NRFit CATALOGUE NRFit RANGE
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Vygon in the world
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OUR STORY Pierre Simonet founded Vygon in France in 1962. He was one of the first to introduce the concept of disposable medical equipment. Shortly thereafter, the company established subsidiaries in Europe, the United States, India, South America, and more. Today it is present worldwide. Vygon also relies on many production units, starting with its first plant in France and continuing on to its latest, brand-new plant that opened in Portugal in 2015.
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Vygon is changing for you
Today the company is present in 100 countries and works for 4,000 clients worldwide. We owe this rapid expansion to all of our clients, both old and new, and to our employees’ capacity for innovation. Thanks to their commitment, we are able to offer the products and devices that healthcare professionals expect, and that provide their
R&D
patients with relief. We are also grateful for all of our employees' positive
Europe
attitudes, whether they work in our laboratories, in our plants, or in our subsidiaries. Turkey
Everyone is devoted to their jobs in the service of healthcare. Today, our development and our results have led us to prioritise an even more efficient approach for project management and to structure our activity in five business units.
Europe
Since our product range is managed in a decentralised fashion, our staff members are able to concentrate on more specific projects, shorten the innovation cycles, and be Japan
Algiers
United States
Singapore
Retaining the values, vocation, and professional approach that are unique to Vygon, and intensifying our inventive spirit, are the very objectives of this new
Dubai Colombia
more responsive in managing their relations with you.
organisational structure.
India
Brazil
Stéphane Regnault CEO
Mauritius Uruguay
Subsidiary
2
Production
Office
Research and
R&D Development 3
NRFit RANGE Product index
Table of contents
Product code
Designation EPIDURAL ANAESTHESIA neurafit mini-kit with peripur epidural catheter
10
191.70A1
neurafit mini-kit with peristyl epidural catheter
10
5191.3371A1
neurafit mini-kit with peribax epidural catheter
11
80189.322A1
neurafit mini-kit with peribax (without XRO line) epidural catheter
11
Spinal Anaesthesia / Lumbar Puncture................................... 12
Whitacre needles
13
180 - 5180 - 5183
Quincke needles
14
VYSET...................................................................................... 21
vygoplex® echo NRFitTM
16
AEYMVF - AEQMVF
vygoplex® ENS & echo NRFitTM
17
ACCESSORIES
18
VGU15461125
neurafit Extension Line - 125 cm
19
VGU15291050
neurafit Drawing up Needle - 18G 50 mm
19
VGU15241001
neurafit 3-way Stopcock
19
80822A1
Filter
19
101810A1
LOR syringe
19
V05101
neurafit syringes
20
VYSET
Legal Disclaimer .................................................................. 28
4
15
AEQMNVF - AEYMNVF
Peripheral Nerve Blocks.......................................................... 15 Accessories............................................................................ 18
12
181 - 5181
PERIPHERAL NERVE BLOCKS
Epidural Anaesthesia................................................................ 7
7
191.30A1
SPINAL ANAESTHESIA / LUMBAR PUNCTURE
NRFitTM RANGE
Page
21
V05776901
Basic set: Bronze Edition
22
V05776902
Basic set: Silver Edition
23
V05776903
Basic set: Gold Edition - Mini-kit 191.30A1 Basic set: Gold Edition - peripur
25
V05776904
Basic set: Gold Edition - Mini-kit 191.70A1 Basic set: Gold Edition - peristyl
25
V05776905
Basic set: Gold Edition - Mini-kit 5191.3371A1 Basic set: Gold Edition - peribax
26
V05776906
Basic set: Gold Edition - Mini-kit 80189.322A1 Basic set: Gold Edition - Cristal
26
5
A range developed for more patient safety Why has it been developed ? [1, 2]
What is NRFitTM ? [3]
For years, drug errors have caused acute levels of harm and deaths due to neuraxial misconnection. 14% of drug errors in the anesthesia field are due to wrong route injections. Some of these accidents are due to local anaesthetics being injected intravenously or drugs being administered epidurally when they were not intented for the neuraxial route.
The ISO 80369 series of Standards for small bore-connectors, aims to avoid misconnections between unrelated delivery systems (such as intravenous, enteral and epidural routes) which can cause injuries and death to patients.
