VS-800 Vital Signs Monitor Operator’s Manual Ver 2.4

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the 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. Contents of this manual are subject to changes without prior notice.

© 2005 - 2007 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

I

Manufacturer’s Responsibility

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; and

„

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

„

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

Warranty This warranty is exclusive and is in lieu of all other warranties, expressed or implied, including warranties of merchantability or fitness for any particular purpose.

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

Any Mindray product which has been subjected to misuse, negligence or accident; or

„

Any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; or

„

Any product of any other manufacturer.

II

Return Policy

In the event that it becomes necessary to return a unit to Mindray, follow the instructions below. 1.

Return authorization.

Contact the Customer Service Department and obtain a Customer Service Authorization number. This number must appear on the outside of the shipping container. Returned shipments will not be accepted if the number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. 2.

Freight policy

The customer is responsible for freight charges when this product is shipped to Mindray for service (this includes customs charges). 3.

Return address

Please send the part(s) or equipment to the address offered by the Customer Service Department.

III

Contact Information

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057, P. R. China

Tel:

+86 755 26582479

+86 755 26582888

Fax:

+86 755 26582934

+86 755 26582500

Website:

www.mindray.com

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraße 80, Hamburg 20537, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

IV

Contents

1

Safety ... 1-1 1.1 Safety Information ... 1-2 1.1.1 Dangers ... 1-3 1.1.2 Warnings ... 1-3 1.1.3 Cautions... 1-4 1.1.4 Notes ... 1-5 1.2 Equipment Symbols ... 1-6 1.3 CE Marking... 1-7 1.4 Reference Literature... 1-8

2

The Basics ... 2-1 2.1 Monitor Description ... 2-2 2.1.1 Intended Use... 2-2 2.1.2 Contraindications ... 2-2 2.1.3 Components... 2-3 2.1.4 Functions ... 2-3 2.2 Appearance... 2-4 2.2.1 Front Panel ... 2-4 2.2.2 Rear Panel ... 2-8 2.2.3 Recorder ... 2-9 2.3 Display ... 2-10 2.3.1 Cursor... 2-10 2.4 Battery ... 2-11 2.4.1 Battery Maintenance ... 2-12 2.4.2 Battery Recycling ... 2-13

3

Installation and Maintenance... 3-1 3.1 Installation... 3-2 3.1.1 Unpacking and Checking ... 3-2 3.1.2 Environmental Requirements ... 3-3 3.1.3 Power Supply Requirements ... 3-3 3.1.4 Bracket Mounting... 3-3 3.1.5 Installation Method ... 3-4 3.1.6 Powering on the Monitor... 3-8 3.1.7 Powering off the Monitor ... 3-8 3.2 Maintenance ... 3-9 3.2.1 Inspection ... 3-9 3.2.2 Cleaning ... 3-10 3.2.3 Disinfection ... 3-11 1

Contents 4

Menus and Screens... 4-1 4.1 Patient Information Setup... 4-2 4.2 System Setup... 4-3 4.2.1 Common Setup... 4-3 4.2.2 Default Setup... 4-4 4.2.3 Nurse Call Setup... 4-5 4.2.4 Network Setup... 4-6 4.2.5 Data Output ... 4-7 4.2.6 Time Setup ... 4-7 4.2.7 Version ... 4-8 4.2.8 Maintenance ... 4-8 4.3 Alarm Setup ... 4-9 4.4 Trend Data Screen... 4-10 4.5 PLETH Waveform Screen ... 4-11 4.6 INTERVAL... 4-11 4.7 Standby State... 4-12 4.7.1 Entering the Standby State ... 4-12 4.7.2 Exiting the Standby State ... 4-13

5

Alarms ... 5-1 5.1 Overview ... 5-2 5.1.1 Alarm Categories... 5-2 5.1.2 Alarm Levels ... 5-3 5.2 Alarm Modes... 5-4 5.2.1 Visual Alarms... 5-4 5.2.2 Audible Alarms ... 5-4 5.2.3 Alarm Messages ... 5-5 5.3 Alarm Status... 5-5 5.3.1 Alarms Disabled... 5-5 5.3.2 Alarms Paused... 5-6 5.3.3 System Silenced ... 5-6 5.3.4 Status Switchover... 5-7 5.4 Clearing Alarms ... 5-8 5.5 When an Alarm Occurs ... 5-9

6

Recording ... 6-1 6.1 Overview ... 6-2 6.2 Recorder Operations... 6-2 6.3 Installing Recorder Paper ... 6-3

7

Management System Software... 7-1 7.1 Installation and Uninstallation ... 7-3 7.1.1 Installing the PV Software ... 7-3 7.1.2 Uninstalling the PV Software... 7-5 7.1.3 Network Connection ... 7-5 7.2 Main Window... 7-6

