BeneVision TM80 Operations Manual Rev 9.0

Intellectual Property Statement

Introduction

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

TM80 Telemetry Monitor Operator’s Manual

Introduction

Manufacturer’s Responsibility

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

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

■

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

■

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

WARNING

• •

Only skilled/trained clinical professionals should operate this equipment. 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.

TM80 Telemetry Monitor Operator’s Manual

III

Warranty

Introduction

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 does not extend to:

IV

■

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

■

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

■

Malfunction or damage caused by force majeure events such as earthquake.

■

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.

■

Others not caused by instrument or part itself.

fire and

TM80 Telemetry Monitor Operator’s Manual

Introduction

Company Contact

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:

[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

TM80 Telemetry Monitor Operator’s Manual

V

Preface

Introduction

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 questions, please contact Mindray. 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

VI

■

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

■

[ ] is used to enclose screen texts.

■

→ is used to indicate operational procedures.

TM80 Telemetry Monitor Operator’s Manual

Contents 1 Safety... 1 - 1 1.1 Safety Information... 1 - 2 1.1.1 Warnings... 1 - 3 1.1.2 Cautions... 1 - 5 1.1.3 Notes... 1 - 6 1.2 Equipment Symbols... 1 - 7 2 General Product Description... 2 - 1 2.1 Intended Use... 2 - 2 2.2 Applied Parts... 2 - 2 2.3 Key Features... 2 - 3 2.4 Components... 2 - 3 2.5 Physical View... 2 - 4 2.6 Screen Display Status... 2 - 5 3 Getting Started... 3 - 1 3.1 Unpacking and Checking... 3 - 3 3.2 Environmental Requirements... 3 - 3 3.3 Preparation... 3 - 4 3.3.1 Connecting the ECG Leadwire... 3 - 4 3.3.2 Installing the Batteries... 3 - 6 3.4 Powering On the TM80... 3 - 9 3.5 Using the Pouch...3 - 10 3.5.1 Securing the Pouch for TM80...3 - 11 3.5.2 Securing Pouches for TM80 and BP10...3 - 13 4 Basic Operations... 4 - 1 4.1 Overview... 4 - 2 4.1.1 Display Screen... 4 - 2 4.1.2 On-Screen Keyboard... 4 - 3 4.2 Understanding the Touch Screen Gestures... 4 - 5 4.3 Basic Operations... 4 - 5 4.3.1 Entering the Main Menu... 4 - 5 4.3.2 Understanding the Screen Display Orientation... 4 - 7 4.3.3 Browsing the Screen Display... 4 - 7 4.3.4 Switching the Screen Display Orientation... 4 - 7 4.3.5 Displaying the Quick Keys Area... 4 - 8 4.3.6 Turning the Display Off... 4 - 9 4.3.7 Turning the Display On... 4 - 9 4.3.8 Configuring the Screen Lock... 4 - 9 4.3.9 Unlocking the Screen in Locked Mode... 4 - 9 4.3.10 Acknowledging the Nurse Call...4 - 10

