Animas 315 Users Manual

Download

CAUTION - Investigational device. Limited by Federal Law to investigational use.

Owner’s booklet.

Here’s everything you’ll need to know.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 1 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 2 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

Welcome

Congratulations. You have chosen one of the most advanced diabetes management systems available

today. Your OneTouch

Ping® Glucose Management System will play an integral part in the blood glucose management and continuous insulin delivery regimen that you have established with your health care professional.

Your OneTouch OneTouch

Ping® System combines the functionality of an OneTouch® Ping® Insulin Pump and a

Ping® Meter Remote through radio frequency (RF) communication. Both devices will work independently of one another, but using them together can provide you with options to help make insulin delivery more discreet and flexible.

Your OneTouch

Ping® Insulin Pump uses advanced technology, providing continuous insulin delivery to help maintain your blood glucose targets as recommended by your health care professional. It delivers insulin in two ways: 1) continuous “basal” insulin delivery and 2) “bolus” insulin delivery to cover foods eaten and/or reduce a high blood glucose level.

Your OneTouch

Ping® Meter Remote combines the accuracy expected from OneTouch® Verio™ products with features designed to make testing and tracking more convenient. These include a meter remote memory that serves as an electronic logbook for storing all your glucose test results along with other diabetes-related health records. Another feature is a Food Database which can be easily accessed on your meter remote. The Food Database helps take the guesswork out of carb counting.

When the devices are used together, your OneTouch access to insulin delivery functions available with the OneTouch

System also allows your most recent blood glucose results from the OneTouch® Ping® Meter

Ping

Ping® Meter Remote gives you convenient remote

Ping® Insulin Pump. Your OneTouch®

Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.

This Owner’s Booklet is designed to provide the information that you are looking for, when you need it. We hope you keep it handy.

Of course you may still have questions. If you do, our customer service representatives will be happy to answer your call. You can reach them at Customer Service at 1 877 937-7867. You can also obtain information at www.animas.com.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 3 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

TABLE OF CONTENTS

BEFORE YOU BEGIN I

SECTION I : ONETOUCH® PING® INSULIN PUMP

CHAPTER 1 - Important Information 3

CHAPTER 2 - Explanation of symbols 9

CHAPTER 3 - Introduction to your OneTouch

Ping® Insulin Pump 11

CHAPTER 4 - Getting your pump ready 15

CHAPTER 5 - Using the Normal Bolus feature 27

CHAPTER 6 - Using Basal Program features 29

CHAPTER 7 - Suspend/Resume feature 37

CHAPTER 8 - History feature 39

CHAPTER 9 - feature 45

CHAPTER 10 - Advanced features/Setup and activation 49

CHAPTER 11 - Using Advanced features 59

CHAPTER 12 - Care and maintenance 73

CHAPTER 13 - Safety system and alarms 75

CHAPTER 14 - Troubleshooting guidelines 85

CHAPTER 15 - Sick day guidelines 91

CHAPTER 16 - Lifestyle issues 93

CHAPTER 17 - My information 95

CHAPTER 18 - Warranty and other technical information 99

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 4 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

SECTION II : ONETOUCH® PING® METER REMOTE

CHAPTER 1 - Setting up your OneTouch

Ping® Meter Remote 107

CHAPTER 2 - Setting up and using the Food Database 123

CHAPTER 3 - Estimating bolus insulin amounts with the bolus calculator 125

CHAPTER 4 - Testing your blood glucose 127

CHAPTER 5 - Adding comments to glucose test results 141

CHAPTER 6 - Making logbook entries 145

CHAPTER 7 - FastFacts

/ Using your meter remote logbook 151

CHAPTER 8 - Control solution testing 161

CHAPTER 9 - Caring for your meter remote and test strips 165

CHAPTER 10 - Understanding meter remote error and other messages 169

CHAPTER 11 - Detailed information about your meter remote and test strips 173

SECTION III: ONETOUCH® PING® SYSTEM/USING YOUR ONETOUCH® PING® METER

REMOTE AND ONETOUCH

PING® INSULIN PUMP TOGETHER

CHAPTER 1 - Overview of your OneTouch

Ping® System 177

CHAPTER 2 - Establishing communication between your

meter remote and your insulin pump 179

CHAPTER 3 - Pump Home and Meter Home screens on your meter remote 189

CHAPTER 4 - Insulin delivery functions on your meter remote 191

CHAPTER 5 - Checking the Status of your OneTouch

CHAPTER 6 - Troubleshooting your OneTouch

CHAPTER 7 - OneTouch

Appendix A: Glossary

223

Ping® System Communication Technical Specifications 221

Ping® System 207

Ping® System 211

Index 227

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 5 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

BEFORE YOU BEGIN

Do Not attempt to connect to your pump before you have been trained on your pump, or until you have watched the training video. Check with your health care professional regarding your individual training needs.

As part of your training, your health care professional will assist you in making the appropriate selections for your insulin pump and meter remote settings. Your insulin pump must be programmed for your own personal use. Your insulin pump settings impact the calculations for insulin delivery using either your meter remote or insulin pump. Be comfortable with using your insulin pump before you activate the RF feature on your insulin pump and meter remote. See the appropriate chapters in Section I, pages 1–106 for the steps on setting up and using your insulin pump.

Insulin Pump

Ping

The following insulins have been tested by the pump manufacturer and found to be safe for use in the insulin cartridge of the pump: Humalog this pump, check the insulin drug label to make sure it can be used with the pump.

Many people also find it helpful to practice the blood glucose test process with control solution before testing with blood for the first time. See Chapter 8 in Section II, pages 161–164.

, Novolog®, and Apidra®. Before using a different insulin with

OneTouch

For best results the use of your insulin pump, or your meter remote to access pump functions, is recommended for people with diabetes who:

Test their blood glucose levels four to six times per day or as recommended by their health care team.

Demonstrate adequate carbohydrate counting skills.

Maintain good diabetes self-care skills.

See their health care professional regularly.

Have adequate vision and hearing to recognize the pump alerts.

You should carefully read this Owner’s Booklet and any inserts that come with your OneTouch System prior to use. These include inserts for:

OneTouch® Verio™ Test Strips

OneTouch® Verio™ Control Solutions

While reading this Owner’s Booklet, please note the following:

Display screens throughout the Owner’s Booklet are examples only. They should not be considered

suggestions for individual programming and may not be representative of current health states.

“Blood Glucose” is often abbreviated as BG in both instructional copy as well as in example display

screens.

Your OneTouch® Ping® Insulin Pump will often be referred to as simply “your pump”. Similarly, your

OneTouch often be used when referring to both the OneTouch Remote.

Ping®

Ping® Meter Remote will often be referred to as “your meter remote”. “The devices” will

Ping® Insulin Pump and OneTouch® Ping® Meter

Take special note of Warnings and Cautions throughout this Owner’s Booklet, which are identified with

.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 1 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.CAUTION - Investigational device. Limited by Federal Law to investigational use.

BEFORE YOU BEGIN

Intended use

Your OneTouch® Ping® Glucose Management System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary blood.

Your OneTouch treatment of insulin-requiring diabetes.

Your OneTouch quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote controller to deliver insulin from the the OneTouch

Ping® Insulin Pump is indicated for continuous subcutaneous infusion of insulin for the

Ping® Meter Remote Blood Glucose Monitoring System is intended to be used for the

Ping® Insulin Pump.

Your OneTouch

Ping® Meter Remote Blood Glucose Monitoring System is intended for use for self-

testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor

the effectiveness of diabetes control. Your OneTouch

Ping® Meter Remote Blood Glucose Monitoring

System is specifically indicated for use on the finger. It should not be used for the diagnosis of diabetes

or testing of newborns. Your OneTouch

Ping® Meter Remote Blood Glucose Monitoring System is

intended to be used by a single patient and should not be used for testing multiple patients.

About radio frequency (RF) communication

Your meter remote and pump have built-in RF capability. RF is a type of wireless communication. Cell phones use RF technology, as do many other devices. RF is how your meter remote and pump communicate and share data.

The RF feature on your meter remote and pump will be deactivated when you first receive them. In order to begin using your meter remote and pump together as a system, RF must be activated on both devices and they must be paired (synchronized). Activating RF opens a line of communication on both devices and pairing ensures communication will take place only between one meter remote and one pump.

RF communication between your meter remote and pump will work up to a distance of about 10 feet (3.0 meters) and will transmit through clothing. Direct line of sight is not required for RF communication. As long as you have a good RF signal and are within range, you can use your meter remote to access pump functions.

When conditions or distance cause RF communication to be lost or interrupted, you will not be able to use your meter remote to access pump functions. This also means that data transfer between the two devices will stop temporarily. As soon as the problem is resolved, RF communication will resume. Any records stored in your pump during the RF interruption will then be sent to your meter remote.

Your meter remote and pump are subject to and comply with U.S. Federal regulations, Part 15 of the Federal Communications Commission (FCC) Rules regarding devices with RF capability. From these regulations, the two conditions of operation specific to your device are given in the following FCC required statement:

This device complies with Part 15 of the FCC Rules. Operation is subject 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 undesired operation.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 2 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.CAUTION - Investigational device. Limited by Federal Law to investigational use.

BEFORE YOU BEGIN

Compliance with these guidelines means that under normal day-to-day circumstances your OneTouch®

System should not affect the operation of other devices. Additionally, your OneTouch® Ping®

Ping System should operate normally in the presence of other devices in a normal household environment.

In the event there is interference from another device, it is recommended that you increase distance between your system and that device, or turn off the interfering device. Alternatively, you may turn off RF communication between the meter remote and pump and perform insulin delivery functions directly from your pump (see Chapter 2 in Section III, pages 179–188).

Changes or modifications not expressly approved by the manufacturer (Animas

Corporation) could

void the user’s authority to operate the equipment.

There are environments where it is recommended that you not use the RF communication feature linking your meter remote and pump. When you are in radiology and MRI departments and around radiology equipment, it is recommended you first deactivate the RF communication feature on both your meter remote and your pump. Then you must remove both devices and leave them outside the

MRI room. Any metal needle infusion sets should also be removed and left outside the MRI room.

Likewise, during air travel your airline may have specific restrictions about using your System with RF communication activated. It is recommended that you deactivate the RF feature on your pump and meter remote during flights, or check with your airline’s RF restrictions when making your travel plans. To learn more about deactivating the RF feature on your pump and meter remote, see Chapter 2 in Section III, pages 179–188.

Your pump has additional environmental restrictions. See Chapter 1 in Section I, pages 3–8 for recommendations regarding the use of pumps in the presence of radiology equipment.

Using your meter remote and pump together as a system

Once you have established communication between your meter remote and pump, you can access certain pump functions directly from your meter remote. These include delivering a bolus, monitoring pump , and confirming many pump alarms and warnings.

Your pump has its own set of display screens and buttons to provide stand-alone insulin delivery without the use of your meter remote. Some of the buttons work the same way as the buttons on your meter remote. One example is the

button on your pump. Like the

the button on your pump is used to confirm entries. Be sure you know how the buttons work on both your pump and meter remote before you begin using the devices together as a system.

When you use your meter remote to access pump functions, your meter remote display screens will closely resemble your pump display screens.

button on your meter remote,

III

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 3 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.CAUTION - Investigational device. Limited by Federal Law to investigational use.

BEFORE YOU BEGIN

OneTouch® Ping® System Carton Contents

Your OneTouch® Ping® System carton includes your insulin pump, your meter remote, and other accessories you will need to begin using both devices. Your meter remote and BG testing supplies are included within a separate kit within the carton. Check the contents of your carton to make sure all items are included. If any items are missing call Customer Service at 1 877 937-7867.

Your OneTouch

The OneTouch® Ping® Insulin Pump and pump accessories:

Ping® System carton includes:

a. OneTouch

b. One Energizer

Ping® Insulin Pump

c. Low Profile Clip

d. Owner’s Booklet

Lithium L91 AA battery (1.5V) for your pump

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 4 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.CAUTION - Investigational device. Limited by Federal Law to investigational use.

BEFORE YOU BEGIN

The OneTouch® Ping® Meter Remote kit which includes:

Available

Separately*

aeh

a. OneTouch® Ping® Meter Remote

OneTouch

Delica™ Lancing Device

If another type of lancing device is included, see the separate instructions for that lancing device.

c. Sterile Lancets

d. Carrying Case

e. Two 1.5V AAA Alkaline Batteries* (batteries included but not installed)

f. OneTouch

Verio™ Test Strips

g. USB Cable

h. OneTouch

Verio™ Mid Control Solution

A warranty card for your meter remote is also included.

* OneTouch

Verio™ High Control Solution is available separately. Ask for OneTouch® Verio™ High

Control Solution when you obtain your test strips.

See Chapter 9 in Section II, pages 165–168, for important information on the correct way to install the batteries in your meter remote.

 WARNING: Keep the pump, meter remote, and accessories away from young children. Small

items such as the battery door, batteries, battery cap, clip, test strips, lancets, protective disks on the lancets, and control solution vial cap are choking hazards. Do Not ingest or swallow any items.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 5 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.CAUTION - Investigational device. Limited by Federal Law to investigational use.

BEFORE YOU BEGIN

Important Safety Instructions

t5IJTNFUFSBOEMBODJOHEFWJDFBSFJOUFOEFEUPCFVTFECZBTJOHMFQFSTPOBOETIPVMEOPUCFTIBSFE

even with a family member.

t"GUFSVTFBOEFYQPTVSFUPCMPPEBMMQBSUTPGUIJTLJUBSFDPOTJEFSFECJPIB[BSEPVT"VTFELJUDBO

potentially transmit infectious diseases even after you have performed cleaning and disinfection. For more information, see:

FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.

CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/FingerstickDevicesBGM.html.

t"MUFSOBUFTJUFUFTUJOH"45TIPVMEOPUCFVTFEUPDBMJCSBUFDPOUJOVPVTHMVDPTFNPOJUPST$(.TOPS

for use in insulin dose calculations.

Supply Reordering

You can place orders for cartridges, infusion sets, skin prep, test strips, batteries and many meter remote and pump accessories by calling our Reorder Department or by visiting our eStore at https://estore.animas.com/. In the United States and Puerto Rico, you may also call 1 877 937-7867.

Emergency Kit

Keep an emergency kit with you at all times to make sure you always have necessary supplies. This kit should include but is not limited to:

Quick-acting glucose tablets or gel

BG monitoring supplies including meter, test strips, lancing device, lancets, meter remote batteries

(2 AAA alkaline)

Blood or urine ketone testing supplies

Rapid-acting and other insulin as recommended by your health care team

Extra infusion sets and Animas® 2.0mL Cartridges (200 unit/2ml)

Dressing and adhesive, if used

An extra Energizer® Lithium L91 AA battery for your pump

An extra pump battery cap

An extra pump cartridge cap (In the U.S. and Puerto Rico, call 1 877 937-7867 to order

an extra cartridge cap. All other customers contact your local Animas

Glucagon Emergency Kit

distributor.)

Emergency contact phone numbers

Be sure to inform a family member, co-worker and/or friend where this emergency kit is kept.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 6 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.CAUTION - Investigational device. Limited by Federal Law to investigational use.

BEFORE YOU BEGIN

VII

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 7 4/11/11 9:53 AM

Section I

OneTouch® Ping

Insulin Pump

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 6 4/11/11 9:53 AM

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 7 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

Welcome and Congratulations

You have begun a new way of life with your OneTouch® Ping® Insulin Pump.

Your choice of pump therapy is a sign that you are committed to taking excellent care of yourself. Your pump has been specially designed to help you manage your diabetes, using advanced technology and sophisticated safety systems.

Your pump is used for insulin therapy to help maintain your blood glucose (BG) targets as recommended by your health care team. You program it to deliver two ways: a continuous, 24-hour “basal” rate and “bolus” insulin deliveries to accommodate for immediate doses to cover foods eaten and high BG. It is important to remember that successful pump therapy is a partnership of advanced technology and responsible self-care.

Please take a moment to look at the back of your pump and write down the serial number.

My pump serial number is: ______________________________________

ONETOUCH® PING® INSULIN PUMP

West Chester, PA

Rx ONLY (U.S.)

24/7 TECHNICAL SUPPORT

1-877-937-7867

OneTouch

Ping

Insulin Pump

Serial Number (S/N)

MRI

IPX8

US patent pending

Made in USA

FCC ID: VWT115

Label P/N: 400-274-00 Rev.A

Technical and Clinical Help

If there is anything you do not understand in the Owner’s Booklet or if you have a question or need assistance with your pump, our Customer Service Department is available to you every minute of every day.

In the United States and Puerto Rico, call 1 877 937-7867 for assistance every minute of every day. For non-urgent technical questions, please email customersupport@anmus.jnj.com.

We understand that you may have questions and concerns when using a new product. Please do not hesitate to call for assistance!

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 1 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

Important Note

Do Not Remove the New Factory-Installed Plastic Display Lens Protection Film.

Your pump now comes with a new factory-installed transparent plastic lens protection film covering the display lens. This protective film is highly durable and is designed to protect your pump display lens from incidental damage. Please do not attempt to remove this film. This protective film must

remain in place at all times to fully protect your pump display lens from scratches and other cosmetic damage. This film will not protect your pump display lens from extreme abuse.

Insulin Pump

Ping

Should the pre-installed lens protection film become damaged or separate from the display, the film should be replaced. Replacement films are available through the following sources:

In the United States and Puerto Rico, call Animas for Reorders.

Please note that the Animas normal wear and tear, accidents, negligence or misuse, and abuse, including scratched display

OneTouch

lenses. We urge you to protect your pump screen from damage and use a lens protection film at all times.

at 1 877 YES-PUMP (1 877 937-7867) and press 2

insulin pump limited warranty does not cover damage resulting from

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 2 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 1 - IMPORTANT INFORMATION

This section of the Owner’s Booklet contains information about how to use, program and maintain your new pump. It is important to read it carefully. Even if you are an experienced pumper, keep your Owner’s Booklet handy for reference. Warnings, cautions and safety tips are found throughout this Owner’s Booklet, indicated by a

 symbol.

