VS-900 Vital Signs Monitor Operator’s Manual Ver 1.0 May 2013

© Copyright 2013 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is May 2013.

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Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, , and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

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

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

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

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

WARNING z

This equipment must be operated by skilled/trained clinical professionals.

z

It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

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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 „

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

„

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

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Malfunction or damage caused by force majeure such as fire and earthquake.

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Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

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Malfunction of the instrument or part whose serial number is not legible enough.

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Others not caused by instrument or part itself.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address

Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057, P.R.China

Website

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

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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 corresponding working knowledge of medical procedures, practices and terminology.

Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your equipment.

Conventions „

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

„

[ ] is used to enclose screen texts.

„

→ is used to indicate operational procedures.

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Contents 1 Safety... 1-1 1.1 Safety Information...1-1 1.1.1 Dangers...1-2 1.1.2 Warnings...1-2 1.1.3 Cautions...1-3 1.1.4 Notes ...1-3 1.2 Equipment Symbols ...1-4 2 The Basics ... 2-1 2.1 Intended Use ...2-1 2.2 Main unit...2-2 2.2.1 Front View ...2-2 2.2.2 Side View ...2-4 2.2.3 Rear View ...2-5 2.2.4 Bottom View...2-6 2.3 Main Screen ...2-7 2.4 Menu ... 2-10 2.5 Operating Modes... 2-11 2.5.1 Monitor Mode... 2-11 2.5.2 Spot Check Mode ... 2-11 2.5.3 Standby Mode ... 2-12 2.5.4 Demo Mode... 2-12 3 Basic Operations... 3-1 3.1 Installation...3-1 3.1.1 Unpacking and Checking...3-1 3.1.2 Environmental Requirements...3-2 3.2 General Operation...3-3 3.2.1 Connection to AC Power ...3-3 3.2.2 Using a Battery ...3-3 3.2.3 Connecting Accessories...3-3 3.3 Turning On/Off Power...3-4 3.3.1 Check before Power On ...3-4 3.3.2 Turning Power On ...3-4 3.3.3 Turning off the Monitor...3-5 3.4 Using Key, Knob, Touchscreen ...3-5 3.4.1 Using Keys...3-5 3.4.2 Using the Knob...3-5 3.4.3 Using the Touchscreen...3-6 3.5 Changing General Settings...3-6 3.5.1 Setting up a Monitor...3-6 3.5.2 Changing Language...3-6 3.5.3 Configuring the Timeout of Clinician ID...3-6 3.5.4 Adjusting Alarm Volume...3-6 3.5.5 Adjusting Key Volume ...3-7 3.5.6 Adjusting the Screen Brightness ...3-7 3.5.7 Setting Screen ...3-7 3.5.8 Configuring the Timeout of Measured Value...3-7 3.5.9 Configuring Measurement Colors ...3-7 1

3.5.10 Setting the Date and Time ... 3-8 3.5.11 Configuring Unit ... 3-8 3.5.12 Configuring Printout ... 3-8 4 Patient Data Management... 4-1 4.1 Admitting a Patient... 4-1 4.1.1 Admitting a Patient by the Admit Patient Hardkey... 4-1 4.1.2 Admitting a Patient by Barcode Scanner ... 4-2 4.1.3 Admitting a Patient from [Patient List] ... 4-2 4.2 Manually Input Patient Data ... 4-3 4.3 Manually Save Patient Data ... 4-5 4.4 Reviewing Patient Data... 4-5 4.4.1 Spot Check Trends ... 4-6 4.4.2 Continuous Trends... 4-7 4.4.3 Graphic Trends ... 4-8 4.5 Transferring Data from the Monitor to USB Disk ... 4-9 5 Managing Configurations... 5-1 5.1 Overview... 5-1 5.2 Accessing [Manage Configuration] Menu... 5-1 5.2.1 Setting Default Configuration... 5-1 5.3 Saving Current Settings ... 5-2 5.4 Deleting a Configuration... 5-2 5.5 Transferring a Configuration ... 5-2 5.6 Loading a Configuration... 5-3 5.7 Restoring the Latest Configuration Automatically ... 5-3 6 Alarms ... 6-1 6.1 Alarm Categories ... 6-1 6.2 Alarm Levels ... 6-1 6.3 Alarm Indicators... 6-2 6.3.1 Alarm Lamp ... 6-2 6.3.2 Audible Alarm Tones... 6-2 6.3.3 Alarm Messages... 6-3 6.3.4 Flashing numerics... 6-3 6.3.5 Alarm Status Symbols... 6-3 6.4 Setting Alarms ... 6-4 6.5 Selecting Alarm Properties ... 6-4 6.5.1 Changing the Alarm Volume ... 6-4 6.5.2 Setting the Minimum Alarm Volume... 6-5 6.5.3 Setting the Interval between Alarm Sounds ... 6-5 6.5.4 Adjusting Alarm Limits Automatically ... 6-5 6.6 Pausing Alarms... 6-6 6.7 Switching Off Alarm Sound ... 6-7 6.8 Silencing Alarms ... 6-7 6.9 Setting the Reminder Tone... 6-8 6.10 Latching Alarms... 6-8 6.11 Clearing Technical Alarms... 6-9 6.12 Actions for Alarm Occurrence ... 6-9 6.13 Nurse Call ... 6-9 7 Monitoring SpO2 ... 7-1 7.1 Overview... 7-1 2

