BeneVision Central Monitoring System Operator's Manual Rev 8.0 April 2019

© Copyright 2016 -2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■

Release time: April 2019

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Revision: 8.0

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Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, , and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: ■

All installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

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The electrical installation of the relevant room complies with the applicable national and local requirements;

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The product is used in accordance with the instructions for use.

WARNING

• This equipment must be operated by skilled/trained clinical professionals. • It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

II

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to ■

Malfunction or damage caused by improper use or man-made failure.

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Malfunction or damage caused by unstable or out-of-range power input.

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Malfunction or damage caused by force majeure such as fire and earthquake.

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Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

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Malfunction of the instrument or part whose serial number is not legible.

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Others not caused by instrument or part itself.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address

Mindray Building,Keji 12th Road South,High-tech industrial park,Nanshan,Shenzhen 518057,P.R.China

Website

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

III

Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact Mindray. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.

Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.

Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your central monitoring system. The “XX” symbol in an illustration may refer to parameter numeric values, waveform data, or descriptive text for a functionality.

Conventions ■

Italic text is used in this manual to quote the referenced manuals, chapters, sections and formulas.

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Bold text is used to indicate the screen texts and names of hard keys.

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→ is used to indicate operational procedures.

IV

Contents 1 Safety ... 1 - 1 1.1 Safety Information ...1 - 1 1.1.1 Warnings ...1 - 1 1.1.2 Cautions ...1 - 2 1.1.3 Notes ...1 - 3 1.2 Equipment Symbols ...1 - 3 2 System Overview ... 2 - 1 2.1 Intended Use ...2 - 1 2.2 Contraindications ...2 - 1 2.3 System Components ...2 - 1 2.3.1 CentralStation ...2 - 2 2.3.2 WorkStation ...2 - 2 2.3.3 ViewStation ...2 - 3 2.3.4 CMS Viewer ...2 - 3 2.3.5 Computer Platform ...2 - 3 2.3.6 License ...2 - 3 2.3.7 Network Device ...2 - 4 2.3.8 Remote Display and Data Transmission Device ...2 - 4 2.3.9 Recorder ...2 - 4 2.3.10 Printer ...2 - 4 2.4 Networking Mode ...2 - 4 2.4.1 Bedside Device Network ...2 - 5 2.4.2 CMS Network ...2 - 5 3 Getting Started ... 3 - 1 3.1 Overview ...3 - 1 3.2 Equipment Preparation Safety Information ...3 - 1 3.3 Environmental and Power Requirements ...3 - 2 3.3.1 Environmental Requirements ...3 - 2 3.3.2 Power Requirements ...3 - 2 3.4 Turning On the System ...3 - 2 3.5 Multibed Screen ...3 - 2 3.5.1 Example Multibed Screen ...3 - 3 3.5.2 Symbols on the Multibed Screen ...3 - 4 3.5.3 Patient Sector Status ...3 - 6 3.5.4 Patient Sector in the Monitoring State ...3 - 6 3.5.5 Sorting Patient Sectors ...3 - 8 3.5.6 Patient Summary ...3 - 8 3.6 ViewBed Screen ...3 - 9 3.6.1 Accessing the ViewBed Screen ...3 - 9 3.6.2 Example ViewBed Screen ... 3 - 10 3.6.3 Changing ViewBed Screen Settings ... 3 - 11 3.6.4 Displaying the Parameter List ... 3 - 11 3.6.5 Quick Keys ... 3 - 12

