Contec Medical Systems Co. PM50 User manual

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Contents
Chapter1 Introduction ................................................................................................................... 1
1.1 General Information ........................................................................................................ 3
1.2 Main Parameters ............................................................................................................. 6
1.3 Button Functions ............................................................................................................. 7
1.4 Interfaces......................................................................................................................... 9
1.5 Accessories ................................................................................................................... 11
Chapter2 Getting Started ............................................................................................................ 12
2.1 Open the Package and Check ........................................................................................ 12
2.2 Dry Battery Installation ................................................................................................. 12
2.3 Power on the Monitor ................................................................................................... 12
2.4 Connect Oximeter Probe ............................................................................................... 13
2.5 Connect NIBP Cuff ....................................................................................................... 14
Chapter3 Function Interface ....................................................................................................... 16
3.1 Main Interface ............................................................................................................... 16
3.2 SYSTEM MENU .......................................................................................................... 17
3.2.1 System Setup ...................................................................................................... 18
3.2.2 BP SETUP.......................................................................................................... 20
3.2.3 SpO
2
SETUP ...................................................................................................... 22
3.2.4 Patient Information ............................................................................................. 23
3.2.5 BP TABLE ......................................................................................................... 23

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3.2.6 SpO
2
TABLE ...................................................................................................... 24
3.2.7 TREND .............................................................................................................. 25
Chapter4 SpO
2
Monitoring ......................................................................................................... 30
4.1 What is the SpO
2
Monitoring ........................................................................................ 30
4.2 Precautions during SpO
2
/Pulse Monitoring ................................................................... 31
4.3 Monitoring Procedure ................................................................................................... 32
4.4 Maintenance and Cleaning ............................................................................................ 33
Chapter5 NIBP Monitoring ......................................................................................................... 34
5.1 Introduction ................................................................................................................... 34
5.2 NIBP Monitoring .......................................................................................................... 35
5.3 NIBP Message and Explanations .................................................................................. 38
5.4 Maintenance and Cleaning ............................................................................................ 39
5.5 Transportation and Storage............................................................................................ 41
5.6 Key of Symbols............................................................................................................. 42
Chapter6 Installation of the software .......................................................................................... 44
6.1 Demand of Editor .......................................................................................................... 44
6.2 Installation of Software ................................................................................................. 44
Chapter7 Introduce the Software ................................................................................................ 45
7.1 User Register................................................................................................................. 45
7.2 The Main Interface ........................................................................................................ 46
7.3 Wear .............................................................................................................................. 48

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7.4 Design the Measurement Plan ....................................................................................... 48
7.5 Data Download ............................................................................................................. 52
7.6 Choose Patient Data to Edit .......................................................................................... 53
7.7 Delete Data File ............................................................................................................ 54
7.8 Data File Backup........................................................................................................... 55
7.9 Edit Blood Pressure Data .............................................................................................. 57
7.10 Trend Edit ................................................................................................................... 59
7.11 Display the Statistics Information ............................................................................... 65
7.12 Edit of Diagnose Information. ..................................................................................... 66
7.13 Sleep Period Change ................................................................................................... 67
7.14 BP Thresholds ............................................................................................................. 68
7.15 Histogram ................................................................................................................... 69
7.16 Pie Chart ..................................................................................................................... 70
7.17 Correlation Line .......................................................................................................... 71
7.18 Print Report ................................................................................................................. 72
7.19 Help ............................................................................................................................ 74
Chapter8 Troubleshooting Guide ................................................................................................ 75
Appendix .................................................................................................................................... 76

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Chapter1 Introduction
 For an overall introduction to the monitor, please refer to General Information.
 For basic operating instructions, please refer to Button Function.
 For allocation of interface sockets, please refer to Interfaces.
Warning
Possible explosion hazard if used in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or nitrous
oxide.
Warning
You must verify if the device and accessories can function safely and normally before use.
Warning
Ensure that the environment in which the device is operated is not subject to any sources of
strong electromagnetic interference, such as radio transmitters, mobile telephones, etc.
Keep them far away high level electromagnetic radiation emitted from such devices may
greatly affect the monitor performance.
Warning
The disposal of scrap instrument and its accessories and packing (including battery, plastic
bags, foams and paper boxes) should follow the local laws and regulations.
Warning
Please choose the accessories and oxygen probe which are manufactured by the
manufacturer, or else it may damage the device.
Warning

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Dispose of the packaging material, observing the applicable waste control regulations and
keeping it out of children’s reach.
Warning
The monitor is only use on one patient in same times.
Warning
When the monitor is wetted, please stop using it and contact us.
Warning
A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a
pulse oximeter monitor.
Warning
If Luer lock connectors are used in the construction of tubing, there is a possibility that
they might be inadvertently connected to intravascular fluid systems, allowing air to be
pumped into a blood vessel.
Warning
When used with Electro-surgery equipment, you must give top priority to the patient
safety.
Warning
It is recommended that you check if there is any damage on the monitor or the accessories
regularly, if you find any damage, stop using it, and contact the biomedical engineer of the
hospital or our Customer Service immediately.
In addition, the overall check of monitor, including the safety check such as the leakage
current, should be only performed by qualified personnel once every 12 months.