7.2 Safety...7-2 7.3 Identifying SpO2 Module ...7-2 7.4 Applying the Sensor...7-2 7.5 Changing SpO2 Settings...7-3 7.5.1 Accessing SpO2 Menu...7-3 7.5.2 Adjusting the Desat Alarm...7-3 7.5.3 Setting SpO2 Sensitivity ...7-3 7.5.4 Changing Averaging Time ...7-3 7.5.5 Monitoring SpO2 and NIBP Simultaneously...7-4 7.5.6 Sat-Seconds Alarm Management ...7-4 7.5.7 Changing the Speed of Pleth Wave...7-5 7.5.8 Setting the Alarm Level for SpO2 Sensor Off Alarm ...7-5 7.6 Measurement Limitations ...7-6 7.7 Masimo Information...7-7 7.8 Nellcor Information...7-7 8 Monitoring PR... 8-1 8.1 Overview...8-1 8.2 PR Source...8-1 8.3 Pulse Tone...8-1 9 Monitoring NIBP ... 9-1 9.1 Overview...9-1 9.2 Safety...9-1 9.3 Measurement Limitations ...9-2 9.4 NIBP Measurement Mode...9-2 9.5 Measuring NIBP...9-3 9.5.1 Preparation ...9-3 9.5.2 Starting NIBP measurement...9-3 9.5.3 Stopping NIBP Measurement ...9-4 9.5.4 Correcting the Measurement if Limb is not at Heart Level...9-4 9.6 Understanding the NIBP Numerics...9-4 9.7 Setting NIBP...9-4 9.7.1 Setting Interval...9-5 9.7.2 Setting the Initial Cuff Inflation Pressure...9-5 9.7.3 Setting NIBP End Tone...9-6 9.7.4 Switching On/Off Measurement on Clock...9-6 9.7.5 Configuring a Custom Program...9-6 9.7.6 Setting NIBP Alarm Properties ...9-6 9.7.7 Setting the Pressure Unit...9-6 9.8 Assisting Venous Puncture...9-7 10 Monitoring Temp ... 10-1 10.1 Overview ... 10-1 10.2 Setting Temp... 10-2 10.3 Preparation ... 10-2 10.3.1 Selecting Measuring Site ... 10-2 10.3.2 Taking a Temperature in Predictive Mode... 10-3 10.3.3 Taking a Temperature in Monitor Mode... 10-4 10.4 Disinfecting Temperature Probe ... 10-5 11 Recording... 11-1 11.1 Using a Recorder ... 11-1 3

11.2 Loading Paper ...11-1 11.3 Setting the Recorder...11-2 11.4 Starting and Stopping Recordings...11-2 11.5 Reports...11-3 11.5.1 Real-time Recording ...11-3 11.5.2 Graphic Trend Recording ...11-3 11.5.3 Continuous Trends Recording ...11-3 11.5.4 Spot Check Trends Recording ...11-3 11.6 Removing Paper Jam...11-4 11.7 Cleaning the Recorder Printhead...11-4 12 Other Functions... 12-1 12.1 MEWS System...12-1 12.2 Network ...12-2 12.2.1 Network Type and Settings...12-2 12.2.2 ADT Communication Setup...12-2 12.2.3 EMR Communication Setup ...12-3 12.2.4 DIAP Communication Setup ...12-3 13 Battery... 13-1 13.1 Overview ...13-1 13.2 Charging a Battery...13-1 13.3 Replacing a Battery ...13-2 13.4 Battery Guidelines ...13-2 13.5 Battery Maintenance ...13-3 13.5.1 Conditioning a Battery ...13-3 13.5.2 Checking a Battery ...13-3 13.6 Recycling a Battery...13-4 14 Care and Maintenance ... 14-1 14.1 Cleaning and Disinfection ...14-1 14.1.1 Cleaning ...14-2 14.1.2 Disinfecting...14-2 14.2 General Inspection ...14-2 14.3 Maintenance and Testing Schedule...14-3 14.4 Checking Monitor Information...14-4 14.5 NIBP Leakage Test ...14-5 14.6 NIBP Accuracy Test...14-6 14.7 Calibrating NIBP...14-7 14.8 Calibrating the Touchscreen...14-7 14.9 Formatting the Storage Card...14-7 14.10 Modifying Password...14-7 15 Accessories... 15-1 15.1 SpO2 Accessories...15-1 15.2 NIBP Accessories...15-3 15.3 Temp Accessories ...15-4 A Product Specifications... A-1 A.1 Classifications ...A-1 A.2 Environmental Specifications...A-1 A.3 Power Supply Specifications...A-2 A.4 Physical Specifications ...A-2 4

