V60 - Daray Medical
Contents
1. aseajd 5 YONS 9A9I99J YSIM JOU j pue sayo sinb eioeds pues Ae eq Aj euoriseo2Q eseg aseyoind jo ejeq 78 1S 3X9A SVHH snid 16049944 peseuoung Aiue EM ABSA 19151891 ssalppe 1sode9JJ JNO 0 1119 pue 42. WARAY Medical V60 Pulse Oximeter Manual WARAY Medical INTRODUCTION SAFETY OVERVIEW PRINCIPLE OF OPERATION TECHNICAL DATA INSTALLATION OPERATION MAINTENANCE TRANSPORTATION AND STORAGE TROUBLESHOOTING SYMBOLS 10 TECHNICAL SPECIFICATION RETURNS POLICY WARRANTY WARRANTY REGISTRATION OI NI as Uo A WIN Tel 0800 878 9864 Fax 0333 321 0973 email info daray com url www daray com INTRODUCTION Thank you for purchasing the DARAY V60 Pulse Oximeter This manual is written and compiled in accordance with the 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 The manual describes the V60 Pulse Oximeter s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage and the safety procedures to protect both the user and equipment Please read this manual carefully before using the product The user manual which describes the operating procedures should be followed strictly Failure to follow the user manual may cause abnormalities in measuring equipment damage and patient injury The manufacturer is NOT responsible for the safety reliability and perfor
3. 6 This agreement does not give any rights other than those expressly set out above and in particular Daray will not be responsible for any loss of income profits or contracts or any direct or indirect consequential loss damage caused to or suffered by the purchaser as a direct result of this agreement 7 This warranty is offered subject to these terms and conditions in addition to and does not affect your statutory rights 8 Daray may disclose your details and other personal information to companies within the Daray group including any subsidiary company or sub contractor of Daray for the purposes of performing our obligations hereunder 9 You must not resell outside the UK any products supplied by Daray and covered by the Export of Goods Control Order 1992 or any law that replaces it with out obtaining all necessary licences You also agree not to sell the product in the UK if you know or think that the person buying the product intends to export it without getting the necessary licences You agree to impose similar conditions to these on anyone you sell the product to 10 These conditions shall in all respect be governed and construed in accordance with English law and the exclusive jurisdiction of the English courts 24 ON aseq 01 pue sued AjueJeM JonpoJd 9 0 25894 Ayed pay Aue oi uo ssed 100 AYHVO 1ueuiajeis 39
4. When the upload of stored data is finished OFF will be shown behind the upload item 16 Setting the time and date On the main menu interface press the up button or down button to select Clock then enter the clock setting interface by Press the left button or right button Fig 15 clock setting interface When entering the clock setting menu the menu choice bar would be on the item of set time and the state would always be no whenever it enters the clock setting menu on the purpose of avoiding unexpected changes of time due to improper operation You can change the state by press the left button or right button choose yes to reset the time choose no to forbid time resetting Press the up button or down button to select the parameter that you want to change then adjust the data by press the left button or right button Exit the clock setting menu directly by press the menu button If you have reset the time or date when exiting the clock setting menu firstly the renewed time and date would be displayed on the screen then it returns to the main menu if you didn t reset the time and date when exiting the clock setting menu the device would return to the main menu directly Exit the main menu On the main menu interface press the menu button to exit the main menu Real time data transmission Connect the device with the computer using the US
5. Whilst in the Measuring Screen press the up button a to enter the Review Screen mode 1 as shown in figure 6 In the Review Screen press the menu button El to switch between Review Screen mode 1 and Review Screen mode 2 Press the down button to enter the Review Screen for the next or previous hour In Review Screen mode 1 press the left button Fig 6 Review Screen mode 1 Ye or the right button 7 gt to move the trend graph for storage data When the trend graph cannot be moved any more the sign lt gt at the bottom of the LCD screen disappears In Review Screen mode 2 press the left or right button to move the arrow Press the up button to exit In Review Screen mode 1 the trend waveform from stored data is displayed Each screen shows 114 seconds of data The yellow line shows the 5 2 trend waveform and the red line shows the PR trend waveform The time underneath is the start time of the displayed data The centered and at the bottom of the screen indicate the down button s operation e Press the right button is displayed Press the down button to go to the next hour Fig 7 Review Screen mode 2 e Press the left button is displayed Press the down button to go to the previous hour The Review Screen mode 2 shown is based on Review Screen mode 1 The stored 5 2 value and PR value for each second can be viewed here Underneath are the time 5 2 value
