If Innovo® has been dropped or knocked, you must carry out a function check (see " Function check " section).

Innovo® insulin doser should only be used in combination with products that are compatible and allow Innovo® to function safely and effectively.

PenFill® 3 mL cartridges and NovoFine® needles are designed to be used with Innovo® insulin doser.

Needles and cartridges not included.

Innovo®, PenFill® and NovoFine® are trademarks owned by Novo Nordisk A/S.

Protected by US Patent Nos. 5,957,889; 5,961,496; and 6,045,537. Additional patents pending.

The CE-mark on a medical device indicates that the product conforms with the provisions in the EC Directive for Medical Devices 93/42/EEC. Innovo® fullfils the specification limits for dose accuracy according to ISO 11608 -1 Pen-Injectors for Medical use, Part 1: Requirements and test methods.

Contents

Introduction

Getting started

Priming Innovo® by doing an air shot

Choosing your dose

Giving the injection

Checking your previous injection

Subsequent injections

What to do when PenFill® is nearly empty

Changing PenFill®

Function check

What do I do if...?

How to store and look after your Innovo® insulin doser

Display information

Important information

Warranty information

Introduction

Thank you for choosing Innovo®, the insulin doser designed to make insulin therapy easier to live with.

This manual contains instructions for using, storing, and cleaning your Innovo®. Here are some of the unique features Innovo® has to offer:

Easy to carry. Innovo® is short and compact, making it easy to carry in your pocket or purse.

Easy to inject. Innovo® is designed to fit perfectly in your hand, and is ideal for making quick and discreet injections.

Easy to read. The display on Innovo® is large and clear, making it easy to read the dose of insulin dialed and delivered.

Easy to remember. Innovo® has a built-in memory function, displaying your previous dose of insulin and the time passed since your last delivery.

Easy to dial. Innovo® is accurate and can easily be dialed to deliver doses from 1 to 70 units, in steps of 1 unit.

Easy to change dose. The insulin dose can easily be changed without wasting insulin simply by dialing up or down.

Easy to change PenFill®. Innovo® is specially designed for the easy changing of PenFill® 3 mL cartridges and NovoFine® needles with a length of up to 8 mm.

Easy reminders. Innovo® has a battery that lasts for about 5 years from manufacturing date when used at a rate of four daily injections (including the priming air shots). After this time, the display flashes to tell you that Innovo® will expire.

Be sure to replace Innovo® within 30 days. The battery cannot be changed. This is to guarantee quality and safety at all times.

Thank you for choosing Innovo®. It is important that you follow the instructions carefully to make insulin therapy as easy to live with as possible.

Please complete and return the Innovo® warranty card.

Customer service and satisfaction are our top priority. If you have any questions about your Innovo®, please call Novo Nordisk Pharmaceuticals, Inc. Our toll free number is 1-800-727-6500.

Getting started

Pull off the cap. Put the cap to one side and keep it. You will need to replace the cap after your injection.

The very first time the cap is pulled off, the display stays blank until the slide is opened.

Make sure that the push button is pressed completely in. A Otherwise the slide will be locked.

Open the slide in the direction of the arrow shown below. B

The display now shows 0.

In the PenFill® Information For The Patient you will find instructions on how to:

• check that PenFill® is full and intact. If not, do not use it.
• resuspend the insulin, if PenFill® contains an insulin suspension (cloudy insulin).

Use only a new PenFill® when loading Innovo®. Never load a partially filled PenFill®. Never try to refill a used PenFill®.

Put PenFill® into Innovo® by pushing it slightly backwards as shown. The end with the rear rubber stopper goes in first.

Make sure that the threaded plastic cap fits firmly into place.

Close the slide completely. The release button is locked until the slide has been closed.

Keep the slide closed until PenFill® is empty.

Wipe the front rubber stopper with an alcohol swab.

Never place a NovoFine® needle on your Innovo® until you are ready to prime Innovo® by doing an air shot before giving an injection.

