Operators Manual
100 Pages
Preview
Page 1
PM-60
Pulse Oximeter
Operator’s Manual
© 2007-2011 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2011-07.
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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 copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or 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, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
,
and
are the trademarks, registered or
otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.
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Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or 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;
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.
WARNING 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.
NOTE z
This equipment must be operated by skilled/trained clinical professionals.
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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.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified orunauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
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Company Contact Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
E-mail Address:
Tel:
+86 755 26582479 26582888
Fax:
+86 755 26582934 26582500
EC-Representative:
Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestraβe 80, Hamburg 20537, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
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FOR YOUR NOTES
VI
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. VII
FOR YOUR NOTES
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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 ... 1-4 1.2 Equipment Symbols ... 1-5 2 The Basics... 2-1 2.1 Introduction... 2-1 2.1.1 Intended Use ... 2-1 2.1.2 Contraindications ... 2-1 2.1.3 Components ... 2-1 2.2 Main Unit ... 2-2 2.2.1 Front View... 2-2 2.2.2 Rear View and Right View ... 2-4 2.3 Display Views ... 2-5 2.3.1 SpO2 Area ... 2-6 2.3.2 PR Area ... 2-7 2.3.3 Information Area... 2-7 3 Getting Started ... 3-1 3.1 Unpacking and Checking... 3-1 3.2 Environmental Requirements ... 3-2 3.3 Starting the Pulse oximeter ... 3-2 3.4 Shutting Off the Pulse oximeter... 3-3 4 Basic Operations ... 4-1 4.1 Selecting the Work Mode... 4-1 4.2 Admitting a Patient ... 4-2 4.2.1 Continuous Monitoring Mode ... 4-2 4.2.2 Spot-checking Mode ... 4-2 4.3 Selecting the Screen ... 4-3 1
4.4 Adjust the Screen Brightness ... 4-3 4.5 Changing the Language ... 4-3 4.6 Setting the Clock... 4-4 4.7 Adjusting the Volume... 4-4 4.7.1 Setting the Beat Volume... 4-4 4.7.2 Setting the Key Volume ... 4-5 4.8 Entering/Exiting the Demo Mode... 4-5 4.9 Checking the Version ... 4-5 4.10 Entering/Exiting the Standby Mode ... 4-6 4.10.1 Entering the Standby Mode ... 4-6 4.10.2 Exiting the Standby Mode ... 4-6 4.11 Setting Auto Poweroff... 4-7 4.12 Configuration ... 4-7 4.12.1 Restoring the Factory Configuration ... 4-7 4.12.2 Saving the User Configuration ... 4-8 4.12.3 Loading the User Configuration ... 4-8 5 Alarms ... 5-1 5.1 Alarm Categories ... 5-1 5.2 Alarm Levels ... 5-2 5.3 Alarm Indicators... 5-3 5.3.1 Alarm Lamp ... 5-3 5.3.2 Alarm Tones ... 5-3 5.3.3 Alarm Messages ... 5-4 5.3.4 Alarm Status Symbols... 5-4 5.4 Alarm Tone Configuration ... 5-5 5.4.1 Setting the Minimum Alarm Volume... 5-5 5.4.2 Changing the Alarm Volume... 5-6 5.4.3 Pausing the Alarm Tones ... 5-7 5.5 Setting the Alarm Level ... 5-8 5.6 Switching On/Off the Reminder Tone ... 5-9 5.7 When an Alarm Occurs ... 5-9 6 Measuring SpO2 ... 6-1 6.1 Introduction... 6-1 6.2 Safety... 6-2 6.3 Applying the Sensor... 6-3 2
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 7.6 Storing data ... 7-1 7.6.1 Continuous Monitoring Mode ... 7-1 7.6.2 Spot-checking Mode ... 7-2 7.7 Reviewing Trend Data ... 7-3 7.7.1 Continuous Monitoring Mode ... 7-3 7.7.2 Spot-checking Mode ... 7-4 7.8 Data Exporting ... 7-5 7.8.1 Real-time Exporting... 7-5 7.8.2 Exporting Trend Data... 7-7 8 Battery ... 8-1 8.1 Overview ... 8-1 8.2 Installing the Batteries ... 8-3 8.2.1 Opening the Battery Door... 8-3 8.2.2 Installing the Alkaline Batteries ... 8-4 8.2.3 Installing the Lithium Ion Battery ... 8-4 8.3 Charging the Lithium Ion Battery... 8-5 8.4 Conditioning the Lithium Ion Battery ... 8-6 8.5 Checking the Lithium Ion Battery ... 8-7 8.6 Disposing of the Batteries... 8-8 9 Maintenance and Cleaning... 9-1 9.1 Safety Checks... 9-2 9.2 Cleaning ... 9-3 9.3 Disinfecting... 9-4 9.4 Disposal... 9-4 10 Accessories ... 10-1
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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-2 E Symbols and Abbreviations ... E-1 E.1 Units...E-1 E.2 Symbols ...E-2 E.3 Abbreviations...E-3
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1 Safety 1.1 Safety Information DANGER z
Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING z
Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury.
CAUTION z
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
NOTE z
Provides application tips or other useful information to ensure that you get the most from your product.
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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
WARNINGS z
Before putting the system into operation, verify that the equipment, connecting cables and accessories are in correct working order and operating condition.
z
To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics, vapors or liquids.
z
Do not open the equipment housings; electric shock hazard may exist. All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only.
z
When using the equipment with electrosurgical units (ESU), make sure the patient is safe.
z
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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z
To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to avoid risk of entanglement or strangulation by patients or personnel.
1.1.3 Cautions
CAUTIONS z
To ensure patient safety, use only parts and accessories specified in this manual.
z
At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact us.
z
Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.
z
Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual.
z
Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.
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1.1.4 Notes
NOTES z
Put the equipment in a location where you can easily see the screen and access the operating controls.
z
Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.
z
The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized.
z
This manual describes all features and options. Your equipment may not have all of them.
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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
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Mark of conformity to European Medical Device Directive 93/42/EEC 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 Introduction 2.1.1 Intended Use The pulse oximeter is intended for continuously monitoring, spot checking, displaying, storing and transferring oxygen saturation and pulse rate of single adult, pediatric and neonatal patients in hospitals, emergency treatment, patient 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