Operators Manual
76 Pages
Preview
Page 1
PM-50 Pulse Oximeter
Operator's Manual
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.
© 2004-2007 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
I
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.
II
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.
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.
III
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 26522479
+86 755 26582888
Fax:
+86 755 26582500
+86 755 26582501
Website:
www.mindray.com.cn
EC-Representative:
Shanghai International Holding Corp. GmbH (Europe)
Address:
Eiffestraße 80, Hamburg 20537, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
IV
Preface Manual Purpose This manual provides the instructions necessary to operate PM-50 Pulse Oximeter (hereinafter called as PM-50) in accordance with its function and intended use. Observance of this manual is a prerequisite for proper performance and correct operation, and ensures patient and operator safety. This manual is an integral part of and should always be kept close to the your PM-50, so that it can be obtained conveniently when necessary.
Intended Audience This manual is geared for the clinical medical professionals. Clinical medical professionals are expected to have working knowledge of medical procedures, practices and terminology as required for monitoring patients.
Version Information This manual has a version number. This version number changes whenever the manual is updated due to software or technical specification change. Content of this manual is subject to change without prior notice. The version information of this manual is as follows. Version number
Release date
2.2
October, 2007
V
Illustrations and Names All illustrations in this manual are provided as examples only. They may not necessarily accord with the graph, settings or data displayed on your PM-50.
All names appeared in this manual and illustrations are fictive. It is a mere coincidence if the name is the same with yours.
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 or seriousness.
VI
Contents
Intellectual Property Statement ... I Manufacturer’s Responsibility ... II Return Policy... III Contact Information... IV Preface... V Contents... VII 1
Safety... 1 1.1 Safety Information... 1 1.1.1
Dangers ... 2
1.1.2
Warnings ... 2
1.1.3
Cautions... 4
1.1.4
Notes... 4
1.2 Equipment Symbols ... 5 1.3 CE Marking ... 6 2
General ... 7 2.1 Introduction ... 7 2.2 Functions ... 8 2.3 Appearance ... 9 2.4 Displayed Information ... 10 2.5 Button Operation...11
3
2.5.1
Power Button ...11
2.5.2
Backlight Button ...11
2.5.3
Confirm ID Button ... 12
2.5.4
Delete ID Button... 12
Installation... 13 3.1 Unpacking and Inspection... 13
VII
Contents
3.2 Install Batteries ... 13 3.3 Power-on ... 15 3.4 Connect SpO2 Sensor ... 15 3.5 Connect Computer... 16 4
Measurement ... 17 4.1 Measuring Principle ... 17 4.2 Precautions ... 18 4.3 Measuring Steps ... 19 4.3.1
Adult Measurement ... 19
4.3.2
Neonatal Measurement... 21
4.3.3
Placing Neonatal SpO2 Sensor... 21
4.4 Measuring Limitations ... 23 5
Other Functions ... 25 5.1 Data Management ... 25 5.1.1
Data Storage ... 25
5.1.2
Data Adding ... 26
5.1.3
Data Protection ... 27
5.1.4
Data Deletion ... 27
5.2 Messages Prompting ... 28 5.3 Power Management... 30
6
5.3.1
Battery Detection ... 30
5.3.2
Energy Saving... 30
Maintenance ... 31 6.1 System Check... 31 6.2 Cleaning... 32 6.3 Sterilization/Disinfection ... 33 6.4 Disposal ... 34
7
Pulse Oximeter Management System... 35 7.1 Installation and Uninstall ... 35
VIII
Contents
7.1.1
Installation... 35
7.1.2
Uninstall ... 36
7.2 Main Interface ... 37 7.2.1
Menu Bar ... 37
7.2.2
Tool Bar... 40
7.2.3
Data Area ... 41
7.3 Functions ... 42
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7.3.1
Data Output... 42
7.3.2
Software Upgrade ... 43
7.3.3
File Management ... 47
7.3.4
Modify Patient Information ... 48
7.3.5
Print Data ... 49
7.3.6
Prompt Message ... 50
Accessories... 51
Appendix A Specifications ... 53 Appendix B EMC... 58
IX
Contents
FOR YOUR NOTES
X
1
Safety
1.1
Safety Information
The safety statements presented in this chapter refer to the basic safety information that the operator of PM-50 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 Indicates an imminent hazard situation that, if not avoided, will result in death or serious injury.
WARNING Indicates a potential hazard situation or unsafe practice that, if not avoided, could result in death or serious injury.
