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Chapter 15: Specifications

15-6

Operation Manual SurgiVet

V3404 Plus

List of Applicable Standards

EN60601-1/IEC601-1/UL2601/CSA601-1

Reviewer’s Guidance, NOV. 93

EN60601-1-2 (EMC)

IEC601-2-27 (ECG)

AAMI EC-13 (ECG)

EN865 (SpO2)

EN475 (alarms)

prEN1441 (risk analysis)

HE48 Human Factors AAMI Standard

Equipment Classification

Type of Protection:

Class II with functional ground & Internally Powered

Degree of Protection:

Type CF (SpO

)

(Against Electric Shock) Type CF defib protected (ECG)
Mode of Operation:

Continuous

Degree of Protection:

IPX1, drip proof (Against Ingress of Liquids)

Degree of Mobility:

Portable

Safety Requirements:

EN60601-1: 1990

Calibration

Factory calibrated over the range of 50% to 100% SpO

. All accuracy claims are based on testing the subject

monitor on healthy adult volunteers in desaturation studies across the specified range of functional saturation.
Test methods will be made available upon request. No in-service calibration is required.

•

Содержание SurgiVet V3404 Plus

Страница 1: ...SurgiVet V3404 Plus ECG Pulse Oximeter Respiration Temperature Operation Manual English Catalog Number V1888TR Version 2 August 2007 2007 Smiths Medical family of companies All rights reserved RR m 25 ...

Страница 2: ......

Страница 3: ...s Cautions and Notes 1 6 Respiration Temperature Warnings Cautions and Notes 1 7 Chapter 2 Description of Measurements Controls and Features 2 1 Intended Use 2 1 General Description 2 1 Front Panel 2 2 EL Display 2 3 Keys 2 4 Side Panel 2 5 Rear Panel 2 5 Chapter 3 Setting Up the Monitor 3 1 Unpacking the Monitor and Checking the Shipment 3 1 Turning High and Low Priority Alarm Tones On and Off 3 ...

Страница 4: ...ECG Leads to the Patient 5 3 Attaching the Patient 5 3 ECG Display 5 4 ECG Menu 5 5 ECG Messages 5 6 Alarm Messages 5 6 Status Message 5 6 Chapter 6 Oximetry 6 1 General Description 6 1 Pulse Oximetry Theory of Operation 6 1 Patented Technology 6 2 Oximeter Display 6 2 Oximeter Menu 6 3 Adjusting the Pulse Beep Volume 6 3 Adjusting or Viewing the Averaging Settings 6 4 Oximeter Messages 6 4 High P...

Страница 5: ...spiration Display 7 2 Chapter 8 Temperature 8 1 Temperature Theory of Operation 8 1 Temperature Menu 8 1 Setting up Temperature Monitoring 8 1 Attaching the Patient 8 1 Units 8 1 Alarms 8 2 Messages 8 2 Chapter 9 Trends 9 1 Trends Menu 9 2 Chapter 10 Serial Output 10 1 Serial Out Menu 10 1 Serial Output Setup for RS 232 Connections 10 2 Serial Output Setup for Graphics Printer 10 4 Output Examples...

Страница 6: ...ter and Serial Interface 15 4 Trend Storage 15 4 Sound Control 15 4 Brightness Control 15 4 Analog Outputs 15 4 Digital Alarm Output to Remote Sensing Location Nurse Call 15 4 Power 15 4 Environment 15 5 Physical 15 5 Display 15 5 Keypad 15 5 List of Applicable Standards 15 6 Equipment Classification 15 6 Calibration 15 6 Appendix A Guidance and Manufacturer s Declaration A 1 Guidance and Manufact...

Страница 7: ... 096 and 5 615 091 BCI SurgiVet and the Smiths design mark are trademarks of the Smiths Medical family of companies The symbol 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 ...

Страница 8: ...Table of Contents vi Operation Manual SurgiVet V3404 Plus This page is intentionally left blank ...

Страница 9: ...iginal 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 disposa...

