Medingo 07SOLORP3, 08SOLORC3 Users Manual

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Solo™ Insulin Pump

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Solo User Guide_version 080911 Page 1 of 81

1. Congratulations

Congratulations on your choice of the Solo™ system for diabetes p ump therapy. You are about to discover the ease with which the Solo™ insulin dispensing patch system will assist you in managing your diabetes discreetly and conveniently.

The Solo™ is a user-friendly product which enables you to achieve your treatment goals with minimum i nterferenc e in your lif e.

Please read this User Guide thoroughly and feel free to address our customer care team with any questions, concerns or remarks you may have.

The Study care team is available 24/7 through the Telephone number XXXX .

Medin go M edi cal Sol utio ns L td. www.me din go.c om

This product is covered by U.S. Patents

Other U.S.A. and/or foreign patents may be pending.

Solo™ is a registered trademark of Medingo

Solo User Guide_version 080911 Page 2 of 81

2. General Details

1) Take time to che ck the conte nts of your So lo™ System kit

2) Please familiarize yourself thoroughly with the User Guide, including the safet y precautions sections and alarms and errors indications.

3) Pump training is essential

and must be completed successfully

before using the

Solo™

system.

healthcare team.

Notes: ______________________________________________________________________________

______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________

Please start by filling in the important information on this page and retain it for your records:

Your Personal Info rmatio n:

Insulin-to-Carbohydrate Ratio: (one (1) unit of insulin will cover __ grams of carbohydrates, if counting grams, or __ units of insulin will cover one (1) carb, if counting exchanges:

Time range: _____ - _____ Ratio: _____ Time range: _____ - _____ Ratio: _____

Please set up an appointment for pump training with your

Time range: _____ - _____ Ratio: _____ Time range: _____ - _____ Ratio: _____ Time range: _____ - _____ Ratio: _____ Time range: _____ - _____ Ratio: _____ Time range: _____ - _____ Ratio: _____ Time range: _____ - _____ Ratio: _____

Insuli n S ens it ivit y Ra te Time range: _____ - _____ Ratio: _____ Time range: _____ - _____ Ratio: _____

: (one (1) unit of insulin will lower my blood glucose level by):

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Blood glucose target(s): Time range: _____ - _____ Upper Limit ____________ Lower Limit ___________ Time range: _____ - _____ Upper Limit ____________ Lower Limit ___________ Time range: _____ - _____ Upper Limit ____________ Lower Limit ___________ Time range: _____ - _____ Upper Limit ____________ Lower Limit ___________ Basal Rate(s) Time/Activity: ___________ Rate ____________ Time/Activity:_________ Rate ________

Time/Activity: ___________ Rate ____________ Time/Activity:_________ Rate ________ Time/Activity: ___________ Rate ____________ Time/Activity:_________ Rate ________ Time/Activity: ___________ Rate ____________ Time/Activity:_________ Rate ________ Time/Activity: ___________ Rate ____________ Time/Activity:_________ Rate ________

Solo™ System:

Remote Control ID Number: ________________________ Issue Date: __________________ (Can be found on the back of the remote)

Date Solo™ System received: _________________________ Time: ________________ Location received: _____________________________

Physician (Endocrinologist/General Practitioner):

Name: ______________________________________ Tel: ________________________ Fax: _________________________ Address: _______________________________________

Email:________________________ Comments: _____________________________________

Diabetes Nurse / Certified Diabetes Educator:

Name: ______________________________________ Tel: ________________________ Fax: _________________________ Address: _______________________________________ Email:________________________ Comments: _____________________________________

Pump Trainer:

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Insuranc e C om pan y:

Pharmacy:

Name: _______________________________ Pharmacist: ______________________________ Tel: ____________________________ Fax: _____________________________ Address: ______________________________________________________________________ Email:________________________ Comments: _____________________________________

Medingo:

Representative: _________________ Tel: ______________________ email: ______________ Clinical Specialist: ______________ Tel: ______________________ e-mail: _____________ Customer care: Tel: _______________________ Email: ______________________ Supply reordering: Tel: _______________________ Email: ______________________

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3. Table of Contents

1. Congratulations

2. General Details................................................................................................................... 3

3. Table of Contents .............................................................................................................. 6

1. Introduction............................................................................................................................... 9

1.1 The Solo™ System User Guide ...................................................................................................... 9

1.1.1 Conventions & Terms 9

1.2 Disclaimer.................................................................................................................................10

1.3 Radio Frequency Disclamer..........................................................................................................12

1.4 Symbols & Signs........................................................................................................................12

2. About The Solo™ System ............................................................................................................13

2.1 How Does It Work? ....................................................................................................................13

2.2 Intended Use.............................................................................................................................13

2.3 Caring For the Environment.........................................................................................................14

2.4 System Components & Accessories ...............................................................................................14

2.5 Stand-By Emergency Kit..............................................................................................................18

2.6 Important Safety Information ......................................................................................................19

2.6.1 Safety Features ......................................................................................................................... 19

2.6.2 Important Information ................................................................................................................19

2.6.3 Warnings ..................................................................................................................................20

2.6.4 Cautions ...................................................................................................................................23

2.7 Sound and Visual Features ..........................................................................................................24

2.7.1 Errors.......................................................................................................................................25

2.7.2 Alarms......................................................................................................................................25

2.7.3 Alerts.......................................................................................................................................26

2.7.4 Reminders.................................................................................................................................26

3. Using Your Solo™ System............................................................................................................27

3.1 Getting Started..........................................................................................................................27

3.1.1 Setting up your Solo™ System.....................................................................................................27

3.1.1.1 The Remote Control..............................................................................................................27

3.1.1.1.1.1

3.1.1.1.1.2

3.1.1.1.1.3

3.1.1.1.1.4

3.1.1.1.1.5

3.1.1.2 Set Your Pump.....................................................................................................................31

3.1.1.2.1 Time & Date Settings (Menu -> Settings -> Time & Date)......................................................31

3.1.1.2.2 Password Settings (Menu -> Settings -> Password Settings)..................................................32

3.1.1.2.3 System Settings (Menu -> Settings -> System Settings)........................................................32

3.1.1.2.4 Units Settings (Menu -> Settings -> Units Settings)..............................................................33

3.1.1.2.5 Personalize Pump (Menu -> Settings -> Personalize Pump) ....................................................34

3.1.1.2.6 Basal Profiles Settings (Menu -> Settings -> Basal Profile) ....................................................34

3.1.1.2.7 Reminder Settings (Menu -> Settings -> Reminder Settings)..................................................35

Indications, Icons and Symbols ......................................................................................28

Navigation ...................................................................................................................28

Editing........................................................................................................................29

Menu Screens ..............................................................................................................30

Communication ............................................................................................................31

.................................................................................................................. 2

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3.1.1.2.8 Alerts Settings (Menu -> Settings -> Alerts Settings)............................................................36

3.1.2 Activating Your Solo™ ................................................................................................................37

3.1.2.1 Your Cradle .........................................................................................................................37

3.1.2.1.1 Select the insertion site ....................................................................................................37

3.1.2.1.2 Instructions for Cradle replacement and Cannula insertion.....................................................39

3.1.2.1.3 Detaching and Reconnecting Patch to Cradle........................................................................40

3.1.2.1.4 Removing the cradle and adhesive backing ..........................................................................40

3.1.2.2 Your Reservoir.....................................................................................................................40

3.1.2.2.1 Reservoir replacement menu directions (Main -> Maintenance -> Replace Reservoir)................41

3.1.2.2.1.1

3.1.2.2.2 Your Patch (Main -> Maintenance -> Replace Patch).............................................................43

3.1.2.2.2.1

3.1.3 Insulin Delivery .........................................................................................................................44

3.1.3.1 About Basal Profiles..............................................................................................................44

3.1.3.1.1 Activating Basal Profiles (Menu ->Select Basal) ....................................................................44

3.1.3.1.2 Temporary Basal Profiles (Menu -> Temp Basal)...................................................................45

3.1.3.1.2.1

3.1.3.2 About Bolus Delivery ............................................................................................................45

3.1.3.2.1 Bolus types......................................................................................................................46

3.1.3.2.1.1

3.1.3.2.1.1.1 Delivering a Normal Bolus..............................................................................................47

3.1.3.2.1.2

3.1.3.2.1.3

3.1.3.3 Record Your Blood Glucose Values..........................................................................................49

3.1.3.3.1 Blood glucose registry instructions (Main -> Menu -> Blood Glucose)......................................49

3.1.3.4 Suspend/Resume Activity ......................................................................................................50

3.1.3.4.1 Suspending Delivery (Main -> Menu -> Suspend) .................................................................51

3.1.3.4.2 Protection Caps................................................................................................................51

3.1.3.4.3 Resuming Delivery (Main -> Menu -> Resume*) ...................................................................52

3.1.3.5 Status (Menu -> Status) .......................................................................................................52

3.1.3.6 Reports (Menu -> Reports)....................................................................................................53

3.1.3.6.1 Blood Glucose History Report (Menu -> Reports -> BG History)..............................................53

3.1.3.7 Device Maintenance..............................................................................................................53

3.1.3.7.1 Remote Control Battery Replacement..................................................................................54

3. Help & Troubleshooting ..............................................................................................................56

3.1 Assistance & Help Line (24 hours)................................................................................................56

3.2 Alarms & Alerts List.................................................................................................................... 56

3.3 General Problem Solving Guide....................................................................................................59

3.3.1 Improper Patch attachment.........................................................................................................59

3.3.2 Improper Patch attachment to cradle............................................................................................59

3.3.3 Insulin delivery not resumed after Patch or Reservoir replacement ...................................................60

3.3.4 Electrical interference.................................................................................................................60

3.3.5 Electrostatic Discharge ...............................................................................................................60

3.3.6 My bolus stopped.......................................................................................................................60

Instructions for filling your Reservoir with insulin.............................................................41

Instructions for Patch Replacement.................................................................................43

Setting and stopping a temporary basal profile.................................................................45

Normal (Main -> Bolus -> Normal Bolus*) .......................................................................46

Long (Main -> Bolus -> Long Bolus) ...............................................................................47

Stopping a Bolus ..........................................................................................................48

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3.3.7 My remote control buttons are not responding ...............................................................................60

3.3.8 I dropped my remote control .......................................................................................................61

3.3.9 I dropped my Patch....................................................................................................................61

3.3.10 I submerged my Patch in water....................................................................................................61

3.3.11 I submerged my remote control in water.......................................................................................61

4. Appendices................................................................................................................................62

4.1 Diabetes terminology..................................................................................................................62

4.1.1 About Diabetes ..........................................................................................................................62

4.1.2 Carbohydrate Counting...............................................................................................................62

4.1.3 High Blood Glucose (Hyperglycemia).............................................................................................63

4.1.4 Ketoacidosis (Diabetic Coma).......................................................................................................64

4.1.5 Low Blood Glucose (Hypoglycemia)...............................................................................................64

4.1.6 Self-Care ..................................................................................................................................66

4.1.7 Total Daily Insulin Dose (TDD).....................................................................................................67

4.2 Abnormal Daily Use Guidelines.....................................................................................................67

4.2.1 Sick-Day Recommendations.........................................................................................................67

4.2.2 Travel Recommendations ............................................................................................................68

4.2.3 Sports Activity Recommendations .................................................................................................71

4.2.4 Emergency Room Recommendations.............................................................................................73

For Physicians and Medical Staff: ..........................................................................................................74

4.2.5 Outpatient Surgery Procedures (including dental procedures/surgery)...............................................75

4.2.6 Inpatient Hospitalization Recommendations ...................................................................................77

5. Glossary ...................................................................................................................................79

6. Technical Specifications ..............................................................................................................80

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1. Introduction

If you are a first-time Solo™ System user, turn to the Study Nurse for step-by-step guidance on use. Do NOT attempt to apply or use the system until you have been trained by the Study Nurse. Use of the System with inadequate training or improper setup could put your health and safety at risk.

1.1 The Solo™ System User Guide

This Solo™ system user guide will guide you in proper setup and use of your new patch pump. We recommend that you become familiar with the s ystem's multiple features to make the product work better for you and your lifestyle. Please keep this comprehensive guide in easy reach for quick ref erence at all times .

We suggest you read this guide thoroughly and until you feel comfortable using your Solo™ System.

Please no te examples only (unless stated otherwise) and should not be considered programming suggestions.

that the values and screen shots indicated in this user guide are given as

1.1.1 Conventions & Terms

Highlight – To select or highlight a screen item Bold - Names of buttons, menus, and screens are in bold. Italics - Words in italics are defined in the Glossary at the end of this User Guide. Press - Press and release a button or soft key. Hold - Keep pressing a button until its function is completed (also called Long Press). Menu - A list of options on the remote control. Options allow you to perform tasks. Screen - Displays programming, operating, and alarm/alert information. Button - A physical button on the remote control, such as the Power button. Indicator - An image on the remote control’s indicator bar, that indicates a certain status. Soft keys – Three buttons which relate to text written on the bottom of the screen (changing

functions according to task) see the Remote Control chapter3.1.1.1

< > - Soft key names are written in brackets Please Note – Additional information

Solo User Guide_version 080911 Page 9 of 81

Caution – A warning informing you of potential hazard which may harm the device or accompanying equipment, if not avoided

Warning – A warning informing you of potential hazard which may result in bodily harm, if not avoided

-> - A pathw ay indicato r used whe n describi ng how to reach a certain screen. For example, Menu -> Settings explains that you need to enter the Menu screen and then the Settings screen.

1.2 Disclaimer

This guide does not contain all of the necessary information for proper care and treatment of people with diabetes who use an insulin pump; therefore, please consult your physician or diabetes professional healthcare team before implementing any changes to your diabetes treatment plan. This guide is not intended as a substitute for informed medical advice. The user of this guide should not use the information provided in this guide to diagnose or treat a health problem or disease without consulting a qualified healthcare provider.

We at Medingo have taken every reasonable precaution while preparing this user guide; yet no author, editor, or publisher shall have any responsibility for errors or omissions, nor for the uses made of the materials herein and the decisions based on such use. No warranties are made, expressed or implied, with regard to the contents of this guide or to its appl icability to specific patient s or circum stances. N o author, editor, or pu blisher shall be liable for direct, indirect, special, incidental or consequential damages arising out of the use or inability to use the contents of this guide.

This book is NOT meant to be a subst itution for pro fess ional me dica l care . Always consu lt a member of your professional healthcare team for treatment plans and recommenda tions.

