Mindray VS-800 User manual

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VS-800

Vital Signs Monitor

Operator’s Manual

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 A 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: 2.0  Release time: 2008-06

reserved.

WARNING

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

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.

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.

III

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.

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.

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 patient monitor.

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 of severity.

 → is used to indicate operational procedures.

FOR YOUR NOTES

Contents

1 Safety................................................................................................................................. 1-1

1.1 Safety Information ..........................................................................................................1-1

1.1.1 Dangers .............................................................................................................. 1-1

1.1.2 Warnings............................................................................................................. 1-2

1.1.3 Cautions ............................................................................................................. 1-3

1.1.4 Notes .................................................................................................................. 1-4

1.2 Equipment Symbols ........................................................................................................ 1-4

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

2.1 Monitor Description........................................................................................................ 2-1

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

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

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

2.1.4 Functions............................................................................................................ 2-2

2.2 Appearance...................................................................................................................... 2-3

2.2.1 Front Panel ......................................................................................................... 2-3

2.2.2 Rear Panel .......................................................................................................... 2-7

2.2.3 Recorder ............................................................................................................. 2-8

2.3 Display ............................................................................................................................ 2-9

2.3.1 Cursor................................................................................................................. 2-9

2.4 Battery........................................................................................................................... 2-10

2.4.1 Battery Maintenance .........................................................................................2-11

2.4.2 Battery Recycling............................................................................................. 2-12

3 Installation and Maintenance.......................................................................................... 3-1

3.1 Installation....................................................................................................................... 3-1

3.1.1 Unpacking and Checking ................................................................................... 3-1

3.1.2 Environmental Requirements............................................................................. 3-2

3.1.3 Power Supply Requirements .............................................................................. 3-2

3.1.4 Bracket Mounting............................................................................................... 3-2

3.1.5 Installation Method ............................................................................................ 3-3

3.1.6 Powering on the Monitor.................................................................................... 3-7

3.1.7 Powering off the Monitor................................................................................... 3-7

3.2 Maintenance .................................................................................................................... 3-7

3.2.1 Inspection ........................................................................................................... 3-8

3.2.2 Cleaning ............................................................................................................. 3-8

3.2.3 Disinfection...................................................................................................... 3-10

4 Menus and Screens........................................................................................................... 4-1

4.1 Patient Information.......................................................................................................... 4-1

4.2 System Setup................................................................................................................... 4-2

4.2.1 Common Setup................................................................................................... 4-2

4.2.2 Network Setup.................................................................................................... 4-3

4.2.3 Time Setup ......................................................................................................... 4-4

4.2.4 User Maintenance............................................................................................... 4-4

4.2.5 Nurse Call Setup ................................................................................................ 4-5

4.2.6 Version................................................................................................................ 4-6

4.2.7 Configuration ..................................................................................................... 4-6

4.2.8 Exporting Data ................................................................................................... 4-7

4.3 Normal Screen................................................................................................................. 4-7

4.4 Trend Screen ................................................................................................................... 4-8

4.5 Standby State................................................................................................................... 4-9

4.5.1 Entering the Standby State ................................................................................. 4-9

4.5.2 Exiting the Standby State................................................................................... 4-9

4.6 Patient Review System Software .................................................................................... 4-9

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

5.1 Overview......................................................................................................................... 5-1

5.1.1 Alarm Categories................................................................................................ 5-1

5.1.2 Alarm Levels ...................................................................................................... 5-2

5.2 Alarm Indications ............................................................................................................ 5-2

5.2.1 Alarm Lamp ....................................................................................................... 5-3

5.2.2 Audible Alarms................................................................................................... 5-3

5.2.3 Alarm Messages ................................................................................................. 5-3

5.3 Alarm Status .................................................................................................................... 5-4

5.3.1 Audio Off ........................................................................................................... 5-4

5.3.2 Physiological Alarm Off..................................................................................... 5-5

5.3.3 Alarms Paused .................................................................................................... 5-5

5.3.4 Alarm Silenced ................................................................................................... 5-6

5.3.5 Status Switchover............................................................................................... 5-6

5.4 Clearing Alarm Indications ............................................................................................. 5-7

5.5 Setting Alarms................................................................................................................. 5-7

5.6 SpO

Sensor Off Alarm ................................................................................................... 5-8

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

6 Recording.......................................................................................................................... 6-1

6.1 Overview......................................................................................................................... 6-1

6.2 Using the Recorder..........................................................................................................6-1

6.2.1 Printing Real-time PLETH waveform................................................................ 6-1

6.2.2 Printing Currently Displayed Trend Data........................................................... 6-1

6.2.3 Printing All Trend Data of the Current Patient................................................... 6-1

6.3 Loading Paper ................................................................................................................. 6-2

6.4 Removing Paper Jam....................................................................................................... 6-3

7 SpO2 Monitoring.............................................................................................................. 7-1

7.1 Introduction..................................................................................................................... 7-1

7.2 Safety .............................................................................................................................. 7-2

7.3 Monitoring Procedure ..................................................................................................... 7-3

7.4 Measurement Limitations................................................................................................ 7-3

7.5 Masimo Information........................................................................................................ 7-4

7.6 Nellcor Information.........................................................................................................7-4

8 NIBP Monitoring.............................................................................................................. 8-1

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

8.2 Monitoring Procedure ..................................................................................................... 8-2

8.2.1 Cuff Selection and Placement ............................................................................ 8-2

8.2.2 Operation Guides ............................................................................................... 8-3

8.3 Measurement Limitations................................................................................................ 8-4

8.4 NIBP Reset, Calibration and Test for Air Leakage.......................................................... 8-5

8.4.1 Resetting NIBP................................................................................................... 8-5

8.4.2 Calibrating NIBP................................................................................................ 8-5

8.4.3 NIBP Leakage Test............................................................................................. 8-6

9 TEMP Monitoring............................................................................................................ 9-1

9.1 Overview......................................................................................................................... 9-1

9.2 Temperature Setup...........................................................................................................9-2

9.3 Monitoring Procedure ..................................................................................................... 9-2

9.3.1 TEMP position ................................................................................................... 9-2

9.3.2 Oral Temperature Measurement......................................................................... 9-3

9.3.3 Axillary Temperature Measurement................................................................... 9-3

9.3.4 Measuring Rectal Temperature .......................................................................... 9-4

9.3.5 Temperature Measurement in MONITOR Mode ............................................... 9-5

9.4 Precautions...................................................................................................................... 9-6

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

10.1 SpO

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

10.2 NIBP Accessories........................................................................................................ 10-3

10.3 TEMP Accessories ...................................................................................................... 10-4

10.4 Others.......................................................................................................................... 10-4

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

A.1 Safety Specifications..................................................................................................... A-1

A.2 Environmental Specifications........................................................................................ A-1

A.3 Power Requirements ..................................................................................................... A-2

A.4 Hardware Specification................................................................................................. A-3

A.5 Signal Output ................................................................................................................ A-4

A.6 SpO

Specification ........................................................................................................ A-4

A.6.1 Mindray SpO

Specification............................................................................. A-4

A.6.2 Masimo SpO2 Specification ............................................................................. A-5

A.6.3 Nellcor SpO

Specification .............................................................................. A-6

A.7 NIBP Specification........................................................................................................ A-6

A.8 TEMP Specification ...................................................................................................... A-7

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

C Alarm Messages and Prompt Information................................................................... C-1

C.1 Physiological Alarm Messages .......................................................................................C-1

C.2 Technical Alarm Messages .............................................................................................C-1

C.2.1 General Alarm Messages of Parameter Modules...............................................C-2

C.2.2 NIBP Module Alarm Messages .........................................................................C-2

C.2.3 Mindray SpO

C.2.4 Masimo SpO

C.2.5 Nellcor SpO

Module Alarm Messages ...........................................................C-4

Module Alarm Messages............................................................C-5

Module Alarm Messages .............................................................C-7

C.2.6 SmarTemp™ TEMP Module Alarm Messages..................................................C-8

C.2.7 Recorder Module Alarm Messages....................................................................C-9

C.2.8 System Alarm Messages ..................................................................................C-11

C.3 Prompt Messages..........................................................................................................C-12

D Factory Defaults............................................................................................................. D-1

D.1 Patient Information........................................................................................................ D-1

D.2 System Setup................................................................................................................. D-2

D.3 Alarm Limit ................................................................................................................... D-3

E Symbols and Abbreviation..............................................................................................E-1

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

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

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

1 Safety

1.1 Safety Information

The safety statements presented in this chapter refer to the basic safety information that the

operator 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 that, if not avoided, will result in death or serious

injury.

WARNING

z Indicates a potential hazard 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.

1.1.1 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

1.1.2 Warnings

WARNING

z This monitor is not applicable for prolonged and continuous SpO

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 Do not rely exclusively on the audible alarm system for patient monitoring.

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

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 trained and authorized by Mindray only.

z Do not touch the patient or equipment connected to the patient during

defibrillation. A risk of serious injury or death is present.

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

patient is safe.

z Dispose of the package material according to the applicable waste control

regulations and keep it out of children’s reach.

z 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.

1-2

1.1.3 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 Carefully route patient cabling to reduce the possibility of patient entanglement

or strangulation.

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.

z If you spill liquid on the equipment or accessories, contact us or your service

personnel.

1-3

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 This monitor complies with the requirements of CISPR11 (EN55011) class A. z The software was developed per IEC60601-1-4. The possibility of hazards

arising from program errors 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.

z Devices connected the RS232 port shall be Mindray-specified only.

1.2 Equipment Symbols

Caution: Consult

accompanying documents

(this manual).

Power ON/OFF

Alternating current (AC)

Battery indicator

Defibrillation-proof type CF

applied part

Selection

Down

Pulse Rate (PR)

Neonate

NIBP

PATIENT INFO.

1-4

Pediatric/Child

Adult

Equipotential grounding

SET ALARMS

DISPLAY

INTERVAL

European community

representative

RECORD

Alarm Silenced

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire

and mechanical hazards, only in accordance with UL 60601-1,

CAN/CSA C22.2 NO.601-1, IEC 60601-1-1, IEC 60601-2-30,

NurseCall output

RS-232 connector

Date of manufacture

Manufacturer

Serial number

Network connector

IEC 60601-2-49.

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.

1-5

FOR YOUR NOTES

1-6

2 The Basics

2.1 Monitor Description

2.1.1 Intended Use

This device is to monitor physiologic parameters, including SpO

adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or

appropriate medical staff under the direction of physicians. It is not intended for transport or

home use.

, PR, NIBP and TEMP, on

WARNING

z This device is to be operated by clinical physicians or appropriate medical staffs

under the direction of physicians. The operator of the monitor must be well tranined. Any operation by unauthorized or non-tranined personnel is forbidden.

z The physiological parameters and the alarm information displayed by the monitor

are only for the reference of physicians, but cannot be used directly to determine the clinical treatment.

CAUTION

z The environment and power supply of this monitor must meet the requirements

specified in A Product Specifications.

2.1.2 Contraindications

None

2-1

2.1.3 Components

This monitor is composed of a main unit, NIBP cuff, SpO

that some of the mentioned parts are optional and may not be found in your monitor.

sensor and TEMP probe. Note

2.1.4 Functions

This monitor has the following functions and features:

 SpO

 NIBP measurement: systolic pressure (S), diastolic pressure (D), mean pressure (M),

 TEMP measurement: temperature (TEMP).  Alarm: support visual/audible alarms and prompt messages.  Record: support the function of recording NIBP trend data and PLETH waveform.  Patient ID input by bar code scanning.  Nurse call.  Storage of trend data: support the function of storing up to 1200 groups of measured

 Powerful system menu.  Large LED digit display.  Adjustable LCD brightness and contrast.  Network communication: support the function of being connected to the CMS or PC

measurement: pulse oxygen saturation (SpO2), pulse rate (PR), and SpO2

plethysmogram.

and pulse rate (PR).

results.

for data output or upgrade.

 Rechargeable lead-acid battery or lithium battery.

2-2

2.2 Appearance

2.2.1 Front Panel

18 19

Figure 2-1 Front Panel

2-3

27 28

1. Alarm indicator

The alarm indicator of this monitor is in compliance with the requirement of

EN60825-1 A11 Class 1 for LED. The LED indicator varies its flash color and

frequency to indicate different alarm levels. For details, refer to 5.2.1 Alarm Lamp.

2. SYS

This LED displays the systolic pressure reading in the NIBP measurement.

3. DIA

This LED displays the diastolic pressure reading in the NIBP measurement. At the

right side of the NIBP reading, it is the NIBP unit: kPa or mmHg. The illuminating one

is the unit selected. NIBP unit can be set in the system setup menu

4. MAP

This LED displays the mean pressure reading in the NIBP measurement.

