Search Results

The BC1® Model WW1030 pulse oximeter is intended to be used for continuous monitoring of a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home use. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW 1030 may be used in the hospital or clinical environment, during emergency land transport, and the home.

The BCI model WW1030 is a handheld pulse oximeter intended for continuous monitoring. The WW1030 monitors and displays patient functional oxygen saturation %SpO2, pulse rate, perfusion index, and pulse signal strength information. It is equipped with audible and visual patient alarms. The user interface includes a blue LED display, speaker, a 5-button keypad control, and an ON/OFF button. The WW1030 comes with disposable batteries, a reusable pulse oximetry sensor with extension cable and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, nurse call cables, universal mounting bracket and protective glove. The WW1030 is compatible with BCI oximetry sensors, Nellcor DS100A oximetry sensor and extension cables.

WW1021 is intended for use with any oximeter/device which supports the BCI® Communication Protocol 1030 (BCICP 1030), if the device is connected to the PC through the USB port. It can be used to view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, sleep technicians and other qualified health care providers. The WW1021 may be used in the hospital or clinical environment.

The BCI® WW1021 is intended for use with any device which supports the BCI® Communication Protocol (BCICP), if the device is connected to the PC through the USB port. It can be used to configure the device; view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data; view event logs and self diagnostic information from the device and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It cannot be used to configure or download data to the PC from devices that are wirelessly connected. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians and other qualified health care providers. BCI® WW1021 may be used in the hospital or clinical environment. Communication between the device and BCI® WW1021 is possible using any standard USB cable.

The BCI® model WW1000 handheld pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians, and home users. The intended patient population ranges from infant to adult. It can be used on patients with low perfusion. The WW1000 may be used in the hospital or clinical environment, during emergency land transport, and in the home.

The BCI® model WW1000 handheld pulse oximeter is intended for spot-check applications. The WW1000 monitors and displays patient functional oxygen saturation (%SpO2), pulse rate, pulse amplitude index, and pulse signal strength information. It does not have audible or visual patient alarms. The user interface includes a red LED display and an ON/OFF button. The WW1000 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, universal mounting bracket and protective

The BCI® model WW1020 pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home users. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW1020 may be used in the hospital or clinical environment, during emergency land transport, and in the home.

The BC10 model WW1020 pulse oximeter is intended for spot-check applications. The WW1020 monitors and displays patient functional oxygen saturation (%SpO2), pulse rate, pulse amplitude index, and pulse signal strength information. It does not have audible or visual patient alarms. The user interface includes a blue LED display and an ON/OFF button. The WW1020 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, universal mounting bracket and protective glove. The WW1020 is compatible with BCT® oximetry sensors, Nellcor DS100A oximetry sensor, and extension cables.

The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits patient monitoring with adjustable alarms limits as well as visible and audible alarm signals.

The subject device is the same as the legally marketed predicate device BCl 3304 Autocorr M Digital Pulse Oximeter (K962156) with one minor change to the labeling that does not raise new questions of safety and efficacy. This pulse oximeter was originally cleared with the current algorithms. However, it was not clinically validated under motion conditions and no motion claims were made. The aim of this premarket submission is to obtain clearance for an additional motion claim. The 3304 Autocorrille pulse oximeter is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifiact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence. Alarm Volume, Pulse Volume). The oximeter has a printer/pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location. This Special 510(k) covers the labeling modification of BCI® Autocorr™ 3304 Digital Pulse Oximeter that was cleared under 510(k) K962156. The modification involves revising the 3304 labeling to add pulse oximetry performance specifications with motion. Results from clinical evaluation are provided to support the labeling change. No significant device modifications have been made to the 3304. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.