PHILIPS ED843 IntelliBridge Bedside Medical Device Interfacing Module Owner’s Manual

PHILIPS ED843 IntelliBridge Bedside Medical Device Interfacing Module

Introduction

Indications for Use

The IntelliBridge EC10 module together with the IntelliBridge EC5 ID module is generally indicated for use when the clinician decides there is a need to include physiological and device measurement data and alarms generated by external devices into the IntelliVue patient monitors. From the monitor this data can go on to the patient monitoring network, central station, charting system, electronic medical records (EMR), or hospital information systems (HIS). There are no limitations for frequency of use, the module can be used for continuous monitoring.
For the patient population, refer to the documentation for the external device. These Instructions for Use apply only to the above mentioned indication for use. When the IntelliBridge EC40 or IntelliBridge EC80 hub is used together with the IntelliBridge EC5 ID module, please refer to the Instructions for Use delivered with the IntelliBridge EC40 or IntelliBridge EC80 product.
This guide may contain descriptions of functionality and features that are not in the equipment currently shipped to Japan and/or products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Contact your local sales representative and/or Philips Customer Support for details.

Text Conventions

• A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.
• A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.
• Display refers to the physical display unit.
• Screen refers to everything you see on the monitor’s display, such as measurements, alarms, patient data and so forth.

Manufacturer’s Information

Philips Medizin System Boeblingen GmbH
Hewlett-Packard-Str. 2
71034 Boeblingen
Germany
Visit our website at : www.philips.com.
© Copyright 2022. Koninklijke Philips Electronics N.V. All Rights Reserved.
The IntelliBridge Driver complies with the Medical Device Directive 93/42/EEC. Further information can be found in the Instructions for Use of the IntelliVue monitor.

Incident Reporting

Any serious incident that has occurred in relation to this software should be reported to Philips and the competent authority of the member state in which the user and/or patient is established. In this context “member state” refers to European Economic Area (EEA) countries including Switzerland and Turkey.

Availability

Not all the devices are available in all countries. Please contact your local Philips sales representative for further details.

References

For all additional required information refer to the patient monitor instructions for use..

Trademark Acknowledgments

INOmax is a trademark of a Mallinckrodt company.

External Device Information

General

These instructions for use are for clinical professionals using the IntelliBridge EC10 module together with an IntelliVue monitor and the IntelliBridge EC5 ID module, patient monitoring network, central station, charting system, electronic medical records (EMR), or hospital information systems (HIS).

Familiarize yourself with all instructions in this document and in the user documentation of your patient monitor, including warnings and cautions, before starting to monitor patients. Read and keep the Instructions for Use that come with any external devices, as these contain important information that is not repeated in this document.

This document contains information about data from Mallinckrodt INOmax that can be transferred to IntelliBridge. This includes:

• A list of numerics, alarms, INOPs and modes.
• An indication of which Numerics are available for further processing, for example, trending and HL7 output.

If you are using an Information Center, please also refer to the IntelliVue Information Center HL7 Parameter Data Interface Programmer’s Guide for Numerics available via the HL7 Parameter Data Interface.

WARNING

The signal labels and alarm messages used on the patient monitor may be different from those used on the external device. The labels used on the patient monitor are listed on the following pages, along with the full name of each signal and alarm message.
The alarm priorities used on the patient monitor may also be different from those used on the external device.

Compatibility

Supported Devices

IntelliBridge device driver for Mallinckrodt INOmax is compatible with Mallinckrodt INOmax devices with firmware version 2.1.0 and higher, and protocol revision 01.

Supported Hosts

IntelliBridge device driver for Mallinckrodt INOmax is compatible with IntelliVue patient monitors that support IntelliBridge EC10.

Connecting IntelliBridge

Use the following procedure to connect an external device:

1. Connect the IntelliBridge EC5 ID module to the Mallinckrodt INOmax device as described in “Instruction for connection” on page 21. Ensure that the correct module is used (“Mallinckrodt INOmax”).
2. Connect the supplied cable to the IntelliBridge EC10 module/IntelliBridge EC10 Interface Board (or an alternative cable: max. 10 m, CAT5 or better, straight wired).
3. Complete the IntelliBridge setup procedure, as described in the instructions for use for the patient monitor, or for the patient monitoring network, central station, charting system, electronic medical record, or hospital information system.
   

Connected IntelliBridge EC5 and EC10

1. Mallinckrodt INOmax device

2. IntelliBridge EC5 ID module (labeled: “Mallinckrodt INOmax”)

3. Supplied cable (or alternative cable: max. 10 m, CAT5 or better, straight wired)

4. 4a Patient monitor with IntelliBridge EC10 module
   4b Patient monitor (for example, IntelliVue MX400) fitted with optional IntelliBridge EC10 Interface Board

5. Information Center

6. HL7 export

7. Charting system

8. Electronic medical records (EMR)

9. Hospital information system (HIS)

Alarms

WARNING

Alarms, INOPs and numeric signals from the external device may be delayed before transmission to the patient monitor. These delay times can vary depending on the conditions under which the device is operating. For this reason, specified delay times, other than those stated in the following output signal tables, are not available.

