Description
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DESCRIPTION
The Disinfectant Cap is a single-use accessory Medical Device manufactured by SPM
Medicare Pvt. Ltd. It is intended to disinfect needle-free Luer access connectors prior to line
access. The device consists of a cap body containing a medical-grade polyurethane foam
impregnated with 70% v/v Isopropyl Alcohol (IPA) and sealed with aluminium foil.
The Disinfectant Cap is designed to fit ISO-compliant needle-free Luer access connectors. The
device is available in sterile and non-sterile variants. The sterile variant is sterilized by
gamma irradiation.
INTENDED PURPOSE
The disinfectant cap is a single-use device intended to disinfect needle-free Luer access
connectors prior to line access in operation theaters.
INDICATIONS FOR USE
• Intended for use with needle-free Luer access connectors
• Intended for disinfection prior to line access
INTENDED PATIENT POPULATION
The Disinfectant Cap is intended to be used in patients irrespective of age and gender.
INTENDED USER
The Disinfectant Cap is intended to be used by trained healthcare professionals including
doctors, registered practitioners, paramedics, or nursing staff.
INTENDED USE ENVIRONMENT
The Disinfectant Cap is intended to be used in hospitals and clinics (Operation Theator).
CLINICAL BENEFITS
• Helps in disinfection of needle-free access connectors prior to line access
PRINCIPLE OF OPERATION
The Disinfectant Cap contains a polyurethane foam impregnated with 70% v/v Isopropyl
Alcohol (IPA).
When applied to a needle-free Luer access connector, the alcohol disinfects the external
surface of the connector prior to access.
PERFORMANCE CHARACTERISTICS
• Disinfection of needle-free Luer access connectors
MATERIALS USED
• Cap Body – Polypropylene (PP) / Polyethylene (PE)
• Internal disinfectant reservoir/foam – Polyurethane (PU)
• Disinfectant agent – Isopropyl Alcohol (IPA) 70% v/v
• Seal – Aluminium foil
• Internal sealing interface – Medical-grade Elastomer (TPE)
CONTRAINDICATIONS
• Do not use if the patient has known sensitivity to isopropyl alcohol or device materials
POTENTIAL COMPLICATIONS
• Inadequate disinfection if instructions for use are not followed
HOW SUPPLIED
• Sterile variant: Individually packed in blister with medical paper
• Non-sterile variant: Strip pack of 10
WARNINGS
• Single use only
• Do not reuse
• Do not re-sterilize
INSTRUCTIONS FOR USE
• Do not use if packaging is damaged
• Do not use after expiry date
PRECAUTIONS
• Use only with needle-free Luer access connectors
• Follow institutional procedures for disinfection
CAUTIONS
• Carefully read all instructions prior to use
• Discard after single use
STORAGE
Store at a controlled temperature (10–40°C).
Do not store at freezing temperature.
EXPIRATION PERIOD
Shelf life: 3 years from the date of manufacturing.
Do not use after the indicated expiration date.
RETURN OF DAMAGED PRODUCT
Return the product in its original packaging with batch number, purchase information, and
reason for return.
Contact the manufacturer or local distributor.
DISPOSAL OF THE USED DEVICE
• Dispose of the used product as biomedical waste
• Follow hospital procedures and applicable regulations
REPORTING
In case of any adverse events or product-related incidents, contact the manufacturer or
