paradigm training

Paradigm 515/715

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Training Materials

• User guide• Training CD

– Interactive user guide on a CD

• Paradigm® at a Glance– “Cheat sheet” for reservoir & set change and

Bolus Wizard programming

• Medtronic CareLink® Therapy Management System — online tutorial for data management

• Pump School Online

NEW! Replaces instructional video.

NEW! Includes more information. Now shipped to each patient in the pump box.

Paradigm® Insulin Pump 515/715

Holds 300 units

Same as 712

Paradigm 515 Paradigm 715

Same size : new software

Holds 176 units

Same as 512

New/Expanded Features

Backlight available in all menus

On-pump data management

Save/restore settings

Medtronic CareLink® Therapy Management System

ParadigmPAL™ 2.0 Software

Keypad lock

Enhanced Bolus Wizard:• Multiple active insulin curves• BG target ranges• Broader limits for settings

New home-screen icons

The Home ScreenMore information at a glance …

Paradigm 512 & 712 Paradigm 515 & 715

Home Screen Displays MiniMed on front of screen

(Indicates normal mode of operation) 6 open/closed circles

Open circles (Special Mode – i.e., temp. basal, low battery, low reservoir, dual/square bolus) Closed circles (Attention Mode – i.e., Suspended - pump is not delivering insulin)

(Picture shows normal mode of operation)

Home Screen Displays Time (12hr or 24 hr)

Displays Icons• Battery Life (4 segments) • Reservoir Volume (4 segments)

1 open/closed circle for pump status

(Picture shows normal mode of operation)

Each segment

represents 25% *

When using a 1.76 ml

reservoir in a 715 pump, icon

will show 3 segments

when reservoir is full.

Main Menu

Bolus

Suspend

Basal

Prime

Utilities

Bolus

Paradigm 512 / 712 Paradigm 515 / 715

Main Menu Same Menu

New Information

MiniMed

Main Menu

Bolus

Suspend

Basal

Prime

Utilities

Bolus

Current Battery & Reservoir Status always displayed on Home Screen & in Menu Mode

Bolus Menu

Set Bolus

Bolus History

Bolus Wizard Set Up

Max Bolus

Dual/Square Bolus

Easy Bolus

BG Reminder

Bolus Menu Exciting New

Features Paradigm 512 / 712

MiniMed

Bolus Menu

Set Bolus

Bolus History

Bolus Wizard Set Up

Max Bolus

Dual/Square Bolus

Easy Bolus

BG Reminder

Paradigm 515 / 715

Bolus Wizard Set Up

Two new features in

Wizard Set up

Press

Bolus Menu

Set Bolus

Bolus History

Bolus Wizard Set Up

Max Bolus

Dual/Square Bolus

Easy Bolus

BG Reminder

Paradigm 515 / 715

Bolus Wizard Setup

Enhanced Bolus Wizard™ CalculatorExpanded Setup Ranges

The set-up ranges have

been expanded to better meet the needs of patients with very high and

very low insulin requirements.

Enhanced Bolus Wizard™ Calculator Expanded Setup Ranges

60-250 mg/dL80-160 mg/dLTarget BG

10-400 mg/dL/unit10-250 mg/dL/unit Insulin Sensitivity

3-150 grams/unit 0.1-5.0 unit/exch

3-75 grams/unit 0.2-5.0 unit/exch

Carbohydrate Ratios

515/715512/712

NOTE: The Bolus Wizard will now allow a bolus to be delivered when BG’s are below 70 mg/dL, after the user has Activated through a Warning message.

Edit Settings

Wizard:

Carb units:

Carb Ratios:

BG Units:

Sensitivity:

BG Target:

Active Insulin Time:

on

grams

15

mg/dL

50

100 – 100

6 hrs.

MiniMed

Edit Settings

Wizard:

Carb units:

Carb Ratios:

BG Units:

Sensitivity:

BG Targets:

on

grams

15

mg/dL

50

100 B G Target:

2 New Programming

Features


Two New Features in the Bolus Wizard™ CalculatorBG Targets &

Selectable Active Insulin Curves


Edit Settings

Wizard:

Carb units:

Carb Ratios:

BG Units:

Sensitivity:

BG Target:


on

grams

15

mg/dL

50

100 – 100

6 hrs.

B G Target:

New Features in the Bolus Wizard™

BG Targets

Press

TARGET RANGE 1

12:00A mg / dL

– 10010099989796959493929190The first number must be the same or LOWER than the second number.

