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Veterinary V3402 HandHeld Digital Pulse Oximeter

1. PEN 7 2 Chapter 8 PC Communication Setup eee eere ee eene eene eeesseeess B 1 Irene 8 1 PC Communication SetuP e 8 1 Chapter 9 Maintenance ssssosssssoocessssocesssoocessosocesosocesssoosesssoocesssoosessossesssss J T Schedule of Maintenance SIRO E a E EAR A AAE AE E E A AA IA EAEE Chapter 10 Troubleshooting isccsssssssscsesssssesecsevscsecstscssecosnssseceencssosssvsasseseces 10 1 EMI Interference Chapter 11 Optional Supplies and Accessories 11 1 Ordering Information irte tene aedi D trt PED etc ENSE EHE 11 1 ii Handheld Digital Pulse Oximeter Operation Manual Table of Contents Chapter 12 Specifications i en etii ttr db ense r riri rine e cbeidbesonon 12 1 Equipment ClassifICatiOn aniceitecoto ttti tbe Ea Su EO eU RED cR tes RR EEEa Displays Indicators amp Keys A dible Alarm Indicatots sse iret terrore traer sb tarte Restrepo ciassecdnavectasstensectasstel Trend Storage Interval csssscssssssccssssccsssecccnseccesusesssnsessssseesesuseccsnteceessseessnsesessseesssuseessnsecessseesssnsesssnseesenssesees Power Requiremiehts croire coe theta tese ceca tore bs E derai Sedaaa BEER SEE CE Rea REESE STERBEN SEHR Ro cde ERR aaa Battery Wie m
2. 2 1 Jaen USE sor e 2 1 Wfernproldu s rf M Q 2 1 Theory of Operation ieoop oce roo pU t E I acie e EE e ei dee ba te 2 2 Patented Technology iisi hnnain a a aaa iaaea setaa oe iNi aa 2 3 Chapter 3 Controls and Features sssosesssoocessosocesssoscessooceesooocessssoeessssesessss 37 T MohitorErontPallel sss tee ttetesirit ette esetees eter a aE EAE ra ddar a EAEE EAEE 3 1 Monitor Operatirig Keys ceeerioreiietet toit reins rn Ir tentare etre carb LEE Ge ooa Dea reso EORR NEAR esai Saanane aet 3 3 Chapter 4 Operating Instructions eee e eee eere eee eee eere eee eee eosseeees osse A 1 Unpacking the Monitor iicet rtt erii Rb He EAR te ER I teer tpe a int 4 1 Install thie Batteries sccisiscsssscssccuiscsusscensssteassecusnsnssecvessnovastacabondcodsstecusltvocseyechesscstusdbosideducnsatecdessectastdcadeaseedsciecsivlted 4 1 Deu 4 1 Attaching the Sensor to the Patient 0 sessssssssccssseccssssscsssesesssssessnssecsssesessssesssssssesssscessnseceessecessnsesssnseessses 4 2 Choosing the SOMSON e 4 2 Care and Handling of the SQnsor ssssssssssccsssssccssseccsssescsssssessssesssnsecessssseesnsesssnssessssseessnseseessesessnsesesneeeesees 4 3 Pulse Oximeter Senisois caie concen rorteseite tie ce heel ERU OE OD Tie cei top Celo Hie Ss do eee droit 4 4 Refl
3. DIGI SIONS oec itr oreet aaea ere iei aeaa ise sva buses dario PEN UU US ERE ins ie Pepe eese DeL Environmental Specifications Appendix A Guidance and Manufacturer s Declaration A 1 Guidance and Manufacturer s Declaration c sssssssscsssccsssccseccssccssecsssecssecssccsssecsuseesseeesuseesueecsueeesneeesaes A 1 Electromagnetic Emissions Emissions Test sssscsssssscsssesessssecsssecessssceessseeesssecesssseessnseessaneesaneeees A 1 Electromagnetic Emissions Immunity eese tenent tenent ttennntttnnnntttnnntttnnnttttnnnitenn A 1 Recommended Separation Distances ccsccssecsssecsssecssecsseccsscescccssccessceesssessseccsscsssesseeseaecsseeesaeecsaeeeessees A 4 Appendix B Revision History eere esee eene e eere neenon eee sese eesesesesecesssece B 1 The serial autocorrelation technology in the monitor is covered by U S Patent No 5 558 096 SurgiVet and the Smiths design mark are trademarks of the Smiths Medical family of companies The symbol B indicates the trademark is registered in the U S Patent and Trademark Office and certain other countries All other names and marks mentioned are the trade names trademarks or service marks of their respective owners Handheld Digital Pulse Oximeter Operation Manual iii Table of Contents This page is intentionally left blank Handheld Digital Pulse Oximeter Operation Manual Warr
4. Deleted any mention of Veterinary Division Veterinary Handheld Digital Pulse Oximeter Operation Manual B 1 Appendix B Revision History This page is intentionally left blank B 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual CE Authorized Representative as defined by the Medical Device Directive Smiths Medical International Ltd Phone 44 1923 246434 Colonial Way Watford Herts Fax 44 1923 240273 WD24 4LG UK aal Manufactured By Smiths Medical PM Inc N7W22025 Johnson Drive Waukesha WI 53186 1856
5. Figure 4 7 Alarm Example Q During a high priority alarm the numbers flash that correspond to the alarm The high priority alarm LED flashes a The alarm tone sounds if not silenced The high priority alarm tone consists of 3 short bursts a pause followed by 2 more short bursts Note The alarm tone does not sound if the Alarm Silenced indicator is on or flashing NOTE Both SpO and pulse rate numbers will flash if both readings match or exceed their alarm range 4 8 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 4 Operating Instructions Low Priority Alarms A low priority alarm warns you about an abnormal monitor condition A low priority alarm is activated when the Sensor is not connected to the monitor e Sensor is not attached to the patient Sensor is not properly attached to the patient Signal contains artifact BPM Sensor Figure 4 8 Alert Example Q During a low priority alarm the SENSOR or Artifact indicator illuminates C During a low priority alarm the monitor cannot measure the patients SpO or pulse rate Dashes are displayed The Low Priority LED lights steadily and the low priority alarm tone sounds if not silenced The low priority alarm tone consists of 2 long bursts Note The alert tone does not sound if the Alarm Silenced indicator is on or flashing WARNING While SENSOR is lit the monitor cannot measure the patient s SpO or pulse rate
6. D Patient s SpO Shown Here 2 Patient s Pulse Shown Here Patient s Pulse Strength Shown Here 1 To turn on the monitor press the key When turned ON the monitor does the following The top segment of the pulse strength bar graph illuminates The monitor s software revision is momentarily displayed The patient number is momentarily displayed WARNING Verify that all LEDs light emitting diodes on the display light up upon startup of the device Veterinary Handheld Digital Pulse Oximeter Operation Manual 4 7 Chapter 4 Operating Instructions 2 The monitor has two averaging settings for SpO and pulse rate To change the averaging setting press and hold the A Up Arrow while turning on the monitor This will set the 96SpO and pulse rate averaging to 16 16 Press and hold the sv Down Arrow while turning on the monitor to set the SpO and pulse rate averaging to 4 8 NOTE Increasing or decreasing the averaging setting has no effect on the data update rate NOTE SpO averaging is the number of pulse beats over which the SpO value is averaged pulse averaging is the number of seconds over which the pulse value is averaged High Priority Alarms A high priority alarm warns you about an abnormal patient condition A high priority alarm is activated when e the patient s SpO reading matches or exceeds the SpO alarm range e the patient s pulse rate reading matches or exceeds the pulse rate alarm range
7. If the Artifact indicator is lit the patient s readings may not reliably reflect his her actual condition The patient s condition should be checked immediately After checking the patient s condition correct the SENSOR or Artifact low priority alarm See Correcting the SENSOR Artifact Alert in the Troubleshooting section for help Veterinary Handheld Digital Pulse Oximeter Operation Manual 4 9 Chapter 4 Operating Instructions Low Battery Indicator Figure 4 9 Low Battery Attention i The Low Battery indicator red lights up steadily until the batteries are replaced o The Low Priority Alarm LED yellow indicator lights up steadily and the low battery tone sounds WARNING When the LOW BATTERY INDICATOR is illuminated you must immediately replace the monitor s batteries Otherwise the monitor turns itself off about 30 minutes after the low battery indicator illuminates NOTE The Alarm Silence key cannot disable the Low Battery audible tone During a LOW BATTERY ATTENTION The Low Battery indicator L lights up steadily Thelow priority alarm LED lights up steadily Aseries of five high pitch beeps will sound every minute until the batteries are replaced 4 10 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 4 Operating Instructions High and Low Priority Alarm Summary DISPLAY INDICATOR LED INDICATOR EFFECTS High Priority Numbers corresponding High priority alarm Overrides pu
8. Trend Interval Low Priority Alarms Delay Alarm Volume Pulse Volume o Alarm Silence Momentarily pressing the Alarm Silence key disables the alarm tone for two 2 minutes Pressing and holding the Alarm Silence key for about three 3 seconds disables the alarm tone indefinitely until canceled or the monitor is turned off To cancel either the indefinite or the two minute alarm and alert tone silenced condition momentarily press the Alarm Silence key The Alarm Silenced indicator will turn off 2 Alarm Select Pressing this key cycles through each of the alarm settings PRINT CLEAR Key Located on the side of the monitor Pressing this key will send data to the optional IR printer Pressing the key again will stop printing Pressing and holding the Print Clear key will clear the trend data Veterinary Handheld Digital Pulse Oximeter Operation Manual 3 3 Chapter 3 Controls and Features This page is intentionally left blank 3 4 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 4 Operating Instructions Chapter 4 Operating Instructions WARNING This device must be used in conjunction with clinical signs and symptoms This device is only intended to be an adjunct in patient assessment Unpacking the Monitor 1 Carefully remove the monitor and its accessories from the shipping carton Save the packing materials in case the monitor must be shipped or stored 2 Compare the packing list wi