6. 1 Pulse rate 1bpm Measurement Performance in Weak Filling Condition SpO2 and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO2 error is 4 pulse rate error is 2 bpm or 2 whichever is greater 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 Power supply requirement DC 3 0V Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW Adjustable alarm range SpO2 0 100 Pulse Rate Obpm 254bpm 5 INSTALLATION 5 1 View of the front panel probe jack 1 pulse sound indication alarm indication SpO2 ALM SpO2 SpO2 ALM LO pulse waveform battery status indication pulse rate pulse bar graph power on off button up button left button alarm pause button USB menu button right button down button Fig 2 Front View 5 2 Underside View and Left View 95 2 8 Fig 3 Underside View and Left View 1 Probe socket to connect the SpO2 sensor 2 USB port for exporting trend data to a PC 10 5 3 Battery and probe installation Refer to Fig 4 and insert the two AA size batteries properly in the right direction Please take care when you insert the batteries as improper insertion may damage the device 08050004 x m Fig
7. gas such as some ignitable anaesthetic e DO NOT use the oximeter while the patient is being measured by MRI CT e Do not use this device on a patient with an allergy to rubber e The disposal of scrap instrument and its accessories and packaging including battery plastic bags foams and paper boxes should follow the local laws and regulations e Please check the packaging 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 e Only use accessories and probes approved or manufactured by DARAY or the device may be damaged 1 3 Attention 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 transported from a cold environment to a warm or humid environment please do not use it immediately and allow the product to acclimatise to the area DO NOT operate the buttons on front panel with sharp objects e g pens High temperature or high pressure steam disinfection of the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for instructions of cleaning and disinfection Do not have the oximeter submersed 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
8. have been subjected to improper handling or abuse or have been used If you send us goods that do not qualify for return you will invalidate your claim to any refund and you will be obliged to compensate DARAY Ltd for the cost of return postage and any other reasonable costs incurred processing the goods Your statutory rights are not affected 23 Warranty TERMS AND CONDITIONS OF WARRANTY 1 To qualify for this warranty you must register on www daray co uk or return to Daray Ltd Daray the duly completed warranty registration form accompanying the product 2 Daray warrants this product excluding lamp against faulty material and workmanship during the period of the warranty The period of warranty is the period stated on your warranty card and commences on the date of purchase of the product In the event that the product is not in good working order Daray will provide during the warranty period a free repair service within the United Kingdom The warranty is subject to proof of purchase being provided therefore you should retain your original receipt 2 1 The repair service consists of the provision of spare parts and or replacement products at Daray s discretion which will be provided on an exchange basis and will either be new equivalent to new or reconditioned All replaced spare parts and products shall become the property of Daray 2 2 Daray s only obligation under this warranty is the provision of the service as set ou
9. into figure 12 Fig 11 In the status shown in Figure 11 press left button or right button can change the setting of the item then press menu button to exit the status in Figure 11 and perform setting YES for starting recording NO for do not recording In the status shown in Figure12 press left button or right button can change the setting press menu button will exit the Figure12 and perform setting YES for stopping recording NO for continue recording If the data storage function is being turned on when return to the measuring interface a red REC sign and a flashing red dot would appear on screen which means the device is in a state of storing Fig 12 In the state of storing whatever interfaces the device is on measuring interface menu interface the sign Recording would appear on the screen in 30 seconds and then the screen will be automatically shut down If pressing any button power on off excluded at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if pressing the power on off button the device would return to the former interface If turning on the data storage function the former data storage will be automatically removed 15 In the state of data storing after the screen is automatically shut down the pulse sound indication would be off for saving power When the storage space is full
10. it displays Memory is full on the screen and then shut down in a few seconds But it will still display Memory is full by the next time you turn on the device on the purpose of warning the user if press any button power on off excluded again it will enter the measuring interface Stored data transmission setting Firstly please install the affiliated software into the computer and then two icons would appear the desktop after installation The icon of 5 2 is a program for receiving real time data which is shown as figure 13 the icon of SpO2 Review is a program for receiving stored data which 15 shown as figure 14 Fig 13 5202 program SPUABNEV TER Fig 14 5 2 Review program Connect the device with computer by the data line which is affiliated with the device then double click SpO2 Review icon to 5 2 Review program click the New Session Icon in the software enter the patient data and then click ok The Software will then display device connected waiting for data On the main menu interface press the up button or down button to select Upload Press the left button or right button to select on then the data will be transferred to your computer In the state of storing it is not applicable for the users to upload the stored date to computer When the stored data is being uploaded ON will be shown behind the upload item
