Distributed by: Innovo Groups 406 Sterling Street, Building
Contents
1. chamber measurement will be inaccurate Note Before each test clean the measured finger and the Thread the thin end of the sling through the sling hole Product Structure and Operation Steps and thread the coarse end of the sling through the thin 24 end of the sling and tighten the sling Schematic Structural Diagram LED screen Power on key Shaft housing 4 Battery cover 3 3 3 Switching On the Power Supply of the Pulse Oximeter Stick one finger completely into the silicon pad cavity of the Oximeter keep the fingernail surface upward and release the clip Then press the power key to power on the Pulse Oximeter 2 2 Schematic Diagram of Display The following figure shows the information display on the LED AN ensure that the batteries are installed with correct screen of the Oximeter in normal detection state Low voltage Symbol of oxygen polarities so as to avoid damage to the instrument indication saturation Measured value of oxygen saturation Symbol of pulse rate Min Measured SANA Pulse rate strength value of pulse se t t rate Oe 2 3 Operation Steps 3 3 1 Installing the Batteries Install the two AAA dry batteries into the battery slot according to polarity indication and mount the battery cover 3 3 2 Installing the Sling2. 4 Working power supply and current Internal Power Supply Two 1 5 V dry batteries The user suffers from hypotension severe vascular atrophy severe anemia or low oxygen 4 The user is in sudden cardiac arrest or shock state Working Current 4 The user is wearing nail polish or artificial nails 5 Normal working condition 1 2 Warnings Working Temperature 5 C to 40 C 41 F to 104 F Warning Do not use the Oximeter in an environment with any flammable gases flammable anesthetic or other flammable substances Relative Humidity 15 to 80 non condensing Symptom Possible Cause Solution The screen 1 Ifthe Oximeter 1 This is normal turns off does not detect Just tum on suddenly any signal the pulse within 16 oximeter seconds it will again automatically power off Replace the batteries The batteries are empty Chapter 5 Technical Description and Safety Type 5 1 Technical Specifications 1 Dimensions 58 0 mm Width x 32 0 mm Depth x 33 2 mm Height Weight 49 5 g including the weight of two AAA batteries 2 Peak wavelength range of the light emitted from the probe Warning Keep unit and lanyard away from children as the included lanyard may present an entanglement or choking hazard to small children Adult supervision required never leave children unattended with unit or lanyard Warning Do not throw the batteries into fire as that could cause an explosion
3. Do not rub the body of the instrument using materials such as steel wire balls or polished metal objects Caution Ensure that there is no any washing liquid on the surface of the instrument silicon part of the Oximeter that contacts the finger with medical alcohol The silicon is non toxic soft and hypoallergenic 3 3 4 Reading Measured Data of Oxygen Saturation and Pulse Rate from the LED Screen Do not move your finger during measurement Keep your body as still as possible After the readings become stable read the measured values of the oxygen saturation and pulse rate on the LED screen 3 3 5 Switching Off the Power Supply of the Pulse Oximeter The Oximeter will automatically shut down 16 seconds after you remove your finger 3 3 6 About the Display The instrument uses an LED screen with unidirectional display Note Replace the batteries when the batteries run out of power and the symbol flickers on the LED screen approximately 30 hours 2 4 Limitations The pulse oximeter works by measuring the amount of oxygenated haemoglobin in your blood over a period of time Most spot check pulse oximeter on the market takes a reading every second and takes an average of 4 6 readings before displaying the result Hence you will have to wait at least 4 6 seconds before a result will be displayed on the monitor If the pulse oximeter fails to detect blood flow for the first few seconds then the results will be
4. Chapter 1 Precautions Warnings and Symbol 1 1 Precautions e Do not attempt to repair the Pulse Oximeter by yourself Only certified engineers should maintain and repair it Change the contact position between the Oximeter probe and the finger periodically if you are monitoring your SpOz levels and pulse rate for more than 2 hours Stop immediately if you have broken skin or the blood circulation of your finger is affected during prolong use This product is not designed to be used by newborn babies 7 Capability to resist ambient light interference Compared to taking oxygen saturation measurements under natural indoor lighting and or other illumination sources the deviation is smaller than 1 when compared to being taken in a darkroom 5 2 Technical Description 6 2 1 Oxygen Saturation Accuracy The accuracy is 2 in the absence of movement between 70 to 100 Note The oxygen saturation accuracy is a root mean square of a difference The measured values of the instrument are distributed according to statistical probability Only about two thirds of the measured values of the Pulse Oximeter fall within Arms of the measured values of a carbon monoxide blood gas analyzer 6 2 2 Determination of Oxygen Saturation Accuracy The claimed oxygen saturation should be supported by coverage of the entire range of clinical research measurements e The pulse oximeter uses infrared light invisible to your Atmospheric Pressu
