolus 0 to 25 units Default 10 units Normal bolus Range is 0.025 to 25 units of insulin, and limited by the Max Bolus setting. Occlusion detection When occlusion is detected, the Insulin flow blocked alarm occurs.
Percent temp basal The default value is 100 percent of basal programming. For example, if you program six units of basal per day, the default temp basal will be six units per day. Range 0 to 200% Default 100% of basal programming Increment 5% Program safety checks A single fault condition will cause the pump to suspend insulin delivery. Maximum infusion with a single fault condition is 0.2 units. Pump dimensions The pump dimensions in inches are no greater than 3.78 length x 2.11 width x 0.96 depth.
High sensor settings Item Default Limits Increments setting - - Time before high 15 minutes 5 to 30 minutes 5 minutes Rise Alert Off - - Rise Limit Two up arrows • 1 up arrow (1 mg/dL/min) Product specifications and safety information Off ■ Alert on high • 2 up arrows (2 mg/dL/min) • 3 up arrows (3 mg/dL/min) • Custom limit (1.0 to 5.
Auto Mode settings Item Default Limits Increments setting Auto Mode Off - - Auto Mode BG alert On - - 314 Chapter 16
Wireless communication The MiniMed 770G insulin pump communicates using Bluetooth wireless technology. FCC notice • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Decrease the distance between the transmitter and the insulin pump to 6 feet (1.8 meters) or less. • Decrease the distance between the meter and the insulin pump to 6 feet (1.8 meters) or less.
IMPORTANT: Do not change or modify the internal RF transmitter or antenna unless expressly approved by Medtronic Diabetes. Doing so could interfere with your ability to operate the equipment. Note: Harmful interference is defined by the FCC as follows. Any emission, radiation or induction that endangers the functioning of a radio navigation service or of other safety services or seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with FCC rules.
Guidance and manufacturer's declaration Guidance and Manufacturer's Declaration - Electromagnetic Emissions The MiniMed 770G insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the MiniMed 770G insulin pump should make sure that it is used in such an environment. Emissions Test • Maximum Output Power: Complies The MiniMed 770G insulin pump must emit electromagnetic energy in order to perform its intended function.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The MiniMed 770G insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the MiniMed 770G insulin pump should assure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity Voltage dips, short interruptions, and voltage variations on power supply lines 0% UT; 0.5 cycle IEC 61000-4-11 0% UT; 1 cycle Not applicable Requirement does not apply to this battery powered device. 30 A/m (continuous field at 60 seconds) 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The MiniMed 770G insulin pump is intended for use in the electromagnetic environment specified below. The customer or user of the MiniMed 770G insulin pump should assure that it is used in such an electromagnetic environment. Immunity Test Radiated RF IEC 61000-4-3 IEC 60601-1-2 IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance 10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz 10 V/m 80 MHz to 2.
670G Performance Data and Technical Information
■ I. Performance data for users 14 years old and older A. Device performance for users 14 years and older The MiniMed 670G System can automatically increase or decrease insulin delivery when informed by continuous glucose monitoring (CGM) values; however, the user must still calculate and administer meal boluses.
Suspend on low event occurs, you can choose to continue to keep insulin suspended, or you can choose to resume insulin delivery. When a Suspend before low occurs, insulin delivery will automatically resume when the sensor glucose (SG) levels recover. The Suspend on low and Suspend before low features are optional features available when the system is in Manual Mode. • The second level of SmartGuard technology automatically calculates insulin dose using CGM data, referred to as Auto Mode.
maximum of 19 hours. The observation period included the suspension period, the insulin resumption period, and if applicable, an insulin resuspension after insulin delivery resumed. Five adverse events were reported during the study. Four adverse events were neither device nor procedure related. One adverse event was procedure related. This study consisted of a 2-week run-in phase and a 3-month study phase.
CAUTION: Note that since this study did not include a control group, no claims regarding effectiveness can be made. However, the study does support that the device is relatively safe for use. Device related adverse events reported during the different phases of the pivotal trial are listed in the following table.
Table A-3: Number of Subjects with Change in HbA1C at Different Baselines HbA1C Change Range Number of Subjects (% of Subjects) with Change in A1C Baseline A1C (%) Decrease >1% Decrease 0 to 1% No Change Increase 0 to 1% Increase >1% 9% ≤ A1C < 10% 6 (4.8%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Overall 26 (21.0%) 67 (54.0%) 7 (5.6%) 23 (18.5%) 0 (0.
• There was no control group for comparison purposes. • The amount of time the system was used in the Manual Mode was much shorter than the time it was programmed to the Auto Mode. Additionally, for each subject, the study period lasted only three months.
The SG data collected by the blinded GSRs were retrospectively processed through the real-time CGM algorithm. This is the same algorithm used in the Guardian Connect and pump CGM systems. Thus all data is representative of real-time sensor usage. A total of 93 subjects previously diagnosed with type 1 or 2 diabetes were enrolled in the study, and 88 subjects participated in at least one day of FST.
Mean absolute relative difference, by number of daily calibrations Table B-1 shows the sensor accuracy measured by the mean absolute relative difference (MARD). MARD represents the average relative difference (regardless if positive or negative) between the SG values and the paired BG values measured by YSI. Table B-1: SG MARD Versus YSI (within YSI glucose ranges).
Table B-2: Overall agreement (%) of SG-YSI paired points within SG ranges on FST Days 1, 3, and 7; Calibration every 12 hours, Abdomen. SG ranges (mg/dL) Number of paired SG-YSI Percent of YSI Percent of YSI Percent of YSI Percent of YSI Percent of YSI within 15/15% of within 20/20% of within 30/30% of within 40/40% of greater than SG (%) SG (%) SG (%) SG (%) 40/40% of SG (%) >180–300 2833 80.8 90 97.1 98.9 1.1 >300–350 286 86.4 95.1 99.
Table B-5: Agreement (%) of SG paired points within SG ranges on FST Day 1; Calibration 3 or 4 times a day, Abdomen. SG ranges (mg/dL) Number of paired SG-YSI Percent of YSI Percent of YSI Percent of YSI Percent of YSI Percent of YSI within 15/15% of within 20/20% of within 30/30% of within 40/40% of greater than SG (%) SG (%) SG (%) SG (%) 40/40% of SG (%) ≥40–60* 247 50.2 64.4 84.6 95.5 4.5 >60–80* 429 66.2 73.9 86.5 92.8 7.2 >80–180 2353 70.6 81.4 91.8 95.5 4.
Table B-8: Overall agreement (%) of SG-YSI paired points within SG ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day, Arm. SG ranges (mg/dL) Number of paired SG-YSI Percent of YSI Percent of YSI Percent of YSI Percent of YSI Percent of YSI within 15/15% of within 20/20% of within 30/30% of within 40/40% of greater than SG (%) SG (%) SG (%) SG (%) 40/40% of SG (%) Overall 10771 84.3 91.6 97.3 99.1 0.9 ≥40–60* 503 77.1 87.5 96.6 99.6 0.4 >60–80* 1291 89.3 93.
Table B-10: The number and percentage of YSI values collected when CGM displays "Below 40 mg/dL" (LOW); Calibration every 12 hours.
Table B-14: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration every 12 hours, Abdomen Percent of matched pairs in each YSI glucose range for each SG range (mg/dL) SG ranges Number (mg/dL) of paired SG-YSI YSI Glucose Range (mg/dL) <40 ≥40–60 0.0% (0/0) 50.0% (77/154) B) ≥40–60 781 1.2% (9/781) C) >60–80 1350 0.2% (3/1350) 8.3% (112/ 1350) D) >80–120 2953 0.
Table B-15: Concurrence of YSI values and SG readings using SG ranges on FST Day 1; Calibration every 12 hours, Abdomen Percent of matched pairs in each YSI glucose range for each SG range (mg/dL) SG ranges Number (mg/dL) of paired YSI Glucose Range (mg/dL) <40 SG-YSI ≥40–60 >60–80 >80–120 >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 2.7% (18/662) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 56.3% 33.8% (290/515) (174/515) 3.3% (17/515) 0.4% (2/515) 0.0% (0/0) 52.6% 35.
