MiniMed Paradigam Veo System Step-by-step Guide Sept 2010

Your HCPs Contact Details

Staying in touch with your Healthcare Professionals (HCPs)

Your Endocrinologist: Phone number: Email: Your Diabetes Educator: Your Diabetes Centre: Address: Phone number: Email:

Medtronic Diabetes Customer Service: 1800 668 670 Medtronic Diabetes 24 Hour Helpline: 1800 777 808

www.medtronic-diabetes.com.au www.medtronic-diabetes.co.uk

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INTRODUCING THE PARADIGM™ VEO™ SYSTEM

Contents

Introducing the Paradigm™ Veo™ System • Paradigm Veo System Overview • Menu & Menu Options  • Operation Mode and Key Alarms 

4 6 8 10

Infusion Set and Reservoir12 • Medtronic Paradigm Reservoirs and Infusion Sets • Inserting the Infusion Set and Filling the Reservoir  • Fill the Infusion Set Tubing • Insertion of the Medtronic Quick-Set™ Infusion Set • Insertion of the Medtronic Silhouette™ Infusion Set

14 16 18 19 21

Basal and Bolus

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• Setting the Basal Rate • Medtronic Bolus Wizard™ Calculator • Setting the Missed Bolus Reminder • Temporary Basal Rate • Express Bolus

25 27 30 32 33

Continuous Glucose Monitoring (CGM) 34 • Insertion of Sensor • Starting a Sensor • Key CGM Alarms • Trend Graphs • Alerts and Glucose Limits • Predictive and Rate of Change Alerts  • Low Glucose Suspend (LGS)

36 38 39 40 42 44 46

Optional Extras48 • Medtronic CareLink® Therapy Management Software • Personalise Your Pump • Notes

48 49 50

For further information on a specific topic, please refer to the highlighted chapters in the MiniMed Paradigm Veo User Guide. 2

INTRODUCING THE PARADIGM™ VEO™ INSULIN PUMP

Introducing the Paradigm™ Veo™ Insulin Pump The key elements in managing your diabetes with insulin pump therapy RESERVOIR VOLUME

BATTERY STATUS

BATTERY COMPARTMENT EASY BOLUS/ scroll up

BACKLIGHT/ scroll down

RESERVOIR compartment

express Bolus ESCAPE to prior screen RESERVOIR TRANSFER GUARD

4 4

MINILINK™ TRANSMITTER & SENSOR

ACT confirm information or menu selection PARADIGM CONNECTOR

infusion set

Refer to Chapter 3 in the MiniMed Paradigm™ Veo™ User Guide A step-by-step guide to using the Paradigm® Veo™

Getting Started

Getting Started Thank you for choosing Medtronic Diabetes as a partner in managing your diabetes. Whether you are just starting pump therapy or upgrading from a previous model, this step-by-step guide is designed to help you understand the basic operation of the MiniMed Paradigm Veo System. It is intended to be used in conjunction with the guidance of a healthcare professional. Please consult your healthcare professional before making any therapy adjustments. For full product details, please refer to the MiniMed Paradigm Veo User Guide and Instructions for Use for each system component.

Understanding the basics For this section, you will need the: • MiniMed Paradigm Veo Insulin Pump • MiniMed Paradigm Veo User Guide

www.medtronic-diabetes.co.uk/gettingstarted

The Paradigm™ Veo™ insulin pump shown in purple.

5

GET TING STARTED

The Paradigm Veo Insulin Pump

A patient-friendly insulin pump With the Paradigm Veo pump: • You only need to press a few buttons to make appropriate selections and adjustments • Simple on-screen instructions help with the infusion set and reservoir changes • An easily-accessible backlight illuminates the pump’s screen in the dark • Large, clear text makes all on-screen information easy to read • Inserting the infusion set is straightforward and virtually painless In this section, we’ll explain technical terms, give you practical assistance, and make sure you feel as comfortable as possible using the Paradigm Veo pump from day one. * Information contained herein does not replace the recommendations of your Healthcare Professionals (HCPs). Please refer to the User Guide and your healthcare team for more information. When using an insulin pump, check your blood glucose a minimum of 4 times per day.

6

Refer to Chapter 3 in the MiniMed Paradigm™ Veo™ User Guide

The Paradigm Veo pump is discrete and can be easily attached to your waistband.

Getting Started

GET TING STARTED

Breakdown of the Buttons

Simple buttons for simple use The buttons on the Paradigm Veo insulin pump are designed to make it simple and effective to manage your Paradigm Veo pump.

