Passport 12-Passport 8 Patient Monitor Operators Manual Ver 13.0 July 2019

© Copyright 2014 - 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. 

Release time:

2019-07



Revision:

13.0

WARNING 

Federal Law (USA) restricts this device to sale by or on the order of a physician or other practitioner licensed by U.S. state law to use or order the use of this device.

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.

This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://www.mindrayna.com/patents.

Passport 12/Passport 8 Operator’s Manual

I

Manufacturer’s Responsibility Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray is not 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;



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



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

WARNING 

Only skilled/trained clinical professionals should operate this equipment.



It is important for the hospital or organization that uses this equipment to perform a recommended service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

II

Passport 12/Passport 8 Operator’s Manual

Service Mindray maintains a network of service representatives and factory-trained distributors. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist, contact Mindray Service. In North America contact the Service Department at (800) 288-2121, ext: 8116 for Technical Support or (201) 995-8000 for assistance in determining the nearest field service location.

Please include the instrument model number, the serial number, and a description of the problem with all requests for service.

Any questions regarding the warranty should be directed to your local sales or service representative.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, Hi-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

Distributor:

Mindray DS USA, Inc.

Address:

800 MacArthur Boulevard, Mahwah, New Jersey, 07430 USA

Tel:

1.800.288.2121, 1.201.995.8000

Website:

www.mindray.com

Passport 12/Passport 8 Operator’s Manual

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 questions, 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 conveniently referenced when needed.

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

Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your monitor.

Manual Conventions

IV



Italic text is used to quote the referenced chapters or sections.



[ ] is used to enclose screen text.



→ is used to indicate operational procedures.

Passport 12/Passport 8 Operator’s Manual

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 The Basics ... 2-1 2.1 Intended Use ... 2-1 2.2 Applied Parts ... 2-2 2.3 Main Unit ... 2-2 2.3.1 Front View ... 2-2 2.3.2 Side View ... 2-4 2.3.3 Rear View... 2-6 2.4 Modules... 2-8 2.5 Display Screen ... 2-9 2.6 QuickKeys ...2-11 3 Basic Operations... 3-1 3.1 Installation ... 3-1 3.1.1 Unpacking and Checking ... 3-2 3.1.2 Environmental Requirements ... 3-2 3.2 Getting Started ... 3-3 3.2.1 Connecting to Power Source ... 3-3 3.2.2 Turning Power On ... 3-3 3.2.3 Starting Monitoring ... 3-4 3.3 Turning Off the Monitor ... 3-4 3.4 Using the Knob ... 3-5 3.5 Using Keys ... 3-5 3.6 Using the Touchscreen... 3-5 3.7 Using the On-screen Keyboard ... 3-5 3.8 Using the Main Menu ... 3-6 3.9 Setting the Screen ... 3-6 3.10 Displaying the Timer ... 3-8 3.11 Changing General Settings ... 3-8 3.11.1 Setting up a Monitor ... 3-8 3.11.2 Changing Language ... 3-8 3.11.3 Adjusting the Screen Brightness ... 3-9 3.11.4 Showing/Hiding Help Text ... 3-9 3.11.5 Setting the Date and Time ... 3-9 3.11.6 Adjusting Volume ...3-10 3.12 Setting Parameters ...3-10 3.12.1 Switching the Parameters On/Off ...3-10 Passport 12/Passport 8 Operator’s Manual