 WARNING:

Do Not attempt to connect to your pump before you have been trained on your pump or

unless your certified OneTouch

Incorrect use of your pump, failure to follow the instructions in this Owner’s Booklet or

improper/inadequate self-care and troubleshooting techniques can lead to death or serious injury. If you do not understand something or have questions, ask your health care team or call our Customer Service representatives at 1 877 937-7867.

Your pump is designed to deliver insulin reliably but because your pump uses only rapid-

acting insulin, you will not have long-acting insulin in your body. To avoid the risk of diabetic ketoacidosis (DKA) or very high BG, you must be prepared to give yourself an injection of insulin if delivery is interrupted for any reason.

Your pump is designed and calibrated to deliver U100 insulin. Use of any insulin with lesser

or greater concentration can result in serious injury or death.

Ping® Insulin Pump trainer is present.

OneTouch

Ping

Insulin Pump

Never start the Prime/Rewind sequence on your pump while the infusion set is connected

to your body. The Prime/Rewind sequence includes steps for rewinding the pump motor, loading an insulin cartridge and tightening the cartridge cap, and priming the infusion set tubing. Failure to disconnect your infusion set from your body before performing these steps can result in over delivery of insulin, and possible injury or death. If your pump sustains internal damage, the amount of unintended insulin delivery could be significant. This could result in serious injury or death from hypoglycemia.

Warnings and Precautions



Radiology Equipment

Your pump has been designed to operate in the presence of common sources of electrostatic and electromagnetic interference, such as store security systems. However, like all portable electronic devices, your pump should not be exposed to very strong electromagnetic fields, such as in MRI’s, RF welders or magnets used to lift automobiles. Very strong magnetic fields, such as in an MRI, can re-magnetize the portion of the motor that regulates insulin delivery. If you plan to undergo an MRI,

remove your pump beforehand and keep it outside the room during the procedure.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 3 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 1 - IMPORTANT INFORMATION



Medical Procedures and Equipment

Automatic Implantable

Insulin Pump

Ping

OneTouch

Defibrillator (AICD)

Catheterization

Nuclear Stress Test

Procedure

Pacemaker/

Cardioverter-

EKG

Cardiac

Colonoscopy

Patient is Pumper

Disconnect pump and leave outside room during insertion of device and reprogramming. Infusion set can remain in place.

Follow normal safety practices and proceed to the designated safe area while each X-ray is taken and during reprogramming.

Health Care

Professional/Technician

is Pumper

No need to disconnect. No need to disconnect.

Disconnect pump and leave outside room during procedure.

Disconnect pump and leave outside room during scan. Can remain connected during injection of radioisotope.

Follow normal safety practices and proceed to the designated safe area while each X-ray is taken.

No need to disconnect. No need to disconnect.

Pump and infusion set can be worn; however some lasers can create interference and cause pump to alarm.

Determination based on what medical equipment is being used in the procedure.

Laser Surgery

General Anesthesia

Pump and infusion set can be worn; however some lasers can create interference and cause pump to alarm.

Determination based on what medical equipment is being used in the procedure.

For procedures not included above or on the chart on the following page, call (in advance of your procedure) 1 877 937-7867 in the U.S. and Puerto Rico.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 4 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 1 - IMPORTANT INFORMATION



Medical Procedures and Equipment

Procedure Patient is Pumper

No need to disconnect.

Pump should remain covered by lead apron

Dental X-Rays

Ultrasound

Mammogram

and Bone

Density Test

placed on the patient by the dentist or technician.

No need to disconnect.

Transducer should not be pointed directly

at pump or site. If site is directly in range of transducer, site should be removed.

Do Not expose pump to test.

Disconnect pump prior to test and leave pump

in locked dressing room.

Infusion set can remain in place during test.

Body X-Rays,

Do Not expose pump to X-ray beam.

Fluoroscopy

(chest, neck,

abdomen,

Disconnect pump prior to exam and leave

pump in locked dressing room.

Infusion set can remain in place during X-ray.

torso, etc.)

Therapeutic

Radiation/

Oncology

(cancer treatment radiation)

Do Not expose pump to radiation treatment.

Disconnect pump prior to radiation treatment

and leave pump in locked dressing room.

If the infusion set doesn’t interfere with the

area being treated, the set can remain in place during radiation.

Health Care Professional/Technician

No need to disconnect.

Follow normal X-ray safety practices and

proceed to the designated safe area when each X-ray is taken.

No need to disconnect.

Transducer should not be pointed

directly at pump or site.

No need to disconnect.

Follow normal safety practices and

proceed to the designated safe area while each test is being performed.

No need to disconnect.

Follow normal X-ray safety practices

and proceed to the designated safe area when each X-ray is taken.

No need to disconnect.

Follow normal radio-protection practices

and proceed to the designated safe area while the patient is undergoing treatment.

is Pumper

OneTouch

Ping

Insulin Pump

MRI: Do Not bring pump into the same

room as the MRI machine at any time.

If pump is accidentally allowed in the

MRI room disconnect pump immediately and contact Customer Service for instructions.

CT Scan: No need to disconnect.

Follow normal CT Scan safety practices

and proceed to the designated safe area when each Scan is performed.

No need to disconnect.

CT Scans and

MRI’s (Magnetic

Resonance

imaging)

Electro-cautery

surgery

Do Not bring pump into the exam room at any

time.

Disconnect pump and metal needle infusion

set prior to exam and leave in a locked dressing room.

Soft cannula infusion sets can remain in place.

If pump is accidentally allowed in the exam

room disconnect pump immediately and contact Customer Service for instructions.

Disconnect from pump during surgery.

Disconnect prior to surgery and leave pump in

locked dressing room.

If the infusion set doesn’t interfere with the

area being treated, the set can remain in place during surgery.

When in doubt, disconnect and leave pump in locked dressing room. Follow usual instructions for bolusing to cover any missed basal insulin when you reconnect.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 5 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 1 - IMPORTANT INFORMATION



Amusement Parks

Very powerful electromagnets are sometimes used on “free-fall” amusement park rides. Pumps

Insulin Pump

should be removed and not taken on these “free-fall” types of rides.

High gravity forces can be experienced when riding on some roller-coasters. It is recommended that you disconnect (NOT suspend) your pump while on roller-coaster rides.



Aircraft without Cabin Pressurization

If flying in aircraft without cabin pressurization or flying in aircraft used for aerobatics or combat simulation (pressurized or not), it is recommended that you disconnect (NOT suspend) pump.

Ping

Precautions

Your pump is a sealed device that should be opened ONLY by the manufacturer. If your pump seal

OneTouch

When using your pump, if the pump is placed at a vertically higher position than the infusion site, a

Occasionally check the infusion site for proper placement and leaks. Improperly placed infusion

Occasionally check the infusion set tubing for any damage, leaks or kinks while using your pump.

Only use Animas® 2.0mL Cartridges (200 unit/2ml) infusion sets with a standard Luer connector.

Cartridges are for single use only. Reuse of the cartridge can negatively impact product performance

is broken by anyone other than an authorized Animas and your pump is no longer waterproof. If the back label on your pump is removed or damaged, the warranty is voided and your pump is no longer waterproof.

very small amount of additional insulin infusion may occur. To minimize this condition and maintain pump delivery accuracy, the vertical distance between your pump and the infusion site should be no more than 12 inches (30 centimeters). If your pump is placed at a vertically lower position than the infusion site, this condition is eliminated.

sites or leaks around the infusion site can result in under infusion.

Damaged, leaking or kinked tubing may restrict or stop insulin delivery and result in under infusion.

Efficacy of pump cannot be guaranteed if cartridges other than those manufactured by Animas Corporation are used or if cartridges are used more than once.

and can potentially contribute to infection, under delivery of insulin, and insulin contamination.

factory technician, the warranty is voided

Always dispose of used cartridges and infusion sets following the regulations in your community.

Failure to follow these guidelines may pose health hazards.

Prior to replacing the battery cap, make sure the o-ring fits securely and is not damaged. A damaged

o-ring may impact the battery contact and/or the waterproof feature of your pump. See Chapter 4 in Section I, pages 15–26.

Prior to inserting a cartridge into your pump, check the o-rings on the cartridge to be sure they are

not damaged. Damaged cartridge o-rings can result in under or over delivery of insulin.

Occasionally check the vents to be sure they are clear of debris. See Chapter 12 in Section I,

pages 73–74.

Occasionally check that your pump personal settings are correct.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 6 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 1 - IMPORTANT INFORMATION

Occasionally check to make sure your pump emits audible tones that are easily detectable and

that the vibrate feature is working correctly. For example, audible tones should be heard and the vibration pulse felt every time you replace the battery.

If using the upload or download feature, keep the communication window free of obstructions

and refer to the Instructions for Use included with the wireless download cable. Contact your local Animas download cable.

distributor for information on ezManager® Diabetes Management Software and wireless

OneTouch

NOTE: Your pump uses battery power to notify you of alerts, warnings, and alarms. If you do not confirm the notification, your pump will continue to use battery power as the notifications repeat and progress. This will result in reduced battery life and the Replace Battery Alarm screen appearing sooner than expected.

Additionally, certain warnings (e.g., Low Cartridge Warning, Occlusion Alarm) take precedence over less critical ones (e.g., Low Battery Warning). This means if you do not confirm the more critical warning, battery life will be reduced and your pump may skip the Low Battery Warning and go directly to the Replace Battery Alarm, or battery life will end before a Replace Battery Alarm is displayed.



Safety Information

Your pump is designed only for Continuous Subcutaneous Insulin Infusion (CSII). It is not intended

for use with any other delivery substance.

This section of the Owner’s Booklet gives instruction on how to program and operate your pump.

Animas diabetes care program. Consult your health care team for instructions specific to your treatment plan.

Corporation does not make any recommendations on specific programming related to your

Consult your health care team before using your pump to determine which programming features

are appropriate for you. Some features require a greater knowledge of insulin pumping and advanced self-care skills. Additionally, some advanced programming features require that testing and fine-tuning of basic settings be completed in order to achieve the best possible results. Your health care team will give you specific training on programming and using your pump.

Use of Extended Bolus, Combo Bolus, ezCarb (carb calculator), Insulin on Board (IOB) and ezBG

(BG correction calculator) all require input from your health care team. Do Not attempt to use these features until you have specific information for your treatment plan and have had specific training on each programming feature.

Ping

Insulin Pump

Only your health care team can determine your Insulin to Carbohydrate (I:C) ratios, Insulin

Sensitivity Factors (ISFs), BG Target ranges and duration of Insulin on Board (IOB).

Basal rates that are too high or too low can adversely affect BG levels. Work with your health care

team to fine-tune basal rates.

The way your body uses insulin can be affected by many things. Contact your health care team

about lifestyle changes such as starting/stopping your exercise program or significant weight loss/gain. Your basal rates may need to be modified.

Do Not stop using your pump if you are ill. Even when you’re sick, your body still needs insulin. See

Chapter 15 in Section I, pages 91–92.

When you begin using the Audio Bolus feature, always look at the screen as you program so that

you are completely comfortable with the feature before delivering a bolus via audio prompts only.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 7 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 1 - IMPORTANT INFORMATION

Animas® Corporation recommends that you have someone around you (family, friends, etc.) who

understands diabetes and pump therapy, so in the event of an emergency, they can help you. Be

Insulin Pump

Ping

OneTouch

sure they are familiar with any information given to you by your health care team.

Before Bedtime

Try to arrange infusion set changes at meals or one to two hours before bedtime. If a change

is needed at bedtime, then check BG in one to two hours. Always check BG one to two hours after infusion set change.

Always check that your cartridge has enough insulin to last through the night before going to bed.

Unless otherwise recommended by your health care team, Do Not use the vibrate feature during sleep. It is recommended that you set the volume to high for all warnings and alarms before going to sleep.

Always remove all air bubbles from cartridge and tubing before beginning insulin delivery. Air

bubbles can compromise accuracy of delivery. Refer to the Instructions for Use included with your cartridge packaging.

Interference with your pump electronics by cell phones can occur if worn in close proximity. It is

recommended that you wear your pump and cell phone at least 6 inches (15.2 centimeters) apart. When RF is turned on and you are using your pump and meter remote together as a system, RF interference is possible. See Chapter 7 in Section III, pages 221–222.

If you return your pump for service and a replacement pump is sent, Do Not use the replacement

pump until all the settings specific to your treatment plan have been programmed.

If you drop your pump or it has been hit against something hard, inspect it to be sure it is still

working properly. Check that the display screen is working and clear, that the cartridge cap, battery cap and infusion set are properly in place. Check for leaks around the cartridge by wrapping a piece of tissue around the connection area. Cracks, chips or damage to your pump may impact the battery contact and/or the waterproof feature of your pump. Call our Customer Service representatives at 1 877 937-7867 if you identify or suspect your pump has been damaged. They will help determine if your pump should be replaced.

Your pump is designed to operate in conditions where temperatures are between 40°F (5°C) and

104°F (40°C). If your pump is exposed to temperatures outside these parameters, extra care should be taken to protect it from extreme temperatures.

Your pump and pump cartridges are latex free.

To avoid risk of explosion, Do Not use your pump in the presence of explosive gases.

Your pump is designed to achieve optimum performance and battery life with an Energizer® Lithium

L91 AA battery (1.5V). Rechargeable batteries and Carbon-Zinc batteries do not have the necessary characteristics to power your pump and should not be used. Some AA lithium batteries are available with other voltages such as 3.6V or 4.0V. Do Not use these batteries. Use of anything other than a

1.5V battery could permanently damage your pump and voids its warranty.

Do Not use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to

clean your pump. Never put your pump in the dishwasher or use very hot water to clean it.

Never use a hair dryer, microwave oven or baking oven to dry your pump. Use a soft towel.

 WARNING: Your pump and pump accessories include small component pieces that could

pose a choking hazard for small children.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 8 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 2 - EXPLANATION OF SYMBOLS

Shown below are symbols you will find on your OneTouch® Ping® Insulin Pump and its packaging.

On your system packaging:

Do Not Reuse

On the front of your pump:

OneTouch

Up Arrow button

Down Arrow button

OK button

On the top of your pump:

Contrast button

On the back of your pump:



S/N Serial Number

IPX8 Water-Tight Equipment (protected against the effects of submersion; tested to 12 feet (3.6 meters)

for 24 hours)

Rx Only

CAUTION: Federal (U.S.) law restricts this device to sale by, or on the order of a physician.

Important Information (See Owner’s Booklet for Instructions for Use)

Date of Manufacture

Type BF Medical Equipment (patient isolated, not defibrillator protected)

Ping

Insulin Pump

Consult Owner’s Booklet

MRI

Do Not wear or operate around MRI devices. Remove and leave outside MRI room before entering.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 9 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 2 - EXPLANATION OF SYMBOLS

Insulin Pump

Ping

OneTouch

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 10 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 3 - INTRODUCTION TO YOUR ONETOUCH® PING® INSULIN PUMP

An insulin pump is a tool to allow you to better manage your diabetes by mimicking the way a healthy pancreas delivers insulin. When connected to a properly inserted infusion set, your pump delivers insulin at a continuous level (basal rate), 24 hours a day. You program delivery of an immediate dose (bolus) of insulin to cover food eaten or to correct high BG.

Your pump is engineered and manufactured to the highest standards of quality. Although it is a highly sophisticated medical device, it has been carefully designed to be easy to use.

OneTouch

Get to Know Your OneTouch® Ping® Insulin Pump

Contrast button

Up button

Down button

™

Audio bolus/ezBolus button

High contrast

color display

OK button

Main Programming Buttons

There are 3 buttons for main programming functions. The and buttons allow you to move through screen selections and to scroll up and down to enter values such as a bolus amount.

button allows you to select an item or activate a function.

The

Ping

Insulin Pump

Programming Basics

Use the / buttons to scroll to the desired selection and then press the button to select.

buttons,

If the cursor is flashing, it means your pump is in Edit Mode and by scrolling with the you can edit the flashing field.

Once you have finished editing, press the button to confirm your entry and to exit the Edit Mode.

Display Screen

All programming, operations, warnings and alarms are shown on the display screen.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 11 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 3 - INTRODUCTION TO YOUR ONETOUCH® PING® INSULIN PUMP

Contrast Button

Pressing this button adjusts the contrast of your display. There are three contrast levels: Dim, Default

and Bright. To preserve battery life, your pump display will Auto-dim when a button is not pressed for half the time your display time-out is set. While in Auto-dim mode, you can restore the default contrast level you have set by pressing the while in Auto-dim mode will restore the default contrast level as well as perform the function of the key. To adjust contrast during a Call Service alarm, you must use the Section I, pages 49–58.

button on top of your pump. Pressing a function button

button. See Chapter 10 in

Insulin Pump

Ping

NOTE: When viewing your pump display in bright sunlight, it is recommended you shade the screen or move to a shady area for best visibility.

Audio Bolus/ezBolus

This button allows you to program a bolus without looking at your pump, by using audible tones to confirm programming and delivery. If you choose not to activate the Audio Bolus feature, this button

OneTouch

provides a shortcut to the Normal Bolus screen.

NOTE: When you first use the Audio Bolus feature, you should always look at the screen to confirm correct programming until you are comfortable with using audio feedback to program a bolus. See Chapter 10 in Section I, pages 49–58.

Battery Cap/Vent

This cap unscrews easily with a coin or the battery cap tool to replace and secure your battery. There is an o-ring around the cap, which prevents water from entering. The battery cap also is equipped with a built-in vent to allow air to enter your pump to maintain pressurization but prevent water from entering. Be careful not to over tighten the battery cap. See Chapter 4 in Section I, pages 15–26.

Primary Vent

This vent is part of the redundant vent safety system, which allows air inside your pump to maintain equalized pressure but prevents water from getting inside.

