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Care and Cleaning

Care and Cleaning
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Care and Cleaning

Product catalog summary
Care and Cleaning Guide for BK Medical Products
Introduction: This guide provides comprehensive instructions for the care, cleaning, and maintenance of BK Medical products, emphasizing updated disinfection and sterilization methods available on the company's website.
Chapter 1: Warnings and Cautions
  • Ensure transducer plugs are dry to prevent electrical shock.
  • Clean transducers and storage containers to avoid contamination.
  • Follow infection control procedures to prevent cross-contamination.
  • Pre-clean devices immediately after use to prevent bioburden.
  • Use only approved reprocessing methods for transducers.
  • Be aware of latex sensitivity and use appropriate covers.
  • Avoid using transducers on patients with suspected Creutzfeldt-Jakob disease.
Chapter 2: Markings on Systems and Accessories
  • Details the markings and symbols used on BK Medical systems and accessories for identification and safety.
Chapter 3: Introduction & Safety
  • Outlines general safety measures and specific instructions for various BK Medical systems and transducers.
Chapter 4: Reprocessing Information and Methods
  • Describes levels of reprocessing, precautions, and methods for cleaning and disinfecting equipment.
  • Includes information on manual and automatic reprocessing methods.
Chapter 5: Checking and Maintaining Ultrasound Equipment
  • Guidelines for regular checks and maintenance of ultrasound equipment to ensure functionality and safety.
Chapter 6: Watertight Protection Devices
  • Instructions on using watertight plug lids to protect equipment during cleaning and storage.
Chapter 7: Disposal
  • Provides guidelines for the proper disposal of BK Medical products and accessories.
Appendix: Reprocessing Information and Tables
  • Includes tables of approved disinfectants, transducer compatibility, and validated reprocessing methods for various BK Medical systems and transducers.
Annual Check and Maintenance
Transducers marked with BF or the symbol must be checked annually by qualified personnel to ensure compliance with standards. Contact BK service for assistance.
Disposal of Contaminated Items
Follow established disposal control policies for contaminated items like transducer covers or needle guides.
Usage Restrictions and Environmental Conditions
Devices are restricted to sale by or on the order of a physician in the USA. Avoid excessive heat, dust, sunlight, and condensation to prevent system damage. Handle equipment carefully to avoid damage.
Gel and Liquid Precautions
Use only water-based gel. Protect plugs from liquid contact. Do not immerse transducers without proper protection.
Reprocessing and Testing
Inspect watertight protection devices and plugs for damage before reprocessing. Use a leakage tester to ensure watertight integrity. Follow specific guidelines for immersion and gas reprocessing.
Markings and Symbols
Various symbols indicate compliance, usage restrictions, and handling instructions. Notable symbols include CE Mark, Rx only, and Type BF/B.
Introduction and Safety
This guide provides information on caring for BK Ultrasound equipment, including cleaning, disinfection, and sterilization. Follow established procedures and pay attention to warnings and cautions.
Battery-Powered Systems
Ensure proper ventilation and avoid flammable materials near battery-powered systems. Follow maintenance and replacement guidelines for batteries.
Transducer Care and Storage
Regular inspection and careful handling of transducers are essential. Store transducers in a clean, dry place, maintaining their reprocessing level. Use appropriate containers for transportation to prevent damage.
Transducer Storage and Cleaning: Transducer holders are recommended for short-term storage of non-critical transducers, while semi-critical and critical types should be stored in appropriate containers. Regular cleaning of transducer holders is advised.
Operating and Storage Environment: Environmental limits for BK Ultrasound systems and transducers are specified, including temperature, pressure, and humidity. Avoid excessive heat, dust, and sunlight to prevent system damage.
Transducer Covers and Gels: Use sterile covers to reduce cross-contamination, especially for rectal or vaginal imaging. In certain regions, specific regulations apply to the use of transducer sheaths. Only water-based gels should be used to avoid damage.
Reprocessing Information: Personnel must be trained in reprocessing procedures. Regular checks are necessary to ensure equipment integrity. Reprocessing methods should be consistent to minimize material degradation.