9. c Tail Wrap Sensor Reflectance sensor V1710 Figure 4 4 Reflectance Sensors V1700 For best results while using the tail wrap sensor V1710 apply to the ventral base of the tail with the divider positioned centrally Moisten the fur and parting at the application site or shaving a small area is required The sensor works best on medium to large sized patients Secure sensor strap Y Tail Clip Sensor Figure 4 5 Attaching the Sensor to the Animal For best results while using the reflectance sensor V1700 apply to the base of the tail This sensor can also be used rectally if needed When using either of the reflectance sensors ultrasound gel is recommended to enhance performance Fur dark pigmentation poor perfusion and movement can affect the sensor s ability to obtain accurate readings 4 4 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 4 Operating Instructions Pulse Oximeter Sensor Application Tips There is some variation depending on the manufacturer but there are three basic types of pulse oximeter sensors made for the small animal patient Large and Mini Y sensors Mini Clip sensor C sensor may also be used on large animals Tail Wrap sensor Reflectance sensor It is very important to have a variety of sensors in order to monitor the majority of the small animal patients It is also important to select the proper sensor for animals based on their size color fur type
10. CAUSE CORRECTIVE ACTION No pulse shown on Patient cable or sensor is Check sensor connections to the patient cable and to the bargraph disconnected from the the oximeter oximeter Sensor is incorrectly Reposition the sensor positioned on the patient Poor patient perfusion Reposition the sensor Defective sensor or patient Try a new sensor or contact your authorized repair cable center for help Pulse rate is erratic Sensor incorrectly Reposition the sensor intermittent or positioned Incorrect Patient motion Patient must remain still to obtain an accurate measurement SpO value is Poor patient perfusion Reposition the sensor erratic intermittent Patient motion Patient must remain still to obtain an accurate or incorrect measurement The oximeter Batteries weak Replace the batteries doesn t turn on Batteries not installed Ensure the batteries are installed correctly or batteries incorrectly installed The oximeter turns Batteries are weak or dead Replace the batteries off unexpectedly No printout on Batteries are weak Replace the batteries optional printer Batteries are not properly Ensure the batteries are installed properly installed No trends in memory Take trend data Sensor must be Disconnect the sensor disconnected for trend data printout Printer interface Contact Smiths Medical PM Inc Veterinary Clinical malfunction Support for help Printer and oximet
11. It is also important to note that some anesthetic drugs such as Xylazine Rompun Acepromazine or Medetomidine Domitor can affect peripheral pulse pressures causing very weak pulsations All pulse oximeters require a good quality pulse to work properly Other drugs such as ketamine can cause the tongue to twitch limiting the use of a lingual clip on that site Checking the Sensor and Oximetry Cable Follow these instructions each time before you attach the sensor to the patient This helps ensure the sensor and oximetry cable are working properly WARNING Using a damaged sensor may cause inaccurate readings Inspect each sensor If a sensor appears damaged do not use it Use another sensor or contact your authorized repair center for help WARNING Using a damaged oximetry cable may cause inaccurate readings Inspect the oximetry cable If the oximetry cable appears damaged do not use it Contact your authorized repair center for help 1 Carefully inspect the sensor to make sure it does not appear damaged 2 If using the oximetry cable carefully inspect the oximetry cable to make sure it does not appear damaged 3 If using the oximetry cable a If the sensor is not already connected to the oximetry cable connect the sensor to the oximetry cable Push the connectors together firmly and close the latch to secure the connectors b If the oximetry cable is not already connected to the monitor connect the oximetry cable
12. SpO and Pulse Rate has a high and low alarm limit setting Press the Alarm Select key 2 until the alarm limit you want to change is shown then press the Up or Down key Aor Y to increase or decrease the setting ALARM SEL KEY DISPLAY ALARM LIMIT PRESS First Press p H High SpO2 alarm limit Example only Second press B5 bo 85 Low SpO alarm limit Example only Fourth press 1 50 Low pulse rate alarm limit Example only Fifth press g i 4 97 SpO2 measurement Example only i i 74 Pulse rate measurement Example only WARNING Be aware of alarm limits of similar units in the same area when adjusting alarm limits of this device to avoid confusion Third press 5 z 155 High pulse rate alarm limit Example only Veterinary Handheld Digital Pulse Oximeter Operation Manual 5 1 Chapter 5 Changing the Monitor s Settings NOTE inthe alarm limit display means the limit is set to off NOTE Alarm limits are non overlapping You cannot set the high alarm equal to or lower than the low alarm and you cannot set the low alarm equal to or higher than the high alarm NOTE Alarm limits are retained through power cycles with the exception of the following note NOTE If either the low or high SpO alarm limit is set below 80 they will reset to 85 or higher when the monitor is next powered on NOTE While setting alarm limits if no keys are pressed for twenty seconds the alarm limit set
13. any instrument verify proper operation before clinical use Refer to the instrument s user manual for full instructions Accessory equipment connected to the monitor s data interface must be certified according to the respective IEC standards i e IEC 60950 for data processing equipment or IEC 601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC 601 1 1 systems requirements Anyone connecting additional equipment to the signal input port or the signal output port configures a medical system and therefore is responsible that the system complies with the requirements of the system standard IEC 601 1 1 Veterinary Handheld Digital Pulse Oximeter Operation Manual 7 1 Chapter 7 Printer Trend Printouts Collecting Trend Data Whenever the monitor is on it stores one SpO and one pulse rate reading every four 4 to thirty 30 seconds The stored readings are called trend data The monitor remembers trend data for up to 99 patients and 90 hours of run time The trend data can then be printed at any time on the optional printer Trend data is saved for each patient number When you turn on the monitor if valid trend data was collected from the previous patient the patient number is automatically incremented If no valid trend data was collected from the previous patient the patient number is displayed only and is not incremented Follow these steps for trend data printouts 1 Turn on the prin
14. be eliminated by covering each site with an opaque material Tissue damage may result from overexposure to sensor light during photodynamic therapy with agents such as verteporphin porfimer sodium and metatetrahydroxyphenylchlorin mTHPC Change the sensor site at least every hour and observe for signs of tissue damage More frequent sensor site changes inspections may be indicated depending upon the photodynamic agent used agent dose skin condition total exposure time or other factors Use multiple sensor sites Chapter 1 Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING When connecting this monitor to any instrument verify proper operation before clinical use Refer to the instrument s user manual for full instructions Accessory equipment connected to the monitor s data interface must be certified according to the respective IEC standards i e IEC 60950 for data processing equipment or IEC 601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC 601 1 1 systems requirements Anyone connecting additional equipment to the signal input port or the signal output port configures a medical system and therefore is responsible that the system complies with the requirements of the system standard IEC 601 1 1 IEC 60950 approved equipment must be placed outside the patient environment The patient environment is defined as an are
15. feature delays the audible low priority alarm during a SpO searching or artifact event for a specified amount of time To set the delay interval press the Be Alarm Select key three times upon entering Setup Mode The display will show gi oFF To adjust the delay interval press the A Up Arrow The delay interval choices are OFF 15 30 or 45 seconds Permanent Silence Disable Alarm audio can be disabled by using the Alarm Silence key for 2 minutes or permanently as previously described in this chapter Permanent silence disable in the Setup Mode will allow the user to set the alarm audio preferences 2 minute silence or permanent silence 1 To set the alarm audio preferences press the Det Alarm Select key four times upon entering Setup Mode 2 The display will show Pr Hifg if the monitor has been set to allow the user to permanently disable the alarm audio 3 To only permit 2 minute alarm silence press the N7 Down Arrow The display will show e Rud NOTE If set to 2 minute alarm silence the alarm audio can only be disabled for 2 minutes Veterinary Handheld Digital Pulse Oximeter Operation Manual 5 3 Chapter 5 Changing the Monitor s Settings This page is intentionally left blank 5 4 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 6 Patient Numbers and Trend Data Chapter 6 Patient Numbers and Trend Data Description Whenever the monitor is on it stores one SpO and one pulse rate