™

Cartridge Cap

Primary Vent

Battery Cap/Vent

 WARNING: Under no circumstances should you introduce any kind of sharp object into the

vent openings to clean them. Doing so will compromise your pump’s waterproof capabilities. If at any time you suspect the vent openings are clogged, replace the battery cap or call Animas Customer Service for questions about the Primary Vent.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 12 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 3 - INTRODUCTION TO YOUR ONETOUCH® PING® INSULIN PUMP

Cartridge Compartment Cap

This cap secures your cartridge and infusion set in your pump.

 WARNING: Never tighten the cartridge cap when your infusion set is attached to your body.

Tightening the cartridge cap while your infusion set is attached to your body may result in unwanted insulin delivery, which can result in serious injury or death.

ONETOUCH® PING® INSULIN PUMP

IR Window for Download

The IR window is framed in blue. This is the infrared communication window used for downloading your pump data.

IR Window

Sounds

West Chester, PA

Rx ONLY (U.S.)

US patent pending

Made in USA

24/7 TECHNICAL SUPPORT

1-877-937-7867

MRI

IPX8

FCC ID: VWT115

Label P/N: 400-274-00 Rev.A

OneTouch

Ping

Insulin Pump

Your pump allows you to customize the volume level or use the vibrate function to notify you of

warnings and alarms and to confirm certain deliveries. With ezManager

Diabetes Management

Software, you can also add tunes to play as your initial audible notification for some Alerts,

Reminders, Warnings and Alarms. Refer to your ezManager

Diabetes Management Software User

Guide included with the software.

Tamper Resistant (Locked) Feature

You can use the tamper resistant feature to prevent accidental button pressing. Simply wake up your pump and press and hold the This locks your pump buttons. To unlock your pump, wake up your pump so the screen reads “(LOCKED)” and press and hold the

Basic Display Screens

Verify Screen

When you insert a battery, an all-black screen with an hourglass symbol will appear followed by the VERIFY screen. From here you should verify the settings for time, date, language and battery type. With “Confirm” highlighted, press

NOTE: If you do not confirm the settings on the VERIFY screen, you will be notified with an alarm beep sequence on your pump. If not confirmed after 1 hour, the sequence will progress to 3 chirps/vib and then 4 long tones/vib within an hour.

to confirm the settings and go to the Home screen.

and buttons at the same time until the screen reads “(LOCKED)”.

and buttons at the same time until the screen display wakes up.

VERIFY

Mode Month Day

Year ENGLISH Battery = Lith

Confirm

2:27PM

12 Hr

Jan

2007

Home Screen

2 : 27

Once you have your pump set up, the Home screen is the first screen that is displayed when you “wake up” your pump. Press any button to wake up your pump. The Home screen shows the time of day, a battery life indicator, if you have an extended bolus or temp basal currently active, current basal rate, and how much insulin remains in your cartridge. You access the Main Menu from here or you can take a shortcut to the menu. The battery life indicator

Basal Rate

0.025U/Hr

Insulin: 105U

Status

is shaded to show approximate battery life remaining.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 13 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 3 - INTRODUCTION TO YOUR ONETOUCH® PING® INSULIN PUMP

NOTE: When the RF feature is activated on your pump, an RF ( appear on the top left of your pump Home screen.

After a set amount of time with no button presses, your pump display screen will “time out” to conserve battery life. When your pump times out, the screen display is blank.

Main Menu Screen

Insulin Pump

Ping

This screen shows all Main Menu options.

Bolus

OneTouch

This selection takes you to the Normal Bolus screen. If you have activated Advanced Bolus features, the Bolus Menu will be displayed. From the Bolus Menu you can select the bolus type, program and deliver the bolus dose.

Suspend/Resume

The Suspend function stops all insulin deliveries and Resume restarts basal delivery.

) symbol will

2 : 27

Basal Rate

0.025U/Hr

Insulin: 105U

Status

MAIN MENU

Bolus

Suspnd/Resum History Basal Setup Prime/Rewind Status

Home

History

This option allows you to review history of boluses, total daily dose (TDD), alarms, primes, suspend and basal information.

Basal

The Basal Menu allows you to access and program your basal rate. This continuous rate maintains your blood glucose between meals. This rate will be determined by your health care team. The default Basal Menu will display one basal program and the Temp Basal option. You can activate additional basal program options with the Setup Advanced menu.

Setup

This menu allows you to personalize the settings and features of your pump, as well as add advanced features to the menu. Your health care team will advise you on which features are best suited for your plan of treatment, as well as train you to achieve the best results.

Prime/Rewind

This function enables you to properly align the cartridge and piston rod as well as prime your infusion set tubing and fill your cannula or needle before connecting to your pump.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 14 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

This feature allows you to quickly see your current/most recent settings and pump deliveries.

 WARNING: Before proceeding with this chapter, you should have completed your pump

training and/or watched your training video.

OneTouch

To complete this section, you will need the following items:

OneTouch® Ping® Insulin Pump

Energizer® Lithium L91 AA battery (1.5V)

Battery cap tool or coin

Infusion set with standard Luer connector

Animas® 2.0mL Cartridges (200 unit/2ml)

Alcohol wipe (to clean top of insulin vial)

Vial of U100 insulin (rapid-acting) at room temperature

Skin prep such as IV Prep™ (to clean and prepare site for infusion set insertion)

 CAUTION: Under no circumstances should you use an alcohol wipe or skin prep to clean

your pump. See Chapter 12 in Section I, pages 73–74.

Battery Type

Your pump is designed to achieve optimum performance and battery longevity with an Energizer® Lithium L91 AA battery (1.5V).

Ping

Insulin Pump

 CAUTION: It is possible to safely power your pump with a conventional AA Alkaline battery

(1.5V), but battery life is significantly reduced. Be sure you select the correct Battery Type on the VERIFY screen when you change the battery to ensure accuracy of battery life indicator.

If you must use an AA Alkaline battery, the following is recommended:

Energizer® E91 (labeled as Energizer® MAX)

 WARNING:

Rechargeable batteries and Carbon-Zinc batteries do not have the necessary characteristics

to power your pump and must not be used. Use of these batteries voids your pump warranty.

Under no circumstances should you attempt to power your pump with a high-energy 3.6V AA

Lithium battery. Use of these batteries could permanently damage your pump and voids its warranty.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 15 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

expected.

Insulin Pump

Changing the Battery

Ping

OneTouch

Each time you change the battery

A full rewind and prime sequence is required. See Priming your Pump and Infusion Set, pages 22–24

in this chapter.

The Insulin on Board (IOB) calculation starts over at zero.

The Combo bolus returns to the factory set default duration and split.

You should review your basal program settings.

 WARNING: Low Battery Warning means battery life will only last a minimum of 30 minutes.

1. Use a coin to unscrew the battery cap with a counter-clockwise motion.

2. Check your battery cap for damage such as cracks or missing threads, and be sure the colored

o-ring fits securely and is not torn or damaged.

3. Check the vent hole on the top of the battery cap

to be sure it is clear of debris. This vent maintains pressurization while preventing water from entering the compartment.

NOTE: The battery cap should be replaced every 6 months, or if the o-ring or cap is damaged or the vent is clogged. See Chapter 12 in Section I, pages 73–74.

Battery Cap Vent HoleO-ring

4. Insert the Energizer

battery into the battery compartment with the positive (+) end going in first.

Lithium L91 AA (1.5V)

Energizer® Lithium L91 AA battery

5. Replace the cap by turning clockwise until you cannot see

the o-ring. Then slowly tighten the cap until flush with pump body.

NOTE: Over tightening the battery cap can cause your pump case to crack. Cracks, chips, or damage to your pump may impact the battery contact and/or the waterproof feature of your pump.

6. Each time you change the battery, your pump will run a series of self-tests which will last a few

seconds. An all black screen with an hourglass symbol will appear followed by the VERIFY screen. Your pump will give a beep to alert you to verify (or change) the time/date, language and battery type.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 16 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

7. Check the displayed time/date, battery type and language. If correct, scroll

down to highlight “Confirm” and press the

button. The Home screen will be

2 : 27

displayed. For more details on changing the time and date, see Setup - Basics, Setting/Changing Time and Date, pages 17–18 in this chapter.

Basal Rate

NOTE: The time and date must be programmed to confirm the VERIFY screen.

8. To change the battery type, highlight the “Battery” field and press to

0.025U/Hr

Insulin: 105U

Status

activate Edit mode (indicated by flashing cursor).

9. Use the

buttons to change battery type and press

to confirm and exit Edit Mode.

NOTE: The correct battery type must be selected in order for your battery life indicator to be accurate. “Lith” = Lithium, “Alkl” = Alkaline.

Alert

10. Scroll to “Confirm” and press . The Home screen is displayed.

NOTE: Until you have programmed a basal rate, the Alert screen shown here will appear when your pump is awakened. Simply scroll to “Confirm” and press

to move past this Alert screen.

Your active

basal

program

is empty.

0.000U/Hr

Confirm

Basal Menu

Setup – Basics

You can use your computer, with ezManager® Diabetes Management Software, to upload Time/ Date and Sound settings. For instructions on uploading Time/Date Sound settings, refer to your ezManager

Diabetes Management Software User Guide.

OneTouch

Ping

Insulin Pump

Setting/Changing the Time and Date

When you change your battery, the VERIFY screen allows you to edit the time and date.

You can also access the Time/Date SETUP screen by selecting “Setup” from the MAIN MENU.

1. From the Home screen,

press Scroll to “Setup” on the MAIN MENU. Press

to select “Menu”.

2. Scroll to Time/Date on

the SETUP menu. Press

SETUP

Time/Date

Hour: Minute

2: 27PM

Mode Month Day Year

Main Menu

12 Hr Jan

29 2007

2 : 27

Basal Rate

0.025U/Hr

Insulin: 105U

Status

3. Press the button to activate Edit Mode (indicated by flashing cursor).

4. Use the /

button to confirm your setting and exit Edit mode.

buttons to change to your desired settings. Press the

MAIN MENU

Bolus Suspnd/Resum History Basal

Setup

Prime/Rewind Status

Home

SETUP

Time/Date

Sound

Advanced

Main Menu

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 17 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

5. Use the /

“Main Menu” and press

Insulin Pump

Ping

NOTE:

tIf you select the 12-hour time format, the AM/PM indicators will change as you scroll to set the time.

Be sure the desired AM or PM selection is correctly displayed when setting the time.

tIf you select the 24-hour time format, the time will be shown in military time.

Daylight Saving Time (certain states and countries only)

“Spring Forward”

If you advance the hour on your pump clock after 11pm but before midnight, you must also manually forward the date by one day. If you change your pump clock after midnight, your pump date will have changed automatically to the appropriate date.

OneTouch

“Fall Back”

It is recommended that you set your clock back before midnight on Saturday or after 1am on Sunday. This keeps your pump set to the correct date. Your pump will register an additional hour in the Daily Totals History because the day has essentially been altered to consist of 25 hours. If you change the clock between midnight and 1am, you must also change the date. This will result in a duplicate date entry in your history. (This duplicate entry will contain up to one hour’s worth of insulin delivered.)

buttons to select the next field. Repeat the above process. Scroll to highlight

button when finished. The MAIN MENU screen will be displayed.

Sounds - Setting/Changing

Note that this menu only adjusts sounds. It does not activate the feature. For example, Audio Bolus Sound is adjusted in this menu, but to turn the Audio Bolus feature on, go to the Setup Advanced menu. See Chapter 10 in Section I, pages 49–58.

Your pump comes pre-loaded with a tune for most Alerts, Reminders and Alarms on medium and high volume settings. This tune plays only for the initial audible notification. If you do not confirm the initial notification, the next sound will be the factory default. If not confirmed, Warnings and Alarms will automatically progress to high volume and vibrate within one hour. With ezManager Management Software, you can change or add tunes to play as your initial notification for some Alerts, Reminders, Warnings and Alarms. Refer to your ezManager Guide included with the software.

The options from the first SETUP SOUND menu are listed below. Normal Bolus Sound and Temp Basal Sound can be set to one of the following: Vibrate (Vib), Low volume (L) , Medium volume (M) , High volume (H) or can be shut off (OFF) completely. For safety reasons, some sounds cannot be turned off.

Normal Bolus Sound

Audio Bolus Sound

Remote Bolus Sound

Temp Basal Sound

(OFF is not an option for this sound setting)

(Vibrate and OFF are the only options for this sound)

Diabetes Management Software User

Diabetes

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 18 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

The Remote Bolus Sound on your pump signals you when you use your meter remote to deliver a bolus from your pump. This setting applies only when you begin using your meter remote and pump together as a system (see Section III). Vibrate (Vib) is the default setting and OFF is the only other option for this sound setting.

The options from the second Setup Sound menu are listed below. They can be set to one of the following: Vibrate (Vib), Low volume (L), Medium volume (M), High volume (H) or can be shut off (OFF). For safety reasons, some sounds cannot be turned off.

Alert Sound

Reminder Sound (OFF is not an option for this sound setting)

Warning Sound (OFF is not an option for this sound setting)

Alarm Sound (OFF is not an option for this sound setting)

NOTE: If you download tunes from ezManager

Diabetes Management Software to play on your initial

audible notification, they will not play for any sound set at the Low volume (L) level.

 CAUTION: Unless otherwise recommended by your health care professional, vibrate mode

should not be used during sleep. It is recommended that you set the volume to high for all warnings before going to sleep.

OneTouch

Ping

Insulin Pump

1. From the MAIN MENU, scroll to “Setup”. Press the button.

2. Scroll to “Sound”. Press the button to go to the SETUP SOUND screen.

3. Use the /

4. The cursor will flash to indicate you can edit the selection. Use /

setting. Press the

MAIN MENU

Bolus Suspnd/Resum History Basal

Setup

Prime/Rewind Status

Home

buttons to scroll to your selection. Press the

button to confirm.

SETUP

Time/Date

Sound

Advanced

Main Menu

SETUP SOUND

N-Bolus A-Bolus R-Bolus

T-Basal

Next Menu Main Menu

button.

L Vib

OFF

buttons to change to desired

SETUP SOUND

Alert

Reminder

Warning

Alarm Main Menu

5. Repeat for remaining selections.

6. Scroll to “Next Menu” to access second SETUP SOUND menu or scroll to “Main Menu” when

finished to return to the MAIN MENU.

Vib

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 19 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

The Cartridge

Filling the Cartridge

Refer to the Instructions for Use included with your cartridges.

Connecting the Tubing to the Cartridge

To complete this section, you will need the following:

Insulin Pump

Ping

Filled Animas® 2.0mL Cartridge (200 unit/2ml)

Infusion set compatible with your OneTouch® Ping® Insulin Pump

 WARNING: The efficacy of your pump cannot be guaranteed if cartridges other than those

manufactured by Animas

OneTouch

Only infusion sets marketed for use with insulin infusion pumps using insulin-compatible tubing and with a standard Luer lock can be used with your OneTouch The efficacy of your pump cannot be guaranteed if infusion sets other than those specified are used.

Do Not connect infusion set to your body until after you have completed the Prime process.

Never start the Prime/Rewind sequence on your pump while the infusion set is connected to your body. Failure to disconnect your infusion set from your body before you start the Prime/Rewind process can result in over delivery of insulin, and possible injury or death. If your pump sustains internal damage, the amount of unintended insulin delivery could be significant. This could result in serious injury or death from hypoglycemia.

1. Clean the workspace where you will be connecting the infusion set to the cartridge. Wash your

hands thoroughly with soap and water.

2. Open sterile infusion set package carefully. If the package is damaged or opened, use another set

and contact your supplier.

3. Unscrew the cartridge compartment cap from

your pump, using a counter-clockwise motion.

Corporation are used.

Ping® Insulin Pump.

Luer connector of infusion set

4. Remove infusion set tubing cap from the

Luer connector. (Not all infusion sets have these caps.)

Top of cartridge compartment cap

5. After removing protective cap, thread the Luer

connector of the infusion set through the top (smaller) opening of the cartridge compartment cap, being careful not to touch Luer tip with hands or work surface.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 20 4/11/11 9:53 AM

Correctly threaded through cap

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

6. Remove cap from the filled cartridge tip. To

avoid insulin spillage and introduction of air in the cartridge, it should never be filled beyond the

2.0 mL mark. The plunger is properly positioned for maximum fill when the black o-ring nearest the plunger tip is centered on the 2.0 mL mark. Attach infusion set Luer connector to cartridge tip using clockwise motion until finger tight and then twist

another quarter of a turn.

Connect infusion set to cartridge here

 WARNING: Be sure to twist the Luer connector an extra quarter of a turn to ensure a secure

connection. If the connection is not secure, insulin may leak around the cartridge, resulting in under delivery of insulin.

7. Put cartridge/tubing assembly aside.

NOTE:

t$IFDLGPSMFBLTDSBDLTPSEBNBHFFBDIUJNFZPVDIBOHFZPVSDBSUSJEHFBOEJOGVTJPOTFU5PBWPJE

leakage, be sure to tighten the Luer connection securely. You can check for moisture periodically by wrapping a tissue around the Luer connection between the cartridge and infusion set.

tWhen handling the cartridge, take care not to twist or turn the plunger in the cartridge body.

Maintaining straight alignment of the plunger keeps the o-rings properly seated, which minimizes the possibility of introducing air into the cartridge and will prevent insulin spillage.

OneTouch

Ping

Insulin Pump

Changing the Cartridge

1. Disconnect infusion set from your body.

2. Unscrew the cartridge cap, leaving tubing connected to the cartridge.

3. With the tubing connected to the cartridge, pull cartridge straight out of your pump.

4. Disconnect tubing from cartridge and discard. Proceed with filling the new cartridge as

outlined above.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 21 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

Priming your Pump and Infusion Set

NOTE: As each step is completed, the check box on the ezPrime menu will be shaded.

 WARNING: Never prime tubing or tighten the cartridge cap while the infusion set is

connected to your body. Failure to disconnect your infusion set from your body before performing this step can result in over delivery of insulin, and possible injury or death. If your pump sustains internal damage, the amount of unintended insulin delivery could be significant. This could result in serious injury or death from hypoglycemia.

