GE Vivid 7 User Manual
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User maintenance Vivid7/Vivid7 PRO Users Manual457 FC092326-03 Prevention of static electricity interference Interference from static electricity can damage electronic components in the system. The following measures help to reduce the likelihood of electrostatic discharge: • Wipe the alphanumeric keyboard and monitor with lint-free tissue or a soft cloth dampened with anti-static spray on a monthly basis. • Spray carpets with anti-static spray because constant walking on carpets in or near the scanning room may be a source of static electricity. WARNINGAllow the filter to dry thoroughly before re-installing it in the unit.
User maintenance 458Vivid7/Vivid7 PRO Users Manual FC092326-03 Troubleshooting The Vivid 7/Vivid 7 PRO ultrasound unit is engineered for reliable operation and consistent, high-quality performance. Automatic self-testing facilities are provided to monitor system operation and to detect faulty operation as soon as possible, thereby eliminating unnecessary downtime. The detection of any serious malfunction results in immediate interruption of scanning, and is indicated by an error message on the monitor screen. System malfunction In the event of error or system malfunction generate a log file as described below and contact authorized service personnel. Generating a logfile 1. Press ALT - D on the alphanumeric keyboard. The Problem description dialogue window is displayed. Figure 13-2: The Problem description dialogue window 2. Type in a description of the problem. Notes should be made regarding the selected probe, the imaging mode and the application that was being used at the time of malfunction.
User maintenance Vivid7/Vivid7 PRO Users Manual459 FC092326-03 If applicable, try to record the button or key pushing sequence that immediately preceded the problem. 3. Select where to store the logfile. 4. Press OK. 5. Turn the unit off (see page 18) 6. Do not use the unit until authorized service personnel have restored it to its fully operational state.
User maintenance 460Vivid7/Vivid7 PRO Users Manual FC092326-03
Safety Vivid7/Vivid7 PRO Users Manual461 FC092326-03 Chapter 14 Safety This chapter includes the following information: • Introduction ................................................................................... .. 463 • Owner responsibility .................................................................... .. 464 • Important safety considerations ................................................. .. 465 • Notice against user modification .............................................. 465 • Regulatory information ................................................................ .. 466 • Standards used ........................................................................ 466 • Device labels ................................................................................. .. 468 • Acoustic output ............................................................................. .. 471 • Definition of the acoustic output parameters ............................ 471 • Acoustic output and display on the Vivid 7/Vivid 7 PRO .......... 472 • ALARA ..................................................................................... 473 • Safety statement ...................................................................... 473 • System controls affecting acoustic output ................................ 473 • Patient safety ................................................................................. .. 476 • Patient identification ................................................................. 476 • Diagnostic information .............................................................. 476 • Mechanical hazards ................................................................. 476 • Personnel and equipment safety ................................................. .. 478 • Explosion hazard ...................................................................... 478 • Implosion hazard ...................................................................... 478 • Electrical hazard ....................................................................... 478 • Moving hazard .......................................................................... 479 • Biological hazard ...................................................................... 479 • Pacemaker hazard ................................................................... 480 • Electrical safety ............................................................................. .. 481 • Device classifications ............................................................... 481 • Internally connected peripheral devices ................................... 481
Safety 462Vivid7/Vivid7 PRO Users Manual FC092326-03 • External Connection of other peripheral devices ...................... 481 • Allergic reactions to latex-containing medical devices ............ ... 482 • Electromagnetic Compatibility (EMC) ........................................ ... 483 • Environmental protection ............................................................ ... 485 • System disposal ........................................................................ 485
Safety Vivid7/Vivid7 PRO Users Manual463 FC092326-03 Introduction This section describes the important safety measures which should be taken before operating the Vivid 7/Vivid 7 PRO ultrasound unit. Procedures for simple care and maintenance of the unit are also described. Various levels of safety precautions may be found on the equipment, and different levels of severity are identified by one of the following icons that precede precautionary statements in the text. The following icons are used to indicate precautions: Other precautions or prudent-use recommendations are indicated in the note sections in the left column. These are: • Use of the Vivid 7/Vivid 7 PRO ultrasound unit as a prescription device, under the order of a physician. • Maintaining an optimum unit environment. • Reference to the Users Manual. DANGERIndicates that a specific hazard exists that, given inappropriate conditions or actions, will cause: • Severe or fatal personal injury • Substantial property damage WARNINGIndicates that a specific hazard exists that, given inappropriate conditions or actions, will cause: • Severe or fatal personal injury • Substantial property damage CAUTIONIndicates that a potential hazard may exist that, given inappropriate conditions or actions, can cause: • Minor injury • Property damage Marks sections or chapters in the user manual which give information related to components on the ultrasound unit or to accessories marked with this same label (see also page 469).
