Shenzhen mindray PM 50 User manual

PM-50
Pulse Oximeter
Operation Manual

Copyright
© SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Version: 1.0
Issued Date: December 20, 2004
ALL RIGHTS RESERVED.
Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
(hereinafter called Mindray) owns all rights to this published work and
intends to maintain this work as confidential. Mindray may also seek to
maintain this work as an unpublished copyright. This publication is to be
used solely for the purposes of reference, operation, maintenance, or
repair of Mindray equipment. No part of this can be disseminated for
other purposes.
In the event of inadvertent or deliberate publication, Mindray intends to
enforce its rights to this work under copyright laws as a published work.
Those having access to this work may not copy, use, or disclose the
information in this work unless expressly authorized by Mindray.
All information contained in this publication 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, performan-
ce, or use of this material. This publication 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
does not assume any liability arising out of any infringements of patents
or other rights of third parties.
PM-50 Pulse Oximeter Operation Manual（V1.0） I

Content of this manual is subject to change without prior notice.
Trademark
is Mindray’s trademark. Mindray states that other trademarks that
appear in this manual are used only for editorial purpose and to the
benefit of the trademark owner with no intention of improperly using.
Responsibility of the Manufacturer
Mindray is responsible for the safety, reliability, and performance of the
referenced equipment only under the following conditions:
 all installation, expansion, change, modification and repair of
this device are conducted by Mindray qualified personnel;
 applied electrical appliance is in compliance with relevant
National Standards;
 the
device is operated under strict observance of this manual.
Note
 This device is not intended for home use.
 Federal Law (USA) restricts this device to sale by or on the order of
a physician.
Warning
 This device is not intended as a device used for treatment
purposes.
It is important for the hospital or organization that uses this equipment
to carry out a reasonable maintenance schedule. Failure to do so may
result in equipment failure, or injury to the patient or operators.
II PM-50 Pulse Oximeter Operation Manual（V1.0）

Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY
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 conseq-
uential damages or delay resulting from the improper use or application
of the product, or the substitution of parts or accessories not approved
by Mindray, or repairs performed by anyone other than a Mindray
authorized representative.
This warranty shall not apply to any instrument subjected to misuse,
negligence or accidents. Any instrument from which Mindray's original
serial number tag or product identification markings have been altered
or removed, or any product from any other manufacturer.
Safety, Reliability and Performance
Mindray is not responsible for the effects on safety, reliability and perfor-
mance of the product if:
 assembly operations, extensions, re-adjusts, modifications or
repairs are carried out by persons unauthorized by Mindray.
 the product is not used in accordance with the instructions for
use, or the electrical installation of the product, and its location
does not comply with NFPA 70: National Electric Code or
NFPA 99: Standard for Health Care Facilities (Outside the
United States, the relevant installation location must comply
with all electrical installation regulations mandated by the local
and regional bodies of government).
PM-50 Pulse Oximeter Operation Manual（V1.0） III

Return Policy
In the event that it becomes necessary to return a unit to Mindray, follow
the instructions below.
1. Obtain a return authorization.
Contact Mindray to obtain a Customer Service Authorization number.
This number must be marked clearly on the outside of the shipping
container. Return shipments will not be accepted if this 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 equipment is
shipped to Mindray for service (including any relevant customs fees or
other freight related charges).
Company Contact
Address: Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan District
Shenzhen, 518057, P. R. China
Phone: [phone]
Fax: [phone]
Free hot line: [phone]
Warning
It is important for the hospital or organization that uses this equipment
to carry out a reasonable maintenance schedule. Failure to do so may
result in equipment failure, or injury to the patient or operators.
IV PM-50 Pulse Oximeter Operation Manual（V1.0）

Safety Symbols
Warning
A Warning indicates that failure to follow proper instructions can cause
death or injury to the patient, the operator, or serious damage to the
equipment.
Caution
A Caution indicates that failure to follow proper instructions may cause
serious injury to the patient, the operator, or may cause damage to the
equipment.
Note
A Note is an indication of supplemental information to the operation, or
handling, of the equipment, or associated accessories.
This symbol indicates type BF applied part according to IEC 60601-1.
This symbol indicates the dual-purpose socket can connect with the PC
communication cable.
Illustrations
All illustrations in this manual are provided as examples only. They
may not necessarily reflect your setup or data displayed on your PM-50
Pulse Oximeter.
PM-50 Pulse Oximeter Operation Manual（V1.0） V