Table B-16: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day, Abdomen. Percent of matched pairs in each YSI glucose range for each SG range (mg/dL) SG ranges Number (mg/dL) of paired SG-YSI YSI Glucose Range (mg/dL) <40 ≥40–60 >60–80 >80–120 >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 >400 65 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 18.
Table B-18: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration every 12 hours, Arm. Percent of matched pairs in each YSI glucose range for each SG range (mg/dL) SG ranges Number (mg/dL) of paired SG-YSI YSI Glucose Range (mg/dL) <40 ≥40–60 >60–80 1.0% 41.9% 51.7% (5/520) (218/520) (269/520) >80–120 >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 >400 5.4% (28/520) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Table B-19: Concurrence of YSI values and SG readings using SG ranges on FST Day 1; Calibration every 12 hours, Arm. Percent of matched pairs in each YSI glucose range for each SG range (mg/dL) SG ranges Number (mg/dL) of paired SG-YSI YSI Glucose Range (mg/dL) <40 ≥40–60 >60–80 >80–120 >160– >200– >250– >300– >350– 160 200 250 300 350 400 >400 63.9% (227/ 355) 27.0% (96/355) 0.8% (3/355) 0.0% (0/0) 0.0% (0/0) 10.9% 65.7% (19/175) (115/175) 21.1% (37/175) 2.3% (4/175) 0.
Table B-20: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day, Arm. Percent of matched pairs in each YSI glucose range for each SG range (mg/dL) SG ranges Number (mg/dL) of paired SG-YSI K) >400 8 YSI Glucose Range (mg/dL) <40 0.0% (0/0) ≥40–60 0.0% (0/0) >60–80 0.0% (0/0) >80–120 0.0% (0/0) >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Tables B-22 and B-23 show the percent agreement rates post calibration for sensors inserted into the abdomen. Performance when sensors are inserted in the arm is at least comparable to results when sensors are inserted in the abdomen. Table B-22: Agreement rates for every 2-hour period post calibration period; Calibration every 12 hours, Abdomen.
Table B-24: Trend accuracy; Calibration every 12 hours, Abdomen. Percent of Matched Pairs-in Each YSI Rate-of-Change Range for Each SG Rate-of-Change Range YSI Rate-of-Change Ranges (mg/dL/min) SG Rate-of- Number of <-2 Change Range Paired SG-YSI [-2, -1] [-1, 0] 40.1% (65/162) 20.4% (33/162) [0, 1] [1, 2] >2 (mg/dL/min) A) <-2 162 38.3% (62/162) B) [-2, -1] 1001 4.8% (48/1001) 39.9% (399/1001) 51.3% (514/1001) 0.6% (1/162) 0.6% (1/162) 0.0% (0/162) 3.7% (37/1001) 0.3% (3/1001) 0.
Sensor life After the first successful calibration, 72.3% of sensors worn operated more than six days and up to the full seven days of wear (144 to 168 hours). The mean functional sensor life for sensors worn in the abdomen insertion site over the course of the study was 144.2 hours, with a median functional life of 167.6 hours. C.
The device will always alert the user when the CGM system reads that the user is below 50 mg/dL, regardless of the high threshold, low threshold, or predictive alerts that the user sets. Glucose TRUE Alert Rate The glucose true alert rate is the rate at which the BG confirmed that the CGM alert was triggered correctly. For example: True Threshold Hypoglycemic alert rate alerted when the CGM system read that the user was below the low threshold and the user’s BG was actually below that low threshold.
Table C-1: Glucose TRUE Alert Performance using Calibration every 12 hours Glucose TRUE Alert Rate mg/dL Insertion Site Threshold Only 30 min 50 60 15 min Predictive Only 30 min 15 min Threshold & Predictive 30 min 15 min Abdomen 25.0% 25.0% 15.2% 12.3% 18.2% 16.2% Arm 36.8% 36.8% 21.9% 16.7% 26.1% 22.4% 51.9% 40.7% 37.1% 46.2% 43.4% 69.0% 67.8% 47.5% 45.6% 55.1% 53.5% 70 Abdomen 66.9% 66.9% 52.7% 47.7% 58.3% 55.2% Arm 77.4% 75.3% 57.4% 54.5% 65.6% 63.
The false alert rate is important because it is necessary that users be correctly notified when their BG is low (or high) so that they can correct the low (or high) BG. A low false alert rate indicates that when the CGM system says that their glucose values are, or will reach a specified threshold, the user’s BG is likely to be at or approaching that threshold. For example, per the following table, the high glucose threshold alerts would have incorrectly indicated that the user was above (i.e.
Glucose detection rates are important because it is necessary that users be notified when their BG is low (or high) so that they can correct the low (or high) BG. A high glucose correct detection rate indicates that users can have confidence that they will be notified by the device if their BG is low or high. Glucose Correct Detection Rate mg/dL Insertion Site Threshold Only 30 min 50 60 15 min Predictive Only 30 min 15 min Threshold & Predictive 30 min 15 min Abdomen 64.0% 64.0% 76.0% 68.
Missed detection rates are important because it is necessary that users be notified when their BG is low (or high), so that they can correct the low (or high) BG. A low missed detection rate indicates that users can have confidence that they will be notified by the device if their BG is low or high.
aged 7 to 13 years of age diagnosed with type 1 diabetes mellitus and who were on pump therapy for more than 6 months prior to screening. All study subjects had an HbA1C less than 10.0% at the time of screening. The second level of SmartGuard technology was the evaluation of Auto Mode, which was accomplished during the 3-month study phase.
to 7.5±0.6 (median 7.5) at the end of study. There was a small change in mean total daily dose of insulin/kg (0.8±0.2 baseline to 0.9±0.2 end of study) and modest increase in weight. Weight gain would also be expected for pediatric patients 7 to 13 years of age as part of the normal growth process. CAUTION: Note that since this study did not include a control group, no claims regarding effectiveness can be made. However, the study does support that the device is relatively safe for use.
Table D-1: Run-In Period Severe Hyperglycemia: Cause Total Infusion set change 9 Occlusion Alarm 3 Infusion set fell out 2 Bent or Kinked Cannula 1 Total 15 Cause ■ Table D-2: Study Period Severe Hyperglycemia: Total 28 Occlusion Alarm 12 Infusion set fell out 7 Bent or Kinked Cannula 5 Infusion set change or safe basal 3 Safe basal 2 Suspend before low suspension 1 Automatic & manual suspensions 1 Unclipped infusion set 1 Internal Battery Connector Resistance 1 Manual suspe
Table D-4: Number of Subjects with Change in HbA1C at Different Baselines HbA1C Change Range Number of Subjects (% of Subjects) with Change in A1C Baseline A1C (%) Decrease >1% Decrease 0 to 1% No Change Increase 0 to 1% Increase >1% 5% ≤ A1C < 6% 0(0.0%) 0(0.0%) 0(0.0%) 1(1.0%) 0(0.0%) 6% ≤ A1C < 7% 0(0.0%) 1(1.0%) 0(0.0%) 9(8.6%) 0(0.0%) 7% ≤ A1C < 8% 3(2.9%) 22(21.0%) 6(5.7%) 16(15.2%) 0(0.0%) 8% ≤ A1C < 9% 9(8.6%) 21(20.0%) 3(2.9%) 4(3.8%) 0(0.0%) 9% ≤ A1C < 10% 4(3.
• The study involved a relatively small number of patients. • There was no control group for comparison purposes. • The amount of time the system was used in the Manual mode was much shorter than the time it was programmed to the Auto Mode. • Additionally, for each subject, the study period lasted only three months.
The SG data collected by the blinded GSRs were retrospectively processed through the real-time CGM algorithm. This is the same algorithm used in the Guardian Connect and pump CGM systems. Thus all data is representative of real-time sensor usage. The CONTOUR NEXT LINK 2.4 Wireless Meter was the study meter used for all calibrations in this study, and was the only meter evaluated with the Guardian Sensor (3) CGM systems. The sensor has not been tested with other meters.
