DPM 2 Pulse Oximeter Operators Manual Rev 3.0 April 2010

FOR YOUR NOTES

II

Intellectual Property Statement Mindray DS USA, Inc. (hereinafter called Mindray DS) 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 copyright and the patent rights of Mindray DS, nor the rights of others.

Mindray DS 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 DS is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray DS is strictly forbidden.

is a trademark or a registered trademark of Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All third-party trademarks that appear in this manual are used solely for editorial purposes and are the property of their respective owners. Contents of this manual are subject to changes without prior notice. © 2008-2010 Mindray DS USA, Inc. All rights reserved.

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

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Manufacturer’s Responsibility All information contained in this manual is believed to be correct. Mindray DS shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing or use of this manual. Mindray will not be liable for the effects on safety, reliability and performance of this product if: „

any installation operations, expansions, changes, modifications and repairs of this product are not conducted by Mindray DS authorized personnel; and

„

the electrical installation of the relevant room does not comply with the applicable national and local requirements; and

„

the product is not 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 DS'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 DS or repairs by people other than Mindray DS authorized personnel. This warranty shall not extend to „

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

„

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

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Any product of any other manufacturer.

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Return Policy In the event that it becomes necessary to return a unit to Mindray DS, 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 DS 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:

Mindray DS USA, Inc.

Address:

800 MacArthur Blvd.Mahwah, New Jersey 07430 USA

Tel:

1.800.288.2121,

Website:

www.mindray.com

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1.201.995.8000

FOR YOUR NOTES

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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 a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.

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

Password Password is required to access maintenance. The password is 321.

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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FOR YOUR NOTES

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Contents 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 Warnings... 1-2 1.1.2 Cautions ... 1-3 1.1.3 Notes ... 1-3 1.2 Equipment Symbols ... 1-4 2 The Basics ... 2-1 2.1 Introduction... 2-1 2.1.1 Intended Use... 2-1 2.1.2 Contraindications ... 2-1 2.1.3 Components ... 2-1 2.2 Main Unit ... 2-2 2.2.1 Front View... 2-2 2.2.2 Rear View and Right View... 2-3 2.3 Display Views ... 2-4 2.3.1 SpO2 Area... 2-5 2.3.2 PR Area ... 2-5 2.3.3 Information Area ... 2-5 3 Getting Started ... 3-1 3.1 Unpacking and Checking ... 3-1 3.2 Environmental Requirements... 3-1 3.3 Starting the Pulse oximeter ... 3-2 3.4 Shutting Off the Pulse oximeter ... 3-2 4 Basic Operations ... 4-1 4.1 Selecting the Work Mode ... 4-1 4.2 Admitting a Patient... 4-1 4.2.1 Continuous Monitoring Mode... 4-2 4.2.2 Spot-checking Mode ... 4-2 4.3 Selecting the Screen ... 4-2 4.4 Adjust the Screen Brightness ... 4-2 4.5 Changing the Language... 4-3 4.6 Setting the Clock ... 4-3 4.7 Adjusting the Volume ... 4-4 4.7.1 Setting the Beat Volume ... 4-4 4.7.2 Setting the Key Volume... 4-4 4.8 Entering/Exiting the Demo Mode ... 4-4 4.9 Checking the Version ... 4-5 1

4.10 Entering/Exiting the Standby Mode ... 4-5 4.10.1 Entering the Standby Mode... 4-5 4.10.2 Exiting the Standby Mode... 4-5 4.11 Setting Auto Poweroff ... 4-6 4.12 Configuration ... 4-6 4.12.1 Restoring the Factory Configuration... 4-6 4.12.2 Saving the User Configuration... 4-6 4.12.3 Loading the User Configuration... 4-7 5 Alarms ... 5-1 5.1 Alarm Categories... 5-1 5.2 Alarm Levels ... 5-1 5.3 Alarm Indicators... 5-2 5.3.1 Alarm Lamp ... 5-2 5.3.2 Alarm Tones ... 5-2 5.3.3 Alarm Messages ... 5-3 5.3.4 Alarm Status Symbols ... 5-3 5.4 Alarm Tone Configuration ... 5-4 5.4.1 Setting the Minimum Alarm Volume ... 5-4 5.4.2 Changing the Alarm Volume ... 5-4 5.4.3 Pausing the Alarm Tones... 5-5 5.5 Setting the Alarm Level ... 5-5 5.6 Switching On/Off the Reminder Tone... 5-6 5.7 When an Alarm Occurs ... 5-6 6 Measuring SpO2 ... 6-1 6.1 Introduction... 6-1 6.2 Safety ... 6-2 6.3 Applying the Sensor ... 6-3 6.4 Changing SpO2 Settings... 6-3 6.4.1 Switching On/Off SpO2 and PR Alarms... 6-3 6.4.2 Setting Alarm Level ... 6-3 6.4.3 Adjusting the Alarm Limits ... 6-4 6.4.4 Switching On/Off the Alarm Limit Display ... 6-4 6.4.5 Setting SpO2 Sensitivity ... 6-4 6.5 Measurement Limitations... 6-5 7 Data Management ... 7-1 7.1 Storing data ... 7-1 7.1.1 Continuous Monitoring Mode... 7-1 7.1.2 Spot-checking Mode ... 7-2 7.2 Reviewing Trend Data... 7-2 7.2.1 Continuous Monitoring Mode... 7-3 7.2.2 Spot-checking Mode ... 7-4 2

