TANDEM DIABETES CARE TWM001 t:slim Insulin Delivery System User Manual manual
TANDEM DIABETES CARE, INC t:slim Insulin Delivery System manual
manual
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| Document ID | 1721024 |
| Application ID | eDXESK5h1KKD0M2Xni7lSQ== |
| Document Description | manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 202kB (2525038 bits) |
| Date Submitted | 2012-06-12 00:00:00 |
| Date Available | 2012-06-12 00:00:00 |
| Creation Date | 2012-05-24 11:24:39 |
| Document Lastmod | 2012-05-24 11:24:39 |
| Document Title | manual |
"TANDEM CONFIDENTML" Thws \5 a RELEASED rrrrrrrr
. TM
1° SI l l l l Insulin Delivery System
User Guide
TANDEM"
DIABETES CARE
PRINTED COPIES OF THIS DOCUMENT ARE NOT CONTROLLED
aniqitor 2
Introduction
Welcome ..................................................................................... 17
What yourt:slun Insulin Dehvery System Package IncJudes ........... 17
Explanation of Symbols .............................................................. 18
Explanatron of t:slwm Colors ........................................................ 18
Warranty Informatlon .................................................................. 19
"TANDEM CONFIDENTIAL" This Is a RELEASED revision
Chapter 2 Introduction
2.1 Welcome
Congratulattons on the purchase 01 your new tzsltm System. Your decision to use insulin pump
therapy IS a stgn of your commitment to your diabetes care The tzsltm Pump is designed using
the latest technology. The Iollowtng pages provtde step-by-step illustrative inslructlons on now to
properly program, manage, and care for your pump,
2.2 What your t:s|im Insulin Delivery System Package Includes
Your tzsllm System should contain the lollowing items:
|. tzslim Insulin Pump
2. t:s|im Screen Protector (preapplied)
3. Protective Case with Rotatable Clip
e use Cable (5 ft)
5. Well Power USB Adapter
6. Car Power USB Adapter
1. t:s|tm Reference Guide
8. Emergency Wallet Card
9. USB Memory Card (with User Guide)
If any of these items are missing, contact Tandem Diabetes Care Customer Technical Support
at 1-877-801-6901
NOTE
Your t'sllnl Pump ts sntpoea from Tardem Diabetes Care. tl'c wrtn a clear screen proleclor Do not remove
the screen protector Aootttonal screen protectors can be ordered by conlacllng Tandem Dlabetes Care
Customer rechntcal suppon at raw—em —690l
NOTE
Your t’slllll Pump ls sntppeo lrorn tandem uaoetes Care Inc will a plolecllye cover tn the place where
the canndge ls normally lrserleu The cover rnust De removed and replaced Wlln a cartrtoge ortor lo rtttllatlng
tnsttltn therapy
Customer Technlcal Support 14774014001 1 17 P
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"TANDEM CONFlDENTlAL" This l5 3 RELEASED revlsmn
Section 1 Welcome
2.3 Explanation of Symbols
Chapterz ‘ Introduction
The following are symbols (and their descriptions), which you may find on your (zslim
Pump and/or its packaging:
Cannon. Consult Manual lor Imponanl
Salew Ducumenlalmn
i Consul! lnslrucnons lur Use
SN Serlal Number 0! new
EF Pan Number
Type BF Appllen Pan
lpanenl usolanon. nol nellbnllalm prcremeu)
Manu'acmrel
For sale by or on me order 01 a physlclan
unly u 5)
Dwecl Current (DC) voltage
IP><7 Walerrtlgm Equlpmenl (protected agamsl me
ellecls cl lemporary lmmerslon m water]
2.4 Explanation of tzslim Colors
Touch Screen Colors
Blue
- The use of blue text may relate to Bolus delivery achvuty.
' The orange text relates to lelrn's setup or dellvery semngs.
