Tracheostomy HME (Heat Moisture Exchange) Hepa Filter

Product Specs

HOUSING: PP

HME PART: paper HME

DEAD SPACE: 11ml

WEIGHT: 5.4g

CONNECTOR: 15F

OXYGEN PORT: None

SUCTION PORT: None

STERILE: E.O

Product Specification: Tracheostomy HME Filter

 

1. Product Overview:

The Tracheostomy HME (Heat and Moisture Exchange) Filter is a medical device designed to optimize respiratory therapy for patients with tracheostomies. This filter serves as an effective solution for maintaining heat and moisture levels in inhaled air while also acting as a barrier against airborne contaminants.

 

2. Purpose:

The primary purpose of the Tracheostomy HME Filter is to enhance respiratory comfort and safety for tracheostomy patients by preserving the heat and moisture of exhaled air during the breathing process and filtering out potentially harmful particles.

 

3. Key Features:

 

Heat and Moisture Exchange: The HME filter should efficiently capture and transfer heat and moisture from the patient's exhaled air to the inhaled air, reducing airway irritation and promoting optimal breathing conditions.

Filtration Efficiency: The filter material should effectively filter out bacteria, viruses, and particulate matter to prevent respiratory infections and other complications.

Low Resistance: The filter should offer minimal resistance to airflow, allowing for comfortable and efficient breathing.

Hydrophobic Properties: The filter material should be hydrophobic to prevent moisture buildup and maintain effective filtration and heat exchange.

Low Dead Space: The filter design should have minimal dead space to minimize rebreathing of exhaled air.

Compatibility: The filter should be compatible with a wide range of tracheostomy tubes and respiratory devices available in the market.

4. Technical Specifications:

 

Filter Material: Medical-grade hydrophobic material with high bacterial and viral filtration efficiency.

Filtration Efficiency: Minimum 99.9% for particles ≥0.3 microns.

Airflow Resistance: Maximum allowable pressure drop of 2 cm H2O at a flow rate suitable for tracheostomy patients.

Connector: Standard 15mm diameter connector compatible with common tracheostomy tubes and adaptors.

Dimensions: Compact and lightweight design to ensure patient comfort.

Dead Space: Maximum allowable dead space of 50 mL for effective ventilation.

Usage Duration: Recommended usage duration of up to 24 hours, adhering to medical guidelines.

Sterilization: Filters should be ethylene oxide (EtO) sterilized to ensure microbiological safety.

5. Packaging:

 

Individually sealed in sterile packaging.

Clear labeling indicating filter specifications, compatibility, and usage guidelines.

Batch/lot number and expiration date for quality control.

6. Regulatory Compliance:

The Tracheostomy HME Filter must adhere to applicable medical device regulations, standards, and guidelines, such as ISO 13485, ISO 18562, and FDA regulations.

 

7. Instructions for Use:

 

Ensure hands are clean before handling the filter.

Attach the filter to the tracheostomy tube connector.

Ensure a secure fit and proper alignment.

Replace the filter after the recommended usage duration or if it becomes visibly soiled or damaged.

8. Maintenance:

The filter is disposable and should be replaced as per medical guidelines or manufacturer recommendations.