VPOD Ultra Manual
Contents
1. drained away The device can not The battery is not full charged Please recharge the battery be used for full time The battery is broken Please contact VirtuOx after charge The battery can not The battery is broken Please contact VirtuOx be full charged even after 10 hours charging time 9 Key of Symbols Signal Description A Warning See User Manual oSpO2 The pulse oxygen saturation PRbpm Pulse rate bpm PI Perfusion Index The battery power is full a P Low power i E Menu button power button IPX1 Ingress of liquids rank ey Ch WEEE 2002 96 EC 10 Function Specification Information i Display Mode The Pulse Oxygen Saturation SpO 2 digit digital OLED display Perfusion Index PI 3 digit digital OLED display Pulse Intensity bar graph i bar graph OLED display 30bpm 100bpm 2bpm gt 101 bpm 250bpm 2 Perfusion Index Specification Range 0 20 the resolution is 0 1 Accuracy 0 1 40 2 1 20 41 Accuracy Safety Type Interior Battery Type BF application part Pulse Intensity Continuous bar graph display the higher display i indicates the stronger pulse Battery Requirement Voltage 3 7 rechargeable lithium battery x 1 The red wire on the battery denotes anode the black wire on the battery denotes cathode Dimensions 63 L x 55 W x 15 H mm i About 45g with a lithium battery 102. VPOD Ultra USER INSTRUCTIONS Thank you for purchasing the VPod Ultra Series Wrist Pulse Oximeter This manual is written and compiled in accordance with council directive MDD93 42 EEC for medical devices and harmonized standards In case of modifications and software upgrades the information contained in this document is subject to change without notice For the most up to date manual please visit www VirtuOx net click on products and choose VPOD Ultra The manual describes in accordance with the Pulse Oximeters features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage etc It also includes safety procedures to protect both the user and the equipment Refer to the respective chapters for details Please read the manual carefully before using this product The section describing operating procedures should be followed carefully Failure to follow the instructions given 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 through improper use or operation contrary to these written instructions The manufacturer s warranty is Null and Void under these circumstances as well WARNING Discomfort or pain may appear if using the device c
3. arge the battery soon after the over discharge The device should be recharged every six months when it is not regularly used It can extend the battery life if you follow this procedure D This device does not need any calibration 7 3 Transportation and Storage A The device can be transported by ordinary conveyance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material B The packed device should be stored in room with no corrosive gases and good ventilation Temperature 40 C 60 C Relative Humidity 95 8 Troubleshooting Trouble Possible Reason Solution The SpO and Pulse The finger is not properly positioned Place finger in the probe properly Rate can not be and try again displayed normally The patient s SpO2 is too low to be Try again Go to a hospital for a detected diagnosis if you are sure the device works all right The SpO2 and Pulse The finger is not placed inside deep Place finger in the probe properly Rate are not enough and try again displayed stably The finger is shaking the patient is Let the patient keep calm moving The device can not The battery is drained or almost drained Please charge battery be turn ed on The malfunction of the device Please contact VirtuOx The display is off The malfunction of the device Please contact VirtuOx suddenly The battery is drained away or almost Please charge up battery
4. asuring range 0 100 Accuracy 70 100 42 Below 70 unspecified B Measurement of Pulse rate Measuring range 30bpm 250bpm Accuracy 30bpm 100bpm 2bpm 101 bpm 25 0bpm 2 C Perfusion Index Range 0 20 D Resolution SpO2 1 Pulse rate 1bpm Perfusion Index 0 1 E Measurement Performance in Weak perfusion conditions SpO2 and pulse rate can be shown correctly when pulsefilling ratio is 0 4 SpO2 error is 4 pulse rate error is 2 bpm or 2 select larger F 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 G Power Supply Requirement 3 6 V DC 4 2V DC H Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW 5 Installation 5 1 View of the Front Panel Time Power indication Pulse rate value Prob ae Perfusion Index SpO2 value Menu button SpO gt alarm low limit Power button Pulse bar graph Pulse waveform Wristband Figure 2 Front View 5 2 Probe Installation A Open the USB cover insert the probe into the USB port of the pulse oximeter and the red light of probe will flicker B Insert finger into the probe the side with finger sign and the nail should be in the same side The connected probe should work normally when the luminescent tube in the device emits red light continually AN In order to ensure device life and m
5. charging When the state bar is full the charging is finished 6 2 Best Practices for Operation A Please check the device before using and confirm that it operates normally B The finger should be in a proper position see the attached illustration as Figure 3 for reference or else it may result in an inaccurate measure ment C The beam of lightbetween the red light and photoelectric receiving tube must go through subject s arteriole D The oximeter should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Ensurenothing such as bandage or Nail polish can impede the light passage or else it may result in inaccurate measurement of SpO pulse rate and PL F Excessive ambient light may affect measurement accuracy It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Intense activity of the subject or extreme electrosurgical interference may also affect the accuracy H Subject may NOT wear false fingernails or metallic nail polish I Please clean and disinfect the device after operating according to the User Manual 7 1 J Remember to set time date after each upload thru VirtuOx website K Remember to clear memory after each upload 6 L Remember to call patient before you drive out to patients home and ask them to power on off unit to determine if there is sufficient data to successfully create a report See below un
