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Contec Medical Systems Co., Ltd
No.112 Qinhuang West Street, Economic & Technical
Development Zone, Qinhuangdao, Hebei Province, 066004
PEOPLE'S REPUBLIC OF CHINA
M35111ENRev.1.05.15
Shanghai International Trading Corp. GmbH (Europe)
Eiffestrasse 80, 20537, Hamburg, Germany
0123
PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. 199 400 401 - fax 199 400 403
Export: tel. +39 02 953854209/221/225 - fax +39 02 95380056
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
ATTENTION: The operators must carefully read and completely understand
the present manual before using the product.
GIMA ABPM PULSE RATE MONITOR
WITH SpO
2
User Manual
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2
Page 3
3
Chapter 1 INTRODUCTION ................................................................. 5
1.1 General Information ............................................................ 6
1.2 Button Functions ................................................................ 8
1.3 Interfaces ............................................................................ 8
1.4 Accessories ........................................................................ 9
Chapter 2 GETTING STARTED ......................................................... 10
2.1 Open the Package and Check .......................................... 10
2.2 Dry battery installation ...................................................... 10
2.3 Power on the instrument................................................... 10
2.4 Connect Sensor ................................................................ 11
Chapter 3 Function Interface ............................................................ 11
3.1 Main Interface ................................................................... 11
3.2 Measuring Interface .......................................................... 12
3.3 Measure Result Interface .................................................. 16
3.4 System Menu .................................................................... 17
3.5 ABPM Working Interface................................................... 26
Chapter 4 SpO2 MONITORING ......................................................... 28
4.1 What is the SpO2 Monitoring ............................................ 28
4.2 Precautions during SpO2/Pulse Monitoring ...................... 29
4.3 Monitoring Procedure ....................................................... 29
4.4 Maintenance and Cleaning ............................................... 30
Chapter 5 NIBP MEASURING ........................................................... 30
5.1 Introduction ....................................................................... 30
5.2 NIBP Measuring ................................................................ 31
5.3 Operation Hints ................................................................. 33
5.4 NIBP Error Message and Explanations............................. 35
5.5 Maintenance and Cleaning ............................................... 35
5.6 Transportation and Storage .............................................. 36
5.7 Key And Symbols ............................................................. 37
Chapter 6 INSTALLATION OF THE SOFTWARE .............................. 37
6.1 Demand of editor .............................................................. 37
6.2 Installation of software ...................................................... 38
Chapter 7 INTRODUCTION TO THE SOFTWARE ............................ 38
7.1 Main Interface ................................................................... 38
7.2 Wear ................................................................................. 39
INDEX
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4
7.3 Set File Path ..................................................................... 39
7.4 Set Collection Project ....................................................... 40
7.5 Download Data ................................................................. 42
7.6 Select the Case to be Edited ............................................ 42
7.7 Delete Case ...................................................................... 43
7.8 Copy Case ........................................................................ 44
7.9 Edit BP Data ..................................................................... 45
7.10 Edit Trend Graph .............................................................. 46
7.11 Edit of Diagnose Information ............................................ 48
7.12 Set BP Thresholds ............................................................ 49
7.13 Histogram ......................................................................... 50
7.14 Pie Chart ........................................................................... 50
7.15 Set Print Report ................................................................ 51
7.16 Print Report Preview ......................................................... 52
7.17 Help .................................................................................. 54
7.18 Exit .................................................................................... 54
Chapter 8 TROUBLESHOOTING GUIDE .......................................... 55
SPECIFICATION ..................................................................................... 56
APPENDIX .......................................................................................... 57
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Chapter 1
INTRODUCTION
For an overall introduction to the Blood Pressure 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 ammable
anesthetics or other ammable substance in combination with air,
oxygen-enriched environments, or nitrous oxide.
Warning
You must verify if the device and accessories can work safely
and normally before using.
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 instrument performance.
Warning
Dispose of the packaging material, observing the applicable waste
control regulations and keeping it out of children’s reach.
Warning
Please choose the accessories which are approved or manufactured
by the manufacturer, or else it may damage the device.
Warning
The monitor is only for use on one patient at a time.
Warning
When the monitor is wetted, please stop using it and contact us.
Warning
If Luer lock connectors are used in the construction of tubing,
there is a possibility that they might be inadvertently connected
to intravascular uid systems, allowing air to be pumped into
a blood vessel.
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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 nd 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 qualied personnel once every 12 months.
Note
Please choose the computer which should be ensured compliance
with the requirements of IEC 60950, or else it may damage the device.
Note
The software was developed per IEC60601-1-4. The possibility
of hazards arising from errors in the software program is minimized.
Note
The 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).
Caution
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.
1.1 General Information
Environment:
Temperature Working 5~40 (˚C)
Transport and Storage -20~55 (˚C)
Humidity Working 15%~80%
Transport and Storage ≤ 95 %
Altitude 80kPa~105kPa
Power Supply 3 (V) DC
P ≤2.4VA
The device has life for 10000 times of BP measure(within 5 years).
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Safety:
This device is debrillator protected. Note that no precautions
specic to the device is required during debrillation, and debrillation
discharge has no effect on the monitor. The equipment uses
the gray silicone airway, in case of the effect to the equipment
when debrillation device was used on the patient.
General instruction
The device is applied to Blood Pressure(BP) measure and monitor for adult,
pediatric, and neonatal. It most stores 300 records of common user and
350 of ambulatory Blood Pressure data. Every record includes the detailed
measure time, systolic blood pressure, diastolic blood pressure, mean blood
pressure, pulse rate, error message and record number, etc.
This device has friendly operation interface, and adopts 2.4inch color LCD.
It integrates data review function and display function which includes
large-print single record data review, data list, BP data trends chart,
the current time,date,power,alarm and so on.
User can power on/off the monitor,start manual measure, set system
parameters and so on with ve keys in the front panel. (Please refer
to “Button Functions” part for detail).
There are sound and light alarm functions that the buzzer intermittently
beeping and the red light ashing to prompt low power. When the measure
result exceed the alarm limit, the color of the measure results style
becomes red and aroses sound alarm. The user can turn on or off the alarm
sound if necessary.
The cuff socket is located on the top of the device and the USB socket
at the bottom of the device. The stored data can be transferred to computer
with the USB interface, and then various operations can be performed
by using the PC software. (Please refer to “Software Functions” part for
detailed contents).
Note
If there is no operation in the common user mode, the device will turn
off backlight according to the “BACKLIGHT TIME” you set, and if
no action for three minutes, the device will automatically turn off.
