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A groundbreaking new technology for regional anaesthesia

Product index

NRFitTM Peripheral Nerve Block Needles...................... 3 vygoplex® echo NRFitTM..................................................................... 4 vygoplex® ENS & echo NRFitTM.......................................................... 5

SAFIRA®...................................................................... 6 How to use SAFIRA®........................................................................... 8 A groundbreaking new technology for regional anaesthesia............. 10 SAFIRA® reduces the risk of nerve damage and improves patient outcomes....................................................... 11 5 reasons to make the switch to SAFIRA®......................................... 12

For a safer & controlled block

NRFit Peripheral Nerve Block Needles TM

vygoplex®: The new generation of echogenic needles Single shot needles for peripheral nerve blocks • vygoplex® echo NRFitTM

01 NEEDLE For optimized echogenicity under ultrasound Sandblasting on the first 2 cm and PTFE coating surrounding the entire needle all the way up to the tip for smooth insertion.

03 HUB For quick identification of the NRFitTM needle & clear visualization of a possible blood reflux Yellow transparent hub

For precise control of the needle depth 360° marking on every millimeter on the first 2 cm & a double mark at 5 cm allowing control of the needle’s position all through the procedure

For easy handling Curved & ergonomic hub

02 BEVEL For a more or less important perception of the fascias Choice between 2 types of Lancet point bevels : • 20° • 30°

04 EXTENSION LINE For easy injection Removable extension line which enables the connection of a syringe directly to the needle if required

Code

Length (mm)

Gauge (G)

AEQMNVF24080

Bevel

Bevel Type

Quantity (box) 10 / box

AEQMNVF24040

10 / box

AEQMNVF25050

10 / box

AEQMNVF25080

AEQMNVF25120

120

AEQMNVF22050

10 / box

AEQMNVF22080

10 / box

AEQMNVF21100

100

10 / box

AEQMNVF20100

100

AEYMNVF24080

AEYMNVF24040

10 / box

AEYMNVF25050

10 / box

AEYMNVF25080

AEYMNVF25120

120

AEYMNVF22050

10 / box

AEYMNVF22080

10 / box

AEYMNVF21100

100

10 / box

AEYMNVF20100

100

10 / box

10 / box 30°

10 / box

Lancet point

10 / box 10 / box

10 / box 20°

10 / box

For a safer & controlled block • vygoplex® ENS & echo NRFitTM

01 NEEDLE For optimized echogenicity under ultrasound Sandblasting on the first 2 cm and PTFE coating surrounding the entire needle all the way up to the tip For precise control of the needle depth 360° marking on every millimeter on the first 2 cm & a double mark at 5 cm allowing control of the needle’s position all through the procedure

02 BEVEL For a more or less important perception of the fascias Choice between 2 types of Lancet point bevels : • 20° • 30° 04 EXTENSION LINE For easy Injection Removable extension line which enables the connection of a syringe directly to the needle if required

03 HUB For quick identification of the NRFitTM needle & clear visualization of a possible blood reflux Yellow transparent hub

05 NEUROSTIMULATION CABLE For quick identification of the bevel orientation Cable position

For easy handling Curved & ergonomic hub

Code

Length (mm)

Gauge (G)

AEYMVF25050 AEYMVF25080 AEYMVF25120 AEYMVF24040 AEYMVF24100 AEYMVF24080 AEYMVF24070 AEYMVF23035 AEYMVF22050 AEYMVF22080 AEYMVF21100 AEYMVF21120 AEYMVF20120 AEQMVF25050 AEQMVF25080 AEQMVF25120 AEQMVF24040 AEQMVF24100 AEQMVF24080 AEQMVF24070 AEQMVF23035 AEQMVF22050 AEQMVF22080 AEQMVF21100 AEQMVF21120 AEQMVF20120

50 80 120 40 100 80 70 35 50 80 100 120 120 50 80 120 40 100 80 70 35 50 80 100 120 120

25 25 25 24 24 24 24 23 22 22 21 21 20 25 25 25 24 24 24 24 23 22 22 21 21 20

Bevel

Bevel Type

Quantity (box)

Lancet point

10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box 10 / box

20°

30°

SAFIRA

Giving Anaesthetists Control A groundbreaking new technology for regional anaesthesia

For a safer & controlled block

What do leading consultant anaesthetists say? According to 30 world leading regional consultant anaesthetists (EU & US): 1

1/30 confident in their assistant applying the correct pressure1

2/30 confident they themselves could apply the correct pressure1

23/30 believed SAFIRA® would allow them to save 5 (or more) minutes per procedure2

How to use SAFIRA® SAFIRA® is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia. SAFIRA® consists of 3 separate components:

Sterile Syringe

Driver

Foot Pedal

SAFIRA® is engineered to help prevent injection above 20psi

The Sterile Syringe is connected to the SAFIRA® driver unit

SAFIRA® has been developed in compliance with international standards. SAFIRA® has CE Mark Certification.

For a safer & controlled block

How to use SAFIRA®

The device incorporates an engineered safety solution to limit the maximum anaesthetic administration pressure to 20 psi.

Light indicators

Syringe release button

Aspiration Infusion

The green light indicator appears when the infusion function is active. The yellow light indicator appears when the aspiration function is active. If the driver unit detects an unsafe pressure during the infusion process, the driver will automatically stop infusion and a red flashing light will appear

A groundbreaking new technology for regional anaesthesia

SAFIRA® - SAFer Injection for Regional Anaesthesia. A revolutionary new technology.

