User and Service Manual
40 Pages
Preview
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VitaScan LT USB Ultrasound Bladder Scanner
User and Service Manual Version 4.5.4.14 | Date: 7th of January 2020
VitaScan LT
User and Service Manual
Ver/Rel. No
Release Date
4.5.4
23rd-June-17
4.5.4
24th-Nov-17
4.5.4
17th-Jan-18
4.5.4
8th-Feb-18
4.5.4
9th-Oct-18
4.5.4
4th-Jul-19
4.5.4
25th-Oct-19
4.5.4.14
7th-Jan-20
Mod. By Mod. Date
Rev. By Relevant Stakeholders Rev. Dt.
Auth. By Auth. Date
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Remark/Revision Details
Page revised
Added Manual Contour Correction, start from INI file, Annual calibration update, Manufacturer and US office Added Easy-mode, Setup GUI update.
Included Probe ID in INI file
29,30,31
Amended Warranty policy for US market.
32
Added Acer Switch 3 as tablet option Added Discard Pubic bone feature
5, 12
Updated text and images to VitaScan v2 probe Updated text and images to VitaScan v2 probe Updated Accuracy on Phantom Specs, and required software
19,20,28
4, 11
The Information contained in this user and service manual is proprietary to Vitacon. It is only used for convenience of our customers. It may be changed in whole or in part without written notice. Any service work performed by persons who are not authorized by Vitacon may void your warranty.
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VitaScan LT
User and Service Manual
Contacting Vitacon: In Europe:
In North America:
Office Address:
Vitacon US 600 Twelve Oaks Center Drive Suite 685, Wayzata MN 55391, USA E-mail: [email protected] http://www.vitacon.us
Vitacon AS Vegamot 8B 7049 Trondheim, Norway E-mail: [email protected] http://www.vitacon.com Manufacturer:
Copyright 2020.
UAB Vitacon LT Naujoji g. 12-525 Alytus 63250 Lithuania
All rights reserved. PN: 6100-500
Disclaimer Vitacon provides this publication as is without warranty of any kind, either expressed or implied, including but not limited to the implied warranties of merchantability or fitness for any particular purpose. Further, Vitacon reserves the right to revise this publication and to make changes from time to time to the content
hereof, without obligation to Vitacon or its local representatives to notify any person of such revisions or changes. Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions; therefore, this statement may not apply to you.
Limited Warranty Vitacon warrants that the VitaScan LT Ultrasound Bladder Scanner will substantially conform to published specifications and to the documentation, provided that it is used for the purpose for which it was designed. Vitacon will, for a period of sixty (60) months from date of purchase, replace or repair any defective device, if the fault is due to a manufacturing defect. In no event will Vitacon or its local representatives be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of or inability to use the VitaScan LT Ultrasound Bladder Scanner, even if advised of the possibility
of such damages. Vitacon or its local representatives are not responsible for any costs, loss of profits, loss of data, or claims by third parties due to use of, or inability to use the VitaScan LT Ultrasound Bladder Scanner. Neither Vitacon nor its local representatives will accept, nor be bound by any other form of guarantee concerning the VitaScan LT Ultrasound Bladder Scanner other than this guarantee. Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions; therefore, this statement may not apply to you.