Table E-1: SG MARD Versus YSI (within YSI glucose ranges) YSI Glucose Ranges (mg/dL) Abdomen Insertion Site Calibration every 12 hours Buttock Insertion Site Calibration 3 or 4 times a Calibration every 12 hours Calibration 3 or 4 times a day Number of MARD (%) Paired SG-YSI Number of day MARD (%) Paired SG-YSI Number of MARD (%) Number of Paired SG-YSI MARD (%) Paired SG-YSI 733 10.46 710 9.84 710 9.14 686 8.79 40-60* 4 19.16 2 31.9 7 5.43 7 3.61 61-80* 20 10.59 18 8.
Table E-3: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Day 1; Calibration every 12 hours, Abdomen Percent of SG YSI Glucose Number of Paired Percent of SG Percent of SG Percent of SG Percent of SG Ranges (mg/dL) SG-YSI Within 15/15% of Within 20/20% of Within 30/30% of Within 40/40% of greater than YSI YSI YSI YSI 40/40% of YSI Overall 403 81.9 90.6 96.5 99 1 ≥40-60* 2 100 100 100 100 0 >60-80* 11 63.6 72.7 90.9 100 0 >80-180 196 75.5 84.
Table E-6: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Days 1, 3, and 7; Calibration every 12 hours, Buttock Percent of SG YSI Glucose Number of Paired Percent of SG Percent of SG Percent of SG Percent of SG Ranges (mg/dL) SG-YSI Within 15/15% of Within 20/20% of Within 30/30% of Within 40/40% of greater than YSI YSI YSI YSI 40/40% of YSI Overall 710 84.8 92.3 96.8 98.6 1.4 ≥40-60* 7 100 100 100 100 0 70.6 79.4 94.1 100 0 80.9 89.8 94.9 97.
Table E-9: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Day 1; Calibration 3 or 4 times a day, Buttock Percent of SG YSI Glucose Number of Paired Percent of SG Percent of SG Percent of SG Percent of SG Ranges (mg/dL) SG-YSI Within 15/15% of Within 20/20% of Within 30/30% of Within 40/40% of greater than YSI YSI YSI YSI 40/40% of YSI 1.3 Overall 311 80.7 90.4 95.5 98.7 >60-80* 13 69.2 76.9 100 100 0 >80-180 159 77.4 86.8 92.5 97.5 2.
Table E-13: The number and percentage of YSI values collected when CGM displays "Above 400 mg/dL" (HIGH); Calibration 3 or 4 times a day. CGM Readings Insertion Site HIGH Abdomen CGM-YSI pairs Buttocks >340 >320 >280 >240 <240 Total 0 Cumulative, n 0 0 0 0 0 Cumulative % 0% 0% 0% 0% 0% Cumulative, n 0 0 0 0 0 Cumulative % 0% 0% 0% 0% 0% 0 ■ Concurrence of SG and YSI values The following tables show the percentage of concurring SG readings with FST reference values.
Table E-15: Overall concurrence of YSI values and SG readings using YSI ranges on FST Day 1; Calibration every 12 hours, Abdomen Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose Ranges (mg/dL) SG (mg/dL) Number of Paired SGYSI <40 ≥40–60 >60–80 >80–120 >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 D) >80-120 50 0.0% (0/0) 6.0% (3/50) 8.0% (4/50) 62.0% (31/50) 24.0% (12/50) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Table E-17: Overall concurrence of YSI values and SG readings using YSI ranges on FST Day 1; Calibration 3 or 4 times a day, Abdomen Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose Ranges (mg/dL) SG (mg/dL) Number of Paired SGYSI <40 ≥40–60 >60–80 >80–120 >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 0.0% (0/0) 0.0% (0/0) 55.6% (5/9) 44.4% (4/9) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Table E-19: Overall concurrence of YSI values and SG readings using YSI ranges on FST Day 1; Calibration every 12 hours, Buttock Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose Ranges (mg/dL) SG (mg/dL) Number of Paired SG-YSI <40 ≥40–60 >60–80 >80–120 >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 >400 B) ≥40-60 4 100.0% (4/4) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Table E-21: Overall concurrence of YSI values and SG readings using YSI ranges on FST Day 1; Calibration 3 or 4 times a day, Buttock Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose Ranges SG (mg/dL) Number (mg/dL) of Paired SG-YSI <40 ≥40–60 >60–80 >80–120 >120– >160– >200– >250– >300– >350– 160 200 250 300 350 400 >400 100.0% (4/4) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Table E-23: Agreement rates for every 2-hour period post calibration; Calibration 3 or 4 times a day, Abdomen Time after calibration Number of paired YSI-sensor points Percentage (%) Agreement ±15% ±20% ±30% ±40% >±40% (±15 mg/dL) (±20 mg/dL) (±30 mg/dL) (±40 mg/dL) (±40 mg/dL) 0-2 hours 360 83.3 90.8 97.8 99.4 0.6 2-4 hours 174 83.9 92.5 98.3 100 0 4-6 hours 53 75.5 90.6 98.1 100 0 6-8 hours 64 73.4 82.8 96.9 100 0 8-10 hours 36 75 77.8 83.3 94.4 5.
Table E-26: Trend Accuracy; Calibration every 12 hours, Abdomen SG Rate Ranges Percent of Matched Pairs-in Each YSI Rate Range for Each SG Rate Range (mg/dL/min) YSI (mg/dL/min) Numbered of <-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2 47.4% (9/19) 47.4% (9/19) 0.0% (0/19) 5.3% (1/19) 0.0% (0/19) 0.0% (0/19) 0.0% (0/107) Paired SG-YSI [-2, -1] 107 2.8% (3/107) 31.8% (34/107) 60.7% (65/107) 3.7% (4/107) 0.9% (1/107) [-1, 0] 276 0.7% (2/276) 5.8% (16/276) 71.7% (198/276) 21.
Table E-29: Trend Accuracy; Calibration 3 or 4 times a day, Buttock SG Rate Ranges Percent of Matched Pairs-in Each YSI Rate Range for Each SG Rate Range (mg/dL/min) YSI (mg/dL/min) Numbered of <-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2 Paired SG-YSI [-1, 0] 261 0.0% (0/261) 5.0% (13/261) 71.6% (187/261) 21.1% (55/261) 2.3% (6/261) 0.0% (0/261) [0, 1] 194 0.0% (0/194) 0.5% (1/194) 22.2% (43/194) 62.9% (122/194) 13.4% (26/194) 1.0% (2/194) [1, 2] 94 0.0% (0/94) 0.0% (0/94) 4.
Safety There were no moderate or severe device-related or procedure-related adverse events, device-related or procedure-related serious adverse events, or unanticipated adverse device effects through seven days of use. F. Alert performance for user ages 7 through 13 Predictive alerts notify users that their SG level may soon reach a high or low limit setting. Users may select how early they would like to be notified before their SG level reaches a high limit setting.
True Threshold Hypoglycemic alert rate alerted when the CGM system read that the user was below the low threshold and the user’s BG was actually below that low threshold. True Threshold Hyperglycemic alert rate alerted when the CGM system read that the user was above the high threshold and the user’s BG was actually above that high threshold.