Take the protective tab off a NovoFine® needle and screw the needle tightly onto the threaded plastic cap.

Pull off the outer and inner needle caps. Do not bend or damage the needle before use.

Priming Innovo® by doing an air shot

Always prime your Innovo® by doing an air shot, to ensure the insulin flow:

• before each injection
• after changing PenFill®
• after changing the needle
• after opening and closing the slide.

It is important that insulin appears at the tip of the needle before you make your injection. Otherwise you will not receive the full insulin dose.

How to prime your Innovo® by doing an air shot

1. Make sure that a needle is mounted, the push button is pressed completely in, and the slide is closed. If the slide is not closed, the release button will be locked.
2. Press the release button A . You will see that the push button jumps out.
     
3. Dial 1 unit B .
     
   When inserting a new PenFill®, start with 8 units.
   After opening and closing the slide you will need to dial a larger number of units, depending on the amount of insulin left in PenFill®.
4. Hold Innovo® with the needle upwards and tap the slide gently with your finger a few times C .
5. Press the push button completely in until it locks D .
6. A drop of insulin should appear at the needle tip.
7. If not, repeat the priming procedure dialing 1 unit. Repeat until a drop of insulin appears.
     

Choosing your dose

Make sure that a needle is mounted and that the push button is pressed completely in.

Press the release button A and the push button will jump out. The display will show 0.

Dial the number of units you need by turning the dose selector at a steady speed B . In this example a dose of 10 units has been dialed.
The number of units you have dialed is shown in the display. You cannot use the clicks as you dial to determine the dose.

Changing a dose

If you accidentally dial a larger dose than you need, dial back to the correct number of units. The dose dialed can be changed until you press the push button.

Canceling a dose

If you want to cancel a chosen dose, dial back to zero and press the push button completely in. Your last delivered dose (or priming air shot) and the time passed since its delivery will reappear on the display.

Giving the injection

Follow the injection technique recommended by your Health Care Professional.

To inject, press the push button completely in until it locks. You may feel that it becomes a little harder to press the push button towards the end of the injection. This is normal.

Do not change the dose after you have pressed the push button.

With all insulin injection devices the needle should be left under the skin for at least 6 seconds to ensure that the full insulin dose has been delivered. Innovo® helps you to do this by providing a built-in timer.

When the push button is pressed completely in, the segments turn on two by two telling you to leave the needle under your skin.

When the circle appears, the full insulin dose has been delivered and you can withdraw the needle.

After you have withdrawn the needle, a few drops of insulin may appear at the needle tip. This is normal and has no effect on the dose delivered.

After the injection follow the instructions of your Health Care Professional to:

• carefully replace the outer needle cap on the needle.
• unscrew the needle and discard it properly.

Always replace the cap after using Innovo®.

Checking your previous injection

Pull off the cap.

After the display test, your previous dose (or priming air shot) and the time passed since delivery can be seen on the display. Each timer segment represents 1 hour.

For example, if 4 segments are displayed, more than 4 hours have passed since the previous injection.

If 12 segments are displayed, more than 12 hours have passed. In this example the display tells you that a dose of 10 units were delivered more than 12 hours ago.

If the last thing you did before replacing the cap was to dial a dose, this dose will appear on the display.

Always replace the cap after using Innovo®.

Subsequent injections

Pull off the cap.

When the cap is pulled off, all the display symbols are turned on telling you that the display is fully functioning.

Your previous dose (or priming air shot) and the time passed since delivery then appear on the display.

Check that Innovo® contains the type of insulin you want to inject.

If PenFill® contains a soluble (clear) insulin, follow the instructions from " Getting started " section in this manual.

If Innovo® contains an insulin suspension (cloudy insulin), you must turn Innovo® up and down between position A and B - as shown in the picture.

The movement must be performed so that the glass ball in the cartridge moves from one end to the other.

Do this at least 10 times, until all the liquid is white and uniformly cloudy.

