CMS Mobility Inc dba Summit DME 12919 Southwest
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1. by coverage of the entire range of clinical research measurements 5 2 2 1 Data Collection In the clinical test process data points are recorded with comparable density in the entire claimed range 5 2 2 2 Data Analysis For each claimed range the oxygen saturation accuracy of the pulse Oximeter should be 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 Arms Arms accuracy n test sample quantity SPQ gt Measured value of pulse oxygen saturation during the first measurement using the finger pulse Oximeter 29 Standard Packing List 1 Pulse oximeter 1 PCS 2 AAA Battery aiina iian 2 PCS Sc Lanyard seda a a aai 1 PCS 4 Silicon Cover c cece cece eee ee eee 1 PCS 5 User Manual ccceeee cence ees 1PCS 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 e 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 e Stop immediately if you have broken skin or the blood circulation of your finger is affected during prolong use e This product is not designed to be used by newborn babies e The pulse oximeter uses infrared light invisible to you2. steel wire balls or polished metal objects Caution Ensure that there is no washing liquid on the surface of the instrument 2 5 Innovative features of the CMS 500DL The CMS 500DL attempts to ameliorate some of the above problems by 1 Increasing the sensitivity of the sensor so that it can measure the user s SpOz2 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 are not affected 12 Product Structure and Operation Steps 2 6 Schematic Structural Diagram 1 LED screen Power on key Shaft housing 0 Battery cover medical alcohol The silicon is non toxic soft and hypoallergenic 2 8 4 2 8 5 2 8 6 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 Switching Off the Power Supply of the Pulse Oximeter The Oximeter will automatically shut down 16 seconds after you remove your finge
3. use 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 CMS 50D Finally it is generally accepted that the saturation percentage is unreliable on the steep part around 60 mm Hg of the oxyhemoglobin dissociation curve 11 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 An not clean the instrument by using high temperature and or high pressure disinfecting gas Chapter 3 Cleaning and Disinfection 3 1 Cleaning 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 Do not rub the body of the instrument using materials such as
4. Distributed by CMS Mobility Inc dba Summit DME 12919 Southwest Freeway Suite 100 ATE Stafford TX 77477 Phone 1 832 939 8290 http www cmsmobilityusa com cs cmsmobilityusa com Acc U Rate CMS 500DL ATE Finger Pulse Oximeter EE User Manual CMS Mobility Inc dba Summit DME 12919 Southwest Freeway Suite 100 Stafford TX 77479 http www cmsmobilityusa com Copyright CMS Mobility INC All rights reserved CMS Mobility Inc 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 CMS Mobility Inc 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 CMS Mobility Inc reserves the right of final interpretation of this document IRATE is a registered trade mark of CMS Mobility Inc Version 1 6 Prepared in May 2015 5 4 Storage and Transportation 50 Temperature j o 10 C to 50 C 10 j 10 4 gt 1060 o s00 e 646 Place upward a Atmospheric bd pressure 500 hpa to 1060 hpa j 32 RH 10 to 93 non condensing Limited height 15 stories Guard against moisture measure the portion of over
5. all errors of the Contents mainframe probe system of the Oxim eter attributable to the Letter to USES 4 Nedonces sosecevecesebcsescsuceoaccscbecescestececcecesesescuscccescsevecescestccesss 1 nf F tho Oum ter he tunctional tester can fost tie Standard Packing List ssssescsssnesrsseneersssneessssneersssneessssneeesssneeseseneeseees 2 mainirame o 7 Chapter 1 Precautions Warnings and SymMbol sssssssssssssssssssssss 2 accuracy of a pulse Oximeter that duplicates the calibration 1 1 PSC AULIOMS I cosssasecudicicacdcsavcasetesecssdvssacscesesecesecetucecnsueucucususiss 2 curve 1 2 WArniNgS sesseseeesseseccsseseccssseeccseseecoseseecoseseceossseeeossseeeosseeeesesse 4 1 3 SALLAN 010 PAEA E TEE 7 Note The product does not provide the alarm function and napit 2 AoT MIMS PHOCUCL 7 anccnnadinciiininninnaninundud Pa W IUEI AE AAAA E EA is not suitable for continuous long term monitoring When 2 2 Working Principles aN fU Sa 9 the probe of the Oximeter fails the Oximeter displays 2 3 Product FO tureS seiseisceeseveiesevesevesceeesececesnesenesseesenessueseni 10 and 2 4 CMAI ONS tees late codscecttstutdes Misetivantereinaddvedeacaeiienmetaecsuss Il 2 5 Innovative features of the CMS 500DL sessesesssesoe 12 5 3 Safety Type 2 6 Schematic Structural DiagramM sssesssssssssscossecossecosssee 13 i 2 7 Schematic Diagram of Display sessssssescscscscscsescsesssse 14 Anti electric shock type interna
