Welcome to CareLink Pro

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1 Reference Guide

2 Welcome to CareLink Pro This guide was developed to serve as a reference for obtaining patient data and reviewing CareLink Pro reports. Getting Started with CareLink Pro Adding New Patients and Obtaining Patient Data... Generating CareLink Pro Reports... CareLink Pro Report Overview Therapy Management Dashboard... 8 Episode Summary Adherence Report... Sensor & Meter Overview Report: Sensor Overlay... Sensor & Meter Overview Report: Statistics and Meter Overlay Sensor & Meter Overview Report: Daily Snapshots... Logbook Report... Device Settings Snapshot... Daily Detail Report

3 Adding New Patients and Obtaining Patient Data Adding a New Patient To obtain patient data, you will first need to establish a new patient profile in the CareLink Pro system. To add a new patient: Select File > New Patient or click the Add Patient icon. The Patient Profile will display. Complete the fields in the Patient Profile section. Click SAVE. Obtaining Patient Data There are two options for obtaining patient data in CareLink Pro linking to your patient s CareLink Personal account or uploading your patient s device data in your office. Option : Linking to Your Patient s CareLink Personal Account CareLink Personal Software allows patients to upload their device data to a personal computer. With CareLink Pro and your patient s authorization, you can link to CareLink Personal to receive your patient s data, thus reducing the need to upload device data in your office.* STEP : Ensure you are connected to the Internet. STEP : Select File > Open Patient or click the Open Patient icon. STEP : Double-click the Patient s Name or select the patient s name and click Open. * Note: The patient needs to have established a CareLink Personal account prior to linking. If the patient does not yet have a CareLink Personal account, they can establish one at Getting Started with CareLink Pro I

4 Obtaining Patient Data STEP : Click Profile. STEP : Click LINK TO EXISTING ACCOUNT. The CareLink Personal login screen will display. STEP : Ask your patient to do the following: a. Enter his or her CareLink Personal Account Username and Password. b. Click Sign In. A grant access page is displayed. c. Read the Terms of Use. Click the check box next to I agree to the Terms of Use above. d. Click Grant Access. a b e. Inform you when the Thank You page is displayed. e Note: To obtain new patient CareLink data at future appointments, open the patient, go directly to the Reports section, and click the SYNC DATA icon. I Getting Started with CareLink Pro c d

5 Obtaining Patient Data Option : Uploading in Your Office The other way to obtain patient data is to upload from the patient s device directly to CareLink Pro in your office. To do this, you will need the patient s device and any additional cables or communication devices needed to upload the patient s data. STEP : Select File > Open Patient or click the Open Patient icon. STEP : Double-click the Patient s Name or select the name and click OPEN. Note: The patient must have a saved Profile in the system to add a patient device. STEP : Set up the patient s device to communicate with your computer using the appropriate connectivity device (e.g. CareLinkUSB, serial connection, etc.). Getting Started with CareLink Pro I

6 Obtaining Patient Data STEP : To add a new device, click ADD DEVICE and follow the on-screen instructions. STEP : Find the device you want to obtain data from on the Active Devices list. Ensure the Choose port field is correct. For pumps, click the Amount of Data dropdown menu and select the amount of data you want to receive. STEP : Click the associated READ DEVICE button. STEP : Follow the device-specific instructions and then click OK. STEP 8: When the system finishes reading data from the device, you will see a message that confirms that the device was read. Click OK and follow the on-screen instructions to take the pump out of suspend mode. Note: For further information on obtaining patient data, reference Chapters,, and in the CareLink Pro User Guide (available in the CareLink Pro software). I Getting Started with CareLink Pro

7 Generating CareLink Pro Reports To generate CareLink Pro reports: Select File > Open Patient or click the Open Patient icon. Double-click the Patient s Name or select the name and click Open. The Reports workspace is displayed. Step : Specify Reporting Period and Data Sources To select the reporting period to review, In the data calendar area, the blue bars click the Duration drop-down menu and represent device information that is available select the amount of time to review (the and the orange block represents the maximum amount of time to select is reporting period you have selected. weeks of data). Be sure to verify that patient information is To select a custom date range, click the available for the dates you have selected and From and Through drop-down menus to then click NEXT. select your desired date range. Getting Started with CareLink Pro I

