TMS60 Telemetry Monitoring-System Operators-Manual Ver 4.0 April 2019 H-046-007056-00

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. This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://www.mindrayna.com/patents.

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:

II

■

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.

TMS60 Operator’s Manual

Introduction

Company Contact

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.

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

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

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

TMS60 Operator’s Manual

III

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

IV

■

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

■

Bold text is used to indicate the screen texts and names of hard keys.

■

→ is used to indicate operational procedures.

TMS60 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 2.4.1 Telemetry Transmitter (TD60) ... 2 - 3 2.4.2 Antenna Array ... 2 - 4 2.4.3 Telemetry Receiver (RC60) ... 2 - 4 2.5 TD60 Physical View ... 2 - 5 2.6 Touch Screen Display ... 2 - 6 2.6.1 Display Screen ... 2 - 7 2.6.2 On-Screen Keyboard ... 2 - 8 3 Getting Started ... 3 - 1 3.1 Unpacking and Checking ... 3 - 3 3.2 Environmental Requirements ... 3 - 3 3.3 Connecting the ECG Leadwire ... 3 - 4 3.4 Installing the Batteries ... 3 - 5 3.4.1 Installing the Lithium-ion Rechargeable Battery Pack ... 3 - 6 3.4.2 Installing the AA Batteries ... 3 - 7 3.5 Powering On the Unit ... 3 - 8 3.6 Understanding Touch Gestures ... 3 - 9 3.7 Basic Operations ... 3 - 9 3.7.1 Understanding the Screen Display Orientation ...3 - 10 3.7.2 Browsing the Screen Display ...3 - 10 3.7.3 Switching the Screen Display Orientation ...3 - 10 3.7.4 Flipping the Landscape Display ...3 - 11 3.7.5 Displaying the Quick Keys Area ...3 - 11 3.7.6 Entering the Main Menu ...3 - 12 3.7.7 Turning the Display Off ...3 - 13 3.7.8 Turning the Display On ...3 - 13 3.7.9 Unlocking the Screen in Locked Mode ...3 - 13 3.7.10 Unlocking the Screen in View Only Mode ...3 - 14 3.7.11 Acknowledging the Nurse Call ...3 - 14 3.8 Using the Pouch ...3 - 14

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3.8.1 Securing the Pouch for the TD60 ...3 - 15 3.8.2 Securing Pouches for the TD60 and BP10 ...3 - 17 4 User Configurations ... 4 - 1 4.1 Introduction ... 4 - 2 4.2 Configuring the Display ... 4 - 2 4.2.1 Setting the Default Display Orientation ... 4 - 2 4.2.2 Understanding Portrait Orientation Display Rules ... 4 - 2 4.2.3 Setting the Portrait Display ... 4 - 2 4.2.4 Understanding Landscape Orientation Display Rules ... 4 - 3 4.2.5 Setting the Landscape Display ... 4 - 3 4.2.6 Setting the Display Brightness ... 4 - 4 4.3 Configuring the Audio Volume ... 4 - 4 5 Patient Management ... 5 - 1 5.1 Introduction ... 5 - 2 5.2 Admitting a Patient ... 5 - 2 5.3 Changing the Patient Category ... 5 - 2 5.4 Placing a Device in Standby ... 5 - 3 5.5 Exiting the Standby Mode ... 5 - 3 5.6 Discharging the Patient ... 5 - 4 5.6.1 Selecting the Discharge Patient menu ... 5 - 4 5.6.2 Restarting the TD60 ... 5 - 4 6 Alarms ... 6 - 1 6.1 Introduction ... 6 - 2 6.2 Alarm Categories ... 6 - 2 6.3 Alarm Levels ... 6 - 2 6.4 Alarm Indicators ... 6 - 3 6.4.1 Alarm Light ... 6 - 3 6.4.2 Alarm Tones ... 6 - 3 6.4.3 Alarm Messages ... 6 - 4 6.4.4 Alarm Status Symbols ... 6 - 4 6.5 Configuring Alarms ... 6 - 5 6.6 Resetting Alarms ... 6 - 5 7 Monitoring ECG ... 7 - 1 7.1 Introduction ... 7 - 2 7.2 Safety ... 7 - 2 7.3 Preparation for Monitoring ECG ... 7 - 3 7.3.1 Preparing the Patient’s Skin ... 7 - 3 7.3.2 Positioning the Electrodes ... 7 - 3 7.3.3 Setting ECG Lead Labeling ... 7 - 5 7.3.4 Placing the Electrodes ... 7 - 5 7.3.5 Checking the Lead Placement ... 7 - 9

