Shenzhen mindray PM 50 Specifications

MINDRAY®
PM-50 Pulse Oximeter
OperatiNG Manual
Important: Do not operate the PM-50 Pulse Oximeter
without first reading and understanding this manual!
Save this manual for future use.
Federal Law (USA) restricts this device to sale by or on the order of a physician. This
product should not be used unless the operator has been instructed by a qualified
healthcare professional.
Contents
Preface............................................................................................................................................................ 4
The Purpose of this Manual........................................................................................................4
The Intended Audience of this Manual....................................................................................4
Version Information of this Manual........................................................................................4
Illustrations and Names of this Manual...............................................................................4
Conventions of this Manual........................................................................................................4
1 Safety........................................................................................................................................................ 4
Safety Information.................................................................................................................................4
Dangers.......................................................................................................................................................5
Warnings.....................................................................................................................................................5
Cautions......................................................................................................................................................6
Notes.............................................................................................................................................................6
Equipment Symbols..........................................................................................................................7
CE Marking...........................................................................................................................................7
2 General..................................................................................................................................................... 8
Introduction.............................................................................................................................................8
Contraindications...........................................................................................................................8
Functions....................................................................................................................................................8
PM-50 Appearance....................................................................................................................................9
Table 2-1: Appearance Description, Front and Back Panel.............................................9
Displayed Information........................................................................................................................10
Table 2-2 Description of Displayed Information...............................................................10
Button Operation..................................................................................................................................11
Power Button..................................................................................................................................11
Backlight Button...........................................................................................................................11
Confirm ID Button..........................................................................................................................11
Delete ID Button.............................................................................................................................11
3 Installation........................................................................................................................................... 12
Unpacking and Inspection.................................................................................................................12
Install Batteries...................................................................................................................................12
Power on...................................................................................................................................................13
Connect SpO2 Sensor...........................................................................................................................13
Connect Computer...............................................................................................................................13
4 Measurement........................................................................................................................................ 14
Measuring Principle............................................................................................................................14
Precautions.............................................................................................................................................14
Measuring Steps....................................................................................................................................15
Measurement, Adult or Child....................................................................................................15
Measuring Limitations.........................................................................................................................16
Inaccurate measurements may be caused by:...................................................................16
Loss of pulse signal can occur in the following situations:...................................16
5 Other Functions................................................................................................................................. 17
Data Management .................................................................................................................................17
Data Storage....................................................................................................................................17
Data Adding........................................................................................................................................18
Data Protection..............................................................................................................................18
Data Deletion....................................................................................................................................18
Messages...................................................................................................................................................19
Table 5-1 Messages.........................................................................................................................19
Table 5-2 Error messages...........................................................................................................19
Power Management..............................................................................................................................20
Battery Detection..........................................................................................................................20
Energy Saving...................................................................................................................................20
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6 Maintenance......................................................................................................................................... 21
System Check..........................................................................................................................................21
Cleaning....................................................................................................................................................21
Disinfection......................................................................................................................................22
Disposal.....................................................................................................................................................22
7 Pulse Oximeter Management System......................................................................................... 23
Install and Uninstall..........................................................................................................................23
Install.................................................................................................................................................23
Uninstall............................................................................................................................................24
Main Interface........................................................................................................................................24
Menu Bar.............................................................................................................................................24
Tool Bar..............................................................................................................................................26
Table 7-1 Shortcut Icons.............................................................................................................26
Data Area............................................................................................................................................27
Functions..................................................................................................................................................27
Data Output.......................................................................................................................................27
Software Upgrade.........................................................................................................................28
File Management.............................................................................................................................30
Modify Patient Information........................................................................................................31
Print Data...........................................................................................................................................31
Prompt Message..............................................................................................................................32
Table 7-2 Error prompt messages...........................................................................................32
8 Accessories.......................................................................................................................................... 33
9 Specifications...................................................................................................................................... 34
General specifications.......................................................................................................................34
Basics...................................................................................................................................................34
Safety Designations (per IEC 60601-1 Standard)..................................................................34
Display and Control............................................................................................................................34
Display.................................................................................................................................................34
Buttons...............................................................................................................................................34
Power Saving Features................................................................................................................34
Connector.........................................................................................................................................34
Electrical specifications.................................................................................................................35
Printing.....................................................................................................................................................35
Physical Characteristics.................................................................................................................35
Environment and Safety....................................................................................................................35
Temperature.....................................................................................................................................35
Humidity..............................................................................................................................................35
Altitude...............................................................................................................................................35
Transportation...............................................................................................................................35
Shock...................................................................................................................................................35
10 Limited Warranty................................................................................................................................ 36
11 Index......................................................................................................................................................... 37
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Preface
The Purpose of this Manual
This manual provides the instructions necessary to operate the PM-50 Pulse Oximeter
(hereinafter called the 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.
The Intended Audience of this Manual
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 of this Manual
This manual has a revision number. This revision 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 revision information of this manual is printed at the bottom of every page.
Illustrations and Names of this Manual
All illustrations in this manual are provided as examples only. They may not necessarily
concur with the graph, settings or data displayed on your PM-50.
Conventions of this Manual
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 (See next section 1 SAFETY).
1 Safety
Safety Information
The safety statements presented in this chapter refer to the basic safety information
that the operator of the 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 following, 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.
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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 recommendations or other useful information to ensure that you
get the most from your product.
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.
Warnings
WARNING:Federal Law (USA) restricts this device to sale by or on the order of a
physician.
