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Tandem 1004000 Manuals
Manuals and User Guides for Tandem 1004000. We have
1
Tandem 1004000 manual available for free PDF download: User Manual
Tandem 1004000 User Manual (386 pages)
Brand:
Tandem
| Category:
Medical Equipment
| Size: 9 MB
Table of Contents
Table of Contents
4
Section 1: before You Begin
17
Conventions of this Guide
18
Explanation of Symbols
20
System Terminology
22
System Description
24
About this User Guide
26
Compatible Insulins
26
Indications for Use
26
Compatible Apps
27
Compatible Cgms
27
Important User Information
27
Important Pediatric User Information
28
Emergency Kit
29
Section 2: Tandem Mobi System Features
31
Insulin Pump Warnings
32
Magnetic Resonance Imaging Safety
35
Radiology and Medical Procedures and Your Tandem Mobi System
35
Tandem Mobi Mobile App Warnings
36
Mobile Tandem Device Updater Warnings
37
Insulin Pump Precautions
38
Mobile Tandem Device Updater Precautions
41
Tandem Mobi Mobile App Precautions
41
Cybersecurity Preventative Measures
42
Cybersecurity Threat Notification
43
Potential Benefits from Using Your System
43
Possible Risks from Using Your System
44
Verification of Proper System Functionality
45
Working with Your Healthcare Provider
45
What Your Package Includes
48
Pump Components/Diagram
49
Pump Status Light Colors
50
Pump Status Light Patterns
50
Charging the Pump
52
Check Status
52
Turning the Pump off
54
Turning the Pump on
54
Updating the Pump Software
54
Explanation of Icons
58
Navigation Bar
62
Dashboard Screen
64
Dashboard Screen - Pump Status Bar
66
Dashboard Screen - Glucose & IOB Bar
68
Dashboard Screen - Graph
70
Dashboard Screen - Current Status
72
Bolus Screen
74
Actions Screen
76
Notifications Screen
78
Settings Screen
80
Pump Screen
82
Dexcom G6 Screen
84
Dexcom G7 Screen
86
Control-IQ Screen
88
Connection between the Tandem Mobi Mobile App and the Tandem Mobi Insulin Pump
90
About Bluetooth Technology
91
Disconnection between Pump and Smartphone
91
Reconnect Bluetooth Connection
92
Restart the Tandem Mobi Mobile App
93
Using the Pump Without the Tandem Mobi Mobile App
93
Tandem Mobi Mobile App Authentication
94
Using the Tandem Mobi Mobile App Without the Pump
94
Chapter 5 • Getting Started
95
Download the Tandem Mobi Mobile App
96
Log in to the Tandem Mobi Mobile App
96
Pairing the Tandem Mobi Mobile App with Your Pump
98
Unpairing the Tandem Mobi Mobile App from Your Pump
100
Mobile Connection Security
100
Set Mobile Notifications
101
Enable and Set Snooze
102
Set Time and Date
102
Overview
106
Max Bolus
106
Basal Rate Limit
106
Personal Profiles Overview
107
Creating a New Personal Profile
109
Programming a New Personal Profile
110
Editing or Reviewing an Existing Profile
113
Duplicating an Existing Profile
113
Activating an Existing Profile
114
Renaming an Existing Profile
114
Deleting an Existing Profile
114
Starting a Temporary Basal Rate
115
Stopping a Temp Rate
116
Infusion Site Selection and Care
118
Cartridge Instructions for Use
120
Filling and Loading a Cartridge
120
Filling Tubing
125
Filling Cannula
128
Setting Site Reminder
129
Manual Bolus Overview
132
Initiating a Bolus
133
Correction Bolus Calculation
133
Bolus Override
136
Food Bolus Using Units
137
Food Bolus Using Grams
137
Deliver a Bolus
137
Extended Bolus
138
Quick Bolus
140
Canceling or Stopping a Bolus
141
Starting, Insulin Delivery
146
Stopping Insulin Delivery
146
Resuming Insulin Delivery
146
Disconnecting When Using Control-IQ Technology
146
Pump Information
148
Pump History
148
Low BG Reminders
150
High BG Reminder
151
After Bolus BG Reminder
151
Missed Meal Bolus Reminder
152
Bolus Confirmation Reminder
152
Site Reminder
153
Low Insulin Alerts
156
Auto-Off Alarm
156
Max Basal Alert
158
Low Insulin Alerts
161
Low Power Alerts
162
Incomplete Bolus Alert
164
Incomplete Temp Rate Alert
165
Incomplete Load Sequence Alerts
166
Incomplete Setting Alert
169
Basal Rate Required Alert
170
Basal and Carb Ratio Required Alert
171
Max Hourly Bolus Alert
172
Max Bolus Alert
173
Max Basal Alert
174
Min Basal Alert
175
Pump Button Alert
176
Quick Bolus Alert
177
Data Error Alert
178
Temperature Alert
179
Chapter 14 • Alarms
181
Resume Insulin Alarms
183
Low Power Alarm
185
Empty Cartridge Alarm
186
Cartridge Error Alarm
187
Temperature Alarm - Pump
188
Occlusion Alarms
189
Pump Button Alarm
191
Pump & IOB Reset Alarm
192
Malfunction
194