1 Orange Highlight
o The orange hrghllghted area lnolcales a recent change
made to a setting,
l r w 3 ‘ 1—877-501-6901 4 l“ ’
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"TANDEM CONFIDENTlAL" This {5 a RELEASED revlsmn
Section 1 Wel Chapter 2 Introduction
LED Colors
Red LED
- 1 red blink every 30 seconds indicates a malfunction or
alarm COrldIthn.
_Ve|iow LED
1 yellow blink every 30 seconds indicates an alert or
reminder condition,
Green LED
- 1 green blink every 90 seconds indicates the pump |s
lunctioning normally.
3 green blinks every 90 seconds indicate the pump
is charging.
2.5 Warranty Information
Warranty
t:s|im"' Insulin Pump
Tandem Diabetes Care Inc l"Tandem"l warrants the t slim insulln pump against detects in materials
and WOlkmaflShlp for the period oi 4 years from the original date of Sthmem of the pump to the
original end use purchaser (the “Warranty Perlotfl During the Warranly Perlod‘ Tandem Will replace
any detective t slim Pump subiecl to the continuum and exclusrons stated herein
The warranty is valid only if the t:slim Pump is used in accordance with Tandem‘s
instructions and will not apply:
If damage results lrom changes or modifications made to the tzslim Pump by the user or
third persons after the date of manulacture:
Il damage results lrom sen/ice or repairs perlormed to any part at the t:s|im Pump by any
person or entity other than Tandem:
It the tzslim Pump seal IS broken:
It a nonaTandem cartridge is used wrth the t:slim Pump;
It damage results lrom a force mapeure or other event beyond the control of Tandem; or
Il damage results from negligence or improper use. including but not Ilmited to improper
storage or phySical abuse such as dropplng or othemvise.
iii “m.” if v mt. umu' LBW-601690! 1 19 P
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"TANDEM CONFIDENTIAL" This Is a RELEASED revision
Chapter 2 Introduction
This warranty shall be personal to the original and use purchaser. Any sale. rental or other transfer
or use of the tzslim Pump covered by this warranty to or by a user other than the original end use
purchaser shall cause this warranty to immediatety terminate. This warranty only applies to the
tzsllm Pump and does not apply to other products or accessories.
THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES
AVAILABLE FOR ANY WARRANT CLAIMS. NEITHER TANDEM NOR ITS SUPPLIERS OR
DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, OR SPECIAL
DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE
PRODUCT ALL OTHER WARRANTIES, EXPRESS OR IMPLIED. ARE EXCLUDED, INCLUDING
THE WARRANTIES OF MERCHANTABle AND FITNESS FOR A PARTICULAR PURPOSE.
Warranty
Infusion Sets and Cartridges
Tandem Diabetes Care. Inc. (“Tandem") warrants its infusion sets and cartridge against defects in
materials and workmanship Ior the period 3 days after the mdivrdual cartridgefinfusion set sterile
packaging has been opened. not to exceed 6 months from date of shipment of the infusion set or
cartridge to the end user (the "Warranty Period"), During the Warranty Pen‘od, Tandem will replace
any deIective cartridge or infusion set, subject to the conditions and exclusions stated herein.
The warranty is valid only ifthe infusion sets and cartridges are used in accordance with
Tendem’s instmctions and will not appiy:
° II the infusion set or cartridge has been used for more than a single-time use by a
single end-user:
- II damage results during the improper opening of the sterile package not in conformance
with the procedures outlined in the associated Instructions for Use:
c If the sterile package is compromised while in the control of the user by any means other
than purposeful opening by the user at the time of intended product use;
~ II damage results from changes or modifications made to the infusion set or cartridge by
the user or third persons after the date of manufacture;
- II damage results from service or repairs performed to any part of the infusions set or
cartridge by any person or entity other than Tandem:
0 II damage is caused by use 0! the cartridge or infusion set with any non~Tandem
insulin pump:
° If damage results from a force majeure or other event beyond the control of Tandem; or
- II damage results from negligence or improper use. including but not limited to improper
storage or physical abuse such as dropping or otherwise.