Страница 10: ...om 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 ne...

Страница 11: ...eturn N7W22025 Johnson Drive Waukesha WI 53186 Clinical Support Telephone 1 262 513 8500 Toll Free 1 888 745 6562 USA only 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 informatio...

Страница 12: ...Warranty and Service Information Operation Manual SurgiVet V3404 Plus This page is intentionally left blank ...

Страница 13: ...llow warnings cautions and instructions could result in death or serious injury to the patient Definition of Symbols symbol definition 6 Caution Federal U S A law restricts this device to sale by or on the order of a licensed veterinarian 2 Attention see instructions for use 7 Refer servicing to qualified service personnel q Defibrillator proof type CF equipment q Type CF equipment T Class II devi...

Страница 14: ...adversely affected in the presence of computed tomograph CT equipment WARNING Do not plug the monitor into an outlet controlled by a wall switch WARNING This monitor is NOT for use in the home WARNING This device is intended for use by persons trained in professional health care The operator must be thoroughly familiar with the information in this manual before using the monitor WARNING This devic...

Страница 15: ...yone 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 WARNING In the event that earth ground integrity is lost the performance of this device and or other devices nearby may be affected due to excessive RF emissions WARNING The mon...

Страница 16: ...g the patient unattended WARNING Verify that all LEDs light emitting diodes on the display light up upon startup of the device WARNING Do not autoclave ethylene oxide sterilize or immerse in liquid Unplug before cleaning or disinfecting CAUTION Pressing front panel keys with sharp or pointed instruments may permanently damage the keypad Press front panel keys only with your finger CAUTION Should t...

Страница 17: ...ot heat causes the blisters WARNING 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 SpO2 reading WARNING Any condition that restricts blood flow such as use of a blood pressure cuff or extremes in systemic vascular resistance may cause an inability to determine accurate pulse and...

Страница 18: ...emaker patients the heart rate readouts derived from the ECG patient connections are likely to display erroneous high or erratic rates Keep pacemaker patients under close surveillance For pacemaker patients it may be advisable to select the SpO2 parameter as the primary heart rate source WARNING Connect only three lead or five lead ECG lead wires from the patient to the ECG patient cable Do not co...

Страница 19: ...anual SurgiVet V3404 Plus 1 7 Respiration Temperature Warnings Cautions and Notes WARNING The monitor may not detect all episodes of inadequate breathing NOTE Use only sensor supplied with specifically intended for use with this device ...

Страница 20: ...Chapter 1 Introduction 1 8 Operation Manual SurgiVet V3404 Plus This page is intentionally left blank ...

Страница 21: ...on all monitored parameters except for temperature ECG The monitor continuously measures and displays an ECG waveform Either 3 or 5 lead monitoring may be selected The monitor beeps with each heartbeat The volume of the heartbeat is adjustable The pitch of the heartbeat varies with the heart rate value Oximeter The monitor continuously measures and displays arterial blood oxygen saturation SpO2 an...

Страница 22: ...ent trends alarm or alert messages and temperature and or respiration values The display also shows menus and a pulse strength bar Display LED s The display LED s provide continuous real time updates of oximetry values SpO2 and pulse rate p If the p source is set to ECG in the SETUP VOLUME menu the display LED for p will show a heart rate value Charge LED green Is on steady while external power is...

Страница 23: ...ame line then they alternate once per second Waveforms Trends Menus One or two waveforms are displayed here A trend graph or a menu can be displayed in place of waveforms Alarm Silence Indicator Flashes during two minute alarm silence Stays on steady during indefinite alarm silence If alarms are not silenced the indicator stays on steady and appears without the slash Temperature Respiration Temper...

Страница 24: ...the audible alarm tone for two minutes The Alarm Silence indicator on the EL display flashes Pressing and holding this key for about three seconds disables the alarm tone indefinitely The Alarm Silence indicator on the EL Display is lit and not flashing The indicator appears with a slash through it Pressing this key momentarily cancels either alarm silence condition The monitor defaults to two min...

