DPM 5 Patient Monitor Operators Manual Rev 12.0 March 2015 0

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: 12.0 „ Release time: 2015-03 © Copyright 2008-2015 Mindray DS USA, Inc. All rights reserved.

WARNING z

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

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Intellectual Property Statement Mindray DS USA, Inc. (hereinafter called Mindray DS) 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 copyright and patent rights of Mindray DS, nor the rights of others. Mindray DS 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 DS is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation and translation of this manual in any manner whatsoever without the written permission of Mindray DS is strictly forbidden.

is a trademark or a registered trademark of Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All third-party trademarks that appear in this manual are used solely for editorial purposes and are the property of their respective owners. Contents of this manual are subject to changes without prior notice.

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Manufacturer’s Responsibility All information contained in this manual is believed to be correct. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (hereinafter called Mindray) shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing or use of this manual. The manufacturer will not be liable for the effects on safety, reliability and performance of this product if: „

any installation operations, expansions, changes, modifications and repairs of this product are not conducted by Mindray authorized personnel; and

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the electrical installation of the relevant room does not comply with the applicable national and local requirements; and

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the product is not used in accordance with the instructions for use.

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.

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Return Policy In the event that it becomes necessary to return a unit to Mindray DS, follow the instructions below. 1. Return authorization. Contact the Customer Service Department and obtain a Customer Service Authorization number. This number must appear on the outside of the shipping container. Returned shipments will not be accepted if the 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 DS for service (this includes customs charges). 3. Return address Please send the part(s) or equipment to the address offered by the Customer Service Department.

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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

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

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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.

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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 ... 2-1 2.1.3 Components ... 2-1 2.1.4 Functions... 2-2 2.2 External Appearance ... 2-3 2.2.1 Front Panel ... 2-3 2.2.2 Left Side Panel ... 2-4 2.2.3 Right Side Panel... 2-5 2.2.4 Rear Panel ... 2-6 2.3 Control Panel... 2-7 2.4 Display ... 2-8 2.5 Batteries ... 2-10 2.5.1 Battery Guidelines...2-11 2.5.2 Battery Maintenance ... 2-12 2.5.3 Battery Recycling... 2-13 2.6 Wireless Network Card ... 2-13 3 Installation ... 3-1 3.1 Unpacking and Checking ... 3-2 3.2 Environmental Requirements... 3-2 3.3 Power Source Requirements ... 3-3 3.4 Installation Method ... 3-3 3.4.1 Bracket Mounting... 3-3 3.4.2 Connecting to AC Power Supply ... 3-3 3.4.3 Installing the Battery ... 3-4 3.4.4 Connecting Patient Sensors and Probes ... 3-4 3.4.5 Connecting the Network Cable ... 3-4 3.4.6 Auxiliary Output Port... 3-5 3.4.7 Connecting to VGA Monitor... 3-5 3.4.8 Equipotential Grounding... 3-6 3.5 Powering on the Monitor ... 3-6 3.6 Powering off the Monitor... 3-6 1

4 System Menu ... 4-1 4.1 Overview... 4-1 4.2 Patient Setup ... 4-2 4.2.1 Admit Patient... 4-3 4.2.2 Quick Admit Patient... 4-5 4.2.3 Modify Patient... 4-5 4.2.4 Clear Patient Data ... 4-5 4.2.5 Discharge Patient ... 4-5 4.3 Configuration Setup ... 4-6 4.4 System Setup... 4-7 4.4.1 Face Select ... 4-8 4.4.2 Alarm Setup... 4-8 4.4.3 Time Setup ... 4-10 4.4.4 Recorder Setup ...4-11 4.4.5 Data Output ... 4-12 4.4.6 Analog Output ... 4-13 4.4.7 Module Setup ... 4-14 4.4.8 Trace Setup... 4-15 4.4.9 Mark Event... 4-16 4.5 Selection Setup... 4-17 4.6 Monitor Version ... 4-18 4.7 Maintenance ... 4-19 4.7.1 Alarm Setup... 4-22 4.7.2 IP Address Setup ... 4-23 4.7.3 Self Definition of Color ... 4-24 4.7.4 Nurse Call Setup ... 4-25 4.7.5 IBP Pressure Calibration ... 4-26 4.7.6 CO2 User Maintain... 4-26 4.7.7 Gas Calibrate... 4-26 4.7.8 Monitor Status... 4-27 4.8 DEMO Function... 4-28 5 Face Selection ... 5-1 5.1 Standard Screen... 5-1 5.2 Trend Screen ... 5-2 5.3 OxyCRG Screen... 5-3 5.4 Viewbed Screen... 5-4 5.5 Large Font Screen ... 5-6 5.6 Standby Mode ... 5-7 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... 6-2 2