WARNING:The PM-50 is intended for use by qualified clinical physicians or appropriatelytrained nurses in a hospital setting.
WARNING:The 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.
WARNING:The 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.
WARNING:To ensure patient safety, verify that this device and its accessories can
function safely and normally before use.
WARNING:EXPLOSION HAZARD: Do not use the PM-50 in the presence of flammable
anesthetics, explosive substances, vapors or liquids.
WARNING:Failure to implement a satisfactory maintenance schedule may cause undue
device failure and possible health hazard.
WARNING:When using the PM-50 with electrical surgery equipment, pay attention to and
guarantee safety of the patient being measured.
WARNING:Do not pull or lift the PM-50 by its connection cable. That may lead to falling
and consequent patient injuries.
WARNING:Magnetic and electrical fields are capable of interfering with the proper
performance of the PM-50. For this reason, ensure that all external devices operated in
the vicinity of the PM-50 comply with the relevant EMC requirements. Mobile phones,
X-ray equipment and/or MRI devices are a possible source of interference, as they may
emit high levels of electromagnetic radiation.
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WARNING:The PM-50 and its accessories may be contaminated by microorganisms
during transporting, use, and/or storage. Use the methods recommended in this manual
to sterilize and disinfect the PM-50 and/or its accessories when the packing material is
damaged, or it has not been used for a long time.
Cautions
CAUTION: The device should be appropriately placed. Keep it from falling, strong
vibration or other mechanical damage.
CAUTION: To ensure patient safety, use only parts and accessories specified in this
manual.
CAUTION: The PM-50 is a commonly sealed device. Keep its surface dry and clean, and
prevent any liquid from infiltrating it.
CAUTION:Do not use mobile phones near the PM-50 when it is in operation.
CAUTION: The PM-50 should be maintained only by qualified personnel.
CAUTION: Before using the PM-50 on patients, the user should be familiar with its
operation.
Notes
Note:Important! Before use, carefully read this manual, all safety information and
specifications.
Note:This device is not intended for home use.
Note:This device complies with the requirements of CISPR11 (EN55011) class A.
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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 your Graham-Field Health
Products equipment provider.
* For system products, this label may be attached to the main unit only.
CE Marking
The patient monitor bears the 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.
This product complies with the requirement of standard EN60601-1-2
“Electromagnetic Compatibility - Medical Electrical Equipment”.
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2 General
Introduction
The PM-50 Pulse Oximeter is a noninvasive, spot-check, oxygen saturation and pulse rate
monitor. It operates only on battery power using specified sensors labeled for patients
ranging from infants to adults.
Parameters measured by the PM-50 include:
• Arterial oxygen saturation (SpO2)
• Pulse rate (PR)
• Pulse strength
The PM-50 measures these parameters with an SpO2 sensor and displays them on the
LCD after certain further processing.
The PM-50 is operated and controlled by three buttons: the 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.
Contraindications
None
Functions
The 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
on a PC equipped with a printer, and connect the PM-50 to the PC with a communication
cable. For details, please refer to section 7 Pulse Oximeter Management System.
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PM-50 Appearance
1
2
3
4
5
6
7
8
Figure 2-1
Front Panel
Figure 2-2
Back Panel
Table 2-1: Appearance Description, Front and Back Panel
No.
Description
Remarks
1
Dual-purpose socket
Connects SpO2 sensor or PC communication cable
2
LCD
Displays information listed in Table 2-2
3
Power
Turns the device on or off
4
Confirm ID
Confirms the patient ID for current measurement
5
Delete ID
A key combination of 4 and 6
6
Backlight
Turns on or off the backlight
7
8
Caution - refer to this manual
Battery door
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Open it to install or remove batteries
Displayed Information
The figure below shows information displayed on the PM-50’s LCD.
1
2
3
5
6
4
7
Figure 2-3
Displayed Information
Table 2-2 Description of Displayed Information
No.
Description
Remarks
1
ID number
Displays current ID number ranging from 000 to 100
2
ID Full
Appears when ID≥95 and blinks when stored ID is being covered by new ID
3
Memory Full
Appears when previous data is to be covered by new data. Please refer to 5.1.1
Data Storage
4
Pulse Strength
Can display 7 segments at most to indicate real time pulse strength
5
SpO2 value
Displays SpO2 value and is refreshed every second
6
PR value
Displays PR value and is refreshed every second.
Unit: bpm (beats/minute)
7
Low battery
Appears only when the battery energy is low
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Button Operation
There are three soft buttons, shown below, on the PM-50’s front panel.
Power
Backlight
Confirm ID
Figure 2-4 Buttons
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 as
described in section 3, INSTALLATION, Install Batteries.
Note:If the SpO2 cable becomes disconnected or the finger moves away from the sensor, the
PM-50 will automatically enter standby mode. In this mode, when a finger is inserted
into the sensor, the PM-50 will automatically resume operation mode. Otherwise, if no
finger is inserted in 5 minutes, the PM-50 will automatically turn off.
Backlight Button
• Backlight on: Press the Backlight button to turn on backlight.
• Backlight off: Press the Backlight button to turn off backlight.
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.
Note:Refer to section 5 OTHER FUNCTIONS, Data Management for detailed use of this
button.
Delete ID Button
The Delete ID button is a key combination of the Backlight button and the Confirm ID
button.
Note:Refer to section 5 OTHER FUNCTIONS, Data Management for detailed use of this
button.
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3 Installation
Unpacking and Inspection
Before unpacking, examine the packing case carefully for signs of damage. If you detect
any damage, contact the carrier or our company.
