uMEC10, uMEC12 and uMEC15 Patient Monitor Operators Manual Rev 1.0 Jan 2016 046-008784-00(1.0)

© Copyright 2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2016-1.

WARNING z

Federal Law (USA) restricts this device to sale by or on the order of a physician.

I

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.

II

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;

„

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 z

This equipment must be operated by skilled/trained clinical professionals.

z

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.

III

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.

„

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

„

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

„

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

„

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

„

Others not caused by instrument or part itself.

IV

Customer Service Department 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

EC-Representative:

Shanghai International Holding Corp. GmbH(Europe)

Address:

Eiffestrae 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

V

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 us. 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 patient monitor.

Conventions „

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

„

[ ] is used to enclose screen texts.

„

 is used to indicate operational procedures.

VI

Content 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 Warnings... 1-2 1.1.2 Cautions ... 1-3 1.1.3 Notes ... 1-3 1.2 Equipment Symbols ... 1-4 2 The Basics ... 2-1 2.1 Monitor Description ... 2-1 2.1.1 Intended Use... 2-1 2.1.2 Applied Parts ... 2-1 2.2 Front View ... 2-2 2.3 Side View ... 2-4 2.3.1 uMEC10 ... 2-4 2.3.2 uMEC12/uMEC15 ... 2-5 2.4 Rear View ... 2-6 2.5 Display Screen ... 2-7 2.6 QuickKeys ... 2-9 3 Basic Operations ... 3-1 3.1 Installation ... 3-1 3.1.1 Unpacking and Checking ... 3-1 3.1.2 Environmental Requirements ... 3-2 3.2 Getting Started ... 3-3 3.2.1 Turning Power On ... 3-3 3.2.2 Starting Monitoring ... 3-3 3.3 Disconnecting from Power ... 3-4 3.4 Using Keys ... 3-4 3.5 Using the Touchscreen ... 3-5 3.6 Setting the Screen... 3-5 3.7 Using the On-screen Keyboard ... 3-6 3.8 Using the Main Menu... 3-7 3.9 Changing General Settings ... 3-8 3.9.1 Setting up a Monitor... 3-8 3.9.2 Changing Language ... 3-8 3.9.3 Adjusting the Screen Brightness ... 3-8 3.9.4 Showing/Hiding the Help ... 3-9 3.9.5 Setting the Date and Time ... 3-9 3.9.6 Adjusting Volume ... 3-9 3.10 Setting Parameters ... 3-10 3.10.1 Switching the Parameters On/Off... 3-10 1

3.10.2 Accessing the Parameters Menu ...3-11 3.11 Operating Modes ...3-11 3.11.1 Monitoring Mode ...3-11 3.11.2 Night Mode ...3-11 3.11.3 Privacy Mode ... 3-12 3.11.4 Demo Mode ... 3-13 3.11.5 Standby Mode ... 3-13 4 Managing Patients... 4-1 4.1 Discharging a Patient ... 4-1 4.1.1 Auto Discharging a Patient after Monitor Power Off ... 4-1 4.1.2 Manually Discharging a Patient ... 4-2 4.2 Admitting a Patient ... 4-2 4.2.1 Auto Admitting a Patient ... 4-2 4.2.2 Manually Admitting a Patient ... 4-3 4.3 Managing Patient Information ... 4-3 4.3.1 Editing Patient Information ... 4-3 4.3.2 Querying and Obtaining Patient Information ... 4-3 4.3.3 Associating Patient Information ... 4-4 4.4 Transferring Patient Data via USB Drive ... 4-4 4.4.1 Transferring Data from the Monitor to a USB Drive ... 4-5 4.4.2 Viewing Data on the Monitor via USB Drive ... 4-5 4.4.3 Transferring Data from the USB Drive to Monitor ... 4-6 4.5 Connecting to a Central Monitoring System ... 4-7 5 Managing Configurations ... 5-1 5.1 Introduction ... 5-1 5.2 Entering the [Manage Configuration] Menu ... 5-2 5.3 Setting Default Configuration ... 5-2 5.4 Saving Current Settings... 5-3 5.5 Editing Configuration... 5-3 5.6 Deleting a Configuration ... 5-4 5.7 Transferring a Configuration ... 5-5 5.8 Loading a Configuration ... 5-5 5.9 Restoring the Latest Configuration Automatically ... 5-6 5.10 Modifying Password ... 5-6 6 User Screens ... 6-1 6.1 Tailoring Your Screens ... 6-1 6.1.1 Changing the Wave 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 2

