EASYDROP FLOW REGULATOR
Easydrop is a single-use disposable flow regulator which allows highly accurate control of flow rate in gravity admi- nistered I.V. solutions. It'is a very low-cost alternative to highly expensive I.V. pump systems (with expensive and dedicated high pressure I.V. sets).
Easydrop is used with standard gravity I.V. sets and requires a “two hands” safety operation for any adjustment. The Easydrop operating principle is the “triple labyrinth”, the GVS patented technology that ensures a very accurate flow rate and high stability in delivery throughout the whole infusion session. No electrical power is required. Easydrop has a very light weight and a modern look. Easydrop can be added as a component of a standard gra- vity I.V. line or can be provided into an extension set to be connected to an existing standard gravity I.V. line.
SPECIFICATIONS:
Biosafety
Materials comply with USP class VI-121°C test and ISO 10993
Dimensions
Diameter x Height: 32.00 x 34.20 mm (body) Weight: 9.00 g
Operating range
20 to 250 ml/h*
Inlet/Outlet connectors
Standard IV tubing connectors (2.7x3.5mm or 3.0x4.1mm)
Materials of construction
Housing: White ABS (also available in other materials and colors) Gasket: SEBS (also available in other materials)
Calibrated scale
Sterilization
Suitable for EtO (44°C/111°F max) and gamma (50kGy) steri- lization. Higher temperature can cause a reduction in per- formance.
Maximum operating pressure
0.5 bar (7 psi) in static condition, Gravity set. Maximum storage and operating temperature 40°C (104°F) indoor operation
Tolerance of flow rate*
range 5-15 ml/h not defined
range 20ml/h tolerance on flow rate -10 / + 50% range 21-40ml/h tolerance on flow rate -10 / + 30% range 41-250ml/h tolerance on flow rate -10 / + 20% Stability of flow rate
10% flow rate fluctuation during 24 hours infusion (tested with NaCl 0.9% solution from glass bottles).
Easydrop is available in single and double calibration scale. Easydrop single scale has a general purpose scale that can be used for any kind of solution. Easydrop double scale has one first scale for liquid having density lower than 10% (i.e. light solutions with basis of NaCl 0.9% or Glucose 5% and 10% or Mannitol 5% and 10%) and a second scale for liquid having higher density (40% scale calibrated for solutions made with a basis of Glucose 20% or Mannitol 18%).
Personalized scales are available upon request.
Pyrogenicity
<0.25 EU/ml using the LAL test method. Operating instruction
Place the I.V. solution container (plastic bag or glass bottle or burette) at about 80 cm above the outlet level of the I.V. ad- ministration set.
Connect the I.V. set to the container.
Connect the Extension Set with Easydrop to the I.V. set (not necessary if Easydrop is already contained in I.V. set) Open the clamp to begin priming the line.
Check that liquid is flowing out through the end of the line. Easydrop is provided by GVS in the OPEN position.
Prime Easydrop completely turning Easydrop from OPEN position to OFF position and then adjust the Easydrop scale to the required value.
Connect the I.V. line to the catheter or needle.
At the first stage of infusion, double check that Easydrop is delivering the required flow rate by counting the drops.
In order to change the flow rate adjust height of I.V. solution container. Raise the container to increase the flow rate, lower the container to decrease it.
Note
* Easydrop scales have been calibrated according to GVS standard test conditions:
- Head pressure 80 cm (Head pressure is considered the differential height between the inlet and outlet of liquid in
the I.V administration set).
- Standard ISO8536-4 gravity I.V. line: vented drip chamber 20 drops/ml with 15 micron filter, tubing 3.0 x 4.1 mm, Y-site connector, equipped with the Easydrop and Male
Luer Lock connector at the end of the line.
- Needle used is 20G, 36 mm length.
- Total length of the line 150 cm.
- Liquid used: NaCl 0.9% physiological solution from glass bottles of 500ml.
- Changing of any of the above parameters can cause a different response in flow regulation.
Example
Drip chamber 20 drops/ml
200 ml/h = 66 drops per minute. 100 ml/h = 33 drops per minute. 50 ml/h = 16 drops per minute. Drip chamber 15 drops/ml
200 ml/h = 50 drops per minute. 100 ml/h = 25 drops per minute. 50 ml/h = 12 drops per minute. Drip chamber 10 drops/ml
200 ml/h = 33 drops per minute. 100 ml/h = 16 drops per minute. 50 ml/h = 8 drops per minute.
IMPORTANT
- Do not use Easydrop in OPEN position, this will cause an uncontrolled liquid delivery (about 3 liters/hour).
- Easydrop cannot be used for the administration of blood or blood components.
- Using a high viscosity solution can cause lower flow rate than indicated on the scale. Compensate for this by
increasing the head pressure applied.
- Use of a 15 micron filter into the drip chamber is sugge- sted in order to prevent crystals from blocking the fluid path inside Easydrop.
- Drop counting is always necessary in order to confirm proper flow rate. If necessary, adjust the height of the I.V.
solution container to increase or decrease the flow rate.
EASYDROP Ordering Information:
Product Code Description
RN067BTEK0000D02 Easydrop Flow Regulator white / single scale RN130BTEK0000D02 Easydrop Flow Regulator white / double scale
Packaging: Dimension Weight Quantity / Box
60 x 40 x 35 cm 15.9 kg 1,500 units