If the packing case is intact, open the package and remove the device and accessories
carefully. Check all materials against the packing list and check for any mechanical damage. Contact our Customer Service Department in case of any problem.
Note:Save the packing case and packaging material for future transport and storage.
WARNING:Be sure to keep the packaging materials from children’s reach.
WARNING:Disposal of the packaging materials in accordance with your local laws.
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 shown in Figure 3-1.
4. Place batteries in the slots per the
+ and - indications as shown in Figure 3-2.
5. Push back the battery cover.
Figure 3-1
Figure 3-2
CAUTION:Dispose of the batteries in accordance with your local laws.
CAUTION: Use AA alkaline batteries or rechargeable batteries. Do not use carbon or
poor quality batteries. Remove the batteries if the device will not be used for a long time.
WARNING:Always use charged batteries; abnormal power supply may lead to product
damage or even personal injury.
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Power on
Press the Power button to turn on the PM-50. The startup interfaces and version information will be displayed; then the initialization interface, as shown in Figure 3-3, will be
displayed. After that, the PM-50 will automatically switch to standby mode as shown in
Figure 3-4.
Figure 3-3
Figure 3-4
Connect SpO2 Sensor
Connect the SpO2 sensor to the PM-50 by inserting the sensor’s connector in the PM-50’s
dual-purpose socket, as shown below.
Figure 3-5
Connect SpO2 sensor
Connect Computer
The PM-50 can be connected to a Personal Computer with a communication cable, to
transmit patient trend to the computer for printing.
Connect one end of the PC communication cable to the PM-50’s dual-purpose socket, and
the other end to the PC’s serial port.
Figure 3-6
Connect Symbol
The PM-50 will display the above symbol, indicating that the PM-50 has connected with
the PC successfully.
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4 Measurement
Measuring Principle
SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated
hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light.
The light generated in the probe passes through the tissue and is converted into electrical signals by the photodetector in the probe. The PM-50 processes the electrical signal
and displays digital values for SpO2 and pulse rate on the LCD. The displayed SpO2 value
is of functional saturation.
The sensor measurement wavelengths are nominally 660nm for the red LED and 940nm
for infrared LED. The maximum optical power output for LED is 4mW.
Precautions
Note:Do not perform SpO2 monitoring and NIBP measurements on the same arm
simultaneously. Obstruction of blood flow during NIBP measurements may adversely
affect the reading of the SpO2 value.
Note:A measurement shall last longer than 15 seconds. Otherwise, new data of next
measurement can’t be added to the same patient.
Note:Do not use the PM-50 for prolonged monitoring.
WARNING:Inspect the sensor cable before monitoring. Do not use the SpO2 sensor if the
package or the sensor is damaged.
WARNING:Do not use the PM-50 to measure patients whose pulse rate is lower than
25bpm, which may cause incorrect results.
WARNING:Remove the SpO2 sensor from the patient immediately after measurement.
WARNING:Route cables carefully to reduce the possibility of patient entanglement or
strangulation. Cables of electrical surgical equipment should not be wound around that of
the SpO2 sensor.
WARNING:Do not put the sensor on extremities with arterial catheter or venous syringe.
WARNING:If no pulse is found or the reading is unreasonable, first check the patient’s
condition, and then check the device and the SpO2 sensor for proper function.
WARNING:Do not reuse disposable SpO2 sensors.
WARNING:Ensure that no obstruction (contamination, scar tissue, acrylic fingernails,
fingernail polish, etc.) exists at the site where the sensor is placed. Otherwise, the
measured result may be incorrect because the signal received by the sensor is affected.
14
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WARNING:When used on different patients, the PM-50 is prone to cross-contamination,
which should be prevented and controlled by the user. Disinfect the SpO2 sensor before
use with other patients.
Measuring Steps
Sensor selection for SpO2 measurement depends on the patient type. For an adult patient, choose a finger SpO2 sensor. Refer to the following procedures for adult and child
measurement.
Measurement, Adult or Child
Follow the steps below to use the adult or child finger SpO2 sensor:
1. Select the appropriate sensor (adult or child) *.
*Note:Use adult sensor for patient weighing > 30 kg (66 lb.).
Use child sensor for child weighing 10 - 50 kg (22 - 110 lb.)
2. Insert the sensor’s connector in the PM-50’s dual-purpose socket.
3. Turn on the PM-50 to enter standby mode.
4. Attach the sensor to an appropriate site on the patient.
Figure 4-1 Placing the adult SpO2 Sensor
5. The readings will be displayed on the PM-50’s LCD a moment later.
Note:Place the SpO2 sensor cable at the backside of the patient hand. Ensure that the
fingernail is just opposite to the light emitted from the sensor.
Note:To acquire accurate results, please read data until the sensor is steadily placed.
Note:Readings may not be accurate when either the sensor or the patient is moving.
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15
Measuring Limitations
If the accuracy of any measurement does not seem reasonable, first check the patient’s
vital signs using an alternate method, then check the device for proper function.
Inaccurate measurements may be caused by:
• Incorrect sensor application or use.
• Significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or methemoglobin).
• Intravascular dyes such as indocyanine green or methylene blue.
• Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct
sunlight (exposure to excessive illumination can be corrected by covering the sensor
with a dark material).
• Excessive patient motion.
• Venous pulsations.
• Placement of a sensor on the same extremity with a blood pressure cuff, arterial catheter, or intravascular line.