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3.12.2 Accessing the Parameters Menu ...3-11 3.13 Operating Modes ...3-11 3.13.1 Monitoring Mode ...3-11 3.13.2 Night Mode ...3-11 3.13.3 Privacy Mode ...3-11 3.13.4 Standby Mode ...3-12 4 Managing Patients ... 4-1 4.1 Admitting a Patient ... 4-1 4.2 Quick Admitting a Patient ... 4-2 4.3 Setting the Monitor Location ... 4-2 4.4 Querying and Obtaining Patient Information ... 4-2 4.5 Querying from Local Facility... 4-3 4.6 Associating Patient Information ... 4-3 4.7 Editing Patient Information ... 4-3 4.8 Discharging a Patient ... 4-4 4.9 Transferring Patient Data ... 4-4 4.9.1 Transferring Data from the Monitor to a USB Drive ... 4-5 4.9.2 Transferring Data from a USB Drive to the Monitor ... 4-5 4.10 Connecting to a CMS ... 4-6 5 Managing Configurations ... 5-1 5.1 Introduction ... 5-1 5.2 Entering the [Manage Configuration] Menu ... 5-2 5.3 Changing Department ... 5-2 5.4 Setting Default Configuration ... 5-3 5.5 Saving Current Settings ... 5-3 5.6 Editing Configurations... 5-4 5.7 Deleting a Configuration ... 5-5 5.8 Transferring a Configuration ... 5-5 5.9 Loading a Configuration ... 5-6 5.10 Restoring the Latest Configuration Automatically ... 5-6 6 User Screens... 6-1 6.1 Configuring Your Screens ... 6-1 6.1.1 Changing the Waveform Line Size ... 6-1 6.1.2 Changing Measurement Colors ... 6-1 6.1.3 Changing Screen Layout ... 6-1 6.2 Viewing Minitrends ... 6-2 6.2.1 Having a Split-Screen View of Minitrends ... 6-2 6.2.2 Setting Minitrends ... 6-2 6.3 Viewing OxyCRG ... 6-3 6.4 Viewing Other Patients ... 6-4 6.4.1 Care Group ... 6-4 6.4.2 Viewing the Care Group Overview Bar ... 6-4 6.4.3 Understanding the View Other Patient Window... 6-5 2

Passport 12/Passport 8 Operator’s Manual

6.5 Understanding the Big Numerics Screen ... 6-6 7 Alarms ... 7-1 7.1 Alarm Categories ... 7-1 7.2 Alarm Levels... 7-2 7.3 Alarm Indicators ... 7-2 7.3.1 Alarm Lamp... 7-2 7.3.2 Alarm Messages ... 7-2 7.3.3 Flashing Numeric ... 7-3 7.3.4 Audible Alarm Tones ... 7-3 7.3.5 Alarm Status Symbols ... 7-3 7.4 Alarm Tone Configuration ... 7-4 7.4.1 Setting the Minimum Alarm Volume ... 7-4 7.4.2 Changing the Alarm Volume ... 7-4 7.4.3 Setting the Interval Between Alarm Sounds ... 7-4 7.4.4 Changing the Alarm Tone Pattern ... 7-5 7.4.5 Setting the Reminder Tones... 7-5 7.5 Understanding the Alarm Setup Menu ... 7-6 7.5.1 Setting Alarm Properties for All Parameters ... 7-7 7.5.2 Adjusting Alarm Limits Automatically ... 7-7 7.5.3 Setting Alarm Delay Time ... 7-9 7.5.4 Setting SpO2 Technical Alarm Delay ...7-10 7.5.5 Setting Recording Length...7-10 7.5.6 Entering CPB Mode (Cardiopulmonary Bypass Mode) ...7-10 7.6 Pausing Alarms ...7-11 7.7 Switching Off All Alarms...7-11 7.8 Resetting Alarms ...7-12 7.9 Latching Alarms...7-13 7.10 Testing Alarms ...7-14 7.11 Using Care Group Alarms ...7-14 7.11.1 Care Group Auto Alarms ...7-14 7.11.2 Setting Care Group Alert Tone ...7-14 7.11.3 Resetting Care Group Alarms ...7-15 8 Monitoring ECG ... 8-1 8.1 Introduction ... 8-1 8.2 Safety ...8-1 8.3 Preparing to Monitor ECG ... 8-2 8.3.1 Preparing the Patient and Placing the Electrodes ... 8-2 8.3.2 Choosing AHA or IEC Lead Placement ... 8-2 8.3.3 ECG Lead Placements ... 8-2 8.3.4 Checking Paced Status... 8-4 8.4 Understanding the ECG Display ... 8-5 8.5 Changing ECG Settings... 8-5 8.5.1 Accessing ECG Menus ... 8-5 8.5.2 Choosing the Alarm Source ... 8-6 Passport 12/Passport 8 Operator’s Manual