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3.6.6 SpO2 Statistics ... 3 - 13 3.6.7 Starting/Stopping NIBP Measurement ... 3 - 14 3.6.8 Freezing/Unfreezing Waveforms ... 3 - 14 3.6.9 Loading Configurations for Telemetry Devices ... 3 - 15 3.6.10 Viewing Device Location ... 3 - 15 3.6.11 Minitrends Window ... 3 - 15 3.6.12 OxyCRG Window (Displaying ABD Events) ... 3 - 18 3.6.13 OxyCRG Window (Not Displaying ABD Events) ... 3 - 20 3.6.14 Early Warning Score (EWS) ... 3 - 20 3.6.15 ECG 24h Summary ... 3 - 24 3.6.16 Pace View ... 3 - 24 3.6.17 Using 6-lead Placement to Derive 12-lead ECG (D12L) ... 3 - 24 3.6.18 InfusionView ... 3 - 25 3.6.19 EERAS Dashboard ... 3 - 27 3.6.20 Exercise Time and Pain Score Parameter Area... 3 - 28 3.6.21 Arrhythmia Alarm Timeout ... 3 - 29 3.7 Operating Mode ... 3 - 31 3.7.1 Standby Mode ... 3 - 31 3.7.2 Night Mode ... 3 - 32 3.7.3 Privacy Mode ... 3 - 32 3.8 Defibrillator’s Self-Test Reports ... 3 - 33 3.8.1 Viewing Defibrillator’s Self-Test Reports ... 3 - 33 3.8.2 Printing Defibrillator’s Self-Test Reports ... 3 - 34 3.8.3 Confirming Defibrillator Self-Test Failure ... 3 - 34 3.9 Third-Party Application ... 3 - 34 3.9.1 Opening a Third-Party Application ... 3 - 34 3.9.2 Closing a Third-Party Application ... 3 - 34 3.10 Viewing System Information ... 3 - 35 3.11 Restarting the System ... 3 - 35 3.12 Turning Off the System ... 3 - 35 4 Patient Management ...4 - 1 4.1 Patient Management Overview ...4 - 1 4.2 Admitting Monitoring Devices at the CentralStation ...4 - 1 4.2.1 Automatically Admitting Monitoring Devices ...4 - 1 4.2.2 Manually Admitting Monitoring Devices ...4 - 1 4.3 Assigning Monitoring Devices from the Host CentralStation to the WorkStation/Viewstation ...4 - 2 4.4 Assigning an Overview Bed to a Patient Sector ...4 - 3 4.5 Connecting a Patient Monitor with a Telemetry Device ...4 - 3 4.5.1 Connecting Procedures ...4 - 3 4.5.2 Disconnecting a Patient Monitor with a Telemetry Device ...4 - 3 4.6 Accessing the Patient Management Screen ...4 - 3 4.7 Patient Information Management ...4 - 4 4.7.1 Entering Patient Information ...4 - 4 4.7.2 Changing Patient Information ...4 - 5 4.7.3 Searching Patient Information ...4 - 5 4.7.4 Patient Information Synchronization ...4 - 6 4.8 Discharging A Patient ...4 - 6 4.9 Transferring Patient Data ...4 - 6 2

