VENTNET; CENTRAL MONITORING STATION

{0} 467 DEC 16 1996 K963633 # PREMARKET NOTIFICATION [510(k)] SUMMARY August 12, 1996 | VitalCom Contact Person: | Mr. Ray Pizinger | | --- | --- | | Trade Name: | VentNet | | Common Name: | Central Monitoring Station | | Classification Name: | Monitor, breathing frequency | | Trade Name: | NSMS-900 | | Common Name: | Transmitters and Receivers | | Classification Name: | Transmitters and Receivers, Physiological Signal, Radiofrequency | | Substantially Equivalent to: | Spacelabs PCMS Monitor, Model 90845 (K913038) Spacelabs Flexport Interface, Model 90436-01 (K903702) | ## SUMMARY OF VENTNET INTENDED USE ### 9A. PURPOSE AND FUNCTION OF DEVICE The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventilator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports. VentNet’s intended use is to supplement the operation of dispersed or remotely located mechanical ventilators. VentNet allows the remote monitoring of multiple ventilators from a central station. VentNet displays ventilator settings, ventilator alarm status and physiological patient information as communicated from the monitored mechanical ventilator. VentNet also includes an optional feature which causes automatic notification, via paging system to defined users of certain ventilator alarms. VentNet is not intended to replace on-hand competent medical staff in monitoring for, or responding to ventilator alarms but is intended to support that staff by notifying other respiratory care staff or ventilator specialists in the event of certain alarm conditions. {1} 468 VentNet’s secondary intended use is the automation of some of the record keeping and reporting functions performed during mechanical ventilation. ## 9B. INTENDED PATIENT POPULATION The intended population are those patients who are being ventilated by the 7200 Series Ventilator. ## 9C. INTENDED ENVIRONMENT OF USE The VentNet is intended to be used in an environmentally controlled hospital and hospital type environment. ## 9D. DEVICE CLAIMS ### 9D1. ADVERTISING CLAIMS 9D1.1) VentNet can be installed as either a hardwire system which can monitor up to sixteen (16) 7200 Series Ventilators or an FCC approved radio system which can monitor up to twenty-four (24) 7200 Series Ventilators. 9D1.2) From a VentNet central monitoring station a user can remotely monitor ventilator settings, alarm status, and physiological patient information for up to 24 7200 Series Ventilators. 9D1.3) VentNet uses established graphical user interface conventions to improve ease of learning and operation for operators familiar with Windows software applications. The VentNet system can be installed to operate either with a mouse or with a touch screen. 9D1.4) VentNet is compatible with Nellcor Puritan-Bennett 7200 Series Ventilator supporting the host port or DCI communications option or with future Nellcor Puritan-Bennett continuous critical care ventilators which support the same communications protocols. 9D1.5) VentNet automatically records ventilator settings and ventilator alarm events for monitored ventilators and displays that information in a spreadsheet format for review. VentNet will record the most recent events, up to 1000 records, as they occur. The time and date of settings changes and alarm events are automatically recorded to allow a chronological history. Physiological patient information is recorded along with the alarm events to assist the user in understanding the alarm event. {2} 469 9D1.6) VentNet has predefined report formats allowing the user to print reports of the system configuration, and monitored ventilator information. VentNet also provides means for archiving data and exporting that data to third party information systems. 9D1.7) VentNet displays the alarm status of the monitored ventilators which are indicated by color coded software buttons representing each ventilator. Each software button includes labels allowing the user to designate a patient identification and location. The user may further investigate the specific alarm codes which are active at each ventilator. 9D1.8) VentNet can optionally be configured to work with paging systems to allow the remote notification of certain alarm conditions. The user can designate where alarm messages are sent and can modify the conditions under which a ventilator alarm will result in a notice being sent. For each ventilator a primary and a secondary message path can be designated. The user can modify the conditions for notification individually for each monitored ventilator, and for each alarm condition of the ventilator. 