Insulin Pump

Ping

OneTouch

1. Make sure you are disconnected from your pump.

MAIN MENU

Bolus Suspnd/Resum History Basal Setup

Prime/Rewind

Status

Home

3. On the ezPrime menu, “Rewind” is highlighted.

Press

4. Scroll up to “Go Rewind”. Press . Your pump

will rewind the piston rod.

NOTE: Before starting the rewind, your pump will vibrate as it performs a self test.

2. From the MAIN MENU, select “Prime/Rewind”.

. The REWIND MOTOR screen is displayed.

ezPrime

Rewind



Load Cart



Prime



Fill Cannula



Main Menu

REWIND MOTOR

Disconnect

infusion set

from your body!

Go Rewind

Cancel

REWIND MOTOR

Disconnect

infusion set

from your body!

Go Rewind

Cancel

REWIND

ACTIVE

Please wait.

Full rewind

required.

<<------<<------<<------

5. When the rewind action is complete, the REWIND COMPLETE screen is displayed. Your pump will

beep once to let you know the rewind is complete.

REWIND

ACTIVE

Position:

160U

<<------<<------<<------

Stop

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 22 4/11/11 9:53 AM

NOTE: If using a partially filled cartridge, you can select Stop during the Rewind Active function to stop the rewind at the position desired. After every third rewind, your pump is required to do a Full Rewind and will not offer the option of selecting the “Stop” position. A Full Rewind is always required when a battery is inserted.

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

6. Insert your filled cartridge.

7. Secure cartridge compartment cap to pump by turning in a clockwise motion until finger tight but

Do Not over tighten.

 WARNING: Never tighten the cartridge cap while the infusion set is connected to your body.

Failure to disconnect your infusion set from your body before performing this step can result in over delivery of insulin, and possible injury or death. If your pump sustains internal damage, the amount of unintended insulin delivery could be significant. This could result in serious injury or death from hypoglycemia.

ezPrime

Rewind



Load Cart



Prime



Fill Cannula



Main Menu

NOTE: If screen display has timed out while loading your cartridge, select Prime/Rewind from the MAIN MENU and highlight “Load Cart” from the ezPrime menu. Press

to display the REWIND COMPLETE screen.

Continue with Step 8.

OneTouch

Ping

Insulin Pump

REWIND

8. On the REWIND COMPLETE screen, “Continue” is

highlighted. Press rod with the cartridge. The LOAD CARTRIDGE ACTIVE screen is displayed, followed by the PRIME screen. Your pump will beep once to let you know the cartridge is aligned with the piston rod.

PRIME

Be sure set is disconnected

from your body.

Then select

Continue.

Insulin: 200U

Continue

Cancel

. Your pump will align the piston

9. On the PRIME screen, “Continue” is highlighted. Press .

COMPLETE

Load U100

cartridge.

Attach cap.

Select Continue.

Continue

Cancel

10. The DELIVER PRIME screen is displayed. Be sure the infusion set is not

connected to your body until the prime is complete.

LOAD

CARTRIDGE

ACTIVE

Please wait.

>>------>>------>>------

DELIVER

PRIME

Press AND HOLD

OK button

while priming

tubing.

Insulin: 200U

Go Prime

Cancel

 WARNING: Never prime while the infusion set is connected to your body. Failure to

disconnect your infusion set from your body before performing this step can result in over delivery of insulin, and possible injury or death. If your pump sustains internal damage, the amount of unintended insulin delivery could be significant. This could result in serious injury or death from hypoglycemia.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 23 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

11. Make sure “Go Prime” is highlighted. Press

and hold the

insulin come out the end of your infusion set. This

means your tubing is primed. The PRIMING ACTIVE screen is displayed, followed by the PRIMING DONE screen.

Insulin Pump

Refer to the Instructions for Use included with your infusion set for proper insertion guidelines. See Selecting the Infusion Site and Inserting the Infusion Set, page 25 in this chapter.

Ping

12. From the ezPrime menu, “Fill Cannula” is

highlighted. Press the screen is displayed.

OneTouch

NOTE: This step is not necessary for needle sets.

button until you see 5 drops of

button. The FILL CANNULA

PRIMING

ACTIVE

Press AND HOLD

OK button

while priming

tubing.

Insulin: 177U

>>------>>------>>------

ezPrime

Rewind



Load Cart



Prime



Fill Cannula



Main Menu

PRIMING

DONE

Primed

23U

177U

Amount

Remaining

FILL CANNULA

0.00

Go Main Menu

13. Use the /

buttons to enter the amount of insulin needed to fill the cannula. Refer to the Instructions for Use included with your infusion set for details on how much insulin is required to fill the cannula. Press

. “Go” is highlighted. Press to fill the cannula.

NOTE: The maximum Fill Cannula amount is 1U at a time.

ezPrime

Pump

If your pump is suspended, the screen will alert you with the ezPrime “Pump suspended” screen. You must resume delivery of your pump in order to complete the Priming function.

suspended.

Priming

disabled.

Rewind

Home

NOTE: The Fill Cannula step is not required for your pump to operate. For example, when you prime your pump after a battery change and you are not inserting a new infusion set, this step is not necessary. Filling the cannula when not necessary can result in unwanted delivery of insulin.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 24 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

Selecting the Infusion Site and Inserting the Infusion Set

Your health care team will review appropriate site selections and techniques for insertion based on your body type. Refer to the Instructions For Use included with your infusion set for proper insertion guidelines.

 WARNING: Do Not attempt to insert the infusion set into your body until you have been

trained by your health care team. Improper insertion of your infusion set can lead to death or serious injury.

OneTouch

Ping

Changing the Cartridge and Infusion Set

Cartridges and infusion sets require replacement and are not to be reused. Infusion sets should be replaced approximately every 2–3 days or as directed by your health care team. Refer to the insulin labeling and follow the direction of your health care team for frequency of replacing the cartridge.

 CAUTION: Occasionally check the infusion set tubing for any damage, air bubbles, leaks or

kinking, which may restrict or stop insulin delivery and result in under infusion.

Insulin Pump

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 25 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 4 - GETTING YOUR PUMP READY

Insulin Pump

Ping

OneTouch

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 26 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 5 - USING THE NORMAL BOLUS FEATURE

This chapter covers the basics of a Normal bolus, which is used to cover food you have eaten and high BG.

Your pump also offers advanced bolus features. See Chapter 10 in Section I, pages 49–58.

MAIN MENU

Bolus

Suspnd/Resum History Basal Setup Prime/Rewind Status

Home

2. The cursor will flash over the amount field

to indicate that it can be edited. Use the buttons to enter desired bolus amount. Press

NORMAL BOLUS

Amount

2.35

Main Menu

1. From the MAIN MENU, select “Bolus”.

NORMAL BOLUS

Amount

Main Menu

0.00

3. Go is highlighted. Press to deliver the bolus.

NORMAL BOLUS

Amount

2.35

Go Main Menu

DELIVERING

OneTouch

Ping

Insulin Pump

1.35

4. The DELIVERING bolus screen is displayed. If you have activated the Normal

Bolus sound in the SETUP SOUND menu, your pump will beep to confirm start

Press any

function button

to cancel.

of delivery, as well as when delivery is complete.

Warning

NOTE: During a bolus delivery, you can stop delivery at any time by pressing any button on the front panel of your pump. The Warning screen shown here will be displayed. Confirm the Warning by pressing

and check your Bolus

History for the amount delivered.

Confirm

Bolus

delivery canceled by user button

press.

Delivered:

1.35U of 2.35U

NOTE: You can check when you last gave a bolus by looking in History or . These features are covered later. See Chapter 8, pages 39–44, and Chapter 9, pages 45–48, in Section I.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 27 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 5 - USING THE NORMAL BOLUS FEATURE

NOTE: If you have Advanced Bolus and Reminders features turned on, the BOLUS MENU at right will be displayed when you select “Bolus” from the MAIN MENU. Select Normal and press

Insulin Pump

Ping

chapter.

OneTouch

. Follow steps 2 through 4 in this

BOLUS MENU

Normal

ezCarb ezBG Combo Bolus Reminders

Main Menu

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 28 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

You can program your pump to display either 1 or 4 basal program options. Basal insulin is delivered continuously to help keep your BG in target between meals. Having more than one pre-set basal program makes it easy for you to switch based on your needs including weekends, weekdays, shift work, and menstruation. If you are new to pumping, your health care team may suggest you first become comfortable with one program before using multiple basal programs. The factory default displays one basal program and the temporary basal program. To display multiple basal options, see Chapter 10 in Section I, pages 49–58.

You can use your computer and ezManager names as well as basal rates. For instructions on uploading basal program information, refer to the ezManager

Diabetes Management Software User Guide included with the software.

Diabetes Management Software to upload basal program

Setting a Basal Program

Each basal program can be set with up to 12 different basal rates (doses) in a 24-hour period. These 12 start times can be set to accommodate your changing basal needs throughout the day. For example, your body may need more insulin in the early morning to compensate for the “dawn phenomenon.” You can program time segments to begin at any hour or half hour.

buttons will move the cursor through fields when not in Edit mode. When in Edit

NOTE: The mode, the can edit the entry. Use the

buttons will change the value of the field. If the cursor is flashing, that means you

button to start/stop Edit mode.

OneTouch

Ping

Insulin Pump

Use the My Information chart in Chapter 17 in Section I, pages 95–98 to record and enter your basal program times and doses as recommended by your health care team.

MAIN MENU

Bolus Suspnd/Resum History

Basal

Setup Prime/Rewind Status

Home

The BASAL MENU displays the following:

Total basal insulin programmed for the 24-hour

period

Temp (if you wish to program a Temporary Basal

rate)

The active basal program, designated by number

and by name, as well as an “A” to indicate the active program. (If you have activated multiple basal programs in the Setup Advanced menu, all 4 basal program options will be displayed as shown on the far right.)

1. From the MAIN MENU, select “Basal”. Press .

BASAL MENU

Total 0.00U

Temp

A1-WEEKDAY

Main Menu

BASAL MENU

Total 0.00U

Temp

A1-WEEKDAY 2-other

3-weekend 4-exercise

Main Menu

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 29 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

2. Scroll to select the program “1-WEEKDAY” and press .

NOTE: You do not have to Suspend your pump to edit an active program. When you select “Edit” from the BASAL MENU, your pump automatically suspends delivery. When you exit the Edit mode, the active program delivery automatically resumes.

3. The BASAL OPTIONS screen is displayed. “Edit” is highlighted. Press

Insulin Pump

Ping

OneTouch

the of the selected program.

EDIT BASAL

Total 0.00U

Start

12:00A

--:--

Save/Review

EDIT BASAL

Total 0.60U

Start

12:00A

--:--

button. From the EDIT BASAL screen, you can edit the basal segments

U/Hr

4. Scroll to the desired “U/Hr” field. Press to

activate Edit mode (indicated by flashing cursor).

5. Use /

and exit Edit mode for this field.

buttons to set desired basal rate. Press

0.000

--.---

U/Hr

0.025

--.---

BASAL MENU

Total 0.00U

Temp

A1-WEEKDAY

Main Menu

BASAL OPTIONS

A1-WEEKDAY Total 0.00U

Clear

Edit

Review Go

Main Menu

to confirm

Save/Review

EDIT BASAL

Total 0.60U

Start

12:00A

4:00A

Save/Review

EDIT BASAL

Total 13.60U

Start

12:00A 4:00A

--:--

Save/Review

U/Hr

0.025

--.---

U/Hr

0.025

0.675

--.---

6. Scroll down to select the next “Start” time field. Press the button to

activate Edit mode (indicated by flashing cursor).

NOTE: The next available empty basal segment will appear automatically as you program the previous segment. If the next empty basal segment does not appear, you have programmed all 12 possible segments.

7. Change next “Start” time field as desired, press the button to exit Edit

mode. Segments can start on the hour or half hour.

NOTE: The 24-hour Total changes automatically as you change U/Hr settings.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 30 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

8. Continue until basal segments have been set as recommended by your health care team.

9. When finished, scroll to “Save/Review” and press . If you have edited the active program, it is

now resumed automatically. The BASAL OPTIONS screen is displayed.

Warning

Basal edit

not saved.

Basal

delivery

suspended.

Edit Basal

10. “Review” is highlighted. Press to review your entries for accuracy.

Your basal segment settings are shown (5 on first screen, 5 on second screen and 2 on last screen). If you have more than 5 segments programmed, scroll to “Next” to see second and third screens as desired.

NOTE: If your screen display has timed out (gone to sleep) before you have selected Save/Review while editing, a Warning screen will remind you the basal edit has not been saved. See Chapter 13 in Section I, pages 75–84.

BASAL OPTIONS

A1-WEEKDAY Total 13.60U

Clear Edit

Review

Main Menu

11. “Options” is highlighted. Press . The BASAL OPTIONS screen is displayed.

a. If you’ve edited and saved/reviewed the active program, it is resumed

automatically. You can also select “Go” and the Home screen is displayed, which shows the current rate of delivery for the program that is active.

b. If you’ve edited an inactive program and wish to activate it, select “Go”

from the BASAL OPTIONS screen. When you select “Go”, the Home screen is displayed, which shows the current rate of delivery for the program that is active.

BASAL OPTIONS

A1-WEEKDAY Total 13.60U

Clear Edit Review

Main Menu

OneTouch

Ping

Insulin Pump

Adding/Changing Segments in an Existing Basal Program

1. From the BASAL MENU, select desired program.

2. “Edit” is highlighted. Press .

3. Scroll to highlight the field you wish to change or to next available blank line to add a segment.

Press

4. Use /

5. Check that the AM/PM settings are correct.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 31 4/11/11 9:53 AM

to activate Edit mode. (The cursor will flash to indicate Edit mode.)

buttons to set Start times and U/Hr amounts.

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

NOTE:

t*GZPVQSPHSBNBTFHNFOUUPTUBSUBUUIFTBNFUJNFBTBOFYJTUJOHTFHNFOUUIFQSFWJPVTMZFOUFSFE

segment is deleted.

t If you program a segment to start at a time that precedes an existing segment, the new segment is

automatically inserted in the correct place. You must then scroll to the new segment, highlight the corresponding U/Hr field and enter or change amount, if desired.

6. When finished, scroll to “Save/Review” and press . If you have edited the active program, it is

Insulin Pump

Ping

OneTouch

now resumed automatically. The BASAL OPTIONS screen is displayed.

a. Select “Review” from the BASAL OPTIONS screen to review your entries for accuracy. Your basal

segment settings are shown (5 on first screen, 5 on second screen and 2 on last screen). If you have more than 5 segments programmed, scroll to “Next” to see second and third screens as desired.

b. If you’ve edited an inactive program, select the program from the BASAL MENU. Press . Select

“Go” from the BASAL OPTIONS screen to activate the program you’ve selected.

When you select “Go”, the Home screen is displayed, which shows the current rate of delivery for the program that is active. (Or you can simply wait for your pump display to time out. When you press any button, your active basal program rate information is displayed on the Home screen.)

 CAUTION: Always review changes to your basal program to be sure they are correct. Incorrect

basal rates can result in under or over delivery of insulin. See Reviewing Basal Programs, page 32 in this chapter.

Reviewing Basal Programs

1. From the BASAL MENU, scroll to highlight desired program. Press .

2. Scroll to “Review” from the BASAL OPTIONS

screen. Press shown (5 on first screen, 5 on second screen and 2 on last screen). If you have more than 5 segments programmed, scroll to “Next” to see second and third screens as desired.

. Your basal segment settings are

BASAL OPTIONS

A1-WEEKDAY Total 13.60U

Clear Edit

Review

Main Menu

3. When finished, “Options” is highlighted. Press .

4. Scroll to “Main Menu” and press . The MAIN MENU screen is displayed. The active basal

program continues.

5. If reviewing an inactive program and you wish to activate it, select the program you wish to activate

from the BASAL MENU screen. Press

A1-WEEKDAY

Total 13.60U Start U/Hr

12:00A 4:00A

--:--

Options

0.025

0.675

--.---

6. Select “Go” from the BASAL OPTIONS screen to activate the program. The Home screen is

displayed to show the current rate per hour of the program you have activated.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 32 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

Clearing Basal Programs

This feature allows you to clear all information from a basal program.

1. From the BASAL MENU, scroll to desired program.

2. From the BASAL OPTIONS screen, scroll to “Clear”. Press .

If you press clear all the segments of the basal program selected. The Alert screen shown here is displayed. If you do wish to clear all the basal segments of the selected program, scroll to “Clear Program” and press

If you do not wish to clear all the basal segments, scroll to “Basal Options” and press

If all segments of your active basal program are set to 0.000U/Hr your pump will not deliver any basal insulin. Each time you wake up your pump, the Alert screen shown here is displayed. If you have turned on the sound for Alerts, you will also be notified by a beep or vibrate. This Alert screen does not progress to higher audible alarms. You have the option to either select “Confirm” to quickly go to the MAIN MENU screen or select “Basal Menu” to reset rates in your active program. For more information see Chapter 13 in Section I, pages 75–84.

to select “Clear”, your pump will check to be sure you want to

. The BASAL OPTIONS screen will be displayed.

BASAL OPTIONS

A1-WEEKDAY Total 13.60U

Clear

Edit Review Go

Main Menu

Alert

Clear Program

deletes all

basal segments

in this program.

Clear Program

Basal Options

Alert

Your active

basal

program

is empty.

0.000U/Hr

Confirm

Basal Menu

OneTouch

Ping

Insulin Pump

Temporary Basal Feature

This feature allows you to increase your active basal delivery rate for events such as sick days or decrease for events such as exercise. You can decrease your basal rate by 90% (in 10% decrements) or increase your basal rate by 200% (in 10% increments). You can also set to OFF. You can set the duration up to 24 hours in half-hour increments. (If you have activated multiple basal programs in the Setup Advanced menu, all 4 basal program options will be displayed as shown on screen example below, right.)