Safety 464Vivid7/Vivid7 PRO Users Manual FC092326-03 Owner responsibility It is the responsibility of the owner to ensure that anyone operating the system reads and understands this section of the manual. However, there is no representation that the act of reading this manual renders the reader qualified to operate, inspect, test, align, calibrate, troubleshoot, repair or modify the system. The owner should make certain that only properly trained, fully-qualified service personnel undertake the installation, maintenance, troubleshooting, calibration and repair of the equipment. The owner of the Vivid 7/Vivid 7 PRO ultrasound unit should ensure that only properly trained, fully qualified personnel are authorized to operate the system. Before authorizing anyone to operate the system, it should be verified that the person has read, and fully understands, the operating instructions contained in this manual. It is advisable to maintain a list of authorized operators. Should the system fail to operate correctly, or if the unit does not respond to the commands described in this manual, the operator should contact the nearest field GE Ultrasound Service Office. For information about specific requirements and regulations applicable to the use of electronic medical equipment, consult the local, state and federal agencies. CAUTIONFor USA only: Federal law restricts this device to use by, or on the orders of, a physician.
Safety Vivid7/Vivid7 PRO Users Manual465 FC092326-03 Impor tant safety considerations Notice against user modification Never modify this product, including system components, software, cables, and so on. User modification may cause safety hazards and degradation in system performance. All modification must be done by a GE qualified person. This section includes considerations for the following: • Patient safety • Personnel and equipment safety The information contained in this section is intended to familiarize the user with the hazards associated with the use of the unit, and to alert them to the extent to which injury and damage may occur if the precautions are not observed. Users are obligated to familiarize themselves with these safety considerations and to avoid conditions that could result in injury or damage.
Safety 466Vivid7/Vivid7 PRO Users Manual FC092326-03 Regulator y infor mation The GE Vingmed Ultrasound product families are tested to meet all applicable requirements in relevant EU Directives and European/International standards. (See “Standards used” below.) Any changes to accessories, peripheral units or any other part of the system must be approved by the manufacturer: GE Vingmed Ultrasound. Ignoring this advice may compromise the regulatory approvals obtained for the product. Please consult your local GE Vingmed Ultrasound representative for further details. Standards used The Vivid 7/Vivid 7 PRO ultrasound unit is a Class I device, type CF, according to Sub-clause 14 of IEC 60601-1 (1988). To fulfill the requirements of relevant EC directives and/or European Harmonized/International standards, the following documents/standards have been used: Standard/Directive Scope 93/42/EEC Medical Devices Directive (MDD) EN 55011/CISPR 11/ 3.1991Emitted noise according to Class B requirements + Electromagnetic Susceptibility IEC 60601-1 (1988) EN 60601-1 (1990) UL 2601-1/ 8 (1994)Medical Electrical Equipment, Part 1; General Requirements for Safety “CLASSIFIED BY UNDERWRITERS LABORATARIES INC WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL2601-1 AND CAN/CSA C22.2 NO.601.1” IEC 1157/ EN 61157/ (1994)Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment. EN 60601-1-2 (2001) Medical Electrical Equipment - part 2. Collateral standard: Electromagnetic compatibility - Requirements and tests.