6.2.2 Setting Minitrends ... 6-3 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 ... 6-5 6.4.3 Understanding the View Other Patient Window ... 6-5 6.5 Understanding the Big Numerics Screen ... 6-7 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 Message ... 7-3 7.3.3 Flashing Numeric ... 7-3 7.3.4 Audible Alarm Tones ... 7-3 7.3.5 Alarm Status Symbols ... 7-4 7.4 Alarm Tone Configuration... 7-5 7.4.1 Setting the Minimum Alarm Volume ... 7-5 7.4.2 Changing the Alarm Volume ... 7-5 7.4.3 Setting the Interval between Alarm Sounds ... 7-5 7.4.4 Changing the Alarm Tone Pattern ... 7-6 7.4.5 Setting the Reminder Tones ... 7-7 7.5 Understanding the Alarm Setup Menu ... 7-7 7.5.1 Setting Alarm Properties for All Parameters ... 7-8 7.5.2 Adjusting Alarm Limits Automatically ... 7-9 7.5.3 Setting Alarm Delay Time ... 7-12 7.5.4 Setting SpO2 Technical Alarm Delay ... 7-12 7.5.5 Setting Recording Length... 7-13 7.6 Pausing Alarms ... 7-13 7.7 Switching Off All Alarms ... 7-14 7.8 Resetting Alarms ... 7-15 7.9 Latching Alarms ... 7-16 7.10 Testing Alarms... 7-17 7.11 Using Care Group Alarms ... 7-17 7.11.1 Care Group Auto Alarms ... 7-17 7.11.2 Setting Care Group Alert Tone ... 7-17 7.11.3 Resetting Care Group Alarms... 7-18 7.12 When an Alarm Occurs ... 7-18 8 Monitoring ECG ... 8-1 8.1 Introduction ... 8-1 8.2 Safety ... 8-1 8.3 Preparing to Monitor ECG ... 8-2 3

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... 8-3 8.3.4 Checking Paced Status ... 8-5 8.4 Understanding the ECG Display ... 8-6 8.5 Changing ECG Settings ... 8-7 8.5.1 Accessing ECG Menus ... 8-7 8.5.2 Choosing the Alarm Source... 8-7 8.5.3 Setting the ECG Lead Set... 8-7 8.5.4 Choosing an ECG Display Screen ... 8-7 8.5.5 Changing the ECG Filter Settings ... 8-8 8.5.6 Setting the Notch Filter ... 8-8 8.5.7 Changing the Pacer Reject Settings ... 8-9 8.5.8 Changing ECG Wave Settings ... 8-9 8.5.9 Enabling Smart Lead Off ... 8-10 8.5.10 Setting the Alarm Level for ECG Lead Off Alarms ... 8-10 8.5.11 Adjusting QRS Volume ... 8-10 8.5.12 About the Defibrillator Synchronization ... 8-10 8.6 About ST Monitoring ...8-11 8.6.1 Switching ST On and Off ...8-11 8.6.2 Changing ST Filter Settings ...8-11 8.6.3 Understanding the ST Display ... 8-12 8.6.4 Saving the Current ST Segment as Reference ... 8-13 8.6.5 Changing the Reference Segment ... 8-13 8.6.6 Deleting a Reference Segment ... 8-14 8.6.7 Recording the ST Segment ... 8-14 8.6.8 Changing the ST Alarm Limits ... 8-14 8.6.9 Setting the ST Alarm Delay Time ... 8-14 8.6.10 Adjusting ST Measurement Points ... 8-14 8.7 About Arrhythmia Monitoring ... 8-16 8.7.1 Understanding the Arrhythmia Events ... 8-16 8.7.2 Changing Arrhythmia Alarm Settings ... 8-18 8.7.3 Changing Arrhythmia Threshold Settings ... 8-18 8.7.4 Setting the Extended Arrhythmia ... 8-19 8.7.5 Reviewing Arrhythmia Events ... 8-19 8.8 About QT/QTc Interval Monitoring ... 8-20 8.8.1 QT/QTc Monitoring Limitations ... 8-20 8.8.2 Enabling QT/QTc Monitoring ... 8-21 8.8.3 Displaying QT Numerics and Segments ... 8-21 8.8.4 Saving the Current QTc as Reference ... 8-22 8.8.5 Changing QT Settings ... 8-22 8.9 About HR Analysis... 8-23 8.10 ECG Relearning ... 8-24 8.10.1 Initiating an ECG Relearning Manually ... 8-24 4