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7.3.6 Setting the Paced Status ...7 - 10 7.3.7 Maintaining Quality ECG Signal ...7 - 11 7.4 Changing the ECG Settings ...7 - 12 7.4.1 Configuring the ECG Setup ...7 - 12 7.4.2 ECG Leadwire Types ...7 - 13 7.4.3 Configuring the ECG Waveforms ...7 - 13 7.4.4 Configuring the Pacer ...7 - 14 7.4.5 Configuring the ECG Waveform Size ...7 - 14 7.4.6 Setting the Notch Filter ...7 - 15 7.5 Understanding the ECG Display ...7 - 15 7.5.1 HR Digital Area ...7 - 15 7.5.2 About the HR Digital Area ...7 - 15 7.5.3 ECG Waveform Area ...7 - 16 7.5.4 About the ECG Waveform Area ...7 - 16 8 Monitoring Respiration (Resp) (Optional) ... 8 - 1 8.1 Introduction ... 8 - 2 8.2 Safety ... 8 - 2 8.3 Preparation for Monitoring Resp ... 8 - 3 8.3.1 Preparing the Patient’s Skin ... 8 - 3 8.3.2 Positioning the Electrodes ... 8 - 3 8.4 Changing the Resp Settings ... 8 - 4 8.4.1 Configuring the Resp Setup ... 8 - 4 8.4.2 Configuring the Resp Waveform ... 8 - 5 8.5 Understanding the Resp Display ... 8 - 6 8.5.1 Resp Digital Area ... 8 - 6 8.5.2 About the Resp Digital Area ... 8 - 6 8.5.3 Resp Waveform Area ... 8 - 6 8.5.4 About the Resp Waveform Area ... 8 - 7 9 Monitoring Pulse Oxygen Saturation (SpO2) (Optional) ... 9 - 1 9.1 Introduction ... 9 - 2 9.2 Measurement Limitations ... 9 - 2 9.3 Safety ... 9 - 3 9.4 Connecting the SpO2 Module ... 9 - 4 9.5 Changing the SpO2 Settings ... 9 - 5 9.5.1 Configuring the SpO2 Setup ... 9 - 5 9.5.2 Configuring the SpO2 Waveform ... 9 - 8 9.6 SpO2 Measurement ... 9 - 8 9.6.1 Identifying SpO2 Modules ... 9 - 8 9.6.2 Applying the Sensor ... 9 - 8 9.7 Understanding the SpO2 Display ... 9 - 9 9.7.1 SpO2 Digital Area ... 9 - 9 9.7.2 About the SpO2 Digital Area ...9 - 10 9.7.3 SpO2 Waveform Area ...9 - 11

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3

9.7.4 About the SpO2 Waveform Area ...9 - 11 9.8 Masimo Information ...9 - 12 9.9 Nellcor Information ...9 - 12 10 Monitoring Noninvasive Blood Pressure (NIBP) (Optional) ... 10 - 1 10.1 Introduction ...10 - 2 10.2 Pairing the TD60 with the BP10 ...10 - 2 10.2.1 Pairing Procedure ...10 - 2 10.2.2 System Responses after Successfully Pairing ...10 - 3 10.3 Unpairing the TD60 with the BP10 ...10 - 4 10.3.1 Unpairing via the TD60 ...10 - 4 10.3.2 Unpairing via BP10 ...10 - 5 10.3.3 System Responses after Successfully Unpairing ...10 - 5 10.4 Screen Display after Pairing a TD60 with a BP10 ...10 - 5 10.5 Interactions after Pairing a TD60 with a BP10 ...10 - 6 10.5.1 Overview of Interactions ...10 - 6 10.5.2 Operating the BP10 via the TD60 ...10 - 7 10.5.3 NIBP Operations at the TD60 ...10 - 7 11 Configuring the TD60 ... 11 - 1 11.1 Introduction ...11 - 2 11.2 Entering the Maintenance menu ...11 - 2 11.3 Configuring the General Menu ...11 - 2 11.4 Configuring the Alarms Menu ...11 - 3 11.5 Quick Keys Menu ...11 - 5 11.5.1 Changing the Quick Keys ...11 - 5 11.5.2 Deleting a Quick Key ...11 - 6 11.6 Configuring the Defaults Menu ...11 - 6 11.6.1 Transferring a Configuration ...11 - 7 11.7 Screen Lock Menu ...11 - 8 11.7.1 Understanding the Screen Lock Mode ...11 - 8 11.7.2 Setting the Screen Lock ...11 - 8 11.7.3 Changing the Current Screen Lock Passcode ...11 - 8 11.7.4 Changing the Screen Lock Mode ...11 - 9 11.8 Changing the Passwords ...11 - 9 11.9 Changing the Device Name ...11 - 9 11.10 Demo Mode ...11 - 9 11.11 Service Menu ...11 - 9 12 Monitoring with the TMS60 at the CMS ... 12 - 1 12.1 Introduction ...12 - 2 12.2 Monitoring at the CMS (Version Earlier than 03.00) ...12 - 2 12.2.1 Physiological Alarms ...12 - 2 12.2.2 ECG Monitoring ...12 - 9