Table F-1: Glucose TRUE Alert Performance using Calibration every 12 hours Glucose TRUE Alert Rate mg/dL Insertion Site Threshold Only Predictive Only Threshold & Predictive 30 min 15 min 30 min 15 min Abdomen 55.0% 55.0% 46.2% 30.8% 47.7% 38.6% Buttock 70.8% 70.8% 58.3% 44.4% 62.5% 53.6% Abdomen 78.4% 78.4% 66.2% 66.2% 70.5% 70.5% Buttock 83.3% 81.3% 64.3% 62.9% 70.6% 68.8% 220 Abdomen 87.5% 87.5% 60.0% 57.8% 68.2% 66.7% Buttock 75.0% 75.0% 51.0% 49.0% 58.
predictive only), or both (threshold and predictive) 21.6%, 33.8%, or 29.5% of the time within 30 minutes (or 21.6%, 33.8%, or 29.5% of the time within 15 minutes) when the user had BG less than 180 mg/dL. Table F-2: Glucose FALSE Alert Performance using Calibration every 12 hours Glucose FALSE Alert Rate mg/dL Insertion Site Threshold Only Predictive Only Threshold & Predictive 30 min 15 min 30 min 15 min 30 min 15 min Abdomen 66.7% 66.7% 87.5% 87.5% 81.8% 81.8% Buttock 75.0% 75.0% 88.
For example, per the following table, when wearing the sensor in the abdomen, the threshold alert, the predictive alert, or both (threshold and predictive) notified the user 100%, 100%, or 100% of the time within 30 minutes (or 100%, 100%, or 100% within 15 minutes) when the user had BG less than 50 mg/dL.
For example, per the following table, when wearing the sensor in the abdomen, the threshold alert, predictive alert, or both alerts (threshold and predictive) did not sound 0%, 0%, or 0% of the time within 30 minutes (or 0%, 0%, or 0% within 15 minutes) when the user had BG less than 50 mg/dL.
diabetes mellitus and who were on pump therapy for more than 90 days prior to screening. All study subjects had an HbA1C less than 10.0% at the time of screening visit. For the first level of SmartGuard technology, the "Suspend before low" feature, subjects 2-6 years of age were set up but did not participate in frequent sample testing. CAUTION: Note that since this study did not include a control group, no claims regarding effectiveness can be made.
Of the 138 adverse events reported through the end of the study period, 39% (N=54) were classified as device related, including glycemic events (severe hyperglycemia) and skin issues (abscess, dermatitis, skin infection at the infusion set site and skin irritation). Of the 54 device-related adverse events, 49 were severe hyperglycemia events that were thought to be device related. There were no procedure related events.
The following table shows the time spent per day in specific glucose ranges during the run-in and study phases by all subjects. Table G-3: Time Spent in Specific Glucose Ranges During the Run-In and Study Phases by All Subjects Glucose Range (mg/dL) Run-In Phase Study Phase Time in Glucose Range (min) Mean±SD 7.5±8.8 7.4±6.5 ≤60 22.4±20.2 21.4±13.6 ≤70 51.9±37.7 49.7±23.7 797.6±191.6 915.5±134.8 >180 590.5±211.1 474.8±142.6 >250 210.6±136.0 153.5±85.4 >300 75.0±70.8 53.5±41.2 >350 23.
Table G-5: Number of Subjects that Spent a Certain Time Range in Each Glucose Range During the Study Phase Time Range Number of Subjects (% of Subjects) in the Glucose Range (mg/dL) Indicated ≤ 50 mg/dL ≤ 60 mg/dL ≤ 70 mg/dL 70 to 180 > 180 mg/dL > 250 mg/dL >300 mg/dL >350 mg/dL mg/dL 4-8 hr 0(0.0%) 0(0.0%) 0(0.0%) 0(0.0%) 18 (39.1%) 7 (15.2%) 0(0.0%) 0(0.0%) 8-12 hr 0(0.0%) 0(0.0%) 0(0.0%) 3(6.5%) 22 (47.8%) 0(0.0%) 0(0.0%) 0(0.0%) 12-16 hr 0(0.0%) 0(0.0%) 0(0.0%) 25 (54.
The use of the Guardian Sensor (3) with the Guardian Link (3) transmitter enables CGM technology. The transmitter transmits sensor glucose values calculated by the real-time algorithm to a primary display device, allowing you to monitor your sensor glucose values. Clinical study description 1. One Guardian Sensor (3) connected to the Guardian Connect Transmitter, which transmitted to the Guardian Connect app, a standalone CGM display device. 2.
Analyzer every 5 to 15 minutes. During the FSTs, the subjects were instructed to calibrate the sensors once every 12 hours, or as requested by the display device. During home use (outside the clinic), subjects were instructed to calibrate both sensors three to four times spread throughout the day. The overall number of subjects that participated in FST procedures on day 1, 3, or 7 were 6, 7, and 8, respectively.
Table H-1: SG MARD Versus YSI or BGM (within YSI glucose ranges) Abdomen Insertion Site YSI Glucose Ranges Calibration every 12 hours (mg/dL) Buttock Insertion Site Calibration 3 or 4 times a day Calibration every 12 hours Calibration 3 or 4 times a day Number of Mean Number of Mean Number of Mean Number of Mean Paired SG-YSI Absolute Paired SG-YSI Absolute Paired SG-YSI Absolute Paired SG-YSI Absolute Relative Relative Relative Relative Difference Difference Difference Differ
Table H-3: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing (FST) Day 1; Calibration every 12 hours, Abdomen YSI Glucose Number of Paired Percent of SG Percent of SG Percent of SG Percent of SG Percent of SG Ranges (mg/dL) SG-YS Within 15/15% of Within 20/20% of Within 30/30% of Within 40/40% of Within >40/40% YSI YSI YSI YSI of YSI ≥40-60* - - - - - - >60-80* - - - - - - >80-180 1 100 100 100 100 0 >180-300
Table H-5: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing Day 1; Calibration 3 or 4 times a day, Abdomen YSI Glucose Number of Paired Percent of SG Percent of SG Percent of SG Percent of SG Percent of SG Ranges (mg/dL) SG-YS Within 15/15% of Within 20/20% of Within 30/30% of Within 40/40% of Within >40/40% YSI YSI YSI YSI of YSI *For glucose ranges ≤ 80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Table H- 8: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing (FST) Days 1, 3, and 7; Calibration 3 or 4 times a day, Buttock YSI Glucose Number of Paired Percent of SG Percent of SG Percent of SG Percent of SG Percent of SG Ranges (mg/dL) SG-YS Within 15/15% of Within 20/20% of Within 30/30% of Within 40/40% of Within >40/40% YSI YSI YSI YSI of YSI >60-80* 12 75 91.7 100 100 0 >80-180 78 78.2 83.3 93.6 96.2 3.
Table H-10: The number and percentage of YSI (or BGM) values collected when CGM displays ‘Below 40 mg/dL’ (LOW); Calibration every 12 hours.
Table H-14: Overall concurrence of YSI (or BGM) values and SG readings using YSI ranges on FST Days 1, 3, and 7; Calibration every 12 hours, Abdomen Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose SG (mg/dL) Ranges (mg/dL) Number <40 ≥40-60 >60-80 >80-120 of >120-16 >160-20 >200-25 >250-30 >300-35 >350-40 0 0 0 0 0 0 >400 Paired SG-YSI C) >60-80 1 0.0% (0/0) 0.0% (0/0) 100.0% (1/1) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Table H- 15: Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Day 1; Calibration every 12 hours, Abdomen Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose SG (mg/dL) Ranges (mg/dL) Number <40 ≥40-60 >60-80 >80-120 of >120-16 >160-20 >200-25 >250-30 >300-35 >350-40 0 0I 0 0 0 0 - - - - - - >400 Paired SG-YSI - - - - - - ■ J) >350-400 Note: For the blank Cells (-), there are no paired points
Table H-17: Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Day 1; Calibration 3 or 4 times a day, Abdomen Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose SG (mg/dL) Ranges (mg/dL) Number <40 ≥40-60 >60-80 >80-120 of >120-16 >160-20 >200-25 >250-30 >300-35 >350-40 0 0 0 0 0 0 >400 Paired SG-YSI D) >80-120 - - - - - - - - - - - - E) >120-160 1 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.
Table H-18. Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Days 1, 3, and 7; Calibration every 12 hours, Buttock Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose SG (mg/dL) Ranges (mg/dL) Number 40 ≥40-60 >60-80 >80-120 of >120-16 >160-20 >200-25 >250-30 >300-35 >350-40 0 0 0 0 0 0 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 100.0% (1/1) >400 Paired SG-YSI 1 0.0% (0/0) 0.