TM80 Telemetry Monitor Operator’s Manual

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5 User Configurations... 5 - 1 5.1 Introduction... 5 - 2 5.2 Configuring the Display... 5 - 2 5.2.1 Entering the Display Setup Menu... 5 - 2 5.2.2 Configuring the Default Display Orientation... 5 - 2 5.2.3 Understanding Portrait Orientation Display Rules... 5 - 3 5.2.4 Configuring the Portrait Display... 5 - 3 5.2.5 Understanding Landscape Orientation Display Rules... 5 - 3 5.2.6 Configuring the Landscape Display... 5 - 4 5.2.7 Configuring the Display Brightness... 5 - 5 5.3 Configuring the Audio Volume... 5 - 5 6 Patient Management... 6 - 1 6.1 Introduction... 6 - 2 6.2 Admitting a Patient... 6 - 2 6.3 Changing Patient Information... 6 - 2 6.3.1 Changing the Patient Category... 6 - 2 6.3.2 Changing the Paced Status... 6 - 3 6.3.3 Changing the Department Name, Room Number, and Bed Number... 6 - 4 6.4 Entering the Standby Mode... 6 - 5 6.5 Exiting the Standby Mode... 6 - 6 6.6 Discharging the Patient... 6 - 6 6.6.1 Selecting the Discharge Patient Menu... 6 - 6 6.6.2 Restarting the TM80... 6 - 7 7 Alarms... 7 - 1 7.1 Introduction... 7 - 2 7.2 Alarm Safety Information... 7 - 2 7.3 Understanding the Alarms... 7 - 3 7.3.1 Alarm Categories... 7 - 3 7.3.2 Alarm Priorities... 7 - 3 7.3.3 Alarm Indicators... 7 - 3 7.3.4 Alarm Status Symbols... 7 - 5 7.4 Viewing Alarms... 7 - 5 7.5 Changing Alarm Settings... 7 - 6 7.5.1 Changing Alarm Properties... 7 - 6 7.5.2 Changing the Alarm Volume... 7 - 6 7.5.3 Initiating Auto Alarm Limits... 7 - 6 7.5.4 Restoring Default Alarm Settings... 7 - 7 7.6 Pausing Alarms... 7 - 8 7.7 Resetting Alarms... 7 - 9 7.7.1 Resetting Physiological Alarms... 7 - 9 7.7.2 Resetting Technical Alarms... 7 - 9 7.8 Latching Alarms...7 - 10 7.9 Actions When an Alarm Occurs...7 - 10 2

TM80 Telemetry Monitor Operator’s Manual

7.10 Operator’s Position...7 - 11 8 Monitoring ECG, Arrhythmia, ST and QT... 8 - 1 8.1 Introduction... 8 - 2 8.2 ECG Safety Information... 8 - 2 8.3 Preparation for Monitoring ECG... 8 - 3 8.3.1 Preparing the Patient’s Skin... 8 - 3 8.3.2 Positioning the Electrodes... 8 - 3 8.3.3 Configuring the ECG Lead Labeling... 8 - 5 8.3.4 Placing the Electrodes... 8 - 6 8.3.5 Checking the Lead Placement...8 - 11 8.3.6 Checking the Paced Status...8 - 12 8.3.7 Maintaining Quality ECG Signal...8 - 13 8.4 Changing ECG Settings...8 - 13 8.4.1 Entering the ECG Menu...8 - 13 8.4.2 Configuring ECG Settings...8 - 13 8.4.3 ECG Leadwire Types...8 - 14 8.4.4 Configuring ECG Waveforms...8 - 15 8.4.5 Configuring the Pacer...8 - 15 8.4.6 Configuring the ECG Waveform Size...8 - 16 8.4.7 Configuring ECG Alarm Settings...8 - 16 8.4.8 Configuring the Notch Filter...8 - 17 8.5 Configuring the HR Alarm Source...8 - 17 8.6 Understanding the ECG Display...8 - 18 8.6.1 HR Digital Area...8 - 18 8.6.2 About the HR Digital Area...8 - 19 8.6.3 ECG Waveform Area...8 - 19 8.6.4 About the ECG Waveform Area...8 - 19 8.7 Arrhythmia Monitoring...8 - 20 8.7.1 Arrhythmia Safety Information...8 - 20 8.7.2 Arrhythmia Events...8 - 21 8.7.3 Changing Arrhythmia Alarm Settings...8 - 22 8.7.4 Arrhythmia Alarms Timeout...8 - 27 8.7.5 Understanding the Arrhythmia Display...8 - 29 8.8 ST Segment Monitoring...8 - 29 8.8.1 ST Safety Information...8 - 30 8.8.2 Enabling ST Monitoring...8 - 30 8.8.3 Displaying ST Numerics...8 - 30 8.8.4 Configuring ST Alarm Settings...8 - 31 8.9 QT/QTc Interval Monitoring...8 - 33 8.9.1 QT/QTc Monitoring Limitations...8 - 33 8.9.2 Enabling QT/QTc Monitoring...8 - 34 8.9.3 Displaying QT/QTc Numerics and Segments...8 - 34 8.9.4 Configuring QT/QTc Alarm Settings...8 - 34 8.10 Relearning...8 - 35 8.10.1 Automatically Initiating an ECG Relearning...8 - 36