Страница 25: ...connected here Temperature Connector The temperature cable is connected here Rear Panel Figure 2 6 Rear Panel Power Input The external power supply attaches to this connector NOTE Connect the AC charger to the AC power connector of the monitor first and then the AC charger to the wall outlet second 1617 Charger AC 105 125V 60 Hz 1618 Charger AC 208 264V 50 60 Hz 1619 Charger AC 90 110V 50 Hz ECG q...

Страница 26: ...he monitor during use secure the cord to the monitor several inches from the connection CAUTION Ensure the device s AC rating is correct for the AC voltage at your installation site before using the monitor The monitor s AC rating is shown on the external power supply If the rating is not correct do not use the monitor contact Smiths Medical PM Inc Veterinary Division service department for help D...

Страница 27: ...nes are already silenced press B 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 B the Alarm Silence indicator turns off Working With Menus Menu Structure Alarm Set SpO2 High and Low Alarms Set Pulse Rate High and Low Alarms Set Respiration Ra...

Страница 28: ...will return and any current menu selections will be accepted Freezing and Releasing Displayed Waveforms Displayed waveforms except trends can be frozen and released quickly To freeze or release waveforms press the b key twice x2 The first key press displays the Main Menu The second key press selects the first item in the Main Menu which is FREEZE WAVE This automatically exits to the waveform scree...

Страница 29: ...t rate NOTE Disabling the ECG parameter also disables Respiration Respiration RR M Oximeter Plethysmogram SpO2 pulse rate pulse strength Temperature C F When turned off displays indicators and alarms related to the parameter are disabled The parameter occupies a space on the display and in the serial output but its value is shown as dashes If the parameter is assigned to an analog channel that cha...

Страница 30: ...arameter s trend display scales can be adjusted separately through the TRENDS SCALES menu Adjusting the Line Filter Parameter The line filter needs to be adjusted based on the frequency of the line voltage being supplied to the monitor For 50Hz line voltage frequency select the 50Hz line filter option For the 60Hz line voltage frequency select the 60Hz line filter option The line filter frequency ...

Страница 31: ...tient s measured SpO2 is 90 a high priority alarm is triggered During a high priority alarm Figure 4 1 Alarm Example The High Priority ALARM indicator flashes red The digits for the violated alarm limit flash A message is displayed subject to the display priority The High Priority Alarm tone sounds if not silenced NOTE The alarm actions occur for each violated alarm even if more than one alarm is ...

Страница 32: ...alarm LED yellow flashes A message is shown on the display will alternate with other messages Dashes indicate the measurement is unavailable The low priority alarm tone sounds if not silenced Working With the Alarms Menu This section describes working with alarms using the ALARMS menu For information on the parameter menus refer to the chapter of the manual that describes the parameter Figure 4 3 ...

Страница 33: ...sound at the same volume The volume can be adjusted in the SETUP VOLUME menu The volume can not be set to OFF All alarm tones can be silenced NOTE Information signals i e Low Battery cannot be silenced Turning Alarm Tones On and Off When the monitor is turned on the alarm tones are silenced for two minutes The Alarm Silence indicator on the EL Display flashes during the two minute time out To sile...

Страница 34: ...until the monitor is connected to power The low priority alarm LED is lit A unique tone a burst of 5 beeps 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 tone is equal to or greater than the alarm volume setting The low battery audible cannot be disabled by the B key Permanent Silence When the monit...

Страница 35: ...e source WARNING Connect only three lead or five lead ECG lead wires from the patient to the ECG patient cable Do not connect any other signal source to the ECG patient cable WARNING False low heart rate indicators or false Asystole calls may result with certain pacemakers because of electrical overshoots WARNING Reliable monitoring of pacemaker patients can only occur with the pace detect on WARN...

Страница 36: ...r The remainder of this chapter assumes the monitor is installed and turned on The ECG parameter can be turned on or off in the ECG menu To ensure the ECG parameter is on press the b key Use the ARROW no keys to highlight the ECG option Press the b key again to enter the ECG menu Use the ARROW no keys to highlight the ECG Monitor option and confirm the option is set to YES Calibration Waveform The...