This warranty shall be personal to the original and use purchaser. Any sale, rental or other transfer
or use of the product covered by this warranty to or by a user other than the original end use
purchaser shall cause this warranty to immediately terminate This warranty does not apply to
insulin pumps and other accessories.
THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES
AVAILABLE FOR ANY WARRANT CLAIMS. NEITHER TANDEM NOR ITS SUPPLIERS OR
DISTRIBUTORS SHAU. BE LIABLE FOR ANY INCIDENTAL. CONSEQUENTIAL. OR SPECIAL
DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE
PRODUCT. ALL OTHER WARRANTIES. EXPRESS OR IMPUED. ARE EXCLUDED, INCLUDING
THE WARRANTIES OF MERCHANTABle AND FITNESS FOR A PARTICULAR PURPOSE.
Cuslomer Technical Support 1—577-601-m1 1 20 P
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Chapter 8
tslim Pump Overview
tzsiim Pump Overview ........ 22
tzsiim System Terminology. .22
Home Screen ..................... .24
Status Screen ............................................................................. 25
Bolus Screen ............................................................................... 26
Options Screen ........................................................................... 27
My Pump Screen ........................................................................ 28
Number Keypad Screen .............................................................. 29
Letter Keypad Screen ................................................................. 30
"TANDEM CONFIDENTIAL" Thls Is a RELEASED revision
Chapter 3 tslim Pump Overview
m Pump Overview
Your t:slim Pump uses touch screen technology. To activate and interact with your t:slim Pump.
use the pad oi your finger to quickly and lightly tap on the screen. Do not use your finger nail or
another object to interact with the screen. It will not activate the screen or its functions.
Your tzslim Pump is designed to give you quick and easy access to the functions that you will use
in your day to day diabetes management — whether basic or advanced,
NOTE
The Screen Lock ieaitre IS automatically activated on your l slim Pump Yl’lls setting cannot be changed
NOTE
Tum oil the pump screen by Dressmg the Screen On/Oulck Bolus button Deidre Dieting the pump back in its case
or any pocket/clothing to prevent unintentional lnle'aCllOnS with the touchscreen. Always oosriion ine pump screen
away mm the Skill when worn under cioiiiing
3.2 t: Iim System Terminology
Basal
Basal is a slow continuous delivery of insulin. which keeps BG levels stable between meals and
during sleep. It is measured in units per hour (units/hn.
BG-
BG is the abbreViation for blood glucose. which is the level of glucose in the blood.
measured in mg/dL.
56 Target
BG target is a specific blood glucose goal. an exact number, not a range. When a BS is entered
in the t:slim Pump. the calculated insulin bolus will be adjusted up or down as needed to attain
this target.
Bolus
A bolus is a quick dose oi insulin that is usually delivered to cover lood eaten or an elevated BG.
With tzslim Pump it can be delivered as a Standard. 3 Correction, an Extended, or a Qutck Bolus.
Cannula
The cannula is part ol the inlusion set that is inserted under the skin through which insulin
is delivered,
Curb
Carbohydrates are sugars and starches that the body breaks down into glucose and uses as an
energy source, measured in grams.
Garb Ratio
The carb ratio is the number 01 grams oi carbohydrate that one unit 01 insulin Will cover Also
known as insulin—to—carbohydrate ratio.
Correctlon Bolus
A correction bolus is given to correct elevated BG.
Customer Technical Support 1-877-W-GW1 4 22 P
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"TANDEM CONFIDENTlAL" This is a RELEASED revision
Chapter 3 tzslim Pump Overview
Correction Factor
A correction factor is the amount ot BG that is lowered by one unit of insulin. Also known as the
Insulin Sensitivity Factor (ISF).
Extended Bolus
An extended bolus is a bolus that is delivered over a period of time. it is commonly used to cover
tood that takes longer to digest. When administering an extended bolus with your tzslim Pump,
enter the DELIVER NOW portion to dose a percentage oi insulin immediately and the remaining
percentage over a period time.
Grams
Grams are a unit of measurement for carbohydrates,
Insulin Duration
Insulin duration is the amount of time that insulin [5 active and available in the body after a bolus
has been delivered. This also relates to the calculation for Insulin on Board (IOB).