• Acrylic fingernails and/or dark fingernail polish.
Loss of pulse signal can occur in the following situations:
• The sensor is too tight.
• There is excessive illumination from light sources such as a surgical lamp, a bilirubin
lamp, or sunlight.
• A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor
attached.
• The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
• There is arterial occlusion proximal to the sensor.
• The patient is in cardiac arrest or shock.
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5 Other Functions
Data Management
Data Storage
The PM-50 oximeter has internal memory to store data. The memory is divided into the
ID Data Zone and the Trend Data Zone.
The ID Data Zone is capable of storing 100 patients’ ID data (ID, as shown below) at
most. When the number exceeds 100, new data will automatically overwrite the oldest
data.
ID001 data
ID002 data
ID003 data
……
ID100 data
One ID data includes:
• Number of the SpO2 and pulse rate values stored to this ID.
• Maximum SpO2 value of this ID.
• Minimum SpO2 value of this ID.
• Average SpO2 value of this ID.
• Maximum PR value of this ID.
• Minimum PR value of this ID.
• Average PR value of this ID.
The Trend Data Zone is capable of storing 200 trend data (TD, as shown below) at most.
When the number exceeds 200, new data will automatically overwrite the oldest data.
TD 001
TD 002
TD 003
……
TD 200
The first trend data will be stored 15 seconds after the pulse is found. Thereafter one
trend data will be stored every 2 minutes. One trend data includes:
• Average SpO2 value within the 2 minutes.
• Average PR value within the 2 minutes.
Note:The first trend data are the instant values of SpO2 and PR.
Note:A patient’s ID data are calculated from all measured trend data of that patient.
Note:Once the trend data of a patient is covered, all trend data of that patient will be
deleted; however, the ID data will not be deleted.
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Data Adding
The previously stored ID number appears on the LCD when a finger is inserted into the
SpO2 sensor. It will keep blinking for 8 seconds after the pulse is found.
• Press the Confirm ID button before the ID number stops blinking; the PM-50 will set
the ID number as current patient ID. The data measured thereafter will be superadded to the previous ID.
• If the user doesn’t press the Confirm ID button before the ID number stops blinking, a
new ID number, which is the blinking number plus 1, will be set as the current patient
ID.
The Confirm ID button is of no use when the current ID number is 000, which will automatically change to 001 when the pulse is found.
Data Protection
The PM-50 has data protection function. When the power is turned off accidentally during the process of storing a data, the PM-50 will evaluate completeness of the last stored
data when it is turned back on. If the data is complete, it will be validated; otherwise it
will be invalidated.
Data Deletion
Press the Delete ID button in standby mode; the message DELETE ALL? will be displayed
as shown in Figure 5 1.
Figure 5-1
Figure 5-2
• To delete all stored data: Press the Delete ID button again. As shown in Figure
5-2, the message ALL DELETED will be displayed for 2 seconds. The PM-50 will
then switch back to standby mode, the ID number will restore to 000, and the
Memory Full and ID Full symbols will disappear.
• To not delete all stored data: Do not press the Delete ID button; wait for 10 seconds.
The DELETE ALL? message will disappear automatically and the previous operation
will be cancelled. The PM-50 will then switch back to the previous mode.
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Messages
The PM-50 can display various messages. Table 5-1 lists messages with their causes and
solutions.
Table 5-1 Messages
Message
Cause
Solution
Low Battery
Battery energy lower than 4.0 Voltage
Replace batteries in time
Memory Full
The internal memory is almost full
Stored data is to be covered. Export
data in time.
Blinking “Memory
Full”
Memory is full
Stored data is being covered. Export
data in time.
ID Full
ID number Stored is greater than 95.
ID data is to be covered. Export data
in time.
Blinking “ID Full”
ID data is being covered.
Export data in time.
Standby
The device is in standby mode.
None.
Communication
The device is in communication mode.
None.
DELETE ALL?
The Delete ID button is pressed.
Refer to previous Data Deletion
ALL DELETED
The Delete ID button is pressed again
after “DELETE ALL?” appears.
None.
The PM-50 can also display technical error messages. Table 5-2 lists error messages with
their causes and solutions.
If the LCD can’t display anything, it may be damaged, or error occurs during system selftest. Please turn off the device (if you can’t turn it off, remove the batteries) and contact
our Customer Service.
Table 5-2 Error messages
Error Message
Cause
Solution
Initiate Error
Failed self-test
Turn off the device (if can’t, remove the batteries) and
contact us for service.
Please Release the
Button
Button error
Check for jammed button. If problem remains, contact us for
service.
Pulse Not Found
Searching…
Pulse not found
Check the patient and alert the doctor.
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Power Management
Battery Detection
The PM-50 can detect the battery energy and
• display Low Battery message when battery voltage is less than 4.0 V.
• turn off the device automatically when battery voltage is less than 3.85V.
Energy Saving
The PM-50 can save battery energy by
• switching to standby mode automatically when the finger disconnects from the sensor or the sensor disconnects from the PM-50.
• turning off automatically if no finger is inserted into the sensor within 5 minutes in
standby mode.
Note:The PM-50 will automatically switch from standby mode to operation mode when a
finger is inserted into the sensor.
Note:If your PM-50 has been provided with PMS software, refer to section
7 Pulse Oximeter Management System for more functions.
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6 Maintenance
System Check
To ensure the safe operation of the PM-50, ensure that your qualified service personnel
have performed a complete inspection before operating the PM-50, after service or system upgrade, or after the PM-50 has been used for six consecutive months.