16. gauze Other sites include the prepuce or vulva of larger dogs the achilles tendon of a cat or small dog ears or toe webbing C Sensor For cats and small breed dogs place the sensor on the thigh metatarsal or metacarpal or hock near the saphenous vein For larger breed dogs place the sensor over the Achilles tendon tongue prepuce or vulva or through toe webbing It may be necessary to wet and part the fur with water in order to get the sensor closer to the skin of the patient For large animals e g horses place the sensor on the tongue Veterinary Handheld Digital Pulse Oximeter Operation Manual 4 5 Chapter 4 Operating Instructions Tail Wrap Sensor and Reflectance Sensor e In most animals wet and part the fur at the ventral tail base and use the straps on the tail wrap to hold the tail wrap sensor in place When using the reflectance sensor wet and part the fur at the ventral tail base and use non adhesive tape to hold the sensor in place The reflectance sensor may be used rectally if the patient has a small or no tail t may be necessary to shave a small spot on the ventral tail base in patients with a thick undercoat such as a Husky Limitations Experience will quickly tell you which probes work best under different conditions Fur dark pigmentation poor perfusion and movement can all affect the sensors ability to obtain accurate readings Well perfused sites with little or no hair are preferable
17. medical condition and type of procedure Testing Sensor Function 1 To test the large and mini Y sensor functions turn on the monitor with the lingual sensor attached View the sensor to make sure a red light is being emitted then place the sensor on a small finger without nail polish Rest the hand with the sensor on it on a table to minimize motion Note that in most cases the red light should be shining in the same direction as the overhead or surgical lights It is important that the light receptor is shielded in order to avoid interference from ambient light Once placed on a patient site the red light should be shining continuously In some cases a blinking light indicates that the tissue thickness is either too thin or thick Once the sensor is placed properly both the SpO and pulse rate should appear in a short period of time 10 15 seconds 2 Testing the C sensor is performed in the same manner This is a stronger sensor and can be used with greater tissue thickness 3 Testing the tail wrap and reflectance sensors are performed in the same manner but it should be pressed between thumb and index finger or into the palm of your hand Primary Applications for Sensors Large and Mini Y Sensor and Mini Clip Sensor The primary application site is the tongue for most animals On cats and small dogs fold the tongue like a taco or use a wet gauze pad of single thickness folded over the tongue and then place the sensor over the
18. reading every four 4 to thirty 30 seconds These intervals are adjustable as described later in this chapter The stored readings are called trend data The monitor remembers trend data for up to 99 patients and 90 hours of run time Trend data is saved for each patient number When you turn on the monitor the patient number is automatically incremented and displayed during the power up sequence If valid trend data was collected from the previous patient the patient number is incremented If no valid trend data was collected from the previous patient the patient number is displayed only and is not incremented Trend data for all patients can be printed on the optional printer Trend data will be preserved for about one and a half minutes without battery power allowing battery replacement without losing trend data NOTE See Printer section for information on printing trend data Incrementing the Patient Number The patient number will be advanced at power up if any patient data has been collected during the previous on time Adjusting the Trend Storage Interval 1 Enter Setup Mode press and hold the Doe Alarm Select key while turning the monitor on 2 Press the Dee Alarm Select key once The trend storage interval will appear on the display showing the default interval of 30 seconds 3 Use the A Up or V Down Arrow keys to increase or decrease the trend storage interval The interval range is 4 seconds to 30 seconds SAMPL
19. to the monitor Push the connector firmly into the monitor 4 If not using the oximetry cable connect the sensor to the monitor Push the connector firmly into the monitor 5 If the monitor is not already on press the 96 key to turn on the monitor WARNING If any of the integrity checks fail do not attempt to monitor the patient Use another sensor or oximetry cable or contact the equipment dealer for help if necessary 4 6 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 4 Operating Instructions 6 Before the sensor is attached to the patient check the integrity of the sensor oximetry cable and oximeter as follows a Make sure the red light in the sensor is illuminated NOTE Obstructions or dirt on the sensor s red light or detector may cause the checks to fail Make sure there are no obstructions and the sensor is clean 7 You are now ready to attach the sensor to the patient Cleaning or Disinfecting the Sensors Clean or disinfect reusable sensors before attaching to a new patient WARNING Do not autoclave ethylene oxide sterilize or immerse the sensors in liquid CAUTION Unplug the sensor from the monitor before cleaning or disinfecting Clean the sensor with a soft cloth moistened in water or a mild soap solution To disinfect the sensor wipe the sensor with isopropyl alcohol Turning On the Monitor Figure 4 6 SpO pulse rate and pulse strength bar graph
20. E INTERVAL SECONDS RUN TIME HOURS Clearing Trend Data To clear trends press and hold the PRINT key for 15 seconds The Lir message on the 7 segment displays will flash to indicate that the trend clear is about to happen Veterinary Handheld Digital Pulse Oximeter Operation Manual 6 1 Chapter 6 Patient Numbers and Trend Data This page is intentionally left blank 6 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 7 Printer Chapter 7 Printer Description Data can be printed in either data log or trend data mode In the trend data mode up to 90 hours of previously stored data collected from 1 to 99 patients is printed Data log prints real time data A maximum of twenty four 24 characters will be printed on one line Data will be printed at a rate of one line every 5 seconds TREND PN 01 H M S SpO2 BPM 00 00 00 96 120bpm 00 00 30 97 119bpm PN 02 H M S SpO2 BPM 00 00 00 120bpm 00 00 30 97 119bpm Figure 7 1 Sample Trend Printout DATA LOG SpO2 BPM 98 70bpm 97 72bpm Figure 7 2 Sample Data Log What You ll Need for Printing You ll need these items to print trend printouts Digital Oximeter e Optional infrared HP 82240B printer Trend and Data Log Print outs part 8411 e Accessories required for the printer such as paper can be purchased from an authorized distributor WARNING When connecting this monitor to
21. IEU OF AND EXCLUDES ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED BY OPERATION OF LAW OR OTHERWISE INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE Seller disclaims responsibility for the suitability of the Product for any particular medical treatment or for any medical complications resulting from the use of the Product This disclaimer is dictated by the many elements which are beyond Seller s control such as diagnosis or patient conditions under which the Product may be used handling of the Product after it leaves Seller s possession execution of recommended instructions for use and others Conditions of Warranty This warranty is void of the Product has been altered misused damaged by neglect or accident not properly maintained or recharged or repaired by persons not authorized by Seller Misuse includes but is not limited to use not in compliance with the labeling or use with accessories not manufactured by Seller This warranty does not cover normal wear and tear and maintenance items Limitation of Remedies The original purchaser s exclusive remedy shall be at Seller s sole option the repair or replacement of the Product THIS IS THE EXCLUSIVE REMEDY In no event will Seller s liability arising out of any cause whatsoever whether such cause is based in contract negligence strict liability tort or otherwise exceed the price of the Product and in no event shall Se
22. NT key Alarm Silence Up Arrow Vv Down Arrow v cu Alarm Select Veterinary Handheld Digital Pulse Oximeter Operation Manual 12 1 Chapter 12 Specifications SpO Range 0 9996 Functional SpO 196 increments Accuracy 2 at 70 9996 3 at 50 69 Alarms Low 5096 9996 and OFF High 5096 9996 and OFF Steps 196 Factory Defaults Low OFF High OFF Averaging 4 8 16 pulse beat average selectable Display Response The display is to functional saturation The pulse strength bar graph is not proportional to pulse volume Display Update Rate 1 Hz SpO 60 Hz pulse strength Calibration Factory calibrated over the range of 5096 to 10096 SpO using human blood samples to functional saturation Test methods available upon request No in service calibration is required Sensor Red 660nm 2 0 mW Infrared 905 nm 2 0 2 4 mW Because pulse oximeter measurements are statistically distributed only about two thirds of pulse oximeter equipment measurements can be expected to fall within the Agus of the value measured by the CO oximeter The 3402 has been validated in human desaturation studies on 10 adult volunteers that did not have health problems and were non smokers The study was conducted at oxygen concentrations evenly distributed over an SaO range of 50 to 100 Pulse Rate Range 20 350 bpm 1 bpm increments Accuracy 1 beat or 2 whichever is greater Alarms Low 5 350 bpm and OFF High 5 350 bpm and OFF St