Insulin On Board (IOB)
lOB 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.
Land
Load refers to the process of removing. replacing and filling a new cartridge and infusion set.
Personal Profile
A Personal Profile is a personalized group of settings that defines the delivery of basal and bolus
insulin within specific time segments throughout a 24 hour period.
Quick Bolus
Quick bolus (using the Quick Bolus Button) is a way to deliver a bolus by following beep/Vibration
commands without navigating through or viewing the t:slim Pump screen.
Temp Rate
Temp rate is an abbreviation for a temporary basal rate. It is used to increase or decrease the
current basal rate for a short period ot time to accommodate special situations. 100% is the
same basal rate as programmed: 120% means 20% more and 8096 means 20% less than the
programmed basal rate.
Unit:
Units are the measurement for insulin.
USB Cable
USB is the abbreviation for Universal Serial Bus. The cable connects into the leim Pump's
micro USB port.
Customer Technical Support 14774014”! 1 23 b
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"TANDEM CONFIDENTIAL" ThIS IS a RELEASED vewslor‘
Sechon 1 Welcome Chapter 3 I tslim Pump Overview
3.3 Home Screen
1. BATTERY Level: Dways the wave a? 7. Status: DwspIavs current pump sefimgs and
DaIten power remauw‘q When 0 memes: msuh“ newew status
Iur chargmg the chmgmg w Wight-mg new W >, 7 ,, 777 7 7 ,, 7 777
wwH (mow,
7 B. INSULIN Lev ‘ DwspIavs the currem
amoum OI msnhn m We cartmge
2. USB Port: Purl Io (7772.qu my I mun 4.1
lmllely (Hoes the covey when not In us,
9. Tandem Logo: Remma m the I Iome Same“
3. BOLUS:P'OgmwzwI15mm (I!)UI‘..5
, W m. Cartridge Tubing: Tumnq mm IS Murine-(I
-<> the (tPIIIIILIqe
4. OPTIONS: Smp Resume mm H (miner.
manage PHI-m Smquz, um} nmwige
puxymm u Twuv Rue mm mm Hmm 11- Luer-Lock Connection: Covmecti the
mmwirw 1“!qu m the ummrm fieI Iulwm
5. INSULIN ON BOARD (IOB): Av'mu”1 m':
Mme vpnummm m any em w wm w Imam 12. Screen On/Quick Bolus Button: Tums
(m on mm h-v Pumps Nov wr)r;r;1m<.I
0ka Sum m .u‘IIv.II(—MI
5. Time and Date Display: mew. . Hm , ,7 W , , ,
unrsm' runs and rime
13. LED Indicator: HIL‘IIHIHISS when covmemed
'<: A power mum and wmlwmes; mower
mum cram
I 1—877—801-6901 4 ‘I '
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"TAVDEM coNnDENTwAL" Tm we, a RELEASED revwmur
Sec on 1 Welcome Chapter 3 tzslim Pump Overvuew
3.4 Status Screen
u, 6. Correction Factor' Suaus current
T1317 halo ”sari NO 1: curate mom
I.
