Mindray PM-60Vet Operator's Manual

PM-60Vet

Pulse Oximeter

Operator’s Manual

I

CE Marking

The product bears CE mark indicating its conformity with the provisions of the Council

Directive 93/42/EEC concerning medical devices and fulfils the essential requirements

of Annex I of this directive.

The product is in radio-interference protection class B in accordance with EN55011.

The product complies with the requirement of standard EN 60601-1-2 “Electromagnetic

Compatibility – Medical Electrical Equipment”.

Revision History

This manual has a revision number. This revision number changes whenever the manual

is updated due to software or technical specification change. Contents of this manual are

subject to change without prior notice.

 Revision number: 1.1
 Release time: 2007-11

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

reserved.

WARNING

z Federal Law (USA) restricts this device to sale by or on the order of a

physician.

II

FOR YOUR NOTES

III

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.

IV

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

 th

e 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.

V

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.

VI

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.

VII

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: [phone] [phone]

Fax: [phone] [phone]

Website: www.mindray.com

EC-Representative: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestraße 80, Hamburg 20537

, Germany

Tel: [phone]

Fax: [phone]

VIII

FOR YOUR NOTES

1

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 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 pulse oximeter.

Conventions

 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.

2

FOR YOUR NOTES

1

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 The Basics..................................................................................................................2-1

2.1 Introduction..................................................................................................... 2-1

2.1.1 Intended Use ...................................................................................... 2-1

2.1.2 Contraindications ............................................................................... 2-1

2.1.3 Components ....................................................................................... 2-1

2.2 Main Unit ........................................................................................................ 2-2

2.2.1 Front View..........................................................................................2-2

2.2.2 Rear View and Right View ................................................................ 2-4

2.3 Display Views ................................................................................................. 2-5

2.3.1 SpO2 Area........................................................................................... 2-6

2.3.2 PR Area .............................................................................................. 2-7

2.3.3 Information Area................................................................................ 2-7

3 Getting Started .........................................................................................................3-1

3.1 Unpacking and Checking ................................................................................ 3-1

3.2 Environmental Requirements .........................................................................3-2

3.3 Starting the Pulse oximeter ............................................................................. 3-2

3.4 Shutting Off the Pulse oximeter...................................................................... 3-3

4 Basic Operations ......................................................................................................4-1

4.1 Selecting the Work Mode................................................................................ 4-1

4.2 Admitting a Patient ......................................................................................... 4-2

4.2.1 Continuous Monitoring Mode ........................................................... 4-2

4.2.2 Spot-checking Mode.......................................................................... 4-2

4.3 Selecting the Screen ........................................................................................ 4-3

2

4.4 Adjust the Screen Brightness .......................................................................... 4-3

4.5 Changing the Language .................................................................................. 4-3

4.6 Setting the Clock............................................................................................. 4-4

4.7 Adjusting the Volume...................................................................................... 4-4

4.7.1 Setting the Beat Volume..................................................................... 4-4

4.7.2 Setting the Key Volume ..................................................................... 4-5

4.8 Entering/Exiting the Demo Mode................................................................... 4-5

4.9 Checking the Version ...................................................................................... 4-5

4.10 Entering/Exiting the Standby Mode .............................................................4-6

4.10.1 Entering the Standby Mode ............................................................. 4-6

4.10.2 Exiting the Standby Mode ............................................................... 4-6

4.11 Setting Auto Poweroff................................................................................... 4-7

4.12 Configuration ................................................................................................4-7

4.12.1 Restoring the Factory Configuration ............................................... 4-7

4.12.2 Saving the User Configuration ........................................................ 4-8

4.12.3 Loading the User Configuration ...................................................... 4-8

5 Alarms .......................................................................................................................5-1

5.1 Alarm Categories ............................................................................................ 5-1

5.2 Alarm Levels ................................................................................................... 5-2

5.3 Alarm Indicators.............................................................................................. 5-2

5.3.1 Alarm Lamp ....................................................................................... 5-3

5.3.2 Alarm Tones .......................................................................................5-3

5.3.3 Alarm Messages ................................................................................. 5-3

5.3.4 Alarm Status Symbols........................................................................ 5-4

5.4 Alarm Tone Configuration .............................................................................. 5-5

5.4.1 Setting the Minimum Alarm Volume................................................. 5-5

5.4.2 Changing the Alarm Volume..............................................................5-5

5.4.3 Pausing the Alarm Tones ................................................................... 5-6

5.5 Setting the Alarm Level .................................................................................. 5-7

5.6 When an Alarm Occurs ................................................................................... 5-8

6 Measuring SpO2.......................................................................................................6-1

6.1 Introduction..................................................................................................... 6-1

