VitaScan PD User and Service Manual Ver 2.0.3 Jan 2020 PDF download

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VitaScan PD

Ultrasound Bladder Scanner

User and Service Manual Version 2.0.3 | Date: 7th of January 2020

VitaScan PD User and Service Manual

Ver/Rel. No

Release Date

1.0.0

25-Jan-16

1.0.1

24-Apr-17

1.0.2

6-Jun-17

1.0.2

27-Sep-17

1.0.3

1.1.5

2.0.3

11-Dec-17

23-Aug-19

7-Jan-20

Mod. By Mod. Date

Rev. By Relevant Stakeholders Rev. Dt.

Auth. By Auth. Date

MW

25-Jan-16

MW

24-Apr-17

SW

6-Jun-17

SW

27-Sep-17

SW

11-Dec-17

MW

23-Aug-19

MW

7-Jan-20

Remark/Revision Details

Initial release

Update specs, images, and screenshots

Specification update page 7

Manufacturer information update

Easy mode included

Added new VitaScan PD images v.2. Added page 22 patient info

Updated Accuracy on Phantom Specs, and required SW version

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 PD 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:

UAB Vitacon LT Naujoji g. 12-525 Alytus 63250 Lithuania

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 PD 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 the 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 PD, 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 PD. Neither Vitacon nor its local representatives will accept, nor be bound by any other form of guarantee concerning the VitaScan PD 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 PD User and Service Manual

Table of Contents Tables of Contents�� 1 Introduction �� 2 Important Information�� 2 Indications for Use�� 3 Product Features�� 3 Unpacking and Inspection�� 3 Content of the packaging�� 4 Storage �� 4 Technical Specifications �� 4 AC/DC Adaptor �� 5 Battery �� 5 Product Upgrades and Updates �� 5 System Familiarization�� 6 About the System Software �� 10 Electrical Safety �� 10 Equipment Safety �� 11 Safety and Performance Summary �� 11 Labeling Symbols �� 12 Applicable Standards/Approvals �� 13 Applying the Ultrasound Gel �� 14 Measuring Bladder Volume �� 14 Regular Inspections and Maintenance �� 15 Care, Cleaning and Disinfecting �� 16 Powering up the System �� 16 Scan Operation��18 Adjust result�� 20 Setup �� 21 Patient information��22 Service ��23 Manufacturer �� 26

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VitaScan PD User and Service Manual

Introduction VitaScan PD - 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 PD is a B-mode ultrasound 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 PD automatically calculates the estimated bladder volume in milliliters and displays it on a screen. VitaScan PD 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 PD 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 PD. 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 medical professionals when clinically indicated, using the lowest exposure times possible commensurate with clinical utility. The ultrasound output power of the VitaScan PD is not user-adjustable and is limited to the minimum level necessary for effective performance. Data on acoustic

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/ewhsemt/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 PD 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 PD is not intended for fetal use or pregnant patients.

!

Warning: Exposure to low power diagnostic ultrasound has not been shown to produce adverse effects. However, medical professionals should use ultrasound only when clinically indicated.

!

Warning: There is the hazard of possible explosion if the VitaScan PD instrument is used in the presence of flammable anesthetics. First time users: We advise new operators to use the VitaScan PD on patients with moderately full bladders, rather than initially attempting to locate nearly empty bladders.

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VitaScan PD User and Service Manual

!

Caution:

•

Touch Screen

The VitaScan PD should not be used on a patient with open skin or wounds in the suprapubic region.

•

USB port to save on external memory device

•

Integrated carry handle

•

Battery operated

•

The manual measurement function should be used on patients with catheters, as a catheter can reflect ultrasound signals that can lead to an inaccurate volume measurement.

•

User care with suprapubic/pelvic surgery patients, Scar tissue, incisions, sutures, and staples affect ultrasound transmission and reflection.

•

Accuracy may be affected for patients with ascites or free floating fluid in the peritoneum.

Unpacking and Inspection There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it. When unpacking the VitaScan PD 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 PD. Save the damaged shipping carton and packing material for the carrier’s inspection and contact the respective carrier. If there is any damage to the scanner equipment, contact Vitacon.

•

If there is no shipping damage, continue removing the VitaScan PD from the shipping case. Save the box and packing materials; they will be needed when returning the VitaScan PD to Vitacon for recalibration or future service.

•

Verify that all items listed on the packing list have been received and are in good condition.

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.

Product Features •

Real-time 3D Ultrasound Bladder Scanner.