11. work on arrival or develop a fault Goods which do not work within 28 days we will advance replace the item GOODS DEVELOPING A FAULT If the fault develops after 28 days but within the warranty period we will initiate the returns procedure Goods which have developed a fault within the warranty period NON WARRANTY If a fault develops outside the warranty period we will Goods which have developed a initiate the returns procedure charges may be fault outside the warranty period OTHER Any situation which is not covered by any of the above We will always try to help but we cannot normally offer a refund For additional clarification please refer to our terms and conditions at www daray co uk terms In a small number of cases we may determine that a replacement would not work any better than the original product we supplied In such cases we will only offer a refund rather than a replacement for qualifying returns Replacement bulbs and spare parts ordered on our website or from supplied part codes are not eligible for credit We will accept returns and exchange for the correct item If your purchase an item incorrectly you can return it within 14 days and it can be exchanged for another product of equal or higher value excluding transportation charges incurred Goods and packaging must be returned in their original condition Under no circumstances will goods be accepted for return if they are damaged
12. 4 batteries installation Replace the cover Insert the SpO2 probe of the pulse oximeter in the upper socket If the alarm function is on the device will provide high priority alarm signal when the battery is in low power status intermittent alarm will occur and the battery icon turns flashes red High priority indicates that immediate operator response is required 5 4 Accessories e Battery 2 x AA e User Manual e USB data cable e PC software e SpO2 probe 11 6 OPERATION 6 1 Application method Insert a suitable probe into the socket on the top of the oximeter Clip the probe onto the patient s finger or ear Refer to Figure 5 Press the power button until the device turns on Keep the patient still The data can be read directly from the screen on the measuring interface If the alarm function is on the device will provide medium priority alarm signal when probe is out intermittent alarm will occur and the user interface presents SENSOR OFF Medium priority indicates that prompt operator response is required Pause alarm including data out of limits alarm low voltage alarm probe off alarm When the alarm is on press the alarm pause button to pause the alarm it can renew alarm in about 60s and if pressing the alarm pause button again with in 60s it can renew alarm If you want to turn off the alarm for good you should enter the menu for operation 12 Review screen
13. B cable supplied Open the SpO2 program Shortly the data is displayed in the program When you unplug the USB cable a dialog box Save data at view appears where you can enter some basic information 17 6 2 Attention for operation Please check the device before using and confirm that it works normally The measured part should be in a proper position see the attached illustration of figure 5 for reference or else may result in inaccurate measure The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between The 5 2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection Do not fix the SpO2 sensor with adhesive or else may result in venous pulsation and inaccurate measure of SpO2 and pulse rate Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy Please clean and disinfect the device after operating according to the User Manual 7 1 6 3 Clinical restrictions As the measure is taken on the basis of arteriole pulse substantial pulsating blood flow of subject is required For a subject with weak pulse due to shock low ambient body temperature major bleeding o
14. E OF OPERATION The principle we use for our Oximeter calculations are based of the formula for the Lambert Beer Law according to the Spectrum Absorption Characteristics of Reductive Haemoglobin Hb and Oxyhemoglobin HbO2 in glow near infrared zones The operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology this is adopted in accordance with Capacity Pulse Scanning and Recording Technology This provides two beams of different wavelength being focused onto the patient s finger or ear through the sensors reading point The measured signal is received by a photosensitive element which is electronically processed and the results and subsequently displayed on the V60 s screen Fig 1 Emitter Recorded Body Part 4 TECHNICAL DATA 4 1 Main performance e SpO2 value display e With alarm function e Pulse rate value display bar graph e Stored data can be uploaded to display computers e Pulse waveform display e Real time data can be transmitted to e Low battery indicator appears before computers abnormal operation due to low voltage e Review function e Screen brightness can be changed e Clock function e A pulse sound indication 4 2 Main Parameters Measurement of 5 2 Measuring range 0 100 Accuracy SpO2 range 70 100 2 below 70 unspecified Measurement of pulse rate Measuring range 30bpm 250bpm Accuracy 2 bpm 2 whichever is greater Resolution 5 2