5. PR

This LED displays the PR value in the NIBP measurement or SpO

measurement, with

the unit (bpm) on the right.

6. SpO

This LED displays the SpO

value, with the unit (%) on the right.

7. TEMP

This LED displays the temperature reading. At the right side of the TEMP reading, it is

the TEMP unit: ℃ or ℉. The one illuminates is the unit selected. TEMP unit can be

set in the system setup menu.

8. LCD

The LCD displays menus, trend data and PLETH waveforms, etc.

9. PATIENT INFO.

Press this key to set patient information.

10. MENU

Press this key to switch between the SYSTEM SETUP menu and the Normal screen.

11. Power On/Off, standby, working status indicator

Press this key to power on/off the monitor and to enter/exit the standby state. To power

off the monitor, press and hold this key for more than 2 seconds.

Inside this key is a working status indicator:

 ON: It indicates that the monitor is powered on;  OFF: It indicates that the monitor is powered off.

2-4

12. Battery indicator

It indicates the status of the battery. For details, refer to 2.4 Battery.

13. AC power indicator

 ON: It indicates that the AC power is applied to the monitor;  OFF: It indicates that the monitor is not applied to the monitor.

14. Patient type indicator

It indicates the patient types: respectively adult, pediatric and neonate from left to

right.

15. Temperature site and mode indicator

It indicates the temperature measurement site and monitoring mode: respectively oral,

axillary, rectal and monitor.

16. Pulse strength indicator

It indicates the pulse strength of a patient.

17. RECORD

Press this key to start or stop the recording.

18. NIBP status indicator

 ON: It indicates that the monitor is performing the NIBP measurement;  OFF: It indicates that the monitor is not performing the NIBP measurement.

19. NIBP

Press this key to start an NIBP measurement, or press this key during measurement to

stop it.

20. SILENCE

Shortly pressing this key pauses the current alarm for 2 minutes. Pressing and holding

this key for more than 2 seconds disables audible alarms, thus entering the alarm

silenced mode. During alarm silenced, the system will return to the normal status when

a new alarm occurs.

21. Silence indicator

 OFF: normal status; in this status, when an alarm occurs, the system can give an

audible alarm according to the alarm level;

 ON: alarm silenced status; in this status, the system cannot give audible alarm.  FLASH: alarm paused status; in this status, the system cannot give the audible

and visual alarm.

22. Up

Press this key to move the cursor upward.

2-5

23. OK

Press this key to select the highlighted option. In the trend view, pressing this key pops

up the REVIEW SETUP menu.

24. Down

Press this key to move the cursor down.

25. INTERVAL

Press this key to switch between the INTERVAL menu and the Normal screen.

26. DISPLAY

Press this key to switch between the normal screen and trend view.

27. NIBP cuff connector

This connector is used to connect the NIBP cuff to the monitor.

28. SpO

This connector is used to connect the SpO

sensor connector

sensor to the monitor.

29. SET ALARMS

Press this key to switch between the SET ALARMS menu and the Normal screen.

2-6

2.2.2 Rear Panel

Figure 2-2 Rear Panel

1. TEMP probe sheath

2. TEMP probe connector

3. RS-232 connector:: used to connect the bar code scanner.

4. Nurse call connector: used to connect the monitor to the hospital’s nurse call system.

5. Network connector: used to connect the monitor to the CMS or PC.

6. Equipotential grounding connector: connects the equipotential grounding connectors of

other devices.

7. AC power input connector: used to connect the monitor to the AC power through a

3-core power cable.

2-7

2.2.3 Recorder

The recorder is on the left side of the monitor. See the following figure.

Paper outlet

Recorder door

Power indicator

Figure 2-3 Recorder

For details about the recorder, refer to 6 Recording

2-8

2.3 Display

Figure 2-4 Display

This monitor adopts the LCD display. It is able to display the following three parts:

1. Patient information area

This area displays patient ID, patient category and alarm status symbol.

2. PLETH wave/NIBP timing area

This area displays the PLETH wave and/or NIBP timing.

3. Alarm information area

On the left of this area is the technical alarm message or prompt message. If there are

multiple messages, they will be displayed circularly.

On the right of this area are the physiological alarm message and the current system time.

2.3.1 Cursor

In menus or trend data view, when the cursor moves to an option or a data, the background

of the option or the data becomes black and the texts turn white. You can press

to move the cursor, and press to confirm the selection.

NOTE

z and are used to move the cursor, and is used for

selection.

2-9

2.4 Battery

Rechargeable batteries can be used to supply power to the monitor where AC mains is

unavailable or whenever the power supply is interrupted. The battery is charged

automatically when the monitor is connected to AC mains till it is full. If the power supply

is lost during monitoring, the monitor can run on internal battery.

The battery indicator indicates the status of the battery.

 ON: The battery is being charged or the battery is fully charged.  OFF: The battery is removed from the monitor, or the monitor is equipped with battery

but is not connected to AC mains and not turned on.

 Flashes: The monitor is powered by the internal battery.

The capacity of the internal battery is limited. When the battery capacity is too low, a high

level alarm is triggered and the “Battery too low” message is given in the technical alarms

area. At this moment, the AC mains shall be applied to the monitor; otherwise the monitor

will power off automatically before the battery is depleted.

For details about installation of the battery, refer to 3.1.5 Installation Method:Installing the battery.

WARNING

z Keep the battery out of the reach of children. z Use only the battery specified by the manufacturer.

NOTE

z Remove the battery before transport, or if the monitor is not likely to be used

for an extended period of time.

2-10

2.4.1 Battery Maintenance

2.4.1.1 Conditioning a Battery

A battery needs at least two conditioning cycles when it is used for the first time. A battery

conditioning cycle is one uninterrupted charge of the battery, followed by an uninterrupted

discharge of the battery. Batteries should be conditioned regularly to maintain their useful

life. Condition a battery once when it is used or stored for two months, or when its run time

becomes noticeably shorter.

To condition a battery, follow this procedure:

1. Disconnect the monitor from the patient and stop all monitoring or measuring.

2. Insert the battery in need of conditioning in the battery compartment of the monitor.

3. Apply AC power to the monitor and allow the battery to charge uninterruptedly for 10

hours.

4. Remove AC power and allow the monitor to run on the battery until it shuts off.

5. Apply AC power again to the monitor and allow the battery to charge uninterruptedly

for 10 hours.

This battery is now conditioned and the monitor can be returned to service.

2.4.1.2 Checking a Battery

The performance of a rechargeable battery may deteriorate over time. To check the

performance of a battery, follow this procedure:

1. Disconnect the monitor from the patient and stop all monitoring or measuring.

2. Apply AC power to the monitor and allow the battery to charge uninterruptedly for 10

hours.

3. Remove AC power and allow the monitor to run on the battery until it shuts off.

4. The operating time of battery reflects its performance directly.

If the oprating time of the battery is noticeable shorter than that stated in the specifications,

replace it or contact your service personnel,

2-11

NOTE

z Life expectancy of a battery depends on how frequent and how long it is used.

For a properly maintained and stored lead-acid or lithium ion battery, its life expectancy is about 2 or 3 years respectively. For more aggressive use models, life expectancy can be less. We recommend replacing lead acid batteries every 2 years and lithium ion batteries every 3 years.

z The operating time depends on the configuration and operation. For example,

measuring NIBP more frequently will also shorten the operating time.

2.4.2 Battery Recycling

When a battery has visual signs of damage, or no longer holds a charge, it should be

replaced. Remove the old battery from the monitor and recycle it properly. To dispose of the

batteries, follow local laws for proper disposal.

WARNING

z Do not disassemble batteries, or dispose of them in fire, or cause them to short

circuit. They may ignite, explode, leak or heat up, causing personal injury.

2-12

3 Installation and Maintenance

3.1 Installation

WARNING

z The installation of the monitor must be carried out by personnel we authorize.

The software copyright of the monitor is solely owned by our company. Any action to change, copy or exchange the software by any organization or person is regarded as copyright infringement and is not allowed.

3.1.1 Unpacking and Checking

Before unpacking, examine the packing case carefully for signs of damage. If any damage is

detected, contact the carrier or our company.

If the packing case is intact, open the package and remove the instrument and accessories

carefully. Check all materials against the packing list and check for any mechanical damage.

Contact our Customer Service Department for any problem.

NOTE

z Please save the packing case and packaging material for future transport and

storage.

WARNING

z Dispose of the packaging material accordint to applicable waste control

regulations and keep it out of children’s reach.

z The equipment might be contaminated in storage, transport or when used.

Verify the package and the single use accessories are intact. In case of any damage, do not apply it to patients.

3-1

3.1.2 Environmental Requirements

The operating environment of the monitor must meet the requirements specified in the

section A.2 Environmental Specifications

The environment where this monitor is to be used should be free from noise, vibration, dust,

and corrosive or explosive and inflammable substances. For a cabinet mounted installation,

allow sufficient room at the front and the rear of the cabinet for operation, maintenance and

servicing. Besides, allow at least 2 inches clearance around the instrument for proper air

circulation.

Condensation can form when the monitor is moved from one location to another, and being

exposed to differences in humidity or temperature. Make sure that during operation the

instrument is free from condensation.

3.1.3 Power Supply Requirements

The power applied to the monitor must meet the requirements specified in Section A.3 Power Requirements

WARNING

z Make sure that the operating environment and the power applied to the monitor

comply with the specified requirements. Otherwise its performance might not meet the specifications claimed in AProduct Specifications, and unexpected results, such as damages to the monitor, may be incurred.

z The monitor shall be powered according to the requirement for the system

power voltage. Otherwise, serious damage might be caused to the system.

3.1.4 Bracket Mounting

For details, please refer to the corresponding instructions for use of bracket mounting

3-2

3.1.5 Installation Method

WARNING

z Equipments connected to this monitor must be certified according to the

respective IEC standards (e.g. IEC 60950 for information technology equipment and IEC 60601-1 for medical electrical equipment). Furthermore all configurations shall comply with the valid version of IEC 60601-1-1. Any person who connects additional equipment to the signal input or signal output is responsible to ensure the system complies with the requirements of the valid version of IEC 60601-1-1. If in doubt, contact our company or customer service.

z If the monitor is connected to another electrical instrument and the instrument

specifications cannot tell whether the instrument combination is hazardous (e.g. due to summation of leakage currents), you should consult us or experts in the field to ensure the required safety of all instruments concerned.

NOTE

z The following operations are not all required. User-customized installation by

authorized personnel is provided.

3.1.5.1 Connecting to AC mains

1. Use the original 3-core power cable.

2. Connect the power cable to the AC mains input connector on the rear panel of the

monitor.

3. Connect the other end of the power cable to a compatible 3-prong hospital grade AC

power outlet.

The 3-prong power outlet must be grounded. In case of any doubt, contact related personnel

of the hospital.

WARNING

z Do not use three-wire to two-wire adapter with this instrument. z To avoid unexpected power interruption, do no use power outlet with a

wall-mounted switch control.

3-3

3.1.5.2 Installing the battery

The battery compartment is located at the bottom of the patient monitor. Follow the steps

given below to install the battery.

1. Push the compartment door in the marked direction to open the door.

2. Flip the battery stopper to the left, as Figure 3-1 shows.

3. Follow the marked polarity to insert the battery into the compartment, as Figure 3-2

shows.

4. Push the battery to the bottom and flip the stopper back to the original position, as

Figure 3-3 shows.

5. Close the battery door.

Figure 3-1

Figure 3-2

3-4

NOTE

Figure 3-3

z Be sure to charge the battery after a long-term storage or when you find the

battery energy is low. A low-energy battery may not provide enough power to start the patient monitor.

z To charge the battery, connect the AC power to the monitor. The battery will be

charged regardless the monitor is on or off.

3.1.5.3 Equipotential Grounding

When other equipment is used together with the monitor, a grounding cable should be used

to connect the equipotential grounding connectors of the monitor and other equipment. This

helps to eliminate the potential differences between different equipment, and ensure the

safety of the operator and patient.

WARNING

z If the grounding system is in doubt, the monitor shall run on its internal battery.

3.1.5.4 Connecting the accessories

Connect the necessary accessories to the monitor. For details, see the chapters for specific

parameter monitoring in the following pages, or corresponding instructions for the

accessories.

3-5

3.1.5.5 Connecting the network cable

The network connector of the monitor is a standard RJ45 connector. It connects the monitor

with the specified central monitoring system, or with a PC for software upgrade and data

export. To connect the monitor with CMS or PC,

1. Connect one end of the network cable to the network connector of the monitor.

2. Connect the other end of the network cable to the hub of the central monitoring system,

or to the network connector of a PC.

WARNING

z Upgrading the system through network is only to be executed by personnel we

authorize.