23. TM Veterinary V3402 HandHeld Digital Pulse Oximeter Operation Manual as Sez Lt Emmy BPM SENSOR A Q Ww T English Catalog Number V1896 Version 4 April 2008 O 2008 Smiths Medical Family of companies All rights reserved smiths medical Table of Contents Table of Contents Warranty and Service Information eere eee eee eene eene eene ee een ese essseess V Proprietaty NOTICE ossicles ente cer etae eer sed vitet et iniee Ven tee tee tabe vel Vent estis aai so Ee Neo re Eee Uer ani V Warranty V limited Warranty certet paite ted rad pue a nep QR n V Loaner Device Domestic Sales Only cesssscssscsssscsssecsssccsssccssecssusccssceessccsssecesscessecsasecsseesaseesseecsaceesasees V Disclaimer Of E IECIDD vi Conditions of Wartanty iade tieniti tens tena A vi Limitation of Remedies datione tritt tees bre trei rc aeter aiki vi Ecos e vi CE NOTICE T vii Chapter 1 Introduction ooi niei ieri bb ob E Op FERRE EREN UR EEApe ER eeu iesic ines P5 Aboutthis Manu al 5 tenendam iion aie iet eti usd a 1 1 Definition of SYMONS pee 1 1 MES 1 2 Rec o re M 1 5 per R 1 5 Chapter 2 Intended Use and General Information
24. The operator must be thoroughly familiar with the information in this manual before using the device This device must be used in conjunction with clinical signs and symptoms This device is only intended to be an adjunct in patient assessment It is the operator s responsibility to set alarm limits appropriately for each individual patient Prolonged use or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours ELECTRICAL SHOCK HAZARD when cover is removed Do not remove covers Refer servicing to qualified personnel Veterinary Handheld Digital Pulse Oximeter Operation Manual WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 1 Introduction In the event that earth ground integrity is lost the performance of this device and or other devices nearby may be affected due to excessive RF emissions Any monitor that has been dropped or damaged should be inspected by qualified service personnel prior to use to insure proper operation If the accuracy of any measurement is in question verify the patient s vital sign s by an alternative method and then check the monitor for proper functioning Remove device ba
25. a 1 5 m 4 92 feet from the patient PATIENT ENVIRONMENT e S e Disconnect the AC power supply from the outlet before disconnecting it from the monitor Leaving the AC power supply connected to an AC power outlet without being connected to the monitor may result in a safety hazard Do not allow any moisture to touch the AC power supply connectors or a safety hazard may result Ensure that hands are thoroughly dry before handling the AC power supply Failure to place the monitor away from the patient may allow the patient to turn off reset or damage the monitor possibly resulting in the patient not being monitored Failure to carefully route the cable from the sensor to the monitor may allow the patient to become entangled in the cable possibly resulting in patient strangulation Route the cable in a way that will prevent the patient from becoming entangled in the cable If necessary use tape to secure the cable If there is a risk of the AC power supply becoming disconnected from the monitor during use secure the cord to the monitor several inches from the connection Under certain clinical conditions pulse oximeters may display dashes if unable to display SpO and or pulse rate values Under these conditions pulse oximeters may also display erroneous values These conditions include but are not limited to patient motion low perfusion cardiac arrhythmias high or low pulse rates or a combi
26. al C Sensor Large Animals over Pinna ears Toe Webbing V1711 Large Y Sensor 60 pounds Tongue V1702 Mini Y Sensor V3078 Mini Clip Sensor Rectum Tail V1700 Reflectance Sensor V1710 Tail Wrap Sensor Hock Achilles Tendon etc V1707 Universal C Sensor 4 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 4 Operating Instructions Care and Handling of the Sensor WARNING Misuse or improper handling of the sensor and cable could result in damage to the sensor This may cause inaccurate readings Hold the connector rather than the cable when connecting or disconnecting the sensor to the device as shown in Figure 4 1 Cable Connector Figure 4 1 Disconnecting or connecting the sensor Do not use excessive force or unnecessary twisting when connecting disconnecting storing or when using the sensor Veterinary Handheld Digital Pulse Oximeter Operation Manual 4 3 Figure 4 2 Attaching the Y sensor to the lingual clip Chapter 4 Operating Instructions Pulse Oximeter Sensors NOTE Please see insert accompanying each sensor for further details PY Large Y Sensor Mini Y Sensor Mini Clip V1711 V1702 V3078 Figure 4 2 Lingual Sensors Attach the sensor and clip to the patient s tongue Make sure the light source is topside of the tongue Figure 4 3 Attaching the Sensor to the Animal Reflectance Sensors
27. andheld Digital Pulse Oximeter Operation Manual 4 11 Chapter 4 Operating Instructions This page is intentionally left blank 4 12 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 5 Changing the Monitor s Settings Chapter 5 Changing the Monitor s Settings Silencing Alarm Tones The high and low priority alarm tones can be silenced for two minutes or indefinitely until canceled or until the monitor is turned off 1 To silence the alarm tones for two minutes momentarily press the Alarm Silence key If alarms were already silenced you must press the Alarm Silence key Q again The alarm SILENCE indicator A flashes during the two minute time out 2 To silence the alarm and alert tones indefinitely press and hold the Alarm Silence key for about three seconds The alarm SILENCE indicator A lights steady while alarms are silenced indefinitely 3 To cancel either the indefinite or the two minute alarm tone silenced condition momentarily press Alarm Silence key the alarm silenced indicator turns off Changing the Pulse Beep Volume A beep tone sounds with each pulse beat The volume of the beep can be adjusted to fifteen 15 settings and off To adjust the volume to the off setting press and hold the WV Down Arrow From the off setting set the volume by pressing the A Up Arrow The volume is increased decreased with each key press Changing the Alarm Limits Each measurement
28. anty and Service Information Warranty and Service Information Proprietary Notice Information contained in this document is copyrighted by Smiths Medical PM Inc and may not be duplicated in full or part by any person without prior written approval of Smiths Medical PM Inc Its purpose is to provide the user with adequately detailed documentation to efficiently install operate maintain and order spare parts for the device supplied All information contained in this document is believed to be current and accurate as of the date of publication or revision but does not constitute a warranty Warranty Limited Warranty Smiths Medical PM Inc Seller warrants to the original purchaser that the Product not including applicable accessories shall be free from defects in material and workmanship under normal use if used in accordance with its labeling for two years from the date of shipment to the original purchaser Seller warrants to the original purchaser that the reusable oximeter sensors supplied as accessories shall be free from defects in materials and workmanship under normal use if used in accordance with its labeling for one year from the date of shipment to the original purchaser USA only Seller warrants to the original purchaser that the AC Power supply charger supplied with the exception of part number 3005 shall be free from defects in materials and workmanship under normal use if used in accordance with its labeli
29. ct the Smiths Medical PM Inc Clinical Support department or your local distributor for help CAUTION Connect only the printer PC interface cable specifically intended for use with this device see Optional Supplies and Accessories CAUTION Chemicals used in some cleaning agents may cause brittleness of plastic parts Follow cleaning instructions in this manual Notes NOTE NOTE NOTE NOTE NOTE NOTE NOTE NOTE Batteries are user replaceable Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components including batteries When using AC power the Digital Oximeter is a class Il device with functional earth This earth connection is for device electromagnetic compatibility and does not provide protection to the patient or user It is recommended that batteries be used with the monitor when operating with AC power to prevent monitor shutdown with loss of AC power SpO averaging is the number of pulse beats over which the SpO value is averaged pulse averaging is the number of seconds over which the pulse value is averaged All user and patient accessible materials are non toxic Each input and output connection of the monitor is electrically isolated Performance and safety test data are available upon request To comply with government requirements for patient monitoring the indefinite high priority alarm medium priority alarm and low priority alar
30. ct will be shipped freight prepaid by Seller to Purchaser To obtain warranty information outside the USA contact your local distributor Keep all original packing material including foam inserts If you need to ship the device use only the original packaging material including inserts Box and inserts should be in original condition If original shipping material in good condition is not available it should be purchased from Smiths Medical PM Inc Veterinary Division Damages occurred in transit in other than original shipping containers are the responsibility of the shipper All costs incurred returning devices for repair are the responsibility of the shipper CE Notice Marking by the symbol C indicates compliance of this device to the Medical Device Directive 93 42 EEC Authorized Representative as defined by the Medical Device Directive Smiths Medical International Ltd Tel 44 1923 246434 Colonial Way Watford Herts Fax 44 1923 240273 WD24 4LG UK Veterinary Handheld Digital Pulse Oximeter Operation Manual vii Warranty and Service Information This page is intentionally left blank viii Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 1 Introduction Chapter 1 Introduction About this Manual The Operation Manual provides installation operation and maintenance instructions for veterinary health care professionals and other users trained in monitoring respiratory and veterinar
