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INFUSION SET 'Y', Luer-lock, air inlet, sterile, s.u.

https://unicat.msf.org/cat/product/18702
STD SINSSETI2--

Valid Article

Former Code(s): SCTDOCBZLB0002 SINSZIN2001
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
A030401 - Infusion kits (including those via pump), single use
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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INFUSION SET

Definition

A collection of noninvasive sterile devices designed to conduct fluids from an intravenous fluid container to a patient's venous system. It includes tubing, connectors, chamber, clamp, and an injection port. It is used for gravitational intravenous administration of infusions, excluding blood and blood products.

Synonym

IV infusion set, giving set

Specifications

Image

Quality standards

ISO 8536-4, 2019, edition 6, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

Technical specifications

  • PERFORATOR
    • double channel
    • built-in air inlet with hydrophobic filter (bacteriological filtration: 0.22 to 0.35 µ)
    • with protector
  • DROP-COUNTING CHAMBER
    • transparent & flexible
    • calibrated at 20 drops/ml
    • with filter of 15 µm
  • THUMB WHEEL REGULATOR
    • allows to adjust infusion flow rate between 0 and the maximal value
  • TUBING
    • transparent PVC (DEHP-free)
    • length: minimum 150 cm
    • diameter: internal = 3 mm, external = 4.1 mm
    • death volume: ± 15 ml
  • INJECTION PORT
    • latex-free
    • Y-shaped
    • self-sealing membrane made of synthetic elastomer
    • located near the distal connector (below the thumb regulator)
  • DISTAL CONNECTOR
    • rotating male Luer lock
    • with protective cap
    • without needle
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

The air inlet must remain

  • closed for administering infusion solutions in bags
  • opened for administering infusion solutions in rigid bottles.

During the infusion, check the flow rate periodically by counting drops.

SEE TABLE BELOW

Please consult the Manual of nursing Care Procedures, MSF, 2020 available online via the Nursing care working Group sharepoint page.

Precautions for Use

For blood transfusions, use the blood giving set intended for that purpose (see related articles below).

Do not use for light sensitive products.

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Extra Tables

Calibration drop-counting chamber = 20 drops / ml                

Calibration chamber compte gouttes = 20 gouttes / ml

 

 

 

 

 

Target rate ml/h

Counting for 15 seconds / Compter pendant 15 secondes

Counting for 60 seconds / Compter pendant 60 secondes

Débit souhaité ml/h

Drops to count

Gouttes à compter

= rate

= débit

Max error %

Drops to count

Gouttes à compter

= rate

= débit

Max error %

10

 

 

 

3

6 – 12

40 %

15

 

 

 

5

12 – 18

20 %

20

2

12 – 36

80 %

7

18 – 24

20 %

25

2

12 – 36

52 %

8

21 – 27

16 %

30

3

24 – 48

60 %

10

27 – 33

10 %

35

3

24 – 48

37 %

12

33 – 39

11 %

40

3

24 – 48

40 %

13

36 – 42

10 %

50

4

36 – 60

28 %

17

48 – 54

8 %

60

5

48 – 72

20 %

20

57 – 63

5 %

70

6

60 – 84

20 %

23

66 – 72

6 %

75

6

60 – 84

20 %

25

72 – 78

4 %

80

7

72 – 96

20 %

27

78 – 84

5 %

100

8

84 – 108

16 %

33

96 – 102

4 %

110

9

96 – 120

13 %

37

108 – 114

4 %

120

10

108 – 132

10 %

40

117 – 123

3 %

125

10

108 – 132

14 %

42

123 – 129

3 %

150

13

144 – 168

12 %

50

147 – 153

2 %

175

15

168 – 192

10 %

58

171 – 177

2 %

200

17

192 – 216

8 %

67

198 – 204

2 %

225

19

216 – 240

7 %

75

222 – 228

1 %

250

21

240 – 264

6 %

83

246 – 252

2 %

300

25

288 - 312

4 %

100

297 - 303

1 %