Description
-
- With Safety Needle, With Hypodermic Needle, Without Needle
- Packaging: Blister Pack
Size Product code Packaging Qty. Inner/Outer 1ml 1BQ9B1WL Blister Pack 100/1000 100/1000 3ml 1BQ9B3WL Blister Pack 100/1000 100/1000 1ml 1BQ9B1JL Blister Pack 100/1000 100/1000 3ml 1BQ9B3JL Blister Pack 100/1000 100/1000
Please Download eIFU
DESCRIPTION:
The SPM’s In-line arterial Blood sampling Kit range is an In-line Arterial Blood Sampling Kit syringes
are used for blood collection by manual aspiration and are supplied without needles. They are
designed to be used for arterial blood collection from an arterial line.
Once the sample is obtained, care is taken to eliminate visible gas bubbles, as these bubbles can
dissolve into the sample and cause inaccurate results. The sealed syringe is taken to a blood gas
analyser. If a plastic blood gas syringe is used, the sample should be transported and kept at room
temperature and analysed within 30 min. The SPM’s “In-line arterial Blood sampling Kit is Gamma
Irradiation sterilized. Sterilized using Gamma Irradiation in accordance with ISO 11137, SAL 10⁻⁶.
INTENDED PURPOSE:
In-line Arterial Blood Sampling Kit designed to obtain an in-line arterial blood
specimen while maintaining a closed system.
INDICATIONS FOR USE
The In-line Arterial Blood Sampling Kit is designed for arterial blood specimen collection for further
blood gas analysis.
INTENDED PATIENT POPULATION:
In-line Arterial Blood Sampling Kit is intended to be used in patients irrespective of age and gender.
INTENDED USER:
In-line Arterial Blood Sampling Kit is intended to be used by the trained healthcare professionals like
Doctors, paramedics, or nursing staff experienced in blood sampling.
INTENDED USE ENVIRONMENT:
In-line Arterial Blood Sampling Kit is intended to be used in hospital, or a clinical Kitting.
CLINICAL BENEFITS:
• The Sampling Kit contains Heparin lithium which prevents the blood coagulation.
• The Air bubble filter in the In-line arterial Blood sampling Kit variant, facilitate the removal of
arterial gas bubble.
• Minimize the chances of error in Blood gas analyser.
• Strong sealing capacity which minimizes the possibility of contamination.
PRINCIPLE OF OPERATION:
The SPM’s In-line arterial Blood sampling Kit is a sterile, single-use luer lock syringe without needle is
intended to use for arterial blood sampling. The air is removed from the syringe and put the luer cap
on. The collected blood sample is further stored and tested using Blood gas analyser. The AirPro
variants also contains hydrophobic filter which help to completely remove air bubble filter.
PERFORMANCE CHARACTERISTICS:
• The SPM’s In-line Arterial Blood Sampling Kit offers Safe arterial blood sample collection.
• The In-line Arterial Blood Sampling Kit contains fixed units of Heparin Lithium which prevents
blood coagulation.
• Comes with luer cap which prevents the blood sample spillage and reduce contamination
chances.
MATERIAL USED:
Barrel – Polypropylene
Plunger – Polypropylene
Gasket – TPE
Luer cap – Polypropylene
Lubricant – Silicone oil
Anticoagulant coating – Lithium heparin (dry coating)
POTENTIAL COMPLICATIONS:
Possible complications with Syringe may encounter some challenges like:
• The improper sampling may result in sample contamination.
• Do not inject the aspirated blood back into patient circulation, may leads to blood thinning,
internal bleeding, and other complications.
• Inaccurate Blood Gas Measurements.
INSTRUCTIONS FOR USE:
• Step 1. Take pre heparinized Arterial Blood Collection Kit 1ml or 3ml as required for blood
sample.
• Step 2. Collect 1ml or 3ml arterial blood in this heparinized syringe (filling the syringe
completely is very important).
• Step 3. Remove air bubbles quickly (if any), and place the luer cap. Mix the blood in the syringe
gently by rotating the syringe between the palms of the hands to ensure mixing of blood with
heparin.
• Step 4. Send the sample to the laboratory immediately. If it is not possible to send immediately
then keep the syringe in a container having ice-water slurry (not with ice alone) but not for too
long because the plastic syringes are partially gas permeable and this permeability increases at
a lower temperature.
HOW SUPPLIED:
The SPM’s In-line arterial Blood sampling Kit is supplied in sterile, single-use, Blister packaging,
complete with instructions for use and accessories (if any).
WARNINGS:
• For Professional Use Only: This device must be used by trained healthcare professionals
only
• Sterile Packaging: Do not use if the packaging is damaged or opened prior to use.
• Single Use Only: The Syringe is designed for single use. Do not reuse or re-sterilize.
• Proper Handling: Handle with care to avoid damage to the device, which could
compromise its sterility and functionality.
• Allergic Reactions: Check patient history for allergies to materials in the syringe.
• Inspect Before Use: Ensure all components are present and undamaged before use.
• Follow Instructions: Carefully follow the included instructions for use to avoid
complications
• Dispose Properly: Dispose of the device in accordance with local regulations for medical
waste.
PRECAUTIONS:
• Check the integrity and functionality of the sampling Kit before use. Do not use if the
package is open or damaged.
• Determine patient’s condition and vitals status during device application / Operation.
• When handling the product care should be taken to avoid damage from handling. Avoid
crushing and crimping damage to the product due to application of surgical instruments
such as forceps, etc.
• Conduct procedure under strict surgical protocol and ensure complete asepsis.
• Do not Re-sterilize. Do not Re-use.
• Single use only.
• Do not use after the Expiry Date
CAUTIONS:
• Store in a cool and dry place
• Discard after single uses
• Do not use if the package is open or damage
• Do not store at extreme temperature and humidity
• Dispose the blood/medicine contaminated product as per local applicable laws.
STORAGE:
Store at controlled temperature (10 to 40°C) and humidity (55RH to 75RH).
EXPIRATION PERIOD:
In-line arterial Blood sampling Kit has a shelf life of 2.5 years from the date of manufacturing. The
product should not be used after the indicated sterility expiration date.
RETURN OF DAMAGED PRODUCT:
Return the product in its original packing identified by the batch number, purchase information,
your reference and reason for return. Please contact your local distributor office regarding product
return/exchange.
DISPOSAL OF THE USED DEVICE:
• Disposal of the used product should be done according to hospital procedures, State
Regulations, National legislation or regional legislation.
• Device should be disposed after use on individual patient during a single procedure.
• Disposal of the packaging material should be done as biomedical waste.
• Any open packaging should be done as biomedical waste.
• Leftover products should be disposed as biomedical waste.
REPORTING:
In case of any adverse events and/or potential threat/ complications that may reasonably by
regarded as product related and that were not previously expected in nature, severity or occurrence,
contact the manufacturer or authorized representative and competent authority of the member
state where the user and/or patient is established.
