Gima OXY-3 User manual

Instructions to User
Dear Users, thank you very much for purchasing our product.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and har-
monized standards. The Manual is written for the current Pulse Oximeter. In case of modications and software upgrades,
the information contained in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter’s features and requirements, main structure, functions, speci-
cations, correct methods for transportation, 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 Manual very carefully before using this equipment. These instructions describe the operating procedures to
be followed strictly, failure to follow these instructions can cause measuring abnormality, equipment damage and personal
injury. The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality,
personal injury and equipment damage due to user’s 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 descrip-
tion of this User Manual. We would sincerely regret for that.
This product is medical device, and can be used repeatedly.
WARNING:
The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation barrier
patients. It is recommended that the sensor should not be applied to the same nger for over 2 hours.
For the individual 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,
can not stare at the light.
Testee can not use enamel or other makeup.
Testee’s ngernail can not be too long.
Please peruse the relative content 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.
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 monitor.
• Necessary maintenance must be performed by qualied service engineers ONLY. Users are not permitted to maintain it
by themselves.
• The oximeter cannot be used together with devices not specied in User’s Manual. Only the accessory that appointed 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 environment with inammable gas such as some ignitable anesthetic
agents.
• DO NOT use the oximeter while the testee measured by MRI and CT.
• The person who is allergic to rubber can not use 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 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
If the oximeter 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 oximeter is not permitted. Refer to User Manual in the relative
chapter for instructions of cleaning and disinfection.
Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with medical alcohol 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’ SpO2and
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 and adults (Weight should be between 15kg to 110kg).
The device may not work for all patients. If you are unable 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.
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 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 function, it only shows the low-voltage.please change the battery when
the battery energy is used out.
When the parameter is particularly, 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 exible 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 intended for the spot-check of oxygen saturation of arterial hemo-
globin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in
internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.
2 Overview
The pulse oxygen saturation is the percentage of HbO2in the total Hb in the blood, so-called the O2 concentration in the
blood. It is an important bio-parameter for the respiration. For the purpose of measuring the SpO2more easily and accura-
tely, 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 Classification
Class II a, (MDD93/42/EEC IX Rule 10)
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 carrying.
• Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for
20 hours.
• The product will enter standby mode when no signal is in the product within 5 seconds.
• Display direction can be changed automatically,easy to view.
2.3 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin 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.
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 mo-
noxide, the device is not recommended to be used under this circumstance.
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 formula 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 & ne-
ar-infrared zones. Operation principle of the instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted
in accordance with Capacity 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 microprocessor.
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 obstacles 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 electrosurgical 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 ambient/body temperature, major bleeding, or use of vascular contracting
drug, the SpO2waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
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 serious
error of SpO2measure.
4. As the SpO2value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with
serious anemia may also report good SpO2measurement.
4 Technical Specifications
1) Display Format: OLED Display;
SpO2Measuring Range: 0% ~ 100%;
Pulse Rate Measuring Range: 30 bpm ~ 250 bpm;
Pulse Wave Display: columniation display and the waveform display.
2) Power Requirements: 2×1.5V AAA alkaline battery (or using the rechargeable battery instead), adaptable range:
2.6V-3.6V.
3) Power Consumption: Smaller than 30mA.
4) Resolution: 1% for SpO2and 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 during the pulse rate range of 30-99 bpm and ±2% during the pulse rate range of 100~250 bpm .
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 during the pulse rate range of 30~99 bpm and ±2% during
the pulse rate range of 100~250 bpm.
7) Resistance to surrounding light: The deviation between 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 product will enter standby mode when no signal is in the product within 5
seconds.
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 Figure 4 Mounting the hanging rope
6.2 Battery
Step 1. Refer to Figure 3. and insert the two AAA size batteries 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 device.
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.
7 Operating Guide
1) Insert the two batteries properly to the direction, and then replace the cover.
2) Open the clip as shown in Figure 5.
Figure 5 Put nger in position
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.
4) Press the button once on front panel.
5) Do not shake the nger and keep the patient at ease during the process. Meanwhile, human body is not recommended in
movement status.
6) Get the information directly from screen display.
7) The button has two functions.When the device is in standby mode, pressing the button can exit it; When the device is in
operation status, pressing the button long can change brightness of the screen.
8) The device could change display direction according to the handing direction.
Fingernails and the luminescent tube should be on the same side.
8 Repairing and Maintenance
• Please change the batteries when the low-voltage displayed 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% relative
humidity.
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
User manual
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
OXY-3 FINGER PULSE OXIMETER
The display SpO2
Pulse rate
bar graph
Waveform
Pulse
rrate
PROFESSIONAL MEDICAL PRODUCTS

Appendix
Guidance and manufacture’s declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LI-
FE-SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and the EQUIP-
MENT or SYSTEM for EQUIPMENT or SYSTEM that not LIFE-SUPPORTING.