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TMS60 Operator’s Manual

12.2.3 QT Monitoring ... 12 - 14 12.2.4 ST Monitoring ... 12 - 18 12.2.5 Arrhythmia Monitoring ... 12 - 22 12.2.6 SpO2 Monitoring ... 12 - 27 12.2.7 Measurement Limitations ... 12 - 27 12.2.8 SpO2 Settings ... 12 - 28 12.2.9 SpO2 Display ... 12 - 29 12.3 Monitoring at the CMS (Version 03.00 or Above) ... 12 - 30 12.3.1 Physiological Alarms ... 12 - 30 12.3.2 ECG Monitoring ... 12 - 36 12.3.3 QT Monitoring ... 12 - 39 12.3.4 ST Monitoring ... 12 - 42 12.3.5 Arrhythmia Monitoring ... 12 - 46 12.3.6 Resp Monitoring ... 12 - 50 12.3.7 SpO2 Monitoring ... 12 - 51 12.3.8 NIBP Monitoring ... 12 - 54 13 Battery ... 13 - 1 13.1 Introduction ...13 - 2 13.2 Safety ...13 - 2 13.3 Installing the Battery ...13 - 4 13.4 Checking the Battery Charge Status ...13 - 4 13.5 Removing the Battery ...13 - 4 13.6 Charging the Rechargeable Lithium-ion Battery ...13 - 5 13.7 Storing the Batteries ...13 - 6 13.7.1 Storing Rechargeable Lithium-ion Battery ...13 - 6 13.7.2 Storing AA Batteries ...13 - 7 13.8 Maintaining the Rechargeable Lithium-ion Battery ...13 - 7 13.9 Disposing of the Batteries ...13 - 8 13.9.1 Disposing of the Rechargeable Lithium-ion Battery ...13 - 8 13.9.2 Disposing of the AA Batteries ...13 - 8 14 Troubleshooting ... 14 - 1 14.1 General Problems ...14 - 2 14.2 Physiological Alarm Messages at the CMS ...14 - 3 14.3 Technical Alarm Messages at the TD60 ...14 - 6 15 Cleaning and Disinfecting ... 15 - 1 15.1 Introduction ...15 - 2 15.2 Safety Information ...15 - 2 15.3 Cleaning and Disinfecting the Equipment ...15 - 3 15.3.1 Approved Cleaning and Disinfecting Agents ...15 - 3 15.3.2 Cleaning the Equipment ...15 - 5 15.3.3 Disinfecting the Equipment ...15 - 7 15.4 Cleaning and Disinfecting ECG Leadwires and SpO2 Sensors ...15 - 7

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15.5 Cleaning and Disinfecting Other Parts ...15 - 8 15.6 Sterilization ...15 - 9 15.7 Impact of Improper Cleaning or Disinfection ...15 - 9 16 Maintenance ... 16 - 1 16.1 Introduction ...16 - 2 16.2 Safety ...16 - 2 16.3 Regular Check ...16 - 3 16.4 Maintenance and Testing Schedule ...16 - 4 16.5 Power-on Test ...16 - 4 16.6 Verifying the ECG at the TD60 ...16 - 5 16.7 NIBP Accuracy Test ...16 - 5 16.8 NIBP Leakage Test ...16 - 5 16.9 Nurse Call Test ...16 - 5 16.10 Electrical Safety Tests ...16 - 5 16.11 Battery Check ...16 - 6 16.12 Viewing System Information ...16 - 6 17 Accessories ... 17 - 1 17.1 ECG Accessories ...17 - 2 17.1.1 ECG Electrodes ...17 - 2 17.1.2 ECG Leadsets ...17 - 3 17.2 SpO2 Accessories ...17 - 3 17.2.1 Masimo SpO2 Module ...17 - 3 17.2.2 Masimo SpO2 Sensor ...17 - 4 17.2.3 Nellcor SpO2 Module ...17 - 4 17.2.4 Nellcor SpO2 Sensor ...17 - 4 17.3 NIBP Accessories ...17 - 5 17.4 Miscellaneous ...17 - 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.3.1 TD60 ...A - 3 A.3.2 RC60 ...A - 3 A.3.3 Central Charger ...A - 4 A.4 Physical Specifications ...A - 4 A.5 Hardware Specifications ...A - 5 A.5.1 TD60 ...A - 5 A.5.2 RC60 ...A - 6 A.5.3 Central Charger ...A - 6 A.6 Wireless Specification ...A - 7 A.6.1 WMTS Specification ...A - 7

