User Guide - Sanitaria Varesina
Contents
1. lanyard Nba E GO2R Clip on retractable holder WARNING Certain activities may pose a risk of injury including strangulation if the lanyard should become wrapped around your neck Use the lanyard with caution For more information about Nonin parts and accessories contact your distributor or contact Nonin at 877 577 2635 USA and Canada or 763 553 9968 Specifications Oxygen Saturation Display Range Pulse Rate Display Range Oxygen Saturation Declared Accuracy Range A ms Low Perfusion Oxygen Saturation Declared Accuracy Range A n Pulse Rate Declared Accuracy Range A Low Perfusion Pulse Rate Declared Accuracy Range A ms Measurement Wavelengths and Output Power Red Infrared 1 Ams represents approximately 68 of measurements 096 to 10096 18 to 321 beats per minute BPM 70 to 10096 SpO 2 digits 70 to 10096 SpO 2 digits 20 to 250 BPM 3 digits 40 to 240 BPM 3 digits 660 nanometers 0 8mW Max Average 910 nanometers 1 2mW Max Average Temperature Operating Storage Transportation Device temperature will not exceed 41 C as measured during a controlled environment test Humidity Operating Storage Transportation Operating Altitude Battery Life Continuous Battery Life Storage 41 F to 104 F 5 C to 40 C 22 F to 158 F 30 C to 70 C 1096 to 9096 relative humidity non condensing 1096 to 95962. a Eos CE Marking conformance to EC Directive No 93 42 EEC for medical devices EN Type BF Applied Part patient isolation from electrical shock Not for Continuous Monitoring no alarm for SpO zs Slo UL Mark for Canada and the United States with respect to electric shock us fire and mechanical hazards only in accordance with IEC 60601 1 UL 60601 1 and CAN CSA C22 2 No 601 1 K Indicates separate collection for electrical and electronic equipment WEEE Protected against spraving water and against access to hazardous parts with a tool per IEC 60529 SN Serial Number Authorized Representative in the European Community 70 C y Temperature Limitation for storage shipping 30 C SpO Percent Oxygen Saturation Display Q Pulse Rate Display Intended Use GO LED Model 9571 is intended to measure blood oxygen saturation 96SpO the amount of oxygen in your blood and pulse rate mi of both adults and children It is de signed for fingers not the thumb between 0 3 and 1 0 inch 0 8 2 5cm thick The GO2 LED Model 9571 is intended for low perfusion conditions as defined in the specifications in this manual Limit finger movement as much as possible when using this device Con tact your licensed health care professional for your expected oxygen saturation level to compare with your readings The GO LED Model 9571 is intended for Home Health Care Only Contraindications Do not use the GO LED in
3. least 2 meters 7 feet away from the device each new GO LED NOTE You may use rechargeable batteries however they may Field strengths from fixed transmitters such as base stations for radio cellular cordless require more frequent replacement telephones and land mobile radios amateur radio AM and FM radio broadcast towers 1 R the battery door located on the left side of the GO LED by sliding it and TV broadcast towers may affect accuracy Bieb ARMAR ae yee towards you see page 9 diagram Use in emergency vehicles with communication systems may affect accuracy 2 Insert one new 1 5 volt AAA size battery Follow the plus and minus markings for battery direction as shown inside of the battery compartment Follow local disposal and recycling laws for the GO LED and its components including the battery Technical Service 3 Carefully reposition the battery door NOTE Do not force it into place it fits only Applying the GO LED Model 9571 to Your Finger when positioned correctly Hold the GO LED with the display facing toward you slide your finger into the opening at the bottom of the device as shown below until the fingertip touches the built in stop guide For best results make sure the finger is centered within the finger guide keep the GO LED at heart or chest level When battery is low the numeric displays flash once per second Replace battery as soon as possible Re
4. is 1 5 seconds O7L 0 08 Testing Summary SpO accuracy and low perfusion testing were conducted by Nonin Medical Inc as described below SpO Accuracy Testing SpO accuracy testing is conducted during induced hypoxia studies on healthy non smoking light to dark skinned subjects during motion and no motion conditions in an independent research laboratory The measured arterial hemoglobin saturation value SpO of the sensors is compared to arterial hemoglobin oxygen SaO value determined from blood samples with a laboratory co oximeter The accuracy of the sensors in comparison to the co oximeter samples measured over the SpO range of 70 10096 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 9919 2005 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use Pulse Rate Motion Testing This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse oximeter tester This test determines whether the oximeter meets the criteria of ISO 9919 2005 for pulse rate during simulated movement tremor and spike motions Low Perfusion Testing This test uses a SpO Simulator to provide a simulated pulse rate with adjustable amplitude settings at various SpO levels for the oximeter to read The oximeter must maintain accuracy in accordance with ISO 9919 2005 for heart