Before using the PM-50, perform the following steps.
1. Check the PM-50 for mechanical damage.
2. Check all cables and accessories for damage.
3. Check all functions of the PM-50 to ensure that it is in proper operating condition.
In case of any damage or exception, do not use the PM-50. Contact your hospital technician or our Customer Service immediately.
WARNING:Failure on the part of the responsible hospital or institution using the PM-50
to implement a satisfactory maintenance schedule may cause device failure and health
hazard.
WARNING:The safety inspection or maintenance, which requires opening the monitor
housing, must be performed by trained, authorized personnel only. Otherwise, device
failure and health hazard may occur.
Cleaning
Clean the PM-50 regularly. If there is pollution, dust or sand in your environment, the
PM-50 should be cleaned more frequently. Before cleaning the PM-50, consult your hospital’s regulations.
Cleaning agents:
• Mild soap and water
• Quaternary ammonia
• Water/bleach solution (100:1)
• 3 vol% Hydrogen peroxide in water solution
• 70 vol% isopropyl or ethyl alcohol
1. Power off the oximeter.
2. Wipe the surface and LCD lens with a cotton swab moistened with a cleaning agent.
3. Wipe the oximeter case with a soft cloth dampened with a cleaning agent.
CAUTION:Do not allow liquid to enter the sensor connector.
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To avoid damage to the device, follow these rules:
CAUTION: ALWAYS dilute the agents according to the manufacturer’s suggestions.
CAUTION: ALWAYS wipe off excessive cleaning agent with a dry cloth after cleaning.
CAUTION: NEVER submerge the device in water or any cleaning agent, or pour or spray
water or any cleaning agent on the device.
CAUTION: NEVER permit fluids to run into the casing, switches, connectors, or any
ventilation openings in the device.
CAUTION: NEVER use abrasive, erosive cleaners, or cleaners containing acetone.
CAUTION: Failure to follow these rules may erode and/or fray the casing, blur lettering
on the labels, and/or cause device failure.
For cleaning information of accessories, please refer to the accessory instructions.
Disinfection
CAUTION:Disinfection may cause damage to the device.
We recommend the disinfection be performed only when necessary. The device should
be cleaned prior to disinfection.
Recommended disinfection material: Alcohol based (Ethanol 70%, Isopropanol 70%), and
aldehyde based.
WARNING:Never use ethylene oxide and formaldehyde to disinfect.
WARNING:The cleaning agents above can only be used for general cleaning. If you use
them to control infections, we shall assume no responsibility for the effectiveness.
CAUTION:Do not autoclave, pressure sterilize, or gas sterilize the oximeter.
CAUTION:Disinfection may cause damage to the device; therefore, when preparing to
disinfect the device, consult your hospital’s infection controllers or professionals.
Disposal
To avoid contaminating or infecting personnel, the environment, or other equipment,
ensure that you disinfect or decontaminate the device appropriately before disposing
of it in accordance with federal and local law for equipment containing electrical and
electronic parts. When disposing of the SpO2 sensor, follow local regulations regarding
disposal of hospital waste.
22
JB7401-INS-LABRevA07
7 Pulse Oximeter Management System
The optional Pulse Oximeter Management System software (PMS software) was developed to achieve more functions with the PM-50. The PMS software runs in (English)
Windows 98/2000/XP operating system. In conjunction with the internal software of the
PM-50, the following functions can be achieved.
• Outputting data and upgrading internal software
• Previewing exported data
• Adding patient information
• Printing patient data
Install and Uninstall
Before you use PMS software, you must first install it on your PC. The following Install
and Uninstall sections are provided as examples for Windows 2000 operating system.
Install
To install the PMS software:
1. Insert the installation CD into the CD-ROM.
2. Run the file Setup.exe in the installation CD (symbol shown below).
Figure 7-1
3. Choose your favorite language according to the prompt. Click OK, and then click
Next in the next dialog box.
4. Input the correct serial number, and click Next to resume.
5. Select the serial port to connect the PM-50 Pulse Oximeter with your PC, and click
Next to resume.
6. Choose the destination folder where the PMS software is to be installed.
7. Click Next and Finish according to the prompt.
8. After the installation is complete, a new shortcut icon will appear in the desktop of
your computer as shown below.
Figure 7-2
9. Double click the icon to run the PMS software.
JB7401-INS-LABRevA07
23
Uninstall
To uninstall the PMS software:
1. Click Start-Setting-Control Panel, and double click the Add/Remove Programs icon
to open the Add/Remove Programs dialog box.
2. Select Pulse Oximeter Management System, and click Change/Remove. Then follow
the prompt to uninstall the PMS software.
Note:The preceding steps are provided as examples only. Yours may be slightly different,
depending on your operating system.
Main Interface
Double click the shortcut icon for PMS software on the desktop of your computer; the
PMS software Main Interface will be displayed as shown below.
1
2
3
3
Figure 7-3
1 Menu Bar 2 Tool Bar 3 Data Area
Menu Bar
Four menus are available In the Menu Bar: File, Setup, Operation, and Help. Descriptions follow.
File: Click the File menu to see its pull-down menu as shown below.
Figure 7-4 File Menu
24
JB7401-INS-LABRevA07
The File menu has five submenus:
• File Management: Click to open the File Management dialog box.
• Print: Click to print the current patient data.
• Print Preview: Click to preview the data to be printed.
• Print Setting: Click to open the Print Setting dialog box.
• Exit: Click to exit the PMS software.