Страница 37: ...The ECG cable uses a standard AAMI three lead or five lead ECG connector Use only standard AAMI three lead or five lead ECG wires NOTE The ECG patient circuit is electrically isolated NOTE The monitor is protected against damage from defibrillator diathermy and electrocautery discharge NOTE To remove the ECG cable grip the connector and pull back firmly DO NOT pull on the ECG cable to remove the E...

Страница 38: ... lead label The following lead selections are available I II III aVR aVL aVF and V Heart Rate p The heart rate is shown if ECG is selected as the bpm source in the SETUP VOLUME menu Messages ECG alarm and alert messages appear on the first line of the message area at the upper left of the display If more than one message is to be displayed the messages will alternate at a rate of about one per sec...

Страница 39: ... has a pacemaker All pacemaker pulses as specified by AAMI are detected or rejected in the ECG waveform when PACE DETECT is turned ON An artificial pulse is added to all displayed ECG waveforms marking the pacemaker discharge The monitor defaults OFF so if you have a patient with a pacemaker you will have to turn ON the PACE DETECT option WARNING False low heart rate indicators or false Asystole c...

Страница 40: ...ment is equal to or higher than the high ECG alarm limit x is the high alarm limit setting ECG BPM x Indicates the ECG measurement is equal to or lower than the low ECG alarm limit x is the low alarm limit setting ASYSTOLE This high priority alarm is generated and the text is displayed in the parameter box when all ECG lead are connected to the patient ECG processing is turned on and no ECG QRS si...

Страница 41: ... 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 Low intensity Red and Infrared LED light sources Detector Oximetry processes these signals separating the time invariant parameters tissue thickness skin color light...

Страница 42: ...graph should be shown NOTE If measurements are not shown check the patient attachment to make sure it is applied correctly Also check for oximeter messages in the alarm and alert message area and see Oximeter Messages later in this chapter for help Plethysmogram The plethysmogram is shown assuming it is assigned to a trace Press the a key to assign the plethysmogram to a trace SpO2 Measurement The...

Страница 43: ...TE Turning off the SpO2 parameter turns off the plethysmogram SpO2 pulse rate and pulse strength measurements Adjusting the Pulse Beep Volume Select SET VOLUME from the Main menu Under VOLUME select the PULSE item Press the b key to select the item Use the ARROW keys no to adjust the pulse volume A visual graph displays the pulse volume level Press b to set the value NOTE The pulse beep sounds whi...

Страница 44: ...ter messages are shown on the second line of the message area at the upper left of the display If there are several messages to be displayed then they alternate showing one message every second High Priority Alarm Messages SpO2 x Indicates the SpO2 measurement is equal to or higher than the high SpO2 alarm limit x is the high alarm limit setting SpO2 x Indicates the SpO2 measurement is equal to or...

Страница 45: ...ates the oximeter is adjusting to the patient s signal If this message persists check for proper sensor positioning on the patient Small Pulse Indicates the oximeter signal strength is low Try repositioning the sensor on the patient or warming the extremity to encourage blood flow Attaching the Patient Oximetry Choose the Sensor Patient Site Catalog No Description Small Medium Animal up to 60 poun...

Страница 46: ...ght with the detector so they are less than 1 8 inch away from each other Make sure the SpO2 SENSOR message is displayed on the message area of the EL Display 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 W...

Страница 47: ...sitioned centrally Moisten the fur and parting at the application site or shaving a small area is required The sensor works best on medium to large sized patients Figure 4 5 Attaching the Sensor to the Animal For best results while using the reflectance sensor V1700 apply to the base of the tail This sensor can also be used rectally if needed When using either of the reflectance sensors ultrasound...

Страница 48: ...d 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 SpO2 and pulse rate should appear in a short period of time 10 15 seconds Testing the C sensor is performed in the same manner This is a stronger sensor and can be used with greater tissue thickness Testing the tail wrap a...

