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Operation Manual

1. c eeeeeee eere eere eene eee 2 lec i eia 2 1 General DSSCHIDTOM casccsssscassscsussscsecsasczasadetessacossssnssesssscssssssnasennsecesassnsatecassechaao atensdsodsasosessnasactasaseusteensisazazedasssansssosd chaassasdecoastastsistasi 2 1 mfoidzinle RE 2 2 pir e M M Side Panel Chapter 3 Setting Up the Monitor eee eere eere e eene eene ee eee o osse ee eossseeesessseseesessesees 37 Unpacking the Monitor and Checking the SHIPMeNt eessssessssssescssseccsseeccssscecsssecesssecessusecesnsecessnscessusecesnneceesneeeesnsecesssees 3 1 Turning Alarm and Alert Tones On and Off sssssssssssscsssesssssssscsssecesssssecssseessssscssssscecssssesssseeessseeesnssesssusesesnseeesunseessnseessnseessate 3 1 Working With System Wide Settings reete cnet steer set bit octets d edente etie rttpeE 3 1 Setting the Time or Date e 3 2 TOMA IPPC CN saccsssctesrceessecasesosatecssnsedsascasseossacessz esesscuscoavacesasssostecessertaccodadecsdatedsascdasenstacibaasevstecnsesavasecassteseagesiectacseoutessdsradisietast 3 2 AG POWEM sesssscsdicsssssss cetusaccsssszestssoscsebssccesdsceyacroaiavaanetseanscoasadesstasssncpaeraiasisassidciossaceossddedosenusucheaseousscsuss2esdazedehacassteusseouansosanssbcedssssedsssioianseiss 3 2 Chapter 4 Alarms and Aler
2. To silence the alarm and alert tones for two minutes Momentarily press the e39 LED flashes If tones are already silenced press Q twice the first press cancels alarm silenced the second press silences the alarms for two minutes Tocancel either two minute or indefinite alarm silence and enable alarm and alert tones Momentarily press O the 39 LED turns off Working With System Wide Settings This section describes working with system wide settings using the System Settings mode 1 To enter the System Settings mode press and hold the ALARM SET 2 7 key for 3 seconds 2 The patient mode L Ft will display in the systolic and diastolic display areas This is the mode of choice for animals 10 pounds or larger 5 Hl is used for animals under 10 pounds Ww Press the 2 key again to edit the initial cuff inflation pressure that is displayed in the systolic display area Use the W and v keys to set this value 4 Pressing the 2 key again displays the data logging trends output destination in the MAP display area Use the A and V keys to toggle between Pr mk for optional integral printer output and Par E for serial port data output NOTE If the printer has not been factory installed this setting will always show P gr E 5 Press the 2 key again to view the display intensity in the INTERVAL area Use the W and WV keys to change the intensity 6 Press START or Bun
3. EZITA SurgiVet V6004 NIBP Monitor Operation Manual GI English Catalog Number V1876 Version 8 February 2008 2008 Smiths Medical family of companies All rights reserved sm ths medical Table of Contents Table of Contents Warranty and Service id nr pJPee RS v Proprietary Notice Warranty sisses Limited Warranty Loaner Device D mestie Sales Only nsssucnissununiunsnniiiiisasananani ann vi Disclaimer of EH CDI C vi Conditions of Wartahty u rir HERO RUR GT OMEN QURE REN ATHIDNRIDOSH CURIE NUR ER OMEN M NERIS DOSE EX HE vi Eft guerres REESE vi Wairanty gres ol nee vii Chapter 1 IntroduUctiONn ssssssssssssssssssssssssssisscsssssssessssssssossssssssssssssssssssssosssssssrssossssosssssssssssssss A 1 About this Manuall eesssscssecssesscsscsseescssccsssecsssecsssccssscssssecsuscessscessscesuscessecesucessuceesuccesuscesuccesuecesscessuceesuccessecessecessessaseesssecssseceaseessees 1 1 Denion of Symbols tena pieno R UO RE RUNDE DUO DET RNC RO ORITUR OI aH dani idin 1 1 General WAALS assisia a S a 1 3 NIBP Warnings Oximetry Watnihgs teta asaan eioen ie ieaS E ESEE TH MERE E EE ENEAS 1 5 General CaUtiONS veccevssacesstcossectascavcecsasstesadehosacedsssnssacsnsatesaccvnsectsacesasstsduecossachasovatecssatodsssonssenassdeasadevssacusteavazecadstevestevibctasssontecodasecussetast 1 6 INIBP Ca Ut OIA e 1 7 here 1 7 Chapter 2 Intended Use and General Information
4. HR 120 bpm SpO2 98 Signal 6 Dashes will be printed for invalid data The SpO values will be printed only if the SpO function is installed and not disabled The printout will be sent to either the printer or to the serial port whichever has been selected in the System Settings mode If the optional printer is not installed the printout will always be sent to the serial port To turn off the Data Logging mode on the optional printer press the PRINT key again or press and hold the key for 3 seconds A DATA LOG OFF message will be printed to indicate that the Data Logging mode has been exited NOTE To tear paper off gently pull paper away from you tightly against the cutter and use the cutter to tear it off Use caution not to pull paper through the printer as this might damage the paper feed rollers V6004 Operation Manual 8 1 Chapter 8 Serial Output Printer WARNING WARNING 8 2 The NIBP monitor is suitable for use within the patient environment IEC 60950 approved equipment must by placed outside of the patient environment The patient environment is defined as any volume in which intentional or unintentional contact can occur between the patient and parts of the system or between the patient and other persons touching parts of the system When connecting this monitor to any instrument verify proper operation before clinical use Refer to the instrument s user manual for full instructions Accessory equ
5. Trended data includes NIBP SpO Pulse Rate and Signal Pulse Strength The following descriptions outline the trend display s features Trend Storage 1 When trend memory becomes full newer data will overwrite the oldest data 2 Trend memory will be retained when the monitor is turned off 3 All trend records up to the maximum number approximately 240 measurements at 5 minute intervals about 20 hours will remain in battery backed memory until trend memory is cleared through the Recall mode or trend memory writes over itself as mentioned above NOTE The amount of elapsed time that the monitor was off does not affect stored trend records unless battery backed trend memory fails Each new trend gets a Time Date Stamp It will be possible to dump the entire trend memory to the optional printer or out the serial port Recall Mode This mode allows the user to review all recorded NIBP measurements SpO Pulse Rate and Signal Pulse Strength are displayed with NIBP records 1 Press the RECALL G9 key to enter Recall Mode The date of the most recent trend data will be displayed in the SYS DIA display area while the time will be displayed in the MAP area N The arrow keys N or v allow the user to scroll through all recorded measurements alternating between the time and date stamp and the trend data w Pressing and holding the A key for 3 seconds or pressing the PRINT 7 key on the optional printer initiates a
6. correct do not use the monitor contact Smiths Medical PM Inc Veterinary Clinical Support for help Do not allow water or any other liquid to spill onto the monitor Evidence that liquid has been allowed to enter the monitor voids the warranty Unplug the external power supply from the monitor before cleaning or disinfecting the monitor Chemicals used in some cleaning agents may cause brittleness of plastic parts Follow cleaning instructions in this manual Should the device become wet wipe off all moisture and allow sufficient time for drying before operating For devices with the optional electronic thermometer or printer servicing is required for proper function after accidental wetting Pressing front panel keys with sharp or pointed instruments may permanently damage the keypad Press front panel keys only with your finger Do not disassemble the unit The unit is not user serviceable Refer to qualified service personnel Operation of this device may be adversely affected in the presence of portable and mobile communications equipment V6004 Operation Manual Chapter 1 Introduction NIBP Cautions CAUTION Verify the proper cuff size before each measurement CAUTION Extremity and cuff motion should be minimized during blood pressure determinations CAUTION Proper blood pressure cuff size and placement are essential to the accuracy of the blood pressure determination CAUTION Any blood pressure recording
7. data log trend output destination and display intensity Rear Panel Figure 2 6 Monitor Rear Panel l E PRINTER OUTPUT ONLY USE 6 8V 0 35A A AC ADAPTER INPUT 24V 1 5A CONNECTOR NAME DESCRIPTION Serial I O An external RS 232C communication device can be connected to the monitor through this port Power Input The external power supply attaches to this connector V6004 Operation Manual 2 5 Chapter 2 Intended Use and General Information This page is intentionally left blank V6004 Operation Manual Chapter 3 Setting Up the Monitor Chapter 3 Setting Up the Monitor Unpacking the Monitor and Checking the Shipment Carefully remove the monitor and accessories from the shipping carton Save the packing materials in case the monitor or accessories must be shipped or stored Compare the packing list with the accessories received and make sure the shipment is complete CAUTION If damage has occurred to the package a calibration needs to be done at an authorized service center Turning Alarm and Alert Tones On and Off When the monitor is turned on the alarm and alert tones are silenced for two minutes The SILENCE Aa LED flashes during the two minute time out e To silence the alarm and alert tones indefinitely Press and hold for about three seconds the Ao LED lights steady
8. vulva and hocks Moisten the hock area with isopropyl alcohol water and clip hair if needed To get better reading on the smaller tongues fold the sides of the tongue up into a taco shape and pass the light through both layers Don t fold the tip of the tongue back because you will restrict blood flow to the tongue Mini Clip Figure 6 3 Mini Clip OS Kom NES mU rd Y 2 SSN The Mini Clip is much like the Universal Y lingual sensor but less than a quarter of the size of the lingual clip The smaller clip proves effective on the small breeds and especially on smaller cats The clip will work on a cat s ear tongue and toe webbing The Mini Clip also works well on larger animals V6004 Operation Manual 6 5 Chapter 6 Using the Oximeter Option Universal C sensor Figure 6 4 Universal C Sensor Nm w t Nes w 4 N N SEE Ww N wet ly NS n L im DA ni aA qum ra AN T V M AL PS INT 4 ko The C sensor is designed specifically for use in the larger tissue areas It has brighter LED s and therefore will shine through thicker tissues The C sensor can effectively be applied to the tongue or lip of larger dogs and equine It can also be applied across the Achilles tendon across the metatarsals or metacarpals of cats and dogs on vulva tails and across the front leg of smaller animals The C has a space between the two LED s The tissue needs to be at least that thick to get an SpO reading