EXPRESS Bolus to set a Bolus

RETURN to prior screen

aCT to confirm information or menu selection

SCROLL UP

SCROLL DOWN

NOTE: The Paradigm Veo insulin pump

ACT

buttons will be referred to throughout the brochure using the icons shown to the right. Refer to Chapter 3 in the MiniMed Paradigm™ Veo™ User Guide

7

GET TING STARTED

Menus and Menu Options

MAIN MENU Bolus Suspend Sensor Capture Event Basal Reservoir + Set Utilities

Navigation Press the ACT button from the MAIN MENU to get to the sub-menus. button from a submenu Press the screen to return to the MAIN MENU. Scroll bar (appears on the right of the screen when more screen text is available) Press to scroll down to view additional screen text. Press

to scroll back up.

Note: All screens are samples only. Actual screens depend on the current active functions. Blue Arrows ( ) indicate submenus. 1. Displays only when the Bolus Wizard feature is off. 2. Displays only when the Bolus Wizard feature is on.

Bolus MENU Set Bolus Use Bolus Wizard2 Manual Bolus2 Set Bolus Bolus History Bolus Setup Bolus Wizard Setup Edit Settings Wizard Carb Units Carb Ratios BG Units Sensitivity BG Target Active Ins Time Review Settings Max Bolus Max Bolus Setup Scroll Rate Scroll Rate Setup Dual/Square Bolus Off On Easy Bolus Off On/Set BG Reminder Off On Missed Bolus Reminder Off On/Set 1

SUSPEND Press ACT to Stop Pump 3. Displays only when the sensor is communicating with the pump. 4. Displays if Sensor is on.

SENSOR MENU Calibrate3 Enter BG Alert Silence4 Off Hi Alerts Lo Alerts Hi and Lo Alerts All Sensor Alerts Link to Sensor4 New Sensor Reconnect Old Sensor Find Lost Sensor Turn Off Sensor Transmtr ID Edit Settings Sensor Glucose Alerts Glucose Limits Hi Repeat5 Lo Repeat5 Predict Alert Rate Alerts Low Suspend Cal Repeat Cal Reminder Auto Calibrate BG Units Transmtr ID Weak Signal Graph Timeout Sensor Demo Calibration Hist4 Sensor Alert History4 Review Settings4 Turn Off Sensor4 5. Displays if Glucose Alerts feature is on.

Getting Started

Status Screens CAPTURE EVENT

Getting Started

6

Enter BG Insulin marker Meal marker Exercise marker Other History BG Units Carb Units

Basal MENU Set/Edit Temp Basal Set Duration Cancel Temp Basal7 Select Patterns8 Basal Review Basal Setup Set/Edit Basal Set Basal Rate 1 Max Basal Rate Patterns Off On Temp Basal Type Insulin Rate Percent of Basal

RESERVOIR + SET Reservoir Setup Fill Tubing9 Fill Cannula History

6. Displays if Capture Option is turned on in Utilities Menu. 7. Displays only after setting Temp Basal.

UTILITIES MENU Lock Keypad Alarm Alarm History Alert Type Auto-Off Low Resv Warning Insulin Units Time Daily Totals Daily Average Calculate AUC Time / Date 12 Hour Setup 24 Hour Setup Alarm Clock Off On / Set Connect Devices Meters Remotes Other Devices Block Off On Selftest User Settings10 Save Settings Restore Settings11 Clear Settings History Capture Option Off On Language

8. Displays only when the Patterns feature is on. 9. Displays only after a rewind.

button to go to the PUMP Press the AND SENSOR STATUS screens. PUMP STATUS Screen STATUS U100 Last Alarm: 24APR 11:30 LoBat Active ins: 1.050U Last Bolus N 3.800U 9:07 24 MAR Basal 1: 0.15U/H Reservoir Started: 23APR, 12:44 Units left: 144.0U Time left: > 24 hours BG Reminder in 2:04h Meter: On Battery: Normal Auto Off - 12HR Fri 25 APR 2008 S/N# 123456 Paradigm 554 VER X.XX X.X

Sensor Status Screen

SENSOR STATUS Next Cal: 08:30 Sensor Age: 2d 3h Sensor Isig: 25.97 Transmtr Batt: Good Transmtr Ver: 1.1 Transmtr ID: 2111111 Pump SN#: 123456

and press ACT . 10. Displays only when you hold 11. Displays only after the patient settings have been saved.