4.10 Discharged Patients Management ...4 - 7 4.10.1 Accessing the Discharged Patients Management Screen ...4 - 7 4.10.2 Viewing Discharged Patient Information ...4 - 7 4.10.3 Deleting Discharged Patient Information ...4 - 7 4.10.4 Printing Historical Data of Discharged Patients ...4 - 8 5 Alarms ... 5 - 1 5.1 Alarm Introduction ...5 - 1 5.2 Understanding the Alarms ...5 - 1 5.2.1 Alarm Categories ...5 - 1 5.2.2 Alarm Priorities ...5 - 1 5.2.3 Alarm Indicators ...5 - 2 5.2.4 Alarm Status Symbols ...5 - 3 5.3 Viewing Alarms ...5 - 3 5.3.1 Viewing All Alarms ...5 - 3 5.3.2 Viewing Alarms Triggered from A Single Monitoring Bed ...5 - 3 5.4 Clearing Alarms in the Alarm List ...5 - 3 5.5 Setting Alarm Properties ...5 - 4 5.5.1 Setting Parameter Alarm Properties ...5 - 4 5.5.2 Changing Arrhythmia Alarm Settings ...5 - 5 5.5.3 Changing ST Alarm Settings ...5 - 5 5.5.4 Setting Alarm Volume ...5 - 5 5.5.5 Setting Alarm Sound Pattern, Alarm Interval, Alarm Volume Escalation, and Audio Off Priority ...5 - 6 5.5.6 Setting Alarm Sound for a Single Bed ...5 - 6 5.5.7 Setting Reminder Tones ...5 - 6 5.5.8 Setting Alarm Latching ...5 - 6 5.5.9 Setting Alarm Properties for External Devices ...5 - 7 5.6 Alarm Pause ...5 - 7 5.6.1 Pausing Alarms ...5 - 7 5.6.2 System Responses after Pausing Alarms ...5 - 8 5.7 Alarm Audio Pause ...5 - 8 5.7.1 Pausing Alarm Sound ...5 - 8 5.7.2 System Responses after Pausing Alarm Sound ...5 - 8 5.8 Alarm Reset ...5 - 9 5.8.1 Resetting Alarms Triggered for Beds ...5 - 9 5.8.2 Resetting System Alarms ... 5 - 10 5.9 CMS System Silence ... 5 - 10 5.9.1 Silencing CMS ... 5 - 10 5.9.2 System Responses after Silencing CMS ... 5 - 10 5.9.3 Exiting CMS Silenced Status ... 5 - 10 6 Review ... 6 - 1 6.1 Overview ...6 - 1 6.2 Accessing the Review Screen ...6 - 1 6.2.1 Entering the Review Screen for Online Patients ...6 - 1 6.2.2 Entering the Review Screen for Discharged Patients ...6 - 1 6.3 Example Review Page Structure ...6 - 2 6.4 Symbols on Review Pages ...6 - 3

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6.5 Common Operations on Review Pages ...6 - 3 6.5.1 Browsing Trend Data ...6 - 3 6.5.2 Viewing Events ...6 - 3 6.5.3 Displaying Two Review Pages Simultaneously ...6 - 4 6.6 Tabular Trends Review Page ...6 - 4 6.6.1 Entering the Tabular Trends Review Page ...6 - 4 6.6.2 Configuring Trends ...6 - 4 6.6.3 Printing a Tabular Trends Report ...6 - 5 6.6.4 Exporting Trend Data ...6 - 5 6.7 Graphics Trends Review Page ...6 - 6 6.7.1 Entering the Graphic Trends Review Page ...6 - 6 6.7.2 Setting Graphic Trends ...6 - 6 6.7.3 Printing a Graphic Trends Report ...6 - 7 6.7.4 Exporting Trend Data ...6 - 7 6.8 Full Disclosure Review Page ...6 - 7 6.8.1 Entering the Full Disclosure Review Page ...6 - 7 6.8.2 Selecting Waveforms ...6 - 7 6.8.3 Compressed Waveform ...6 - 8 6.8.4 Detail Waveform Window ...6 - 8 6.8.5 Printing Compressed Waveforms or Detail Waveforms ... 6 - 12 6.8.6 Recording Detailed Waveforms ... 6 - 12 6.8.7 Exporting Waveform Data ... 6 - 13 6.9 Events Review Page ... 6 - 13 6.9.1 Entering the Events Review Page ... 6 - 13 6.9.2 Event List ... 6 - 13 6.9.3 Event Detail Window ... 6 - 14 6.9.4 Printing Events ... 6 - 15 6.9.5 Recording Event Detail ... 6 - 16 6.10 OxyCRG Review Page ... 6 - 16 6.10.1 OxyCRG Review Page (Displaying ABD Events) ... 6 - 16 6.10.2 OxyCRG Review Page (Not Displaying ABD Events) ... 6 - 18 6.11 12-Lead ECG Review Page ... 6 - 18 6.11.1 Entering the 12-Lead Review Page ... 6 - 18 6.11.2 Median Complex Window (For Glasgow Algorithm Only) ... 6 - 18 6.11.3 Configuring 12-Lead ECG Waveforms ... 6 - 18 6.11.4 Caliper Measurement ... 6 - 19 6.11.5 Printing 12-Lead Analysis Reports ... 6 - 19 6.12 ST Review Page ... 6 - 19 6.12.1 Entering the ST Review Page ... 6 - 19 6.12.2 Setting ST Reference Templates ... 6 - 19 6.12.3 Displaying/Hiding ST Reference Templates ... 6 - 20 6.12.4 Displaying/Hiding Markers ... 6 - 20 6.12.5 Printing ST Segment Waveforms ... 6 - 20 6.13 Arrhythmia Statistics Page ... 6 - 20 6.13.1 Entering the Arrhythmia Statistics Page ... 6 - 20 6.13.2 Viewing Arrhythmia Statistics ... 6 - 20 6.13.3 Printing Arrhythmia Statistics Results ... 6 - 21 7 Calculation ...7 - 1