What is the difference between Luer and NRFitTM? Standard Luer connector
connector 20% smaller in diameter
Advantages • A reduction in the risk of misconnections (impossibility to connect to Luer devices) • Yellow colour coding and the neurafit® label on the packaging for time saving procedures • No risk of accidentally connecting to other small fittings • A safe and reliable connection to NRFitTM elements • The ISO series of Standards aims to have designated small bore connectors for different indications that do not fit devices used for other indications
Epidural Anaesthesia
[1] Eldor, J., To NRFit or not to NRFit?, J Health Sci Dev Vol: 2, Issu: 1 (09-13), 2019 [2] Y entis, S. M.,Randall K., Drug errors in obstetric anaesthesia: a national survey, International Journal of Obstetric Anesthesia, Volume 12, Issue 4, 246 - 249 [3] I SO 80369-1:2018(en) Small-bore connectors for liquids and gases in healthcare applications — Part 1: General, requirementshttps:// www.iso.org/obp/ui/#iso:std:iso:80369:-1:ed-2:v1:en, visited on 16/12/2019
6
7
The Twist & Click Connector For 60% of doctors the key features of a connector is the click hearing and the tactile marker. [4]
Designed to be
Click hearing
An innovative design : a transparent part to see the catheter through the connector
Ergonomic To facilitate the insertion of the catheter
A secured end of the catheter into the connector
Safe To avoid any leaks during the injection
Easy set-up
2 steps only To connect the catheter A visual cue: an open & closed position
A tactile marker
Insert and click
[4] E SRA Congress 2019 Questions form.
8
9
The NRFitTM mini-kits Each mini-set includes: a catheter with catheter guide, Twist & Click connector, Tuohy needle, 10mL LOR syringe, 0.2µm filter and yellow label.
191.30A1
5191.3371A1
neurafit mini-kit with peripur epidural catheter
neurafit mini-kit with peribax epidural catheter
This mini kit includes a peripur catheter (soft material, no stylet, transparent with XRO line), closed tip with 3 lateral eyes.
This mini kit includes a peribax catheter (material with a good compromise between flexibility & rigidity, no stylet, transparent with XRO line)
Peripur Catheter
Tuohy Needle
Code
G
Length cm
Ext. Ø mm
Int. Ø mm
G
Length mm
Stylet material
191.30A1
19
90
1,0
0,5
17
90
Metal
G
Length cm
Ext. Ø mm
Int. Ø mm
G
Length mm
Stylet material
20/120
5191.3371A1
20
90
0,85
0,45
18
80
Plastic
80189.322A1
neurafit mini-kit with peristyl epidural catheter
neurafit mini-kit with cristal (peribax without XRO line) epidural catheter
This mini kit includes a peristyl catheter (very soft material, with metallic stylet, transparent with XRO line), closed tip with 3 lateral eyes.
This mini kit includes a peribax catheter (material with a good compromise between flexibility & rigidity, no stylet, transparent without XRO line), closed tip with 3 lateral eyes.
Tuohy Needle
Code
G
Length cm
Ext. Ø mm
Int. Ø mm
G
Length mm
Stylet material
191.70A1
19
90
1,0
0,5
17
90
Metal
Tuohy Needle
Code
191.70A1
Peristyl Catheter
10
Peribax Catheter
Quantity Box/Case
Cristal Catheter (peribax without XRO line)
Tuohy Needle
Quantity Box/Case
Code
G
Length cm
Ext. Ø mm
Int. Ø mm
G
Length mm
Stylet material
20/120
80189.322A1
20
90
0,85
0,45
18
80
Plastic
Quantity Box/Case 20/120
Quantity Box/Case 20/120
11
Whitacre pencil point design
181 - 5181 Whitacre needles Reduces the risk of post-spinal headache after intrathecal injection. The shape, size and positioning of the eye ensures optimum needle placement and excellent cerebrospinal fluid (CSF) response time.
180.0 5 5180 .94 5180 .04
• A crystal clear hub for CSF visualisation
• A yellow protector for easy NRFitTM identification
Needle Code
12
5183 .51 5183 .72
183.9 9 5180 .27
Spinal Anaesthesia / Lumbar Puncture
• A recessed notch for a quick indication of the distal eye
Colour
Introducer
Quantity Box/case
Diameter G
Length mm
Diameter G
Length mm
181.042A1
27
90
22
38
25/1000
181.942A1
26
90
20
38
25/1000
181.052A1
25
90
20
38
25/1000
181.252A1
25
120
20
38
25/700
181.072A1
22
90
18
38
25/1000
5181.27A1
22
120
-
-
25/700
13
Quincke needle design
180 - 5180 - 5183 Quincke needles Ideal for performing an effective lumbar puncture with a rapid CSF reflux.
180.0 5 5180 .94 5180 .04
5183 .51 5183 .72
183.9 9 5180 .27
• A recessed notch for a quick indication of the bevel orientation
• A crystal clear hub for CSF visualisation
• A yellow protector for easy NRFitTM identification
Peripheral Nerve Blocks
• An optimized stylet-needle adjustment to reduce lesions during insertion.