Страница 49: ...ine 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 desir...

Страница 50: ...Chapter 6 Oximetry 6 10 Operation Manual SurgiVet V3404 Plus This page is intentionally left blank ...

Страница 51: ...monitoring settings Figure 7 1 Respiration Menu Using the Respiration Parameter If not familiar with this monitor and the Respiration parameter follow this chapter s sections in order Setting Up Respiration Monitoring Ensure the respiration parameter is enabled RESP MONITOR Indicates whether the respiration parameter is enabled or disabled Allows the respiration parameter to be turned on or off Th...

Страница 52: ...Connect the airway adapter to the endotracheal tube and breathing circuit Tracheal Tube Airway Adapter Respiration Sensor and Cable V3422 Breathing Circuit Figure 7 2 Tracheal Tube and Adapter Respiration Display Figure 7 3 Respiration Display Respiration Measurement The respiration measurement is shown Dashes indicate the measurement is invalid or unavailable This portion of the display alternate...

Страница 53: ... there is no valid temperature reading Setting up Temperature Monitoring Ensure the temperature parameter is enabled The temperature parameter can be turned on or off in the TEMPERATURE menu To ensure the temperature parameter is on press the b key Use the ARROW o n keys to highlight the TEMPERATURE option Press the b key again to enter the temperature menu Use the ARROW o n keys to highlight the ...

Страница 54: ...arms Warning There are no temperature alarm limit settings There are no alarms on temperature measurements Messages TEMP SENSOR If the temperature parameter is enabled this message is displayed in the upper left message area when the temperature probe is not attached ...

Страница 55: ... minutes or hours Gaps will appear in the trend graph for the length of time the monitor has been off or the parameter data has been invalid Trended Parameter The name of the trended parameter is displayed here Trended parameters are the following signal respiration SpO2 pulse and temperature Trend Time The time scale of the trend is displayed here Trend data and time are continuously updated When...

Страница 56: ...r The scale for oximeter signal strength is not selectable CLEAR Select Yes to erase trend memory Trend data will not be lost if this selection is set back to No before EXIT is selected or the menu times out NOTE Yes means all trended data will be erased when the trend menu is exited or allowed to time out NOTE If trends are not cleared trend data is remembered at power down Sp02 SENSOR TIME 1hr S...

Страница 57: ...cs SWEEP SPEED If the BCI printer has been selected this shows the paper speed WARNING When connecting this monitor to any instrument verify proper operation before clinical use Refer to the instrument s user manual for full instructions Accessory equipment connected to the monitor s data interface must be certified according to the respective IEC standards i e IEC 950 for data processing equipmen...

Страница 58: ...progress so proceed with step 2 Otherwise START PRINT YES and you must select NO to halt the current output before the serial output data settings can be changed To change the data format Patient Data or Trend Tables Use the ARROW keys no to point to the DATA FORMAT item then press b Use the ARROW keys no to switch between formats When the format changes the menu item below it changes Press b to a...

Страница 59: ... to exit menus If serial output is in progress exiting menus will not stop it To STOP serial output Select SERIAL OUT from the main menu Set START PRINT to NO NOTE Serial output is always disabled when the monitor is powered off then on but the format and times are remembered NOTE If printing trend tables START PRINT changes to STOP PRINT until all trend data is printed When all data is printed se...

Страница 60: ... no to switch between formats When the format changes the menu item below it changes Press b to accept the selection If PATIENT DATA is selected the menu item displayed below it is INTERVAL Figure 9 4 Serial Out Menu Patient Data BCI Printer To change the output INTERVAL Use the ARROW keys no to point to INTERVAL then press b Use the ARROW keys no to change the value Press b to accept the selectio...

Страница 61: ...se the ARROW keys no to select the desired print speed then press b When the output format has been chosen press waveform key on BCI printer to start waveform printing or SpO2 key for text printing Select EXIT or press a to exit menus If serial output is in progress exiting menus will not stop it To STOP serial output Select SERIAL OUT from the main menu Set STOP PRINT to NO NOTE Serial output is ...