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8.5.3 Changing ECG Wave Settings... 8-6 8.5.4 Changing the ECG Filter Settings ... 8-6 8.5.5 Setting the ECG Lead Set ... 8-7 8.5.6 Choosing an ECG Display Screen ... 8-7 8.5.7 Setting the Notch Filter ... 8-7 8.5.8 Changing the Pacer Reject Settings ... 8-8 8.5.9 Enabling Smart Lead Off ... 8-8 8.5.10 Setting the Alarm Level for ECG Lead Off Alarms... 8-8 8.5.11 Adjusting QRS Volume ... 8-8 8.5.12 Adjusting the Minimum QRS Detection Threshold ... 8-8 8.5.13 About the Defibrillator Synchronization ... 8-9 8.6 About ST Monitoring... 8-9 8.6.1 Switching ST Monitoring On and Off ...8-10 8.6.2 Understanding the ST Display ...8-10 8.6.3 Saving the Current ST Segment as Reference ... 8-11 8.6.4 Changing the Reference Segment ...8-11 8.6.5 Deleting a Reference Segment ...8-11 8.6.6 Recording the ST Segment ...8-11 8.6.7 Changing the ST Alarm Limits ...8-11 8.6.8 Setting the ST Alarm Delay Time ...8-12 8.6.9 Adjusting ST Measurement Points ...8-12 8.7 QT/QTc Interval Monitoring ...8-13 8.7.1 QT/QTc Monitoring Limitations ...8-14 8.7.2 Enabling QT/QTc Monitoring ...8-14 8.7.3 Displaying QT/QTc Parameters and Waveform ... 8-14 8.7.4 Accessing the QT View ...8-15 8.7.5 Changing QT Settings ...8-16 8.8 About Arrhythmia Monitoring ...8-17 8.8.1 Understanding the Arrhythmia Events... 8-18 8.8.2 Changing Arrhythmia Alarm Settings...8-19 8.8.3 Changing Arrhythmia Threshold Settings ... 8-19 8.8.4 Setting the Extended Arrhythmia ...8-20 8.8.5 Reviewing Arrhythmia Events...8-20 8.9 ECG Relearning ...8-20 8.9.1 Initiating an ECG Relearning Manually ... 8-20 8.9.2 Automatic ECG Relearning ...8-21 8.10 Troubleshooting ...8-21 9 Monitoring Respiration (Resp) ... 9-1 9.1 Introduction ... 9-1 9.2 Safety Information ... 9-1 9.3 Understanding the Resp Display ... 9-1 9.4 Placing Resp Electrodes ... 9-2 9.4.1 Optimizing Lead Placement for Resp ... 9-2 9.4.2 Cardiac Overlay ... 9-2 9.4.3 Abdominal Breathing... 9-3 4

Passport 12/Passport 8 Operator’s Manual

9.4.4 Lateral Chest Expansion ... 9-3 9.5 Choosing the Respiration Lead... 9-3 9.6 Changing the Apnea Alarm Delay ... 9-3 9.7 Changing Resp Detection Mode ... 9-3 9.8 Changing Resp Wave Settings ... 9-4 9.9 Setting Respiration Rate Source ... 9-4 9.10 Setting Alarm Properties ... 9-5 10 Monitoring PR ... 10-1 10.1 Introduction ...10-1 10.2 Setting the PR Source ...10-1 10.3 Selecting the Active Alarm Source...10-2 10.4 QRS Tone...10-2 11 Monitoring SpO2... 11-1 11.1 Introduction ...11-1 11.2 Safety ...11-2 11.3 Identifying SpO2 Modules ...11-2 11.4 Applying the Sensor ...11-2 11.5 Changing SpO2 Settings ...11-3 11.5.1 Accessing SpO2 Menus ...11-3 11.5.2 Adjusting the Desat Alarm ...11-3 11.5.3 Setting SpO2 Sensitivity ...11-3 11.5.4 Changing Averaging Time ...11-3 11.5.5 Monitoring SpO2 and NIBP Simultaneously ...11-3 11.5.6 Sat-Seconds Alarm Management ...11-4 11.5.7 Changing the Speed of the Pleth Wave ...11-5 11.5.8 Zooming PI Value ...11-5 11.5.9 Setting the Alarm Level for SpO2 Sensor Off Alarm ...11-5 11.5.10 Setting the SpO2 Tone Mode ...11-5 11.6 Measurement Limitations ...11-6 11.7 Masimo Information ...11-6 11.8 Nellcor Information ...11-7 11.9 Troubleshooting ...11-7 12 Monitoring NIBP ... 12-1 12.1 Introduction ...12-1 12.2 Safety ...12-2 12.3 Measurement Limitations ...12-2 12.4 Measurement Methods ...12-3 12.5 Setting Up the NIBP Measurement ...12-3 12.5.1 Preparing the Patient ...12-3 12.5.2 Preparing to Measure NIBP ...12-3 12.5.3 Starting and Stopping Measurements ...12-4 12.5.4 Correcting the Measurement if Limb is not at Heart Level ...12-4 12.5.5 Enabling NIBP Auto Cycling and Setting the Interval ...12-4 Passport 12/Passport 8 Operator’s Manual

