SunTech Vet30 M30A, Vet30 M30B, Vet25 User Manual

Continuous Vital Signs Monitor for Companion Animals
User Manual
Changes
Other office location:
SunTech Medical, Inc. 507 Airport Blvd, #117 Morrisville, NC 27560-8200 Phone: 1-919-654-2300 1-800-421-8626 Fax: 1-919-654-2301
SunTech Medical, Ltd. Oakfield Industrial Estate Stanton Harcourt Road Eynsham, Oxfordshire OX29 4TS England Phone: + 44 (0) 1865-884-234 Fax: + 44 (0) 1865-884-235
SunTech Medical (Shenzhen) Co., Ltd. 10
5 HuanGuan South Road, Suite 15 2~3/F DaHe Community Guanlan, LongHua District, Shenzhen GuangDong PRC 518110 Tel: + 86-755-29588810 + 86-755-29588986 (Sales) + 86-755-29588665 (Service) Fax: + 86-755-29588829
This manual is identified as part number: 80-0075-00-RevF. This manual is for use with Vet30 models M30A and M30B. An updated version may be available for download from the SunTech Medical website. Should you notice errors or omissions in this manual, please notify us at: SunTech Medical, Inc. 507 Airport Boulevard, Suite 117 Morrisville, NC 27560 USA Tel: 800.421.8626
919.654.2300 Fax: 919.654.2301 Email: CustomerService@SunTechMed.com Web: www.SunTechMed.com
Copyright Information
All content in this manual is the proprietary information of SunTech Medical and is provided solely for purposes of operation of the SunTech Vet30. This manual and the Vet30 described in it are protected under copyright law under 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 inaccura cies that may appear in this manual. © 2018 SunTech Medical. All rights reserved.
Welcome to the SunTech Vet30
Thank you for choosing the Vet30 vital signs monitor! For over 30 years, SunTech Medical has been the preeminent supplier of leading edge technology and innovative products to obtain blood pressure (BP) measurements. Developed specifically for the veterinary care environment, the Vet30 can perform automatic BP, pulse oximetry (SpO
), and body temperature measurements for veterinary professionals.
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For measuring BP, a BP cuff is placed around the patient’s forelimb or tail. The cuff is inflated automatically and blood pressure is determined by the oscillometric method, which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured.
The pulse oximetry function measures the patient’s percent functional oxygen saturation of arterial hemoglobin using principles of plethysmography via a SpO determined by measuring the absorption of red and infrared light passing through the tissue. Changes in absorption caused by pulsations of blood in the vascular bed are used to determine arterial saturation and pulse rate. The Vet30 provides two options for SpO
: AccuVetTM or MasimoTM SET®. The oximeters require no routine calibration or
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maintenance. The display features a pulse oximetry focus screen, which displays the SpO waveform is not normalized.
Temperature can be measured using a rectal temperature probe. The temperature probe contains a thermistor that generates a voltage based on changes in temperature, and these voltages are recorded by the temperature circuitry.
The Vet30 is a portable device, weighing approximately 2.65 lb (1202 g). Control buttons allow the user to turn on or off the device and stop/start a BP measurement. The touchscreen display shows the device status and measurement information, and allows 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/vet30-data-capture. all parameters.
sensor placed on the patient. Arterial oxyhemoglobin saturation is
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plethysmograph. The
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Upper and lower alarm limits can be set for
Intended Use
The SunTech Vet30 and Vet25 monitors are clinical grade automated blood pressure measurement devices that provide oscillometric non-invasive blood pressure. The Vet30 provides additional pulse oximetry and temperature measurement capabilities. These portable devices are for use in the veterinary clinic on companion animals (cats and dogs). The devices can be used for spot-check or continuous monitoring activities. They are not intended for human use.
The devices are contraindicated for use on humans or any species other than those described above.
Vet30 Essential Performance:
The Essential Performance of the Vet30 models are designed to measure, record, and display a patient’s blood pressure within a blood pressure accuracy range of +/- 5 mmHg mean error & 8mm Hg standard deviation (max inflate 280 mmHg).
