BeneHeart D5 and D6 Instructions for Use Rev 1.0

© Copyright 2022 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■

Release time: 2022-05

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Revision: 1.0

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Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. are the registered trademarks or trademarks owned by Mindray in China and and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

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

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

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

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

WARNING

• This equipment must be operated by skilled/trained clinical professionals. • It is important for the hospital or organization that employs this equipment to carry out a

reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

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

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

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

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

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

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

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

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Others not caused by instrument or part itself.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

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

Website:

www.mindray.com

E-mail Address:

service@mindray.com

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

Summary of Safety and Clinical Performance (SSCP):

https://www.mindray.com/etc.clientlibs/xpace/clientlibs/clientlib-site/ resources/plugins/web/viewer.html?file=/content/dam/xpace/en/site/ mdr-sscp/KF-0651-4-202-%20%20Summary-of%20safety-and%20-clinicalperformance.pdf

Defibrillator/Monitor Operator’s Manual

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Notification of Adverse Events As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state in which the user and / or patient is established. These events, include device-related death and serious injury or illness. In addition, as part of our Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. requests to be notified of device failures or malfunctions. This information is required to ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the highest quality products.

Preface 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 equipment.

Conventions

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

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[ ] is used to enclose screen texts.

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→ is used to indicate operational procedures.

Contents 1 Safety ... 1 - 1 1.1 Safety Information ...1 - 1 1.1.1 Dangers ...1 - 1 1.1.2 Warnings ...1 - 1 1.1.3 Cautions ...1 - 2 1.1.4 Notes ...1 - 3 2 The Basics ... 2 - 1 2.1 Intended Use ...2 - 1 2.1.1 Intended Purpose Statement ...2 - 1 2.1.2 Indication for Use ...2 - 1 2.1.3 Intended Users ...2 - 1 2.1.4 Intended Patient Population ...2 - 1 2.1.5 Intended Medical Conditions ...2 - 1 2.1.6 Contra-indications ...2 - 2 2.1.7 Side-effects ...2 - 2 2.1.8 Clinical Benefit ...2 - 2 2.2 Applied Parts ...2 - 2 3 Basic Operations and Settings ... 3 - 1 3.1 Equipment Installation ...3 - 1 3.1.1 Unpacking and Checking ...3 - 1 3.1.2 Environmental Requirements ...3 - 1 3.2 Basic Operation ...3 - 2 3.2.1 Connecting the AC Mains ...3 - 2 3.2.2 Turning On the Equipment ...3 - 2 3.2.3 Turning Off the Equipment ...3 - 2 4 Alarms ... 4 - 1 4.1 Alarm Indicators ...4 - 1 4.2 Alarm Tone Configuration ...4 - 1 4.2.1 Changing the Alarm Volume ...4 - 1 4.2.2 Setting the Interval between Alarm Sounds ...4 - 1 4.3 Understanding the Alarm Setup Menu ...4 - 2 4.3.1 Setting Alarm Properties for All Parameters ...4 - 2 4.3.2 Adjusting Alarm Limits Automatically ...4 - 2 5 Monitoring ECG ... 5 - 1 5.1 ECG Safety Information ...5 - 1 5.2 Preparing for ECG Monitoring and Measurement ...5 - 1 5.2.1 Using ECG Electrodes ...5 - 1 5.2.2 Checking Paced Status ...5 - 2 5.3 Changing ECG Settings ...5 - 2 5.3.1 Setting the ECG Filter ...5 - 2 5.3.2 Switching On or Off the Notch Filter ...5 - 2 5.4 Arrhythmia Analysis ...5 - 2