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1.3 Radio Frequency Disclaimer

FCC ID:WNR08SOLORC3 – remote control unit FCC ID:WNR07SOLORP3 – pump unit Manufacturer: M edingo Ltd. These devices comply with Part 15 of the FCC Rules. Operat io n is su bj e ct t o t he f ol lo wing two c on d iti on s :

• This device may not cause harmful interference, and

• This device must accept any interference received, including interference that

may cause undesired operation.

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver.

• Connect the equipment into an outlet on a circuit different from that to which the

receiver is co nne cted.

• Consult the dealer or an experienced radio/TV technician for help.

Caution: Changes or modifications to this equipment not expressly approved by the party responsible for compliance (Medingo Ltd.) could void the user’s authority to operate the equipment.

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DO NOT REUSE

USE BY

BATCH CODE

CAUTION, C ONS ULT ACCOMPANYING DOCUMENTS

MANUFACTURER

PRESCRIPTION WARNING

CONSULT INSTRUCTIONS FOR USE

DATE OF MANUFACTURE

METHOD OF STERILIZATION USING ETHYLENE OXIDE

CATALOGUE NUMBER

KEEP DRY

TEMPERATURE LIMITATI ON

FRAGILE, HANDLE WITH CARE

KEEP AWAY FROM DIRECT SUNLIGHT

PROTECT FR OM HEA T A N D RADIOACTIVE SOU RCES

Latex Free

SERIAL NUMBER

1.4 Symbols & Signs

Below you will find a list of symbols which may appear throughout the Solo™ System’s user guide, on packaging or on the actual system parts. Next to each symbol, an explanation is provided.

Solo User Guide_version 080911 Page 12 of 81

2. About The Solo™ System

2.1 How Does It Work?

The Solo™ system is a miniature, tubeless, patch-like insulin pump that is attached to your body at a desi red location and cont rolled by a remote control de vice. The Solo™ is designed for CSII - Continuous Subcutaneous Insulin Infusion (under the skin), provi ding

continuous 24-hour basal and bolus insulin deliveries through a short and thin tube (cannula).

The latex-free Solo™ has no exposed tubes or wires, is exceptionally user-friendly, and is compatible with variable meal, exercise and lifestyle routines. A remote control unit controls patch programming, and enables data collection and transmission from and to the Patch, using wireless technology.

Please Note: within the period of three (3) days, simply remove the patch from the cradle and apply a new cradle and cannula assembly in the newly desired location without having to waste any of the patch parts or insulin reservoir. It’s as simple as that! (please see Chapter C.b.3.1.2.1 for instruction of use)

You may prog ram a nd ad just up to 7 ba sal prof ile s, set a tempora ry ba sal rate , suspe nd insulin del ivery, and del iver an d us e a varie ty of bo lus types, su ch as Norma l and Long (please see Chapter 3 for instruction of use).

Blood glucose information can be entered and saved in your Solo™ together with real-time written comments for future reference. Should you choose to view the history of your blood glucose levels, you can do so with ease through the reports section.

Should you choose to change the cannula insertion location on your body

2.2 Intended Use

The Solo™ System is intended for the continuous delivery of insulin, at set and variable rates, for the mana gement o f diabet es mel litus in person s requir ing insulin .

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Warning: The Solo™ System is an investigational device not approved for sale in the

European community

Warning: The Solo™ system should only be used by independent adults (over the age of

18)

Warning: Continuous subcutaneous insulin infusion therapy with the Solo™ System is

not recommended for people who are:

1. Unable to perform at least four (4) blood glucose checks per day.

2. Unable to keep contact with their professional healthcare team.

3. Unable or lack the ability to follow the instructions of use of the system.

4. Unable to see or hear pump signals o r alarms.

Warning: Treatmen t with the Solo™ system sho uld only be initiate d after rece iving

training by a Study Nurse.

2.3 Caring For the Enviro nment

The system was designed and built with an environment-friendly approach, using leadfree components, Zinc-air batteries in the Pump part and recyclable materials

2.4 System Components & Accessories

As soon as you receive your Solo™ system starter kit, please unpack it and check that it contains the following parts:

One (1) remote control with two (2) AA Alkaline batteries

• One (1) pump

• One (1) Inserter

• Two (2) Reservoirs kits, each containing:

o One (1) Cradle o One (1) Cannula cartridge

One (1) fill ing dev ice

Two (2) protection caps for disconnections.

•

User guide

•

Solo User Guide_version 080911 Page 14 of 81

All Solo™ system parts and accessories are available from the Study Nurse.

Warning: Should you have an y reason to suspect damage to an y of the Solo™ system’s components, whether seen or unseen, please contact the Study Nurse immediately. DO NOT try to service the s ystem yourself.

Part Name Purpose Comments

Patch – Reservoir

Patch – Pump

Power sou rce an d

insulin reservoir

A disposable componen t, chan ged every 2-3 days

Contains 180 units of insulin (filled before use)

Pumping mechan ism communicat ion and control

A reusable component, reused for 3 months

Remote Control

Used to store, program, disp lay and download insu lin delivery and bl ood glucose data, inclu din g h ist or y

A reusable hand-held device w ith co lor LCD backlight displa y; suited for indoor/outdoor use

Mini USB connector

records.

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Cradle

Patch

Cradle

Latch -

to disconnect the Patch from the Cradle

Hollow connector -

holds the cannula assembly and prevents its movement during

Cannula

used in order

Attached to the skin with adhesive backing

The patch clicks into the cradle, allowing flexibility of use and easy disconnections

Disconnect and reconnect by using the latch

For single use only, the cradle and the inser t ion s it e s ho ul d be replaced every two to three (2-3) days.

Please see the Crad le

Cannula Cartridge

Inserte r

The cannula is a soft Teflon-type tube that delivers the insulin

Sterile and disposable component for single

use only from the Patch to your bo dy, wh il e being inse rted un der the skin

Adheres the cradle to the desire d ins ertion locatio n an d in ser ts the cannula into the

Reusable c omponen t,

quick and e asy

inser t ion , e l im ina te s

needle exposure subcutaneous tissue for insulin delivery

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Filling device

Protecting cups

Connects to the insulin bottle for insul in w it h dra wa l, and to the Reservoir

Sterile and disposable

component for single

use only

for insulin filling purposes

Used to:

Non sterile, reusable

1. prevent water ingres s int o th e cannula insertion site

2. prevent contamination of the cannula septum and connecting needle during cradle-patch detachmen t

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2.5 Stand-By Emergency Kit

We recommend that you prepare a stand-by emergency kit which includes essential spare parts and supplies. This kit should be accessible to you at all times. Inform a family membe r o r f rie nd of its loc ati on .

The kit should include the following spare items: The So lo D is pos ab le K it:

a. Cradle b. Reservoir c. Filling device d. Cannula Cartridge e. Protection caps

2) Pump

3) Inserter

4) 100IU rapid acting insulin bottle

5) 2 spare AA Alkaline batteries

6) Glucose tablets or another fast acting source of carbohydrates

7) Glucagon In jection as prescr ibed by your doctor and writte n instructions for giving an injection if you are uncons cious

8) Urine ketone monitoring supplies

9) Blood glucose monitoring supplies: Blood glucose meter, test strips, lancets and lancet device

10) Instr uct io ns fro m S tu dy D oc tor ab ou t h ow muc h ins uli n t o in je ct if del iv ery from the Solo™ is interrupted

11) Dressing and IV Prep: Tissues, alcohol swabs, cotton balls

12) Medical identif ication card with contac t info rmat ion fo r your profe ssional healthcare team in case of need

13) A copy of your pump program (basal rates, target blood glucose, etc.)

Please Not e: As always, discuss with your doctor or healthcare professional any special supplies you might need in your emergency kit.

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Caution heat and direct sunlight.

: Keep insulin as cool as possible without freezing it. Also protect it from direct

2.6 Important Safety Informatio n

Familiarize yourself with the following safety precautions before using the Solo™ System. These instructions contain valuable information on safe and proper use that will prevent harm to its user and damage to the product.

The Solo™ system is built for high performance under strict adherence to international quality standards. The Solo™ design incorporates technologically advanced safety features to facilitate proper use and function.

2.6.1 Safety Features

The Solo™ system is tubeless; therefore cannot be caught, tangled, twisted or

•

snagged.

• Occlusion Sensor – In the event that flow of insulin from the pump becomes

blocked, due to sediment in the insulin solution, or a twisted or bent infusion cannula, the patch will sound an alarm to inform you of the occlusion. This situation will be identified quickly to prevent any harm. You are then required to check your blood sugar level and follow the instructions as detailed in the Help & Troubleshooting chapter of the User Guide.

• Password –You can secure the remote control with a password to prevent

unauthorized use. Please see Chapter C.1.3.1.1.2.2 for further instructions on how to activate this feature.

• Delivery sensors – Sensors are positioned to ensure proper insulin delivery.

Software self-test – A self-test is occasionally performed to ensure proper

•

software function.

2.6.2 Important Information

Read all of the in structio ns provided in this us er guide be fore usin g the syste m. Incorrect use of this system, failure to apply, implement or follow the instructions and

important information contained in this user guide, or improper/inadequate self-care can lead to death or serious injury.

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The Help & Troubleshooting section contains information on troubleshooting system alarms & alerts. Certain alarms (such as the occlusion alarm) will cause system deactivation. Be sure to respond to all alerts and alarms when they occur.

Warnings, cautions and other important safety information can be found in this section and throughout the guide.

2.6.3 Warnings

This section informs you of poten t ial h azards that may result in bodily harm, if not avoi d ed

Please note that the Solo™ system is intended solely for infusing insulin into the

•

body of its user, a person with diabetes that has been prescribed this device by an authorized healthcare professional.

• The Solo™ is an invest igational de vice that is no t approve d for sa le in the

European community.

• The Solo™ system should only be used by independent adults (over the age of 18)

• DO NOT attempt to use the Solo™ system before you have been trained by Study

Nurse. He or she will initialize and configure the system based on your individual needs.

• The Solo™ insulin pump is designed only for Continuous Subcutaneous Insulin

Infusion (CSII). Use the pump only as you have been trained, and as instructed in this guide. DO NOT use this pump for an y other type of therapy.

• We highly recommend that you have someone around you (family, friends, etc.)

that understands diabetes and pump therapy, and can help you in the event of an emergency. Make sure they are familiar with any information given to you by the Study Nurse.

•

Only 100UI rapid acting

Using other insulin type compromises delivery accuracy and the safety of using other rapid acting insulin types has not been determined.

You must be prepared to inject insulin in the event that pump operation is

•

interrupted for any reason. Because the pump uses only rapid acting U100 insulin, high blood glucose (hyperglycemia) can quickly develop (within 2 to 4 hours) into Diabe t ic Ke to ac i dos is (DKA) if n ot t r ea t ed .

To avoid risk of explosion, do not use the Solo™ remote control in the presence of

•

flammable anesthetics or explosive gases.

insulin should be use d to f ill the Solo™ Reservoir part.

Solo User Guide_version 080911 Page 20 of 81

• Whenever you fill a new Reservoir and attach a new cradle and canula, you should

test your blood glucose level within one to two hours to ensure that insulin is being properly delivered. If you do not test within this time-frame, and insulin delivery is delayed or bl ocked, you may deve lop hyperglycem ia. It is recommende d to use the blood glucose testing reminders feature (see the Reminder Settings chapter).

There are potential environmental and health hazards associated with improper

•

disposal of batteries, electronics, and contaminated (used) cradles, cannula cartridges, Reservoirs and pumps. Dispose of all these products in a safe manner according to any regulations that may apply.

The Solo™ insulin pump and accessories include small component pieces that could

•

pose a choking hazard to small children.

• DO NOT apply a new patch until you have dea ctivated and rem oved the old one. A

patch that has not been deactivated properly may continue to deliver insulin as programmed, putting you at risk of over-infusion and possible hypoglycemia.

• When replacing your patch or a new Reservoir, please follow all the replacement

screen instructions (see chapter 3.1.2) to ensure that insulin delivery is resumed. Should there be other Solo™ system users in your close surroundings, we advise

•

you to color code or label your remote control to avoid mix-ups. Although the Solo™ system has many safety alarms, it cannot notify you if the

•

Patch is leaking or the in sulin has los t its poten cy. Therefo re, it is esse ntial that you check your blood glucose levels at least four times per day. If your blood glucose is out of range, check the Patch to ensure that the necessary amount of insulin is being delivered. Consult with your professional healthcare team regarding pro per gluco se mon itorin g.

• When you are in a loud or noisy environment where you may not hear a system

alarm, please use your Remote Control to frequently check system operation.

• If you are having symptoms that are not consistent with your blood glucose test

and you have followed all instructions described in the user guide, call the Study Nurse or your professional healthcare provider for further guidance.

• The reservoir, cannula cartridge and filling device are sterile in their unopened,

undamaged packages. DO NOT use any Solo™ component if its sterile package has been previously opened or damaged, as this may increase the risk of infection.

• Always wash your hands with soap and water before opening any Solo™ component

sterile package.

Solo User Guide_version 080911 Page 21 of 81

• Always cover the Cannula septum with the protective cup before wetting the

insertion area. Not doing so may cause to water gathering beneath the cradle and may cause the area to be infected

• Do NOT attach a cradle without first using an a septic techn ique. This means to:

o Wash your hands with soap and water o Clean the insulin vial with an alcohol swab

Clean the insertion site with an antimicrobial solution, such as an alcohol

swab

o Keep sterile materials away from any possible contamination

• Do not apply the cradle on injured skin.

• Check frequently that the cradle and cannula are securely connected and that the

cannula is positioned under the skin. A loose or dislodged cannula may interrupt insulin delivery.

Establish a rotation schedule for the cannula insertion locations, so that two

•

sequential insertions will not be on the same location. Avoid locations that are constrained by clothing, accessories, or subjected to rigorous movement e.g. during exer cise.

You should not change your infusion site right before bed, as you would be

•

unaware of any problems with the site. You must test your blood glucose level one to two hours after starting a new patch or changing your infusion site to ensure insulin is bein g prope rly del ivered.

• When suspending delivery, remember that since the pump uses only rapid-acting

insulin, your insulin level will start to fall and blood glucose level to rise very quickly (in as little as 60 minutes). You must test your blood glucose when suspending delivery for any length of time. Talk to Study Nurse or your health care professional abou t what you need to do if pump delivery is s topped fo r longer th an one hour.

• Many things can affect how your body uses insulin. Contact the Study Nurse or your

health care professional before making major lifestyle changes; for example, starting or stopping an intensive exercise program, or if you experience a significant weight loss or weight gain, etc. In these cases your basal rates may need to be modifie d.

• The infusion rate of Solo limits bolus s ize to less than 15IU.