Table H-20. Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day, Buttock Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose SG (mg/dL) Ranges (mg/dL) Number <40 ≥40-60 >60-80 >80-120 of >120-16 >160-20 >200-25 >250-30 >300-35 >350-40 0 0 0 0 0 0 >400 Paired SG-YSI C) >60-80 12 0.0% (0/0) 25.0% (3/12) 33.3% (4/12) 41.7% (5/12) 0.0% (0/0) 0.0% (0/0) 0.
Table H-21. Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Day 1; Calibration 3 or 4 times a day, Buttock Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range YSI Glucose SG (mg/dL) Ranges (mg/dL) Number <40 ≥40-60 >60-80 >80-120 >120-16 >160-20 >200-25 >250-30 >300-35 >350-40 0 0 0 0 0 0 of >400 Paired SG-YSI 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 66.7% (2/3) 0.
Table H-23. Agreement rates for every 2-hour period post calibration period; Calibration 3 or 4 times a day, Abdomen Time after No. paired YSI- calibration sensor points Percentage (%) Agreement ± 15% (± 15 ± 20% (± 20 ± 30% (± 30 ± 40% (± 40 > ±40% (± 40 mg/dL) mg/dL) mg/dL) mg/dL) mg/dL) *There are no paired points in this reference range. So these cells are blank. Table H-24.
Table H-26. Trend Accuracy; Calibration every 12 hours, Abdomen Percent of Matched Pairs-in Each YSI Rate Range for Each SG Rate Range SG Rate Ranges (mg/ YSI (mg/dL/min) dL/min) Number of <-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2 0.0% (0/7) 14.3% (1/7) 14.3% (1/7) 57.1% (4/7) 0.0% (0/7) 14.3% (1/7) Paired SG-YSI [0, 1] 7 (1, 2] 5 0.0% (0/5) 0.0% (0/5) 60.0% (3/5) 20.0% (1/5) 20.0% (1/5) 0.0% (0/5) >2 3 0.0% (0/3) 0.0% (0/3) 33.3% (1/3) 33.3% (1/3) 0.0% (0/3) 33.
Table 29. Trend Accuracy; Calibration 3 or 4 times a day, Buttock Percent of Matched Pairs-in Each YSI Rate Range for Each SG Rate Range SG Rate Ranges (mg/ YSI (mg/dL/min) dL/min) Number of <-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2 0.0% (0/7) 0.0% (0/7) 0.0% (0/7) 0.0% (0/7) 42.9% (3/7) 57.1% (4/7) Paired SG-YSI >2 7 Precision Precision of the System was evaluated by comparing the results from two separate sensors worn on the same subject at the same time.
I. Alert performance for users ages 2 through 6 CGM enables your device to display sensor glucose readings, glucose trend arrows, glucose trend graphs, and sensor glucose alerts (for example, High and Low Limit Threshold alerts, High and Low Predictive alerts, and Rise and Fall rate-of-change alerts). A predictive alert is simply an estimation of a future sensor glucose level compared to the high or low limit setting.
True Threshold Hyperglycemic alert ratealerted when the CGM read that the user was above the high threshold and the user’s blood glucose was actually above that high threshold. True Predictive Hypoglycemic alert ratealerted when the CGM predicted that the user would reach below the low threshold and the user’s blood glucose was actually below that low threshold within 15 or 30 minutes.
Table I-1. Glucose TRUE Alert Performance using Calibration every 12 hours Glucose TRUE Alert Rate mg/dL 220 250 Threshold Only Predictive Only 30 min 15 min Threshold & Predictive 15 min 30 min 15 min Abdomen 100.0% 100.0% 50.0% 50.0% 61.5% 61.5% Buttock 90.0% 85.0% 62.1% 55.2% 70.5% 63.6% Abdomen 100.0% 100.0% 83.3% 83.3% 90.9% 90.9% Buttock 80.0% 73.3% 65.2% 56.5% 70.3% 62.2% Abdomen 60.0% 60.0% 40.0% 40.0% 50.0% 50.0% Buttock 66.7% 66.7% 35.0% 30.0% 42.
For example, per the following table, when wearing the sensor in the buttock, the high glucose threshold alerts would have incorrectly indicated that the user was above (i.e. threshold only), or predicted to reach above the threshold (i.e. predictive only), or both (threshold and predictive) 10.3%, 15.2% or 14.3% of the time within 30 minutes (or 10.3%, 18.2%, or 16.1% of the time within 15 minutes) when the user had blood glucose less than 180 mg/dL. Table I-2.
Glucose detection rates are important because it is necessary that users be notified when their blood glucose is low (or high) so that they can correct the low (or high) blood glucose. A high glucose correct detection rate indicates that users can have confidence that they will be notified by the device if their blood glucose is low or high.
The Missed Detection Rate is the rate that the device did not alert when it should have. For example, the blood glucose was below the hypoglycemic threshold, or above the hyperglycemic threshold, and the device did not sound a threshold or predictive alert. Missed detection rates are important because it is necessary that users be notified when their blood glucose is low (or high), so that they can correct the low (or high) blood glucose.
Appendix A: End user software license agreement
■ End user software license agreement NOTICE TO USER: Certain portions of software contained in this product may be covered by the GNU General Public License, Version 2 or Version 3 (“Open Source”), which can be obtained through the GNU web site at www.gnu.org/copyleft/ gpl.html. The source code for any Open Source can be obtained, for a nominal fee to cover the cost of shipping and media, by contacting Medtronic MiniMed, Inc.
402 Appendix A
Glossary
■ Glossary Glossary active insulin Bolus insulin that has been delivered by the pump and is still working to lower your BG levels. active insulin adjustment The amount of insulin that is subtracted from your BG correction bolus to account for the active insulin that is tracked by the Bolus Wizard feature. Active Insulin Time A Bolus Wizard setting that lets you set the length of time that bolus insulin is tracked as active insulin.
Auto Basal The automatically adjusted basal insulin delivered by Auto Mode based on your SG values. Auto Mode Auto Mode is an insulin delivery feature that automatically controls basal insulin delivery to regulate BG levels to a target SG value. Auto Mode Bolus feature The Auto Mode Bolus feature assists the user in calculating a recommended bolus amount based on optional carbohydrate intake and optional BG measurement. The user may enter one or both of the two optional inputs.
A reminder that you set just after you program a bolus. The reminder tells you to check your BG when the time period that you specified has passed. bolus insulin Insulin used to cover an expected rise in BG levels due to carbohydrates, or to lower a high BG value down to your target range. Bolus Speed A feature that lets you choose the speed at which your device delivers bolus insulin.
energy. This process produces ketones which upset the body's acid-base balance, leading to a potentially life threatening situation. Dual Wave bolus A type of bolus that provides a dose of insulin delivered as a combination of a Normal Bolus followed by a Square Wave bolus. Easy Bolus feature A feature that lets you deliver a Normal Bolus in preset increments using only audio or vibrate confirmation.
Manual Mode refers to system functions other than Auto Mode. In other words, if Auto Mode is not active, the system is in Manual Mode. Max Basal Rate A feature that lets you set the maximum amount of basal insulin that can be delivered per hour. Max Bolus A feature that lets you set the maximum bolus amount that can be delivered in one dose. meter A term for any BG meter.
Resume basal alert An alert that can be set to occur when your pump has automatically resumed basal insulin delivery after a Suspend before low or Suspend on low event because your SG values have met the necessary criteria. This alert always occurs if basal insulin delivery has resumed because the two-hour maximum suspend time has elapsed. Rewind A feature used when you change a reservoir. It returns the piston to its start position and lets a new reservoir be placed into the pump.
This feature stops all insulin delivery until you resume it. Only the basal insulin restarts when delivery is resumed. Suspend on low A feature that suspends insulin delivery when your SG value reaches or falls below your low limit. Temp Basal rate (temporary basal rate) A feature that lets you temporarily increase or decrease your current basal rate for a duration of time that you specify. transfer guard The plastic piece that comes attached to the reservoir.
