VM-2101 User Manual
Contents
1. The finger has been removed from the finger oximeter Check that the finger is correctly inserted into the finger oximeter Low battery battery symbol blinking red The battery is almost completely discharged Replace batteries immediately 3 3 Problems Causes Corrective Actions Problem There is no response to the power but ton Cause Corrective Action Ensure that the power button is fully depressed The batteries may be mis sing discharged or oriented incorrectly Install new batteries Problem No pulse signal found Cause Corrective Action Check the patient Check that the finger oximeter is placed correctly Test the monitor on another subject Perfusion may be too low for the monitor to track the pulse Check the patient Test the monitor on yourself Change the application site VM 2101 User Manual Viamed Ltd 2008 Interference due to patient activity may be preventing the monitor from tracking the pulse Keep the patient still if possible Change the appli cation site There may be interference due to ambient light or the finger oximeter may be on an extremity with a blood pressure cuff arterial catheter or intravascular line Reposition the finger oximeter as necessary Electromagnetic interference may be preventing the monitor from tracking the pulse Remove the source of interference 3 4 EMI Electromagnetic Interference Caution This device has be2. VIAMED Mt i 0 il 0 n Q E jE My ill M VIAMED Table of Contents 1 Intended Use and Warnings 3 1 1 Intended Use 1 2 Warnings W Uv 2 Operation 2 1 Battery Installation 2 2 Switching on the Device 2 3 Inserting the Finger 2 4 Commencing Monitoring 2 5 Switching off the Device 2 6 Symbols and Indicators 2 7 Alternating Between Display Modes short button press 6 2 8 Adjusting Display Brightness long button press 6 UV bp Sb HB HW amp 3 Error Messages Problems Corrective Actions 7 3 1 General Information 7 3 2 Error Messages Causes 7 3 3 Problems Causes Corrective Actions 7 3 4 EMI Electromagnetic Interference 7 4 Maintenance Cleaning 8 5 Symbol Definitions 8 6 Technical Specifications 8 7 Packing List 8 8 Declaration of Conformity 9 9 Contact address 10 VM 2101 User Manual Viamed Ltd 2008 1 Intended Use and Warnings 1 1 Intended Use The VM 2101 finger oximeter is indicated for spot monitoring of functional arterial oxygen saturation SpO and pulse rate of adults and pediatrics in hos pital hospital type facilities pre and postoperative monitoring transport emergency care and mobile environments sports medicine as well as in the home care environment A 1 2 Warnings Warnings are identified by the WARNING symbol shown above Warnings alert the user to potential serious outcomes such as death injury or adverse events
3. ation Road Cross Hills Keighley West Yorkshire BD20 7DT United Kingdom Tel 44 0 1535 634542 Fax 44 0 1535 635582 E mail info viamed co uk www viamed online com
4. e visible Pleth waveform at all times Multifunctional button switch device on short press change rotate display short press when the device is switched on Adjustable brightness press for more than one second when the device is switched on VM 2101 User Manual Viamed Ltd 2008 2 7 Alternating Between Display Modes short button press Depending on the personal preferences and applica tion it is possible to alternate between a display with plethysmographic waveform and a display which shows the readings in a larger font size but without the waveform Additionally it is possible to rotate the screen orientation When the VM 2101 is in operating mode each short press of the button will change the display mode Examples of different display modes Horizontally orientated screen with plethysmo graphic waveform Horizontally orientated screen with large digits but without plethysmo graphic waveform Vertically orientated display VM 2101 User Manual Viamed Ltd 2008 2 8 Adjusting Display Brightness long button press Attention Using high display brightness will consume more battery power than medium or low brightness levels and a more frequent change of batteries may be required The finger oximeter has 6 levels of adjustable bright ness If whilst in operation the button is kept pressed for longer than one second the brightness adjustment be comes active and the b