9. Cuff Medium Large Dogs or similar size animals 31543B3 Medium Cuff Large Dogs or other large animals 31543B4 Large Cuff V6004 Operation Manual 5 1 Chapter 5 Non Invasive Blood Pressure Suggested Application Sites Figure 5 1 Suggested Application Sites Cuffs can be placed on a variety of locations including Median palmar artery proximal to the metacarpal pad Overthe dorsal pedal artery on the dorsomedial aspect of the hind limb below the hock Overthe coccygeal artery on the ventral aspect of the base of the tail Over the femoral artery on the medial aspect of the thigh use this location last the other locations usually give better readings Connect the Cuff and Hose Attach the hose to the monitor N Select the appropriate cuff for your patient See table on page 5 1 for guidance w Place the cuff on the limb with the SurgiVet logo facing up away from the patient The width of the cuff should be approximately 30 6096 of the circumference of the limb Remember that you do not need to align along an artery 4 Secure the Hook amp Loop closure The cuff should be snug 5 Attach the cuff to the hose and initiate the inflation of the cuff 6 Lift the Hook amp Loop closure tap to remove the cuff NOTE The Hook amp Loop closure system is designed so that it will not come apart unless the cuff is placed incorrectly or is too small for the patient 5 2 V6004 Operation Man
10. QU X HH EHE DHe oS EE 5 3 Manual NIBP Me aSUrenne rntcsssiscsassecsosssassusseciasstesossvacsassecsassoasezstescasssesossieceansochaiadassasteciasatgeoassacrasseccandadtenstesseuveeroisiesrantectosasees 5 3 Automati NIBP ME aSUTEMeMtissscscscsasssstessstssssesssdsseaberusseassndbcedossdseseossedvsovensz eosseceseessodussbosndascaverdsasosseaudedessastsopareisgosuscasiestese Stat NIBP ci Canceling NIBP Measurement sssscsssssscssssscessseccsssescsssseccsssesesnseceesssecssnsesesnsseessssesesnseseessseessnsesessseeeesusesesnseceenssesssnsesessseessenseees Changing the Auto NIBP Measurement Interval NIBP Alerts and Status Messages eno picence ten a E ORBE RENO EO DAI NO RI IHNEN Ea E UE eei I a Rab Status ILLCbIte Application Note NIBP Cuff Inflation Method sessssessssesssssssssccssscessecsssccessecssusccsucccsuscesscessusesssccessecessecessessssccessecssseceaseessees 5 6 Chapter 6 Using the Oximeter Option cesse eee eere eee eere esee ee esss sees essseeeesssseeees 6 T General Description Pulse Oximetry Theory of Operation Disabling the OXxiMettiy Ot ot M Adjusting the Pulse Beep Volume u ssssscssssssccssssccssseccssssescssseccssseceesseessnseccssssescsssesessseccessseessusesesusesessusesesaseceenseesesssesesase
11. Telephone 1 262 513 8500 N7W22025 Johnson Drive Toll Free 1 888 745 6562 USA only Waukesha WI 53186 Fax 1 262 513 9069 Web www surgivet com Seller will not be responsible for unauthorized returns or for loss or damage to the Product during the return shipment The repaired or replaced Product will be shipped freight prepaid by Seller to Purchaser To obtain warranty information outside the USA contact your local distributor NOTE Shipments received without a return number will be returned to sender 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 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 V6004 Operation Manual vii Warranty and Service Information This page is intentionally left blank viii V6004 Operation Manual Chapter 1 Introduction Chapter 1 Introduction About this Manual The Operation Manual provides installation operation and maintenance instructions for the veterinary professional trained in monitoring cardiovascular activity Definition of Symbols SYMBOL DEFINITION On Off NIBP S
12. The customer or the user of the V6004 non invasive blood pressure monitor should assure that itis used in such an environment Electromagnetic Emissions Emissions Test EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions Group 1 The V6004 non invasive blood pressure monitor uses CISPR 11 RF energy only for its internal 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 V6004 non invasive blood pressure monitor is CISPR 11 suitable for use in all establishments including domestic establishments and those directly connected to the public IEC 61000 3 2 low voltage power supply network that supplies buildings Voltage fluctuations flicker Complies e Meste DHLROS RR emissions IEC 61000 3 3 V6004 Operation Manual A 1 Appendix A Guidance and Manufacturer s Declaration Electromagnetic Emissions Immunity IMMUNITY TEST Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz IEC 61000 4 8 NOTE IEC 60601 TEST LEVEL 6 kV contact X 8 kV air COMPLIANCE LEVEL 6 kV contact X 8 kV air 2 kV for power supply lines 1 kV for input output lines 2 kV on 220 VAC power line 1 kV on
13. 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 Seller be responsible for consequential incidental or special damages of any kind or nature whatsoever including by not limited to lost business revenues and profits vi V6004 Operation Manual Warranty and Service Information Warranty Procedure To obtain warranty service or repair of SurgiVet equipment in the USA please contact Veterinary 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 Veterinary Clinical Support Attn Repairs return
14. not light If operating on battery battery Recharge battery may need charging Green charge LED not lit External power supply Connect power supply disconnected Malfunctioning power supply Connect power supply to different outlet preferably on a different electrical circuit or replace with new power supply Cat No 1614 1615 1616 No pulse registering on bargraph Sensor or patient cable Check connections to patient cable disconnected from monitor and sensor Sensor incorrectly positioned Reposition sensor on patient Poor patient perfusion Reposition sensor on patient Defective sensor or patient cable Try a new sensor or contact Smiths Medical PM Inc Veterinary Clinical Support Pulse rate erratic intermittent or Sensor incorrectly positioned Reposition sensor on patient incorrect Poor patient perfusion Reposition sensor on patient Patient motion Patient must be still for monitor to function properly Place extremity on a pillow which will act as a buffer to motion Ambient light Shield with towel V6004 Operation Manual 10 1 Chapter 10 Troubleshooting ERROR CODE MEANING ACTION Unrecoverable errors Contact Smiths Medical PM Inc Veterinary Clinical Support E 05 Key press detected at powerup Turn the unit off and then on If the message reappears contact Smiths Medical PM Inc Veterinary Clinical Support SA mode not allowed Turn the unit off and then on If the message reap
15. or hospital environment V6004 Operation Manual Appendix A Guidance and Manufacturer s Declaration IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT IMMUNITY TEST LEVEL LEVEL GUIDANCE Conducted RF 3 Vrms 3V Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the V6004 non invasive blood Radiated RF pressure monitor including cables than IEC 61000 4 3 3V m the recommended separation distance 80 Mhz to 2 5 GHz calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2JP d 0 35VP 80 MHz to 800 MHz d 0 74P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol e NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land m
16. resistance may cause an inability to determine accurate SpO and pulse rate readings V6004 Operation Manual 6 1 Chapter 6 Using the Oximeter Option 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 NOTE Pulse rate will be provided by the NIBP function When the SpO option is enabled and is providing valid data its pulse rate will override the NIBP pulse rate Disabling the Oximetry Option Press the key once to enter the Set Alarms mode N Using the 2 key select the high oximetry alarm limit 3 Use the arrow keys to adjust the value The monitor may be disabled by scrolling the high alarm limit to 100 then OFF and then to 7 d Press the 2 key to set the value 4 Press the oY key to toggle through the menu or press the amp 7 key to save the new settings and exit Pressing 2 exits without saving the changes The oximetry functions are disabled as denoted by the 7 d inthe 96SpO area and may be re enabled by repeating steps 1 3 and selecting either OFF or a specif
17. the lowest cuff pressure that provides the maximum cuff oscillations Therefore the MAP is the largest signal received and is the most accurate reading using oscillometric methods Systolic pressure is calculated as the cuff pressure when an increase in perceived cuff oscillations begins The diastolic pressure is the cuff pressure when oscillations are no longer decreasing as pressure is released from the cuff The first and fourth Korotkoff sounds were used to determine the overall efficacy Using the NIBP Parameter If you are not familiar with this monitor and the NIBP parameter then follow this chapter s sections in order Connecting the Cuff and Hose Connect the cuff to the patient and the hose to the cuff and monitor Verifying the Initial Cuff Inflation Pressure Verify the initial cuff inflation pressure setting Taking NIBP Measurements Describes how to take Manual Automatic and Stat measurements and how to cancel measurements NIBP Alerts and Messages Defines the NIBP alerts and messages e Application Note NIBP Cuff Inflation Method Describes the method used to determine the cuff inflation pressure for each measurement Connecting the Cuff and Hose Choose the appropriate size cuff Below are the ranges to use when deciding which seize cuff to use PATIENT DESCRIPTION Small Mammals Cats amp Small Dogs or similar size 31543B1 Extra Small Cuff animals Small Medium Dogs or similar size animals 315432B2 Small
18. the tail and wrap with non adhesive wrap 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 Lingual sensor C sensor Reflectance rectal esophageal 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 medical condition and type of procedure Testing Sensor Function 1 To test the lingual clip function 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
19. trend printout which will either be sent to the printer or the serial port whichever is currently selected as the data logging trend output destination Refer to Trend Printout for a sample printout 4 To stop the trend printout at any time press and hold the up key A for three seconds or press the PRINT Z key The Recall mode is exited when the RECALL GO key is pressed again when no key is pressed for 20 seconds when the CANCEL D key is pressed or when the monitor is in Auto mode and it is time to take a measurement Ui 6 If the START Q A key is pressed while the monitor is in Recall mode the monitor will immediately exit Recall mode and start a Manual NIBP measurement To clear the trend memory the RECALL GO key is pressed and held for six seconds while the monitor is in normal operation After the RECALL G2 key is held for more than one second the message L Ir flashes in the MAP display area After six seconds L 1 stops flashing and trend memory is cleared N Time Stamps 1 Each trend record will have a time and date stamp corresponding to the monitor s current real time clock setting 2 Time will be stored and displayed as military time 0 00 23 59 hours 3 If the user changes the Time Date setting only new trend records those recorded since the monitor was last turned on will have the time date stamp adjusted accordingly V6004 Operation Manual 7 1 Chapter 7 Trends Trend Disp
