SunTech Vet30E, User Manual

Page 1: ...Continuous Vital Signs Monitor for Animals User Manual ...

Page 2: ...er which they may not be copied in whole or in part without written consent of SunTech Medical The information in this manual is furnished for guidance only is subject to change without notice and should not be construed as a commitment by SunTech Medical SunTech Medical assumes no liability for errors or inaccuracies that may appear in this manual 2019 SunTech Medical All rights reserved Other of...

Page 3: ...for selection of settings The device uses a microprocessor with software which is not accessible to the user The unit is powered by a single rechargeable lithium ion battery at the bottom of the device Bluetooth can be used to wirelessly connect and send data to a PC application which may be downloaded from the SunTech website at https www suntechmed com Vet30E data capture Upper and lower alarm l...

Page 4: ...sical condition and use outside of the operating instructions detailed in this guide The interpretation of BP and oxygen saturation measurements should only be made by a veterinarian AccuVet SpO2 Module Use only AccuVet SpO2 sensors supplied by SunTech Medical Masimo SET SpO2 Module Use only original Masimo SpO2 sensors and cables Check the application site of the SpO2 sensor frequently to confirm...

Page 5: ...erature Measurement 24 7 SpO2 Measurement 24 7 1 Masimo Pulse Oximetry 25 7 2 AccuVet Pulse Oximetry 28 7 3 Heart Rate Measurement 29 8 Reviewing and Transferring Data 29 8 1 Viewing Stored Measurements 29 8 2 Averaging Measurements 30 8 3 Bluetooth Connection 30 8 4 Data Transfer 31 8 5 Reviewing Data and Creating Reports 31 9 Alarms 33 9 1 Technical Alarms 33 9 2 Clinical Alarms 34 10 Taking Car...

Page 6: ...ssurization of the cuff can temporarily cause loss of functionality of SpO2 if simultaneously using device on the same limb WARNING DO NOT use if device is dropped and or is damaged Have a qualified service representative check the unit before using again Repairs should only be conducted by an authorized SunTech Medical service representative WARNING Before performing a procedure when device is no...

Page 7: ...e undertaken only by personnel trained or authorized by SunTech Medical CAUTION DO NOT sterilize this device CAUTION Too frequent measurements may cause injury to the patient due to blood flow interference CAUTION At the end of product life the monitor accessories components and other consumable goods may become contaminated from normal use Consult local codes and ordinances for proper disposal of...

Page 8: ...ON To minimize radio interference other electrical equipment that emits radio frequency transmissions should not be in close proximity to the pulse oximeter 2 Icons and Symbols Some of the symbols listed in the table below refer to the following FDA SDO Consensus standards Recognition 5 103 ISO 7000 2014 Graphical symbols for use on equipment Registered symbols Recognition 5 116 ISO 7010 2011 Grap...

Page 9: ...7000 2493 Type BF Applied Part IEC 60417 5333 Fragile handle with care ISO 7000 0621 Humidity Limits ISO 7000 2620 Temperature Limits ISO 7000 0632 Keep Dry ISO 7000 0626 Accesses Settings screen SunTech Design Small animal mode SunTech Design Large animal mode SunTech Design Equine mode SunTech Design Opens the Icon Menu SunTech Design Begins Interval BP Mode SunTech Design Adjusts volume SunTech...

Page 10: ...llowing diagram 3 2 Device Placement WARNING As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation CAUTION Do not position the monitor so that it is difficult to access and remove the AC adapter from the electrical supply mains The power supply is the means of disconnection to the supply mains Bluetooth Bluetooth Begins dat...

Page 11: ... adapter into a power supply to begin charging the battery Only use AC Adapter supplied by SunTech Medical WARNING The AC adapter must be unplugged and the battery must be disconnected in order to completely disconnect device from power See Section 10 2 for information on battery disconnection 2 Connect the patient hose to the back of the monitor making sure the connector clicks into the locking p...

Page 12: ...n on how to take a temperature measurement see Section 6 4 Connect SpO2 Sensor A AccuVet SpO2 Plug AccuVet SpO2 Y lingual Sensor Reflectance Sensor or extension cable into the back of the monitor Lift retaining clip in place If applicable attach sensor to extension cable and lock plastic hinged cover to prevent accidental disconnection For additional information on how to take an SpO2 measurement ...

Page 13: ...et30E and insert b Attach the M LNC Patient Cable connector to an M LNCS reusable sensor connector Orient sensor connector 1 to patient cable connector 2 as shown Insert sensor connector 1 completely into patient cable connector 2 Close sensor connector cover 3 over patient cable connector until it locks in place For additional information on how to take an SpO2 measurement see Section 7 AccuVet S...