• Users are advised to calibrate the device termly (or according to the calibrating program of hospital). It also can be per-
formed at the state-appointed agent or just contact us for calibration.
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
device, or even damage it.
9 Troubleshooting
10 Key of Symbols
11 Function Specification
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 diagnosis 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 product will enter standby mode
when no signal is in the product within
5 seconds.
2. The batteries are almost drained.
1. Normal.
2. Change batteries.
Display Information Display Mode
The Pulse Oxygen Saturation (SpO2) OLED
Pulse Rate (PR) OLED
Pulse Intensity (bar-graph) OLED bar-graph display
Pulse wave OLED
SpO2Parameter Specification
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 Specification
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
Battery Useful Life
Two batteries can work continually for 20 hours
Dimensions and Weight
Dimensions 57(L) × 31(W) × 32(H) mm
Weight About 50g (with the batteries)
Guidance and manufacture’s declaration – electromagnetic emission
The OXY-3 Pulse Oximeter is tended for use in the electromagnetic environment specied below. The customer of the
user of the OXY-3 Pulse Oximeter should assure that it isused in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions CISPR 11 Group 1 The OXY-3 Pulse Oximeter uses RF energy only for their in-
ternal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class B The OXY-3 Pulse Oximeter is suitable for use in all establi-
shments, including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purpo-
ses.
Harmonic emissions IEC 61000-3-2 Not applicable
Voltage uctuations/ icker emission
IEC 61000-3-3
Not applicable
Guidance and manufacture’s declaration-electromagnetic immunity
The OXY-3 Pulse Oximeter is intended for use in the electromagnetic environment specied specied below. The the
user of OXY-3 Pulse Oximeter should assure that it is used in such an environment.
Immunity test IEC60601
test level
Compliance level Electromagnetic environment-
guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6KV contact
±8KV air
±6KV contact
±8KV air
Floors should be wood, concrete or cera-
mic tile. If oor are covered with synthetic
material, the relative humidity should be
at least 30%.
Power frequency (50Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
Guidance and manufacture’s declaration-electromagnetic immunity
The OXY-3 Pulse Oximeter is intended for use in the electromagnetic environment specied below. The customer or the
user of OXY-3 Pulse Oximeter should assure that it is used in such an environment.
Immunity test IEC60601 test
level
Compliance level Electromagnetic environment -guidance
Radiated RF
ICE 61000-4-3
3V/m
80MHz to 2.5GHz
3 V/m Portable and mobile RF communication equip-
ment should be used no closer to any part of the
OXY-3 Pulse Oximeter, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
80MHz to 800MHz
800MHz to 2.5GHz
Where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separa-
tion distance in meters (m).
Field strengths from xed RF transmitters, as de-
termined by an electromagnetic site survey,ashould
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 80MHz and 800MHz, 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.
aField strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcastcannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be consi-
dered. If the measured eld strength in the location in which The OXY-3 Pulse Oximeter is used exceeds the applicable
RF compliance level above, the OXY-3 Pulse Oximeter should be observed to verify normal operation. If abnormal perfor-
mance is observed, additional measures may be necessary, such as reorienting or relocating the OXY-3 Pulse Oximeter.
bOver the frequency range 150 KHz to 80 MHz, eld strengths should be less than 3V/m.
3.5
E1
√P
d=
7
E1
√P
d=
Recommended separation distances between portable and mobile RF communications equipment and the OXY-3
Pulse Oximeter
The OXY-3 Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the OXY-3 Pulse Oximeter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OXY-
3 Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power
of transmitter (W)
Separation distance according to frequency of transmitter (m)
150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
0.01 0.3500 0.3500 0.2334
0.1 1.1068 1.1068 0.7378
1 3.5000 3.5000 2.3334
10 11.0860 11.0860 7.3786
100 35.0000 35.0000 23.3334
For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (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 80MHz and 800MHz, the separation distance for 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.
3.5
V 1
√P
d=3.5
E 1
√P
d=7
E 1
√P
d=
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in China
(P.R.C.)
35090 0476
IP22
Symbol Description
Type BF
Refer to instruction manual/booklet
%SpO2The pulse oxygen saturation(%)
FCbpm 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
1. Exit standby mode
2. Change brightness of the screen
SN Serial number
Alarm inhibit
WEEE (2002/96/EC)
IP22 International Protection
This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993,
a directive of the European Economic Community
Manufacturer
Manufacture Date
Storage and Transport Temperature limitation
Storage and Transport Humidity limitation
Storage and Transport Atmospheric pressure limitation
This side up
Fragile, handle with care
Keep dry
Recyclable
+60°C
-40°C
%
95%
0%
106kPa
50kPa
0476
M-35090-GB-Rev.0.03.18
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 specific recycling point for electric and electronic equi-
pment. For further information on recycling points contact the local authorities, the local recycling center or the shop
where the product was purchased. If the equipment is not disposed of correctly, fines or penalties may be applied in
accordance with the national legislation and regulations.