• Elevated BG’s are corrected DOWN to this number.

• Upper range should not be set above 100 mg/dl unless there are obvious hypoglycemia concerns.

BG TargetsCan Now be Programmed in Ranges

Factory default ranges are

set at 100 – 100.

May set up to 8 different

targets in 24 hrs.

Press to confirm

(for patients who do NOT want a negative correction when BG is just below target)

To program or change ranges, simply press the or when the number is flashing.

TARGET RANGE 1

12:00A mg / L

– 100100 150

BG Target Ranges Can Now be Programmed in BG Ranges!

80

If ranges are set below 90 or above 140, a

warning screen appears, just as a friendly

reminder.

BG Target RangesReminder Message

WARNING

A target range of

80 to 150

is valid but outside the

usual range of 90 to 140

ESC to correct.

ACT to continue.

TARGET RANGE 1

12:00A mg / dL

80 – 100

If BG falls within the programmed

range – NO Correction insulin is

calculated.

If BG falls above or below the programmed

range – Correction insulin

is calculated.

Example

BG Within Programmed Range

BG: 82 mg/dL

Example

BG Below Programmed Range

BG: 70 mg/dL

Example

BG Programmed Above Range

BG: 150 mg/dL

Negative Correction insulin is

calculated.

BG Targets Can Now be Programmed in BG Ranges

NO Correction is calculated.

Correction insulin

is calculated.

Estimate Details

Est total: 3.7U

Food intake: 60 gm

BG: 70

Food: 4.0U

Correction: 0.3U

Active ins: 0.0U

ACT to proceed,

ESC to back up

–

Food:

Correction:

Est total:

Example

BG Below Programmed RangeBG: 70 mg/dL SF = 30Carbs: 60 gms ICR = 15

70 – 80 = -0.3U30

BG Below Target Range Negative Correction Insulin Calculated

NOTE: Corrects to lowest end of range.

60 = 4.015 gm

TARGET RANGE 1

12:00A mg / dL

80 – 100

Estimate Details

Est total: 4.0U

Food intake: 60 gm

BG: 82

Food: 4.0U

Correction: 0.0U

Active ins: 0.0U

ACT to proceed,

ESC to back up

–

Food:

Correction:

Est total:

Example

BG Within Programmed RangeBG: 82 mg/dL SF = 30Carbs: 60 gms ICR = 15

BG is between

80 – 100 No correction

calculated

BG Within Target RangeNo Correction Insulin Calculated

60 = 4.015 gm

TARGET RANGE 1

12:00A mg / dL

80 – 100

Estimate Details

Est total: 6.0U

Food intake: 60 gm

BG: 82

Food: 4.0U

Correction: 2.0U

Active ins: 0.0U

ACT to proceed,

ESC to back up

Example

BG Above Programmed RangeBG: 160 mg/dL SF = 30 Carbs: 60 gms ICR = 15

60 = 4.015 gm

160 – 100 = +2.0U30

NOTE: Corrects to

highest end of set range.

BG Above Target Range Positive Correction Insulin Calculated

Food:

Correction:

Est total:

TARGET RANGE 1

12:00A mg / dL

80 – 100

MiniMed

Edit Settings

Wizard:

Carb units:

Carb Ratios:

BG Units:

Sensitivity:

BG Target:


on

grams

15

mg/dL

50

100 – 100

6 hrs.Active Insulin Time:

Can be adjusted in 1 hour

increments from 2-8 hours.

Adjustable Active Insulin Can be Individualized

Press

ACTIVE INSULIN TIME

12:00A

hr66 hrs. is the length of

time that most closely mimics the

published information on insulin

pharmacodynamics.

Adjustable Active Insulin Default is set to 6 hours

Adjustable Active Insulin Curves

Active Insulin Curve

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8 9

Time (hours)

% Insulin Remaining

8 Hour7 Hour6 Hour

5 Hour4 Hour3 Hour2 Hour

Adjustable Active Insulin What is different and what is the same?

• The 6 hour Active Insulin curve most closely matches the published scientific data on insulin pharmacodynamics. The 515/715 defaults to the 6 hour curve, and we recommend using the default unless prescribed otherwise by a clinician.

• For simplicity, the curve now stops when less than 5% of active insulin remains. This eliminates the long, low tail that lingered for several more hours, which caused confusion for some patients.