SAFIRA® makes regional anaesthesia a one person procedure, putting control in the hands of the anaesthetist. A unique engineered in safety solution monitors and limits injection pressure. This improves patient safety by reducing the risk of patient nerve damage resulting from the regional anaesthesia procedure. SAFIRA® helps promote better outcomes for both professionals and patients.

For a safer & controlled block

SAFIRA® reduces the risk of nerve damage and improves patient outcomes3

A clinician led approach

Regional anaesthesia is currently a two-person procedure

Anaesthetic solutions are often injected at high pressure

One anaesthetist holds the ultrasound scanner to guide the needle tip placement, while a second operator injects the anaesthetic at the required pressure.

This can cause nerve damage, serious nerve damage occurs in up to 1% of procedures and transient nerve damage in up to 8% of cases.4, 5

SAFIRA® transforms regional anaesthesia into a one-person procedure

SAFIRA® helps to prevent injection at unsafe pressures

It allows a single operator, an anaesthetist, to conduct the whole regional block at safer pressures.

A built in system helps to prevent injection at pressures above 20psi which reduces the risk of incidences of transient or serious nerve damage occurring as a result of the regional anaesthesia procedure.

5 reasons to make the switch to SAFIRA®

SAFIRA® gives anaesthetists the tools to take control

1. SAFIRA® - SAFer Injection for Regional Anaesthesia SAFIRA® is a safer injection system for regional anaesthesia, allowing a single anaesthetist to conduct a whole regional block at safer pressures.

2. It makes regional anaesthesia a one operator procedure

4. SAFIRA® promotes better outcomes for patients With its integrated safety solution to help limit the injection pressure threshold, SAFIRA® can help reduce the risk of accidental nerve damage, omitting follow up procedures.3 Minimising the risk of nerve damage also reduces the chance of potential medical negligence compensation claims.

By giving anaesthetists control of the whole procedure, they can manage all aspects of the regional block including injection of the anaesthetic. This improves safety and frees up resource as a second supporting operator is no longer required.

5. It saves time and reduces costs

3. It helps improve patient safety by controlling the injection pressure threshold SAFIRA® incorporates a safety feature to help prevent injection at pressures above 20psi. This reduces the risk of nerve damage in patients, promoting improved safety for regional anaesthesia.

SAFIRA® saves 5 minutes per procedure6 and limits the costs associated with extra operators. When time is money, SAFIRA® saves you both.

For a safer & controlled block

References and characteristics Code

Product

900029

Driver

900044

Foot Pedal

900058

NRFitTM syringe

Volume (mL) 20

Number of use

Sterile

200

Single use

Yes

Bibliography 1. Health Enterprise East (HEE). Research results using a cohort of volunteer anaesthetists 2. F ong-Soe-Khioe R.Health Economic report Medovate commissioned written by a health economist from the University of East Anglia (UEA). 3. H eij R, Eldin E,Young P, Carter J, Gibson J, Ali A, et al. Regional Anesthesiology Injection Pressures comparing Skilled Assistants With SAFIRA in a Simulated Ultrasound Guided Technique. In: The Anesthesiology annual meeting [Internet]. 2013 [cited 2020 Mar 31]. Available from: http://www.asaabstracts.com/strands/ asaabstracts/abstract.htm?year=2013&index=17&absnum=3085 4. B orgeat A, Blumenthal S. Nerve injury and regional anaesthesia [Internet].Vol. 17, Current Opinion in Anaesthesiology. 2004 [cited 2020 Mar 31]. p.417–21. Available from: http://www.ncbi.nlm.nih.gov/ pubmed/17023899 5. J eng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth [Internet]. 2010 [cited 2020 Mar 31];105(S1):97–107. Available from: https://academic.oup.com/bja/article-abstract/105/suppl_1/ i97/235950 6. F ong-Soe-Khioe R.Health Economic report Medovate commissioned written by a health economist from the University of East Anglia (UEA)

Legal disclaimer NRFit™ Range Peripheral Nerve Blocks Peripheral Nerve Block Needles - vygoplex echo - vygoplex ENS & echo – Medical devices indicated for Peripheral Nerve Blocks, – vygoplex needles and extension line, class IIa , Sterile, CE 0426 Manufacturer : MDL SRL,Via Tavani 1/A Delebio (So), Italy, 23014 Distributor :VYGON 5, rue Adeline 95440 Ecouen, France. These devices must be used by trained healthcare professionals. Please refer to the IFU for more information. For reimbursement information, please refer to your local market and health insurance organization SAFIRA® Device SAFIRA® device – class IIb CE 0068 Medical device indicated for Peripheral Nerve Blocks for anesthesia and analgesia SAFIRA® driver, Non-sterile - SAFIRA® Foot Pedal, Non-sterile - SAFIRA® NRFitTM syringe, Sterile. Manufacturer : Medovate Limited Camboro Business Park, The Workplace, Girton, Cambridge CB3 0QH, UK Distributor :VYGON 5, rue Adeline 95440 Ecouen, France. These devices must be used by trained healthcare professionals. Please refer to the IFU for more information. For reimbursement information, please refer to your local market and health insurance organization

07/2021 - DB ANES21596E

ANAESTHESIA & EMERGENCY For further information, please contact: questions@vygon.com The specifications shown in this leaflet are for information only and are not, under any circumstances, of a contractual nature.

Vygon – 5, rue Adeline • 95440 ECOUEN • FRANCE Reception: +33 (0)1.39.92.63.63 – Service clients France: +33 (0)1.39.92.63.81 Export customer service: +33 (0)1.39.92.64.15 Fax.: +33 (0)1.39.92.64.44 • www.vygon.com