 CAUTION: The lowest basal delivery amount possible is 0.025U/Hr. The highest basal

delivery amount possible is 25U/Hr or the Max Basal amount you set in the Setup Advanced menu in chapter 11.

1. From the BASAL MENU, scroll to “Temp”.

Press

BASAL MENU

Total 0.00U

Temp

A1-WEEKDAY

Main Menu

BASAL MENU

Total 0.00U

Temp

A1-WEEKDAY 2-other

3-weekend 4-exercise

Main Menu

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 33 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

2. The “Change” % field will flash to indicate

Edit mode. Use the percentage change desired. Press the

Insulin Pump

Ping

OneTouch

exit Edit mode.

A1-WEEKDAY TEMP BASAL

Change:

Duration:

Main Menu

4. Use the /

5. “Go” is highlighted. Press to activate Temp Basal.

 CAUTION: The lowest basal delivery amount possible is 0.025U/Hr.

When you set a negative temporary basal rate, your pump will beep and display an Alert screen to remind you of the minimum delivery limit. This screen will display once for 5 seconds and give one audible alert (if you turned on Alert sounds in Setup).

-40%

2.0Hr

A1-WEEKDAY

buttons to enter the

button to

TEMP BASAL

Change:

Duration:

4.0Hr

Main Menu

3. The “Duration” field is highlighted. Press to activate Edit mode.

buttons to enter the duration desired. Press

to exit Edit mode.

A1-WEEKDAY TEMP BASAL

Change:

-40%

Duration:

4.0Hr

Main Menu

Alert

Temp Active

Minimum

Basal rate

limited to

0.025U/Hr

6. The Home screen is displayed and shows your Temp Basal is active, the

2 : 27

percentage change, the duration and how much time is left. When the duration of time is complete, your pump will automatically resume the active basal program.

NOTE: If you turned on the Temp Basal sound in Setup, your pump will beep once every 30 minutes to remind you of Temp Basal .

TEMP BASAL

-40%%4.0 Hr

TTime Left 1.2 Hr

Insulin: 105U

Status

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 34 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

Canceling a Temporary Basal Program

1. From the BASAL MENU, select “TEMP BASAL”. Press .

2. Details of the current active Temp Basal program will be displayed. Scroll

up to “CANCEL” and press

Your previously active basal program will be activated and the Home screen will be displayed to show the current rate per hour of the active basal program.

NOTE: If you Suspend your pump while a Temp Basal program is active, the Temp Basal program will be canceled and an Alert screen will notify you that the Temp Basal program has been canceled. This Alert is displayed once and gives an audible tone once (if you turned on Alert sounds in Setup). Temp Basal is also canceled when you change the battery and/or prime.

A1-WEEKDAY TEMP ACTIVE

0.675 U/Hr

-40%

= 0.405 U/Hr

Time left

1.2 Hr

CANCEL

Main Menu

Alert

Pump Suspended

If active,

Temp Basal &

Combo Bolus

have been

canceled.

OneTouch

Ping

Insulin Pump

 CAUTION: When you switch to another basal program or set a Temp Basal, you will most

likely be changing the total insulin units delivered over a period of time. Be sure to review the total insulin units before you switch basal programs or set a Temp Basal. Units that are too high or too low may result in a hypoglycemic or hyperglycemic event.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 35 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 6 - USING BASAL PROGRAM FEATURES

Insulin Pump

Ping

OneTouch

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 36 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 7 - SUSPEND/RESUME FEATURE

This feature allows you to stop and restart delivery quickly and easily.

It also cancels delivery of any Temp Basal or Bolus, including Combo Bolus that may be currently active.

The Combo Bolus feature is covered in Chapter 10 in Section I, pages 49–58.

Suspending Delivery

OneTouch

MAIN MENU

Bolus

Suspnd/Resum

History Basal Setup Prime/Rewind Status

Home

Pump

Delivery

1. From the MAIN MENU, scroll to “Suspnd/Resum” and press .

“Suspend” is highlighted. Press .

Suspend

Main Menu

The screen will display a message reminding you that this mode not only suspends your active basal delivery but also cancels any Temp Basal or Combo Bolus that may be active.

Alert

Pump Suspended

If active,

Temp Basal &

Combo Bolus

have been

canceled.

Ping

Insulin Pump

2 : 27

SUSPENDED

Basal Rate

0.675U/Hr

Insulin: 105U

Status

Periodically, your pump will beep (or vibrate if that is the setting you

NOTE:

selected) to remind you of the Suspend . progress to high volume in one hour. audible sequence.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 37 4/11/11 9:53 AM

The Home screen is then displayed, showing that pump deliveries are

suspended.

If not confirmed, the beeps will

You can confirm the Warning to reset the

See Chapter 13 in Section I, pages 75–84.

Warning

No delivery.

Pump is suspended.

Confirm

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 7 - SUSPEND/RESUME FEATURE

Resuming Delivery

Insulin Pump

Ping

OneTouch

MAIN MENU

Bolus

Suspnd/Resum

History Basal Setup Prime/Rewind Status

Home

Main Menu

The Home screen is displayed to show you that your pump is no longer in Suspend mode. resumed.

Pump

Suspended

at 1:13PM

Oct 2, 2007

Resume

From the MAIN MENU, scroll down to “Suspnd/Resum” and press .

Resume” is highlighted. Press .

“

Your previously active basal program is automatically

2 : 27

Basal Rate

0.025U/Hr

Insulin: 105U

Status

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 38 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 8 - HISTORY FEATURE

Your pump stores important records for your review. You can access your pump’s history and view it directly on your pump screen or download it onto your computer using ezManager Management Software. your pump history screens will include a “(P)” or “(M)”. This indicates if the action was initiated from your pump (P) or your meter remote (M) when you begin using the devices together as a system (see Chapter 1 in Section III, pages 177–178).

Your pump stores basal rates, boluses, alarms and settings. Your pump stores these records indefinitely, even when batteries are removed.

MAIN MENU

Bolus Suspnd/Resum

History

Basal Setup Prime/Rewind Status

Home

Refer to the User Guide included with the software. Certain information on

From the MAIN MENU, select “History”. The HISTORY menu is displayed.

Diabetes

Bolus History

Your pump displays the last 500 Bolus records.

NOTE: BG values and carb values are not displayed on your pump. However, when you download

your pump history with ezManager including any BG and Carb values used in bolus calculations, will be displayed on the ezManager Diabetes Management Software reports. Additionally, blood glucose values from your meter remote (900 total) will be stored in pump history and displayed on the ezManager Software reports.

Diabetes Management Software, up to 500 bolus records,

Diabetes Management

OneTouch

Ping

Insulin Pump

From the HISTORY menu, select “Bolus”. This screen displays the following:

Bolus Record number

Date of bolus

Time of bolus

Type of bolus delivered and whether it was

initiated from your pump (P) or meter remote (M)

Normal

Combo

Audio

Amount of bolus programmed and delivered

of bolus

ACTIVE

COMPLETED

CANCELED and whether the bolus was canceled from your pump (P) or meter remote (M)

If ezBG or ezCarb was used

HISTORY

Bolus

Total Daily Dose (TDD) Alarm Prime Suspend Basal

Main Menu

Record 1

NORMAL (P)

COMPLETED

ezCarb

History Menu

BOLUS

Mar 23, 2007

1:13PM

2.80U of 2.80U

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 39 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 8 - HISTORY FEATURE

Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing cursor).

Record 1 indicates the most recent record. Use the / to other records.

Insulin Pump

Ping

When finished reviewing, press to exit Review Mode.

History Menu” is highlighted. Press to return to the HISTORY menu.

“

OneTouch

Total Daily Dose (TDD) History

buttons to scroll

BOLUS

Record 2

Mar 23, 2007

12:13PM

NORMAL (P)

0.80U of 3.80U

CANCELED (M) ezBG

History Menu

Your pump displays the last 120 TDD records.

From the HISTORY menu, select “TDD”. This screen displays the following:

Record number

Date of record

If Temp Basal was active on that date

If Suspend was activated on that date

Total Bolus for the date

Total Basal for the date

Total dose for the date

HISTORY

Bolus

Total Daily Dose (TDD)

Alarm Prime Suspend Basal

Main Menu

Record 1

Temp Suspend

Bolus Basal

TOTAL

History Menu

TDD

Mar 23, 2007

Each daily total is the total delivered since midnight.

NOTE:

Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing cursor).

Record 1 indicates the most recent record. Use the /

buttons to scroll to other records.

No No

6.200U

0.700U

6.900U

When finished reviewing, press to exit Review Mode.

“History Menu” is highlighted. Press to return to the HISTORY menu.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 40 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 8 - HISTORY FEATURE

Alarm History

Your pump displays the last 30 Alarm records.

From the HISTORY menu, select “Alarm”. The screen displays the following:

Record number

Date of alarm

Time of alarm

Alarm Code

Alarm Type

Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing cursor).

HISTORY

Bolus Total Daily Dose (TDD)

Alarm

Prime Suspend Basal

Main Menu

ALARM

Record 1

Mar 23, 2007

01:13PM

Code XXX-XXX

EMPTY CARTRIDGE

History Menu

OneTouch

Ping

Insulin Pump

Record 1 indicates the most recent record. Use the /

When finished reviewing, press to exit Review Mode.

“History Menu” is highlighted. Press to return to the HISTORY menu.

buttons to scroll to other records.

Prime History

Your pump displays the last 60 Prime and Fill Cannula records. Prime and Fill Cannula records are stored as separate records.

From the HISTORY menu, select “Prime”. The screen displays the following:

Record number

Date of prime

Time of prime

Amount of prime

Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing cursor).

Record 1 indicates the most recent record. Use the / to other records.

HISTORY

Bolus Total Daily Dose (TDD) Alarm

Prime

Suspend Basal

Main Menu

buttons to scroll

PRIME

Record 1

Mar 23, 2007

01:15PM

Fill Cannula Total 1.0U

History Menu

PRIME

Record 2

Mar 23, 2007

01:13PM

Primed Total 23.7U

History Menu

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 41 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 8 - HISTORY FEATURE

When finished reviewing, press to exit Review Mode.

History Menu” is highlighted. Press to return to the HISTORY menu.

“

Suspend History

Your pump displays the last 30 Suspend records.

From the HISTORY menu, select “Suspend”.

Insulin Pump

Ping

OneTouch

The screen displays the following:

Record number

Date and time pump delivery was suspended

Date and time pump delivery was resumed

Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing cursor).

Record 1 indicates the most recent record. Use the /

When finished reviewing, press to exit Review Mode.

History Menu” is highlighted. Press to return to the HISTORY menu.

“

Basal History

Your pump displays the last 270 Basal delivery records.

From the HISTORY menu, select “Basal”. The screen displays the following:

Record number

Date and time basal rate was adjusted

Basal rate adjustment

HISTORY

Bolus Total Daily Dose (TDD) Alarm Prime

Suspend

Basal

Main Menu

buttons to scroll to other records.

HISTORY

Bolus Total Daily Dose (TDD) Alarm Prime Suspend

Basal

Main Menu

SUSPEND

Record 1

Suspended

Mar 23, 2007

01:13PM

Resumed

Mar 23, 2007

01:13PM

History Menu

BASAL

Record 1

Mar 23, 2007

01:13PM

Rate = 0.670

History Menu

Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing cursor).

Record 1 indicates the most recent record. Use the /

When finished reviewing, press to exit Review Mode.

History Menu” is highlighted. Press to return to the HISTORY menu.

“

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 42 4/11/11 9:53 AM

buttons to scroll to other records.

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 8 - HISTORY FEATURE

NOTE: The History records each basal rate change. When no basal is being delivered, the Basal History Record will show 0 units delivered.

This can happen for the following reasons:

Cartridge change

Battery change

Suspend

Alarm

Basal segment set to 0

Basal edit screen accessed

Prime menu accessed

Loss of prime

OneTouch

Ping

Insulin Pump

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 43 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 8 - HISTORY FEATURE

Insulin Pump

Ping

OneTouch

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 44 4/11/11 9:53 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 9 - STATUS FEATURE

CHAPTER 9 - FEATURE

CHAPTER 9 - STATUS FEATURE

This feature gives you easy access to a summary of information about your pump’s current programming and performance.

From the MAIN MENU or from the Home screen, scroll to “Status” and press .

MAIN MENU

Bolus Suspnd/Resum History Basal Setup Prime/Rewind

Status

Home

There are six screens.

2 : 27

Basal Rate

0.025U/Hr

Insulin: 105U

Status

OneTouch

Ping

Insulin Pump

Status Screen 1 – Active Basal

The screen displays the following information:

Which basal program is currently active

The 24-hour total for the active basal program

Units per hour currently being delivered

Insulin currently remaining in cartridge

The cursor is flashing on the STATUS 1 screen. press

to highlight “Main Menu” and exit Status screens.

Press the

button to move to the STATUS 2 screen or

STATUS 1

ACTIVE BASAL

A1-WEEKDAY 24-Hr Total

13.60U

0.675U/Hr

Insulin: 105U

Main Menu

Status Screen 2 – IOB, Last Bolus

The screen displays the following information:

Amount of insulin currently “on board” (IOB). For more information on this feature, see Chapter 10

in Section I, pages 49–58.

Type and amount of last completed bolus

N = Normal

STATUS 2

IOB=1.70U

LAST BOLUS

C = Combo (normal portion only)

A = Audio

Time and date of last bolus

N 3.30U

9:55AM

Jul 8, 2007

Main Menu

The cursor is flashing on the STATUS 2 screen. press

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 45 4/11/11 9:53 AM

to highlight “Main Menu” and exit Status screens.

Press the

button to move to the STATUS 3 screen or

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 9 - STATUS FEATURE

Status Screen 3 – Delivery Today

The screen displays the following information since midnight and up to the

Insulin Pump

Ping

OneTouch

current time:

Insulin type

If Temp Basal has been active

If Suspend has been active

Total bolus amount delivered

Total basal amount delivered

Total insulin delivered (excluding prime amounts)

The cursor is flashing on the STATUS 3 screen. press

Status Screen 4 – Combo Bolus

The screen displays the following information:

Most recent Combo Bolus status

Active or Completed or Canceled

Start date

Start time

End time

Amount delivered (if active, shows amount delivered as of current time)

For more information on Combo Bolus, see Chapter 10 in Section I, pages 49–58.

Press the

to highlight “Main Menu” and exit Status screens.

STATUS 3

DELIVERY TODAY

Temp Suspend

Bolus Basal

TOTAL =

Main Menu

button to move to the STATUS 4 screen or

Start End

Main Menu

U100

No No

9.400U

0.200U

9.600U

STATUS 4

COMBO BOLUS

CANCELLED

Mar 23, 2007

07:23AM 07:31AM

Delivered:

3.28/9.00U

The cursor is flashing on the STATUS 4 screen. press

to highlight “Main Menu” and exit Status screens.

Press the

button to move to the STATUS 5 screen or

Status Screen 5 – Temp Basal

The screen displays the following information:

Most recent Temp Basal status

Active/Inactive

Start date

Start time

End time

% adjustment

STATUS 5

TEMP BASAL

ACTIVE

Mar 23, 2007

Start End Change:

Main Menu

04:00PM 06:00PM

-50%

The cursor is flashing on the STATUS 5 screen. press

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 46 4/11/11 9:54 AM

to highlight “Main Menu” and exit Status screens.

Press the

button to move to the STATUS 6 screen or

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 9 - STATUS FEATURE

Status Screen 6 – Codes

The screen displays the following information:

Software revision

Last seven digits of the serial number of your pump

Codes for manufacturer’s use

The cursor is flashing on the STATUS 6 screen. “Main Menu” and exit Status screens.

Press to highlight

STATUS 6

CODES

REV M=XXX.XX.XX D=XXX P=XXX S/N# 76543-21

Main Menu

OneTouch

Ping

Insulin Pump

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 47 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 9 - STATUS FEATURE

Insulin Pump

Ping

OneTouch

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 48 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

Now you’ve made it through the basics! Your pump offers many advanced features that you may find helpful in managing your diabetes. features are appropriate for you.

This chapter tells you how to set up and turn on the advanced features. pages 59–72, covers how to use each advanced feature.

You can also use your computer and ezManager for Advanced Setup. with the software.

From the MAIN MENU screen, select “Setup”. Then select “Advanced” from the SETUP screen and press

Refer to the ezManager® Diabetes Management Software User Guide included

Consult with your health care team to determine which advanced

Chapter 11 in Section I,

Diabetes Management Software to upload settings

MAIN MENU

Bolus Suspnd/Resum History Basal

Setup

Prime/Rewind Status

Home

SETUP

Time/Date

Sound

Advanced

Main Menu

OneTouch

Ping

Insulin Pump

Setup Advanced Screen 1 – Audio Bolus Feature

This screen allows you to:

Turn Audio Bolus on or off

Select the Audio Bolus delivery step size

0.1, 0.5, 1.0, 5.0 Units

Use the /

Press to change to flashing cursor for Edit mode.

Use the /

Press when setting is made.

NOTE:

If Audio Bolus is activated, you cannot use the side button as a shortcut to Normal Bolus. You

can still give a Normal Bolus via the MAIN MENU.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press Section I, pages 59–72.

buttons to scroll to the desired field.

buttons to change to desired setting.

. For more information, see Chapter 11 in

SETUP ADV 1

AUDIO BOLUS

Enable OFF

Delivery Step 0.1U

Home

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 49 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

Setup Advanced Screen 2 – Advanced Bolus Features and Multiple Basal Programs

Insulin Pump

Ping

OneTouch

This screen allows you to:

Turn Advanced Bolus Features (ezCarb, ezBG, Combo Bolus) on or off

Turn personal Reminders feature on or off

Select bolus delivery speed (NRML (normal): 1U every second

or SLOW:

NOTE:

changing the bolus delivery speed to “SLOW” may reduce the stinging sensation.