Additionally, these models are designed to measure, record, and display a patient’s functional oxygen saturation over the range of 70% to 100% with an increment of 1% within an accuracy of +/- 3%. These models shall also measure, record, and display a patient’s conti nuo us temperature within an accuracy of no greater than 0.3C (+/- 3 digits) used with a minimum temperature
range of 26C to 46⁰C.
User Responsibility
The Vet30 is designed to perform in conformity with the description thereof contained in this operation manual when operated. This operation manual is for use with Vet30 models M30A and M30B. The user of this monitor shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than SunTech Medical or their authorized service personnel. The Vet30 is for use only by or on the direction of a licensed veterinarian.
when
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Use of Vet30
Use only veterinary BP cuffs supplied by SunTech Medical. Observe the patient carefully during the measurement. Accuracy of any BP reading or oxygen saturation measurement may be affected by the position of the patient, their physical 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 SpO
Masimo SET SpO
Check the application site of the SpO
Module: Use only AccuVet SpO2 sensors supplied by SunTech Medical.
2
Module: Use only original Masimo SpO2 sensors and cables.
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sensor frequently to confirm proper positioning of the sensor and to check the
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circulation and skin sensitivity of the patient.
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Table of Contents
Changes .................................................................... 2
Copyright Information .............................................. 2
Welcome to the SunTech Vet30 .............................. 3
Intended Use ............................................................ 3
1. Warnings and Precautions ................................. 6
2. Icons and Symbols ............................................ 8
3. Getting to Know SunTech Vet30 .......................10
3.1 Applied Parts and Patient Environment .......... 10
3.2 Device Placement ............................................ 10
3.3 Front Panel ....................................................... 11
3.4 Connect Power, Hose, and Sensors ................ 11
3.5 Display .............................................................. 14
3.6 Start/Stop Button ............................................. 16
4. Selecting Your Settings .....................................16
4.1 Animal Mode .................................................... 16
4.2 Volume ............................................................. 16
4.3 Settings............................................................. 16
5. Blood Pressure Measurement ...........................21
5.1 Cuff Sizing ........................................................ 21
5.2 Where to Apply the Cuff ................................... 21
5.3 Taking a BP Measurement .............................. 22
5.4 Interval BP Mode .............................................. 22
5.5 STAT Mode ....................................................... 23
5.6 Interrupting/Stopping a Measurement ........... 23
5.7 Heart Rate Measurement ................................ 23
6. Temperature Measurement ...............................23
6.1 Where to Apply the Temperature Probe .......... 23
6.2 Taking a Temperature Measurement ............. 24
7. SpO2 Measurement ............................................24
7.1 Masimo Pulse Oximetry ................................... 25
7.2 AccuVet Pulse Oximetry .................................. 27
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 ................................................. 33
10. Taking Care of the SunTech Vet30 ...................34
10.1 Battery ............................................................ 34
10.2 Cleaning .......................................................... 34
10.3 Preventative Maintenance ............................. 35
10.4 System Components ..................................... 36
10.5 Accessories & Replacement Parts ................ 37
10.6 Status Messages ........................................... 38
11. Frequently Asked Questions ............................40
12. Limited Warranty .............................................41
13. Technical Information ......................................42
13.1 Monitor Model Numbers ............................... 42
13.2 Factory Default Settings ................................ 42
13.3 Performance Specifications .......................... 43
13.4 Radio Frequency Compliance Requirements 44
13.5 Electromagnetic Compatibility (EMC) ........... 45
Appendix A: Service Screens ................................. 50
Service Information ................................................ 50
Calibration Check ................................................... 50
Air Leak Check........................................................ 51
Restore Factory Defaults ....................................... 52
Software Update .................................................... 53
1. Warnings and Precautions
General warnings and cautions are listed here and repeated where relevant throughout this guide. A WARNING indicates a situation which, if not avoided, could result in serious injury or death.
WARNING: DO NOT connect patient hose or monitor to any other devices or connections, especially intravenous (IV) tubes as there is potential for air to be pumped into a blood vessel which could cause serious injury. WARNING: DO NOT use in the presence of flammable anesthetics; this could cause an explosion. This device is not suitable for use in an oxygen enriched environment. WARNING: This monitor may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures such as re-orienting, relocating or shielding the location.
