Gima RS01 User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
SLEEP APNEA SCREEN METER
User manual
M33676-GB-Rev.1-01.20
ATTENTION: The operators must
carefully read and completely
understand the present manual
before using the product.
33676 / RS01
CONTEC MEDICAL SYSTEMS CO., LTD
ADD: No 112 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, 066004,
PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537 Hamburg, Germany
PROFESSIONAL MEDICAL PRODUCTS
0123
IP22
%
95%
0%
55°C
-40°C
1060hPa
500hPa

2
USER NOTICE
Announce
This user manual includes special documents, which is under protection of cop-
yright law. All rights reserved. Without written announcement from our company,
the contents in this manual should not be transferred, copied or translated into
other language.
Owing to the forthcoming renovation or error contained in the manual, the specic
products you received may not be totally in accordance with the description of
this User Manual. We would sincerely regret for that.
Our company reserves the nal elucidative right.
Manufacture’s Responsibility
Our company is responsible for safety, reliability and performance of this product
only in the condition that: all installing and repairs of this product are conducted
by our company’s authorized personnel; and this product is operated under strict
observance of this manual.
Warning: This device is not intended for treatment. If the result is dis-
trustful, please use other methods to verify immediately.
Warranty
The unit can not be repaired by users themselves. All services must be done by
the engineers approved by manufacturer. We warrant that each product we sell
you is free from defects in labour and materials and shall conform to its product
specications as dened in the user documentation. If the product doesn’t func-
tion as warranted during the warranty period, we will repair or replace it for free
charge. Misuse, improper maintenance may void from the warranty.
Explanation of label in the manual
Warning: the information that should be noted to avoid injury to the patient
and the operator.
Attention: important information that you should know.
•Item: item message.
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Contents
1 Safety ............................................................................................................... 4
1.1 Safety Instructions ..................................................................................... 4
1.2 Warnings..................................................................................................... 4
1.3 Attention ..................................................................................................... 5
2 Brief Introduction............................................................................................ 6
2.1 Overview ..................................................................................................... 6
2.2 Main Functions and Features ..................................................................... 6
2.3 Accompanying Accessories ...................................................................... 7
3 External Appearance and Structure ............................................................ 7
3.1 Buttons and Connections........................................................................... 7
3.2 Instructions for Front Panel ....................................................................... 8
4 Device Operation Explanation ..................................................................... 10
4.1 Button Operation ...................................................................................... 10
4.2 Menu Operation........................................................................................ 10
4.3 Sensor Connection ................................................................................... 15
4.4 Clinical Restrictions .................................................................................. 19
4.5 Time Powering on Function...................................................................... 20
4.6 USB Data Uploading.................................................................................20
4.7 Charging Operation .................................................................................. 21
5 PC Software Operation Explanation ........................................................... 22
5.1 Data Importing and Case Management.................................................... 22
5.2 System Setting..........................................................................................25
5.3 Waveform Display..................................................................................... 28
5.4 Function Menus ........................................................................................ 31
6 Product Specication................................................................................... 35
7 Cleaning, Disinfection and Maintenance.................................................... 36
7.1 Cleaning.................................................................................................... 36
7.2 Disinfection ............................................................................................... 37
7.3 Maintenance ............................................................................................. 37
8 Symbol Meanings ......................................................................................... 38
9 Trouble Shootings......................................................................................... 40
Appendix 1 ........................................................................................................ 40
Appendix 2 ........................................................................................................ 41
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1 Safety
1.1 Safety Instructions
• Test at regular period to verify there is not evident damage that may affect
safety and monitor performance. The period is recommended to be less than
one month. If there is any damage, stop using it immediately.
• The maintenance of the device should only be carried out by personnel au-
thorized and specied by our company, and the user shall not maintain it by
himself.
• The device should not be used with other devices that not specied in this
manual. Especially for those accessories specied or recommended by manu-
facture.
• The device has been calibrated before leaving factory.
1.2 Warnings
The infrared is harmful to the eyes, so the user and the maintenance man
should not stare at the light part of the SpO2probe (the infrared is invisible).
For the special patients, there should be a more prudent inspecting in the
placing process. The SpO2probe can not be clipped on the edema and ten-
der tissue.
Please don’t use this device when charging.
Explosive hazard—DO NOT use the device in environment with inammable
gas such as some ignitable anesthetic.
DO NOT use the device while the patient is being scanned by MRI or CT.
Protect the wrist band for normal use; and wear it tightly to avoid dropping
to broken in the operation; the user who is allergic to rubber shall not use the
wrist band.
Please use the accessories and probe that the manufacture species or rec-
ommends to avoid damage to this device.
The disposal of scrap instrument and its accessories and packings (including
battery, plastic bags, foams and paper boxes) should follow the local laws
and regulations.
Please do not test the related information of this device with function tester.
Do not transport this device with poisonous, deleterious or mordant sub-
stances.
No modication of this equipment is allowed.
When the equipment was used in home, patients might be expected,
and the patient should pay attention to the specications of 1.2 on the
operator’s warning and note 1.3
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The equipment is prohibit from repairing or vindicating during it is using.
Moreover, the external computer, CD or Type with recording cable which con-
nected with the Sleep apnea screen meter must be certicated according to
the relevant IEC standards (such as: IEC 60601-1). For the requirements that
are applicable to an ME SYSTEM, the RESPONSIBLE ORGANIZATION shall
be referred to this standard.
1.3 Attention
Please check the packing before use to make sure the device and acces-
sories are totally in accordance with the packing list, or else the device may
have the possibility of working abnormally.
The device may be a little different from the picture of manual, please make
the actual device as standard.
Keep a operation environment without dust, vibration, ammable or mordant
substances.
When moved from a place cold to another warm and wet one, do not use it
at once.
Do not operate the buttons with sharp tools.
Do not disinfect this device with high temperature and pressure or gas.
Do not immerse this device in liquid. When cleaning its surface with medical
alcohol, do not spoil it directly on the device.
This device has prompt sound function, if it is not necessary, you can choose
to silence it.
The mode of operation for this device is continuous, and it is common equip-
ment, if splashed and coagulated, stop operation.
The service life of this device is ve years.
At the end of this device’s service life, return it to your manufacture for circle
use or dispose it in compliance with local regulations.
Please refer to respective chapter for more notes.
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