• Change your Reservoir part in a room temperature environment only.

• Use only room temperature insulin when filling the reservoir.

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• Avoid using insulin from more than one vial, which may introduce air into the

syringe. DO NOT fill the Reservoir far in advance of connecting to the Pump. Doing so may

•

cause insulin deteriorat ion

• DO NOT use the Solo™ if you are sensitive or allergic to acrylic adhesives or have

fragile or eas ily dam aged skin.

• DO NOT use the Solo™ if you are sensitive or allergic to Teflon.

• Handle the system components with care. Beware of unintended sharp injury while

handing the Filling device and a loaded inserter.

2.6.4 Cautions

This section informs you of potential hazard which may harm the device or accompanying equipment, if not avoided

• DO NOT use pump cases that have a magnetic clasp. They can affect the internal

electronics and cause delivery inaccuracy and/or s ystem faults. Avoid using any system parts with broken seals or expired “use by” dates.

•

DO N OT a tt ac h o r u se a co mp on e nt if it is d am a ge d in a n y wa y. A d am ag ed

•

component may not work properly.

• If you drop the remote control or hit it against something hard, always inspect it

carefully to make sure it is still working properly. Ma ke sure the display is working correctly. If the display has missing or incomplete characters, or if the remote control does not seem to be working correctly, contact technical support imme dia t el y.

• DO NOT disconnect the Reservoir from the Pump part during the Patch’s operation

period. This will cause immediate insulin delivery suspension.

• DO NOT insert the filling device into the filling port of the Reservoir more than

once.

• The cradle and cannula are designed for single use only. Once removed, the unit

cannot b e reatta che d. We strongly urge you to deliver your pre-meal bolus doses in accordance with the

•

guidelines set by your professional healthcare team.

• The Solo™ patch and remote control are not water-proof and should be removed

before bathing, showering or wat er sports.

Solo User Guide_version 080911 Page 23 of 81

• Do NOT expose the Patch to direct sunlight or extreme temperatures as defined in

the Maintenance Chapter. The Patch must be removed prior to Magnetic Resonance Imaging (MRI), CT scan,

•

direct x-ray, ultrasound examination or any other potential exposure to a strong electromagnetic field, as they can affect the patch’s function.

• We do not recommend using NiCad, nickel metal hydride, carbon zinc (heavy

duty), lithium or any rechargeable batteries in the remote control.

• DO NOT skip over the manual primin g process, which is required when joining the

Pump and the Reservoir part. This process verifies proper connection of the Patch before use.

• DO NOT store or leave the remote control unit where it may be exposed to

extreme temperatures e.g. inside a car. Extreme heat or cold can cause the device irrevers ible dama ge result ing in malfu nctio n.

• Turning on the remote control during flights is prohibited by FAA regulations.

• Strong household cleaners and chemicals will damage the Patch and remote

control’s outer cover if applied directly or indirectly (if it is on your hands, for instance). Avoid the following in particular:

• Household cleaners (such as Formula 409®)

• Jewelry cleaner

• Petroleum-based products (such as gasoline and GooGone®)

• Products that contain high levels of D.E.E.T. (such as Deepwoods Off® insect repellent)

• Never use abrasive cleaners, solvents, bleach, scouring pads or sharp instruments when

cleaning your Patch or remote control, as they can scratch, discolor or damage the outer shell.

DO NOT use the Patch in hyp erbaric chambers.

•

2.7 Sound and Visual Feature s

The remote control is equipped with sound signals to notify you of alarms, alerts, reminders and e rrors that may occu r. The patch will also s ound Patch-related alarm s and errors. Sounds also provide feedback to certain actions such as bolus insulin delivery.

You may choose to deactivate the sound signals from your remote control. Please see the System Settings chapter. If you choose to do so, a mute sound indicator will appear on the top indicator bar of the remote control.

Please Not e

: This will not deact ivate alarm or e rror sounds generated f rom the Pump.

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A list of alarms, alerts and reminders can be found under HELP AND TROUBLE-SHOOTING, section 3.

The remote control and patch both alert you to an alarm requiring your attention by sounding a beep; a message is also displayed on the remote control screen.

All Pump errors and alarms are also displayed on the remote control screen after establishing communication with remote control. For instructions on handling alarms, please turn to HELP AND TROUBLE-SHOOTING.

2.7.1 Errors

Once an error alarm is sounded, you will be prevented from entering new commands until tending to the alarm. Your immediate attention is required.

The errors are sounded on the remote control and patch. An explanatory error message is also displayed on your remote control screen.

Appearance of error alarms results in insulin delivery suspension. Because the pump uses rapid-acting insulin, your blood glucose level will start to rise very quickly. Respond to errors immediate ly.

Examples of these alarms include:

• Pump exceeds maximum operation time

• Reservoir exceeds maxi mum operat ion time

• Empty Reservoir

Patch failure

•

2.7.2 Alarms

Once an alarm is sounded, you will be prevented from entering new commands until tending to the alarm. Your immediate attention is required.

Alarms are sounded on the remote control, and pump-related alarms are also sounded by your patch. An explanatory alarm message is also displayed on your remote control screen.

Appearance of alarms relating to Patch failure are accompanied by immediate suspension of insulin delivery.

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Because the pump uses rapid-acting insulin, your blood glucose level will start to rise very qu ic k ly. Re s po n d t o a la rm s im me d iat e ly.

Examples of these alarms include:

• Occlusion alarm

• 24 hours with no communication alarm

• Unexpected rese t alar m

• Battery status related alarms

2.7.3 Alerts

Alerts are sounded before alarms, in order to provide pre-warning which directs your attention to the anticipated occurrence.

Some alerts are a normal part of system use, such as trying to set a basal rate higher than the maximum basal rate set. There are alerts that warn of a system malfunction, such as an alert to rep lace the rese rvoir or re place you r remote cont rol batterie s.

These alerts are sounded on your remote control and are accompanied by an explanatory alert message on your remote control screen.

2.7.4 Reminders

You can program meal reminders and blood glucose check reminders according to your preference (See Reminder settings section 3.1.1.2.7).

These reminders are sounded on your remote control only and are accompanied by an explanatory reminde r messa ge on your remote co ntrol screen .

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3. Us ing Your So lo™ Sys tem

3.1 Getting Started

This section describes how to set up your Solo™. The Study Nurse will set up your Solo™ parameters after you have not completed an

introductory training session according to your individual needs. Do not use your Solo™ system before completing training and becoming thoroughly familiar with the contents of this guide.

3.1.1 Setting up your Solo™ System

Your Solo™ system is operated by its remote control unit, which communicates with the Patch.

The remote control is switched on by pressing the on/off button. Once this is done, you may enter the menus as instructed in the following section. Automatic communication with the Patch ensures programme d param eters are saved.

3.1.1.1 The Remote Control

The Patch will continue to deliver insulin as programmed, regardless of the proximity of the remote control, which does not have to be nearby at all times. However, you will need the remote control to deliver a bolus, edit the basal delivery settings or rates, set your parameters and make other programming changes.

The remote control operates with two (2) AA Alkaline batteries, which may be purchased at any grocery, hardware, or convenience store. On the average, a pair of batteries powers the remote control for more than four (4) weeks. An alert will sound when batteries are low.

For remote control maintenance instructions, please refer to the Maintenance, chapter

3.1.3.7.

Please note time period as preset in the system settings (see Settings, chapter 3.1.1.2). Alternately,

Solo User Guide_version 080911 Page 27 of 81

: The remote control will automatically switch off if not used for a certain

you may switch the remote control off by pressing the on/off button. Turning off the remote control does not turn off your Patch, which will continue delivering insulin as programmed.

3.1.1.1.1.1 Indications, Icons and Symbols

Insulin Reservoir Status Indicator and no. of u nits left

ctive Basal Profile Name and Rate

Screen

itle

Screen area

Left Soft Key Related Text

Center Soft Key Related Text

ime

Communication Status In dicator

Battery Power Indicator

Mute Sound Indicator

Right Soft Key Related Text

3.1.1.1.1.2 Navigation

Navigation between the remote control screens is accomplished by using the navigation keys.

You may scroll up and down, and select the chosen field by using the soft keys or center key as indicated by the text written on the bottom of the screen during the time of use.

The field you are currently on is highlighted in orange. When in a data screen, the orange arrows above and below the value indicate the field you are highlighting and referring to.

Solo User Guide_version 080911 Page 28 of 81

Pressing on t he le ft s oft key will lead you to what is written on the screen

Choose center key to select, when written ‘Select’.

Choose center ke y to edit, when written ‘Edit’.

Choose center key to save, when written ‘Save’.

3.1.1.1.1.3 Editing

In order to enter values into the fields, you must be in edit mode for the relevant field. Blinking orange arrows surrounding the value of the relevant field indicate you a re in edit

mode, and pressing on the central key will save your selection.

Soft key

down

Pressing on the right soft key will lead you to what is written on th e screen

Soft key

rightleft center

On / Off button

Please Not e

: Static orange arrows indi cate that you are highlightin g a c ertain f ield but are not in edit mode. You must either press the central key if it reads <edit>, or go <back> if you have no <edit> key a vailable and wish to return to an editin g screen (such as when confronted with a confirmation screen before delivering a bolus).

Once entering the relevant screen, you will need to edit and save each parameter separately, as follows:

a. In order to edit the values, highlight the requested field by placing the arrows

on the value.

b. Once the relevant field is chosen, press the center <Edit> key. The arrows will

now blink, in dicati ng edit mode.

c. Select the value you wish to display by pressing the up/down navigation keys

for increasing/decreasing values. And while on the same line press the right/left navigation keys to move between the fields and choose the va lue you wish to display.

d. Once the desired values are displayed, press the central <Save> key to save

your entry. After saving, the arrows will highlight the next row. In order to edit the value fields in the next row, press the central <Edit> key and repeat the process.

Solo User Guide_version 080911 Page 29 of 81

e. Press the right <Close> soft key in order to close the window. Your entries will

be saved.

Please Note:

In the bolus sub-menus the editing process is different, and you enter

the screen while in edit m ode.

3.1.1.1.1.4 Menu Screens

All programm ing be gins on th e main scree n, as in dicate d in the follow ing na vigation tree.

Main Screen

Bolus

Normal

Long

Combo

Bingo

Suspend/Resume

Blood Glucose

Temp B asal

Select Basal

Reports

BG History

Settings

Basal profile

Profile A Profile B

. :

Profile G

Personalize Pump Password

Tim e & Date System Units Reminders Alerts

Maintenance

Replace Set Replace Pump Priming Comm unication About

Status

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3.1.1.1.1.5 Communication

Communication between the remote control and Patch is wireless. Communication is initiated by switching th e remote control on.

The re mote con tro l un it n eed s to be with in tw o (2) mete rs (7 8.7 4 in che s) of th e pa tch in order to chan ge any of th e Pat ch o r in sul in de live ry se tt ings, s uch as to de liver a bolu s.

3.1.1.2 Set Your Pump

In order to prepare your Solo™ system for operation, please set the following:

1) Pump settings: time & date, password, system, units

2) Personal parameters

3) Basal profiles

4) Reminder preferences

5) Alert preferences

3.1.1.2.1 Time & Date Settings

Date)

Accurate time and date settings are crucial for correct functioning of the program you have selected. Basal profiles, target blood glucose data history and some alarms and alerts are time-based.

Please Note savings adjustments, adaptation to different time zones, or every time the remote control batteries are changed or removed from their compartment.

: You will need to adjust the time and date from time to time due to daylight

(Menu -> Settings -> Time &

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• Time = edit the hour, minutes and format symbol if choosing AM/PM format

• T. Zone = choose the time zone

• T. Format = cho ose the time disp lay forma t AM/ PM o r 24 hrs.

• Date = edit the date in month, day and year segme nts

• D. Format = choose the date display format MMM/DD/YY

3.1.1.2.2

Password Settings

(Menu -> Sett ings - > Pass wor d

, DD/MMM/YY, MMM/DD/YYYY

Settings)

Should you choose to do so, you may create a password which will lock your

•

keypad and prevent access to your remote control by anyone other than yourself. Define your remote control protection password (by pressing on the numbered keys when in edit-mode)

• Activate (default manufacturing setting) or deactivate the password.

The password must consist of four (4) digits chosen from the numbers 1, 2, 3, 4, 5 or 6 arranged in any combination. These numbers are written on the navigation keys and soft keys of the remote control.

Warnin g

user in your surroundings, if there are any children present that might tamper with your remote control, or if you feel that device protection is needed.

3.1.1.2.3

In the System settings screen you can set certain system related functions, or view their current se ttin g:

: We strongly advise you activate your password if there is more than one Solo

System Settings

(Menu -> Settings -> System Settings)

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• Left key = definition of the left soft key while on main screen.

• Right key = definition of the right soft key while on ma in screen.

• Backlight = backlight brightness volume

• Keypad snd. = Keypad sound activation

• Logout = duration of the automatic shut off period from last key press

• RC vol. = remote control’s volume level

3.1.1.2.4 Units Settings

(Menu -> Settings -> Units Se ttings)

In the Un its settings screen you can set certain Insulin Unit definition-related functions, or view their setting, such as:

BG value = the units used in relation to the blood glucose value.

•

Carbs = the units used in relation to the carbohydrates value displayed.

•

Solo User Guide_version 080911 Page 33 of 81

3.1.1.2.5

Bolus inc = Bo lus in cre me nt

•

Basal inc = Basal increment

•

Max basal = The ma ximum amou nt o f insul in that c an be delivere d per hour as a

•

basal rate

Personalize Pump

(Menu -> Settings -> Personalize Pump)

• Max bolus = ma ximum amoun t of insul in that can be deli vered in one bolus

• TDD = total dai ly dose. The ma ximum value of in sulin dos es you a re per mitted pe r

day (Bolus and Basal together).

• BG targets - You can set up four (4) different blood glucose targets (high and low).

Blood glucose targets will alternate automatically according to the time set. If no target was set, N O blood gluco se -relate d al erts w il l be act ivated.

Please Not e: You should receive the input values for personalizing your pump from your professional healthcare team. Please consult them every time you wish to edit or change a value.

3.1.1.2.6

Basal Profiles Settings

(Menu -> Settings -> Bas al

Profile)

The Solo™ allows you to set up to 7 different basal profiles for a continuous flow of insulin. Each profile contains an insulin rate def inition for u p to 4 8 time segments, at a minimum rate of 0.05 U/hr.

In order to activate a basal profile you need to follow the instructions written in chapter

3.1.3.1.1

Solo User Guide_version 080911 Page 34 of 81

Please Note: A minimum of one (1) profile needs to be set by you or a member of your professional healthcare team.

