Gima ABPM50 User manual

PROFESSIONAL MEDICAL PRODUCTS
GIMA ABPM PULSE RATE MONITOR
User manual
ATTENTION: The operators must carefully read and completely understand the present
manual before using the product.
M35110-EN-Rev.4-09.23
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street, Economic & Technical
Development Zone, Qinhuangdao, Hebei Province,
PEOPLE’S REPUBLIC OF CHINA
Made in China
ABPM50 (Gima 35110)
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany
0123
0%
%
700hPa
1060hPa
-20˚C
55˚C

I
Foreword
Please read the User Manual carefully before using this product. The User Manual which
describes the operating procedures should be followed strictly. This manual detailed introduce
the steps must be noted when using the product, operation which may result in abnormal, the risk
may cause personal injury and product damage and other contents, refer to the chapters for details.
Any anomalies or personal injury and device damage arising from use, maintain, store do not follow
requirements of the User Manual, Our company is not responsible for the safety, reliability and
performance guarantees! The manufacturer’s warranty service does not cover such faults!
Our company has a factory record and user profile for each device, users enjoy free maintenance
services for one year from the date of purchase. In order to facilitate us to provide you with a
comprehensive and efficient maintenance service, please be sure to return the warranty card when
you need repair service.
Note: Please read the User Manual carefully before using this product.
Described in this User Manual is in accordance with practical situation of the product. In case of
modifications and software upgrades, the information contained in this document is subject to
change without notice.

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The warning items
Before using this product, you should consider the safety and efficacy of the following
described:
Described each measurement results combined with clinical symptoms by qualified doctors.
The reliability and operation of using this product whether meets the operation of this manual
relate to the maintenance instructions.
The intended operator of this product may be the patient.
Do not perform maintenance and service while the device is in use.
Responsibility ofoperator
The operator must carefully read the User Manual before use this product, and strictly follow
the operating procedure of the User Manual.
Fully consider the security requirements during product design, but the operator should not
ignore the observation for the patient and the state of machine.
The operator has the responsibility to provide the use condition of the product to our
company.

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Responsibility for our company
Our company have the responsibility to provide qualified product which conform to company
standard of this product.
Our company will provide the circuit diagram, calibration method and other information at
the request of the user to help the appropriate and qualified technicians to repair those parts
designated by our company.
Our company have the responsibility to complete product maintenance according to the
contract.
Our company have the responsibility to respond the requirements of user in time.
In the following case, our company is responsible for the impact on the safety, reliability and
performance of the device:
Assembly, addition, debugging, modification or repair are carried out by personnel approved
by our company.
The electrical facilities in the room are in compliance with the relevant requirements and the
device is used in accordance with the User Manual.
The User Manual is written by our company. All rights reserved.

IV
CONTENTS
Chapter1 Introduction ....................................................................................................................... 1
1.1 Safety Precautions ............................................................................................................ 1
1.2 General Information ......................................................................................................... 6
1.3 Button Functions .............................................................................................................. 8
1.4 Interfaces ........................................................................................................................ 10
1.5 Accessories ...................................................................................................................... 11
Chapter2 Getting Started ................................................................................................................ 15
2.1 Open the Package and Check ......................................................................................... 15
2.2 Battery Installation ......................................................................................................... 15
2.3 Power on the Instrument ................................................................................................. 17
2.4 Connect Sensor ............................................................................................................... 18
Chapter3 Function Interface ........................................................................................................... 19
3.1 Main Interface ................................................................................................................ 19
3.2 Measuring Interface ........................................................................................................ 20
3.3 Measure Result Interface ................................................................................................ 21
3.4 System Menu .................................................................................................................. 21
3.5 Ordinary User Data Review ........................................................................................... 34

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Chapter4 NIBP Measuring .............................................................................................................. 35
4.1 General ........................................................................................................................... 35
4.2 Applying the Cuff and NIBP Measuring......................................................................... 38
4.3 Operation Hints .............................................................................................................. 40
4.4 NIBP Error Messages and Solutions ............................................................................... 44
4.5 Maintenance and Cleaning ............................................................................................. 46
4.6 Transportation and Storage ............................................................................................. 49
4.7 Key and Symbols ........................................................................................................... 50
Chapter5 Requirements of Hardware .............................................................................................. 53
Chapter 6 Software Functions ......................................................................................................... 54
6.1 User Register .................................................................................................................. 54
6.2 Main Interface ................................................................................................................ 56
6.3 Wear ............................................................................................................................... 57
6.4 Setting for Collection Plan ............................................................................................. 58
6.5 Data Download ............................................................................................................... 60
6.6 Open Data File ............................................................................................................... 61
6.7 Delete Data File .............................................................................................................. 62
6.8 Data File Backup ............................................................................................................ 63

