Gima OXY-1 User manual

OXY-1 FINGER OXIMETER
OXÍMETRO DE PULSO OXY-1
ΠΑΛΜΙΚΌ ΌΞΎΜΕΤΡΌ OXY-1
OXY-1 FINGEROXIMETER
OXY-1 VINGEROXIMETER
PULSOXIMETRU PENTRU DEGET OXY-1
Imported by / Importado por / Εισαγωγή από /
Importeret af / Geïmporteerd door / Importat de:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [email protected]
www.gimaitaly.com
M35070-M-Rev.0.01.21
35070 / CMS50DL
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
PROFESSIONAL MEDICAL PRODUCTS
95%
0%
1060 hPa
500 hPa
60°C
-40°C

2ENGLISH
Instructions to User
Dear users, thank you very much for purchasing the Pulse
Oximeter.
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 soft-
ware upgrades, the information 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,
specications, 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 specic 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
repeatedly.
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

3ENGLISH
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 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.
Caution: Federal law restricts this device to sale by or on
the order of a physician. 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 ca-
bles and transducers. It is recommended that the device
should be inspected once a week at least. When there is
obvious damage, stop using the monitor.
• Necessary maintenance must be performed by qualied
service engineers ONLY. Users are not permitted to main-
tain it by themselves.
• The oximeter cannot be used together with devices not
specied 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 Warnings
• Explosive hazard—DO NOT use the oximeter in environ-
ment with inammable gas such as some ignitable anes-
thetic agents.
• DO NOT use the oximeter while the testee measured by
MRI and CT.