TM80 Telemetry Monitor Operator’s Manual

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8.10.2 Manually Initiating an ECG Relearning...8 - 36 9 Monitoring Respiration (Resp) (Optional)... 9 - 1 9.1 Introduction... 9 - 2 9.2 Resp Safety Information... 9 - 2 9.3 Preparation for Monitoring Resp... 9 - 3 9.3.1 Preparing the Patient’s Skin... 9 - 3 9.3.2 Positioning the Electrodes... 9 - 3 9.4 Changing Resp Settings... 9 - 4 9.4.1 Enabling/Disabling the Resp Functionality... 9 - 4 9.4.2 Entering the Resp Menu... 9 - 5 9.4.3 Configuring the Resp Setup... 9 - 5 9.4.4 Configuring the Resp Waveform... 9 - 5 9.4.5 Configuring Resp Alarm Settings... 9 - 6 9.5 Understanding the Resp Display... 9 - 7 9.5.1 Resp Digital Area... 9 - 7 9.5.2 About the Resp Digital Area... 9 - 7 9.5.3 Resp Waveform Area... 9 - 7 9.5.4 About the Resp Waveform Area... 9 - 8 10 Monitoring Pulse Oxygen Saturation (SpO2) (Optional)...10 - 1 10.1 Introduction...10 - 2 10.2 SpO2 Safety Information...10 - 2 10.3 Measurement Limitations...10 - 3 10.4 Connecting and Disconnecting the SpO2 Module...10 - 3 10.5 Changing SpO2 Settings...10 - 4 10.5.1 Entering the SpO2 Menu...10 - 4 10.5.2 Configuring SpO2 Settings...10 - 5 10.5.3 Configuring the SpO2 Waveform...10 - 6 10.5.4 Configuring SpO2 Alarm Settings...10 - 6 10.6 Performing SpO2 Measurement...10 - 7 10.7 Understanding the SpO2 Display...10 - 8 10.7.1 SpO2 Digital Area...10 - 8 10.7.2 About the SpO2 Digital Area...10 - 9 10.7.3 SpO2 Waveform Area... 10 - 10 10.7.4 About the SpO2 Waveform Area... 10 - 10 11 Monitoring Noninvasive Blood Pressure (NIBP) (Optional)...11 - 1 11.1 Pairing Introduction...11 - 2 11.2 Pairing a TM80 with a BP10...11 - 2 11.2.1 Pairing Procedures...11 - 2 11.2.2 System Responses after Successful Pairing...11 - 3 11.3 Unpairing the TM80 with the BP10...11 - 4 11.3.1 Unpairing via the TM80...11 - 4 11.3.2 Unpairing via the BP10...11 - 5

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TM80 Telemetry Monitor Operator’s Manual

11.3.3 System Responses after Successful Unpairing...11 - 5 11.4 Screen Display after Pairing a TM80 with a BP10...11 - 6 11.5 Interactions after Pairing a TM80 with a BP10...11 - 7 11.5.1 Overview of Interactions...11 - 7 11.5.2 Operating the BP10 via the TM80...11 - 7 11.5.3 Configuring NIBP Settings...11 - 8 11.5.4 Configuring NIBP Alarm Settings...11 - 9 12 Review...12 - 1 12.1 Introduction...12 - 2 12.2 Tabular Trends Review Page...12 - 2 12.2.1 Entering the Tabular Trends Review Page...12 - 2 12.2.2 Example Tabular Trends Review Page...12 - 2 12.2.3 Example Tabular Trends Data Search Page...12 - 4 12.2.4 Changing the Resolution of Trend Data...12 - 5 12.3 Events Review Page...12 - 5 12.3.1 Entering the Events Review Page...12 - 5 12.3.2 Example Events Review Page...12 - 6 12.3.3 Example Event Details Page...12 - 7 13 Configuring the TM80...13 - 1 13.1 Introduction...13 - 2 13.2 Entering the Maintenance Menu...13 - 2 13.3 Configuring the General Menu...13 - 2 13.3.1 Configuring Device Location...13 - 3 13.4 Configuring the Alarms Menu...13 - 4 13.5 Quick Keys Menu...13 - 5 13.5.1 Changing the Quick Keys...13 - 5 13.5.2 Deleting a Quick Key...13 - 7 13.6 Configuring the Network Menu...13 - 7 13.6.1 Configuring IP Settings...13 - 8 13.6.2 Configuring WLAN Settings...13 - 9 13.6.3 Configuring CMS Connection... 13 - 10 13.6.4 Selecting a CMS... 13 - 11 13.6.5 Selecting WiFi Bands and Channels... 13 - 11 13.6.6 EAP Certificate Management... 13 - 12 13.7 Defaults Menu... 13 - 12 13.7.1 Configuring the Defaults Menu... 13 - 12 13.7.2 Transferring a Configuration... 13 - 13 13.8 Screen Lock Menu... 13 - 14 13.8.1 Understanding the Screen Lock Mode... 13 - 14 13.8.2 Configuring the Screen Lock Mode... 13 - 15 13.8.3 Changing the Current Screen Lock Passcode... 13 - 15 13.8.4 Changing the Screen Lock Mode... 13 - 15 13.9 Changing the Passwords... 13 - 15