• To accommodate specific clinician requests, the Active Insulin Curve is now adjustable in 1 hour increments from 2-8 hours.

0.05 Delivery 0.05 Delivery

MiniMed

BASAL MENU

Set / Edit Temp Basal

Set / Edit Basal

Basal Review

Max Basal Rate

Patterns

Temp Basal Type


Basal Menu No Changes

BASAL MENU

Set / Edit Temp Basal

Set / Edit Basal

Basal Review

Max Basal Rate

Patterns

Temp Basal Type

Exactly the same Features as found

on 512 / 712

PRIME MENU

Fixed Prime

Rewind

Prime History

Insulin Change

MiniMed

PRIME MENU

Fixed Prime

Rewind

Prime History

Insulin Change

Contains Only Options Specific to Reservoir Change

“Insulin Change” (Insulin type)

Option has been removed.


Prime Menu Simplified Choices

Insulin Change

MiniMed

UTILITIES MENU

Alarm

Daily Totals

Time/Date

Alarm Clock

Remote Option

Meter Options

Block

Selftest

Clear Pump

Language

UTILITIES MENU

Lock Keypad

Alarm

Daily Totals

Time/Date

Alarm Clock

Meter Options

Remote Options

Block

Selftest

User Settings

Language

Press

Lock Keypad

User Settings

Daily Totals

Expanded data management

Utilities Menu

2 New Optional Features

2 New Optional Features

Press ACT to Lockout Keypad

Press ESC to Cancel

When this feature is activated, it prevents all accidental keypad presses.

Note: What’s the difference between Block & Lock?

• The LOCK feature ensures that NO programming/delivery changes can be made.

• The BLOCK feature still allows the pump to be placed in Suspend.

Lock Keypad Feature Great Option for the Active Individual

Press

However, the “STATUS” screen may still be viewed, by pressing the key.

KEYPAD LOCKED

To unlock press B and UP keys at the same time

Lock Keypad Feature Prevents All Accidental Keypad Presses

NEW Programming Technique

This new technique involves pressing the

key simultaneously with another

key. This allows for: Dual function of all keys, & Increases programming capacity.

(Similar to “Ctrl” key on computer)

UTILITIES MENU

Lock Keypad

Alarm

Daily Totals

Time/Date

Alarm Clock

Meter Options

Remote Options

Block

Selftest

User Settings

Language

User SettingsAllows Patient to Save

Basal Rates & all Bolus Wizard™ Settings

User Settings

Press

Press

&The “User Settings” screen is only

accessible when the &

are pressed simultaneously.

This feature is not normally accessible.

To access, consult your User Guide.

This screen appears if ACT is pressed from the Utilities Menu.

User Settings Allows Patient to Save Settings

SETTINGS SAVED

User settings have been saved24JUN2004 at 8:31A

Press ACT to over write settings saved 20APR2004 at 9:41A ESC to CANCEL

USER SETTINGSSave Settings

Restore Settings

Clear Settings

History

Save Settings

Save Settings Saves current pump

settings. These settings can be

restored when the pump is cleared for any reason (e.g. clearing active insulin in training session).

Settings saved include: basal rates & wizard settings.

NOTE:Date & Time are not saved.The date & time must be reset every time the pump is cleared.

User Settings FeaturePump Settings can be Saved

Press

Press

CLEAR CANCELLED

User settings willNOT be cleared

CONFIRM

No

Yes


Restore Settings

Clear Settings

History

Clear Settings

No

Beep

Beep

Beep

Beep

Beep

User Settings Feature Pump Settings can be Cleared

Press

RESET

CONFIRM

No

Yes


Restore Settings

Clear Settings

History

Clear Settings

Beep

Beep

Beep

Beep

Beep

Beep

RESETCLEAR SETTINGS

Clears programmed information (including Date/Time).

Restores pump to factory default settings.

Clears ALL ACTIVE insulin from the Bolus Wizard™ memory.

NOTE:Last 24 boluses can still be viewed in bolus history screen. However, the insulin from these boluses will no longer be counted as “active insulin” by the Bolus Wizard™.

YesNo

User Settings Feature Pump Settings can be Cleared

Press

SETTINGS RESTORED

User settings have been restored PLEASE CHECK SETTINGS


Restore Settings

Clear Settings

History

Restore Settings

User Settings Feature Pump Settings can be Restored

Press

Press

Press ACT to restore settings saved on 20APR2004 at 9:41A ESC to CANCEL

CHECKSETTINGS

Check SettingsAlways recheck the

settings to verify that the restored settings are the most current settings being used by the patient.