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12.5.6 Enabling Measurement on Clock ...12-4 12.5.7 Starting a STAT Measurement ...12-5 12.6 Understanding the NIBP Numerics ...12-5 12.7 Changing NIBP Settings...12-6 12.7.1 Setting the Initial Cuff Inflation Pressure ... 12-6 12.7.2 Setting NIBP Alarm Properties ...12-6 12.7.3 Displaying NIBP List...12-6 12.7.4 Setting the Pressure Unit ...12-6 12.7.5 Switching On NIBP End Tone ...12-6 12.8 Assisting Venous Puncture ...12-7 13 Monitoring Temp ... 13-1 13.1 Introduction ...13-1 13.2 Safety ...13-1 13.3 Making a Temp Measurement ...13-1 13.4 Understanding the Temp Display ...13-1 13.5 Setting the Temperature Unit ...13-2 14 Monitoring IBP ... 14-1 14.1 Introduction ...14-1 14.2 Safety ...14-1 14.3 Zeroing the Transducer ...14-1 14.4 Setting Up the Pressure Measurement ...14-2 14.5 Understanding the IBP Display ...14-3 14.6 Changing IBP Settings ...14-4 14.6.1 Changing a Pressure for Monitoring ...14-4 14.6.2 Setting Alarm Properties ...14-5 14.6.3 Changing Averaging Time ...14-5 14.6.4 Setting Up the IBP Wave ...14-5 14.6.5 Setting the Pressure Unit ...14-5 14.6.6 Enabling PPV Measurement and Setting PPV Source... 14-5 14.7 Overlapping IBP Waveforms ...14-6 14.8 Measuring PAWP ...14-7 14.8.1 Preparing to Measure PAWP...14-8 14.8.2 Setting Up the PAWP Measurement...14-8 14.8.3 Understanding the PAWP Setup Menu ... 14-9 14.9 Troubleshooting ...14-9 15 Monitoring Cardiac Output ... 15-1 15.1 Introduction ...15-1 15.2 Understanding the C.O. Display ...15-1 15.3 Influencing Factors ...15-2 15.4 Setting Up the C.O. Measurement ...15-2 15.5 Measuring the Blood Temperature ...15-5 15.6 Changing C.O. Settings ...15-6 15.6.1 Setting the Temperature Unit ...15-6 6