Contents
Contents
Charpter 1 Safety Information........................................................... 1
Charpter 2 General........................................................................... 3
2.1 Introduction ............................................................................. 3
2.2 Functions ................................................................................ 3
2.3 Appearance............................................................................. 4
2.4 Displayed Information ............................................................. 5
2.5 Button Operation..................................................................... 6
2.5.1 Power Button ................................................................ 6
2.5.2 Backlight Button............................................................ 6
2.5.3 Confirm ID Button ......................................................... 7
2.5.4 Delete ID Button............................................................ 7
Charpter 3 Installation....................................................................... 8
3.1 Unpacking and Inspection....................................................... 8
3.2 Install Batteries........................................................................ 8
3.3 Power-on............................................................................... 10
3.3 Connect SpO
2
Sensor ........................................................... 10
3.4 Connect Computer.................................................................11
Charpter 4 Measurement................................................................ 12
4.1 Measuring Principle............................................................... 12
4.2 Precautions........................................................................... 13
4.3 Measuring Steps ................................................................... 15
4.3.1 Adult Measurement..................................................... 15
4.3.2 Neonatal Measurement............................................... 16
4.3.3 Placing Neonatal SpO
2
Sensor.................................... 16
4.4 Measuring Restrictions.......................................................... 18
Charpter 5 Other Functions............................................................ 20
5.1 Data Management................................................................. 20
5.1.1 Data Storage............................................................... 20
PM-50 Pulse Oximeter Operation Manual（V1.0） I

Contents
5.1.2 Data Adding ................................................................ 21
5.1.3 Data Protection........................................................... 21
5.1.4 Data Deletion.............................................................. 22
5.2 Messages Prompting ............................................................ 23
5.3 Power Management.............................................................. 25
Charpter 6 Maintenance................................................................. 26
6.1 System Check....................................................................... 26
6.2 General Cleaning.................................................................. 27
6.3 Sterilization/Disinfection........................................................ 28
6.4 Disposal ................................................................................ 29
Charpter 7 PM-50 Management System ........................................ 30
7.1 Installation and Uninstall ....................................................... 30
7.1.1 Installation................................................................... 30
7.1.2 Uninstall...................................................................... 31
7.2 Main Interface ....................................................................... 32
7.2.1 Menu Bar .................................................................... 32
7.2.2 Tool Bar....................................................................... 35
7.2.3 Data Area.................................................................... 35
7.3 Functions .............................................................................. 36
7.3.1 Data Output................................................................. 36
7.3.2 Software Upgrade....................................................... 38
7.3.3 File Management ........................................................ 40
7.3.4 Modify Patient Information .......................................... 41
7.3.5 Print Data.................................................................... 42
7.3.6 Prompt Message......................................................... 44
Charpter 8 Accessories .................................................................. 45
Appendix A EC Declaration of Conformance................................ 46
Appendix B Specifications................................................................ 47
Appendix C EMC............................................................................. 50
II PM-50 Pulse Oximeter Operation Manual（V1.0）

Safety Information
Charpter 1 Safety Information
This chapter contains important safety information related to general
use of the PM-50 Pulse Oximeter (hereinafter referred to as the PM-50).
Other important safety information appears throughout the manual in
sections that relate specifically to the precautionary information.
Note
 Important! Before use, carefully read this manual, all safety
information and specifications.
 The PM-50 complies with Class-A requirements of the EN55011
standard.
Warning
 The PM-50 is intended only as an adjunct in patient assessment. It
must be used in conjunction with clinical signs and symptoms.
 The PM-50 is to be operated only by medical doctors or trained
healthcare personnel to measure the SpO
2
of clinical patients
(including adult, pediatric and neonatal patients) in hospitals and
healthcare agencies or in the process of transporting patients.
 The PM-50 is designed for real-time and rapid measurement of the
patient’s SpO
2
. It is not suitable for long-time continuous patient
monitoring. Continual measurement must not exceed 2 hours.
 Before using the PM-50, the user should check and make sure the
device and its accessories can work properly and safely.
 When using the PM-50 together with the electrical surgery
equipment, the user should pay attention to and guarantee safety
of the patient being measured.
PM-50 Pulse Oximeter Operation Manual（V1.0）1