Check Settings

The “Check Setting” screen will automatically be displayed any time settings have been cleared or restored from the pump.

User Settings Feature Always check restored settings


Restore Settings

Clear Settings

History


Restore Settings

Clear Settings

History

Backlight Always AvailableParadigm® Insulin Pump Enhancements

The backlight can be turned on

from any menu by pressing

& simultaneously.

UTILITIES MENU

Lock Keypad

Alarm

Daily Totals

Time/Date

Alarm Clock

Meter Options

Remote Options

Block

Selftest

User Settings

Language

On-Pump Data Management Provides additional BG and insulin delivery data

Daily Totals

Press

DAILY TOTALS

Daily Average

Today 0.00U

26JUL 112.30U

26JUL 112.30U

On-Pump Data Management

Provides MORE InformationDetail can be viewed by day or by averages

Press

26JUL BG AVG 128

BG Low/Hi 92/178

Number BGs 6


Provides additional BG and insulin delivery data

Information can be displayed by single day or average of 2-30 days

Data Mgmt Detail ScreensBG Average Screen shows: Average BG Average Low BG (lowest entered each day) Average Hi BG (highest entered each day) Total number of BG’s entered

26JUL INSULIN 112.3

Basal 60.2/54%

Bolus 52.1/46%

Carbs 253g


Provides MORE information

Data Mgmt Detail ScreensInsulin Total Screen shows: Amount and percent of insulin

delivered for Basal and Bolus Total number of carbohydrates

entered

26JUL BOLUS 52.1

Food Bolus 36.5/70%

Corr Bolus 10.3/20%

Manual Bolus 5.3/10%



Data Mgmt Detail ScreensBolus Screen shows: Total amount of insulin delivered

via boluses Total amount and percent of

bolus insulin delivered for food, correction and manual doses

26JUL NUM BOLUS 5

Food/Corr 2/1

Food+Corr 1

Manual Bolus 1



Data Mgmt Detail ScreensNumber Bolus Screen shows: Total number of boluses Breakdown count regarding

boluses for food, correction, both, and/or manual

Utilities Menu

Lock Keypad

Daily Totals

User Settings

PRIME MENU

Insulin Change

BASAL MENU

Bolus Menu

Bolus Wizard Set Up

No Changes

Insulin Change option has been removed.

Prevents accidental keypad presses.

Saves current pump settings (basal rates & wizard settings).

Two Changes: BG Target Ranges Active Insulin

Provides detailed BG & insulin data.

Quick Review Paradigm Enhancements

Therapy Management Software Solutions

• Medtronic MiniMed offers a combination of Web- and PC-based therapy management software solutions

• Included as part of the Paradigm 515/715 insulin pump system, patients are eligible to receive:

– Access to the new Web-based Medtronic CareLink Therapy Management System for Diabetes

– ParadigmPAL™ 2.0 Software

– Paradigm Link™ Interface Cable

• Solutions Software has been updated to support 515/715 pumps, and will continue to be offered to healthcare professionals for use during patient appointments

PC-based

PC-based

Web-based

PC- or Web-Based

Paradigm 512/712 & 515/715Patients & Healthcare ProfessionalsParadigmPAL 2.0

MiniMed 508Paradigm 511, 512/712, 515/715

Healthcare ProfessionalsSolutions Software 6.0

Paradigm 515/715 PumpPatientsMedtronic CareLink

Therapy Management System

Currently Supported DevicesTarget User(s)Software Application

Medtronic CareLinkTherapy Management System for Diabetes

• A new Web-based therapy management system for patients

• Transforms data from the following sources into a series of meaningful treatment reports:

– 515 / 715 insulin pumps– A variety of BG meters– Patient self-reported

treatment data

• Patients can easily print reports and bring them to office appointments to support therapy adjustments

Medtronic CareLinkTherapy Management System for Diabetes

Quick View Summary Report Trends Summary Report Modal Day Periods Report

8 Customizable Reports(3 samples displayed below)

ParadigmPAL™ 2.0for Paradigm® 512/712 and 515/715 pumps

PC-based software that enables patients and their healthcare providers to review, modify, reprogram, and backup pump settings using a PC

Paradigm Link™ Interface Cable

Connects the Paradigm Link Blood Glucose Monitor to a PC, allowing both meter and pump data to be uploaded to therapy management software

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