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7.1 Calculation Overview ...7 - 1 7.2 Calculation Safety Information ...7 - 1 7.3 Accessing the Calculation Screen ...7 - 1 7.4 Drug Calculations ...7 - 2 7.4.1 Performing Drug Calculations ...7 - 2 7.4.2 Viewing a Titration Table ...7 - 2 7.4.3 Printing a Titration Table ...7 - 2 7.4.4 Drug Calculation Formula ...7 - 3 7.4.5 Titration Table Calculation Formula ...7 - 3 7.5 Hemodynamic Calculations ...7 - 3 7.5.1 Performing Hemodynamic Calculations ...7 - 3 7.5.2 Viewing Hemodynamic Calculation Results ...7 - 4 7.5.3 Printing Hemodynamic Calculation Results ...7 - 4 7.5.4 Input Parameters for Hemodynamic Calculations ...7 - 4 7.5.5 Calculated Parameters and Formulas for Hemodynamic Calculations ...7 - 4 7.6 Oxygenation Calculations ...7 - 5 7.6.1 Performing Oxygenation Calculations ...7 - 5 7.6.2 Viewing Oxygenation Calculation Results ...7 - 5 7.6.3 Printing Oxygenation Calculation Results ...7 - 5 7.6.4 Input Parameters for Oxygenation Calculations ...7 - 6 7.6.5 Calculated Parameters and Formulas for Oxygenation Calculations ...7 - 6 7.7 Ventilation Calculations ...7 - 7 7.7.1 Performing Ventilation Calculations ...7 - 7 7.7.2 Viewing Ventilation Calculation Results ...7 - 7 7.7.3 Printing Ventilation Calculation Results ...7 - 7 7.7.4 Input Parameters for Ventilation Calculations ...7 - 7 7.7.5 Calculated Parameters and Formulas for Ventilation Calculations ...7 - 8 7.8 Renal Calculations ...7 - 8 7.8.1 Performing Renal Calculations ...7 - 8 7.8.2 Viewing Renal Calculation Results ...7 - 8 7.8.3 Printing Renal Calculation Results ...7 - 8 7.8.4 Calculated Parameters and Formulas for Renal Calculations ...7 - 9 7.8.5 Calculated Parameters and Formulas for Renal Calculations ...7 - 9 8 Blood Pressure Analysis Report ... 8 - 1 8.1 Overview ...8 - 1 8.2 Accessing the Blood Pressure Analysis Screen ...8 - 1 8.3 Patient Management ...8 - 1 8.3.1 Adding a New Patient ...8 - 1 8.3.2 Changing Patient Information ...8 - 1 8.3.3 Searching Patients ...8 - 2 8.3.4 Importing Patient Data ...8 - 2 8.3.5 Exporting Patient Data ...8 - 2 8.3.6 Deleting Patients ...8 - 3 8.4 Blood Pressure Analysis Reports ...8 - 3 8.4.1 Viewing Blood Pressure Analysis Reports ...8 - 3 8.4.2 Printing Blood Pressure Analysis Reports ...8 - 3 8.5 Basic Settings ...8 - 3