6.2.1 Visual Alarms ... 6-2 6.2.2 Audible alarms ... 6-3 6.2.3 Alarm Messages ... 6-3 6.2.4 Parameter Flashes... 6-4 6.2.5 Reminder Tones... 6-4 6.3 Alarm Statuses... 6-4 6.3.1 Alarms Disabled ... 6-4 6.3.2 Alarms Paused... 6-5 6.3.3 System Silenced ... 6-5 6.3.4 Alarm Sound Off ... 6-5 6.3.5 Status Switchover... 6-6 6.4 Latching Alarms... 6-6 6.5 Clearing Alarms ... 6-7 6.6 Testing Alarms ... 6-8 6.7 When an Alarm Occurs ... 6-8 7 Freezing Waveforms ... 7-1 7.1 Overview... 7-1 7.2 Freezing and Unfreezing ... 7-1 7.3 FROZEN Menu... 7-2 7.4 Waveform Recall... 7-3 7.5 Recording Frozen Waveforms... 7-3 8 Recording... 8-1 8.1 Overview... 8-1 8.2 Recording Types... 8-1 8.3 Recorder Operations ... 8-3 8.4 Installing Recorder Paper... 8-5 9 Recall... 9-1 9.1 Overview... 9-1 9.2 Trend Graph Recall ... 9-2 9.3 Trend Table Recall ... 9-4 9.4 NIBP Recall ... 9-6 9.5 Alarm Event Recall ... 9-7 9.6 Non-Volatile Data Storage ... 9-9 10 ECG/RESP Monitoring ... 10-1 10.1 Overview... 10-1 10.2 ECG Monitoring Procedure ... 10-1 10.2.1 Preparation ... 10-1 10.2.2 Electrode Placement... 10-2 10.2.3 Characteristics of Quality ECG Signal... 10-7 10.3 ECG Display ... 10-8 10.3.1 ECG Waveform ... 10-8 10.3.2 ECG Parameters ... 10-9 3

10.4 ECG Setup Menu ... 10-10 10.5 ST Analysis ... 10-18 10.5.1 Overview... 10-18 10.5.2 3/5-Lead ST Analysis Menu... 10-18 10.5.3 Adjusting ST Measurement Point... 10-20 10.6 Arrhythmia Analysis ... 10-22 10.6.1 Overview... 10-22 10.6.2 Arrhythimia Options... 10-23 10.6.3 Arrhythmia Analysis Menu ... 10-24 10.6.4 Arrhythimia Relearn... 10-25 10.6.5 Arrhythmia Alarm Setup ... 10-25 10.6.6 Arr Threshold ... 10-27 10.6.7 Arrhythmia Recall ... 10-28 10.7 12-Lead ... 10-30 10.7.1 12-Lead Monitoring Display... 10-30 10.7.2 12-lead ST Analysis Menu ... 10-31 10.8 RESP Monitoring ... 10-33 10.8.1 Overview... 10-33 10.8.2 Electrode Placement... 10-34 10.8.3 Respiration Setup ... 10-35 10.9 Maintenance and Cleaning... 10-37 11 SpO2 Monitoring ...11-1 11.1 Overview ...11-1 11.2 Mindray DS SpO2 Module ...11-2 11.2.1 Principles of Operation...11-2 11.2.2 Precautions ...11-3 11.2.3 Monitoring Procedure ...11-3 11.2.4 Measurement Limitations...11-6 11.2.5 SpO2 Setup Menu ...11-7 11.3 Nellcor SpO2 Module ...11-9 11.3.1 Principles of Operation...11-9 11.3.2 Precautions ...11-11 11.3.3 Monitoring Procedure ...11-11 11.3.4 Measurement Limitations...11-12 11.3.5 SpO2 Setup Menu ...11-13 11.3.6 Accessories ...11-15 11.3.7 Nellcor Information...11-15 12 NIBP Monitoring... 12-1 12.1 Overview... 12-1 12.2 Monitoring Procedure ... 12-2 12.2.1 Cuff Selection and Placement ... 12-2 12.2.2 Operation Guides ... 12-3 12.3 Measurement Limitations... 12-4 4

