Gima 35111 User manual

M35111-GB-Rev.5-12.20
GIMA ABPM PULSE RATE MONITOR
WITH SpO2
0123
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
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
35111 / PM50
IPX1
PROFESSIONAL MEDICAL PRODUCTS

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.
The warning items
Before using this product, you should consider the safety and efficacy of the following
described:
⚫The safety classification of this product is Type BF applied part (Internally powered).

II
⚫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 of operator
⚫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.
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:

III
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
Chapter 1 Introduction................................................................................................................................ 1
1.1 General Information................................................................................................................... 6
1.2 Button Functions........................................................................................................................ 7
1.3 External Interfaces...................................................................................................................... 9
1.4 Accessories............................................................................................................................... 10
Chapter 2 Installation ............................................................................................................................... 13
2.1 Open Package and Check......................................................................................................... 13
2.2 Battery Installation................................................................................................................... 13
2.3 Power on .................................................................................................................................. 15
2.4 Connect SpO2Probe................................................................................................................. 15
Chapter3 Function Interface ..................................................................................................................... 17
3.1 Main Interface.......................................................................................................................... 17
3.2 System Menu............................................................................................................................ 21
Chapter4 SpO2Monitoring....................................................................................................................... 29
4.1 What is the SpO2Monitoring ................................................................................................... 29
4.2 Precautions during SpO2/Pulse Monitoring .............................................................................. 31
4.3 Monitoring Procedure............................................................................................................... 35
Chapter5 NIBP Monitoring ...................................................................................................................... 38
5.1 Introduction.............................................................................................................................. 38
5.2 NIBP Monitoring...................................................................................................................... 39
5.3 NIBP error messages and causes.............................................................................................. 43

V
Chapter6 Maintenance and Cleaning........................................................................................................ 46
Chapter 7 Software installation................................................................................................................. 50
7.1 Requirements of Hardware....................................................................................................... 50
7.2 Software Installation................................................................................................................. 50
Chapter 8 Software Functions................................................................................................................... 51
8.1 User Register............................................................................................................................ 51
8.2 Main Interface.......................................................................................................................... 53
8.3 Wear......................................................................................................................................... 54
8.4 Setting for Collection Plan ....................................................................................................... 55
8.5 Data Download......................................................................................................................... 59
8.6 Open Data File ......................................................................................................................... 60
8.7 Delete Data File........................................................................................................................ 61
8.8 Data File Backup...................................................................................................................... 62
8.9 Edit IP Data.............................................................................................................................. 64
8.10 Trend Graph ........................................................................................................................... 65
8.11 Display of Statistics Information............................................................................................ 71
8.12 Patient Information Settings................................................................................................... 72
8.13 Sleep Time Setting ................................................................................................................. 73
8.14 BP Threshold Setting.............................................................................................................. 74
8.15 Histogram............................................................................................................................... 75
8.16 Pie Chart................................................................................................................................. 76
8.17 Correlation Line ..................................................................................................................... 77

VI
8.18 Print Report............................................................................................................................ 78
8.19 Help........................................................................................................................................ 81
Chapter 9 Key of Symbols........................................................................................................................ 82
Chapter10 Specification ........................................................................................................................... 84
Appendix.................................................................................................................................................. 87

1
Chapter 1 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 damage or loss due to improper use, please refer to
Safety Precautions and use this product properly.
◼For an overall introduction to the monitor, please refer to General Information.
◼For basic operating instructions, please refer to Button Function.
◼For allocation of interface sockets, please refer to External Interfaces.
Safety Precautions
Note
◼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. If the arm is squeezed during measurement, it may cause
acute internal hemorrhage or inaccurate measurement results.
◼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.
◼For patients with severe disturbances of blood coagulation, whether automatically
measure the blood pressure should be based on the clinical evaluation, because limb friction
with the cuff may cause the risk of hematoma.

2
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
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.

3
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.
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

4
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
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.

5
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
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 IEC6060101 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..