Each profile contains an initial insulin rate setup for four (4) different time segments (each segment contains six (6) hours), at a minimum rate of 0.05 U/hr increments.

Choose ‘right’/’left’ navigation key to increase / decre ase time .

Choose ‘up’/’down’ navigation key up to incre ase/d ecrea se bas al rat e.

Setting a basal profile: Once entering the Basal Prof ile settings screen, you will need to choose the basal rate

and time period for each section of the prof ile.

• Press the up or down navigation keys to increase or decrease the number of units (in 0.05 u/hr increments)

• Press the right or left navigation keys to increase or decrease the time period for each segment (in 30 minute increments)

3.1.1.2.7

Reminder Settings

(Menu -> Settings -> Reminder

Settings)

In the Rem inde rs settings screen you can set reminders, or view the current reminder setting as indicated be low:

Solo User Guide_version 080911 Page 35 of 81

Reminders = enable/disable the reminders mode

•

meal = a reminder that you should eat your first meal of the day and administer

•

bolus.

• 2

meal = a reminder that you should eat your second meal of the day and

administer bolus.

meal = a reminder that you should eat your third meal of the day and

• 3

administer bolus.

meal = a reminder that you should eat your fourth meal of the day and

• 4

administer bolus.

BG Check = a reminder that you should check your blood glucose level at a certain

•

time period after g iving yo urself an ins ulin bo lus.

• Low BG = a reminder to check your blood glucose level after experiencing a

reading below 60 mg/d L.

• High BG = a reminder to check your blood glucose level after experiencing a reading above 180 mg/dL.

3.1.1.2.8

Alerts Settings

(Menu -> Settings -> Alerts Settings)

In the Alerts settings screen you can set and view the se ttings of a lert-related functions, such as:

Solo User Guide_version 080911 Page 36 of 81

• Alerts = disable/enable the alerts mode, which provide you with early warning about the system status following changes made by you o r that o ccur in t he system.

• Res. exp. = set the time in which an alert would appear informing you that your Reservoir unit is about to expire.

Low res. = set the amount of insulin units from which you would like to get a low

•

reservoir al ert.

3.1.2 Activating Your Solo™

3.1.2.1 Your Cradle

The Cradle is a single use component attached to your skin with a biocompatible adhesive tape. The cradle holds the cannula securely in position under your skin.

The system is provided with a tiny cannula (9mm length) which is inserted vertically. The cannula remains under the skin for the entire usage period of up to 72 hours.

3.1.2.1.1 Select the insertion site

Before applying a new cradle, you should first select an appropriate site. Please make sure you have full view of the site; it is suggested you use a mirror if needed.

There are many appropriate sites you may use, although the insulin absorption in each site may vary. Consult with your professional healthcare team on the sites which are suitable for you.

The most common sites are those with a layer of fat between the skin and the muscle such as:

Solo User Guide_version 080911 Page 37 of 81

• Abdomen (stom ach area) - is co nside red to be th e best a bsorpt ion a rea

• Hip, lower back, buttocks – have a slower absorption than the abdomen, yet are

preferred for active users or those who have low body fat. Upper thigh, and upper arm - have a slower absorption than the abdomen,

•

although absorption rate may increase with activity. Interior thigh area should be avoided due to higher risk of irritation and infection.

Please Note: absorption capabilities. Please consult your professional healthcare team for the rates suited to you.

You ma y need to adjust your basal rates when using different areas with different

Warning:

1. Successful and effective insulin pumping is dependent on proper site management; by

2. Avoid insertion sites where belts, waistbands, or tight clothing may rub against the Patch.

3. A new infusion site should be at least 2" (5 cm)" away from the last site.

4. DO NOT apply the cradle within 2" (5 cm) of your navel (belly button) or waistline.

5. Avoid highly sensitive or highly mobile areas.

Solo User Guide_version 080911 Page 38 of 81

rotating insertion sites and changing site every time you changeyour Reservoir part. Doing so will optimize insulin absorption,and reduc e the potential for high blood glucose incidents, scarring and skin infections and long-term complications.

6. DO NOT apply the cradle on any of the following areas: scar tissue, lipohypertrophy, body piercing, over a mole, surgical scars, tattoo, liposuction site, bruising, or over a protruding bone.

7. It is recommended that you change your site early in the day to enable blood glucose monitoring (1) to two (2) hours after insertion to ensure correct placement of the cannula..

3.1.2.1.2 Instructions for Cradle replacement and Cannula insertion

a. Wash your hands thoroughly with soap a nd wate r before opening the Cradle

package. Clean the skin at the desired insertion site thoroughly with an antiseptic solution,

such as isopropyl or 70% alcohol, to minimize the risk of an infection. Start at the center of the site and gently rub outward in a circular manner.

c. Allow the area to air dry for at least 60 seconds; DO NOT blow on the s ite to help

it dr y fa ste r. d. Avoid touching the insertion site after cleaning it. e. Apply the cradle only after the area is dry. f. Hold the Inserter in one hand and lock the Cradle into it g. Wind the Inserter’s spring knob until it stops h. Insert the Cannula Cartridge into the Inserte r slot. i. Peel off the protective backing from the Cradle adhesive. j. Affix the Cradle to the skin at the desired insertion location. k. Pres s the <Go > butto n o n the In serte r for cannula insertion. l. Release the Inserter from the cradle by p ressing the release button. m. Remove the Cannula Cartri dge from the Inserter and discard it. n. Inspect the site and press on the adhesive tape to ensure proper adhesion to the

skin.

Warnin g

1. Avoid touching or breathing on the cannula cartridge

2. If experiencing any of the following, change insertion site: blood in the cannula

area, wet or leaky adhesive, rash, redness, itching, burning.

3. Check your in sertion site daily for irritation, redness, s oreness, or swelling (sig ns

of infection).

Solo User Guide_version 080911 Page 39 of 81

4. If the adhesive backing of the Cradle doesn't stick properly, consult with a

member of your professional healthcare team regarding methods of improving

adherence to your skin.

5. During pregnancy sets should be changed every 1-2 days due to the importance of

tight blood glucose control

6. The cradle should be changed immediately if ketones are present, if pain,

irrita tion , o r ble edin g oc curs , or if a bo lus has faile d to b rin g dow n an unex plain ed

elevated blood glucose reading (an injection should be given in addition to

changing the infusion set in this case).

Caution

: The Cradle is a disposable part for a single use only.

3.1.2.1.3 Detaching and Reconnecting Patch to Cradle

You may detach the Patch from the Cradle at a ny t ime you choose to do so. In order to keep the cradle's cannula connector and the Pump's connecting needle area clean, you are advised to cover those areas with the orange protection caps supplied.

If you wish to reconnect the Patch to an adhered cradle, simply remove the protection caps, clean the cradle connector and the Patch connecting needle area with an antiseptic solution, such as isopropyl or 70% alcohol swab and snap the Patch back into the cradle.

3.1.2.1.4 Removing the cradl e and adhesive backi ng

1. It is recomme nded that you remove your cra dle with warm water or oily o intment to loosen the adhesive from your skin.

2. Remove the adhesive by loosening all the edges and peeling it towards the center.

3. Inspect the cannula after removal to ensure complete removal.

3.1.2.2 Your Reservoir

The Reservoir part is a sterile single use component which connects to the pump to form the Patch.

The Patch is designed to be worn for up to 72 hours at a time. At the end of that time period, you simply remove the Patch, change the insertion site, and attach a new insulinfilled Reservoir to the Pump. The used Reservoir part is discarded.

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The replacement must be initiated via your remote control, so that all the necessary inform a tion is tra ns fer r ed in an or de rly fas hio n and th e ins ul in del ive ry is co ntin ue d.

3.1.2.2.1

Reservoir repl acement menu dire ctions

(Main ->

Maintenance -> Replace Reservoir)

Before replacing your Reservoir please enter the Replace Reservoir screen to verify proper data downloa d from your cu rrent Reservo ir part.

After communicating with the old Reservoir you are requested to fill you new Reservoir with insulin a nd re place you r old on e.

3.1.2.2.1.1 Instructions for filling yo ur Reserv oir

with insulin

Please Note: When you are ready to fill your Reservoir part, you should have all of your supplies ready.

These include: a new Reservoir part, a filling device, an insulin bottle and your remote control.

a. Handling the insulin

1. If you are using a new bottle of insulin pull the plastic cap from the top of the

bottle and discard it.

2. Write the date you opened the bottle on the bottle's label. Insulin expires

after 28 da ys and must be disca rded.

3. Check the insulin closely under bright light for lumps, crystals or discoloring.

If any of these are observed, dispose of the insulin and use a new bottle.

4. Use only room temperature insulin to fill your Reservoir.

b. Filling the reservoir

1. Fill your Reservoir in a room-temperature environment. If your Reservoir is

above/below that then allow it to be brought back into room temperature befor e fi l lin g it w i th in s ulin .

2. Pull the protective strip from the battery of the Reservoir part before filling.

3. Pull back the plunger of the filling device syringe to draw 2 ml of air.

4. Hold the insulin bottle upright in one hand (or on a table top) and the filling

device in the other hand. Connect the filling device to the bottle, by placing

Solo User Guide_version 080911 Page 41 of 81

its bottle slot over the bottle and pushing it down until it comes to a stop, indicating that the needle is fully engaged. Push the plunger slowly to inject the air into the bottle.

5. With the plunger still fully pressed down, turn the bottle upside-down. Then

pull out the plunger slowly to withdraw slightly more insulin than you actually need (2ml), so you can use it to remove any air bubbles. While the needle is still in the bottle, you can push insulin back into the bottle to remove any air bubbles, and may repea t this p rocess severa l time s as ne eded un til air bubble s are cleared.

6. With the needle still in the bottle (and the bottle still upside-down), tap the

side of the syringe gently. Any air bubbles will rise to the top. Then push the plunger in just enough to remove the air and the extra insulin. You should now have just the right amount of insulin in the syringe (2ml or 200 units) and no air bubbles. Double-check to make sure you have the right amount of insulin. Then disconnect the bottle from the filling device.

7. Hold the Filling device with one hand and the Reservoir part in the other.

Connect the Filling device to the Reservoir part matching the markings on both parts .

8. Hold the filling device, with the Reservoir part connected to it, in the upright

position, so that the Reservoir part is on top.

9. Fill the Reservoir slowly with insulin until you see one drop of insulin exit the

tip of the connecting needle.

10. Disconnect the Filling device and discard it.

Warnin g

Caution:

1. Avoid using insulin from more than one insulin bottle, wh ich may in troduce a ir into the syringe.

2. The filling device sh ould on ly be u sed to in ject ins ulin into the Res ervoi r before use. DO NOT inject anything besides insulin.

Do not use any other type of needle o r filling device besides the one provided with each Reservo ir.

2. Do not insert the filling device into the Reservoir more than once.

3. The filling device should only be used once and only with the intended Patch-pump Reservoir

c. Forming the Patch

1. Form the Patch by joining the filled Reservo ir part to the Pump part un til you hear a click sound from the patch.

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2. You are then requested to press <Done> to indicate replacement.

3. Press <Prime> when receiving a request to prime to verify proper function of the Patch. observe the connecting needle area to see a drop of insulin at the tip of the needle which indicates successful priming, and then press <Done>. If the drop is not v isible press <Re try>.

d. Snap the Patch into the Cradle. And press <Done> when finished to

begin insulin delivery

e. A confirmation message should appear indicating a successful

replacem ent and insu lin d eli very.

Warning during the day so you will be able to monitor your blood glucose levels approximately two (2) hours after replacement.

3.1.2.2.2

The Patch is formed by a Pump and a Reservoir part coupled together. Every 3 months you are requested to replace the two parts with a new Pump and a newly insulin-filled Reservoir. You will receive an alert and an alarm informing you of the scheduled replacement time.

We recommend you initiate the replacement via your remote control, so that all the necessary info rmation and data is s aved and transfe rred in an orderly fa shion to the new Pump.

: It is recommended that you change your infusion site and Reservoir part early

Your Patch

(Main -> Maintenance -> Replace Patch)

3.1.2.2.2.1 Instructions for Patch Replacement

a. Attach new cradle and insert cannula as instructed in section 3.1.2.1. b. Open the Pump package. c. Connect the filled Reservoir part (as detailed in section 3.1.2.2.1 and the Pump

to form the Patch. The two parts are correctly joined when you hear a “click”.

Wait for acknowledgement of communication from the RC. d. Enter your new Pump’s serial number into the remote control. e. Press <Prime> when receiving a request to prime to verify proper function of

the Patch. View the connecting needle area to see a drop of insulin at the tip

of the needle which indicates successful priming and then press <Done>. If the

drop is not visible pre ss <Ret ry>.

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f. You will receive a confirmation message from the remote control indicating

“Pump replaced successfully”. g. Snap the Patch into the Cradle. And press <Done> when finished to begin insulin

delivery h. Now your Solo™ System is up and running.

Warnin g

replaced properly, the old Patch may continue to deliver insulin as programmed putting you at risk of over delive ry and po ssible hypogly cemia.

: DO NOT apply a new Patch before you have removed the old one. If not

3.1.3 Insulin Delivery

There are two main insulin delivery regimens: 1) basal which provides a continuous steady backg round dose of insulin, an d 2) bolus which is a large dose of insulin normally administered to cover an amount of carbohydrates consumed during a meal or snack or to decrease high blood glucose values.

3.1.3.1 About Basal Profiles

A basal insulin dose is intended to provide a steady amount of continuous background insulin throughout the day and assist in maintaining target blood glucose needs and satisfy our normal da ily l iving requ iremen ts, as su pplied by a he althy pancreas .

Similar to other pumps the Solo™ uses short/rapid acting insulin.

Caution

1) The Solo™ shou ld only b e use d w ith 100 U/ ml ra pid ac ting insul in. The stability of other insulin drugs has not been proven.

2) Most people’s basal rates vary throughout the day. Contact a member of Study Doctor team t o set your basal profiles (a 24 hour basal rate profile)

Please see section 3.1.1.2.6 for instructions on how to set your basal profiles.

3.1.3.1.1 Activating Basal Profiles

You may act ivate a pre-de fined bas al prof ile, vi a the Se lect Basal screen. Each time you wish to change your basal profile, you are requested to activate it via the

Select Basal screen.

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(Menu ->S elect Bas al)

3.1.3.1.2 Temporary Basal Profiles

Basal rates can also be temporarily increased or decreased in set increments (as determined in the Personalize Pump settings menu section 3.1.1.2.5) for a desired time period (30 minutes to 8 hours) to support better control during illness, exercise or other situations that require a temporary basal adjustment.