412 Glossary
Index
accessories 32 active insulin about 96 adjustment 96 clearing settings 164 Home screen 43 injection warning 96 viewing amount 44 Active Insulin cleared alert 245 Active Insulin Time about 91 changing 96 Alarm History 143 alarms about 241 audio options 243 Auto Mode 273 Auto Suspend 245 Battery failed 246 Battery not compatible 246 Bolus not delivered 246 Bolus stopped 246 CGM 262 Critical pump error 247 Delivery limit exceeded 247 emergency siren 243 Fill Cannula? 249 Insert battery 250 Insulin flow blocked
Device not compatible 248 Device not found 249 Lost sensor signal 267 Low battery Pump 254 Low battery transmitter 267 Low reservoir 254 No calibration occurred 269 notification light 243 overview 243 Possible signal interference 270 pump 244, 278 Replace battery 259 Reservoir estimate 260 Rise alert 270 sensor 262 Sensor alert occurred 270 Sensor expired 271 Sensor signal not found 271 silencing 213 Transmitter battery depleted 273 yellow icon 243 areas, for inserting infusion set 126 arrows, trend 212 aud
Easy Bolus 87, 107 Manual Bolus 86, 101 Max bolus setting 87 Normal bolus 98, 101 options 85 preset bolus 86, 110 resume message 260, 261 Square Wave 101 stopping 112 types 83 Bolus Estimate Setup 91 Bolus not delivered alarm 246 Bolus stopped alarm 246 bolus types Dual Wave 84 examples 84 Normal 83 Square Wave 84 Bolus Wizard Active Insulin Time 91 alerts 97 BG target 91 Dual Wave 105 High BG alert 97 injection warning 96 Insulin Sensitivity Factor 91 Low BG alert 97 Max Bolus exceeded alert 98 Normal bolu
carb ratio 94 CareLink Personal Software 146 CareLink uploader not found.
L icons Home Screen 44 sensor status 173 SmartGuard 184 SmartGuard suspend 176 language changing 161 starting 41 light, red 242 Loading incomplete alarm 253 Lost sensor signal alert 267 Low battery Pump alert 254 glucose alerts, silencing 213 graph, sensor 211 Auto Mode 230 H Index Index I G ■ High BG, Bolus Wizard warning 97 High Limit SG setting 178 high SG settings about 177 entering 192 history about 139 ISIG 145 pump settings, viewing 165 summary 139 Home Screen about 43 active insulin amount
Low battery transmitter alert 267 Low BG, Bolus Wizard warning 97 Low limit 179 low management mode summary 142 Low Reservoir alert 153, 254 reminder 153 low SG settings about 178 entering 195 examples 186 M main menu accessing 49 Manage Settings error alarm 255 managing, pump settings 162 Manual bolus Dual Wave 106 Easy Bolus 109 Normal bolus 101 Square Wave 104 Max Basal rate 64 setting 65 max basal alarm 247 Max bolus alarm 247 setting 87 Max Bolus exceeded 98 warning 88 Max Fill reached alarm 255 Menu
P ■ Index pair device 199 pump, meter 134 pump, transmitter 199 patterns, basal about 66 adding 70 changing 70 copying 70 deleting 70 example 66 personal reminder 151 Possible signal interference alert 270 power save mode 58 preset bolus about 110 changing 111 deleting 111 delivering 112 renaming 111 setting up 110 Preset Bolus Dual Wave 110 Square Wave 110 Preset Temp basal rate about 64, 74 editing 75 managing 74 setting up 74 starting 75 previous screen 37 pump alarms 244, 278 alerts 244, 278 buttons 3
Loading incomplete alarm 253 Low Reservoir alert 254 Max Fill reached alarm 255 No reservoir detected alarm 256 ordering 32 plunger rod 121 removal 117 Reservoir estimate at 0 U 260 setting up 117 transfer guard 121 type 30 Reservoir estimate alert 260 restoring, pump settings 163 Resume basal alert 186 Resume bolus message 260 Resume Dual bolus message 260, 261 Resume Square bolus message 261 resuming SmartGuard suspended delivery 78 resuming suspended delivery 186, 198 return to previous screen 37 returni
Index 423 Index SmartGuard about 172 Auto Mode 219 icon 176, 184 SmartGuard suspend features and Auto Mode 223 SmartGuard suspended delivery, resuming manually 78 Square Wave 84 about 101 Bolus Wizard 102 example 84 Manual bolus 104 resume message 260, 261 setting up 102 starting sensor 203 Startup Wizard about 41 re-entering settings 286 using 41 status 50 status bar about 44 audio mode 46 Auto Mode Readiness icon 49, 175 Block Mode 49 CGM, with 173 CGM, without 43 Connection icon 47 icons 45 insulin am
stopping bolus 112 insulin delivery 78 storage mode 294 Stuck button alarm 262 summary screen about 139 basal 140 BG meter readings 142 bolus 140, 141 overview 140 total carbs 140 total daily dose 140 viewing 140 supplies, ordering 32 Suspend before low about 179 examples 189, 190 unavailable 181 Suspend on low about 183 example 191 unavailable 184 suspended delivery, resuming automatically 186 manually 198 suspending insulin delivery 78, 159, 179, 183 system security 27 T temp basal rate about 72 percent
M998590A011_A
TM MiniMed 770G
SYSTEM USER GUIDE
MiniMed™ 770G SYSTEM USER GUIDE
Copyright & trademarks © 2019 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. Bolus Wizard™, CareLink™, Dual Wave™, Guardian™, MiniLink™, MiniMed™, Mio™, Quick-set™, Silhouette™, SmartGuard™, Square Wave™, and Sure-T™ are trademarks of Medtronic MiniMed, Inc. ACCU-CHEK and ACCU-CHEK GUIDE are trademarks of Roche.
Contacts: Africa: Medtronic South Africa and Southern Africa Office Reception Tel: +27(0) 11 260 9300 Diabetes: 24/7 Helpline: 0800 633 7867 Sub-Sahara 24/7 Helpline: +27(0) 11 260 9490 Albania: Net Electronics Albania Tel: +355 697070121 Argentina: Corpomedica S.A. Tel: +(11) 4 814 1333 Medtronic Directo 24/7: +0800 333 0752 Armenia: Exiol LLC Tel: +374 98 92 00 11 or +374 94 38 38 52 Australia: Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 Bangladesh: Sonargaon Healthcare Pvt Ltd.
Lithuania: Monameda UAB Tel: +370 68405322 Helpline: +370 68494254 Republic of Korea: Medtronic Korea, Co., Ltd. Tel: +82.2.3404.3600 Macedonia: Alkaloid Kons Dooel Tel: +389 23204438 Romania: Medtronic Romania S.R.L Tel: +40372188017 Helpline: +40 726677171 Magyarország: Medtronic Hungária Kft. Tel: +36 1 889 0688 Malaysia: Medtronic International Ltd. Tel: +603 7946 9000 Middle East and North Africa: Regional Office Tel: +961-1-370 670 Montenegro: Glosarij d.o.o.
Warranty The expected life of the MiniMed insulin pump is a maximum of 4 years. Medtronic Diabetes warrants the MiniMed insulin pump against defects in materials and workmanship for a period of 4 years from the date of purchase. During the warranty period, Medtronic Diabetes will, at its discretion, replace (with a new or recertified pump, at Medtronic Diabetes’ discretion) any defective pump or motor, subject to the conditions and exclusions stated herein.