There can be differences between the alarm categories used by your patient monitor and the categories used by the external devices interfaced using IntelliBridge. In these cases alarms coming from an external device can appear on a patient monitor and an external device with different hierarchies.

Please check which alarms are assigned and how they are prioritized..

Not all alarms and INOPs available on external devices can be handled via the IntelliBridge module. In the case that another device is connected to the external device, alarms and INOPs from this other device are not transferred to IntelliBridge. The supported alarms and INOPs are listed in this document.

The terminology used for the alarms in this IntelliBridge IfU may differ from the terminology used by Mallinckrodt INOmax.

All Alarms and INOPs are exported to the Information Center, and the HL7 data stream..

External Device Signals

The following tables list the output signals from the external device that are offered by IntelliBridge.

• Depending on the host monitor these signals may be visible on the screen.
• Signal ranges, resolution, and validity follow the external device specification unless otherwise noted.
• Output signals, configured to be available for display and trending, can be used for recordings and calculation in the same way as signals measured by the IntelliVue monitor directly.
• Trending and HL7 output capabilities are listed in the tables below. Please note that they are dependent on the revision of the IntelliVue Patient Monitor (Rev. G.0 or higher) and Philips Patient Information Center (PIC iX) (Rev. A.0 or higher).

NOTE The terminology used for the Labels and Units in this IntelliBridge If U may differ to that used by Mallinckrodt INOmax.

Numerics

Measurements

Label| Measurement Description| Unit| Selectable for Trend| PIC HL7 IHE/Classic 1
---|---|---|---|---
NO| NO monitored value| ppm| ✓| 195479
0002FB97
NO 2| NO2 monitored value| ppm| ✓| 195480
0002FB98
inO 2| O2 monitored value| %| ✓| 152196
00025284

Settings

Label| Setting Description| Unit| Selectable for Trend| PIC HL7 IHE/Classic 1
---|---|---|---|---
sNO| NO Delivery Set Point| ppm| ✓| 67304343
0402FB97

1. Subject to change for future revisions of PIC iX.

Non-Numerics

Label| Non-numeric Description| Range| Selectable for Trend| PIC HL7 IHE/Classic 1
---|---|---|---|---
sCStaL| Left Cylinder Status| Open , Close| –| 195984
0002FD90
sCStaR| Right Cylinder Status| Open , Close| –| 195985
0002FD91

1. Subject to change for future revisions of PIC iX.

External Device Alarms

Severity

Depending on the alarm severity assigned by the external device, IntelliBridge generates alarms at corresponding severity levels. Possible alarm levels are:

The alarm severity shown on the patient monitor will always be at least as high as the alarm severity assigned by the external device. The mapping of the alarm messages and severities from the external device to the corresponding alarm messages and severities on the patient monitor can be seen in the tables below.

Since the device is located close to the patient monitor, only alarms which indicate a communication problem between the external device and IntelliBridge are audible at the patient monitor. All alarms are audible on the Patient Information Center.

Delay

There is a maximum delay of 8 seconds until alarms received from Mallinckrodt INOmax are displayed on the patient monitor screen. This delay is in addition to the alarm detection and processing delays of the external device.

Pausing Audible Alarm Indicators

Alarms are shown on the bedside monitor and on the PIC iX. Alarms are not audible on the bedside monitor, but will sound on the PIC iX. When an audible alarm indicator of an alarm has been paused on the Mallinckrodt INOmax, the audible alarm indicator of this alarm is also paused on the PIC iX.

Physiological Alarms

Alarm Message originating from External Device 1| Alarm Message as displayed on Patient Monitor| Condition| PIC HL7 IHE 2
---|---|---|---
Alarm Message| Alarm Severities| Alarm Message| Alarm Severities| |
Low NO| High| NO Low| Red| Low NO Alarm| 69650
258583
High NO| High| NO High| Red| High NO Alarm| 69650
258585
High NO2| High| NO2 High| Red| High NO2 Alarm| 69650
258587
Low O2| High| inO2 Low| Red| Low O2 Alarm| 69650
258589
High O2| High| inO2 High| Red| High O2 Alarm| 69650
258591

1. Message text according to the user documentation of the external device
2. Subject to change for future revisions of PIC iX.