TM80 Telemetry Monitor Operator’s Manual

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13.10 Changing the Device Name... 13 - 16 13.11 Configuring the CMS Disconnect Alarm... 13 - 16 14 Monitoring with the TM80 at the CMS...14 - 1 14.1 Introduction...14 - 2 14.2 Network Safety Information...14 - 3 14.3 Adjusting the Minimum QRS Detection Threshold...14 - 3 14.4 QT Monitoring...14 - 4 14.4.1 Changing the QTc Formula...14 - 4 14.4.2 QT View...14 - 5 14.5 ST Monitoring...14 - 6 14.5.1 Adjusting ST Measurement Points...14 - 8 14.5.2 Entering the ST Graphic Window...14 - 8 14.5.3 Entering the ST View...14 - 9 14.6 Arrhythmia Monitoring... 14 - 10 14.6.1 Configuring the PVC-Related Alarm Threshold... 14 - 10 14.6.2 Configuring the Arrhythmia Shield Time... 14 - 11 14.7 Locating the TM80... 14 - 12 14.8 Sending a Notification to the TM80... 14 - 12 14.9 Triggering an Alarm Reminding Patients' Location... 14 - 13 15 Battery...15 - 1 15.1 Introduction...15 - 2 15.2 Battery Safety Information...15 - 3 15.3 Installing the Battery...15 - 5 15.4 Checking the Battery Charge Status...15 - 5 15.5 Removing the Battery...15 - 5 15.6 Charging the Rechargeable Lithium-ion Battery...15 - 6 15.7 Storing the Batteries...15 - 7 15.7.1 Storing Rechargeable Lithium-ion Batteries...15 - 7 15.7.2 Storing AA Batteries...15 - 7 15.8 Maintaining the Rechargeable Lithium-ion Battery...15 - 8 15.9 Disposing of the Batteries...15 - 9 15.9.1 Disposing of the Rechargeable Lithium-ion Battery...15 - 9 15.9.2 Disposing of the AA Batteries...15 - 9 16 Troubleshooting...16 - 1 16.1 General Problems...16 - 2 16.2 Physiological Alarm Messages at the TM80...16 - 4 16.3 Technical Alarm Messages at the TM80...16 - 7 17 Care and Cleaning...17 - 1 17.1 Introduction...17 - 2 17.2 Care and Cleaning Safety Information...17 - 2 6