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Warning
Please choose the computer which should be ensured compliance with the requirements of
IEC60950, or else it may damage the device.
Warning
The software was developed per IEC60601-1-4. The possibility of hazards arising from
errors in the software program is minimized.
Warning
The Patient Monitor shall comply with the standard EN1060 series: Part 1: General
requirements; Part 3: Supplementary requirements for electro-mechanical blood pressure
measuring systems (in course of preparation).
Warning
At the end of its service life, the product described in this manual, as well as its accessories,
must be disposed of in compliance with the guidelines regulation the disposal of such
products. If you have questions concerning disposal of the product, please contact us or its
representatives.
Note
In the United States and the European Union, the monitor is only applicable for adult, the
cuff and oxygen probe for pediatrics and neonate can not be used.
1.1 General Information
Environment:
Temperature

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Working 5~40 °C
Transport and Storage -20~60 °C
Humidity
Working ≤ 80 %
Transport and Storage ≤ 95 %
Altitude
Working -500 to 4,600m (-1,600 to 15,000ft)
Transport and Storage -500 to 13,100m (-1,600 to 43,000ft)
Power Supply
3 (V) DC
Pmax ≤ 3 VA
Safety
This device is defibrillator protected. Note that no precautions specific to the device
are required during defibrillation, and defibrillation discharge has no effect on the monitor. The
equipment uses the gray silicone airway, in case of the effect to the equipment when
defibrillation device was used on the patient.
General instruction:
The monitors not only measure the ambulatory blood pressure, but also monitor the parameters

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of NIBP, Pulse Rate and SpO
2
. it is applicable for adult, pediatric, and neonatal. It integrates
parameter measuring modules function and display function in one device, featuring in
compactness, lightweight.
The POWER switch is on the front panel. The RUN indicator and the ALARM indicator flash
one time when the device is powered on. The ALARM indicator flashes when alarm occurs. The
sockets of the sensors are at the top. USB is at the bottom of monitor.
This monitor is a user-friendly device with operations conducted by a few buttons on the front
panel. Refer to Button Functions for details.
Measuring the ambulatory blood pressure function:
In this mode, the monitor can work 24 hours continuously. The monitor have the capable of
recording up to 4800 measurements, BP data trends chart. The stored readings in the monitor are
downloaded into the computer to proceed the function including editing the data. Editing the
trend graph, statistic, displaying the information. Editing the diagnostic information, setting the
parameters and printing and so on. However, this monitor cannot transmit data real-time in the
process of measuring.
Monitoring function:
NIBP
— From left to right, there are Systolic pressure, MAP pressure and Diastolic pressure(unit:
mmHg)
SpO
2
— SpO
2
(unit: %)
— Pulse Rate(unit: beats/minute)

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the stored values of SpO
2
in the monitor can be downloaded into the computer too.
Alarm processing:
The user may turn on the alarm monitor by hand. When alarm is on, SpO
2
alarm is as follows:
oxygen saturation and pulse rate displayed circularly for 5 times in 1scecond and tested the
measured value whether it was exceeded or not at the same time; the blood pressure alarm is as
follows: after the finish of the test, it will measure the high pressure, low pressure and the mean
pressure every 4 second, until the end of the next test. The voices of the pressure and SpO
2
are
same the only difference between them is the interval. Audible alarm is accompanied by visual
alarm and the symbol of the alarm condition in the main interface was red.
Alarm priority: technical alarm such as low power, probe off > physiological alarm such as over
the prescribed limit of the pressure and SpO
2
.
Note
In this mode, the length of working time continuously is decided by the interval of
measurement set by the user.
It is useful that the software at the state of monitoring as the ambulatory blood pressure.
Refer to Software Functions for details.
1.2 Main Parameters
A. Measurement of SpO
2
Measuring range: 0%~100%
Accuracy: when the SpO
2
measuring range is 70%~100%, the permission of absolute error is
±2%; below70% unspecified
B. Measurement of a pulse rate

