(184 days)
The PM-8000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 Express Patient Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and an intuitive menu system.
The patient parameters that can be monitored by PM-8000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP) and Carbon Dioxide (CO2). Its design allows the operator to adjust the settings of parameter alarms. that audibly and visually notify the operator when an excursion occurs.
The PM-8000 Express Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PM-8000 Express Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
The PM-8000 Express Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG(3-lead or 5-lead selectable), respiration (RESP), non-invasive blood pressure (NIBP), saturation of pulse oxygen (SpO2>, temperature (TEMP), invasive pressure (IBP) and carbon dioxide(CO2). These physiological signals are converted into digital data and processed. The PM-8000 Express Patient Monitor examines the data for alarm conditions and presents them on the color TFT display. The Patient Monitor also provides advantageous operating control for the user.
The optional built-in recorder, the optional CF memory card provides hard copies of all digital data and waveforms as well as Tabular and Graphic Trend Information, and storage the previous monitoring data information when power off accidentally.
The provided text describes the PM-8000 Express Patient Monitor, its intended use, and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria, device performance tables, or details of a study (like sample sizes, ground truth establishment, or expert qualifications) that prove the device meets specific acceptance criteria.
The document primarily focuses on:
- Identifying the device and its classification.
- Comparing its technological characteristics to predicate devices.
- Listing the standards it complies with during testing.
- Highlighting potential risks and how they are addressed.
The "Testing" section mentions that "Laboratory testing was conducted to validate and verify that the PM-8000 Express Patient Monitor met all design specifications and was substantially equivalent to the predicate devices." It lists several standards (e.g., ANSI/AAMI EC13, SP10, IEC60601 series, EN865, ISO14971) that the device was tested against for compliance. However, it does not provide the specific performance metrics or acceptance criteria for each parameter (ECG, NIBP, SpO2, etc.) nor the results of such tests in a detailed manner.
Therefore, I cannot fulfill your request for the specific table, sample sizes, expert details, or study information as that data is not present in the provided text.
Based only on the provided text, I can infer the general approach to demonstrating compliance, but not the detailed study results you've asked for.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).