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The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to < 30 days. The recommended pediatric weight range is 11 kg to 35 kg. The recommended tidal volume is 75 to 250 ml.

The Inter-Therm Mini Pediatric is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated, humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has a 22F/15M connector at the machine end and a 22M/15F connector at the patient end. The Inter-Therm Mini Pediatric angled HMEF is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has an angled 15M machine connecter end, eliminating the need to use an elbow in the breathing circuit. The patient end is a straight 22M/15F connector.

The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatrics and prescribed by a physician. A pediatric is defined as 10 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.

Double limb breathing systems comprising of an inspiratory and expiratory limb is commonly used for respiratory care. To reduce waste and clutter single limb breathing systems can be used with an exhalation valve to dispel exhaled air from the patient. Some ventilator designs or specifications do not require proximal pressure monitoring; airway pressure is monitored inside the ventilator. There are three variants of the exhalation valve in this submission. Exhalation valve with proximal pressure port (1924501 &1924504): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. A pressure monitor line and exhalation valve control line directly connects the valve to the ventilator. Via exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases yet allowing for a single limb breathing system to be used instead of a double limb system. The pressure line monitors the pressure in the valve body. The patient end of the exhalation valve has a swivel connector end. Exhalation valve without proximal proximal prossure port (1923500): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. An exhalation valve control line directly connects the valve to the ventilator. Via the exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases vet allowing for a single limb breathing system to be used instead of a double limb system. The patient end of the exhalation valve has a swivel connector end. Different ventilators require valves which work with different pressure ratios. The MKIII exhalation valve (1923500 and 1924501) has a 1:1.5 pressure ratio which caters for the majority of ventilators. However, there are markets which have applications for ratio of 1:1, and 1:2. The MK3b exhalation valve (1924504) has a 1:2 pressure ratio. The pressure ratio is the pressure difference between the control line pressure and the pressure that will be generated on the patient side of the valve.

The FaceFit Ported Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.

The Intersurgical FaceFit Ported NIV Mask provides a seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. The Intersurgical Face Fit Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. FaceFit Ported Mask with a CO2 port for use with BIPAP and CPAP machines. The FaceFit Ported Mask features an anti-asphyxiation valve that will allow patients using a CPAP or BIPAP machine to breathe spontaneously through the mask in the event of a machine failure or system disconnection. The FaceFit ported mask is available in small, medium and large sizes.