HARTMANN MEDISET 3-WAY INFUSION SET BPA-FREE

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.

The INFINEED "Gravity" 3-ways infusion set without DEHP, BPA-free was designed to minimize the environmental impact of the device. 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.) The polycarbonate-free 3-way stopcock has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bars.

Infuser with:

Two-channel perforator

Air intake (0.2µm filter): Delivered closed for immediate use on a pocket

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15µm particle filter.

Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.

BPA-free 3-way stopcock: Lipid-resistant with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube. Only the main line can be disconnected from the stopcock.

Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 3 x 4.1mm

End cap: Mobile Luer Lock, end cap with 0.8 µm purge filter (hydrophobic membrane) enabling automatic purging of the infusion line.

Length: 150cm + 30cm
Residual volume: 15.8 ml

Indications
This device allows the administration by gravity of injectable preparations by parenteral way: drugs, solutions, nutrition For peripheral lines, the infusion line can remain in place for a maximum of 96 hours (i.e. the maximum time the peripheral catheter can be in place). For central lines, the infusion line must be changed at least every 72 hours (or according to the institution's validated protocol).

Used materials
PVC DINCH (DEHP<0.1%(m/>)): Chamber, air intake, tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Tritan® BPA-free: Stopcock body - Acrylonitrile butadiene styrene: Perforator, regulator, mobile Luer Lock - Nylon: Particle 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 modifiée par 2007/47/CEE
annexe : II

sterile

sterile : yes
sterilization method : ethylene oxide

conformity

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Medical devices - Part 1 : Application of usability engineering to medical devices
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Sterilization of health-care products - Ethylene oxide - Part 1 : Requiremnets for the development, validation and routine control of a sterilization process for medical devices
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1
Medical devices - Application of risk management to 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

Protected from light, humidity and at a temperature between 5 and 40 ° C

Infuser with:

Two-channel perforator

Air intake (0.2µm filter): Delivered closed for immediate use on a pocket

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 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. Diameter: 3 x 4.1mm

End cap: Mobile Luer Lock, end cap with 0.8 µm purge filter (hydrophobic membrane) enabling automatic purging of the infusion line.

Length: 150cm + 30cm
Residual volume: 15.8 ml

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 modifiée par 2007/47/CEE
annexe : II

sterile

sterile : yes
sterilization method : ethylene oxide

conformity

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Medical devices - Part 1 : Application of usability engineering to medical devices
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Sterilization of health-care products - Ethylene oxide - Part 1 : Requiremnets for the development, validation and routine control of a sterilization process for medical devices
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1
Medical devices - Application of risk management to 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

Protected from light, humidity and at a temperature between 5 and 40 ° C

Conditioning	Parts quantities	Dimensions in cm	Weight in kg	Ean 13 of conditioning
UNIT	1

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HARTMANN MEDISET 3-WAY INFUSION SET BPA-FREE

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