6. e screen during test process pull the finger out and reinsert to restore normal recording amp The device has an average 3 year lifespan before replacement of the internal battery amp The device may be not fit for all patients If you are unable to receive a stable measurement discontinue use amp Do not twist or sharply bend the wires of the probe 1 amp The Probe warranty is separate from the device The Probe warranty is 90 days 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O Saturation It is an important bio parameter for respiration A number of diseases relating to respiratory system may cause the decrease of SpO2 in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical procedures can also lead to difficulty of oxygen supply in human body and the corresponding symptoms would appear vertigo impotence vomiting etc Serious symptoms may be life threatening Therefore prompt information regarding a patients SpO is necessary forthe doctor to discover any potential danger and is critical in the clinical field The Pulse Oximeter is small in volume low in power consumption convenient in operation and portable With a high definition display screen the device is precise and simple It is only necessary for patient to put one finger into probe for diagno
7. easurement accuracy the external probe is limited to the matching model and cannot be replaced with a non compatibleprobe or the device will be damaged or readings invalidated 5 3 Accessories A A User Manual B A power adapter C A data line D An Adult Boot Probe Reusable 6 Operating Guide A Please refer to Best Practice Guide on VPOD Ultra web page or booklet 6 1 Application Methodology 6 1 1 Measurement a Insert the finger into the probe of the device b press power button 3 to5 seconds to turn the device on c Do not shake the finger and keep the patient in a stable state during the process d The data can be read directly from the display screen in the measuring interface 6 1 2 Lay Finger The right method of laying finger is as Figure 3 Figure 3 A Red light should emanate from Top of finger downward 6 1 3 Change Display Direction The device can change display direction by pressing the menu button quickly to change display direction 6 1 4 Menu Operations Long press menu button to enter the main menu in Figure 4 The user can adjust the settings through the main menu such as backlight The specific operation methods are as follows A Brightness Adjustment In the main menu interface short press menu button to move the choice bar to the Brightness item then long press menu button to adjust the brightness of screen 4 levels adjust able Figure 4 Main Menu Interface B Syst
8. em Setting In the main menu interface short press menu button to move the choice bar to the System item then long press menu button to enter the system setting menu as Figure 4 a Hard Ver The version number of hardware for the device b Soft Ver The version number of software for the device c Exit Inthe System Menu interface short press menu button to move the choice bar to Exit item then long press button to exit System Menu and return to the main menu C Exit Main Menu In the main Menu interface short press menu button to move the choice bar to Exit item then long press button to exit main Menu and return to the measure interface D Clock Setting Setting the Clock Time Date is done via the VirtuOx website portal via Device Admin please refer to Best Practice Guides 6 1 5 Charge There are two kinds of charging method a Connect the device to computer with data line then the device should be in charging state b Connect the device to power supply with power adaptor then the device should be in charging state The power adapter of the device accords with the requirements of IEC 60601 1 A When charging in poweroff state short press power button and the device will display green dynamic state bar It means that the device is charging When the state bar is full the charging is finished When charging in power on state dynamic Power indication symbol displays It means that the device is
9. iction S ie or eee anaran e ART EEA R ARAA EEA O EEE AEE er i 7 Maintain Transportation and Storage 7 1 Cleaning and Disinfecting 7 2 Maintainence 73 Transp rtand Storage aeoe r E A N EEEN E ES 7 8 Troubleshooting 9 Symbol Key 10 Function Specification H 1 Safety 1 1 Instructions for Safe Operations lt Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect monitoring performance and the patient s safety It is recommended that the device should be inspected a minimum of once a week When there is obvious damage stop using the device and contact VirtuOx for RMA or Repair V The Oximeter cannot be used with any devicenot specified in the user s Manual Only VirtuOx approved accessories can be attached to the Oximeter lt This product has been calibrated before leaving factory no further calibration is necessary 1 2 Warning Explosive hazard DO NOT use the Oximeter in the environment with flammables such as anesthetic DO NOT use the Oximeter while the patient is being scanned by MRI or CT The person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packing 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
