Аппарат узи сименс acuson х 300 инструкция

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ACUSON X300 Ultrasound Imaging System

Instructions for Use

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1 Introduction

1 Introduction

1 Introduction

System Overview

The X300 system is a portable, digital diagnostic ultrasound imaging system. The system utilizes advanced imaging processing and transducer technology. The operating system is based on Windows® technology.

The system software supports standard applications, exam-specific imaging presets, measurements, pictograms, annotations, reports, worksheets, and system diagnostics.

Operating modes for the system include:

2D-mode

Split mode

Dual-mode

4B-mode

2D/M-mode

Anatomical M-mode (for Cardiac imaging)

Pulsed Doppler

Color Doppler

Power Doppler

Steerable Continuous Wave Doppler

Auxiliary Continuous Wave Doppler

The system is equipped with a DIMAQ-IP integrated workstation. The workstation provides capabilities for digital acquisition, storage, and review of ultrasound studies. Additional system options provide integration into a networking environment.

See also: Technical Description, Appendix A, Instructions for Use

1 Introduction

Intended Use

Caution: In the United States of America, federal law restricts this device to sale or use by, or on the order of, a physician.

The X300 ultrasound system supports the following applications:

Abdomen

Obstetrics

Obstetrics (Japan)1

Early Obstetrics

Gynecology

Musculoskeletal

Small Parts

Breast

Testicle

Thyroid

Urology

Orthopedic

Cerebrovascular

Cardiac

Peripheral vascular

Venous

Renal

Superficial Musculoskeletal

Pediatric Abdomen

Pediatric Echo

Penile

Emergency Medicine

Fetal Echo

Transcranial

Digital

Neonatal Head

TEE (Adult transesophageal)

1 SONOVISTA Systems Only

1 Introduction

Transducers and Intended Applications

Only the following transducers from Siemens are compatible with the

Siemens ACUSON X300 ultrasound imaging system:

EMC Note: Operating the transducer in close proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations may lead to temporary degradation or interference visible on the monitor screen. A lightening of image background may be noticed while visualizing hypoechoic structures, or color spectral interference, or jitter, or horizontal lines in the image screen may occur. The transducer and the system have been designed and tested to withstand such interference and will not be permanently damaged. Refer to the Electromagnetic Emissions and Immunity Guidance and Manufacturer’s Declaration.

1 Introduction

Image Screen Layout

The monitor on the ultrasound system displays clinical images together with important operating parameters and patient data. There is a variety of on-screen overlays and graphical objects to aid in image evaluation.

Many fields or areas of data displayed on the screen are multi-functional. The image field can display a 2D-mode image, M-mode sweep, Doppler spectrum, and their combinations, sets of calipers, pictograms and annotation text, and CINE icons. An image can be inverted on a vertical axis and reversed on a horizontal axis to facilitate viewing and measurements.

The system displays reduced-size reference images (thumbnails) of images, clips, and volumes stored during the exam.

EMC Note: Operating the ultrasound imaging system in close proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations, may lead to interference visible on the monitor screen. However, the device has been designed and tested to withstand such interference and will not be permanently damaged.

Screen Saver

The screen saver feature automatically replaces the display with a blank screen after the system has been inactive for a specified number of minutes.

When the screen saver is activated, the system is automatically placed into freeze mode.

Restore the screen display by pressing any key or adjusting any control. The first key that you press will restore the view without performing a function. Press the key again to execute the command.

Use the system presets to enable the screen saver feature and to specify the delay period and the background for the blank screen.

Display > Monitor > Enable Screen Saver

Display > Monitor > Screen Saver Delay

Display > Monitor > Screen Saver Type

1 Introduction

Sample Image Screen

3

8

7

6

4

5

Example of a typical image screen.

1Information for identifying the patient, operator, and the hospital or clinic.

2Time and Date

3Panels including Thumbnails with controls for printing, deleting, and deselecting an image, clip, or volume and Patient Info for displaying patient information.

4Soft key selections for a mode or function, including controls for image optimization, post-processing, measurement types, annotations, and playback. Use the corresponding toggle key on the control panel to activate the selection. Rotate the PAGE control on the control panel to access additional selections for the mode or function. Press the PAGE control to access soft key selections for other modes or functions.

5Page Indicator for the soft key selections. The number of available «pages» for a specific mode or function are identified by the number of sections in the «page indicator». The highlighted section corresponds to the displayed «page» of soft key selections.

6Tab Indicator. Identifies the mode or function for the soft key selections.

7Status bar. Indicates the function currently assigned to the trackball, SELECT control, UPDATE key, ESCAPE key. During video recording, provides recording status and an icon to indicate microphone function is active.