WARNING: The cuff should not be applied over a wound as this can cause further injury.
WARNING: DO NOT use a defibrillator, full body irradiation, or ultrasonic device on the patient at the same time as it
may affect the operation and/or safety of the patient due to interactions. WARNING: DO NOT immerse the monitor in any fluid or attempt to clean the unit with liquid detergents, cleaning agents, or solvents. This may cause an electrical hazard. Do not use the monitor if accidental wetting occurs. Refer to the cleaning section of this guide for instructions on cleaning. WARNING: Check the limb frequently to ensure that operation of the monitor does not result in prolonged impairment of the circulation of the patient.
WARNING: DO NOT apply the BP cuff to a limb being used for IV infusions or any other intravascular access, therapy, or an arteriovenous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.
WARNING: Pressurization of the cuff can temporarily cause loss of functionality of SpO 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 not plugged into main power, ensure there is sufficient battery charge. If battery loses charge, device must be plugged into power supply to function. WARNING: The USB port is only a service port and cannot be used to download data or interface with the monitor. When updating the software, the monitor cannot be in use and the accessories should not be contacting the patient.
WARNING: Do not open the memory screen while readings are in progress. If the memory screen is open while pulse oximetry or temperature readings are being taken, any new readings will not be added to memory, or be recoverable in any way.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
WARNING: Do not place the monitor or accessories in any position that might cause it to fall on the patient. WARNING: Do not start or operate the monitor unless the setup was verified to be correct. WARNING: Do not use the monitor during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Do not use the monitor if it appears or is suspected to be damaged. WARNING: Explosion hazard: Do not use the monitor in the presence of flammable anesthetics or other flammable
substance in combination with air, oxygen-enriched environments, or nitrous oxide.
WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. WARNING: To protect against injury, follow the directions below:
x Avoid placing the device on surfaces with visible liquid spills. x Do not soak or immerse the device in liquids. x Do not attempt to sterilize the device.
if simultaneously using
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x Use cleaning solutions only as instructed in this operator's manual. x Do not attempt to clean the device while monitoring a patient.
WARNING: To protect from electric shock, always remove the sensor and completely disconnect the monitor before bathing the patient. WARNING: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check the monitor for proper functioning.
WARNING: The monitor should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms.
WARNING: The monitor is not an apnea monitor.
WARNING: The monitor may not be used during electrocautery.
WARNING: The monitor should not be used for arrhythmia analysis.
WARNING: Do not adjust, repair, open, disassemble, or modify the monitor or accessories. Injury to personnel or
equipment damage could occur. Return the monitor for servicing if necessary.
A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor o r moderate injury to the user, patient or damage to the equipment or other property.
CAUTION: For use only by or on the direction of a licensed veterinarian. NOT for use on humans. CAUTION: DO NOT use the monitor for any purpose other than specified in this manual without written consent and
approval from SunTech Medical.
CAUTION: DO NOT use this monitor when oscillometric pulses may be altered by other devices or techniques. CAUTION: DO NOT disassemble device. Doing so may increase the risk of electrical shock. This monitor does not
contain any user serviceable parts except for the battery. Substitution of a component or accessory different from that supplied may result in measurement error. Repairs should be 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 equipment and other consumable goods. CAUTION: This device contains a lithium ion battery that contains materials which may be hazardous to human health. DO NOT dispose of battery in domestic waste! Instead, please dispose of in an environmentally responsible way, or return the battery to SunTech Medical. A prepaid return label can be obtained. Please see our website for more information about our environmental policy at http://www.suntechmed.com/about-suntech/environmental-
policy.
CAUTION: Accuracy of any blood pressure measurement may be affected by the position of the subject, the patient’s physical condition, and use outside of the operating instructions detailed in this manual. Interpretation of BP measurement should be made only by a veterinarian or trained medical staff. Minimize limb movement during the measurement.
CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient. If the cuff fails to deflate, the operator should be instructed on how to remove the cuff.
CAUTION: Performance can be affected if used or stored outside the specified temperature and humidity ranges. CAUTION: Replace user replaceable parts that are broken, worn, missing, damaged, incomplete, or contaminated.
Contact SunTech Medical for service on parts that are not user replaceable and stop using device until repaired. Failure to repair a damaged product may cause injury to the user and/or patient. CAUTION: Do not place the monitor where the controls can be changed by the patient.
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CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from
Symbol
Description
Standard/Source
General Warning Sign
ISO 7010-W001 Batch Code
ISO 7000-2492
Caution
ISO 7000-0434A
Classification
– Class II
IEC 60417-5172
Refer to Instruction Manual
ISO 7010-M002
Authorized representative in the European Community
SunTech Design USB-A or USB-B
Industry
Direct Current
IEC 60417-5031
Alternating Current
IEC 60417-5032 Polarity of DC power connector
IEC 60417-5926
Rechargeable battery
IEC 60417-5639
Consult Instructions for Use
ISO 7000-1641
This product meets the requirements of the applicable Directives
EU Directive Disposal in compliance with WEEE
Directive
WEEE Directive
any power source. CAUTION: Do not place the monitor on electrical equipment that may affect the device, preventing it from working properly. CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time the monitor is used. CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur.
CAUTION: Disposal of product - Comply with local laws in the disposal of the device and/or its accessories. CAUTION: 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:
x Recognition #5-103, ISO 7000: 2014: Graphical symbols for use on equipment - Registered symbols x Recognition #5-116, ISO 7010: 2011: Graphical symbols - Safety colours and safety signs - Registered
safety signs
x Recognition #5-102, ISO 60417: 2002 DB: Graphical symbols for use on equipment
x Recognition #5-117, ISO 15223-1: 2016: Medical devices - Symbols to be used with medical device labels,
labelling, and information to be supplied - Part 1: General requirements
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Manufacturer
ISO 7000-3082 Date of Manufacture
ISO 7000-2497 Serial Number
ISO 7000-2498 Cuff index line must fall within range markings
SunTech Design
Arrow should be placed over
SunTech Design Symbol indicating limb circumference
SunTech Design Index line
SunTech Design Not made with natural rubber latex
SunTech Design Not made with PVC
SunTech Design Reference
ISO 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 Opens the Icon Menu
SunTech Design Begins
SunTech Design Adjusts volume
SunTech Design View Memory
SunTech Design Exits or closes a screen
SunTech Design Goes back to previous screen
SunTech Design Deletes all stored memory data
SunTech Design Averages selected BP readings
SunTech Design Begins STAT Mode
SunTech Design Bluetooth
Bluetooth
Number
artery
Interval BP Mode
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Begins data transfer
SunTech Design Provides practical advice for using monitor
SunTech Design Maximize or minimize a focus screen
SunTech Design Standby (Powers device on/off)
IEC 60417-5009
Start/Stop a BP measurement
IEC 60417-5107B
IEC 60417
Battery Indicator
SunTech Design
SpO2 Sensors only: These items are protected against ingress of vertically dripping water only
IEC 60529
TIP:
IPX1
-5110B
3. Getting to Know SunTech Vet30
3.1 Applied Parts and Patient Environment
The applied parts are type BF. The following are the applied parts of the Vet30:
x BP Cuffs x SpO x Temperature Probes
The Vet30 has been tested with specific parts of the system used within the patient environment. The parts of the system that can be used in the patient environment are:
Sensors
2
x Vet30 monitor x All applied parts as defined above x All accessories as defined in Section 10.5, excluding the AC Adapter
The patient environment is defined in the following 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.
Place the Vet30 monitor in a convenient location to ensure user’s ability to monitor the screen continuously. Ensure monitor is placed away from table top edges and route the patient cables so that if pulled, the monitor will not fall.
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3.3 Front Panel
Power button. Press once to turn ON. The button is illuminated when power is on. To turn OFF, press the button again.
Start/Stop button. Starts measurement at any time.