Page 14: ...tionally the animal mode can be toggled using the animal selection icon on the Main screen Main Screen After you begin using your Vet30E your main screen will display your most recent patient measurements Here is a quick overview of the key symbols and numeric values you will see Prior to the first reading upon power on the screen will display dashes instead of values Battery life indicator Size o...

Page 15: ...For more information on Interval BP Mode see Section 5 4 8 Bluetooth Connect For more information on Bluetooth connection see Section 8 3 9 Data Transfer For more information on reviewing and transferring data see Section 8 Focus Screens For more detailed information on temperature BP or SpO2 touch the in the top left corner of the measurement section This expanded view provides a more detailed lo...

Page 16: ...ned for animals requiring a 4 BP cuff or larger This size typically applies to dogs weighing more than 8 kg 17 5 lbs Equine mode is designed for measuring BP on horses If a problem arises try switching animal modes by touching the Animal Selection button on the main screen or in the menu 4 2 Volume The SunTech Vet30E monitor s default setting is Speaker Off so that patients are not disturbed by so...

Page 17: ... adjusted by dragging the blue bar The value on the left side represents the value for which all values below that number will trigger the alarm The value on the right side represents the value for which all values above that number will trigger the alarm Using the keypad type in the desired value and touch the checkmark To reset to default clinical alarms touch Use Defaults For information on the...

Page 18: ...N Note Only use the power cord provided Part Number 19 0020 00 Interval BP To set the time between BP measurements during Interval Mode select the interval time desired To access the Interval BP options select the Settings screen in the Icon Menu then choose Interval BP Intervals include 1 2 3 4 5 10 15 30 60 and 90 minutes After setting the interval time there will be a choice to either begin Int...

Page 19: ...u then choose Temperature Time To set the internal clock select the Settings screen in the Icon Menu then choose Time Two time formats are available AM PM and 24 Hour Select the desired time format and touch Continue Use the and buttons to select the hour and minute In AM PM format touch the AM or PM button to toggle between them To exit without changing the time touch Cancel To save the time sele...

Page 20: ...Use the and buttons to set the day month and year and touch Set to save the date Touch Cancel to return to the Date Format screen without changing the date Press X to exit to the main screen Language Multiple languages are available including English French Italian German Spanish and Portuguese To access the languages select the Settings screen in the Icon Menu then choose Language Touch the desir...

Page 21: ... Taking a BP Measurement on Small Animals WARNING The cuff should not be applied over a wound as this can cause further injury SunTech recommends that the cuff be placed on a front limb while the patient is lying on the right or left side This helps ensure that the cuff is at heart level which is best for measurement accuracy Also the patient is less likely to retract the front limb when the cuff ...

Page 22: ... the Vet30E Select equine mode 3 If patient is awake allow patient to acclimate for approximately 5 minutes in a quiet area Press START STOP button to start blood pressure measurement START STOP button turns blue during measurement Reading is complete when START STOP button returns to magenta Main Screen will show systolic SYS and diastolic DIA values plus mean arterial pressure MAP and heart rate...

Page 23: ...e To exit STAT Mode touch the STAT icon again or press the START STOP button while a BP measurement is in progress STAT Mode will automatically stop after 10 minutes 5 6 Interrupting Stopping a Measurement To abort a measurement while in progress touch the START STOP button When a BP reading is in progress pressing the START STOP button will immediately stop the measurement and deflate the cuff An...

Page 24: ...ent and connect to Vet30E Position patient so that they are lying down Apply disposable non rigid probe cover if using Place the probe either in the esophagus or rectum TIP Placement is not interchangeable so proper probe labeling is encouraged to avoid cross contamination 2 Power up and select animal mode Once the temperature probe senses a reading from a patient the values will display on the sc...

Page 25: ... Measuring SpO2 in the presence of bright light may result in inaccurate measurements In such cases cover the sensor site with an opaque material WARNING Do not apply tape to secure the sensor in place or to tape it shut Venous pulsations may lead to inaccurate saturation measurements WARNING Pressurization of the cuff can temporarily cause loss of functionality of SpO2 if simultaneously using dev...

Page 26: ... readings and unanticipated loss of patient monitoring Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time Where to Apply the Masimo M LNCS YI AH Multisite Reusable Sensor CAUTION Exercise extreme caution with poorly perfused patients skin erosion and or pressure necrosis can be caused when the sensor is not frequently moved Assess site as frequently as every...

Page 27: ...sor and patient cable to the Vet30E see Section 3 To disconnect the sensor 1 Lift the protective cover to gain access to the sensor connector 2 Pull firmly on the sensor connector to remove the patient cable To avoid damage pull on the sensor connector not the cable Taking a Masimo SpO2 Measurement 1 Place SpO2 sensor on patient and connect to Vet30E as described above 2 Power up and select animal...