5. rate 2 The finger is not placed properly between the sensor and the LED The user s blood perfusion is too low to be detected 1 Place the finger at the correct position Make sure nothing is restricting your blood flow BF type application part Caution Please see this manual Oxygen saturation Pulse rate Manufacture information including the name and address of the manufacturer Attention Temperature limitation When end users abandon this product they must send the product to the collection place for recycling Information that you must learn about possible harm of this product to users Some important information that you must learn Information that is necessary for you to protect this product against damage Chapter 4 Maintenance and Troubleshooting 4 1 o Maintenance Replace the batteries if they are low on power Clean the Oximeter and the fingertip before use to ensure accurate reading Remove the batteries from the battery slot and properly store them if you do not plan to use the Oximeter for a long period of time Store the Oximeter between 14 122 F 10 to 50 C and at humidity levels no greater than 93 Periodically check the Oximeter for damage Avoid using the Oximeter in an environment with inflammable gases or using it in an environment where the temperature or humidity is excessively high or low Check the accuracy of the oxygen saturation a
6. Distributed by Innovo Groups a 406 Sterling Street Building 2 Camphill PA 17011 I NNOVO Phone 1 858 888 9781 cs Dinnovogroups com MOVING FRONTIERS INV 430J Ss INNOVO MOVING FRONTIERS Finger Pulse Oximeter User Manual Innovo Groups 406 Sterling Street Building 2 Camphill PA 17011 Copyright Innovo Groups 2014 All rights reserved Innovo Groups owns and reserves all of the rights comprised in the copyright of this document No part of this document may be changed excerpted copied reproduced or imitated in any form or by any means without prior written consent of Innovo Groups All statements information and recommendations in this document are provided AS IS without warranties guarantees or representations of any kind either express or implied The information in this document is subject to change without notice Innovo Groups reserves the right of final interpretation of this document Version 1 1 Released on October 2014 5 4 Storage and Transportation a Et a a mainframe probe system of the Oximeter attributable to the mainframe of the Oximeter the functional tester can test the accuracy of a pulse Oximeter that duplicates the calibration curve Note The product does not provide the alarm function and is not suitable for continuous long term monitoring When the probe of the Oximeter fails the Oximeter displays and 5 3 Safety Type Anti el
7. Warning Do not attempt to charge the included batteries as that could cause leakage fire disaster or even explosion Dispose the used batteries in accordance to the local laws and regulations of your region Warning Do not use the Oximeter in an MRI or CT environment Caution Do not operate the Oximeter if it is wet Avoid moving the oximeter from a cold to a hot and humid environment Caution Install the batteries properly before powering on the Oximeter for normal use Please remove the batteries if you are not planning to use the Oximeter for a long time Caution Close the battery cover when the instrument is in use Symptom Possible Cause Solution The displayed value of the oxygen saturation or pulse rate fluctuates The Oximeter cannot be powered on 1 The finger is not placed properly between the sensor and the LED 2 The user is moving his finger or body The batteries are empty or are not installed at all The batteries are incorrectly installed The Oximeter is damaged Insert the finger again Ensure that the user s body is stationary Replace the batteries Correctly install the batteries according to the polarity indication Contact the distributor 4 2 Fault Symptoms Causes and Solutions Symptom Possible Cause Solution 1 The Oximeter fails to display data about the oxygen saturation and pulse