31. cted RF IEC 60601 TEST LEVEL Recommended separation distance IEC 61000 4 6 3V rms 150 kHz to 80MHz COMPLIANCE LEVEL 3 Vrms 8096 AM modulation 0 5kHz 150 kHz to 80 MHz Radiated RF IEC 60601 TEST LEVEL Recommended separation distance IEC 61000 4 3 3V m 80 MHz to 2 5 GHz COMPLIANCE LEVEL d 0 35 vP 800 MHz to 2 5 GHz 20 V m 80 AM e 80 MHz to 1 GHz d 0 18 vP 80MHzto 800 Mhz PzManufacturer s output power in watts W d Recommended distance in meters m Field strengths from fixed RF transmitter as determined by an electromagnetic site survey should be less than the compliance level in each frequency range P CAUTION Interference may occur in the vicinity of equipment marked with the following symbol e W Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed RF transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the V3402 pulse oximeter is used exceeds the a
32. ectance Sensors acc cmt pe tette verte res eris ete ree E voveo tosstsnysdvestestectsa eestesteevastucnseaeatscienstvlied 4 4 Pulse Oximeter Sensor Application Tips csssecsssccsssecsssecsssccssccessscesecsssccssscecssecsssecsscesuseesaceesuseesuceesueerses Testing Sensor Function sss Primary Applications for Sensors Large and Mini Y Sensor and Mini Clip Sensor C SONS OF iuto endete bu NR E re ra Ne NO he un oae n na eau d eet ipee Tail Wrap Sensor and Reflectance Sensor ssssssssscsssecsseccssecssscssecssecsseessneecssseesseecsutecssecsaeesseessuses Handheld Digital Pulse Oximeter Operation Manual i Table of Contents EInilieueoiec c 4 6 Checking the Sensor and Oximetry Cable essescssssccssessssecseccsseccsesssseccssecsssccssecssecsaeeccseecsseesaeessneeessees 4 6 Cleaning or Disinfecting the Sensors Tumming ON the MONITO e High Priority ALANIS tccsssccsssssstesscssascsectsesznazssescusssacapsserasesceussssnazsetestosentasaivbesbeostesustazsenscasausdeps SARDOR RR LOW Priority Alarms tecti irr re Pr EH Ebo ERR HU RE iis E rf eerie e LOW Battery ajo iato f High and Low Priority Alarm SUMIMALY sssssssssssescsssescsssscccssscccsssecesssscessnsceesnseecssnsesesssecesnsecessnseeesneeeesnees 4 11 Turning OFF the MOhItOL uti tre teret rite tenir ORENSE SHEER Na Nt Checking the Moni
33. ed through body tissue to a photodetector Information about wavelength range can be especially useful to clinicians Wavelength information for this device can be found in the SpO Specifications section of this manual Pulse identification is accomplished by using plethysmographic techniques and oxygen saturation measurements are determined using spectrophotometric oximetry principles During measurement the signal strength resulting from each light source depends on the color and thickness of the body tissue the sensor placement the intensity of the light sources and the absorption of the arterial and venous blood including the time varying effects of the pulse in the body tissues Figure 2 1 Theory of Operation 1 Low intensity Red and Infrared LED light sources Detector Oximetry processes these signals separating the time invariant parameters tissue thickness skin color light intensity and venous blood from the time variant parameters arterial volume and SpO to identify the pulses and calculate functional oxygen saturation Oxygen saturation calculations can be performed because blood saturated with oxygen predictably absorbs less red light than oxygen depleted blood WARNING Since measurement of SpO depends on a pulsating vascular bed any condition that restricts blood flow such as the use of a blood pressure cuff or extremes in systemic vascular resistance may cause an inability to determine accurate SpO and
34. eps 5 bpm Factory Defaults Low OFF High OFF Averaging 80r 16 second average selectable Display Update Rate 1 Hz Audible Alarm Indicators Audible alarm with user adjustable volume and two minute or indefinite alarm silence Alarm Volume 45dBA to 85 dBA at 1 meter distance adjustable Trend Storage Interval 4 to 30 seconds selectable Default 30 seconds Steps 1 second 12 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 12 Specifications Power Requirements AC Power supplies 1611 AC power supply 105 125VAC 60Hz 1612 AC power supply 208 252VAC 50 60Hz 1613 AC power supply 90 110VAC 60Hz Or six standard AA alkaline cells IEC Type LR6 Battery Life Alkaline Cells 24 hours with no printing Dimensions Width 69 85mm 2 75 inches Height 167 64mm 6 6 inches Depth 36 322mm 1 43 inches Weight 595 grams 1lb 5 ounces with batteries and optional boot Environmental Specifications Operating Temp 0 to 55 C 32 to 131 F Storage Temp 40 to 75 C 40 to 167 F Relative Humidity 15 to 95 operating non condensing 10 to 95 storage non condensing Veterinary Handheld Digital Pulse Oximeter Operation Manual 12 3 Chapter 12 Specifications This page is intentionally left blank 12 4 Veterinary Handheld Digital Pulse Oximeter Operation Manual Appendix A Guidance and Manufacturer s Declaration Appendix A Guidance and Manufacturer s Declarat
35. er Realign printer and oximeter alignment incorrect for infrared printers E00 ROM Error Contact Smiths Medical PM Inc Veterinary Clinical Support or your local distributor E01 RAM Error Contact Smiths Medical PM Inc Veterinary Clinical Support or your local distributor Sensor Patient cable or sensor is Check sensor connections to the patient cable and to disconnected from the the oximeter oximeter Sensor is incorrectly Reposition the sensor positioned on the patient Poor patient perfusion Reposition the sensor Defective sensor or patient Try a new sensor or contact Smiths Medical PM Inc cable Veterinary Clinical Support for help Artifact Patient motion Patient must remain still to obtain an accurate measurement Veterinary Handheld Digital Pulse Oximeter Operation Manual 10 1 Chapter 10 Troubleshooting EMI Interference CAUTION This device has been tested and found to comply within the limits for medical devices to IEC 601 1 2 1993 EN 60601 1 2 1994 and the Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in a typical medical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the heath care and home environments for example cellular phone mobile two way radios electrical appliances it is possible that high levels of such interference due to c
36. ery Bypass 90 110 VAC 60Hz Japan each V1700 Sensor Oximetry reflectance R E Small Medium each 3311 Oximetry Cable 1 5m 5 ft each Ordering Information For ordering information contact your local distributor or the Smiths Medical PM Inc Veterinary Clinical Support Smiths Medical PM Inc Telehone 262 513 8500 N7W22025 Johnson Drive Toll Free 888 745 6562 Waukesha Wisconsin 53186 1856 Fax 262 513 9069 Website www surgivet com Veterinary Handheld Digital Pulse Oximeter Operation Manual 11 1 Chapter 11 Optional Supplies and Accessories This page is intentionally left blank 11 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 12 Specifications Chapter 12 Specifications Equipment Classification Type of Protection Against Electric shock Internally Powered Mode of operation Continuous Degree of Protection Against ingress of IPX1 drip proof Liquids Degree of Mobility Portable Degree of Protection Against Electric Shock Type CF Safety Requirements EN60601 1 1990 Displays Indicators amp Keys SpO LED numeric display 7 62 mm 0 30 inches high Pulse Rate LED numeric display 7 62 mm 0 30 inches high Pulse Strength Logarithmically scaled 8 segment LED bargraph Indicators Low Battery indicator SENSOR Sensor alert indicator O Alarm Silence MM Artifact LEDs High Priority red Low Priority yellow Line Power green Keys 96 On Offkey 0 PRI
37. gh the sensor connector when the sensor patient cable is not plugged in An additional cable is used to connect the device to a serial printer or PC computer The following items will be needed 1 Printer Cable 2 DB 9 Null Modem Cable 3 DB 9 Printer Connector PC Communication Setup Power up the monitor 2 Connect the printer communication cable to the monitor 3 Set up the communication software to accept the following RS 232 data format Data Type ASCII Data Format 9600 baud 1 start bit 8 data bits 1 stop bit no parity 4 Connect the standard RS 232 null modem cable s DB 9 connector to the mating connector of the printer cable 5 Connect the standard RS 232 null modem cable s DB connector to the mating connector on the PC NOTE The DB 9 null modem cable is an industry standard RS 232 modem cable DB9 Null Modem Cable ap DB9 PC Figure 8 1 PC Communication Setup Veterinary Handheld Digital Pulse Oximeter Operation Manual 8 1 Chapter 8 PC Communication Setup This page is intentionally left blank 8 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 9 Maintenance Chapter 9 Maintenance Schedule of Maintenance MAINTAIN THIS ITEM HOW OFTEN BY DOING THIS Battery When Low Battery Follow the instructions for installing the batteries Attention indicator is flashing and or audible battery indicator so
38. his page is intentionally left blank 2 4 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 3 Controls and Features Chapter 3 Controls and Features Monitor Front Panel Y G N J Figure 3 1 Monitor Controls and Features aD Sensor Printer Connector The sensor connects here or an oximetry extension cable can be connected between the monitor and the sensor The serial printer or PC communication cable is also connected here SpO Numeric Display A number shows the patient s SpO value in percent Dashes mean the monitor is not able to calculate the SpO value Pulse Rate Numeric Display A number shows the patient s pulse rate value in beats per minute Dashes mean the monitor is not able to calculate the pulse rate value Pulse Strength Bar Graph The pulse strength bar graph sweeps with the patient s pulse beat The height of the bar graph shows the patient s pulse strength Sensor Problem Alert Indicator This indicator lights steadily to inform the operator of an oximeter sensor problem Q o Alarm Silence Indicator This indicator flashes during temporary two minute alarm silence The indictor lights steadily during permanent indefinite alarm silence Q Ww Artifact Alert Indicator This ind