4
• 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 paper
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 don’t measure this device with function test paper
for the device’s related information.
1.3 Attentions
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-
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 for instructions of cleaning and disin-
fection.
 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°C.
 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.
Do not use the device on infant or neonatal patients.
The product is suitable for children above four years old
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5
and adults(Weight should be between 15kg to 110kg).
The device may not work for all patients. If you are una-
ble to achieve stable readings, discontinue use.
The update period of data is less than 5 seconds, which
is changeable according to different individual pulse rate.
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 electried use.
The hanging rope attached the product 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 avoiding cause harm to the patient.
The instrument dose not have low-voltage alarm func-
tion, it only shows the low-voltage, please change the
battery when the battery energy is used out.
When the parameter is particularly low, the instrument
dose not have alarm function. Do not use the device in
situations where alarms are required.
 Batteries must be removed if the device is going to be
stored for more than one month, or else batteries may
leak.
A flexible circuit connects the two parts of the
device. Do not twist or pull on the connection.
1.4 Indication for Use
The Fingertip Pulse Oximeter is a non-invasive device in-
tended for the spot-check of oxygen saturation of
arterial hemoglobin (SpO2) and the pulse rate of adult and
pediatric patients in home and hospital environments (in-
cluding clinical use in internist/surgery, anesthesia, intensive
care ect.).
This device is not intended for continuous monitoring.
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6
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. For the purpose of measuring the SpO2more easily
and accurately, our company developed the Pulse Oximeter.
At the same time, the device can measure the pulse rate
simultaneously.
The Pulse Oximeter features in small volume, low power
consumption, convenient operation and being portable. It
is only necessary for patient to put one of his ngers into
a ngertip photoelectric sensor for diagnosis, and a display
screen will directly show measured value of Hemoglobin
Saturation.
2.1 Classication:
Class II b(MDD93/42/EEC IX Rule 10)
Class II (U.S.FDA)
2.2 Features
• Operation of the product is simple and convenient.
• The product is small in volume, light in weight (total weight
is about 50g including batteries) and convenient in carry-
ing.
• Power consumption of the product is low and the two origi-
nally equipped AAA batteries can be operated continuous-
ly for 24 hours.
• The product will automatically be powered off when no
signal is in the product within 5 seconds.
• Low-battery indicator as battery icon ash manner.
2.3 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemo-
globin Saturation and pulse rate through nger, and indicate
the pulse intensity by the bar-display.
The product is suitable for use in family, hospital (Ordinary
sickroom ), Oxygen Bar, social medical organizations and
also the measure of saturation oxygen and pulse rate.
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7
The product is not suitable for use in continuous
supervision for patients.
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 circum-
stance.
2.4 Environment Requirements
Storage Environment
a) Temperature: -40°C~+60°C
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Temperature: 10°C~40°C
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700hPa~1060hPa
3 PRINCIPLE AND CAUTION
3.1 Principle of Measurement
Principle of the Oximeter is as follows: An experience formu-
la of data process is established taking use of Lambert Beer
Law according to Spectrum Absorption
Characteristics of Reductive Hemoglobin (Hb) and Oxyhe-
moglobin (HbO2) in glow & near-infrared zones. Operation
principle of the instrument is: Photoelectric Oxyhemoglobin
Inspection Technology is adopted in accordance with Ca-
pacity Pulse Scanning & Recording Technology, so that two
beams of different wavelength of lights can be focused onto
human nail tip through perspective clamp nger-type sensor.
Then measured signal can be obtained by a photosensitive
element, information acquired through which will be shown
on screen through treatment in electronic circuits and mi-
croprocessor.
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8
Figure 1. Operating Principle
3.2 Caution
1. The nger should be placed properly (see the attached
illustration of this manual, Figure 5), or else it may cause
inaccurate measurement.
2. The SpO2sensor and photoelectric receiving tube
should be arranged in a way with the subject’s arteriole
in a position there between.
3. The SpO2sensor should not be used at a location
or limb tied with arterial canal or blood pressure cuff or
receiving intravenous injection.
4. Make sure the optical path is free from any optical obsta-
cles like rubberized fabric.
5. Excessive ambient light may affect the measuring result.
It includes uorescent lamp, dual ruby light, infrared
heater, direct sunlight and etc.
6. Strenuous action of the subject or extreme electrosurgi-
cal interference may also affect the accuracy.
7. Testee can not use enamel or other makeup.
3.3 Clinical Restrictions
1. As the measure is taken on the basis of arteriole pulse,
substantial pulsating blood ow of subject is required.
For a subject with weak pulse due to shock, low ambi-
ent/body temperature, major bleeding, or use of vascu-
lar contracting drug, the SpO2waveform (PLETH) will
decrease. In this case, the measurement will be more
sensitive to interference.
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
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9
2. For those with a substantial amount of staining dilution
drug (such as methylene blue, indigo green and acid
indigo blue), or carbon monoxide hemoglobin (COHb),
or methionine (Me+Hb) or thiosalicylic hemoglobin, and
some with icterus problem, the SpO2determination by
this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine
and butacaine may also be a major factor blamed for se-
rious error of SpO2measure.
4. As the SpO2value serves as a reference value for judge-
ment of anemic anoxia and toxic anoxia, some patients
with serious anemia may also report good SpO2meas-
urement.
4 TECHNICAL SPECIFICATIONS
1. Display Format: Digital tube Display
SpO2Measuring Range: 0% - 100%
Pulse Rate Measuring Range: 30 bpm - 250 bpm
Pulse Intensity Display: columniation display
2. Power Requirements: 2 ×1.5V AAA alkaline battery, ad-
aptable range: 2.6V~3.6V
3. Power Consumption: Smaller than 25 mA
4. Resolution: 1% for SpO2 and 1 bpm for Pulse Rate
5. Measurement Accuracy: ±2% in stage of 70%-100%
SpO2, and meaningless when stage being smaller than
70%. ±2 bpm or ±2% (select larger) for Pulse Rate.
6. Measurement Performance in Weak Filling
Condition: SpO2and pulse rate can be shown correctly
when pulse-lling ratio is 0.4%. SpO2error is ±4%, pulse
rate error is ±2 bpm or ±2% (select larger).
7. Resistance to surrounding light: The deviation be-
tween the value measured in the condition of man-made
light or indoor natural light and that of darkroom is less
than ±1%.
8. It is equipped with a function switch. The Oximeter can be
powered off in case no nger is in the device.
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10
9. Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
5 ACCESSORIES
• One hanging rope
• Two batteries (optional)
• One User Manual
6 INSTALLATION
6.1 View of the Front Panel
Figure 2. Front View
Figure 3. Batteries Installation
Pulse rate
Pulse rate
bargraph display
ENGLISH
Power switch
The display SpO2
Low voltage display