Please Not e Reminder. A reminder will be set to alert you 15 minute prior to the end of temp basal time. In addition, the basal profile indicator on the upper bar will change to “T Basal”.

: You must set an actual value in at least one of the fields: Durat ion or

(Menu -> Te mp B asa l)

3.1.3.1.2.1 Setting and stopping a temporary basal profile

a. Enter the type of change you wish to make to the temporary basal rate - either

Ratio or an Amount.

b. If you choose Ratio, you will be able to increase or decrease your active basal

profile by a specified percentage. For example, if you intend to jog and would like to reduce your basal rate by 20%, you will choose Ratio and press the down navigation button until you reach -20%.

c. If you choose Amount, you will be able to increase or decrease your active basal

rate profile by a specified number of insulin units per hour, according to the basal increment you set in the “Personalize Pump” screen, section 3.1.1.2.5.

3.1.3.2 About Bolus Delivery

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A bolus is an extra large dose of insulin which is given as a booster before eating a meal or snack in order to re gulate the sudden rise in glucose levels generate d by carbohydrate consumption or to correct high blood glucose levels. As with any ins ulin delivery, you will need to exper iment and keep records to determine what works best for you.

When using the Solo™ pump, normal meal boluses under 15 units should be given 20 minutes before eating to achieve optimum post-meal control. In the occasions when a bolus above 15 un its is r equire d sta rt bolus deliv ery 40 m inutes before eatin g.

3.1.3.2.1 Bolus types

With the Solo™ you have the o ption to del iver several different bolus types according to your needs at an y specific meal: a Normal bolus and a Long bolus.

Warning

A Normal Bolus is a dose o f insulin which is delivered at once to co ver the carbohydrates consumed during a meal or snack, according to your carbohydrate calculation (see section

4.1.2).

1. You should always discuss your insulin delivery options with your professional healthcare team. Please turn to them fo r suggestions and guidelines.

2. If you attempt to deliver a normal bolus while the previous normal bolus you delivered is still active, the system will sound an alarm and will not deliver the bolus. You can del iver a nor mal bo lus on top of an a ctive lon g bolus.

3. If, by delivering the newly programmed bolus, you will exceed your maximum bolus value, an alarm will sound and you will have the option of changing the bolus dose, editing the maximum bolus value or of approving delivery of the requested do se.

4. If your Reservoir does not contain enough insulin to cover the bolus amount you programmed, an alarm will sound requesting you to either replace your Reservoir or edit your bolus amount.

3.1.3.2.1.1

Normal

(Main -> Bolus -> Normal Bolus*)

The increments of insulin can be set on the Personalize Pump menu (Please see Personalize Pump settings menu section 3.1.1.2.5).

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Please Note: You may also access the Normal Bolus screen through the left soft key on the main screen (set as a default manufacturing setting).

3.1.3.2.1.1.1 Delivering a Normal Bolus

a. Press the up and down navigation keys in order to choose your insulin bolus

dose. b. Once the desired amount is displayed, press the center <save> navigation key. c. Press the center navigation key once more, which now reads <Go> on the

screen. d. You have now delivered a normal bo lus, and will be directe d back to the main

screen. If you wish to stop the bolus delivery for any reason, choose “Stop

Bolus”.

3.1.3.2.1.2 Long

A Long Bolus is an ins ulin bolus delivered o ver a longer period of time. This type of bolus is suited for meals that are high in protein and/or fat and that require a longer digestion period. We should not give this information in the UM, it is the CDE Job. We do not want to take a responsibility on what to give when Long Bolus can be set for delivery over a period of thirty (30) minutes to eight (8) hours.

Please no te delivery type s tailo red to your l ifestyle.

: Consult with your professional healthcare team for suggestions for bolus

(Main - > Bol us -> Long Bolu s)

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Long bolus delive ry inst ructio ns:

a. Press the up and down navigation keys in order to choose your insulin bolus

dose. b. Press the left and right navigation keys in order to choose the required time

period in wh ich the bolus sho uld be delive red. c. Once the de sired dosage a nd t ime are displaye d, pre ss the cente r <save >

navigation key. d. Press the center navigation key once more, which now reads <Go> on the

screen e. You have now delivered a long bolus, and will be directed back to the main

screen. If you wish to stop the bolus de livery for any reason, choose “Stop

Bolus”.

3.1.3.2.1.3 Stopping a Bolus

When delivering a bolus of any type, the Solo™ main screen will display a “delivering bolus” ba r in dicati ng t hat a bo lus is be ing de live red.

a. To stop an active bolus, you must select the “stop bolus” button on the main

screen and press the center key, followed by a communication attempt. b. A "bolus stop ped" confirmation me ssage will appea r on the screen indica ting a

successful action.

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3.1.3.3 Record Your Blood Glucose Values

You may register your blood glucose readings in the Solo™ remote control. Your blood glucose measurement values are important for achieving full system

efficiency, enabling you to receive blood glucose related alerts and reminders (expected measurement time reminders, out-of-range alerts etc.) and retrieve relevant report and history data.

Please Note

be altered.

3.1.3.3.1 Blood glucose regist ry instructio ns

Check your blood glucose with your blood glucose meter and enter your measurement data manually in the Solo™.

: All test results which are saved are stored in the system's history and cannot

(Main ->

Menu -> Blood Gluco se)

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Blood glucose parameters

You will be reques ted to define the following p arameters which will be displa yed on the blood glucose reports and saved in the blood glucose history data:

a. Event –You can choose to label the measurement data by choosing

1. Activity

2. Normal

3. Pre / Post breakfa st

4. Pre / Post lunch

5. Pre / Post dinn er

6. Pre / Post sn ack

b. Glucose – Your blood glucose level in mg/dl or mmol/L (as per your system

definitions) c. Carbs – The carbohydrate range of the food you are about to consume. If not

meal rela ted th en do n’t ch oose a range. d. Time – The time of the blood glucose measurement (current time set as

default) e. Date - The date of the blood glucose measurement (current date set as

default)

3.1.3.4 Suspend/Resume Activity

Choosing to suspen d your insulin deliver y will stop all deliverie s including the ac tive basal flow and any bolus that is currently active.

In order to resume insulin delivery, you will need to choose Resume. Once resumed only the basal insu lin will be delivere d again (no t th e bolus th at w as sto pped) .

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Please note:

If you don’t have the remote control available, you may disconnect the Patch from

•

the Cradle to suspend insulin delivery. The insulin, however, will continue to drip from the connecting needle.

3.1.3.4.1

Should you decide to suspend insulin delivery, you may do so by using the suspend delivery option.

Please note:

You will be requested to set the reminder for resuming the insulin delivery.

•

• When suspend delivery is chosen, the “Bolus” button on the main page will change

to "Resume" for easy delivery resumption.

• Once you have defined the reminder, you will receive a confirmation message.

Warnin g

a. DO NOT disconnect the Reservoir from the Pump part during the Patch’s

b. You c an only sus pend for a period of up to tw o (2) hour s.

Suspending Delivery

operation period.

(Main -> Menu -> Suspend)

3.1.3.4.2 Protection Caps

Two orange Protection Caps are packaged with each Reservoir part. The Protection caps are used to cover the connectors of the Reservoir part and of the

Cradle when the Patch is removed temporarily from the Cradle during suspension of insulin delivery (such as for bathing), and protect them from contamination.

Please Note

in a clean container when not in use (e.g. clean bag, contact lenses case, film case etc.).

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: The caps are not sterile components but are reusable and should be stored

Instruct ions f or Use

a. After suspension of the pump or after disconnection of the Patch from the

cradle, place the caps o n th e a ppro pria te hollo w po ints on th e c radle a nd on

the Reservoir.

b. If you wish to reconnect the Patch to an adhered cradle, simply remove the

protection caps, clean the cradle connector and the Patch connecting needle

area with an antiseptic solution, such as isopropyl or 70% alcohol swab and

snap the Patch back into the cradle.

3.1.3.4.3 Resuming Delivery

1. In order to resume de livery, while the Patch is bac k in its c radle, h ighligh t the "Resume" button on the main screen, and press the center key, or enter the command from the Main -> Menu -> Resume screen.

2. A confirmation message will appear indicating successful action.

(Main -> Menu -> Resum e*)

3.1.3.5 Status

This screen provides a summary of the most recent system updates. If the status is not updated, it will state: status – not updated.

Parameters displayed:

Reservoir (U ) – Upda ted res ervoi r statu s Battery (%) – The charge d percentage est imation of the battery Bolus (U) – Most recent bolus with indication of type ('N'-Normal, 'L' - Long)

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(Menu -> Status)

Basal (U/hr) – Th e ac tive basa l rat e profile Reminders – The reminder nearest to alarming will appear in hh:mm hr and name Alerts – The alert nearest to alarming will appear in hh:mm hr and name

3.1.3.6 Reports

The Solo™ system saves and displays information needed for better diabetes management. You can view this information on the remote control

3.1.3.6.1

Blood Glucose History Report

(Menu -> Reports)

(Menu -> R epor ts -> B G

History)

The blood glucose report can be displayed is in the form of a table, with access to indi vidu al sin gl e- lin e re gi str ie s, at y ou r d isc re tio n.

The report will contain information for the past 30 days

•

The table will display the blood glucose value, date and time of measurement

•

In order to vie w a single-line reading, highlight the required registry and press

•

<Select>. The values are view-only and cannot be changed.

3.1.3.7 Device Maintenance

Adherence to maintenance instructions for the System ensures proper operation over the product lif etime.

When cleaning the external closures of the Patch or the remote control, please use a soft damp fabric.

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Caution:

Should you be required to replace your remote control, you need to also replace

•

your Pump part and navigate through the Pump Replacement procedure in order to identify the Pump with the new remote control.

• Only clean the outer shells, DO NOT attempt to clean any internal parts.

• Never use abrasive cleaners, solvents, bleach, scouring pads or sharp instruments

when cleaning your patch or any of its parts, as they can scratch, discolor, or damage the patch’s outer shell. If the outer shell is chipped or cracked, it may cause harm to the device and will require service.

• You should not use water and/or soap to clean the Patch.

• Your remote control and Patch are not water proof and should not be submerged in

water during bathing, swimming, or other water activities. We recommend that you disconnect from the Patch before coming in contact with water.

• Avoid the following in particular: i. Household cleaners

ii. Jewelry cleaner

iii. Petroleum-based products (such as gasoline)

iv. Products that contain high levels of D.E.E.T. (such as insect

repellents)

• If the display of the remote control becomes scratched, it may be difficult to read

and you will need to have it replaced.

• Avoid exposure of your remote control to temperatures above 140°F (60°C) or

below -4°F (-20°C).

• Insulin solutions freeze near 32°F (0°C) and degrade at high temperatures (>37°C).

If you are outside in cold weather, make sure the Patch which is adhered to your skin is covered with warm clothing. If you are in a warm environment, take measures to keep your Patch and insulin cool.

• Do not steam, sterilize or autoclave your remote control.

3.1.3.7.1 Remote Control Battery Replacement

The Solo™ remote control uses two AA alkaline batteries. Follow these simple steps for replacing your batte ries:

1. Open the batteries compartment door by sliding it outwards

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2. Remove the old batteries

3. Place a couple of new AA Alkaline batteries according to the + and – symbols inside the compartment

4. Close the battery compartment by sliding the door back on

Please Note

: when you install the new battery. You will need to perform the following

steps:

1. Set your pump clock to the correct time, date, and year (see the relevant Getting

Started chapter 3.1)

2. Check to make sure that all your settings, such as basal rate, are set as desired.

Caution

• The use of cold batteries may cause erratic pump behavior. To prevent this, do

not use batteries that have been in cold storage (i.e., in the refrigerator or your car in the winter). It takes several minutes for these batteries to warm to room temperature.

• Certain features on the remote control use a lot of battery power, therefore a

short battery life does not mean something is wrong with your system.

• The battery pow er varies and is base d on the f ollo wing:

i. The brand of battery you use (we recommend Duracell or

Energizer).

ii. The storage and /or handling of the battery before use (avoid high

or low temperatures).

iii. The usage of the remote control in cold temperatures; this may

shorten the battery life.

iv. Backlight - To conserve your battery, the backlight will turn off

automatically while the remote control is on and waiting for a keypress.

v. Remote control activity - amount of button presses, alarms/alerts,

status report viewing etc.

vi. Amount of insulin delivered.

• Use only a new AA alkaline battery. In order to ensure proper use and a longer life

duration we h ighly reco mme nd you do not mix o ld bat terie s w ith n ew on es an d us e the same battery brand for the two (2) batteries used each time .

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• Batteries contain harmful substances, such as acids and heavy metals. If batteries

are not correctly used, stored and discarded, these harmful substances may leak, or the batteries may overheat or burst.

• Batteries should be kept out of reach of children.

• Store batteries in their origina l packag ing in a c ool, dark place .

• Dispose of the used batteries in an environmentally safe way and according to any

regulations that may apply.

3. Help & Troubleshooting

3.1 Assistance & Help Line (24 hours)

The Study Sponsor and the Study Nurse provides assistance 24 hours a day, 7 days a week via the toll free XXXX number (1-888-676-5648). Certified assistants will answer your call and provide you with the necessa ry guidance for pump set- up and operation. In order for us to tend to your request efficiently, please have your pump and serial code available when contacting the service.

3.2 Alarms & Alerts List

When an alarm or alert is activated, the pump goes into attention mode and an alarm message will show on the screen of the remote control.

You are requested to read the alarm/alert text and then respond according to the soft keys available and actions required.

The following is the list of alarms respondin g to each :

Alarm Screen No. Action Required

"Alarm AM001: Insulin reservoir empty. Please replace Reservoir" "Alarm AM002: Res ervoir expired , pl ease replace" "Alarm AM003: Res ervoir expired , pl ease replace" "Alarm AM004: Reservoir error, please replace"

that may be sounded and the instructions for

Replace Reservoir part with a new fill ed Reservoir Reservoir passed 72 hours. Repl ace Reservoir part with a new filled Reservoir Reservoir passed 72 hours. Replace Reservoir part with a new filled Reservoir An error was detected in the Re servoir. Rep lace Reservoir part with a new filled Reservo ir

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"Alarm AM005 Bolus amount exceeds amount of insulin available. Please replace Reservoir"

"Alarm no. AM006: Pump failure, please replace pump" "Alarm no. AM007: Pump failure, please replace Pump"

"Alarm AM008: Pump expired, please replace Pump"

"Alarm no. AM009: Pump failure, please replace Pump" "Alarm no. AM010: Pump failure, please replace Pump" "Alarm no. AM011: Pump failure, please replace Pump" "Alarm no. AM012: Pump failure, please replace Pump"

"Alarm AM013: Previ o us bolus is still active. Stop bolus?"