3.1.5.6 Nurse call connector

The nurse call connector is used for the nurse call function. If connected to the hospital’s

nurse call system through a special nurse call cable, the monitor can generate nurse call

signals when an alarm occurs. The output end of the nurse call cable consists of two free

cords that is neutral. The nurse call system shall be installed by the maintenance engineer

from the manufacturer or the engineer of the hospital.

3.1.5.7 Connecting the Bar Code Scanner

The bar code scanner shall be connected to the RS232 connector. Use only bar code

scanners supplied by us.

3-6

3.1.6 Powering on the Monitor

After installing the monitor, please power on it in the following procedure:

1. Before using the monitor, please carry out corresponding safety inspection in

accordance with Section 3.2.1Inspection.

2. Press the Power Switch on the control panel. A beep will be heard.

3. The system starts self-test and the start-up screen will be displayed.

4. Several seconds later, the system finishes the self-test and displays the Normal screen.

5. Then you can operate the monitor through the control panel.

When AC mains is connected, the battery will be charged regardless the monitor is on or

off.

3.1.7 Powering off the Monitor

To power off the monitor, please follow the procedures below:

1. Confirm the patient monitoring is to be finished.

2. Disconnect the cables and sensors between the monitor and the patient.

3. Confirm whether to store or clear the patient monitoring data.

4. Press the Power switch and hold it for more than 2 seconds to power off the monitor.

3.2 Maintenance

WARNING

z Failure to implement a satisfactory maintenance schedule may cause undue

equipment failure and possible health hazards.

z The safety inspection before equipment disassembly or the servicing of the

equipment must be performed by professional servicing personnel. Otherwise, equipment failure and possible health hazard may be caused.

3-7

3.2.1 Inspection

Make sure the qualified service personnel have implemented a complete inspection before

putting the monitor into operation, after monitor servicing or system upgrading, or after the

monitor has been used for 6-12 consecutive months. This is to ensure the normal operation

of the system.

Check that

 The environment and the power supply meet the specified requirements.  The monitor surface is free from stains.  The monitor surface, keys, connectors and accessories have no signs of physical

damage.

 The power cords are not worn and the insulation is in good performance.  The grounding cables are properly connected.  Only specified accessories are applied.  The monitor clock is correct.  The audible and visual alarms are normal.  The recorder functions normally and the recorder paper meets the requirement.  The monitoring functions of the system are in good performance.

In case of any damage or exception, do not use the monitor. Contact the biomedical

engineers of the hospital or our Customer Service immediately.

3.2.2 Cleaning

WARNING

z Be sure to shut down the system and disconnect all power cords from the outlet

before cleaning the equipment.

Your equipment should be cleaned regularly. If there is heavy pollution or lots of dust and

sand in your place, the equipment should be cleaned more frequently. Before cleaning the

equipment, consult your hospital’s regulations for cleaning, disinfecting and sterilizing

equipment.

3-8

The exterior surfaces of the equipment may be cleaned with a clean and soft cloth, sponge

or cotton ball, dampened with a non-erosive cleaning solution. Drying off excess cleaning

solution before cleaning the equipment is recommended. Following are examples of

cleaning solutions:

 Diluted soap water  Diluted ammonia water  Diluted sodium hypochlorite (bleaching agent)  Diluted formaldehyde (35 to 37%)  Hydrogen peroxide (3%)  Ethanol (70%), or Isopropanol (70%)

NOTE

z The sodium hypochlorite of the concentration ranging from 500ppm (1:100

diluted bleaching agent for home use) to 5000ppm (1:10 diluted bleaching agent for home use) is effective. The required concentration depends on the quantity of the organic substances (such as blood, mucus) on the equipment surface.

To avoid damage to the equipment, please follow these rules:

 ALWAYS dilute the solutions according to the manufacturer’s suggestions.  ALWAYS wipe off all the excess cleaning solution with a dry cloth after cleaning.  NEVER submerge the equipment into water or any cleaning solution, or pour or spray

water or any cleaning solution on the equipment.

 NEVER permit fluids run into the casing, switches, connectors, or any ventilation

openings in the equipment.

 NEVER use abrasive or erosive cleaners of any kind as well as cleaners containing

acetone.

CAUTION

z Failure to follow these rules may erode or fray the casing, or blur lettering on

the labels, or cause equipment failures.

For cleaning information of accessories, please refer to the chapters for specific patient

parameters and the instructions for use of the accessories.

3-9

3.2.3 Disinfection

WARNING

z Disinfection may cause damage to the equipment; therefore, when preparing to

disinfect the equipment, consult your hospital’s infection controllers or professionals.

z The cleaning solutions above can only be used for general cleaning. If you use

them to control infections, we shall assume no responsibility for the effectiveness.

Disinfection may cause damage to the equipment. We recommend the sterilization and

disinfection are contained in the hospital’s servicing schedule only when necessary. The

equipment should be cleaned prior to sterilization and disinfection.

Recommended sterilization material: Alcohol based (Ethanol 70%, Isopropanol 70%), and

aldehyde based.

CAUTION

z ALWAYS dilute the solutions according to the manufacturer’s suggestions and

adopt lower concentration if possible.

z NEVER submerge the equipment into water or any solution, or pour water or

any solution on the equipment.

z ALWAYS wipe o ff all the excess liquids on the equipment surface and accessory

surface with a dry cloth.

z NEVER use EtO and undiluted formaldehyde to disinfect the equipment. z Never permit high-pressure and high-temperature disinfection of the equipment

and accessories.

3-10

4 Menus and Screens

4.1 Patient Information

The figure shows the PATIENT INFORMATION menu.

Figure 4-1

In the PATIENT INFORMATION menu, you can set:

 PATIENT ID: The system automatically creates a patient ID each time the monitor is

turned on. You can also:

 Input a patient ID by scanning the bar code:

In the event BARCODE POWER is switched on, you can scan the bar code

information using a bar code scanner. The PATIENT INFORMATION menu pops up

if the bar code is sucessfully identified. You can admit the patient using the current bar

code by selecting OK. You can also keep the original patient ID by selecting

CANCEL.

 Input a patient ID by pressing the PATIENT INFO button:

In the event QUICK ADMIT is switched on, pressing

INFORMATION menu. The system creates a patient ID according to the current time

and admits the patient using this patient ID. You can also keep the original patient ID

by selecting CANCEL.

opens the PATIENT

To switch on/off QUICK ADMIT, select SYSTEM SETUP→MAINTAIN.

 Keep patient ID unchanged:

If patient ID is not input by bar code scanning or by pressing PATIENT INFO button,

or the bar code scanner fails to identify the bar code, the system will keep original

patient ID unchanged.

 PATIENT TYPE: You can set patient type to ADU, PED or NEO.

4-1

NOTE

z The system automatically creates a patient ID each time the monitor is turned

on.

z Select appropriate patient type each time a patient is admitted. z If you need to change patient type after the patient has been admitted, switch off

QUICK ADMIT; press PATIENT INFORMATION menu.

z If you need to admit a patient in the event both BARCODE POWER and

QUICK ADMIT are set to OFF, switch either of them on.

and then change PATIENT TYPE in the pop-up

4.2 System Setup

By pressing on the front panel of the monitor, you can open the SYSTEM SETUP

menu as shown in Figure 4-2.

Figure 4-2

4.2.1 Common Setup

In the SYSTEM SETUP menu, select COMMON SETUP. In the COMMON SETUP menu,

you can set the following items.

 ALARM VOL MIN ALARM VOL to 10

In the following circumstance, the setting of ALARM VOL may be lower than the

setting of MIN ALARM VOL. In this case, ALARM VOL is automatically adjusted

according to MIN ALARM VOL.

 Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required

password; and then change MIN ALARM VOL in the pop-up menu.

4-2

 Select SYSTEM SETUP→DEFAULT; and then select LOAD FACTORY

CONFIG or LOAD USER CONFIG in the pop-up menu;

 Restart the monitor after turning it off for more than 120s;  Change patient ID;  Change patient type.

 KEY VOL 0 to 10  PULSE VOL 0 to 10  LCD BRIGHT 1 to 10  LCD CONTRAST 1 to 10  NIBP UNIT mmHg, kPa

When the key volume or pulse volume is set to 0, it indicates that the key tone or pulse tone

is disabled.

4.2.2 Network Setup

In the SYSTEM SETUP menu, select NET SETUP. In the NET SETUP menu, you can set

the following items.

 NET TYPE: CMS, CMS+  LOCAL NET NO.: It indicates the bed number of a monitor in the monitoring network.

If the NET TYPE is CMS, the LOCAL NET NO can be set between 1 and 64; if the

NET TYPE is CMS+, it can not be set.

 IP ADDRESS SETUP: When the monitor is connected with the central monitoring

system, and the NET TYPE is CMS+, you can set the IP address for your monitor .

The network type and local net No. are related to the central monitoring system (CMS) to

which the monitor is connected. Contact the CMS technical personnel for any doubt.

WARNING

z This monitor 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.

4-3

4.2.3 Time Setup

In the SYSTEM SETUP menu, select TIME SETUP. In the TIME SETUP menu, you can

set the following items.

1. DATE FORMAT: You can set DATE FORMAT to any of the following formats:

 YY-MM-DD  MM-DD-YY  DD-MM-YY

2. System time: you can set the year, month, day, hour and minute respectively as

required.

4.2.4 User Maintenance

Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password. You

can set the following items in the pop-up menu:

 MIN ALARM VOL: 0 to 10  BARCODE POWER: You can toggle BARCODE POWER between ON and OFF.

You can set it to OFF if bar code scanner is not used for a prolonged time.

 SPO2 SENSOR OFF: You can set the alarm level of SPO2 SENSOR OFF to HIGH,

MED, LOW or OFF.

 AUDIO OFF PROMPT: You can toggle AUDIO OFF PROMPT between ON and

OFF. If you switch it on, the monitor clanks at an interval of one minute. The volume

level of prompt tone is 2.

 LANGUAGE: You can select a desired language for user interface.  SAVE USER CONFIG: You can save the current configuration as user configuration.  SELECT CONFIG: You can select LAST CONFIG, USER CONFIG or

FACTORY CONFIG as desired.

4-4

4.2.5 Nurse Call Setup

Select SYSTEM SETUP→MAINTAIN→NURSE CALL. You can set the following items

in the pop-up menu:

 SIGNAL DURATION

1. CONTINUUM

It indicates that the nurse call signal duration is the same with the alarm duration,

namely, the nurse call signal lasts from the beginning of the alarm to the end of the

alarm.

2. PULSE

It indicates that the nurse call signal is a pulse signal whose duration is 1s. When

multiple alarms occur, the monitor outputs only one pulse signal; if another alarm

occurs before the current alarm is cleared, the monitor will output another pulse signal.

 SIGNAL TYPE

1. NORMAL CLOSE: set the signal type to NORMAL CLOSE when the nurse call

system of the hospital is set to normally-closed;

2. NORMAL OPEN: set the signal type to NORMAL OPEN when the nurse call system

of the hospital is set to normally-open.

NORMAL CLOSE and NORMAL OPEN are technical terms which describe the type of

relay in nurse call system. The hospitals should select the right signal type consistent with

their nurse call system.

 ALM LEV: HIGH, MED, LOW; check box  ALM TYPE: TECH, PHYS; check box.

The system will send the nurse call signal according to the selected alarm level and alarm

type. If neither alarm level nor alarm type is selected, the system will not send any nurse

call signal when alarms occur.

The Nurse Call function doesn't distinguish among ALM LEV and ALM TYPE. As long as

any type is checked and when the alarmable event occurs, the monitor will send the same

signal to the interface of the Nurse Call System.

NOTE

z The medical/nursing staff are not expected to take the nurse call function as the

major alarm notification. The patient conditions should be determined based on the audible/visual alarm of the monitor and the clinical symptoms of the patient.

z In the Alarm Paused or Standby State, the nurse call function will be disabled.

4-5

WARNING

z Then nurse call settings shall not be changed by non-medical staff.

4.2.6 Version

Select SYSTEM SETUP→MAINTAIN→VERSION, you can view information on the

monitor’s hardware version and software version.

4.2.7 Configuration

4.2.7.1 Presetting Configuration

If the monitor is turned off for less than 60 seconds, last configuration will be loaded

automatically when it is restarted. If it has been turned off for more than 120 seconds,

different configuration will be loaded according to the setting when it is restarted, or when

patient type or patient ID is changed.

1. Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password

to enter the USER MAINTAIN menu.

2. Select SELECT CONFIG.

3. Select LAST CONFIG, USER CONFIG or FACTORY CONFIG as desired.

4. Select OK.

NOTE

z When the monitor is restarted after being turned off for 60 to 120 seconds, the

configuration loaded may be last configuration, user configuration or factory configuration

4.2.7.2 Saving User Configuration

1. Make sure the modification you make is appropriate and correct.

2. Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password

to enter the USER MAINTAIN menu.

