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VentStar Dual Heated / VentStar Heated: Disposable inspiratory heated breathing circuit with humidifier chamber for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and adult patients with a body weight of at least 40 kg (88 lbs). VentStar Heated (N) / VentStar Heated (N) basic: Disposable inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and neonatal patients with a body weight of up to 5 kg (11 lbs). Infinity ID Breathing Circuit Heated (N): Inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for moping moistened breathing gas between the humidifier and neonates with a body weight of up lo 5 kg (11 Ibs) Intended for single-use only. Breathing circuit with integrated transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment. Infinity ID Breathing Circuit Dual Heated / Infinity ID Breathing Circuit Heated: Heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidfier and adults with a body welght of at least 40 kg (88 moration broaining goo Doching circuit with integrated transponder. The transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.

The 510(k) comprises heated breathing gas hose systems including a humidifier chamber for the ventilation of neonatal or adult patients in Intensive Care Units. The hose systems consist of two breathing hoses (inspiratory and expiratory limb) with an additional y- piece. Inside the inspiratory and in case of the dual heated systems also in the expiratory limb of the hose system there is a heating wire which can be connected to a Fisher & Paykel humidifier MR850 to heat up the breathing gas to minimise condensation. An expiratory limb without heating wire includes a water trap. There are additional sensor ports where the temperature sensors of the Fisher & Paykel humidifier MR850 (e.g. Fisher & Paykel 900MR868) can be placed in. In case of the neonatal system, the hose is equipped with an incubator extension for use inside an incubator. The Infinity ID heated breathing circuits are based on the heated breathing circuits additionally equipped with an RFID identification tag. The tag stores characteristics of the breathing hose (e.g. patient type, hose diameter, resistance and compliance values, manufacturing date and shelf life) and is automatically be readout when connected to the outlets of a ventilator device which supports this function.

The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability. The valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient in labor and delivery environments. It is suitable for newborn patients from birth to 1 month of age (maximum body weight of 10 kg (22 lb)). It is intended exclusively for use in combination with the Resuscitaire Radiant Warmer. The VentStar Resuscitaire CEU is a prescription device.

The VentStar Resuscitaire CEU with PEEP valve is indicated as accessory to add positive end expiratory pressure breathing capability. The valve is designed into the T-Piece of the breathing circuit with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The Dräger Dräger Infinty MCable Mainstream CO2 sensor is meant to be used for continuous, real time measurement of CO2 concentrations of ventilated patients from neonates to adults. This sensor is only intended for use with devices made by Dräger Medical, or with devices which are approved for use with Dräger CO2 components (Dräger-compatible devices).

The Infinity MCable - Mainstream CO2 uses infrared absorption technology to accomplish mainstream CO2 measurements. The sensor is able to measure end-tidal CO2 and inspired CO2 and calculates the respiratory rate. This measurement module is integrated inside the sensor and no longer part of the host device (e.g. ventilator). CO2 compensation has been advanced for the foreign gases helium and nitrous oxide.

Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement. Dräger cuffs are compatible with Dräger and Siemens patient monitors. Neonatal cuffs are designed for single-patient use.

The devices comprise tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook-and-loop fastener. The devices tubing is connected to a non-invasive blood pressure measurement system with an extension hose. The portfolio includes different standard sizes reusable and single-patient-use non-invasive blood pressure cuffs for adults, paediatrics, infants and single-patient-use NiBP-cuffs for neonates. Longer cuffs are marked with an additional range to which they can be safely used.

Long-term ventilator for intensive care. For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option.