8During the Measurement function, the system displays the Measurement Label menu for the priority imaging mode and exam type. Use the CALIPER key to access the Measurement Menu. During annotation, the system displays the library of pre-defined labels for identifying body position and anatomical structures by exam type.

9Imaging Parameters. Displays settings for parameters adjusted by the soft key selections. Measured Results. Displays values from measurements and calculations when the Measurement function is active.

10Transducer Frequency

11Gain for the priority mode

12Active Exam type

13Active transducer name

1 Introduction

Status Bar

Icon Description

Indicates recording status during video recording using a VCR or DVR. A red icon displays during recording and a white icon displays during pause or stop. The recording time also displays beside the icon.

Indicates the function currently assigned to the SELECT control.

Indicates the function currently assigned to the UPDATE key.

Indicates the function currently assigned to the ESCAPE key. Press the ESCAPE key to cycle through the functions for other active modes under control of the key, if any.

Indicates the function currently assigned to the trackball. Press the SET key to cycle through other functions under control of the trackball, if any.

When displayed, indicates recording function with the built-in microphone is activated.

User-Defined System Settings

You can customize many features of the ultrasound system by using the system presets to designate default settings, or presets. The values are stored in non-volatile memory and will remain intact when the system is powered off.

Each user of the system can determine settings for imaging preferences and default settings, then store them on a disk. Those user-defined settings can then be loaded along with new system software. The disk also serves as a backup.

QuickSets

The QuickSet™ feature allows you to capture an optimized configuration of imaging parameter settings for a combination of a specific transducer and exam.

2 Safety and Care

2 Safety and Care

Operating Safety and Environment

Do not operate the ultrasound imaging system until you fully understand the safety considerations and procedures presented in this manual.

System Symbols

The table below is provided for your identification of important symbols located in labels on the ultrasound imaging system and transducers.

2 Safety and Care

Symbol Explanation

Signal Input

Signal Output

Video Connection (monochrome video signals)

Start (of action for equipment)

Digital Interface, RS-232-C connection

USB Connection

Ethernet 10/100BaseT Connection

Equipotential Connection

Footswitch Connector

Printer Connection

2 Safety and Care

-40ºC

Indicates this side up

Do not stack

Shipping weight (example)

Do not allow to get wet

Fragile. Handle with care

2 Safety and Care

Symbol Explanation

Do not dispose of by dumping in garbage. Use a separate collection for electrical and electronic equipment.

Fuse

Pinch hazard.

Control panel height adjustment

Do not lean against the monitor.

2 Safety and Care

Example of monitor label.

Example of system warning label with certification labels.

Siemens Medical Solutions USA, Inc. Mountain View

CA 94043 USA

Made in Korea

Example of identification label.

2 Safety and Care

Biohazard Considerations

WARNING: This equipment is not suitable for intracardiac use or direct cardiac contact.

WARNING: For neonatal head imaging, Siemens recommends that you exercise special care during neonatal cephalic scanning to avoid possible damage to the posterior region of the eye. The ultrasound energy emitted by the transducer easily penetrates the fontanels of the infant.

WARNING: Siemens makes every effort to manufacture safe and effective transducers. You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. These precautions should be considered in the use of any application that may indicate the need for such care, and during endocavity or intraoperative scanning; during biopsy or puncture procedures; or when scanning patients with open wounds.

WARNING: To eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials, always dispose hazardous or infectious materials according to medical regulations for biohazardous waste.

WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1.

WARNING: Ultrasound energy is transmitted more effectively through water than through tissue. When using a standoff device of any kind, for example, a gel pad, the actual mechanical and thermal indices, MI and/or TI, may be higher than indicated in the output display on the system.

The assessment of the biological effects of diagnostic ultrasound on humans is a subject of ongoing scientific research. This system, and all diagnostic ultrasound procedures, should be used for valid reasons, for the shortest possible period of time, and at the lowest mechanical and thermal indices necessary to produce clinically acceptable images.

According to the ALARA (As Low As Reasonably Achievable) principles, acoustic output should be set to the lowest level required to satisfactorily perform the examination.

The ultrasound imaging system complies with the standards of the American Institute of Ultrasound in Medicine (AIUM), the National Electrical Manufacturer’s Association (NEMA), the guidelines of the United States Food and Drug Administration (FDA), and the guidelines of the International Electrotechnical Commission (IEC) in terms of safety and acoustic output levels. The ultrasound output levels are stated to permit the user to critically evaluate the system settings in the event of new research findings being announced.