Passport 12/Passport 8 Operator’s Manual

15.6.2 Setting Alarm Properties ...15-6 16 Monitoring CO2 ... 16-1 16.1 Introduction ...16-1 16.2 CO2 Module...16-2 16.3 Preparing to Measure CO2 ...16-2 16.3.1 Making a Sidestream CO2 Measurement ...16-3 16.3.2 Making a Microstream CO2 Measurement ...16-4 16.4 Changing CO2 Settings ...16-4 16.4.1 Accessing CO2 Menus ...16-4 16.4.2 Entering the Standby Mode ...16-4 16.4.3 Setting the CO2 Unit ...16-5 16.4.4 Setting up Gas Compensations ...16-5 16.4.5 Setting up Humidity Compensation ...16-5 16.4.6 Setting the Apnea Alarm Delay ...16-6 16.4.7 Choosing a Time Interval for Peak-Picking ...16-6 16.4.8 Setting the Flow Rate ...16-6 16.4.9 Setting up the CO2 Wave...16-7 16.5 Setting RR Source ...16-7 16.6 Barometric Pressure Compensation ...16-7 16.7 Measurement Limitations ...16-8 16.8 Leakage test ...16-8 16.9 Troubleshooting the Sidestream CO2 Sampling System ...16-8 16.10 Removing Exhaust Gases from the System ...16-9 16.11 Zeroing the Sensor ...16-9 16.12 Calibrating the Sensor... 16-10 16.13 Oridion Information ... 16-10 17 Monitoring AG ... 17-1 17.1 Introduction ...17-1 17.2 Understanding the AG Display ...17-2 17.3 MAC Values ...17-3 17.4 Preparing to Measure AG ...17-4 17.5 Changing AG Settings ...17-5 17.5.1 Setting Gas Unit ...17-5 17.5.2 Setting the Apnea Alarm Delay ...17-5 17.5.3 Changing the Sample Flow Rate ...17-5 17.5.4 Entering the Standby Mode ...17-5 17.5.5 Setting up the AG Wave ...17-6 17.5.6 Setting RR Source ...17-6 17.6 Changing the Anesthetic Agent ...17-6 17.7 Measurement Limitations ...17-6 17.8 Troubleshooting ...17-7 17.8.1 When the Gas Inlet is Blocked...17-7 17.8.2 When an Internal Occlusion Occurs...17-7 17.9 Removing Exhaust Gases from the System ...17-7 Passport 12/Passport 8 Operator’s Manual

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18 Freezing Waveforms ... 18-1 18.1 Freezing Waveforms ...18-1 18.2 Viewing Frozen Waveforms ...18-1 18.3 Unfreezing Waveforms ...18-2 18.4 Recording Frozen Waveforms ...18-2 19 Review ... 19-1 19.1 Accessing Respective Review Windows ...19-1 19.2 Reviewing Graphic Trends ...19-1 19.3 Reviewing Tabular Trends ...19-2 19.4 Reviewing Events ...19-3 19.4.1 Marking Events ...19-3 19.4.2 Reviewing Events ...19-4 19.5 Reviewing Waveforms ...19-6 20 Calculations ... 20-1 20.1 Introduction ...20-1 20.2 Dose Calculations ...20-2 20.2.1 Performing Calculations ...20-2 20.2.2 Selecting the Proper Drug Unit...20-2 20.2.3 Titration Table ...20-3 20.2.4 Drug Calculation Formulas ...20-3 20.3 Oxygenation Calculations ...20-3 20.3.1 Performing Calculations ...20-3 20.3.2 Entered Parameters ...20-4 20.3.3 Calculated Parameters and Formulas ... 20-4 20.4 Ventilation Calculations ...20-5 20.4.1 Performing Calculations ...20-5 20.4.2 Entered Parameters ...20-5 20.4.3 Calculated Parameters and Formulas ... 20-6 20.5 Hemodynamic Calculations ...20-6 20.5.1 Performing Calculations ...20-6 20.5.2 Entered Parameters ...20-7 20.5.3 Calculated Parameters and Formulas ... 20-7 20.6 Renal Calculations...20-8 20.6.1 Performing Calculations ...20-8 20.6.2 Entered Parameters ...20-8 20.6.3 Calculated Parameters and Formulas ... 20-9 20.7 Understanding the Review Window ...20-9 21 Recording ... 21-1 21.1 Using a Recorder ...21-1 21.2 Overview of Recording Types ...21-1 21.3 Starting and Stopping Recordings ...21-2 21.4 Setting up the Recorder ...21-2 21.4.1 Accessing the Record Setup Menu ...21-2 8