TM80 Telemetry Monitor Operator’s Manual

17.3 Cleaning and Disinfecting the TM80...17 - 3 17.3.1 Approved Cleaning Agents and Disinfectants...17 - 3 17.3.2 Cleaning the TM80...17 - 6 17.3.3 Disinfecting the TM80...17 - 7 17.4 Cleaning Accessories and SpO2 Module...17 - 8 17.5 Disinfecting Accessories and SpO2 Module...17 - 9 17.6 Sterilization...17 - 9 18 Maintenance...18 - 1 18.1 Introduction...18 - 2 18.2 Maintenance Safety Information...18 - 2 18.3 Regular Check...18 - 3 18.4 Maintenance and Testing Schedule...18 - 3 18.4.1 Power-on Test...18 - 4 18.4.2 ECG Verification...18 - 5 18.4.3 NIBP Accuracy Test...18 - 5 18.4.4 NIBP Leakage Test...18 - 5 18.4.5 Nurse Call Test...18 - 5 18.4.6 Electrical Safety Tests...18 - 6 18.4.7 Network Print Test...18 - 6 18.4.8 Battery Check...18 - 6 18.5 Viewing System Information...18 - 6 19 Accessories...19 - 1 19.1 ECG Accessories...19 - 2 19.1.1 ECG Electrodes...19 - 2 19.1.2 ECG Leadsets...19 - 3 19.2 SpO2 Accessories...19 - 4 19.3 NIBP Accessories...19 - 5 19.4 Miscellaneous...19 - 5 A Product Specifications...A - 1 A.1 Classifications...A - 2 A.2 Environmental Specifications...A - 2 A.3 Power Supply Specifications...A - 3 A.4 Physical Specifications...A - 4 A.5 Hardware Specifications...A - 5 A.6 Data Storage...A - 6 A.7 Wi-Fi Specifications...A - 6 A.7.1 Technical Specifications...A - 6 A.7.2 Implemented Functions...A - 7 A.7.3 Specifications of Wireless Functions...A - 7 A.8 MPAN Specifications...A - 8 A.8.1 Technical Specifications...A - 8 A.8.2 Implemented Functions...A - 9 TM80 Telemetry Monitor Operator’s Manual

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A.8.3 Specifications of Wireless Functions...A - 9 A.9 Measurement Specifications... A - 10 A.9.1 ECG... A - 10 A.9.2 Resp... A - 13 A.9.3 SpO2... A - 14 B EMC and Radio Regulatory Compliance...B - 1 B.1 EMC... B - 2 B.2 Radio Regulatory Compliance... B - 7 B.2.1 RF Parameters (Panlink2 Module)... B - 7 B.2.2 RF Parameters (SX-SDMAC-2832S+)... B - 7 B.3 Radiofrequency Radiation Exposure Information... B - 8 C Electrical Safety Inspection...C - 1 C.1 Power Cord Plug...C - 2 C.2 Device Enclosure and Accessories...C - 3 C.2.1 Visual Inspection...C - 3 C.2.2 Contextual Inspection...C - 3 C.3 Device Labeling...C - 3 C.4 Earth Leakage Test...C - 3 C.5 Patient Leakage Current...C - 4 C.6 Mains on Applied Part Leakage...C - 4 C.7 Patient Auxiliary Current...C - 5 D Symbols and Abbreviations... D - 1 D.1 Units... D - 2 D.2 Symbols... D - 3 D.3 Abbreviations... D - 3 E Declaration of Conformity... E - 1

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TM80 Telemetry Monitor Operator’s Manual

1

Safety

Safety Information...1-2 Equipment Symbols...1-7

TM80 Telemetry Monitor Operator’s Manual

1-1

Safety Information

1.1

Safety

Safety Information 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

•

1-2

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

TM80 Telemetry Monitor Operator’s Manual

Safety

1.1.1

Safety Information

Warnings WARNING

• • • • • •

• • • •

The TM80 Telemetry Monitor must be operated by medical personnel in hospitals or medical institutions. For continued safe use of the TM80 Telemetry Monitor, the instructions given in this manual must be followed. But instructions in this manual in no way supersede established medical procedures. To avoid explosion hazard, do not use the TM80 Telemetry Monitor in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents. The TM80 Telemetry Monitor is not to be used in the vicinity of electrosurgical units because such use may interrupt or interfere with the transmission of signals from the TM80 Telemetry Monitor. Do not use the TM80 Telemetry Monitor in conjunction with Electro Surgical Unit (ESU). Do not expose the equipment to a Magnetic Resonance (MR) environment. ◆ Thermal injury and burns may occur due to the metal components of the equipment which can heat during MR scanning. ◆

The equipment may present a risk of projectile injury due to the presence of ferromagnetic materials which can be attracted by the MR magnet core.

◆

The leadwires and electrodes will generate artifacts in the MR image.

◆

The equipment will not function properly due to the strong magnetic and radio frequency fields generated by the MR scanner.

The TM80 Telemetry Monitor is intended to be used for a single patient at a time. The TM80 Telemetry Monitor should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Central Monitoring System. Before putting the system into operation, the operator must verify that the TM80 Telemetry Monitor, connecting cables and accessories are in correct working order and operating condition. Do not open the equipment housings. All servicing and future upgrades must be carried out by trained and authorized personnel.

