TrueCare Biomedix TCBINF033G - 92" GVS EASYDROP GRAVITY FLOW REGULATOR SET, 1 Y-SITE, UNIV SPIKE, 20-DROP FILTERED (15 MICRON) DRIP, ROLL CLAMP, MALE L/L GRAVITY ADMIN SET, 40/CS

TrueCare Biomedix TCBINF033G - 92" GVS EASYDROP GRAVITY FLOW REGULATOR SET, 1 Y-SITE, UNIV SPIKE, 20-DROP FILTERED (15 MICRON) DRIP, ROLL CLAMP, MALE L/L GRAVITY ADMIN SET, 40/CS

IV Administration Set With GVS EasyDrop Flow Regulator

Our IV Administration Set with Flow Regulator consists of a universal spike, male swivel luer lock, roller clamp, flow regulator, and drip chamber. Each set is individually blister-packaged in quantities of 40 per box and features patient information directly on the exterior of the package.

Features

• 20 drops/ml
• One (1) Y-injection site 6" from distal end
• Male swivel luer lock connector
• Universal vented/non-vented spike
• Roller clamp
• GVS EasyDrop Flow Regulator
• 15 micron flter located in drop chamber
• 92" length
• DEHP-free
• Latex-free

Device Characteristics

• What MRI safety information does the labeling contain? Labeling does not contain MRI Safety Information
• Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No
• Device labeled as "Not made with natural rubber latex": No
• For Single-Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): No

Sterilization

• Device Packaged as Sterile: Yes.
• Requires Sterilization Prior to Use: No.

Why Universal Spike?

A vented/non-vented or "universal" spike allows an administration set to be used with all types of solution containers. The vent should be open when infusing from non-collapsible containers (glass and semi-rigid plastic) and closed when infusing from collapsible plastic containers (bags).

EasyDrop Flow Regulator

Easydrop is a single-use disposable flow regulator which allows highly accurate control of flow rate in gravity administered 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 gravity I.V. line or can be provided into an extension set to be connected to an existing standard gravity I.V. line.

IV Flow Regulator Characteristics

Safe
GVS IV Flow Regulators provide constant flow rate during the entire infusion procedure. There is no need for continuous adjustment of flow rate and there is no risk of over-infusion. Because it takes two hands to set and adjust our products, this prevents accidental changes in flow.

Easy
It is very easy to accomplish the required flow rate, and prime the IV line. Just set the requested flow rate and count the drops and the GVS IV Flow Regulator is ready to use.

Inexpensive
The GVS IV Flow Regulator is the best solution for guarding against the high investment required to purchase infusion pumps which are also involving costly IV set. GVS IV Flow Regulators can be used to upgrade any gravity IV set. No expensive maintenance is required; GVS IV Flow Regulators are disposable single use products.

Accurate
Accuracy is always important and The GVS IV Flow Regulator is the solution for the well known problem of inconsistency provided by the roller clamps.

Stable
Stability is a key characteristic of GVS IV Flow Regulators. Stability of flow rate over the 24 hours of infusion allows use of an IV set equipped with the GVS IV Flow Regulators in critical applications. This is due to the large size of the channels in its triple labyrinth path which avoids the risk of clogging due to micro-crystals (the use of our Speedflow IV filter downstream of the GVS IV Flow Regulator eliminates crystalline components, dirt, air, and bacteria. See section IV Solution Filter).

Wide use
GVS IV Flow Regulators are compatible with any existing gravity IV set or they can be provided in an Extension Set. The product can be used in a variety of applications, including drug delivery and parenteral nutrition can be made through them. GVS IV Flow Regulators are Latex, PVC and free of animal origin substances.

Specifications of Flow Regulator

Biosafety
Materials comply with USP class VI-121C 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
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.

Sterilization
Suitable for EtO (44C/111F max) and gamma (50kGy) sterilization. Higher temperature can cause a reduction in performance.

Maximum operating pressure
0.5 bar (7 psi) in static condition, Gravity set.

Maximum storage and operating temperature
40C (104F) 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).

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 suggested 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.

DEHP Free

Our IV sets are DEHP free. Infusion Therapy Standards of Practice advise to usee administration sets free of di-ethylhexyl-phthalate (DEHP) to administer lipid-based infusates, such as IVFE or TNA. DEHP is lipophilic and is extracted into the lipid solution with commonly used polyvinyl chloride administration sets and containers. DEHP is considered a toxin, and studies have demonstrated increased DEHP levels in lipid solutions, which is especially a risk with neonatal, pediatric, and long-term home care patients (42).