39. icator informs the operator about the presence of excess artifacts O 7 Low Battery Indicator During a Low Battery Attention this LED is lit and an audible burst of 5 beeps notifies the user that approximately 30 minutes of battery use remains Veterinary Handheld Digital Pulse Oximeter Operation Manual 3 1 Chapter 3 Controls and Features o High Priority Alarm LED red This LED flashes twice every second during a high priority condition This signal indicates that immediate operator attention is needed Q Low Priority Alarm LED yellow This LED indicates a low priority alarm which lights steadily during a low priority alarm condition D Line Power Indicator green This LED lights steadily while external power is applied 12 IR Printer Output The Digital Oximeter can transmit data to an optional HP printer via an infrared link through this port AC Power Jack An optional AC power supply connects here 3 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 3 Controls and Features Monitor Operating Keys T 1 ZI ca 3 H BPM SENSOR A eo Figure 3 2 Monitor Operating Keys ON OFF Key Pressing this key turns the monitor ON and OFF Q Upand v Down Arrows The Up and Down arrow keys are used to adjust the following settings Alarm Limits SpO Pulse Rate averaging
40. ion Guidance and Manufacturer s Declaration The V3402 pulse oximeter is intended for use in the electromagnetic environment specified in the tables within this appendix NOTE The customer or user of the V3402 pulse oximeter should ensure that it is used in such an environment Electromagnetic Emissions Emissions Test EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions Group 1 The V3402 pulse oximeter uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The V3402 pulse oximeter is suitable for use in all CISPR 11 establishments including NA Harmonic emissions Domestic establishments IEC 61000 3 2 Establishments directly connected to the public low Voltage fluctuations voltage power supply network that supplies buildings flicker emissions used for domestic purposes IEC 61000 3 3 Electromagnetic Emissions Immunity ELECTROMAGNETIC ENVIRONMENT IMMUNITY GUIDANCE Electrostatic discharge ESD IEC 60601 TEST LEVEL Floors should be made of IEC 61000 4 2 6 kV contact Wood 8kKVair Concrete COMPLIANCE LEVEL Ceramictile If floors are covered with synthetic material the t6kVcontact relative humidity should be at least 30 8kVair Veterinary Handheld Digital Pulse Oximeter Operation Manual A 1 Appendix A Guidance a
41. l products are published on the internet at http www smiths medical com recycle Disposal other countries When disposing of this device its batteries or any of its accessories ensure that any negative impact on the environment is minimized Contact your local waste disposal service and use local recycling or disposal schemes Separate any other parts of the equipment where arrangements can be made for their recovery either by recycling or energy recovery The main batteries are potentially harmful and will require separate disposal according to manufacturer s instructions or local regulations Note If applicable EU national or local regulations concerning waste disposal must take precedence over the above advice KEYWORD DEFINITION WARNING Tells you something that could hurt the patient or hurt the operator CAUTION Tells you something that could damage the device NOTE Tells you other important information Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING 1 2 Do not use this device in the presence of flammable anesthetics Do not use this device in the presence of magnetic resonance imaging MR or MRI equipment Use only SpO sensors supplied with or specifically intended for use with this device Do not plug the monitor into an outlet controlled by a wall switch This device is intended for use by persons trained in professional health care
42. ller be responsible for consequential incidental or special damages of any kind or nature whatsoever including but not limited to lost business revenues and profits Warranty Procedure To obtain warranty service or repair of SurgiVet equipment in the USA please contact Clinical Support to obtain a Return Authorization Number Please provide the serial number of all equipment that will be returned Any equipment returned for evaluation must be cleaned and decontaminated prior to being handled by our service technicians For cleaning instructions please refer to the appropriate section in the operation manual If equipment is returned prior to cleaning and in our opinion it represents a potential biological hazard the equipment will be returned to the sender as is Reference the return authorization number when returning your Product freight and insurance prepaid by Purchaser to Smiths Medical PM Inc Clinical Support Veterinary Division Telephone 1 262 513 8500 Attn Repairs return Toll Free 1 888 745 6562 USA only N7W22025 Johnson Drive Fax 1 262 513 9069 Waukesha WI 53186 Web www surgivet com NOTE Shipments received without a return number will be returned to sender vi Veterinary Handheld Digital Pulse Oximeter Operation Manual Warranty and Service Information Seller will not be responsible for unauthorized returns or for loss or damage to the Product during the return shipment The repaired or replaced Produ
43. lose proximity or strength of a source may result in disruption of performance of this device The monitor is designed for use in environments in which the signal can be obscured by electromagnetic interference During such interference measurements may seem inappropriate or the monitor may not operate correctly The monitor generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference with other devices in the vicinity Disruption may be evidenced by erratic readings cessation of operation or other incorrect function If this occurs the site of use should be surveyed to determine the source of this disruption and actions taken to eliminate the source Turn equipment in the vicinity off and on to isolate the offending equipment e Reorient or relocate the other receiving device e Increase the separation between the interfering equipment and this equipment If assistance is required contact the Smiths Medical PM Inc Clinical Support Department or your local representative 10 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 11 Optional Supplies and Accessories Chapter 11 Optional Supplies and Accessories CAT NO DESCRIPTION QTY 1606 Simulator amp Cable Oximeter 1 5m 5 ft each 1611 Battery Bypass 105 125 VAC 60Hz domestic each 1612 Battery Bypass 208 252 VAC 50 60Hz international each 1613 Batt
44. lse Alarm tone Alarms to violated alarm will flash LED red flashes beeps sounds SpO and pulse rate Low Priority Attention indicators light Low priority alarm Overrides pulse Low priority Alarms up steadily SENSOR or LED yellow lights beeps alarm tone Artifact up steadily sounds Information Low battery indicator Low priority alarm Overrides all 5 beeps that Signal LED lights steady audio occur once every one shot 30 seconds Turning Off the Monitor Turn off the monitor when you are not monitoring a patient To turn off the monitor press the key Checking the Monitor s Performance Pulse oximeters do not require user calibration If checking the function of the device is desired an optional Oximeter Patient Simulator Smiths Medical catalog number 1606 is available as an accessory The simulator attaches to the oximeter in place of the sensor or oximetry cable It provides a known SpO and pulse rate signal to the oximeter This allows the oximeter s performance to be checked NOTE The 1606 Oximeter Patient Simulator does not calibrate the monitor the monitor does not require calibration The 1606 provides a known SpO and pulse rate to the monitor that allows you to check the monitor s performance NOTE The 1606 Oximeter Patient Simulator cannot be used to assess the accuracy of a pulse oximeter and or sensor NOTE Follow the instructions included with the Oximeter Patient Simulator Veterinary H
45. m tone silence feature may not be available in monitors shipped to your country Veterinary Handheld Digital Pulse Oximeter Operation Manual 1 5 Chapter 1 Introduction This page is intentionally left blank 1 6 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 2 Intended Use and General Information Chapter 2 Intended Use and General Information Intended Use The Veterinary Handheld Digital Pulse Oximeter is a low cost monitor for spot checking or continuous monitoring of SpO pulse rate and pulse strength The monitor is a battery powered pulse oximeter It may be used in the hospital or clinical environment and during emergency land transportation The oximeter will operate accurately over an ambient temperature range of 32 to 131 F 0 to 55 C The oximeter works with all SurgiVet oximetry sensors providing SpO and pulse rate on all patients from neonatal to adult This device is intended for continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals NOTE The monitor was not designed or tested to be an apnea monitor Monitor Features Provides fast reliable SpO pulse rate and pulse strength measurements Ideally suited for use in intensive care units outpatient clinics emergency rooms and during emergency land transport Portable and lightweight Weighs only 454 grams 16 ounces with batteries Ergonomically designed to fit comfortably in the