3. Select SAVE USER CONFIG.

4-6

4.2.7.3 Resuming Default Configuration

In actual applications, the operator may change some settings. However, these changes may

not always be appropriate or correct, particularly for a newly admitted patient. The monitor

has the function of loading factory configuration so that you can resume the factory default

configuration as desired. You can also load the saved user configuration.

1. In the SYSTEM SETUP menu, select DEFAULT.

2. Select LOAD FACTORY CONFIG or LOAD USER CONFIG.

3. Select OK in the pop-up menu.

4.2.8 Exporting Data

To export data to a PC,

1. Ensure that the monitor is connected to a PC; run the Patient Review System software

on the PC.

2. In the SYSTEM SETUP menu of the monitor, select DATA OUT.

3. If the connection is available, the data (including patient ID, patient type and trend data

of all the patients) will be export to the PC. For more information, please refer to the

help information of the Patient Review System software.

4.3 Normal Screen

You can enter the Normal screen by pressing .

Time to next

IBP icon

measurement

IBP interval

PLETH wave

Figure 4-3

4-7

4.4 Trend Screen

The Trend screen displays systolic pressure (S), diastolic pressure (D) and mean pressure

(M), SpO

stored.

The monitor stores trend data in either of the following modes:

, PR and TEMP, as shown in the figure below. Up to 1200 groups of data can be

 For SpO

interval of sampling is 30 seconds. Additionally, the last value obtained before the

“SENSOR OFF” or “TEMP SENSOR OFF” alarm occurs will also be stored.

 For NIBP and TEMP values obtained in predict mode, the trend data is the actual value

measured when the data is sampled.

and TEMP values in monitor mode, the trend data is sampled value. The time

NOTE

z If the difference between the time when two storage modes happen is less than

one second, the trends displayed may be of the same time, but SpO2 trends and/or TEMP trends in monitor mode may be different.

Figure 4-4

Press

 REVIEW ID: Select the patient ID you want to review.  REVIEW MODE: You can set REVIEW MODE to ALL, NIBP EVENTS or TEMP

 DELETE: By selecting DELETE, you can toggle between CURRENT ITEM,

to enter the REVIEW SETUP menu where you can change:

EVENTS. If you select ALL, all the trend data of the selected

patient will be displayed. If you select NIBP EVENTS, the trend

data which includes all NIBP measurements of the selected patient

will be displayed. If you select TEMP EVENTS, the trend data

which includes all TEMP measurements of the selected patient

will be displayed.

ITEMS OF CURRENT ID, or ITEMS OF ALL ID. Then select

OK to respectively delete the current trend data, all trend data of

current ID, or data of all ID.

4-8

4.5 Standby State

4.5.1 Entering the Standby State

To enter the Standby state, press for less than 2 seconds and then select OK in the

CONFIRM STANDBY STATE dialog box.

4.5.2 Exiting the Standby State

In the Standby state, press any key on the front panel of the monitor. The EXIT STANDBY

dialog box appears. Select YES to exit the Standby state. If no operation is done within 30

seconds, the monitor will automatically select NO, this dialog box will disappear, and the

monitor will keep in the Standby state.

In the following circumstance,

 The monitor presents a prompt to ask if you want to exit the Standby mode when a

button is pressed.

 The monitor exits the Standby mode when a bar code scanner is used to identify

patient ID.

 The monitor exits the Standby mode automatically after continuously receiving SpO

signal for 5 seconds.

 The monitor exits the Standby mode automatically when the TEMP probe is

withdrawn from the probe sheath.

 In the case that the monitor runs on internal battery, the monitor exits the Standby

mode and presents an alarm “BAT. VOLTAGE LOW” when the battery power is low.

4.6 Patient Review System Software

The monitor can be configured with the optional patient review system software (hereafter

called PrsView software ) to implement the following functions:

 Exporting data;  Viewing exported data;  Editing patient information; and

 Printing data.

Refer to PrsView software instructions for installation and help information for detailed

software instructions for use.

4-9

FOR YOUR NOTES

4-10

5 Alarms

5.1 Overview

The monitor gives audible or visual alarms to indicate the medical staff when a vital sign of

the patient appears abnormal, or mechanical or electrical problems occur to the monitor.

WARNING

z A potential hazard can exist if different alarm presets are used for the same or

similar equipment in any single area, e.g. an intensive care unit or cardiac operating room.

NOTE

z For details about alarm setup of this monitor, please refer to 5.5 Setting Alarms.

5.1.1 Alarm Categories

By nature, the alarms are divided into three categories: physiological alarms, technical

alarms and prompt information.

1. Physiological alarms

A physiological alarm either indicates that a monitored physiological parameter goes

beyond specified limits or indicates an abnormal patient condition. For example, no pulse is

detected.

2. Technical alarms

A technical alarm indicates that the monitor or parts of the monitor is not capable of

accurately monitoring the patient’s condition due to improper operation or system failure.

Technical alarms are also referred to as system error messages. For example, an error occurs

during module initialization.

3. Prompt information

As a matter of fact, prompt messages are not alarm messages. They are usually information

relating to the system status, but not concerning vital signs of patients. For example, the

monitor prompts “REC INITIALIZING”.

5-1

5.1.2 Alarm Levels

By severity, the alarms of this monitor are divided into three priority levels: high level

alarms, medium level alarms and low level alarms.

1. High level alarms

 The patient is in danger and requires emergency treatment, or  A serious technical problem occurs to the monitor, such as an error in the NIBP

module self-test.

2. Medium level alarms

 The patient’s vital signs appears abnormal and an immediate treatment is required, or  A specific technical problem occurs to the monitor, such as the leakage in the NIBP

hose.

3. Low level alarms

 A specific technical problem occurs to the monitor, for example, the SpO

weak during the measurement.

The levels of some technical and physiological alarms are predefined before the monitor

leaves the factory and cannot be changed.

For all physiological alarms, technical alarms and prompt information, refer to C Alarm Messages and Prompt Information.

signal is too

5.2 Alarm Indications

When an alarm occurs, the monitor indicates it to the user through the following audible or

visual indications:

 Visual alarms  Audible alarms  Alarm messages

The alarm indications are presented in different ways to match the alarm levels.

5-2

5.2.1 Alarm Lamp

When an alarm occurs, the alarm lamp on the front panel of the monitor flashes in different

color and frequency to match the alarm levels as follows:

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

5.2.2 Audible Alarms

The monitor uses different alarm tone patterns to indicate different alarm levels.

 High level alarm: “DO-DO-DO--DO-DO---DO-DO-DO--DO-DO”.  Medium level alarm: “DO-DO-DO”.  Low level alarm: “DO”.

Different intervals correspond to different alarm levels: High level alarm phonates once

every 6.2 or 11 seconds. Medium level alarm phonates once every 15 or 25 seconds. Low

level alarm phonates once every 25 seconds.

5.2.3 Alarm Messages

When alarms occur, the alarm messages are displayed in the physiological or technical

alarm area in black. Asterisks before the alarm messages matches the alarm level as follows:

 High level alarms: triple asterisks “***”  Medium level alarms: dual asterisks “**”  Low level alarms: single asterisk “*”

5-3

5.3 Alarm Status

Apart from the aforementioned alarm indicators, the patient monitor still uses symbols to

indicate the alarm status: You can set alarms to the following status as desired:

 Audio off: is displayed at the right side of patient information area and a

prompt message “AUDIO ALARM OFF” appears at the right side of the alarm

information area.

 Physiological Alarm off:

and a prompt message “ALARM OFF” appears at the right side of the alarm

information area.

 Alarm paused: is displayed at the right side of patient information area ; a

prompt message “ALARM PAUSE” and remaining alarm pause time appear at the

right side of the alarm information area.

 Alarm silenced:

is displayed at the right side of patient information area.

is displayed at the right side of patient information area

5.3.1 Audio Off

To switch off alarm tones, follow this procedure:

1. Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password

and set MIN ALARM VOL to 0 in the pop-up menu.

2. Select SYSTEM SETUP→COMMON SETUP; set ALMAR VOL to 0 in the pop-up

menu. Thus alarm tones are switched off.

If AUDIO OFF PROMPT in the USER MAINTAIN menu is set to ON, the monitor clanks

at an interval of one minute. The volume level of prompt tone is 2.

The monitor automatically exit the audio off status when:

 ALARM VOL is manually changed to a level other than 0;  The monitor is restarted after being turned off for more than 120s, or when patient ID

or patient type is changed in the case it is preset to load factory configuration or user

configuration at startup.

 LOAD FACTORY CONFIG or LOAD USER CONFIG is selected in the DEFAULT

menu.

5-4

WARNING

z If alarm tones are switched off, the monitor does not give audible alarm signal

even if new alarms occur. So take care when you switch off alarm tones.

5.3.2 Physiological Alarm Off

If alarms related to a parameter are switched off, the monitor does not generate alarms even

if the measured parameter values exceed the alarm limit. This status is called Alarms Off.

To disable the alarms of a parameter, you need to open SET ALARMS menu .Take NIBP

(Non-Invasive Blood Pressure) as an example.

1. Press

2. Move the cursor to the pane to the right of SYS ALM.

3. Select OFF and the NIBP alarms are disabled.

to open the SET ALARMS menu.

NOTE

z Within 30s after the NIBP, SPO2 and TEMP modules are loaded, physiological

and technical alarms related to these modules are switched off automatically.

5.3.3 Alarms Paused

Shortly pressing for less than 2 seconds can pause all alarms for 2 minutes. When

alarms are paused,

 Alarm lamp flashing and alarm tones are suspended.  For a physiological alarm, alarm message is not displayed.  For a technical alarm, alarm message is displayed if Alarm lamp flashing and alarm

tones can be cleared.

 For a technical alarm, alarm message is not displayed if all alarm indications can be

cleared completely.

 The remaining alarm pause time is shown at the right side fo alarm information area.

5-5

In the alarm paused status,

 All alarm indications are disabled when a new physiological alarm occurs.  Alarm lamp flashing and alarm tone are disabled and only alarm message is displayed

when a new technical alarm occurs.

The monitor automatically exits the alarm paused status when the alarm pause time expires.

You can also press

to manually leave the larm paused status.

5.3.4 Alarm Silenced

You can silence alarms by press and hold for more than 2 seconds. In the alarm

silenced status, alarm indications except alarm tones operate properly. The monitor

automatically exits the alarm silenced status if a new technical or physiological alarm

occurs.

5.3.5 Status Switchover

1. In the normal status,

 Press

status, or

for less than 2 seconds to switch the monitor to the Alarms Paused

 Press

status.

2. In the alarm paused status,

 Press

status.

3. In the alarm silenced status,

 Press

status, or

 Press

for 2 seconds or more to switch the monitor to the Alarms silenced

for less than 2 seconds to switch the monitor to the normal status, or

for 2 seconds or more to switch the monitor to the Alarms silenced

for less than 2 seconds to switch the monitor to the Alarms Paused

for 2 seconds or more to switch the monitor to the normal status.

5-6

5.4 Clearing Alarm Indications

1. Clearing alarm light flashing and alarm tones

For some technical alarms, the alarm lamp flashing and alarm tones are cleared and the

alarm messages change to prompt messages during and after the alarm paused period if

is pressed for less than 2 seconds. If the technical alarm is triggered again after the

monitor restores to the normal status, the monitor will give alarm indications as normal. For

technical alarms whose alarm light flashing and alarm tones can be cleared, refer to C

Alarm Messages and Prompt Information.

2. Clearing all alarm indications

For some other technical alarms, all alarm indications are cleared during and after the alarm

paused period if

triggered again after the monitor restores to the normal status, the monitor will give alarm

indications as normal.

is pressed for less than 2 seconds. If the technical alarm is

5.5 Setting Alarms

By pressing , you can enter the SET ALARMS menu to set NIBP and SpO2 alarm

switches and change alarm limits.

You can switch on or off NIBP-related physiological alarms by selecting the pane to the

right of SYS ALM and toggling between ON and OFF. You can switch on or off

physiological alarms related to SpO

ALM and toggling between ON and OFF.

To adjust alarm limits, move the cursor respectively to HI and LO and select a desired value

by pressing

When any of the pressure values exceeds the alarm limits, an alarm will be triggered. The

ranges of NIBP limits is listed below:

, and .

and PR by selecting the pane to the right of SPO2

Patient type Adult Pediatric Neonate

Sys 40 to 270 mmHg 40 to 200 mmHg 40 to 135 mmHg

Map 20 to 230 mmHg 20 to 165 mmHg 20 to 110 mmHg

Dia 10 to 210 mmHg 10 to 150 mmHg 10 to 100 mmHg

5-7

When any of the SpO

The ranges of SpO

SpO

module SpO2 PR

Mindray SpO2 0 to 100％ 0 to 254 bpm

Masimo SpO2 0 to 100％ 25 to 240 bpm

Nellcor SpO2 0 to 100％ 20 to 250 bpm

or PR values exceeds the alarm limits, an alarm will be triggered.

and PR limits are listed below:

5.6 SpO2 Sensor Off Alarm

Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password

and set SPO2 SENSOR OFF to HIGH, MED, LOW or OFF in the pop-up menu. When the

alarm level of SPO2 SENSOR OFF is set to OFF, all alarm indications related to this alarm

is disabled.

