SPROTTE NRFit EpiLong NRFit Quincke NRFit New ISO standard for spinal / epidural anesthesia

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

2 NRFit New ISO Standard Enhanced patient safety in Neuraxial Anesthesia Due to various incidents of misconnections on various supply lines to the patient, the new ISO standard has been developed and approved internationally in 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 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, 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 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 misconnections 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) ISO design standards developed for system-specific applications Series -1 General requirements -2 Respiratory -3 Enteral -4 Urological -5 Limb Cuff -6 Neuraxial -7 Intravscular New ISO Connector Requirements: 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 Spinal, Epidural Anaesthesia, CSE Peripheral Anaesthesia Lumbar Punture Wound Infiltration 2

3 NRFit New ISO Standard Connector and packaging changes Current LUER connectors New ISO NRFit Connectors (about 20% smaller) Syringe Needle Hub Syringe Needle Hub Reduced likelihood of misconnections between applications Syringe Needle Hub Syringe Needle Hub 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 Current LUER New ISO NRFit Regular product packaging NRFit product packaging Yellow clamping adapter Clear plunger Clear connector Yellow clamping adapter Yellow plunger Yellow connector Without individual labeling Individual NRFit labeling The NRFit standard is currently being extended in the fields of peripheral nerve blocks, wound infiltration, and lumbar puncture. 3

4 SPROTTE NRFit Atraumatic spinal needles with magnification SPROTTE NRFit Needle SPROTTE needle with NRFit connector Improved magnifying function: enlarged magnifying glass in the hub permits a faster detection of the CSF Introducer with NRFit connector Without introducer NRFit With introducer NRFit 30 mm With introducer NRFit 40 mm Product Size Item no. Item no. Item no. PU SPROTTE NRFit 22 G x 90 mm C C G x 103 mm C G x 120 mm C G x 150 mm C G x 90 mm A A G x 103 mm A G x 120 mm A G x 150 mm A G x 90 mm A A G x 103 mm A G x 120 mm A G x 150 mm A G x 90 mm A A G x 103 mm A G x 120 mm A 10 4

5 SPROTTE NRFit Sets New Connector same original SPROTTE needle Introducer NRFit 30 mm Filter needle NRFit Product Size Item no. PU SPROTTE NRFit 24 G x 90 mm Introducer NRFit 30 mm 5 ml Slip Filter needle NRFit 5 ml Slip Product Size Item no. PU SPROTTE NRFit 25 G x 90 mm

6 EpiLong NRFit Needle and Catheter Sets for Epidural Anesthesia Tuohy NRFit Needle Tuohy needle NRFit with plastic stylet With plastic stylet With metal stylet Product Size Item no. Item no. PU Tuohy NRFit 17 G x 90 mm M G x 90 mm K Tuohy NRFit Single Shot Set LOR 5 ml Lock (glass) 5ml Lock 20 ml Lock Filter needle NRFit Product Tuohy needle NRFit Item no. PU Tuohy NRFit Tuohy needle NRFit with plastic stylet 20 G x 90 mm

7 EpiLong Tuohy NRFit Set Product Tuohy needle NRFit EpiLong catheter Item no. PU EpiLong Touhy NRFit Tuohy needle NRFit with plastic stylet 18 G x 90 mm 20 G x 90 cm closed tip with three lateral openings EpiLong Soft NRFit Set Clamping- Adapter NRFit Filter NRFit 0.2 μm LOR 5 ml Lock (glass) 5 ml Lock 20 ml Lock Filter needle NRFit Clamping- Adapter NRFit Filter NRFit 0.2 μm LOR 10 ml Slip (plastic) 5 ml Lock 20 ml Lock Filter needle NRFit Product Tuohy needle NRFit EpiLong Soft catheter Item no. PU EpiLong Soft NRFit Tuohy needle NRFit with plastic stylet 17 G x 90 mm 19 G x 90 cm closed tip with six lateral openings

8 EpiSpin NRFit Combined Spinal Epidural Catheter Set EpiSpin NRFit CSE Set Clamping- Adapter NRFit Filter NRFit 0.2 μm LOR 5 ml Lock (glass) 5 ml Slip 5 ml Lock 20 ml Lock Filter needle NRFit Product Tuohy NRFit SPROTTE NRFit EpiLong Soft catheter Item no. PU EpiSpin 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 EpiLong NRFit Set Accessories Product Item no. PU ClampingAdapter NRFit V 10 Filter NRFit 0.2 μm X 10 ClampingAdapter NRFit Filter NRFit 0.2 μm LOR NRFit 10 ml Slip LOR NRFit 10 ml Slip 8

9 Quincke NRFit Spinal Needles with Quincke Bevel Quincke NRFit Spinal Needle Product Size Item no. PU Quincke NRFit 20 G x 90 mm G G x 90 mm E G x 90 mm C

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

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

12 NRFit is a registered trademark of GEDSA used with their permission. PAJUNK Medical Systems, L.P Bay Circle, Suite 140 Norcross, Georgia Toll Free: 1 (888) 9PAJUNK ( ) Phone: (770) Fax: (678) info@pajunk-usa.com Web: RAG-02 01/17

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