2

Contents

7.3

7.2.1 Menu Bar... 7-6 7.2.2 Patient Management ... 7-7 Software Functions... 7-8 7.3.1 Trend Review ... 7-8 7.3.2 NIBP Review... 7-10

8

SpO2 Monitoring ... 8-1 8.1 Mindray SpO2 Module ... 8-3 8.1.1 Principles of Operation... 8-3 8.1.2 Precautions ... 8-3 8.1.3 Monitoring Procedure ... 8-4 8.1.4 Measurement Limitations... 8-7 8.2 Masimo SpO2 Module... 8-9 8.2.1 Principles of Operation... 8-9 8.2.2 Precautions ... 8-12 8.2.3 Monitoring Procedure ... 8-13 8.2.4 Measurement Limitations... 8-13 8.2.5 Masimo Information... 8-15 8.3 Nellcor SpO2 Module ... 8-16 8.3.1 Principles of Operation... 8-16 8.3.2 Precautions ... 8-19 8.3.3 Monitoring Procedure ... 8-20 8.3.4 Measurement Limitations... 8-20 8.3.5 Nellcor Information... 8-22

9

NIBP Monitoring... 9-1 9.1 Overview ... 9-2 9.2 Monitoring Procedure ... 9-3 9.2.1 Cuff Selection and Placement ... 9-3 9.2.2 Operation Guides... 9-4 9.3 Measurement Limitations... 9-6 9.4 Reset, Calibration and Test for Air Leakage ... 9-7 9.4.1 Reset... 9-7 9.4.2 Calibration... 9-7 9.4.3 Test for Air Leakage ... 9-9 9.5 Maintenance and Cleaning ... 9-10

10

TEMP Monitoring... 10-1 10.1 Overview ... 10-2 10.2 Monitoring Procedure ... 10-4 10.2.1 TEMP position ... 10-4 10.2.2 Oral Temperature Measurement... 10-4 10.2.3 Axillary Temperature Measurement... 10-5 10.2.4 Rectal Temperature Measurement... 10-5 10.2.5 Temperature Measurement in MONITOR Mode... 10-6 10.3 Precautions ... 10-7

3

Contents 10.4 Maintenance and Cleaning ... 10-8 11

Accessories ... 11-1 11.1 SpO2 Accessories ... 11-2 11.1.1 Mindray SpO2 Accessories... 11-2 11.1.2 Masimo SpO2 Accessories ... 11-3 11.1.3 Nellcor SpO2 Accessories ... 11-3 11.2 NIBP Accessories... 11-4 11.3 TEMP Accessories ... 11-4

12

Appendices ... 12-1 Appendix A Product Specifications ... 12-2 A.1 Safety Classifications ... 12-2 A.2 Environmental Specifications... 12-3 A.3 Power Requirements ... 12-4 A.4 Hardware Specification ... 12-5 A.5 Signal Output... 12-6 A.6 SpO2 Specification ... 12-7 A.7 NIBP Specification... 12-9 A.8 TEMP Specification ... 12-10 Appendix B EMC... 12-11 Appendix C Alarm Messages and Prompt Information ... 12-16 C.1 Physiological Alarm Messages ... 12-16 C.2 Technical Alarm Messages ... 12-16 C.3 Prompt Messages... 12-25 Appendix D Symbols and Abbreviations... 12-27 D.1 Symbols... 12-27 D.2 Abbreviations ... 12-29

4

Preface

Manual Purpose This manual provides the instructions necessary to operate the VS-800 Vital Signs Monitor (hereinafter called as this monitor) in accordance with its function and intended use. Observance of this manual is a prerequisite for proper performance and correct operation, and ensures patient and operator safety. This manual is written based on the maximum configuration. Part of this manual may not apply to your monitor. If you have any question about the configuration of your monitor, please contact our Customer Service. This manual is an integral part of and should always be kept close to the monitor, so that it can be obtained conveniently when necessary.

Intended Audience This manual is geared for the clinical medical professionals. Clinical medical professionals are expected to have working knowledge of medical procedures, practices and terminology as required for monitoring of patients.

Version Information This manual has a version number. This version number changes whenever the manual is updated due to software or technical specification change. Content of this manual is subject to change without prior notice. The version information of this manual is as follows. Version number

Release date

2.4

October 2007

1

Preface

Illustrations and Names All illustrations in this manual are provided as examples only. They may not necessarily accord with the graphs, settings or data displayed on your monitor. All names appeared in this manual and illustrations are fictive. It is a mere coincidence if the name is the same with yours.

