Gima 35111 User manual

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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
M35111ENRev.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. [phone] - fax [phone]
Export: tel. [phone]/221/225 - fax [phone]
[e-mail] - [e-mail]
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 SpO2
User Manual

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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 SpO2MONITORING ......................................................... 28
4.1 What is the SpO2Monitoring ............................................ 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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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 qualied 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 debrillator protected. Note that no precautions
specic to the device is required during debrillation, and debrillation
discharge has no effect on the monitor. The equipment uses
the gray silicone airway, in case of the effect to the equipment
when debrillation 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.
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Note
Cuff is connected to the monitor through the extended gas pipe.
1Port of extended gas pipe
2The 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
1A cuff for adult
2A USB data line
3A disk (PC software)
4BP extending tube
5A 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.
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Figure 1
The top external airway
Figure 2
Bottom
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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 overow, the rst record will be overwritten,
“Overow” 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 SpO2SETUP
Select [PM SpO2SETUP] in the “SYSTEM MENU”.
The following menu will pop up.
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Figure 6
Measuring interface
Figure 7
SpO2setup

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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 [SpO2ALM HI/LO] item, you can set up [SpO2ALM H] and [SpO2ALM
LO].Alarm occurs, when SpO2value overows.
For the [PR ALM HI/LO] item, you can set up [PRALM HI] and [SpO2ALM
LO].Alarm occurs, when PR value overows.
SpO2and 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
SpO2100 0 1
PR 254 0 1
Figure 8
ABPM infor

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3.2.3 SpO2TABLE
Pick the [SpO2TABLE] 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
SpO2table
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 SpO2
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 ap-
pear 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
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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 “Conrm” 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 “Conrm”, 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