Then carry on as shown from " Getting started " and inject shortly after resuspending the insulin suspension.

What to do when PenFill® is nearly empty

Do not try to inject an insulin suspension (cloudy insulin) if the rear rubber stopper is below the arrow marks on the slide as shown in the picture. The glass ball must have adequate space to resuspend the insulin.

Innovo® will not let you dial a larger dose than that remaining in PenFill®.

Do not force the dose selector to turn; instead change PenFill®.

If you need more insulin than the amount in the cartridge, you can either:

• change PenFill® and inject the whole dose at once,
  or
• inject the remaining insulin and insert a new PenFill® cartridge for the rest of your dose.

Change PenFill® as described in the " Changing PenFill® " section. Then prime Innovo® by doing an air shot as described in the "Priming Innovo® by doing an air shot" section.

Dial the remaining number of units to complete your dose.

Inject, making sure that you have now injected your full dose.

If you have changed PenFill® so your total dose was divided into two doses, note that Innovo® will only remember the second of the two doses given.

Changing PenFill®

• Make sure that the push button is pressed completely in.
• Unscrew the needle.
• Open the slide.
• Take out the used PenFill® cartridge.
• Take a new PenFill® cartridge and continue as described from " Getting started ".

Function check

You should check the functioning of your Innovo®:

• if you think that Innovo® is not working properly
• regularly for your peace of mind (for example once a month or before starting a new box of PenFill® cartridges).

To perform a function check:

1. Screw on a new NovoFine® needle as described in " Getting started " section.
2. Prime Innovo® by doing an air shot as described in " Priming Innovo® by doing an air shot " section.
3. Put the outer needle cap over the needle.
4. Dispense 20 units into the outer needle cap.

The insulin should fill the lower part of the outer needle cap. If Innovo® has released too much or too little insulin, repeat the test.

If it happens again, do not use your Innovo®. Contact Novo Nordisk Pharmaceuticals, Inc. at our toll free number (1-800-727-6500), or see the warranty section for further information.

Do not try to repair a faulty Innovo®.

What do I do if...?

Here are the answers to some questions you might ask when using your Innovo® insulin doser.

Display

The display does not respond when I turn the dose selector.

Press the release button so that the push button jumps out before a dose can be dialed.

The display shows a minus sign.

The dose selector has been dialed below 0. Dial forward until the display shows the correct number of units.

The display is off.

If the display goes off, press the release button, and the push button will jump out. Press the push button completely in, and the display should reappear.

If the display does not reappear, open and close the slide. Prime Innovo® by doing an air shot as described in " Priming Innovo® by doing an air shot " section.

If the display remains off, Innovo® is not working. Do not use Innovo® but contact Novo Nordisk Pharmaceuticals, Inc. to get a new Innovo®. Our toll free number is 1-800-727-6500.

Priming by doing an air shot

No insulin appears when I try to prime Innovo® by doing an air shot.

The needle may be blocked. Change the needle and prime Innovo® by doing air shots until insulin appears at the needle tip.

Check that the push button is pressed completely in and locked. Open the slide and make sure that PenFill® is inserted correctly. If PenFill® is damaged or empty, change it.

Check that the slide is closed, and prime Innovo® until insulin appears at the needle tip.

No insulin appears when I prime Innovo® and the push button will not go in.

The needle may be blocked. Change the needle and prime Innovo® until insulin appears at the needle tip.

To open the slide, dial back to zero and press the push button completely in until it locks.

Then change PenFill® as described in " Changing PenFill® " section.

Choosing the dose

I cannot release the push button.

Make sure that the slide is closed completely. The release button is locked until the slide is closed.

I want to cancel or change the dialed dose.

Dial back to zero and press the push button completely in. Your last dose and the time passed since delivery will reappear on the display. You can increase, decrease or cancel the dialed dose up until the time you press the push button.

Do not change the dose after you have pressed the push button.