Levels of Reprocessing: Devices are classified based on use, determining the level of disinfection or sterilization required. Noncritical devices require cleaning and disinfection, semi-critical devices require high-level disinfection or sterilization, and critical devices require sterilization.
Reprocessing Equipment: Immediate cleaning after use is crucial. The process includes pre-cleaning, leakage testing, thorough cleaning, and disinfection or sterilization. Proper handling and storage during transportation to the reprocessing area are emphasized.
Manual Cleaning by Immersion: Detailed steps for manual cleaning include using a detergent solution, brushing, and rinsing. Special attention is given to lumens and other intricate parts to ensure thorough cleaning.
Overview: This document provides detailed guidelines for the cleaning, disinfection, and sterilization of medical devices, specifically focusing on transducers and related accessories. It outlines manual and automated reprocessing methods, emphasizing the importance of thorough cleaning before disinfection or sterilization.
Manual Cleaning and Disinfection:
  • Devices must be flushed with water and dried before disinfection or sterilization.
  • Manual cleaning involves wiping with manufacturer-recommended wipes, ensuring all surfaces are cleaned.
  • For manual disinfection by immersion, use approved disinfectants and follow manufacturer instructions for immersion times and rinsing procedures.
Reprocessing Accessories:
  • Accessories used for puncture must be pre-cleaned and sterilized unless supplied sterile.
  • Non-puncture accessories may only require cleaning and disinfection.
  • Specific instructions are provided for cleaning dummy channel brackets and reusable water standoff systems.
System Cleaning and Disinfection:
  • System surfaces are resistant to chemicals but should not be exposed to strong chemicals.
  • Cleaning involves using non-abrasive cloths and mild detergents, with specific instructions for cleaning monitors, control panels, and trackballs.
  • Disinfection can be performed using validated disinfectants, with precautions for remote controls and barcode readers.
Automated Reprocessing Methods:
  • Medivators Advantage Plus and STERIS SYSTEM 1 models are validated for high-level disinfection and sterilization of heat-sensitive devices.
  • STERRAD systems use hydrogen peroxide gas plasma technology for sterilization, validated for 100 cycles for transducers and 50 cycles for remote controls.
Key Recommendations:
  • Always follow manufacturer instructions for cleaning and disinfection products.
  • Ensure thorough cleaning before any disinfection or sterilization process.
  • Regularly inspect devices for damage to determine the maximum number of reprocessing cycles.
Overview: The document provides detailed guidelines for the sterilization and maintenance of BK Medical ultrasound equipment, focusing on various sterilization systems and procedures to ensure the safe and effective reprocessing of medical devices.
Sterilization Systems:
  • STERRAD Systems: These systems use vaporized hydrogen peroxide for sterilizing heat- and moisture-sensitive devices. Specific cycles are recommended for different BK Medical transducers, with a validation for 100 cycles.
  • STERIS V-PRO Systems: Utilizes low-moisture, low-temperature vaporized hydrogen peroxide. Approved trays and cycles are specified for BK devices, with a validation for 100 cycles.
  • STERIZONE VP4: Employs vaporized hydrogen peroxide and ozone in a multiphase process. It offers a single preset cycle validated for 100 cycles.
  • LTSF Systems: Uses low-temperature steam formaldehyde for sterilization. The 60°C sterilization program is recommended, with specific instructions for valve attachment and packaging.
  • Autoclaving: Suitable for steel puncture attachments, with specific parameters for temperature and pressure. Non-steel parts require lower temperatures to avoid damage.
Maintenance and Checks:
  • Regular Checks: Equipment should be inspected for damage such as cracks, scratches, and sealant issues. Specific checks are recommended between uses, especially for critical applications.
  • Leakage Testing: Regular testing is advised to ensure equipment integrity. A detailed procedure is provided for detecting leaks using a pressure test.
  • Preventive Maintenance: Yearly checks and performance tests are recommended to ensure compliance and functionality.
Warnings and Cautions:
  • Do not use watertight protection devices during gas processing to avoid damage.
