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