12.4 NIBP Setup Menu ... 12-5 12.4.1 Calibration... 12-7 12.4.2 Testing for Air Leakage... 12-8 12.5 Maintenance and Cleaning... 12-9 13 TEMP Monitoring... 13-1 13.1 Overview... 13-1 13.2 Measurement Procedure... 13-2 13.3 TEMP Setup Menu... 13-3 13.4 Maintenance and Cleaning... 13-4 14 IBP Monitoring... 14-5 14.1 Overview... 14-5 14.2 Precautions ... 14-6 14.3 Monitoring Procedure ... 14-7 14.4 IBP Menu ... 14-8 14.4.1 IBP Setup Menu ... 14-8 14.4.2 IBP Pressure Zero Menu ... 14-12 14.5 Maintenance and Cleaning... 14-14 15 CO2 Monitoring... 15-1 15.1 Overview... 15-1 15.2 Mindray DS CO2 Module... 15-2 15.2.1 Principles of Operation ... 15-2 15.2.2 Preparations for CO2 Measurement... 15-3 15.2.3 CO2 Setup Menu ... 15-4 15.2.4 CO2 User Maintain Menu... 15-9 15.2.5 Maintenance and Cleaning ... 15-10 15.3 Oridion CO2 Module...15-11 15.3.1 Principles of Operation ...15-11 15.3.2 Preparations for CO2 Measurement... 15-12 15.3.3 CO2 Setup Menu ... 15-13 15.3.4 CO2 User Maintain Menu... 15-16 15.3.5 Maintenance and Cleaning ... 15-17 15.3.6 Oridion Information ... 15-18 15.4 Removing Exhaust Gases from the System ... 15-18 16 Anesthesia Gas Monitoring ... 16-1 16.1 Overview... 16-1 16.2 Measurement Principles and Procedure ... 16-3 16.3 MAC ... 16-5 16.4 AG Setup Menu... 16-6 16.5 Calibrating AG ... 16-10 16.6 Maintenance and Cleaning...16-11 16.6.1 Occlusion handling...16-11 16.6.2 Removing Exhaust Gases from the System ...16-11 5

17 Maintenance ... 17-1 17.1 Inspection and Maintenance... 17-1 17.2 Cleaning ... 17-2 17.3 Disinfection and Sterilization... 17-3 18 Accessories ... 18-1 18.1 ECG Accessories... 18-2 18.2 SpO2 Accessories ... 18-3 18.3 NIBP Accessories... 18-4 18.4 TEMP Accessories ... 18-5 18.5 IBP Accessories... 18-5 18.6 CO2 Accessories... 18-7 18.6.1 Mindray DS CO2 Accessories ... 18-7 18.6.2 Oridion CO2 Accessories... 18-7 18.7 AG Accessories ... 18-7 18.8 Others... 18-8 A Product Specifications...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 Wireless Network ...A-4 A.7 Signal Output Specifications...A-4 A.8 ECG Specifications ...A-5 A.9 RESP Specifications...A-10 A.10 SpO2 Specifications...A-11 A.11 NIBP Specifications ...A-13 A.12 TEMP Specifications...A-14 A.13 IBP Specifications ...A-14 A.14 CO2 Specifications ...A-15 A.15 AG Specifications...A-17 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 C.3 Prompt Messages...C-14 D Symbols and Abbreviations ...D-1 D.1 Symbols...D-1 D.2 Abbreviations ...D-3