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VitaScan LT
User and Service Manual
Table of Contents Tables of Contents ... 1 Introduction... 2 Important Information ... 2 Indications for Use ... 3 Product Featues... 3 Unpacking and Inspection ... 3 Content of the packaging: ... 4 Storage ... 4 Technical Specifications ... 4 Product Upgrades and Updates ... 5 About the System Software ... 5 About the Ultrasound System ... 5 Electrical Safety ... 6 Equipment Safety ... 7 Safety and Performance Summary ... 7 Labeling Symbols ... 8 Applicable Standards/Approvals... 9 Applying the Ultrasound Gel ... 10 Measuring Bladder Volume ... 10 Regular Inspections and Maintenance ...11 Care, Cleaning and Disinfecting ... 12 VitaScan LT Application Software Installation ... 13 System Requirements ... 13 Installation of the VitaScan LT application ... 13 USB driver Installation ... 16 User Guide ... 19 PC Software Application Key Features ... 19 Application Features ... 19 Run VitaScan LT application... 20 Scanning on Vitacon Phantom... 29 How to run VitaScan LT application remote from INI file... 30 Application – Troubleshooting... 32 Warranty and Disclaimer Information... 33 Service... 34 Manufacturer:... 37
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VitaScan LT
User and Service Manual
Introduction VitaScan LT Ultrasound Bladder Scanner Real-time bladder scanning is a safe and easy, non-invasive method to measure bladder volume. Bladder scanning measures ultrasonic reflections within a patient’s body and differentiates the urinary bladder from the surrounding tissues. The VitaScan LT is a B-mode ultrasonic instrument, portable and battery operated, intended for the non-invasive measurement of urinary bladder volume. A mechanical sector scanning transducer provides cross-sectional images of the
bladder from up to twenty four scan planes. Based on these images the VitaScan LT automatically calculates the estimated bladder volume in milliliters and displays it on a screen. VitaScan LT is applicable in many clinical areas to determine bladder volume, time for bladder emptying and detection of post void residual volume (PVR). A real-time image of the bladder during pre-scan makes it easier to detect the bladder before scanning.
Important Information Notice To All Operators: The VitaScan LT should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care. All operators should read this manual prior to using the VitaScan LT. Failure to comply with these instructions may compromise the performance of the instrument and the safety of the patient. Biological Safety: To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse physiological effects. However, ultrasound should be used only by a medical professionals when clinically indicated, using the lowest exposure times possible commensurate with clinical utility. The ultrasonic output power of the VitaScan LT is not user-adjustable and is limited to the minimum level necessary for effective performance. Data on acoustic
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Warning: Exposure of low power diagnostic ultrasound has not been shown to produce adverse effects.
output levels can be found in the section titled, “Technical Specifications” in this manual. It is recommended that users read the Health Canada Guidelines for the Safe Use of Diagnostic Ultrasound before using this, or any other diagnostic ultrasonic device. (http://www.hc-sc.gc.ca/ ewh-semt/alt_formats/hecs-sesc/pdf/ pubs/radiation/01hecs-secs255/01hecssecs255-eng.pdf , note this link may change over time). Statement of Intended Use: The VitaScan LT projects ultrasound energy through the lower abdomen of the patient to obtain an image of the bladder. This image is used to determine bladder volume noninvasively. Contraindications The VitaScan LT is not intended for fetal use or pregnant patients.
However, medical professionals should use ultrasound only when clinically indicated. PAGE
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VitaScan LT
User and Service Manual
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Warning:
Product Features
There is the hazard of possible explosion if the VitaScan LT instrument is used in the presence of flammable anesthetics.
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Real-time Ultrasound Bladder Scanner.
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3D ultrasound scanner & PC running Windows 10 OS
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USB ultrasound probe connection
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Bladder volume calculations in large digits
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Storage of ultrasound images
First Time Users: We advise new operators to use the VitaScan LT on patients with moderately full bladders, rather than initially attempting to locate nearly empty bladders.
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Caution: The VitaScan LT should not be used on a patient with open skin or wounds in the suprapubic region. •
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The manual measurement function should be used on patients with catheters, as catheter can reflect ultrasound signals that can lead to inaccurate volume measurement.
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User care with suprapubic/pelvic surgery patients, Scar tissue, incisions, sutures and staples affect ultrasound transmission and reflection.
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Accuracy may be affected for patients with ascites or free floating fluid in the peritoneum.
Caution:
Unpacking and Inspection •
There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it. When unpacking the VitaScan LT to check for damage during shipment:
•
Inspect the shipping carton for damage. If the shipping carton is damaged, carefully continue unpacking the instrument and note any dents and scratches on the VitaScan LT. Save the damaged shipping carton and packing material for the carrier’s inspection and contact the respective carrier. If there is any damage on the scanner equipment, contact Vitacon.