A.5 Hardware Specifications... A-3 A.6 Measurement Specifications... A-4 B EMC and Radio Regulatory Compliance ... B-1 B.1 EMC...B-1 B.2 Radio Regulatory Compliance...B-6 C Default Configurations ... C-1 C.1 Parameter Configuration...C-1 C.2 General configuration ...C-4 C.3 User Maintenance Items...C-5 D Alarm Messages ...D-1 D.1 Physiological Alarm Messages ... D-1 D.2 Technical Alarm Messages... D-1 E Electrical Safety Inspection... E-1 E.1 Power Cord Plug ... E-1 E.2 Device Enclosure and Accessories ... E-2 E.3 Device Labeling ... E-2 E.4 Protective Earth Resistance ... E-2 E.5 Earth Leakage Test ... E-2 E.6 Patient Leakage Current ... E-3 E.7 Mains on Applied Part Leakage ... E-4 F Symbols and Abbreviations... F-1 F.1 Symbols ... F-1 F.2 Abbreviations ... F-2

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FOR YOUR NOTES

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1 Safety 1.1 Safety Information

DANGER z

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

WARNING z

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

CAUTION z

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

NOTE z

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

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1.1.1 Dangers There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual.

1.1.2 Warnings WARNING z

This equipment is used for single patient at a time.

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Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.

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The equipment 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 it from the power line and operate it on battery power, if possible.

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To avoid explosion hazard, do not use the equipment in the presence of oxygen –rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).

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Do not open the equipment housings. All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only.

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Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.

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Do not touch the equipment’s metal parts or connectors when in contact with the patient; otherwise patient injury may result.

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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.

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The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation.

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To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel.

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Dispose of the package material, observing the applicable waste control regulations and keeping it out of children’s reach.

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Make sure that the power supply is continuous for patient monitoring. The power interruption will result in patient data loss.

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1.1.3 Cautions CAUTION z

Use only parts and accessories specified in this manual.

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Take out the battery before the monitor is transported or will not be used for a long time.

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Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

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Disposable accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

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

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

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

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Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.

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

1.1.4 Notes NOTE z

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

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Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.

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The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized.

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This manual describes all features and options. Your equipment may not have all of them.

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1.2 Equipment Symbols Some symbols may not appear on your equipment. Caution (Attention, consult accompanying documents)

ON/OFF for a part of equipment

Alternating current

Battery indicator

AUDIO PAUSED

NIBP Start/Stop key

ALARM PAUSED

Graphical recorder

Admit patient

Insertion Direction

DEFIBRILLATION –PROOF TYPE CF APPLIED PART

Input/Output

Network connector

Equipotentiality

USB connector

MANUFACTURER

Serial number

DATE OF MANUAFACTURE

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

Protection against fluid ingress

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 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.

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2 The Basics 2.1 Intended Use The Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

WARNING z

This equipment 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.

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2.2 Main unit 2.2.1 Front View 1

2 3

4

5 6

7 1.

8

9

10

11

Alarm indicator When a physiological alarm or a technical alarm occurs, this indicator will flash as defined below.

2.

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High priority alarm: the lamp quickly flashes red.

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Medium priority alarm: the lamp slowly flashes yellow.

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Low priority alarm: the lamp is yellow without flashing.

Display screen

3.

Temperature probe well

4.

Probe cover pack holder

5.

AC power indicator

6.

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On: indicates that the monitor is connected to the AC power.

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Off: indicates that the monitor is not connected to the AC power.

Power ON/OFF switch ‹

Press this key to turn the monitor on.

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If no parameter is being measured, press this key to enter Standby mode.

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When the monitor is on, press and hold this key for above 2 seconds to turn the monitor off.

An indicator is built in this switch. It turns on when the monitor is on and turns off when the monitor is off. 2-2

7.

8.

9.

Battery indicator ‹

On: indicates that the battery is installed and AC power is connected.

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Off: indicates that the battery is not installed.

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Flash: indicates that the monitor is powered by battery.

Silence key ‹

Press this key to disable the audio of present alarms.

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Press and hold this key for above 2 seconds to pause or restore alarms.

NIBP Start/Stop key Press to start or stop NIBP measurements.

10. Admit patient key ‹

Press this key to admit a new patient.

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Press this key to return to the main screen.

11. Knob ‹

Rotate the knob clockwise or anti-clockwise to move the cursor.

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Press the knob to select one item, such as accessing a menu or confirming the selection

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2.2.2 Side View 1

2

3

7

4

5 SpO 2 NIBP

8

6

1.

Handle

2.

Recorder indicator

3.

Start/stop recording key

4.

Paper outlet

5.

Recorder door

6.

Connector for NIBP cuff

7.

Recorder latch

8.

Connector for SpO2 cable

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2.2.3 Rear View

1 3 4

2

5 6 7

1.

Temperature probe well

2.

Connector for temperature probe

3.

Network connector: It is a standard RJ45 connector used to communicate with external devices, such as central monitoring system, Gateway, or upgrade the system.

4.

Multi-function connector: connects to the hospital's nurse call system, or connects external devices through DIAP protocol.

5.

USB connector: connects to barcode scanner or USB disk.

6.

AC power input

7.

Equipotential grounding terminal: When the equipment and other devices are to be used together, their equipotential grounding terminals should be connected together to eliminate the potential difference between them.

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