10. it will display the hours minutes and seconds of stored data 6 3 Clinical Restrictions A Becausethe measurement is taken on the basis of arteriole pulse substantial pulsating blood flow is required In subjects with a weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more sensitive to interference B 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 problems SpO determination with this device may be inaccurate C The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor resulted in serious error of SpO2 measurement D The SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia for some patients with serious anemia may also report good SpO2 measurement 7 Maintain ance Cleaning Transportation and S torage 7 1 Cleaning and Disinfecting Using medical alcohol to wipe the device and probe in to disinfect Air dry or clean with clean soft cloth 7 2 Maintainance A Please clean and disinfect the device before using according to the User Manual 7 1 B Please recharge the battery when the screen shows low power the battery power is E C Rech
11. nciple of 2 the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through an encompassing finger type sensor Then measured the signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor ANA vv Glove and infraeed ray j Emission Tebe gt T UU Pea reas 7 I N Garand aaay gt C3 Receipt Tube oe S N TAANA V v Figure 1 Work Elements 4 Technical S pecifications 4 1 Main Display and Functionality When powered off units displays Good Study Indicator hrs mn sec of stored data SpO value display Pulse rate value display bar graph display Pulse waveform display Perfusion Index value display Charge function aLithium rechargeable battery supplies power for the device Low power indication low power indication symbol appears before working abnormally which is due to low power Power off long press power button to turn off the device The display direction can be changed Short press menu button to change display direction Screen brightness can be adjusted The record data can be uploaded to the computer It can be connected with oximeter probe 4 2 Main Parameters A Measurement of SpO Me
12. ontinuously for longer than specified periods of time especially with microcirculation barrier patients For the special patients there should be a more prudent inspecting in the placing process The device can not be clipped on edemic or tender tissue The light the infrared is invisible emitted from the device is harmful to the eyes so the user should not look at the lightsource Subjects for test should not use enamel Nail polish Subjects for test should not have excessive finger nail length Please refer to the correlative literature concerning clinical restrictions and cautions This device is not intended as a treatment Contents 1 1 Instructions for Safe Operation seek 12A WAtDin 8S ssc ee temae Lah so tue sec cue tendons ceete nas gus send E E tens tasadeoneat deb ecascviaea cess 1 ES E ETN O EEA sh Ses EEE E oz ea eeesas sbiuus EE EEE 1 2 Overview 2 1 Features 2 2 Major Applications and Scope of Application sssssseeeseesssrerrrrrrrerrersssessseererrrrrrrrrrree 2 2 3 Environmental Requirements 3 Principle 4 Technical Specifications 41 Main Performance t esner a de cslabscsvedees wegee EE E E E ees 3 Bie Ma Pare ES a E E N oe 3 5 Installation 5 1 View of the Front Panel 5 2 Probe Installation i enan n a r O E avira Ow acne 4 oT N E E I n EE EEEE TE EE 4 6 Operating Guide 6 1 Application Method 6 2 Best practices for Operation 6 3 Clinical Restr
13. sis the display screen will directly show the SpO2 value pulse ratevalue Perfusion Index value and pulse waveform with high accuracy and repetition 2 1 Features Ultra thin wrist design Small in size light in weight and conveniently worn Low power consumption Display direction can be changed automatically easy to view Perfusion Index measurement m OQ e Patented Good Study Indicator displays the hours minutes and seconds recorded G Customize device with your logo optional for small fee 2 2 Major Applications and Scope of Application The Pulse Oximeter can be used in measuring the pulse oxygen saturation pulse rate and perfusion index through finger The product is fit for family hospital oxygen bar community healthcare Sports Medicine It can be used before or after doing sports and it is not recommended to use the device during Certain Interactive sports and etc 2 3 Environmental Requirements Storage Environment a Temperature 40 95 f b Relative humidity 95 c Atmospheric pressure 5O0hPa 1060hPa Operating Environment a Temperature Of 95 f b Relative Humidity 75 c Atmospheric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter is as follows An experience formula of data process is es tablished taking use of Lambert BeerLaw according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO2 in glow amp near infrared zones Operation pri
14. with the packing list or else the device may have the possibility of working abnormally Please choose the accessories which are appointed or recommended by the manufacturer for avoiding device damage Please don t measure this device with functional tester for the device s related information 1 3 Attention A Keep the Oximeter away from dust vibration corrosive substances combustibles high temperature and moisture amp Ifthe Oximeter gets wet pleas e cease operation A When it is carried from cold environment to warm or humid environment please do not use it immediately amp DONOT operate button on panel with sharp things amp High temperature or high pressure steam disinfection will damage this device and void warranty Refer to User Manual in the relative chapter 7 1 for cleaning and disinfection amp Do not submerge the Oximeter 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 amp When cleaning the device with water the temperature should not be lower than 60 degrees amp Fingers which are too thin or too cold may affect the measure accuracy please use a thicker finger such as thumb or middle finger that will fit into the probe amp Optional probes are available for Pediatric and Neo Natal use amp Please wait until the reading has stabilized before taking a visual reading amp If some abnormalities appear on th
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