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If there is no shipping damage, continue removing the VitaScan LT from the shipping case. Save the box and packing materials; they will be needed when returning the VitaScan LT to Vitacon for recalibration or future service.
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Verify that all items listed on the packing list have been received and are in good condition.
It is recommended to operate this equipment only on battery power if you are using the software on a non-medical grade computer. Indications for Use This manual is directed toward the reader who is familiar with Ultrasound techniques. Sonography training and clinical procedures are not included here. This manual is not intended as training material for the principles of ultrasound, anatomy, scanning techniques, or applications. You should be familiar with all of these before attempting to read this manual or using the device.
Note: This box contains specifically designed foam inserts to ensure safe shipment of the VitaScan LT. Save these for future shipment of the unit for service or calibration. PAGE
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VitaScan LT
User and Service Manual Content of the packaging: •
VitaScan v.2 probe
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USB Memory stick with Application Software and User & Service Manual
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VitaScan v.2 probe holder
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Installation guide in English
Storage If the system is to be stored, pack it in the original soft case container, and keep it in an environment free of corrosive material, fluctuations in temperature and humidity, and vibration and shock.
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Warning: Do not have VitaScan LT connected to any device while stored in the original soft case container. Storage Requirements: Storage temperature from -30°C to 50°C Relative humidity of 20% to 90% @ 30°C, non-condensing Atmospheric pressure from 700 hPa to 1060 hPa As with most electronic equipment, the unit should be operated in a dry area within normal temperature limits (+10°C to +45°C, 10% - 80% humidity). Dispose electronic waste: VitaScan LT complies with the WEEE Directive (2002/96/EC) marking requirements. The affixed label indicates that you must not discard this Medical Electric Equipment in domestic household waste. Product category: With reference to the equipment types in WEEE directive annex IA, this product is classed as category 8 “Medical Devices”. To return unwanted products, contact Vitacon at the address mentioned at the front of this manual or your local VitaScan distributor. Technical Specifications - Vitascan v.2 • •
Volume range:...0 – 1000 ml Accuracy... ± 7.5% on volumes greater than 100 ml¹ ...± 7.5 ml on volumes less than 100 ml¹
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Frequency:... 3.40 MHz
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Acoustic Output:... MI max: 0.38, Power: 0.25 mW/cm²
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Thermal Index – TI... < 0.02
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Scanning method:... Sector, 180 degrees
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Rotation positions:... 6, 12 or 24 rotating positions
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Sweep angle:... 130 degrees
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Max detection depth:... 100, 160 or 230 mm
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Max probe temperature:... 35°C @ 22°C ambient temperature
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Dimension... (L x W x H) 18.5 x 4.5 x 4.5 cm (7.3 x 1.8 x 1.8 in.)
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Weight incl. cable:... 0.36kg (0.79lb)
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IP rating:...IPX7
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Power Supplied by...USB port: 0.5A @ 5V
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Operating conditions:...+10°C to + 45°C, 10 % - 80 % relative humidity
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Storage temperature:... -30°C to +50°C
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PC requirements:...Windows 10 OS
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PC Input method:... Mouse, keyboard and touchscreen
¹ Accuracy specifications in accordance with stated instructions, scanning on Vitacon phantom and using software version 4.5.4.14 and above.
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VitaScan LT
User and Service Manual Product Upgrades and Updates Vitacon may offer software upgrades and new features that may improve system performance. User and Service Manual updates, explaining the effects of upgrades and new features on system performance, will accompany the upgrades.
PC UBM Application Block
Device Driver / API Interface
VitaScan LT System
Number
Features
Specifications
1
USB Scanner
VitaScan v.2
2
Tablet/Computer
Lamina T-1022
3
Software version 4.5.4 or higher
VitaScan LT
4
USB Memory stick With Software & Documentation
About the System Software The VitaScan LT system contains software that controls its operation. Vitacon will provide you with a USB Memory stick containing the software. Typically new software provides new capabilities. About the Ultrasound System The VitaScan LT System includes: USB Probe, and tablet computer Lamina T-1022. For electrical safety reasons you should always power tablet with only battery power.