20. 04 Operation Manual 9 1 Chapter 9 Routine Maintenance Maintenance Chart ITEM ACTION INTERVAL Battery Charge When Ciis lit After continuous use under battery power NOTE Use the AC Power Supply whenever possible This will extend the life of the rechargeable battery The monitor s Clean or disinfect As required surfaces Clean or disinfect When attaching a new patient 6 3 Long Term Storage Storage Facility Indoor Temperature 40 to 70 C 40 to 158 F Relative Humidity 10 to 95 non condensing Periodic Inspection None required Special Procedures Store the monitor and accessories in the original packing materials and shipping carton 9 2 V6004 Operation Manual Chapter 10 Troubleshooting Chapter 10 Troubleshooting PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION SENSOR is illuminated Sensor not connected to monitor Connect the sensor to the patient or patient cable and connect the patient cable to the monitor Place sensor on patient Sensor improperly positioned on Reposition the sensor on the patient patient Incorrect sensor for application Choose the correct sensor for the application Defective sensor or patient cable Change the sensor or contact Smiths Medical PM Inc Veterinary Clinical Support Unit operates when connected Battery shelf life exceeded Contact Smiths Medical PM Inc to external charger but not on Veterinary Clinical Support battery power Display does
21. 6 Date 12 31 96 SYS 117 mmHg Dia 76 mmHg MAP 96 mmHg HR 67 mmHg SpO2 98 Signal 6 If the SpO function was disabled within the trend interval preceding a trend record the SpO parameters for that trend record would read pO2 DISABLED NOTE Only trend records containing NIBP data will be printed Clearing Trends The trend memory may be cleared reset by pressing and holding the RECALL O key for 6 seconds or more while in normal operation 7 2 V6004 Operation Manual Chapter 8 Serial Output Printer Chapter 8 Serial Output Printer Serial Output Requirements FUNCTION SPECIFICATION I O Port serial RS 232C Data Type ASCII 19200 baud 1 start bit 8 data bits 1 stop bit no parity hardware handshaking 1 0 Connector DB 9 serial cable catalog 3339 null modem catalog 3362 straight through PC cable Approvals IEC 950 or IEC 601 1 Data Logging Mode The user enables Data Logging mode by pressing the PRINT key on the optional printer or by pressing and holding the A key for 3 seconds while the monitor is in normal operation AYDATA LOG ON message will be printed to indicate entry into the Data Log mode When the Data Logging mode is enabled both the NIBP and the oximetry parameters will be printed each time an NIBP measurement is completed The format of the printout will be as follows DATA LOG ON PATIENT DATA Name HH MM MM DD YY SYS 117 mmHg DIA 76 mmHg MAP 96 mmHg
22. Chapter 1 Introduction This page is intentionally left blank 1 8 V6004 Operation Manual Chapter 2 Intended Use and General Information Chapter 2 Intended Use and General Information Intended Use The V6004 monitor is a non invasive blood pressure monitor with optional SpO and printer It is intended for spot checking or monitoring a patient s systolic diastolic and mean arterial pressure MAP pulse rate and SpO with the oximetry option The NIBP monitor may be used in the hospital or clinical environment The oximetry option works with all SurgiVet oximetry sensors providing SpO and pulse rate on all patients The V6004 monitor permits continual patient monitoring with adjustable alarm limits as well as visible and audible alarm signals The V6004 will operate accurately over an ambient temperature range of 0 to 55 C 32 to 131 F The V6004 is for veterinary use only General Description Figure 2 1 Monitor Front m sO NE Diao Ec gt U 3 i LC ra em F3 DY ym mmi ao c cu BL S So cs Sel Parameters The V6004 is a Non Invasive Blood Pressure NIBP monitor with optional oximetry NIBP parameters include systolic diastolic and mean arterial pressures and pulse rate Alarm limits can be set on all monitored parameters The NIBP function of the monitor is designed for use with large and small animals A variety of disposable and
23. G 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 Attach 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 animal s Skin lack of skin respiration not heat causes the blisters 6 4 V6004 Operation Manual Chapter 6 Using the Oximeter Option Application Guide Universal Y Lingual Sensor Figure 6 2 Universal Y Sensor Your monitor is equipped with a lingual sensor Position the lingual clip on the base of the tongue and placement is dependent on the thickness of the tongue Start at the tip and work your way towards the base Always direct the light downward towards the floor regardless of the animal s position to reduce the effects of ambient light Keep the tongue moist during longer procedures and monitor for significant temperature loss Ensure that there is a minimum of 2 pulse strength bars displayed on the pulse oximeter If necessary the lingual clip may also be positioned on lips cheeks prepuce
24. Reflectance Sensor Figure 6 5 Reflectance Sensor The reflectance sensor is an excellent sensor to use if you are doing dental procedures or other oral work that precludes you from using the lingual clip Clean the reflectance sensor by wiping it down with isopropyl alcohol or chlorhexidine A thin coating of lubricant can be used ensuring that the two LED s are kept clean and free of lubricant This sensor may be used in the esophagus or cloaca of reptiles and large avians The animal does not need to be anesthetized when using the reflectance sensor making it very useful in critical care or post operative settings and for spot checking A simple glove swipe to remove existing feces may be needed The sensor is placed very shallow just so the 2 LED s are covered reading the perfusion around the sphincter A slight rotation may be needed to insure that the LED s are up against tissue and not in fecal material 6 6 V6004 Operation Manual Chapter 6 Using the Oximeter Option Figure 6 6 Reflectance Sensor p S ll ZU fl Figo AS M yy Js N NS Reflectance Sensor Secure the sensor to the tail with a non adhesive wrap e Lights should be positioned as shown The reflectance sensor may also be placed on the ventral base of the tail The LED s should be positioned dorsally You may need to clip a small patch of hair only large enough for the LED s to lay on the skin and clean surface Hold the sensor snugly against
25. SpO and temperature probe cables 1 kV differential mode Common mode not applicable as the device has no safety ground functional ground only 5 Ur gt 95 96 dip in Uy for 0 5 cycle 40 96 Ut 60 96 dip in Uy for 5 cycles 70 Ur 30 96 dip in U7 for 25 cycles 5 96 Ur gt 95 96 dip in Uy for 5 sec 1 kV differential mode 2 kV common mode 5 96 Ut gt 95 96 dip in Uy for 0 5 cycle 40 96 Ut 60 96 dip in Uy for 5 cycles 7096 Ut 30 96 dip in U7 for 25 cycles 5 96 Ut gt 95 96 dip in U1 for 5 sec Uz is the AC mains voltage prior to application of the test level ELECTROMAGNETIC ENVIRONMENT GUIDANCE Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the V6004 non invasive blood pressure monitor requires continued operation during power mains interruption it is recommended that the V6004 non invasive blood pressure monitor be powered from an uninterruptible power supply or the internal battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial
26. ays and front panel indicators The indicator tones and visual responses are described below INDICATION DISPLAY LED TYPE INDICATOR INDICATOR EFFECT ALARMS Numbers flash that Red ALARM Overrides ALERT Alarm tone sounds ten High Priority correspond to the LIA T LED flashes audio tones pulses repeated every parameter alarm SYS ten seconds DIA MAP SpO and or Rate ALARMS N A not applicable Medium priority ALERTS Yellow ALERT Overrides pulse beeps Low priority alarm Low priority LIA LED is Alert tone sounds two illuminated pulses repeated every 20 seconds ALERTS Yellow SENSOR LED is Overrides pulse beeps Low priority alarm Low priority illuminated Alert tone sounds two pulses repeated every 20 seconds ALERTS Yellow Overrides all audio 6 beeps that occur Low priority BATT 7 LED is one shot once every 30 seconds illuminated 10 segment bar graph N A N A Beeps with each heart pulse beat The beep pitch corresponds to the SpO value As the SpO value increases the beep pitch increases Conversely as the SpO gt value decreases the beep pitch decreases Key click N A N A N A Clicks when a key is pressed 4 4 V6004 Operation Manual Chapter 5 Non Invasive Blood Pressure Chapter 5 NIBP Theory of Operation The monitor uses oscillometric principles to calculate the systolic diastolic and mean arterial pressure MAP values The MAP is calculated as
27. betes asthma and were non smokers The study was conducted at oxygen concentrations evenly distributed over an SaO range of 70 10096 V6004 Operation Manual 12 1 Chapter 12 Specifications Pulse Rate Range Accuracy Averaging Display Display Update Rate Pulse Strength Range Display Display Update Rate Audible Alarms Volume Alarm Limit Ranges NIBP Pulse Rate 5pO Serial Output RS232C Data Format Options Power AC Power Supply Battery 12 2 20 240 bpm NIBP 20 350 bpm SpO 296 or 1 bpm whichever is greater 8 seconds Oximetry Only 3 digit 0 300 inch high LED s 1 hertz 20 350 bpm 10 segment bargraph 1 0 inch long full scale 60 Hertz A45dBA 85cBA at 1 meter distance adjustable High 15 285 mmHg 1 mmHg steps and OFF Low 10 280 mmHg 1 mmHg steps and OFF Defaults SYS High 200 mmH Low 90 mmHg DIA High 105 mmHg Low 40 mmHg MAP High 140 mmHg Low 50 mmHg High 20 350 bpm 1 bpm steps and OFF Low 20 350 bpm 1 bpm steps and OFF Defaults High 150 bpm Low 45 bpm High 50 100 196 steps and OFF Low 50 99 1 steps and OFF Defaults High OFF Low 8596 19200 baud 1 start bit 8 data bits 1 stop bit no parity Text only no graphics Patient data log or trend tables Input of 105 125VAC 60 Hz Input of 90 110VAC 50 Hz optional Input of 208 252VAC 50 60 Hz optional Output of 24VDC 1 5A with 4kV isolat
28. can be affected by the position of the patient his or her physiologic condition and other factors CAUTION Blood pressure measurements should be interpreted by a veterinarian General Notes NOTE All user and patient accessible materials are non toxic NOTE The equipment is suitable for connection to public mains NOTE To tear paper off gently pull paper towards you tightly against the cutter and use the cutter to tear it off Use caution not to pull paper through the printer as this might damage the paper feed rollers NOTE Connect the AC Charger to the AC Power Connector of the monitor first and the AC Charger to the Wall Outlet second NOTE Alarm limits are retained during power cycles except for the following note NOTE If the low alarm limit for SpO is set to a value lower than 80 when the monitor is powered down then this low alarm limit will be reset to 80 at power up NIBP Notes NOTE Systolic and Diastolic blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Electronic or Automated Sphygmomanometers AAMI SP10 1992 NOTE Mean Arterial blood pressure measurements determined with this device are equivalent to those obtained by an intra arterial blood pressure measurement device as determined by Smiths Medical PM Inc V6004 Operation Manual 1 7
29. cccessstssassssvsatsctwasestussvesserssatssicesesssnseensedeanscetssts0sdatisacan bcteudesdiscresserdusetedscedsensasectasdeatibetss 6 8 Lingual Sensor Lingual and Mini Clip 0 2 ecsesssssccseccsseccsseccseccsccssccsssecsssccssscesssccsssecsaseesueeesuccesusessuccessccesseeesuceesuceesesees 6 8 eR I M Reflectance SENSO Mee EEE Elle c Checking the Oximeter s Performance ii V6004 Operation Manual Table of Contents ier CFI HY 1 URicf c 7 1 Recall Mode c 7 1 Time SAAS RR Trend Display Trend ui rlaicori Clearing Trelds usan ite reti AA E PERIERE THREE Dee REOR ERE RUPEE ue HERE e Eater eU REIR SHIRE 7 2 Chapter 8 Serial Qutput Printer s sssssssssisscsssssessssssscocssssssssssscsssossessssossssssscsssssssssscsssssssscses 8 Serial Output Requirements Data Logging MOde te nan nee gon N ORI UR OR Ii dani Chapter 9 Routine Maintenanxce eere eene eee e eere e eee eene esee eoss sees essssseeeessseeeessseeees On T Charging the Battery Cleaning and Disinfecting Maintenance Chart ssssccssssscssssccssseccssessesssssecssescessescsssesesns