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Measuring range: 30bpm~250bpm
Accuracy: ±2bpm
C. Measurement of blood pressure
Measuring range:
ADULT: SYS: 40-270 mmHg
MAP: 20-235 mmHg
DIA: 10-215 mmHg
PEDIATRIC: SYS: 40-200 mmHg
MAP: 20-165 mmHg
DIA: 10-150 mmHg
NEONATAL: SYS: 40-135 mmHg
MAP: 20-110 mmHg
DIA: 10-100 mmHg
Maximum mean error of measurement: ±5 mmHg.
Maximum experimental standard deviation: 8 mmHg.
D. Resolution
SpO
2
: 1%, Pulse rate: 1bpm, blood pressure: 1mmHg
E. Measurement Performance in Weak Filling Condition
SpO
2
and pulse rate can be shown correctly when pulse filling ratio id 0.4%. SpO
2
error is ±4%,
pulse rate error is ±2bpm.
1.3 Button Functions
All the operations to the monitor are through the buttons at the bottom of the panel. The names

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of the buttons are above them. They are:
Press the button for a long time, then the system will start. When turning on and off the monitor,
the red light and the green both flash once to prompt that the on or off operation is successful.
Press the button for 3 second, the instrument turns off. If power is low than 2.2V, the instrument
can not turn on.
Note
When the battery power is low, the alarm occurs. The battery's frame becomes red, and
ceaseless flash.
MENU
The text in the middle bottom of the screen indicate the function of this key. Whatever levels of
menu the system is in, press the button and the system immediately executes a certain function.
UP
The text in the left bottom of the screen indicate the function of this key.

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Press the button to select the menu item and modify the setup. In main interface, press UP key to
enter silence state, again press UP key to cancel silence state.
DOWN
The text in the right bottom of the screen indicate the function of this key.
Press the button to select the menu item and modify the setup. In main interface, press DOWN
key to enter alarm pause state, again press this key to cancel alarm silence state.
NIBP
Press to inflate the cuff to start a blood pressure measurement, and display the main interface.
When measuring, press this button to cancel the measurement, deflate the cuff and "CANCEL"
will appear in the main interface.
Note: When the frame of battery power sign is red in the main interface, pressing measure button
is disabled.Here, self-motion measure can't be carried through too.
Note
Plug in USB to carry on upload and download data when no battery. That the topside of
the screen displays USB symbol shows the instrument triumphantly connects with the
computer. NIBP key is invalidation when plug in USB line.
1.4 Interfaces
For the convenience of operation, the different kinds of interfaces are in different parts of the

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monitor.
At the top is the Socket for SpO
2
Sensor and socket for NIBP cuff (Figure 1.4.1①)
①the Socket for NIBP cuff
②the Socket for SpO
2
Sensor
Figure1.4.1 Top
At the bottom is the socket for USB, as shown in Figure 1.4.2.
①the Socket for USB
①
②
①

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Figure1.4.2 Bottom
1.5 Accessories
A cuff for adult
B a USB data line
C an oximeter probe
D a disk (PC software)
E a pouch
F a user manual
Warning
Please use the accessories supplied by the manufacturer or replace the accessories
according to the requirements of the manufacturer in order to avoid making harms to
patients.

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Chapter2 Getting Started
■ Open the package and check
■ Dry battery installation
■ Power on the monitor
■ Connect patient sensors
2.1 Open the Package and Check
Open the package and take out the monitor and accessories carefully. Keep the package for
possible future transportation or storage. Check the components according to the packing list.
■ Check for any mechanical damage.
■ Check all the cables, modules and accessories.
If there is any problem, contact the distributor immediately.
2.2 Dry Battery Installation
The monitor will be supplied with two 'AA' alkaline batteries or high capacity. Before using the
monitor, you shall put the battery in the box of battery.
Note
When you don't use the monitor, you will take out the dry battery.
2.3 Power on the Monitor
Press to power on the monitor. The indicator will flash, the system will enter

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monitoring screen of monitoring or ABPM, and you can perform normal monitoring now. Refer
to System Menu for details.
Warning
If any sign of damage is detected, or the monitor displays some error messages, do not use
it on any patient. Contact biomedical engineer in the hospital or our Customer Service
Center immediately.
Note
Check all the functions that may be used to monitor and make sure that the monitor is in
good status.
2.4 Connect Oximeter Probe
Note

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For information on correct connection, refer to Figure 2.4..
Figure2.4
2.5 Connect NIBP Cuff
Connect NIBP extension conduit between the monitor and the patient.
Note
For information on correct connection, refer to Figure 2.5.
The
SpO
2
Probe

15
Figure2.5

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Chapter3 Function Interface
■ Main Interface
■ System Menu
3.1 Main Interface
Press POWER to power on the monitor. The indicator will flash, the system will enter the main
interface successfully.
ABPM: If there is no key-press operation within the time set in the BACKLIGHT TIME item,
the monitor will enter standby mode. RUN indicator light flashes once every other 2seconds,
indicating the monitor is under working mode.
Monitoring mode: BACKLIGHT TIME item setup is of no effect. The backlight is bright all the
time.
The red symbol of battery will flash in the main interface when the power is low.
The main interface is shown as the follow:
Figure3.1.1 ABPM main menu