INS-830-1
Distribu ted by:
Contents
[A] Needle gu ard
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[B] Soft cannu la ■ [C] Adhesive tape ■ [D] Introducer needle ■ [E ] Cannula housing ■ [F ] Tubing ■ [G] Connector n eedle ■ [H] Circular p rotective ca p
[I] Disconn ect cover
Infusion S et
Instruct ions for use
Unomedical a/s . Aaho lmvej 1-3 . Osted . 4320 Lejr e . Denm ark . ww w.infusion-set.com
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Consult pump manufacturer’s
instructions for use when connecting
infusion set to the insulin pump.
Fill the empty space in the cannula with the
following prime:
U-100 insulin:
0.7 u (0.007ml)
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INS_830-1.indd 1 31-05-2011 11:21:05
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E N G L I S H
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DISCONNECTIN G
RECONNECTING
Rx ONLY
0459
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Use by (year / month)
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Do not re-use
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Lot number
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Sterilized using ethylene oxide
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Reference / model number
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Attention: see accompanying documents
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Manufacturer
Indications for use:
The comfort™ infusion set is indicated for subcutane ous infusion
of medication, including insulin, administered by an external
pump.
CONTRAINDICA TIONS c omfort™ is neither inte nded
nor indicated for use with blood or blood products (i.v. infu-
sion).
WARNINGS
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The comfort™ inf usion set is only sterile and nonpyrogeni c if th e packagi ng is un opened an d undamaged. Do not use it if t he packa ging is already open
or is dam aged.
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Go through instru ctions for use carefully bef ore inserting comfort™, as failure to fo llow ins tructions may
result i n pain or injur y.
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Inaccura te m edication deli very, infection and /or s ite irri-
tation may re sult from impro per insertio n and maintenan ce
of infusi on site.
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When us ing comfor t™ for th e first t ime, do s o in the pres-
ence of a h ealthcare p rovider.
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comfort™ is a sing le use ite m, which m ust be dis posed of
after us age. Do not cle an or re-ste rilise.
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Be sure tha t the needle g uard is remove d before inser tion.
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People with small or large amount s of subcu taneous fat
should choos e the ins ertion angle carefu lly, as the can -
nula could be placed in underly ing mus cle of derma l
layer and hereby c ause reduced or bloc ked medicatio n
deliver y. Normal inse rtion ang le between 20-45°. Con sult
your heal thcare provi der concern ing this mat ter.
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Do not leave air i n the in fusion se t. Make sure t o fill
comfort™ completely.
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Do not in any w ay put disinfe ctants, per fumes, deo dorants
or other produc ts containing al cohol or desinfect ants in
contact wi th the luer-loc k connector an d the tubing, as
these may affect the i ntegrity of the infusio n set.
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Replace th e infusion set if t he adhesive ta pe be comes
loose.
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Check the infusion set freque ntly t o ens ure th at th e sof t
cannula remains firmly in p lace, and re place if it is not in
place. Since the cannula is soft , it wil l not cau se any p ain
if the sof t cannula be comes fully o r partially dislodge d
from the skin, and this may th erefore take place without
notice . The so ft c annula mus t alwa ys be co mpletely
inserte d to receive f ull amount of medication .
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Replace infu sion s et ever y 48 -72 hour s acc or ding to
Centers for Dise ase Contr ol guidel ines, or per heal th care
provider ’s instructi ons.
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If infusio n site becomes i nflamed, repl ace set and use new
site unti l the first s ite has heale d.
■ Do not r e-inse rt introd ucer nee dle into inf usion set .
Re-inse rtion coul d cause tearin g of soft cann ula which
would res ult in unpred ictable med i cation flo w.
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Never p rime th e infusi on set or atte mpt to free a clogged
tubing whi le set is inserted . You may accidentally i nject too
much med ication.
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Use aseptic tech niques when tempor arily disconne cting
comfort™, and seal th e ca nnula hou sing wit h t he c over
provided. Con sult wi th heal thcare provider on how to
compens ate for misse d medication when discon nected.
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Protect com fort™ f rom di rect s unlight. Sto re at room
temperat ure.
■ Reuse of the infusion set m ay cause infect ion, si te irri ta-
tion, or d amage to the cannu la/needle. A damaged can-
nula/ne edle may lead to inaccurat e medicatio n delivery
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If infusing insuli n, ca refully monitor blood gluc ose l evels
when disc onnected an d after reco nnecting.
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If infusi ng i nsulin, and bl ood g lucose leve l be comes
unexplai nably h igh, or occlu sion a larm oc curs, check for
clogs an d leaks. If in doubt, ch ange infus ion set sinc e soft
cannula could be dislodged, crimped or partia lly clogg ed.
Discuss plan for rapid replaceme nt of insulin with health
care provid er should any of the se problems ari se. Test
blood gl ucose level to make sure pro blem is corr ected.
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Check t he blood glucose level 1-2 hours aft er introd ucing
comfort™ and chec k the pl ace of inf usion seve ral times a
day, and meas ure your bloo d glucose re gularly.
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If in fusing i nsulin, do not change infusion set j ust prio r to
bedtime, unless blood glu cose can be chec ked 1-2 hou rs
after in sertion.
INS_830-1.indd 2 31-05-2011 11:22:01
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