Safety Information
 To avoid fire or explosion hazards, do not use the PM-50 at places
where such flammable material as anaesthesia gas is present.
 Do not pull or lift the PM-50 by its connection cable. That may lead
to device falling and consequent patient injuries.
 It is not recommended to hang the PM-50 when transporting
patients. Safety hazards may arise from the large amplitude swing
during the transportation.
 Do not use the PM-50 or its sensor around working MRI equipment.
Induction current may lead to damages. The device may affect
operation of MRI equipment and vice versa.
 The PM-50 and its accessories may be contaminated by
microorganism during transporting, use and storage. Use the
recommended methods to sterilize and disinfect the PM-50 or its
accessories when the packing material is damaged, or it has not
been used for a long time.
Caution
 The PM-50 should be appropriately placed. Keep it from falling,
strong vibration or other mechanical damage.
 The PM-50 is a commonly sealed device. The user should keep its
surface dry and clean, and prevent any liquid from infiltrating it.
 Don’t use mobile phones around when the PM-50 is in operation.
 The PM-50 should only be maintained by personnel approved by
Mindray.
 Before use the PM-50 on patients, the user should be familiar with
its operation.
2 PM-50 Pulse Oximeter Operation Manual（V1.0）

General
Charpter 2 General
2.1 Introduction
The PM-50 pulse oximeter is a portable measuring device powered by
common or rechargeable batteries. It is compact, light, flexible to use
and easy to learn.
Parameters measured by the PM-50 include: arterial oxygen saturation
(SpO
2
), pulse rate (PR) and pulse strength. The PM-50 measures these
parameters through a SpO
2
sensor and displays them on the LCD
screen after certain further processing.
The PM-50 is operated and controlled by three buttons, which are
Power button, Backlight button and Confirm ID button. The 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.
2.2 Functions
The PM-50 has the following functions:
 Measuring: SpO
2
, 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, date deletion;
 Data Printing: patient information and trend data;
For the data printing function, you must install the PM-50 management
system in a PC equipped with a printer, and connect the PM-50 with the
PC by a communication cable.
PM-50 Pulse Oximeter Operation Manual（V1.0）3

General
2.3 Appearance
Figure 2-1 Front Panel Figure 2-2 Back Panel
Table 2-1 Appearance description
No. Description Remarks
①Dual-purpose
socket
It connects SpO2 sensor or PC communication cable.
②LCD It displays information listed in Table 2-2.
③Power It turns on or off the device.
④Confirm ID It confirms the patient ID for current measurement.
⑤Delete ID A key combination of ④and ⑥.
⑥Backlight It turns on or off the backlight.
⑦Caution. Refer to this manual.
⑧Battery door Open it to install or remove batteries.
③
⑧
⑦
⑥
⑤
④
②
①
4 PM-50 Pulse Oximeter Operation Manual（V1.0）

General
2.4 Displayed Information
Figure 2-3 shows information displayed on the PM-50’s screen.
Figure 2-3 Displayed Information
Table 2-2 Description of displayed information
No. Description Remarks
①ID number It displays current ID number ranging from 000 to 100
②ID Full It appears when ID≥95 and blinks when stored ID is
being covered by new ID.
③Memory Full It appears when previous data is to be covered by
new data. Please refer to 5.1.1 Store data.
④Pulse Strength It can display 7 segments at most to indicate real time
pulse strength.
⑤％SpO
2
It displays “％SpO
2
”.
⑥SpO
2
value It displays SpO
2
value and is refreshed every second.
⑦PR It displays “PR”.
⑧PR value It displays PR value and is refreshed every second.
Unit: bpm (beats/minute)
⑨Low battery It appears only when the battery energy is low.
⑨
⑧
⑦
⑥
⑤
④
③
②
①
Please refer to Chapter 3 Installation for displayed information of
startup and standby modes.
PM-50 Pulse Oximeter Operation Manual（V1.0）5

