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Neuraxial anaesthesia Enhancing Patient Safety SPROTTE ® NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO standard for spinal / epidural anesthesia

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Page 1: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

Neuraxial anaesthesia

Enhancing Patient Safety

SPROTTE® NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO standardfor spinal / epidural anesthesia

Page 2: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

2

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:

Page 3: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

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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.

Page 4: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

4

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

Page 5: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

5

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

Page 6: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

6

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

Page 7: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

7

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

Page 8: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

8

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

Page 9: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

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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

Page 10: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

“Speak to the paper Write down your preferred product for future thought!”

Page 11: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

“Speak to the paper Write down your preferred product for future thought!”

Page 12: SPROTTE NRFit™ – EpiLong NRFit™ Quincke NRFit™ New ISO … · 2018-03-27 · SPROTTE® needle with NRFit connector Introducer with NRFit connector Improved magnifying function:

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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