When the backlight turn off in the Ambulatory Blood Pressure mode,
the green indicator intermittently ashes to prompt the device
in running state.
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1.2 Button Functions
All the operations of the Blood Pressure Monitor could be completed
with the buttons. The names of button are on 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 ash
once to prompt that the on or off operation is successful. Press it for
a short time to return the boot-strap interface.
The text in the middle bottom of the screen indicate the function
of this key. Whatever menus the system is in, press the button
and the system immediately executes a certain function.
The text in the left bottom of the screen indicate the function of this
key.
Such as: The button is the alarm switch in the boot-strap interface,
up key in the “System Menu”, and left key in the “trend “chart.
The text in the right bottom of the screen indicate the function of this
key.
Such as: the button is the data review key of current user in the
boot-strap interface and down key in the “System Menu” and right
key in the “trend” chart.
Start/Stop button. If measuring, press this key to cancel the current
measurement
Note
During uploading data with the USB, all of the buttons are disabled.
If measuring, the measurement is to be canceled..
Note
During measurement, three buttons are all disabled.
The rectangular mark in the screen moving with the operation of ,
buttons is called “cursor”. Operation can be performed in any
position at which the cursor can stay. When the item is not selected,
the cursor is yellow; when selected, the cursor becomes red.
1.3 Interfaces
For the convenience of operation, different kinds of interfaces are in different
parts of the instrument. NIBP cuff socket is at the top.
OK
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Note
Cuff is connected to the monitor through the extended gas pipe.
1 Port of extended gas pipe
2 The socket for Gas pipe
At the bottom is the socket for USB
1 the Socket for USB, connect the data line to upload data
1.4 Accessories
1 A cuff for adult
2 A USB data line
3 A disk (PC software)
4 BP extending tube
5 A pouch
Warning
Please use the special accessories supplied by the manufacturer
or replace the accessories according to the requirements
of the manufacturer in order to avoid making harms to patients.
1
2
Figure 1
The top external airway
Figure 2
Bottom
1
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Chapter 2
GETTING STARTED
• Open the package and check
• Dry battery installation
• Power on the instrument
• Connect patient sensors
2.1 Open the Package and Check
Open the package and take out the equipment and accessories carefully.
Keep the package material 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 instrument will be supplied with two ‘AA’ alkaline batteries or high
capacity. Before using the instrument, you shall put the battery in the battery
box in the back of the monitor.
Note
When you don’t use the equipment, you should take out the dry
battery.
2.3 Accensione apparecchio
Press button to power on the instrument. The indicators will ash once,
which shows the boot-strap is success, then end pressing, the system will
enter into the main interface.
Warning
If any sign of damage is detected, or the instrument 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 possibly be used and make sure that the
equipment is in good status.
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2.4 Connect Sensor
Note
For information on correct connection of NIBP cuff,
refer to Figure 3
Connect the sensor between the monitor and the measure part of the patient.
Chapter 3
FUNCTION INTERFACE
• Interfaccia principale
• Menu sistema
3.1 Main Interface
Press to power on the instrument. The indicator will circularly ash
once, which show the boot-strap is success, then end pressing, the system
will enter into the main interface.
In common user mode, if there is no key-press operation during the time
which system sets, the device will turn off LCD and enter into standby
mode, if there is no any operation in the standby mode, the device
will automatically turn off; the “RUN” indicator ashes once every 2 seconds
to prompt the device in working state.
When the power is low, the battery progress bar is empty, at the same
time the alarm sound occurs, and the red indicator ashes in xed time.
In the Main Interface:
Alarm-switch status is displayed in the left top of the screen, button
can switch the alarm status shortly.
User bar displays the current patient type (adult, pediatric, neonatal),
and the amount of the common user’s data record.
Current date and time is displayed in the middle top of the screen,
the precision of the time is second.
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Figure 3
Connection method
CUFF
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The boot-strap interface is shown as the follow
Note
All interfaces except the trend retain power icon, alarm switch, as well
as a small font of the current time.
Note
After the register overow, the rst record will be overwritten,
“Overow” message is shown in the boot-strap interface.
The interface is shown as the follow:
3.2 Measuring Interface
Measuring interface displays real-time cuff pressure and the current
measurement information. In the measurement process, except the
and the buttons, other buttons are disabled.
Figure 4
Common user boot-strap
interface 1
Figure 5
Common user boot-strap
interface 2
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The measuring interface is shown as the follow:
Note
In any interface except the measurement, press key to exit
current interface and back to the boot-strap interface.
3.2.1 SpO2 SETUP
Select [PM SpO2 SETUP] in the “SYSTEM MENU”.
The following menu will pop up.
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Figure 6
Measuring interface
Figure 7
SpO
2
setup
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For the [PULSE SOUND] item, you can choose its state. When it is “ON”,
pulse sound plays while the monitor measure the ambulatory blood pressure.
When it is “OFF”, pulse sound dosen’t play while the monitor measure
the ambulatory blood pressure.
For the [SpO
2
ALM HI/LO] item, you can set up [SpO2 ALM H] and [SpO2 ALM
LO].Alarm occurs, when SpO
2
value overows.
For the [PR ALM HI/LO] item, you can set up [PRALM HI] and [SpO
2
ALM
LO].Alarm occurs, when PR value overows.
SpO
2
and PR ALARM analysis alarm limits:
3.2.2 Patient Information
Pick the [ABPM INF0] item in the “SYSTEM MENU” to call up the following
menu.
The information in this interface can’t be changed, until reinstall
the parameter in software.
PARAMETERS Max. HI Min. LO Step
SpO2 100 0 1
PR 254 0 1
Figure 8
ABPM infor
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3.2.3 SpO2 TABLE
Pick the [SpO2 TABLE] item in the “SYSTEM MENU” to call up the following
menu.
[total]: the number is the total of all data have been measured, while
accessing this interface for the rst time. The sequence number of the rst
line currently will be displayed, while changing the data or turning over page.
Every page can contain 10 data at most.
Select the [change] item to enter the [Change The Number] menu:
When the number which you input is more than the total, it will prompt
“>total”. The blood pressure is measured once per 1 s, and the most number
of times is 183000.
Figure 9
SpO2 table
Figure 10
Change
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3.2.4 DEMO function
Select the [DEMO] item to enter DEMO status. In the DEMO status, press the
“MENU KEY”, and system returns to the “MAIN MENU”.
Note
In clinical application, this function is forbidden because the DEMO
will mislead the medical staff to treat the DEMO waveform and
parameter as the actual data of the patient, which may result
in the delay of treatment or mistreatment.
When it is ambulatory blood pressure state,[PM BP SETUP]、[PM SpO
2
SETUP] and [TABLE] can’t be changed in the “MAIN MENU”.