INOPs

Alarm Message originating from External Device 1| Alarm Message as displayed on Patient Monitor| Condition| PIC HL7 IHE 2
---|---|---|---
Alarm Message 3| Alarm Priorities| Alarm Message| Alarm Priorities| |
CylinPPMMismat| High| !!! Cylin PPMMismat| !!!Red| Cylinder PPM Mismatch| 70661
258557
Delivery stop| High| !!! Delivery stop| !!!Red| Delivery stopped| 70661
258563
Cylin Expired| High| !!! Cylin Expired| !!!Red| Cylinder Past Expiration Date| 70661
258559
CylinNoDetect| High| !!! Cylin NoDetect| !!!Red| Cylinder Not Detected| 70661
258551
Cylin Close| High| !!! Cylin Close| !!!Red| Cylinders Closed| 70661
258553
InjectModFail| High| !!! Inject ModFail| !!!Red| Injector Module Fail Alarm| 70661
258561
Low Battery| High| !!!Low Battery| !!!Red| Low Battery Alarm| 70661
258549
Alarm Message originating from External Device 1| Alarm Message as displayed on Patient Monitor| Condition| PIC HL7 IHE 2
---|---|---|---
Alarm Message 3| Alarm Priorities| Alarm Message| Alarm Priorities| |
Low NO/ NO2Press| High| !!! Low NO/ NO2Press| !!!Red| Low NO/NO2 Pressure Alarm| 70661
258545
Set NO & Backup On| High| !!! Set NO & Back **up On| !!!Red| Set NO and Backup On Alarm| 69650
258575
Delivery Fail| High| !!! Delivery Fail| !!!Red| Delivery Failure Alarm| 70661
258565
Aux Failure| High| !!! Aux Failure| !!!Red| Unused bits active| 70661
258569
–| Low| Aux Chk Config| Cyan| Communication could not be established due to errors| 70661
203275
–| Low| Aux Chk Setup| Cyan| Communication could not be established due to timeout| 70661
203279
Low Calib fail| Low| Low Calib fail| Cyan| Low calibration failed| 69650
258571
Under Delivery| Low| Under Delivery| Cyan| Under Delivery Alarm| 70661
258567
Both Cylin’s Open| Low| Both Cylin’s Open| Cyan| Two cylinders open| 70661
258555
Sensors Failed| Low| Sensors Failed| Cyan| Failed NO2 Cell Alarm| 70661
258543
Failed O2 Cell Alarm
Failed NO Cell Alarm
Water Bottle Full| Low| Water Bottle Full| Cyan| Water Bottle Full Alarm| 70661
258541
Sample Filter Block| Low| Sample Filter Block| Cyan| Sample Line Filter Block Alarm| 70661
258547
Monitoring Fail| Low| Monitoring Fail| Cyan| Monitoring Failure Alarm| 69650
258577
Manual Bypass Act| Low| Manual Bypass Act| Cyan| Manual Bypass Active Alarm| 69650
258573**

1. Message text according to the user documentation of the external device
2. Subject to change for future revisions of PIC iX.
3. Different alarm messages, originating from the external device, may be issued as one and the same alarm message on the patient monitor.

Configurable Settings

The item names correspond to the menu labels in the related setup in the monitor.

The Configuration and Monitoring mode columns indicate in which operating mode the setting is available/visible. If both columns are marked with a checkmark (✓), the setting is available in both modes. If only one column is marked, the setting is available in the corresponding mode only.

Settings which are configured in Configuration mode are stored automatically in the IntelliBridge EC10 module.

Settings which are selectable in Monitoring mode cannot be stored permanently.

Item Name| Configuration Mode| Monitoring Mode| Menu Label| Factory Default| User Default
Use this column to enter your default settings.
---|---|---|---|---|---
Device Alarms| ✓| –| Device Alarms| Accepted|
Default Color| ✓| –| Default Color| White|

Differences in Displayed Values

In certain cases, there may be differences between the numerics seen on the patient monitor and those seen on the external device. The table below lists some possible reasons why this behavior would be seen.

Differences between the measured or calculated parameter values processed within the patient monitor and interfaced numerics from the external device.| There are some calculated values in the patient monitor which are also sent by the external device. These values are directly or indirectly dependent on other measurements or user inputs (for example height, weight) which may be different in the patient monitor and in the external device. For this reason, the same numeric may be seen with slightly different values.
Differences between related numerics within the IntelliVue patient monitor database.| It is possible that one of the original measurement numerics is trended from the patient monitor, whereas physiological values are interfaced from the external device. This could lead to a situation where it seems that a calculation or relation between two numerics is incorrect.
Aperiodic values are set to blank on the patient monitor.| All aperiodic values are set to blank on the patient monitor, if connection is interrupted (for example, the monitor is switched off) or new values are selected for standard display, trending, recording or calculations. The values will remain blank until the next measurement is performed on the external device, after communication is re-established.
Differences in displayed values between IntelliBridge and Mallinckrodt INOmax| The values sent to the IntelliBridge device from Mallinckrodt INOmax may not be identical to the values sent to its own display due to, for example, rounding up/down, or differences in resolution.

Service Information

This service information describes the connection of the IntelliBridge to the Mallinckrodt INOmax device.

Data communication

The IntelliBridge EC10 module supports RS232 serial data communication with the following specifications for connection with the external device:

• Baud rate: 38400
• Start/Stop bits : 1
• Word length: 8 bits
• Parity/Checking: None

RS232 parameters must be set and verified according to the Mallinckrodt INOmax service manual by authorized personnel.

Instruction for connection

Connect the IntelliBridge EC5 D-Sub 9-pin connector to the RS232 connector of the Mallinckrodt INOmax device as shown below. Make sure to tighten the screws of the connector properly.

IntelliBridge EC5 connection to RS232 ports

1. Mallinckrodt INOmax – RS232 (COM1) port
2. IntelliBridge EC5 ID module
3. EC5 device label: “Mallinckrodt INOmax”

References

For further service information, refer to the patient monitor service guide.

References

• Philips - United States | Philips

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