2 Safety and Care

Note on Fetal Examinations

The following recommendation is excerpted from the National Institute of Health in the United States of America. Consensus Statement on the Use of Ultrasound Imaging During Pregnancy, Volume 5, No. 1, based on the recommendation issued at the Health Consensus Development Conference, February, 1984:

Ultrasound examination in pregnancy should be performed for a specific medical indication. The data on clinical efficacy and safety do not allow a recommendation for routine scanning at this time.

Ultrasound examination performed solely to satisfy the family’s desire to know the fetal sex, to view the fetus, or to obtain a picture of the fetus should be discouraged. In addition, visualization of the fetus solely for educational or commercial demonstrations without medical benefit should not be performed.

In August 1994, the Food and Drug Administration (FDA) notified the medical community and the ultrasound industry regarding its concerns about the misuse of diagnostic ultrasound equipment for non-medical purposes, and to discourage patients from having sonograms for non-medical reasons.

The American Institute of Ultrasound in Medicine (AIUM) has also advocated the responsible use of diagnostic ultrasound for all fetal imaging (August 2005).

Acoustic Output — Mechanical and Thermal Indices

WARNING: Ultrasound procedures should be used for valid reasons, for the shortest period of time, and at the lowest mechanical/thermal index setting necessary to produce clinically acceptable images.

The ultrasound system incorporates an output display of Mechanical and Thermal Indices to allow you to monitor, and to limit, the amount of ultrasound energy that is transferred to the patient.

Note: For systems distributed in the United States of America, refer to the Medical Ultrasound Safety ultrasound education program brochure produced by the AIUM that is shipped with the ultrasound system.

See also: Acoustic Output Reference, Appendix D, Instructions for Use

2 Safety and Care

Mechanical and Thermal Indices

The system displays the Mechanical and Thermal Indices during real-time imaging, in all imaging modes, when the Mechanical Index or the Thermal Indices are equal to or exceed a value of 0.4.

Location of mechanical and thermal indices on the image screen.

Indices display in the abbreviated form shown below:

MI: Mechanical Index

TIB: Bone Thermal Index (fetal application)

TIS: Soft Tissue Thermal Index

TIC: Cranial Thermal Index

2 Safety and Care

Transmit Power Control

Adjust the transmit power and the corresponding acoustic pressure delivered through the transducer to the patient by using the designated control on the system. It is the main system function that determines the transmitted intensity of ultrasound for all transducers and imaging modes during real-time imaging, though it is not the only function that affects the mechanical and thermal indices. The range and especially the maximum level of the mechanical and thermal indices differ depending on the transducers. In addition, each diagnostic exam type has preset values for mechanical and thermal indices.

See also: Imaging Functions that Change Acoustic Output, p. 2-14

Note: Maximum transmit acoustic intensity and the mechanical index for each exam type are limited in accordance with the United States Food and Drug Administration’s (FDA) recommendations and guidelines. System default transmit intensity and mechanical index values are always below the FDA recommendations for each exam type. Although some exam types may default to a condition of maximum allowable transmit power, there are other system controls or functions that could raise acoustic output levels.

To increase the transmit power:

During real-time imaging, press the toggle key for P upward to increase transmit power.

To decrease the transmit power:

During real-time imaging, press the toggle key for P downward to decrease transmit power.

2 Safety and Care

Transmit Power Display

The transmit power range is from 0% to 100%. Selecting 100%, in combination with other system controls or functions, generates the maximum acoustic intensity and mechanical index for each transducer, where:

ISPTA.3 : ≤ 720 mW/cm2 and MI ≤ 1.9

Comparison of decibels to percentages.

When the power level is changed, the system briefly highlights the power value to indicate the change.

Location of power display on the image screen.

2 Safety and Care

Imaging Functions that Change Acoustic Output

WARNING: Observe the real-time display of mechanical and thermal indices (MI/TI) at all times.

In addition to the adjustment of the transmit power, adjustment of the following imaging functions and/or controls may affect the acoustic output:

Automatic Time-out

M-mode cursor

Color and Power ROI Position and Size; Steering Angle for linear array transducers

Doppler Gate Position and Size; Steering Angle for linear array transducers

Doppler PRF

Color PRF

Exam Type

Field of View (Scan Angle); 2D Steering Angle for linear array transducers

Focus

Zoom

Frame Rate

Freeze

Image Depth

Imaging Mode

Multi-Frequency

Power On/Off

System Presets and QuickSets

THI

Resolution/Speed

Simultaneous/Update

Transducer

Gel pad use

2 Safety and Care

Transducer Surface Temperature Limits

The following table provides the maximum surface temperature of the transducers compatible with the system.

Maximum surface temperatures are in accordance with IEC 60601-2-37.