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5.4.1 Changing Arrhythmia Alarm Settings ...5 - 2 5.4.2 Initiating Arrhythmia Relearning Manually ...5 - 3 6 Resting 12-Lead ECG Analysis ... 6 - 1 6.1 Placing 10-leadwire Electrodes ...6 - 1 6.2 Entering the 12-lead ECG Screen ...6 - 1 6.3 Changing 12-Lead ECG Analysis Settings ...6 - 1 6.3.1 Enabling Patient Information Input Prompt ...6 - 1 6.3.2 Setting the Baseline Drift Removal ...6 - 1 6.3.3 Setting Tachy and Brady Threshold ...6 - 1 6.4 Initiating Resting 12-lead ECG Analysis ...6 - 1 7 AED ...7 - 1 7.1 AED Safety Information ...7 - 1 7.2 AED Procedure ...7 - 1 7.3 CPR ...7 - 2 8 Manual Defibrillation ...8 - 1 8.1 Manual Defibrillation Safety Information ...8 - 1 8.2 Manual Defibrillation Procedure ...8 - 2 8.2.1 Using Internal Paddles ...8 - 2 8.3 Synchronized Cardioversion ...8 - 3 8.3.1 Performing Synchronized Cardioversion ...8 - 3 8.4 Remote Synchronized Cardioversion ...8 - 3 8.5 Patient Contact Indicator ...8 - 3 9 CPR Assistance ...9 - 1 9.1 CPR Assistance Introduction ...9 - 1 9.2 Using CPR Metronome ...9 - 1 9.3 Using CPR Filter ...9 - 1 9.4 Reviewing CPR Events ...9 - 2 10 Noninvasive Pacing ...10 - 1 10.1 Pacing Introduction ... 10 - 1 10.2 Pacing Safety Information ... 10 - 1 10.3 Pacer Mode ... 10 - 2 10.4 Preparing for Pacing ... 10 - 2 10.4.1 Demand Mode Pacing ... 10 - 2 10.4.2 Fixed Mode Pacing ... 10 - 2 11 Monitoring Resp ...11 - 1 11.1 Resp Safety Information ... 11 - 1 11.2 Placing Resp Electrodes ... 11 - 1 11.2.1 Optimizing Lead Placement for Resp ... 11 - 1 12 Monitoring PR ...12 - 1 12.1 PR Introduction ... 12 - 1

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13 Monitoring SpO2 ...13 - 1 13.1 SpO2 Safety Information ... 13 - 1 13.2 SpO2 Display ... 13 - 2 13.2.1 Setting SpO2 Sensitivity (for Masimo SpO2) ... 13 - 2 13.3 SpO2 Desat Alarm ... 13 - 2 14 Monitoring NIBP ...14 - 1 14.1 NIBP Introduction ... 14 - 1 14.2 NIBP Safety Information ... 14 - 1 14.3 NIBP Measurement Procedure ... 14 - 1 14.3.1 Preparing the Patient ... 14 - 1 14.3.2 Starting Auto NIBP Measurements ... 14 - 2 14.4 Setting Initial Cuff Inflation Pressure ... 14 - 2 15 Monitoring Temp ...15 - 1 15.1 Temp Measurement Procedure ... 15 - 1 16 Monitoring IBP ...16 - 1 16.1 IBP Safety Information ... 16 - 1 16.2 IBP Measurement Procedure ... 16 - 1 16.3 IBP Troubleshooting ... 16 - 1 17 Monitoring CO2 ...17 - 1 17.1 CO2 Safety Information ... 17 - 1 17.2 Preparing for Measuring CO2 ...17 - 1 17.2.1 Measuring CO2 Using the Microstream CO2 Module ... 17 - 1 17.2.2 Zeroing the CO2 Sensor ... 17 - 2 17.2.3 Selecting Gas Compensations ... 17 - 2 17.3 Removing the Exhaust Gases from the System ... 17 - 2 17.4 CO2 Calibration ... 17 - 2 18 Review ...18 - 1 18.1 Reviewing Events ... 18 - 1 19 Data Management ...19 - 1 19.1 Generating Patient Data ... 19 - 1 19.2 Exporting Patient Data ... 19 - 1 20 Recording ...20 - 1 20.1 Setting the Recorder ... 20 - 1 20.2 Loading Paper ... 20 - 1 20.3 Cleaning the Recorder Print Head ... 20 - 1 21 Network Connection ...21 - 1 21.1 Network Safety Information ... 21 - 1 22 Configuration Management ...22 - 1 22.1 Configuration Management Introduction ... 22 - 1

