GIMA Finger Oximeter OXY-2 User Manual

PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A. Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com – export@gimaitaly.com
www.gimaitaly.com

OXY-2 FINGER OXIMETER

User manual

ATTENTION : The operators must carefully read and completely understand the present manual before using the product.

Instructions to User

Dear users, thank you very much for purchasing the Pulse Oximeter. The Manual describes, in accordance with the Pulse Ox-imeter’s features and requirements, main structure, functions, specifications, 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 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 responsible for the safety, reliability, and performance issues and any monitoring abnormality, human injury, and equipment damage due to users’ negligence of the operating instructions. The manufacturer’s warranty service does not cover such faults.

Owing to the forthcoming renovation, the specific products you received may not be totally in accordance with the description of this User Manual. We would sincerely regret that. This product is a medical device, which can be used repeatedly.

WARNING
Uncomfortable or painful feelings 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 finger for over 2 hours.
For special patients, there should be a more prudent inspection 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.
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.

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 the 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 qualified service engineers ONLY. Users are not permitted to maintain it by themselves.

• The oximeter cannot be used together with devices not specified in the User’s Manual. Only the accessory that is appointed or recommendatory by the manufacture can be used with this device.

• This product is calibrated before leaving the factory.
  1.2 Warnings

• Explosive hazard—DO NOT use the oximeter in an environment with inflammable gas such as some ignitable anesthetic agents.

• DO NOT use the oximeter while the testee is measured by MRI and CT.

• The person who is allergic to rubber can not use this device.

• The disposal of scrap instrument and their accessories and packings(including batteries, 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 a cold environment to a warm or humid environment, please do not use it immediately.
DO NOT operate keys on the 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 on cleaning and disinfection.
Do not have the oximeter immersed 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 fingers which are too thin or too cold, it would probably affect the normal measure of the pa- patient’s SpO2 and pulse rate, please clip the thick finger such as thumb and middle finger 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 to110kg).
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 rates.
If some abnormal conditions appear on the screen during the test process, pull out the finger and reinsert to restore normal use.
The device has normal useful life for three years since its first electrified use.
The hanging rope attached to the product is made from Non- allergy material, if the particular group is 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 causing harm to the patient.
The instrument does not have a 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 does not have an 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 intended 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 (including clinical use in internist/surgery, anesthesia, intensive care, etc.). This device is not intended for continuous monitoring.

OVERVIEW

The pulse oxygen saturation is the percentage of Hb02 in the total Hb in the blood, so-called the 02 concentration in the blood. It is an important bio- parameter for respiration. For the purpose of measuring the Sp02 more 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 the patient to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show the measured value of Hemoglobin Saturation.

2.1 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 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 flash manner.

2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through a finger, 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 monoxide, the device is not recommended to be used under this circumstance.

2.3 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

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 & near-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 wavelengths of lights can be focused onto human nail tip through per- respective clamp finger-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 finger should be placed properly (see the attached illustration of this manual, Figure 5), or else it may cause inaccurate
   measurement.

2. The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there
   between.

3. The SpO2 sensor should not be used at a location or limb tied with the arterial canal or blood pressure cuff or receiving an 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 a fluorescent 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, the substantial pulsating blood flow of the subject is required. For a subject with a weak pulse due to shock, low ambient/body temperature, major bleeding, or use of the vascular contracting drug, the SpO2 waveform (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 this salicylic hemoglobin, and some with icterus problem, the SpO2 determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine, and butacaine may also be a major factors blamed for serious errors of SpO2 measure.
4. As the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO2 measurement.

TECHNICAL SPECIFICATIONS

1. Display Format: Digital tube Display Sp02 Measuring Range: 0% – 100% Pulse Rate Measuring Range: 30 bpm – 250 bpm Pulse Intensity Display: columniation display
2. Power Requirements: 2 x1.5V AAA alkaline battery, adaptable range: 2.6V-3.6V
3. Power Consumption: Smaller than 25 mA
4. Resolution: 1% for Sp02 and 1 bpm for Pulse Rate
5. Measurement Accuracy: ±2% in the stage of 70%-100% Sp02, and meaningless when stage being smaller than 70%. ±2 bpm or ±2% (select larger) for Pulse Rate.
6. Measurement Performance in Weak Filling Condition: Sp02 and pulse rate can be shown correctly when the pulse-filling ratio is 0.4%. Sp02 error is ±4%, pulse rate error is ±2 bpm or ±2% (select larger).
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 the darkroom is less than ±1%.
8. It is equipped with a function switch. The Oximeter can be powered off in case no finger is in the device.

Optical Sensor

Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)

Optical sensor is a light-emitting component, which will affect other medical devices applying the same wavelength range.

ACCESSORIES

• One hanging rope
• Two batteries (optional)
• One User Manual

INSTALLATION

6.1 View of the Front Panel

Figure 2. Front View

Figure 3. Batteries Installation

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 first one and then tighten it.

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 finger put into the rubber cushions of the clip (make sure the finger is in the right position) and then clip the
finger.
7.4 Press the switch button once on the front panel.
7.5 Do not shake the finger and keep the patient at ease during the process. Meanwhile, the human body is not recommended in movement status.
7.6 Get the information directly from the screen display.
7.7 In the boot-strap state, press the button, and the device is reset.

Fingernails and the luminescent tube should be on the same side.

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 it. Wipe the device with medical alcohol first, and then let it dry in the air or clean it by dry clean fabric.
• Using medical alcohol to disinfect the product after use, prevent 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.
• Users are advised to calibrate the device termly (or according to the calibrating program of the hospital). It also can be performed 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.

TROUBLESHOOTING

properly positioned.

2. The patient’s Sp02 is too low to be detected.

| 1. Place the finger properly and try again.

2. Try again; Go to a hospital for a diagnosis if you are sure the device works all right.

The Sp02 and Pulse Rate are not displayed stably.| 1. The finger is not placed inside deep enough.

2. The finger is shaking or the patient is moving.

| 1. Place the finger 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.

SYMBOLS

avoiding the inexact measure)

—

| 1.  No finger inserted

2.  M indicator of signal inadequacy

+

| Battery positive electrode

–

| Battery cathode
| Power switch
| Serial number
|  Alarm inhibit
****| 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
| Manufacturer
---|---
****| Authorized Representative in the European

community

| of manufacture
| Store between -40 and 60°C
| Humidity limitation
| Atmospheric pressure limitation

FUNCTION SPECIFICATION

Sp02 Parameter Specification
Measuring range| 0%-100%, (the resolution Is 1%).
Accuracy| 70%-100%: ±2% Below 70% unspecified
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 x 2 or rechargeable battery
Battery Useful Life
Two batteries can work continuously for 24 hours
Dimensions and Weight
Dimensions| 60(L) x 30.5(W) x 32.5(H) mm
Weight| About 50g (with the batteries)

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 equipment. 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.

35072 / CMS50DL

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

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IP22

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