8 Generating CareLink Pro Reports Step : Verify Report Settings When setting up a patient for the first time, the report settings will be programmed to their defaults. These settings can be individualized for each patient and can be saved for future reports. Set the Glucose Target (mg/dl) values by Adjust the meal period settings by clicking typing the desired target values or clicking on the meal name bar and entering text or the up or down arrows. clicking the up or down arrows in the bottom section of the screen. In the Analysis Periods section, set the bedtime, wake-up, and meal periods by To add a new meal period, click ADD MEAL. dragging their respective edges. Enter the meal name, meal time period, pre- and post-meal targets, and analysis periods. To save the patient settings, click SAVE CHANGES. Click NEXT. I Getting Started with CareLink Pro

9 Generating CareLink Pro Reports Step : Select and Generate Reports Select the check box next to the report(s) In the Daily Detail section, select the check you want to include in the report set. box next to dates you would like to review. Note: To generate the Dashboard & Episode Summary, a minimum of five days of pump and sensor data are required. To include all Daily Detail report dates, select the check box in yellow at the top of the data table. Guardian and sensor data without pump data are not supported. The report check box will not be available if one of these conditions exist. After you verify your report selections, click GENERATE REPORTS. Reports can be viewed in the software, printed, and/or saved in PDF and TIFF formats. Getting Started with CareLink Pro I

10 NEW Therapy Management Dashboard Sensor Overlay* Displays sensor glucose tracings to assist in identifying excursions and/or patterns. Insulin Profile Graph Displays -hour insulin delivery information. The solid green line represents the basal profile at the end of the reporting period. The dashed green line represents the average active daily bolus insulin based on the active insulin time set in the patient s device. Provides a summary of the patient s glucose control, insulin profiles, patterns, and statistics for the reporting period. Therapy Management Dashboard //00 - //00 -Hour Analysis Sensor, Insulin, & Settings Sensitivity and Carb Ratio Section Displays sensitivity factors and carbohydrate ratios over hours based on the most recently programmed device settings. Basal Rate Bolus Insulin Bedtime to Wake-up Bedtime: 8:00 PM - :00 AM Wake-up: :00 AM - 9:00 AM Breakfast: :00 AM - 0:00 AM () Pre-meal SG Avg: ± mg/dl Post-meal SG Avg: 8 ± 8mg/dL Avg Carbs: 8 ± g Avg Food Bolus:. ± 0.U Bedtime to Wake-up Sensor Overlay* Displays sensor tracings from bedtime to wake-up to help identify overnight patterns. Meal Sensor Overlay* Realigns sensor tracings around meals (at the time carbohydrates are entered into the Bolus Wizard ) to assess pre- and postmeal control. * Most recent pump settings are displayed 0 Action Plan Note: To obtain the Therapy Management Dashboard, a minimum of five days of pump and sensor data are required. *Targets determined by provider during report setup Below Target* 8 I CareLink Pro Report Overview Above Target* Target Sensor Glucose Range*

11 Statistics Table Shows key summary statistics over the reporting period. Estimated AC is calculated using average sensor glucose data in the reporting period. Data Sources: Paradigm Revel - Statistics Avg BG Estimated AC BG Readings Carbs Entered ± mg/dl.9%.8 per day ± g per day Hypoglycemic Patterns Table* Provides the number of hypoglycemic patterns identified, the time period in which the patterns occurred, and the number of episodes that occurred during each time period. The top three patterns are shown and they are listed based on the frequency of episodes. Hypoglycemic Patterns ()** 9: PM-:9 AM () Time Period : PM-8:9 PM () Bolus Insulin (U, active hr) : AM-:0 AM () Lunch: :00 AM - :00 PM () Pre-meal SG Avg: ± mg/dl Post-meal SG Avg: ± 9mg/dL Avg Carbs: 0 ± g Avg Food Bolus:. ±.U 8 Hyperglycemic Patterns () : AM-: AM Time Period 9 Pump Use 9: AM-0:0 AM Per Day Insulin TDD.0 ±.U Basal/Bolus Ratio 8 / 8 Manual Boluses 0.0U (0.0 boluses) Bolus Wizard.0U (8.8 boluses) Food.U (. boluses) Correction.U (.9 boluses) Override (+) 0.U (0. boluses) Override (-) -0.U (0. boluses) Dinner: :00 PM - 0:00 PM () Pre-meal SG Avg: ± mg/dl Post-meal SG Avg: 9 ± mg/dl Avg Carbs: ± g Avg Food Bolus:.8 ± 0.9U Suspend Duration 0m per day Res./Site Change Every. /. days Hyperglycemic Patterns Table* Provides the number of hyperglycemic patterns identified and the time period in which the patterns occurred. The top three patterns are shown and they are listed based on the magnitude of AUC (Area Under the Curve) above target. 9 Sensor Use Avg SG Wear Duration Pump Use and Sensor Use Tables Displays key pump and sensor statistics over the reporting period. ± mg/dl d h per week Low SG Alarms 0. per day High SG Alarms.8 per day ** Only highest priority shown. 0 Reviewed By Date Darker shading corresponds to the number of high or low excursions Time Action Plan Section can be used to record notes for patient records, to provide comments and recommendations for patient therapy, and/ or to record documentation for health insurance providers. Dotted line indicates average sensor tracing CareLink Pro Report Overview I 9