Select either 1 basal program or 4 basal programs to be displayed in the BASAL MENU

NOTE:

setting to display 1 basal program. displayed to remind you.

Scroll to the desired field.

Press to change to flashing cursor for Edit mode.

Use the /

SETUP ADV 2

BOLUS

Adv. Bolus Reminders Delivery

BASAL

Programs 4

1U every 4 seconds)

Users may experience a slight stinging sensation with normal bolus delivery. If this occurs

If a program other than 1-Weekday is active, you cannot change this

The Alert screen shown here will be

buttons to change to desired setting.

Home

Alert

1-weekday

must be the

active program

to change the

basal display

setting.

Confirm

OFF OFF

NRML

Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press

Setup Advanced Screen 3 – Insulin Limits

This screen allows you to:

Set maximum basal delivery per hour

Set maximum bolus amount

Set maximum daily (24-hour) delivery amount. Your pump checks that total

insulin delivery each 24-hour period (running from midnight of the previous day to midnight of the current day) does not exceed this limit.

Set maximum 2-hour delivery amount. Your pump checks that total insulin

delivery over each rolling 2-hour period does not exceed this limit.

Scroll to the desired field.

Press to change to flashing cursor for Edit mode.

Use the /

buttons to change to desired setting.

SETUP ADV 3

Max LIMITS

Basal

Bolus

Daily

2Hr

Home

25.00U/Hr

35.00U

600.00U

100.00U

Press when setting is made.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 50 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press

 CAUTION: Should you attempt a delivery that exceeds the limits you have set, your pump will

alert you and display a text message. information.

See Chapter 13 in Section I, pages 75–84 for additional

Setup Advanced Screen 4 – Language Setup, Display Timeout, Contrast and Battery Type

This screen allows you to:

Select a different language

Set the length of time your display stays on before timing out to save

battery life

15, 30, 45 or 60 seconds

Select a contrast setting

SETUP ADV 4

Language ENGLISH Display Timeout in 60 secs Contrast

8 Battery Lith

Home

OneTouch

Ping

Insulin Pump

Select Lithium (recommended) or Alkaline battery type. You can also change the battery type on the

VERIFY screen when you insert a new battery.

Scroll to the desired field.

Press to change to flashing cursor for Edit mode.

Use the /

Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press

buttons to change to desired setting.

Contrast Button

Pressing the button on the top of your pump adjusts the contrast. There are three contrast levels: Dim, Default and Bright. pressed for half the time your display time out is set. default contrast level you have set by pressing the button while in Auto-dim mode will restore the default contrast level as well as perform the function of the key.

If in Call Service Alarm mode, you must use the button to restore the default contrast level.

To preserve battery life, your pump display will Auto-dim when a button is not

While in Auto-dim mode, you can restore the

button on top of your pump. Pressing a function

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 51 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

To return contrast setting to original factory default, press the time. contrast setting.

NOTE:

move to a shady area for best visibility.

Setup Advanced Screen 5 – Auto-OFF Feature

Insulin Pump

Ping

OneTouch

This screen allows you to set your pump to automatically suspend basal delivery and sound an alarm if no buttons are pressed in a user-selected number of hours. in case the user is unconscious.

Scroll to the desired field.

Press to change to flashing cursor for Edit mode.

Use the /

Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight Next.

To return to the Home screen, scroll to “Home” and press

button and

When the word “Contrast” is displayed on the screen, press any button to return to the default

When viewing your pump display in bright sunlight, it is recommended you shade the screen or

This feature can be used as a safeguard

buttons to change to desired setting.

Press .

button at the same

SETUP ADV 5

AUTO OFF

Enable

When enabled,

suspend in 12 Hr

if no buttons are pressed.

Home

OFF

Setup Advanced Screen 6 – Low Cartridge Warning Setting and Occlusion Sensitivity Setting

This screen allows you to:

Set your low cartridge warning to alert you at 10, 20, 30, 40 or 50 units remaining

Set your occlusion detection sensitivity to High (more sensitive) or Low (less sensitive)

Use the /

Press to change to flashing cursor for Edit mode.

Use the /

Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”.

To return to the Home screen, scroll to “Home” and press

buttons to scroll to the desired field.

buttons to change to desired setting.

Press .

Low Cartridge Warning 20U

Occlusion Sensitivity L

Home

SETUP ADV 6

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 52 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

NOTE:

The Low Cartridge Warning only alerts you one time. For example, if you

Warning

have it set to 30U and receive an alert, and then change the setting to 20U, it will not alert at 20U until after the next cartridge has been primed.

If a bolus is delivered which causes a Low Cartridge Warning, your

remaining insulin may be less than the Warning screen displays.

Confirm

Low

cartridge.

10U or

less left.

Setup Advanced Screen 7 – Personal Settings - Insulin to Carb (I:C) Ratios

Your health care team may recommend you use different Insulin to Carb (I:C) ratios for different times of day. current time of day.

When you use the ezCarb feature, your pump will automatically select the I:C ratio for the

 WARNING: Your health care team will determine your personal settings for the bolus

calculator feature. Use of incorrect personal settings can result in over or under delivery of insulin.

OneTouch

Ping

Insulin Pump

This screen allows you to:

Set different I:C ratios for 12 different time slots

NOTE:

If you set only one ratio, it will be used for the entire 24-hour period.

From the SETUP ADV 7 screen, scroll up to “I:C Ratio”.

The first segment always starts at midnight. The last time slot available is 11:30pm.

Press to change to flashing cursor for Edit Mode.

Use the /

Press when setting is made.

To move to the next I:C Ratio screen, scroll to “

Scroll up to the “Time” field and press to change to flashing cursor

Use the /

buttons to change to desired setting.

buttons to scroll to the “1U:” (grams) field.

Press .

”

and press .

--->>

for Edit Mode.

Use the /

buttons to change the segment start time.

Press .

SETUP ADV 7

I:C Ratio

ISF

BG Target

Home

I:C Ratio

1 of 12

Time:

12:00A

1U: 13

<<---- ---->>

Done

I:C Ratio

2 of 12

Time:

6:00A

1U: 15

<<---- ---->>

Done

Home

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 53 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

Scroll to the “1U:” (grams) field and press to change to flashing cursor for Edit mode.

Use the /

remaining segments per your health care team’s recommendations.

To review your settings, highlight “ times and setting values are correct.

When finished, scroll to “Done” and press

Insulin Pump

Ping

To return to the Home screen, scroll to “Home” and press

Setup Advanced Screen 7 – Personal Settings - Insulin Sensitivity Factor (ISF)

Your health care team may recommend you use different Insulin Sensitivity Factors (ISFs) for different times of day. the current time of day.

OneTouch

This screen allows you to:

Set different ISFs for 12 different time slots

NOTE:

SETUP ADV 7

I:C Ratio

buttons to change the “1U:” (grams) field as desired.

and press

--->>

”

to return to the SETUP ADV 7 screen.

to scroll through each segment. Confirm the

When you use the ezCarb or ezBG feature, your pump will automatically select the ISF for

If you set only one ratio, it will be used for the entire 24-hour period.

From the SETUP ADV 7 screen, scroll up to “ISF”.

Press . Repeat to set

Press .

ISF

BG Target

Home

The first segment always starts at midnight. The last time slot available is 11:30pm.

Press to change to flashing cursor for Edit mode.

Use the /

Press when setting is made.

To move to the next ISF screen, scroll to “

Scroll up to the “Time” field and press to change to flashing cursor for

Use the /

buttons to change to desired setting.

buttons to scroll to the “1U:” (mg/dL) field.

and press

--->>

”

Edit mode.

ISF

1 of 12

Time:

12:00A

1U: 40

<<---- ---->>

Done

Time:

6:00A

1U: 50

<<---- ---->>

Done

mg/dL

Home

ISF

2 of 12

mg/dL

Home

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 54 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

Use the /

Scroll to the “1U:” (mg/dL units) field and press to change to flashing cursor for Edit Mode.

Use the /

buttons to change the segment start time.

buttons to change the “1U:” (mg/dL units) field as desired.

Press .

Press . Repeat to set

remaining segments per your health care team’s recommendations.

”

To review your settings, highlight “

and press to scroll through each segment. Confirm the

--->>

times and setting values are correct.

When finished, scroll to “Done” and press

To return to the Home screen, scroll to “Home” and press

to return to the SETUP ADV 7 screen.

Setup Advanced Screen 7 – Personal Settings - BG Target Ranges

Your health care team may recommend you use different BG Target ranges for different times of day. When you use the ezCarb or ezBG feature, your pump will automatically select the BG Target range for the current time of day.

This screen allows you to:

Set different BG Targets and ranges for 12 different time slots

If you set only one ratio, it will be used for the entire 24-hour period.

NOTE:

OneTouch

Ping

Insulin Pump

SETUP ADV 7

I:C Ratio

ISF

BG Target

Home

The first segment always starts at midnight. The last time slot available is

11:30pm.

Press to change to flashing cursor for Edit mode.

Use the /

Press when setting is made.

Scroll to the “+/-”(range) field. Press to change to flashing cursor for

Use the /

From the SETUP ADV 7 screen, scroll up to “BG Target”.

buttons to scroll to the BG Target field.

buttons to change to desired setting.

Edit mode.

Press .

BG Target

1 of 12

Time:

12:00A

120 +/- 10

<<---- ---->>

Done

Time:

12:00A

120 +/- 5

<<---- ---->>

Done

mg/dL mg/dL

Home

BG Target

1 of 12

mg/dL mg/dL

Home

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 55 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

NOTE: By setting a range (+/-) your pump will not calculate a BG correction dose if your actual BG is within that range. range to +/- 0. This screen allows you to:

Use the /

To move to the next BG Target screen, scroll to “

Scroll up to the “Time” field and press to change to flashing cursor for Edit mode.

Insulin Pump

Ping

Use the /

10.

Scroll to the BG Target field. Press to change to flashing cursor for

Edit mode.

If you prefer to correct to one target number rather than a range, simply set your

buttons to change the range as desired.

--->>”

buttons to change the segment start time.

Press .

and press .

Press .

BG Target

2 of 12

Time:

6:00A

120 +/- 10

<<---- ---->>

Done

mg/dL mg/dL

Home

11.

12.

OneTouch

13.

14.

segments per your health care team’s recommendations.

To review your settings, highlight “ times and setting values are correct.

When finished, scroll to “Done” and press

To return to the Home screen, scroll to “Home” and press

Setup Advanced Screen 8 – Insulin on Board (IOB) Setting

This feature allows you to program the rate at which your body uses your bolus. Even with rapid-acting insulin, your body takes some time to use your entire bolus insulin. you give a bolus, your pump will tell you how much Insulin on Board (IOB) is currently remaining and will calculate a decreased bolus dose as an option. help reduce your risk of hypoglycemia*. and can vary based on the infusion site you have selected and your activity level, among other factors. Your health care team will give you a recommended duration to program into your pump.

Use the /

Press when setting is made.

Scroll to the “+/-”(range) field. Press to change to flashing cursor for Edit mode.

Use the /

buttons to change to desired setting.

buttons to change the range as desired.

and press to scroll through each segment. Confirm the

--->>”

to return to the SETUP ADV 7 screen.

This helps to prevent “stacking” insulin and can

The duration of insulin action varies from person to person

Press . Repeat to set remaining

When this feature is activated and

*Recommended reading for pump users includes:

Pumping Insulin, by John Walsh, PA, CDE and Ruth Roberts, MA

Smart Pumping, by Howard Wolpert, MD

 WARNING: This feature is intended for use only with U100 rapid-acting insulin analogs

such as Novolog

Apidra result in serious injury or death.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 56 4/11/11 9:54 AM

, Do Not use this feature. Use of any insulin with lesser or greater concentration can

, Humalog® or Apidra®. If you use an insulin other than Novolog®, Humalog® or

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

This screen allows you to:

Turn the IOB feature on or off

Select the duration

Use the /

Press to change to flashing cursor for Edit mode.

Use the /

Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press

Your pump is constantly tracking IOB, so when you turn on the feature, your pump will

NOTE:

immediately take into account the current amount remaining from previous bolus doses within the time frame you’ve selected during set up of the feature.

Points to remember about the IOB feature on your pump

A curvilinear algorithm is used, which more closely mimics the way drugs decay in the body versus a

straight line decay.

buttons to scroll to the desired field.

buttons to change to desired setting.

SETUP ADV 8

Insulin on Board

IOB-2

Duration

4.0 Hr

Home

OFF

OneTouch

Ping

Insulin Pump

With BG below target, IOB amount is displayed and is subtracted from the carb portion of the bolus.

With BG within target, IOB amount is displayed for reference but not subtracted from bolus total.

With BG above target, IOB amount is displayed and is subtracted from BG bolus.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 57 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 10 - ADVANCED FEATURES / SETUP AND ACTIVATION

Setup Advanced Screen 9 – Sick Day Guidelines

During your pump training, your health care team will discuss guidelines to use when you’re sick.

Insulin Pump

Ping

OneTouch

This is a convenient way to store your basic sick day guidelines as recommended by your health care team. contact your health care team.

This screen allows you to:

Set a BG limit as a reminder for testing when sick

Set the frequency of checking for ketones when sick

Set the frequency of checking your BG when sick

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press

NOTE: This screen is intended as a reference only. Alerts are NOT triggered based on values displayed on this screen.

Setup Advanced Screen 10 – Establishing Communication with Your Meter Remote

This screen allows you to activate the RF and pairing features on your pump. When you are ready to begin using your pump and meter remote together as a system, you will need to activate RF communication and pair the devices. See Chapter 2 in Section III, pages 179–188.

For more information on sick day guidelines, refer to Chapter 16 in Section I, pages 93–94, and

SETUP ADV 9

Sick days

BG over

Check ketones every

Check BG every

Home

240

mg/dL

4 Hrs

2 Hrs

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 58 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

 CAUTION: Using the features in this chapter requires an advanced understanding of insulin

pump therapy and should not be used without training and advice from your health care team. In order to achieve optimal results, some of these features should only be used once you have tested and fine-tuned your basal rates and your health care team has determined your individual targets and ratios.

NOTE:

Before using these features, you must turn them on in the Setup Advanced menu.

See Chapter 10 in Section I, pages 49–58.

Audio Bolus and ezBolus

The Audio Bolus feature of the OneTouch® Ping® Insulin Pump allows you to bolus without looking at the screen display. This is convenient if you wear your pump under your clothing. When first using the audio bolus feature, also check the display screen until you are comfortable with the programming steps. If you do not wish to use the Audio Bolus feature, this button serves as a shortcut to the Normal Bolus screen. See ezBolus

™

, page 61 in this chapter.

 CAUTION: When you first use the Audio Bolus feature, you should always look at the screen

to confirm correct programming until you are comfortable with the feature.

OneTouch

Ping

Insulin Pump

1. Turn on Audio Bolus in the Setup Advanced menu and select your preferred step size. See

Chapter 10 in Section I, pages 49–58.

2. The Audio Bolus button is the soft rubber button on the end of your pump. Press it once. Your

pump will beep (or vibrate) to indicate you’ve accessed Audio Bolus mode as well as indicate the step size you’ve set up.

The number of beeps (or vibrate pulses) reminds you of the step size you’ve set.

1 indicates 0.1U step size

2 indicates 0.5U step size

t

3 indicates 1.0U step size

4 indicates 5.0U step size

3. Press the Audio Bolus button once for each step size you’ve programmed

to reach the desired total amount. For example, if you are using 1.0U step size and you wish to bolus 4 units, press the button 4 times. You will hear a beep tone or vibrate for each button press. If you are using 0.5U step size and you wish to bolus 4 units, press the button 8 times.

Audio Bolus

Step size=

1.0U/Press

Enter

bolus amount

Press any other

key to CANCEL

0.00

4. Within 5 seconds, your pump will respond with a number of confirmation beeps equal to the

number of times you pressed the Audio Bolus button.

NOTE: Do Not press any of the function buttons at this time unless you wish to cancel delivery.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 59 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

5. Within 5 seconds, your pump will beep twice to “ask” you to confirm that

you wish to activate delivery and “Confirm” is displayed on the Audio Bolus screen.

Insulin Pump

Ping

OneTouch

6. Within 5 seconds, press the button again to activate delivery. Your pump

will beep twice to confirm your delivery command. The DELIVERING bolus screen is displayed and your pump will beep once to signal the start of delivery and once to signal end of delivery (if you turned on Normal Bolus Sounds in Setup).

If you wish to cancel the Audio Bolus, press any function button (not the contrast button).

If you cancel a bolus delivery after you’ve activated it, the screen at right will be displayed. See Chapter 13 in Section I, pages 75–84.

Audio Bolus

Confirm

3.00

Press any other

key to CANCEL

DELIVERING

3.00

Press any

function button

to cancel.

Warning

Bolus

delivery canceled by user button

press.

Delivered:

2.00U of 3.00U

Confirm

If during a bolus delivery your low cartridge level is reached, your pump will not display the

NOTE:

warning until after the bolus is completed. So you could possibly have less insulin available than your low cartridge setting.

Example: Your low cartridge warning is set to 10 (units). You have 20 units of insulin remaining and you deliver a 15 unit bolus. The Low cartridge warning appears after bolus is completed and you have only 5 units left – not 10 units. The Wake up screen will show the remaining insulin amount.

The maximum number of Audio Bolus button presses is 20. Therefore, if you’ve set the step size to

0.1U, the maximum audio bolus amount is 2U. If you’ve set the step size at 0.5U, the maximum audio bolus amount is 10U and if your step size is 1.0U, the maximum audio bolus amount is 20U. With a

5.0U step size, the maximum cannot be greater than 35U, which is the maximum amount for any type of bolus.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 60 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

ezBolus

™

If you do not have your Audio Bolus feature turned on, the button on the end of your pump will function as a shortcut to the Normal Bolus screen.

NORMAL BOLUS

Amount

0.00

1. Press the button on the end once. The Normal Bolus screen is displayed.

Program a Normal Bolus as usual.