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9 Printing ...9 - 1 9.1 Supported Printers ...9 - 1 9.2 Starting Printing ...9 - 1 9.2.1 Manually Starting Printing ...9 - 1 9.2.2 Automatically Starting Printing ...9 - 6 9.3 Stopping Printing ...9 - 7 9.4 Viewing Printer Statuses ...9 - 7 9.5 Configuring Reports ...9 - 7 9.5.1 Accessing the Print Setup Menu ...9 - 7 9.5.2 Setting Realtime Reports and ECG Reports ...9 - 7 9.5.3 Setting End Case Reports ...9 - 8 9.5.4 Setting Scheduled Reports ... 9 - 10 9.6 Printer Out of Paper ... 9 - 10 10 Recording ...10 - 1 10.1 Supported Recorders ... 10 - 1 10.2 Loading Paper ... 10 - 3 10.2.1 Loading Paper for the TR6-B Recorder ... 10 - 3 10.2.2 Loading Paper for the TR6-F Recorder ... 10 - 4 10.3 Setting the Recorder ... 10 - 4 10.4 Starting Recordings ... 10 - 5 10.4.1 Manually Starting Recordings ... 10 - 5 10.4.2 Automatically Starting Recordings ... 10 - 5 10.5 Stopping Recordings ... 10 - 6 10.5.1 Manually Stopping Recordings ... 10 - 6 10.5.2 Automatically Stopping Recordings ... 10 - 6 11 Viewing Other Patients ...11 - 1 11.1 Overview ... 11 - 1 11.2 Network Settings and Bed Authorization for Remote View ... 11 - 1 11.3 Viewing Other Patients ... 11 - 1 11.3.1 Assigning an Overview Bed to a Patient Sector ... 11 - 1 11.3.2 Viewing a Bed Temporarily through the Bed List ... 11 - 2 11.4 Clearing an Overview Bed ... 11 - 2 12 System Setup ...12 - 1 12.1 System Setup Overview ... 12 - 1 12.2 General Tab ... 12 - 1 12.2.1 Accessing the General Setup Page ... 12 - 1 12.2.2 Adjusting Alarm Volumes ... 12 - 1 12.2.3 Viewing System Help Information ... 12 - 1 12.2.4 Calibrating the Screen ... 12 - 1 12.2.5 Resetting the Recorder Service ... 12 - 2 12.3 Display Tab ... 12 - 2 12.3.1 Accessing the Display Setup Page ... 12 - 2 12.3.2 Setting Parameter Colors ... 12 - 2 12.3.3 Screen Setup ... 12 - 2

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12.3.4 Setting Sectors ... 12 - 4 12.3.5 Setting Patient Window ... 12 - 4 12.3.6 Setting Other Display Items ... 12 - 4 12.4 Alarm Tab ... 12 - 5 12.4.1 Accessing the Alarm Setup Page ... 12 - 5 12.4.2 Configuring Alarm Audio Properties ... 12 - 5 12.4.3 Configuring Other Alarm-Related Items ... 12 - 6 12.4.4 Exporting the Alarm Log ... 12 - 6 12.5 Patient Management Tab ... 12 - 6 12.5.1 Accessing the Patient Management Page ... 12 - 6 12.5.2 Configuring Patient Fields ... 12 - 7 12.5.3 Setting ADT Query ... 12 - 7 12.5.4 Setting Discharged Patients ... 12 - 7 12.5.5 Setting Patient Location ... 12 - 7 12.5.6 Setting Patient Group ... 12 - 7 12.5.7 Setting Care Groups ... 12 - 7 12.5.8 Setting Other Patient Information Items ... 12 - 8 12.6 Device Management Tab ... 12 - 9 12.6.1 Accessing the Device Management Screen ... 12 - 9 12.6.2 Device Management Tab at the CentralStationAdmitting Monitoring Devices ... 12 - 9 12.6.3 Device Management Tab at the WorkStation/ViewStation ...12 - 10 12.6.4 Setting the Bed List ...12 - 11 12.7 Review Tab ...12 - 11 12.7.1 Accessing the Review Setup Page ...12 - 11 12.7.2 Setting Trend Groups ...12 - 12 12.7.3 Setting Full Disclosure ...12 - 12 12.7.4 Setting Events ...12 - 13 12.7.5 Setting Arrhythmia Mark Colors ...12 - 13 12.7.6 Setting Patient Data Export ...12 - 13 12.8 Telemetry Tab ...12 - 13 12.8.1 Accessing the Telemetry Setup Page ...12 - 13 12.8.2 Setting Alarm Properties for Telemetry Devices ...12 - 13 12.8.3 Setting ECG Related Items for Telemetry Devices ...12 - 14 12.8.4 Setting Nurse Call Properties ...12 - 14 12.8.5 Frequency Setup ...12 - 15 12.9 Network Tab ...12 - 15 12.9.1 Accessing the Network Setup Page ...12 - 15 12.9.2 Setting General Communication Conditions ...12 - 15 12.9.3 Setting the Master Server ...12 - 16 12.9.4 Setting Results Service ...12 - 16 12.9.5 Configuring eGateway ...12 - 17 12.9.6 Setting CentralStation Authorization ...12 - 18 12.9.7 Setting CentralStation Connection ...12 - 19 12.9.8 Setting Bed Authorization ...12 - 19 12.9.9 Setting the AP Management Tab ...12 - 19 12.9.10 MLDAP ...12 - 20 12.9.11 Installing and Setting Mobile Server ...12 - 20 12.10 Print Tab ...12 - 21 12.10.1 Accessing the Print Setup Page ...12 - 21