Pump Malfunction
195
Chapter 16 • Taking Care of Your Pump
197
Taking Care of Your Pump
198
Lifestyles Issues and Travel for Your Pump
202
CGM Warnings
206
CGM Precautions
206
Potential Benefits from Using the Tandem Mobi Insulin Pump with CGM
207
Possible Risks from Using the Tandem Mobi Insulin Pump with CGM
207
CGM System Overview
210
Device Connection Overview
210
Receiver (Insulin Pump) Overview
210
Dexcom G6 Transmitter Overview
211
Sensor Overview
211
About Bluetooth Technology
214
Transferring a Sensor Session to the Tandem Mobi System
214
Setting CGM Volume
214
CGM Info
217
High and Low Glucose Alerts
220
Setting Your High Glucose Alert and Repeat Feature
220
Setting Your Low Glucose Alert and Repeat Feature
221
Rate Alerts
221
Setting Your Rise Alert
222
Setting Your Fall Alert
222
Setting Your out of Range Alert
223
Choosing Your Sensor Type
226
Enter Your Dexcom G6 Transmitter ID
226
Start the Dexcom G6 Sensor
227
Dexcom G6 Sensor Startup Period
229
Dexcom G6 Automatic Sensor Shut-Off
230
Ending a Dexcom G6 Sensor Session before Automatic Shut-Off
230
Removing the Dexcom G6 Sensor and Transmitter
231
Start the Dexcom G7 Sensor
231
Dexcom G7 Sensor Startup Period
232
Dexcom G7 Automatic Sensor Shut-Off
233
Ending a Dexcom G7 Sensor Session before Automatic Shut-Off
234
Removing the Dexcom G7 Sensor
235
Calibration Overview
238
Startup Calibration
239
Calibration BG Value and Correction Bolus
240
Reasons You May Need to Calibrate
240
Overview
242
CGM Graphs
242
Rate of Change Arrows
243
CGM History
245
Missed Readings
245
Startup Calibration Alerts - Dexcom G6 Only
249
Second Startup Calibration Alert - Dexcom G6 Only
250
Hour Calibration Alert - Dexcom G6 Only
251
Incomplete Calibration
252
Calibration Timeout
253
Calibration Error Alert - Dexcom G6 Only
254
Calibration Required Alert - Dexcom G6 Only
255
CGM High Alert
256
CGM Low Alert
257
CGM Fixed Low Alert
258
CGM Rise Alert
259
CGM Rapid Rise Alert
260
CGM Fall Alert
261
CGM Rapid Fall Alert
262
Unknown Sensor Glucose Reading
263
Out of Range Alert
264
Low Transmitter Battery Alert - Dexcom G6 Only
265
Transmitter Expired Alert - Dexcom G6 Only
266
Transmitter Error - Dexcom G6 Only
267
Failed Sensor Error
268
Failed/Incompatible Sensor Alert - Dexcom G7 Only
269
Invalid Pairing Code - Dexcom G7 Only
270
Unable to Pair - Dexcom G7 Only
271
CGM Error - Dexcom G7 Only
272
CGM Unavailable
273
CGM Error
274
CGM Pairing Troubleshooting
276
Calibration Troubleshooting
276
Unknown Sensor Reading Troubleshooting
276
Out of Range/No Antenna Troubleshooting
277
Failed Sensor Troubleshooting
278
Sensor Inaccuracies
278
Section 4: Control-IQ Technology Features
281
Responsible Use of Control-IQ Technology
282
Control-IQ Technology Warnings
282
Control-IQ Technology Precautions
283
Control-IQ Technology Overview
286
How Control-IQ Technology Works
286
Control-IQ Technology Actions
295
Required Settings
300
Turn Control-IQ Technology on
300
Turn Control-IQ Technology off
301
Schedule Sleep
301
Start or Stop a Sleep Schedule
303
Manually Start or Stop Sleep
304
Manually Stop or Start Exercise
305
Control-IQ Technology Information on Your Screen
305
Out of Range Alerts - Control-IQ Technology off
311
Out of Range Alert - Control-IQ Technology on
312
Control-IQ Technology Low Alert
314
Control-IQ High Alert
315
Max Insulin Alert
316
Chapter 31 • Control-IQ Technology Clinical Study Overview
317
Clinical Study Overview
318
Demographics
320
Adverse Effects
324
Intervention Compliance
328
Primary Analysis
332
Secondary Analysis
335
Insulin Delivery Differences
340
Control-IQ Technology High and Low Alert Accuracy
342
Additional Analysis of Sensor Glucose Value Auto-Population with CGM
344
Section 5: Technical Specifications and Warranty
347
Overview
348
Tandem Mobi Insulin Pump Specifications
348
Accessory Specifications
351
Tandem Mobi Insulin Pump Options and Settings
352
Pump Performance Characteristics
354
Electromagnetic Compatibility
359
Wireless Co-Existence and Data Security
359
Tandem Mobi Mobile App Security
360
Electromagnetic Emissions
361
Electromagnetic Immunity
362
IEC 60601-1-10: Physiological Closed-Loop Controlled System
364
Quality of Wireless Service
365
Wireless Technology
366
FCC Notice Concerning Interference
367
Warranty Information
367
Returned Goods Policy
370
System Event Data
371
Product List
371
Index
372
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