Gima OXY 9 Mode d’emploi
PULSOXIMETRO OXY 9 - wireless
OXY 9 OXIMETER - wireless
OXYMÈTRE OXY 9 - sans l
OXY 9 OXÍMETRO - inalámbrico
OXY 9 OXYMETER - kabellos
OXY 9 OXÍMETRO - sem o
M35078-M-Rev.0.04.21
PROFESSIONAL MEDICAL PRODUCTS
Importato da / Imported by / Importé par /
Importado por / Importado por / Eingeführt von:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
CMS50D-BT (35078)
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
IP22
95%
0%
1060 hPa
500 hPa
60°C
-40°C
32ENGLISH
Instructions to User
Dear users, thank you very much for purchasing the Pulse
Oximeter.
In case of modications and software upgrades, the informa-
tion contained in this document is subject to change without
notice.
The Manual describes, in accordance with the Pulse Oxime-
ter’s features and requirements, main structure, functions,
specications, correct methods for transportation, installa-
tion, 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 measuring abnormality, equipment
damage and human injury. The manufacturer is NOT re-
sponsible for the safety, reliability and performance issues
and any monitoring abnormality, human injury and equip-
ment damage due to users’ negligence of the operation
instructions. The manufacturer’s warranty service does not
cover such faults.
Owing to the forthcoming renovation, the specic products
you received may not be totally in accordance with the de-
scription of this User Manual. We would sincerely regret for
that.
This product is medical device, which can be used repeat-
edly.
WARNING:
Uncomfortable or painful feeling may appear if using
the device ceaselessly, especially for the microcircula-
tion barrier patients. It is recommended that the sensor
should not be applied to the same nger 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.
33 ENGLISH
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 ngernail 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.
1 SAFETY
1.1 Instructions for Safe Operations
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 performance about cables
and transducers. It is recommended that the device should
be inspected once a week at least. When there is obvious
damage, stop using the device. In addition ,the overall check
of monitor, including the safety check such as the leakage
current, should be performed only by qualied personnel
once every 12 months.
• Necessary maintenance must be performed by qualied
service engineers ONLY. There are no user serviceable
parts and users are not permitted to maintain it by them-
selves.
• The oximeter cannot be used together with devices not
specied in User’s Manual. Only the accessory that ap-
pointed or recommendatory by manufacture can be used
with this device.
• This product is calibrated before leaving factory.
1.2 Warning
Explosive hazard—DO NOT use the oximeter in envi-
ronment with inammable gas such as some ignitable
anesthetic agents.
Ensure that the environment in which the device is op-
34
erated is not subject to any sources of strong electro-
magnetic interference, such as radio transmitters, mobile
telephones, etc. Keep them far away High level electro-
magnetic radiation emitted from such devices may great-
ly affect the monitor performance.
DO NOT use the oximeter while the testee measured by
MRI and CT.
Be careful with the use of the lanyard cord. Improper use
of the lanyard cord will cause device damage not cov-
ered under the manufacturer’s warranty. Swinging the
device by the lanyard cord will void the warranty. Please
do not use lanyard cord if allergic to lanyard cord.
The person who is allergic to rubber can not use this de-
vice.
The disposal of scrap instrument and its accessories and
packings(including battery, plastic bags, foams and pa-
per boxes) should follow the local laws and regulations.
Please check the packing before use to make sure the
device and accessories 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 ap-
proved or manufactured by the manufacturer, or else it
may damage the device.
Please don’t measure this device with functional tester
for the device’s related information.
When uploading, do keep the patient form touching the
USB port. The computer used when uploading must be
in accordance with EN60950. In addition, when the data
line connected to a computer, the medical electrical sys-
tems should be in accordance with IEC60601-1-1.
1.3 Attention
Keep the oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and
moisture.
If the oximeter gets wet, please stop operating it.
When it is carried from cold environment to warm or hu-
ENGLISH
35
mid environment, please do not use it immediately.
DO NOT operate keys on front panel with sharp materi-
als.
High temperature or high pressure steam disinfection of
the oximeter is not permitted. Refer to User Manual in
the relative chapter (7.1)for instructions of cleaning and
disinfection.
Do not have the oximeter immerged in liquid. When it
needs cleaning, please wipe its surface with medical al-
cohol by soft material. Do not spray any liquid on the
device directly.
When cleaning the device with water, the temperature
should be lower than 60℃.
As to the ngers which are too thin or too cold, it would
probably affect the normal measure of the patients’ SpO2
and pulse rate, please clip the thick nger such as thumb
and middle nger deeply enough into the probe.
The update period of data is less than 5 seconds, which
is changeable according to different individual pulse rate.
The waveform is normalized. Please read the measured
value when the waveform on screen is equably and
steady-going. Here this measured 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 nger and reinsert to restore
normal use.
The device has normal useful life for three years since
the rst electried use.
The hanging rope attached to the device is made from
Non- allergy material, if particular group are sensitive to
the hanging rope, stop using it. In addition, pay attention
to the use of the hanging rope , do not wear it around the
neck on the purpose of avoiding harm to the patient.
This device has the function of alarming, users can
check on this function according to chapter 6.2 as a ref-
erence.
The device has the function of limits alarming, when the
ENGLISH
36
measured data is beyond the highest or lowest limit, the
device would start alarming automatically on the premise
of the alarming function is on.
The device has the function of alarming, this function can
either be paused, or closed (default setting) for good.
This function could be turned on through menu operation
if you need. Please check the chapter 6.2 as a reference.
The device may not work for all patients. If you are una-
ble to achieve stable readings, discontinue use.
A exible circuit connects the two parts of the device. Do
not twist or pull on the connection.