6.2 Safety............................................................................................................... 6-2

6.3 Applying the Sensor........................................................................................ 6-3

6.4 Changing SpO2 Settings.................................................................................. 6-3

3

6.4.1 Switching On/Off SpO2 and PR Alarms............................................ 6-3

6.4.2 Setting Alarm Level........................................................................... 6-3

6.4.3 Adjusting the Alarm Limits ............................................................... 6-4

6.4.4 Switching On/Off the Alarm Limit Display ...................................... 6-4

6.4.5 Setting SpO2 Sensitivity..................................................................... 6-4

6.5 Measurement Limitations ............................................................................... 6-5

7 Data Management....................................................................................................7-1

7.1 Storing data .....................................................................................................7-1

7.1.1 Continuous Monitoring Mode ........................................................... 7-1

7.1.2 Spot-checking Mode.......................................................................... 7-2

7.2 Reviewing Trend Data .................................................................................... 7-3

7.2.1 Continuous Monitoring Mode ........................................................... 7-3

7.2.2 Spot-checking Mode.......................................................................... 7-4

7.3 Data Exporting ................................................................................................ 7-5

7.3.1 Real-time Exporting........................................................................... 7-5

7.3.2 Exporting Trend Data......................................................................... 7-7

8 Battery.......................................................................................................................8-1

8.1 Overview ......................................................................................................... 8-1

8.2 Installing the Batteries ....................................................................................8-3

8.2.1 Opening the Battery Door.................................................................. 8-3

8.2.2 Installing the Alkaline Batteries ........................................................8-4

8.2.3 Installing the Lithium Ion Battery .....................................................8-4

8.3 Charging the Lithium Ion Battery................................................................... 8-5

8.4 Conditioning the Lithium Ion Battery ............................................................ 8-6

8.5 Checking the Lithium Ion Battery .................................................................. 8-7

8.6 Disposing of the Batteries ............................................................................... 8-8

9 Maintenance and Cleaning......................................................................................9-1

9.1 Safety Checks.................................................................................................. 9-2

9.2 Cleaning ..........................................................................................................9-3

9.3 Disinfecting ..................................................................................................... 9-4

9.4 Disposal........................................................................................................... 9-4

10 Accessories ............................................................................................................10-1

A Product Specifications............................................................................................ A-1

4

B EMC......................................................................................................................... B-1

C Factory Defaults ..................................................................................................... C-1

C.1 Alarm Setup................................................................................................... C-1

C.2 System Setup ................................................................................................. C-2

C.3 SpO2 Setup..................................................................................................... C-2

D Alarm Messages...................................................................................................... D-1

D.1 Physiological Alarm Messages ..................................................................... D-1

D.2 Technical Alarm Messages............................................................................ D-1

E Symbols and Abbreviations................................................................................... E-1

E.1 Units................................................................................................................E-1

E.2 Symbols ..........................................................................................................E-2

E.3 Abbreviations..................................................................................................E-3

1-1

1 Safety

1.1 Safety Information

DANGER

z Indicates an imminent hazard that, if not avoided, will result in death or

serious injury.

WARNING

z Indicates a potential hazard or unsafe practice that, if not avoided, will

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

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 manual.

1.1.2 Warnings

WARNINGS

z Before putting the system into operation, verify that the equipment,

connecting cables and accessories are in correct working order and
operating condition.

z To avoid explosion hazard, do not use the equipment in the presence of

flammable anesthetics, vapors or liquids.

z Do not open the equipment housings; electric shock hazard may exist.

All servicing and future upgrades must be carried out by the personnel
trained and authorized by our company only.

z When using the equipment with electrosurgical units (ESU), make sure

the animal is safe.

z Do not come into contact with the animal during defibrillation. Otherwise

serious injury or death could result.

z Do not rely exclusively on the audible alarm system for animal

monitoring. Adjustment of alarm volume to a low level or off may result
in a hazard to the animal. Remember that alarm settings should be
customized according to different animal situations and always keeping
the animal under close surveillance is the most reliable way for safe
animal monitoring.

z The physiological data and alarm messages displayed on the equipment

are for reference only and cannot be directly used for diagnostic
interpretation.

1-3

z To avoid inadvertent disconnection, route all cables in a way to prevent a

stumbling hazard. Wrap and secure excess cabling to avoid risk of
entanglement or strangulation by animals or personnel.

1.1.3 Cautions

CAUTIONS

z To ensure animal safety, use only parts and accessories specified in this

manual.

z 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. If you have any questions concerning disposal
of the equipment, please contact us.

z 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 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 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.

z Always install or carry the equipment properly to avoid damage caused

by drop, impact, strong vibration or other mechanical force.