Note: The systemic uncertainty of the transducer surface temperature is estimated as 1.39° C.

TMM = Tissue Mimicking Material

Electrical Safety

WARNING: For systems used in the U.S.A.: To ensure grounding reliability, only connect the system to a hospital-grade power outlet.

WARNING: The AC power connector plug for the ultrasound system is a three-prong grounded plug (in the U.S.A.) and should never be adapted to any two-prong (non-grounded) outlet, either by modifying the plug or by using an adapter. In the U.S.A., proper grounding requires the

AC power connector plug to be plugged into a hospital-grade power outlet.

WARNING: To avoid electrical shock, never modify the ultrasound system’s AC power connector plug, as doing so may overload your facility’s power circuits. To ensure grounding reliability, connect the system only to an equivalent outlet.

WARNING: To avoid electrical shock, never use equipment or a MAINS power cord that shows signs of wear or tampering, or whose ground plug has been bypassed using an adapter.

WARNING: Equipment connected to the ultrasound system and in the patient zone must be powered from a medically-isolated power source or must be a medically-isolated device. Equipment powered from a non-isolated source can result in chassis leakage currents exceeding safe levels. Chassis leakage current created by an accessory or device connected to a non-isolated outlet may add to the chassis leakage current of the ultrasound system.

2 Safety and Care

WARNING: Using an extension cord or multi-socket outlet setup to provide power to the imaging system, or to the system’s peripheral devices may compromise the system grounding and cause your system to exceed leakage current limits.

WARNING: To avoid electrical shock and damage to the ultrasound system, power off and unplug the equipment from the AC power outlet before cleaning and disinfecting.

WARNING: Do not pour any fluid onto the ultrasound system surfaces, as fluid seepage into the electrical circuitry may cause excessive leakage current or system failure.

WARNING: To ensure proper grounding and leakage current levels, it is the policy of Siemens to have an authorized Siemens representative or Siemens-approved third party perform all on-board connections of documentation and storage devices to the ultrasound system.

WARNING: To maintain the safety and functionality of the ultrasound system, maintenance must be performed every 12 months. Electrical safety tests must also be performed at regular intervals as specified by local safety regulations, or as needed.

Caution: To avoid the possibility of static shock and damage to the system, avoid the use of aerosol spray cleaners on the monitor screens.

Caution: Do not use spray cleaners on the ultrasound system, as this may force cleaning fluid into the system and damage electronic components. It is also possible for the solvent fumes to build up and form flammable gases or damage internal components.

Caution: To reduce the risk of fire and subsequent equipment damage, use only 26 gauge (0.14 mm2) or heavier wire for the cable connecting to the Ethernet port located on the ultrasound system.

EMC Note: Operating the ultrasound system in close proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations, may lead to interference visible on the monitor screen. However, the device has been designed and tested to withstand such interference and will not be permanently damaged.

2 Safety and Care

Level of Protection Against Electrical Shock — Transducers

WARNING: Only use Type BF transducers with the ultrasound system to maintain a level of protection against electrical shock.

According to EN 60601-1 and IEC 60601-1, the assemblies for the linear, curved, and phased array transducers provide a «Level of Protection Against Electrical Shock» of «Type BF.»

The Type BF icon is located on the transducer label.

Defibrillators

WARNING: The ECG function is designed to withstand the effects of defibrillation. However, when possible, disconnect the ECG leads during defibrillation since a malfunction of the safety controls could otherwise result in electrical burns for the patient.

For patient safety, be sure to use defibrillators that do not have grounded patient circuits.

Pacemakers

WARNING: Pacemakers may be susceptible to the high frequency electrical signal generated by ultrasound equipment. Use precautions when using ultrasound equipment on or near someone with a pacemaker. If there is interference, immediately discontinue the examination and power off the ultrasound system.

Possible Combinations with Other Equipment

WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN and IEC standards (for example, EN 60950 and IEC 60950 for data processing equipment and EN 60601-1 and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standards

EN 60601-1-1 and IEC 60601-1-1. Anyone who connects additional equipment to any of the signal input or signal output ports configures a medical system and is therefore responsible that the system complies with the requirements of the system standards EN 60601-1-1 and

IEC 60601-1-1. Siemens can only guarantee the performance and safety of the devices listed in the Instructions for Use. If in doubt, consult the Siemens service department or your local Siemens representative.

The ultrasound system supports three on-board documentation devices. The ultrasound system can support two on-board documentation devices at one time.

On-board peripheral devices must be installed by an authorized Siemens representative or by a Siemens-approved third party. Devices installed by other people will be at the user’s risk and may void the system warranty.

