sprotte nrfit™ – epilong nrfit™ quincke nrfit™ new iso … · 2018-03-27 · sprotte®...
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Neuraxial anaesthesia
Enhancing Patient Safety
SPROTTE® NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO standardfor spinal / epidural anesthesia
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Due to various incidents of misconnections on various supply lines to the patient,
the new ISO standard 80369-6 has been developed and approved internationally in
2016. This standard defines new requirements for small bore connectors in the field
of Regional Anesthesia and intends to prevent the risk of accidental misconnections
and injections, thus improving patient safety. The new connector following the ISO
80369-6 standard is termed NRFit.
Commencing January 1st, 2017, California law prohibits a health facility from using
an Epidural connector that would fit into a connector other than the type it was
intended for, unless an emergency or urgent situation exists and the prohibition
would impair the ability to provide health care. This means California health
facilities should no longer use epidural products with Luer connectors as of
January 1st, 2017.
As a leading manufacturer in the field of Regional Anesthesia, PAJUNK® sees the
necessity to advance these measures to improve patient safety and therefore will
provide a full portfolio of NRFit products for Spinal, Epidural and CSE procedures in
2017. Products for Peripheral Nerve Blocks and Continuous Wound Infusion will be
available at a later date.
PAJUNK® will actively accompany and support the transition process in your facility!
Our staff is ready to advise and assist you with upcoming NRFit product questions!
NRFit advantages at a glance:
Enhanced patient safety
Reduced likelihood of miscon-nections between applications
The new connector does not require a change in technique
Yellow color coding for easier identification (not required by ISO Standard)
All individual and secondary packaging will come with clear and easy to read labeling (this helps to prevent mix-ups, especially in the early stage of the conversion process)
NRFit™ – New ISO Standard
Enhanced patient safety in Neuraxial Anesthesia
ISO design standards developed for system-specific applications
-1 General requirements
80369 Series
Not connectable with others in series
Rigid or semi-rigid
Passes misconnection, risk analysis, usability/human factors testing
Not connectable with Luer or needleless connector ports
-2 Respiratory -3 Enteral -4 Urological -5 Limb Cuff -6 Neuraxial -7 Intravscular
Spinal, Epidural Anaesthesia, CSE
Peripheral Anaesthesia
Lumbar Punture
Wound Infiltration
New ISO Connector Requirements:
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New ISO NRFit Connectors (about 20% smaller)Current LUER connectors
SyringeSyringe Needle HubNeedle Hub
Reduced likelihood of misconnections between applications
Syringe SyringeNeedle Hub Needle Hub
Current LUER New ISO NRFit™
Clear plunger Clear connector
Without individual labeling
Regular product packaging
Yellow plunger Yellow connector
Individual NRFit labeling
NRFit product packaging
Yellow clamping adapterYellow clamping adapter
NRFit™ – New ISO Standard
Connector and packaging changes
Individual and secondary packaging with clear and easy to read labeling
To help prevent mix-ups, especially in the early stage of the conversion process, PAJUNK® is taking the extra step of labeling
all NRFit individual and secondary packaging
The NRFit standard is currently being extended in the fields of peripheral nerve blocks, wound infiltration, and lumbar puncture.
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SPROTTE ® NRFit Needle
SPROTTE ® needle with NRFit connector
Introducer with NRFit connectorImproved magnifying function: enlarged magnifying glass in the hub permits a faster detection of the CSF
Product Size Item no. Item no. Item no. PUSPROTTE ® NRFit