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12.10.2 Setting a Printer ...12 - 21 12.10.3 Setting Scheduled Reports ...12 - 21 12.10.4 Setting End Case Reports ...12 - 22 12.10.5 Setting Report Layout ...12 - 22 12.10.6 Setting ECG Reports ...12 - 22 12.10.7 Setting PDF File Name ...12 - 22 12.10.8 Setting the Recorder ...12 - 22 12.10.9 Setting Other Print-Related Items ...12 - 23 12.11 Configuration Tab ...12 - 23 12.11.1 Accessing the Configuration Setup Page ...12 - 23 12.11.2 Setting Telemetry Configurations ...12 - 23 12.11.3 Setting Department Configurations ...12 - 23 12.11.4 Setting the Department List ...12 - 24 12.11.5 Setting Assignment between Telemetry Devices and Departments ...12 - 24 12.11.6 Printing, Backing Up, and Restoring All Settings ...12 - 25 12.12 Other Tab ...12 - 25 12.12.1 Accessing the Other Setup Page ...12 - 25 12.12.2 Setting Units ...12 - 25 12.12.3 Setting Units for Integrated Devices ...12 - 25 12.12.4 Configuring Module ...12 - 25 12.12.5 Setting Time ...12 - 26 12.12.6 Setting Authorization Setup ...12 - 26 12.12.7 Setting Language ...12 - 28 12.12.8 Setting A Device Location ...12 - 28 12.12.9 Defining the Night Time ...12 - 28 12.12.10 Exporting Logs ...12 - 28 12.12.11 Third-Party Application ...12 - 29 12.13 Factory Maintenance Tab ...12 - 31 12.14 Configuring CentralStation’s System Settings via the WorkStation ...12 - 31 13 Maintenance ...13 - 1 13.1 Overview ... 13 - 1 13.2 Maintenance Safety Information ... 13 - 1 13.3 General Inspection ... 13 - 2 13.4 Cleaning ... 13 - 2 A Technical Specifications ... A - 1 A.1 Requirements ... A - 1 A.2 Audio Signals ... A - 2 A.3 Maximum Number of Monitoring Devices ... A - 2 A.4 Maximum Number of Patient Sectors on the Multibed Screen ... A - 2 A.5 Wired Network ... A - 2 A.6 Review ... A - 2 A.7 Calculation ... A - 3 A.8 Print ... A - 3 A.9 Recorder ... A - 3 A.10 Data Export ... A - 4 B CMS Alarm Messages ...B - 1 8