30. d 0 35JP 1 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation 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 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structure objects and people A 4 V6004 Operation Manual Appendix B Revision History Appendix B Revision History REVISION DATE February 2008 CHANGES Added design frame Smiths Medical logo and new SurgiVet logo to front cover Added Smiths design mark to trademark information Added Patent information Updated Warranty and Service Information section Updated symbol table and warnings cautions and note Added LED warning Added AC Power section to Chapter 3 Added note about how to test alarms while monitor is in use Added Audible and Visual Indicators section to Chapter 4 Changed Veterinary Technical Service to Veterinary Clinical Support everywhere Updated Oximetry Theory of Operation in Chapter 6 Added Checking the Sensor and Oximetry Cable section to Chapter 6 Added Checking the Oximeter s Performance section to Chapter 6 Added note about tearing paper
31. d 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 WARNING Use only original manufacturer or recommended patient cables Use of accessories other than those specified may result in increased electro magnetic EM emissions or decreased EM immunity of the device To avoid potential electro static discharge interference do not use cables which incorporate metal or metal coated connectors WARNING It is the operator s responsibility to set alarm limits appropriately for each individual patient WARNING Verify that all LEDs light emitting diodes on the display light up upon startup of the device NIBP Warnings WARNING Readings may be difficult to obtain in animals smaller than five 5 pounds WARNING Blood pressure measurements may be inaccurate if cuffs and or hoses are used other than those specified by Smiths Medical PM Inc Veterinary WARNING Make sure that hoses are not kinked compressed or restricted WARNING Check that operation of the equipment does not impair the circulation of the monitored patient WARNING Repeated use of the stat mode for periods longer than 15 minutes should be avoided to reduce the patient s risk for soft tissue or nerve damage When using the monitor for long periods of time select the longest clinically appropriate measurement interval and periodically e
32. d not flashing Pressing this key momentarily cancels either alarm silence condition The monitor defaults to two minute alarm silence at power up Of 76 CANCEL Press this key to stop an NIBP measurement that is in progress The cuff will automatically deflate when this key is pressed Pressing A for 3 three seconds restores the initial cuff inflation pressure to 200 mmHg in SA mode D or 175 mmHg in LA mode and causes the NIBP display areas to show dashes This key is also used to exit user menus without saving new settings and to acknowledge NIBP alarms and alerts Note In Japan the initial cuff inflation pressure is reset to 150 mmHg when in SA mode STAT Press this key to begin Stat mode in which NIBP readings are taken continuously for 5 minutes Upon exiting Stat mode either after 5 minutes of Stat mode readings or when the user presses YA to exit Stat mode the monitor will resume normal operation in Auto mode with a 5 minute interval MANUAL AUTO Press this key to toggle between Manual and Auto NIBP mode ex In Auto mode NIBP measurements are made at regular user selectable intervals In Manual mode the user must initiate each NIBP measurement by pressing the QQ key RECALL Press this key once to enter Recall mode Saved NIBP and SpO data will o be displayed along with the time at which each measurement was taken Il j Press Tim for 6 seconds to show z f steady on the display a
33. e NOTE Alarms can be tested while the monitor is in use by setting alarm limits such that the measured parameter reading is outside the alarm limits Be sure to restore alarm limits to the required settings after testing Manually Reset NIBP Alarms The NIBP alarms require a manual reset The alarm actions stop when the alarm is no longer violated and the CANCEL YA key is pressed V6004 Operation Manual 4 1 Chapter 4 Alarms and Alerts Alerts An alert warns you about a condition that prevents the monitor from taking a measurement For example if the SpO sensor is not connected to the monitor the monitor cannot measure the patient s pulse rate or SpO value In this case an alert is triggered During an alert Figure 4 2 Alert Example A 1 Li 2g gt _ a es La 3 X e La 1m Ba ox Lg tng ui MAP mmHg bpm x MJ S 1 The AAA LED is illuminated o9 Dashes indicate a measurement is unavailable The alert tone sounds if not silenced o A message E n nin is an error number is displayed in the MAP area for NIBP only Adjusting or Viewing Alarm Limits 1 Press the 2 key once to enter the Set Alarms mode 2 Using the key select the alarm limit to be changed 3 Use the arrow keys to adjust the value Press the 2 key to set the value High alarm limits may be set to OFF by scroll
34. en light is not illuminated the NIBP function is in the Larger Animal Mode LA Mode This is the suggested mode for animals greater than 10 pounds Large Animal Mode NOTE Start with the LA Mode for all animals and if you have difficulty obtaining a reading switch to the SA Mode The front panel keys control the monitor s functions Dedicated keys are provided for turning the monitor on and off silencing alarm and alert tones selecting menus and additional NIBP functions 2 2 V6004 Operation Manual Chapter 2 Intended Use and General Information Display Figure 2 3 Monitor Front Panel Parameter Items esee ES SYS mmHg DIA mmHg 96SpOs art Om Of cu O ES ad ono AAA SENSOR o ADA o i ri Ba Lt L L L D MAP mH bpm PARAMETER DESCRIPTION SYS mmHg This area displays the systolic pressure in mmHg millimeters of Mercury DIA mmHg This area displays the diastolic pressure in mmHg MAP mmHg This area displays the mean arterial pressure in mmHg SpO gt This area displays the SoO gt measurement This area displays the pulse rate measurement in bpm SP bpm NOTE Dashes displayed in any parameter indicate the measurement is invalid or unavailable Periodically indicates the time since the last NIBP reading up to 99 minutes For more than 99 minutes the interval display section will sho
35. engths of low intensity light one red and one infrared 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 6 1 Pulse Oximetry Theory of Operation Q Low intensity Red and Infrared LED light sources o 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
36. esesneses 6 2 Attaching the Patient OxiMe try vcscsvssscssasscccssssscrsssaceatavscsusveceasesesevceenss rete R con 6 2 Choosing the Seisor ons aatmieostetmaredinenigeetieicrs a feto tbul de oder dee utere io eet Rod 6 3 Clean or Disinfect the Sensors sessssscsssecssccsseesssscssecssscessecsssecsssccssscsssscessecsuscesasecsuscessceesuseesuecsssccssuecessecsssecessecesuecesseessaes 6 3 Checking the Sensor and Oximetry Cable sssssccsssscsssssscsseescsssecsssseesssnsessssseesessesssssesesssesssnsesessseseesssesssssessensessaee 6 3 Attach the Sensor to the Patent cssccssssssecssssccesassecssccsssssssacsassecssssssssuacessacsacsesstecssusodsssocassoasactasasissssrssisaratesasssovestessrenacsiasdacsassieinaatiss 6 4 Application G U Lo ee ERTEILEN 6 5 Universal Y Lingual Sens O ERR G n 6 5 Mini Clip Universal C sensor ssescssssccsssessssessseccssecsssecensccessecessecsssecsssecsssecsssecensecsusecsuscesssecsusccsusessasecsasecsaseesuscesuecesusessuceesuccesuecesuceesueessaeees 6 6 aerial Mem 6 6 Pulse Oximeter Sensor Application Tips csssscssssccssecsssscssssccssecssscssssecsuscessscesuscessscesuscessccessccessecsssecsssecsasecssscesseecsaseesaeesuseeses 6 7 Testirig Sensol EUnctloHh adsense poete better irte eter itte p Pet Dr Eas eiS ESEA iaaea PASA ER ERE EDEN Ue beri brc 6 7 Primary Applications for SensOts seicccatsccesc
37. gently Added display update rate to NIBP specs Added display update rate maximum age of data calibration and desat study info to SpO2 specs Added display update rate to Pulse Rate and Pulse Strength specs Added alarm volume spec Added Equipment Classification section to Specs chapter Added Appendix A Guidance and Manufacturer s Declaration Moved Revision History from Appendix A to Appendix B Added company address to back cover V6004 Operation Manual B 1 Appendix B Revision History REVISION DATE CHANGES Updated company name from SurgiVet to Smiths Medical PM Inc Veterinary Division Added registered trademark information to table of contents Updated Warranty and Service Information section to new Veterinarian Warranty Added keys SN symbol REF symbol IPX1 monitor only symbol date of manufacturing symbol Rx Only symbol and Collect Separately symbol to the symbol chart in Chapter 1 Changed Default Cuff Pressure to 175 in LA and 200 in SA on pg 2 6 number 5 Added to page 3 1 Caution If damage has occurred to package a calibration needs to be done at an authorized service center Removed NIBP Calibration Verification from Chapter 5 Section Using the NIBP Parameter Updated Connecting the Cuff and Hose section of Chapter 5 Redrew pictures for suggested application sites Updated Sensor Table in Chapter 6 Removed text talking about temperature from everywhere in the manual Added note abo
38. hould be disposed of properly NiCd batteries should not be disposed of in normal rubbish containers They should be sent to the proper facilities so that the metals in them may be reclaimed and or recycled In the US call 1 800 822 8837 to obtain information about the proper disposal of the NiCd battery Regulations in Europe vary from country to country Consult local authorities for information about the proper disposal of the NiCd battery NOTE Smiths Medical PM Inc recommends that all Surgivet monitors are used with the power supply whenever possible Doing so will extend the life of the rechargeable battery which is ideally used for transport and field situations where AC is not available NOTE Connect the AC charger to the AC power connector of the monitor first and the AC charger to the wall outlet second Cleaning and Disinfecting CAUTION Do not immerse the monitor or any of its accessories in liquid Do not autoclave or ethylene oxide sterilize the monitor or any of its accessories Unplug the external charger before cleaning or disinfecting the monitor or its accessories CAUTION Chemicals used in some cleaning agents may cause brittleness of plastic parts Follow cleaning instructions in this manual Clean the surfaces of the monitor and the accessories with a soft cloth moistened in a mild soap solution If disinfection is required wipe the surfaces with isopropyl alcohol then wipe with a water moistened soft cloth V60