2 Safety and Care

Ultrasound System — Care

It is the responsibility of the user to verify that the ultrasound system is safe for diagnostic operation on a daily basis. Each day, prior to using the system, perform each of the steps in the Daily Checklist.

All exterior parts of the system, including the control panel, keyboard, and transducers, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect components to kill vegetative organisms and viruses.

The air filter on the ultrasound system must be cleaned regularly to maintain proper system cooling. Remove and check the air filter weekly, and clean as needed.

Daily Checklist

Perform the following each day before using the ultrasound system:

Visually inspect all transducers. Do not use a transducer which has a cracked, punctured, or discolored casing or a frayed cable.

WARNING: To avoid electrical shock, you must visually inspect a transducer prior to use. Do not use a transducer that has a cracked, punctured, or discolored casing or a frayed cable.

Discoloration Exception: The use of the approved disinfectants, Cidex OPA and Gigasept FF, may cause discoloration of transducer housings, including the face of the transducer. You can continue to use a transducer if it is discolored due to the use of these specific disinfectants only.

See also: Approved List of Disinfectants, p. 2-33.

Visually inspect all power cords. Do not turn on the power if a cord is frayed or split, or shows signs of wear.

If your system’s power cord is frayed or split, or shows signs of wear, contact your Siemens service representative for power cord replacement.

Visually inspect the ECG connector and the cable. Do not use the ECG function if the connector or cable is damaged or broken.

Verify that the trackball, DGC slide controls, and other controls on the control panel are clean and free from gel or other contaminants.

Once the system is powered on:

Visually check the on-screen displays and lighting.

Verify that the monitor displays the current date and time.

Verify that the transducer identification and indicated frequency are correct for the active transducer.

2 Safety and Care

Maintenance

WARNING: To maintain the safety and functionality of the ultrasound system, maintenance must be performed every 12 months. Electrical safety tests must also be performed at regular intervals as specified by local safety regulations, or as needed.

Repair

For questions regarding repair or replacement of any equipment parts on your system, contact your Siemens service representative.

Siemens Authorized Care

Installers and operators must observe any statutory regulations that govern the installation, operation, inspection, and maintenance of this equipment.

To ensure the safety of patients, operators, and third parties, the equipment must be inspected every 12 months, and the replacement of parts is performed as necessary. This maintenance must be performed by a qualified Siemens authorized representative. It is important to inspect the equipment more frequently if it is operated under extraordinary conditions.

Perform inspections and maintenance at the prescribed intervals to avoid worn and hazardous parts due to wear. Contact the Siemens service department for information regarding the required maintenance. As manufacturers and installers of ultrasound equipment, Siemens cannot assume responsibility for the safety properties, reliability, and/or performance of the equipment, if:

Installations, extensions, readjustments, modifications, additions, or repairs are carried out by persons not specifically authorized by Siemens.

Components that affect the safe operation of the system are replaced by parts not authorized by Siemens.

The electrical installation of the room where the equipment is located does not meet the power and environmental requirements stated in this manual.

The equipment is not used in accordance with the operating instructions.

The system is operated by personnel not adequately educated or trained.

2 Safety and Care

Siemens suggests that you request any person who performs maintenance, or repairs, to provide you with a certificate showing:

The nature and extent of the work performed

Changes in rated performance

Changes in working ranges

Date of service

Name of person or firm performing the service

Signature of person performing the service

Technical documentation pertinent to the ultrasound system is available at an additional charge. However, this does not in any way constitute an authorization to conduct repairs or maintenance. Siemens refuses all responsibility whatsoever for repairs that are performed without the express written consent of the Siemens service department.

WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN and IEC standards (for example, EN 60950 and IEC 60950 for data processing equipment and EN 60601-1 and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standards

EN 60601-1-1 and IEC 60601-1-1. Anyone who connects additional equipment to any signal input or signal output ports configures a medical system and is therefore responsible that the system complies with the requirements of the system standards EN 60601-1-1 and

IEC 60601-1-1. Siemens can only guarantee the performance and safety of the devices listed in the Instructions for Use. If in doubt, consult the Siemens service department or your local Siemens representative.

2 Safety and Care

Cleaning and Disinfecting

You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. Use universal precautions when cleaning and disinfecting. You should treat all portions of the imaging system that come in contact with human blood or other body fluids as if they were known to be infectious.

All exterior parts of the system, including the control panel, and transducers, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect the components to kill vegetative organisms and viruses.

Cleaning and Disinfecting the System

WARNING: To avoid electric shock and damage to the system, always power off and disconnect the equipment from the AC power source before cleaning and disinfecting.