Contents ■ ■ Contents Before you begin 3 Using this user guide 5 Acronyms and abbreviations 6 Emergency kit 7 User safety 7 Indications 8 Guardian Sensor (3) 8 One-press Serter 8 Guardian Link (3) Transmitter 8 Accu-Chek Guide Link Blood Glucose Monitoring System 9 Contraindications 10 Potential risks 13 General warnings 25 General precautions 27 Security precautions 29 Adverse reactions 29 Keeping track of your system information 29 Insulin guidelines 30 Consumables 3
■ ■ First steps 35 Your pump 36 Using the buttons 37 About batteries 38 Inserting the battery 39 Removing the battery 40 Getting to know your pump 41 Entering your startup settings 43 Unlocking your pump 43 Home screen 44 Status icons 49 Using the menu 50 Status screens 52 Modes 53 Manual Mode 56 SmartGuard Auto Mode 57 Scroll bar 58 Power modes 58 If you remove your pump Basal viii 63 Basal rate 64 Basal insulin settings 65 Max Basal rate 65 Example 1: Max bas
71 Temp basal rates 72 About temp basal rates 73 Example 1: Temp basal rates 73 Starting a temp basal rate 74 Preset temp basal rates 77 Canceling a temp basal or preset temp basal rate 77 Viewing your basal information 78 Stopping and resuming your insulin delivery Contents Example 2: Basal patterns ■ ■ 71 Bolus 83 About bolus deliveries 83 Bolus types 84 Bolus type example 85 Bolus delivery options 87 Bolus settings 88 Max bolus 89 Example 1: Max bolus 89 Example 2: Max
■ ■ ■ 102 Turning on or off the Square Wave bolus feature 102 Delivering a Square Wave bolus with the Bolus Wizard feature 104 Delivering a Square Wave bolus using Manual Bolus 104 Dual Wave bolus 105 Turning on or off the Dual Wave bolus feature 105 Delivering a Dual Wave bolus with the Bolus Wizard feature 106 Delivering a Dual Wave Bolus using Manual Bolus 107 Easy Bolus feature 108 Understanding the Easy Bolus step sizes 108 Setting up the Easy Bolus feature 109 Delivering a bolu
■ 144 Using SG Review 145 ISIG History 146 Event Markers Reminders 151 Personal reminders 152 Bolus BG Check reminder 153 Missed Meal Bolus reminder 153 Low Reservoir reminder 154 Set Change reminder 155 Calibration reminder Contents ■ Alarm History ■ ■ 143 General settings 159 Audio Options 159 Auto Suspend 160 Block Mode 161 Display Options 161 Language 162 Managing your pump settings 166 Upload to CareLink software 166 Self Test 167 Sensor Demo 168 Time and dat
■ ■ 192 Turning on the Sensor feature 192 Setting up the high SG settings 195 Setting up the low SG settings 198 Manually resuming basal delivery during a SmartGuard suspend event 199 Pairing your pump and transmitter 202 Deleting the transmitter from your pump 202 Inserting the sensor 203 Connecting the transmitter to the sensor 203 Starting the sensor 204 Reconnecting the sensor 204 Calibrating your sensor 205 Where to enter your calibration BG meter reading 206 When to calibrat
226 Safe Basal 228 Example: Safe Basal 228 Block Mode when in SmartGuard Auto Mode 228 Setting Temp Target 230 SmartGuard Auto Mode sensor graph 231 Enter BG 232 SmartGuard Auto Mode Bolus 234 Alert Silence 237 Exiting SmartGuard Auto Mode 237 Returning to SmartGuard Auto Mode Contents ■ Using SmartGuard Auto Mode ■ ■ 226 Alarms, alerts, and messages 241 About alarms, alerts, and messages 242 Alarms 243 Alerts 244 Messages 244 Pump alarms, alerts, and messages 262 CGM (s
■ ■ 288 Troubleshooting sensor issues 288 My pump cannot find the sensor signal 289 Calibration not accepted 289 Why does the SmartGuard suspend icon on my Home screen appear gray? Maintenance 293 Cleaning your pump 294 Cleaning your transmitter 294 Storing your pump 295 Storing your transmitter 295 Pump disposal Product specifications and safety information xiv 299 Product specifications 299 Alarm and alert escalation 300 Altitude range 300 Audio frequency 301 Backlight 302
Insulin delivery default settings 310 Insulin sensitivity factor 310 Low Reservoir reminder 311 Max Bolus 311 Normal bolus 311 Occlusion detection 312 Percent temp basal 312 Program safety checks 312 Pump dimensions 312 Pump memory 312 Pump weight 312 Sensor default settings 315 Wireless communication 315 FCC notice 316 IEC60601-1-2:4th Edition notice 316 IEC60601-1-2:4th Edition; Special EMC Precautions for Medical Electrical Equipment 316 IEC60601-1-2:4th Edition; 5.2.1.
■ 376 H. Guardian Sensor (3) Performance in users ages 2 through 6 393 I.
Before you begin
■ This user guide is designed to help you understand the operation of the MiniMed 770G System with Bluetooth wireless and SmartGuard technology, our latest advancement in diabetes management. In the MiniMed 770G System, SmartGuard technology can automatically adjust insulin delivery based on your sensor glucose (SG) values. The system can be used in two modes: Manual mode and SmartGuard Auto Mode. Work closely with your healthcare professional when you start insulin pump therapy.
Convention What it means Press To push and then release a button. Press and hold To push and keep pressure on a button. Bold text To indicate screen items and buttons. For example, "Select Next to continue." X To indicate a numeric value or name that appears differently on your pump screen. Note Note: A note provides helpful information. Caution CAUTION: A caution tells you of a potential hazard which, if not avoided, may result in minor or moderate injury or damage to the equipment.
Device For instructions see Meter Accu-Chek® Guide Link User's Manual Acronyms and abbreviations The following table defines acronyms and abbreviations used in this guide.
Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Tell a family member, co-worker, or friend where you keep your emergency kit. It is important that you test your blood glucose (BG) more frequently while you travel. The routine hassle of travel, including stress, changes in time zones, schedules and activity levels, meal times and types of food, can all affect your diabetes control.
WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode. ■ Before you begin For details on pump safety, see User safety, on page 7.
WARNING: Do not use the Suspend on low feature to prevent or treat low glucose. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional to treat low glucose. Using Suspend on low alone to prevent or treat low glucose may result in prolonged hypoglycemia. Guardian Sensor (3) The Guardian Sensor (3) is intended for use with the MiniMed 770G system to continuously monitor glucose levels in persons with diabetes.
The Accu-Chek Guide Link Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes The Accu-Chek Guide Link Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosing or screening for diabetes mellitus and not for neonatal use. ■ Alternative site testing should be done only during steaty-state times (when glucose is not changing rapidly).
Potential risks Risks related to insulin pump infusion set General risks related to insulin pump infusion set may include: • Localized infection • Skin irritation or redness • Bruising • Discomfort or pain • Bleeding • Irritation • Rash • Occlusions that can interrupt insulin delivery and lead to hyperglycemia or diabetic ketoacidosis Patients should be instructed to follow the provided user guides for insertions and care of infusion sets.
• Bleeding • Pain • Rash • Infection • Raised bump • Appearance of a small "freckle-like" dot where needle was inserted • Allergic reaction • Fainting secondary to anxiety or fear of needle insertion • Soreness or tenderness • Swelling at insertion site • Sensor fracture, breakage or damage • Minimal blood splatter associated with sensor needle removal • Residual redness associated with adhesive, tape, or both • Scarring Before you begin Redness ■ • Specific risks related to
For persons that are fourteen years of age and older, sensor placement and insertion has been studied in the belly (abdomen) and back of upper arm only and is not approved for other sites. Specific risks related to meter use • Do not use the meter at high hematocrit levels above 65% or low hematocrit levels below 10%. • Not for use in diagnosis or screening of diabetes mellitus. • Not for neonatal use.
General warnings Pump • Always use the fingertip for blood samples used for calibrating the sensor while in Auto Mode. The fingertip was the only site studied for use with Auto Mode. Do not use blood samples from the palm to calibrate the sensor as this site was not studied for use with Auto Mode and the performance of the system is not known. • Always use the values from your BG meter for treatment decisions. The MiniMed 770G system CGM does not replace a BG meter to make treatment decisions.
buttons. Remove the pump and begin using your backup insulin plan per the direction of your healthcare professional. If the pump is accidentally programmed while the screen is broken or unreadable, this could result in high or low BG levels. If your screen is damaged, contact 24-Hour Technical Support to arrange for shipment of a replacement pump. • Only use rapid-acting U-100 insulin (Humalog and NovoLog) that has been prescribed by your healthcare professional for use with an infusion pump.