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VitaScan LT
User and Service Manual Electrical Safety This system meets EN60601-1, Class I and Type BF isolated patient-applied parts safety requirements. This system complies with the applicable medical equipment requirements published in the European Norm Harmonized Standards, Underwriters Laboratories (UL) and the Canadian Standards Association (CSA). For maximum safety observe the following warnings and cautions:
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Warning: To avoid the risk of electrical shock or injury, do not open the system enclosure. All internal replacements must be made by a qualified technician. To avoid the risk of injury, do not operate the system in the presence of flammable gasses or anesthetics. To avoid the risk of electrical shock, use only properly grounded equipment. Shock hazards exist if the power supply is not properly grounded. Grounding reliability can only be achieved when equipment is connected to a receptacle marked “Hospital Only” or “Hospital Grade” or the equivalent. The grounding wire must not be removed or defeated. Run Tablet on battery (internal electrical source) whenever integrity of the external protective earth conductor arrangement is in doubt. To avoid the risk of electrical shock, before using the VitaScan LT, inspect the housing and USB cable. Do not use the VitaScan LT if these are damaged. To avoid the risk of electrical shock, always disconnect the USB Cable from the PC before cleaning the system. To avoid the risk of electrical shock, do not use any transducer that has been accidentally immersed in any liquid, or has been immersed in any liquid for cleaning or any other purpose.
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Caution: Although your system has been manufactured in compliance with existing EMC/EMI requirements (EN60601-1-2), use of the system in the presence of an electromagnetic field can cause degradation of the ultrasound image. If this occurs often, Vitacon suggests a review of the system environment. Identify and remove the possible sources of the emissions or move your system. Medical Electric Equipment can be affected by portable or mobile RF communication devices. Turn OFF any portable or mobile RF device before operating your system. Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system. The following precautions can help reduce ESD: anti-static spray on carpets, antistatic spray on linoleum, and antistatic mats. Do not use the system if an error message appears on the display: note the error code; call Vitacon or your local representative; turn off the system.
To avoid the risk of electrical shock, do not touch Tablet/Computer output connector (like USB port and others) and the patient at the same time.
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VitaScan LT
User and Service Manual Equipment Safety To protect your ultrasound system, scanner, and accessories, follows these precautions.
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Caution:
•
Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system.
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Use the system on with only battery power, do not use while charging. •
Do not spill liquid on the system.
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To avoid the risk of excessive heating or damage to the system, use the system in a well ventilated environment.
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If the operating environmental temperature exceeds 25°C, limit scans to 5 minutes and allow a 10-minute cooling period between scans.
Do not use the system if it exhibits erratic or inconsistent behaviour. Turn Off the power of the system and call Customer Service.
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Do not dispose of the battery in fire.
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Immediately discontinue use of the battery if, while using, charging or storing the battery, the battery emits an unusual smell, feels hot, changes colour or shape, or appears abnormal in any other way. Contact a customer service representative if any of these problems are observed.
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Excessive bending or twisting of cables can cause a failure or intermittent operation.
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Do not submerge the VitaScan LT in any solution, follow the cleaning instructions.
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To avoid damaging the power supply, verify the power supply input is within the correct voltage range.
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Do not use the VitaScan LT if its head or cable is damaged.
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Do not short the battery terminals.
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Always charge the tablet battery before using the system, to avoid the risk of the system turning off while in use.
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Incorrect cleaning or disinfecting of any part of the system can cause permanent damage.
Do not use the VitaScan LT if there is evidence of leakage of internal liquids. Wash hands immediately in warm, soapy water. Consult the MSDS on Polypropylene Glycol for additional information/precautions.
•
To avoid the risk of electrical shock, do not use any VitaScan LT that has been immersed in liquid.