12 Hypoglycemic/Hyperglycemic Episode Charts* Shows the number of hypoglycemic and hyperglycemic episodes that were preceded by a particular event type. More than one event can precede a single episode. It is possible that no events preceded an episode. NEW Episode Summary Provides a summary of the events preceding hypoglycemic and hyperglycemic episodes and offers therapy considerations. Episode Summary //00 - //00 Hypoglycemic Episodes, by preceding Event Type - Threshold: <0 mg/dl Data Sources: Paradigm Revel - Hyperglycemic Episodes, by preceding Event Type - Threshold: >0 mg/dl Most Common Event Pie Charts Shows the total number of occurrences for each event and the percentage of time the event was followed by a hypoglycemic or hyperglycemic episode. Event Type Descriptions Table Shows the percentage of the total number of hypoglycemic and hyperglycemic episodes that were preceded by the listed event type and offers considerations for possible therapy adjustments. Other Observations Table Offers considerations for other patient behavioral or compliance adjustments related to pump, CGM, and/or meter usage. Most Common Event Types preceding Hypoglycemia Event Type Descriptions Event Types Bolus Wizard Food Bolus Rapid Falling Sensor Rate Of Change Hyperglycemia Preceding Hypoglycemia Other Observations Infusion Site Change % Description Consider assessing the Bolus Wizard settings, counseling your patient on accurate carbohydrate counting, and/or the timing of insulin delivery with respect to carbohydrate intake. Consider counseling your patient to take action to avoid hypoglycemia. Consider assessing your patient s insulin sensitivity factors.consider counseling your patient on the management of hyperglycemia. Most Common Event Types preceding Hyperglycemia Event Type Descriptions Event Types Rising Sensor Rate of Change Without Bolus Bolus Wizard Food Bolus Bolus with Rising Sensor Rate of Change % 0 Description Consider counseling your patient on bolus use with meals and/or correcting rapid glucose excursions. Consider counseling your patient on changing infusion sites a minimum of every three days or review the correct way to change an infusion site with the patient. Consider assessing the Bolus Wizard settings, counseling your patient on accurate carbohydrate counting, and/or the timing of insulin delivery with respect to carbohydrate intake. Consider counseling your patient to modify bolus amounts when sensor glucose values are rising (upward arrow is present). *Targets determined by provider during report setup 0 I CareLink Pro Report Overview Note: To obtain the Episode Summary, a minimum of five days of pump and sensor data are required.

13 Adherence Report Provides insights into a patient s self-management behavior and helps confirm optimal device use. Wednesday //00 Thursday //00 Friday //00 Glucose Measurements BG Readings Adherence ( of ) //00 - //00 Sensor Duration (h:mm) : : : Bolus Events Manual Boluses Bolus Wizard Events 8 9 With Food With Correction Overridden Fill Events Rewind Cannula Fills Data Sources: Paradigm Revel - Cannula Amount (U) Tubing Fills Tubing Amount (U) Suspend Duration (h:mm) Glucose Measurements Shows whether the patient is performing blood glucose (BG) meter readings and wearing glucose sensors as prescribed. Bolus Events Displays the number of times the patient delivered manual boluses and Bolus Wizard food, correction, and override boluses. Saturday //00 Sunday //00 Monday //00 Tuesday /8/00 Wednesday /9/00 Thursday /0/00 :00 :00 : : : 8: Fill (Priming) Events Shows the frequency in which the patient is filling (priming) his or her pump cannula and tubing. Friday //00 Saturday //00 Sunday //00 Monday //00 Tuesday //00 9:0 :00 0: :0 : Suspend Duration Displays the frequency and the duration in which the patient is suspending insulin delivery. Summary.8/day 0d h m 0.0/day 8.8/day.%.% 9.8% 0.U /fill 8.U/fill 0m Partial day Note: Partial days will not be included in summary averages. Days on which a time change occurred are considered to be partial days. CareLink Pro Report Overview I