"Alarm AM014: Bolus amount exceeds maximum bolus value"

"Alarm AM015 Basal amount exceeds maximum daily basal value "

"Alarm AM016: Illegal pas sw o rd"

Not enough insul in left for bolus am ount, Can either replace Reservo ir, edit b olus am ount or cancel bolus command An error was detected in the Pump. Replace Pump with a new Pump part An error was detected in the Pump. Replace Pump with a new Pump part The Pump has expired reaching 3 mont hs of use. Enter the Replace Patch screen and replace with a new Pump and Reservoir parts An error was detected in the Pump. Replace Pump with a new Pump part An error was detected in the Pump. Replace Pump with a new Pump part An error was detected in the Pump. Replace Pump with a new Pump part An error was detected in the Pump. Replace Pump with a new Pump part A previous normal bolu s is still acti ve. In order to prevent stacking insulin, second bolus not permitted in p arallel. Can eit her stop previo us bolus, or cancel second bolus com mand Bolus amount exc eeds the maximum bolus amount set in the Per sonalize Pump section. Can either continue to deliver bol us, alter the maximum bolus am ount or cancel bo lus Basal amount exc eeds the maximum Basal amont set in the Pers onalize Pump section for a profile. The password e ntered d oes not match the one defined in the remote contro l

"Alarm AM017: The fo llowing param eters were not set: "

"Alarm AM018: Please set time and date"

"Alarm AM020: Communication failed. To retry move to a different location and click retry"

A defined parameter was not set in the Personalize Pump sect ion

The time and date of the remote control need to be set The communicat ion betwee n the Patch and remote control has been unsucc essful. Try moving to another location and press Retr y.

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"Alarm AM022: RC bat teries empt y. Please replace batteries"

"Alarm AM023: Communication failure"

"Alarm AM025: Unexpected reset. Please call technical suppor t” "Alarm AM026: New Pump Not Detected. Please try again"

“Alarm AM027 : Blockage detec t ed. Please turn to user manual for fu rther instructions”

"Alarm AM028: communication failure. Status last updated on <time & date>"

The batteries in th e remote contro l are empty and need repla cing with new b atteries

The communicat ion betwee n the Patch and remote control has been unsucc essful. Try moving yourself with the remote control to another location an d press Retr y. An unexpected reset occurred. Call technical support New Pump not detected. Retry process until full completion Blockage/occlusion det ected int erferin g with insulin delivery. Check your blood glucose level, remove Patch from Cradle and perform a Reservoir replacement by entering Menu-> Maintenance -> Re place Reserv oir (see chapter

3.1.2.2.1). If th e alarm rea ppears cha nge the insertion site a nd repl ace Crad le. Monitor your blood g lucose clo sely and take an insulin injection if necessar y. Due to commun ication f ailure, t he statu s viewed is that of the last update

"Alarm AM029: Please s et at least one basal profile"

The following is the list of alerts to each:

that may be sounded and the instructions for responding

Alert Screen No. Action Required

"First Alert (AT001): Low insulin reservo ir"

"Second Alert (AT002): Low insulin reservoir" "Alert AT003: Reservoir will expire in 12 hours, please replace i t"

"Alert AT004: Pump wi ll expire in 24 hours. Please replace Pum p"

No basal profile s were set. At least on e profile needs to be set.

Appears after re aching the low reser voir amou nt defined in the Alerts settin gs Appears after reaching half the low reservoir amount defined in the Alert s settings

Appears 12 hours pri or to ex piry ti me

Pump is about to exp ire. Appears 24 hours prior to expiry date. You will need to enter the Replace Patch screen and replace both Pump and Reservoir parts

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“Alert AT005: No communication with Patch for 24 hours, please retry" "Alert AT006: Please log i n" Enter your password to activate remo te control "Alert AT007: Value exceeds ma ximum basal rate"

“Alert AT009: Low RC ba ttery. Please change”

"Alert AT010: You have used 50% of your total daily insuli n dose. W ould you like to continue?"

“Alert AT011: New Reservoir detected. D id you initiate it?"

Please Not e:

1. If you follow the steps r equested and still re ceive the same alarm or ale rt, call the 24 hour help-line.

Alerts if no successful communication was established in th e last 24 hour s

The value ent ered exc eeds t he maxim um ba sal rate set in the Personalize Pump section The remote control b atterie s are ru ndown. Change to new bat teries, see instr uctions at

3.1.3.7.1. Reminder of 50% us age of t otal da ily insu lin dose as set in the Personalize Pump section. Can either corr ect in sulin d ose or continue. A new Reservoir was detec ted without going through the Replac e Reservoir pro cedure. If not initiated by user, contact techn ical support

2. In addition to the alarms and alerts provided, the Solo™ provides you also with reminders that are user defined (see section 3.1.1.2.7 for Reminder Settings)

3.3 General Problem Solving Guide

3.3.1 Improper Patch attachment

If you are facing problems attaching the Reservoir to the Pump to form the Patch, detach the two parts and try again while following the instruction written in section 3.1.2.2.2.1

3.3.2 Improper Patch attachment to cradle

There are two latches holding the Patch and cradle together. Attach Patch to cradle by inserting the latch of the cradle on the side of the connecting needle first and then force it into the cradle in a horizontal position till it clicks in place. See drawing in section

3.1.2.2.2.1

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3.3.3 Insulin delivery not resumed after Patch or

Reservoir r eplacement

In order to resume insulin delivery you must complete the entire replacement procedure via the intended screens, until you receive confirmation of successful replacement.

For reservoir replacement see section 3.1.2.2.1 For Patc h re placemen t see s ec t i on 3. 1. 2.2.2.1

3.3.4 Electrical interference

The Solo™ remote control is designed to withstan d normal radio interference and electromagnetic fields. However, as with all wireless communication technology, certain operating conditions can interrupt communication. For example, electric appliances such as microwave ovens and electric machinery located in manufacturing environments may cause interference. In most cases, try moving the remote control and yourself to another location not near any appliance disturbances.

3.3.5 Electrostatic Discharge

The Solo™ electronic parts comply with international regulations an d designed to withstand a wide range of electromagnetic interferences. The Solo™ does not create electromagnetic field that may interfere with the operation of other medical devices nearby. The system was testes in accordan ce with Eu ropean an d US standa rds and found to be c ompatib le with t ho se stand a rds.

3.3.6 My bolus stopped...

1. The bolus stopped without me selecting the “Stop Bolus” button.

2. This can happen if the remote control or Patch is bumped or dropped during a bolus.

3. It can also happen if the remote control or Patch receives a static shock. As a safety measure, the Patch stops the bolus when this happens.

4. If you dropped your pump, visually inspect it to make sure that it is not damaged in any way .

5. Review your bolus history and reprogram the remaining bolus, if needed.

3.3.7 My remote control buttons are not

responding

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1. If a button is pressed longer then a few seconds the system will ignore it .

2. If remote control is on and buttons don’t respond, contact the 24 hour help-line.

3.3.8 I dropped my remote control

1. Check that all connections are still tight.

2. Check the screen, keypad and outer shell for cracks or damage.

3. Review the stat us screen, basal rates and other pump settings.

4. Call the 24 hour help-line for assi stance.

3.3.9 I dropped my Patch

1. Check that the Reservoir and Pump are still tightly connected together.

2. Check the outer shell for cracks or damage.

3. Call the 24 hour help-line for assi stance.

3.3.10 I submerged my Patch in water

1. Your Patch should not be deliberately submerged in water during bathing, swimming, or other water activities as it is not water tight.

2. Pat the outside of the case until dry.

3. Detach the Reservoir from the Pump and check the compartment and reservoir for water. If wet, dry it completely within ten (10) minutes of exposure to water. Exposure to liquids, including water or insulin can corrode the mechanism.

4. Dry the parts completely - do NOT connect a wet Reservoir to the Pump.

5. Do not use hot air to dry your Patch. This may damage the internal electronics.

3.3.11 I submerged my remote control in water

1. Your remote control should not be deliberately submerged in water during bathing, swimming, or other water activities as it is not water tight.

2. Pat the outside of the case until dry.

3. Open the battery compartment, remove batteries and check for water. If wet, dry it completely within ten (10) minutes of exposure to water. Exposure to liquids, including water or insulin can corrode the mechanism.

4. Dry the parts completely - do NOT connect any wet parts.

5. Do not use hot air to dry your remote control. This may damage the internal electronics.

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4. Appendices

4.1 Diabetes terminology

4.1.1 About Diabetes

Diabetes is a chronic illness that affects the body’s capabilities of handling glucose generated by the food we eat, which is our body’s main energy source. Insulin, produced by a healthy pancreas, burns the energy down so that it is used by the body cells, which is essential for proper body function. Impaired insulin effect can increase the levels of glucose in the blood (hyperglycemia), which can, if prolonged, cause serious damage to the body. Common complications of diabetes include visual impairment, kidney failure, angina, myocardial infarction, stroke, foot ulceration and erectile dysfunction.

There are two major types of diabetes, type-1 and type-2. Type-1 diabetes (also called juvenile diabetes or insulin-dependent diabetes) is caused by a lack of insulin, as the pancreas makes little or no insulin. Therefore, people with type-1 diabetes depe nd on da ily e xterna l ins ulin infusi on to sur vive. Type-2 (also called adult-onset diabetes or non-insulin-dependent diabetes) occurs when the body does not respond or cannot use its own insulin (insulin resistance). Type-2 diabetes is a progressive disease in which insulin production declines as the disease progresses.

4.1.2 Carbohydrate Counting

Your Solo™ system will assist you in controlling your blood sugar by delivering basal and bolus amounts of insulin when and as needed. Basal rates replace the background release of insulin from a normal pancreas (see Chapter 3.1.3.1). The amount of bolus insulin required for a meal or snack depends on how many carbohydrates are consumed (see section 3. 1.3.2 ) or give n as a corre ction bolus to redu ce an y high read ing that may o ccur.

The amounts of insulin you need should be calculated according to your Insulin Sensitivity (IS) rate, your Carbohydrate to Insulin Ratio (CIR), and the rules and guidelines provided by your healthcare professional for counting.

Calculating carbohydrates is done either according to servings (15 grams per serving) or grams. Once the CIR and IS factors are known, you can then estimate the insulin bolus amount you need to receive in order to cover those carbohydrates. Please consult with your physician or diabetes health care professional team to find the calculation method which is be st su ite d to y ou .

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4.1.3 High Blo od Gluco se ( Hyper glyc emia)

Blood glucose levels above 180 mg/dl (10 mmol/L) may be hazardous to your health. Insufficient delivery of insulin, high carbohydrate intake, lack of physical activity, illness, infection, stress and pump malfunction may be some of the reasons for hyperglycemia. Hyperglycemic incidents often require several correction boluses, less food, or more exercise to return the blood sugar to target.

Symptoms of Hyperglycemia - Treatment

Symptoms associated with high blood glucose tend to come on gradually. For this reason, they may be hard to recognize. A high reading on your glucose meter may be your first indication that blood glucose levels are running too high.

Symptoms: extreme thirst, more urine output than usual, shakiness, irritability, clammy skin, poor healing of wounds, flu-like aching, headache, nausea, vomiting, nervousness, coldness, fatigue, drowsiness, lack of energy, increased appetite, tingling in the hands lips or tongue, blurred vision.

In severe cases: Ketones in the urine (which can lead to DKA), “fruity” or acetone breath, rapid heartbeat, abdominal pain.

Treatment: Check your blood glucose every hour and treat high blood glucose as directed by your professional healthcare team until it is within target. Deliver a correction bolus, check for ketones and call your professional healthcare team if the results are positive. Check your insertion site for irritation, redness, soreness, or swelling (signs of infection). Drink at least 8 to 10 ounces (240 to 300 ml) of sugar-free, caffeine free fluids (water is preferable) every 30 to 60 minutes until blood glucose is below 240 mg/dl (14 mmol/L) and ketones are negative. Adjust basal rate(s), insulin-to-carbohydrate ratio(s), or correction factor(s) as indicated by your professional healthcare team as necessary.

Please note: One or more of these signs may warn you that you have high blood sugar. Warning signs can often be very subtle or you might think they are caused by other conditions. If you have warning signs of high blood sugar, even very subtle ones, do not ignore them.

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4.1.4 Ketoacidosis (Diabetic Coma)

Ketoacidosis (D KA) develops when your body does n ot have enough insulin. It is a critical situation that requires immediate hospitalization. Continuous subcutaneous (under the skin) insulin delivery pumps, such as the Solo™ system, use rapid-acting insulin which is delivered in small amounts throughout the day. In multiple injection therapy, long-acting insulin is generally injec ted several times a day.

The effect of ra pid-acti ng insulin is shorter and if the insulin de livery is interrupted fo r any reason, the blood sugar may rise ninety (90) minutes later, and within three (3) hours the blood insulin level will have fallen to about half of its original level. Lack of insulin means the body cannot use glucose for fuel and causes an energy crisis, where body cells start to use more and more fat for fuel. So, your body breaks down fats to use for energy. When your body breaks down fats, a variety of waste by-products, called ketones, are produced, and enter your bloodstream. Your body cannot tolerate large amounts of ketones and will try to get rid of them through the urine. following the interruption of insulin delivery from a pump, a dangerous acidic state called ketoacidosis begins, where the access ketones are built up in the body. Ketoacidosis is life-threatening and needs immediate treatment as it may lead to coma, shock or death. Symptoms include: shortness of breath, breath that smells fruity, nausea and vomiting, and a very dry mouth.

Four (4) to five (5) hours

When treating diabetes using an insulin pump, the risk of ketoacidosis is increased: rapidacting insulin can cause sudden changes, mechanical pump problems can occur, and defected insulin can be used. These occasions are very rare and your Solo™ system will alert you if an occlu sion or blo ckage is detected interfering with the correc t delivery of the insulin. Frequent blood sugar tests (four or more a day) are critical to detect these problems before they reach a critical stage.

Warning missing insulin, usually by an injection of rapid-acting insulin. Ask your professional healthcare team for instructions on handling interrupted insulin delivery.

: if insulin delivery is interrupted for any reason, you may need to provide the

4.1.5 Low Blood Glucose (Hypoglycemia)

A blood glucose level below 75 mg/dl (4 mmol/L) can be hazardous to your health and should be treated immediately by ingesting some form of quick-acting carbohydrate or lowering your basal rate. Low blood glucose can have several causes, such as delivery of too much insulin over a short period of time, not enough food ingested, strenuous activity, alcohol consumption, and others.