B.1 Overview ... B - 1 B.2 Alarm Messages in the System Alarm Area ... B - 1 B.3 Alarm Messages in Patient Sectors ... B - 2 C Default Settings ...C - 1 C.1 Overview ... C - 1 C.2 General Tab ... C - 1 C.3 Display Tab ... C - 2 C.4 Alarm Tab ... C - 3 C.5 Patient Management Tab ... C - 4 C.6 Review Tab ... C - 5 C.7 Telemetry Tab ... C - 7 C.8 Network Tab ... C - 7 C.9 Print Tab ... C - 9 C.10 Other Tab ...C - 10 D Units, Symbols and Abbreviations ... D - 1 D.1 Units ...D - 1 D.2 Symbols ...D - 2 D.3 Abbreviations ...D - 3

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Safety

1.1

Safety Information The safety statements presented in this chapter refer to the basic safety information that the operator of the BeneVision Central Monitoring System (hereinafter referred to as the CMS) shall pay attention to and abide by. There are additional safety statements in other chapters or sections, which may be the same as or similar to the following, or specific to the operations

WARNING

• Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION

• Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE

• Provides application tips or other useful information to ensure that you get the most from your product.

1.1.1

Warnings WARNING

• The CMS is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on it.

• The physiological waveforms, parameters and alarms displayed on the CMS screen are for clinician’s reference only and cannot be directly used as the basis for clinical treatment. Before giving invasive treatment to a patient, you must go to the corresponding monitoring devices to confirm the results you have obtained from the CMS.

• If any value displayed on the CMS screen is abnormal or questionable, first determine the patient’s

vital signs by alternative means and then verify that the CMS and the monitoring devices connected to the CMS are working properly.

• The CMS is a clinical information device. Except for using such components as the mouse,

touchscreen and keyboard to perform normal operations, do not touch or disassemble any other component, especially the power component; otherwise, it may result in personnel injury.

• The computer running the CMS software must comply with local relevant regulations. The CMS is intended to connect with Mindray monitoring devices only. Connecting devices made by other manufacturers may cause the values displayed on the CMS to be inaccurate.

• The CMS can be constructed using a wireless local area network (WLAN) for connecting patient monitors. When data is transmitted via radio frequency (RF) signals, it may impact the performance of other WLANs in the environment or the use of other RF equipment. Therefore, the wireless RF equipment must comply with CE, FCC and other local relevant standards and regulations.

1-1

WARNING

• When the CMS is transmitting data via a WLAN, loss of patient data may occur due to interference from other RF sources. • The CMS software copyright is solely owned by Mindray. No organization or individual shall resort to altering, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

• Data communication must be performed within a closed network or within a virtually isolated

network provided by a hospital for all network functions. The hospital is responsible for ensuring the security of the virtually isolated network.

• Do not connect any external audio device to the CMS. • Do not block the speaker of the CMS. • Do not rely exclusively on audible alarm system. Setting alarm volume to a low level may result in a hazard to the patient. • PACEMAKER PATIENTS – On ventricular paced patients, episodes of Ventricular Tachycardia may not always be detected. Do not rely entirely upon the system’s automated arrhythmia detection algorithm. Keep pacemaker patients under close surveillance.

• A hazard can exist if different alarm presets are used for the same or similar equipment in any single area.

1.1.2

Cautions CAUTION

• The service life of the CMS depends on its hardware. Rough treatment, dropping or collision should be avoided in the operation on the keyboard, mouse and computer; otherwise, the service life of the CMS may be shortened.

• Components of the CMS, such as the keyboard and mouse, may be contaminated by microorganisms during transport, storage and use. • Before removing components of the CMS from their packaging, the packaging should be inspected for damage. In case of any damage, contact the carrier or Mindray immediately. • All CMS equipment must utilize the hospital emergency power system. Failure to do so will result in loss of monitoring during extended periods of power failure. Hospitals without an emergency power system should use an Uninterruptible Power Supply (UPS) to power the CMS. When there is a power failure, the system should be shut down by following the specified shutdown procedure before the UPS is turned off. If the system has a sudden power failure, system failure may occur and consequently the system will not work correctly next time or may even have a serious result.

