STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 MOBILE LUER LOCK VENT FILTER 160 CM

Reference : PER1FL25

  • Bisphenol A and DEHP free (<0.1% m/m.)
  • Designed to minimise the environmental footprint by reducing the weight of plastic materials.
  • Packaging developed with users to provide excellent readability of the main information needed immediately.

Description

The DEHP-free, BPA-free INFINEED lt;Gravity lt; 1-way infusion set was designed to minimize the device's environmental impact. Two methods have been used: first, by reducing the plastic mass used by around 10%, without making any changes to functionality; second, by exclusively using raw materials that are free from endocrine disruptors (elimination of components comprising DEHP or BPA.)
For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.

For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.
The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).

Two-channel perforator
Air intake: Delivered closed for immediate use on a 0.2µm filter bag, Chamber: Chamber: 5.5 mL / 5 cm long - Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml. With 15µm particle filter.
Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.
Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks.
End fitting: Mobile Luer Lock, end stopper equipped with a purge filter with anti-bacterial membrane. Very pressure-resistant purge filter.

Length: 160cm

Residual volume: 15ml

Made in China.

Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and while the luer lock is connected, therefore under physical stress, presents a significant risk of cracking of the luer lock, and should be avoided as much as possible.

In accordance with the recommendations of the SF2H (2019), disinfecting the connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective in disinfecting inert materials and there is much less risk of altering plastic materials.

Technical
information

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Gravity infusion set, do not use for pressure infusion, transfusion or medicine that need a 0.2µm filter. Dispose according to the state member regulation.

Used materials 
PVC (DEHP < 01.% (m/m)): Chamber, air intake, tubing - DINCH: plasticizer - HDPE: protective perforator cap, end cap - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator, roller, mobile Luer Lock - Polyamide: Particle filter - Polyethylene/PTFE: Purge filter

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

  • MD class : IIa
  • MD notified body : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • Infusion equipment for medical purposes - Part 14: Clamps and flow limiters for non-contact fluid transfusion and infusion devices
  • Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized medical devices;
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.

economic operator 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Logistics
information

Transport conditions 

Protect from light and humidity and store at a temperature between 5°C and 20°C.

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 21 x 10 x 1 0.029 3661809028939
BAG 25 48 x 27 x 4 0.660 3661809128936
CASE 250 59 x 39 x 27 7.624 3661809228933
PALLET 6000

The DEHP-free, BPA-free INFINEED lt;Gravity lt; 1-way infusion set was designed to minimize the device's environmental impact. Two methods have been used: first, by reducing the plastic mass used by around 10%, without making any changes to functionality; second, by exclusively using raw materials that are free from endocrine disruptors (elimination of components comprising DEHP or BPA.)
For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.

For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.
The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).

Two-channel perforator
Air intake: Delivered closed for immediate use on a 0.2µm filter bag, Chamber: Chamber: 5.5 mL / 5 cm long - Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml. With 15µm particle filter.
Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.
Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks.
End fitting: Mobile Luer Lock, end stopper equipped with a purge filter with anti-bacterial membrane. Very pressure-resistant purge filter.

Length: 160cm

Residual volume: 15ml

Made in China.

Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and while the luer lock is connected, therefore under physical stress, presents a significant risk of cracking of the luer lock, and should be avoided as much as possible.

In accordance with the recommendations of the SF2H (2019), disinfecting the connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective in disinfecting inert materials and there is much less risk of altering plastic materials.

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Gravity infusion set, do not use for pressure infusion, transfusion or medicine that need a 0.2µm filter. Dispose according to the state member regulation.

Used materials 
PVC (DEHP < 01.% (m/m)): Chamber, air intake, tubing - DINCH: plasticizer - HDPE: protective perforator cap, end cap - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator, roller, mobile Luer Lock - Polyamide: Particle filter - Polyethylene/PTFE: Purge filter

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

  • MD class : IIa
  • MD notified body : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • Infusion equipment for medical purposes - Part 14: Clamps and flow limiters for non-contact fluid transfusion and infusion devices
  • Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized medical devices;
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.

economic operator 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Transport conditions 

Protect from light and humidity and store at a temperature between 5°C and 20°C.

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 21 x 10 x 1 0.029 3661809028939
BAG 25 48 x 27 x 4 0.660 3661809128936
CASE 250 59 x 39 x 27 7.624 3661809228933
PALLET 6000

Video(s)

Associated products

STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 MOBILE LUER LOCK VENT FILTER 160 CM
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 FIXED LUER LOCK VENT FILTER 170 CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 LUER LOCK MOBILE PURGE FILTER 180CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 SITE Y LUER LOCK MOBILE PURGE FILTER 150+30CM

Associated products

STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 MOBILE LUER LOCK VENT FILTER 160 CM
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 FIXED LUER LOCK VENT FILTER 170 CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 LUER LOCK MOBILE PURGE FILTER 180CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 SITE Y LUER LOCK MOBILE PURGE FILTER 150+30CM

Request for technical documentation

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