8.10.2 Automatic ECG Relearning ... 8-24 8.11 12-Lead ECG Monitoring (for uMEC12/uMEC15) ... 8-25 8.11.1 Entering the 12-lead ECG Monitoring Screen ... 8-25 8.11.2 Extending the Rhythm Lead Waveform Area ... 8-26 8.12 Troubleshooting ... 8-26 9 Monitoring Respiration (Resp) ... 9-1 9.1 Introduction ... 9-1 9.2 Safety Information ... 9-1 9.3 Understanding the Resp Display ... 9-2 9.4 Placing Resp Electrodes ... 9-2 9.4.1 Optimizing Lead Placement for Resp ... 9-3 9.4.2 Cardiac Overlay ... 9-3 9.4.3 Abdominal Breathing ... 9-3 9.4.4 Lateral Chest Expansion... 9-4 9.5 Choosing the Respiration Lead ... 9-4 9.6 Changing the Apnea Alarm Delay ... 9-4 9.7 Changing Resp Detection Mode ... 9-4 9.8 Changing Resp Wave Settings ... 9-5 9.9 Setting RR Source ... 9-5 9.10 Setting Alarm Properties ... 9-6 9.11 Switching Resp Measurement On/Off... 9-6 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 Applying the Sensor ...11-2 11.4 Changing SpO2 Settings ...11-3 11.4.1 Accessing SpO2 Menus ...11-3 11.4.2 Adjusting the Desat Alarm ...11-3 11.4.3 Changing Averaging Time ...11-3 11.4.4 Monitoring SpO2 and NIBP Simultaneously ...11-4 11.4.5 Changing the Speed of the Pleth Wave...11-4 11.4.6 Zooming PI Value ...11-4 11.4.7 Setting the Alarm Level for SpO2 Sensor Off Alarm ...11-4 11.4.8 Setting the SpO2 Tone Mode ...11-4 11.5 Measurement Limitations ...11-5 11.6 Troubleshooting ...11-5 5

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 ... 12-5 12.5.6 Starting a STAT Measurement... 12-5 12.6 Understanding the NIBP Numerics ... 12-6 12.7 Making NIBP Analysis... 12-7 12.8 Changing NIBP Settings ... 12-7 12.8.1 Setting the Initial Cuff Inflation Pressure... 12-7 12.8.2 Setting NIBP Alarm Properties ... 12-8 12.8.3 Displaying NIBP List ... 12-8 12.8.4 Setting the Pressure Unit ... 12-8 12.8.5 Switching On NIBP End Tone... 12-8 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 ... 13-2 13.5 Setting the Temperature Unit ... 13-2 14 Monitoring IBP (for uMEC12/uMEC15) ... 14-1 14.1 Introduction ... 14-1 14.2 Safety ... 14-1 14.3 Zeroing the Transducer ... 14-2 14.4 Setting Up the Pressure Measurement ... 14-3 14.5 Understanding the IBP Display ... 14-4 14.6 Changing IBP Settings ... 14-5 14.6.1 Changing a Pressure for Monitoring ... 14-5 14.6.2 Setting the Pressure Label Order ... 14-6 14.6.3 Setting Alarm Properties ... 14-6 14.6.4 Changing Averaging Time ... 14-6 14.6.5 Setting Up the IBP Wave ... 14-6 14.6.6 Setting the Pressure Unit ... 14-7 14.7 Troubleshooting ... 14-7 15 Monitoring Cardiac Output (for uMEC12/uMEC15) ... 15-1 6

