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The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes hospitals, nursing homes, extended care facilities, patient homes, and respiratory device service and repair centers.

The Smart Check O2 is an ultrasonic oxygen analyzer, used to verify the performance of oxygen concentrators. The device is typically used by durable medical equipment technicians while servicing concentrators in their workshops or while visiting patient homes, but it is not left with the patient and is not patient contacting. The device measures the performance of the oxygen concentrator by making ultrasonic time-of-flight measurements, both upstream and downstream. Gas flow rate and oxygen concentration are determined using the resulting data. Temperature and pressure sensors inside the sample cell allow for accurate flow and oxygen readings over the range of specified operating environment conditions. Oxygen and flow readings are shown to the user on the display. The Smart Check O2 can be toggled into a mode for testing pulsing (conserving) oxygen concentrators wherein it displays oxygen concentration and pulse volume instead of flow rate. The user may initiate a pressure check mode by stopping the sample exhaust port with their finger during which the Smart Check O2 measures and displays the maximum pressure generated by the concentrator. The user may also enter a calibration check mode and deliver pure oxygen to the Smart Check O2 to verify its performance. However, it does not require regular calibration after manufacturing. The Smart Check O2 is for prescription use only. Key Components: - Handheld analyzer unit - Removable battery door - Replaceable sample tube - Two Alkaline AA cells

The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor measures the oxygen concentration from a gas source, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also the user to monitor pressure simultaneously and provides user selectable high and low pressure alarms.

Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

The subject device is a family of Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices. The oxygen sensors are all electrochemical galvanic type devices. The difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time. The family of oxygen sensors concept extends to OEM manufacturers of anesthesia and respiratory therapy equipment. Again, the difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time in order for the OEM to exercise a degree of control over the recurring replacement of oxygen sensors.

The OxyMinder is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics.

The OxyMinder is an air / oxygen blender mounted oxygen monitor capable of measuring the oxygen concentration from 18 to 100%. A Bio-Med specified oxygen sensor mounted to the blender outputs a voltage which is used by the OxyMinder to determine the concentration of oxygen. The OxyMinder calibrates at ambient air (21%) and 100% oxygen. The OxyMinder is software controlled. To measure the gas mixture of the blender the OxyMinder takes a sample of the gases to the sensor through a separate port and manifold which is separate from the gas pathway to the patient. This sample is then exhausted to the room. The OxyMinder sampling stream is not part of the gas pathway to the patient. The OxyMinder is used for continuous monitoring of the concentration of oxygen delivered to patients via air oxygen blenders. The monitor provides the following features: - Continuously displays the concentrated Oxygen level delivered to a patient. - Accepts user inputs via touch screen or button (power button). - Provides visual alarm messages, and audible alarms. - Displays the current alarm setting levels (High and Low O2 alarms). - Provides on-screen configuration tools such as O2 sensor calibration, touchscreen calibration, audio test, etc. - Monitors and displays the battery level and power source. - Ensures clean hospital airlines by automatically purging system periodically. The OxyMinder is designed to be mounted to a Bio-Med Devices air / oxygen blender via a manifold that houses the oxygen sensor and a solenoid. In addition to the primary function of monitoring oxygen concentration, the OxyMinder provides an automatic gas supply line purge function.

The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.

The PM5950 Accu O2 Analyzer measures and displays the amount of oxygen present, percent (%), in an air/oxygen breathing circuit. Oxygen measurement is accomplished by placing an oxygen sensor into a breathing circuit. The sensor employs amperometric electrochemical measurement principles (e.g. galvanic fuel cell; lead oxygen battery). The sensor is connected to the analyzer unit via an interface cable. The analyzer unit is battery powered. The analyzer is microprocessor based and interfaces with user push buttons and a LCD display. User push buttons allow the user to turn the unit on/off and to initiate calibration. The LCD provides indication of the per-cent oxygen measured, low battery indication and calibration required. The device consists of four basic elements: Base Device, Extendible Cable, Oxygen Sensor W/ Diverter Fitting, and Tee Adaptor.

The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.

The MaxO-ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E oxygen sensor outputs a voltage which is used by the Max O2ME to determine the concentration of oxygen based on a calibration at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the user to set a maximum or minimum allowable oxygen concentration.

The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.

The CARESCAPE™ Respiratory Modules, E-sCO, E-sCOV, E-sCAiO and E-sCAiOV and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate) and ventilatory parameters (airway pressure, flow and breathing volumes) of hospital patients. Parameters measured by the CARESCAPE™ Respiratory Modules and accessories are CO2, N2O, O2, Anesthetic agents, Agent ID and Spirometry depending on the model used. The CARESCAPE™ Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPETM Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE™ Respiratory Modules acquire the detected signals from the sensors of the modules, calculate the parameter values and communicate them to the host device. The CARESCAPE™ Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system. The CARESCAPE™ Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host monitors based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

The oxygen measuring device MySign® O is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas. MySign® O can be used for monitoring the breathing gases dispensed by the following devices: Anaesthesia breathing systems Respiratory equipment Infant incubators Oxygen therapy systems The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.

The EnviteC MySign® O Oxygen Measuring Device is a hand held oxygen monitor which uses the established technology of the EnviteC electrogalvanic oxygen sensor type OOM111. The EnviteC OOM111 medical oxygen sensor has been previously evaluated and cleared under 510(k) K082655. The MySign® O Oxygen Measuring Device incorporates a medical oxygen sensor placed in the inspired air path or gas supply, a sensor cable, and a monitor to display the measurements. The device is intended for continuous or spot monitoring of inspired oxygen concentrations in breathing gas and provides settable low and high alarm limits. The optional MySign® PC Software can be used to configure MySign® devices and to transmit data from the device to the PC for the readout of measurement data which is stored in the memory of MySign® monitor. The PC software is not intended for diagnostic functions nor will it influence essential performance functions of the monitor - the MySign® O monitor will not perform measurements when PC connected.

The UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.

The UltraMaxO2 device is used for checking oxygen concentrator performance with the measure of oxygen purity, and flow at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer functions by passing an ultrasonic pulse through the gas sample and measuring the amount of time required for the pulse to transit the sample chamber. The transit time is converted into a gas concentration via calibration data stored in the device. This can be done because the transit time varies according to the molecular mass of the gas in the chamber. Flow is determined using the difference between the ultrasonic pulse traveling against the flow and the ultrasonic pulse traveling with the flow. Pressure is measured using a separate pressure sensor that measures the pressure build-up in the device when the output port is blocked. The pressure is displayed in either kPa or PSI determined by a user operable switch in the battery compartment. The materials of the UltraMaxO2 include ABS plastic for the enclosures and the ultrasonic oxygen sensor tube body, adhesive backed Polycarbonate labels, PVC tubing and nickel plated brass fittings for the flow path, electronic circuitry including transducers/receivers, pressure, temperature and humidity sensors and an LCD screen.

The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The subject of this 510(k) is a family of EnviteC Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices. The EnviteC Medical Oxygen Sensors all utilize the commonly accepted electro-galvanic operating principle with defined variations in the mounting configuration and electrical connections to correspond to common industry family replacement types.