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SET, INFUSION, paediatric, precision, sterile, s.u.

https://unicat.msf.org/cat/product/18704
STD SINSSETP150

Valid Article

Former Code(s): -X
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).
Article is intended to be used with children (<12 years) ONLY.
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.
A03010101 - Infusion controllers with or w/o air inlet
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.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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, paediatric

Definition

A sterile device designed to conduct fluids from an intravenous fluid container to a patient's venous system. It includes a calibrated burette for fluid volume measurement, tubing, connectors, chambers, clamps, and an injection port. It is used for gravitational intravenous administration of a precise volume of solution, excluding blood and blood products.

Synonym

Burette infusion set

Specifications

Quality standards

  • ISO 8536-5, 2004, edition 2, (confirmed 2018) Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
  • 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
  • GRADUATED BURETTE
    • transparent plastic
    • capacity: 150 ml
    • graduations every 10 ml minimum
    • air inlet that can be closed
    • injection port above the graduations
    • latex free security valve for stopping the infusion when the liquid reaches the 0 graduation
    • with handle
  • DROP-COUNTING CHAMBER
    • flexible & transparent
    • calibrated at 60 drops/ml
    • with filter of 15 µm
  • 2 THUMB WHEEL REGULATORS
    • 1 below the burette, one above (this one may also be a clamp as it is used to fill the burette)
    • allows to adjust infusion flow rate between 0 and the maximal value
  • TUBING
    • transparent PVC
    • length: minimum 150 cm
    • internal diameter: ± 3 mm
    • dead volume: ± 15 ml
  • DISTAL CONNECTOR
    • mobile male Luer lock
    • with protective cap
  • INJECTION PORT
    • Y-shaped
    • self-sealing membrane made of synthetic elastomer
    • located near the distal connector
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

To be used in cases where the volume of solution must be carefully supervised and controlled, especially in paediatrics.

It is essential that the burette is suspended in a vertical position allowing the valve to remain in horizontal position and to be correctly set in the bottom of the burette.

The injection site allows addition of an injectable medicine to a precise volume of solution.

The air inlet must remain closed for administering infusion solutions in bags, and be opened for administering infusion solutions in rigid bottles.

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

SEE TABLE BELOW

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

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

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Extra Tables

Calibration drop-counting chamber = 60 drops / ml                 Calibration chamber compte gouttes = 60 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 %

5

5

4 - 6

20 %

10

3

8 – 16

60 %

10

9 - 11

10 %

15

4

12 – 20

33 %

15

14 – 16

7 %

20

5

16 – 24

20 %

20

19 – 21

5 %

25

6

20 – 28

20 %

25

24 – 26

4 %

30

8

28 – 36

20 %

30

29 – 31

3 %

35

9

32 – 40

14 %

35

34 – 36

3 %

40

10

36 – 44

10 %

40

39 – 41

3 %

45

11

40 – 48

11 %

45

44 – 46

2 %

50

13

48 – 56

12 %

50

49 – 51

2 %

55

14

52 -60

9 %

55

54 – 56

2 %

60

15

56 – 64

7 %

60

59 – 61

2 %

70

18

68 – 76

9 %

70

69 – 71

1 %

75

19

72 – 80

7 %

75

74 – 76

1 %

80

20

76 – 84

5 %

80

79 – 81

1 %

100

25

96 – 104

4 %

100

99 – 101

1 %

110

28

108 – 116

5 %

110

109 – 111

1 %

120

30

116 – 124

3 %

120

119 – 121

1 %

125

31

120 – 128

4 %

125

124 – 126

1 %

130

33

128 – 136

5 %

130

129 – 131

1 %

150

38

148 – 156

4 %

150

149 – 151

1 %

175

44

172 - 180

3 %

175

174 - 176

1 %