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 ... 15-6 15.6 Changing C.O. Settings ... 15-6 15.6.1 Setting the Temperature Unit ... 15-6 15.6.2 Setting Alarm Properties ... 15-6 16 Monitoring Carbon Dioxide (for uMEC12/uMEC15) ... 16-1 16.1 Introduction ... 16-1 16.2 Safety ... 16-1 16.3 Measurement Limitations... 16-2 16.4 Understanding CO2 Display ... 16-2 16.5 Measuring CO2 ... 16-3 16.5.1 Making a CO2 Measurement ... 16-3 16.5.2 Zeroing the CO2 Module ... 16-5 16.6 Changing CO2 Settings ... 16-6 16.6.1 Changing CO2 Alarm Settings ... 16-6 16.6.2 Changing the CO2 Unit ... 16-6 16.6.3 Setting the CO2 Waveform ... 16-6 16.6.4 Setting the RR Source ... 16-6 16.6.5 Entering the Standby Mode ... 16-7 16.6.6 Setting the Auto Standby ... 16-7 16.6.7 Setting the Gas Compensations ... 16-7 16.6.8 Setting Humidity Compensation ... 16-8 16.7 Calibrating the CO2 Module... 16-8 17 Freezing Waveforms ... 17-1 17.1 Freezing Waveforms... 17-1 17.2 Viewing Frozen Waveforms ... 17-1 17.3 Unfreezing Waveforms... 17-2 17.4 Recording Frozen Waveforms ... 17-2 18 Review ... 18-1 18.1 Accessing Respective Review Windows ... 18-1 18.2 Reviewing Graphic Trends ... 18-1 18.3 Reviewing Tabular Trends... 18-3 18.4 Reviewing Events... 18-4 18.5 Reviewing Waveforms ... 18-6 19 Calculations ... 19-1 19.1 Introduction ... 19-1 19.2 Dose Calculations... 19-2 7

19.2.1 Performing Calculations... 19-2 19.2.2 Selecting the Proper Drug Unit ... 19-2 19.2.3 Titration Table ... 19-3 19.2.4 Drug Calculation Formulas ... 19-3 19.3 Hemodynamic Calculations ... 19-4 19.3.1 Performing Calculations... 19-4 19.3.2 Entered Parameters... 19-4 19.3.3 Calculated Parameters and Formulas ... 19-5 19.4 Understanding the Review Window ... 19-6 20 Recording ... 20-1 20.1 Using a Recorder ... 20-1 20.2 Overview of Recording Types ... 20-2 20.3 Starting and Stopping Recordings ... 20-2 20.4 Setting Up the Recorder ... 20-3 20.4.1 Accessing the Record Setup Menu ... 20-3 20.4.2 Selecting Waveforms for Recording ... 20-3 20.4.3 Setting the Realtime Recording Length ... 20-3 20.4.4 Setting the Interval between Timed Recordings... 20-3 20.4.5 Changing the Recording Speed ... 20-3 20.4.6 Clearing Recording Tasks ... 20-4 20.5 Loading Paper ... 20-4 20.6 Removing Paper Jam... 20-5 20.7 Cleaning the Recorder Printhead... 20-5 21 Printing ... 21-1 21.1 Printer ... 21-1 21.2 Connecting a printer ... 21-1 21.3 Setting Up the Printer ... 21-2 21.4 Starting Report Printouts ... 21-2 21.5 Stopping Reports Printouts ... 21-2 21.6 Setting Up Reports ... 21-3 21.6.1 Setting Up ECG Reports ... 21-3 21.6.2 Setting Up Tabular Trends Reports ... 21-3 21.6.3 Setting Up Graphic Trends Reports ... 21-4 21.6.4 Setting Up Realtime Reports ... 21-4 21.7 Printer Statuses ... 21-4 21.7.1 Printer Out of Paper ... 21-4 21.7.2 Printer Status Messages... 21-5 22 Other Functions ... 22-1 22.1 Analog Output ... 22-1 22.2 Exporting the Log ... 22-1 22.3 Transferring Data ... 22-1 8