Go Main Menu

Advanced Bolus Features

ezCarb

ezBG

Combo Bolus

Reminders

All Advanced Bolus features are activated in the Setup Advanced Menu. See Chapter 10 in Section I, pages 49–58. When the Advanced Bolus features and Reminders are activated, the full BOLUS MENU is displayed.

 WARNING: Be sure to review all the values used in bolus calculations to make sure they

are correct. You may always adjust the insulin units up or down before you decide to administer your bolus. If you dose an insulin amount that is too high or too low, this may result in a hypoglycemic or hyperglycemic event. Please discuss the bolus calculator feature and all relevant personal settings with your health care professional before using the calculator for the first time.

BOLUS MENU

Normal

ezCarb ezBG Combo Bolus Reminders

Main Menu

OneTouch

Ping

Insulin Pump

ezCarb

This feature allows you to manually enter the number of carbs eaten, and your pump will automatically calculate your bolus dose, based on the I:C ratio, ISF and BG Target range you have entered for the current time of day. Consult your health care team for your personal I:C ratios, ISFs and BG Target ranges. See Chapter 10 in Section I, pages 49–58.

If the IOB feature is activated, your pump will calculate a reduced amount for high BG correction boluses and for Carb Boluses if you entered a below-target BG value.

When you use your meter remote to deliver an ezCarb Bolus, you may also select the number of carbs eaten directly from a Food Database stored in your meter remote, see Chapter 4 in Section III, pages 191–206. The Food Database is available through an upload to your meter remote from ezManager the ezManager

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 61 4/11/11 9:54 AM

Diabetes Management Software. For instructions on uploading the Food Database, refer to

Diabetes Management Software User Guide included with the software.

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

Entering Carbs Manually

Insulin Pump

Ping

BOLUS MENU

Normal

ezCarb

ezBG Combo Bolus Reminders

Main Menu

2. The cursor will flash on the “Carbs” field to indicate that you can edit the

total number of carbs eaten. Use the carbs. Press pages 63–64 in this chapter.)

OneTouch

NOTE: The max limit for ezCarb Total is 999g.

3. Check that the grams of carb entered and your I:C ratio at the top of the screen are correct.

a. If the entries are correct, scroll to “Show Result”. Press

b. If not correct, scroll up to highlight the field and press

Mode. Use Press

4. Scroll down to “Show Result”. Press .

1. From the BOLUS MENU, scroll to “ezCarb”. Press . The ezCarb Home

screen is displayed.

buttons to enter the number of

. “Add BG” is highlighted. (See Adding a BG Bolus to ezCarb,

to activate Edit

buttons to enter your I:C ratio and/or change the carb entry.

and go to Step 5.

ezCarb Home

Carbs: 34 g

I:C 1U: 15g

Add BG Show Result

Main Menu

ezCarb Home

Carbs: 34g

I:C 1U: 15g

Add BG

Show Result

Main Menu

5. The Bolus Total screen is displayed. The bolus

amount field is highlighted and flashing to indicate you can enter the total amount as shown or adjust as needed. Enter your bolus amount. Press

NOTE: Calculated total units will be rounded to the

Bolus Total

Carb BG + IOB Total =

0.00U

Go Type Normal

Main Menu

2.26U

0.00U

--.--U

2.25U

Bolus Total

Carb BG + IOB Total =

2.25U

Go Type Normal

Main Menu

2.26U

0.00U

--.--U

2.25U

nearest .05 units.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 62 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

6. “Go” is highlighted. If you wish to give a Normal

Bolus, press

Bolus Total

Carb BG + IOB Total =

2.25U

Go Type Combo

Main Menu

8. Use the /

to deliver.

2.26U

0.00U

--.-- U

2.25U

7. If you wish to give a Combo Bolus, scroll to the “Type” field and press

to edit.

buttons to select bolus type: “Normal” (default) or “Combo”. Press

Bolus Total

Carb BG + IOB Total =

2.25U

Type Normal

Main Menu

2.26U

0.00U

--.--U

2.25U

DELIVERING

2.25

Press any

function button

to cancel.

9. “Go” is highlighted. Press .

NOTE: If you select the Combo Bolus option, the Combo Bolus screen will be displayed. See Combo Bolus, pages 67–68 in this chapter for instructions on delivering the Combo Bolus.

OneTouch

Ping

Insulin Pump

Entering Carbs Using the Food Database

This feature is only available on your meter remote, and can be accessed when delivering an ezCarb Bolus from your meter remote. See Chapter 4 in Section III, pages 191–206.

Adding a BG Bolus to ezCarb

1. On the ezCarb Home screen, enter the number of carbs. Press .

ezCarb Home

Carbs: 34g

I:C 1U: 15g

Add BG

Show Result

Main Menu

2. “Add BG” is highlighted. Press . The BG CORRECT screen is displayed.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 63 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

3. The “Actual” field is highlighted and flashing

to indicate Edit mode. Use the enter your BG value. Press

highlighted.

4. Check that the BG Target range and ISF are correct.

Insulin Pump

Ping

a. If they are correct, press

highlighted.

b. If they are not correct, scroll up to highlight the

fields and press the values. Press

OneTouch

“Show Result”. Press

Carb BG + IOB Total =

Go Type Normal

Main Menu

Bolus Total

--.--U

0.00U

buttons to

. “Show Result” is

with “Show Result”

. Use the /

to exit Edit mode. Scroll down to

buttons to adjust

2.26U

2.70U

4.95U

5. The Bolus Total screen is displayed and shows the calculated bolus units

from your ezCarb Bolus. The bolus amount field is highlighted and flashing, and displays 0.00 units.

BG CORRECT

Actual Target = +

ISF 37 mg/dL Show Result

Main Menu

BG CORRECT

Actual Target = +

ISF 37 mg/dL Show Result

Main Menu

mg/dL

220

120 100

mg/dL

220

120

100

BG CORRECT

Actual Target = +

ISF 37 mg/dL

Show Result

Main Menu

BG CORRECT

Actual Target = +

ISF 37 mg/dL Show Result

Main Menu

mg/dL

220 120 100

mg/dL

220 120 100

Bolus Total

6. Enter the Bolus amount and press

“Go” is highlighted. Press

to deliver as a Normal Bolus or scroll to the “Type” field to select Combo Bolus, then select “Go”.

Carb BG + IOB Total =

4.95U

Go Type Normal

Main Menu

2.26U

2.70U

--.--U

4.95U

If you selected the Combo Bolus option, you will begin the steps for delivering the ezCarb units as a Combo Bolus (see Combo Bolus, pages 66–67 in this chapter). The bolus amount you entered on the Bolus Total screen in step 6 will appear in the “Total” field on the first Combo Bolus screen.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 64 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

ezBG

This feature allows you to enter your BG reading and your pump will automatically calculate a BG correction bolus based on the ISF and BG Target range for the current time of day. If the IOB feature is activated, your pump will calculate a reduced dose for high BG correction boluses.

OneTouch

1. From the BOLUS MENU, select “ezBG”. Press the

BOLUS MENU

Normal ezCarb

ezBG

Combo Bolus Reminders

Main Menu

2. The “Actual” field will be highlighted and flashing

buttons to enter

to indicate Edit mode. Use the your actual BG reading. Press the the entry and exit Edit mode.

button to confirm

button.

ezBG

Actual Target = + ISF 37 mg/dL

Show Result

Main Menu

mg/dL

224

120 104

3. Check to be sure the BG Target and Insulin Sensitivity Factor (ISF) are

correct. Your health care team will give you these values. If you need to edit these fields, scroll up to highlight the field and press

buttons to change target. Press

Use

to confirm and to exit Edit mode.

to activate Edit mode.

ezBG

Actual Target = +

ISF 37 mg/dL

Show Result

Main Menu

Actual Target = +

ISF 37 mg/dL

mg/dL

224

120

104

ezBG

mg/dL

224 120 104

Ping

Insulin Pump

Show Result

ezBG

Actual Target = + ISF 37 mg/dL

Show Result

Main Menu

mg/dL

224 120 104

4. “Show Result” is highlighted. Press .

Main Menu

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 65 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

5. The ezBG Total screen is displayed with a suggested bolus amount. The bolus amount field is

highlighted and flashing to indicate you can enter the total amount as shown or adjust as needed. Enter your bolus amount. Press

to deliver.

BG + IOB

Total =

Insulin Pump

Ping

OneTouch

Main Menu

ezBG Total

BG + IOB -

Total =

Main Menu

NOTE: If you enter a BG amount below 70 mg/dL or above 250 mg/dL, your pump will alert you that you’ve entered an out of range BG. To confirm the Alert, press recommended by your health care team.

ezBG Total

2.81U

--.--U

2.80U

0.00U

2.81U

1.00U

1.80U

ezBG Total

BG + IOB

Total =

2.80U

Main Menu

2.81U

--.--U

2.80U

DELIVERING

2.80

Press any

function button

to cancel.

NOTE: If the IOB feature is activated, your pump will calculate a reduced BG Bolus amount for your review.

. Treat the out of range BG as

Alert

LOW BG

Treat low BG.

No bolus

recommended.

Monitor BG.

Confirm

Alert

HIGH BG

Treat high

BG.

Check site.

Check

ketones.

Monitor BG.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 66 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

Combo Bolus

The Combo Bolus feature is used to give both a Normal and Extended Bolus. This feature is useful for consumption of high fat meals such as pizza, if you will be “grazing” over a few hours or if you have gastroparesis. You can program part of your bolus amount to be delivered immediately and part of it to be delivered slowly over the course of up to 12 hours. Your health care team can help you determine the “split” of Normal to Extended insulin amounts, as well as the duration that is most appropriate for you.

OneTouch

BOLUS MENU

Normal ezCarb ezBG

Combo Bolus

Reminders

Main Menu

2. Use the /

1. From the BOLUS MENU, select “Combo Bolus”. If you used the ezCarb

Bolus option to calculate a bolus and chose to deliver it as a Combo Bolus, you will begin at the Combo Bolus screen in step 2.

buttons to enter the Total bolus amount. Press

. “Go” is highlighted. The factory default setting for Duration is 30 minutes, and the Ratio is 0% Normal and 100% Extended. If these settings are appropriate, press

Total Duration

Main Menu

to deliver.

Combo Bolus

30:

2.55:

Extend

70%

5.95U

Normal:

8.50U

4.0Hr

3. To change either the Duration or Ratio, scroll up to the desired field and

press

to activate Edit mode.

Combo Bolus

Total Duration

Normal:

0.00:

Main Menu

Combo Bolus

Total Duration

8.50U

0.5Hr

Extend

100%

0.00U

8.50U

0.5Hr

Ping

Insulin Pump

30:

2.55:

Extend

70%

5.95U

4. Use the /

buttons to change settings. As you change the Ratio by

percentage, the amount in units is automatically changed. You cannot change

the ratio by units, only by percentage.

5. When settings are correct, press

to confirm and exit Edit Mode.

Normal:

Main Menu

NOTE: Your pump is “smart”; it will remember your last duration and the ratio (as percentages) you programmed. So if you use the same duration and ratio for certain types of meals, you need only change the total bolus amount the next time you use this feature. However, the last programmed Combo Bolus settings will be cleared each time you change the battery.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 67 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

6. Scroll to “Go” and press to activate. The Home

screen shows Combo Bolus active.

Insulin Pump

Ping

OneTouch

Combo Bolus

Duration

0.0 : 4.0Hrs

Delivered

2.55U : 8.50U

CANCEL

Main Menu

Reminders

This feature allows you to set personal reminders. You can set two bolus reminders for times of day, and one reminder to check BG at a certain time after a bolus. Confirm the Reminder by pressing Once you’ve confirmed the Reminder, you will not be alerted again.

ACTIVE

Combo Bolus

Total Duration

Normal:

30:

2.55:

Main Menu

8.50U

4.0Hr

Extend

70%

5.95U

2 : 27

BOLUS ACTIVE

Basal Rate

0.675U/Hr

Insulin: 105U

Status

To cancel an active Combo Bolus from the BOLUS MENU, select “Combo Bolus”. Details of the active Combo Bolus will be displayed.

Scroll to “CANCEL” and press

to cancel the Combo Bolus.

NOTE: If you Suspend your pump, any active Combo Bolus will also be canceled and the screen display will alert you. Combo Bolus is also canceled when you change the battery and/or prime your pump.

Bolus Reminders for Time of Day

BOLUS MENU

Normal ezCarb ezBG Combo Bolus

Reminders

Main Menu

2. The “Reminder-1” field will be highlighted with a flashing cursor to indicate

Edit mode. Use the exit Edit mode.

1. From the BOLUS MENU, select “Reminders”. Press .

buttons to turn on or off. Press

to confirm and

REMINDERS

Reminder-1

Time =

Reminder-2

Time =

BG Check

After Bolus =

Main Menu

OFF

12:00PM

OFF

12:00PM

OFF 1 Hr

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 68 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

3. The “Time” field for this reminder will be

highlighted. Press

buttons to enter the time you wish a reminder

/ to sound (or vibrate, if that is the setting you selected in the SETUP SOUND menu). Press setting and exit Edit mode. When the feature is turned on, your pump will display the “Reminder” screen on the right at the selected time of day.

to activate Edit mode. Use the

to confirm your

REMINDERS

Reminder-1

Time =

Reminder-2

Time =

BG Check

After Bolus =

Main Menu

OFF

12:00PM

OFF

12:00PM

OFF 1 Hr

4. Repeat for the Reminder 2.

BG Check Reminder

REMINDERS

Reminder-1

Time =

Reminder-2

Time =

BG Check

After Bolus =

Main Menu

2. Scroll down to highlight the “After Bolus” field. Press

and activate Edit mode. Use the Normal Bolus you wish your pump to sound (or vibrate) to remind you to check your BG. You can select a reminder time of 1, 2, 3 or 4 hours.

OFF

12:00PM

OFF

12:00PM

OFF

1 Hr

1. From the REMINDERS menu, select “BG Check”. Press

mode to turn this reminder on or off. Press

buttons to enter how long after a

to select the field

to confirm and exit Edit mode.

Reminder

12:00PM

Confirm

to activate Edit

REMINDERS

Reminder-1

Time =

Reminder-2

Time =

BG Check

After Bolus =

Main Menu

OFF

12:00PM

OFF

12:00PM

1 Hr

OneTouch

Ping

Insulin Pump

Reminder

Check BG

1 Hr

When this feature is turned on, your pump will display the BG Reminder screen immediately after a bolus. On this screen you can use the

buttons to select a different reminder time (1, 2, 3, or 4 hours), or opt

/ not to be reminded by entering 0. For example, if you have given a bolus in the evening, you may not wish to have the Reminder sound while you are sleeping. If the Reminder is not confirmed, battery life will be reduced and the

Confirm

Replace Battery Alarm will appear sooner than expected.

Reminder

NOTE: When you enter a time, your pump will sound a reminder and display this screen at that time after any Normal Bolus is programmed, including the Normal portion of a Combo Bolus. If you program an Extended Bolus only, the reminder will sound at the default time you have set.

3. When finished setting reminders, scroll to “Main Menu” and press

to display the MAIN MENU.

Check

Last bolus

12:15PM

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 69 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

Delivery Speed - Bolus

On rare occasions, usually with very large boluses, users may experience a slight stinging sensation

with rapid bolus delivery. If this is a concern, you can set the bolus delivery speed to slow to accommodate your needs. If you use the slow setting, your pump will pause approximately 4 seconds in between delivery of each unit of insulin programmed.

Multiple Basal Programs

Insulin Pump

This feature allows 4 different Basal programs to show on your BASAL MENU screen. Users find this feature beneficial if their activity level is different during the week than on weekends. Switching work shifts at work is another

Ping

reason to use multiple basal programs. Some use a different basal program during menstruation. An “A” will appear to the left of the basal program that is currently active.

OneTouch

NOTE: If a program other than 1-Weekday is active, you cannot change this setting to display 1 basal program. The Alert screen shown here will pop up to remind you.

IOB

Even with rapid-acting insulin, your body takes some time to use the entire bolus amount. If you have activated this feature, your pump will track the bolus insulin remaining in your system - IOB - and calculate a suggested lower BG correction bolus dose. The lower dose is only recommended if you use the ezBG feature or if you add a BG bolus to an ezCarb bolus. For this feature to give optimal results, you should always use either ezBG or the Add BG feature during ezCarb programming when entering a BG correction bolus.

BASAL MENU

Total 13.60U

Temp

A1-WEEKDAY

2-other

3-weekend 4-exercise

Main Menu

Alert

1-weekday

must be the

active program

to change the

basal display

setting.

Confirm

Bolus Total

Carb BG + IOB – Total =

3.95U

Type Normal

Main Menu

2.25U

2.70U

1.00U

3.95U

 CAUTION: Your health care team will give you recommendations specific to your plan of

treatment.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 70 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

In the examples shown here, the IOB amount is subtracted from the BOLUS TOTAL screen and the ezBG Total screen.

ezBG Total

BG + IOB -

Total =

1.80U

Main Menu

2.81U

1.00U

1.80U

NOTE:

t8IFOZPVSFQMBDFUIFCBUUFSZUIF*0#BNPVOUJTDMFBSFE

tYour pump constantly tracks IOB. If you’ve given a bolus before turning on the feature, your pump

will show the remaining amount from that bolus as IOB immediately.

Sick Day Guidelines

To review your basic sick day guidelines, refer to this screen. For more information on sick day guidelines, refer to Chapter 15 in Section I, pages 91–92, and contact your health care team.