General
2.5 Button Operation
Three soft buttons are available on the PM-50’s front panel.
Power Backlight Confirm ID
Figure 2-4 Buttons
2.5.1 Power Button
Power-on: Press to turn on the device.
Power-off: Press and hold for two seconds to turn off the device.
Note
 The PM-50 is powered by batteries only. Please install batteries
before use according to the descriptions in 3.2 Install Batteries.
 In case the SpO
2
cable becomes disconnected or the finger moves
away from the sensor, the PM-50 will automatically enter the
standby mode. Under this mode, when a finger is inserted into the
sensor, the PM-50 will automatically resume the operation mode.
Otherwise, if no finger is inserted in 5 minutes, the PM-50 will
automatically shut down.
2.5.2 Backlight Button
Backlight on: Press the Backlight button to turn on backlight.
Backlight off: Press the Backlight button to turn off backlight.
6 PM-50 Pulse Oximeter Operation Manual（V1.0）

General
2.5.3 Confirm ID Button
The Confirm ID button is used to add data. It enables the user to add
data, without using a new ID number, to a re-test for the same patient
after the sensor is accidentally disconnected.
Refer to section 5.1 Data Management for detailed use of this button.
2.5.4 Delete ID Button
The Delete ID button is a key combination of the Backlight button and
the Confirm ID button.
Refer to section 5.1 Data Management for detail use of this button.
PM-50 Pulse Oximeter Operation Manual（V1.0）7

Installation
Charpter 3 Installation
3.1 Unpacking and Inspection
Please carefully remove the PM-50 and its accessories from the
package and check items by comparing them to the packing list.
 Check the device for any mechanical damages.
 Check all cables and accessories for damage.
In case of any problem, please contact Mindray Customer Service.
Note
 Please save all packaging materials for future transportation or
storage use.
Warning
 The user should keep the packing materials at places out of
children’s reach. Before disposing the packing materials, check
with your local waste officials for details in your area for recycling
options or proper disposal.
3.2 Install Batteries
The PM-50 is powered by four batteries. Follow the steps below to
install batteries before use:
1. Hold the PM-50 in one hand.
2. Place the other hand on the battery cover.
3. Push the cover away as Figure 3-1 shows.
4. Place batteries into the slots per the “+” and “-” indications as
8 PM-50 Pulse Oximeter Operation Manual（V1.0）

Installation
shown in Figure 3-2.
5. Push the door back.
Note
 Before disposing of the battery, check with your local solid waste
officials for details in your area for recycling options or proper
disposal.
Caution
 Please use AA alkaline batteries or rechargeable batteries. Do not
use carbon or poor quality batteries. Remove the batteries if the
device is not to be used for a long time.
 During use, replace batteries of insufficient energy in time with
good ones; abnormal power supply may lead to product damages
or even personnel injuries.
Figure 3-1 Install battery 1 Figure 3-2 Install battery 2
PM-50 Pulse Oximeter Operation Manual（V1.0）9

Installation
3.3 Power-on
Press the Power button to turn on the device. The following startup
interfaces will be displayed.
Figure 3-3 Startup interface 1 Figure 3-4 Startup interface 2
Figure 3-3 shows Mindray’s logo. Figure 3-4 shows the product name
and software version. Figure 3-5 is the initialization interface of the
PM-50. After the startup interfaces, the PM-50 will automatically
switch to the standby mode as shown in Figure 3-6.
Figure 3-5 Startup interface 3 Figure 3-6 Standby interface
3.3 Connect SpO
2
Sensor
As the Figure 3-7 shows, you can connect the SpO
2
sensor to the
PM-50 by simply inserting the sensor’s connector to the PM-50’s
dual-purpose socket.
10 PM-50 Pulse Oximeter Operation Manual（V1.0）