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The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip-style connection.

The ReddyPort Elbow is an NIV elbow that replaces the elements AF541 style masks and AF531 masks with a clip-style comection and provides oral access for clinicians to the patient's airway during CPAP and bi-level therapy. The ReddyPort Elbow is compatible with both Over the Nose (OTN) cushion ((S, M, L, XL sizes) and an Under the Nose (UTN) cushion (A, B, C sizes) configurations of the AF541 EE Mask and AF531 mask with clip-style connection. ReddyPort permanently replaces the conventional elbow on the mask and maintains positive pressure. This elbow allows for respiratory care procedures (e.g. oral care, suctioning, bronchoscopy) to be performed on a patient while the patient is receiving non-invasive ventilation. The elbow contains a duckbill valve that allows the patient's airway and that seals with similar leak rates to conventional NIV elbows. In addition, the elbow includes an anti-asphysia valve to ensure safety of the patient.

The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.

The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea or respiratory insufficiency by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse. The proposed device is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O. Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient and multi-patients

The ReddyPort NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed.

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The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The Juno VPAP ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

The subject device Juno VPAP ST-A retains all the same hardware, technologies and manufacturing characteristics as previously cleared in K153061. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver a prescribed positive airway pressure treatment to patients. Some of the kev features of the device include an in-line power supply: fully integrated humidifier: alarms module; heater controller; colour LCD and simple controls for ease of use. The device also allows data transfer/connectivity via an integrated wireless module (When used in a hospital setting, remote changes may not be appropriate for certain patients, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's regular care provider such that the desired therapy outcome is achieved). Juno VPAP ST-A utilizes a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHJO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmH2O for the treatment respiratory insufficiency. The therapy modes available in the Juno VPAP ST-A include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. In this subject device now features an optional "AutoEPAP" function on iVAPS mode. AutoEPAP automatically adjusts EPAP pressure (within set values) in response to flow limitations of the upper airway. Juno VPAP ST-A is intended to be used under the conditions and purposes indicated in the labelling provided with the product. It is a prescription device, supplied non-sterile.

The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP TX is intended to be used in a clinical environment. The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.

The VPAP Adapt SV is identical to the predicate device VPAP Adapt SV (K051364), using a blower based positive pressure system. The device platform is identical to the VPAP Adapt SV (K051364) and contains a blower (motorfan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation. The VPAP Tx is identical to the predicate device VPAP Tx (K092186), using a blower based positive pressure system. The device platform is identical to the VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The VPAP Tx system comprises the flow generator, patient interface) and optional humidifier. The S9 VPAP Tx is identical to the predicate device S9 VPAP Tx (K123511), using a blower based positive pressure system. The device platform is identical to the S9 VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The S9 VPAP Tx comprises the flow generator, patient interface) and optional humidifier.

The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The Juno VPAP ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

The Juno VPAP ST-A System is a positive pressure device which design is based on the previously cleared ResMed S9 WANDA VPAP ST (K140159) platform. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver the prescribed positive pressure treatment to patients. Some of the key features of the platform include: in-line power supply; fully integrated humidifier; heater controller; colour LCD and simple controls for ease of use. An integrated wireless module for data transfer/connectivity is also included (note: Remote changes in a hospital setting may not be appropriate, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's reqular care provider such that the desired therapy outcome is achieved). Juno VPAP ST-A contains a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHyO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmH2O for the treatment respiratory insufficiency. The device also incorporates an Alarm function as a fully integrated module. The therapy modes available in the Juno VPAP ST-A come from the predicate ResMed S9 VPAP ST-A (K113288). These include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. Juno VPAP ST-A is intended to be used under the conditions and purposes indicated in the labelling provided with the product. It is a prescription device, supplied non-sterile.

EasyCare Online is a web based solution for healthcare specialists intended to: • assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an EasyCare Online compatible home sleep test device. • transfer and display, usage and therapeutic information that has been transmitted remotely from the patient's therapy device located in the home. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. EasyCare Online also provides remote settings capabilities

EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from (ResMed compatible flow generators) and diagnostic data from (ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module, or with the aid of an SD card and internet technology, to a central database and then displayed on the clinician's/DME's computer, through a web based application such as internet Explorer. EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device or home sleep test study device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users. Home Medical Equipment (DME) providers and other healthcare specialists can access data with ResMed approved user accounts. Also, clinical users and DMEs are able to address any clinical issues in a timely manner and provide the necessary patient support, including the modification of device settings. EasyCare Online supports physicians in the diagnosis Sleep Disordered Breathing, by reviewing home sleep test results via their web browser or download the clinical data to their PC for further analysis.

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.

The S9 VPAP Tx is similar to the predicate devices VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947). The S9 VPAP Tx provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The S9 VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional H5i humidifier. The performance and functional characteristics of the S9 VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

EasyCare Online transfers and displays to clinicians, usage and therapeutic information that has been transmitted remotely from the patient's flow generator located in the home. EasyCare Online also provides remote settings capabilities. EasyCare Online is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed flow generator for the treatment of obstructive sleep apnea or respiratory insufficiency.

EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from ResMed flow generators. The data is transferred from the flow generators either wirelessly through a communications module or with the aid of an SD card, to a central database and then displayed in a clinician computer, through a web application. EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance. Clinical users, Home Medical Equipment (HME) providers and other healthcare specialists can access data to monitor patient compliance. Also, clinical users and HMEs are able to address any noncompliance issues in a timely manner and provide the necessary patient support, including the modification of device settings.