Conventions „

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

„

The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level or seriousness.

2

1 Safety 1.1

1.2 1.3 1.4

Safety Information ... 1-2 1.1.1 Dangers ... 1-3 1.1.2 Warnings ... 1-3 1.1.3 Cautions... 1-4 1.1.4 Notes ... 1-5 Equipment Symbols ... 1-6 CE Marking... 1-7 Reference Literature... 1-8

1-1

Safety

1.1

Safety Information The safety statements presented in this chapter refer to the basic safety information that the operator of the monitor shall pay attention to and abide by. There are additional safety statements in other chapters or sections, which may be the same as or similar to the followings, or specific to the operations.

DANGER z

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

WARNING z

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

CAUTION z

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE z

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

1-2

Safety

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

This monitor is not applicable for prolonged and continuous SpO2 monitoring, which may increase the risks of irritation and burns at the site of the sensor.

z

This monitor is not applicable for prolonged and continuous temperature monitoring for more than 5 minutes.

z

This monitor is intended for use by qualified clinical physicians or well-trained nurses in the specified places.

z

It is your responsibility to verify the device and accessories can function safely and normally before use

z

The disposable accessories should be disposed of in accordance with the hospital regulations.

z

A possible fire or explosion hazard exists when used in the presence of flammable anesthetics or other flammable or explosive substances in combination with air, oxygen-enriched environments, or nitrous oxide.

z

You must customize the alarm setups according to the individual patient situation, and make sure the alarm sound can be activated when an alarm occurs.

z

Opening the monitor housing presents a risk of hazard due to electrical shock. All servicing and future upgrades to this equipment must be carried out by personnel tranined and authorized by Mindray only.

z

Do not touch the patient during defibrillation. A risk of serious injury or death is present.

z

When used in conjunction with electro-surgery equipment, you must give top priority to the patient safety.

z

Dispose of the package material, observing the applicable waste

1-3

Safety control regulations and keeping it out of children’s reach. z

1.1.3

The device must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect the monitor from the power line and operate it on battery power, if possible.

Cautions

CAUTION z

To ensure patient safety, use only parts and accessories specified in this manual.

z

Remove the battery from the monitor if it will not be used or not be connected to the power line for a long period.

z

Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.

z

At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the products, please contact with us.

z

Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

z

Before connecting this monitor to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the label or in this manual.

z

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

1-4

Safety

1.1.4

Notes

NOTE z

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

z

This monitor complies with the requirements of CISPR11 (EN55011) class A.

z

The software was developed per IEC60601-1-4. The possiblility of hazards arising from errors in software program is minimized.

z

Put the monitor in a location where you can easily see the screen and access the operating controls.

z

The instructions of this manual are based on the maximum configuration. Some of them may not apply to your monitor.

1-5

Safety

1.2

Equipment Symbols Caution: Consult accompanying documents (this manual).

Up

Power ON/OFF

Selection

Alternating current (AC)

Down

Battery indicator

Pulse Rate (PR)

Defibrillation-proof type CF applied part

Neonate

NIBP

Pediatric/Child

PATIENT INFO.

Adult

MENU

Equipotentiality

SET ALARMS

(Nurse call) Output

DISPLAY

RS-232 connector

INTERVAL

Date of manufacture

RECORD

Serial number

SILENCE

Network connector

CE marking

1-6

Safety

1.3 CE Marking

The vital signs monitor bears CE mark CE-0123 indicating its conformity with the provision of Council Directive 93/42/EEC concerning medical devices, and fulfills the essential requirement of Annex I of this directive. This monitor is in radio-interfernce protection class A in accordance with EN55011. The product complies with the requirement of standard EN60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”.

1-7

Safety

1.4

Reference Literature

1.

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices

2.

IEC60601-1 or EN60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety

3.

IEC60601-1-1 or EN60601-1-1, Medical Electrical Equipment- Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems

4.

IEC60601-1-4, Medical Electrical Equipment- Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems.

5.

IEC60601-2-49, Medical Electrical Equipment-Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment.

1-8

2 The Basics 2.1

2.2

2.3 2.4

Monitor Description ... 2-2 2.1.1 Intended Use... 2-2 2.1.2 Contraindications ... 2-2 2.1.3 Components... 2-3 2.1.4 Functions ... 2-3 Appearance... 2-4 2.2.1 Front Panel ... 2-4 2.2.2 Rear Panel ... 2-8 2.2.3 Recorder ... 2-9 Display ... 2-10 2.3.1 Cursor... 2-10 Battery... 2-11 2.4.1 Battery Maintenance ... 2-12 2.4.2 Battery Recycling... 2-13

2-1