5.7 When an Alarm Occurs

WARNING

z When an alarm occurs, always check the patient’s condition first.

When an alarm occurs to the monitor, refer to the following steps and take action properly.

1. Check the patient’s condition.

2. Identify the alarming parameter and the alarm category.

3. Identify the cause of the alarm.

4. Take proper action to eliminate the alarm condition.

5. Make sure the alarm condition is corrected.

NOTE

z For details about how to deal with specific alarms, refer to C Alarm Messages

and Prompt Information.

5-8

6 Recording

6.1 Overview

A thermal recorder can be installed on the left side panel of the monitor to print:

 Real-time PLETH waveform.  Currently displayed trend data.  All trend data of the current patient.

6.2 Using the Recorder

6.2.1 Printing Real-time PLETH waveform

1. Press to enter the PLETH screen.

2. Press

waveform.

for less than 2 seconds to print the currently displayed PLETH

6.2.2 Printing Currently Displayed Trend Data

1. Enter the Trend screen.

2. Press

for less than 2 seconds to print the currently displayed trend data.

6.2.3 Printing All Trend Data of the Current Patient

1. Enter the Trend screen.

2. Press

for 2 seconds or more to print all trend data of the current patient.

NOTE

z You can stop printing at any time by pressing .

z For information on recorder status and corresponding handling measures, refer

to C Alarm Messages and Prompt Information.

6-1

6.3 Loading Paper

1. Press the latch at the upper right of the recorder door to open the door.

2. Lift the roller lever located at the upper left of the recorder as shown in the following

figure.

3. Install a new roll of paper into the compartment as shown below. The roller scrolls

automatically to send the paper out of the compartment.

4. Push down the roller lever.

5. Close the recorder door.

Paper roll

Figure 6-1 Installing Recording Paper

CAUTION

z Use only specified thermal paper. Otherwise, it may cause damage to the

recorder’s printhead, the recorder may be unable to print, or poor print quality may result.

z Never pull the recorder paper with force when the printing is in process.

Otherwise, it may cause damage to the recorder.

z Do not leave the recorder door open except when you are replacing the paper or

removing a fault.

6-2

6.4 Removing Paper Jam

If the recorder works improperly or produces unusual sound, check whether there is a paper

jam. If yes, remove it following this procedure:

1. Open the recorder door.

2. Take out the jammed paper and tear off the draped part.

3. Lift the lever on the upper left of the recorder.

4. Draw out the paper from the paper inlet.

5. Reload the paper and close the recorder door.

6-3

FOR YOUR NOTES

6-4

7 SpO

This monitor can be equipped with any of the following SpO

 Mindray SpO  Masimo SpO  Nellcor SpO

A monitor, equipped with a Masimo or Nellcor SpO

or “Nellcor” at the lower left corner of the front panel. The following pages respectively

gives introduction to the above three SpO

your monitor configuration before operation.

Monitoring

module

module.

modules:

module, is marked by “Masimo SET”

modules. Please read this chapter according to

7.1 Introduction

SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated

haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light.

The light generated in the probe passes through the tissue and is converted into electrical

signals by the photodetector in the probe. The SpO

and displays a waveform and digital values for SpO

This device is calibrated to display functional oxygen saturation. It provides four

measurements:

module processes the electrical signal

and pulse rate.

1. PLETH waveform (PLETH): visual indication of patient’s pulse. The waveform is

normalized.

2. Oxygen saturation of arterial blood (SpO

relation to the sum of oxyhemoglobin and deoxyhemoglobin.

3. Perfusion indicator: the pulsatile portion of the measured signal caused by arterial

pulsation.

4. Pulse rate (derived from pleth wave): detected pulsations per minute.

): percentage of oxygenated hemoglobin in

7-1

7.2 Safety

WARNING

z Use only SpO

sensors specified in this manual. Follow the SpO2 sensor’s

instructions for use and adhere to all warnings and cautions.

z When a trend toward patient deoxygenation is indicated, blood samples should be

analyzed by a co-oximeter to completely understand the patient’s condition.

z Do not use SpO

sensors during magnetic resonance imaging (MRI). Induced

current could potentially cause burns. The sensor may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.

z Prolonged continuous monitoring may increase the risk of undesirable changes in

skin characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two hours and move the sensor if the skin quality changes. For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently.

z Check if the sensor is in normal condition before monitoring. Do not use the SpO

sensor once the package or the sensor is found damaged.

z After unplugging the SpO

sensor cable from the connector of the monitor, the

system shall display the alarm message "SPO2 SENSOR OFF" and give the audible alarm.

z ES (Electrosurgery) equipment wire and SpO z Do not apply the SpO

sensor on a limb with an intravenous infusion or arterial

cable must not be tangled up.

catheter in place.

z Do not perform SpO

monitoring and NIBP measurements on the same limb

simultaneously. Obstruction of blood flow during NIBP measurements may adversely affect the SpO

reading.

z Measure the monitor’s leakage current whenever an external device is connected to

the serial port. Leakage current must not exceed 100 mA.

z To ensure patient electrical isolation, connect only to other equipment with

electronically isolated circuits.

z Do not connect the monitor to a mains outlet with a wall switch or dimmer. z Interfering Substances, such as carboxyhemoglobin, may erroneously increase

SpO

readings. The level of increase is approximately equal to the amount of

carboxyhemoglobin. Dyes, or any substance containing dyes, that change usual arterial pigmentation may also cause the increase of SpO

readings.

7-2

NOTE

z Place the SpO

sensor cable along the backside of patient’s hand. Make sure the

fingernail is just opposite to the light emitted from the sensor.

z SpO z SpO

waveform amplitude is not proportional to the pulse strength.

value is not proportional to the pulse rate.

7.3 Monitoring Procedure

1. Power on the monitor.

2. Remove colored nail polish from the application site.

3. Apply the sensor to the patient.

4. Plug the connector of the sensor extension cable into the SpO

connector on the

monitor.

7.4 Measurement Limitations

If you doubt the measured SpO2, check patient vital signs first. Then check the patient

monitor and SpO2 sensor. The following factors may influence the accuracy of

measurement:

 Ambient light  Physical movement (patient and imposed motion)  Diagnostic testing  Low perfusion  Electromagnetic interference, such as MRI environment  Electrosurgical units  Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin

(MetHb)

 Presence of certain dyes, such as methylene and indigo carmine  Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor  Drop of arterial blood flow to immeaurable level caused by shock, anemia, low

temperature or vasoconstrictor.

The absorption of oxyhemoglobin (HbO

wavelength may also affect the accuracy of the SpO

) and deoxyhemoglobin to the light of special

measurement. In the presence of other

substances (such as carbon hemoglobin, methemoglobin, methylene blue and indigo

carmine) that absorb the light of the same wavelengths, false or low SpO

readings may

result.

7-3

7.5 Masimo Information

The MASIMO SET

 Masimo Patents

This device is covered under one or more of the following U.S. Patents: 5,482,036;

5,490,505; 5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462;

6,206,830; 6,157,850 and international equivalents, U.S.A and international patents

pending.

 No Implied License

Possession or purchase of this device does not convey any express or implied license to use

the device with unauthorized replacement parts which would, alone, or in combination with

this device, fall within the scope of one or more of the patents relating to this device.

Product

7.6 Nellcor Information

 Nellcor Patents

This device is covered under one or more the following U.S. Patents: 4,802,486; 4,869,254;

4,928,692; 4,934,372; 4,960,126; 5,078,136; 5,485,847;5,743,263; 5,865,736; 6,035,223;

6,298,252; 6,463,310; 6,591,123; 6,675,031; 6,708,049; 6,801,791; Re.35,122 and

international equivalents, U.S.A and international patents pending.

 No Implied License

Possession or purchase of this device does not convey any express or implied license to use

the device with unauthorized replacement parts which would, alone, or in combination with

this device, fall within the scope of one or more of the patents relating to this device.

7-4

8 NIBP Monitoring

8.1 Overview

The Non-invasive Blood Pressure (NIBP) module measures blood pressure using the

oscillometric method. This monitor can be applied to adult, pediatric, and neonatal patients.

Three modes of measurement are available:

 Manual: Pressing  Auto: NIBP measurement is performed automatically at a preset interval.

 STAT: NIBP measurement is performed continually over a five minute period.

The systolic, mean and diastolic pressure readings are displayed on the monitor. If SpO

measurement is not performed, the PR data can be obtained from the NIBP measurement.

starts an NIBP measurement manually.

WARNING

z Be sure to select the correct patient category setting for your patient before

measurement. Do not apply the higher adult settings for pediatric or neonatal patients. Otherwise it may present a safety hazard.

z Do not measure NIBP on patients with sickle-cell disease or any condition where

skin damage has occurred or is expected.

z Use clinical judgement to determine whether to perform frequent unattended

blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff.

z Do not use the NIBP cuff on a limb with an intravenous infusion or arterial

catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.

z If you doubt the NIBP readings, determines the patient’s vital signs by

alternative means and then verify that the monitor is working correctly.

8-1

8.2 Monitoring Procedure

To perform NIBP measurement on a patient, follow the procedure below.

1. Power on the monitor.

2. Enter the PATIENT INFORMATION menu to select correct patient type.

3. Plug the air hose in the NIBP connector of the monitor.

4. Apply a cuff of proper size to the upper arm or the thigh of the patient.

5. Connect the cuff with the air hose.

6. Press

to start the NIBP measurement.

8.2.1 Cuff Selection and Placement

1. Determine the patient’s limb circumference.

2. Select appropriate cuff according to limb circumference.

NOTE

z The width of the cuff should be either 40% of the limb circumference (50% for

neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to circle 50-80% of the limb. Wrong cuff size may cause erroneous readings. If the cuff size is in question, use a larger cuff.

3. Ensure that the cuff is completely deflated. Apply the cuff to the patient’s upper arm or

thigh and make sure the Φ marking on the cuff matches the artery location.

4. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and

ischemia of the extremities.

8-2

5. Make sure that the cuff edge falls within the marked range. If it does not, use a larger

or smaller cuff that will fit better.

6. The limb chosen for taking the NIBP measurement should be placed at the same level

as the patient's heart. If this is not possible, use the following method to correct the

measurement result:

 If the cuff is placed higher than the heart level, add 0.75 mmHg (0.10 kPa) to the

measured result for each centimeter of difference.

 If the cuff is placed lower than the heart level, deduct 0.75 mmHg (0.10 kPa) from

the measured result for each centimeter of difference.

WARNING

z Do not use the NIBP cuff on a limb with an intravenous infusion or arterial

catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.

z Make sure the air hose connecting the NIBP cuff and the monitor is not blocked,

twisted, or tangled.

8.2.2 Operation Guides

1. To start a manual NIBP measurement.

 Press

press

shown on the Normal screen.

 Directly press

cycles.

to enter the INTERVAL menu; set INTERVAL to MANUAL; and then

to start a manual NIBP measurement. In this case, a symbol “ ” is

to start a manual NIBP measurement between two auto NIBP

2. To start an Auto NIBP measurement.

Press

and then press

automatically repeat NIBP measurements at the preset time interval.

to enter the INTERVAL menu; set INTERVAL to a desired time (e.g.5MIN);

to start the first auto NIBP measurement. The monitor will then

8-3

3. To start a STAT NIBP measurement:

Press

continuous NIBP measurement.

to enter the INTERVAL menu and then select NIBP STAT to start a 5-minute

WARNING

z Continuous non-invasive blood pressure measurements may cause purpura,

ischemia and neuropathy in the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If any abnormity occurs, move the cuff to another site or stop the NIBP measurements immediately.

4. To stop an NIBP measurement

You can stop an NIBP measurement by pressing

or STAT mode.

whenever you are in Manual, Auto

NOTE

z If you doubt the NIBP readings, determine the patient’s vital signs by

alternative means and then verify that the monitor is working correctly.

8.3 Measurement Limitations

Measurements are impossible with heart rate extremes of less than 40bpm or greater than

240bpm, or if the patient is on a heart-lung machine.