SETUP ADV 9

1. From the SETUP menu, select “Advanced”.

2. Scroll to the Setup Advanced Screen 9.

3. Enter or review the guidelines as recommended by your health care team.

Sick days

BG over

Check ketones every

Check BG every

Home

240

mg/dL

4 Hrs

2 Hrs

OneTouch

Ping

Insulin Pump

Establishing Communication with your Meter Remote

When you are ready to begin using your pump and meter remote together as a system, you will need to activate RF communication and pair the devices. See Chapter 2 in Section III, pages 179–188.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 71 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 11 - USING ADVANCED FEATURES

Insulin Pump

Ping

OneTouch

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 72 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 12 - CARE AND MAINTENANCE

The Vents

Your pump features a redundant Vent Safety System. Vents serve two purposes. First, they allow air to enter and exit your pump so that pressure is equalized under a variety of environmental circumstances, such as changes in altitude. Second, the vents are backed by a special membrane, which keeps water from entering your pump.

Battery Cap with O-ring and Vent

Your battery cap contains an o-ring and vent. There is a tiny hole backed by a membrane, which allows air to pass through but prevents water from entering. The o-ring helps to keep your pump waterproof. It is recommended that you change the battery cap/vent every 6 months. If you work in a dusty environment such as a construction site, mill, cement factory, etc., or if you are a frequent swimmer, you should change your battery cap every 3 months. You can call Animas battery cap.

O-ring

to order an extra

Vent Hole

OneTouch

Ping

Insulin Pump

 WARNING: Under no circumstances should you introduce any kind of sharp object into the

vent openings to clean them. Doing so could compromise your pump’s waterproof capabilities. If at any time you suspect the vent opening is clogged, replace the battery cap.

Cleaning

 CAUTION: Do Not use household or industrial cleaners, chemicals, solvents, bleach,

scouring pads or sharp instruments to clean your pump. Never put your pump in the dishwasher or use very hot water to clean it. Use only a very mild detergent (for example a drop of liquid soap in a glass of water) and a lint-free cloth.

Never put your pump in a microwave oven or baking oven to dry it. Use a soft towel.

Never clean the battery or insulin cartridge compartments.

General Wear and Tear

If you drop your pump or it has been hit against something hard, inspect it to be sure it is still working properly. Check that the display screen is working and clear, that the cartridge cap, battery cap and infusion set are properly in place. Check for leaks around the cartridge by wrapping a piece of tissue around the connection area. Cracks, chips or damage to your pump may impact the battery contact and/or the waterproof feature of your pump. Call our Customer Service representatives at 1 877 937-7867 if you identify or suspect your pump is damaged. They will help determine if your pump should be replaced.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 73 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Disposal

International and US regulations require controlled disposal of devices such as insulin pumps.

Dispose of batteries according to your local environmental regulations.

Insulin Pump

Ping

OneTouch

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 74 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Your pump has a progressive warnings and alarms safety system. This means if you do not confirm the warning or alarm, it will progress to the sweep alarm with vibrate within one hour. At the high volume stage, if you do not confirm the warning or alarm, the sweep alarm will begin and will not stop until appropriate action is taken.

Alerts are automatically displayed to remind you of a function that you’ve set or a condition that exists. Warnings are triggered for a variety of reasons. They require you to confirm the warning by pressing All require you to address the alarm by taking appropriate action in order to clear the alarm condition.

- Indicates that this alert, warning or alarm can play a tune as the initial notification for medium and high volume settings. The pump default for sounds at the low volume setting is a factory-set sound and cannot be modified with ezManager

and/or taking action to address the warning. Alarms are triggered by several conditions.

Diabetes Management Software.

OneTouch

Ping

Insulin Pump

IMPORTANT: Many of the following pump alerts, warnings and alarms will also sound and/or display on your meter remote, once you begin using the devices together as a system. See Chapter 6 in Section III, pages 211–220 for a complete list.

NOTE: Alarms, warnings and alerts will display actual insulin units during pump operation, rather than the “XX” or “XXX” units displayed on some of the screens in this list.

Alert: Active Basal Program Empty

Cause

Effect

Message

Action

Beeps/Vib

Active basal program is empty.

No basal deliveries.

Displayed once until confirmed or until pump goes to sleep and each time manually awakened.

None required but can confirm or select Basal Menu.

User selected, one time and each time manually awakened. No progression.

Confirm

Basal Menu

Alert

Your active

basal

program

is empty.

0.000U/Hr

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 75 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Alert: Temp Basal Minimum Rate

Cause

Effect

Message

Insulin Pump

Ping

OneTouch

Action

Beeps/Vib

Alert: Suspend (Temp Basal/Combo Bolus Canceled)

Cause

Effect

Message

Negative Temp Basal activated.

Basal delivery will not go below 0.025U/Hr.

Displayed once for 3 seconds.

None required.

User selected, one time. No progression.

Pump suspended

Any active Temp Basal/Combo Bolus canceled.

Displayed once for 3 seconds.

Alert

Temp Active

Minimum

Basal rate

limited to

0.025U/Hr

Alert

Pump Suspended

If active,

Temp Basal &

Combo Bolus

have been

canceled.

Action

Beeps/Vib

Alert: Low BG

Cause

Effect

Message

Action

Beeps/Vib

None required.

User selected, one time. No progression.

BG entry below 70 mg/dL.

Requires user confirmation to continue.

Displayed until confirmed or until pump goes to sleep.

Press

to confirm.

User selected, one time. No progression.

Alert

LOW BG

Treat low BG.

No bolus

recommended.

Monitor BG.

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 76 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Alert: High BG

Cause

Effect

Message

Action

Beeps/Vib

BG entry above 250 mg/dL.

Requires user confirmation to continue.

Displayed until confirmed or until pump goes to sleep.

Press

to confirm.

User selected, one time. No progression.

Alert: Clear Program Basal Segments

Cause

Effect

Message

Clear command selected from BASAL OPTIONS screen.

Requires user confirmation to continue.

Displayed until one of the two options is selected or until pump goes to sleep.

Alert

HIGH BG

Treat high

BG.

Check site.

Check

ketones.

Monitor BG.

Confirm

Alert

Clear Program

deletes all

basal segments

in this program.

Clear Program

Basal Options

OneTouch

Ping

Insulin Pump

Action

Beeps/Vib

Select “Clear Program” or “Basal Options”.

User selected, one time.

Alert: Basal Program Display Change

Cause

Effect

Message

Action

Beeps/Vib

Changing display of basals from 4 to 1 but program 1 is not currently active.

Requires user confirmation to continue.

Displayed until confirmed or until pump goes to sleep.

Press

to confirm.

User selected, one time.

Alert

1-weekday

must be the

active program

to change the

basal display

setting.

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 77 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Warning: Basal Delivery Suspended

Cause

Effect

Insulin Pump

Ping

Message

Action

Beeps/Vib

OneTouch

Warning: Suspend

Cause

Effect

Message

Basal Edit was not saved.

Basal delivery stopped.

Displayed when manually awakened until confirmed.

Press

to select “Edit Basal”. Review basal edits and

select “Save/Review”.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Pump suspended manually.

All deliveries stop.

Displayed each time pump is awakened until confirmed and once every 15 minutes until action is taken.

Warning

Basal edit

not saved.

Basal

delivery

suspended.

Edit Basal

Warning

No delivery.

Pump is

suspended.

Confirm

Action

Press

to confirm. Resume delivery.

User selected, once every 15 min. No progression if

Beeps/Vib

confirmed each time displayed. Sweep/vibe within one hour if not confirmed.

Warning: No Cartridge Detected, Deliveries Disabled

Cause

Effect

Message

Action

No cartridge detected after “Load cartridge” step during Rewind/Prime.

No deliveries.

Displayed when manually awakened until confirmed.

Press

to confirm. Be sure Rewind/Prime sequence is

completed with cartridge properly in place.

User selected, once every 3 min. No progression if

Beeps/Vib

confirmed each time displayed. Sweep/vibe within one hour if not confirmed.

Warning

No cartridge

detected.

Delivery

disabled.

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 78 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Warning: Low Battery

Cause

Effect

Battery life will only last a minimum of 30 minutes.

Deliveries continue.

Displays when pump is awake until confirmed. Displays

Message

when triggered by event (such as bolus) & when manually awakened.

Action

Beeps/Vib

Press

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning: Low Cartridge

Cause

Effect

Message

Low insulin level reached.

Deliveries may continue until Empty Cartridge alarm is triggered.

Displayed when manually awakened until confirmed.

to confirm. Insert new battery.

Warning

battery.

Confirm

Warning

cartridge.

XX U or

less left.

Confirm

Low

OneTouch

Ping

Insulin Pump

Action

Beeps/Vib

Press

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

to confirm. Replace with filled cartridge.

Warning: Exceeds Max Bolus

Cause

Effect

Message

Action

Beeps/Vib

Audio bolus delivery exceeds user-set maximum.

Bolus delivery stops.

Displayed when manually awakened until confirmed.

Press

to confirm. Reprogram max bolus amount in

the Setup Advanced menu.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning

Exceeds

max bolus

XX.XX U.

No bolus delivery.

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 79 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Warning: Exceeds Max TDD

Cause

Effect

Message

Insulin Pump

Ping

OneTouch

Action

Beeps/Vib

Warning: Exceeds Max Basal

Cause

Effect

Bolus delivery exceeds user-set maximum.

All deliveries stop until action is taken. Any Combo Bolus or Temp Basal is temporarily suspended.

Displayed when manually awakened until confirmed.

Press

to confirm. Reprogram max TDD amount in the Setup Advanced menu. If the Warning is not confirmed by the time your pump clock passes midnight, the message will continue to be displayed, but any Combo Bolus or Temp Basal that is currently suspended will resume.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Basal delivery rate (or Temp Basal delivery) exceeds user-set maximum.

Basal delivery stops.

Warning

Exceeds

max TDD

XXX U.

No delivery.

Confirm

Warning

Exceeds

max basal

XXX U/Hr.

No basal delivery.

Message

Action

Beeps/Vib

Displayed when awakened (by basal delivery attempt every 3 min. or manually) until confirmed.

Press

to confirm. Reprogram Max Basal amount in the Setup Advanced menu (or reprogram Temp Basal).

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 80 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Warning: Exceeds Max 2-hour Delivery

Cause

Effect

Message

Action

Beeps/Vib

Combined basal and bolus delivery exceeds user-set 2-hour maximum.

Insulin delivery stops.

Displayed when manually awakened until confirmed.

Press

to confirm. Reprogram Max 2-Hr amount in the Setup Advanced menu.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning: Delivery Canceled due to Low Cartridge

Cause

Effect

Message

Basal or Bolus delivery exceeds insulin remaining in cartridge.

Basal or Bolus delivery stopped.

Once per occurrence and each time awakened until confirmed.

Warning

Exceeds

max 2 Hr

No delivery.

Confirm

Warning

Delivery

canceled

due to

cartridge.

Confirm

XX U.

low

OneTouch

Ping

Insulin Pump

Action

Beeps/Vib

Press

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

to confirm. Replace with full cartridge.

Warning: No Prime, No Delivery

Cause

Effect

Message

Action

Beeps/Vib

Pump is not primed.

All deliveries stop.

Every 3 minutes or when awakened manually.

Press

to confirm. Disconnect, reprime.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning

Pump is

not primed.

No delivery.

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 81 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Warning: Bolus Delivery Canceled

Cause

Effect

Insulin Pump

Ping

Message

Action

Beeps/Vib

OneTouch

Warning: Battery Change Requires Rewind Prime

Cause

Effect

Message

Action

User pressed function button on pump during bolus delivery.

Bolus delivery stopped.

Every 3 minutes or when awakened manually.

Press

to confirm. If button was pressed accidentally, repeat steps to deliver remaining insulin units.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Prime attempted without rewind.

All deliveries stopped.

Every 3 minutes or when awakened manually.

Press

to confirm. Rewind and prime.

Warning

Bolus

delivery canceled by user button

press.

Delivered:

X.XX U of X.XX U

Confirm

Warning

Battery

change

requires

Rewind-Prime.

Confirm

Beeps/Vib

Alarm: Occlusion

Cause

Effect

Message

Action

Beeps/Vib

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Occlusion detected.

All deliveries stop.

Continuous until confirmed.

Press

to confirm. Disconnect and prime to clear occlusion. Option to select Suspend (see Suspend Warning screen, page 76).

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour. (Once confirmed, No Prime warning triggered, see No Prime Warning screen, page 81.)

ALARM

OCCLUSION

DETECTED

No delivery.

Suspend

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 82 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Alarm: Empty Cartridge

Cause

Effect

Message

Cartridge empty.

All deliveries stop.

Continuous until confirmed.

Press

Action

to select “Suspend” (see Suspend Warning screen, page 76).

User selected, every 3 minutes until confirmed. If not

Beeps/Vib

confirmed, progresses to sweep/vibe within one hour. (Once confirmed, No Prime warning triggered, see No Prime Warning screen, page 81.)

Alarm: Replace Battery

Cause

Effect

Battery either has minimum 3 minutes left or battery is dead.

All deliveries stop.

to confirm. Replace with full cartridge. Option

ALARM

EMPTY CARTRIDGE No delivery.

Replace

cartridge.

Suspend

Confirm

ALARM

REPLACE BATTERY

No delivery.

Remove battery

to silence

the alarm.

OneTouch

Ping

Insulin Pump

Message

Action

Beeps/Vib

Continuous until battery is removed.

Remove battery to silence alarm. Insert new battery.

MAX volume every 3 minutes until action taken. If not confirmed, will progress to 4 long tones/vib.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 83 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 13 - SAFETY SYSTEM AND ALARMS

Alerts, Warnings and Alarms

Alarm: Call Service

Cause

Effect

Insulin Pump

Ping

OneTouch

Message

Action

Beeps/Vib

NOTE: Some Call Service Alarms have a unique sound/vibration sequence and cannot be silenced by pressing

For these Alarms the usual progression is replaced by 3 chirps/vib repeated every 9 minutes for the first half hour. This is followed by 4 long tones/vib after that.

Hardware or software problem detected.

All deliveries stop.

Continuous until battery is removed.

Press

to silence alarm for 30 minutes (alarm can only be silenced once). Call Customer Service at 1 877 937-7867.

User-selected, every 3 minutes. If not confirmed, progresses to sweep/vibe within one hour.

ALARM

CALL SERVICE

No delivery.

054-0108

Remove battery

to silence

the alarm.

Alarm: Auto-Off

Cause

Effect

Message

Action

Beeps/Vib

Suspended due to no key press in user-set time period.

All deliveries stop.

Continuous until confirmed.

Press

to confirm. Adjust time period in the Setup Advanced menu.

MAX volume every 3 minutes. If not confirmed, progresses to sweep/vibe within one hour. (Once confirmed, No Prime warning triggered, see No Prime Warning screen, page 81.)

ALARM

AUTO-OFF

No delivery.

No button

presses in last

XX hours.

Confirm

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 84 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 14 - TROUBLESHOOTING GUIDELINES

It’s a good idea to set up a troubleshooting procedure to use anytime you suspect something might be wrong. Work with your health care team to establish guidelines* in the event of a problem.

Hypoglycemia

 WARNING: Low blood glucose is a risk for anyone using insulin therapy. You may

experience one or more of the following symptoms:

t4IBLJOFTTSBQJEIFBSUSBUFOFSWPVTOFTTQFSTQJSBUJPODPMEDMBNNZTLJOXFBLOFTT

CMVSSFEPSEPVCMFWJTJPOTVEEFOIVOHFSUJOHMJOHJOZPVSIBOETMJQTPSUPOHVFIFBEBDIF

and confusion.

t*GZPVFYQFSJFODFTZNQUPNTPGIZQPHMZDFNJBZPVTIPVMEJNNFEJBUFMZFBUBRVJDLBDUJOH

carbohydrate (glucose tablets, juice, or hard candy).

t*GZPVS#(JTBCOPSNBMMZMPXDo Not attempt to program your pump yourself. Get help.

t5SFBUIZQPHMZDFNJBJNNFEJBUFMZ

OneTouch

Ping

Insulin Pump

Rule of 15

1. Consume 15 grams of quick-acting carbohydrate

2. Wait 15 minutes

3. Recheck BG

4. If BG is < 70 mg/dL, repeat above

Troubleshooting hypoglycemia:

INSULIN PUMP

POSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION

Basal rate programmed incorrectly

Clock time incorrect

Pump exposed to MRI

Check times and rates, remember to review basal programs when making any changes.

Reset clock to current time, being careful to check AM & PM.

Disconnect from pump. Call Customer Service at 1 877 937-7867.

* Walsh JA & Roberts R, Pumping Insulin. 2006. San Diego: Torrey Pine Press.

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 85 4/11/11 9:54 AM

CAUTION - Investigational device. Limited by Federal Law to investigational use.

CHAPTER 14 - TROUBLESHOOTING GUIDELINES

Troubleshooting hypoglycemia:

FOOD INTAKE

POSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION

Bolus too large

Low carbohydrate intake for bolus

Insulin Pump

Ping

Improper timing of bolus

Alcohol consumption

OneTouch

Did not Suspend pump or activate Temp Basal

Check bolus amounts and times. Bolus only enough to lower your BG to normal level.

Measure carbohydrates accurately. See dietitian for carb counting review. May need recalculation of I:C ratio; consult with health care team.

Match timing of bolus with intake of food. Check BG prior to meal bolus and adjust accordingly.

May cause hypoglycemia. Eat food when drinking alcohol. Be cautious with bedtime bolus. Always check BG before going to bed. Check BG at 3 am. Consult health care team.

ACTIVITY

POSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION

Consult health care team for guidelines for use of Temp Basal rate during exercise.

Low carbohydrate intake prior to exercise

Unplanned activity (shopping)

Long or intensive exercise

41027500_Rev 2_OB_Titan_US_EN_MGDL_1_R1.indd 86 4/11/11 9:54 AM

If not decreasing insulin prior to exercise, may need to eat foods containing carbohydrate prior to exercise.

If BG is <100 mg/dL, eat snack prior to exercise. Frequent BG testing before, during and after any activity.

Effects of exercise can be present for hours after activity has stopped. Consult with health care team for specific guidelines.

Animas 315 Users Manual

Specifications and Main Features

Frequently Asked Questions

User Manual