15. and PR value When the stored data exceeds the upper and lower limit set by user the relevant value turns green Clock interface On the measuring interface press the right button can enter the clock interface of figure 8 Press the right button again can return to the measuring interface Fig 8 Clock interface 13 Menu operations On the measuring interface press the menu button can enter the menu of figure 9 Users can adjust the settings through the main menu such as alarm pulse sound indication backlight data storage data transmission with the use of data line the specific method is as follows Fig 9 Main Menu Interface Alarm setting On the main menu interface press the up button down button to select Alarm then press the left button or right button to enter the alarm setting menu of figure 10 The highest lowest alarm limit setting Press the up button down button to choose the parameter to be adjusted then press the left button or right button to change data Each press of the left button or right button the Fig 10 Alarm Setting Menu data will raise or descend for one time accordingly If the alarm function is on the device will provide medium priority alarm signal when the data of 5 2 or pulse rate is beyond the limit Intermittent alarm will occur and the measurement shows in yellow Medium priority indicating that p
16. device with water the temperature of the water should be lower than 60 C The update period of data is less than 5 seconds this can be altered to allow different pulse rates to be detected Please read the measured value when the waveform on screen is displaying equably and consistently this measured value is the optimal value And the waveform at the moment is the standard one If any abnormal conditions or results appear on the screen during the test process please remove the measured part and then reinsert to reset and restore normal use The device has an average product lifetime of three years since first use The V60 has an alarm function users can check and set this function according to the instructions in chapter 6 1 as a reference The V60 has the functionality to allow settable alarm limits when the measured data is beyond the highest or lowest limits the alarm will sound automatically The V60 s alarm system can be paused or completely stopped according to user preference This function can be adjusted through the menu system shown in chapter 6 1 2 OVERVIEW The pulse oxygen saturation 5 02 is the percentage of 2 Oxyhaemoglobin in the total Hb haemoglobin in the blood so called the O2 concentration in the blood It is an important bio parameter for measuring respiration A number of diseases relating to the respiratory system can cause a decrease of 5 2 in the blood furthermore various other illne
17. e error 3 Signal inadequacy indicator IPX1 Ingress of liquids level WEEE 2002 96 EC EB Y 21 10 TECHNICAL SPECIFICATION Measuring range 0 100 resolution 1 Accuracy 70 100 2 below 70 unspecified Average value Calculate the Average value in every 4 measure value The deviation between average value and true value does not exceed 1 Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1bpm Accuracy 2bpm or 2 select larger Average pulse Calculates the average pulse rate every 4th cardio cycle rate Deviation between average value and true value does not exceed 1 Safety Type Interior battery BF type Dimensions and Weight Appendix Alarm condition delay Alarm signal generation delay 22 Returns Policy IMPORTANT Before returning your item you must call us on 0800 878 9864 We want you to be completely satisfied with your purchase If you need to return goods purchased from DARAY Ltd please read the following information carefully The DARAY Ltd returns policy provides guidance on when you can return goods we have supplied and what you can expect from us once you do To see our detailed returns policy and procedure visit www daray co uk returns TYPE OF RETURN REMEDY DAMAGED GOODS Goods which are physically We must be notified within 24 hours of receipt damaged on delivery Dead On Arrival DOA Goods which do not
18. evice should be stored in room with no corrosive gases and good ventilation Temperature 40 C 60 C Humidity lt 95 19 8 Troubleshooting The SpO2 and Pulse Rate do 1 The measured part is not 1 Place the measured part not be display normally properly positioned properly and try again 2 The patient s SpO2 is too 2 Try again Go to a low to be detected hospital for a diagnosis if you are sure the device works all right The SpO2 and Pulse Rate are 1 The measured part is not 1 Place the measured part not stable placed inside deeply properly and try again enough 2 Keep the patient still 2 The measured part is shaking or the patient is moving The device can not be The battery is drained away Please change batteries turned on or almost drained away Please install the battery 2 The battery is installed again incorrectly 3 Please contact the local 3 The malfunction of the service center device The display is off suddenly The battery is drained away Please change batteries or almost drained away 20 9 SYMBOLS Symbol Description Warning Read User Manual Oxygen saturation SpO2 Alarm sound active Pulse sound muted Pulse sound active Battery power full gt Battery power low Power on off Left button alarm pause button Right button down button nn Type BF SN 1 Dont find measured part A gt of 4 j gt 2 Prob
19. mance issues any monitoring abnormality patient injury or equipment damage due to users negligence of the operation instructions The manufacturer s warranty service does not cover such faults WARNING e Discomfort or pain may occur if using the device for prolonged durations It is recommended that the sensor should be applied to the same area for no more than two hours e The light the infrared is invisible emitted from the device can be harmful to the eyes Do not stare at the light e Please refer to the associated literature about the clinical restrictions and caution e This device is not intended for treatment 1 SAFETY 1 1 Instructions for safe operation Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and monitoring performance about cables and transducers lt is recommended that the device should be inspected once a week at least When there is obvious damage stop using the device 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 User s Manual Only the accessory that appointed or recommendatory by manufacture can be used with this device This product is calibrated before leaving factory 1 2 Warning e Explosive hazard DO NOT use the oximeter in environment with inflammable