14 Sensor Overlay* Displays sensor glucose tracings to assist in identifying excursions and/or patterns. Sensor & Meter Overview Report: Sensor Overlay Displays sensor glucose tracings to allow for quick identification of glucose excursions and patterns. Bedtime to Wake-up Sensor Overlay* Displays sensor tracings from bedtime to wake-up to help identify overnight patterns. Sensor & Meter Overview ( of ) Data Sources: Paradigm Revel - //00 - //00 -Hour Glucose Sensor Overlay - Readings & Averages (mg/dl) eal Sensor Overlay* M Realigns sensor tracings around meals (at the time carbohydrates are entered into the Bolus Wizard) to assess pre- and postmeal control. Glucose Sensor Overlay Bedtime to Wake-Up and Meal Periods Readings & Averages (mg/dl) Bedtime to Wake-up Bedtime: 8:00 PM - :00 AM Wake-up: :00 AM - 9:00 AM Sensor trace *Targets determined by provider during report setup I CareLink Pro Report Overview Below Target* Interrupted Breakfast: :00 AM - 0:00 AM Meals Analyzed: Lunch: :00 AM - :00 PM Meals Analyzed: Dinner: :00 PM - 0:00 PM Meals Analyzed: Avg Carbs: 8g Avg Insulin:.U Avg Carbs/Insulin:.g/U Avg Carbs: 0g Avg Insulin:.U Avg Carbs/Insulin:.9g/U Avg Carbs: g Avg Insulin:.U Avg Carbs/Insulin:.g/U Average Above Target* Darker shading corresponds to the number of high or low excursions Target Sensor Glucose Range* Dotted line indicates average sensor tracing

15 Sensor & Meter Overview Report: Statistics and Meter Overlay Displays blood glucose meter readings and statistics to allow for identification of glycemic excursions and patterns. Meter Overlay* Displays BG meter readings to assist in identifying excursions and/or patterns. Sensor & Meter Overview ( of ) Data Sources: Paradigm Revel - //00 - //00 -Hour Meter Glucose Overlay - Readings & Averages (mg/dl) Statistics Avg BG (mg/dl) BG Readings Readings Above Target / - / ±.8/day % Statistics Table* Displays BG meter, sensor glucose, carbohydrate, and insulin statistics over the reporting period. Meter Glucose Overlay Bedtime to Wake-Up and Meal Periods Readings & Averages (mg/dl) Bedtime to Wake-up Breakfast: :00 AM - 0:00 AM Lunch: :00 AM - :00 PM Meals Analyzed: 9 Meals Analyzed: Bedtime: 8:00 PM - :00 AM Wake-up: :00 AM - 9:00 AM Avg Carbs: 8g Avg Carbs: 0g Avg Insulin:.U Avg Insulin:.U Avg Carbs/Insulin:.g/U Avg Carbs/Insulin:.8g/U Dinner: :00 PM - 0:00 PM Meals Analyzed: 9 Avg Carbs: 0g Avg Insulin:.U Avg Carbs/Insulin:.g/U Readings Below Target Sensor Avg (mg/dl) Avg AUC > 0 (mg/dl) Avg AUC < 0 (mg/dl) Avg Daily Carbs (g) Carbs/Bolus Insulin (g/u) Avg Total Daily Insulin (U) Avg Daily Basal (U) Avg Daily Bolus (U) ± ±.0.0 ±..0.0 % 0d h 0d h 8% % Bedtime to Wake-up Meter Overlay* Displays BG meter readings from bedtime to wake-up to help identify overnight patterns. Meal Meter Overlay* Realigns BG meter readings around meals (at the time carbohydrates are entered into the Bolus Wizard) to assess preand post-meal control. BG reading BG reading Off chart Average within target range Average outside target range *Targets determined by provider during report setup CareLink Pro Report Overview I