Needle Code
14
Colour
Introducer
Quantity Box/case
Diameter G
Length mm
Diameter G
Length mm
5180.05A1
25
90
-
-
25/1000
180.052A1
25
90
20
38
25/1000
5183.47A1
22
38
-
-
25/1000
5183.97A1
22
90
-
-
25/1000
5180.27A1
22
120
-
-
25/700
5183.49A1
20
38
-
25/1000
5183.99A1
20
90
-
-
25/1000
5183.92A1
18
90
-
-
25/1000
15
vygoplex®: The new generation of echogenic needles Single shot needles for peripheral nerve blocks AEQMNVF - AEYMNVF
vygoplex® ENS & echo NRFitTM Echogenic and neurostimulating needles
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
vygoplex echo NRFit Echogenic needles ®
AEYMVF - AEQMVF
TM
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.
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 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
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
02 BEVEL For a more or less important perception of the fascias Choice between 2 types of lancet point bevels : • 20° • 30°
Code AEQMNVF24080 AEQMNVF24040
16
Length (mm) 80 40
04 EXTENSION LINE For easy injection Removable extension line which enables the connection of a syringe directly to the needle if required
Gauge (G)
Bevel
Bevel Type
24 24
Length (mm)
Gauge (G)
AEYMVF25050
50
25
10/200
AEYMVF25080
80
25
10/200
AEYMVF25120
120
25
10/200
AEYMVF24040
40
24
10/200
AEYMVF24100
100
24
10/200
AEYMVF24080
80
24
AEYMVF24070
70
24
10/200
AEYMVF23035
35
23
10/200
10/200
AEYMVF22050
50
22
10/200
Quantity (box/ case)
Bevel
Bevel Type
Quantity (box/ case)
Code
10/200 10/200
20°
AEQMNVF25050
50
25
10/200
AEYMVF22080
80
22
10/200
AEQMNVF25080
80
25
10/200
AEYMVF21100
100
21
10/200
AEQMNVF25120
120
25
10/200
AEYMVF21120
120
21
10/200
AEQMNVF22050
50
22
10/200
AEYMVF20120
120
20
AEQMNVF22080
80
22
10/200
AEQMVF25050
50
25
AEQMNVF21100
100
21
10/200
AEQMNVF20100
100
20
AEQMVF25080
80
25
AEYMNVF24080
80
24
30°
Lancet point
10/200 10/200
AEYMNVF24040
40
24
10/200
AEYMNVF25050
50
25
10/200
AEYMNVF25080
80
25
AEYMNVF25120
120
25
10/200
AEYMNVF22050
50
22
10/200
AEYMNVF22080
80
22
10/200
20°
10/200
AEYMNVF21100
100
21
10/200
AEYMNVF20100
100
20
10/200
Lancet point
10/200 10/200 10/200
AEQMVF25120
120
25
10/200
AEQMVF24040
40
24
10/200
AEQMVF24100
100
24
10/200
AEQMVF24080
80
24
10/200
AEQMVF24070
70
24
AEQMVF23035
35
23
30°
10/200 10/200
AEQMVF22050
50
22
10/200
AEQMVF22080
80
22
10/200
AEQMVF21100
100
21
10/200
AEQMVF21120
120
21
10/200
AEQMVF20120
120
20
10/200
17
A full range of NRFitTM accessories designed for totally safe procedures
VGU15461125 Code
Designation
Quantity Box
VGU15461125
neurafit Extension Line 125 cm
25
VGU15291050 Code
Designation
Quantity Box
VGU15291050
neurafit Drawing up Needle 18G 50 mm
100
VGU15241001 Code
Designation
Quantity Box
VGU15241001
neurafit 3-way Stopcock
50
Code
Designation
Quantity Box/case
80822A1
Filter
25/600
Code
Designation
Quantity Box/case
101810A1
LOR syringe
20/240
80822A1
Accessories
101810A1
18
19
A full range of syringes to fit your needs
Code
Designation
V051010011A1
neurafit syringe 1 mL slip
V051010031A1
neurafit syringe 2.5 mL slip
V051010032A1
neurafit syringe 2.5 mL lock
V051010051A1
neurafit syringe 5 mL slip
V051010052A1
neurafit syringe 5 mL lock
V051010101A1
neurafit syringe 10 mL slip
V051010102A1
neurafit syringe 10 mL lock
V051010201A1
neurafit syringe 20 mL slip
V051010202A1
neurafit syringe 20 mL lock
V051010602A1
neurafit syringe 60 mL lock
VYSET
NRFit syringes are only available via a customized pack (VYSET). 20
21
Basic set: Bronze Edition
Basic set: Silver Edition
V05776901
V05776902
The Bronze Basic set is a standard set containing the essential components to perform epidural anesthesia procedures. It is presented in a soft blister pack and includes : Designation
Quantity
NRFitTM 20 mL Lock syringe
1
NRFitTM 10 mL Lock syringe
1
NRFitTM filter needle 18Gx50 mm
1
Clear fenestrated peelable drape 75x100 cm, opening of 12x7cm
1
Filter needle 18G (Luer)
1
Swabs 7.5 x 7.5cm
5
5 mL LS syringe (Luer)
1
2,5 mL LS syringe (Luer)
1
Outer wrap 100x120 cm
1
Tray 3 sections 19x13x3 cm
1
Hypodermic needle 25G orange
1
Hypodermic needle 21G green
1
Foam sticks
2
Turn your Basic set into a VYSET to get it personnalized.