7.3 Data Exporting ... 7-5 7.3.1 Real-time Exporting ... 7-5 7.3.2 Exporting Trend Data... 7-6 8 Battery... 8-1 8.1 Overview... 8-1 8.2 Installing the Batteries... 8-2 8.2.1 Opening the Battery Door ... 8-2 8.2.2 Installing the Alkaline Batteries ... 8-3 8.2.3 Installing the Lithium Ion Battery ... 8-3 8.3 Charging the Lithium Ion Battery ... 8-4 8.4 Conditioning the Lithium Ion Battery... 8-4 8.5 Checking the Lithium Ion Battery... 8-5 8.6 Disposing of the Batteries ... 8-6 9 Maintenance and Cleaning... 9-1 9.1 Safety Checks... 9-2 9.2 Cleaning ... 9-2 9.3 Disinfecting... 9-3 9.4 Disposal... 9-3 10 Accessories ... 10-1 A Product Specifications... A-1 B EMC...B-1 C Factory Defaults ... C-1 C.1 Alarm Setup...C-1 C.2 System Setup ...C-2 C.3 SpO2 Setup ...C-2 D Alarm Messages... D-1 D.1 Physiological Alarm Messages... D-1 D.2 Technical Alarm Messages ... D-1 D.3 Prompt messages... D-2 E Symbols and Abbreviations ...E-1 E.1 Units ... E-1 E.2 Symbols ... E-2 E.3 Abbreviations... E-2

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FOR YOUR NOTES

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1 Safety 1.1 Safety Information 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

1.1.1 Warnings

WARNINGS z

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

z

To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics, vapors or liquids.

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Do not open the equipment housings; electric shock hazard may exist. All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only.

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When using the equipment with electrosurgical units (ESU), make sure the patient is safe.

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Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could 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 avoid risk of entanglement or strangulation by patients or personnel.

1-2

1.1.2 Cautions

CAUTIONS z

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

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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.

z

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

z

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

1.1.3 Notes NOTES z

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

z

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

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

z

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

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1.2 Equipment Symbols Direct Current (DC) Attention: Consult accompanying documents (this manual). Auxiliary output connector Audio pause Battery door locked/unlocked Power supply connector Left/Right button Power button Up button Down button Date of manufacture Manufacturer European community representative Serial number Safety Class II equipment Type BF applied part, defibrillation protected 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. 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.

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2 The Basics 2.1 Introduction 2.1.1 Intended Use The handheld pulse oximeter is intended for continuous monitoring, spot checking of functional pulse oxygen saturation(SpO2) and pulse rate(PR) of single adult, pediatric and neonatal patients in hospitals, out-of-hospital transport and home care.

WARNING z

This pulse oximeter is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on it.

2.1.2 Contraindications None.

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

2-1

2.2 Main Unit 2.2.1 Front View 4

1

8 7

6

2 9 3

5

10 1.

Display screen

2.

Power button

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Press this button to turn the pulse oximeter on after the batteries are installed.

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Press and hold it for 2 seconds to turn the pulse oximeter off.

3.

Power indicating lamp It is a LED that lights green and yellow. The status of the LED is specified as follows:

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Green:

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Yellow: when a lithium ion battery is used and is being charged.

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Off:

4.

Alarm indicating lamp

when the pulse oximeter is placed in the Charger stand and the AC mains is connected, or when the battery is fully charged if a lithium battery is used.

When the AC mains is not connected.

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

High level alarms:

the lamp quickly flashes red.

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Medium level alarms:

the lamp slowly flashes yellow.

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Low level alarms:

the lamp lights yellow without flashing.

5.

Press this button to pause or reactivate the alarm sound.

6.

Left button Press this button to enter the main menu or select the highlighted menu item. 2-2

7.

Right button Press this button to return to the previous menu or exit the current menu. In the case that no menu is opened, you can press and hold this button for 2 seconds to lock or unlock buttons except the Power button.

8.

Up button Press this button to move the cursor upwards, increase the value of selected menu item or raise the beat volume.

9.

Down button Press this button to move the cursor downwards, decrease the value of selected menu item or lower the beat volume.

10. Power supply connector It is used to connect the Charger stand.

2.2.2 Rear View and Right View 1 4 2

3

1.

5

Multifunctional connector It is used to connect an SpO2 sensor to measure the oxygen saturation or connect a personal computer through a PC communication cable to export the trend data.

2.

Speaker

3.

Battery door

4.

Cord hole

5.

Infrared port It is a port through which a personal computer is communicated to export data in real time.

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2.3 Display Views The following figures show the layout of the wave screen and the normal screen. 3

4

5 2

2

6 5

1 7 8 Wave screen

1.

Normal screen

Waveform Area This area displays Pleth waveform (Pleth). The label of this waveform is shown at the top left corner.

2.

SpO2 area

3.

Technical alarm area This area shows the technical alarm message, prompt message and the pulse oximeter’s operating mode. When multiple messages come, they will be displayed circularly.

4.

Alarm status area indicates that alarm sounds are paused; indicates that alarm sounds are turned off.

5

PR area

6.

Physiological alarm area This area shows physiological alarm messages. When multiple alarms come, they will be displayed circularly.

7.

Information area

8.

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

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