Safety and Performance Summary The VitaScan LT computes the volume of the urinary bladder based upon twenty four crosssectional ultrasound images (or less). For maximum accuracy, be sure to hold the Scan head motionless while scanning. The most accurate measurements are obtained when the patient rests quietly in the supine position. Accuracy is compromised if the user does not obtain an optimal, repeatable image. Errors in usage tend to result in the underestimation of bladder volume, except in cases where the Scan head is moved during scanning. In this case, the measurement may overestimate the patient’s bladder volume. The patient being scanned should not have a catheter in his/her bladder. This could create micro bubbles in the bladder, which affect the accuracy of the measurement. Do not use the VitaScan LT on patients with open skin or wounds in the suprapubic region. Use care when scanning suprapubic and pelvic surgery patients. Scar tissue, surgical incisions, sutures, and staples can affect ultrasound transmission and reflection. PAGE
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VitaScan LT
User and Service Manual
!
Warning There is the possible hazard of explosion if the VitaScan LT is used in the presence of flammable anesthetics. Labeling Symbols CE mark – Notified body no.2274
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Warning, consult accompanying documents
Test Agency Certification Mark – North America
Read the documentation
BF type (Body Floating)
Ultrasound radiation
WEEE - Waste Electrical and Electronic Equipment
Water submersion
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VitaScan LT
User and Service Manual
Applicable Standards/Approvals 93/42/EEC
Council Directive concerning medical devices
EN ISO 13485:2012+ AC:2012 Medical devices- Quality management systemsRequirements for regulatory purposes EN ISO 14971:2012 Medical devices – Application of risk management to medical devices EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice EN 60601-1:2006+ AC:2010 + A1:2013 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance EN 60601-1-1:2001 Medical electrical equipment. Part 1-1: General requirements for safety. Collateral standard: Safety requirements for medical electrical systems (IEC 606011- 1:2000) EN 60601-1-2:2015 Medical electrical equipment Part 1: General requirements for safety 2.Collateral Standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-4: 1996+ A1:1999 Medical electrical equipment-Part 1-4 General requirements for safety- Collateral Standard: Programmable electrical medical systems EN 60601-1-6:2010 Medical electrical equipment-Part 1-6: General requirements for safety- Collateral Standard: Usability EN 60601-2-37:2008+A11:2011 Medical electrical equipment-Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment) EN 62304:2006+АС:2008 Medical device software – Software life-cycle processes EN 62366:2008 Medical Devices. Application of usability engineering to medical devices EN 60529:1991+A1:2000 Degrees of protection provided by enclosures (IP code)
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VitaScan LT
User and Service Manual Applying the Ultrasound Gel Palpate the patient’s symphysis pubis (pubic bone) and apply the Gel immediately superior to the patient’s symphysis pubis, as shown in images below. Or apply the Gel around the dome of the Scanhead. Smooth the gel out and remove any air bubbles, which may block ultrasound transmission. Using Ultrasound Gel Pad: Sometimes it may be convenient to use ultrasound transmission Gel pad. The Gel pad is an easy-to-use coupling medium. To apply the ultrasound Gel Pad, peel back the foil lid of the individual gel pad package, exposing the gel pad. Measuring Bladder Volume Palpate the patient’s symphysis pubis and place the Scanhead midline on the patient’s abdomen, approximately 4 cm (1.5 inches) superior to the symphysis pubis, as shown in images below.
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VitaScan LT
User and Service Manual •
•
Aim the Scanhead so the ultrasound is projected toward the expected location of the bladder. For most patients, this means aiming the tip of the Scanhead toward the patient’s coccyx.
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Locate the bladder.
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Press and release the scan button and hold the Scanhead steady throughout the scan.
Press and release the scan button, located on the Scanhead.
Note: While scanning, avoid making any changes in the position, angle or pressure of the Scanhead.
Regular Inspections and Maintenance VitaScan LT is a Medical Electric Equipment and therefore needs special precautions regarding EMC. VitaScan LT needs to be installed and put into service according to the EMC information provided in the accompanying documents. Weekly Inspections: Once a week, you should inspect the Scanhead and cable for physical faults or cracks. Cracks that allow the leakage or ingress of fluid may affect the safety and/or the performance of the instrument. Any apparent faults or cracks must be referred to your authorized VitaScan Service Center or your local VitaScan distributor. Monthly Accuracy Check:
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Caution: In the event of changes in the performance of the instrument, discontinue use and contact your authorized VitaScan LT Service Center or your local VitaScan LT distributor. Each month, or whenever accuracy assessment is desired or in question, the accuracy of the VitaScan LT should be tested using the following procedure: •
Take a Pre-void measurement of bladder volume.