The measurement may be inaccurate or impossible:

 If a regular arterial pressure pulse is hard to detect  With excessive and continuous patient movement such as shivering or convulsions  With cardiac arrhythmias  Rapid blood pressure changes  Severe shock or hypothermia that reduces blood flow to the peripheries  Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming

from the artery

8-4

8.4 NIBP Reset, Calibration and Test for Air Leakage

8.4.1 Resetting NIBP

If the blood pressure pump works incorrectly but the monitor does not alarm for it, you can check the pump by resetting it. To reset the pump, select SYSTEM SETUP→MAINTAIN→

NIBP RESET.

8.4.2 Calibrating NIBP

In SYSTEM SETUP menu, select MAINTAIN and then select NIBP CALIBRATE to start

NIBP calibration. Then the button NIBP CALIBRATE changes to STOP CALIBRATE. By

selecting STOP CALIBRATE, you can stop the calibration.

Follow this procedure to calibrate the cuff pressure with a calibrated reference manometer

(or mercury manometer) with accuracy 1mmHg:

1. Disconnect the NIBP cuff from the monitor and replace it with a metal vessel with

capacity 500±25ml.

2. Connect a calibrated reference manometer (with an error less than 0.8 mmHg), a ball

pump and a hoses to the monitor, as shown in the figure below:

3. Select NIBP CALIBRATE.

4. Inflate the metal vessel with the ball pump until the reference manometer reads 0, then

50, and finally 200 mmHg.

5. The difference between the indicated pressure of the reference manometer and that of

the monitor shall not exceed 3 mmHg. Otherwise, contact Our Customer Service.

Figure 8-1 NIBP Calibration

8-5

NOTE

z NIBP calibration shall be performed every two years or according to your

hospital’s protocol.

8.4.3 NIBP Leakage Test

You can test the pump for air leakage by selecting SYSTEM SETUP→MAINTAIN→NIBP

LEAK TEST. With the NIBP cuff connected, you can test the air way for leakage by

selecting NIBP LEAK TEST. If the NIBP leakage test is passed, no prompt will be given; If

it fails, error information will be displayed in the NIBP parameter area.

To test air leakage, follow the procedure below:

1. Connect the NIBP cuff to the NIBP cuff connector of the monitor.

2. Wrap the cuff around a cylinder of proper size, as shown in the following figure.

Figure 8-2 NIBP Leakage Test

3. Select NIBP LEAK TEST in the MAINTAIN menu, the message “Pneum testing...”

displays in the information area..

4. The cuff automatically deflates in 20s which means NIBP leakage test is completed.

5. If no message appears in the NIBP parameter area, it indicates the airway is in good

condition and no air leak exists. However, if the system prompts “PNEUMATIC

LEAK”, it indicates the airway may have an air leak. In this case, check for loose

connections. After confirming that all connections are secure, perform the test again.

If the problem persists, contact our Customer Service.

NOTE

z The leakage test is intended for use to simply determine whether there are

leakages in the NIBP airway. It is not the same as that specified in the EN 1060-3 standard.

8-6

9 TEMP Monitoring

9.1 Overview

The SmarTemp™ TEMP module is intended for monitoring oral, axillary and rectal

temperature of adult and pediatric patients and axillary temperature of neonatal patients. Be

sure to set correct monitoring mode and position and to select appropriate temperature

probe before taking measurement. TEMP TYPE can be set to PREDICT or MONITOR. The

default TEMP TYPE is PREDICT.

 PREDICT MODE: In PREDICT mode, the TEMP probe warms up automatically as

the probe is withdrawn from the probe sheath. Warming up takes approximately 10s at 25℃ and when it is done, the monitor gives two beeps. Final temperature is obtained

in approximately 10s to12s and the monitor gives a beep. Temperature reading remains

on the display till the probe is removed from the sheath again. In this mode, if no

accurate patient temperature is reached, or after the probe is removed from the sheath

for 60s, neither measurement is taken nor the probe is not replaced in its sheath, the

monitor automatically enters the MONITOR mode.

 MONITOR MODE: In MONITOR mode, final temperature is reached in 3 to 5

minutes and the temperature reading is continuously shown. In this mode, the monitor

does not beep when the final temperature is obtained.

The TEMP reading is display above the LCD.

WARNING

z The TEMP module shall only be operated under specified environment. When

the probe is removed from the probe sheath, the monitor detects the ambient temperature. An auditory alarm will be triggered and the alarm message “ENV TEMP OVERRANGE”will be displayed if the ambient temperature is over range.

z For neonatal patient, only axillary temperature can be taken. z Choose appropriate probe according to temperature position. Incorrect probe

may result in erroneous measurement.

z Prolonged and continuous monitoring beyond 5 minutes is not recommended in

any mode.

z In PREDICT mode, temperature probe shall be placed to the measured site as

soon as probe warmup is completed; otherwise, inaccurate temperature reading may result.

9-1

WARNING

z In MONITOR mode, the monitor stops measurement after performing

measurement for five minutes later and the TEMP reading disappears. Long-time TEMP measurement may cause patient discomfort.

9.2 Temperature Setup

In the SYSTEM SETUP menu, select TEMP SETUP, you can adjust:

 TEMP TYPE: PREDICT or MONITOR. If MONTIOR is selected, The LED

indicating measuring mode on the front panel illuminates.

 TEMP POSITION:: ORAL, AXILLARY or RECTAL. Corresponding indicating lamp

on the front panel illuminates if a measurement site is selected.

 TEMP UNIT: ℃ or ℉.

9.3 Monitoring Procedure

9.3.1 TEMP position

The TEMP module can be configured with 2 types of TEMP probe: oral/axillary probe (blue)

and rectal probe (red). The blue oral/axillary probe shall only be used with blue probe

sheath, while the red rectal probe shall only be used with red sheath. Be sure to select

correct probe.

 Oral/axillary probe: This type of probe is intended for taking oral or axillary

temperature of adult and pediatric patients, or axillary temperature of neonatal patient.

 Rectal probe: This type of probe is intended for taking rectal temperature of adult and

pediatric patient.

9-2

9.3.2 Oral Temperature Measurement

Follow the procedure below to measure oral Temperature.

1. Make sure that the oral/axillary probe is connected to the probe connector and the

indication lamp beside the temperature unit lights to indicate that TEMP module

properly operates.

2. Select desired temperature type (the following procedure taking predict mode as an

example) and set TEMP POSITION to ORAL.

3. Unplug the probe from the probe sheath and insert it into a cover in the probe cover

box. Press the probe handle down firmly until the cover engages with the probe.

4. After the probe warmingup is ready, apply it under the patient’s tongue from either

side of the mouth. Verify that the probe reaches the rear sublingual pocket. Have the

patient close his/her lips to hold the probe.

5. Hold the probe in place. Make sure that the probe contacts with the patient’s oral tissue

throughout the measurement.

6. The monitor will give a beep as the temperature measurement is complete. The

temperature reading displays continuously.

7. Withdraw the probe from the patient’s mouth when accurate temperature reading is

obtained. Press firmly the ejection button on the top of the probe to eject the probe

cover. Return the probe into the sheath.

Temperature reading displays when final temperature is reached.

9.3.3 Axillary Temperature Measurement

1. Make sure that the oral/axillary probe is connected to the probe connector and the

indication lamp beside the temperature unit lights to indicate that TEMP module

properly operates.

2. Select desired temperature type (the following procedure taking predict mode as an

example) and set TEMP POSITION to AXILLARY.

3. Unplug the probe from the probe sheath and insert it into a cover in the probe cover

box. Press the probe handle down firmly until the cover engages with the probe.

4. After probe warmingup is ready, lift the patient’s arm to show the entire armpit. Apply

the probe as high as possible in the armpit. Check that the probe tip is completely

surrounded by the axillary tissue. Lower the patient’s arm so that it is tightly placed at

the patient side. Keep the patient’s arm and the probe in place throughout the

measurement.

9-3

5. The monitor will give a beep as the temperature measurement is complete. The

temperature reading is shown continuously.

6. Withdraw the probe from the patient’s armpit when accurate temperature reading is

obtained. Press firmly the ejection button on the top of the probe to eject the probe

cover. Return the probe into the sheath.

Temperature reading displays when final temperature is reached.

9.3.4 Measuring Rectal Temperature

1. Make sure that the rectal probe is connected to the probe connector and the indication

lamp beside the temperature unit lights to indicate that TEMP module properly

operates.

2. Select desired temperature type (the following procedure taking predict mode as an

example) and set TEMP POSITION to RECTAL.

3. Unplug the probe from the probe sheath and insert it into a cover in the probe cover

box. Press the probe handle down firmly until the cover engages with the probe.

4. After probe warmingup is ready, seperate the patient’s buttocks with one hand and

insert the probe 1.5 cm inside the rectum with the other hand. For pediatric patient,

depth of insertion shall be less. Tilt the probe so that it always contacts with patient’s

tissue. Lubricant can be used in rectal mode.

5. The monitor will give a beep as the temperature measurement is complete. The

temperature reading is shown continuously.

6. Withdraw the probe from the patient’s rectum when accurate temperature reading is

obtained. Press firmly the ejection button on the top of the probe to eject the probe

cover. Return the probe into the sheath.

Temperature reading displays when final temperature is reached.

9-4

9.3.5 Temperature Measurement in MONITOR Mode

Temperature measurement can be taken in MONITOR mode. The monitor automatically

enters the MONITOR mode in the following two cases:

 Accurate temperature is not reached in the PREDICT mode.  Neither measurement is taken nor the probe is replaced in the probe sheath in 60s after

the probe is withdrawn from the sheath.

In MONITOR mode, temperature reading remains on the display as long as the probe is

kept at the measurement position and the patient’s temperature is within the measuring

range. Final temperature value is reached in 3 to 5 minutes, however, the monitor does not

beep in this mode.

To measure temperature in the Monitor mode,

1. Make sure that the probe is connected to the probe connector and the indication lamp

beside the temperature unit lights to indicate that TEMP module properly operates.

2. Set TEMP TYPE to MONITOR and select appropriate TEMP POSITION.

3. Unplug the probe from the probe sheath and insert it into a cover in the probe cover

box. Press the probe handle down firmly until the cover engages with the probe.

4. Apply the probe to the measuring site and take measurement according to the

instructions as described in the PREDICT mode.

5. Remain the probe in place for 3 to 5 minutes till accurate measurement is reached.

6. Remove the probe when accurate temperature reading is obtained. Press firmly the

ejection button on the top of the probe to eject the probe cover. Return the probe into

the sheath.

9-5

9.4 Precautions

WARNING

z Check the probe before taking temperature measurement. The prompt

information “TEMP NO PROBE” will be presented and an auditory alarm will be triggered if the TEMP probe is disconnected from the probe connector.

z Check the disposable probe cover for damage before using. Never use any probe

cover for temperature measurement in case of damage or contamination.

z Be careful to avoid damaging the TEMP probe. Replace the TEMP probe in the

probe sheath if not in use.

z Calibration of the TEMP module is required every two years or according to

your hospital’s policy. Please contact our Customer Service if calibration is needed.

z Only TEMP probes and probe covers supplied by our company shall be used.

The use of any other TEMP probe and probe cover may result in erroneous temperature measurements.

z Taking temperature without using probe cover or reusing the disposable probe

cover may result in cross contamination.

NOTE

z TEMP TYPE automatically returns to PREDICT mode when TEMP probe is

replaced in the probe sheath.

z In the PREDICT mode, please cool the TEMP probe before taking measurement

if ambient temperature is higher than 32.5℃.

z Patient actions may interfere with oral temperature readings. Ingesting hot or

cold liquids, eating food, chewing gum or mints, brushing teeth, smoking, or performing strenuous activities may affect temperature readings for up to 20 minutes after the activity has ended.

z Prolonged and continuous monitoring for more than 3 minutes in oral or rectum

mode or 5 minute in axillary mode is not recommended.

z In the axillary mode, the probe shall directly contact with patient’s skin.

Measuring through patient’s clothes or long-term exposal of patient’s armpit to the air may result in inaccurate temperature reading.

z In the rectal mode, incorrect probe placement may result in bowel perforation.

Washing hands after temperature measurement is complete will significantly reduce the risk of cross infection and nosocomial contamination.

9-6

10 Accessories

WARNING

z Use specified accessories only. Accessories of other types may cause damage to

the monitoror not meet the claimed specifications.

z Single-use accessories are not designed to be reused. Reuse may cause a risk of

contamination and affect the measurement accuracy.

z Check the accessories and their packages for any sign of damage. Do not use

them if any damage is detected.

10.1 SpO2 Accessories

Extension Cable

Module type PN

Mindray SpO2 Module 0010-20-42594

Masimo SpO2 Module 0010-30-42625

Nellcor SpO2 Module 0010-20-42595

SpO2 Sensor

The SpO2 sensor material that patients or other staff will come into contact with has

undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1.

