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The Press-Mate BX-10 and BX-10An are indicated for use on adult, pediatric, and neonatal patients by a trained and qualified healthcare professional in the hospital, outpatient surgery practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The Press-Mate BX-10 patient monitor is intended to monitor a single patient's noninvasive blood pressure and pulse rate. The Press-Mate BX-10An patient monitor is intended to monitor a single patient's noninvasive blood pressure as well as blood oxygen saturation and pulse rate via Nellcor's oximetry technology.

The Press-Mate BX-10 Series Monitor is a fully portable multiparameter monitoring device which provides the capability for nonitoring of adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings. It is a prescription device intended for use only by health care professionals. The oscillometric method, upper arm measurement is employed. The Press-Mate BX-10 is configurable with Nellcor® oxygen saturation (Pulse Oximetry) utilizing the finger for the placement of the sensor. The monitor uses a single tube reusable cuff or may be optionally used with a disposable single tube cuff. The Press-Mate BX-10 has an optional replaceable and rechargeable battery as well as an optional thermal printer to print displayed data, waveforms and trend information. A liquid crystal display (LCD) and (LED) provides high visibility and clarity in most light conditions. The available parameters displayed will depend on the mode selected by the user. Visual and audible alarms are provided to alert the user to monitor operational conditions or should patient values exceed default or operator-set high/low limits. Model BX-10: Non-Invasive Blood Pressure and Pulse Rate Model BX-10-An: Non-Invasive Blood Pressure and Pulse Rate; and Nellcor® Pulse Oximetry. This portable device includes an optional integrated printer and is capable of operation from an external AC power source or an internal rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press -- Mate 8800 (K890876 cleared 6/22/89),Press -Mate Advantage (K 973637 cleared 9/25/98) and the Press-Mate Prodigy (K022537 cleared 9/13/02) The following accessories are available for use with the device: - 1. Power cord - 2. Printer Paper - 3. Operations Manual - 4. Disposable cuffs - 5. Reusable cuffs - 6. Cuff extension hose - 7. Finger Probe - 8. Extension Cable

The Press-Mate PM-2100 patient monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device capable of monitoring: Pulse rate (via oximetry data) Non-invasive pressure (systolic, diastolic and mean oscillometric NIBP) Temperature Blood oxygen saturation (Sp02 via finger oximeter) This device is intended for use by qualified healthcare personnel trained in its use.

The Press-Mate PM-2100 Series Monitor is a fully portable multiparameter monitoring device which provides the capability for nonitoring of adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings. It is a prescription device intended for use only by health care professionals. The oscillometric method, upper arm measurement is employed. The PM-2100 includes, temperature via ALARIS® electronic predictive thermometry and Nellcor® oxygen saturation (Pulse Oximetry) utilizing the finger for the placement of the sensor. The monitor uses a single tube reusable cuff or may be optionally used with a disposable single tube cuff. The PM-2100 has an optional replaceable and rechargeable battery as well as an optional thermal printer to print displayed data, waveforms and trend information. A liquid crystal display (LCD) and (LED) provides high visibility and clarity in most light conditions. The available parameters displayed will depend on the mode selected by the user. Visual and audible alarms are provided to alert the user to monitor operational conditions or should patient values exceed default or operator-set high/low limits. Model 2100: Non - Invasive Blood Pressure and Pulse Rate Model 2110: Non - Invasive Blood Pressure and Pulse Rate; and Nellcor® Pulse Oximetry and Pulse Rate Model 2120: Non – Invasive Blood Pressure and Pulse Rate; and Monitor/Predictive Oral/Rectal Temperature Model 2140: Non - Invasive Blood Pressure and Pulse Rate; and Monitor/Predictive Oral/Rectal Temperature and Nellcor® Pulse Oximetry and Pulse Rate This portable device includes an optional integrated printer and is capable of operation from an external AC power source or an internal rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press - Mate 8800 (K890876 cleared 6/22/89) and the Press - Mate Advantage (K 973637 cleared 9/25/98) The following accessories are available for use with the device: - 1. Power cord - 2. Printer Paper - 3. Operations Manual - 4. Disposable cuffs - 5. Reusable cuffs - 6. Cuff extension hose - 7. Temperature probe - 8. Finger Probe - 9. Extension Cable

The PressMate Advantage monitors non-invasive blood pressure (NIBP), Oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an Adult, Pediatric or Neonate in the clinical setting.

The PressMate Advantage Monitor measures, displays and (optionally) prints the following parameters: 1. NIBP (systolic, Diastolic, Mean and Pulse Rate) 2. ECG 3. Body Temperature 4. Sp02 ( Oxygen Saturation and Pulse Rate)