9D1.9) VentNet incorporates passcode protection to restrict access to functions which interrupt ventilator monitoring or might cause the loss of data. 9D2. PRODUCT AND TECHNICAL SPECIFICATIONS 9D2.1 Central Station Compliance 9D2.2 Electrical 9D2.3 Physical Characteristics 9D2.4 Environmental 9D2.5 Operational Characteristics 9D2.7 Radio-Link Transceivers Operational Characteristics 9D2.8 Laser Printer Requirements 9D2.9 Component and System Labels 9D2.10 Central Station Compliance This section contains specifications for components of the central station and the bedside station remote radio transceiver. Requirements for the facility provided laser printer are also provided. {3} 470 ## 9D.2.11 Electrical Characteristics **Central Station External AC Input Voltage/Current** 115 Vac, 60 Hz, 5 A (maximum) or 230 Vac, 50 Hz, 2.6 A (maximum) **Remote Radio Transceiver Defibrillation Protection** The remote radio transceiver shall not be damaged by defibrillation and shall return to normal operation within 15 seconds of defibrillation. ## 9D.2.12 Physical Characteristics **Dimensions** **Computer:** 21 cm (8.3 in.) x 40.6 cm (16 in.) x 46 cm (18.1 in.) **Monitor:** 38.2 cm (15 in.) or 43.2 cm (17 in.) diagonal screen **Uninterruptible Power Supply:** 15.0 cm (6.0 in) x 9.0 cm (3.4 in.) x 33.0 cm (13.1 in) **Bedside Station Radio Transceiver** 12.5 cm (4.92 in.) x 6.7 cm (2.64 in.) x 3.0 cm (1.18 in.) **Weight** **Computer** 29.5 kg (65 lbs) **Monitor** 13.8 kg (30 lbs, 7 oz) **Uninterruptible Power Supply** 8.2 kg (18 lbs) **Bedside Station Radio Transceiver** 0.18 kg (6.6 oz) ## 9D.2.13 Environmental **Temperature** **Operating** +10° C to +35° C (+50° F to +95° F) **Shipping/Storage (In sealed shipping container)** -40° C to +70° C (-40° F to +158° F) {4} 471 ## Relative Humidity ### Operating 30% RH to 80% RH (noncondensing) ### Shipping/Storage (In sealed shipping container) 95% (maximum) ## Central Station Ventilation and Cabling Requirements All components of the central station should have a minimum of 1.5 inches clearance around top, sides, back, and front for ventilation. No central station component should be installed in an enclosed cabinet. A minimum of 4 inches is required behind the computer to accommodate cabling. ## 9D.2.14 Operational Characteristics ### Computer - Pentium-100 MHz - 16 MB RAM - 1 GB Hard Drive - 3.5-inch Floppy Drive - Hercules Dynamite Video Board - Serial Mouse - 101-key Keyboard ### Monitor - 15 inch or 17 inch diagonal screen - Touchscreen hardware installed - 800 x 600 pixel resolution - 256 colors ## 9D.2.15 Hard-wired Interface Characteristics - Selectable EIA-232 or EIA-422 - RJ45 interface connector at central station - 9-pin D-connector at the bedside station ## Radio-Link Transceivers Characteristics ### Central Transceiver Transmitter - Frequency 902 to 928 MHz - RF Output Power +20 dBm (100 mW) minimum - RF Power Adj. >20 dB range {5} 472 Settling Time <100 usec Frequency Stability ±0.001% Modulation Type Direct FM, DDS Synthesized NRZ Modulation Rate 62.5 kilobaud (nominal) Antennas Omni-directional Spectrum Usage Spread spectrum (IAW FCC Par. 15.247) FCC CISPR 11 - Class A with exceptions for intentional radiators covered by FCC Part 15, Section 247 Central Transceiver Receiver Frequency 902 to 928 MHz Frequency Spacing 1 kHz Settling time 100 usec Frequency Stability ±0.001% Selectivity 180 kHz (3 dB) nominal 300 kHz (20 dB) nominal Sensitivity: -80 dBm (minimum) in 180 kHz bandwidth for 10 dB SNR Modulation Type Direct FM, DDS Synthesized NRZ Modulation Rate 133 kilobaud Diversity Full voting, 2 channels Input impedance 2:1 VSWR maximum (50 ohm) Host PC Interface Memory-mapped, dual port RAM Antennas Omni-directional Remote Transceiver Transmitter Frequency 902 to 928 MHz RF Output Power +15 dBm nominal, ±2.0 dB RF Power Adj. >20 dB range Settling Time <300 usec Frequency Stability ±0.001% Modulation Type Direct FM, DDS Synthesized NRZ Modulation Rate 133 kilobaud (nominal) Frame Length: 30 milliseconds Data Rate Instantaneous bandwidth variability FCC CISPR 11 - Class B with exceptions for intentional radiators covered by FCC Part 15, Section 247 Remote Transceiver Receiver Frequency 902 to 928 MHz Settling time <300 usec Frequency Stability ±0.001% {6} 473 Selectivity 180 kHz (3 dB) nominal 300 kHz (20 dB) nominal Sensitivity -90 dBm (minimum) in 180 kHz: bandwidth for 10 dB SNR Spurious Rejection 50 dB nominal Modulation Type 100 kHz deviation NRZ Modulation Rate 133 kilobaud Input impedance 2:1 VSWR maximum (50 ohm) ## Laser Printer Minimum Requirements The VentNet monitoring system supports printers that are both HPGL/2 and PCL5 compatible with a minimum of 2 megabytes of printer memory such as the Hewlett-Packard LaserJet models 4, 4SI, 4L, 5, 5SI, and 5L printers. ## Component and System Labels There are two labels on the rear panel of the central station computer described as follows. An identification label showing product title, model, and serial numbers plus agency certifications is affixed on the rear panel of the central station computer by the original manufacturer. This label shows certification compliances at the time the computer was purchased from the manufacturer and is applicable to the computer only. This label also facilitates product traceability through the manufacturer’s product records system. Another identification label showing the system model number is affixed on the rear panel of the central station computer by Nellcor Puritan Bennett. This label shows CSA/NRTL/C certification that is applicable to the VentNet monitoring system as a whole. This certification is based on the Canadian Standard for Electromedical Equipment, C22.2, No. 125 and the Underwriters Laboratories Standard for Medical and Dental Equipment, UL544. {7} # 9E. COMPARISON MATRIX VentNet