39. ic high alarm limit value Adjusting the Pulse Beep Volume 1 Make sure that alarms are silenced 2 Use the W and keys to adjust the pulse volume The pulse volume level will be displayed in the lower left corner of the display in the e INTERVAL area NOTE The pulse beep sounds while adjusting the volume Attaching the Patient Oximetry Smiths Medical PM Inc manufactures a variety of SurgiVet pulse oximetry sensors to allow you to accurately and reliably monitor all of your different types and weights of patients It is very important to select the proper sensor for each patient based on their size color condition and type of procedure you are performing Experience will quickly teach you which probes work best under different conditions Well perfused sites with little or no hair are preferable It is also important to note that some anesthetic drugs such as xylazine acepromazine and domitor can affect peripheral pulse pressures causing very weak pulsations All pulse oximeters require a good pulse to work properly The sensors available to you for your SurgiVet pulse oximeters include a mini clip sensor a Lingual Sensor a reflectance sensor and a Universal C sensor 6 2 V6004 Operation Manual Chapter 6 Using the Oximeter Option Choosing the Sensor Choose the appropriate sensor from the following chart PATIENT SENSOR DESCRIPTION Small Medium Animal Tongue V1703 Lingual Clip Set with Y Sensor u
40. ic measurement interval time has elapsed another automatic measurement is taken 3 If the measurement is unsuccessful dashes are shown for the measured values and the monitor stops taking measurements until the measurement interval has elapsed A message E amn rim is an error number is displayed in the MAP area for NIBP only Manual measurements may be initiated using the amp amp key in Auto mode provided that the cuff has been deflated for at least 30 seconds otherwise the interval display will flash for a few seconds to indicate that the monitor is in Auto mode and the cuff has been recently inflated A Manual measurement will take the place of an Auto measurement if the measurement was scheduled to occur during the manual measurement The NIBP interval counter will be reset at the conclusion of a successful manual measurement NOTE After 10 ten minutes of Auto mode measurements at 1 minute intervals the monitor will switch to an interval of 5 minutes Stat NIBP Measurement In Stat mode five minutes of successive NIBP measurements are taken 1 Press the ae key 2 The digital manometer will not be displayed and 7 7 will be displayed in the C INTERVAL display section to indicate Stat mode 3 When the amp key is pressed a five minute time out is started NIBP measurements are taken successively until the five minute time out has elapsed or until the ae key is pressed If an NIBP alarm or alert is occur
41. ing past the highest setting Low alarm limits may be set to OFF by scrolling past the lowest setting NOTE The SpO function the monitor may be disabled by scrolling its high alarm limit to 100 then OFF and then to d 4 Press Bto access other alarm limits 5 Press the gunt key to toggle through the menu or press the A 7 key to save the new settings and exit Pressing YA exits without saving the changes NOTE Alarm limits are retained during power cycles except for the following note NOTE If the low alarm limit for SpO is set to a value lower than 80 when the monitor is powered down then this low alarm limit will be reset to 85 at power up 4 2 V6004 Operation Manual Chapter 4 Alarms and Alerts Alarm and Alert Tones The alarm tone is a two tone continuous sound dee doo dee doo The tone for all alerts except low battery is a single tone sound with a pause beep beep pause beep beep The alarm and alert tones sound at the same volume The volume can be adjusted by doing the following a Make sure the alarms are not silenced b Press the W or W keys to either increase or decrease the volume The volume level will be displayed in the lower left corner of the display This volume can not be set to OFF All alarm and alert tones except the Low Battery alert can be silenced with the key Turning Alarm and Alert Tones On and Off When the monitor is turned on the alarm and alert tones are silenced for
42. iodically display the time since the last NIBP reading up to 99 minutes For more than 99 minutes the T INTERVAL display section will show 5 i e with the trailing decimal point 2 Press gt to begin the measurement A digital manometer will display the current cuff pressure in the SYS display section during the measurement If the measurement is successful the systolic diastolic and MAP measured values are updated Pulse Rate is also updated if the oximeter is disabled not installed or oximetry Pulse Rate is invalid 3 If the measurement is unsuccessful dashes are shown for the measured values and the monitor stops taking measurements until is pressed again An error message will be displayed in the MAP area A message E nin rim is an error number is displayed in the MAP area for NIBP only V6004 Operation Manual 5 3 Chapter 5 Non Invasive Blood Pressure Automatic NIBP Measurement In the Auto mode NIBP measurements are taken at the auto measurement interval setting 1 If the unit is in Manual mode press the Ye key to enter Auto mode The measurement interval will be displayed in the INTERVAL area alternating with the time since last NIBP reading 2 Press the Q key to begin a single NIBP measurement immediately the automatic mode continues after the single measurement If the measurement is successful the measured systolic diastolic MAP and pulse rate values are updated When the automat
43. ion NiCad 6VDC Fully charged continuous use life of approximately 6 hours Maximum full time charging time is 4 hours V6004 Operation Manual Physical Dimensions Weight Environment Temperature Relative Humidity Chapter 12 Specifications Width 21 6 cm 8 5 inches Height 8 2 cm 3 24 inches Depth 14 0 cm 5 5 inches 1 6 kg 3 5 pounds Operation 0 to 559 C 32 to 131 F Storage 40 to 70 C 40 to 158 F Operation 15 to 9596 non condensing Storage 10 to 95 non condensing Equipment Classification Type of Protection Degree of Protection Against Electric Shock Mode of Operation Degree of Protection Degree of Mobility Safety Requirements Class Il amp Internally Powered Type CF SpO amp Temp Type CF defib protected NIBP Continuous IPX1 drip proof Against Ingress of Liquids Portable EN60601 1 1990 NOTE The monitor might not meet its performance specifications if stored or used outside the temperature and humidity ranges listed above V6004 Operation Manual 12 3 Chapter 12 Specifications This page is intentionally left blank 12 4 V6004 Operation Manual Appendix A Guidance and Manufacturer s Declaration Appendix A Guidance and Manufacturer s Declaration Guidance and Manufacturer s Declaration IEC 60601 1 2 Requirements The V6004 non invasive blood pressure monitor is intended for use in the electromagnetic environment specified below
44. ipment connected to the monitor s data interface must be certified according to the respective IEC standards i e IEC 950 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 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 Figure 8 1 Patient Environment V6004 Operation Manual Chapter 9 Routine Maintenance Chapter 9 Routine Maintenance Charging the Battery Charge the battery after the monitor is used under battery operation when the low battery L LED is illuminated or after long term storage Connect the external charger to the back of the monitor Verify that the green LED next to the QD INTERVAL display area is illuminated After connecting the external charger the unit automatically goes into fast charge which is indicated by a flashing green LED After 4 hours the battery is fully charged indicated by a continuously lit LED WARNING Using any charger other than the SurgiVet charger supplied with the unit will cause damage to the monitor NOTE NiCad batteries should always be fully charged and discharged to prevent shortened battery life If the battery fails to hold a charge or otherwise becomes inoperable the battery s
45. lay Trend records can be displayed by entering the Recall mode Trend records containing NIBP data will be displayed SpO Pulse Rate and Signal Pulse Strength are trended with each NIBP record No records containing only SpO data will be shown N Trend records will be displayed in the order in which they were recorded beginning with the youngest most recent record The user may scroll through the saved records using the arrow keys N or W The up N key scrolls through older records 3 For NIBP measurements trend record data will be displayed alternately with the trend time date stamp in phases The first phase will be NIBP and SpO data the second will be the time date stamp 4 If SpOj is disabled a 7 tl will be displayed for that trend record 5 When the user has scrolled past the youngest or the oldest trend record End will be displayed in the MAP parameter Trend Printout The printout will contain only ASCII text no graphics The user may select one of two destinations for the trend printout printer if installed or serial port This selection is made in the System Settings menu If no printer is installed the trend data will always be sent to the serial port Trend records will be printed in the order in which they were stored beginning with the youngest record The trend printout format will be ASCII text 16 characters per line as follows For NIBP measurements TREND DATA Time 15 23 0
46. ly if in the opinion of SMPM 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 may make available a loaner device for a fee should it be requested while an out of warranty device is in for service Disclaimer of Warranties THE FOREGOING EXPRESS WARRANTY AS CONDITIONED AND LIMITED IS IN LIEU 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 if 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
47. n 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 labeling for 1 year from the date of shipment to the original purchaser USA only Seller warrants to the original purchaser that the reusable temperature cable supplied as accessories shall be free from defects in materials and workmanship under normal use if used in accordance with its labeling for 6 months from the date of shipment to the original purchaser USA only Seller warrants to the original purchaser that the reusable ECG leads reusable invasive pressure cable reusable NIBP purple hose disposable temperature probe disposable invasive p
48. nd clear the trend memory If the key is released while is flashing trend is not cleared y INTERVAL Press this key once to set the NIBP measurement interval Press and hold for 3 seconds to set the time and date 2 4 V6004 Operation Manual Chapter 2 Intended Use and General Information KEY NAME DESCRIPTION ARROWS During normal operation the ARROW keys WY Jare used to set Alarm Alert volume when alarms are not silenced and pulse beep volume when alarms are silenced The ARROW keys are used to set the NIBP measurement interval the time and date alarm limits and system settings in various user modes During normal operation pressing and holding the UP key for 3 seconds initiates a data log to the printer or serial port When in Recall mode pressing the Nand WY keys scrolls through saved data and pressing and holding the W key for 3 seconds causes all saved data trends to be sent to the printer or serial port ALARM SET Press this key to enter the System Settings menu and Alarm Limits x a menu While menus are displayed press Burt select a menu item or to accept a value which has been adjusted Press this key once to enter the Alarm Limits menu Use the x W keys to adjust the limit values and the Ba to cycle through the alarm limits Press and hold the D y key for 3 seconds to enter the System Settings menu The following system settings may be changed initial cuff inflation pressure
