BENICCI – VOLUMETRIC SPIROMETER (Incentive spirometer)

Instructions for Use (IFU)

Volumetric Incentive Spirometer

 Device Identification

Device Name: Volumetric Incentive Spirometer

Intended Purpose: A non-invasive device designed to encourage voluntary deep breathing to improve lung function, promote lung expansion, and prevent postoperative pulmonary complications (e.g., atelectasis).

Indications for Use

• To promote sustained maximal inspiration.
• To aid in lung expansion following thoracic or abdominal surgery.
• To prevent or treat pulmonary complications such as atelectasis.
• For patients in hospitals or home care who require respiratory rehabilitation.

Contraindications

• Patients unable to follow instructions or cooperate with the therapy.
• Patients with unstable cardiovascular status (e.g., recent myocardial infarction, severe arrhythmia).
• Patients with untreated pneumothorax.
• Use with caution in patients with severe respiratory distress unless under medical supervision.

Warnings

• Device should be used only under the direction of a healthcare professional.
• Not for continuous inhalation therapy—intended for intermittent deep breathing exercises.
• Ensure the device is clean and dry before each use.
• Do not share between patients unless reprocessed according to hospital infection-control protocols.
• Replace immediately if damaged or if any parts are missing.

Precautions

• Monitor patients at risk of dizziness, light-headedness, or hyperventilation.
• Use in a seated or semi-upright position to avoid aspiration risk.
• Children should use the device only under adult supervision.
• Clean device regularly as per instructions to prevent infection.

Instructions for Use

• Sit upright or in a comfortable semi-upright position.
• Hold the spirometer in an upright position.
• Place the mouthpiece in your mouth and seal your lips tightly around it.
• Exhale normally.
• Inhale slowly and deeply through the mouthpiece, raising the piston/ball(s) inside the chamber to the prescribed target volume.
• Hold your breath for at least 3–5 seconds at maximum inspiration, then exhale slowly.
• Remove the mouthpiece and relax before repeating.
• Repeat the exercise 10–15 times per session, or as instructed by your healthcare provider.
• Perform exercises every 1–2 hours while awake, unless otherwise directed.

Cleaning and Maintenance

• After each session, remove the mouthpiece and wash with warm water and mild detergent.
• Rinse thoroughly and allow to air dry completely before reassembly.
• Do not expose to excessive heat or direct sunlight.
• Replace device if cracks, discoloration, or damage appear.

Storage Conditions

• Store in a clean, dry place at room temperature.
• Keep away from dust, moisture, and direct sunlight.

Disposal

• Dispose of the device according to hospital waste protocols or local regulations for plastic medical devices