vs. Spacelabs PCMS and VitalCom Model 1100 NOTE: THE 7200 VENTILATOR CONNECTS TO THE SPACELABS PCMS VIA THE FLEXPORT INTERFACE (90436-01) | Characteristic | VentNet Central Monitoring Station | Spacelabs Patient Care Management System (PCMS) (K913038) | VitalCom Model 1100 Central Monitoring Station (K942147) | | --- | --- | --- | --- | | Display | SVGA Color Monitor with and without touchscreen | SVGA Color Monitor with and without touchscreen | SVGA Color Monitor with and without touchscreen | | Channels | Up to 24 Patients (wireless) Up to 16 Patients (hardwire) | Access of up to 16 Patients (telemetry or hardwire) | 8 independent with 2 waveforms per channel; (16 for remote displays) | | Hardware | PC based, Pentium, 75 MHz or higher, 16 MB RAM, 1.2 GB HD | CPU based 80486, 50 MHz, 48 MB RAM, 700 MB HD | Mini-tower personal computer 486 or higher. | | Hardwire Interface | RS232 or RS422 Interface | Spacelabs Flexport Interface (K903702) | RS232 | | Radio Transmitter Interface (wireless) | 1. Remote Transceiver - Frequency 903 - 920 MHz - Output 50 mW (Max) 2. Central Transceiver - Frequency 903 - 922 MHz - Output 500 mW (Max) | Not Provided | Multiple, Applicable option: 1. Remote Transceiver - Frequency 903 - 920 MHz - Output 50 mW (Max) 2. Central Transceiver - Frequency 903 - 922 MHz - Output 500 mW (Max) | | Software Operating System | Microsoft Window 3.11 | unknown | VRTX | | Ventilator Settings | Provided by the 7200 Series Ventilator | Provided by the 7200 Series Ventilator | not applicable | | Patient Data | Provided by the 7200 Series Ventilator | Provided by the 7200 Series Ventilator | not applicable | | Ventilator Alarm Settings | Provided by the 7200 Series Ventilator | High/Low Limits Adjustable at the Bedside Monitor, a remote location and at the Central Monitor | not applicable | | Individual patient real time alarm status | Status of the ventilator alarms for a selected patient as provided by the 7200 series ventilator. | Patient displayed status in the patient block | ECG, Arrhythmia, and Bedside Monitor alarm status for individual patients | | Paging | User selectable for each patient, either no page, autopage to one number, or manual page to a preset number. VentNet uses a hospital paging system using the standard TAP protocol | Not provided | (Optional) Paging via user prompt to hospital paging system, including Zone paging. | {8} | Characteristic | VentNet Central Monitoring Station | Spacelabs Patient Care Management System (PCMS) (K913038) | VitalCom Model 1100 Central Monitoring Station (K942147) | | --- | --- | --- | --- | | Tabular Trends | Future Options | Tabular trends include both settings and monitored patient data | ST and others if available from the Bedside | | Graphical Trends | Future Options | Graphical trends of tidal volume and respiratory rate | Pressure (NIBP), and Pleth and others if available from the Bedside | | Waveforms | Future Options | Pressure and Flow waveforms are available if the ventilator provides them | ECG, Pressure (NIBP), and Pleth and others if available from the Bedside | | Reports | Multiple available, user selectable intervals, automatic print on alarms, and manual requests | User selectable intervals, automatic print on alarms, and manual requests | Multiple available, user selectable intervals, automatic print on alarms, and manual requests | | Ventilation Calculations | As provided by the 7200 Series Ventilator | Calculations for minute volume, dynamic & static compliance, dead space volume, dead space to tidal volume ratio, and alveolar ventilation | not applicable | | Logs | Alarm, ventilator setting changes, and patient monitoring status | Events Logs | Events Logs | {9} 476 ## 9F. TECHNOLOGICAL CHARACTERISTIC REVIEW The VentNet Central Monitoring Station is substantially equivalent to the Spacelabs PCMS Monitor, Model 90845 (K913038) with the use of the Spacelabs Flexport Interface, Model 90436-01(K903702). The VentNet uses a pentium based personal computer and offers both a hardwire interface and a wireless interface (radio transceivers). This technology is equivalent to the VitalCom Model 1100 systems provided to other manufacturers for communication from bedside monitors to a centralized monitoring station which was determined substantially equivalent in 1995 (K942147). VentNet also utilizes Microsoft Windows 3.11 as it's operating system which is currently being utilized through out the monitoring industry in a variety of products, including the Zymed Central Station Monitor System, Model T8010 (K951370), the Acuity Central Monitor (K935846) and the VMAX Pulmonary / Medabolic System, (K942211). ## 9G. NON-CLINICAL PERFORMANCE DATA REVIEW The determination of substantial equivalence was based on an assessment of non-clinical performance data. The data includes testing for EMI compatibility and susceptibility, software verification and validation of both the system software performance as well as the operating system software performance, environmental testing and stress testing both at the integration level and the system level. The conclusion drawn from a review of the data indicates that the VentNet is substantially equivalent to the predicate devices.