3.3 Measure Result Interface
The measure result includes:
SYS: systolic blood pressure (mmHg/kPa)
DIA: diastolic blood pressure (mmHg/kPa)
PR: pulse rate (bpm)
Figure 11
Demo
Figure 12
Measure results interface 1
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If there is an error during the measurement, an error message text will appear on the screen. If the ALARM SOUND is set to be on, the sound would
occur. Press the SILENCE key to stop the sound and press it once more
to continue.
3.4 System Menu
In the boot-strap interface, according to the text in the middle bottom
of the screen, press button, then enter the system menu and execute
different option operations by using keys.
3.4.1 System setup
Enter “SYSTEM SETUP” item in the [SYSTEM MENU], the following menu
will pop up:
Figure 14
System menu
Figure 13
Measure result interface 2
OK
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“SYSTEM SETUP” menu includes:
“
LANGUAGE” item has two choices: Chinese, English;
“
UNIT” item has two choice: mmHg, kPa;
“
USER PURVIEW” item cannot be operated: all;
“
MEASURE MODE” item has three options: adult, pediatric, neonatal,
“
BACKLIGHT TIME(s)”item has four choices: 15, 30, 60, 120.
Note
“Backlight Time” in the “System Settings” is used by the common
user, backlight time in ambulatory blood pressure monitor (ABPM)
is a xed value of 5S.
Select “ABPM Setup” item in [System Setup] menu, the following menu
will pop up:
Figure 15
System setup
Figure 16
ABPM Setup
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“AWAKE INTERVAL” (min/h) could be options: 15, 30, 60, 120;
“
ASLEEP INTERVAL” (min/h) could be options: 15, 30, 60, 120, 240;
“
AWAKE TIME” and “ASLEEP TIME” transformation unit are 30 minutes.
3.4.2 System Time
Select “System Time” item in [System Menu], the following menu will pop up:
Select “Conrm” after time setup complete, time change is successful
and exit system time setup and return the previous menu.
Select “Exit” to cancel the setting and return to the previous menu.
3.4.3 Data Delete
Select “Yes” in “Data Delete” menu
of [SYSTEM MENU], after you press
certain key, the following menu
will pop up:
If press “Conrm”, the common user data will be daleted, if press “Exit”,
the operation will be cancelled.
Figure 17
System time
Figure 18
Data delete
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3.4.4 Alarm Setup
Select “ALARM SOUND” item in [SYSTEM MENU] to switch on or off the
sound of alarm. [refer to Figure 19 system menu]. Select “ALARM SETUP”
item in [SYSTEM MENU], the following menu will pop up:
“SYS ALARM” and “DIA ALARM” can control closing or unsealing of the SYS
and DIA alarm separately.
The alarm is on or off according to the high and low limits which have been
set up. When the measure result is higher than the high limit or lower than the
low limit, and meanwhile, the “ALARM SOUND” is on, “SYS ALARM” or “DIA
ALARM” accordingly on, the alarm will occur.
The adjustable ranges of the high and low limits of the adult mode alarm
are as follows:
SYS ALM: 40~270 mmHg
DIA ALM: 10~215 mmHg
The adjustable ranges of the high and low limits of the pediatric mode alarm
are as follows:
SYS ALM: 40~200 mmHg
DIA ALM: 10~150 mmHg
The adjustable ranges of the high and low limits of the neonatal mode alarm
are as follows:
SYS ALM: 40~135 mmHg
DIA ALM: 10~100 mmHg
Figure 19
Alarm setup
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“Default” includes the main content:
Measure mode: adult;
Alarm parameter:
Alarm switch: close;
Measure unit: mmHg;
Ordinary user backlight time: 15s;
ABPM switch: close;
Asleep time: 22:00;
Asleep measurement interval: 30 minutes;
Awake measurement interval: 15 minutes;
Awake time: 7:00;
SYS Alarm switch: close;
DIA Alarm switch: close.
3.4.5 ABPM Menu
Select “ABPM” menu in [System Menu], the following menu will pop up.
Use
mode
Adult
Pediatric
Neonatal
High pressure
high limit
140
120
100
High pressure
low limit
90
70
60
Low pressure
high limit
90
70
60
Low pressure
low limit
40
40
20
Figure 20
ABPM
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In “ABPM” menu, “ABPM ON-OFF” select “ON”, then prompt message
of ABPM of the current user, such as:
Press button, clear the ambulatory blood pressure measure data,
and enter ambulatory Blood Pressure Mode;
Press button, save ambulatory Blood Pressure measure data,
and enter ambulatory Blood Pressure Mode;
Press button, give up the choice, and return the previous menu.
Figure 21
ABPM prompt menu
OK
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3.4.6 ABPM Data Review
3.4.6.1 ABPM “large-print” Data Review
Select “ABPM Data” item in “ABPM” menu, the following interface
will pop up.
Every record is an interface, and display content include: the current user,
total of the current user record data, serial number of the record, stored time
of the record, high pressure, low pressure, mean pressure, Pulse Rate.
3.4.6.2 ABPM Data “Table”
Press button to select “trend” in ABPM large-print data review menu,
the following interface will pop up
Figure 22
ABPM “large-print”
OK
Figure 23
ABPM “Table”
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A interface contain 5 records, every record includes time, high pressure,
low pressure, mean pressure, Pulse Rate.
3.4.6.3 ABPM Trend
Press button to select “trend”, in ABPM large-print data review menu,
the following interface will pop up:
Trend interface can trace 100 record trends, if measuring data are more than
100 items, press , buttons can glide trend curve for left and right,
the scale of the vertical axis and the starting point, end point automatically
adjust according to the width of the stored data. The displayed dates
that are at the bottom of trends shown the trend for the rst point and last
point of data recording time.
Figure 24
ABPM “trend”
OK
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3.4.7 Ordinary User Data Review
3.4.7.1 Ordinary User “large-print” Data Review
Press button to enter the ordinary user “large-print” data review in
boot-strap interface, the following interface will pop up:
Display content is similar to ambulatory blood pressure large-print
data review.
3.4.7.2 Ordinary User Data Table
Press button to pop up the ordinary user data table in the ordinary user
large-print data review, the interface is as shown:
OK
Figure 26
Ordinary user data table
Figure 25
Ordinary user “large-print”
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Display content is similar to ambulatory blood pressure large-print data review.
3.4.7.3 Ordinary User Measure Data Trends
Press button to pop up the ordinary user data table in the ordinary user
data table, the interface is as shown:
Display content is similar to ambulatory blood pressure large-print
data review.
