Tandem t:slim X2 Installation guide

MMOL/L
SOFTWARE VERSION:
CONTROL-IQ 7.6
Training Manual
for Professional Educators

1
For Professional Use Only
This manual is designed to educate you on the features and functions of the
t:slimX2™insulin pump with Control-IQ™technology, also referred to in this manual
as the “System.” This training manual is for use by professional educators to train
end users of the System. This training manual is not intended to be distributed to
end users and is not meant to replace the t:slim X2 insulin pump with Control-IQ
technology user guide. This training manual provides step-by-step illustrative
instructions that you should follow sequentially when training an end user on how
to properly operate, manage, and care for their System. Look for special content
boxes, which highlight useful tips and important Notes that may help end users
interact with the System. For more comprehensive information on the System,
please refer to the t:slim X2 insulin pump with Control-IQ technology user guide.
If end users have questions or need further clarication on their pump use, they
should be instructed to ask their healthcare provider or contact their local custom-
er support service.
You should instruct all end users that they MUST NOT deliver insulin with their
t:slim X2 insulin pump with Control-IQ technology until they have received training.

2
Table of Contents
Chapter 1: Getting Started
Important Safety Information .........................................5
Pump Overview ...................................................5
Pump Terminology .................................................6
Control-IQ Screen Lock .............................................8
Control-IQ Home Screen ............................................9
Status Screen ...................................................10
Bolus Screen Using Grams .........................................12
Bolus Screen Using Units...........................................13
Options Screen ..................................................14
Number Keypad..................................................16
Letter Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
My Pump Screen .................................................18
Control-IQ Screen ................................................19
Charging the Pump ...............................................20
Turning On Pump Screen...........................................21
Unlock Pump Screen ..............................................21
Selecting a Language .............................................22
Edit Time .......................................................23
Edit Date .......................................................25
Sound Volume and Display Settings ..................................27
Chapter 2: My CGM
Entering the Transmitter ID..........................................31
Starting a Sensor Session ..........................................33
Calibrating the Sensor .............................................35
Setting Up CGM Alerts.............................................38
Chapter 3: Insulin Delivery Settings
Basal Limit ......................................................49
Personal Prole Overview...........................................52
Creating a New Prole .............................................52
Programming a New Prole .........................................54
Edit an Existing Prole .............................................59
Duplicate an Existing Prole .........................................63
Activate, Delete, or Rename a Prole ..................................65
Setting a Temp Rate...............................................68
Stop Insulin Delivery...............................................71
Resume Insulin Delivery ............................................72

3
Table of Contents
Chapter 4: Load
Fill and Load a Cartridge ...........................................75
Chapter 5: Bolus
Bolus Overview ..................................................85
Food Bolus Using Grams ...........................................85
Food Bolus Using Units ............................................87
Correction Bolus .................................................89
Extended Bolus ..................................................91
Cancel or Stop a Bolus ............................................94
Quick Bolus Setup ................................................97
Quick Bolus ....................................................100
Max Bolus .....................................................102
Chapter 6: Control-IQ Technology
Control-IQ Overview..............................................107
Control-IQ Technology on the Screen ................................109
Activity Settings .................................................112
Required Settings ...............................................112
Setting Up Control-IQ Technology ...................................114
Setting a Sleep Schedule..........................................117
Manually Start or Stop Sleep .......................................121
Manually Start or Stop Exercise .....................................123
Chapter 7: Pump Features
Pump History ...................................................127
Alerts and Reminders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Chapter 8: Alerts and Technical Support
Alerts .........................................................133
Alarms ........................................................133
Malfunction ....................................................133
Hazards .......................................................134
Customer Technical Support .......................................134