Страница 62: ...interval between tables is selected in the SERIAL OUT menu Each line of text in the patient data table ends with a carriage return line feed Sample Output RS 232 Source Optional BCI Printer A real time Patient Trace is recorded Sample Output BCI Printer Figure 9 7 Real Time ECG Pleth Traces Figure 9 8 Real Time Pleth Waveform Figure 9 9 Real Time ECG Trace PATIENT DATA Patient_____________________...

Страница 63: ...s data from days ago might be printed because trend data is remembered when the monitor is turned off For this reason time stamps are stored and output along with trended parameter data Each line of text in the trend tables ends with a carriage return line feed Each new block of many trend data records has the following title information Trend data records will be output as follows Trend Table Pat...

Страница 64: ...Chapter 10 Serial Output 10 8 Operation Manual SurgiVet V3404 Plus This page is intentionally left blank ...

Страница 65: ... 1Volt Figure 10 1 Analog Out Menu To select the data to be output to any analog channel Select ANALOG OUT from the Main Menu Use the ARROW keys no to select the channel number 1 or 2 Then press b Use the ARROW keys no to select the desired parameter ECG Waveform Plethysmogram SpO2 Heart Rate Resp Rate Temperature Press b to accept the value Select EXIT or press a to exit the menu 1 2 3 4 5 RR m 2...

Страница 66: ...Chapter 11 Analog Output 11 2 Operation Manual SurgiVet V3404 Plus This page is intentionally left blank ...

Страница 67: ...When attaching a new patient Respiration Sensor Clean or disinfect When attaching a new patient ECG Electrodes Disposable discard after single patient use When attaching a new patient Charging the Battery Charge the battery after the monitor is used under battery operation when the LOW BATTERY message is displayed or after long term storage Connect the external charger to the back of the monitor V...

Страница 68: ...04 Plus Long Term Storage Storage Facility Indoor Temperature 40 to 75 C 40 to 167 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 ...

Страница 69: ...xternal charger disconnected Connect charger No pulse registering on bargraph Sensor or patient cable disconnected from monitor Sensor incorrectly positioned Poor patient perfusion Defective sensor or patient cable Check connections to patient cable and sensor Reposition sensor on patient Reposition sensor on patient Try a new sensor or contact Smiths Medical PM Inc Veterinary Division service dep...

Страница 70: ...f the monitor is still not functioning properly contact Smiths Medical PM Inc Veterinary Division service department for help Smiths Medical PM Inc Veterinary Division N7W22025 Johnson Drive Waukesha WI 53186 1856 Phone 262 513 8500 Toll Free 888 745 6562 Fax 262 513 9069 ...

Страница 71: ...404 Plus Operation Manual each 3049 Adhesive Strips 40 pkg 3106 Cable ECG 3 lead each V3110 ECG Shielded leads 40 safety type wires veterinary 3 lead each 3311 Cable Oximetry 1 5 meters 5 feet each 3356 IV Pole Bracket each 3357 Stack Bracket each 3361 Cable Printer Seiko each 3362 Cable PC Interface each 3368 Roll Stand with Mounting Bracket each 3371 Graphics Printer Interface each 3406 Cable EC...

Страница 72: ...Chapter 14 Supplies and Accessories 14 2 Operation Manual SurgiVet V3404 Plus This page is intentionally left blank ...

Страница 73: ...tion Factory calibrated over 50 to 100 SpO2 using human blood samples to functional saturation Test methods available upon request No in service calibration required Alarm Ranges Low 50 100 steps 1 and Off High 50 100 steps 1 and Off At power up low SpO2 limit will default to 85 if the low SpO2 limit was set to less than 85 Display 3 digit 0 56 inch high LED s update rate 1 Hz Averaging 4 8 16 Fas...