For Mindray SpO2 Module Type Model Applicable Patient

MAX-A Adult (>30 kg) 0010-10-12202

Disposable

Single

patient

MAX-P Pediatric (10 to 50 kg) 0010-10-12203

MAX-I Infant (3 to 20 kg) 0010-10-12204

520A Adult 520A-30-64101

520P Pediatric 520P-30-64201

520I Infant 520I-30-64301

520N Neonate 520N-30-64401

10-1

DS-100A Adult 9000-10-05161

OXI-P/I Pediatric, infant 9000-10-07308

518B Adult, pediatric, neonate (Multi-sites) 518B-30-72107

512D 512D-30-90200

Reusable

512E 512E-30-90390

512F

512G 512G-30-90607

512H

Adult (Finger type)

512F-30-28263

Pediatric (Finger type)

512H-30-79061

ES-3212-9 Pediatric (Ear type) 0010-10-12392

For Masimo SpO2 Module Type Model Applicable Patient Remark PN

FPS-1901 Pediatric, neonate LNCS-NeoPt-L 0010-10-42626

FPS-1862 Neonate LNCS-Neo-L 0010-10-42627

Disposable

FPS-1861 Infant LNCS-Inf-L 0010-10-42628

FPS-1860 Pediatric LNCS-Pdt 0010-10-42629

FPS-1859 Adult LNCS-Adt 0010-10-42630

FPS-1863 Adult LNCS DC-I 0010-10-42600

Reusable

FPS-1864 Pediatric LNCS-DCIP 0010-10-42634

2258 Adult, pediatric, neonate LNCS YI 0010-10-43016

For Nellcor SpO2 Module Type Model Applicable Patient PN

MAX-A Adult (>30 kg) 0010-10-12202

Disposable

MAX-P Pediatric (10 to 50 kg) 0010-10-12203

MAX-I Infant (3 to 20 kg) 0010-10-12204

MAX-N Neonate (<3 kg), Adult (>40 kg) 0010-10-12205

DS-100A Adult 9000-10-05161

Reusable

OXI-P/I Pediatric, infant 9000-10-07308

OXI-A/N Adult, neonate 9000-10-07336

Wavelengths emitted by 512B and 512D sensors intended for Mindray SpO

module are red

light 660 nm and infrared light 940 nm; wavelengths emitted by other sensors for Mindray

SpO

module are red light 660 nm and infrared light 905 nm;

Wavelength emitted by the sensors intended for Masimo SpO

module are red light 660 nm

and infrared light 940 nm.

Wavelength emitted by the sensors intended for Nellcor SpO

module are red light 660 nm

and infrared light 890 nm.

The maximum photic output consumption of the sensor is less than 18 mW.

The information about the wavelength range and maximum photic output consumption can

be especially useful to clinicians, for example, clinicians performing photodynamic therapy.

10-2

10.2 NIBP Accessories

Tubing

Type Applicable Patient PN

Reusable

Cuff

Type Model

CM1201 Infant 10 to 19 9.2 0010-30-12157

CM1202 Pediatric 18 to 26 12.2 0010-30-12158

Reusable

Single

patient

Disposable

CM1203 Adult 24 to 35 15.1 0010-30-12159

CM1204 Large adult

CM1205 Adult Thigh 46 to 66 22.5 0010-30-12161

CM1500A 3.1 to 5.7 2.2 001B-30-70692

CM1500B 4.3 to 8.0 2.9 001B-30-70693

CM1500C 5.8 to 10.9 3.8 001B-30-70694

CM1500D

CM1501 Infant 10 to 19 7.2 001B-30-70697

CM1502 Pediatric 18 to 26 9.8 001B-30-70698

CM1503 Adult 25 to 35 13.1 001B-30-70699

CM1504 Large adult

CM1505 Adult Thigh 46 to 66 20.5 001B-30-70701

M1872A 7.1 to 13.1 5.1 900E-10-04873

M1870A 5.8 to 10.9 4.3 900E-10-04874

M1868A 4.3 to 8.0 3.2 900E-10-04875

M1866A

Adult, pediatric 509B-30-06259

Neonate 509B-30-06260

Applicable Patient

Neonate

Neonate Arm

Measure ment Site

Arm

Limb Circumference (cm)

33 to 47 18.3 0010-30-12160

7.1 to 13.1 4.8 001B-30-70695

33 to 47 16.5 001B-30-70700

3.1 to 5.7 2.5 900E-10-04876

Bladder Width (cm

10-3

10.3 TEMP Accessories

Description Measurement Site PN

TEMP probe

Probe sheath

Disposable probe cover (20 pcs) / M09A-20-62124

Disposable probe cover (200 pcs) / M09A-30-62126

Disposable probe cover (2000 pcs) / M09A-30-62128

oral/axillary 6006-30-39598

rectal 6006-30-39599

oral/axillary M09A-20-62062

rectal M09A-20-62062-51

10.4 Others

Description PN

Lead-acid battery M05-302R3R---

Lithium battery 0010-10-12329

Thermal paper A30-000001---

Bar code scanner 0000-10-10767

Nurse call cable 8000-21-10361

Roll stand 0010-30-42945

Wall-mounting rack 0010-30-42952

10-4

A Product Specifications

A.1 Safety Specifications

Item Specification

Class I; internally/externally powered equipment

Type of protection against

electrical shock

When integrity of the external protection grounding or grounding

cable is doubtable, the equipment must be powered by the

internal power (battery).

Degree of protection

against electric shock

Degree of protection

against hazards of

explosion

Degree of protection

against harmful ingress of

water

Mode of operation Continuous

Equipment type Portable

SpO

/NIBP/TEMP: CF

Not suitable (ordinary)

A.2 Environmental Specifications

Item Specification

Operating ambient

temperature

0 to 40 ºC

10 to 40 ºC (50 to 104 ºF) (SmarTemp™ TEMP module)

Operating relative humidity 15 to 95%, non-condensing

Atmospheric pressure at

working condition

(operating altitude)

Storage temperature -20 to 60 ºC

Storage relative humidity 10 to 95%, non-condensing

atmospheric pressure in

Storage (Storage altitude)

57～107.4KPa

70 to 106 kPa(SmarTemp™ TEMP module)

16～107.4KPa

50～106KPa(SmarTemp™ TEMP module)

A-1

A.3 Power Requirements

Item Specification AC mains

Voltage 100 to 240V

Frequency 50/60Hz

Power 70VA

Battery

Number of batteries 1

Battery type Sealed lead-acid battery or lithium-ion battery

Time to shutdown >5 min (after the first low-power alarm)

Sealed lead-acid battery

Nominal voltage 12VDC

Battery capacity 2.3Ah

260min

Typical operating time

(Using a new, fully charged battery for continuous SpO

monitoring and auto NIBP measurements at an interval of 15 minutes at 25℃ ).

Charge time

A maximum of 8h with monitor operating normally or in

standby mode

Lithium-ion battery

Nominal voltage 11.1VDC

Battery capacity 4.4Ah

620min

Typical operating time

(Using a new, fully charged battery for continuous SpO

monitoring and auto NIBP measurements at an interval of 15 minutes at 25℃ ).

Charge time

A maximum of 8h with monitor operating normally or in

standby mode

A-2

A.4 Hardware Specification

Item Specification

Size 177×240×170mm (width × height × depth))

Weight <3.5kg (battery included)

LCD

Type Monochrome FSTN

Size 80.3×41.0mm

Resolution 320×160 pixels

7-segment LED Digit Displays

Groups 6

LED indicating lamp

Groups 8

Recorder

Type Thermal dot array

Horizontal resolution 160dots/cm 25 mm/s (paper speed: 25mm/s)

Vertical resolution 80dots/cm

Paper width 50mm

Paper length 20m

Paper speed 25 mm/s

Number of waveform

channels

Connectors

Power supply 1 AC power connector

Nurse call 1

Network 1 standard RJ45 network connector, 100 BASE-TX

Serial port 1 standard RS-232 serial port

A-3

A.5 Signal Output

Item Specification

Applicable standards

Nurse call output

Driving mode Driven by relay

Electrical specification ≤60W, ≤2A, ≤36VDC, ≤25VAC

Isolation voltage >1500VAC

Working mode N/O or N/C (optional)

Sound output

Speaker

Meet the requirements of EC60601-1 for short-circuit

protection and leakage current

Issues alarm tones (sound pressure 45 to 85 dB), key tones,

pulse tones and audible temperature done prompt, supporting

Pitch Tone and multiple volume levels. Audible alarm signals

meet the requirement of IEC60601-1-8.

A.6 SpO2 Specification

A.6.1 Mindray SpO2 Specification

All SpO2 sensors for Mindray SpO2 Module specified in the section 10.1meets the

following specifications.

Item Specification

Measurement validation: The SpO2 accuracy has been validated in human studies against

arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are

statistically distributed, and only about two-thirds of the measurements can be expected to fall

within the specified accuracy compared to CO-oximeter measurements.

SpO2

Measurement range 0 to 100%

Resolution 1%

70% to 100%:

Accuracy

*Studies were performed to validate the accuracy of this monitor with neonatal SpO2 sensors by

contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of

22 weeks to full term were involved in this study. The statistical analysis of data of this study

shows the accuracy (Arms) is within the stated accuracy specification. Please see the following

table.

70% to 100%:

0% to 69%:

(adult/pediatric, in non-motion conditions)

±3%(neonate, in non-motion conditions) *

Undefined

A-4

Sensor type Totally neonates Data Arms

520N 122 (65 male & 57 female) 200 pairs 2.88%

518B 97 (51 male & 46 female) 200 pairs 2.38%

This monitor with neonatal SpO2 sensors was also validated on adult subjects.

Update period 1s

Averaging time 7s

Measurement range 20 to 254bpm

Resolution 1bpm

Accuracy ±3 bpm (in non-motion conditions)

Update period 1s

Averaging time 7s

A.6.2 Masimo SpO2 Specification

All SpO2 sensors for Masimo SpO2 Module specified in the section 10.1meets the following

specifications.

Item Specification SpO2

Measurement range 1 to 100%

Resolution 1%

70% to 100%:

70 %to 100%:

Accuracy

70 %to 100%:

0 %to 69%:

Update period 1s

Measurement range 25 to 240bpm

Resolution 1bpm

±2% (adult/pediatric, in non-motion conditions)

±3% (neonate, in non-motion conditions)

±3% (in motion conditions)

Undefined

Accuracy

±3 bpm (in non-motion conditions)

±5 bpm (in motion conditions)

Update period 1s

A-5

A.6.3 Nellcor SpO2 Specification

Item Specification

Sensor Range Accuracy*

MAX-A, MAX-AL, MAX-N,

MAX-P, MAX-I, MAX-FAST

SpO2 measurement range

and accuracy

PR measurement range and

accuracy

Update period 1s

*: When sensors are used on neonatal patients as recommended, the specified accuracy range is

increased by ±1%, to account for the theoretical effect on oximeter measurements of fetal

hemoglobin in neonatal blood.

OxiCliq A, OxiCliq N, OxiCliq

P, OxiCliq I

D-YS, DS-100A, OXI-A/N,

OXI-P/I

MAX-R, D-YSE, D-YSPD

20 to 250 bpm: ±3 bpm

251 to 300 bpm: Undefined

70% to 100%

0% to 69%

70 %to 100%

0% to 69%

70 %to 100%

0% to 69%

70% to 100%

0% to 69%

±2%

Undefined

±2.5%

Undefined

±3%

Undefined

±3.5%

Undefined

A.7 NIBP Specification

Item Specification NIBP

Applicable standards IEC 60601-2-30, EN 1060-1, EN1060-3, AAMI SP-10

Method Oscillometry

Displayed parameters

Mode of operation Manual, auto and STAT

Measurement range in

normal mode

Accuracy

Systolic pressure, diastolic pressure and mean pressure, pulse

rate

Adult Pediatric Neonate

Systolic

pressure

Diastolic

pressure

Mean

pressure

Maximum average error: ±5mmHg

Maximum standard deviation: 8mmHg

40 to 270

mmHg

10 to 210

mmHg

20 to 230

mmHg

40 to 200

mmHg

10 to 150

mmHg

20 to 165

mmHg

40 to 135

mmHg

10 to 100

mmHg

20 to 110

mmHg

A-6

Resolution 1mmHg

Over-pressure protection

Adult:

Pediatric:

Neonate:

297±3 mmHg

240±3 mmHg

147±3 mmHg

Default initial pressure Neonate: 67±5 mmHg

Measurement range 40 to 240bpm

Resolution 1bpm

Accuracy

±3 bpm

A.8 TEMP Specification

Item Specification

Displayed parameter TEMP

Measurement range

In MONITOR mode: 25 to 44 ºC (77 to 111.2 ºF)

In PREDICT mode: 35 to 43

Resolution In MONITOR mode: 0.1 ºC

In MONITOR mode: 25 to 32 ºC (77 to 89.6 ºF): ±0.2 ºC (±0.3

ºF) including 32 ºC (89.6 ºF)

Accuracy

In MONITOR mode: 32 to 44 ºC (89.6 to 111.2 ºF): ±0.1ºC

ºC (89.6 ºF)

Typical measurement time

(±0.2 ºF)excluding 32

typically 10s to 12s from the moment when temperature “----”

displays dynamically

ºC (95 to 109.4 ºF)

A-7

FOR YOUR NOTES

A-8

B EMC

The device meets the requirements of IEC60601-1-2: 2007

NOTE

z Use of accessories, transducers, and cables other than those specified may result

in increased emission and/or decreased electromagnetic immunity of the patient monitoring equipment.

z The device or its components should not be used adjacent to or stacked with

other equipment. and if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.

z The equipment needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided below.

z Other devices may affect this monitor even though they meet the requirements

of CISPR.

z When the inputted signal is below the minimum amplitude provided in technical

specifications, erroneous measurements could result.

z Portable and mobile RF communications equipment may affect this equipment.