CHAPTER 1
Getting Started

5
For Professional Use Only
Getting Started
Important Safety Information
The t:slim X2 insulin pump with Control-IQ technology (the System) consists of the
t:slim X2 insulin pump, which contains Control-IQ technology, and a compatible
continuous glucose monitor (CGM, sold separately). The t:slim X2 insulin pump is
intended for the subcutaneous delivery of insulin, at set and variable rates, for the
management of diabetes mellitus in people requiring insulin. The t:slim X2 insulin
pump can be used solely for continuous insulin delivery and as part of the System.
When used with a compatible CGM, the System can be used to automatically
increase, decrease, and suspend delivery of basal insulin based on CGM sensor
readings and predicted glucose values. The System can also deliver correction
boluses when the glucose value is predicted to exceed a predened threshold.
The pump and the System are indicated for use in individuals six years of age and
greater. The pump and the System are intended for single user use. The pump is
indicated for use with NovoRapid, Admelog (Canada Only), or Humalog
U-100 insulin.
WARNING: Control-IQ technology should not be used by anyone under the
age of six years old. It should also not be used in users who require less than
10units of insulin per day or who weigh less than 25 kilograms.
The System is not indicated for use in pregnant women, people on dialysis, or
critically ill users. Do not use the System if using hydroxyurea. Users of the pump
and the System must: be willing and able to use the insulin pump, CGM, and all
other system components in accordance with their respective instructions for use;
test blood glucose levels as recommended by their healthcare provider; demon-
strate adequate carb-counting skills; maintain sufcient diabetes self-care skills;
see healthcare provider(s) regularly; and have adequate vision and/or hearing to
recognize all functions of the pump, including alerts, alarms, and reminders. The
t:slim X2 pump and the CGM transmitter and sensor must be removed before
MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for addition-
al important safety information.
Pump Overview
The t:slim X2 insulin pump with Control-IQ technology uses touchscreen technol-
ogy. To activate and interact with the System, the user should use the pad of their
nger to quickly and lightly tap on the screen.
Do not use a ngernail or other object to interact with the screen. It will not activate
the screen or its functions. A soft-tipped stylus may be used on the touchscreen.
Quick Tip: Fingers should be clean and dry. Oily or damp ngers may interfere with activation of
the screen.
⚠Alert: Turn screen off and position the screen away from the skin when worn under clothing.

6For Professional Use Only
Getting Started
Pump Terminology
Basal
Basal is a slow, continuous delivery of insulin, which keeps blood glucose (BG)
levels stable between meals and during sleep. It is measured in units per hour
(units/hour).
Blood Glucose
BG is the level of glucose in blood, measured in millimoles per liter (mmol/L).
Bolus
A bolus is a quick dose of insulin that is usually delivered to cover meals or an
elevated BG. There are several types of boluses that can be delivered by the
System, including food, correction, extended, and quick boluses.
Cannula
Insulin is delivered through the cannula, the part of the infusion set that is inserted
under the skin.
Carbs
Carbohydrates (carbs) are the sugars and starches in food that the body breaks
down into glucose and uses as an energy source. Carbs are measured in grams.
Carb Ratio
The carb ratio is the number of grams of carbohydrate that one unit of insulin will
cover. Also known as insulin-to-carbohydrate ratio.
Continuous Glucose Monitor
CGM systems sense glucose in the interstitial uid at regular intervals.
Control-IQ
Control-IQ technology is a feature of the t:slim X2 insulin pump that automatically
adjusts insulin delivery rates and amounts in response to readings from a continu-
ous glucose monitor (CGM).
Correction Bolus
A correction bolus is given to correct elevated BG.
Correction Factor
A correction factor is the amount that BG is lowered by one unit of insulin. Also
known as the insulin sensitivity factor (ISF).
Extended Bolus
An Extended Bolus is delivered over a period of time. It is intended for times when
the user has a high-fat meal or a meal spread out over a long period of time.
Glucose Target
Glucose target is a specic blood glucose goal; it’s an exact number, not a range.
When a BG or CGM value is entered in the t:slim X2 pump bolus calculator, the
calculated insulin bolus will be adjusted up or down as needed to attain this target.

7
For Professional Use Only
Getting Started
Grams
Grams are a unit of measurement used to measure carbohydrates.
Insulin Duration
Insulin duration is the amount of time that insulin is active and available in the
body after a bolus has been delivered. This also relates to the calculation for
insulin on board.
Insulin on Board (IOB)
IOB is the insulin that is still active (has the ability to continue to lower the BG) in
the body after a bolus has been delivered. In addition, when Control-IQ technology
is active, basal modulations will be incorporated into insulin on board.
Load
Load refers to the process of removing, replacing, and lling a new cartridge and
infusion set.
Personal Prole
A Personal Prole is a personalized group of settings that denes the delivery of
basal and bolus insulin within specic time segments throughout a 24-hour period.
Quick Bolus
A Quick Bolus is a way to deliver a bolus (using the Quick Bolus button) by follow-
ing beep/vibration commands without navigating through or viewing the t:slim X2
insulin pump screen.
Temporary Basal Rate (Temp Rate)
Temp Rate is used to increase or decrease the current basal rate for a short
period of time to accommodate special situations, such as exercise or illness. The
programmed basal rate is represented as 100%, with percentages greater or less
than 100% representing how much more or less insulin is delivered compared with
the basal rate. A 120% temp rate, for example, represents 20% more insulin than
the regular basal rate.
Unit
A unit is the increment of measurement for insulin.
USB Cable
USB is the abbreviation for universal serial bus. The cable connects into the
micro-USB port on the t:slim X2 insulin pump with Control-IQ technology.

