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The CuffTrek is intended to measure and regulate the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supractottic airways). The device is intended for single patient use from pediatric to adult, under medical supervision in hospitals, prehospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated. It is for disposable single patient use.

The device is a battery-operated cuff pressure-controlling device intended to be used with ventilation tubes (ETT, Tracheostomy, LMA). It is a single patient-use, non-sterile device designed to be used continuously for up to 7 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the device is 0-99 cmH2O. The device body houses the active pressure monitoring mechanism, which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure or if the pressure is out of the set range of 20-30 cmH2O (red).

The TrachCuff Cuff Controller is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. The TrachCuff Cuff Controller can be used with any mechanical ventilator. The TrachCuff Cuff Controller is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas: - In the intensive care ward by Respiratory Therapist Prescription use only.

The TrachCuff Cuff Controller is an automatic cuff pressure controller specified for use in professional healthcare environments. The device provides the operator with the means to set and control the pressure for cuffed endotracheal tubes and cuffed tracheostomy tubes during mechanical ventilation, and continuous monitoring of the set cuff pressure with alarms. The TrachCuff Cuff Controller is mains powered via a Mains to DC power adapter, and the enclosure may be mounted on a bed rail by means of an optional mounting bracket. The TrachCuff Cuff Controller is provided in an enclosure with touch screen operator panel. It is designed for immediate use; no calibration or maintenance is required. A largescale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data. The associated accessories include: - Disposable Tubing Set with Filter . - Device Mount Solution Bedside Mounting Bracket. .

The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation. 1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user. 2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff. 3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.

The AG100s system is comprised of the following main components: - The AG100s control unit - The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit. Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter. When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the AG ETT). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube. The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.

The CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with adult and pediatric patients during mechanical ventilation in the listed areas: Intensive care unit (ICU) Recovery room Emergency medical care Medical emergency vehicles when the patient is being transported During transport within and outside of the hospital

The Puritan Bennett™ Cuff Pressure Manager (CPM) continuously measures and automatically maintains cuff pressure during ventilation of patients using a cuffed endotracheal tube or tracheostomy tube. It is an integrated and continuous cuff pressure control solution that secures airway management in intensive care units, recovery room and during interhospital and intrahospital transport. It operates in range of 5-50 cm H2O of user-set cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical patient situations. The Puritan Bennett™ Cuff Pressure Manager introduces some new small features and convenient user interface to maximize safe use and usability. Both manual adjusting and one-click inflation function are provided alternatively for user's preference to start inflation. Measure mode allows user to observe the cuff pressure without device intervening before taking actions. Auto Key-lock feature help to avoid mis-operation when there's no user intervene for a long time. For inflation, room air is used and no contact to the respiratory gas system of a patient occurs. It is not intended to connect with ventilator. The cuff pressure manager is designed with closed loop mechanism which is Pl controlled, and the software level of concern is Class C/Major concern. The Puritan Bennett™ Cuff Pressure Manager is provided non-sterile and no re-processing is required. A sterile extension tube is equipped with the Puritan Bennett™ Cuff Pressure Manager for inflating/deflating or measuring cuff pressure. The associated accessories include: - Extension Tube with filter Rechargeable Li-ion Battery Mounting Rack AC/DC Adaptor

The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

The Cuffix is a battery-operated cuff pressure controlling device which is intended to be used with ventilation tubes (ETT, Tracheostomy, LMA) It is a single patient-use, non-sterile device designed to be used continuously for up to 14 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the Cuffix is 0-99 cmH2O. The device body houses the passive pressure mechanism component as well as the active pressure monitoring mechanism which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure (green) or is the pressure is out of the set range (red). The elastic band hanger allows to attach the Cuffix as needed (e.g., to the ventilation circuit, the patient bed rail, etc.).

To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.