• Do not change or modify the MiniMed reservoir or the MiniMed infusion set unless expressly approved by Medtronic Diabetes. Modifying the devices can cause serious injury, interfere with your ability to operate the device, and void your warranty. • Do not rely on preset pump alarms or reminders alone to prompt you to check your BG. This can cause you to forget to check your BG. Set additional reminders on other devices, such as your cell phone.
radiate radio frequency energy and, if not installed and used in accordance with the provided instructions, may cause harmful interference to radio communications. • Portable and mobile RF communications equipment can affect Medical Electrical Equipment as well. If you encounter RF interference from a mobile or stationary RF transmitter, move away from the RF transmitter that is causing the interference.
professional know if any of these conditions apply to you so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks. • For the most current warnings, see the user guide that came with your device. • Only use rapid-acting U-100 insulin (Humalog and NovoLog) that has been prescribed by your healthcare professional for use with an infusion pump. Do not put any other drugs or medications inside your reservoir for use with this pump.
• Dispose of transfer guard safely in sharps container. • Never prime the set or attempt to free a clogged line while the set is inserted. You may accidentally inject too much medication. • Do not put disinfectants, perfumes, or deodorants on the infusion set as these may affect the integrity of the set. • Dispose of the infusion set and introducer needle safely, in a sharps container, after a single use. Do not clean or re-sterilize. • Store infusion sets in a cool, dry place.
• Do not use if package has been opened or damaged. • Ensure sterility by checking that the sterile paper and tamper-proof seal are not damaged. • This device is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use if the package has been opened or damaged. Do not use the infusion set if the tubing connector needle has been damaged. • Do not use the infusion set for more than three days.
• Keep the serter away from children. This product contains small parts and may pose a choking hazard. • A retractable needle is attached to the sensor and minimal blood splatter may occur. If you are a healthcare professional or caregiver, wrap sterile gauze around the sensor to minimize contact with blood. Keep as much distance as possible between you and the patient when removing the needle. • Do not attempt to remove the sensor yourself if you suspect that the sensor is broken.
• Watch for bleeding at the insertion site (under, around, or on top of the sensor). If bleeding occurs, do the following: Apply steady pressure, using sterile gauze or a clean cloth placed on top of the sensor, for up to three minutes. The use of unsterile gauze can cause site infection. b. If bleeding stops, connect the transmitter (or recorder) to the sensor.
• Do not use the transmitter adjacent to other electrical equipment which may cause interference with the normal system operation. This includes mobile communication devices such as cell phones, GPS navigation systems, and other devices that have an output transmitter power greater than 1W. Other electrical equipment that may compromise normal system operation has been contraindicated. • Do not change or modify the device unless expressly approved by Medtronic Diabetes.
• If your blood sugar reading is over 250 mg/dL, wash and dry your hands well and repeat the test with a new strip. If you get a similar result, call your healthcare professional as soon as possible. • About whether Alternate Site Testing (AST) is appropriate for you. When BG is changing rapidly (after a meal, insulin dose, or exercise). • If you have hypoglycemic unawareness (lack of symptoms). • If you get alternate site BG results that do not agree with how you feel.
• Use a new lancet each time you test because it is no longer sterile after use. • Always dispose of test strips and lancets as medical waste or as advised by your healthcare professional. All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.
Do not expose your pump to a magnet, such as pump cases that have a magnetic clasp. Exposure to a magnet may interfere with the motor inside the pump. Damage to the motor can cause the device to malfunction, and result in serious injury. • Always carry the Medical emergency card provided with your device when you are traveling. The Medical emergency card provides critical information about airport security systems and pump use on an airplane, which can help you and others.
Electrostatic discharge • Although the MiniMed 770G insulin pump is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in a reset of the pump's software and a pump error alarm. After clearing the alarm, verify that your pump is set to the correct date and time, and that all other settings are programmed to the desired values. The software reset could erase your previously programmed settings.
Infusion sets and sites Always refer to the infusion set user guide for all precautions, warnings, and instructions relating to the infusion set and your insertion sites. Not referring to the infusion set user guide can result in minor injury or damage to the infusion set. Sensor Always refer to the transmitter user guide for all precautions, warnings, and instructions relating to the transmitter. Not referring to the transmitter user guide can result in minor injury or damage to the transmitter.
• Be attentive to pump notifications, alarms, and alerts because they may indicate that someone else is trying to connect to or interfere with the device. • Disconnect the Blue adapter from the computer whenever it is not being used. • Use good cyber security practices; use anti-virus software and keep computer software up to date. • Refer to the MiniMed Mobile App User Guide for information on how to keep the compatible mobile device safe to use with the Medtronic devices.
Adverse reactions Always refer to the sensor user guide for adverse reactions related to the sensor. Not referring to the sensor user guide can result in minor injury or damage to the sensor. Keeping track of your system information ■ The serial number (SN) is located on the back of your pump. If you are using the pump clip, you need to remove the pump clip to view the serial number. It also displays in your Pump status screen. For more details on the status screens, see Status screens, on page 50.
WARNING: Only use rapid-acting U-100 insulin (Humalog and NovoLog) in the MiniMed 770G insulin pump. Use of the incorrect insulin, or insulin with a greater or lesser concentration, may result in over delivery or under delivery of insulin. Over delivery or under delivery of insulin may result in high or low blood glucose levels. High blood glucose levels may lead to diabetic ketoacidosis. Low blood glucose levels may lead to coma or death.
The following table lists the compatible infusion sets. The MMT numbers may change if other compatible infusion sets become available.
Refer to the app user guide for setup and operation. This product should only be used with supported mobile devices. Refer to your local Medtronic Diabetes website for information about supported devices and operating systems. • Blue adapter (ACC-190)–uploads system data to CareLink software through a USB port on your computer. Refer to the CareLink software user guide for setup and operation of the blue adapter. Accessories The following accessories may be used with the MiniMed 770G System.
First steps
■ This chapter gives you an overview of your pump so you can become familiar with the buttons and screens. Read this entire chapter to understand the basic features before using your pump to deliver insulin. Your pump The following illustration shows the different parts of your pump. The reservoir, with the tubing connector attached, is inserted into the reservoir compartment.
Using the buttons CAUTION: Do not use sharp objects to press the buttons on your pump. The use of sharp objects can damage your pump. The following picture shows the buttons and the notification light on your pump. The notification light flashes when your pump has an alarm or alert. The notification light is not visible unless it flashes. up back graph; sleep mode right left select notification light down The following table describes how to use the buttons.
To do this: Follow these steps: Scroll up or down a menu or list, or increase or decrease the value of a setting. Press the Select an item on a screen or menu. Press the item, and then press the Enter a value into a field. Press the or , , , or , , or buttons to select the desired buttons to select the desired or buttons to enter the desired value, and then press the Return to the previous screen. Press the Display the Home screen. Press and hold the button. The field you select button.
CAUTION: Do not use a carbon zinc battery in your pump. Carbon zinc batteries are not compatible with the pump. Use of carbon zinc batteries can cause the pump to report inaccurate battery levels. Carbon zinc batteries have a short shelf life, they deteriorate rapidly in cold weather, and oxidation of the zinc wall eventually causes the contents to leak out. They will not perform as well as other battery types to power the pump and may potentially damage your pump.
2. Place the battery cap onto the pump. Use the bottom edge of the pump clip to turn the cap to the right and tighten. ■ CAUTION: Do not overtighten or undertighten the battery cap. Overtightening the battery cap can cause damage to your pump case. Undertightening the battery cap will prevent the pump from recognizing the new battery. Turn the battery cap clockwise until the cap is aligned horizontally with the pump case, as shown in the following example.