8For Professional Use Only
Getting Started
1. Alert Icon: Indicates a reminder, alert, or alarm is active behind the screen lock
2. USB Port: Charge the t:slim X2 insulin pump battery. Close the cover when
not in use.
3. Control-IQ Technology Status: Indicates the status of Control-IQ technology
4. Control-IQ Activity Status: Indicates an Activity has been enabled
5. CGM Graph: Visual view of data from the continuous glucose monitor with
bolus icons below the graph
6. 1–2–3: Unlocks pump screen
7. CGM Graph Shading: Red shading indicates Control-IQ technology is,
orwas, delivering 0 units of insulin for the period indicated
8. Screen On/Quick Bolus Button: Turns on the t:slim X2 insulin pump screen
or programs a Quick Bolus (if activated)
9. LED Indicator: Illuminates when the t:slim X2 insulin pump is connected to a
power supply and functioning properly
10. Cartridge Tubing: Tubing attached to the cartridge
11. Tubing Connector: Connects the cartridge tubing to the infusion set tubing
22
18
14
10
6
2
3
HRS
mmol/L
6.0
02:30
14 Nov
100% 235 u
INSULIN ON BOARD 0 u
1
2
3
4
5
2
10 11
1
3
6 7
8
9
Control-IQ Lock Screen

9
For Professional Use Only
Getting Started
1. Time and Date Display: Displays the current time and date
2. Antenna: Indicates communication status between pump and transmitter
3. Battery Level: Displays the level of battery power remaining. When connected
for charging, the charging icon (lightning bolt) will display
4. Insulin on Board: Indicates the amount and time remaining for any active IOB
⚑Note: The IOB time remaining is not displayed when Control-IQ technology is enabled due
to variability of insulin delivery when automatically responding to CGM values.
5. Options: Stop/Resume insulin delivery, loadcartridge, manage My Pump, My
CGM, Activity and Device Settings, program a Temp Rate, and view History
6. Bolus: Program and deliver a bolus
7. Active Bolus Icon: Indicates an active bolus
8. Status: Displays current pump settings and insulin delivery status
9. Insulin Level: Displays the current amount of insulin in the cartridge
10. Tandem logo: Returns to the Home screen
Control-IQ Home Screen
22
18
14
10
6
2
3
HRS
mmol/L
7.0
16:45
14 Nov
100% 235 u
INSULIN ON BOARD
OPTIONS BOLUS
1.1 u
3
4
5 6
10
9
8
71
2

10 For Professional Use Only
Getting Started
22
18
14
10
6
2
3
HRS
mmol/L
6.2
INSULIN ON BOARD
OPTIONS BOLUS
1.1 u
17:30
14 Nov
100% 235 u
22
18
14
10
6
2
3
HRS
mmol/L
5.7
INSULIN ON BOARD
OPTIONS BOLUS
0.27 u
09:36
14 Nov
100% 235 u
1
2
3
22
18
14
10
6
2
3
HRS
mmol/L
8.4
INSULIN ON BOARD
OPTIONS BOLUS
2.2 u
12:40
14 Nov
100% 235 u
Bolus Icons
22
18
14
10
6
2
3
HRS
mmol/L
6.2
INSULIN ON BOARD
OPTIONS BOLUS
1.1 u
17:30
14 Nov
100% 235 u
22
18
14
10
6
2
3
HRS
mmol/L
5.7
INSULIN ON BOARD
OPTIONS BOLUS
0.27 u
09:36
14 Nov
100% 235 u
22
18
14
10
6
2
3
HRS
mmol/L
8.4
INSULIN ON BOARD
OPTIONS BOLUS
2.2 u
12:40
14 Nov
100% 235 u

11
For Professional Use Only
Getting Started
⚑Note: After a bolus has been delivered, you will see a blue square icon on the bottom of your
CGM graph. The icon will move along to the left as time passes, like the CGM graph timeline.
There are three types of icons that you might see, depending on the type of bolus delivered.
1. Standard/Correction Bolus
2. Extended Bolus
3. Control-IQ technology Automatic Correction Bolus
1. t:slim X2 Cartridge: A sinlge-use disposable cartridge can hold up to 300
units (3.0 mL) of insulin.
2. Vent Holes: Vent holes help the pump function correctly. It is important that
these vents remain uncovered.
⚠Precaution: When choosing third-party pump cases or stickers, do not cover the six vent holes
on the back of the pump
Pump Back Side
1
2