46. n applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people WARNING The monitor should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the monitor should be observed to verify normal operation in the configuration in which it will be used A 4 Veterinary Handheld Digital Pulse Oximeter Operation Manual Appendix B Revision History Appendix B Revision History REVISION DATE COMMENT Rev 4 2008 04 e Added CE Notice and European Representative to Warranty section and back cover Added WEEE Recycling instructions and Smiths URL Added warning to verify that all LEDS light up upon start up of the device Update Theory of Operation Added a note about increasing or decreasing the averaging setting having no effect on the data update rate Added a note about how the 1606 Oximeter Patient Simulator cannot be used to assess the accuracy of a pulse oximeter and or sensor Added desat study information to the SpO2 Accuracy spec Added Appendix A Guidance and Manufacturer s Declaration Added this Revision History
47. nation of the above conditions Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury Verify that all LEDs light emitting diodes on the display light up upon startup of the device Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 1 Introduction Cautions CAUTION Do not autoclave ethylene oxide sterilize or immerse the monitor or sensors in liquid Always disconnect the power source and remove all batteries before cleaning or disinfecting the monitor CAUTION Should the device become wet wipe off all moisture and allow sufficient time for drying before operating CAUTION The monitor should be operated from its internal power source if the integrity of the protective earth conductor is in doubt CAUTION Pressing front panel keys with sharp or pointed instruments may permanently damage the keypad Press front panel keys only with your finger CAUTION Do not allow water or any other liquid to spill onto the monitor Unplug the external power supply from the monitor before cleaning or disinfecting the monitor Evidence that liquid has been allowed to enter the monitor voids the warranty CAUTION Ensure the device s AC rating is correct for the AC voltage at your installation site before using the monitor The monitor s AC rating is shown on the external power supply If the rating is not correct do not use the monitor conta
48. nd Manufacturer s Declaration IMMUNITY ELECTROMAGNETIC ENVIRONMENT GUIDANCE Electrical fast transient burst IEC 60601 TEST LEVEL A C Mains power voltage should be the typical IEC 61000 4 4 405kVto 2 kV for Quality of a power supply lines Commercial environment 0 25 kV to 1 kV for I O lines e Hospital environment COMPLIANCE LEVEL 0 5 kV to 2 kV for power supply lines 0 25 kV to 1 kV for I O lines Surge IEC 60601 TEST LEVEL IEC 61000 4 5 1 kV differential mode 2 kV common mode COMPLIANCE LEVEL 1 kV differential mode 2 kV common mode Voltage dips short IEC 60601 TEST LEVEL interruptions and voltage E eooo in Ur for 0 5 cycle 4096 Ur 6096 dip in Uy for 5 cycles 7096 U1 3096 dip in Uy for 25 cycles 596 Ux gt 95 dip in Ur for 5 seconds 596 Uy gt 95 dip in Uy for 0 5 cycle 4096 U1 26096 dip in Uy for 5 cycles 7096 Uy gt 30 dip in Ur for 25 cycles 596 Uz 29596 dip in Uz for 5 seconds Note Uris the A C mains voltage prior to application of the test level A 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Appendix A Guidance and Manufacturer s Declaration IMMUNITY ELECTROMAGNETIC ENVIRONMENT GUIDANCE Power frequency 50 60 Hz IEC 60601 TEST LEVEL Power frequency magnetic fields should be the IEC 61000 4 8 3 A m typical levels of a Commercial environment COMPLIANCE LEVEL Hospital environment 3 A m Condu
49. ng for 1 year from the date of shipment to the original purchaser USA only The foregoing shall be the sole warranty remedy Except as set forth herein seller makes no warranties either expressed or implied including the implied warranties of merchantability and fitness for a particular purpose No warranty is provided if the products are modified without the express written consent of SMPM Veterinary Division and seller shall not be liable in any event for incidental or consequential damage This warranty is not assignable Warranties are subject to change Please contact Smiths Medical PM Inc Veterinary Division for current warranty information Loaner Device Domestic Sales Only Smiths Medical PM Inc SMPM Veterinary Division will for the period of warranty make available at no charge loaner devices domestic sales only if in the opinion of SMPM Veterinary Division the repair of the customer s device would require an unreasonable period of time to repair and there is a suitable loaner available during the time of the repair SMPM Veterinary Division may make available loaner devices for a fee should it be requested while an out of warranty device is in for service The customer is responsible for shipping the loaner device back Veterinary Handheld Digital Pulse Oximeter Operation Manual v Warranty and Service Information Disclaimer of Warranties THE FOREGOING EXPRESS WARRANTY AS CONDITIONED AND LIMITED IS IN L
50. palm of your hand Uses six 6 standard AA type IEC LR6 alkaline batteries Battery life is approximately twenty four 24 hours without printing Bright easy to read LED displays indicate SpO and pulse rate measurements An eight segment LED bar graph indicates pulse strength Adjustable volume including silence beep sounds with each pulse beat Pitch of pulse beep corresponds to SpO value Positive identification of SpO or pulse rate alarm Adjustable high and low alarm limits for SpO and pulse rate measurements Adjustable volume for alarm and alert tones including silence User adjustable delayed audible system alarms SpO and pulse rate averaging settings are user selectable Artifact indicator informs user of excess motion and other artifacts User adjustable trend storage rate ranging from 4 to 30 seconds per sample for many applications Low battery indicator lights when about 30 minutes of battery use remains A yellow Low priority alarm LED turns on and an audible 5 beep burst notifies the user of low battery life Data log prints SpO and pulse rate readings in real time once every five 5 seconds through the IR port to an optional printer Veterinary Handheld Digital Pulse Oximeter Operation Manual 2 1 Chapter 2 Intended Use and General Information Theory of Operation The pulse oximeter determines SpO and pulse rate by passing two wavelengths of low intensity light one red and one infrar
51. pplicable RF transmitter compliance level above the V3402 pulse oximeter should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the V3402 pulse oximeter P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Veterinary Handheld Digital Pulse Oximeter Operation Manual A 3 Appendix A Guidance and Manufacturer s Declaration Recommended Separation Distances The V3402 pulse oximeter is intended for use in an electromagnetic environment where radiated RF disturbances are controlled The customer or the user of the V3402 pulse oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the V3402 pulse oximeter as recommended below according to the maximum output power of the communications equipment The recommended separation distances between portable and mobile RF communication equipment and the V3402 pulse oximeter is SEPARATION DISTANCE ACCORDING TO THE RATED MAXIMUM FREQUENCY OF RF TRANSMITTER METERS 010i iiti don ioli 150 kHz to 80MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz TRANSMITTER WATTS d 1 2 VP d 0 18 P d 0 35yP ww om e o 35 1 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equatio
52. pulse rate readings WARNING Under certain clinical conditions pulse oximeters may display dashes if unable to display SpO and or pulse rate values Under these conditions pulse oximeters may also display erroneous values These conditions include but are not limited to patient motion low perfusion cardiac arrhythmias high or low pulse rates or a combination of the above conditions Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury 2 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 2 Intended Use and General Information Patented Technology The Handheld Digital Oximeter incorporates patented technology and noise reducing hardware to enhance the oximeter s ability to detect pulse amplitude in patients with poor peripheral perfusion Blood Pulse Detection Method Using Autocorrelation patent number 5 558 096 analyzes a digitized signal in real time and compares it with previous pulse data If similar characteristics to previous data are recognized the device confirms a valid pulse In essence an individual s pulse data is retained and used as a template to accept or reject future pulse signals Patented technology digital signal processing and a greatly improved signal to noise ratio provide for improved performance Veterinary Handheld Digital Pulse Oximeter Operation Manual 2 3 Chapter 2 Intended Use and General Information T
53. ser NOTE Intermittent use of AC power will require functional AA cells to maintain memory and keep the oximeter from defaulting to clinician mode from other modes Veterinary Handheld Digital Pulse Oximeter Operation Manual 4 1 Chapter 4 Operating Instructions Attaching the Sensor to the Patient WARNING Prolonged use or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours WARNING When attaching sensors with Microfoam tape do not stretch the tape or attach the tape too tightly Tape applied too tightly may cause inaccurate readings and blisters on the patient s skin lack of skin respiration not heat causes the blisters Attaching the patient to the monitor requires these steps 1 Choose the sensor 2 Check the sensor and oximetry cable 3 Clean or disinfect the sensor if using the reusable type Disposable sensors are for single patient use and do not require cleaning or disinfecting 4 Attach the sensor to the patient Choosing the Sensor Choose the appropriate sensor from the following chart PATIENT SENSOR DESCRIPTION Small Medium Animal Pinna ears Toe Webbing V1711 Large Y Sensor up to 60 pounds Tongue V1702 Mini Y Sensor V3078 Mini Clip Sensor Rectum Tail V1700 Reflectance Sensor V1710 Tail Wrap Sensor Hock Achilles Tendon etc V1707 Univers