22
The Silver Basic set is a standard set containing the essential components to perform an epidural anesthesia procedures. It is presented in a soft blister pack and includes :
Designation
Quantity
Swabs 7.5 x 7.5 cm
5
Filter needle 18G (Luer)
1
Foam stick
2
2,5 mL LS syringe (Luer)
1
Outer wrap 100x120 cm
1
5mL LS syringe (Luer)
1
Grip lok for regional anaesthesia
1
Peelable drape 100x80 cm with adhesive aperture 6.5x12 cm
1
Vygel - ultrasound gel 20 mL
1
Device for safety needle securement – 5 needles
1
Probe cover 15x120 cm and rubber band
1
Lower tray 20,6x13x4 cm
1
Upper tray 21x13x3,5 cm
1
neurafit Drawing up Needle 18G 50 mm
1
NRFitTM 10 mL Lock syringe
1
NRFitTM 20 mL Lock syringe
1
Green plastic pouch 12x15 cm
1
Hypodermic needle 21G green
1
Hypodermic needle 25G orange
1
Turn your Basic set into a VYSET to get it personnalized. 23
Basic set: Gold Edition
V05776903 Basic set: Gold Edition - Mini-kit 191.30A1: peripur catheter
For an improved procedure : turn your Silver Basic set into a Gold one. The Gold Basic set is composed of the Silver Basic set and one of the following mini-kits : - Mini-kit 191.30A1 - Mini-kit 191.70A1 - Mini-kit 5191.3371A1 - Mini-kit 80189.322A1
Silver Basic set
The Gold Basic set is a standard set containing the essential components for the realization of an epidural anesthesia procedure. It is presented in a soft blister pack and includes :
Designation
Quantity
Swabs 7.5 x 7.5 cm
5
Filter needle 18G (Luer)
1
Foam stick
2
2,5 mL LS syringe (Luer)
1
Outer wrap 100x120 cm
1
5mL LS syringe (Luer)
1
Grip lok for regional anaesthesia
1
Peelable drape 100x80 cm with adhesive aperture 6.5x12 cm
1
Vygel - ultrasound gel 20 mL
1
Device for safety needle securement – 5 needles
1
Probe cover 15x120 cm and rubber band
1
Lower tray 20,6x13x4 cm
1
Upper tray 21x13x3,5 cm
1
neurafit Drawing up Needle 18G 50 mm
1
NRFit
10 mL Lock syringe
1
NRFitTM 20 mL Lock syringe
1
Green plastic pouch 12x15 cm
1
Hypodermic needle 21G green
1
Hypodermic needle 25G orange
1
TM
Turn your Basic set into a Vyset to get it personnalized. 24
+ 191.30A1 V05776904 Basic set: Gold Edition - Mini-kit 191.70A1: peristyl catheter Silver Basic set
+ 191.70A1 25
V05776905 Basic set: Gold Edition - Mini-kit 5191.3371A1: peribax
VYSET customized set
Silver Basic set
Time saving
+ 5191.3371A1
V05776906 Basic set: Gold Edition - Mini-kit 80189.322A1: : cristal catheter Silver Basic set
Improving safety
+ 80189.322A1 26
27
Legal Disclaimer Peripheral Nerve Blocks Vygoplex echo NRFit™- Vygoplex ENS & echo NRFit™ 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
Epidural Anesthesia Neurafit™ epidural set – Neurafit™ LOR Syringe – Neurafit™ Epidural Filter – Neurafit™ Syringes – Neurafit™ Extension Line – Neurafit™ 3-Way Stopcock – Neurafit™ Drawing up Needle Medical devices indicated for Epidural anesthesia and analgesia Mini-set, Filter class, Extension Line, 3-Way Stopcock IIa – LOR Syringe class Is – Syringes, Drawing up Needle class I, sterile, CE 0459 Spinal Anesthesia / Lumbar Puncture Neurafit™ Whitacre Needles – Neurafit™ Quincke Needles Medical devices indicated for Spinal Anesthesia / Lumbar Puncture Whitacre and Quincke needles class III – Sterile, CE 0120
28
29
01/2022 - DC ANES 21 613 E
PAIN & AIRWAY MANAGEMENT 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
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