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6.9 Edit IP Data .................................................................................................................... 64
6.10 BP Trend Graph ............................................................................................................ 66
6.11 Display of Statistics Information .................................................................................. 69
6.12 Patient Information Settings ......................................................................................... 70
6.13 Sleep Time Setting........................................................................................................ 71
6.14 BP Threshold Setting .................................................................................................... 72
6.15 Histogram ..................................................................................................................... 73
6.16 Pie Chart ....................................................................................................................... 74
6.17 Correlation Line ........................................................................................................... 75
6.18 Print Report .................................................................................................................. 76
6.19 Help .............................................................................................................................. 78
Specification ...................................................................................................................................... 79
Appendix ........................................................................................................................................... 83

1
Chapter1 Introduction
Operators do not need professional training, but should use this product after fully understanding the
requirements in this manual.
To prevent users from suffering hurt or damnification due to improper use,please refer to "Safety
Precautions" and use this product properly.
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.
1.1 Safety Precautions
Warning
If not use correctly,it exists the possibility of damage for personnel and goods.
Good damage means the damage of house, property,domestic animal and pet.
For severe blood circulation disorder or arrhythmia patients, please use the device
under the guidance of a doctor. Otherwise it may lead to acute hemorrhage, or
measurement error as a result of squeezed arm.
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.

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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.
Contraindication
No contraindications.
Warning
Do not use the device in the case of there are flammable anesthetic gasses mixing with the air
or nitrous oxide.
Otherwise it may cause risk.
For children and the person who can't express oneself, please use the device under the
guidance of a doctor.
Otherwise it may cause accident or dissension.
Self-diagnosis and treatment using measured results may be dangerous. Follow the
instructions of your physician.
Please hand measurement results to the doctor who knows your health and accept diagnosis.
Please do not use for any other purpose except BP measurement.
Otherwise it may cause accident or holdback

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Please use special cuff.
Otherwise it is possible that measurement result is incorrect.
Please do not keep the cuff in the over-inflated state for a long time.
Otherwise it may cause risk.
If liquid splashes on the device or accessories, especially when liquids may enter the pipe or
device, stop using and contact the service department.
Otherwise it may cause risk.
Dispose of the packaging material, observing the applicable waste control regulations and
keeping it out of children's reach.
Otherwise it may cause harm to the environment or children.
Please use approved accessories for the device and check that the device and accessories are
working properly and safely before use.
Otherwise the measurement result may be inaccurate or an accident may occur.
When the device is accidentally damp, it should be placed in a dry and ventilated place for a
period of time to dissipate moisture.
Otherwise the device may be damaged due to moisture.
Do not store and transport the device outside the specified environment.
Otherwise it may cause measurement error.

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It is recommended that you check if there is any damage on the device 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. Do not disassemble, repair and modify the
device without permission.
Otherwise it cannot be accurately measured.
This device can not be used on mobile transport platforms.
Otherwise it may cause measurement error.
This device can not be used on a tilted tabletop.
Otherwise there is a risk of falling.
Dispose of packaging materials, waste batteries and end-of-life products in accordance with
local laws and regulations. The end-of-life products and materials are properly disposed of by
the user in accordance with the authority’s decree.
Replace accessories which not provided by our company may lead to the occurrence of errors.
Without our company or other approved maintenance organizations trained service personnel should
not try to maintain the product.
This device can only be used for one test object at a time.
If the small parts on the device are inhaled or swallowed, please consult a doctor promptly.
The device and accessories are processed with allergenic materials. If you are allergic to it , stop

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using this product.
Do not use a mobile phone near the blood pressure monitor. Excessive radiation fields
generated by mobile phones can interfere with the normal use of the blood pressure monitor.
The blood pressure monitor has slight electromagnetic radiation to the external environment,
but does not affect the normal use of other equipment.
This device is suitable for occasions with electrosurgical equipment, but when used with
electrosurgical equipment, patient safety must be given the highest priority.
The parts of the device that are in contact with the patient (cuffs, air pipes, enclosue, etc.) are
made of insulating material and the device is protected against electric shock. When high
frequency or defibrillation devices are applied to the patient, no special precautions need to be
taken and the defibrillator discharge will not affect the device.
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.
This device is suitable for occasions with electrosurgical equipment, but when used with
electrosurgical equipment, patient safety must be given the highest priority.
When the monitor is wetted, please stop using it and contact us.
After pressing the power button, if the device has display fault such as white screen, blurred