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You should check your blood glucose levels frequently in order to decrease the chances of such conditions and avoid their consequences, you cannot always prevent them. Should you register a low blood glucose value in your Solo™ (below your predefined low blood glucose target value), a reminder for checking your blood glucose level will be sounded as set in your Reminder Settings (see section 3.1.1.2.7).

Warning

1. Hypoglycemia requires immediate treatment, so that related seizures or loss of consciousness are avoided.

2. Consult with a member of your healthcare professional team on how to treat hypoglycemic situations.

3. It is highly recommended that you inform someone in your immediate surroundings on hypoglycemia and of the means of treatment as recommended by your healthcare professional team.

Symptoms of Hypoglycemia - Treatment

Mild Symptoms: Shakiness, sweating, dizziness, irritability, fast heart rate, pale skin, anxiety, headache. Treatment: The Rule of 15 grams of carbohydrate (examples: 4 ounces of juice, or 1 tbsp of honey, or 3-4 glucose tablets). You should also re-check blood glucose after 15-20 minutes; if not above 70 mg/dl (4 mmol/L), repeat treatment.

Moderate Symptoms speech, inability to cooperate, weakness. Treatment: Instant glucose gel or cake frosting gel, squeeze gel between gum and cheek and swallow, juice if able to drink, glucose tablets if able to chew and swallow, re-check blood glucose in 15 minutes; if no response, administer glucagon.

Severe Symp toms Treatment - Glucagon: train someone to administer glucagon as directed, review expiration date an d inst ructio ns of use, ca ll par amedics if ne cessar y, ca ll phys ician.

Warnin g: One or more of these signs may warn you that you have low blood sugar. Warning signs can often be very subtle or you might think they are caused by other conditions. If you have warning signs of low blood sugar, even very subtle ones, do not ignore them.

: Blurred vision, confusion, poor coordination, drowsiness, slurred

: Unconsciousness, seizures

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4.1.6 Self-Care

Insulin pump therapy holds many advantages to its user. We hope you are comfortable with using the system and that your blood glucose values have improved. Daily self-care is constantly referred to during insulin therapy and is associated with its management success. It is a daily, monthly and yearly process which helps you take some control of the situation. Self-care refers to your ability to properly hold the basic knowledge, acquire the skills and manage your responsibilities related to diabetes from blood sugar te sting to nu trition and re gular phys ical activity to a variet y of regular do ctor visits.

General tips

Please see following some general guidelines for self-care. Ask your professional healthcare team for the appropriate guidelines and instructions suited to you.

1. Test before driving and have a fast-acting carbohydrate with you when you drive

2. If your blood glucose level is above 250 mg/dl (13.9 mmol /L ) twice in a row, take an injection and change the cradle and cannula insertion site

3. Check 3:00AM blood glucose level at least once during the month

4. Check 2-hour post-meal blood glucose level for all meals on a given day (once a month)

5. Review blood glucose target values, meal plan and exercise every 3 months with your professional healthcare team

6. Repla ce Stan d-by Emergency Kit contents if expired

Frequency Target

Blood Glucose Checks 4-6 times a day and

always before bed

HbA1C Check Every 3 months < 7% Blood Pressure Every visit Under 130/60 mm/Hg LDL cholesterol* Yearly Under 100 mg/dL

HDL choles t erol Yearly Over 40 m g /dL Triglycerides Yearly Under 150 mg/dL Microalbumin/creatinine ratio (urine

protein) Visual foot exam Every 3 months Normal Complete foot exam Yearly Normal Retinal eye exam Yearly Normal Dental exam Every 6 months Normal

Yearly Under30 mg/g Cr

As defined by profess ional healthcare team

(With h e ar t - diseas e: u n d er 70 mg/ d L )

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Tobacco use Every visit No tobacco use Nutrition Meal plans Fol low dietary advice Body mass index (BMI) Every visit Under 25 (Under 26 for women, I

thought…)

Waist circumference Every 3–6 m ont h s Women: under 35˝

Men: under 4 0 ˝

Treatment plan review Every 3 months Accomplished Diabetes education Yearly Accomplished Flu vaccine Yearly Accomplished

Pneumonia vaccine Starting at age 65 Accomplished

Please Note

reduce your risk of heart disease — no matter what your LDL level is.

: If you are taking medication to lower your LDL, a drop of at least 30% is best to help

4.1.7 Total Daily Insulin Dose (TDD)

The total do se of insulin delivered t hroughou t the day is called TD D. This inc ludes bolu s and basal deliveries during a 24-hour day.

4.2 Ab normal Daily Use Guidelines

Following you will find various general behavior recommendations for abnormal daily situations. Consult with your healthca re prof es sion al team fo r any specific guide lin es and instruc tion s suite d to your needs.

4.2.1 Sick-Day Recommendations

If you are feeling ill, stressed or simply not yourself it may have an impact on your diabetes. Such situations require you to monitor your blood glucose quite closely. It is also very important to check for ketones in your urine or blood. Call your healthcare professional team for specific instructions.

Being ill does not necessarily mean you should stop your insulin delivery, even if you are too sick to eat, as your body still needs insulin, and often even more insulin then on a regular day. Obtain precise instructions from a member of your healthcare professional team with regards to your insulin intake and the following issues:

Your basal rate may need to be adjusted to achieve an d mainta in your tar get blood glucose

levels.

2) Your pre-meal/snack boluses may also need to be increased.

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3) You may need a higher insulin-to-carbohydrate ratio. Check your blood glucose often, and use your correction bolus as needed or as instructed by your healthcare professional team.

4) You may need to give your meal/snack bolus just after eating when you have nausea or vomiting. If you give your bolus before eating, you may not be able to eat the amount of food you planned, and you may have delivered more insulin than needed.

Warning

tenderness, redness or an uneven lumpy surface. Change your site and cardle with canula if necessary.

: Please inspect your cannula insertion site for infection signs, which may include

General Guidelines

• Check your blood glucose every two to four (2-4) hours, as directed by your healthcare professional team.

• Always have up to date ketone test strips available at your disposal, and check your ketones level in your urine or blood every two to four (2-4) hours or as directed by your healthcare professional team.

• Increase the amount of fluids to eliminate ketones, as per the guidelines received from your healthcare professional team.

• Keep caloric beverages handy to replace carbohydrates for times when you are unable to eat.

• Increase your non-caloric fluid intake if your blood glucose level is above 200 mg/dl (11 mmol/L).

• If your blood glucose and ketones remain elevated for more than three to four (2-4) hours, be sure to give a correction bolus of insulin by syringe or pen as directed by your healthcare professional team. Your correction factor may need to be adjusted.

• Call your healthcare professional team if you continue to have persistent nausea or vomiting for more than four (4) hours.

4.2.2 Travel Recommendations

1. You can use your patch while onboard a flight or going through airport metal

detectors.

2. Always ca rry you r suppl ies w ith you on boar d.

3. Upon arrival at your destination reset your time, time zone and date.

4. Take with you extra supplies for maintenance of the Patch and your

emergency kit as detailed in section 2.5. We recommend you take 1½ - 2 times your anticipated need.

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5. Make a copy of your general information as found in section 2 of this guide

and write down your healthcare professional team’s contact details in case of emergency.

6. Before you are scheduled to leave on your trip:

6.1 Call or visit a member of your healthcare professional team and discuss any

questions you have regarding your diabetes care while you are away from home.

6.2 Obtain written instructions for changes or adjustments you may need to

make while you are away from home.

6.3 Obtain written prescriptions for all your medications and supplies that you

carry with you. Bring the prescriptions with you on your trip. Ask your physician to use generic names of prescriptions if traveling out of the country.

6.4 Ask your prescribing physician for a letter stating you use an insulin pump

and are required to carry the listed items (all your prescriptions and supplies).

6.5 Contact your health insurance carrier and ask what you need to do if you

require medical attention while traveling. Find out what your coverage is inside and out of the country. Ask if you need supplemental healthcare insurance for the length of time you will be traveling. Your travel agent may be able to help you with travel insurance.

7. Supplies for you r trip:

7.1 Your usual rapid acting insulin (more than you think you will need) in

original box w ith presc ription label

7.2 New vial of intermediate or long-acting insulin in original box with

prescription label (for emergency use)

7.3 Insulin syringes/pens in case you need injections

7.4 Solo™ system supplies (be sure to bring more than you would normally use

for your amount of Patch changes)

7.5 New AA Alkaline batteries

7.6 Supplies for your glucose meter (strips/sensors, lancets, lancing device, log

book) and spare meter if possible.

7.7 Stand-by Emergency Kit – see section 2.5 (be sure that the person you are

traveling with knows how to administer the Glucagon®) - check with your healthcare professional team

7.8 Urine ketone test strips

7.9 Supplies that you use to treat low blood sugar (glucose tablets, fruit, snacks,

if allowed to leave plane/ship with it etc.)

7.10 Prescriptions for insulin pump supplies and other medications

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The Transportation Sa fety Administration (TS A) has provided guidelin es for travelers with diabetes who carry supplies for the airport security screening process:

1. Notify the Secur ity Off icer t hat you ha ve diabe tes an d are carryin g you r suppl ies with you. The following diabetes-related supplies and equipment are allowed through the checkpoint once they have been screened:

a. Insulin and insulin loaded dispensing products (vials or box of individual

vials, jet injectors, biojectors, epipens, infusers, and preloaded syringes;

b. Unlimited number of unused syringes when accompanied by insulin or other

inject-able medication;

c. Lancets, blood glucose meters, blood glucose meter test strips, alcohol

swabs, meter-testing solutions;

d. Ins ulin pu mp and insul in pum p suppl ies. The y mu st be acc ompan ied by

insul in . e. Glucagon emergency kit; f. Urine ketone test strips; g. Unlimited number of used syringes when transported in Sharps disposal

container or other similar hard-surface container. h. Sharps disposal containers or similar hard-surface disposal container for

storing used syringes and test strips. i. Insulin in any form or dispenser must be clearly identified.

2. If you are concerned or uncomfortable about going through the walk-through metal detector with your insulin pump, notify the Security Officer that you are wearing an insulin pump and would like a full-body pat-down and a visual inspection of your pump in stead.

3. Advise the Security Officer that the insulin pump cannot be removed because it is inserted with a catheter (cannula) under the skin.

4. Advise the Security Officer if you are experiencing low blood sugar and are in need of medical assistance.

5. You have the option of requesting a visual inspection of your insulin and diabetes associated supplies.

The Solo™ system complies with the European and United States Federal Communications Commission and international standards for Electromagnetic Compatibility.

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DO NOT turn on and communicate the remote control with the Solo™ Pump while on board an aircraft. Please not that you can NOT deliver bolus insulin doses, edit or enter parameters and transfer commands to the Pump. This device complies with European directive, harmonized standards and Part 15 of the American FCC Ru les. Operation is subje ct to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesirable operation. It does not interfere with any RF signals transmitted from outside sources. These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. Operation is subject to the following two conditions:

1. This device has been tested and found to comply with the regulations governing such devices in your area. For the specif ic regulation an d test re sults for your area, please contact your Study nurse.

2. This device generates, uses, and can radiate radio frequency energy and, if installed and used in accordance with the instruction, it may cause harmful interference to radio communications. If the device does cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures:

1. Move the remote control to a different location, not near any appliances.

2. Increase the separation between the Patch (worn on your body), the remote control and the device that is receiving/emitting interference. The Patch transmits information to the remote control using radio frequency. If other devices that use radio frequency are in use, such as cell phones, cordless phones and wireless networks, they may prevent communication between the Patch and the remote control. This interference will not harm your device but rather interrupt communication. Moving away from or turning off these other devices may allow correct communication. Refer to the Help & Troubleshooting chapte r 3, to correct interf erence proble ms yo u ma y have.

If you have questions, please contact your Study Nurse.

4.2.3 S ports Activ ity Reco mmenda tions

Maintaining balanced blood glucose levels relies on food intake, insulin regimen, exercise and activity amongst the rest.

The benefits of exercise are numerous and can help in controlling your blood glucose levels, weight, blood pressure, and cholesterol levels.

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Though exercise is generally highly recommended, you may be advised by your healthcare professional team to avoid any exercise when first using the Solo™, because it is important that the body activity is stable when setting the basal rate profiles, CIR, IS etc.

Even mild exercise can have an impact on your blood glucose. If you are an athlete or someone who exercises daily, you will most likely want to continue your usual activities and adjust your insulin delivery to meet your active lifestyle.

In general, blood glucose levels tend to decrease during exercise. Since your body is working harder and burning calories, you need less insulin to keep your glucose levels at your tar ge t.

Changing your basal insulin levels on an insulin pump is easily accomplished before/after or during exercise, by using the Temp Basal option see section no. 3.1.3.1.2.

If you exercise regularly, you can program a separate 24-hour basal profile with specific rates for the times you exercise.

With exercise, you may need to adjust your meal boluses and/or eat extra carbohydrate prior to or during your exercise. Discuss your specific needs with a member of your professional healthcare team and frequently check your blood glucose levels to help determine what works b est for you.

Over time, you and your professional healthcare team will determine what works best for you b y keepin g records which t rack you r activi ty type and inten sity al ongside your bloo d glucose levels, carbohydrate consumption, and other food intake. Keep in mind that very strenuous exercise can actually result in higher blood glucose levels. The release of stress (counter regulatory) hormones from very short but intense exercise, like a competitive event, may require more insulin. Again, keeping detailed records will help determine your exercise management regimen.

Warnin g:

1. Before starting a certain exercise program, obtain a physical assessment and

evaluation test from your professional healthcare team. You may want to consult with an exercise specialist who is experienced in working with diabetes. A Registered Dietitian (RD)/Certified Diabetes Educator (CDE) can provide guidelines for carbohydrate adjustments prior to, during and after exercise.

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2. Always wear medical identification when exercising.

3. Consider exercising with another person or group just in case you need

assistance.

4. Keep carbohydrates close at hand to treat low blood glucose.

5. Do not exercise when your blood glucose is above 250 mg/dl (14 mmol/L) with

ketones. Ask you r profes sional healthca re team for spe cific in structions.

6. Keep detailed activity records to help Study Doctor determine the program

suited to you. Various levels of a sport or activity require different basal rates. The basa l rate change is affected by the duration and intensity of the sport, your current blood glucose reading, your target blood glucose level, the time and amount of your last bolus, and the time, amount, and type of your most recent meal or snack. Checking your blood glucose every 4 hours for the next 24 hours up to 36 hours after exercise will help you determine the “lag effect” of your exercise. It may take several months to determine the changes and adjustments that work best for you.