3.5 ABPM Working Interface
In ABPM working environment, backlight is only for 5 seconds, except the
press any key to wake the backlight, ABPM working interface is as shown:
OK
Figure 27
Trends
Figure 28
ABPM working interface
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If alarm sound occurs, press SILENCE key to stop it and press it again
to continue.
Long press button, the exit ABPM hint interface will pop up:
Press button to exit ABPM working environment, and enter
the ordinary user working environment, and display the boot-strap interface;
Press button to exit the interface, and return the ABPM working interface.
Long press button, turn off device hint interface will pop up :
Press button to turn off the device.
Press button to exit the interface, and return the ABPM working interface.
Figure 30
Turn Off Device Prompt Interface
OK
Figure 29
ABPM exiting prompt interface
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Chapter 4
SpO2 MONITORING
4.1 What is the SpO2 Monitoring
SpO2 Plethysmogram measurement is employed to determine the oxygen
saturation of hemoglobin in the arterial blood. If, for example, 97%
hemoglobin molecules in the red blood cells of the arterial blood combine
with oxygen, then the blood has a SpO
2
oxygen saturation of 97%.
The SpO
2
numeric on the monitor will read 97%. The SpO2 numeric shows
the percentage of hemoglobin molecules which have combined with oxygen
molecules to form oxyhemoglobin. The SpO
2
/PLETH parameter can also
provide a pulse rate signal and a plethysmogram wave.
How the SpO
2
/ PLETH Parameter Works
• Arterial oxygen saturation is measured by a method called pulse oximeter.
It is a continuous, non-invasive method based on the different absorption
spectra of reduced hemoglobin and oxyhemoglobin. It measures how
much light, sent from light sources on one side of the sensor, is
transmitted through patient tissue (such as a nger or an ear), to a receiver
on the other side.
The sensor measurement wavelengths are nominally 660nm for the
Red LED and 940nm for Infrared LED. Maximum optical power output
for LED is 4 mW.
• The amount of light transmitted depends on many factors, most of which
are constant. However, one of these factors, the blood ow in the arteries,
varies with time, because it is pulsating. By measuring the light absorption
during a pulsation, it is possible to derive the oxygen saturation
of the arterial blood. Detecting the pulsation gives a PLETH waveform
and pulse rate signal.
• The SpO2 value and the PLETH waveform can be displayed in the main
screen.
Warning
ES (Electrosurgery) equipment wire and SpO
2
cable must not be
tangled up.
Warning
Do not put the sensor on extremities with arterial catheter or venous
syringe.
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Note
Do not perform SpO2 measuring and NIBP measuring on same arm
at one time, because obstruction of blood ow during NIBP measuring
may adversely affect the reading of SpO
2
value.
4.2 Precautions during SpO2/Pulse Monitoring
Note
、 Make sure the nail covers the light window;
、 The wire should be on the backside of the hand.
Note
SpO
2
waveform is not proportional to the pulse volume.
Warning
Do not use the SpO
2
sensor once the package or the sensor is found
damaged. Instead, you shall return it to the vendor.
Warning
Prolonged and continuous monitoring may increase jeopardy
of unexpected change of dermal condition such as abnormal sensitivity,
rubescence, vesicle, repressive putrescence, and so on. It is especially
important to check the sensor placement of neonate and patient of poor
perfusion or immature dermogram by light collimation and proper
attaching strictly according to changes of the skin. Check per 2~3 hours
the sensor placement and move it when the skin deteriorates.
More frequent examinations may be required for different patients.
4.3 Monitoring Procedure
SpO2 plethysmogram measurement
1.
Switch on the monitor.
2. Attach the sensor to the appropriate site of the patient nger.
3. Plug the connector of the sensor extension cable into the SpO2 socket,
please pay attention to the direction of the sensor.
4. Please pull out the sensor When measure is over.
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4.4 Maintenance and Cleaning
Care and Cleaning
Warning
Turn off the monitor before cleaning the monitor or the sensor
Warning
Do not subject the sensor to autoclaving.
Do not immerse the sensor into any liquid.
Do not use any sensor or cable that may be damaged or deteriorated.
Cleaning:
• Use a cotton ball or a soft mull moistened with hospital-grade ethanol
to wipe the surface of the sensor, and then dry it with a cloth. This cleaning
method can also be applied to the luminotron and receiving unit.
• The cable can be cleaned with 3% hydrogen dioxide, 70% isopropanol,
or other active reagent. However, connector of the sensor shall not be
subjected to such solution.
Chapter 5
NIBP MEASURING
5.1 Introduction
• The Non-invasive Blood Pressure (NIBP) module measures
the blood pressure using the oscillometric method.
• There are two modes of measurement available: manual, automatic.
• Every mode displays the systolic, mean, diastolic blood pressure
and pulse rate.
• It is applicable for adult, pediatric, and neonatal usage.
Figure 31
Mounting of the sensor
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Warning
1. You must not perform NIBP measurements on patients with
sickle-cell disease or under any condition which the skin is damaged
or expected to be damaged.
2. For a thrombasthemia patient, it is important to determine whether
measurement of the blood pressure shall be done automatically.
The determination should be based on the clinical evaluation.
3. Ensure that the correct mode setting is selected when performing
measurements on children and newborn (Refer to measuring mode
menu setting), and use children and newborn special cuff. It may be
dangerous for using error patient mode, because the upper adult
blood pressure level does not apply the children and newborn.
5.2 NIBP Measuring
Warning
• Before starting a measurement, verify that you have selected
a setting appropriate for your patient (adult, pediatric or neonate).
• Do not apply the cuff to a limb that has an intravenous infusion
or catheter in place. This could cause tissue damage around
the catheter when infusion is slowed or blocked during
cuff ination.
Warning
Make sure that the air conduit connecting the blood pressure cuff
and the equipment is neither blocked nor tangled.
1. Plug in the air hose and switch on the system.
2.
Apply the blood pressure cuff to the patient’s upper arm following
the instructions below (Figure 5.1).
• Ensure that the cuff is completely deated.
• Apply the appropriate size cuff to the patient, and make sure that
the symbol “Φ” is over the appropriate artery. Ensure that the cuff is not
wrapped too tightly around the limb. Excessive tightness may cause
discoloration and eventual ischemia of the extremities.
z
z
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Figure 32
Use cuff
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32
Nota
The width of the cuff should be either 40% of the limb circumference
(50% for neonates) or 2/3 of the upper arm length. The inatable part
of the cuff should be long enough to encircle 50-80% of the limb. The
wrong size of cuff can cause erroneous readings. If the cuff size is in
question, then use a larger cuff.