11
6.2 Battery
Step 1. Refer to Figure 3. and insert the two AAA size batter-
ies properly in the right direction.
Step 2. Replace the cover.
Please take care when you insert the batteries
for the improper insertion may damage the de-
vice.
6.3 Mounting the Hanging Rope
Step 1. Put the end of the rope through the hole.
Step 2. Put another end of the rope through the rst one and
then tighten it.
Figure 4. Mounting the hanging rope
Figure 5. Put nger in position
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12
7 OPERATING GUIDE
7.1 Insert the two batteries properly to the direction, and
then replace the cover.
7.2 Open the clip as shown in Figure 5.
7.3 Let the patient’s nger put into the rubber cushions of
the clip (make sure the nger is in the right position),
and then clip the nger.
7.4 Press the switch button once on front panel.
7.5 Do not shake the nger and keep the patient at ease
during the process. Meanwhile, human body is not rec-
ommended in movement status.
7.6 Get the information directly from screen display.
7.7 In boot-strap state,press button ,and the device is re-
set.
Fingernails and the luminescent tube should be
on the same side.
8 REPAIRING AND MAINTENANCE
• Please change the batteries when the low-voltage dis-
played on the screen.
• Please clean the surface of the device before using. Wipe
the device with medical alcohol rst, and then let it dry in
air or clean it by dry clean fabric.
• Using the medical alcohol to disinfect the product after
use, prevent from cross infection for next time use.
• Please take out the batteries if the oximeter is not in use
for a long time.
• The best storage environment of the device is -40ºC to
60ºC ambient temperature and not higher than 95% rela-
tive humidity.
• Users are advised to calibrate the device termly (or ac-
cording to the calibrating program of hospital). It also can
be performed at the state-appointed agent or just contact
us for calibration.
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13
High-pressure sterilization cannot be used on
the device.
Do not immerse the device in liquid.
It is recommended that the device should be
kept in a dry environment.
Humidity may reduce the useful life of the de-
vice, or even damage it.
9 TROUBLESHOOTING
Trouble Possible Reason Solution
The SpO2and
Pulse Rate can
not be displayed
normally.
1. The nger is not
properly positioned.
2. The patient’s SpO2is
too low to be detected.
1. Place the nger
properly and try
again.
2. Try again; Go to a
hospital for a diagno-
sis if you are sure
the device works
all right.
The SpO2and
Pulse Rate are not
displayed stably.
1. The nger is not
placed inside deep
enough.
2. The nger is shaking
or the patient is moving.
1. Place the nger
properly and try
again.
2. Let the patient
keep calm.
The device can not
be turned on. 1. The batteries are drained or almost
drained.
2. The batteries are not
inserted properly.
3. The malfunction of
the device.
1. Change
batteries.
2. Reinstall batteries.
3. Please contact the
local service center.
The display is off
suddenly. 1. The device will power off automatically when
it gets no signal within 5
seconds.
2. The batteries are
almost drained.
1. Normal.
2. Change
batteries.
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14
10 SYMBOLS
ENGLISH
Symbol Description
Type BF applied part
% SpO2The pulse oxygen saturation(%)
PRbpm Pulse rate (bpm)
The battery voltage indication is decient (change
the battery in time avoiding the inexact measure)
1. No nger inserted
2. An indicator of signal inadequacy
Battery positive electrode
Battery cathode
Power switch
Serial number
Alarm inhibit
IP22
Covering Protection rate
Keep in a cool, dry place
Keep away from sunlight
Medical Device complies with Directive 93/42/EEC
Product code
Lot number
Caution: read instructions (warnings) carefully
WEEE disposal
Follow instructions for use

15
11 FUNCTION SPECIFICATION
Display Information Display Mode
The Pulse Oxygen
Saturation (SpO2)
Digital
Pulse Rate (BPM) Digital
Pulse Intensity (bar-graph) Digital bar-graph display
SpO2 Parameter Specication
Measuring range 0%~100%, (the resolution is 1%).
Accuracy 70%~100%: ±2%
Below 70% unspecied
Optical Sensor Red light (wavelength is 660nm)
Infrared (wavelength is 880nm)
Pulse Parameter Specication
Measuring range 30bpm~250bpm (the resolution
is 1 bpm)
Accuracy ±2bpm or ±2% select larger
Pulse Intensity
Range Continuous bar-graph display, the
higher display indicate the stronger
pulse
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
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Manufacturer
Authorized representative in the European
community
Date of manufacture
Store between -40 and 60°C
%
Humidity limitation
Atmospheric pressure limitation