Страница 74: ...dard Limb Lead Configuration aVR aVL aVF and V Gain X1 X2 X4 X8 Input Range 5 0mV to 5 0mV DC Offset Voltage 300mV to 300mV Frequency Response 0 5Hz to 40Hz Input Impedance 5 Mohms differential as required and tested by ANSI AAMI EC 13 System Noise max 30µV p p CMRR 100db 50 60Hz Leakage Current 10µA Patient Isolation 4000VAC Pace Detect Yes minimum pulse amplitude of 3 mV Pace Reject Yes Sweep Sp...

Страница 75: ...ry or indefinite status SpO2 Sensor SpO2 Sensor message indicates an oximeter sensor problem Audible will sound if not silenced yellow ALERT LED continuously lit SpO2 Search SpO2 SEARCH message indicates that device is searching for pulse Artifact ARTIFACT message informs operator about excess of artifacts ECG Lead Fail ECG LEAD FAIL message indicates a lead off condition or ECG amplifier overload...

Страница 76: ...lethysmogram Generic Printing There will be the option to send text data to any RS 232 port Trend Storage Parameters SpO2 Pulse Rate Heart Rate Signal Strength Respiration and Temperature Interval 30 sec non adjustable Capacity 12 hours of storage Sound Control Pulse Beep Volume 15 levels of volume and off Alarm Beep Volume 15 levels of volume and silenced Sound level less than 85dBA Brightness Co...

Страница 77: ...dance for respiratory devices and EN60601 1 2 Safety IEC 601 1 CSA 125 UL 544 and UL2601 Physical Size Width 254 mm 10 inches Height 88 9 mm 3 5 inches Depth 139 7 mm 5 5 inches Weight Approximately 2 27 kg 5 0 pounds Handle on top for portability Display Six LED displays Green CHARGE LED Red ALARM LED Yellow ALERT LED 160 by 80 pixels EL Electroluminescent graphics panel Keypad Device ON OFF x Me...

Страница 78: ...ally Powered Degree of Protection Type CF SpO2 Against Electric Shock Type CF defib protected ECG Mode of Operation Continuous Degree of Protection IPX1 drip proof Against Ingress of Liquids Degree of Mobility Portable Safety Requirements EN60601 1 1990 Calibration Factory calibrated over the range of 50 to 100 SpO2 All accuracy claims are based on testing the subject monitor on healthy adult volu...

Страница 79: ...e its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The V3404 Plus is suitable for use in all establishments including Domestic establishments Establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 NA Vol...

Страница 80: ... 25 kV to 1 kV for input output lines Surge IEC 61000 4 5 IEC 60601 TEST LEVEL 1 kV differential mode 2 kV common mode COMPLIANCE LEVEL 1 kV differential mode 2 kV common mode Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 IEC 60601 TEST LEVEL 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95...

Страница 81: ...iance level in each frequency range b CAUTION Interference may occur in the vicinity of equipment marked with the following symbol 4 Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed RF transmitters su...

Страница 82: ...mitter Meters 150 kHz to 80MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 035 0 07 0 1 0 38 0 11 0 22 1 1 2 0 35 0 7 10 3 8 1 1 2 2 100 12 3 5 7 0 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum ...

Страница 83: ... Added caution about certain cleaning agents causing brittle plastic Added notes about alarm limits being retained through power cycles to Chapter 4 Added note about testing the alarms while the monitor is in use Updated Pulse Oximetry Theory of Operation in Chapter 6 Added paragraph about autocorrelation to Chapter 6 Added notes about SpO2 averaging Updated sensor chart in Chapter 6 Updated senso...

Страница 84: ...Appendix B Revision History B 2 Autocorr Plus Operation Manual This page is intentionally left blank ...

Страница 85: ......

Страница 86: ...H Manufactured By Smiths Medical PM Inc Veterinary Division N7W22025 Johnson Drive Waukesha WI 53186 1856 Phone 262 513 8500 Toll Free 888 745 6562 U S A only Fax 262 513 9069 Website www surgivet com ...

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