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23 Battery ...23 - 1 23.1 Battery Safety Information ... 23 - 1 23.1.1 Low Battery Alarm ... 23 - 1 23.2 Conditioning the Battery ... 23 - 1 23.3 Checking Battery Performance ... 23 - 1 23.4 Storing Batteries ... 23 - 2 23.5 Recycling the Batteries ... 23 - 2 24 Care and Cleaning ...24 - 1 24.1 General Points ... 24 - 1 25 Maintenance ...25 - 1 25.1 Maintenance Safety Information ... 25 - 1 25.2 Routine Maintenance ... 25 - 1 25.2.1 Auto Test ... 25 - 1 25.2.2 User Test ... 25 - 1 26 Accessories ...26 - 1 A Specifications ... A - 1 A.1 General Specifications ... A - 1 A.1.1 Safety Specifications ... A - 1 A.1.2 Physical Specifications ... A - 1 A.1.3 Display Specifications ... A - 1 A.1.4 Audio Indicators ... A - 1 A.1.5 Interface Specifications ... A - 2 A.1.6 Signal Outputs Specifications ... A - 2 A.2 Defibrillator Specifications ... A - 2 A.3 CPR Compression Specifications ... A - 5 A.4 Pacer Specifications ... A - 5 A.5 Monitor Specifications ... A - 6 A.5.1 ECG Specifications (from ECG Lead Set) ... A - 6 A.5.2 ECG Specifications (from Defibrillation Electrodes) ... A - 8 A.5.3 Resp Specifications ... A - 9 A.5.4 SpO2 Specifications ... A - 9 A.5.5 PR Specifications ...A - 11 A.5.6 Temp Specifications ...A - 11 A.5.7 NIBP Specifications ...A - 11 A.5.8 IBP Specifications ...A - 12 A.5.9 CO2 Specifications ...A - 13 A.6 Power Supply Specifications ...A - 14 A.6.1 External Power Supply Specifications ...A - 14 A.6.2 Battery Specifications ...A - 14 A.7 Recorder Specifications ...A - 16 A.8 Alarm Specifications ...A - 16 A.9 Data Storage ...A - 16 A.10 Wi-Fi Specifications ...A - 17 A.11 Environmental Specifications ...A - 18

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A.12 Operating Environment ...A - 19 B EMC and Radio Regulatory Compliance ...B - 1 B.1 EMC ... B - 1 B.2 Radio Regulatory Compliance ... B - 4

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Safety

1.1

Safety Information DANGER

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

Dangers DANGER

• The equipment delivers up to 360 J of electrical energy. Unless properly used as described in these Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to operate this defibrillator unless thoroughly familiar with these operating instructions and the function of all controls, indicators, connectors, and accessories.

• Defibrillation current can cause operator or bystander severe injury or even death. Keep distance from the patient or metal devices connected to the patient during defibrillation. • Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair. • 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). Keep the equipment and the operating environment dry and clean.

1.1.2

Warnings WARNING

• 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. • Make sure the synchronous input system is applied to this equipment and the input signal is correct if necessary. • 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 smart lithium-ion batteries.

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• Ensure that the equipment is supplied with continuous electric power during work. Sudden power failure leads to the loss of patient data. • Use and store the equipment in specified environmental condition. The equipment and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.

• This equipment is used for single patient at a time. • The equipment is not intended to be used within the Magnetic Resonance (MR) environment. • Before each use, the operator must check the equipment condition to ensure that the equipment is ready for operation. • Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation. • Do not defibrillate a patient who lies on the wet ground. • Do not touch the patient and live parts simultaneously. • Do not touch the patient when connecting the peripheral equipment via the I/O signal ports to prevent patient leakage current from exceeding the requirements specified by the standard. • 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.

• Do not perform any functional check if the equipment is connected with a patient; otherwise the patient might be shocked.

• Remain attentive to the patient during applying therapy. Delay in delivering a shock may result in a rhythm that was analyzed as shockable converting spontaneously to non-shockable and could result in inappropriate delivery of a shock.

• For the treatment of patients with implantable pacemakers, place electrode pads or paddles away from internal pacemaker generator if possible to help prevent damage to the pacemaker. • Do not place the equipment or accessories in any position that might cause it to fall on the patient. • Do not start or operate the equipment unless the setup was verified to be correct. • 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. • If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check the equipment for proper functioning. • Physiological data and alarm messages provided by the equipment should not be used as the sole

basis for diagnosis or therapy decisions. They must be used in conjunction with clinical signs and symptoms. Misinterpretation of the measured values or other parameters can endanger the patient.

• Do not touch device connectors, recorder print head, battery connector or other live equipment if in contact with the patient; otherwise patient injury may result. • To ensure patient safety, use only parts and accessories specified in this manual. • When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.

1.1.3

Cautions CAUTION N

• Use of Manual Therapy security password requires the clinician to know and remember the

password. Failure to enter correct password will prevent the delivery of manual defibrillation, synchronized cardioversion and pacing therapy.

• 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 to avoid contaminating the environment.

• 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 phones, X-ray equipment or MRI

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devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

• 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 loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling. • 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. • Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage could occur.

1.1.4

Notes NOTE

• Put the equipment in a location where you can easily view and operate the equipment. • The equipment uses 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. • During normal use, the operator shall stand in front of the equipment. • Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.

• If the equipment operates on a DC power supply, a DC/AC adapter we supply should be used. • This manual describes all features and options. Your equipment may not have all of them.

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The Basics

2.1

Intended Use

2.1.1

Intended Purpose Statement The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion and semi-automated external defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG, Resp, SpO2, PR, NIBP, IBP, Temp and CO2 monitoring.

2.1.2

Indication for Use ■

External defibrillation/AED/internal defibrillation The external defibrillation, AED and internal defibrillation modes are intended for patients with ventricular fibrillation, pulseless ventricular tachycardia and ventricular flutter.

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Synchronized cardioversion Synchronized cardioversion is intended for the treatment of atrial fibrillation and atrial flutter.

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Non-invasive external pacing Non-invasive external pacing is intended for the treatment of bradycardia and asystole.

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Monitoring Monitoring is intended for the monitoring of ECG, Resp, SpO2, PR, NIBP, IBP, Temp and CO2 parameters.

2.1.3

Intended Users The Defibrillator/Monitor is for by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation.

2.1.4

Intended Patient Population ■

AED Mode The AED mode is to be used only on patients in cardiac arrest. The patients must be:

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Unconsciousness

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Absence of normal breathing

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Absence of a pulse or signs of circulation

Manual Defibrillation Mode Manual defibrillation is intended for the initial treatment of ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronized cardioversion is intended for termination of atrial fibrillation.

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Noninvasive Pacing Mode Noninvasive pacing therapy is intended for patients with symptomatic bradycardia.

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Monitoring Mode All the parameters can be monitored on single adult, pediatric and neonatal patients.

2.1.5

Intended Medical Conditions The Defibrillator/Monitor is for use in hospital and pre-hospital areas.

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2.1.6

Contra-indications ■

AED The AED mode is contraindicated in the treatment when the patient is showing any of the following:

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Consciousness

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Breathing

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Detectable pulse or other signs of circulation

Manual Defibrillation Manual defibrillation is contraindicated in the treatment when the patient is showing any of the following:

2.1.7

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Consciousness

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Breathing.

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Detectable pulse or other signs of circulation

Side-effects Through clinical data from literature and clinical data from post-market surveillance activity of device in question, there is no side-effects identified. After search the literature of similar device, the results of SOTA evaluation shown that undesirable effects may include myocardial damage.