20. r use of vascular contracting drug the 5 2 waveform PLETH will decrease In this case the measurement will be more sensitive to interference 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 problem the SpO2 determination by this monitor may be inaccurate Drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor blamed for serious error of SpO2 measure As the 5 2 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 18 7 MAINTENANCE TRANSPORTATION AND STORAGE 7 1 Cleaning and Disinfecting Using medical alcohol to disinfect the device nature dry or clean it with clean soft cloth 7 2 Maintenance Clean and disinfect the device before using according to the User Manual 7 1 Change the battery when the screen shows Take out the battery if leave the equipment unused for long time The device should be calibrated once a year or according to the calibrating program of hospital 7 3 Transportation and storage The packed device can be transported by ordinary conveyance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material The packed d
21. rompt operator response is required The alarm state setting Press the up button or down button to select Alarm then choose the alarm state on off by pressing the left button or right button choose on to turn on the alarms and choose off to turn off the alarms for good Exit the Alarm settings Press the menu button to exit the Alarm Settings Menu 14 Pulse sound indication setting On the main menu interface press the up button or down button to select Pulse Sound then Press the left button Or right button to choose to have the Pulse Sound heart beat on or off Backlight adjustment On the main menu interface press the up button or down button to select Brightness then press the left button or right button to change the number in order to adjust the brightness of screen Data storage setting This device has the ability to store 24 hours worth of data It can store the measured pulse rate and 5 02 value accurately transfer the data to the computer display the data and print reports with the included SpO2 Software Green Heart Are you sure On the main menu interface press the up button or down button to select Record then press the left button or right button again to enter the dialog box of figure 11 or finger 12 if it is not in recording state will come into figure 11 if it is in recording state will come
22. sses can cause a decrease in SpO2 such as a malfunction of the human body s self adjustment to environments surgical injuries and injuries caused by some medical assessments Various issues can lead to difficulty of oxygen supply in the patient body Corresponding symptoms of oxygen deprivation would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might endanger a patient s life Therefore the prompt and accurate display of a patient s SpO2 is essential for doctors and practitioners in the clinical medical field The V60 is a small and portable device allowing convenient operation The V60 uses a fingertip probe system for diagnosis and displays the results in a visual graph showing the measured value of 5 2 which allows for high veracity and repetition 2 1 Features e Operation of the product is simple and convenient e The product is small lightweight and easily portable 2 2 Major applications and scope of application The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through a patient s finger or ear and so on It is recommended you use the device when the patient is still 2 3 Environment requirements Storage Environment Temperature 40 C 60 C Relative humidity 5 95 Atmospheric pressure 500hPa 1060hPa Operating Environment Temperature 10 C 40 C Relative Humidity 30 75 Atmospheric pressure 700hPa 1060hPa 3 PRINCIPL
23. t above 2 3 All products are returned to Daray at the customer s cost and risk Products to be returned should be adequately packed For the address to send returns to please visit www daray co uk 3 Daray s arrangements for providing service provided under this warranty may include the use of sub contractors 4 This warranty does not cover damage or defects in the Product caused by or resulting from Wilful neglect or negligence by anyone other than Daray Improper use storage or handling of the product Use of non Daray approved parts such as replacement lamps not compatible with the Product Fire accident or disaster e Use of non Daray modifications other than in accordance with Daray s instructions Attachment of fittings and accessories not approved by Daray Repairs modifications carried out by service personnel not approved by Daray e Damage caused by chemical corrosion from cleaning agents not approved by Daray e Failure to use or install the product in accordance with the manufacturer s instructions 5 Nothing in this warranty shall have the effect of restricting or excluding the liability of Daray in respect of a Death and personal injury caused by the negligence of Daray or for fraud b Under the Consumer Protection Act 1987 to a person who has suffered damage caused by a defective product or to a dependant or relative of such a person Direct damage to your property caused by the proven negligence of Daray
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