• Do not transport a CMS host or displays while they are running. Doing so may cause damage. • System time should be set before the CMS is put into use. If the system time is changed when the CMS is in use, it may result in patient data loss. • The CMS is capable of connecting up to 64 monitoring devices. The CMS should be connected to the network utilizing a network designed according to the installation guide.

• Restart the CMS every three months. Long time operation of the system may lead to a failure of the operating system. • The CMS should be installed only using Mindray provided Microsoft Windows operating system, service packs, and patches. Use of unauthorized software may lead to abnormal system operation or failure.

• Do not install any third party applications not approved by Mindray or utilize the CMS host for any other purpose. If you wish to open a third-party application at the WorkStation/ViewStation, see Section 12.12.11.2 Requirements on Third-Party Applications.

1-2

CAUTION

• Using the “Show Desktop” feature in Windows is prohibited. Installing or using any other software not provided by Mindray is prohibited. Software that has not been tested or verified by Mindray may cause the instability of the system. Mindray assumes no responsibility for this. If you wish to open a third-party application at the WorkStation/ViewStation, see Section 12.12.11.2 Requirements on Third-Party Applications.

• When printing data through an external printer, be sure to follow the printer’s instructions. In case any problem occurs during printing, consult the printer’s instructions. • At the end of its service life, the CMS must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray.

• Before connecting any storage device to the CMS, ensure that this storage device is free of viruses. After the use of the storage device, verify that there are no viruses in the CMS. Otherwise, the CMS cannot work properly if it is infected with viruses.

1.1.3

Notes NOTE

• This manual describes all features and options. Your equipment may not have all of them. • Keep this manual in the vicinity of the CMS so that it can be obtained conveniently when needed. • During normal use, the operator is expected to face the front of the equipment. • All the CMS host, parts, or accessories should be from Mindray or acknowledged by Mindray.

1.2

Equipment Symbols NOTE

• Some symbols may not appear on your equipment. • This manual describes a series of typical computer symbols, which may be slightly different from what are on your computer. The computer symbols usually have their specific meanings. Refer to your computer’s operator’s manual or contact our service personnel if you have any question.

Symbol

Description

Symbol

Description

Refer to instruction manual/booklet

CAUTION: To reduce the risk of electric shock, do NOT remove cover. Refer servicing to qualified service personnel.

Alternating current

Power switch

Keyboard port

Mouse port

Serial communication (COM) port

Display port

Printer port

USB port or device

1-3

Symbol

0123

Description

Symbol

Description

Network port

Microphone port

Sound input port

Sound output port

Date of manufacture

Manufacturer

Serial number

Equipotentiality

This product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. Note: The product complies with the Council Directive 2011/65/EU. The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only.

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System Overview

2.1

Intended Use The BeneVision Central Monitoring System (hereinafter referred to as the CMS) is intended to conduct centralized monitoring of vital sign information from patient monitors, defibrillator/monitors, and telemetry transmitters through wired or wireless LAN in hospitals or medical institutions. It is intended for use in a hospital or other clinical environment under the direct supervision of a licensed healthcare practitioner.

WARNING

• The CMS is intended for use by qualified physicians or well-trained clinicians. Anyone unauthorized or untrained must not perform any operation on it. • The physiological waveforms, parameters and alarms displayed on the screen of the CMS are for reference only and cannot be directly used as the basis for clinical treatment. • If any value displayed on the CMS screen is abnormal or questionable, first determine the patient’s vital signs by alternative means and then verify that the CMS and monitoring devices are working properly.

2.2

Contraindications None

2.3

System Components The CMS mainly consists of the following components: ■

CentralStation

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ViewStation (optional)

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WorkStation (optional)

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Central Monitoring System Viewer (hereinafter referred to as the CMS Viewer) (optional)

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Computer platform

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License

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Network devices (optional)

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Remote display and data transmission device (optional)

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Recorder (optional)

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Printer (optional)

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