GET TING STARTED

Operational Modes

The 3 Operational Modes

Normal Mode

The pump operates normally.

Press to view the status screen so you can review the reason for the empty circle.

Special Mode

Indicates special circumstances: low battery, low reservoir, temporary basal, etc.

Attention Mode

Administration of insulin is s†opped. Press ACT to view alarm type to take action.

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Refer to Chapters 10 & 13 in the MiniMed Paradigm™ Veo™ User Guide

THE SCREEN INDICATES THE REASON FOR THE ALARM and ACT clear the alarm. Press

Getting Started

Key Alarms

Empty Reservoir

CHANGE THE RESERVOIR immediately.

Weak Battery

REPLACE THE AAA BATTERY immediately.

No Delivery

BLOCKAGE DETECTED: insulin delivery stopped. Check blood glucose and ketone levels.

Failed Batt Test

CHECK SETTINGS BATTERY VOLTAGE INADEQUATE Install a new battery.

Bolus Stopped

CHECK Bolus HISTORY Reprogram Bolus with the amount of insulin not delivered.

Suspend Press ACT to stop pump. Suspend stops all insulin delivery, including the current Basal, any Bolus or Fill Cannula deliveries that are in progress.

Refer to Chapters 10 & 13 in the MiniMed Paradigm™ Veo™ User Guide

11

GET TING CONNECTED

Infusion Set and Reservoir

A Unique Connection Medtronic has developed a range of infusion sets and reservoirs designed for your Paradigm Veo insulin pump. They have one key element in common:

Use it right and use it in good health. Change your infusion set every 2 to 3 days.

• The Medtronic Paradigm Connection – a unique interface between your Medtronic Paradigm infusion set and reservoir. The Paradigm connection builds on our experience of traditional Luer lock systems, with additional benefits for you.

Note: Successful pumping relies on proper infusion set management. Changing your infusion set every 2 to 3 days may help ensure the effectiveness of your therapy.

MEDTRONIC SILHOUETTE™ INFUSION SET MEDTRONIC PARADIGM CONNECTOR

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click! - Two parts, one interface, a secure fit

RESERVOIR

MEDTRONIC Quick-Set™ INFUSION SET TRANSFER GUARD

Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide

Infusion Set & Reservoir

Getting Connected

Understanding Infusion Set and Reservoir

The Paradigm™ Veo™ insulin pump shown in pink.

For this section, you will need: • Reservoir • Infusion Set • Serter (optional) • Insulin www.medtronic-diabetes.co.uk/infusion

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GET TING CONNECTED

Medtronic Paradigm Reservoirs Simplicity and Security

Transfer Guard snaps onto insulin vial OR PEN CARTRIDGE for secure and stable reservoir filling

Needle incorporated into Transfer Guard to help prevent injury Pre-assembled and Ready to Use for fast, efficient reservoir filling

Silicone Membrane seals the reservoir when the TransferGuard is removed to help prevent leakage Rounded Shape helps eliminate air bubbles to promote consistent insulin delivery

Ergonomic design makes it easy to grab the connector for secure handling Vents are built into the connector, so they are replaced every time you change your infusion set

connecter fits securely on both the reservoir and the Paradigm Veo pump, providing a leak-proof connection - click! Airtight seal for reliable insulin delivery when connected to reservoir 14

Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide

GET TING CONNECTED

Medtronic Paradigm Infusion Sets

Medtronic Quick-set infusion set

Is the Quick-set right for you?

• Soft cannula set • 90 degree insertion angle • Medtronic Quick-serter™ insertion device for consistent insertion depth • At-site tubing disconnection • Cannula length: 6 or 9 mm

Due to its versatile design and straight 90 degree insertion angle, you may like the Quick-set if you are of average to heavier build.

Medtronic Silhouette infusion set

Is the Silhouette right for you?

• Soft cannula set • 20-45 degrees variable insertion angle • Medtronic Sil-serterTM insertion device for controlled insertion depth • At-site tubing disconnection • Cannula lengths: 13 or 17 mm

Due to its low profile and adjustable insertion depths, the Silhouette is a good choice for babies, during pregnancy or if you are an active lean adult or child.

Medtronic Sure-T® infusion set

Is the Sure-T right for you?