8. delayed accordingly The pulse oximeter does not work for people with naturally small fingers or low peripheral blood flow This is because the pulse oximeter does not have enough blood to take a measurement Please note that prolong used of a pulse oximeter hypotension vasoconstriction hypothermia and certain medications can lead to low or restricted blood flow Nail polish can also impede the pulse oximeter from taking a reading To see how much blood flow is being detected by the pulse oximeter you will need a more advanced pulse oximeter that has a plethysmograph display See INV 430J DL Finally it is generally accepted that the saturation percentage is unreliable on the steep part around 60 mm Hg of the oxyhemoglobin dissociation curve 2 5 Innovative features of the INV 430J The INV 430J attempts to ameliorate some of the above problems by 1 Increasing the sensitivity of the sensor so that it can measure the user s SpO2 and Pulse Rate PR even at low blood perfusion 2 Using a self adjusting smart spring system to fit the finger snugly but not so tight as to impede blood flow 3 Using soft hypoallergenic medical grade silicon in the finger chamber so that the pulse oximeter will not cause discomfort to your finger 4 Using solid ABS plastic to block ambient light from reaching the sensor so that the precision and reliability of the readings is not affected A you do not insert your finger completely into the
9. e represented in the form of mean root square of the difference between the measured values of oxygen saturation and the reference value The formula is as follows N SPO 2 Sri Arms 2 n Arms accuracy n test sample quantity SPOz measured value of pulse oxygen saturation during the first measurement using the finger pulse Oximeter Sri reference value of pulse oxygen saturation during the i Letter to Users Thank you for choosing our Innovo INV 430J Finger Pulse Oximeter By listening to our customers and applying some simple technological innovations you will come to see that the INV 430J is one of the most user friendly reliable and comfortable pulse oximeters that you will ever come to own Before using this product please carefully read the manual and follow the instructions stated herein Check whether all accessories are complete against the packing list and whether any component is damaged during shipping If there is any damage or if you have any concerns please contact Innovo Groups at cs innovogroups com or phone 1 858 888 9781 with the following information 1 Product model 2 Serial number of the product 3 Your contact information and address Standard Packing List 1 Pulse oximeter 0 0 cece eee ee 1 PCS 2 AAA BAN 0 0 nce a anes 2 PCS 3 Lanyard ctv vai a CR RN Vara ax ek eas 1 PCS 4 Silicon Cover ccc cece cece ee ee es 1 PCS 5 UserManual 1PCS
10. ectric shock type internal power supply device Anti electric shock degree BF type application part Running mode continuous operation Liquid intrusion protection class IPX1 Contents Letter LOPS CFS sacas O EDS SE DOCE Dana Dea c ua 1 Standard Packinquiist nnee nanenrearerrerrerrerrenrerrennn 2 Chapter 1 Precautions Warnings and Symbol 2 1 1 Precautions aiee ETE EEEE A 2 1 2 WAAMINGS c scceavessvessesscenesnerccesmecsmmeetseesssennaes 4 1 3 DV MDOP ee ee eee EEE EEE EEEE E CEE 7 Chapter 2 About This Product ccccceeeeeeeeeeeeeeeeees 9 2 1 ONCE a rea 9 2 2 Working Principles and Usage 9 2 3 Product FOALUTOS cassssssssssraasssassaassassensaarasara do 10 2 4 Limitation S AR PPP oPRRRPPRENPRRE ELT 11 2 5 Innovative features of the INV 430J 12 Chapter 3 Product Structure and Operation Steps 13 3 1 Schematic Structural Diagram 13 3 2 Schematic Diagram of Display 14 3 3 Operation Steps asa et eecewcceurewrceereeeseecewundnes 14 Chapter 4 4 1 4 2 Chapter 5 5 1 5 2 Chapter 6 6 1 6 2 6 3 6 4 Cleaning and Disinfection 19 Cleaning secncccncncccacccsecsseenssnensavenneenmeanswensmensncs 19 Disinfection AALS a dA dd 20 Maintenance and Troubleshooting 21 Maintenance titi dida 21 Fault Symptoms Causes and Solutions 22 Technical Description and Safet
11. nd pulse rate readings by using an appropriate calibration apparatus Attention Do not allow liquid to flow into the instrument during cleaning Attention Do not immerse any part of the instrument into any liquid 3 2 Disinfection Before measurement with the instrument wipe the silicon finger pad using a piece of dry soft cloth dipped with 75 medical alcohol Clean the finger to be measured using the medical alcohol for disinfection purposes before and after use No not clean the instrument by using high temperature and or high pressure disinfecting gas Chapter 2 About This Product 2 1 Overview SpO2 stands for peripheral capillary oxygen saturation Oxygen saturation is defined as the ratio of oxyhemoglobin HbO to the total concentration of hemoglobin i e Oxyhemoglobin reduced hemoglobin present in the blood It is an important physiological parameter involved in respiration and circulation The Pulse Oximeter feature herein is small portable non invasive and easy to use The user only needs to insert a finger into the chamber to measure his her SpO2 and pulse rate 2 2 Working Principles and Usage Oxygenated blood absorbs light at 660nm red light Light beams whereas deoxygenated blood te absorbs light preferentially at se 905nm infra red A pulse PRA eng oximeter works by passing a beam of red and infrared light through a pulsating capillary bed and then measure the amount of red and infrared ligh