1-4

1.1.4 Notes

NOTES

z Put the equipment in a location where you can easily see the screen and

access the operating controls.

z Keep this manual in the vicinity of the equipment so that it can be

obtained conveniently when needed.

z The software was developed in compliance with IEC60601-1-4. The

possibility of hazards arising from software errors is minimized.

z This manual describes all features and options. Your equipment may not

have all of them.

1-5

1.2 Equipment Symbols

Direct Current (DC)

Attention: Consult accompanying documents (this manual).

Auxiliary output connector

Audio pause

Battery door locked/unlocked

Power supply connector

Left/Right button

Power button

Up button

Down button

Date of manufacture

Manufacturer

European community representative

Serial number

Safety Class II equipment

Type BF applied part, defibrillation protected

1-6

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.

2-1

2 The Basics

2.1 Introduction

2.1.1 Intended Use

The pulse oximeter is intended for continuously monitoring, spot checking, displaying,

storing and transferring oxygen saturation and pulse rate of single dog, cat and other

animals.

WARNING

z This pulse oximeter is intended for use only by clinical professionals or

under their guidance. It must only be used by persons who have received
adequate training in its use. Anyone unauthorized or untrained must not
perform any operation on it.

2.1.2 Contraindications

None.

2.1.3 Components

This pulse oximeter consists of a main unit and an SpO2 sensor.

2-2

2.2 Main Unit

2.2.1 Front View

1. Display screen

2. Power button

 Press this button to turn the pulse oximeter on after the batteries are installed.
 Press and hold it for 2 seconds to turn the pulse oximeter off.

3. Power indicating lamp

It is a LED that lights green and yellow. The status of the LED is specified as

follows:

4

8

7

6

2

3

5

9

1

10

2-3

 Green: when the pulse oximeter is placed in the Charger stand and the AC

mains is connected, or when the battery is fully charged if a lithium

battery is used.

 Yellow: when a lithium ion battery is used and is being charged.
 Off: When the AC mains is not connected.

4. Alarm indicating lamp

When an alarm occurs, this lamp will light up as defined below:

 High level alarms: the lamp quickly flashes red.
 Medium level alarms: the lamp slowly flashes yellow.
 Low level alarms: the lamp lights yellow without flashing.

5. Press this button to pause or reactivate the alarm sound.

6. Left button

Press this button to enter the main menu or select the highlighted menu item.

7. Right button

Press this button to return to the previous menu or exit the current menu. In the

case that no menu is opened, you can press and hold this button for 2 seconds to

lock or unlock buttons except the Power button.

8. Up button

Press this button to move the cursor upwards, increase the value of selected menu

item or raise the beat volume.

9. Down button

Press this button to move the cursor downwards, decrease the value of selected

menu item or lower the beat volume.

10. Power supply connector

It is used to connect the Charger stand.

2-4

2.2.2 Rear View and Right View

1. Multifunctional connector

It is used to connect an SpO

2

sensor to measure the oxygen saturation or connect a

personal computer through a PC communication cable to export the trend data.

2. Speaker

3. Battery door

4. Cord hole

5. Infrared port

It is a port through which a personal computer is communicated to export data in

real time.

2

4

3

5

2-5

2.3 Display Views

The following figures show the layout of the wave screen and the normal screen.

Wave screen Normal screen

1. Waveform Area

This area displays Pleth waveform (Pleth). The label of this waveform is shown at

the top left corner.

2. SpO

2

area

3. Technical alarm area

This area shows the technical alarm message, prompt message and the pulse

oximeter’s operating mode. When multiple messages come, they will be displayed

circularly.

4. Alarm status area

indicates that alarm sounds are paused;

indicates that alarm sounds are turned off.

3

4

2

1

5

6

7
8

2

5

2-6

5 PR area

6. Physiological alarm area

This area shows physiological alarm messages. When multiple alarms come, they

will be displayed circularly.

7. Information area

8. QuickKeys area

This area contains QuickKeys that give you fast access to functions.

2.3.1 SpO2 Area

1. SpO

2

label

2. SpO

2

unit

3. SpO

2

high alarm limit

4. SpO

2

low alarm limit

5. Oxygen saturation reading

6. Pleth bar

5

6

1

2

3

4

2-7

2.3.2 PR Area

1. PR label

2. PR unit

3. PR high alarm limit

4. PR low alarm limit

5. Pulse rate reading

2.3.3 Information Area

1. Animal ID

2. Animal category

Animals are classified into three categories: dog, cat and others.

3. Real-time data exporting symbol

This symbol appears when data is being exported in real-time through the infrared

port.

4. Battery symbol

5. Real-time clock

123

5

1
2

3

4

5

4