Setup: Click the Setup menu to see its pull-down menu as shown below.
Figure 7-5 Setup Menu
The Setup menu has two submenus:
• Patient Information: Click to open the Modify Patient Information dialog box.
• Serial Port Selection: Click to open the Serial Port Selection dialog box.
When you use the Data Output or Software Upgrade function, the default serial port
may be occupied. At this time, you can click the Serial Port Selection menu, shown below, to select another serial port.
Figure 7-6
Operation: Click the Operation menu to see its pull-down menu, shown below.
Figure 7-7
The Operation menu has two submenus:
• Data Output: Click to conduct the Data Output function.
• Software Upgrade: Click to open the Input Password dialog box.
JB7401-INS-LABRevA07
25
Help: Click the Help menu to see its pull-down menu, shown below.
Figure 7-8 Help Menu
The Help menu has two submenus:
• Help: Click to open the Help document.
• About PMS: Click to show the copyright information.
Note:When you open the Help document, if a dialog box pops up and tells you to install
language pack, select Never install any language packs, and then click Cancel.
Tool Bar
In the tool bar you can see the following shortcut icons, explained below.
Figure 7-9 Shortcut Icons
Table 7-1 Shortcut Icons
Icon
26
Icon Name
Description
File Management
Shortcut to File Management submenu
Print
Shortcut to Print submenu
Print Preview
Shortcut to Print Preview submenu
Serial Port Selection
Shortcut to Serial Port Selection submenu
Patient Information
Shortcut to Patient Information submenu
Data Output
Shortcut to Data Output submenu
Help
Shortcut to Help submenu
JB7401-INS-LABRevA07
Data Area
The Data Area displays the data of the current ID. The left part of the Data Area is the
Information Area, and the right part is the Patient Data Area.
• Information Area: It displays the patient Name, Sex, Age, and Doctor etc.
• Patient Data Area: It displays the value of measured SpO2, PR, the corresponding
Check Record and Save Time of each measurement.
The content in the Information Area can’t be directly input to or changed. Select Patient
Information under the Setup menu, or click the shortcut icon.
Note:Data displayed as “---” is invalid.
Note:The “(ADD)” appearing beside the check record number is to indicate that the data
thereafter are additional ones to this ID.
Functions
Before performing the following functions, you must first connect the PM-50 to your
PC (Refer to section 3 INSTALLATION, Connect Computer), and then double click the
shortcut icon on the desktop to run the PMS software.
Data Output
PMS software can output the data stored in the PM-50 to your PC.
1. Select Data Output under the Operation menu to start data output as shown below.
During data output, you can click Exit to cancel the operation.
Figure 7-10
2. When data output is complete, the following dialog box will pop up.
Figure 7-11
JB7401-INS-LABRevA07
27
3. You can choose the file directory where the data is to be stored, and change the file
name.
• The default file directory is the Files folder under the directory where the PMS
software is installed.
• The default file name is “PMS********.srd”, where the “********” represents the
current system time. For example, “11091133“ means November 9th, 11 o’clock
and 33 minutes. The hour is 24-hour format.
4. Click Save to save the data. Meanwhile, information and data output from the PM-50
will be displayed in the Data Area.
5. If an error occurs during output, the following prompt will pop up.
Figure 7-12
If this occurs, ensure that the serial port is correctly connected, and select another serial port by clicking the Serial Port Selection menu.
Software Upgrade
You can use the PMS software to upgrade the PM-50 internal software.
1. Click Software Upgrade under the Operation menu; the Input Password dialog box
will pop up as shown below.
Figure 7-13
2. Input the correct password, and then click OK. The Software Upgrade dialog box will
pop up as shown below.
Figure 7-14
28
JB7401-INS-LABRevA07
3. Select the serial port and click Browse to display the dialog box as shown below.
Figure 7-15
4. Select the Upgrade File and click Open. The version of the Upgrade File will be displayed in Figure 7-14.
5. Click Upgrade; the system will check the validity and verify the version of the Upgrade File. If the Upgrade File is valid, and the current version loaded on the PM-50
Pulse Oximeter is lower than the Upgrade file, the following message will be displayed.
Figure 7-16
6. Click Yes; the system will automatically begin to upgrade the software. If you click
Cancel while the upgrade is in process, the software in the PM-50 will be damaged;
you will need to upgrade the software again.
Figure 7-17
• If the Upgrade File version is the same or lower as that installed on the PM-50, a corresponding different message will be displayed in Figure 7-16. Click Yes to continue to
upgrade, and Cancel to cancel upgrading.
JB7401-INS-LABRevA07
29
• If the Upgrade File is invalid, the following message will be displayed.
Figure 7-18
7. Click OK to finish the upgrade.
Figure 7-19
File Management
The File Management function helps you to easily open or delete the outputted data.
1. Click File Management in the File menu; the File Management dialog box will pop up
as shown below.
Figure 7-20
2. You can choose the folder where the outputted data is saved in the File List. The files
contained in that folder will be displayed in the right column.
3. To open a file, choose a file name and click Open; the data contained in the file will
then be displayed in the Data Area of the Main Interface.
4. To delete a file, choose a file name and click Delete. The data of all patients contained
in this file will be deleted. You cannot delete the data of just one patient ID contained
in the file.
30
JB7401-INS-LABRevA07
Modify Patient Information
1. Click Patient Information in the Setup menu; the Modify Patient Information dialog
box will pop up.
Figure 7-21
2. You can input the following information:
•
•
•
•
Name: 30 characters maximum.