12. re 700 hPa to 1060 hPa eyes to measure your SpOz levels Hence please do not stare at the light emitting components of the Oximeter as that could cause harm and or potentially Rated Voltage blind your eyes e This pulse oximeter is not a medical device and is not intended to diagnose or treat any medical condition or disease It is intended for non medical use in healthy people to monitor their pulse and blood oxygen levels 6 Technical parameters are O value during sports and or aviation only People who need 35 to 100 SpO and pulse rate measurements because of a medical Display range saturation 25 bpm to 250 bpm condition sneule not use the INV 430J and should consult with their physician i saturation Resolution The following factors may affect the accuracy of the measurement Oxygen 2 70 to 100 t l Measurement No requirement lt 69 4 The Oximeter is used in an environment involving precision high frequency devices such as high frequency electric knives and CT apparatuses 4 Ambient light intensity is too bright Hence please avoid red light 660 nm 3 infrared light 905 nm 5 direct exposure to strong light such as beams from 3 Maximum optical output power of the probe 1 2 mW for operating lamps or sunlight during measurement infrared light 905 nm The probe of the Oximeter is placed on the same arm that a blood pressure cuff arterial duct or intravenous injection is placed
13. t emerging from the tissues via a sensor To improve accuracy the INV 430J uses a proprietary algorithm to collect data from pulsatile arterial blood only and ignores local noise from the tissues The relative absorption of light by oxyhemoglobin HbO and deoxyhemoglobin is then processed according to the Beer Lambert s law and a qualitative measurement of the users oxyhemoglobin status i e Oxygen saturation level SpOz derived Due to the sensitivity of the pulse oximeter you should keep your finger stationary during measurement It is recommended that you use this instrument for measurement before or after sports It is designed for users 15 to 60 years old Do not use for continuous monitoring 2 3 Product Features o Lightweight portable and easy to use Huge LED screen for easy reading amp Low Battery indicator o The device will automatically shut down if no signal is detected after 16 seconds The device is equipped with two 1 5 V AAA batteries which will allow the pulse oximeter to operate for Chapter 3 Cleaning and Disinfection 3 1 Cleaning Ensure that the appearance of the instrument is clean To clean the instrument power off and remove the batteries first Then clean the outer surface of the instrument including the LED screen using a piece of dry soft cloth dipped with 75 medical alcohol Do not immerse the unit in alcohol Note Do not use any strong dissolving agent such as acetone Caution
14. y Type 24 Technical Specifications cccsccseeeeeeeees 24 Technical DeSCription cccceceeeeeeeeeeeeees 27 Salet NV DG nanan Saas Aa A EIS ABES Aa 30 Storage and Transportation 31 measurement using the carbon monoxide blood gas analyzer 6 2 2 3 Characteristics of Population under Clinical Research The summary clinical research report for evaluating SPO2 accuracy should state whether the tested object suffers from disease or is healthy and should state the skin color age and gender of the tested object 6 2 3 Data updating interval The display data updating interval is 1 second 6 2 4 When the signal detected by the finger pulse Oximeter is incomplete or weak the readings of the oxygen saturation and pulse rate on the LED screen of the Oximeter are an Note The functional tester shall not be used to evaluate the accuracy of the probe of the pulse Oximeter or the accuracy of the pulse oxygen monitor Note The pulse Oximeter has a specific calibration curve and is precise for the combination of the mainframe and probe of the pulse Oximeter If the functional tester can measure the portion of overall errors of the 6 2 2 1 Data Collection In the clinical test process data points shall be recorded with comparable density in the entire claimed range 6 2 2 2 Data Analysis For each claimed range the oxygen saturation accuracy of the pulse Oximeter should b
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