Size of reusable cuff for neonate/children/adult
Size of disposable cuff for neonate
• Make sure that the cuff edge falls within the range of mark <->.
If it does not, use a larger or smaller cuff that ts better.
3. Connect the cuff to the air hose. The limb chosen for taking
the measurement should be placed at the same level as the patient’s
heart.
If this is not possible you should apply the following corrections
to the measured values:
• If the cuff is placed higher than the heart level, add 0.75 mmHg (0.10 kPa)
for each inch of difference.
• If it is placed lower than the heart level, deduct 0.75 mmHg (0.10 kPa)
for each inch of difference.
4. Check whether the measure mode is appropriately selected. (the measure
mode displays in the boot-strap interface information area).
5. Press button on the front panel, and start a measurement.
Patient type Limb perimeter Cuff width
Infant 10 ~19 cm 8 cm
Child 18 ~ 26 cm 10.6 cm
Adult1 25 ~ 35 cm 14 cm
Adult2 33 ~ 47 cm 17 cm
thigh 46 ~ 66 cm 21 cm
z
Hose
1.5 m
or 3 m
Size No. Limb perimeter Cuff width
1 3.1 ~ 5.7 cm 2.5 cm
2 4.3 ~ 8.0 cm 3.2 cm
3 5.8 ~ 10.9 cm 4.3 cm
4 7.1 ~ 13.1 cm 5.1 cm
Hose
1.5 m
or 3 m
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5.3 Operation Hints
1. To start auto measuring:
Access ABPM SETUP menu and pick the “Asleep Interval” item
and “Awake Interval” item, in which the user may select the time interval
value for auto measurement. After that, enter “ABPM” menu and select
the entrance, enter into ABPM working environment, and the system
is automatically inated measurement in accordance with the setting
time interval.
Warning
Prolonged non-invasive blood pressure measurements in Auto mode
may be associated with purport, ischemia and neuropathy in the limb
wearing the cuff. When monitoring a patient, examine the extremities
of the limb frequently for normal color, warmth and sensitivity. If any
abnormality is observed, stop the blood pressure measurements.
2. To stop auto measuring:
During auto measuring, press button at any time to stop auto
measurement.
3. To start a manual measuring:
• Press button to start a manual measuring in the ordinary user working
environment.
• During the idle period of auto measuring process, press button at any
time to start a manual measurement. Then press button to stop
manual measurement and the system continues executing auto-measuring
program.
Note
If you are in doubt about the accuracy of any reading(s), check
the patient’s vital signs by an alternative method before checking
the functioning of the blood pressure monitor.
Warning
If liquid is inadvertently splashed on the equipment or its accessories,
or may enter the conduit or inside the monitor, contact local Customer
Service Center.
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z
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Measurement Limitations
To different patient conditions, the oscillometric measurement has certain
limitations. The measurement is in search of regular arterial pressure pulse.
In those circumstances when the patient’s condition makes it difcult
to detect, the measurement becomes unreliable and measuring time
increases. The user should be aware that the following conditions could
interfere with the measurement, making the measurement unreliable or longer
to derive. In some cases, the patient’s condition will make a measurement
impossible.
• PatientMovement
Measurements will be unreliable or cannot perform if the patient is moving,
shivering or having convulsions. These motions may interfere with
the detection of the arterial pressure pulses. In addition, the measurement
time will be prolonged.
• CardiacArrhythmia’s
Measurements will be unreliable and may not be possible if the patient’s
cardiac arrhythmia has caused an irregular heartbeat. The measuring time
thus will be prolonged.
• Heart-lungMachine
Measurements will not be possible if the patient is connected to a heart-lung
machine.
• PressureChanges
Measurements will be unreliable and may not be possible if the patient’s
blood pressure is changing rapidly over the period of time during which
the arterial pressure pulses are being analyzed to obtain the measurement.
• SevereShock
If the patient is in severe shock or hypothermia, measurements will be
unreliable since reduced blood ow to the peripheries will cause reduced
pulsation of the arteries.
• HeartRateExtremes
Measurements cannot be made at a heart rate of less than 40 bpm
and greater than 240 bpm.
• RoundPatient
The thick fat layer of body will reduce the measurement accuracy, because
the fat that come from the shock of arteries cannot access the cuffs due
to the damping.
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5.4 NIBP Error Message and Explanations
5.5 Maintenance and Cleaning
Warning
• Do not squeeze the rubber tube on the cuff.
• Do not allow liquid to enter the connector socket at the front
of the equipment.
• Do not wipe the inner part of the connector socket when cleaning
the equipment.
ReusableBloodPressureCuff
The cuff can be sterilized by means of conventional autoclaving, gas,
or radiation sterilization in hot air ovens or disinfected by immersion
in decontamination solutions, but remember to remove the rubber bag
if you use this method. The cuff should not be dry-cleaned.
The cuff can also be machine-washed or hand-washed, the latter method
may prolong the service life of the cuff. Before washing, remove the latex
rubber bag, and for machine-washing, close the Velcro fastening.
Allow the cuff to dry thoroughly after washing, then reinsert the rubber bag.
Explanation Cause
Self-test failure A/D sampling error
Loose cuff Cuff is not connected correctly
Air leakage Air leakage in the valve or airway
Atmospheric pressure error Valve cannot be open.
Signal is too weak Object measuring the pulse is too weak or the cuff
is loose
It is over the range Object measuring blood pressure is over the
measurement range
Excessive movement When measuring, signal the presence of excessive
movement or pseudo-differential interference
Overpressure Cuff pressure is over the scope, ADU 300 mmHg,
Newborn: 150mmHg
Saturated signal Movement or other factors lead to too big signal
amplitude
Air leakage There is air leakage in the airway
System failure There is something wrong with NIBP module, A/D
sampling or soft of system after turning on the device
It spends too much time Adult: When cuff pressure is 2KPa (15mmHg,)
it may spend 3 minute (180S)
Newborn: When cuff pressure is 0.67KPa (5mmHg,)
it may spend 90S
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36
To replace the rubber bag in the cuff, rst place the bag on top of the cuff
so that the rubber tubes line up with the large opening on the long side
of the cuff. Now roll the bag lengthwise and insert it into the opening
on the long side of the cuff. Hold the tubes and the cuff and shake
the complete cuff until the bag is in position. Thread the rubber tubes
from inside the cuff, and out through the small hole under the internal ap.
DisposableBloodPressureCuffs
Disposable cuffs are intended for one-patient use only. Do not use the same
cuff on any other patient. Do not sterilize or use autoclave on disposable
cuffs. Disposable cuffs can be cleaned using soap solution to prevent
infection.