49. nd then on Try the reading again If the message reappears contact Smiths Medical PM Inc Veterinary Clinical Support Measurement timed out Try the reading again Check patient condition and cuff placement Initial inflation pressure may need to be increased Cuff leak Check the cuff and hose assembly for leaks and try the reading again If the message reappears replace the cuff Excessive noise or inflation pressure Try the reading again Check patient condition and cuff too low placement Initial inflation pressure may need to be increased Weak signal Try the reading again Reposition the cuff over the artery if necessary System error Turn the unit off and then on Try the reading again If the message reappears contact Smiths Medical PM Inc Veterinary Clinical Support Time error Turn the unit off and then on Try the reading again If the message reappears contact Smiths Medical PM Inc Veterinary Clinical Support NIBP calibration out of range Contact Smiths Medical PM Inc Veterinary Clinical Support NIBP dump valve failure Contact Smiths Medical PM Inc Veterinary Clinical Support PIC pressure transducer error PIC pressure transducer is outside the specified range at initialization Try the reading again If the message reappears contact Smiths Medical PM Inc Veterinary Clinical Support Cuff overpressure condition Check patient condition This message will appear if the pressure exceeds 315 mmHg Pressu
50. nity uu ssesssssesccsssececssesecsssesecssececsnseeesssececsssceesssecessuseeesuseeesnseceenusecesssecesnseecennseeessees Recommended Separation Distances ecsssecssecssseccsseccssecsssessuscessseessseessecessecssueccsuscessccesscsesseceaseessseesueesucecsuceesuceesueecsuceeseeete Appendix B Revision History siccsscssssscscscscccsssconsescsussssessssssasesssnsssssasnssnasescecassescseacsescscecsescses B 1 V6004 Operation Manual iii Table of Contents 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 V6004 Operation Manual Warranty 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 publicatio
51. not use it Contact your authorized repair center for help Carefully inspect the sensor to make sure it does not appear damaged If using the oximetry cable carefully inspect the oximetry cable to make sure it does not appear damaged V6004 Operation Manual 6 3 Chapter 6 Using the Oximeter Option Figure 4 3 Attaching Sensor And Oximetry Cable To Monitor n o g SYS mmHg DIA mmHg SpO SI X OM J 5551 553 S Q Oximetry Cable Q IA SJ 2 Connector Retaining Clip Sensor i e 1 If the sensor is not already connected to the oximetry cable connect the sensor to the oximetry cable as shown Push the connectors together firmly and close the latch to secure the connectors If using the oximetry cable 2 If the oximetry cable is not already connected to the monitor connect the oximetry cable to the monitor as shown Push the connector firmly into the monitor 3 You are now ready to attach the sensor to the patient WARNING 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 not using the oximetry cable 1 Connect the sensor to the monitor Push the connector firmly into the monitor WARNIN
52. obile 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 V6004 monitor is used exceeds the applicable RF compliance level above the V6004 monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the V6004 monitor b Overthe frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m V6004 Operation Manual A 3 Appendix A Guidance and Manufacturer s Declaration Recommended Separation Distances The V6004 non invasive blood pressure monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the V6004 non invasive blood pressure monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the V6004 non invasive blood pressure monitor as recommended below according to the maximum output power of the communications equipment SEPARATION DISTANCES RATED MAXIMUM ACCORDING TO FREQUENCY OF TRANSMITTER METERS Oe 1 50 kHz to 80 MHz TRANSMITTER WATTS PEPEN 80 MHz to 800 MHz 800 MHz to 2 5 GHz
53. 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 1 2 V6004 Operation Manual Chapter 1 Introduction KEYWORD DEFINITION WARNING Tells you about something that could hurt the patient or hurt the operator CAUTION Tells you about something that could damage the monitor NOTE Tells you other important information General Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING This product is intended for veterinary use only Do not use this device in the presence of flammable anesthetics ELECTRICAL SHOCK HAZARD when cover is removed Do not remove covers Refer servicing to qualified personnel Do not use this device in the presence of magnetic resonance imaging MR or MRI equipment Operation of this device may be adversely affected in the presence of computed tomograph CT equipment Operation of this de
54. onitor possibly resulting in the patient not being monitored Make sure the patient cannot reach the monitor WARNING 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 WARNING 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 V6004 Operation Manual 3 3 Chapter 3 Setting Up the Monitor This page is intentionally left blank 3 4 V6004 Operation Manual Chapter 4 Alarms and Alerts Chapter 4 Alarms and Alerts Alarms An alarm warns you when a patient s measurement matches or exceeds the high or low alarm limit for that measurement For example if the high SYS alarm limit is set to 150 and the patient s measured SYS is 150 or higher an alarm is triggered During an alarm Figure 4 1 Alarm Example BJ Hemme ejm SPQ LOA 29 656 BE g8 S J o i 1M Ja T The ac LED flashes o The digits for the violated alarm limit flash The alarm tone sounds if not silenced NOTE The alarm actions occur for each violated alarm even if more than one alarm is violated at the same tim
55. p to 60 pounds Pinna ears Toe Webbing V3078 Mini Clip Sensor Tongue Rectum Tail V1700 Reflectance Sensor Hock Achilles Tendon etc V1707 Universal C Sensor Large Animals over Tongue V1703 Medium Large Animal Lingual Clip Set with Y 60 pounds Sensor Pinna ears Toe Webbing V3078 Mini Clip Sensor Tongue Rectum Tail V1700 Reflectance Sensor Hock Achilles Tendon etc V1707 Universal C Sensor NOTE Refer to sensor insert instructions for application directions Clean or Disinfect the Sensors Clean or disinfect the sensor before attaching a new patient WARNING Donot 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 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
56. pears contact Smiths Medical PM Inc Veterinary Clinical Support Processor communication error Turn the unit off and then on Try the reading again If the message reappears contact the Smiths Medical PM Inc Veterinary Clinical Support Measurement timed out Try the reading again Check patient condition and cuff placement Initial inflation pressure may need to be increased Cuff leak Check the cuff and hose assembly for leaks and try the reading again If the message reappears replace the cuff Excessive noise or inflation pressuretoo Try the reading again Check patient condition and cuff low placement Initial inflation pressure may need to be increased E Weak signal Try the reading again Reposition the cuff over the artery if necessary E 17 System error Turn the unit off and then on Try the reading again If the message reappears contact the Smiths Medical PM Inc Veterinary Clinical Support E 18 Cuff overpressure condition Check patient condition This message will appear if the pressure exceeds 315 mmHg E 19 Time error Turn the unit off and then on Try the reading again If the message reappears contact the Smiths Medical PM Inc Veterinary Clinical Support E 20 NIBP calibration out of range Contact the Smiths Medical PM Inc Veterinary Clinical Support NIBP dump valve failure Contact the Smiths Medical PM Inc Veterinary Clinical Support E 22 PIC pressure transducer error Contact the Smith
57. r resistance may cause an inability to determine accurate pulse and SpO readings Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin with CO poisoning or methemoglobin with sulfonamide therapy will adversely affect the accuracy of the SpO measurement SpO measurements may be adversely affected in the presence of high ambient light If necessary shield the sensor area with a surgical towel for example Dark skin tone or fur pigment may cause an inability to determine accurate pule rates and SpO readings Seeking the most appropriate site for sensor placement is advisable Optical cross talk can occur when two or more sensors are placed in close proximity It can be eliminated by covering each site with an opaque material 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 Cautions 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
58. rating is not correct do not use the monitor contact the Smiths Medical PM Inc Service Department or your local distributor for help Refer also to Chapter 11 Optional Supplies and Accessories to verify the proper AC power supply for your application NOTE Connect the AC Charger to the AC Power Connector of the monitor first and the AC Charger to the Wall Outlet second NOTE Do not plug the monitor into an outlet controlled by a wall switch 1614 AC power supply 105 125V 60 Hz 1615 AC power supply 208 252V 50 60 Hz 1616 AC power supply 90 110V 50 Hz NOTE When using AC power the 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 WARNING 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 3 2 V6004 Operation Manual Chapter 3 Setting Up the Monitor WARNING 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 WARNING Do not place the monitor in the patient s bed Do not place the monitor on the floor WARNING Failure to place the monitor away from the patient may allow the patient to turn off reset or damage the m
59. re transducer error Pressure transducer is outside the specified range at initialization Try the reading again If the message reappears contact Smiths Medical PM Inc Veterinary Clinical Support Application Note NIBP Cuff Inflation Method The NIBP cuff inflation pressure is determined by the following method If you just turned on the monitor thereis no valid systolic pressure reading you just changed the initial cuff inflation pressure setting Then the cuff pumps up to the initial cuff inflation pressure setting in the SYSTEM SETTINGS menu If there is a valid systolic pressure reading then the cuff pumps up to the previous systolic reading plus 35 mmHg 5 6 V6004 Operation Manual Chapter 6 Using the Oximeter Option Chapter 6 Using the Oximeter Option General Description The V6004 s Oximeter option noninvasively and continuously monitors and displays arterial blood oxygen saturation SpO5 and pulse rate The V6004 beeps with each pulse beat The pitch of the pulse beep depends on the SpO value the higher or lower the SpO value the higher or lower the pulse beep pitch The V6004 flexible alarm system lets you choose alarm parameters and audible tone volumes You can select the high and low alarm limits for SpO and pulse rate and independently choose the volume for alarm and pulse beep tones Pulse Oximetry Theory of Operation The pulse oximeter determines SpO and pulse rate by passing two wavel
60. ressure transducer and disposable sample lines supplied as accessories shall be free from defects in materials and workmanship under normal use if used in accordance with its labeling for 90 days from the date of shipment to the original purchaser USA only Blood pressure cuffs carry a 6 six month warranty pending evaluation by Smiths Medical PM Inc SMPM Technical Services Cuffs that are contaminated have liquid in them have been misused abused or are older than 6 months will not be covered under warranty The sole obligation of SMPM under this warranty will be to repair or replace at its option products that prove to be defective during the warranty period 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 Smiths Medical Pm Inc 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 for current warranty information V6004 Operation Manual V Warranty and Service Information Loaner Device Domestic Sales Only Smiths Medical PM Inc SMPM will for the period of warranty make loaner devices available at no charge domestic sales on