16 Glucose Section* Displays the daily sensor tracing and the BG meter readings. Sensor & Meter Overview Report: Daily Snapshots Displays daily snapshots of glucose levels, carbohydrate intake, and insulin delivery to assist in identifying trends. Carbs Section Displays the amount of carbohydrates the patient entered into the Bolus Wizard. Sensor & Meter Overview ( of ) Insulin Section Displays the amount of basal and bolus insulin delivered as well as injected insulin. *Targets determined by provider during report setup I CareLink Pro Report Overview Data Sources: Paradigm Revel - //00 - //00 Sensor trace BG reading Basal Interrupted Off chart Temp basal Below Target* Above Target* Bolus Suspend Time change Exercise Injected insulin (U) Other Target Sensor Glucose Range*

17 Logbook Report Provides logbook information in an hour-by-hour format to help identify repeated patterns and possible causes for glycemic excursions. Wednesday //00 Thursday //00 Friday //00 Saturday //00 Sunday //00 Monday //00 Tuesday /8/00 Wednesday /9/00 Thursday /0/00 Friday //00 Saturday //00 Sunday //00 Monday //00 Tuesday //00 AM AM 0.8 AM Logbook ( of ) //00 - //00 AM AM 0.8 AM AM AM Breakfast 8 AM AM 0 AM AM PM Lunch Dinner Data Sources: Paradigm Revel - PM PM PM PM PM PM PM 8 PM 9 PM 0 PM PM Daily Totals Average (): Carbs: 8g 0mg/dL 0. Insulin:.9U Bolus: % Average (): 90mg/dL Carbs: g Insulin:.U Bolus: 8% Average (): mg/dl Carbs: 08g Insulin: 0.8U Bolus: 8% Average (): mg/dl Carbs: 0g Insulin: 8.U Bolus: 8% Average (): mg/dl Carbs: 9g Insulin:.U Bolus: % Average (): 0mg/dL Carbs: g Insulin:.U Bolus: % Average (): 9mg/dL Carbs: g Insulin:.9U Bolus: % Average (): 0mg/dL Carbs: g Insulin:.8U Bolus: 0% Average (): mg/dl Carbs: 09g Insulin:.U Bolus: 9% Average (): mg/dl Carbs: 08g Insulin:.U Bolus: % Average (): 8mg/dL Carbs: 0g Insulin:.U Bolus: % Average (): 0mg/dL Carbs: g Insulin:.U Bolus: % Average (): mg/dl Carbs: 8g Insulin:.U Bolus: % Average (): 9mg/dL Carbs: g Insulin:.U Bolus: % Logbook Cell Section* Each cell contains up to three numbers: Top Number: BG meter reading Middle Number: Carbohydrates Bottom Number: Bolus Insulin Delivered Meals can be quickly identified by looking for the carbohydrate amounts (in black). Daily Totals Summarizes the following values from each day of the reporting period: Average: Displays the total number of BG meter readings taken and the BG meter average. Carbs: Displays the total amount of carbohydrates entered into the Bolus Wizard. Insulin: Displays the total amount of insulin delivered and the percentage delivered as a bolus. > 0mg/dL Multiple readings (most extreme shown) Suspend Exercise Partial day Time change < 0mg/dL Manual bolus or bolus with correction Other Pump rewind Skipped meal Below Target* Above Target* Carbohydrates *Targets determined by provider during report setup CareLink Pro Report Overview I