5. en tested and found to comply with the limits for medical devices according to EN 60601 1 2 second edition and the Medical Device Directive 93 42 EEC These limits are desig ned to provide reasonable protection against harmful interference in a typical medical installation Due to the proliferation of radio frequency transmit ting equipment and other sources of electrical noise in healthcare environments it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of perfor mance of this device Examples of noise sources in healthcare environments that could cause electromag netic interference include e Electrosurgical units e Cellular phones e Mobile two way radios e Electrical appliances e High definition televisions HDTVs The pulse can be obscured by electromagnetic inter ference During such interference measurements may seem inappropriate or the finger oximeter may not seem to operate correctly Disruption may be evidenced by erratic readings cessation of operation or other incorrect functioning If this occurs the operating environment should be surveyed to determine the source of disruption and the following actions taken to eliminate the source e Turn equipment in the vicinity off and on to isolate the offending equipment e Reposition or relocate the interfering equipment Increase the distance between the interfering eq
6. he patient s finger The light that is emitted by the finger oximeter has to transmit from the upside of the finger oximeter through the patient s finger nail e Turn the patient s hand so that you can see the finger nail e Nip one end of the finger oximeter to open Insert the patient s finger nail facing the top of the finger oximeter so that the finger is placed fully on the silicone pad Release the nipped end of the finger oximeter to secure it on to the patient s finger i i 7 LJ k Hi VM 2101 User Manual Viamed Ltd 2008 2 6 Symbols and Indicators spo2 MI gpm 993 675 Battery level indicator The three segments represent the nn battery charge level The symbol flashes red when the battery capacity is low Sp02 The SpO value shows the blood oxygen saturation level expressed as a percentage Bar graph for pulse amplitude Indicates the dynamic pulse amplitude and rate As the detected pulse becomes stronger more bars light with each pulse The reverse is true for weak pulses The colour of the bar graph is an indicator for signal quality Green good signal quality very accurate measurement Yellow average signal quality measurement may be inaccurate Red poor signal quality unreliable measurement eM Pulse rate in beats per minute KWS The reading is automatically adjusted to the pulse strength therefore a waveform with strong amplitude should b
7. m the patient through out magnetic resonance imaging MRI scanning In duced current could potentially cause burns A Do not use a device that appears damaged Do not use the device when optical components are exposed 2 Operation 2 1 Battery Installation 1 Slide back the cover of the battery compartment on the rear side of the device in the direction of the arrow Tilt the battery compartment cover on its hinge 2 Insert two batteries 1 5 volt AAA ensuring the correct orientation in accordance with the polarity markings 3 Tilt and slide the battery compartment cover closed 2 2 Switching on the Device 2 4 Commencing Monitoring Press and hold the button on the front panel briefly Once the finger oximeter is switched on and the until the opening welcome screen appears After patient s finger is inserted correctly monitoring will the power on self test is successfully completed the begin automatically device is ready for monitoring Monitoring in progress Device ready for monitoring no finger inserted 2 3 Inserting the Finger 2 5 Switching off the Device A Externally applied colouring agents such as nail The VM 2101 will automatically power off after 15 polish may interfere with the monitor s ability to de seconds when the patient s finger is removed tect and display accurate measurements To obtain an accurate reading it is essential that the finger oximeter is placed correctly on t
8. rightness adjustment screen 1s shown For every second that the button is kept pressed the brightness increases by one level Once the highest le vel is reached the brightness will decrease by one level for every second that the button is kept pressed When the lowest brightness level is reached the brightness will increase again Button pressed toggles the brightness level Brightness adjustment lowest level selected Brightness adjustment highest level selected Release the button when the desired brightness level has been reached After a few seconds the device returns automatically into measurement mode The device will always start with the last selected brightness level 3 Error Messages Problems Corrective Actions 3 1 General Information Physiological conditions medical procedures or exter nal agents that may interfere with the finger oximeter s ability to detect and display accurate measurements include e Incorrect application of the finger oximeter e Placement of the finger oximeter on an extremity with a blood pressure cuff arterial catheter or intravascular line e Excessive patient activity e Intravascular dyes Externally applied colouring agents such as nail polish e Failure to shield the application site with opaque material in high ambient light conditions e Venous pulsation e Dysfunctional haemoglobin Low perfusion 3 2 Error Messages Causes Display shows
