Gima OXY-200 User manual

PROFESSIONAL MEDICAL PRODUCTS
OXY-200 PULSE OXIMETER
User manual
M35101-GB-Rev.1-07.19
35101 / CMS70A
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone,
066004 Qinhuangdao, Hebei Province,
PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537 Hamburg, Germany
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
0123
IP21

Instructions to user
Dear users, thank you very much for purchasing the device.
This Manual is written and compiled in accordance with the council directive
MDD93/42/EEC for medical devices and harmonized standards. In case of
modications and software upgrades, the information contained in this docu-
ment is subject to change without notice.
The Manual describes, in accordance with the device’s features and require-
ments, main structure, functions, specications, correct methods for transpor-
tation, installation, usage, operation, repair, maintenance and storage, etc. As
well as the safety procedures to protect both the user and equipment. Refer to
the respective chapters for details.
Please read the User Manual carefully before using this product. The User
Manual which describes the operating procedures should be followed strictly.
Failure to follow the User Manual may cause measure abnormality, equipment
damage and human injury. The manufacturer is NOT responsible for the safety,
reliability and performance issues and any monitoring abnormality, human in-
jury and equipment damage due to users’ negligence of the operation instruc-
tions. The manufacturer’s warranty service does not cover such faults.
Owing to the forthcoming renovation, 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.
This product is medical device, which can be used repeatedly.
WARNING
Uncomfortable or painful feeling may appear if using the device easelessly,
especially for the microcirculation barrier patients.
It is recommended that the device should not be applied to the same finger
for over 2 hours.
For the special patients, there should be a more prudent inspecting in the
placing process. The device can not be clipped on the edema and tender
tissue.
The light (the infrared is invisible) emitted from the device is harmful to the
eyes, so the user and the maintenance man should not stare at the light.
Testee can not use enamel or other makeup.
Testee’s fingernail can not be too long.
Please refer to the correlative literature about the clinical restrictions and
caution.
This device is not intended for treatment.
The User Manual is published by our company. All rights reserved.
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Contents
1 Safety ................................................................................................. 4
1.1 Instructions for safe operation ............................................................ 4
1.2 Warning ............................................................................................... 4
1.3 Attention.............................................................................................. 5
1.4 EMC statement ................................................................................... 5
2 Overview ............................................................................................ 6
2.1 Features .............................................................................................. 6
2.2 Major applications and scope of application ...................................... 6
2.3 Contraindications................................................................................ 7
3 Principle ............................................................................................. 7
4 Technical specications ................................................................... 7
4.1 Main performance............................................................................... 7
4.2 Main parameters ................................................................................. 8
4.3 Environment requirements .................................................................. 8
5 Installation ......................................................................................... 9
5.1 View of the front panel ........................................................................ 9
5.2 View of the back panel...................................................................... 10
5.3 Accessories....................................................................................... 10
6 Operating guide............................................................................... 11
6.1 Application method........................................................................... 11
6.2 Attention for operation ...................................................................... 18
6.3 Clinical restrictions............................................................................ 19
7 Maintenance, transportation and storage .................................... 19
7.1 Cleaning and disinfecting.................................................................. 19
7.2 Maintenance...................................................................................... 19
7.3 Transportation and storage............................................................... 20
8 Troubleshooting............................................................................... 20
9 Key of symbols ................................................................................ 21
10 Function specication .................................................................... 22
11 Factory default ................................................................................ 23
Appendix ................................................................................................... 24
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1. SAFETY
1.1 Instructions for safe operation
• Check the main unit and all accessories periodically to make sure that there
is no visible damage that may affect patient’s safety and monitoring perfor-
mance. It is recommended that the device should be inspected weekly at
least. When there is obvious damage, stop using the device.
• Necessary maintenance must be performed by qualified service engineers
ONLY. Users are not permitted to maintain it by themselves.
• If the battery has to be replaced, the battery shall be provided by manufac-
ture and replaced only by trained service personnel. Incorrect replacement
and model of battery may cause device damage and patient injury.
• The device can’t be used together with devices not specified in User Manu-
al. Only the accessory that is appointed or recommendatory by manufacture
can be used with this device.
• This product is calibrated before leaving factory.
• Users should have basic text distinguish ability.
• The patient is also an intended operator. Patient can use the device for
measurement, storage and data upload. While device maintenance, clean
or batteries replacement is not allowed.
• During normal use please do not position this device to make it difficult to
disconnect form power supply.
• After use, please switch off and unplug the device.
1.2 Warning
Don’t open the enclosure of the device to avoid tip-and-run danger.
Necessary maintenance and upgrade must be performed by qualified ser-
vice engineers who have been trained and accredited by our company ONLY
Explosive hazard - DO NOT use the device in the environment with tinder
such as anesthetic .
DO NOT use the device while the patient is being scanned by MRI or CT.
The person who is allergic to rubber can not use this device.
The disposal of scrap instrument and its accessories and packing (including
battery, plastic bags, foams and paper boxes) should follow the local laws
and regulations, and place them in the place where the children can’t reach.
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.
Please choose the accessories and probe which are approved or manufac-
tured by the manufacturer, or else it may damage the device.
The device can only be matched with the compatible probe.
Please don’t measure this device with functional tester for the device’s relat-
ed information.
Parts of this device are not allowed to be serviced or maintained while in use
with the patient.
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5
1.3 Attention
Keep the device away from dust, vibration, corrosive substances, tinder,
high temperature and moisture.
If the device gets wet, please stop operating it.
When it is carried from cold environment to warm or humid environment,
please do not use it immediately.
DO NOT operate keys on front panel with sharp materials.
High temperature or high pressure steam disinfection of the device is not
permitted. Refer to User Manual in the relative chapter (7.1) for instructions
of cleaning and disinfection.
DO NOT have the device immerged in liquid. When it needs cleaning, please
wipe its surface with medical alcohol by soft material. Do not spray any liq-
uid on the device directly.
When cleaning the device with water, the temperature should be lower than
60°C.
The fingers which are too thin or too cold may affect the measure accura-
cy, please clip the thicker finger such as thumb and middle finger deeply
enough into the probe.
The device can be used to adult and child. Whether the device is used to
adult or children, it depends on the probe selected.
The update period of data is less than 5 seconds, which is changeable ac-
cording to different individual pulse rate.
Please read the measure value when the waveform on screen is equably and
steady-going. This measure value is optimal value, and the waveform at the
moment is the standard one.
If some abnormal conditions appear on the screen during test process, pull
out the finger and reinsert to restore normal use.
The device has life for three years.
The device has alarm function, users can check on this function according
to chapter 6.1 as reference.
The device has the function of limit alarm. When the measure data is beyond
limit, the device would start to alarm automatically if the alarm function is
on.
The device has alarm function. This function can either be paused, or closed
for good. Please check the chapter 6.1 as reference.
The device may not work for all patients. If you are unable to achieve stable
readings, discontinue use.
1.4 EMC statement
Electromagnetic compatibility shall be considered during device in use, be-
cause high electromagnetic portable or mobile RF equipment will interfere the
working of the device.
Usage of other cables will affect the EMC performance of the device, please
use the standard accessories.