Sex: Male or Female.
Age: The patient’s age.
Measure Start Time: The displayed format of the time is dependent on the setting
of the PC’s system. For example, 2004/9/12/15:30, here the hour is 24-hour format.
• Bed Number: Range from 1 to 65535.
• Patient Number: 12 characters (English Character or number) maximum.
• Doctor: Name of the doctor, 30 characters at maximum.
3. Click OK; the dialog box will disappear, and the information inputted will be displayed in the Information Area.
4. Click Cancel; the dialog box will disappear, and no information listed above will be
modified.
Print Data
1. Click Print Setting in the File menu to display the dialog box as shown below. You
can set the print range of the patient ID.
Figure 7-22
2. Click OK and set the properties according to the printer your PC installed in the popup dialog box.
3. Click OK to start printing the selected ID data.
JB7401-INS-LABRevA07
31
4. Before printing, you can select Print Preview in the File menu to preview the content
to be printed, as shown below.
Figure 7-23
5. You can also click Print in the File menu, and click OK in the pop-up dialog box to
start printing.
Prompt Message
Table 7-2 Error prompt messages
Error Message
Cause
Solution
Communication Error,
Communication
Interrupt
The connection between
the PM-50 and the PC is
interrupted
Restart the PM-50 and check the connection
between the PM-50 and the PC
Upgrade File Error
The upgrade file is invalid
Ensure that the right upgrade file is selected and
conduct the upgrade again
Password Error
The input password is
incorrect
Input the correct password or exit the upgrade
operation
Serial Port Error
Another program is using
the selected serial port
Choose another serial port or close the program
that is using the selected serial port
Age Input Error
The input age is outside the
range: 1∼255
Input the age again
Bed Number Input Error
The input Bed Number is
outside the range: 1∼65535
Input the Bed Number again
Measure Start Time and
Output Time are Out of
Conformity
The input Measure Start
Input the Measure Start Time again
Time plus the total measured
time is later than the Output
Time
File not Found
The input file name is not
available under the current
directory
Select file again
ID Range Error
The input ID range is wrong
Input the ID Range again
32
JB7401-INS-LABRevA07
8 Accessories
Graham-Field recommends the following Sp02 sensors for use with the PM-50 Pulse Oximeter.
CAUTION: Using other accessories than those listed below may cause damage to the
device.
Description
Part Number
Pulse Oximeter Management System (Includes PMS
Software CD and Communication Cable); Requires PC
Running Windows 98/2000/XP
JB7401-01
Reusable 518A multi-functional SpO2 Sensor
JB7401-02
Reusable 512D Finger SpO2 Sensor
JB7401-03
Single-Patient Adult SpO2 sensor *
JB7401-04
Single-Patient Child SpO2 sensor *
JB7401-05
Single-Patient Infant SpO2 sensor *
JB7401-06
* Note: Adult > 30 kg (66 lb.)
Child = 10 - 50 kg (22 - 110 lb.)
Infant = 3 - 20 kg (6.6 - 44 lb.)
JB7401-INS-LABRevA07
33
9 Specifications
Note:In addition to the following specifications, a document containing additional technical
specifications, including Parameter Specifications and EMC Specifications, is
also available; if you require further information, please call 800-347-5678 and speak
with Graham-Field Health Products’ Quality Department to request said document.
General specifications
Basics
Product Model: PM-50
Product Name:
Pulse Oximeter
Classification:
IIb (According to MDD 93/42EEC directive) II (21CFR 870.2700, 870.2710)
Safety Designations (per IEC 60601-1 Standard)
Type of protection against electric shock:
Internally powered equipment.
Degree of protection against electric shock: Type BF
Mode of operation:
Continuous
Protection Against Ingress of Liquids:
Not protected (Ordinary) - IPX0 per IEC60529
Display and Control
Display
Display Type:
Matrix LCD
Display Area:
Not less than 42mm×35mm (1.65 x 1.38 in.)
Back Light:
Blue
Display Information:
SpO2, PR, Pulse strength, ID number, Memory Full, ID Full, Low battery,
Standby, Communication, Technical error
Buttons
Power Button:
Switches the oximeter on/off. The power-on is not delayed and the
power-off has a 2 second delay
Backlight button:
Switches the backlight on/off
ID Confirm button:
Confirms whether to use the previous ID for the new measurement
Backlight button + ID
Confirm button
Deletes data
Power Saving Features
Refer to section 5 OTHER FUNCTIONS, Power Management.
Connector
One dual-purpose socket for connecting SpO2 sensor and communication cable.
34
JB7401-INS-LABRevA07
Electrical specifications
Working Voltage:
4.0 to 6.4 VDC
Power Supply:
Batteries
Battery Specifications:
Four Common 1.5V AA alkaline or rechargeable batteries
Shutdown Leakage Current: < 200uA
Battery Run Time:
15-hour continuous operation with alkaline batteries
Power Consumption
720mW
Printing
Printer:
The PC’s printer
Paper:
A4
Content:
ID data and trend data
Physical Characteristics
Maximum Size:
W×H×D: 65 × 140 × 32mm (2.56 x 5.51 x 1.26 in.)
Maximum Weight:
Not including battery and sensor: 130g (.29 lb.)