9. to the patient or user A Do not make any clinical judgments based solely on the VM 2101 The monitor is intended only as an adjunct in patient assessment It must be used in con junction with clinical signs and symptoms The inter pretation of the measurement values should be done only by trained health care professionals A Explosion hazard Do not use VM 2101 in the pre sence of flammable anaesthetic mixture with air oxy gen or nitrous oxide A Routinely monitor the patient to ensure that the VM 2101 is functioning and that the oximeter is correctly placed Pulse oximetry measurements and pulse signals can be affected by certain environmental conditions oximeter application errors and certain patient condi tions See the appropriate sections of this manual for specific safety information A If you are uncertain about the accuracy of any measurement check the patient s vital signs by alter nate means then ensure that the VM 2101 is functio ning correctly A The VM 2101 is not defibrillator proof However it may remain attached to the patient throughout de fibrillation or whilst an electrosurgical unit is in use The measurements may be inaccurate throughout the defibrillation or use of an electrosurgical unit VM 2101 User Manual Viamed Ltd 2008 and shortly thereafter To avoid shock the caregiver should not touch the VM 2101 while using a defibril lator on a patient A Disconnect the VM 2101 fro
10. uipment and the finger oximeter 4 Maintenance Cleaning Maintenance There are no user serviceable parts inside the VM 2101 The housing should not be opened The finger oximeter requires no calibration If service is necessary contact qualified service personnel or your local sales representative Caution Do not spray pour or spill any liquid on the VM 2101 as this may damage the finger oximeter Surface clean Use a soft cloth dampened with either a commercial nonabrasive cleaner or a solution of 70 alcohol in water Lightly wipe the surface of the finger oximeter Disinfection Use a soft cloth saturated with a solution of 10 chlo rine bleach in tap water Lightly wipe the surface of the finger oximeter 5 Symbol Definitions Attention See instructions for use Manufacturer Date of manufacture Type BF Part number Observe applicable waste disposal regulations C 0000 Serial number Furopean Union approval VM 2101 User Manual Viamed Ltd 2008 6 Technical Specifications Measurement Range SpO 0 to 100 Pulse Rate 20 to 300 beats per minute bpm Accuracy SpO 2 70 to 100 Pulse Rate 1 digit lt 100 bpm 1 gt 100 bpm Display e OLED colour graphic display 262 000 colours 128 x 96 pixels e Data displayed oxygen saturation pulse rate plethysmogram bar graph e Indicators signal quality pulse amplitude battery status En
11. vironmental Conditions e Operating conditions 20 to 50 C 15 to 95 RH 600 to 1300 hPa Storage conditions 30 to 70 C 10 to 95 RH 600 to 1500 hPa Other e Class IIa product e Water resistant construction IPX2 e Type BF Dimensions L x W x H 57 x 33 x 27 mm e Weight including batteries approx 50 g e Power Supply 2 batteries 1 5 volt AAA e Battery Life approx 24h of continuous operation Order Number 0012101 Applied Standards EN 60601 1 2 BS EN ISO 9919 2005 7 Packing List e VM 2101 main unit e Lanyard e 2x AAA batteries 1 5 volt e User manual on CD 8 Declaration of Conformity EC Declaration of Conformity We hereby declare under sole responsibility that the product VM 2101 Finger Oximeter for monitoring of functional arterial oxygen saturation SpO2 and pulse rate Product No 0012101 conforms with the essential requirements of Annex Il of the Council Directive 93 42 EEC of 14 June 1993 concerning medical devices In accordance with Annex IX of the Directive 93 42 EEC the product has been classified as Class lla Application of the CE marking CE 0086 Issuer Viamed Ltd 15 Station Road Cross Hills Keighley West Yorkshire BD20 7DT United Kingdom Place Date Keighley 4 August 2008 Legally binding signature A a Steve Nixon Director VM 2101 User Manual Viamed Ltd 2008 VM 2101 User Manual Version EN 1 1 Viamed Ltd 15 St
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