•

Automatic Urinary Bladder volume calculation in large digits

•

Simple, intuitive software with TouchScreen support

Note: This box contains specifically designed inserts to ensure safe shipment of the VitaScan PD. Save these for future shipment of the unit for service or calibration. PAGE

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VitaScan PD User and Service Manual The content of the packaging •

VitaScan PD with thermal printer

•

VitaScan v.2 ultrasound probe and probe holder

•

Power cord

Storage If the system is to be stored, pack it in the original container, and keep it in an environment free of corrosive material, fluctuations in temperature and humidity, and vibration and shock. 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 of electronic waste VitaScan PD 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 • • • • • • • • • • • • • • • • • • •

Display type...LCD Touchscreen Display - 7Inch Input method... Touchscreen Volume range... 0 – 1000 ml Accuracy... ± 7.5 % on volumes greater than 100 ml ¹ ... ± 7.5 ml on volumes less than 100 ml ¹ Frequency... 3.40 MHz Acoustic Output...MI max: 0.38, Power: 0.25 mW/cm² Thermal Index – TI...< 0.02 Scanning method...Sector, 180 degrees Rotation positions... 12 or 24 rotating positions Sweep angle...130 degrees Max detection depth...100, 160 or 230 mm Max probe temperature...35°C @ 22°C ambient temperature IP rating...IPX1 Input Voltage...100 ~ 240VAC, 50 ~ 60Hz Dimension...(D x W x H) 7.5 x 22 x 20 cm - 3.0 x 8.6 x 7.8 in Weight... 1.8 kg - 4.0 lbs Operating conditions... +10°C to + 45°C, 10% - 80% relative humidity Storage temperature...-30°C to +50°C

Accuracy specifications in accordance with stated instructions, scanning on Vitacon phantom and software version 2.0.3 and above.

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VitaScan PD User and Service Manual AC/DC Adaptor Input

Output

Input range

100-240VAC

Maximum Power

25W

Frequency

50 - 60Hz

Nominal output

15V DC

Input current

0.7- 0.35A

Output current

Max 1.66A

Battery

Number

Item

Specifications

1

Rated Capacity (minimum)

7500mAH with 0.2C Charging & 0.2C Discharging

2

Nominal Capacity

75000mAH with 0.2C Charging & 0.2C Discharging

3

Normal Voltage

11.1V

4

Open circuit voltage when shipped

11.40V - 11.85V

5

Charge ending voltage

12.60V

6

Discharge ending voltage

9.0V

7

Battery run time

5 - 6 hours

8

Charging time

2.0 – 2.5 hours

Table 0-0 Battery Specifications

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.

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VitaScan PD User and Service Manual System Familiarization Introduction The VitaScan PD is an Ultrasound Urinary Bladder Scanner System. The VitaScan PD consists of an inbuilt LCD Display with Touch Screen input and utilizes a VitaScan v.2 Ultrasound Probe. Front View The front view of the VitaScan PD is as shown in the figure below:

2 3

1

1 Touch Display 2 Ultrasound probe 3 ON/OFF button

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VitaScan PD User and Service Manual Back View The back view of the VitaScan PD is as shown in the figure below:

3 2

4

1

1 VESA mount - 75 x 75 mm 2 Probe holder mount 3 Thermal printer 4 DC Power Inlet – 15V

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VitaScan PD User and Service Manual Left Side View The left side view of the VitaScan PD is as shown in the figure below:

1 2

1 Power ON/OFF switch 2 Thermal printer

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VitaScan PD User and Service Manual Right Side View The right side view of the VitaScan PD is as shown in the figure below:

3

1 2

1 USB port for external USB memory stick 2 USB port for VitaScan v.2 probe 3 Probe holder

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VitaScan PD User and Service Manual About the System Software The VitaScan PD system contains software that controls its operation. Vitacon will provide software updates on micro SD card. Typically, the new software provides new capabilities. 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:

!

Warning:

Caution:

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.

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.

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. Connect equipotential ground terminal whenever integrity of the external protective earth conductor arrangement is in doubt. To avoid the risk of electrical shock, before using the VitaScan PD, inspect the housing, cable, and probe. Do not use the VitaScan PD if these are damaged. To avoid the risk of electrical shock, always disconnect the power inlet 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.

!

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, anti-static spray on linoleum, and anti-static mats. Do not use the system if an error message appears on the display: note the error code; turn off the system; call Vitacon or your local representative.

To avoid the risk of electrical shock, do not touch USB port or Ethernet port and the patient at the same time.

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VitaScan PD User and Service Manual Equipment Safety To protect your ultrasound system, scanner and accessories follow these precautions.

!

Caution:

•

Do not spill liquid on the system.

•

To avoid the risk of excessive heating or damage to the system, use the system in a well-ventilated environment.

•

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 behavior. Turn Off the power of the system and call Customer Service.

•

Do not dispose of the battery in fire.

•

Immediately discontinue use of the battery if, while using, charging or storing the battery, the battery emits an unusual smell, feels hot, changes color or shape, or appears abnormal in any other way. Contact a customer service representative if any of these problems are observed.

