MEC-1000 Multi-parameter Monitor Operator’s Manual Ver 2.1 Aug 2008

CE Marking

The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. The product is in radio-interference protection class A in accordance with EN55011. The product complies with the requirement of standard EN 60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”.

Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. „

Revision number: 2.1

„

Release time:

2008-08

© Copyright 2002-2008 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

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 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. Contents of this manual are subject to changes without prior notice.

II

Manufacturer’s Responsibility 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 safety, reliability and performance of this product only in the condition that: „

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

„

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

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This product is operated under strict observance of this manual.

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 „

Any Mindray product which has been subjected to misuse, negligence or accident; or

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Any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; or

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Any product of any other manufacturer.

III

Return Policy In the event that it becomes necessary to return a unit to Mindray, follow the instructions below. 1.

Obtain a return authorization.

Contact the Mindray Service Department and obtain a Mindray Customer Service Authorization Number. The Mindray Customer Service Authorization Number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mindray Customer Service Authorization Number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. 2.

Freight policy

The customer is responsible for freight charges when this product is shipped to Mindray for service (including any relevant customs fees or other freight related charges). 3.

Return address

Please send the part(s) or equipment to the address offered by Customer Service Department.

Contact Information 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

Tel:

+86 755 26582479

+86 755 26582888

Fax:

+86 755 26582934

+86 755 26582500

Website:

www.mindray.com.cn

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraße 80, 20537 Hamburg Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

IV

Preface Manual Purpose This manual provides the instructions necessary to operate the Patient Monitor (hereinafter called as this monitor) in accordance with its function and intended use. Observance of this manual is a prerequisite for proper performance and correct operation, and ensures patient and operator safety. This manual is written based on the maximum configuration. Part of this manual may not apply to your monitor. If you have any question about the configuration of your monitor, please contact our Customer Service. This manual is an integral part of and should always be kept close to the patient monitor, so that it can be obtained conveniently when necessary.

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

Illustrations and Names All illustrations in this manual are provided as examples only. They may not necessarily accord with the graph, settings or data displayed on your patient monitor. All names appeared in this manual and illustrations are fictive. It is a mere coincidence if the name is the same with yours.

Conventions „

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

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The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level or seriousness.

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FOR YOUR NOTES

VI

Contents 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 Dangers ... 1-2 1.1.2 Warnings... 1-2 1.1.3 Cautions ... 1-3 1.1.4 Notes ... 1-4 1.2 Equipment Symbols ... 1-5 2 The Basics ... 2-1 2.1 Monitor Description ... 2-1 2.1.1 Intended Use... 2-1 2.1.2 Contraindications ... 2-2 2.1.3 Components ... 2-2 2.1.4 Functions ... 2-2 2.2 External Appearance ... 2-3 2.2.1 Front Panel ... 2-3 2.2.2 Side Panel... 2-4 2.2.3 Rear Panel ... 2-5 2.3 Control Panel... 2-6 2.4 Display ... 2-7 2.5 Batteries ... 2-9 2.5.1 Battery Maintenance ... 2-10 2.5.2 Battery Recycling...2-11 3 Installation and Maintenance... 3-1 3.1 Installation... 3-1 3.1.1 Unpacking and Checking ... 3-1 3.1.2 Environmental Requirements... 3-2 3.1.3 Power Source Requirements ... 3-2 3.1.4 Bracket Mounting... 3-2 3.1.5 Installation Method ... 3-3 3.1.6 Powering on the Monitor... 3-6 3.1.7 Powering off the Monitor... 3-6 3.2 Maintenance ... 3-7 3.2.1 Inspection ... 3-7 3.2.2 Cleaning ... 3-8 3.2.3 Disinfection and Sterilization... 3-9