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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 z z z z

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The device is intended for use by qualified clinical physicians or well-trained nurses in the specified places. To ensure patient safety, verify the device and accessories can function safely and normally before use. EXPLOSION HAZARD: Do not use this device in the presence of flammable anesthetics, explosive substances, vapors or liquids. You must customize the alarm settings according to the individual patient situation, and make sure the alarm sound is activated when an alarm occurs. 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. DEFIBRILLATION: Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could result. When used in conjunction with electro-surgery equipment, you must give top priority to the patient safety. To prevent unwanted skin burns caused by leakage current, applying the electrode ,transducer and the cable as far as possible from the high frequency surgical equipment, a distance of least 15cm/6in. is recommended. DISPOSE: Dispose of the package material, observing the applicable waste control regulations and keeping it out of children’s reach. 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. The aging of the test equipment and the change of environment may have effects on the measuring results of the monitor.

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1.1.3 Cautions CAUTION z z z z

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To ensure patient safety, use only parts and accessories specified in this manual. 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. Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur. 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. 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. 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. 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 z z z z

Keep this manual close to the patient monitor so that it can be obtained conveniently when necessary. This patient monitor complies with the requirements of CISPR11 (EN55011) class A. The software was developed per IEC601-1-4. The possibility of hazards arising from errors in software program is minimized. Put the patient monitor in a location where you can easily see the screen and access the operating controls. The instructions of this manual are based on the maximum configuration. Some of them may not apply to your patient monitor.

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1.2 Equipment Symbols NOTE z

Some symbols may not appear on your equipment.

Attention: Consult accompanying documents (this manual).

Power ON/OFF

Power ON/OFF Alternating current (AC) Battery indicator 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. TYPE BF applied part. Defibrillator-proof protection against electrical shock. Equipotentiality

Auxiliary output

Network connector

VGA connector AG module connector Gas inlet

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ESD sensitivity Manufacture date Serial number 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.

The machine has only one of the certification labels below. Please refer to the label attached to the machine to determine the applicable certification label. The presence of this label indicates the machine was certified by ETL with the statement: CONFORMS TO UL STD 60601-1, IEC 60601-2-27，IEC 60601-2-30，IEC 60601-2-34，IEC 60601-2-49，IEC60601-1-1, CERTIFIED TO CSA STD C22.2 NO 601.1, NO 60601-2-27, NO 60601-2-30, NO 60601-2-34, NO 60601-2-49, CSA STD C22.2 NO 601-1-1 Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards, only in accordance with UL 60601-1, CAN/CSA C22.2 NO.601-1, IEC 60601-1-1, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49.

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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, especially in hospital transport. 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 This monitor is intended to be used for monitoring, recording, and alarming of multiple physiological parameters (see 2.1.4 Functions) on single adult, pediatric and neonate patient. For arrhythmia detection and ST Segment analysis, the target populations are adult and pediatric only. This monitor is to be used in healthcare facilities by trained clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for out-of-hospital transfer or home use.

WARNING z z

The operator of the monitor must be well trained. Any operation by unauthorized or non-trained personnel is forbidden. 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.

2.1.2 Contraindications None.

2.1.3 Components This monitor consists of parameter measuring modules, blood pressure cuff, ECG, IBP cables, SpO2 sensors, CO2 and AG measuring components. Some of the components are optional and may not apply to your patient monitor.

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