TM80 Telemetry Monitor Operator’s Manual

1-3

Safety Information

Safety

WARNING

• • • • • • • • • • • •

1-4

Do not use patient cables or accessory cables and sensors if prior visual inspection reveals cable damage or the presence of liquid, lint or dust inside. Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could result. Do not touch the patient and live parts simultaneously. Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance. PATIENTS WITH A PACEMAKER – On ventricular paced patients, episodes of ventricular tachycardia may not always be detected. Do not rely entirely upon the system’s automated arrhythmia detection algorithm. Keep pacemaker patients under close surveillance. The physiological data and alarm messages displayed on the TM80 Telemetry Monitor are for reference only and cannot be directly used for diagnostic interpretation. Do not operate the touch screen with water on the hand. Only use parts and accessories specified in this manual. Route, wrap and secure the cables to avoid inadvertent disconnection, stumbling and entanglement. Instruct patients not to interact with the display of the TM80 Telemetry Monitor and not to open the battery compartment while the TM80 Telemetry Monitor is in use. We recommend that the WPA2-PSK or WPA2 CCKM security mode be used when the TM80 Telemetry Monitor is in use. Auditory alarm signal sound pressure levels that are less than ambient levels can impede operator recognition of alarm conditions.

TM80 Telemetry Monitor Operator’s Manual

Safety

1.1.2

Safety Information

Cautions CAUTION

• • • •

•

•

• • •

Do not let the display of the TM80 Telemetry Monitor directly touch the patient’s skin when the display is on. When the CMS presents the alarm “Offline”, check the network connection status. When disposing of the packaging material, be sure to observe the applicable local waste control regulations and keep it out of children’s reach. The patient should be required to move in a specified area. If the patient is at the edge of or outside the network coverage range, unstable network connection may compromise the monitoring performance. The patient’s location is of vital importance for the TM80 Telemetry Monitor. If a life-threatening situation occurs for a patient, this patient must be located and found by medical staff immediately. Mindray takes no responsibility for controlling the radio frequency environment in a hospital. If interference for the operating frequency of telemetry equipment exists, the telemetry equipment performance will be affected. Exercise caution when selecting the operating frequency of all the wireless equipment in a hospital as this is very important to avoid mutual interference among them. Magnetic and electrical fields are capable of interfering with the proper performance of the TM80 Telemetry Monitor. For this reason make sure that all external equipment operated in the vicinity of the TM80 Telemetry Monitor comply with the relevant EMC requirements. Mobile phone, X-ray equipment, micro-wave oven, interphone, or MRI equipment are a possible source of interference as they may emit higher levels of electromagnetic radiation. Always install or carry the TM80 Telemetry Monitor properly to avoid damage caused by drop, impact, strong vibration or other mechanical force. Dry the TM80 Telemetry Monitor immediately in case of rain or water spray. When the patient carrying a TM80 Telemetry Monitor moves in a hospital, signal quality can be impacted on an ambulatory patient by the construction materials used within the hospital.

TM80 Telemetry Monitor Operator’s Manual

1-5

Safety Information

Safety

CAUTION

•

1.1.3

At the end of its service life, the TM80 Telemetry Monitor and its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products to prevent bringing potential negative consequences to the environment and human health. If you have any questions concerning disposal of the equipment, please contact Mindray.

Notes NOTE

• • • • • •

1-6

Put the TM80 Telemetry Monitor in a location where you can easily see the screen and access the operating controls. The software of the TM80 Telemetry Monitor was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized. This manual describes all features and options. Your equipment may not have all of them. If you wish to pair a TM80 Telemetry Monitor with a BeneVision N series patient monitor, contact your service personnel. For details about pairing and unpairing procedures, refer to BeneVision N Series Patient Monitor Operator's Manual (PN: 046-009995-00). If you wish to use the 6-lead placement to derive 12-lead ECG at the CMS, contact your service personnel. For details about this functionality, refer to BeneVision Central Monitoring System Operator’s Manual (PN: 046-010282-00). Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.

TM80 Telemetry Monitor Operator’s Manual