Page 28: ...tion 7 2 AccuVet Pulse Oximetry NOTE A functional tester cannot be used to assess the accuracy of the pulse oximetry function of the Vet30E NOTE The recommended site to measure pulse oximetry in horses is the rectum Where to Apply the AccuVet Y lingual SpO2 Sensor 1 Clean the sensor before use 2 Select the sensor clip that is appropriate for the patient 3 Open clip with thumb and a finger For each...

Page 29: ...r location The measurement site must be changed every 4 hours to guarantee the integrity of the patient s skin If the SpO2 sensor falls off or is removed from the patient the pulse rate beep will stop and dashes will appear on the screen in place of the SpO2 reading If volume is on an audible tone will sound TIP For systems that include SpO2 the displayed heart rate is derived from the SpO2 sensor...

Page 30: ... must first be installed on the PC The application is available for download from the SunTech website at https www suntechmed com vet25 data capture The PC application is supported on Windows 10 Windows 8 1 and Windows 7 Installation and Setup 1 Download the Vet Data Capture application from the SunTech website Double click on the zip file to extract the folder The folder can be dragged onto the d...

Page 31: ...Select OK to clear the status message TIP The Vet Data Capture PC application does not retain data when closed To ensure data is saved follow instructions in section 6 5 8 5 Reviewing Data and Creating Reports The SunTech PC application allows the user to create reports of patient data Via the Bluetooth connection all data is downloaded from the Vet30E and displayed on the software main screen in ...

Page 32: ...e data to a PDF or CSV file Configuring Settings To change the date format time format or temperature units within the Vet Data Capture application open the Configure menu from the top of the screen Date Format provides the option to switch between M d yyyy and d M yyyy date formats Time Format provides the option to switch between time formats Temperature Units provides the option to switch betwe...

Page 33: ...owing actions are also available To print report click Data and choose Print Report To save report as a PDF file click Data and choose Create PDF To save report as a CSV file click Data and choose Create CSV 9 Alarms 9 1 Technical Alarms A technical alarm occurs in the following situations Loss of connection to a sensor An error during a BP measurement During an alarm an audible tone will sound an...

Page 34: ...0 Taking Care of the SunTech Vet30E 10 1 Battery WARNING The internal user replaceable battery must be plugged into a power source to maintain the battery to a full charge state Check the battery charge status periodically especially before a procedure where the monitor is not connected to a power source The Vet30E has an internal user replaceable battery that is charging whenever the monitor is p...

Page 35: ...e clip sensor and connecting cable with warm soapy water or 70 isopropyl alcohol Allow the sensor clip and cable to dry thoroughly before use Cleaning the AccuVet SpO2 Reflectance Sensor CAUTION Do not sterilize by irradiation steam or ethylene oxide Clean the sensor before and after each use making sure to remove all bioburden The sensor may be surface cleaned by wiping it with a soft cloth satur...

Page 36: ...ving power supply from wall The start stop button does not remove power from the system To replace the battery use a screwdriver to unscrew the screw and open the battery bay door on the bottom of the device Remove battery by disconnecting the electrical connector Replace battery and reconnect the electrical connector Replace battery bay door and secure with screw Before use battery must be fully ...

Page 37: ...ocking box of 20 6 Cuff 98 0400 F1 12 19 cm white non locking box of 20 7 Cuff 98 0400 F3 17 25 cm white non locking box of 20 8 Cuff 98 0400 F4 23 33 cm white non locking box of 20 9 Cuff 98 0400 F5 31 40 cm white non locking box of 20 Vet Cuff Pack Slip Luer Sizes 1 6 98 0240 00 Pack of 6 cuffs 1 of each size 1 6 Patient Hose 6 ft 1 8 m 91 0028 75 6 ft 1 8 m black individual Patient Hose 10 ft 3...

Page 38: ...k that the hose connections are not damaged or loose Value out of Range The blood pressure value is outside of SunTech Vet30E s published ranges Make sure you are using the proper cuff size Patient may have been moving too much Check that the cuff is properly tightened and in proper position Poor Signal Quality Monitor is not receiving a strong signal from patient Also possible if a rapid deflatio...

Page 39: ...the SunTech Vet30E encounters a problem related to the Masimo SpO2 functionality a warning sign will appear on the main screen Touch the warning symbol to open the SpO2 focus screen where further information will be available about what went wrong Take action as directed on the screen or as suggested in the table below Status Message Reason Solution No Sensor Connected SpO2 sensor is not fully ins...