6. ating capillary bed and then measure the amount of red and infrared light emerging from the tissues via a sensor To improve 9 4 2 Troubleshooting The 1 Oximeter fails to display the blood oxygen saturation 2 levels and or pulse rate The finger is not placed properly between the sensor and the LED The user s blood perfusion is too low to be detected 22 1 Place the finger at the correct position Make sure nothing is restricting your blood flow Chapter 4 4 1 Maintenance and Troubleshooting 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 and pulse rate readings by using an appropriate calibration apparatus 21 accuracy the CMS 500DL uses a proprietary algorithm to collect data from pulsatile arterial blood and ignores local noise from the tissues The relative absorption of light by oxyhemoglobin HbO and d
7. ctly installed The Oximeter is damaged Place the finger at the correct position Ensure that the user s body is stationary Replace the batteries Correctly install the batteries according to the polarity indication Contact the distributor 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 2 About This Product 2 1 Overview SpO2 stands for peripheral capillary oxygen saturation Oxygen saturation is defined as the ratio of oxyhemoglobin HbO2z 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 whereas Light beams deoxygenated blood absorbs as light preferentially at 905nm ae infra red A pulse oximeter saor on works by passing a beam of red and infrared light through a puls
8. eoxyhemoglobin is then processed according to the Beer Lambert s law and a qualitative measurement of the users oxyhemoglobin status i e Oxygen saturation level SpO2 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 Do not use for continuous monitoring 2 3 Product Features Lightweight portable and easy to use Huge LED screen for easy reading Low Battery indicator 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 approximately 30 hours 10 2 4 Limitations The pulse oximeter works by measuring the amount of oxygenated haemoglobin in your blood over a period of time 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 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 would not have enough blood to take a measurement Please note that prolong
9. imensions 58 0 mm Width x 32 0 mm Depth x 33 2 mm 25 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 The screen 1 If the Oximeter 1 This is normal turns off does not detect Just turn on suddenly any signal the pulse within 16 oximeter seconds it will again automatically power off BF type application part Replace the a batteries Caution Please see this manual The batteries are empty Oxygen saturation 4 3 Tips to getting a good reading Pulse rate 1 Make sure that your finger is put deep into the probe such that the fingertip is directly in between the LED sensor and the LED light source Manufacture information including the name and address of the manufacturer 2 Make sure your finger is stationary in the probe while you are measuring your SpO2 levels 7 24 The 1 The finger is not displayed placed properly value of the between the oxygen sensor and the saturation or LED pulse rate 2 The user is fluctuates moving his finger or body The The batteries Oximeter are empty or cannot be are not powered on installed at all The batteries are incorre
10. ing Do not throw the batteries into fire as that infrared light 905 nm could cause an explosion 4 Working power supply and current 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 Internal Power Supply Two 1 5 V dry batteries 5 Normal working condition Warning Do not i i arning Do not use the Oximeter in an MRI or CT Working Temperature 5 C to 40 C 41 F to 104 F environment 3 If your fingernails are too long this may obstruct the sensor from the LED lights Please make sure that your fingernails are kept short 4 Excessive ambient infra red light especially for people who use the pulse oximeter in an overly bright lit room can interfere with the sensor 5 Poor circulation can affect oximeter readings Warm your hands and fingers before taking your measurements Remember your pulse oximeter is measuring your SpO2 and PR based on your blood flow If the blood flow in your finger drops below a certain level the pulse oximeter will not be able to function 6 Some people with medical conditions such as anemia hypotension and hypothermia can experience an inaccurate reading during use If that may be the case for you we suggest that you consult a physician Chapter 5 Technical Description and Safety Type 5 1 Technical Specifications 1 D
11. l power supply device 2 8 Operation St PSisssscsiscrisesceseisccscerseessserersr sssscevscesersesssiss s 14 Anti electric shock degree BF type application part B Meee ee 3 2 PRISTINE CUO Mi sicerscs shacketestucsscsasutersouseczessassetedan saeseussuuesneseas 20 Running mode continuous operation Chapter 4 Maintenance and TroubleShooting csssesssssssssssssssssees 21 aici 4 1 Maintenant E serecaieccsecacccccicorscevicwsecedenasovestieticecsessetecetezieass Liquid intrusion protection class IPX1 42 Fault Symptoms Causes and Solutionsi i oy Chapter5 Technical Description and Safety Type sscsssssee 25 5 1 Technical Specifications csscsscsscescescsssescessessessessers 25 5 2 Technical DescriptiOn esesesesossesesesosoesesesosoesesesosoesesesoe 28 5 3 Safety PYG stassaceecssuntcescvbcucczonses tuncdessercdusesesesouasssapouavereseade 31 5 4 Storage ANd TransSportation ccccccsccccsrssssssscserseres 32 31 Letter to Users Thank you for choosing our Acc U Rate CMS 500DL Finger Pulse Oximeter By listening to our customers and applying some simple technological innovations you will come to see that the CMS 500DL 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
