User's Guide

6 7

2. Explanation of Warning Symbols

1. Introduction

1. Diabecare DANA-i Insulin Pump Introduction

3. Indications for Use

4. Contraindication

5. Potential Risks

The Diabecare DANA-i Insulin Pump herein after will be referred to as ‘Insulin Pump’

throughout the manual.

The Diabecare DANA-i Insulin Pump is intended for the subcutaneous delivery of insulin,

at set and variable rates, for the management of diabetes mellitus in persons requiring

insulin. The Diabecare DANA-i Insulin Pump is not intended for use with blood or blood

products. The pump is able to reliably and securely communicate with compatible, digitally

connected devices, including automated insulin dosing software, to receive, execute, and

confirm commands from these devices.

The pump is intended for single patient, home use and requires a prescription. The pump

is indicated for use with NovoLog/NovoRapid U-100 Insulin. The pump is intended to be

used both alone and in conjunction with digitally connected medical devices for the

purpose of drug delivery.

Insulin Pump therapy is not recommended for people whose vision or hearing does not

allow recognition of pump signals and alarms.

• Infection

• Skin irritation or redness

• Bruising

• Discomfort or pain

• Bleeding

• Irritation

• Rash

• Hypoglycemia

• Hyperglycemia

Warning The Diabecare DANA-i system is only to be used by patients who have

received training from a certified diabetes educator and/or insulin pump trainer and by

advice from a physician.

For safety and optimum benefits read the entire user manual before using the system.

Caution Read these instructions for use carefully and completely before using this

device for the first time. Especially, users who have used other pumps should be

cautious.

Warning Indicates the presence of a hazard which can cause severe personal injury,

death or substantial property damage if the warning is ignored.

Caution Indicates the presence of a hazard which will or can cause minor personal

injury or property damage if the warning is ignored.

Warning

Caution

Notice

Advises the user of installation, operation or maintenance information which is

important but not hazard related.