WARNING: Contents of some disinfecting agents are known to be health hazards. Their concentration in the air must not exceed an applicable specified limit. Comply with the manufacturer’s instructions when using these agents.

Caution: To avoid the possibility of static shock and damage to the ultrasound system, avoid the use of aerosol spray cleaners on the monitor screens.

Caution: Do not clean the system with chlorinated or aromatic solvents, acidic or basic solutions, isopropyl alcohol or strong cleaners such as ammoniated products, as these can damage the surface of the system. Isopropyl alcohol exception: It is acceptable to use isopropyl alcohol only when recommended for cleaning the trackball assembly. Use the recommended cleaning procedure.

See also: Trackball Cleaning, p. 2-22

Caution: Do not use spray cleaners on the ultrasound system, or pour fluid onto the system surfaces, as fluid can seep into the system and damage electronic components. It is also possible for the solvent fumes to build up and form flammable gases or damage internal components.

Caution: Do not pour any fluid onto the ultrasound system surfaces, as fluid seepage into the electrical circuitry may cause excessive leakage current or system failure.

2 Safety and Care

System Surfaces

The following instructions describe cleaning the surface of the ultrasound system, including the trackball and transducer holder.

To clean the surface of the ultrasound system:

1.Power off () the ultrasound system and unplug the power cord from the power outlet.

2.Use a clean gauze pad or lint-free cloth, lightly moistened with a mild detergent, to wipe the surface of the ultrasound system.

Take particular care to clean the areas near the trackball and the slide controls. Ensure these areas are free of gel and any other visible residue.

Ensure that cleaning solution does not seep into the control panel, keyboard, or any other openings.

3.After cleaning, use a clean, lint-free cloth to dry the surface.

4.After cleaning, reconnect the ultrasound system power cord into the power outlet.

To clean the liners of the transducer holders:

1.Use the tab to remove the liner from the transducer holder.

2.Clean the liner under running water, using a mild detergent and dry with a lint-free cloth.

3.Reinsert the liner into the transducer holder.

See also: System Setup, Chapter 3, Instructions for Use

To clean the trackball:

Caution: Do not drop or place foreign objects inside the trackball assembly. This may affect the trackball’s operation and damage the system.

Caution: Do not submerge the front bezel and Teflon seal in isopopyl alcohol — this may damage the adhesive bond between the two components.

1.Remove the trackball front panel bezel by rotating the bezel counterclockwise.

2.Remove the ball.

3.Clean the ball with tissue and isopropyl alcohol.

4.Clean the Teflon seal (located in the front panel bezel) with a tissue and isopropyl alcohol.

5.Clean the inside of the trackball assembly with a cotton swab and isopropyl alcohol.

6.Allow the assembly parts to completely dry before reassembly.

7.Replace the ball and front panel bezel.

2 Safety and Care

Cleaning an Air Filter

The air filter on the ultrasound system must be cleaned regularly to maintain proper system cooling. Remove and check the air filter weekly, and clean as needed.

The filter location is marked with the air filter symbol.

Location of air filter.

2 Safety and Care

To remove and clean the air filter:

Caution: Do not scrub, stretch, or bend the filter, or apply heat to the filter, as doing so could damage the filter.

1.Power off and unplug the power cord from the power outlet.

2.Grasp the air filter tray and pull it out of the system.

1 Air filter

2 Air filter tray

1

2

Removing the air filter tray.

3.Remove the filter.

4.Rinse the air filter with running water and allow the filter to completely dry.

To hasten drying, you may gently shake the filter, or blot the filter with a clean, lint-free cloth.

Caution: Do not insert a wet filter as this can damage the system.

5.Reinsert the filter into the filter tray.

6.Slide the air filter tray back into the ultrasound system.

7.Plug the power cord into the power outlet.

2 Safety and Care

Caring for the Battery Pack

WARNING: Do not strike or drop the battery pack because this can cause heat generation, bursting, or fire. Compromising the structural integrity of the battery pack can result in leakage or explosion and the potential for personal injury.

WARNING: Do not use the battery pack if it leaks fluid or has changed shape. If skin or clothing comes in contact with fluid from the battery pack, thoroughly wash the area immediately with clean water. If any fluid comes in contact with a user’s eyes, immediately flush their eyes with water and seek medical attention.

WARNING: Do not allow the battery pack to contact water. Compromising the structural integrity of the battery pack can result in leakage or explosion and the potential for personal injury.

WARNING: Do not disassemble the battery pack. Compromising the structural integrity of the battery pack can result in leakage or explosion and the potential for personal injury.

The battery pack is designed to maintain system memory for a maximum of forty minutes.

The length of the charge time is three hours.