54. ter 2 Disconnect the SpO sensor from the patient and to the oximeter as previously described 3 Turn on the monitor 4 Align the IR sensor on the Digital Oximeter with the IR sensor on the printer as shown in figure 7 1 or as described in Chapter 9 PC Communication Setup 5 Depress the print key not at start up The oximeter prints the SpO and pulse rate measurements as shown in the sample printout 6 Dashes indicate invalid or unavailable data for example the patient s finger was removed from the SpO gt sensor 7 Depress the print key to quit printing or the unit will print all stored trend data NOTE If unexpected characters or question marks are printed turn the monitor off and on to reset the printer Data log The data log is a real time printout of patient data Data will be printed at a rate of one line every 5 seconds Follow these steps for data log printout 1 Turn on the printer 2 Connect the sensor to the monitor and the patient 3 Align the IR sensor on the Digital Oximeter with the IR sensor on the printer 4 Press the print key to begin printing 5 Press the print key again to stop printing ae CEN EN dd E WI oS e NL Figure 7 1 Aligning the Printer and Oximeter 7 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 8 PC Communication Setup Chapter 8 PC Communication Setup Description The device will send out Trend Data throu
55. th the supplies and equipment you received to make sure you have everything you ll need Install the Batteries The oximeter uses 6 six standard AA alkaline cells IEC Type LR6 To install replace the batteries 1 Depress the battery door tab and lift up 2 Install the negative end of each battery first compressing the battery terminal spring until the positive terminal clears the positive tab Press the battery down into place 3 Place battery door tabs into the slots of the monitor back panel depress the door tab and press the door into place NOTE If you install disposable batteries be sure to dispose of them in compliance with your institution s guidelines and local ordinances NOTE The unit will hold data for about one and a half minutes with no battery power This will insure the safety of trend data during battery replacement AC Power Refer also to Chapter 12 Optional Supplies and Accessories to verify the proper AC power supply for your application NOTE The AC power supply does not act as a battery charger NOTE Do not plug the monitor into an outlet controlled by a wall switch 1611 AC power supply 105 152 VAC 60Hz 1612 AC power supply 208 252 VAC 50 60Hz 1613 AC power supply 90 110 VAC 60Hz NOTE When using AC power the Digital Oximeter is a class Il device with functional earth This earth connection is for device electromagnetic compatibility and does not provide protection to the patient or u
56. ting mode is exited and the SpO and pulse rate measurements are shown Changes are saved NOTE Alarms are not active while setting alarm limits however alarms are active as soon as you exit the alarm limit setting mode NOTE The alarm actions occur for each violated alarm even if more than one alarm is violated at the same time NOTE Alarms may be tested while the monitor is in use by setting alarm limits such that the measured parameter is outside alarm limits Return limits to the required settings after testing Setup Mode Setup mode allows the user to change the settings for the following options Trend Data Storage Interval see Chapter 6 Patient Numbers amp Trend Data for descriptions Alarm Volume Low Priority Alarms Delay Permanent Silence Disable To enter Setup Mode press and hold the Bet Alarm Select key while turning the monitor on Alarm Volume The volume of the alarm tone can be adjusted through a range of 13 settings The alarm volume cannot be disabled through the Setup Mode To adjust the volume of the alarm tone press the aye Alarm Select key twice upon entering Setup Mode The display will show HL and an audible alarm tone will sound To increase the volume press the A Up Arrow The alarm volume setting ranges from 3 to 15 5 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 5 Changing the Monitor s Settings Low Priority Alarms Delay The Low Priority Alarms Delay
57. tor s Performance Chapter 5 Changing the Monitor s Settings csccscccsssssssscssssssccsssseees D 1 Silencing Alarm TOMES ccc sssssiesesssssseessasesssosevessasessusvavensssesssavasenocazesssnssshotertnssseestaduvstetastesavasshesasensapscstaua cesssassenanistns Changing the Pulse Beep Volume Changing the Alarm Lirnits asscssssesassscesasssavavsszeadsisuvassncoaadadensssezveissdonss acuesusczoadddcassateasssheadsianuasotoeaitieeastetoaissionas ETT MM 5 2 ACIE 5 2 Low Priority Alarms Delay itii reti ERR HU MERE iis ERE RR PUR EUER eH 5 3 Permanent Silence Disable ou cssssssssssscsssecsssccsssccsssecsssccsusccsuscessscessecessscesseecssecssscesssessaseesseesaccesuceesuseesesesses 5 3 Chapter 6 Patient Numbers and Trend Data cere 6 1 bajo 6 1 Incrementing the Patient NUMbBEL cssssecsssecsseessssecsseecsssccsseecssscesseccsssessecssscesscesssecsuecsaeessuecesuceesneeesseerses 6 1 Adjusting the Trend Storage Interval eminin 6 1 CIS AMIN hend Dafa eo 6 1 Chapter 7 Printer sssiscscssssscacicsiscicnstisc sacstasseccatadisersiatessdtniieansincameaiceies d bajen oiniiat 7 1 What You ll Need for Printing Trend Printouts Collecting Tend Dr
58. tteries prior to long term storage When attaching sensors with Microfoam tape do not stretch the tape or attach the tape too tightly Tape applied too tightly may cause inaccurate readings and blisters on the patient s skin lack of skin respiration not heat causes the blisters Operation of this device may be adversely affected in the presence of strong electromagnetic sources such as electrosurgery equipment Operation of this device may be adversely affected in the presence of computed tomograph CT equipment Use only SpO sensors supplied with or specifically intended for use with this device SpO measurements may be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary Dyes introduced into the bloodstream such as methylene blue indocyanine green indigo carmine patent blue V PBV and fluorescein may adversely affect the accuracy of the SpO reading Any condition that restricts blood flow such as use of a blood pressure cuff or extremes in systemic vascular resistance may cause an inability to determine accurate pulse rate and SpO readings Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin will affect the accuracy of the SpO measurement The monitor was not designed or tested to be an apnea monitor Optical cross talk can occur when two or more sensors are placed in close proximity It can
59. unds Disinfecting the reusable Before attaching the Follow the instructions for cleaning the reusable sensor sensor to the patient sensor Disinfecting the monitor When necessary 1 Remove the batteries from the unit Note Print trend data before cleaning Trend data will be lost if batteries are disconnected more than one and a half minutes 2 Wipe the surfaces of the monitor with a soft clean cloth dampened in isopropyl alcohol Use only a cloth that is dampened not wet CAUTION Do not allow isopropyl alcohol or water to enter any of the openings on the monitor Evidence that liquid has been allowed to enter the monitor voids the warranty Storage Whenever possible the monitor should be stored at room temperature in a dry environment If it is necessary to store the monitor for an extended period of time the unit should be packed in its original shipping container Storing the monitor for a long period of time may degrade the battery capacity Batteries should be removed from the monitor before storing Storage specifications are as follows Temperature 40 C to 75 C 40 F to 167 F Relative Humidity 10 to 95 noncondensing Veterinary Handheld Digital Pulse Oximeter Operation Manual 9 1 Chapter 9 Maintenance This page is intentionally left blank 9 2 Veterinary Handheld Digital Pulse Oximeter Operation Manual Chapter 10 Troubleshooting Chapter 10 Troubleshooting PROBLEM POSSIBLE
60. y activity These instructions contain important information for the safe use of the product Read the entire contents of these Instructions For Use including Warnings and Cautions before using the monitor Failure to properly follow warnings cautions and instructions could result in death or serious injury to the patient Definition of Symbols SYMBOL DEFINITION typecrequipmens O mwwmg SSCS eoe Oa imu S 5 scene poweatey einer HeartRatelED 0000000 9 bpm Heart Rate LED ew Date of Manufacture E je OoOo IPX1 Drip Proof monitor on o O Rx Caution Federal U S A law restricts this device to sale by or on the order of a ONLY Licensed Veterinarian Veterinary Handheld Digital Pulse Oximeter Operation Manual 1 1 Chapter 1 Introduction H mmm Collect Disposal EU Countries Under the Waste Electrical and Electronic Equipment WEEE Directive 2006 96 EC and implementing regulations all devices and service items within the scope of the Directive purchased new after August 13 2005 must be sent for recycling when ultimately becoming waste Devices and items must not be disposed of with general waste If purchased before that date they may also be sent for recycling if being replaced Separately on a one for one like for like basis this varies depending on the country Recycling K instructions to customers using Smiths Medica

Veterinary V3402 HandHeld Digital Pulse Oximeter

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