(183 days)
The Sabratek Patient Home Monitoring System (PHMS), is a physiological data monitoring and communications system intended for use predominately in alternate care settings.
The system consists of three major components as shown in Fig.1. The Ambulatory Patient Monitor (APM-2000) is an ambulatory device that monitors physiological data of the ambulatory patients. The Virtual Hospital Room Communicator (VHRC) is a data storage and transfer device that resides in a patient's home or at an alternate care center. The VHRC has the capability to detect and monitor the APM-2000. A number of peripheral devices such as a Scale, Non Invasive Blood Pressure device (NIBP), Oral Temperature probe and other devices can also be connected to the VHRC. Sabratek has selected peripheral devices with current agency rulings of substantial equivalence for use with the VHRC is accessible by a standard telephone line (POT). The Remote Device Access Software (RDAS) is a Microsoft Windows 95/NT applications program. The program interacts with the Virtual Hospital Room Communicator (VHRC) via modem and standard telephone line. The program collects the data stored in the VHRC and presents the information for review by the caregivers. The program can also control the functions of the APM-2000 and monitor the functions of other devices connected to the VHRC.
The Sabratek Patient Home Monitoring System (PHMS) is a physiological data monitoring and communications system. The device itself is not a diagnostic tool but gathers various physiological data. Therefore, the "acceptance criteria" discussed here relate to the device's technical specifications and engineering performance rather than diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Sabratek PHMS) |
|---|---|---|
| Respiration | ||
| Measure respiration rate | Yes | Yes |
| Range | 2-150 RPM | 4-40 RPM |
| Accuracy | ± 2 RPM or 2% | ± 2 RPM or 2% |
| Sensor | Pro-Tech 1246 (K#960851) | Pro-Tech 1246 (K#960851) |
| Electrocardiogram | ||
| Records and stores monitor bandwidth ECG | Yes | Yes |
| Single lead (2 active electrodes + ground) | Yes | Yes |
| 5 lead selectable leads | Yes | No |
| Defibrillator-protected input leads | Yes | No |
| Defib Sync. | Yes | No |
| Pacemaker spike detection | Yes | No |
| QRS or arrhythmias detection | Yes | No |
| QRS Tone | Yes | No |
| Detects electrode lead off | Yes | Yes |
| Alarms on low/high rate | Yes | No |
| Wireless operation | Optional | No |
| ECG Electrodes | Lead-Lok, Inc LLE306BX, P-6 (K#911529) | Lead-Lok, Inc LLE306BX, P-6 (K#911529) |
| Patient Weight Scale | AND Medical UC-300 | AND Medical UC-300 |
| K# | Class I Exempt device 880.2700 | Class I Exempt device 880.2700 |
| Temperature Probe | Thermometric MA-200 | Thermometric MA-200 |
| K# | Exempt device | Exempt device |
| Pulse Oximetry | Nonin OEM II | Nonin OEM II |
| Non Invasive Blood Pressure | AND Medical | AND Medical |
| K# | K871720 | K871720 |
| VHRC - General | ||
| Communications capability | Up to 10 external devices | Up to 10 external devices |
| Display | LCD 45.75 X 67.56 mm | 4 row 20 character LCD |
| Display backlight | Yes | Yes |
| Keypad | Separate keys | 5 row by 5 column custom |
| Voice synthesizer | No | Yes |
| Malfunction audio | No | Yes |
| Speaker phone | No | Optional |
| Patient alarm notification | Audio and visual | Audio and visual |
| Size | 9.6" X 8.2" X 7.6" | ≈12" x 12" x 4" |
| Weight | 12.68 Lbs | ≈10 lb |
| Operating temperature | 0 to 40 C | 0 to 60 C |
| Humidity | 15% to 95% non-condensing | 0 to 95% non-condensing |
| Operating altitude | -2000 to 15000 Ft. | -200 to 15,000 ft |
| Shipping/storage temperature | -20 to +60 C | -20 to +60 C |
| Drip proof | Unknown | IEC 529 level IPX1 |
| VHRC power | ||
| 115/230 VAC 50/60 Hz | 100-120 VAC, 50-60 Hz | Yes |
| Internal battery pack operation | Yes 2.5 + Hrs. | Yes, >1 hour |
| Internal battery charger | Yes | Yes |
| Battery recharge time | 8-12 Hrs. | ≈8 hours |
| Double insulation | Yes | Yes |
| Power input | Unknown |
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.