Guidance and Declaration - Electromagnetic Emissions

The device is suitable for use in the electromagnetic environment specified below. The

customer or the user of the device should assure that it is used in such an environment.

Emission tests Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic Emissions

IEC61000-3-2

Voltage

Fluctuations/Flicker

Emissions

IEC 61000-3-3

Group 1 The equipment uses RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in nearby

electronic equipment.

Class A

Compliance

The equipment is suitable for use in all

establishments other than domestic and those

directly connected to the public low-voltage power

supply network that supplies buildings used for

domestic purposes.

B-1

Guidance and Declaration - Electromagnetic Immunity

The device is suitable for use in the electromagnetic environment specified below. The customer

or the user of the device should assure that it is used in such an environment.

Immunity tests

Electrostatic

discharge (ESD)

IEC60601 test level Compliance level

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

IEC 61000-4-2

Electrical fast

transient/burst （EFT）

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

Power frequency

±2 kV for power

cords

±1 kV for

input/output lines

(>3 m)

±1 kV differential

mode

±2 kV common

mode

<5% U

(>95% dip

in UT) for 0.5 cycle

<40% U

(>60% dip

in UT) for 5 cycle

<70% U

(>30% dip

in UT) for 25 cycle

<5% U

(>95% dip

in UT) for 5 seconds

3 A/m 3 A/m Power frequency

±2 kV for power

cords

±1 kV for

input/output lines

(>3 m)

±1 kV differential

mode

±2 kV common

mode

<5 % U

in U

(>95 % dip

) for 0.5 cycle

40 % U

in U

(60 % dip

) for 5 cycles

70 % U

in U

(30 % dip

) for 25 cycles

<5 % U

in U

(>95 % dip

) for 5 s

magnetic field （50/60Hz）

IEC 61000-4-8

Note: UT is the A.C. mains voltage prior to application of the test level.

Electromagnetic environment - guidance

Floors should be wood,

concrete or ceramic tile.

If floors are covered with

synthetic material, the

relative humidity should

be at least 30%.

Mains power quality

should be that of a

typical commercial or

hospital environment.

Mains power quality

should be that of a

typical commercial or

hospital environment. If

the user of our product

requires continued

operation during power

mains interruptions, it is

recommended that our

product be powered from

an uninterruptible power

supply or a battery.

magnetic fields should be

at levels characteristic of

a typical location in a

typical commercial or

hospital environment.

B-2

Guidance and Declaration - Electromagnetic Immunity

The device is suitable for use in the electromagnetic environment specified below. The customer

or the user of the device should assure that it is used in such an environment.

Immunity tests

Conduced RF

IEC61000-4-6

Radiated RF

IEC61000-4-3

IEC 60601 Test level

3 Vrms

150k to 80MHz

3V/m

80M to 2.5GHz

Compliance level

3 Vrms

3V/m

Electromagnetic environment — guidance

Portable and mobile RF communications

equipment should be used no closer to any

part of the device, including cables, than the

recommended separation distance calculated

from the equation applicable to the frequency

of the transmitter. Recommended separation

distance:

Pd 2.1= Pd 2.1=

80M to 800MHz

Pd 3.2=

800M to 2.5GHz

where P is the maximum output power rating

of the transmitter in watts (W) according to

the transmitter manufacturer and d is the

recommended separation distance in meters

(m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,

should be less than the compliance level in

each frequency range

Interference may

occur in the vicinity of equipment marked

with the following symbol:

Note 1: From 80 MHz to 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast

cannot be predicted theoretically with accuracy.

To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site

survey should be considered. If the measured field strength in the location in which the device is

used exceeds the applicable RF compliance level above, the device should be observed to verify

normal operation. If abnormal performance is observed, additional measures may be necessary,

such as reorienting or relocating the device.

b: Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m.

B-3

Recommended Separation Distances between Portable and Mobile RF, Communications Equipment and This Equipment

The equipment is intended for use in an electromagnetic environment in which radiated RF

disturbance are controlled. The customer or the user of the device can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile

RF communications equipment (transmitters) and the device as recommended below, according

to the maximum output power of the communication equipment.

Rated Maximum Output power of Transmitter Watts (W)

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.34

10 3.69 3.69 7.38

100 11.67 11.67 23.34

For transmitters at a maximum output power not listed above, the recommended separation

distanced in meters (m) can be determined using the equation applicable to the frequency of the

transmitter, where P is the maximum output power rating of the transmitter in watts (W)

according to the transmitter manufacturer.

Note 1: From 80 MHz to 800 MHz, the separation distance for the higher frequency range

applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

Separation Distance According to Frequency of Transmitter (m)

150k to 80MHz

5.3

⎡

⎤

⎢ ⎣

⎥

⎦

80M to 800MHz

5.3

⎡

⎤

⎢

⎣

⎥ ⎦

800M to 2.5GHz

⎡

⎤

⎢

⎣

⎥ ⎦

B-4

C Alarm Messages and Prompt Information

C.1 Physiological Alarm Messages

Note: XX represents a parameter label, such as PR, SpO

the alarm level. H means high, M means medium and L means low.

Alarm message L Cause Action

, NIBP, etc.The “L” field indicates

XX TOO HIGH M XX value exceeds the upper alarm

limit.

XX TOO LOW M XX value is lower than the lower

alarm limit..

NO PULSE H The pulse signal of the patient is so

weak that the monitor cannot

perform pulse analysis.

Make sure the alarm

limits are appropriate for

the patient, and check

the patient’s condition.

Check the connection of

the sensor and the

patient’s condition.

C.2 Technical Alarm Messages

Note: XX represents a parameter module such as NIBP or SpO

as PR and SpO

field indicates whether all alarm indications can be cleared or not, and the “B” field

indicates whether all alarm indications except the alarm message can be cleared or not. The

“L” field indicates the alarm level: H means high, M means medium and L means low. “*”

means the alarm level is user-adjustable.

. ## stands for patient category, i.e. adult, pediatric or neonate. The “A”

or a parameter label, such

C-1

C.2.1 General Alarm Messages of Parameter Modules

Alarm message A B L Cause Action

XX INIT ERR N Yes No H An error occurs to

the XX module

during initialization.

Note: N stands for error code.

XX COMM STOP No No H Failure in

communication

between XX module

and the main board.

XX COMM

ERROR

XX ALM LMT

ERR

XX EXCEED No No H The measured XX

No No H Failure in

communication

between XX module

and the main board.

No No H The alarm limit of

the XX parameter is

changed

inadvertently.

value exceeds the

measurement range.

Restart the monitor. If

the problem persists,

contact our service

personnel for repair.

If the problem

persists, contact our

service personnel for

repair.

C.2.2 NIBP Module Alarm Messages

Alarm message A B L Cause Action

NIBP SELFTEST

ERR

NIBP INIT ERR Yes Yes H An error occurs

Yes Yes H An error occurs

during NIBP module

initialization.

during NIBP module

initialization.

Select NIBP RESET

in the MAINTAIN

menu. If the problem

still exists, contact

our service personnel

for repair.

Restart the monitor. If

the problem still

exists, contact our

service personnel for

repair.

C-2

NIBP COMM ERR Yes Yes H Communication

between NIBP

module and the host

fails.

LOOSE CUFF No Yes L The NIBP cuff is not

properly connected.

AIR LEAK No Yes L

CUFF TYPE ERR No Yes M

PNEUMATIC

LEAK

AIR PRESSURE

ERROR

NIBP WEAK

SIGNAL

SATURATED

NIBP

OVERRANGE

EXCESSIVE

MOTION

OVER

PRESSURE

NIBP SYSTEM

FAIL URE

NIBP TIME OUT No Yes M

No Yes L

No Yes M

No Yes L Excessive motion of

No Yes M The airway might be

No Yes M

Leak in the airway.

Failures occur in the

pulse measurement.

The monitor cannot

perform

measurement,

analysis, or calculation. 。

the patient’s arms

blocked.

Failures occur in the

pulse measurement.

The monitor cannot

perform

measurement,

analysis, or

calculation.

Restart the monitor. If

the problem still

exists, contact our

service personnel for

repair.

Check the patient’s

condition and verify

patient type. Replace

with a appropriate

cuff and connect it

correctly. If the

problem still exists,

contact our service

personnel for repair.

Check the patient’s

condition and verify

patient type. Replace

with a appropriate

cuff and connect it

correctly. If the

problem still exists,

contact our service

personnel for repair.

NIBP RESET

ERROR

No Yes M Illegal reset during

NIBP measurement.

C-3

Check the airway and

take measurements

again. If the problem

still exists, contact

our service personnel

for repair.

C.2.3 Mindray SpO2 Module Alarm Messages

Alarm message A B L Cause Action

SPO2 SENSOR

No Yes * The sensor is

OFF

SPO2 LOW

No No L The pulse signal is

PERFUSION

SPO2 NO SENSOR No Yes L

disconnected from

the patient or the

monitor.

too weak.

SpO2 sensor is

detached from the

patient or monitor,

or SpO

sensor is

not properly

connected.

sensor is

SpO

reversely connected

Make sure that the

sensor is placed at an

appropriate position

and the monitor is

connected to cables

correctly.

Move the sensor to a

site with better

perfusion.

Disconnect SpO

sensor and reconnect

it as per instructions

for use. If the alarm

persists, SpO

sensor

or cable may be

damaged.

Disconnect SpO

sensor and reconnect

it as per instructions

for use. Pay attention

to the mark on the

sensor.

C-4

C.2.4 Masimo SpO2 Module Alarm Messages

Alarm message A B L Cause Action

SPO2 SENSOR

OFF

SPO2 PULSE

SPO2

INTERFERENCE

No Yes * The sensor is

disconnected from

the patient or the

monitor.

No No L The monitor is

searching for the

patient’s pulse

signal.

No No L The pulse signals

are subject to great

external

interference.

Make sure that the

sensor is placed at an

appropriate position

and the monitor is

connected to cables

correctly.

If the pulse reading is

not displayed after 30

seconds, check if the

sensor is properly

connected to the

patient. Change the

sensor site for better

signals if necessary.

Reduce or remove

external interference.

SPO2 LOW

PERFUSION

SPO2 TOO MUCH

LIGHT

UNKNOWN SPO2

SENSOR

SPO2 BOARD

FAULT

SPO2 SENSOR

FAULT

No No L The pulse signal is

too weak.

No No L Too much light on

the sensor.

No No L The monitor cannot

recognize the SpO2

sensor type.

No No H The SpO2 board

malfunctions and

might not be able to

measure the pulse

signals correctly.

No No H The sensor is

damaged.

Move the sensor to a

site with better

perfusion.

Turn down or off the

lighting, move the

sensor to a place of

weaker light or cover

the sensor.

Check whether the

type of the sensor is

correct.

Stop using the SpO

module, and contact

biomedical engineers

or us for

maintenance.

Stop using the sensor.

C-5

SPO2 NO SENSOR No Yes L

SPO2 WEAK

No No L The pulse signals

SIGNAL

The sensor is

disconnected from

the patient or the

monitor, or the

sensor is not

properly connected.

sensor is

SpO

reversed.

detected by the

monitor are of poor

quality.

Disconnect and

reconnect the sensor

as directed by the

instructions. If the

alarm remains, the

sensor or the cable

might have been

damaged.

Disconnect and

reconnect the sensor

as directed by the

instructions. Pay

attention to the mark

on the sensor.

Move the sensor to a

site with better

signals.

WRONG SPO2

SENSOR

No No L The SpO2 sensor is

incompatible to the

monitor, or is

damaged.

Stop using the sensor.

C-6

Mindray VS-800 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual