TMS6016 Telemetry Monitoring System Operators Manual Ver 7.0 Nov 2012

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;

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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 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.

IV

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.

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Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

E-mail Address:

[email protected]

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

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Preface Manual Purpose This manual contains the instructions necessary to operate the telemetry monitoring system 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 telemetry monitoring system. 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 your monitoring setup or data displayed on your telemetry monitoring system.

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.

VII

FOR YOUR NOTES

VIII

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 Overview ... 2-1 2.1 General ... 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 Product Overview ... 2-3 2.2.1 Telemetry Transmitter ... 2-3 2.2.2 Telemetry Receiver ... 2-5 2.3 About The Central Monitoring System ... 2-7 2.3.1 Display ... 2-7 2.3.2 Multibed Screen ... 2-13 2.3.3 Viewbed Screen... 2-18 3 Installation and Maintenance... 3-1 3.1 Installation... 3-1 3.1.1 Unpacking and Inspection... 3-1 3.1.2 Environmental Requirements... 3-2 3.1.3 Power Requirements ... 3-2 3.1.4 Installation... 3-3 3.1.5 Starting the System... 3-4 3.1.6 Shutting down the System... 3-5 3.2 Maintenance ... 3-6 3.2.1 Inspection ... 3-6 3.2.2 Cleaning ... 3-7 3.2.3 Disinfection and Sterilization... 3-8 4 Using Transmitters... 4-1 4.1 Installing and replacing batteries... 4-1 4.2 Switching on/off the transmitter... 4-2 4.3 Wearing the transmitter ... 4-2 5 CMS Operation ... 5-1 1

5.1 Nurse call ... 5-1 5.2 Event ... 5-1 5.3 STANDBY ... 5-2 5.4 Patient Management... 5-2 5.4.1 Admitting a Patient... 5-2 5.4.2 Modifying Patient Information... 5-3 5.4.3 Discharging a Patient ... 5-4 5.5 Managing Parameter Settings ... 5-5 5.6 Review ... 5-6 5.6.1 Dynamic Short Trend ... 5-6 5.6.2 Waveform Review... 5-6 5.6.3 Trend Review ... 5-6 5.6.4 Event Review ... 5-7 5.6.5 ST Review... 5-7 5.7 Record ... 5-8 5.7.1 Recording Patient Information ... 5-8 5.7.2 Recording Normal Waveforms... 5-8 5.7.3 Recording Events ... 5-8 5.7.4 Recording ST Segment Waveform ... 5-8 5.7.5 Recording Real-time Waveforms ... 5-9 5.7.6 Recording Real-time Frozen Waveforms ... 5-9 5.7.7 Recording Real-time Alarms... 5-9 5.8 Print... 5-10 5.8.1 Printing Patient Information... 5-10 5.8.2 Printing Trend Graph or Trend Table ... 5-10 5.8.3 Printing Normal Waveforms... 5-10 5.8.4 Printing ECG Report ...5-11 5.8.5 Printing Compressed Waveforms ...5-11 5.8.6 Printing ARR Statistic Result ...5-11 5.8.7 Printing Event List ...5-11 5.8.8 Printing an Event... 5-12 5.8.9 Printing ST Segment Waveform... 5-12 5.8.10 Printing Multi-lead ECG ... 5-12 5.8.11 Printing in Real-time ... 5-12 6 Alarm... 6-1 6.1 Alarm Categories... 6-1 6.2 Alarm Priorities ... 6-2 6.3 Alarm Indicators... 6-2 6.3.1 Audible Alarms... 6-3 6.3.2 Reminder Tone ... 6-3 6.3.3 Alarm Messages ... 6-4 6.3.4 Color Changes... 6-4 6.3.5 Flashing Numeric ... 6-4 2

6.4 Alarm Status Symbols ... 6-5 6.5 Alarm Setup... 6-5 6.6 Alarm Volume ... 6-6 6.7 Alarm Delay Setup ... 6-6 6.8 Alarm Level Setup ... 6-6 6.9 Alarm Pause ... 6-7 6.10 Alarm Silencing... 6-7 6.11 Alarm Latching... 6-8 6.12 CMS System Silence... 6-8 6.13 CMS Alarm Audio Off ... 6-9 7 ECG Monitoring... 7-1 7.1 Preparation ... 7-1 7.2 Electrode Placement... 7-2 7.2.1 3-Leadwire Electrode Placement ... 7-3 7.2.2 5-Leadwire Electrode Placement ... 7-3 7.2.3 Characteristics of a Good Signal... 7-6 7.3 ECG Monitoring ... 7-7 7.3.1 ECG Waveform Area... 7-7 7.3.2 ECG Parameter Area ... 7-8 7.3.3 ECG Setup Screen... 7-9 7.3.4 ECG Lead Type... 7-9 7.3.5 Wave Speed ... 7-10 7.3.6 HR Source ... 7-10 7.3.7 Wave Gain ... 7-10 7.3.8 Filter Mode... 7-10 7.3.9 Pacer Pulse Detection...7-11 7.3.10 Pacer Reject on Waveform ...7-11 7.3.11 Pacer Rate... 7-12 7.3.12 HR Alarm ... 7-12 7.4 ST Analysis ... 7-13 7.4.1 General ... 7-13 7.4.2 Switching on/off ST Analysis... 7-13 7.4.3 Setting ST Parameter Display ... 7-14 7.4.4 Setting ST Alarm... 7-14 7.4.5 Defining ST Point... 7-14 7.5 Arrhythmia Analysis... 7-16 7.5.1 Overview ... 7-16 7.5.2 Arrhythmia Events ... 7-17 7.5.3 Arrhythmia Alarm Setup ... 7-17 7.5.4 Arrhythmia Threshold Setup ... 7-18 7.5.5 Arrhythmia Alarm Review ... 7-18 7.5.6 Arrhythmia Relearn... 7-19 7.5.7 Arrhythmia Troubleshooting ... 7-20 3

7.6 Maintenance and Cleaning ... 7-20 8 Troubleshooting... 8-1 8.1 Common Physiological Alarms and Troubleshooting... 8-2 8.2 Common Problems and Troubleshooting... 8-4 9 Accessories ... 9-1 9.1 ECG... 9-1 9.1.1 ECG Electrodes... 9-1 9.1.2 Cable Sets... 9-1 9.2 Others ... 9-2 A Product Specifications... A-1 A.1 Safety Specifications ... A-1 A.2 Environmental Specifications... A-1 A.3 Power Specifications ... A-2 A.4 Physical Specifications... A-3 A.5 Data Display, Recording and Storage... A-3 A.6 Alarms and Indicators... A-4 A.7 Wireless Transmission... A-4 A.8 ECG Specifications ... A-5 B Factory Defaults ...B-1 C EMC ... C-1 D FCC Compliance ... D-1 E Symbols and Abbreviations ...E-1 E.1 Units ... E-1 E.2 Symbols ... E-2 E.3 Abbreviations... E-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 Telemetry monitoring system 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, serious injury or property damage.

WARNING z

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

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 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 telemetry monitoring system is intended for use by trained clinical professionals in specific situations. Any operations of the system by unauthorized or untrained person are prohibited.

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Check the system and accessories each time before use. Make sure they function properly and safely.

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Possible fire or explosion hazard if used in the presence of flammable anesthetics.

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Do not use this equipment in conjunction with electro-surgery unit (ESU).

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Be sure to set the alarm according to the patient’s conditions. Make sure the system sounds when an alarm is present.

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Opening the receiver housing may present a risk of electric shock. All servicing and future upgrades to this system must be performed by personnel trained and authorized by Mindray only.

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

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

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The telemetry receiver 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 receiver from the power line and operate it on battery power, if possible.

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The equipment generates and uses RF energy. If it is not installed correctly or used by observing the manual, RF interference to other devices could result.

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The telemetry system transmits through space wireless signals. During this process, signals may be interfered by multiple sources of RF interference. Although the telemetry system has certain capability against interference, occasional transmission failure could occur.

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The telemetry transmitter is an IPX3 device. Never immerse the telemetry transmitter in water or other liquids such as cleaning solutions.

1-2

WARNING z

The equipment is not capable of rejecting pacer pulse. Keep pacemaker patients under close observation.

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After the first deploy of antenna array, or after hospital’s building reconstruction or re-decoration, clinician shall confirm the coverage of antenna array, and shall require patients to move around within the confirmed area. Clinician should arrive on time within the area.

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 batteries if you do not intend to use the transmitter for a long period of time.

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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.

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At the end or 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 product, please contact us.

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Magnetic and electrical fields are capable of interfering with the proper performance of the system. For this reason make sure that all external devices operated in the vicinity of the system 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 receiver to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit’s label or in this manual.

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Install or carry the transmitter properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.

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Signal transmission can be disturbed when the patient passes concrete walls or elevator doors.

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High quality alkali batteries are recommended. Remove the batteries when the transmitter is not in use.

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Although the transmitter and receiver are chemically resistant to most common hospital cleaners and non-caustic cleaners, different cleaners are not 1-3

CAUTION recommended and may stain the transmitter and receiver. Many cleaners must be diluted before use. z

Insert the silica gel plug into the programming port when the programming cable is not attached to the transmitter.

1.1.4 Notes NOTE z

Keep this manual close to the Telemetry monitoring system so that it can be obtained conveniently when necessary.

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For detailed introductions of the central monitoring system, refer to the operator’s manual of the central monitoring system.

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Choose a location that affords an unobstructed view of the system and easy access to 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 system.

1-4

1.2 Equipment Symbols

Attention: Consult accompanying documents (this manual).

Power on

Power off

Alternating current (AC) 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. Equipotential terminal

Non-ionizing electromagnetic radiation

Network connector

Antenna interface

Communication status

Manufacture date

Serial number

1-5

European community representative 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 60601-2-49, IEC60601-1-1 CERTIFIED TO CSA STD C22.2 NO 601.1, 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 60601-2-49.

1-6

2 Overview 2.1 General The telemetry monitoring system comprises several telemetry transmitters, a telemetry receiver, an antenna array, the central monitoring system software and certain accessories. It features: „

Compact size and light weight.

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Long battery life.

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Reliable signal reception.

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Easy expandability.

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Powerful central monitoring system software.

2.1.1 Intended Use By using radiofrequency signal, the Telemetry Monitoring System (TMS) is intended to monitor Electrocardiogram (ECG), Heart Rate (HR), Arrhythmia Detection, ST Segment Analysis for adult and pediatric patients. Physical signals are collected by sensors and wirelessly transmitted by transmitters in WMTS band. Receivers get the signals and forward to the Central Monitoring System (CMS) for processing, displaying, storing, printing, etc. It can be used within a defined coverage area in hospitals or medical institutions.

WARNING z

If the accuracy of any value displayed on the screen of the Telemetry monitoring system’s screen is questionable, first determine the patient’s vital signs by alternative means and then verify that the Telemetry monitoring system is working correctly.

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The physiological waves, parameters and alarms displayed on the system screen are for doctor’s reference only to make diagnoses. They can not be directly used as the basis for clinical treatment.

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The system transmits data through wireless connection. Risk of data loss is possible. Keep a close eye on the critical patient.

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One transmitter is to be used on one patient only.

2-1

2.1.2 Contraindications None.

2.1.3 Components The system comprises several telemetry transmitters, a telemetry receiver, an antenna array, the central monitoring system software and ECG cable.

2.1.4 Functions The system provides information on the following parameter. „

ECG

Heart rate (HR) 3-channel of ECG waveforms Arrhythmia and ST segment analysis Pace analysis (PACE)

In addition, the system provides such functions as alarms, freeze, review and recording.

2-2