12. r 2 eyes to measure your SpOz2 levels Hence please do not stare at the light emitting components of the Oximeter as that could cause harm and or potentially blind your eyes e This device 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 during sports and or aviation only People who need SpO and pulse rate measurements because of a medical condition should not use the CMS 500DL and should consult with their physician The following factors may affect the accuracy of the measurement The Oximeter is used in an environment involving high frequency devices such as high frequency electric knives and CT apparatuses Ambient light intensity is too bright Hence please avoid 3 M i Oxygen 2 70 to 100 SAREEN saturation No requirement lt 69 recision i 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 5 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 the difference The measured values of the instrument are distributed according to statistical probabili
13. r or if it does not detect a signal About the Display The instrument uses an LED screen with unidirectional display Note Replace the batteries when the batteries are low and the symbol amp flickers on the LED screen 18 Ax you do not insert your finger completely into the chamber measurement will be inaccurate Note Before each test clean the measured finger and the silicon part of the Oximeter that contacts the finger with 17 2 7 Schematic Diagram of Display The following figure shows the information display on the LED screen of the Oximeter in normal detection state Low voltage Symbol of oxygen indication saturation Measured value of oxygen saturation Symbol of pulse rate Y Min Measured A Pulse rate strength oa Lg value of pulse rate a 2 8 Operation Steps 2 8 1 Installing the Batteries Install the two AAA dry batteries into the battery slot according to polarity indication and mount the battery cover 14 Remove the silicon cover Thread the thin end of the lanyard through the lanyard hole thread the coarse end a that the batteries are installed with correct of the lanyard through the thin end of the lanyard and tighten the lanyard Put the silicon cover back on polarities so as to avoid damaging the instrument 2 8 3 Switching On the Power Supply of the Pulse Oximeter Stick one finger completely into the silicon padded finger chamber of the O
14. ty 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 5 2 2 Determination of Oxygen Saturation Accuracy 28 direct exposure to strong light such as beams from Relative Humidity 15 to 80 non condensing operating lamps or sunlight during measurement The probe of the Oximeter is placed on the same arm that a blood pressure cuff arterial duct or intravenous Atmospheric Pressure 700 hPa to 1060 hPa injection is placed The user suffers from hypotension severe vascular atrophy severe anemia or low oxygen Rated Voltage The user is in sudden cardiac arrest or shock state The user is wearing nail polish or artificial nails 6 Technical parameters Ve SEAN Display range saturation Warning Do not use the Oximeter in an environment with any flammable gases flammable anesthetic or other flammable substances 25 bpm to 250 bpm coe Resolution 27 Warning Keep unit and lanyard away from children as Height the included lanyard may present an entanglement or Weight 49 5 g including the weight of two AAA batteries choking hazard to small children Adult supervision l l required never leave children unattended with unit or 2 Peak wavelength range of the light emitted from the probe lanyard red light 660 nm 3 infrared light 905 nm 5 3 Maximum optical output power of the probe 1 2 mW for Warn
15. whether any component is damaged during shipping If there is any damage or if you have any concerns please contact us at cs cmsmobilityusa com or phone 1 832 939 8290 with the following information 1 Product model 2 Serial number of the product 3 Your contact information and address The manual is updated periodically and the latest manual can be downloaded at http www cmsmobilityusa com cms 500dl html 1 Sr reference value of pulse oxygen saturation during the i measurement using the carbon monoxide blood gas analyzer 5 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 5 2 3 Data updating interval The display data updating interval is 1 second 5 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 and 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 30 The claimed oxygen saturation is supported
16. ximeter The fingernail should be facing upward Release the clip and press the power key to 2 8 2 Installing the Lanyard power on the Pulse Oximeter 15 16
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