Battery Pack Location

The battery pack is located on the front side of the ultrasound system, where the power is located. The battery pack cover must be removed to access the battery pack.

1 Battery pack location

1

Battery pack location.

2 Safety and Care

Battery Pack Replacement and Disposal

Replace the battery pack when it is no longer able to hold a charge.

When the system is used with the Mobile QuickStart option and frequently disconnected from the AC power (for a duration of greater than 20 minutes), replace the battery every 6 months.

When the system is used with the Mobile QuikStart option and only occasionally disconnected from the AC power (for a duration of approximately 20 minutes), replace the battery every year.

Example of an AC Tray panel with the battery pack charge indicator LED.

The battery pack charge indicator LED is located at the rear of the system, on the AC Tray panel. A green blinking LED indicates that the battery is actively charging. A solid green LED indicates that the battery pack is fully charged. If the LED is not illuminated, then there is a problem with the battery pack, or the battery pack may be missing.

2 Safety and Care

Battery Pack Disposal

Caution: Never dispose of a battery pack by burning or by flushing into any waste water system, for example, a lavatory. Compromising the structural integrity of the battery pack can result in leakage or explosion and the potential for personal injury.

Caution: Collect and dispose of used battery packs separate from other waste. Do not throw into trash.

The battery pack should be recycled according to local, state and federal regulations. Use a battery collection program available in your country to dispose of the battery pack. The following agencies may be contacted for further collection information:

Australia – Australian Battery Recycling Program (AMTA)

Austria – UFB

Belgium – Bebat

Canada – Rechargeable Battery Recycling Corporation (RBRC)

Denmark – BatteriForeningens

European Union – European Portable Battery Association

France – Societe de Collecte et de Recyclage des Accumulateurs (SCRA)

Finland – (NBA)

Germany – Stiftung Gemeinsames Rucknahmesystem Batterien (GRS)

Italy – COBAT

Japan – Battery Association of Japan

Netherlands – Stibat

Norway – REBATT AS

Portugal – AGEFE

Sweden – CT

Switzerland – Batterieentsorgungs-Selbsthilfeorganisation (BESO)

United Kingdom – REBAT

United States of America – Rechargeable Battery Recycling Corporation (RBRC)

Note: If a local battery recycling program does not exist then return used batteries to the address below. When returning batteries, label the package: «Attn.: Battery Recycling».

Siemens AG

Medical Engineering

TD ML RE

Betr.: Battery Recycling

Am Pestalozziring 3

D-91058 Erlangen

GERMANY

2 Safety and Care

Documentation and Storage Devices — Care

For information on the care of an optional documentation or storage device, please refer to the manufacturer’s operating instructions that accompanied the device.

Transducers — Care

WARNING: Always place a sterile, non-pyrogenic transducer sheath on a transducer used in procedures requiring sterility.

WARNING: To minimize the risk of cross-contamination and infectious diseases, intraoperative transducers must be cleaned and high-level disinfected after each use. A sterile, non-pyrogenic transducer sheath must be in place during procedures requiring sterility.

WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1.

WARNING: During neurosurgical procedures, if a transducer becomes contaminated with tissue or fluids of a patient known to have Creutzfeld-Jacob disease, the transducer should be destroyed, as it cannot be sterilized.

WARNING: When using an endocavity or intraoperative transducer with a CF type applied part, the patient leakage currents may be additive.

WARNING: The outer surfaces of an endocavity or intraoperative transducer should be checked to ensure there are no unintended rough surfaces, sharp edges, or protrusions that may cause a safety hazard.

Caution: Transducers are sensitive instruments – irreparable damage may occur if they are dropped, knocked against other objects, cut, or punctured. Do not attempt to repair or alter any part of a transducer.

Caution: To avoid cable damage, do not roll the system over transducer cables.

Caution: To avoid damage to the transducer, do not use transducer sheaths containing an oil-based coating or petroleumor mineral oil-based ultrasound coupling agents. Use only a water-based ultrasound coupling agent.

Caution: Follow all instructions provided by manufacturers of sterile goods (transducer sheaths) to ensure proper handling, storage, and cycling of all sterile goods.

Take extreme care when handling or storing transducers. They must not be dropped, jarred, or knocked against other objects. Do not allow transducers to come into contact with any sharp-edged or pointed object.

2 Safety and Care

Cleaning and Disinfecting Transducers

WARNING: To avoid electrical shock and damage to the system, disconnect the transducer prior to cleaning or disinfecting.

WARNING: Disinfectants and cleaning methods listed are recommended by Siemens for compatibility with product materials, not for biological effectiveness. Refer to disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses.