16
Battery Useful Life
Two batteries can work continually for 24 hours
Dimensions and Weight
Dimensions 57(L) × 31(W) × 32(H) mm
Weight About 50g (with the batteries)
Appendix:Electromagnetism Compatibility
Guidance and manufacture’s declaration – electromagnetic
emissions- for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emis-
sion
The CMS50DL is intended for use in the electromagnetic environment
specied below. The customer of the user of the CMS50DL should
assure that it is used in such and environment.
Emission test Compliance Electromagnetic environ-
ment – guidance
RF emissions
CISPR 11
Group 1 The CMS50DL uses RF
energy only for its internal
function. Therefore, its RF
emissions are very low and
are not likely to cause any
interference in nearby elec-
tronic equipment.
RF emissions
CISPR 11 Class B The CMS50DL is suitable for use in all establishments,
including domestic establish-
ments and those directly con-
nected to the public low-volt-
age power supply network
that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage uctuations/
icker emissions
IEC 61000-3-3
N/A
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17
Guidance and manufacture’s declaration – electromagnetic
immunity – for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic im-
munity
The CMS50DL is intended for use in the electromagnetic environment
specied below. The customer or the user of CMS50DL should assure
that it is used in such an environment.
Immunity test IEC 60601
test level Compli- ance level Electromagnetic envi- ronment - guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood,
concrete or ceramic tile.
If oor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for
power
supply lines
N/A Mains power quality
should be that of a typ-
ical commercial or hos-
pital environment.
Surge
IEC 61000-4-5 ±1 kV differential
mode
N/A Mains power quality
should be that of a typ-
ical commercial or hos-
pital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-
4-11
<5% UT
(>95% dip
in UT) for
0.5 cycle
40% UT
(60% dip
in UT)
for 5 cycles
70% UT
(30% dip
in UT) for
25 cycles
<5% UT
(>95% dip
in UT)
for 5 sec
N/A Mains power quality
should be that of a typ-
ical commercial or hos-
pital environment. If the
user of the CMS50DL
requires continued op-
eration during power
mains interruptions, it is
recommended that the
CMS50DL be powered
from an uninterrupti-
ble power supply or a
battery.
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18
Guidance and manufacture’s declaration – electromagnetic
immunity – for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic im-
munity
The CMS50DL is intended for use in the electromagnetic environment
specied below. The customer or the user of CMS50DL should assure
that it is used in such an environment.
Immunity
test IEC 60601 test level Compli- ance level Electromagnetic environ- ment - guidance
Radiated
RF IEC
61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m Portable and mobile RF
communications equipment
should be used no closer to
any part of the CMS50DL,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
3.5
V 1√P
d=
3.5
E 1√P
d=
7
E 1√P
d=
Power
frequency
(50/60Hz)
Magnetic eld
IEC-61000-4-8
3 A/m 3 A/m Power frequency mag-
netic elds sould be at
levels characteristic of
a typical location in a
typical commercial or
hospital environment.
NOTE UTis the a.c. mains voltage prior to application of the test
level.
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19
Where Pis the maximum
output power rating of the
transmitter in watts (W) ac-
cording to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from xed RF
transmitters, as determined
by an electromagnetic site
survey,a should be less than
the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects
and people.
a Field strengths from xed transmitters, such as base stations for radio (cel-
lular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accu-
racy. To assess the electromagnetic environment due to xed RF transmitters,
an electromagnetic site survey should be considered. If the measured eld
strength in the location in which the CMS50DL is used exceeds the applicable
RF compliance level above, the CMS50DL should be observed to verify nor-
mal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the CMS50DL .
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be
less than 3 V/m.
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20
Recommended separation distances between portable and
mobile RF communications equipment and the EQUIP-
MENT or SYSTEM – for EQUIPMENT or SYSTEM that are
not LIFE-SUPPORTING
Recommended separation distances between portable and mo-
bile RF communications equipment and the CMS50DL
The CMS50DL is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the
user of the CMS50DL can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the CMS50DL as
recommended below, according to the maximum output power of the
communications equipment.
Rated maxi-
mum output
power of
transmitter
(W)
Separation distance according to frequency of
transmitter (m)
150 kHz
to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0,01 0,12 0,12 0,23
0,1 0,39 0,37 0,74
1 1,17 1,17 2,33
10 3,69 3,69 7,38
100 11,67 11,67 23,33
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where Pis the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher fre-
quency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects
and people.
3.5
V 1√P
d=3.5
E 1√P
d=7
E 1√P
d=
Disposal: The product must not be disposed of along with other
domestic waste. The users must dispose of this equipment by
bringing it to a specic recycling point for electric and electronic
equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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