CAUTION Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
NOTE Provides application tips or other useful information to ensure that you get the most from your product.
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Safety Information
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
PM-50 is intended for use by qualified clinical physicians or well-trained nurses in the specified places or in the process of transporting patients.
z
PM-50 is designed for real-time and rapid measurement of the patient’s SpO2. It is not suitable for long-time continuous patient monitoring. Continual measurement must not exceed 2 hours.
z
PM-50 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. It is not intended as a device used for treatment purposes.
z
To ensure patient safety, verify this device and accessories can function safely and normally before use.
z
EXPLOSION HAZARD: Do not use PM-50 in the presence of flammable anesthetics, explosive substances, vapors or liquids.
z
Failure to implement a satisfactory maintenance schedule may cause undue device failure and possible health hazard.
2
Safety Information
z
When using PM-50 together with the electrical surgery equipment, the user should pay attention to and guarantee safety of the patient being measured.
z
Do not pull or lift PM-50 by its connection cable. That may lead to falling and consequent patient injuries.
z
It is not recommended to hang PM-50 when transporting patients. Safety hazards may arise from the large amplitude swing during the transportation.
z
Magnetic and electrical fields are capable of interfering with the proper performance of PM-50. For this reason make sure that all external devices operated in the vicinity of PM-50 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
PM-50 and its accessories may be contaminated by microorganism during transporting, use and storage. Use the recommended methods to sterilize and disinfect PM-50 or its accessories when the packing material is damaged, or it has not been used for a long time.
3
Safety Information
1.1.3
Cautions CAUTION
z
Federal Law (USA) restricts this device to sale by or on the order of a physician.
z
The device should be appropriately placed. Keep it from falling, strong vibration or other mechanical damage.
z
To ensure patient safety, use only parts and accessories specified in this manual.
z
PM-50 is a commonly sealed device. Keep its surface dry and clean, and prevent any liquid from infiltrating it.
z
Don’t use mobile phones around when PM-50 is in operation.
z
PM-50 should only be maintained by personnel approved by our company.
z
Before using PM-50 on patients, the user should be familiar with its operation.
1.1.4
Notes
NOTE z
Important! Before use, carefully read this manual, all safety information and specifications.
z
This device is not intended for home use.
z
This device complies with the requirements of CISPR11 (EN55011) class A.
4
Safety Information
1.2
Equipment Symbols
Attention! Consult accompanying documents (this manual). Type BF applied part according to IEC 60601-1. This symbol indicates the socket can connect with the PC through a communication cable. CE marking. 0123 is the number of the EU-notified body. 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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Safety Information
1.3
CE Marking
The patient monitor bears CE mark indicating its conformity with the provision of Council Directive 93/42/EEC concerning medical devices, and fulfills the essential requirement of Annex I of this directive.
The patient monitor is in radio-interference protection class A in accordance with EN55011.
The product complies with the requirement of standard EN60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”.
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2
General
2.1
Introduction
PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using specified disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults.
Parameters measured by PM-50 include: arterial oxygen saturation (SpO2), pulse rate (PR) and pulse strength. PM-50 measures these parameters through a SpO2 sensor and displays them on the LCD screen after certain further processing.
PM-50 is operated and controlled by three buttons, which are Power button, Backlight button and Confirm ID button. PM-50 is also capable of managing measured data and transmitting the patient’s trend through the dual-purpose socket to a PC for printing.
Contraindications None
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General
2.2
Functions
PM-50 has the following functions:
Measuring: SpO2, PR and pulse strength.
Prompting: Memory full, ID full, low battery, standby, and technical error etc.
Power managing: automatic standby, automatic shutdown.
Data Managing: data storage, data protection, data deletion.
Data Printing: patient information and trend data.
For the data printing function, you must install the Pulse Oximeter management system in a PC equipped with a printer, and connect PM-50 with the PC by a communication cable. For details, please refer to the 7 Pulse Oximeter Management System
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General
2.3
Appearance 1
2
3 4 5 6 7 8
Figure 2-1 Front Panel
Figure 2-2 Back Panel
Table 2-1 Appearance description No.
Description
Remarks
1
Dual-purpose
It connects SpO2 sensor or PC communication cable.
socket 2
LCD
It displays information listed in Table 2-2.
3
Power
It turns on or off the device.
4
Confirm ID
It confirms the patient ID for current measurement.
5
Delete ID
A key combination of 4 and 6.
6
Backlight
It turns on or off the backlight. Caution. Refer to this manual.
7 8
Battery door
Open it to install or remove batteries.
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