Caution: Do not sterilize transducers using hot steam, cold gas, or Ethylene Oxide (ETO) methods. Before applying any other methods which might be recommended by manufacturers of sterilization equipment, please contact your Siemens representative.

Caution: To avoid damage to the transducer, observe the immersion levels indicated for each transducer type. Do not immerse or allow the cable or connector of a transducer to become wet.

Caution: The transducers have been designed and tested to be able to withstand high-level disinfection as recommended by the manufacturer of the disinfectant product. Carefully follow the disinfectant manufacturer’s instructions. Do not immerse for more than one hour.

Caution: Do not use abrasive cleaning agents, organic solvents such as benzene, isopropyl alcohol, or phenol-based substances, or cleaning agents containing organic solvents to clean or disinfect transducers. These substances can damage the transducers.

Caution: Do not use a spray cleaner on a transducer, as this may force cleaning fluid inside the housing and damage the transducer.

All transducers should be cleaned and disinfected prior to their use on each patient. Endocavity and intraoperative transducers require high-level disinfection prior to use.

See also: Transesophageal Transducer, Chapter 6, Instructions for Use

2 Safety and Care

To clean a transducer:

1.Disconnect the transducer from the system.

2.Moisten a clean gauze pad with water and wipe the transducer to remove any gel or particles remaining on the transducer. If water is not effective, then you can use an approved pre-cleaner or low-level disinfectant.

3.Carefully wipe the entire transducer, including the cable and connector.

4.After cleaning or disinfecting, use a clean cloth to dry the transducer.

To disinfect or high-level disinfect a transducer:

1.Disconnect the transducer from the system.

2.Thoroughly clean, rinse, and dry the transducer.

3.Take care to keep the cable strain relief and connector of the transducer dry while immersing the transducer in an approved disinfectant to the level indicated in the following illustration.

4.Carefully follow the disinfectant manufacturer’s instructions for disinfection or high-level disinfection.

5.After disinfecting or high-level disinfecting, use a clean cloth to dry the transducer.

2 Safety and Care

IPX8 Immersion Levels

Caution: To avoid damage to the transducer, observe the immersion levels indicated for each transducer type. Transducers with the protection level IPX8 are indicated by the presence of the «IPX8» symbol on the connector of the transducer.

Transducers meet Ingress Protection level IPX8 of EN 60539 and IEC 60539 to the depth of the immersion line shown in the illustration only for transducers with the «IPX8» symbol on the connector of the transducer.

Example of transducer labels with IPX8 symbol.

!

Caution: Do not immerse the label located on the cable of the CW transducer.

Note: Intraoperative transducers are immersible up to the strain relief on the connector.

2 Safety and Care

Approved List of Pre-Cleaners and Low-Level Disinfectants

The following matrix provides a list of approved pre-cleaners and low-level disinfectants for all transducers.

9 = compatible

NC = not compatible

NA = not applicable (not tested)

* = Compatible pre-cleaners and low-level disinfectants for the P5-1 transducer include: T-Spray, ANIOS, Wavicide-01, MetriZyme, and Klenzyme.

2 Safety and Care

Approved List of Disinfectants

The following matrix provides a list of approved disinfectants for all transducers.

Note: The approved disinfectants, Cidex OPA and Gigasept FF, may discolor transducer housings, including the face of the transducer. There is no associated degradation of imaging performance or transducer reliability.

9 = compatible

NC = not compatible

NA = not applicable (not tested)

2 Safety and Care

Sterilizing Transducers — VF13-5SP

Caution: The transducers have been designed and tested to be able to withstand sterilization as recommended by the manufacturer of the sterilization system. Carefully follow the sterilization manufacturer’s instructions.

The STERRAD® sterilization system, a hydrogen peroxide gas plasma sterilization system, is approved for use with the listed intraoperative transducer(s).

VF13-5SP

To sterilize a transducer with the STERRAD system:

Note: This procedure applies to the VF13-5SP transducer only.

1.Disconnect the transducer from the system.

2.Thoroughly clean, rinse, and dry the transducer.

3.Carefully follow the manufacturer’s instructions for sterilization.

Storage

Store transducers in a clean and dry environment. Extreme temperatures or humidity may damage a transducer.

See also: Technical Description, Appendix A, Instructions for Use

Repair

Do not attempt to repair or alter any part of the transducer. Contact your service representative at Siemens immediately if a transducer appears to be damaged or malfunctions in any way.

Protective case

Due to the mechanical sensitivity of transducers, Siemens recommends that you always use the transducer case when you ship a transducer or transport it from one place of examination to another. The case is specially designed to protect the sensitive parts of the transducer. Be sure that all parts of the transducer are properly placed inside the case before you close the lid.