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Void or catheterize into a measuring beaker.
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Take a post-void measurement of bladder volume to check for post-void residual (PVR)
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Subtract the post-void measurement form the pre-void measurement and compare to the voided volume.
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Take a measurement on a Vitacon Phantom.
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The measured volume should be within a range ± 7.5% on volumes greater than 100 ml¹
•
or ± 7.5 ml on volumes less than 100 ml¹
¹Accuracy specifications in accordance with stated instructions, scanning on Vitacon phantom.
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VitaScan LT
User and Service Manual No annual Inspection and Maintenance is required on your VitaScan LT. If the Monthly Accuracy Check fails, you should: •
Perform an online integrity and calibration service using a Calibration Test Tool; or
•
Perform an off-line verification test using a Verification Test Tool; or
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Contact your local dealer to learn about options for sending in the device for manufacturer calibration.
Care, Cleaning and Disinfecting Clean the VitaScan LT with a soft cloth soaked in a mild liquid detergent solution. Rinse with clean water and carefully dry with a clean soft cloth. Dampen a soft cloth with 70% ethanol. Wipe the probe with the dampened soft cloth and let the ethanol evaporate. If the VitaScan probe needs to be disinfected, we recommend CIDEX® OPA Solution, PDI Sani-Cloth AF3 Germicidal Disposable Wipes, or other comparable disposable wipe designed for use on non-porous plastic surfaces. You may also use any glutaraldehyde based hospital disinfection solution or Clorox Healthcare bleach products. Dampen a soft cloth and wipe the instrument thoroughly. To remove all traces of disinfection solution, wipe the VitaScan with a clean soft cloth dampened with sterile water or cleaning solution. Carefully dry the VitaScan with a clean soft cloth before use. Use appropriate hand protection according to the labeling on the disinfectant to avoid skin reactions.
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Warning: •
Do not subject any part of the VitaScan LT to steam sterilization or ethylene oxide sterilization.
•
Do not immerse the instrument in any cleaning or disinfecting solution.
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VitaScan LT
User and Service Manual VitaScan LT Application Software Installation Before use on patient: Read the User Manual which is on the USB Memory stick, and follow user instructions for the scan-procedure. System Requirements : •
Windows 10 Operating System, 32 or 64 bit.
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The minimum recommended system configuration is 1GB RAM & 1.3 GHz processor speed.
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VitaScan USB Probe (Firmware version 4.04 or higher)
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Tablet/Computer type: Lamina T-1022.
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USB 2.0 port to source 500mA @ 5V
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Medical Isolation Device – e.g. Tripp Lite IS150HG (N/A) or Noratel IMEDe 150 (Int’l)
Note: Installing VitaScan LT Application Software on Windows 10 Operating System requires the operator is logged in as “Administrator”. Installation of the VitaScan LT application
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•
Open the folder to view the “VitaScan_LT_Installer” files on the USB Memory stick
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Run the VitaScan_LT_Installer.exe file
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Press Next.
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VitaScan LT
User and Service Manual
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•
The “Next” button gets enabled when user chooses to accept the license agreement terms and conditions.
•
Press Next, (It is recommended to install in the default director)
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User and Service Manual
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•
Press Start.
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Press Next.
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Finish the installation by pressing Exit.
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After a successful installation a VitaScan LT icon will appear on your desktop.
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VitaScan LT
User and Service Manual USB driver Installation
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•
VitaScan LT installation requires installation of the USB driver for the VitaScan LT.
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Press ‘OK’.
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Press ‘Start’ to start the installation process.
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Connect the probe in the USB-port and press ‘OK’.
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User and Service Manual
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•
Disconnect the probe from the USB-port and press ‘OK’.
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Press ‘Install’ to proceed the installation process.
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Press ‘OK’, to finish the installation process.
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