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screen or no display content, please contact our company.
Note
The software was developed in accordance with IEC60601-1. The possibility of hazards
arising from errors in the software program has been minimized.
All analog and digital equipment connected to this device must be certified to IEC
standards(such as IEC60950: Information technology equipment-Safety and IEC60601-1:
Medical electrical equipment-Safety), and all equipment should be connected to in accordance
with the requirement of the valid version of the IEC60601-1-1 system standard. The person
connecting the additional equipment to the signal input and output port is responsible for
whether the system complies with the IEC60601-1 standard.
Refer to the following chapters for the minimum value of patient physiological signals.
Operation of the device below the minimum value may result in inaccurate results.
The Monitor shall comply with the standard IEC 80601-2-30:Particular requirements
for basic safety and essential performance of automated non-invasive sphygmomanometers.
1.2General Information
This device is defibrillator protected,the time of defibrillation recovery is 5 seconds.Note that no
precautions specific to the device is required during defibrillation, and defibrillation discharge has

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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 device is applied to Blood Pressure(BP) measure and monitor for adult(including pregnant
women), 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 BIG FONT single record data review, data list, BP data
trends chart, the current time,date,power and so on.
User can power on/off the monitor,start manual measure, set system parameters and so on with five
keys in the front panel. (Please refer to "Button Functions" part for detail)
The monitor does not have an alarm system, but it will prompt when the power is low, the measure
is wrong, or the measure data exceeds the set limits. When the power is low or the measure is wrong,
the prompt is audible and visual, the device will buzz intermittently and the red light will flash to
prompt the user to replace batteries or prompt the reason of the failed measurement; when the
measure data exceeds the set limits, the prompt is audible, the font color of measure results will
change to red. Users can open and close the prompt according to needs.

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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
In the common user mode, the monitor will periodically turn off backlight if there is no
operation, and automatically shuts down if there is no operation for two minutes. When the
backlight turn off in the ambulatory blood pressure mode, the blue indicator intermittently
flashes to prompt the device in running state.
1.3Button 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 blue both flash once to prompt that the on or off operation is successful. Press it for
a short time to return the boot-strap interface.

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
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 prompt 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
After connecting the USB cable, all of the buttons are disabled. If the BP measurement
is in progress, this measurement is will be automatically canceled.

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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.
1.4Interfaces
For the convenience of operation, different kinds of interfaces are in different parts of the device.
NIBP cuff socket is at the top of the device.
Note
The connection of the NIBP external air pipe is as shown:
①Cuff extension tube metal nozzle
②the socket for air pipe

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Figure 1.4.1 The Top External airway Figure 1.4.2 Bottom
At the bottom is the socket for USB:①The Socket for USB, connect the data line to upload data.
1.5Accessories
1) A cuff for adult
2) An USB data line
①

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3) BP extending tube
4) A pouch
5) User Manual
6) Software
Note
The monitor also can be equipped with pediatric and neonatal cuff, if necessary, please contact our
company or its representatives.
The width of the cuff should be 40% of the limb circumference(50% for the newborn) or 2/3 of
the length of the upper arm.The length of the inflated part of the cuff should be sufficient to
surround 50% to 80% of the limb. Unsuitable cuffs can produce erroneous readings. If there is
a problem with the size of the cuff, use a larger cuff to reduce the error.
Reusable Cuff of adult/ pediatric/ neonatal
Patient type
Limb circumference
Width of the cuff
Length of inflatable tube
Neonatal
6
～
11 cm
4.5 cm
1.5 m or 3 m
Infant
10
～
19 cm
8 cm
Pediatric
18
～
26 cm
10.6 cm
Adult 1
25
～
35 cm
14 cm

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Adult 2
33
～
47 cm
17 cm
Disposable cuff of neonatal
Size
Limb circumference
Width of the cuff
Length of inflatable tube
1
3.3
～
5.6 cm
2.5 cm
1.5 m or 3 m
2
4.2
～
7.1 cm
3.2 cm
3
5.0
～
10.5 cm
4.3 cm
4
6.9
～
11.7 cm
5.1 cm
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.
Note
The cuff is a consumable. In order to correctly measure blood pressure, please replace the cuff
in time.
If the cuff leaks, please contact our company to buy a new one.The cuff purchased separately
does not include the BP extension tube. Please give an explanation if you need to buy a BP extension
tube at the same time. If you do not want to buy a BP extension tube, please do not throw the BP