Passport 12/Passport 8 Operator’s Manual

21.4.2 Selecting Waveforms for Recording ...21-2 21.4.3 Setting the Realtime Recording Length...21-3 21.4.4 Setting the Interval between Timed Recordings ...21-3 21.4.5 Changing the Recording Speed ...21-3 21.4.6 Clearing Recording Tasks ...21-3 21.5 Loading Paper...21-3 21.6 Removing Paper Jam ...21-4 21.7 Cleaning the Recorder Printhead ...21-4 22 Printing ... 22-1 22.1 Printer ...22-1 22.2 Connecting a printer ...22-1 22.3 Setting Up the Printer ...22-2 22.4 Starting Report Printouts ...22-2 22.5 Stopping Report Printouts ...22-3 22.6 Setting Up Reports ...22-3 22.6.1 Setting Up ECG Reports ...22-3 22.6.2 Setting Up Tabular Trends Reports ...22-3 22.6.3 Setting Up Graphic Trends Reports ...22-4 22.6.4 Setting Up Realtime Reports ...22-4 22.7 End Case Reports ...22-4 22.8 Printer Statuses ...22-4 22.8.1 Printer Out of Paper ...22-4 22.8.2 Printer Status Messages ...22-4 23 Other Functions... 23-1 23.1 Analog Output...23-1 23.2 Setting DIAP Baud Rate ...23-1 23.3 Exporting the Log ...23-1 23.4 Transferring Data ...23-1 23.4.1 Data Export System ...23-2 23.4.2 Transferring Data by Different Means ...23-2 23.5 Nurse Call ...23-3 23.6 Network Setup ...23-4 23.6.1 Setting the Network Type...23-4 23.6.2 Wireless Network Connection ...23-4 23.6.3 Viewing the MAC Address ...23-7 23.6.4 Enabling the Data Encryption...23-7 23.6.5 Setting DNS ...23-8 23.6.6 Certificates Maintenance ...23-8 23.6.7 Connecting the Monitor to the CMS ...23-9 23.6.8 Setting the Central Stations...23-9 23.6.9 Setting the Network Service Quality Level ... 23-10 23.6.10 Setting the Multicast Parameters ... 23-10 23.7 MLDAP ... 23-10 23.7.1 Setting MLDAP ... 23-10 Passport 12/Passport 8 Operator’s Manual

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23.7.2 Selecting Password for User Authentication... 23-11 24 Batteries ... 24-1 24.1 Overview ...24-1 24.2 Safety ...24-2 24.3 Battery Guidelines ...24-2 24.4 Installing or Replacing a Battery...24-3 24.5 Charging a Battery ...24-3 24.6 Conditioning a Battery ...24-4 24.7 Checking Battery Performance ...24-5 24.8 Storing a Battery...24-5 24.9 Recycling a Battery ...24-6 25 Care and Cleaning ... 25-1 25.1 General Points ...25-1 25.2 Cleaning and Disinfecting the Main Unit/Module ... 25-2 25.2.1 Approved Cleaning and Disinfecting Agents ... 25-2 25.2.2 Cleaning the Main Unit/Module ...25-3 25.2.3 Disinfecting the Main Unit/Module ...25-3 25.3 Cleaning and Disinfecting the Accessories ...25-4 25.3.1 Approved Accessories Cleaning and Disinfecting Agents ... 25-4 25.3.2 Cleaning the Accessories ...25-6 25.3.3 Disinfecting the Accessories ...25-6 25.4 Sterilization ...25-6 26 User Maintenance ... 26-1 26.1 General Inspection ...26-1 26.2 Maintenance and Testing Schedule ...26-2 26.3 Checking Monitor and Module Information ...26-3 26.4 ECG Verification ...26-3 26.5 NIBP Leakage Test ...26-3 26.6 CO2 Leakage Test ...26-4 26.7 AG Tests...26-5 26.7.1 AG Leakage Test...26-5 26.8 Calibrating the Touchscreen ...26-5 26.9 Entering/Exiting Demo Mode ...26-5 27 Accessories... 27-1 27.1 ECG Accessories ...27-1 27.2 SpO2 Accessories ...27-3 27.3 NIBP Accessories...27-4 27.4 Temp Accessories ...27-5 27.5 IBP/ICP Accessories...27-6 27.6 C.O. Accessories ...27-7 27.7 CO2 Accessories...27-7 27.8 AG Accessories (for Passport 12 only)...27-8 10