5. rate and SpO at the lowest obtainable pulse amplitude 0 396 modulation Warranty Nonin warrants to the purchaser for 2 years from the date of purchase each GO LED Model 9571 exclusive of the battery Nonin will repair or replace any GO LED Model 9571 found to be defective in accordance with this warranty free of charge for which Nonin has been notified by the purchaser by serial number that there is a defect provided notification occurs within the applicable warranty period This warranty excludes cost of delivery to and from Nonin Nonin reserves the right to charge a fee for a warranty repair request on any GO LED Model 9571 found to be within specifications GO LED Model 9571 is a precision electronic instrument and must be repaired by Nonin Technical Service Any sign or evidence of opening the GO LED Model 9571 field service by non Nonin personnel tampering or any kind of misuse of the GO LED Model 9571 shall void the warranty The GO LED Model 9571 is warranted for Home Health Care Use Only All non warranty work shall be done at Nonin s standard rates and charges in effect at the time of delivery to Nonin Nonin Medical Inc 13700 1st Avenue North Plymouth MN 55441 5443 763 553 9968 877 577 2635 web site www nonin com e mail info nonin com ec Rep Authorized EC Representative MPS Medical Product Service GmbH Borngasse 20 D 35619 Braunfels Germany 2010 Nonin Medical Inc 736
6. relative humidity non condensing Up to 40 000 feet 12 192 meters Approximately 2400 spot checks based on 21 hours of operation using one AAA size alkaline battery calculated at 30 seconds per use 6 months minimum Classifications per IEC 60601 1 CAN CSA C22 2 No 601 1 UL 60601 1 Degree of Protection Type BF Applied Part Enclosure Degree of Ingress Protection IP33 Mode of Operation Continuous This equipment complies with International Standard IEC 60601 1 2 2004 for electromagnetic compatibility for medical electrical equipment and or systems This standard is designed to provide reasonable protection against harmful interference in a typical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in health care home and many other environments it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device This product complies with ISO 10993 1 Biological evaluation of medical devices Part 1 Evaluation and testing A Equipment Response Time 100 95 90 85 80 SpO 75 70 65 60 SaO Reference 4 Beat Average 0 0 0 8 N w B B f fa o B N o co o B o o o o o o o Time in seconds Specific to this example The response of the 4 beat average
7. 6 201 01 Please take a moment to find and record the 9 digit serial number found on the back of your GO LED Model 9571 You ll need this number if you have to contact Nonin with technical service issues or if you have any questions regarding the use or performance of your pulse oximeter Nonin s technical service department can be reached at 877 577 2635 My Serial Number 70 C sA CE A Val Warning Keep away from small children this device contains small parts that may pose a choking hazard r www go2nonin com R Live life on the GO
8. E7NONIAV Table of Contents Introduction teri ro eei t a pe t en peas 1 Cares ana Mdaintenamte iss ui tes deii tait eaa cepa bra pao eee a 15 Contents of Package de a ET Heuer 1 SpecifICaliOrs oi ot ter edet espada 20 ky ubl 2 Equipment Response Time oot sites tea suu LR PEE Ge X Ce sed 23 Intended BEL 4 Testing SUIMINIGUY T 24 installing the Battery ii t PEE c di endet 8 SpO Accuracy Testing rsispas iineoae anaa adei aein 24 Applying the GO LED Model 9571 to Your Finger seen 10 Pulse Rate Motion Testing e eed o ERE ERR dud 24 Activating the Device and Verifying Operation 12 Low Perfusion Testing 24 Reading Your Results rr AREE Nel kr o AA EE ERR er 13 WY IT AIDE RE 25 Introduction Thank you for buying the GO LED Model 9571 Fingertip Pulse Oximeter This small por table device will give you important information about your oxygen saturation the amount of oxygen in your blood and pulse rate at your fingertip The Model 9571 is easy to use and needs no routine maintenance except battery replacement This User Guide explains how to use and care for your GO LED Model 9571 Contents of Package GO LED Model 9571 One AAA Alkaline Battery User Guide Quick Guide Back Cover Symbols The following symbols are associated with your GO LED Model 9571 Consult Instructions for Use Caution
9. a magnetic resonance MR environment Warnings Keep the oximeter away from young children Small items such as the battery door battery and lanyard are choking hazards Certain activities may pose a risk of injury including strangulation if the lanyard should become wrapped around your neck Use the lanyard with caution A A Cautions Do not use the GO LED as the only basis for making medical decisions It is intended only to be used as additional information that you can give to your licensed health care professional The GO LED might misinterpret excessive movement as good pulse strength Limit finger movement as much as possible when using the device The GO LED must be able to measure your pulse properly to give you an accurate reading Do not put the device on the same hand arm when using a blood pressure cuff or monitor The GO LED has no alarms It will not sound if the amount of oxygen in your blood is low or if your pulse rate is too high or too low Do not place the GO LED in liquid or clean it with agents containing ammonium chloride isopropyl alcohol or products that are not listed in this User s Guide e The GO LED is not intended for use in institutions Any of the following conditions may reduce the performance of the GO LED flickering or very bright light weak pulse quality low perfusion low hemoglobin arterial catheters nail polish and or art