22 G x 90 mm 001163-30C 021163-30C 25
22 G x 103 mm 221163-30C 10
22 G x 120 mm 131163-30C 10
22 G x 150 mm 141163-30C 10
24 G x 90 mm 001163-30A 121163-30A 25
24 G x 103 mm 021163-30A 25
24 G x 120 mm 041163-30A 10
24 G x 150 mm 131163-30A 10
25 G x 90 mm 021163-29A 211163-29A 25
25 G x 103 mm 041163-29A 25
25 G x 120 mm 051163-29A 10
25 G x 150 mm 061163-29A 10
27 G x 90 mm 021163-27A 211163-27A 25
27 G x 103 mm 041163-27A 25
27 G x 120 mm 031163-27A 10
With introducer NRFit 30 mm
With introducer NRFit 40 mm
Without introducer NRFit
SPROTTE ® NRFit™
Atraumatic spinal needles with magnification
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SPROTTE ® NRFit Sets
New Connector – same original SPROTTE® needle
Filte
r ne
edle
N
RFit
Intr
oduc
er N
RFit
30 m
m
Product Size Item no. PUSPROTTE ® NRFit
24 G x 90 mm 131166-606 10 • • •
Syrin
ge
NRF
it
5 m
l Slip
Filte
r ne
edle
N
RFit
Intr
oduc
er N
RFit
30 m
m
Product Size Item no. PUSPROTTE ® NRFit
25 G x 90 mm 131166-607 10 • • •
Syrin
ge
NRF
it
5 m
l Slip
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Tuohy NRFit Needle
Tuohy NRFit Single Shot Set
Tuohy needle NRFit with plastic stylet
Product Size Item no. Item no. PUTuohy NRFit
17 G x 90 mm 1166-6M091 25
18 G x 90 mm 1166-6K091 25
With plastic stylet With metal stylet
Product Tuohy needle NRFit Item no. PUTuohy NRFit
Tuohy needle NRFit with plastic stylet
20 G x 90 mm 131166-605 10 • • • •
Syrin
ge
NRF
it
5ml L
ock
Filte
r ne
edle
N
RFit
LOR
Syrin
ge
NRF
it
5 m
l Loc
k (g
lass
)
Syrin
ge
NRF
it 20
ml L
ock
EpiLong NRFit™
Needle and Catheter Sets for Epidural Anesthesia
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EpiLong Tuohy NRFit Set
EpiLong Soft NRFit Set
Product Tuohy needle NRFit EpiLong catheter Item no. PUEpiLong Touhy NRFit
Tuohy needle NRFit with plastic stylet
18 G x 90 mm 20 G x 90 cm closed tip with three lateral openings
1332162-51 10 • • • • • •
Filte
r N
RFit
0.
2 μm
Syrin
ge
NRF
it
5 m
l Loc
k
Filte
r ne
edle
N
RFit
Cla
mp
ing
- A
dap
ter
NRF
it
LOR
Syrin
ge
NRF
it
10 m
l Slip
(p
last
ic)
Syrin
ge
NRF
it
20 m
l Loc
k
Product Tuohy needle NRFit EpiLong Soft catheter Item no. PUEpiLong Soft NRFit
Tuohy needle NRFit with plastic stylet
17 G x 90 mm 19 G x 90 cm closed tip with six lateral openings
131166-604 10 • • • • • •
Filte
r N
RFit
0.
2 μm
Syrin
ge
NRF
it
5 m
l Loc
k
Filte
r ne
edle
N
RFit
Cla
mp
ing
- A
dap
ter
NRF
it
LOR
Syrin
ge
NRF
it
5 m
l Loc
k (g
lass
)
Syrin
ge
NRF
it
20 m
l Loc
k
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EpiSpin NRFit CSE Set
EpiLong NRFit Set Accessories
Filter NRFit 0.2 μmClampingAdapter NRFit
LOR NRFit 10 ml Slip
Product Item no. PU
ClampingAdapter NRFit 001163-37V 10
Filter NRFit 0.2 μm 001163-37X 10
LOR NRFit 10 ml Slip 0001166-45 10
Product Tuohy NRFit SPROTTE® NRFit EpiLong Soft catheter Item no. PUEpiSpin NRFit
Tuohy needle NRFit with backeye, metal stylet and SPROTTE® NRFit
17 G x 90 mm 25 G x 152 mm 19 G x 90 cm closed tip with six lateral openings
131166-608 10 • • • • • • •
LOR
Syrin
ge
NRF
it
5 m
l Loc
k (g
lass
)
Syrin
ge
NRF
it
5 m
l Loc
k
Filte
r ne
edle
N
RFit
Filte
r N
RFit
0.
2 μm
Syrin
ge
NRF
it
5 m
l Slip
Syrin
ge
NRF
it
20 m
l Loc
k
Cla
mp
ing
- A
dap
ter
NRF
it
EpiSpin NRFit™
Combined Spinal–Epidural Catheter Set
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Quincke NRFit Spinal Needle
Product Size Item no. PUQuincke NRFit
20 G x 90 mm 1163-3G090 25
22 G x 90 mm 1163-3E090 25
25 G x 90 mm 1163-3C090 25
Quincke NRFit™
Spinal Needles with Quincke Bevel
“Speak to the paper Write down your preferred product for future thought!”
“Speak to the paper Write down your preferred product for future thought!”
NRFit is a registered trademark of GEDSA used with their permission.
PAJUNK® Medical Systems, L.P.6611 Bay Circle, Suite 140Norcross, Georgia 30071Toll Free: 1 (888) 9PAJUNK (72-5865)Phone: (770) 493-6832Fax: (678) 514-3388E-mail: [email protected]: www.pajunkusa.com
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