Evita XL is a time-cycled microprocessor-controlled intensive care ventilator intended to provide continuous ventilation for adults, children, neonates and infants with Neoflow option. The device can be also operated in the mask ventilation mode if the according option is installed. Software modification implements these new software options: - . Option Mask Ventilation Plus (NIV Plus) - Option Inspiratory Termination Criteria (Insp. Term. PIF) . - . Option Proportional Pressure Support (PPS) NIV Plus is a supplement to the existing Mask ventilation option (NIV), which improves ventilation performance (triggering and patient comfort) through higher leakage compensation and smooth ending of Assistant Spontaneous Breathing (ASB) strokes. NIV Plus implements Standby Plus an alternative for starting the active ventilation mode in mask ventilation when the patient takes the first spontaneous breath. Anti Air Shower detects disconnection during mask ventilation if the mask is deliberately removed from the face and reduces the flow supplied for the time of the disconnection. Insp. Term. PIF is an adjustable stop criterion for pressure support strokes. At the end of the inspiratory phase the delivered inspiratory flow falls under a certain level of the maximum inspiratory flow. The ventilator cycles from inspiration phase to expiration phase when a fixed level was reached. The software modification allows it to adjust this inspiration termination criterion. The device can be configured by the user (adjustable inspiration termination criterion or fixed value is active). The ventilation mode Proportional Pressure Support (PPS) is a software option for the ventilator Evita XL designed to assist the spontaneous breathing patient. In PPS, the device supports the patient's spontaneous breathing in proportion to the breathing effort. The degree of support in PPS mode can be set separately according to resistive and elastic components directly proportional to the patient effort.

The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo". The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components. The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.

The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment. The mask ClassicStar NV, with standard elbow is disposable and for single patient use. The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times. The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation. The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure. A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow. The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory. All noninvasive ventilation masks are available in three different sizes (S, M, L),

The Fabius MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume. The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less.

The Fabius MRI is a continuous flow anesthesia system usable in an MRI environment. Fabius MRI is equipped with a compact breathing system, providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: - Volume Controlled Ventilation - Pressure Controlled Ventilation - Pressure Support (Optional) - SIMV/PS (Optional) - Manual Ventilation - Spontaneous Breathing Fabius MRI is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2),

The Carina is a long-term ventilator-dependent patients or ventilator-assisted patients. The device is intended for treatment of sub-acute care patients in hospital or medical rooms. The device is intended for invasive ventilation or non-invasive ventilation. The device is intended for patients with a tidal volume of at least 100 mL. The device is intended for use by qualified medical personnel.

The Carina. is a mechanical ventilator for use inside a hospital (sub-acute care). It offers the following ventilation modes: - · VC-SIMV (Volume controlled synchronized intermittent mandatory ventilation) - · PC-AC (Pressure controlled assisted control) - · PC-SIMV (Pressure controlled synchronized intermittent mandatory ventilation) - · SPN-PS (VG) (Pressure Support + (volume guarantee)) - · SPN-CPAP (Continuous Positive Airway Pressure) - · Apnoea ventilation in SPN group mode (for spontaneously breathing patients) The device can be used for invasive and non invasive ventilation (e.g. trachea tube and mask ventilation). The device offers both high pressure oxygen inlet and oxygen via a low pressure oxygen inlet (max. 500 hPa/10L/min). The device monitors the following ventilation parameters: - · Airway pressure (PIP, Pmean, PEEP) - · Inspiratory Tidal volume (VTi) - · Breath rate (f) - · Minutes volume (MV , MV leak) - The device has the following user-settable alarms: - · Airway pressure high - · Minute volume high / low - · Rapid shallow breathing (high frequency alarm) - · Apnea alarm - · Disconnection alarm Flow and pressure curves are displayed on the display. Spontaneous breathing (Triggered breath) of a patient is indicated on the screen by an asterisk (*). Airway pressure high as a dotted line is displayed on the screen.

CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas conveying parts of the ventilator. TwinStar 55 is a Breathing System Filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchanger are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The products are the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since Heated Humidifiers are almost impossible to use. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

The filters CareStar 30 and SafeStar 55 are designed to reduce possible air or liquid borne cross contamination with microorganisms via anesthetic or ventilator breathing systems. The strategic use of an effective breathing filter protects, bi-directionally, both the patient and equipment. The filter CareStar 30 contains an electrostatic filter pad while the filter SafeStar 55 incorporates a mechanical pleated filter pad. Both filters consist of a plastic body which incorporates 22 female / 15 male connectors in accordance with EN ISO 5326 and a luer lock connector which may only be used for gas monitoring. The Filter/HME TwinStar 55 is designed to combine the feature of reducing possible cross contamination with micro-organisms and an ideal heat and moisture return. The Filter/HME TwinStar 55 consist of a plastic body which incorporates an electrostatic filter pad, 22 female / 15 male connectors in accordance with EN ISO 5326 and a gas luer lock connector which may only be used for gas monitoring.