BVI 6400
48Pages

BLADDERSCAN B\/l (R400 Operations & Maintenance Manual

Operations & Maintenance Manual Effective: September 12, 2022 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

CONTACT INFORMATION To obtain additional information regarding your BladderScan system, please contact Verathon Customer Care or visit verathon.com/service‑and‑support.   Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011 U.S.A. Tel: +1 800 331 2313 (US and Canada only) Tel: +1 425 867 1348 Fax: +1 425 883 2896 verathon.com   MDSS CH GmbH Laurenzenvorstadt 61 5000 Aarau Switzerland Verathon Medical (Australia) Pty Limited Unit 9, 39 Herbert Street St Leonards NSW 2065 Australia Within Australia: 1800 613 603 Tel / 1800 657 970 Fax International: +61 2 9431 2000 Tel / +61 2 9475 1201...

i Operations & Maintenance Manual: Table of Contents

IMPORTANT INFORMATION OVERVIEW PRODUCT DESCRIPTION The BladderScan BVI 6400 bladder volume instrument is a wireless, battery‑powered, ultrasound device that provides a noninvasive measurement of urinary bladder volume. During each scan, the device employs patented Vmode technology to create a three‑dimensional image of the bladder, which automatically calculates and displays measurements based upon this image. Vmode measurements tend to be more accurate than those obtained from conventional two‑dimensional ultrasound, as they are based on a more complete, multi‑faceted image of the bladder....

SAFETY INFORMATION ULTRASOUND ENERGY SAFETY To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects. However, ultrasound should be used prudently, and total patient exposure should be kept as low as reasonably achievable (ALARA). Following the ALARA principle, ultrasound should only be used by medical professionals when clinically indicated, using the lowest possible exposure times necessary to obtain clinically useful information. For more information on ALARA, please refer to the American Institute of Ultrasound in Medicine publication, Medical...

WARNING Ensure that you follow the manufacturer’s instructions for handling and disposing of the cleaning and disinfection solutions provided in this manual. WARNING When preparing and using one of the approved cleaning, disinfection, or sterilization solutions, follow the instructions of the solution manufacturer. Pay close attention to the proper dilution and immersion times. WARNING In order to maintain electrical safety, use only the provided power adapter, battery, and battery charger. WARNING To reduce the risk of electric shock, use only the accessories and peripherals recommended by...

WARNING To reduce the risk of electric shock or burns, do not use the system in conjunction with high‑frequency surgical equipment. WARNING To reduce the risk of electrical shock, do not attempt to open the system components. This may cause serious injury to the operator or damage to the device and will void the warranty. Contact Verathon Customer Care or your local representative for all servicing needs. WARNING Use of accessories, transducers and cables other than those specified or provided by Verathon may cause this system to experience electromagnetic malfunctions, including increased...

WARNING Be aware of the following conditions that can affect ultrasound transmission: • Catheterization—A catheter in the patient’s bladder may affect the accuracy of the bladder volume measurement in two ways: 1) by introducing air into the bladder that may block the ultrasound signal, and 2) by having the catheter‑retaining balloon interfere with the volume measurement. However, the volume measurement may still be clinically useful if it is large (detecting a blocked catheter, for example). • Abdominal Surgery—Scar tissue, surgical incisions, sutures, and staples can affect ultrasound...

CAUTIONS CAUTION When using the system with optional Scan Point software, your computer must be minimally certified to EN/IEC/CSA/UL 60950‑1 or 60601‑1 standards. This configuration ensures that compliance to the EN/IEC 60601‑1 system standard is maintained. Anyone connecting additional equipment to the signal input port or signal output port configures a medical system, and is therefore responsible for ensuring that the system complies with EN/IEC 60601‑1. If you need assistance, contact your biomedical staff, local representative, or Verathon Customer Care. CAUTION Failure to follow these...

CAUTION Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and operated according to the instructions in this manual. For more information, see the “Electromagnetic Compatibility” section. This device can radiate radio frequency energy and is very unlikely to cause harmful interference with other devices in the vicinity. There is no guarantee that interference will not occur in a particular installation. Evidence of interference may include degradation of performance in this device or other devices when operated...

INTRODUCTION SYSTEM OVERVIEW The BladderScan BVI 6400 is a portable, hand‑held ultrasound device that scans the patient’s bladder. It is battery‑powered with an ergonomic design. Using patented Vmode technology, it provides a noninvasive measurement of urinary bladder volume. The display provides aiming assistance and provides an array of bladder measurement information. The device measures ultrasonic reflections on multiple planes inside the body, producing a three‑dimensional image. Based on this image, the device calculates and displays the bladder volume. A sonographer is not required....

Table 1. Required System Components and Accessories Operations & Maintenance Manual: Introduction

OPTIONAL COMPONENTS & ACCESSORIES The following optional items are available to enhance the capabilities of your device. Please contact Verathon Customer Care or your local representative for more information on any of the following Verathon products. Table 2. Optional Components and Accessories PART Scan Point with QuickPrint Install CD Installs Scan Point with QuickPrint software on a network‑enabled Windows PC. For more information, see Scan Point Technology (Optional). Scan Point docking station Used with Scan Point software. Maintains communication between the BladderScan device and...