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A groundbreaking new technology for regional anaesthesia

Product index

Peripheral Nerve Block Needles.................................. 3 Blocks Under Ultrasound & Nerve Stimulation 6194 echoplex®................................................................................ 4

Blocks Under Ultrasound 6094 visioplex®................................................................................. 6

Blocks Under Nerve Stimulation 5194 locoplex®................................................................................. 7

SAFIRA®.................................................................... 8 Giving Anaesthetists control A groundbreaking new technology for regional anaesthesia

For a safer & controlled block

Peripheral Nerve Block Needles

Single Shot Injection

Blocks under Ultrasound & Nerve Stimulation 6194 echoplex®

Echogenic and stimulating needle echoplex+® combines the requirements of both techniques: A nerve stimulation needle has been made fully echogenic thanks to a new insulating coating. The needle is fine, the outer surface is smooth and the echogenic coating goes right to the tip. The bevel combines easy skin penetration and echogenicity.

PERFECT VISIBILITY • 17° or 20° bevel with a specific coating for a maximum echogenicity • The echogenic coating surrounds the entire needle up to the tip • Circular centimetric marking • Gives control of needle position and insertion depth. PRACTICAL • Ergonomic hub for an easy handling.

TRANSPARENT HUB • Allows quick visualization of possible blood reflux VERSATILITY • Removable extension line • Enables connection of a syringe directly to the needle if required. • Low dead space (1 mL).

SAFETY • A long (60cm) electrical cable to work at distance from sterile field. • Quick identification of the bevel orientation thanks to the black cable positioning

For a safer & controlled block

Single Shot Injection

Advanced technology: a patented coating The coating uses the hardness of microscopic glass beads which are distributed in an insulating polymer. The high concentration of glass beads intensifies the ultrasound reflection. The quantity of glass beads has been precisely calculated to maximize reflection whilst minimizing artefacts.

Angle of the bevel

Length

Gauge

6194.253

25 mm

20 / box

6194.353

35 mm

20 / box

6194.503

50 mm

20 / box

6194.853

85 mm

6194.103

100 mm

20 / box

6194.123

120 mm

20 / box

6194.153

150 mm

20 / box

6194.25

25 mm

20 / box

6194.35

35 mm

20 / box

6194.50

50 mm

20 / box

6194.85

85 mm

6194.10

100 mm

20 / box

6194.12

120 mm

20 / box

6194.15

150 mm

20 / box

20°

17°

Bevel type

Quantity (box)

Code

Back-cut

Lancet point

20 / box

These references are also available in VYSET (customized sets) with devices dedicated to ultrasound.

Single Shot Injection

Blocks Under Ultrasound 6094 visioplex®

Echogenic needle visioplex® has a sand-blasted steel tip making the needle highly echogenic.

Safety • Ergonomic hub: easy to manipulate. • Transparent hub: f or quick visualization of a possible blood reflux

Versatility Removable extension line: for a direct connection to the syringe.

Circular centimeter markings: to easily identify the inserted length.

Safety • 30° Bevel: Maximum perception of facias. • Echogenicity up to the tip of the bevel Needles specific treatment on the distal end increases ultrasound reflection

visioplex® is echogenic up to the tip of the bevel. Code

Length

Gauge

Angle of the bevel

Bevel type

6094.3534 6094.503 6094.5034 6094.8534 6094.103

35 mm 50 mm 50 mm 85 mm 100 mm

22 20 22 22 20

30°

Back-cut

Quantity (box) 20 / box 20 / box 20 / box 20 / box 20 / box

These references are also available in VYSET (customized sets) with devices dedicated to ultrasound.

For a safer & controlled block

Single Shot Injection

Blocks Under Nerve Stimulation 5194 locoplex®

Stimulating needle This stimulating needle is insulated over its entire length. Its bevel is completely exposed for a large conduction of current, and for an easier needle insertion.

Security Quick identification of the bevel direction thanks to the black cable positioning.

Ergonomic hub: easy handling Transparent: For quick visualization of a possible blood reflux

Safety Centimeter markings: Needle marked every centimeter on its circumference to identify the inserted length.

30° 17°

Versatility Removable extension line: for a direct connection to the syringe.

A choice of 2 exposed bevels to fit your needs 30° bevel needles (short bevel) facilitate perception of the successive subcutaneous layers. 17° bevel : Easier insertion.

Safety A long (60cm) electrical cable to work at distance from sterile field. Code 17° Lancet-point bevel 5194.25 5194.35 5194.50 5194.85 5194.10 5194.12 5194.15

30° Back-cut bevel 5194.253 5194.353 5194.503 5194.853 5194.103 5194.123 5194.153

Length

Gauge

25 mm 35 mm 50 mm 85 mm 100 mm 120 mm 150 mm

23 23 20/21 21 21 20 20

Quantity (box) 20 / box 20 / box 20 / box 20 / box 20 / box 20 / box 20 / box

These references are also available in VYSET (customized sets) with devices dedicated to ultrasound.

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

900016

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 Peripheral Nerve Blocks Needles echoplex® –visioplex® – locoplex® Needles Medical devices indicated for Peripheral Nerve Blocks under ultrasound and/or neurostimulation for anesthesia and analgesia echoplex® –visioplex® – locoplex® Needles class IIa – Sterile, CE 0459 Manufacturer :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® 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

01/2021 - DB ANES21595E

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