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4 System Menu ... 4-1 4.1 Overview... 4-1 4.2 Patient Setup ... 4-2 4.3 Default Setup... 4-4 4.4 System Setup... 4-5 4.4.1 Face Select ... 4-6 4.4.2 Alarm Setup... 4-7 4.4.3 Time Setup ... 4-8 4.4.4 Record Setup ... 4-9 4.4.5 Module Setup ...4-11 4.4.6 Trace Setup...4-11 4.4.7 Mark Event... 4-12 4.5 Selection Setup... 4-13 4.6 Monitor Version ... 4-14 4.7 Maintenance ... 4-15 4.7.1 COLOR SELF-DEFINE ... 4-16 4.8 DEMO Function... 4-17 5 Face Selection ... 5-1 5.1 Standard Screen... 5-2 5.2 Viewbed Screen... 5-3 6 Alarms ... 6-1 6.1 Overview... 6-1 6.1.1 Alarm Categories... 6-1 6.1.2 Alarm Levels ... 6-2 6.2 Alarm Modes... 6-3 6.2.1 Visual Alarms ... 6-3 6.2.2 Audible alarms ... 6-3 6.2.3 Alarm Messages ... 6-4 6.2.4 Parameter Flashes... 6-4 6.3 Alarm Statuses... 6-5 6.3.1 Alarms Disabled ... 6-5 6.3.2 Alarms Paused... 6-6 6.3.3 System Silenced ... 6-6 6.3.4 Alarms Silenced ... 6-7 6.3.5 Status Switchover... 6-7 6.4 Latching Alarms ... 6-8 6.5 Clearing Alarms ... 6-9 6.6 When an Alarm Occurs ... 6-10 7 Freezing Waveforms ... 7-1 7.1 Freezing and Unfreezing ... 7-1 7.2 FROZEN Menu... 7-2 2

7.3 Recording Frozen Waveforms... 7-3 8 Recording... 8-1 8.1 Overview... 8-1 8.2 Recording Types... 8-1 8.3 Recorder Operations... 8-4 8.4 Installing Recorder Paper... 8-7 9 Recall... 9-1 9.1 Overview... 9-1 9.2 Trend Graph Recall ... 9-2 9.3 Trend Table Recall ... 9-5 9.4 NIBP Recall ... 9-7 9.5 Alarm Event Recall ... 9-8 10 Drug Calculation ... 10-1 10.1 Drug Calculation ... 10-1 10.2 Titration Table ... 10-4 11 ECG/RESP Monitoring...11-1 11.1 Overview ...11-1 11.1.1 ECG Waveform ...11-1 11.1.2 ECG Parameters ...11-3 11.2 ECG Monitoring Procedure...11-4 11.2.1 Preparation ...11-4 11.2.2 Electrode Placement ...11-5 11.3 ECG Setup Menu ...11-9 11.4 ST Analysis ...11-13 11.4.1 Overview ...11-13 11.4.2 ST Analysis Menu ...11-14 11.5 Arrhythmia Analysis...11-17 11.5.1 Overview ...11-17 11.5.2 Arrhythmia Analysis Menu ...11-18 11.5.3 Arrhythmia Alarm Setup ...11-19 11.5.4 Arrhythmia Recall ...11-20 11.6 RESP Monitoring ...11-22 11.6.1 Overview ...11-22 11.6.2 Electrode Placement ...11-23 11.6.3 Respiration Setup ...11-24 11.7 Maintenance and Cleaning ...11-26 12 SpO2 Monitoring ... 12-1 12.1 Overview... 12-1 12.2 Principles of Operation ... 12-3 3

12.2.1 Precautions ... 12-3 12.3 Monitoring Procedure ... 12-4 12.4 Measurement Limitations... 12-6 12.5 SpO2 Setup Menu ... 12-7 13 NIBP Monitoring... 13-1 13.1 Monitoring Procedure ... 13-2 13.1.1 Cuff Selection and Placement ... 13-2 13.1.2 Operation Guides ... 13-4 13.2 Measurement Limitations... 13-5 13.3 NIBP Setup Menu ... 13-6 13.3.1 Calibration... 13-9 13.3.2 PNEUMATIC... 13-10 13.4 Maintenance and Cleaning...13-11 14 TEMP Monitoring... 14-1 14.1 Overview... 14-1 14.2 Measurement Procedure... 14-2 14.3 TEMP Setup Menu... 14-3 14.4 Maintenance and Cleaning ... 14-4 15 Accessories ... 15-1 15.1 ECG Accessories... 15-2 15.2 SpO2 Accessories... 15-4 15.3 NIBP Accessories... 15-5 15.4 TEMP Accessories ... 15-6 A Product Specification ... A-1 A.1 Safety Classifications ... A-1 A.2 Environmental Specifications... A-1 A.3 Power Source Specifications ... A-2 A.4 Hardware Specifications ... A-3 A.5 Data Storage ... A-4 A.6 ECG Specifications ... A-5 A.7 RESP Specifications... A-6 A.8 SpO2 Specifications... A-7 A.9 NIBP Specifications ... A-8 A.10 TEMP Specifications... A-8 B EMC...B-1 C Alarm Messages and Prompt Information... C-1 C.1 Physiological Alarm Messages...C-1 C.2 Technical Alarm Messages ...C-2 4