61. reusable cuffs are available for monitoring small to large animals The NIBP function of the monitor must be in small animal mode SA to be used on small animals Oximeter optional The monitor also supports oximetry which continuously measures and displays arterial blood oxygen saturation SpO gt and Pulse Rate Wbpm Oximetry includes the display of a pulse strength bar The monitor beeps with each pulse beat The volume of the pulse beep is adjustable The pitch of the pulse beep varies with the SpO value A variety of veterinary specific sensors are available Audio The monitor uses a multi frequency speaker for beeps and alarm and alert sounds Volumes are adjustable Serial Output An RS 232C interface allows serial output of text data to a compatible device There is no waveform data on the serial output Power The V6004 operates on power from an external power supply In addition the monitor contains an internal battery that allows operation for approximately six hours Printer optional An optional printer may be installed which prints Data Log and Trend information V6004 Operation Manual 2 1 Chapter 2 Intended Use and General Information Front Panel Figure 2 2 Monitor Front Panel So Om FERE DESCRIPTION The display provides continual real time updates of all measured values and alarm or alert messages and or indications The display also sho
62. ring the first press of the ea key will acknowledge the alarm s and or alert s the second press of the Z key will end Stat mode NOTE When the Stat mode times out or is canceled Stat NIBP measurements stop and the monitor is set to the Auto measurement mode with an interval setting of 5 minutes Canceling NIBP Measurements Pressing YA performs these functions Stops the current measurement While in the automatic mode pressing Z only stops the current measurement another automatic measurement starts after the preset time interval has elapsed Stops all NIBP alarm and alert actions and erases displayed NIBP alerts and messages Pressing Z for 3 seconds restores the initial cuff inflation pressure to 200 mmHg in SA mode or 175 mmHg in LA mode In Japan the initial cuff inflation pressure is reset to 150 mmHg if in SA mode Pressing this key for three 3 seconds causes the NIBP display areas to show dashes 5 4 V6004 Operation Manual Chapter 5 Non Invasive Blood Pressure Changing the Auto NIBP Measurement Interval The automatic NIBP measurement interval setting is shown in the INTERVAL display area when Auto mode is chosen This setting is the time interval between automatic NIBP measurements Follow these steps to change the Auto NIBP measurement interval 1 Press the e key 2 The Auto mode NIBP interval will display in the INTERVAL display area 3 Use the AW and V keys to change the Auto measurement in
63. s Medical PM Inc Veterinary Clinical Support Contact the Smiths Medical PM Inc Veterinary Clinical Support 10 2 V6004 Operation Manual Chapter 11 Optional Supplies and Accessories Chapter 11 Optional Supplies and Accessories CAT NO DESCRIPTION QTY EECA a 1614 AC Power Supply 205 125V 60 Hz 1615 AC Power Supply 208 252V 50 60 Hz 166 ACPower Supply 90 110v 50Hz o V6148SA NIBP Kit includes 31545B1 Cap 31543B1 Cuff 3 9 cm 31543B2 Cuff 5 15 cm 31543B3 Cuff 9 25 cm 31543B4 Cuff 17 41 cm 31544B1 6ft Hose 31544B1 NIBP Cuff Supply Hose 1 8 m 6 ft 31544B2 NIBP Cuff Supply Hose 0 9 m 3 ft 31544B3 NIBP Cuff Supply Hose 3 0 m 10 ft Ordering Information For ordering information contact the customer service department at the address or phone number below Smiths Medical PM Inc Phone 262 513 8500 N7W22025 Johnson Drive Toll Free 888 745 6562 USA only Waukesha WI 53186 Fax 262 513 9069 Website www surgivet com V6004 Operation Manual 11 1 Chapter 11 Optional Supplies and Accessories This page is intentionally left blank 11 2 V6004 Operation Manual Chapter 12 Specifications Chapter 12 Specifications NIBP Range NIBP Accuracy Measurement Method Cuff Pressure Accuracy Determination Time Interval Times Calibration Inflation Pressure LA Mode Inflation Pressure SA Mode Inflation Pressure Display Display Upda
64. seessssecssuseseessseessusesesssesessuecesnsesessseeessusesesssesessusesessseeessseessnsecessseessssees 9 2 L ng Termit Storag Cs cisacisssesisesssvzsds neriie rai eitra Ear TENES E EErEE SEEEN Oae VEVE EEIN ESKES ESE EATS EEE NE EESE COVES Eaa 9 2 Chapter 10 Troubleshooting sssosessssocesssoocessooocessooocessoocesssoocessosocessosocssssossessossesssssssss 10 1 Chapter 11 Optional Supplies and Accessories ccccccccccssssccssscccssccccssccccssccccsscseeees 11 1 Ordering Information etti PW CIERTO PUER OQ Et rente rra HO HH rH ta UE MER Rete rri 11 1 Chapter 12 Specifications i P PUIS S teri Gt caesacedesscssasezsscazsszexensodscsssaesusssccusscosaszoasssadacecustdesocoassncsasersassazeusndisbosassnasacousisbsauseaaataesbssadctoesadansescstosatatsnenaeasntsaaseilcns Audible AL ATMS iiem ipte aae aaa a ees Alarm Limit RAnges ccsssssssssscssscccssscsssccsssccsseecssscessecsssecsssesssscesssccssscssascesssccsuscesscessscesscessuseessecesscessseceaseesasecsaseesasecsaseesaseesaceceaseetes S fial QUH tit sedan M M neis e M EE Environment Equipment Classification Appendix A Guidance and Manufacturer s Declaration eeeeeeeeeeeeee 1 Guidance and Manufacturer s Declaration IEC 60601 1 2 Requirements Electromagnetic Emissions Emissions Test Electromagnetic Emissions Immu
65. sors ability to obtain accurate readings Well perfused sites with little or no hair are preferable 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 Oximeter s Performance Pulse oximeters do not require user calibration If checking the function of the device is desired an optional Oximeter Patient Simulator SMPM 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 Oximetry ECG Patient Simulator cannot be used to assess the accuracy of a pulse oximeter and or sensor NOTE A Follow the instructions included with the Oximeter Patient Simulator 6 8 V6004 Operation Manual Chapter 7 Trends Chapter 7 Trends Trended data will be stored every time a valid NIBP measurement is made
66. 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 Do not place the monitor in the patient s bed Do not place the monitor on the floor 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 Make sure the patient cannot reach the monitor 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 V6004 Operation Manual Chapter 1 Introduction WARNING Medical electrical equipment including this device needs special precautions regarding electro magnetic compatibility EMC and needs to be installed and put into service according to the EMC information provided in this manual WARNING The monitor should not be use
67. t to save the new settings and exit Pressing CANCEL 2 exits without saving the new settings V6004 Operation Manual 3 1 Chapter 3 Setting Up the Monitor Setting the Time or Date The monitor has a real time clock and calendar It remembers the time and date even when the monitor is turned off or is not connected to the external charger The time and date are used for the trends and printouts To set the time and or date do the following 1 Press and hold the INTERVAL key for 3 seconds 2 The system time will be displayed in the MAP display area HH MM and the date will be displayed in the SYS and DIA display areas MM DD YY w Use the key to select the time or date item to be changed 4 Use the N and wW keys to adjust the value Pressing and holding the N and w key changes the value faster Press the key to accept the value and move on to the next UI 6 When the year is flashing press the key to accept the changes and exit Pressing the 7 key also saves the new settings and returns the monitor to normal operation Pressing the 2 key exits without saving the new settings Optional Printer 1 Press the FEED IY key to advance install paper 2 Press the PRINT 2 key to begin printing AC Power CAUTION Ensure the device s AC rating is correct for the AC voltage at your installation site before using this monitor The monitor s AC rating is shown on the external power supply If the
68. tart Alarm Silence Cancel Stat Up and Down Arrows Manual Auto Recall Alarm Set Printer Output or Print Key Print feed Alarm silence LED High Priority Alarm red or Low Priority Alarm Alert yellow LED Low battery LED Small animal patient mode LED Interval 76 AAA SYS Systolic blood pressure DIA Diastolic blood pressure Mean arterial pressure Pulse Rate LED beats per minute SpO2 Percent Oxygen Saturation V6004 Operation Manual 1 1 Chapter 1 Introduction SYMBOL DEFINITION Federal U S A law restricts this device to sale by or on the order of a veterinarian Type CF equipment Os jommewe SOS hem SSCS Loudspeaker 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 a waste Devices and items must not be disposed of with general waste Collect Separately If purchased before that date they may also be sent for recycling if being replaced on a one for one like for like basis this varies depending on the country Recycling instructions to customers using Smiths Medical 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
69. te Rate SpO Range Accuracy Averaging Pulse Tone Display Display update rate Maximum age of displayed data Calibration 20 250 mmHg Accuracy meets or exceeds SP10 1992 standard for non invasive pressure accuracy AAMI Standard 5 mmHg mean error 8 mmHg standard deviation The first and fourth Korotkoff sounds were used to determine the overall efficacy 3 mmHg or 296 whichever is greater 0 330 mmHg 30 50 seconds typical max 120 seconds 1 2 2 5 5 10 15 20 30 45 60 90 minutes Factory calibrated 50 300 mmHg 175 mmHg 200 mmHg 150 mmHg in Japan Systolic amp Diastolic Pressures 3 digit 0 400 inch tall LED s Mean Arterial Pressure 3 digit 0 300 inch tall LED s 1 hertz 0 100 SpO functional 2 counts at 70 100 SpO less than 70 unspecified 8 beats Pitch corresponds to SpO value Value adjustable or OFF 3 digit 0 400 inch high LED s 1 hertz 20 seconds Factory calibrated over 70 to 100 96 SpO using human blood samples to functional saturation Test methods available upon request No in service calibration required Because pulse oximeter equipment 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 6004 has been validated in human desaturation studies on 10 adult volunteers that did not have health problems i e dia
70. terval setting 4 Press either the e key or the QQ4 key to save the setting and exit Pressing the Z key exits the mode without saving the new interval setting NOTE If no key is pressed for 20 seconds while in SET INTERVAL mode the unit will return to normal operation with the new interval setting NOTE Ifthe unit is in Auto mode when the interval setting is changed the unit will continue to run in Auto mode with the new interval when the Set Interval mode is exited NOTE If the INTERVAL was changed the NIBP Auto mode interval will be restarted when the Set Interval mode is exited NOTE If the unit is in Auto mode and it is time to take a measurement the unit will automatically exit the Set Interval mode with the new interval setting and start a measurement V6004 Operation Manual 5 5 Chapter 5 Non Invasive Blood Pressure NIBP Alerts and Status Messages The NIBP status messages are displayed in the MAP display area Only one message can be shown at a time therefore they are prioritized to show what is most important on the display Status Messages Press the ea key to acknowledge the alert The message disappears the ALERT LED AAA turns off and the alert tone silences If the status message i e ri does not disappear the condition has not been removed and will require additional attention as described below ERROR CODE MEANING ACTION Processor communication error Turn the unit off a
