Search Results

The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. They are intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The Esprit and V200 Ventilators are intended for use in either invasive or non-invasive applications. The Esprit and V200 Ventilators with APRV Mode are intended for use for invasively ventilated adult and pediatric patients as prescribed by a physician The intended use is the same as that of the predicate devices, except that the APRV Mode is for use on a subset of the patient population the original devices are cleared for (e.g. neonatal patients and non-invasive applications are excluded).

The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. This modification to the currently marketed Esprit Ventilator and V200 Ventilators is the addition of the APRV Mode. The APRV Mode is an optional software upgrade. It is both a breath type and ventilation mode intended for invasively ventilated adult and pediatric patient populations. APRV enables the ventilator to deliver gas via an endotracheal tube or tracheostomy tube at two levels of pressure (Press High and Press Low), and allows for spontaneous or supported breathing at both levels. The APRV Mode is activated via a software download through an I-button and is integrated into the Esprit and V200 Ventilators in the same way as other currently released software options. It can either be installed in the factory or in the field as an upgrade to existing Esprit and V200 ventilators. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn APRV on and off.

The V200 Ventilator is a microprocessor-controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The V200 Ventilator is intended for use in either invasive or non-invasive applications. The IntelliTrak option provides new triggering and cycling functionality that is intended for use only with adult and pediatric patients in invasive applications.

The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The IntelliTrak Software Option will add a new triggering and cycling mechanism based on the equation of motion for the purpose of improving patient-ventilator synchrony. The IntelliTrak software option is activated and is integrated into the V200 in the same way as other currently marketed V200 software options. It can either be installed in the factory or in the field as an upgrade to existing V200 ventilators. The IntelliTrak option is added to the currently commercially released software version and instrument. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn IntelliTrak on and off.

The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The ventilator is intended for use in either invasive or non-invasive applications. The intended use is identical to that of the predicate the currently marketed Esprit Ventilator. The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The V200 Ventilator is intended for use in either invasive or noninvasive applications and contains the following modes of ventilation: - . Assist/Control (A/C) - Synchronized Intermittent Mandatory Ventilation (SIMV) . - Continuous Positive Airway Pressure (CPAP) - Spontaneous (Spont) . - . Spontaneous/Timed (Spont/T) - Apnea (Backup Mode) .

The V200 Ventilator is a hardware modification to the currently marketed Esprit that upgrades the look of the Esprit through minor changes to some of the external hardware components, as follows: - The position of the encoder knob changed, as well as the attachment method . - Material changes were made to the top and bottom enclosure . - Dimensional, material, and attachment method changes were made to the bezel . assembly - The resins and color of the Heated Filter Assembly were changed ● - Dimensional changes were made to the Overlay, as well as positioning of the hard . keys, indicator lights, and icons Ventilators with this updated look are sold under the brand name of the V200 Ventilator. All electrical components, internal hardware components, firmware, and software are physically and functionally identical to those on the currently marketed Esprit Ventilator. The V200 Ventilator technological characteristics with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, software, environmental specifications, and performance specifications are identical to that of the currently marketed Esprit Ventilator. The V200 ventilator contains the identical software as the currently marketed Esprit Ventilator. The software options are enabled by downloading the operational software and installing the software option. They are integrated into the V200 Ventilator in the same manner as they are on the currently marketed Esprit Ventilator. The options can be installed either in the factory or in the field as an upgrade to existing V200 Ventilators. All available options on the Esprit cleared subsequent to the original 510(k) (K981072) are also available on the V200 Ventilator.

The V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The Ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.

The V60™ ventilator is a microprocessor controlled positive pressure ventilatory assist system incorporating a user interface with multifunction keys, real-time graphic displays, and integral patient and system alarms. The ventilator provides noninvasive and invasive ventilatory support for spontaneously breathing adult and pediatric patients.

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for useradjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

The ESPRIT ventilatory is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or noninvasive applications. The Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

The intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 – 4.0 mm.

The Neonatal Option is a software modification to the currently marketed Esprit Ventilator. Once the software is enabled and the neonatal patient type is selected on the Esprit, it provides the following types of ventilatory support to neonatal patients in invasive applications only: Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CPAP) modes of ventilation. Pressure-Controlled (PC). Available in A/C and SIMV. Pressure Support (PS). Available in SIMV and SPONT. Apnea Ventilation

The Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

The NICO-Esprit Interface is a software upgrade to the Esprit Ventilator, which allows the bi-directional communication of the devices to facilitate the transfer of NICO parameters to the Esprit Ventilator as well as the transfer of a patient's breath type information and FiO2 from the Esprit to the NICO Monitor.

The intended use of the PLV Continuum II ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum II ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, ventilator that provides ventilatory support by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software. The PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings. The PLV Continuum is capable of providing the following types of ventilatory support: - Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). - Assist Control, Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Pressure (CPAP) modes of ventilation. - Volume-Controlled (VC). Available in A/C and SIMV. - Pressure-Controlled (PC). Available in A/C and SIMV. - Pressure Support (PS). Available in SIMV and SPONT.

The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PLV Continuum is capable of providing the following types of ventilatory support: - Positive Pressure Ventilation, delivered either invasively (via endotracheal or . tracheostomy tube) or non-invasively (via mask or mouthpiece). - Assist/Control. Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation. - Volume-Controlled (VC). Available in A/C and SIMV. . - Pressure-Controlled (PC). Available in A/C and SIMV. . - Pressure Support (PS). Available in SIMV and SPONT. ●