• Steel needle set • 90 degree insertion angle • Tubing disconnection 10 cm from infusion site • Additional adhesive for increased security • Cannula lengths: 6, 8, or 10 mm

Due to its very thin, steel needle and dual adhesives, Sure –T is ideal for children of normal to heavier build. This set may also appeal to you if you are pregnant, simply prefer the steel needle set or are allergic to Teflon® cannulas.

Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide

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Infusion Set & Reservoir

Choice and Flexibility

GET TING CONNECTED

Inserting the Infusion Set

Insert the Infusion Set • Wash hands thoroughly before any handling • Prepare materials: insulin, reservoir, infusion set, and pump Prior to filling the reservoir, it is recommended that the insulin should be at room temperature. Refer to instructions for use for the cannula: Medtronic Quick-Set or Silhouette infusion sets.

5 4

1

2 3

Remember to rotate and cleanse insertion sites. Recommended possible sites: • Abdomen • Upper buttock • Outer thigh • Arm

Additional Tips • It is recommended to stand while inserting • Insert the new infusion set before removing the old one; this will ensure you do not re-insert at the same location. • Choose a site free of lumps, bumps, bruises, scars, and tattoos. • Clean the inside of the insertion device (if you use one) with alcohol each month to ensure proper function. • Avoid inserting the infusion set within 5 cm of the belly button.

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WARNING • All “sharps” – introducer needle, transfer guard, old tubing, etc., should be disposed of in a sharps container. • Never change infusion set immediately before going to bed. • Check your blood glucose 2 hours after the infusion set change. • It is recommended to change the infusion set prior to a meal.

Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide

GET TING CONNECTED

Step 1

Step 5

CLEAN the insulin cartridge (or vial) stopper with an alcohol wipe.

REMOVE any air bubbles from the reservoir by gently tapping the side and then slowly pushing plunger up a little.

1 1.8 ml

Step 6

INSERT the needle of the blue Transfer Guard into the cartridge (or vial).

REMOVE the Transfer Guard from the reservoir (1/4 turn) and connect the reservoir to the infusion set.

1.8 ml 1

1.8 ml 1 1.8 ml 1 1

Step 2

Step 3

Step 7

CARTRIDGE: If using a cartridge, pull the plunger back to fill the reservoir. VIAL: PRESSURISE the vial by pushing the plunger down completely.

To PURGE air bubbles that have risen to the top of the reservoir, push up on the plunger until you see insulin in the tubing.

1 1.8 ml

Step 4

Step 8

VIAL (only): INVERT the reservoir and allow the reservoir to fill. Gently pull the plunger, if necessary.

UNSCREW the reservoir plunger. 1 1.8 ml

1.8 ml

Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide

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Infusion Set & Reservoir

Filling the Reservoir

GET TING CONNECTED

Fill the Infusion Set Tubing

Step 1

Step 7

ACT

ACT

Step 2

Step 8

ACT

Step 3

Step 9

ACT

ACT

Step 4

Step 10

ACT

Step 5

Insert set (see instructions for inserting infusion sets). ACT

Step 11

Insert the reservoir (with set connected) into the pump compartment and lock it (1/4 turn). ACT

Using the arrows, ADJUST the volume needed to fill the cannula.* ACT

Step 6

Step 12

ACT

ACT

* Note: if using the Sure-T infusion set, filling the cannula is not required. Press to skip "Fill Cannula" (Step 10).

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Fill until drops are seen at the end of the infusion set tubing. , then ACT

Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide

GET TING CONNECTED

Insertion of the Medtronic Quick-Set Infusion Set

Infusion Set & Reservoir

Please refer to page 16 of this manual before you start

Step 1

Step 3

INSERT the Quick-Set into the insertion device (Quick-Serter).

LOAD the Quick-Serter by pulling back on the plunger.

Step 2

Step 4

REMOVE the protective films from the adhesive.

REMOVE the needle protector (blue cone) by unscrewing it.

(continued on next page)

Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide

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(Insertion of the Medtronic Quick-Set Infusion Set, continued)

Step 5

Step 8

POSITION the Quick-Serter at the desired site.

REMOVE the Quick-Serter while supporting the tubing with your other hand.

Step 6

Step 9

SQUEEZE the 2 white triggers to begin insertion.

Carefully WITHDRAW the introducer needle.

Step 7

Step 10

PRESS the plunger with your index finger to release the introducer needle.

Fold the needle before placing it in a sharps container.

90°

Recommended Cannula Fill: 0.3 U for 6 mm 0.5 U for 9 mm

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Refer to Chapter 5 in the MiniMed Paradigm™ Veo™ User Guide