Environment and Safety
Temperature
Operation:
0°C to 50°C (32°F to 122°F)
Transportation and storage: -20°C to 60°C (-4°F to 140°F)
Humidity
Operation:
15% to 95% (noncondensing)
Transportation and storage: 10% to 95% (noncondensing)
Altitude
Operation:
-500 to 4,600 m (-1,600 to 15,000 feet)
Transportation and storage: -500 to 13,100 m (-1,600 to 43,000 feet)
Transportation
Meets the 1A requirements of the ISTA transportation test procedure.
Shock
Meets all the specifications after being exposed a half sinusoidal pulse that is 15g and
11ms, as required by IEC 68-2-27.
JB7401-INS-LABRevA07
35
10 Limited Warranty
GF Health Products, Inc. warrants the Mindray PM-50 Pulse Oximeter against manufacturing defects in materials and workmanship as listed below:
PM-50 Pulse Oximeter: three (3) years
PM-50 Accessories:
six (6) months
If within the warranty period, the product or component part is proven to GF Health
Products, Inc.'s satisfaction to be defective, GF Health Products, Inc. shall provide, at its
option, one of the following: (1) repair or replacement of any defective or nonconforming part or product or (2) a credit and/or refund of the original selling price. GF HEALTH
PRODUCTS, INC.'S SOLE OBLIGATION AND YOUR EXCLUSIVE REMEDY UNDER THIS WARRANTY SHALL BE LIMITED TO SUCH REPAIR, REPLACEMENT, CREDIT AND/OR REFUND.
LIMITATIONS AND EXCLUSIONS: The foregoing warranty shall not apply to serial numbered products if the serial number has been removed or defaced. Products subjected to
negligence, abuse, misuse, improper operation, improper maintenance, improper cleaning, improper storage, or damages beyond GF Health Products, Inc.'s control are not covered by this warranty, and that evaluation shall be solely determined by GF Health Products, Inc. This warranty shall not apply to problems arising from normal wear and tear
or failure to follow instructions. The warranty shall also not apply to products modified
without GF Health Products, Inc.'s express written consent; nor shall it apply if parts not
complying with original equipment specifications are added to GF Health Products, Inc.
products, or if the product or part is serviced by an entity not authorized by GF Health
Products, Inc.
THE FOREGOING WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER
EXPRESS WARRANTIES AND IMPLIED WARRANTIES, INCLUDING BUT NOT
LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND SHALL NOT EXTEND BEYOND
THE DURATION OF THE EXPRESS WARRANTY PROVIDED HEREIN, AND
THE REMEDY FOR VIOLATIONS OF ANY IMPLIED WARRANTY SHALL BE
LIMITED TO THE REPAIR, REPLACEMENT, CREDIT AND/OR REFUND OF THE
DEFECTIVE PRODUCT OR PART PURSUANT TO THE TERMS CONTAINED
HEREIN. GF HEALTH PRODUCTS, INC. SHALL NOT BE LIABLE FOR ANY
CONSEQUENTIAL OR INCIDENTAL DAMAGES WHATSOEVER.
This warranty gives you specific legal rights and you may also have other legal rights
which vary from state to state. Some states do not allow the exclusion or limitation of
incidental or consequential damage, or limitation on how long an implied warranty lasts,
so the above exclusion and limitations may not apply to you.
36
JB7401-INS-LABRevA07
11 Index
A
Accessories 33
Appearance 9
B
Backlight button 11
Batteries, install 12
Battery detection 20
Button operation 11
C
CAUTION statement, significance 5
Cleaning 21
Computer, connect 13
Contraindications 8
Conventions of this manual 4
D
DANGER statement, significance 4
Data adding 18
Data area 27
Data management 17
Data output 27
Data protection 18
Data storage 17
Disinfection 22
Disposal 22
E
Energy saving 20
Equipment symbols 7
F
File management 30
Functions 8, 27
G
General 8
I
Illustrations in this manual 4
Inaccurate measurements, possible causes 16
Inspection 12
Intended audience of this manual 4
Introduction 8
P
Patient information, modify 31
Power management 20
Print data 31
Prompt message 32
Pulse oximeter management system 23
S
Safety information 4
Sensor measurement wavelengths 14
Software, install 12, 23
Software, uninstall 23
Software upgrade 28
Specifications, additional 34
Specifications, basics 34
Specifications, buttons 34
Specifications, connector 34
Specifications, control 34
Specifications, electrical 35
Specifications, environment and safety 35
Specifications, general 34
Specifications, physical characteristics 35
Specifications, printing 35
SpO2 monitoring 14
SpO2 sensor, connect 13
SpO2 sensor, placement, adult or child 15
System check 21
T
Trend data zone 17
U
Unpacking 12
V
Version information for this manual 4
W
WARNING statement, significance 4
Warranty, limited 36
M
Main interface 24
Maintenance 21
Measurement 14
Measurement, adult or child 15
Measuring principle 14
Menu bar 24
Messages prompting 19
N
Names in this manual 4
Note, significance 5
O
Other functions 17
JB7401-INS-LABRevA07
37
Notes
38
JB7401-INS-LABRevA07
Notes
JB7401-INS-LABRevA07
39
USA, Corporate Headquarters:
Graham-Field Health Products
2935 Northeast Parkway
Atlanta, Georgia 30360
telephone: 800-347-5678, 770-447-1609
fax: 800-726-0601, 678-291-3232
www.grahamfield.com
JB7401-INS-LABRevA07
© GF Health Products, Inc., July 2007
Mindray is a registered trademark of
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
GF and Graham-Field are
registered trademarks of GF Health Products, Inc.
GF Health Products, Inc. is not responsible for typographical errors.
Packaging, warranties and products are subject to change without notice.