Passport 12/Passport 8 Operator’s Manual

27.9 Micellaneous Accessories ...27-9 28 Part Numbers for Canadian Use ... 28-1 A Product Specifications... A-1 A.1 Monitor Safety Specifications ...A-1 A.2 Power Supply Specifications ...A-2 A.3 Physical Specifications...A-2 A.4 Hardware Specifications ...A-3 A.5 Data Storage...A-5 A.6 Wireless Network ...A-5 A.7 Measurement Specifications ...A-7 B EMC and Radio Regulatory Compliance ... B-1 B.1 EMC ...B-1 B.2 Radio Regulatory Compliance ...B-4 C Default Configurations ... C-1 C.1 Parameters Configuration ...C-1 C.2 Routine Configuration ... C-11 C.3 User Maintenance Items ... C-15 D Alarm Messages ... D-1 D.1 Physiological Alarm Messages ... D-1 D.2 Technical Alarm Messages ... D-3 E Symbols and Abbreviations ... E-1 E.1 Symbols ... E-1 E.2 Abbreviations ... E-2

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FOR YOUR NOTES

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Passport 12/Passport 8 Operator’s Manual

1 Safety 1.1 Safety Information 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 WARNINGS 

Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.



To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. If a properly grounded power outlet is not available, operate the monitor on battery power.



The equipment is not intended to be used within the Magnetic Resonance (MR) environment.



To avoid an explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).



Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual.



Do not open the equipment housings. All servicing or future upgrades must be carried out by Mindray trained and authorized personnel.



Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.



Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring.

Passport 12/Passport 8 Operator’s Manual

1-1

WARNINGS 

PATIENTS WITH A PACEMAKER – 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.



The physiological data and alarm messages displayed on the equipment should be reviewed by a clinician before being used for diagnostic interpretation and treatment.



To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement by patients or personnel.



Do not touch the equipment’s metal parts or connectors when in contact with the patient; otherwise patient injury may result.



Never mix patient electrode types or brands. Dissimilar metals or other incompatibilities may cause considerable baseline drift and may increase trace recovery time after defibrillation.



To reduce the hazard of burns during high-frequency surgical procedure, ensure that the monitor’s cables and transducers never come into contact with the electro-surgery unit (ESU).



The neutral electrode of the electro-surgery unit (ESU) shall properly contact the patient. Otherwise, burns may result.



Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

1.1.2 Cautions CAUTIONS 

Only use parts and accessories specified in this manual.



Disposable accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.



Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.



Dry the equipment immediately in case of rain or water spray.



Ensure that the patient monitor is supplied with continuous electric power during work. Sudden power failure may lead to data loss.



This equipment is intended for single patient use.



Store and use the equipment in specified environmental condition. The monitor and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.



1-2

Contact the Mindray service personnel for replacements if you find the housing is broken.

Passport 12/Passport 8 Operator’s Manual

1.1.3 Notes NOTES 

Put the equipment in a location where you can easily view and operate the equipment.



During normal use, the operator is expected to face the front of the equipment.



The equipment uses a mains plug as a means of isolation to the mains power supply. Do not position the equipment in a place difficult to operate the mains plug.



Remove the battery before shipping the monitor or if it will not be used for an extended period of time.



Keep this manual in the vicinity of the equipment so that it can be conveniently referenced when needed.



The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized.



This manual describes all features and options. Your equipment may not have all of them. They are not available in all geographies.



At the end of its service life, the equipment, as well as its accessories, 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.



When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.

1.2 Equipment Symbols Some symbols may not appear on your equipment. Caution

Plastics identification symbol

Refer to instruction manual/ booklet

General warning sign

Power ON/OFF (for a part of the equipment)

Battery indicator

Alternating current

VGA output

Equipotentiality

Graphical record

USB connector

Network connector

Zero key

Input/Output

Check sensor

Calibrate key

Measure/standby

Inserted direction

Gas outlet

Serial number

Passport 12/Passport 8 Operator’s Manual

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