VENTNET; CENTRAL MONITORING STATION

K963633 · Puritan Bennett Corp. · MOD · Dec 16, 1996 · Anesthesiology

Device Facts

• Record ID: K963633
• Device Name: VENTNET; CENTRAL MONITORING STATION
• Applicant: Puritan Bennett Corp.
• Product Code: MOD · Anesthesiology
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2

Intended Use

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. VentNet’s secondary intended use is the automation of some of the record keeping and reporting functions performed during mechanical ventilation.

Device Story

VentNet is a PC-based central monitoring station for remote observation of up to 24 mechanical ventilators (7200 Series). Inputs include ventilator settings, alarm status, and physiological data received via hardwire or wireless radio-link transceivers. The system processes these inputs to display real-time status, record chronological event logs (up to 1000 records), and trigger optional remote paging notifications via TAP protocol. Used in hospital environments by respiratory care staff or ventilator specialists; the system provides a graphical user interface (Windows 3.11) for monitoring, reporting, and data archiving. It does not replace bedside staff but supports them by alerting specialists to alarm conditions. Benefits include centralized oversight of dispersed ventilators, automated record-keeping, and improved response times to ventilator alarms.

Clinical Evidence

Bench testing only. Evidence includes EMI compatibility and susceptibility testing, environmental stress testing, and system-level software verification and validation.

Technological Characteristics

Pentium-100 MHz PC, 16 MB RAM, 1 GB HDD. Wireless communication via 902-928 MHz spread spectrum radio transceivers (100 mW output). Hardwire interface via EIA-232 or EIA-422. SVGA color monitor with touchscreen capability. Operating system: Microsoft Windows 3.11. Defibrillation protection on remote transceivers. Compliant with UL544 and CSA C22.2 No. 125.

Indications for Use

Indicated for patients being ventilated by the 7200 Series Ventilator in hospital or hospital-type environments.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Spacelabs PCMS Monitor, Model 90845 (K913038)
• Spacelabs Flexport Interface, Model 90436-01 (K903702)

Reference Devices

• VitalCom Model 1100 Central Monitoring Station (K942147)
• Zymed Central Station Monitor System, Model T8010 (K951370)
• Acuity Central Monitor (K935846)
• VMAX Pulmonary / Medabolic System (K942211)

Submission Summary (Full Text)

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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.

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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.

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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.

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## 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)

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## 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

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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%

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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.

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# 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. |

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| 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 |

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## 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.