Note
For protecting environment, the disposable blood pressure cuffs must
be recycled or disposed properly.
5.6 Transportation and Storage
A The packed device can be transported by ordinary conveyance
or according to transport contract. The device cannot be transported
mixed with toxic, harmful, corrosive material.
B The packed device should be stored in room with no corrosive gases
and good ventilation. Temperature: -20°C~55°C; Humidity: ≤95%.
Figure 33
Replace Rubber Bag in Cuff
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5.7 Key And Symbols
Chapter 6
INSTALLATION OF THE SOFTWARE
6.1 Demand of editor
Processor: Pentium IV 1.8G or more
Operation System:Windows XP
EMS memory: 256M and more
Hard Disk: 40G or more
Display: 17 inch or more
CD-ROM
USB: 2 or more
Resolution of printer: 600 DPI
Symbols Description
Warning – See User Manual
SYS Systolic pressure
MAP MAP pressure
DIA Diastolic pressure
PR Pulse rate (bpm)
ADU Adult
PED Pediatric
NEO Neonatal
ABPM Ambulatory Blood Pressure Monitor
INFO Information
Open the alarm sound indication
Close the alarm sound indication
WEEE (2002/96/EC)
Type BF debrillator proofed applied parts
SN Serial number
IPX0 Ingress of liquids rank
This item is compliant with Medical Device Directive 93/42/EEC
of June 14, 1993, a directive of the European Economic Community
European Representative
z
0123
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6.2 Installation of software
1 Place the CD-ROM in the CD-ROM compartment located on your computer.
2 If Auto Play for CDs is enabled, place CD in reader and follow instructions
when they appear in the screen; otherwise follow install instructions below:
a. Open Windows Explorer.
b. Click on the root CD-ROM directory.
c. Double click le Setup.exe.
d. Follow the instructions in the screen.
Chapter 7
INTRODUCTION TO THE SOFTWARE
7.1 Main interface
Double click software by left key of the mouse to enter the main operation
interface as follows:
1 Menu bar: main operation menu of the software
2 Toolbar: shortcut operation button of frequent function
3 The middle area is trend graph display area: After choosing the case
that would be edited, display the data trend graph
4 Status bar: after choosing the case that would be edited, display patient
name, ID and data collection date.
Figure 34
Main operating interface
1
2
3
4
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39
7.2 Wear
Click shortcut key , and the “Lead PlaceMent” dialog box will appear..
You can wear the device accroding to the picture above. Please read
the “Matters need” before use.
7.3 Set File Path
Downloaded case data will be recorded in the case path.If you want
to change the case path, you can click menu item “Set le path”.
After the setting dialog box appears, you can change the case path.
Display as follows:
Figure 36
Set le path
Figure 35
Wear
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40
Patient le path: choose patient le path.After downloading data from t
he monitor, the case le is saved in this path.
If you choose “ Always use default path “ item, the default case le path
is program installation le path.
7.4 Set Collection Project
Click shortcut key , or click menu bar item, and the “ Upload
parameters “ dialog box will appear:
As above gure, the doctor could set parameter according to the patient
status and diagnosis requirement, then the monitor could nish the collection
according to the setting.Parameter explanation is as follows:
PatientName: the patient’s name
Patient ID: the patient’s ID number.It is used for marking patient,
and it is exclusive in order to avoid homonymy patient arisen state
CurrentTime: Current system display time
TimePeriods:
AwakeTime: the patient is awake state
AsleepTime: the patient is asleep state
Interval: collection Interval.In order to reduce the effect to the patient sleep,
the asleep collection interval should be longer.
For example as above gure:the awake time area is 7:30-22:30,
and the asleep time area is 22:30-tomorrow7:30. The awake collection
Figure 37
Set Collection Parameter
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41
interval is 30 minutes, and the asleep collection interval is 60 minute.
The asleep time area and awake time area will be display at the right side.
When the parameter setting is nished, click “ Okay “ to upload the project to
the monitor.
The user could select connection way: USB or WIRELESS(the device without
WIRELESS connection way).When uploading, the choice dialog box will
appear to prompt patient to select connection way.If you pitch on “do not
show this next time”, this dialog box will not appear when uploading or
downloading, and upload according to the connection way the use has
chosen.
If the user uses WIRELESS to upload, the dialog box as follows will appear.
Click “Scan” to begin to search.Select device, then click “connect”
to download.
Figure 38
Set Connection Way
Figure 39
Scan Vicinal WIRELESS
Equipment
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42
Uploading schedule is as follows:
7.5 Download Data
Before downloading data, please insure:
1. The monitor is connected with computer accurately.
2. The monitor is on.
3. Ensure that the monitor isn’t connect with patient when the monitor
is connected with computer.
Click shortcut key or menu item “Download”, then select connection
way. After right connecting, begin to download data.
The schedule display is as follows:
After nishing downloading, prompt dialog box will appear, and the case data
will be saved in the case le path.
7.6 Select the Case to be Edited
Before editing case, rst choose the case to be edited.Click shortcut key
or menu item “open data” to enter “Select le to open” interface.
Display as follows:
Figure 40
Uploading Schedule
Figure 42
Select Case
Figure 41
Downloading Schedule
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43
In this interface, you can choose the le to save case. If the le has
case, the le information will be displayed with list form, including these
information:Patient Name,Patient ID, Start Time and File Name.Select the
case le to be edited, and click “ Okay “ or double click to open the case le
and edit it.
7.7 Delete Case
If you are sure that some cases don’t be needed, you can delete then.
Click menu item “Delete data”, and deleting case interface will appear which
is similar to the “Select le to open” interface.Display as follows:
You can delete individual le, also can delete multile. If you want to delete
multile, press “Ctrl” key, at the same time click the le to be delete.
After selecting, click “Okay”, and prompt dialog box will appear. Click “Yes”
to nish deleting operation, and click “ No” to cancel deleting operation.
Figure 43
Select File to Delete
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7.8 Copy Case
Sometimes before you edit case, you may want to save a copy of originality
data.Here you need to copy the case. Our software supplies this function.
Choose menu item “ Copy data “, and the interface will appear as follows:
The copying case method is similar to the deleting le method.You can select
multile at the same time.After selecting the le, click “Okay” , and “Select
destination directory” will appear. You can set destination director path.
After setting path, click “Okay” to nish operation. Display as follows:
Figure 44
Select File to Copy
Figure 45
Set Destination
Director Path
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7.9 Edit BP Data
You can edit every piece of data.Click shortcut key or select menu item
“Edit” to display “BP Data” interface as follows:
In the interface, you can see the particular information of every data.