6
1.1 General Information
General instruction:
The monitor not only measures the ambulatory blood pressure, but also monitors the parameters of
NIBP and SpO2.The monitor integrates parameter measuring modules function and display function
in one device, features in compactness and lightweight.
The POWER switch is on the front panel. The RUN indicator and the PROMPT indicator at the
bottom of the screen flash once when the device is powered on. The PROMPT indicator flashes
when prompt occurs. The cuff and SpO2probe sockets are located on the top of the device. USB
socket is at the bottom of the monitor.
This monitor has friendly operation interface, all operations can be finished by the buttons on the
front panel. (Refer to "Button Functions" for details)
Ambulatory blood pressure measurement functions:
In this mode, the monitor can work 24 hours continuously. The monitor can upload the data to PC
for data editing, trend chart editing, statistic, information displaying, diagnosis information editing,
various parameter settings, printing and other functions.
Monitoring function:
NIBP systolic pressure(SYS), diastolic pressure(DIA), mean pressure(MAP)
SpO2oxygen saturation(SpO2), pulse rate(PR), SpO2PLETH
Note
In this mode, the length of working time continuously is decided by the interval of

7
measurement set by the user.
It is useful that the software at the state of monitoring as the ambulatory blood pressure.
Refer to Software Functions for details.
1.2 Button Functions
User can switch the interface by the buttons to achieve the functions of parameter setting, blood
pressure measuring, SpO2measuring and result checking, the detailed functions for each button are
as followings:
⚫Power button
ON/OFF: long press it to turn on/off the device.
Shortcut function: in any interface, short press it to return to the main interface quickly.
Note
When the battery power is low, the prompt occurs. The battery's frame becomes red, and
ceaseless flash.
⚫MENU button
In any interface, press it to execute the selected function
⚫UP button
Main interface: if the prompt sound is "ON"( displays on the top left corner), short press it

8
to switch between prompt and silence( displays on the top left corner).
Other interfaces: select upward items or page turning.
⚫DOWN button
Select downward items or page turning.
⚫Measure button
Press it to inflate the cuff for blood pressure measuring. During measuring, press it to stop
measuring and deflate.
Note
The yellow rectangular mark that moves along with the selection of the UP and DOWN
buttons on the interface is the cursor, and all the places where the cursor can stay can be
operated. When selecting contents by the menu button, the cursor turns to red, then press the
UP/DOWN to select, press the MENU button again to exist from the selected state and
complete the parameter setting.
Note
Plug in USB to carry on upload and download data when no battery. That the topside of the
screen displays USB symbol shows the instrument triumphantly connects with the computer.
NIBPkey is invalidation when plug in USB line.

9
1.3 External Interfaces
For the convenience of operation, the different kinds of interfaces are in different parts of the
monitor.
(1)At the top is the Socket for SpO2Sensor and socket for NIBP cuff.
Note
NIBP airway tube has been fixed to the Socket for NIBP cuff.
①the Socket for NIBP cuff
②the Socket for SpO2Sensor
Figure 1.3.1 Top
(2) At the bottom is the USB socket
①USB socket
②
①

10
Figure 1.3.2 Bottom
1.4 Accessories
1) a cuff for adult
2) a USB data line
3) a SpO2probe
4) a disk (PC software)
5) a pouch
6) a user manual
Warning
Please use the accessories supplied by the manufacturer or replace the accessories according to
the requirements of the manufacturer in order to avoid making harms to patients.
①

11
Note
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 for adult:
Patient type
Limb circumference
Width of the cuff
Length of inflatable tube
Adult 1
25～35cm
14cm
1.5m or 3m
Adult 2
33～47cm
17cm
◼The cuff is a consumable. Calculate by measuring 6 times a day(3 times each morning and
evening), the service life of the cuff is about 1 year.(using our experimental conditions) 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
extension tube away when replacing the cuff, install it on the new cuff.
◼Pouch is convenient for patients to carry the monitor. It is not necessary to replace it when the
backpack has a slight wear. Patients can according to the actual situation, contact our company to
buy a new backpack when the original backpack can not carry the monitor.

12
Note
When the product and accessories described in this manual are about to exceed the period of use,
they must be disposed according to relevant product handling specification. If you want to know
more information, please contact our company or representative organization.

13
Chapter 2 Installation
2.1 Open Package and Check
Open the package and take out the monitor and accessories carefully. Keep the package well for
possible future transportation or storage. Check the components according to the packing list.
■Check whether there is any mechanical damage.
■Check all the cables, connect some accessories.
If there is any problem, contact the distributor immediately.
2.2 Battery Installation
The device is powered by two 'AA' alkaline batteries or high-capacity batteries. Before using the
device, install two batteries in the battery compartment on the back of the Monitor. Specific steps are
as follows:
①②③