The PYLANT MONITOR is used by personnel trained in pulmonary resuscitation and airway management (ex. anesthesiologists, RN, respiratory therapists, EMT, paramedics) used to measure the trachael cuff pressure of an endotrachael tube or tracheotomy tube by measuring the external pilot line port of the tube. The Pylant Monitor (PM) is a medical device intended to indicate changes inside an endotracheal tube (ETT) cuff. One end of the PM is fabricated to fit into the "pilot balloon" (international standard for all types of intra-tracheal tubes with a cuff) of the ETT cuff. The other end is fabricated to accept a medical syringe (international standard for all intravenous syringes) for adding or removing air from inside the ETT cuff and altering the volume of air and therefore the pressure inside the ETT cuff. The syringe end of the PM has a one way air tight valve that is open when the syringe is connected. When the syringe is not connected the valve is closed and air is trapped within the ETT cuff and the PM creating the seal between the trachea and cuff. In between the two ends of the PM is a silicone diaphragm that expands and contacts with pressure. As pressure rises the more the diaphragm expands and as pressure falls the diaphragm contracts. Attached to the center of the diaphragm is and indicator arrow/needle. The diaphragm and arrow/needle is housed inside a designed case. The case acts as a protector of the silicone diaphragm arrow needle assembly and is labeled, color coded and calibrated to indicate pressure ranges from 20 cm H2O to 30 cm H2O. The PM is designed to remain connected to the ETT pilot balloon and continuously monitor the pressure or monitor pressure intermittently. Pressure changes within the ETT when connected to the PM are indicated by expansion or contraction of the silicone diaphragm causing calibrated movement of the arrow/needle and indicated on the color coded label.

The Accucuff Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatric to adult who have an artificial airway and for which the user would like to monitor cuff pressure.

The Accucuff™ Cuff Pressure Indicator is intended to monitor the cuff pressure of endotracheal, supraglottic airways or tracheostomy tubes. It is designed with different color coded zones to indicate the normal, negative and positive pressure. The black marker on the device will be moved when the cuff pressure is changed. The device is available in 10-20 cmH2O, 20-29 cmH2O and 40-60 cmH2O three different models to accommodate the intended populations from pediatric to adult.

AG 100s is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

The AG100s system is comprised of the following main components: - The AG100s control unit - The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit. - The AnapnoGuard endotracheal tube (ETT) or another FDA cleared cuffed Airway. - Accessories: including cart, secretions canister (Trap Bottle), ● rinsing fluid (saline) bag and antibacterial air filter. AG100s, including its three components, monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.

The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

The TRACOE® cuff pressure monitor (cpm) is a hand-held manometer intended for checking cuff pressure and inflating the cuff of high-volume-low-pressure cuffed endotracheal tubes or tracheostomy tubes. Patient Population: Adult, pediatic, neonatal patients who have high-volume-low-pressure cuffed endotracheal/ tracheostomy tubes.

The TRACOE® cuff pressure monitor (cpm) inflates or measures the intra-cuff pressure in the range of 20 – 100 cmH2O. It is intended for endotracheal or tracheostomy tubes with high-volume low-pressure (HVLP) cuffs. The cpm consists of a pressure gauge/manometer and a bulb. Between the manometer and the bulb is a male Luer connector air outlet which is connected to the (pilot balloon valve) of the endotracheal/tracheostomy tube HVLP cuff. Opposite the Luer connector is an integrated air release valve that can be opened and closed with a knurled screw. To inflate the HVLP cuff, the male Luer connector of the cpm is inserted into the inflation line (pilot balloon valve) of the endotracheal/tracheostomy tube, HVLP cuff and the knurled screw is closed, the bulb is then squeezed to inflate the HVLP cuff. As the pressure increases in the HVLP cuff the pressure value is displayed on the manometer. Once the cuff is inflated to the required cuff pressure the cpm is disconnected from the inflation line (pilot balloon valve). To measure the HVLP cuff pressure, the knurled screw is closed and the male Luer connector is inserted into the open end of the cuff inflation line. The manometer will display the current HVLP cuff pressure. If the pressure is too low the bulb can be squeezed to inflate the cuff, or if the pressure is too high the knurled screw can be opened to release the cuff pressure. Once the required cuff pressure is achieved the cpm is disconnected from the inflation line (pilot balloon valve). The TRACOE® cuff pressure monitor can be used for adult, pediatric, and neonatal patients. It is reusable and provided non-sterile. A sterile connection tube (REF 702, 1.0 m) is supplied with the TRACOE® cpm which provides an extension tube for inflating or measuring cuff pressure. The TRACOE® cuff pressure monitor is not suitable for continuous monitoring of HVLP cuff pressure.