18 Basal Settings Displays the patient s basal rates and temporary basal rates at the time the patient s device was uploaded. Bolus Settings Displays the patient s bolus settings at the time the patient s device was uploaded. Sensor Settings Displays the patient s sensor settings at the time the patient s device was uploaded. Utilities Displays the patient s alert type and low reservoir warning settings at the time the patient s device was uploaded. Notes Section can be used to record notes for patient records, to provide comments and recommendations for patient therapy, and/or to record documentation for health insurance providers. Device Settings Snapshot Displays insulin pump and sensor settings. Device Settings Snapshot Thursday //00 : AM Basal Bolus Sensor Maximum Basal Rate.00 U/hr Maximum Bolus 0.0 U Temp Basal Type Percent of Basal Dual/Square (Variable) On Standard (active) -Hour Total TIME 0:00 :00 :0 :00 8:0 :00 9:00 : U U/hr Pattern A -Hour Total TIME 0:00 :0 :00 8:00 8:00 8. U U/hr Pattern B -Hour Total TIME 0:00 :00 :0 :0 :0 9:00.88 U U/hr TIME 0:00 :0 :0 :0 :00 Blood Glucose Reminder Bolus Wizard Units Active Insulin Time (h:mm) Insulin Concentration Ratio On :00 Off Easy (Audio) Bolus Off Entry (Step) 0.0 U g, mg/dl Carbohydrate Ratio Insulin Sensitivity (g/u) (mg/dl per U) Notes TIME 0:00 :00 :00 Sensitivity Missed Bolus Reminder Start (h:mm) Blood Glucose Target (mg/dl) TIME 0:00 :00 :00 Off End (h:mm) Low High 00 Data Source: Paradigm Revel - Utilities Sensor Transmitter ID BG Units Glucose Alerts TIME 0:00 :00 :00 Alert Repeat Rate Alert: Fall Rise (mg/dl/min) AUC Limit: Low High (mg/dl) Missed Data/Weak Signal (h:mm) Graph Timeout (h:mm) Auto Calibration Calibration Reminder (h:mm) Calibration (Alert) Repeat (h:mm) Alert Type Low Reservoir Warning Amount On mg/dl On Low (mg/dl) Predictive Alert On Low High (mins) 0:0 None 0:0 :00 0 U 0:0.0 0 Beep Medium Insulin Units High (mg/dl) 00 0 :0.0 0 I CareLink Pro Report Overview

19 Daily Detail Report Displays pump, sensor, and blood glucose meter information from a specific day to provide insight on a patient s glucose control, including response to carbohydrate intake and insulin use. Daily Detail ( of ) Thursday //00 Data Sources: Paradigm Revel - Daily Detail Graph* Displays detailed sensor glucose, blood glucose, carbohydrate intake (or meal markers), insulin, and other key information to assist in identifying cause-andeffect relationships. Bolus Events Provides detailed information on each bolus event listed on the Daily Detail graph. Bolus Events Bolus Event 8 9 Time :0 AM :0 AM 9:9 AM 0: AM :0 PM : PM : PM : PM 0: PM Bolus Type Normal Normal Normal Normal Normal Normal Normal Normal Delivered Bolus Norm (U) Square Portion (U, h:mm) Recommended Bolus (U) Statistics Avg BG (mg/dl) BG Readings Readings Above Target Readings Below Target Sensor Avg (mg/dl) / 90 ± 00% 0% / - / ± ±.8/day % % Statistics Provides detailed statistics for the day and compares them to the entire reporting period. Difference (U) Avg AUC > 0 (mg/dl). 0d h 0.9 0d h Carbs (g) 0 0 Avg AUC < 0 (mg/dl) 0. 0d h 0. 0d h Carb Ratio Setting (g/u) Food Bolus (U) BG (mg/dl) Daily Carbs (g) Carbs/Bolus Insulin (g/u) 0.9 ±.0 BG Target Setting (mg/dl) Insulin Sensitivity Setting (mg/dl per U) Total Daily Insulin (U) Daily Basal (U). 0.9 %.0 ±..0 8% Correction Bolus (U) 0... Daily Bolus (U). 8%.0 % Active Insulin (U) Fills.U Sensor trace BG reading Linked BG Basal Bolus Suspend Time change Exercise Glucose alert Interrupted Off chart Calibration BG Temp basal Pump rewind Injected insulin (U) Other Alarm Below Target* Above Target* Target Sensor Glucose Range* *Targets determined by provider during report setup CareLink Pro Report Overview I

20 Need support or more information? We have a dedicated CareLink team ready to assist you. Call Medtronic, Inc. Diabetes 8000 Devonshire Street Northridge, CA 9 USA CareLink, Paradigm, Guardian, and Bolus Wizard are registered trademarks and Revel is a trademark of Medtronic MiniMed, Inc Medtronic MiniMed, Inc. All rights reserved.

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