Page 40: ...ble Connected The SpO2 cable is not attached or not fully inserted into the Vet30E Disconnect and reconnect the cable No Adhesive Sensor Connected When a single patient use sensor is used the adhesive portion of the sensor is not connected Ensure the adhesive portion is firmly connected to the sensor Demo Mode Demo Mode is triggered when an optional Demo Tool available from Masimo only is plugged ...

Page 41: ...f from slipping down the limb or coming off Attach the cuff as tight as possible Extra attention will be needed on species with dense or thick fur If the cuff will not stay attached check the hook loop for fur and remove if possible Are there other power options Yes The device is provided with a mains power supply that recharges the internal battery when connected When the monitor is not connected...

Page 42: ...ion 13 1 Monitor Model Numbers Part Number Model Number Model Description 99 0177 00 M30AE Vet30E with AccuVet SpO2 Flamingo Pink Armour 99 0177 01 M30AE Vet30E with AccuVet SpO2 Peacock Blue Armour 99 0177 02 M30AE Vet30E with AccuVet SpO2 Tree Frog Green Armour 99 0178 00 M30BE Vet30E with Masimo SpO2 Flamingo Pink Armour 99 0178 01 M30BE Vet30E with Masimo SpO2 Peacock Blue Armour 99 0178 02 M3...

Page 43: ... and or AC Adapter Input Voltage Range Universal 100 to 240 Vac Input Frequency Range 50 60 Hz Input Efficiency rating DoE Level VI Isolation Classification Class II Output Voltage 12 Vdc Output Current 0 to 2 5 A Protection from electrical shock Class 2 Duty Cycle Continuous use Battery 7 2 V 2 2 Ah 15 8 Wh Dimensions 6 25 x 5 x 5 25 15 9cm x 12 7cm x 13 3cm Weight M30AE 2 35 lbs 1 1 kg with batt...

Page 44: ...ed for patients weighing 30 kg Pulse Rate Range 25 240 BPM 25 240 BPM Pulse Rate Accuracy 3 BPM for patients weighing 30 kg Undefined for patients weighing 30 kg 3 BPM for patients weighing 30 kg Undefined for patients weighing 30 kg SpO2 Averaging Time 8 second averaging TF I Sensor Wavelength Red 660nm Infrared 880nm Ingress Protection IPX1 AccuVet Pulse Oximetry Specifications SpO2 Range 0 99 S...

Page 45: ...designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If t...

Page 46: ...d those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and Manufacturer s Declaration Electromagnetic Immunity The Vet30E Monitor is intended for use in a Professional Healthcare Facility within the electromagnetic env...

Page 47: ...er quality shall be provided by the supplied power adapter DC Input 3m Line to Ground 0 5 1kV Conducted Disturbances induced by RF fields IEC 61000 4 6 All device input and output connections and cables 3V 0 15MHz 80MHz 6V in ISM bands between 0 15 MHz and 80MHz 80 AM at 1kHz Mains power quality should be that of a typical commercial or hospital environment All handheld and patient coupled parts s...

Page 48: ...Immunity Test Level in V m 𝐸 6 𝑑 𝑃 Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range Rated maximum output power of transmitter Watts W Separation distance according to frequency of transmitter meters m 150 kHz to 80 MHz 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...

Page 49: ...rvice b Modulation b Maximum Power W Distance m IMMUNITY TEST LEVEL V m 358 380 390 TETRA 400 Pulse Modulation b 18Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse Modulation b 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modulation b 18Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDM...

Page 50: ...e power button for approximately 6 seconds when turning the monitor ON When viewing service screens the Start Stop button LED is white No parts on the monitor or its accessories are serviceable Service Information Basic details are logged which includes the number of measurement cycles user interface firmware version both firmware versions for the BP algorithm as well as a count for each status me...

Page 51: ...is within limits then touch the Stop button and the calibration check is complete If the pressure does not agree with the manometer then the transducer needs to be re calibrated Send monitor back to SunTech Medical following the procedure in the Limited Warranty section of the manual Air Leak Check International standards for human NIBP devices require that air leakage within the pneumatic system ...

Page 52: ...ch begins the air leak check and shows the pneumatic pressure and a timer This check takes approximately 2 minutes When the check is complete the monitor will indicate a pass or fail result If pass then touch the Pass button and the air leak check is complete If fail then there is an air leak within the pneumatic system Try repeating the check with a different cuff making sure all connections are ...

Page 53: ...ng the software the monitor cannot be in use and the accessories should not be contacting the patient With the USB drive inserted into the device touch Software Update from the Service Mode screen A status bar will indicate the progress of the update Do not turn off the device during the update The device will restart when OK is pressed after the update is complete ...