Caution: parts in water. Before bathing, sw imming or doing any water activity, you must remove the Patch and place the remote control aside.

The Solo™ system’s components are not waterproof; DO NOT immerse any of its

4.2.4 Emergency Room Recommendations

Should you be cared for in an emergency room, you will need to inform the medical emergency staff of your insulin pump use, the type of insulin used, the basal profile rates, most recent bolus deliverie s, and pers onal paramet ers such as CIR, IS, ta rget blood glucose level etc.

You should also show the physician your blood glucose records, and inform their of your last insertion site change, and inspect insertion site.

Warnin g

take responsibility for the insulin pump. Interrupting the delivery of insulin via the pump without providing an alternate delivery of insulin may lead to the rapid development of hyperglycemia, ketonuria or DKA due to a lack of insulin.

: Insulin pump therapy should be maintained if the pump user is alert and able to

The insulin delivery may be temporarily discontinued if the pump user or their accompanying person in unable to manage their pump therapy.

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For Physicians and Medical Staff:

Document pump removal or tem porar y di scontinuation of insulin pump therapy. Include in your documentation:

1. Condition of the infusion site. Note the presence of inflammation, induration,

tenderness, or drainage at site.

2. Document all details of the person placed in charge of safekeeping the pump. Include

full name and relationship to pump user. Note if the Solo™ is placed in a secured hospital safe.

Prompt treatment of hyperglycemia is essential

1. If the Pump user has delivered a correction bolus and blood glucose has not started to

decrease within one hour:

1.1 The pump user should perform a complete Reservoir change alongside insertion site

change.

1.2 Administer insulin by standard injection or insulin IV infusi on per hospital protocol

1.3 Test for ketones when blood glucose is higher than 250 mg/dl (14 mmol/L). Treat per

protocol.

1.4 Monitor blood glucose every two hours or per protocol.

The most common causes of hyperglycemia and ketonuria in insulin pump users include

1.5 Missed meal/snack bolus(es)

1.6 Failure to treat hyperglyc emia appropriately

1.7 A blocked Cannula (catheter) or occlusion/blockage in Reservoir

1.8 Failure to change infusion site

1.9 Decreased absorption from site

1.10 Decreased insulin potency in Reservoir

1.11 Site irritation

1.12 Failure to change the insulin Reservoir when empty

1.13 Loss of insulin potency (may be due to extreme temperature changes or expired

insulin)

1.14 Interruption of insulin delivery due to unknown cause (may include x-rays, MRIs, and

CAT scans damaging pump)

X-rays, MRIs and CT scans

2. Never expose the insulin pump directly to x-ray beams.

3. The pump should be temporarily removed for MRIs or CAT scans.

4. Follow documentation guidelines previously outlined and note the time the pump was

removed as well as the time it was reconnected.

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5. The pump user may need to replace the basal units which were missed while

disconnected. This is done as a correction bolus after reconnecting if blood glucose is above target value.

Caution: Avoid strong electromagnetic fields, like those present with Magnetic Resonance Imaging (MRI), d irect x-ray , a nd ultrasound a s they ca n affec t how the Solo ™ works. If you cannot avoid them, you must take the Patch off.

4.2.5 Outpatient Surgery Procedures (including

dental procedures/surgery)

Before your procedure or surgery

1. Notify the physician who manages your diabetes that you are having an outpatient

test, procedure, or surgery.

2. Provide your physician with the date, location, name(s), and phone number(s) of the

physician/technician who is performing y our test, pr ocedure, or surgery.

3. Discuss with your physician whether or not you should wear your pump during your

procedure or surgery.

X-rays, MRIs and CAT scans

1. Never expose the Patch directly to x-ray beams.

2. The Patch should be tempora rily removed for MRIs or CAT scans.

Caution Imaging (MRI), direct x-ray, and ultrasound as they can affect how the Patch works. If you cannot avoid them, you must take the Patch off.

: Avoid strong electromagnetic fields, like those present with Magnetic Resonance

3. Be sure to discuss your diabetes management during your outpatient visit with your

professional diabetes healthcare team (physician, certified diabetes educator) prior to your procedur e or surgery. Allow enough time to make an y necessary ch anges in your management plan.

4. Some procedures and surgeries may cause hyperglycemia (high blood glucose) and

increased insulin requirements or hypoglycemia (low blood glucose) and decreased insulin requirements. Develop a plan of action for before, during and after your procedure or surgery. This may include temporary basal rate changes, or using an alternative 24-hour basal rate profile.

If you continue to wear your patch during your pr oc edure or surgery:

1. Review all your alert settings, including low Reservoir, max basal and bolus limits,

blood glucose reminders, automatic off, site reminder, and missed meal bolus alert(s). Remember to re view you r te mp orary ba sal ra te re mi nde r if ne ce ssa ry. Rep rog ra m you r

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temporary basal reminder and alerts settings as needed before and after your procedure/surgery.

2. Inform the technician, physician, surgeon, and/or anesthesiologist that you are using a

Solo™ insulin patch-pump. Provide the following information:

2.1 The name and phone number of the physician who manages your diabetes

2.2 the type of insulin you are using in your pump

2.3 Your target blood glucose level

2.4 Your basal rate settings, correction factor, and insulin-to-carbohydrate ratio (if

needed)

2.5 The 24-hour help line phone number, in case your pump beeps or vibrates

unexpectedly and you are not awake

2.6 Explain that your insulin pump delivers a basal or continuous dose of insulin to

maintain your blood glucose levels when fasting and between meals. Continuing insulin pump therapy during outpatient procedures/surgery provides the most consistent delivery of insulin.

3. Your blood glucose levels should be monitored prior to, during and after your

outpatient procedure or surgery. If the procedure or surgery is longer than two (2) hours, additional glucose monitoring may be necessary.

4. If your blood g lucose levels are above 250 mg/dl (14 mmol/L) during your procedure or

surgery, replacement insulin can be ordered by your physician and provided by subcutaneous injection or intravenously. Your physician may use your correction factor to calcu l at e the ap p r op r i ate dose of ins uli n .

5. Hypoglycemia (blood glucose below 70 mg/dl [4 mmol/L]) during a procedure or

surgery can be treated by the administration of intravenous glucose as per hospital or facility policy.

After your outpatient proced ure/surgery

1. If you changed any of your pump settings for your procedure or surgery, reprogram

your Solo™ settings. Review your settings to make sure they’re correct.

2. Increase the frequency of your blood glucose monitoring. When your blood glucose

levels are stable and/or within your target, you may be advised to re turn to your usual blood glucose checking regimen.

3. Follow your physician’s instructions.

4. Keep your professional healthcare team informed of your diabetes status after your

procedure or surgery.

5. Pro vide your blood glucose resul ts, food intake, e tc. so that approp riate adjustme nts

can be made to help expedite your recovery.

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4.2.6 Inpatient Ho spitaliz ation Recommendatio ns

Overnight hospital stays have a direct impact on your diabetes control. Continuing insulin pump therapy during hospitalization provides the most efficient and predictable delivery of insulin and, when used appropriately, increases favorable outcomes.

Insulin pump therapy in the hospital

1. Insulin pump therapy should generally be maintained if you are alert and able to

manage your Solo™ insulin patch-pump. Your physician will determine if you are to continue pump therapy during your admission.

Warning

alternate delivery of insulin may lead to the development of hyperglycemia (high blood glucose). Untreated hyperglycemia and lack of insulin can lead to ketones in the urine (ketonuria), coma, and death.

2. Inform the appropriate hospital staff that you ha ve diabetes and are using an insulin

3. Provide the admitting physician, consultant physicians , nurses, e tc. with the name an d

4. The hospital must obtain orders from your diabetes physician allowing you to continue

5. Bring diabetes and pump supplies with you, including batteries, Reservoirs, Pumps,

6. Inform the nursing staff of the following:

6.1 Per your physician: your basal rates, insulin-to-carbohydrate ratio(s), insulin

6.2 The type of insulin you are using in your Solo™.

6.3 The location of your cannula insertion site and how often you perform site and

6.4 The number and times of blood glucose checks you perform each day.

6.5 The 24-hour help line phone number for any te chnical assistance with the Solo™ that

6.6 Circumstances warranting temporary discontinuation of insuli n pump therapy:

6.6.1 When you are unable to manage the Solo™

6.6.2 X-rays, MRIs, and CAT scans - Never expose the insulin pump directly to x-ray

: Interrupting the delivery of insulin via the remote control without providing an

pump

phone number of the physician who manages y our diabetes.

your insulin pump therapy.

cradles and cannula cartridges, filling devices, site prep and dressings. Do not bring insulin with you, as this will be prescribed by your physician during your hospital stay.

sensitivity factor(s) and target blood glucose levels.

Reservoir changes.

may occur in case you are not awake and the Patch is beeping unexpectedly.

beams. The pump should be temporarily removed for MRIs or CAT scans. Discuss safe-keeping of your insulin pump with the nursing staff prior to the x-ray scanning procedure.

Solo User Guide_version 080911 Page 77 of 81

Caution: Avoid strong electromagnetic fields, like those present with Magnetic Resonance Imaging (MRI), direct x-ray, and ultrasound as they can affect how the Patch works. If you cannot avoid them, you must take the Patch off.

7. Check your blood glucose before you disconnect, and treat as needed. When you

reconnect, you may need a correction bolus to cover the missed basal insulin while you were disconnected.

8. Check with your physician regarding documentation and treatment of hypoglycemia.

You may be given permission to keep glucose tablets or other appropriate treatment at your bedside. Confirm hypoglycemic symptoms with your glucose me te r , and notify the nursing staff of the results. Unless you are severely hypoglycemic, you should not need to disconnect from your Solo™ Patch. Disconnection may lead to hyperglycemia several hours later due to a lack of basal insulin.

9. Fol l ow the “Rule of 15” to treat low blood glucose:

9.1 Consume 15 grams of carbohydrate; for example, 4 ounces juice, 4 ounces non-diet

soft drink or 3-4 glucose tablets. Re-check blood glucose in 15 minutes. If blood glucose is not above 70 mg/dl, repeat treatment.

9.2 If you are disconnected from the Patch for extended time periods, you must be provided with

an alternative insulin delivery to avoid the development or worsening of high blood glucose, which could lead to the development of ketones. Insulin can be taken/given by injection (subcutaneously) or IV (intravenously). When disconnected for any reason, your Patch and remote control should be stored safely, preferably at home.

Solo User Guide_version 080911 Page 78 of 81

5. Glossary

No. Word/Phrase Explanation

1 Basal Profi le There are 7 different basal profiles the user can determine for different days or

even different t imes of the day. i.e. on a weekend, during sport activities etc.

2 Basal Rate A steady trickle of low levels of insulin

3 Blood Gluc ose The main sugar found in th e blood and the body's main s ource of energy. Also

called blood sugar.

4 Blood Glu c ose Level The amount of glucose in a given amount of blood. It is noted in milligrams in a

deciliter, or mg/dL.

5 Bolus Types There are two different bolus types: Normal and Long. A bolus is an extra

amount of insulin taken to cov e r an ex pec te d ri s e in bloo d glucose, often related

to a meal or snack. 6 Hypergl ycem ia Excessive bl ood glucose. 7 Hypoglycemia A condition that occurs when one's blood glucose is lower than normal, usually

less than 70 mg/ dL. Signs include hunger, nervousness, shakiness,

perspiratio n, diz ziness or light-hea ded ness, sleepiness , and confusion. If left

untreated, hypoglycemia may lead to unconsciousness. 8 Insulin A hormone that helps the body use glucose for energy. The beta cells of the

pancreas make insulin. When the body cannot make enough insulin, insulin is

taken by injection or through use of an insulin pump. 9 Long Bolus A steady amount of insulin delivered over a certain period of time, in bolus form 10 Normal Bolus A steady amount of insulin delivered immediately in bolus form

11 Temporary Basal A basal ratio defined by the user to cover a certain abnormal condition wher e

the predetermined basal rate needs altering. Example: Due to a 3-hour hike, Jo

needs to reduce his basal rate by 20% for 3 hours 12 Type- 1 Diabetes A condition characterized by high blood glucose levels caused by insufficient

insulin. Occurs when the body's immune system attacks the insulin-producing

beta cells in the pancreas and destroys them. The pancreas then produces little

or no insulin. Type 1 diabetes develops m ost often in young people but can

appear in adults. 13 Type- 2 Diabetes A condition in which the beta cells of the pancreas produce insulin but the body

is unable to use it effectively because the cells of the body are resistant to the

action of insulin.

Solo User Guide_version 080911 Page 79 of 81

6. Technical Specifications

This section provides detailed information on specifications related to y our Solo™ patch and remote control.

Technical Parameters

Usage Period Pump 3 months Reservoir, Cannula

cartridge, cradle, filling adapter

RC 4 years Reservoir Capacity Patch

Volume 180 IU

Footprint <40mm (W) x 60mm (L) x 12mm (H) Weight <25 gr Water resistanc e Not water resistant Weight <140 gr Water resistanc e IP6 Dimensions 30 x 40 mm Radio operation range at least 2 meters Memory 90 days of data Communication Seamless to the user (wake on radio) Display Screen Color LCD with backlight

48-72 hours

Delivery

Solo User Guide_version 080911 Page 80 of 81

Flow rate Accuracy NLD 5% for 3 days Rate variance Delivers various rates of bolus and basal Lowest basal increment 0.05 Flow set by the user Minimal basal rate 0.05 U/hr (vq: 0.025 mm3 – when

administrated every 3 minutes) Maximum basal rate 24 U/hr Minimum basal profiles 4 Bolus rate >0.4 U/min Drug administration frequency Total daily Insulin dose Set by the user

1 per hour (@ low basal rate) to 20 per

hour (@ high basal rate)

Insulin types Humalog ®

Alarm indications Patch buzzer (=>61 DB @ 10cm) Insertion Insertion sound < 85 DB @ 10cm Cannula

Environment of Operation Temperature -5°C to 45°C (14°F to 131°F) Atmospheric pressure Humidity Maximum relative level of 90% humidity (non-condensing) at a

RC Buzzer and message screen

Material Teflon Insertion depth 9mm Outer diameter 26 gauge

70 kPa (or 10,000 feet above sea level) to 106 kPa (10.2 PSI to 15.4 PSI)

temperature of 32 +/- 2°C

Solo User Guide_version 080911 Page 81 of 81

Medingo 07SOLORP3, 08SOLORC3 Users Manual

Specifications and Main Features

Frequently Asked Questions

User Manual