AC Adapter
BP measurement. Stops
3.4 Connect Power, Hose, and Sensors
CAUTION: Read all warnings, cautions, and instructions provided prior to using the device.
1. Insert AC adapter plug into the Vet30. Plug other end of the AC 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 position by rotating clockwise. For additional information on how to take a BP measurement, see Section 5.
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BP Hose
Temperature Probe
3. Plug AccuVet temperature probe into the back of the monitor. Be sure to fully insert the connector into the monitor to avoid erroneous temperature values. For additional information on how to take a temperature measurement, see Section 6.
4. Connect SpO2 Sensor
A) AccuVet SpO Plug AccuVet SpO 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 SpO
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2
Y-lingual Sensor, Reflectance Sensor, or extension cable into the back of the monitor. Lift
2
measurement, see Section 7.
2
AccuVet SpO2
Masimo SpO2
B) Masimo SpO
2
a. Attach the M-LNC Patient Cable to the Vet30. Orient the connector of the cable to mate with the
patient cable connector on the back of the Vet30 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 SpO
measurement, see Section 7.
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3.5 Display
Battery life indicator
Size of Animal Mean arterial pressure (MAP)
BP Reading
Menu
Volume SpO
Temperature
STAT
Bluetooth Connection Status
Heart Rate (HR)
Bars indicating SpO2 signal strength
Animal Selection Screen
When you turn on your SunTech Vet30, you will see the Animal Selection Screen. Even if you are not ready to measure BP on a patient, select either Large or Small animal so that you can proceed to the Main Screen. This screen can be turned off (see Animal Selection in Section 4). Additionally, the animal mode can be toggled using the animal selection icon on the Main screen.
Main Screen
After you begin using your Vet30, 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.
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Icon Menu
Temperature Focus Screen
Larger view of the current
BP Focus Screen
Larger view of the current
SpO2 Focus Screen
x Larger view of the current
SpO2 % and HR reading
x Plethysmograph waveform
TIP: The waveform is not
normalized.
7 3 2
1 4 5
6
8
9
After you press on the Menu button on the main screen, the Icon Menu will open. Here you can access various functions and settings of the device. The Icon Menu is not accessible during a BP measurement.
1. Exit Icon Menu
2. Settings
For more information on selecting settings, see Section 4.3
3. Animal Selection
4. Speaker Volume
5. Memory
For more information on reviewing and transferring data, see Section 8
6. STAT Mode
For more information on STAT BP Mode, see Section 5.5
7. Interval BP Mode
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 SpO section. This expanded view provides a more detailed look at the measurement. To exit the focus screen, touch the – in the top left corner of the screen.
x
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temp reading
, touch the + in the top left corner of the measurement
2
x
BP reading
3.6 Start/Stop Button
Clinical Alarms. Provides access to turning ON and setting clinical alarms.
Power Management. Select how long monitor stays on before Auto OFF shutdown. Auto OFF is disabled when powered by an AC adapter.
Animal Selection.
Interval BP. Select time between BP measurements in Interval BP Mode.
The color of the LED on the START/STOP button indicates the status of the Vet30.
x START/STOP button is magenta during normal operation x START/STOP button is blue during a BP reading x START/STOP button is white when in service mode x START/STOP button is red during an error, when a status message is prompted or the device is unable to
connect via Bluetooth
4. Selecting Your Settings
TIP: Selected settings are saved even when device is powered off.
4.1 Animal Mode
Small Animal Mode should be chosen when taking BP measurements on cats and dogs up to a #3 BP cuff size. This size typically applies to dogs or cats weighing less than 8kg (~17.5 lbs.). Large Animal Mode has been designed for animals requiring a #4 BP cuff or larger. This size typically applies to dogs weighing more than 8 kg (~17.5 lbs.). 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 Vet30 monitor’s default setting is Speaker Off so that patients are not disturbed by sounds. To toggle between Speaker Off, Low Volume, and High Volume, press the Speaker button. When sound is OFF, you still will hear a very quiet clicking when you touch buttons but no beeps.
4.3 Settings
To access the settings screen, select the settings button ( ) in the menu.
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