2.1.8

Clinical Benefit Through the parameter monitoring, medical staff have established sufficient conditions to provide patients with a better medical monitoring environment, and the benefits are obvious. Although there is also the possibility of false positives and false negatives in parameter monitoring, the impact of false positives and false negatives is limited and will not cause substantial harm to patients. In addition, the parameter monitoring of the Defibrillator/Monitor has the advantages of simplicity of equipment, convenient operation, timeliness, economy, etc. compared with other known ones. Therefore, from the perspective of benefit and risk, the parameter monitoring of the Defibrillator/Monitor has obvious benefits, controllable risks, and has strong clinical application popularization characteristics. The Defibrillator/Monitors are life-saving device used in emergency situations. They have been shown to have a high benefit for patients with underlying diseases that remain undetected until sudden cardiac arrest occurs. The time from collapse to defibrillation is critical in-patient survival. For every minute that passes between collapse and defibrillation, survival rates from VF SCA decrease 7% to 10%.

2.2

Applied Parts WARNING

• When the equipment is placed at a an ambient temperate above 45ºC, the surface temperature of applied parts should be limit to below 47ºC.

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3

Basic Operations and Settings

3.1

Equipment Installation WARNING

• The equipment shall be installed by personnel authorized by the manufacturer. • The software copyright of the equipment is solely owned by the manufacturer. No organization or

individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

• Devices connected to the equipment must meet the requirements of the applicable IEC standards

(e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to the equipment’s signal input/output port is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please contact the manufacturer.

• If it is not evident from the equipment specifications whether a particular combination is hazardous, for example, due to summation of leakage currents, consult the manufacturers or else an expert in the field, to ensure the necessary safety of all devices concerned will not be impaired by the proposed combination.

CAUTION

• The docking station is part of the equipment. Use only the specified docking station. 3.1.1

Unpacking and Checking WARNING

• When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach. • The equipment might be contaminated during storage and transport. Before use, please verify

whether the packages are intact, especially the packages of single use accessories. In case of any damage, do not apply it to patients.

NOTE

• Save the packing case and packaging material as they can be used if the equipment must be reshipped.

3.1.2

Environmental Requirements NOTE

• Make sure that the operating environment of the equipment meets the specific requirements. Otherwise unexpected consequences, e.g. damage to the equipment, could result.

• 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.

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3.2

Basic Operation

3.2.1

Connecting the AC Mains WARNING

• Always use the accompanying power cord delivered with the equipment. • Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of the power line are the same as those indicated besides the AC power input. • Use the cable retainer to secure the power cord to prevent it from falling off. • Use the battery if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt.

3.2.2

Turning On the Equipment WARNING

• Do not use the equipment for any monitoring or therapy procedure on a patient if you suspect it is

not working properly, or if it is mechanically damaged. Contact your service personnel or Mindray.

NOTE

• Check that visual and auditory alarm signals are presented correctly when the equipment is

powered on. Do not use the equipment for any monitoring procedure on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact your service personnel or Mindray.

, department, height, weight, admit date or doctor information can also be changed on the CMS.

3.2.3

Turning Off the Equipment NOTE

• To completely disconnect the power supply, unplug the power cord.

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4

Alarms

WARNING

• A potential hazard exists if different alarm presets are used for the same or similar device in any single area, e.g. an intensive care unit or cardiac operating room. • If the equipment is connected to a CMS, remote suspension, inhibition, silence and reset of monitoring alarms via the CMS may cause a potential hazard. For details, refer to the operator’s manual of the CMS.

• Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Always make sure that the audio alarm volume level is adequate in your care environment. Always keep the patient under close surveillance.

4.1

Alarm Indicators NOTE

• When multiple alarms of different levels occur simultaneously, the equipment will select the alarm

of the highest level and give visual and audible alarm indications accordingly. Alarm messages will be displayed circularly.

• Some physiological alarms, such as Asystole, are exclusive. They have identical alarm tones and

alarm lights with normal high level physiological alarms, but their alarm messages are displayed exclusively. That is to say, when an exclusive physiological alarm and a normal high level physiological alarms are triggered simultaneously, only alarm message of the exclusive physiological alarm is displayed.

4.2

Alarm Tone Configuration

4.2.1

Changing the Alarm Volume E

NOTE

• You cannot adjust the alarm volume when an alarm is switched off. 4.2.2

Setting the Interval between Alarm Sounds WARNING

• Do not rely exclusively on audible alarm system. Setting alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance.

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