71. ts ssiscccrescnsssnsnsnsvcnenssssonssansssnesensssnssconsoisscecunnsseessahosssovonssinecsnatensen I PATET EE E T ANE A T EEA EES 4 1 Manually Reset NIBP Alanis svssccvssicscasescesssscesusseceatavecessveceasestesveeerassaccovaveceusvesenvestesSbeceraysevea aveerssteceauestnsSoueersssoceovaveeesseecrabersed Alerts Adjusting or Viewing Alarm Limits Alarm and Alert TORCS icssciscscsssessssstesssictcresiveertxatucteossies dtaraatesitien tmninnti avast M 4 3 V6004 Operation Manual i Table of Contents Turning Alarm and Alert Tones On and Off wn esssssssssssseccsssesccssseccsssecesssscesssscessssscessnscessuseecsnseessnsseeesusecessseceesneeeesneeceansess 4 3 System Alert Condition LOW Battery sistssssssssccsssssssstssvasssssnsssedacedsassqznstnaazesseinasscesssbnussontbsspsonstaessssedodnabvedesbiabecnassssnsgensnasosdedl 4 3 Audible and Visual Indicators noii torre ees a npa PERRO as cta san edd da d eed 4 4 Chapter 5 IN IB TASTE ISIDORO 5 1 Theory of Operation Using the NIBP Parameter Connecting the Cuff and Hose sennamiionunssinasnin inae aA Suggested Application Sites Connect THE Cum and HOE c 5 2 Verifying the Initial Cuff Inflation Pressure s ssssssssssssseesssseseesssssseessnsseecsnssseeensssetecsnsseeeensseteesnnsteeenssseteesnstteensseteesnsstteesssnetees 5 3 Taking NIBP Meas remenrts c irit tre te HR RETREAT HOHER IH EM PPA E MR Ce EROS FEES Ee RR ES
72. two minutes The L2A2 LED on the key flashes during the two minute time out To silence the alarm and alert tones indefinitely Press and hold for about three seconds The 929 LED lights steady and you will hear a beep To silence the alarm and alert tones for two minutes Momentarily press Q the eO LED flashes If tones are already silenced press Q twice the first press cancels alarm silenced the second press silences the alarms for two minutes To cancel either two minute or indefinite alarm silence and enable alarm and alert tones Momentarily press Q the G9 LED turns off System Alert Condition Low Battery A low battery condition will be detected when the battery has about 30 minutes remaining When the condition is detected The LED is illuminated This message remains displayed until the monitor is connected to power A unique alert tone a burst of 5 beeps at mid volume sounds as soon as the low battery condition is detected and every 30 seconds thereafter while the condition persists The volume of the low battery alert tone is not adjustable The low battery audible cannot be disabled by the key V6004 Operation Manual 4 3 Chapter 4 Alarms and Alerts Audible and Visual Indicators Each audible indicator is assigned a priority level so only one tone sounds at a time The monitor also provides visual indication of alarm conditions via on screen displ
73. ual Chapter 5 Non Invasive Blood Pressure Verifying the Initial Cuff Inflation Pressure NOTE The NIBP parameter uses a special method for determining the cuff inflation pressure For details on this method see Application Note NIBP Cuff Inflation Method later in this chapter 1 Verify that the cuff is on the correct setting To access the initial cuff inflation pressure setting press and hold the 2 key for 3 seconds Either 5H for all cats and dogs under 10 Ibs or LR for all dogs and animals other than cats 10 Ibs or larger will display in the systolic area of the screen Use the arrow key to adjust between 5H and LA Mode 2 Press the 2 key again to see the current initial cuff inflation pressure for the patient Use the arrow key to adjust the initial cuff inflation pressure Taking NIBP Measurements Decide which measurement mode you want to use Manual In the Manual mode a single NIBP measurement is taken when Q is pressed Automatic In the Automatic mode NIBP measurements are taken at regular intervals according to the interval setting when MANUAL AUTO is pressed and INTERVAL selected Stat In the Stat mode five minutes of successive NIBP measurements are taken when AM is pressed Manual NIBP Measurement In Manual mode a single NIBP measurement is taken when gt is pressed 1 If the unit is in Auto mode press the 525 key to place the unit in Manual mode The INTERVAL display section will per
74. ut using AC power supply whenever possible to Charging the Battery section and Maintenance Chart of Chapter 9 Changed Appendix A to Chapter 11 Supplies and Accessories and updated parts list Changed Appendix B to Chapter 12 Specifications Added this Revision History V6004 Operation Manual m Manufactured By Smiths Medical PM Inc N7W22025 Johnson Drive Waukesha WI 53186 1856 USA
75. vice may be adversely affected in the presence of conducted transients or strong electromagnetic EM or radiofrequency RF sources such as electrosurgery and electrocautery equipment x rays and high intensity infrared radiation Do not plug the monitor into an outlet controlled by a wall switch This device is intended for use by persons trained in veterinary health care The operator must be thoroughly familiar with the information in this manual before using the monitor This device must be used in conjunction with clinical signs and symptoms This device is only intended to be an adjunct in patient assessment If the accuracy of any measurement is in question check the patient s vital sign s by an alternative method and then check the monitor for proper functioning The monitor should not be used in the presence of electrosurgical equipment The device has no protective mechanisms to prevent patient burns when used with high frequency surgical equipment Equipment is protected against defibrillator discharge Rate meters and displays may be temporarily affected during defibrillation but will rapidly recover V6004 Operation Manual 1 3 Chapter 1 Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING The vital signs monitor is suitable for use within the patient environment IEC 60950 approved equipment must be placed outside of the patient en
76. vironment The patient environment is defined as any volume in which intentional or unintentional contact can occur between the patient and parts of the system or between the patient and other persons touching parts of the system Figure 1 1 Patient Environment Dimensions are not prescriptive M 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 950 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 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 Any monitor that has been dropped or damaged should be checked by qualified service personnel to insure proper operation prior to use This monitor will not operate effectively on patients who are experiencing convulsions or tremors Patient safety can be compromised by the use of a power supply not supplied by Smiths Medical PM Inc Use only the power supply included with your monitor or one approved by Smiths Medical PM Inc Disconnect the AC power
77. w with a trailing d decimal point e INTERVAL In Auto NIBP mode alternates between the NIBP interval and the time since the last NIBP reading Q Pulse Strength Bargraph Indicates the patient s pulse activity and strength The bargraph is logarithmically scaled to indicate a wide range of pulse strengths Side Panel Figure 2 4 Monitor Side Panel bcm CONNECTOR DESCRIPTION 0 NIBP Connector The NIBP hose is connected here SpO Connector The oximeter sensor and or the extension cable is connected here V6004 Operation Manual 2 3 Chapter 2 Intended Use and General Information Figure 2 5 Keys o g e SYS mmHg DIA mmHg 9oSpO Mul WARNING Verify that all LEDs light emitting diodes on the display light up upon startup of the device Keys e ra e MAP mmHg bpm M KEY NAME DESCRIPTION 98 ON OFF Press this key turns the monitor ON and OFF ea START Press this key to start a manual NIBP measurement or when in a user menu to save current settings and exit ALARM SILENCE Press this key to disable the audible alarm tone for two minutes Yellow silence G3 LED flashes Pressing and holding this key for about three seconds disables the alarm tone indefinitely Yellow silence 9230 LED is lit an
78. with greater tissue thickness 3 Testing the reflectance sensor is performed in the same manner but it should be pressed between thumb and index finger or into the palm of your hand V6004 Operation Manual 6 7 Chapter 6 Using the Oximeter Option Primary Applications for Sensors Lingual Sensor Lingual and Mini Clip 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 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 Reflectance Sensor In most animals wet and part the fur at the ventral tail base and non adhesive tape not tape in place It 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 sen
79. ws a pulse strength bar if the oximeter is installed Is on steady while external power is applied and battery is fully charged Indicates battery is charging by blinking very slowly while external power is applied If there is no external power then this LED is off Silence LED yellow This Silence LED flashes during two minute alarm silence Stays on steady during AO indefinite alarm silence ALERT LED yellow The Alert LED is illuminated during a system alert AAA SENSOR is illuminated when the sensor is not connected to the monitor the sensor is not attached to the patient or to indicate a searching too long warning WARNING While SENSOR is illuminated the monitor cannot SENSOR LED yellow measure the patient s SpO or pulse rate You must immediately check the patient s condition After you have checked the patient s condition you must correct the SENSOR low priority alarm alert The low battery indicator is illuminated and a short burst of beeps occurs when about 30 minutes of battery use remains The monitor will work until the battery becomes very weak after which the monitor will turn itself off WARNING When f is illuminated you must immediately charge the monitor s battery Otherwise the monitor turns itself off after about 30 minutes When light is illuminated the NIBP function is in the Smaller Animal Mode This is the suggested mode for animals under 10 pounds Wh
80. xamine the patient for signs of injury and ensure proper cuff placement WARNING Blood pressure measurements may not be accurate for patients experiencing moderate to severe arrhythmias Oximetry Warnings WARNING Use only SpO sensors supplied with or specifically intended for use with this device WARNING Incorrectly applied sensors may give inaccurate readings Refer to the sensor insert for proper application instructions 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 SpO 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 animal s skin lack of skin respiration not heat causes the blisters V6004 Operation Manual 1 5 Chapter 1 Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING General CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION 1 6 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 vascula

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