Insulin is delivered when I turn the dose selector.

You have dialed the maximum dose of 70 units and then carried on dialing. If you need to inject a dose of insulin larger than 70 units, you must divide the dose into amounts equal to or less than 70 units.

Injection

The push button blocks during the injection.

Do not try to force the push button in.

The needle may be blocked. Change the needle and prime Innovo® by doing an air shot as described in " Priming Innovo® by doing an air shot " section.

Check if PenFill® is damaged. Dial back to zero and press the push button completely in until it locks. Then open the slide and change PenFill® as described in " Changing PenFill® " section. Prime Innovo® by doing an air shot until insulin appears at the needle tip.

Please observe that part of the insulin dose may have been injected.

If the push button still cannot be pressed completely in, contact Novo Nordisk Pharmaceuticals, Inc. Our toll free number is 1-800-727-6500.

Changing PenFill®

I cannot open the slide.

The needle must be removed. If the push button is out, dial back to zero, and press the push button completely in until it locks. Then open the slide.

If the slide still cannot be opened, contact Novo Nordisk Pharmaceuticals, Inc. Our toll free number is 1-800-727-6500. Do not try to force the slide open.

Function check

I do not think that my Innovo® is working properly.

Carry out the function check described in the " Function check " section. Make sure that the lower part of the outer needle cap is filled with 20 units of insulin.

Never use your Innovo® unless you are sure that it is working properly.

How to store and look after your Innovo® insulin doser

Your Innovo® insulin doser is designed to work accurately and safely. It should be handled with care. Avoid situations where your Innovo® insulin doser can be damaged. Always replace the cap after using Innovo®.

Please read the Information For The Patient in the PenFill® pack. This will tell you how to store the cartridges and how long to keep them.

Storage and handling

• Do not expose your Innovo® insulin doser to temperatures below -25°C / -13°F.
• With PenFill® inserted, store Innovo® at room temperature (up to 25°C / 77°F).
• Your Innovo® is tough but can still be damaged. Handle it with care and protect it against direct sunlight, water, dust and dirt.

Cleaning

• Clean off dirt and dust with a dry, soft brush.
• You can clean your Innovo® by wiping it with cotton moistened with ethyl or isopropyl alcohol.
• Do not soak Innovo® in alcohol, wash it or lubricate it. This may damage the mechanism.

Remember

• Do not try to repair a faulty Innovo®.
• Innovo® must only be used according to the instructions in this manual. The manufacturer will not be held responsible for any equipment problems if you have not followed these instructions.
• If you suspect that Innovo® is faulty, contact Novo Nordisk Pharmaceuticals, Inc. Our toll free number is 1-800-727-6500.

Display Information

Display is off

The very first time the cap is pulled off, the display stays blank until the slide is opened.

If the display goes off, press the release button, and the push button will jump out. Press the push button completely in, and the display should reappear. If the display does not reappear, open and close the slide.

Prime Innovo® as described in the " Priming Innovo® by doing an air shot " section.

If the display remains off, Innovo® is not working. Do not use Innovo® but contact Novo Nordisk Pharmaceuticals, Inc. to get a new Innovo®. Our toll free number is 1-800-727-6500.

Display test

When the cap is pulled off, all the display symbols are turned on, telling you that the display is fully functional.

Dialing a dose

The display shows the number of insulin units dialed.

During delivery

The segments turning on two by two tell you to leave the needle under the skin during injection.

After delivery

The display shows the number of insulin units delivered. The circle confirms that the delivery has been completed.

Previous injection

The display shows the number of insulin units delivered. The segments indicate the time passed since delivery. One segment represents 1 hour. In this example more than 4 hours have passed since Innovo® delivered the previous dose.

Flashing display

A flashing display indicates the battery power is low. Be sure to replace your Innovo® within 30 days. The battery cannot be changed. Contact Novo Nordisk Pharmaceuticals, Inc. to get a new Innovo®. Our toll free number is 1-800-727-6500.