22.3.1 Data Export System... 22-1 22.3.2 Transferring Data by Different Means ... 22-2 22.4 Nurse Call ... 22-3 22.5 Network Connection ... 22-4 22.5.1 Selecting a Network Type ... 22-4 22.5.2 Setting the Wired Network ... 22-4 22.5.3 Setting the Wireless Network ... 22-4 22.5.4 Testing the Wireless Network... 22-5 22.5.5 Setting the Multicast Parameters ... 22-5 22.5.6 Connecting the monitor to the CMS ... 22-6 23 Batteries ... 23-1 23.1 Overview ... 23-1 23.2 Battery Guidelines... 23-1 23.3 Battery Maintenance ... 23-2 23.4 Battery Recycling ... 23-3 24 Care and Cleaning... 24-1 24.1 General Points ... 24-1 24.2 Cleaning ... 24-2 24.3 Disinfection ... 24-3 24.4 Sterilization ... 24-3 25 Maintenance ... 25-1 25.1 Regular Inspection ... 25-1 25.2 Maintenance and Testing Schedule ... 25-2 25.3 Checking Monitor and Module Information ... 25-3 25.4 Calibrating ECG ... 25-3 25.5 NIBP Tests... 25-4 25.5.1 NIBP Leakage Test ... 25-4 25.5.2 NIBP Accuracy Test ... 25-5 25.6 CO2 Tests ... 25-6 25.6.1 CO2 Leakage Test ... 25-6 25.6.2 CO2 Accuracy Test ... 25-6 25.6.3 Calibrating CO2 ... 25-7 25.7 Calibrating the Touchscreen ... 25-8 25.8 Electrical Safety Tests ... 25-8 26 Accessories ... 26-1 26.1 ECG Accessories ... 26-1 26.2 SpO2 Accessories ... 26-4 26.3 NIBP Accessories ... 26-5 26.4 Temp Accessories ... 26-6 26.5 IBP Accessories (for uMEC12/uMEC15) ... 26-7 9

26.6 C.O. Accessories (for uMEC12/uMEC15) ... 26-7 26.7 CO2 Accessories (for uMEC12/uMEC15) ... 26-8 26.8 Others ... 26-9 A Product Specifications ... A-1 A.1 Monitor Safety Specifications ... A-1 A.2 Power Supply Specifications ... A-2 A.3 Physical Specifications ... A-3 A.4 Hardware Specifications ... A-3 A.5 Data Storage ... A-5 A.6 Wireless Network ... A-6 A.7 Measurement Specifications... A-6 B EMC and Radio Regulatory Compliance ... B-1 B.1 EMC ... B-1 B.2 Radio Regulatory Compliance... B-6 C Default Configurations ... C-1 C.1 Parameters Configuration ... C-1 C.2 Routine Configuration ... C-12 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 Electrical Safety Inspection ... E-1 E.1 Power Cord Plug ... E-1 E.2 Device Enclosure and Accessories ... E-2 E.3 Device Labelling... E-2 E.4 Protective Earth Resistance ... E-3 E.5 Earth Leakage Test... E-3 E.6 Patient Leakage Current ... E-4 E.7 Mains on Applied Part Leakage ... E-4 E.8 Patient Auxiliary Current ... E-5 F Symbols and Abbreviations ... F-1 F.1 Symbols ... F-1 F.2 Abbreviations ... F-3

10

1 Safety 1.1 Safety Information WARNING z

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

CAUTION z

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

NOTE z

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

1-1

1.1.1 Warnings WARNING z

This equipment is used to one patient at a time.

z

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.

z

To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.If the installation does not provide for a protective earth conductor, disconnect it from the power line and operate it on battery power, if possible.

z

To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).Use and store the equipment in specified environmental condition. The monitor and accessesories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.

z

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

z

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

z

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.

z

The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation.

z

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 or strangulation by patients or personnel.

z

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

z

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

z

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

z

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.

1-2

1.1.2 Cautions CAUTION z

To ensure patient safety, use only parts and accessories specified in this manual.

z

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 us.

z

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.

z

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.

z

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

z

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

1.1.3 Notes NOTE z

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

z

The equipment use a mains plug as isolation means to the mains power supply. Do not locate the equipment in a place difficult to operate the mains plug.

z

In normal use, the operator shall stand in front of the equipment.

z

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

z

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

z

This manual describes all features and options. Your equipment may not have all of them.

1-3