2 OVERVIEW
The pulse oxygen saturation is the percentage of HbO2in
the total Hb in the blood, so-called the O2concentration in
the blood. It is an important bio-parameter for the respira-
tion. A number of diseases relating to respiratory system
may cause the decrease of SpO2in the blood, furthermore,
some other causes such as the malfunction of human body’s
self-adjustment, damages during surgery, and the injuries
caused by some medical checkup would also lead to the
difculty of oxygen supply in human body, and the corre-
sponding symptoms would appear as a consequence, such
as vertigo, impotence, vomit etc. Serious symptoms might
bring danger to human’s life. Therefore, prompt information
of patients’ SpO2is of great help for the doctor to discover
the potential danger, and is of great importance in the clinical
medical eld.
The Pulse Oximeter features in small volume, low power
consumption, convenient operation and being portable. It is
only necessary for patients to put one of his ngers into a
probe for diagnosis, and a display screen will directly show
the measured value of pulse oxygen saturation with the high
veracity and repetition.
2.1 Classication:
Class II b(MDD93/42/EEC IX Rule 10)
ENGLISH
37
2.2 Features
A. Operation of the product is simple and convenient.
B. The product is small in volume, light in weight and con-
venient in carrying.
C. Low power consumption
2.3 Major Applications and Scope of Application
The Pulse Oximeter can be used in measuring the pulse ox-
ygen saturation and pulse rate through nger. The product is
suitable for being used in family, hospital, oxygen bar, com-
munity healthcare, physical care in sports (It can be used
before or after doing sports, and it is not recommended to
use the device during the process of having sport) and etc.
The problem of overrating would emerge when
the patient is suffering from toxicosis which caused by
carbon monoxide, the device is not recommended to be
used under this circumstance.
2.4 Environment Requirements
Storage Environment
a) Temperature : -40℃ ~ +60℃
b) Relative humidity : ≤ 95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: 10℃ ~ 40℃
b) Relative Humidity: ≤ 75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa
3 PRINCIPLE
Principle of the Oximeter is as follows: An experience for-
mula of data process is established taking use of Lambert
Beer Law according to Spectrum Absorption Characteristics
of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2)
in glow & near-infrared zones. Operation principle of the de-
vice is: Photoelectric Oxyhemoglobin Inspection Technology
is adopted in accordance with Capacity Pulse Scanning &
Recording Technology, so that two beams of different wave-
ENGLISH
38
length of lights can be focused onto human nail tip through
perspective clamp nger-type sensor. Then measured sig-
nal can be obtained by a photosensitive element, informa-
tion acquired through which will be shown on screen through
treatment in electronic circuits and microprocessor.
Figure 1.
4 TECHNICAL SPECIFICATIONS
4.1 Main Performance
A. SpO2value display
B. Pulse rate value display, bar graph display
C. Pulse waveform display
D. Low-voltage indication: low-voltage indicator appears
before working abnormally which is due to low-voltage
E. Display direction can be changed automatically.
F. Enter standby mode automatically.
G. PR sound indication; sound prompt for over-limit, n-
ger-out and low battery
H. Memory function.
I. The data can be uploaded to the terminal equipment by
wired mode(Wire or Bluetooth wired equipment)
J. The data can be uploaded to the terminal equipment by
wireless mode (Bluetooth or Bluetooth wired equipment)
K. Time display(Wire or Bluetooth wired equipment)
4.2 Main Parameters
A. Measurement of SpO2
Measuring range: 0% ~ 100%
Glow and infrared ray
emission tube
Glow and infrared ray
receipt tube
ENGLISH
39
Accuracy: When the SpO2measuring range is 70%~
100%, the permission of absolute error is ±2%; below
70% unspecied
B. Measurement of pulse rate
Measuring range: 30 bpm ~ 250 bpm
Accuracy: ±2 bpm or ±2% (select larger)
C. Resolution
SpO2: 1%, Pulse rate: 1bpm.
D. Measurement Performance in Weak Filling
Condition
SpO2 and pulse rate can be shown correctly when
pulse-lling ratio is 0.4%. SpO2 error is ±4%, pulse rate
error is ±2 bpm or ±2% (select larger).
E. Resistance to surrounding light
The deviation between the value measured in the condi-
tion of man-made light or indoor natural light and that of
darkroom is less than ±1%.
F. Power supply requirement:
2.6 V DC ~ 3.6V DC.
G. Optical Sensor
Red light (wavelength is 660 nm, 6.65 mW)
Infrared (wavelength is 905 nm, 6.75 mW)
H. Adjustable prompt range:
SpO2: 0% ~ 100%
Pulse Rate: 0 bpm ~ 254 bpm
I. Bluetooth specications
Bluetooth protocol: Bluetooth Low Energy
USB protocol: None
Operating frequency: 2.4 GHz ISM band
Modulation: GFSK (Gaussian Frequency Shift Keying)
Transmitting power: 0 dBm, -6 dBm, -23 dBm
Sensitivity: ≤-84 dBm @ 0.1% BER
Transfer rate: 1 Mbps
Safety features: Authentication and encryption
Support Services: Bluetooth Data Transfer
J. FCC ID:2ABOGCMS50D-BT
ENGLISH
40
5 INSTALLATION
5.1 View of the Front Panel
Figure 2
Front view - Bluetooth equipment
Front view - Wire or Bluetooth wired equipment
USB interface: connect with USB cable (Wire or Bluetooth
wired equipment)
Button: exit standby; pause sound prompt, enter menu,
menu operation (Wire or Bluetooth wired equipment).
5.2 Battery Installation
A. Refer to Figure 3 open the battery compartment cover
on the back of the device,and insert the two AAA size
batteries properly in the right direction.
B. Replace the cover.
Please take care when you insert the batteries for
ENGLISH
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