*=0/192(0.0%):192 is total number of data, 0 is the number of deleted data,
0.0% is the percent of deleted data.
Number: data collection serial number
Time: collection time
Date: collection data
BP(mmHg): the number in front of “/” is high pressure value, and the number
in back of “/” is low pressure value.The unit is mmHg.
PR(BPM): pulse rate value.The unit is BPM.
MAP(mmHg): Mean pressure.The unit is BPM
PP(mmHg): Pressure difference between high and low blood pressure.
The unit is BPM
TC: error code (refer to chapter 7)
Comment: comment for the data.
You can also edit the data. The sign “*” stands for the deleted data (the trend
graph doesn’t display this data, and statistic data doesn’t include this data).
You can delete or add “*” sign by click left key of mouse in “*” area.
In comment area, double click any item to edit data and add comment.
The comment will be displayed
in the trend graph and saved in current case le.
Figure 46
Editing BP Date Interface
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7.10 Edit Trend Graph
After selecting case le, the BP trend graph will be shown in the screen
automatically. In other interfaces you can click shortcut key to enter
the BP trend interface .The “BP Trend” has two graph types: color ller type,
dotted line type. You can switch from one graph type to another by push
the “Graph Type” button.
As color ller type trend graph shown, the blue line is PR change curve,
and the green area is the data area below threshold, and the red area
is the data area above threshold.
The display effect of color ller type trend graph is as follows:
As dotted line type trend graph shown, the blue line is PR change curve,
and the yellow line is the high-low pressure threshold line, and the gray
uprightness line is high-low pressure linked line of BP data for one time.
The dotted line type trend graph is as follows:
Figure 47
Color Filler Type
BP Trend Graph
Figure 48
Dotted Line Type
BP Trend Graph
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You can switch from one graph type to another by the “Graph Type” button.
When you move the mouse on the trend graph area, on the top of the screen
the detail data information about the mouse points will be shown, including
the data serial number, collection time and collection date, high/low blood
pressure value, pulse rate, comment, etc. Click left button of the mouse to
delete or add the data point to be shown.
If the distance between the two data points is too short to move the mouse
to one of the points, move the mouse to the time axis area, press left button
of the mouse down, dragging the mouse rightwards to stretch the BP trend
graph. Of course you can also drag the mouse leftwards to shrink the trend
graph. When you stretch the trend graph, if the trend graph length is beyond
the trend graph, the display area will appear a horizontal scroll bar, you can
see any part of the trend graph by changing position of the scroll bar.Move
the mouse to the y-axis area, press left button of the mouse down, dragging
the mouse upwards to stretch the trend graph. Of course you can also drag
the mouse downwards to shrink the trend graph.
Figure 49
Shrink Trend
Graph(Time Axis)
Figure 50
Stretch Trend Graph
(Time Axis)
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7.11 Edit of Diagnose
Information
Diagnose information includes
following items: Patient
information, Current
Medications, Diagnose
Information and Physician
information. Select “Patient
information”, and display
as follows:
Figure 51
Stretch Trend
Graph (Y-Axis)
Figure 52
Shrink Trend
Graph (Y-Axis)
Figure 53
Edit Patient’s Information
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Click “OK”, and the patient information content will be saved in the case le
in order to expediently display next time.At the same time all the information
will be displayed in the report.
7.12 Set BP Thresholds
After BP Thresholds being set up, the trend graph will renew automatically,
statistic data will be recalculated.
From the view select “Edit” and select “Thresholds”, then the following dialog
box will appear.
The default recommended thresholds for calculating Blood Pressure Load
are 140/90 for awake periods (07:00-22:00) and 120/80for asleep periods
(22:00-07:00). These are the defaults used when you select the Factory
Defaults button.
“Day BP load value” and “Night BP load value” is important guide line which
is used for knowing ponderance about heart blood vessel effect.BP load
heightening is important danger factor of end-point event about heart, brain
and kidney.
“Circadian rhythm of BP ranges” is a ration guide line which judge circadian
rhythm state, and is important factor that the doctor knows syndrome about
heart, brain and kidney circadian rhythm state for the patient whose BP
circadian rhythm has disappeared. Generally speaking, “≥10%” means that
the circadian rhythm is normal, and “<10%” means that the circadian rhythm
is weakened or disappeared.
Setting normal value range helps to distinctly comparing of analysis data.
The analytical data displays in the report.
Figure 54
Set BP Thresholds
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7.13 Histogram
Click shortcut key , and the following interface will appear.
All: Show all BP data statistics.
Day: Show only daytime statistics.
Night: Show only nighttime statistics.
7.14 Pie Chart
Click shortcut key , and the following interface will appear.
The interface is divided into four areas.The most left area is maximum,
minimum, and average value. The second area is pie chart. The third area
Figure 55
Histogram
Figure 56
Pie Chart
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51
is the setting area for pie colour and corresponding value, and the BP value
and be set by manual method and real-time displays.The forth area has three
options including: All, Day and Night.
All: Show all BP data statistics.
Day: Show only daytime statistics.
Night: Show only nighttime statistics.
7.15 Set Print Report
After editing previous BP data, diagnosis information and so on, the software
will create a series of analysis reports. You can select all pages or some
of them for printing.
From the view select “Edit”
and select “Congure Report”,
then the following dialog
box will appear.
You can click “Add Report” to add
a new report. If you don’t need
some report, you can click
“Delete Report” to delete it.
You can select an already exist
report cyclostyle for printing.
You may also click “Edit Report”
to edit the selected report.
You must select one report
page at least.
Figure 57
Report Congution
Figure 58
Edit Report
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Demographics: include patient information, current medications, examining
result summary and physician diagnosis information.
Statistics Page: particular data statistic information.
BP Summary Page: include BP benchmark value, BP load value, average
value and diagnosis value.
Colorized Graph Page: display the colorized graph of BP data.
Bar Graph Page: display the bar graph of BP data
Histograms Page: display the histograms graph of BP data (Selected data in
the histograms interface: All, Day, Night)
Pie Chart Page: display the pie chart of BP data (Selected data in the pie
chart interface:All, Day, Night)
Frequency Histograms Page: display the histograms graph of high/low BP
data for day and night.
Correlation Page: display correlation of SYS and DIA
PR/MAP/PP Histograms Page: display histograms graph of PR/MAP/PP
data.
Measure Data Page: display all BP, PP, PR, comment and so on.
7.16 Print Report Preview
When you are sure that you want to print the report, click shortcut key
or from menu select “Report”, then print preview page will appear.
Click button or from menu select “Print” to print.