10. f oxygen in your blood displayed as SpO and your Pulse Rate displayed as a 2 or 3 digit number measuring the number of times your heart beats per minute At the bottom of the display window a tricolor LED Pulse Quality Indicator shows the pulse signal quality while blinking at the corresponding pulse rate This display changes colors to alert you to changes in pulse quality that may affect the readings green good pulse signal yellow marginal pulse signal and red an inadequate pulse signal Percent Oxygen Saturation If you are not getting a pulse rate reading and your pulse quality indicator is marginal or Pulse Quality indicator inadequate warm the finger or reposition to another finger After the startup sequence the GO LED begins sensing the pulse indicated by the blinking Pulse Rate pulse quality indicator Allow the device to stabilize observing about 4 seconds of continu Care and Maintenance The GO LED requires no calibration or periodic maintenance other than battery replace ment Wipe the device with a soft cloth dampened with a mild detergent or 1096 bleach solution Do not use undiluted bleach or any cleaning solution other than those recom mended here as permanent damage could result Dry with a soft cloth or allow to air dry Clean once per week or more frequently if handled by multiple users Caution Do not place the GO LED in liquid or clean it with agents containing ammo nium chlor
11. ide isopropyl alcohol or products that are not listed in this User s Guide Troubleshooting Problems Display Lockup Possible Cause Display does not appear to change you should see the pulse quality indicator flash green or yellow if the device is on the finger Possible Solutions Reposition finger or change fingers Remove and replace battery If the problem persists contact Nonin Technical Service Troubleshooting Problems Display blank Possible Cause Nothing appears on the display Troubleshooting Possible Solutions Problems Reposition finger to activate AL the device Missing segments on LED display Verify battery is correctly p ay inserted Note If battery is installed backwards the unit will not function Dead battery Replace battery May be too cold Allow device to sit No readings at room temperature for at least 30 minutes After unit has been dropped or shocked battery may need to be removed and reinstalled If the problem persists contact Nonin Technical Service Possible Cause Faulty display Low pulse quality no reading Possible Solutions Contact Nonin Technical Service Try the following 1 Reposition finger 2 Warm finger by rubbing 3 Select a different finger For more information please see Reading Your Results Parts and Accessories p GO2CC Black neoprene carrying case with belt loop i GO2L Black 20
12. ificial nails and any tests recently performed on you that required an injection of intravascular dyes The GO LED may not work if you have poor circulation Rub your finger to increase circulation or place the device on another finger The GO LED measures oxygen saturation of functional hemoglobin High levels of dysfunctional hemoglobin caused by sickle cell anemia carbon monoxide etc could affect the accuracy of the measurements Batteries can leak or explode if used or disposed of improperly Remove the battery if the GO LED will be stored for more than 30 days Do not use the GO LED in a combustible environment oxygen enriched environment Do not use the GO LED outside the specified operating and storage temperature ranges Do not use the GO LED for more than 30 minutes without relocating the device to another finger The GO LED needs to be used according to information provided in the User Guide Installing the Battery Do not tamper with or hang lanyard from the flexible circuit Functional tester cannot be used to assess the accuracy of this pulse oximeter The GO LED is a precision electronic instrument and must be repaired by Nonin One 1 5 volt AAA size LRO3 battery powers the GO LED for approximately 2 400 Radios and cell phones or similar devices may affect the GO LED and should be kept at measurements Nonin recommends using alkaline batteries one is included with
13. move battery if the device will be stored for more than 30 days f NOTE Correct positioning of the device on your finger is critical for accurate Activating the Device and Verifying Operation measurements While on the finger do not press the GO LED against any surface and do not squeeze or hold it together The internal spring provides the correct pressure The GO LED automatically turns on when a finger is inserted When a finger is inserted additional pressure may cause inaccurate readings the GO LED performs a brief self test as shown below Verify that all segments of the LED Light Emitting Diode display appear during the startup sequence Reading Your Results ous green colored pulse quality before relying on the displayed values It is common for the displayed values to fluctuate slightly over a period of several seconds If the pulse quality When you put your finger in the GO LED you ll notice an LED display come on The num indicator blinks yellow or red try another finger bers you see show A minus sign appears in the left most digit of the 96SpO display when the GO LED senses that the finger has been removed The last measured SpO and pulse rate values freeze for 10 seconds then the device turns off The device will automatically shut off to conserve battery life approximately 10 seconds after the finger is removed or after a 2 minute period of inadequate pulse signals the amount o
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