Minus sign

A minus sign on the display tells you that the dose selector has been dialed below 0.

Dial forward until the display shows the number of units required.

Important information

• Always keep a spare insulin delivery system available, in case your Innovo® is lost or damaged.
• Always prime your Innovo® by doing an air shot (as described in " Priming Innovo® by doing an air shot " section) to ensure the insulin flow:
  
  • before each injection
  • after changing PenFill®
  • after changing the needle
  • after opening and closing the slide
• With a PenFill® in Innovo®, never press the push button unless a needle is mounted.
• Always make sure that the push button is pressed completely in and locks.
• The display confirms completed delivery when the segments turn on two by two and then the circle appears.
• Do not change the dose after you have pressed the push button.
• Before each injection make sure that you are using the right type of insulin.
• If you are treated with more than one type of insulin in PenFill® 3 mL cartridges, you should use two devices, one for each type of insulin.
• Do not use the residual scale to measure the amount of insulin to be injected.
• Never place a needle on Innovo® until you are ready to use it, and take the needle off Innovo® immediately after each injection.
  If you do not remove it, temperature changes may cause liquid to leak out of the needle. With an insulin suspension (cloudy insulin), this may change the concentration of the insulin.
• Do not initiate injection of an insulin suspension (cloudy insulin) if the rear rubber stopper is below the arrow marks on the slide.
• Your Innovo® insulin doser is designed to work accurately and safely. In the unlikely event that you can not release the push button on your Innovo®, it may be due to a malfunction and you should use another method (such as a spare insulin delivery system) to take your scheduled insulin doses.
• A flashing display tells you that battery power is low. Be sure to replace Innovo® within 30 days. The battery cannot be changed. This is to guarantee quality and safety at all times. Contact Novo Nordisk Pharmaceuticals, Inc. to get a new Innovo®. Our toll free number is 1-800-727-6500.
• Innovo® is tough but could still be damaged. So handle it with care, do not drop it and avoid knocking it against hard surfaces. If Innovo® has been dropped or knocked, you must carry out a function check (see " Function check " section).
• Never use your Innovo® unless you are sure that it is working properly.
• Always replace the cap after using Innovo®.
• Do not play with the dose selector or the push button as this can cause Innovo® to wear out.
• Keep Innovo®, PenFill® and NovoFine® out of the reach of children.
• Your Innovo® is for use by you alone. Do not allow anyone else to to use it, even though you attach a new NovoFine® needle for each injection.
• Health Care Professionals, relatives and other carers should follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.

Warranty Information

Should your Innovo® device be defective in materials or workmanship within three (3) years of purchase, Novo Nordisk Pharmaceuticals, Inc. will replace it at no charge if you mail the defective unit along with a description of the problem and the sales receipt or other proof of purchase to:

Novo Nordisk Pharmaceuticals, Inc. Product Safety 100 College Road West Princeton, New Jersey 08540

No other warranty is made with respect to Innovo®.

This warranty will become invalid and neither Novo Nordisk A/S, Novo Nordisk Pharmaceuticals, Inc., or Bristol-Myers Squibb Co., will assume responsibility in the case of defects or damages arising from:

• The use of Innovo® with products other than PenFill® 3 mL cartridges, NovoFine® single-use disposable needles, or other products specifically recommended by Novo Nordisk.
• The use of Innovo® in a manner other than in strict accordance with the instructions in this booklet or other instructions issued by Novo Nordisk.
• Physical damage to Innovo® caused by neglect, misuse, unauthorized repair, accident, or other breakage.

For assistance or further

information, write to:

Novo Nordisk Pharmaceuticals, Inc.

Customer Relations

100 College Road West

Princeton, NJ 08540

Or call: 1-800-727-6500

Novo Nordisk A/S 2001/2003

Novo Nordisk Pharmaceuticals, Inc.

Princeton, NJ 08540

www.novonordisk-us.com