12 For Professional Use Only
Getting Started
Current Status
Insulin Duration 5 hours
Target BG 6.1 mmol/L
Carb Ratio 1u: 10 g
Correction
Factor 1u: 2.8 mmol/L
Current Status
Weekday
Basal Rate 0.75 u/hr
Last Bolus 10 u
14 Nov - 12:40
Control-IQ ON
Current Status
OK
Transmitter
Battery
14 Nov
11:32
Last Calibration
Time Sensor
Started
14 Nov
12:15
Mobile
Connection OFF
1
2
3
4
6
7
8
9
10
11
12
13
5
Status Screen

13
For Professional Use Only
Getting Started
⚑Note: The Current Status screen can be accessed from the Lock screen and the Home screen by
tapping the insulin level symbol.
⚑Note: No changes can be made from this screen.
1. Prole: Displays current active Personal Prole
2. Basal Rate: Displays current basal rate or Temp Rate in units/hour
3. Last Bolus: Displays the amount, date, and time of last bolus
4. Control-IQ Status: Displays the Control-IQ technology status
5. Up/Down Arrow: Indicates there is more information
6. Correction Factor: Displays current correction factor used to calculate bolus
7. Carb Ratio: Displays current carb ratio used to calculate bolus for food
8. Target BG: Displays current BG target used to calculate bolus
9. Insulin Duration: Displays current insulin duration used to calculate insulin
onboard
10. Last Calibration: Displays date and time of last calibration
11. Time Sensor Started: Displays date and time of last time sensor started
12. Transmitter Battery: Displays transmitter battery status
13. Mobile Connection: Displays whether the mobile connection is turned on or
off, whether a mobile device is paired with the pump, and if so whether the
mobile device is actively connected to the pump. The mobile connection may
not yet be available in your region.

14 For Professional Use Only
Getting Started
units
0
GLUCOSE
View Calculation
Add BG
CARBS
grams
0
units
0
GLUCOSE
View Calculation
Add BG
INSULIN
units
0
2
16
354
2
16
354
Bolus Screen Using Grams
1. : Returns to the Home screen
2. CARBS: Enter grams of carbohydrate
3. Units: Displays total units calculated
4. View Calculation: Displays how the insulin dose was calculated using the
current settings
5. GLUCOSE: Enter BG level
6. : Moves to next step
⚑Note: Use of blue text may relate to bolus delivery activity.

15
For Professional Use Only
Getting Started
units
0
GLUCOSE
View Calculation
Add BG
CARBS
grams
0
units
0
GLUCOSE
View Calculation
Add BG
INSULIN
units
0
2
16
354
2
16
354
Bolus Screen Using Units
1. : Returns to the Home screen
2. INSULIN: Enter units of insulin
3. Units: Displays total units calculated
4. View Calculation: Displays how the insulin dose was calculated using the
current settings
5. GLUCOSE: Enter BG level
6. : Moves to next step

16 For Professional Use Only
Getting Started
Options
STOP INSULIN
My Pump
Load
Activity
Options
My CGM
Device Settings
History
2
3
4
5
7
8
9
6
1
Options Screen

17
For Professional Use Only
Getting Started
1. : Returns to the Home screen
2. STOP INSULIN: Stops insulin delivery. If insulin delivery is stopped,
RESUMEINSULIN will be displayed.
3. Load: Change Cartridge, Fill Tubing, Fill Cannula, and Site Reminder
4. Activity: Exercise, Sleep, Sleep Schedules, and Temp Rate
5. My Pump: Personal Proles, Control-IQ, Alerts & Reminders, and Pump Info
6. Up/Down Arrow: Indicates that there is more information
7. My CGM: STOP/START SENSOR, Calibrate CGM, CGM Alerts,
TransmitterID, and CGM Info
8. Device Settings: Display Settings, Bluetooth Settings, Time and Date,
SoundVolume, and Security PIN
9. History: Pump History (Displays historical log of pump events) and CGM
History (Sessions and Calibrations, Alerts and Errors, and Complete)
⚑Note: Orange text relates to t:slim X2 insulin pump setup or delivery settings.

18 For Professional Use Only
Getting Started
grams
21 3
0
87 9
54 6
20
+
2
3
47
6
51
Number Keypad
1. Value Entered
2. : Returns to previous screen
3. Keypad Numbers
4. +: Allows numbers to be added on gram keypad screen
(if in units, this displays as a decimal point)
5. : Completes task and saves information entered
6. Units/Grams: Value of what is entered
7. : Deletes last number entered
Quick Tip: To change an existing number, begin by tapping the numbers on the keypad to
override the currentvalue.