  • Never autoclave transducers or remote controls as it will cause damage.
  • Inspect equipment for damage before use, and do not use if any damage is detected.
  • Ensure watertight protection devices are dry and properly sealed before immersion.
Specifications and Procedures
The document outlines procedures for leakage testing and maintenance of BK Medical ultrasound transducers. It emphasizes the importance of ensuring connector pins are dry before connection and provides a step-by-step guide for leakage testing, including immersing the transducer in water and observing for bubbles. If a leak is detected, the transducer should be repaired by a service representative. The document also details the use of watertight plug lids for transducer protection during liquid immersion.
Preventive Maintenance
Annual preventive maintenance and performance tests are recommended to ensure the ultrasound system's proper functioning. This includes checking Type BF transducers for compliance with safety standards to prevent electrical shock.
Watertight Protection Devices
BK Ultrasound transducers come with watertight plug lids to protect during immersion. The document describes how to attach and detach these lids, emphasizing the need to inspect for damage before use.
Disposal Guidelines
Disposal of ultrasound equipment must comply with national regulations, especially within the EU, where recycling and recovery are required. The document highlights the presence of materials like epoxy and heavy metals in the equipment.
Reprocessing Information
The document lists approved disinfectants and reprocessing methods for different transducer models, emphasizing the importance of following manufacturer instructions to avoid damage. It includes a table of compatible cleaning and disinfection products.
Key Recommendations
  • Ensure transducer connectors are dry before use.
  • Conduct annual maintenance checks.
  • Use appropriate watertight protection during immersion.
  • Follow local disposal regulations for equipment and contaminated items.
  • Use approved disinfectants and follow reprocessing guidelines.
Reprocessing Methods for T7P2m (9027) Transducer:
  • Tip until 100 cm marker: Submersible.
  • Handle and cable part: Not submersible, wiping only.
  • Connector (and white flex relief): Not submersible, wiping only.
Validated Methods:
  • 3E-Zyme
  • Revital-Ox Resert XL HDL
Material Compatible Methods:
  • Mild pH neutral detergent
  • Aniosyme DD1
  • Clinell Sporicidal wipes
  • Tristel Trio Wipes System
  • Cidex ADS, OPA and Nu-Cidex
  • Ethanol (EtOH) 70% wipes
  • Cidezyme / Enzol
  • Isopropyl alcohol (IPA) 70% wipes
  • Empower Mikrozid® PAA wipes
  • Gigasept AF, Gigasept FF (Neu) and Gigasept PAA concentrate
  • Sani-Cloth AF3 wipes
  • Korsolex extra
  • Metricide, Metricide 28, Metricide OPA Plus and Metricide Plus 30
  • Metrizyme
  • Neodisher MediClean forte/ Neodisher Septo 3000
  • Perasafe
  • Prolystica 2x conc.
  • Revital-Ox Resert XL HDL
  • Sekusept Aktiv
  • Steranios 2%, 2% N.G., 2% E.C.S
  • TD100 & TD5
  • Tristel Trio Wipe System
  • Wavicide 01
Reprocessing Warnings:
  • Extra care must be taken when cleaning this transducer, as there is no automatic cleaning system that can reprocess the entire transducer.
Material Compatible Reprocessing Methods for bkFusion Hardware:
  • Do not immerse electronics unit, transmitter, sensor or cables.
  • EM Transmitter Stand: Use pH neutral (pH 6-8), non-corrosive cleaning products intended for wiping medical devices and ethanol wiping.
  • EM Transmitter Stand (articulated arm): Clean with a soft, non-abrasive cloth moistened with a mild, pH neutral detergent solution, wipe with cold water, and dry with a lint-free cloth. Disinfect with ethanol or isopropanol 70% wipes and spray.
Validated Reprocessing Methods for bk3000/bk3500/bk5000/bkSpecto Transducer Series:
  • Various transducers listed with specific validated methods including manual cleaning, disinfection, and sterilization methods.
Material Compatible Reprocessing Methods for bk3000/bk3500/bk5000/bkSpecto Transducer Series:
  • Various transducers listed with specific material compatible methods for cleaning and disinfection.
Validated Reprocessing Methods for Flex Focus and Pro Focus Transducer Series:
  • Various transducers listed with specific validated methods including manual cleaning, disinfection, and sterilization methods.
Material Compatible Reprocessing Methods for Flex Focus and Pro Focus Transducer Series:
  • Various transducers listed with specific material compatible methods for cleaning and disinfection.
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Catalog excerpts