•

Do not use the VitaScan PD if probe head or cable is damaged.

•

Do not use the VitaScan PD 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 PD that has been immersed in liquid.

•

Excessive bending or twisting of cables can cause a failure or intermittent operation.

•

Do not submerge the VitaScan PD in any solution, follow the cleaning instructions.

•

To avoid damaging the power supply, verify the power supply input is within the correct voltage range.

•

Do not short the USB or Ethernet terminals.

•

Always charge the battery before using the system, to avoid the risk of the system turning off while in use.

•

Incorrect cleaning or disinfecting of any part of the system can cause permanent damage.

•

Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system.

Safety and Performance Summary The VitaScan PD computes the volume of the urinary bladder based upon twenty-four cross-sectional 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

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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 PD 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.

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VitaScan PD User and Service Manual

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Warning: There is a possible hazard of explosion if the VitaScan PD is used in the presence of flammable anesthetics. Labeling Symbols CE mark – Notified body No. 2274

!

Warning, consult accompanying documents

Test Agency Certification Mark – North America

Read the documentation

BF type (Body Floating)

Ultrasound radiation

Drip proof WEEE - Waste Electrical and Electronic Equipment

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Alternating current input

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VitaScan PD 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

Medical devices – Application of risk management to

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 60601-1- 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 processes

Medical device software – Software life-cycle

EN 62366:2008 Medical Devices. devices EN 60529:1991+A1:2000

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Application of usability engineering to medical

Degrees of protection provided by enclosures (IP code)

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VitaScan PD 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 probe. Smooth the gel out and remove any air bubbles, which may block ultrasound transmission. 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. • • • •

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. Press and release the scan button, located on the Scanhead. Locate the bladder. Press and release the scan button and hold the Scanhead steady throughout the scan.

Note: While scanning, avoid making any changes in the position, angle or pressure of the Scanhead. PAGE

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VitaScan PD User and Service Manual Regular Inspections and Maintenance VitaScan PD is a Medical Electric Equipment and therefore needs special precautions regarding EMC. VitaScan PD needs to be installed and put into service according to the EMC information provided in the accompanying documents. Vitacon recommends that the VitaScan PD be certified by an authorized VitaScan PD Service Center once a year. Certification service includes a comprehensive inspection and testing of the instrument, to ensure accurate measurement performance. For more information, please contact your VitaScan PD Service Center or your local VitaScan distributor. 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

!

Caution: In the event of changes in the performance of the instrument, discontinue use and contact your authorized VitaScan PD Service Center or your local VitaScan PD distributor. Each month, or whenever accuracy assessment is desired or in question, the accuracy of the VitaScan PD should be tested using the following procedure: •

Take a Pre-void measurement of bladder volume.

•

Void or catheterize into a measuring beaker.

•

Take a post-void measurement of bladder volume to check for post-void residual (PVR)

•

Subtract the post-void measurement form the pre-void measurement and compare to the voided volume.

•

Take a measurement on a Vitacon Phantom.

•

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. 12-month Regular Inspection and Maintenance Vitacon recommends that the VitaScan PD be certified by an authorized VitaScan PD service center once a year. Certification includes comprehensive inspection and testing of the instruments to ensure accurate performance in clinical use. Customers can maintain device certification via the Internet by accessing the VitaScan online integrity and filed calibration services. For more information contact your local dealer.

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VitaScan PD User and Service Manual Care, Cleaning and Disinfecting Clean the VitaScan PD 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 PD 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 PD with a clean soft cloth dampened with sterile water or cleaning solution. Carefully dry the VitaScan PD with a clean soft cloth before use. Use appropriate hand protection according to the labeling on the disinfectant to avoid skin reactions.

!

Warning: •

Do not subject any part of the VitaScan PD to steam sterilization or ethylene oxide sterilization.

•

Do not immerse the instrument in any cleaning or disinfecting solution.

Powering up the System Running on Mains Power. Push the Mains Switch ON - located at the left-hand side. Press the ON/OFF button on the front. Once the VitaScan PD is powered ON, the system boots up and the Home Screen is displayed. Running on Battery: Push the Main Switch OFF – located at the left-hand side.

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VitaScan PD User and Service Manual

Figure 0-1 Home Screen

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•

Tap on the screen, to navigate through the screen.

•

Tap Woman or Man option

•

For Woman tap Hysterectomy if needed

•

Tap Scan Depth option

•

Tap Start to start Prescan and locate the bladder.

•

Tap Restart to start a new scan

•

Tap Setup to enter setup menu

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Vitacon

Vitacon Bladder Scanners

VitaScan PD User and Service Manual Ver 2.0.3 Jan 2020