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TMS60 Operator’s Manual

A.6.2 Mindray Patient Area Network (MPAN) Specification ...A - 8 A.7 Measurement Specifications ... A - 10 A.7.1 ECG ... A - 10 A.7.2 Resp ... A - 13 A.7.3 SpO2 ... A - 14 B EMC ... B - 1 C FCC Compliance ... C - 1 D Symbols and Abbreviations ...D - 1 D.1 Units ... D - 2 D.2 Symbols ... D - 3 D.3 Abbreviations ... D - 3

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TMS60 Operator’s Manual

1

Safety

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

TMS60 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.

TMS60 Operator’s Manual

Safety

1.1.1

Safety Information

Warnings

WARNING

• • • • • •

• • • •

The Telemetry Transmitter (TD60) is intended to be used for a single patient at a time. The Telemetry Monitoring System (hereinafter called TMS60) must be operated by medical personnel in hospitals. For continued safe use of the TMS60, 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 equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents. Do not use the equipment 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.

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. 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.

TMS60 Operator’s Manual

1-3

Safety Information

Safety

WARNING

• • • • • • • • • •

1-4

Do not open the equipment housings. All servicing and future upgrades must be carried out by trained and authorized personnel. 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 keep the patient under close surveillance. The physiological data and alarm messages displayed on the system are for reference only and cannot be directly used for diagnostic interpretation. 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. Do not operate the touch screen with wet hands. Only use parts and accessories specified in this manual. Route, wrap and secure the cables to avoid inadvertent disconnection, stumbling and entanglement. To avoid risk of electric shock, RC60 and central charger must only be connected to a supply mains with protective earth. Instruct patients not to interact with the display of the TD60 and not to open the battery compartment while the TD60 is in use. Auditory alarm signal sound pressure levels that are less than ambient levels can impede operator recognition of alarm conditions.

TMS60 Operator’s Manual

Safety

1.1.2

Safety Information

Cautions CAUTION

• • • • •

•

• • • •

Do not let the display of the TD60 directly touch the patient when the display is on. When the Central Monitoring System presents the alarm “RF No Signal”, the settings being performed on the TD60 may not be transferred to the central monitoring system. Check the patient condition and the settings on the Central Monitoring System. When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach. After the configurations, such as the patient category, paced status, are changed at the TD60, the medical personnel should check those configurations at the Central Monitoring System to make sure both of the configurations are consistent. 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 equipment. For this reason make sure that all external equipment operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI equipment are a possible source of interference as they may emit higher levels of electromagnetic radiation. 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 or water spray. The system generates and uses the Radio Frequency (RF) energy. If it is not installed correctly or not used as per the manual, RF interference to other equipment could result. When the patient carrying a TD60 moves in a hospital, signal quality can be impacted on an ambulatory patient by the construction materials used within the hospital..

TMS60 Operator’s Manual

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Safety Information

Safety

CAUTION

• •

1.1.3

At the end of its service life, the equipment and 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 equipment, please contact Mindray. When programming the frequency for a transmitter, the frequencies allocated to all other transmitters need to be considered to ensure that no two transmitters are programmed with the same frequency.

Notes NOTE

• • • • •

1-6

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

TMS60 Operator’s Manual

Safety

1.2

Equipment Symbols

Equipment Symbols

Symbol

MR

Description

Symbol

Description

Power On/Off key

Main menu key

Nurse call key

Symbol for aligning the SpO2 connector

Charge indicator

Alternating current

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

Serial number

Date of Manufacture

Manufacturer

MR Unsafe – do not subject to magnetic resonance imaging (MRI)

IPX7

Protection against fluid ingress

Non-ionizing radiation

General warning sign

Refer to instruction manual/booklet

Stand-by

Humidity limitation

Atmospheric pressure limitation

Temperature limitation

Plastics identification symbol

The presence of this label indicates the machine was certified by ETL with the statement: Conforms to AAMI Std ES 60601-1, IEC Std 60601-1-6, IEC Std 60601-1-8, IEC Std 60601-2-27, IEC Std 60601-2-49, ISO Std 80601-2-61, IEC Std. 80601-2-30 Certified to CSA Std C22.2 NO. 60601-1, NO. 60601-1-6, NO. 60601-1-8, NO.60601-227, NO. 60601-2-49, NO.80601-2-61, NO.80601-2-30

TMS60 Operator’s Manual

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Equipment Symbols

Safety

NOTE

•

1-8

Some symbols may not appear on your equipment.

TMS60 Operator’s Manual