C.3 Prompt Messages...C-7 D Symbols and Abbreviations ... D-1 D.1 Symbols... D-1 D.2 Abbreviations ... D-2

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FOR YOUR NOTES

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1 Safety 1.1 Safety Information The safety statements presented in this chapter refer to the basic safety information that the operator of the patient monitor 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 followings, or specific to the operations.

DANGER z

Indicates an imminent hazard situation that, if not avoided, will result in death or serious injury.

WARNING z

Indicates a potential hazard situation 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.

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1.1.1 Dangers There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this operation manual.

1.1.2 Warnings

WARNING z

The device is intended for use by qualified clinical physicians or well-trained nurses in the specified places.

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To ensure patient safety, verify the device and accessories can function safely and normally before use.

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EXPLOSION HAZARD: Do not use this device in the presence of flammable anesthetics, explosive substances, vapors or liquids.

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You must customize the alarm settings according to the individual patient situation, and make sure the alarm sound is activated when an alarm occurs.

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ELECTRIC SHOCK: Do not open the monitor housing. All servicing and future upgrades to this device must be carried out by personnel trained and authorized by our company only.

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DEFIBRILLATION: Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could result.

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When used in conjunction with electro-surgery equipment, you must give top priority to the patient safety.

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DISPOSE: Dispose of the package material, observing the applicable waste control regulations and keeping it out of children’s reach.

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The device must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect the monitor from the power line and operate it on battery power, if possible.

1-2

1.1.3 Cautions

CAUTION z

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

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Remove the battery from the patient monitor if it will not be used or not be connected to the power line for a long period.

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Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.

z

At the end of its service life, the product described in this manual, 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 products, please contact with us.

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Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor 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.

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

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Install or carry the patient monitor properly to avoid damages caused by drop, impact, strong vibration or other mechanical force.

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1.1.4 Notes NOTE z

Keep this manual close to the patient monitor so that it can be obtained conveniently when necessary.

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This patient monitor complies with the requirements of CISPR11 (EN55011) class A.

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The software was developed per IEC601-1-4. The possibility of hazards arising from errors in software program is minimized.

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Put the patient monitor in a location where you can easily see the screen and access the operating controls.

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The instructions of this manual are based on the maximum configuration. Some of them may not apply to your patient monitor.

1-4

1.2 Equipment Symbols

NOTE z

Some symbols may not appear on all equipment.

Attention: Consult accompanying documents (this manual).

Power ON/OFF Type CF applied part. The unit displaying this symbol contains an F-type isolated (floating) patient part providing a high degree of protection against shock, and is suitable for use during defibrillation.

Equipotentiality

Manufacture date

Serial number European community representative CE marking

1-5

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.

1-6

2 The Basics 2.1 Monitor Description This monitor integrates the functions of parameter measurement, waveform monitoring, freezing, and recording, etc. Its color TFT liquid crystal display is able to show patient parameters and waveforms clearly. The monitor also features compact size, lightweight, easy-to-carry handle and built-in battery, which make it portable. The compact control panel and control knob, and the easy-to-use menu system enable you to freeze, record, or perform other operations conveniently. Besides, this monitor can be connected with the central monitoring system whereby a monitoring network will be formed.

2.1.1 Intended Use The intended use of this monitor is to monitor a fixed set of parameters (see 2.1.4 Functions) for single adult, pediatric and neonatal patient, to display patient data and waveforms, to store patient data in a trend database, and to generate alarms and recordings. This monitor is to be used in but not restricted to medical institutions such as ICU, CCU, cardiopathy ICU, operating room, emergency room and postoperative observation ward etc. This monitor is not intended for helicopter transport or home use.

WARNING z

This Monitor is to be operated by clinical physicians or appropriate medical staffs under the direction of physicians. The operator of the monitor must be well trained. Any operation by unauthorized or non-trained personnel is forbidden.

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The physiological waveforms and parameters and the alarm information displayed by the monitor are only for the reference of physicians, but cannot be used directly to determine the clinical treatment.

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