In print preview interface, click button, or press “Ctrl” button
glide mouse idler wheel for zoom.
In Demographics page, double click the black frame of “Current
Medications” and “Comments&Diagnoses” information to edit content,
and the edited content could be saved in the case le.
Examining result includes maximum, minimum, average value, BP threshold,
BP load value and natural load value range (the range can be set in the
benchmark value setting dialog box ), circadian rhythm of BP ranges
(the range can be set in the benchmark value setting dialog box ), BP CV
and so on.
BP CV commonly adopt BP SD (standard deviation)/average value to gain.
The BP CV for All, Day and Night expresses BP uctuant degree.
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In measure Data Page, if the time is night, the background is gray, and if the
Sys or Dia is beyond threshold, the background is red.
Figure 59
Demographics Page Preview
Figure 60
Measure Data Page Preview
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54
7.17 Help
Click shortcut key to pop-up help le.It is the brief explanation
for program function.
7.18 Exit
Click shortcut key to save conguration information and exit
application
Figure 61
Measure Data Page Preview
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Chapter 8
TROUBLESHOOTING GUIDE
Cod Description on in Report Editor Solution
1 No signal Check position of cuff, tighten cuff
2 Overreach movement Remain still during BP reading
4 Measurement timeout Check air hose connections and make
certain cuff is tight
85 Airway obstructed Check air hose connections and make
certain air tubing is not crimped
86 Measurement cancelled Push START/STOP button to start reading
87 Cuff leak Check air hose and cuff
88 Safety pause Retry reading, push START/STOP button.
If problem persists return monitor
for servicing
89 Cuff overpressure Check for blocked or kinked air hose
90 Battery low Replace batteries. If problem persists return
for servicing
105 Self-check failed Return for servicing
110 Out of range Retry again, if problem persists return
for servicing
115 System error Return for servicing
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Name Ambulatory Blood Pressure Monitor
Display 2.4’’ color LCD Display
NIBP Specications
Measurement Method Oscillometric method
Working modes Automatic
Measurement Range Pressure adult 0~290mmHg(0~38.6kPa)
pediatric 0~235mmHg(0~31.3kPa)
neonatal 0~140mmHg(0~18.6kPa)
Pulse: 40~240/min
Ination adult 160mmHg
pediatric 120mmHg
neonatal 70mmHg
Alarm Range adult mode SYS ALM: 40~270 mmHg
DIA ALM: 10~215 mmHg
pediatric mode SYS ALM: 40~200 mmHg
DIA ALM: 10~150 mmHg
neonatal mode SYS ALM: 40~135 mmHg
DIA ALM: 10~100 mmHg
Overpressure protect adult mode 295±5mmHg
pediatric mode 240±5mmHg
neonatal mode 145±5mmHg
Resolution
Pressure 1mmHg
Pulse Rate ±2 bpm or ±2% (select larger)
Measurement Accuracy
Cuff Pressure Accuracy ±3mmHg
Error The BP Value of the device is equivalence with the
measurement value of Stethoscopy. The error meets all the
conditions in the ANSI/AAMI SP-10:2002+A1:2003 +A2:2006.
Operating +5ºC~+40ºC 15%RH~80%RH
Temperature/ Humidity
Transport and Storage -20ºC~+55ºC ≤95%RH
Temperature/Humidity
Atmospheric pressure 80kPa~105kPa
Battery 2 “AA” alkaline batteries
Accessories Standard Congure:
Adult Cuff: limb circumference 25-35cm (middle of upper arm)
Software CD, User Manual, USB data line, BP extending tube,
A pouch.
Separate Sale:
Pediatric Cuff: limb circumference 10-19cm
(middle of upperarm)
Neonatal Cuff: limb circumference 6-11cm
(middle of upper arm)
SPECIFICATION
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57
Guidance and manufacturer’s declaration – electromagnetic emission
The device is intended for use in the electromagnetic environment specied below.
The customer of the user of the device should assure that it is used in such
and environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions Group 1
CISPR 11
RF emission Class B
CISPR 11
APPENDIX
Guidance and manufacturer’s declaration – electromagnetic
emissionsfor all EQUIPMENT and SYSTEMS
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
The device is suitable for use in all
establishments other than domestic and those
directly connected to a low voltage power
supply network which supplies buildings
used for domestic purposes
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below.
The customer or the user of device should assure that it is used in such an environment.
Immunity test IEC60601 Compliance Electromagnetic
test level level environment - guidance
Electrostatic ±6 kV contact ±6 kV contact
discharge (ESD) ±8 kV air ±8 kV air
IEC61000-4-2
Power frequency 3A/m 3A/m
(50/60Hz)
magnetic eld
IEC61000-4-8
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Floors should be wood, concrete
or ceramic tile. If oor are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be
that of a typical commercial
or hospital environment.
Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
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58
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below.
The customer or the user of device should assure that it is used in such an environment.
Immunity test IEC60601 Compliance Electromagnetic
test level level environment - guidance
Radiated RF
IEC 61000-4-3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF
transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in
which the device is used exceeds the applicable RF compliance level above, the device should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the device.
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey, a should be
less than the compliance level in each
frequency range.
b
Interference may occur
in the vicinity of equipment
marked with
the following symbol:
Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
3 V/m
80 MHz
to 2.5 GHz
3 V/m
d
=
3,5
�P
E
1
d
=
7
�P
E
1
Page 59
59
Recommended separation distances between portable and mobile RF
communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter (m)
output power of
transmitter (W) 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.23
0.1 0.37 0.74
1 1.17 2.33
10 3.69 7.38
100 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reection from structures, objects and people.
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
d
=
3,5
�P
E
1
d
=
7
�P
E
1
Page 60
60
Disposal: The product must not be disposed of along with other
domestic waste. The users must dispose of this equipment by
bringing it to a specific recycling point for electric and electronic
equipment. For further information on recycling points contact
the local authorities, the local recycling center or the shop where
the product was purchased. If the equipment is not disposed
of correctly, fines or penalties may be applied in accordance
with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product.This product meets high
qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace
free of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall
not extend the warranty. The warranty is void in the following cases:
repairs performed by unauthorized personnel or with non-original spare
parts, defects caused by negligence or incorrect use. GIMA cannot be held
responsible for malfunctioning on electronic devicesor software due to
outside agents such as: voltage changes, electro-magnetic elds, radio
interferences, etc. The warranty is void if the above regulations are not
observed and if the serial code (if available) has been removed, cancelled
or changed.
The defected products must be returned only to the dealer the product was
purchased from. Products sent to GIMA will be rejected.
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