Care and Cleaning-1

User Guide Care and Cleaning Information for the BK Medical Product Range For Professional Users Only

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Care and Cleaning-2

LEGAL MANUFACTURER BK Medical ApS Mileparken 34 2730 Herlev Denmark Tel.:+45 4452 8100 / Fax:+45 4452 8199 www.bkmedical.com Email: [email protected] The serial number of a BK Medical product contains information about the year of manufacture. New disinfection and sterilization methods are constantly being developed, and we work to make our products compatible with as many methods as possible. You can find the latest information about caring for our products, including disinfection and sterilization compatibility, on our website. New information may have been added since you received this book....

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Care and Cleaning-3

Contents Chapter 1: Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Chapter 2: Markings on the Systems, Transducers and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Chapter 3: Introduction & Safety . . ....

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Care and Cleaning-4

STERIS V-PRO Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 STERIZONE VP4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Matachana 130LF, Webeco FA90, Webeco FA95 . . . . . . . . . . . . . . . . . . . . . . . . . 43 Autoclaving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Chapter 5: Checking and Maintaining Ultrasound Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Check of Equipment Between...

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Care and Cleaning-5

Chapter 1: Warnings and Cautions BK Medical Care and Cleaning Guide

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Care and Cleaning-6

BK Medical Care and Cleaning Guide 6

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Care and Cleaning-7

BK Medical Care and Cleaning Guide 7

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Care and Cleaning-8

BK Medical Care and Cleaning Guide 8

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Care and Cleaning-9

BK Medical Care and Cleaning Guide 9

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Care and Cleaning-10

BK Medical Care and Cleaning Guide 10

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Care and Cleaning-11

Chapter 2: Markings on the Systems, Transducers and Accessories BK Medical Care and Cleaning Guide 11

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Care and Cleaning-12

Manufacturer label Consult accompanying user guide when you encounter this sign on the instrument, to avoid reducing its safety. Consult user guide or other instructions. China ROHS 25 Years Lifetime Complies with EEC Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices. Federal (U.S.A) law restricts sale of this device to physicians or other qualified medical professionals. Environmentally Friendly Use Period for ROHS is 25 years. Corrugated cardboard for recycling. Recycle symbol for corrugated cardboard WEEE waste Within the EU, when you discard the equipment, you must send...

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Care and Cleaning-13

BF: Isolated from ground Maximum patient leakage current under • Normal condition 100A • Single-fault condition 500A Handle with care B: Maximum patient leakage current under • Normal condition 100A • Single-fault condition 500A Dust-protected. Protected against immersion up to 1 m. The tip of the transducer is very delicate. Be very careful not to bump the tip. Single-use device. Do not try to process for reuse. Reuse can result in cross-contamination or can compromise the function of the product. Device may overbalance and fall. Do not push Device is in a sterile condition. STERILE...

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Care and Cleaning-14

Not made with natural rubber latex Do not use if package or label is damaged Not made with natural rubber latex. Do not use if product sterilization barrier or its packaging is compromised. Fragile contents. Do not stack packaging. Do not stack Keep away from sunlight Temperature limitation Keep temperature between the upper and lower limits listed (-20 °C to +60 °C) for BK Medical 88xx/90xx transducers and systems. The 9027 (T7P2m) transducer, BK sterile needle guides, and 3rd party products must be handled according to specific labeling. Atmospheric pressure limitation Indicates the range of...

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Care and Cleaning-15

Can be immersed if cap is tightened as indicated. Must not be immersed if cap is off or not tightened. On the watertight plug lid, indicating the locked and unlocked position for the locking pins that hold the lid onto the plug. Watertight plug lid must be attached during Immersion reprocessing – lid immersion. must be on Watertight plug lid must not be attached during gas reprocessing or whenever pressure Gas reprocessing – lid must is below 700 hPa (10.2 psi). be off Markings on the system, transducers and accessories. BK Medical Care and Cleaning Guide 1

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Care and Cleaning-16

BK Medical Care and Cleaning Guide 16

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Care and Cleaning-17

Chapter 3: Introduction & Safety BK Medical Care and Cleaning Guide 17

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Care and Cleaning-18

Follow established procedures Introduction This user guide contains information about caring for and reprocessing BK Ultrasound equipment. It includes important information about what you must do to ensure the safe and proper performance of the system, transducers and accessories. This includes information about cleaning, disinfection and sterilization. NOTE: The instructions below are meant as a guide. They describe the highest level protocol for this level of reprocessing. Always follow the procedures that have been established for your hospital, clinic or institution, as well as any national...

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Care and Cleaning-19

glass keyboard release handle cable holder and transducers holders transducer sockets lockable wheels The bk3000/bk5000/bk3500 System and UA2361 Remote Control bk3000/bk5000 monitor cap transducer barcode reader keyboard trackball transducers holders touch screen cable holder and release handle transducer sockets lockable wheels BK Medical Care and Cleaning Guide 19

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Care and Cleaning-20

The Flex Focus 1202 System and UA1237 Remote Control monitor & CPU cap keyboard trackball control panel backpack lockable wheels Pro Focus UltraView 2202 System lockable wheels BK Medical Care and Cleaning Guide 20

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Care and Cleaning-21

Battery-Powered Systems The BK battery-powered systems are equipped with high capacity lithium batteries that can power the unit for several hours. General Recommendations for Battery-Powered Systems BK recommends that health care professionals and health care facilities take the following steps to help reduce the potential for injury to patients, staff and visitors: • Do not block any vents. • Do not tape or attach any object or material to the battery compartment. • Keep flammable and explosive objects away from battery-powered systems. • When systems are not in use, but charging, make certain...

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All BK Ultrasound catalogs and technical brochures

  1. Flex-Focus-800
    Flex-Focus-800

    4  Pages

  2. bkSpecto
    bkSpecto

    6  Pages

  3. bk3500™
    bk3500™

    6  Pages

  4. bk5000
    bk5000

    2  Pages

  5. bkFusion
    bkFusion

    6  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.