Profile: Dr
De'somi‘ D
”mm HG [mum when
z. Basal: (NM a
(M u m
‘th’é—Xt W" HHP “r 7
1. BG Target: 3m,
1 uum
a. Insulin Duratm
«WW ~ Wm mm
3. Lastaolusxmw w u, m,mwh'wmlm,”:
Hme ”mil Mm‘
9. Carbohydrates: mmnw AMHI‘VH rummz
4. Garb Rat-u: mefi m aw w , ~ : ~ ‘1' Mr
m nmmmmw,
5. Up/Down Arrow: M 1r m. "u-w
W'Mln HQW‘V u[ (r‘
NOTE
NOTE
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"TANDEM CONFTDENTTAL" Ths T; a RELEASED vewgwr
Section 1 Welco Chapter 3 tzslim Pump Overvuew
3.5 Bolus Screen
Using Grams Using Units
1. BACK: 39m 1. BACK: :‘,—"1 "e way “he Plume SCVF‘EEH
2. CARES: u'equav‘m » 2. iNSULINtEv'e: f
l 6‘ P’mfmv‘vfl
(JV mid H
3 Units: Jiimw, Wt.“ mm
3. Umts:[Mmmzwm min m . m: , ,
7 ' 77 4. 'JT‘;;MW2 ww. W,
4. View Calculation: f/m Mu , T" " v’ w Mm“ 1mm) We
w mm ”WM—WNW mm m »-r1 ._
JIVYH“\ uf—J'TH r , , ,7,77,7, ,, ,
77777 7 7 W "7 7 7 5. 86: F‘WH‘ 1 mm fluwrx‘l—‘HJH
5. 56: run-n :~T w! a“ ‘ku T—vu _, 7, , , 7 , ,
6. NEXT: M ,4« u wm' am;
5. NEXT: Mum, h, vvm‘ 4,1
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"TANDEM coNrmzNT‘AL" Tm s RELEASED rcwsmr
Welcome Chapter 3 tzsnm Pump Overview
3.6 Options Screen
BACK: Returnj “a, r
5. Temp Rate: 3&4quva <1 ‘ev'quvav‘,
2. STOP INSULIN: 5" ‘
mm” 4 w an; 5 aroma:
R 6. Menu Arrows: 1' (1M n19s Mzmumm menu
HT (1li E'-
3, v w 7. M. W! Lfl m; 4
w: H
4. Loadzbhzmge .: , ; »,
(H mm (m 15,
«enramrsgm < >
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"TANDEM coNEtDENTtAL" TNS W5 a RELEASED revwor‘
3.7 My Pump Screen
1. Personal Profiles: A t, J
defines Udb'd am: Imus
3. Pump Senmgs: Custmwze Outuk
Bum, Pump thme Saree" Opuous‘
av E1 Tvve F (1 Dane
2. Alert Settings: Customm— at t
and News 4. Pump Info: D sways t shm Pump sens”
‘ 1 Te hwy” S
pm! phone
1—877—80176901 4 >
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"TANDEM coNFwDENTwAL" rm 5 a RELEASED vewsnov‘
t-sllm Pump Overview
3.8 Number Keypad Screen
1. Value Entered. 5. DONE Compwetes task arm saves
wow: " ed
2. BACK: Rel am; my memmx 31
G. Units/Grams: Vame Pf Nhrzt xx entered
3. Keypad Numbers.
7 7. On: 3961th ms' mn'vhe' swam!
l. +/=- AHUNS Huml‘em‘ u, m— ...1«:H.1 ,,
q::u‘w~;<,veeu ”mum (w. mu... r»
.. mam,” mm»
NOTE
|-877-80| -6901 < ‘ >
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Chapter 19 Technical Specifications
19.9 FCC Notice Concerning Interference
The tzslirn Pump complies with FCC/IO RF exposure limits for general population/uncontrolled
exposure.
ttslim Pumps equipped With a Bluelooth® RF option transmit at a maximum effective radiated
power of 3.4 mW in the 2 4 GHz ISM band. which covers the frequency range from 2.40 GHz to
250 GHZ.
The usllm Pump 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 my cause
undesired operation
Compliance with these guidelines prowdes reasonable protection against harmful interference in a
normal residential enwronment, The tzslim Pump generates. uses. and can radiate radio frequency
energy, and may cause harmful interference to radio communications, There is no guarantee
that interterence Will not occur in a particular installation. If the |:slim Pump does cause harmful
interference to radio or television reception, the interference may be corrected by one of the
lollowing measures:
- Move or relocate the tzslirn Pump
0 Increase the distance between the tzslim Pump and the other device that is emitting or
receiving interference
Changes or modifications not expressly approved by Tandem Diabetes Care, Inc could void the
user's authority to operate the equipment.
Bluetooth is a registered trademark of Bluetooth SIG. Inc.
Customer Technical Support“ 1-877—80I-6901 1 MS P
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