esaote
MyLab Guide User Manual Ver 05B70EN01
User Manual
73 Pages

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User Manual
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The Medical Device, specified hereafter, meets the provisions of the Medical Device Directive 93/42 EEC (93)
The device configuration is listed in the attached configuration list. The CE marking of conformity applied to this device encompasses all other relevant Directives. For US Customers: US Federal Law restricts this device to sale, distribution and use by or on the order of a physician.
Esaote Europe B.V. Philipsweg 1, 6227 AJ Maastricht, The Netherlands Phone +31-43-3824.600 Fax +31-43-3824.601 www.esaote.com Version: 05B70EN01
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MANUFACTURER’S RESPONSIBILITY MyLabTMGuide is manufactured by Esaote Europe B.V., which is part of the Esaote Group. Esaote Europe is responsible for the safety, reliability and functioning of this product only if: • the user follows all the instructions contained in this manual for the use and maintenance of this system; • this manual is kept integral and readable in all its parts; • calibrations, modifications and repairing are performed only by ESAOTE qualified personnel; • the environment where the system is used complies with the current safety rules; • the electricity of the environment where the system is used complies with the current applicable rules and operates efficiently.
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PRODUCT TRACEABILITY To guarantee the product traceability according to the quality standard ISO13485 and by the European Directive on Medical Devices 93/42/EEC, Esaote/Esaote Europe kindly requests the original owner of the equipment to communicate to our central office, or to one of our subsidiaries, or to one of our official distributors of any eventual conveyance of the product property. Please use a duly filled copy of the form below or send the same data indicated in this form. All data relating to the system can be found on its identification label.
Product Traceability Form To:
Esaote Europe B.V. Quality Assurance Department Philipsweg, 1 6227AJ Maastricht (NL)
ESAOTE system/device name: ... REF: ... SN: ... Name and address of the original owner: ... ... Name and address of the new owner: ... ... Date: Signature
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VIGILANCE SYSTEM This equipment is subject to Esaote/Esaote Europe vigilance system (postmarketing vigilance) in case of potential or real hazards for the patient or for the operator which might occur during the normal system functioning, in order to be able to remove them with the best efficiency and timing. Therefore if the user records any malfunction or deterioration in the characteristics and/or performances of the device, as well as any inadequacy in the labelling or the instructions for use which might lead to potential or real hazards for a patient or for an operator, we kindly request to immediately inform the Esaote/Esaote Europe central office, or one of our subsidiaries, or one of our official distributors immediately through the following form, or send the same data indicated in this form. All data relating to the system can be found on its identification label. In this way we will be able to take all adequate measures with the best efficiency and timing.
Post-Marketing Vigilance Form To:
Esaote Europe B.V. Quality Assurance Department Philipsweg, 1 6227AJ Maastricht (NL)
ESAOTE system/device name: ... REF: ... SN: ... Description of the potential/real hazard: ... ... Notes and suggestions: ... ... Contact Person/Department: ... Address: ... Phone: ... Fax: ... Date: Signature
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MANUAL UPDATE SHEET Attached is a complete version of the MyLabTMGuide User’s manual. All pages carry the same version number: 05B70EN01. If there is an update for this version, please remember to recycle the replaced pages.
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MyLabTMGuide User Manual
Device Configuration List MyLabTMGuide
Unit and probe Article #
Description
97154 411501
MyLabTMGuide basic configuration in transport case with the following items: - Scanner and probe hardwired to the unit - 1 Battery (cable included) - Battery charger and travel kit - User manual - AC Mains Supply - Bottle of gel
Options Article #
Description
97154 411042
Roll Stand
97154 411102
Roll Stand Adapter
97154 410057
Battery Pack
97154 411517
MyLabTMGuide Communication Package
97154 411267
Battery Charger
97154 411038
AC Power Supply
97154 411043
Desk Stand
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MyLabTMGuide User Manual
Explanation of Symbols Symbol
Description Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive 93/42/EEC. Equipment conforms to IEC60601 Type CF requirements for medical electrical equipment.
Video Output.
Refer to the user manual before activation of the unit.
Waste of electrical and electronic equipment (2002/96/EC)
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Table of Contents Device Configuration List MyLabTMGuide...ix Intended Clinical Use and Safety Information...1 Safety information ...2 Electrical Safety ...2 Electromagnetic Compatibility...2 Warnings and Precautions...3 Precautions ...5
System Content and Set Up ...7 Contents of the Package ...7 Options...7
MyLabTMGuide Set Up...8 Inspection of the MyLabTMGuide...8 Rear panel of the MyLabTMGuide:...8
Preparing the examination environment ... 10 Should you still have problems starting up the system, please contact Esaote. ... 10 How to attach the MyLabTMGuide to the roll stand ... 10 How to get started ... 10 Operating in a Sterile Environment... 11
Control Panel & Screen Information ...13 The Keypad...13 The direct operating keys...15 The Screen...17 Optimize image presentation ...18 Probe Frequencies...18 Video processing ...18
System and Application Settings ...19 System settings ... 19 Application settings ... 20 Reinstalling manufacturer’s default settings ... 21
Main Menu ...23 Image modes...23 B Mode ...23 Double B Mode ...23 B + M Mode...24 M Mode ...24 Version: 05B70EN01
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MyLabTMGuide User Manual Zoom ...24
Macros (Shortcuts) ... 25 Save/Recall image ... 25 Image to disk...25 Image from disk...26 Delete from disk ...26 Format disk ...27 Format disk ...27
Text ... 27 Enter text...27 Hide text ...27 Expose Text ...28 Erase text line ...28 Erase text option ...28
Applications ... 28 Select Application...28 Settings ...29 Edit ...31 Frequency ...32
Program ... 32 System settings...33 Caliper settings ...35 Gray Maps...36 Macro ...37 How to use a Macro ...39 How to delete a Macro ...39 Installation ...39
About the scanner ... 40
Measurements...41 B Mode Measurements... 42 Distance ...42 Length (manual/auto follow)...42 Area/Circumference (manual/auto follow) ...43 Ellipse (Area/Circumference/Volume)...43 Angle ...44
M Mode measurement ... 44
Vascular Access Procedure...45 General Information ...45 Probe Preparation ...45 Use of the Scanner ...46 Version: 05B70EN01
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Cleaning, Disinfection and Maintenance ...47 Handling and Care ... 47 Probe Warnings and Precautions ... 47 Products and procedures that may damage the probes...47
General probe cleaning ... 48 Probe Disinfection ... 50 Probe Sterilization ... 51 Cleaning of the Scanner... 53 Cleaning of the battery ... 53 Cleaning of the protective case... 53 Cleaning of the roll stand... 53 Ultrasound coupling gel... 54 Sterile Covers... 54
Acoustic Output Information ...55 FDA Tables ... 55
Specifications...59
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MyLabTMGuide User Manual
Intended Clinical Use and Safety Information
The following table lists the intended clinical use of the MyLabTMGuide and its integrated probe. Art.# 97154 411501
Type MyLabTMGuide
Probe Linear 20 mm
configuration
10- 5 MHz
Indications for use Peripheral vascular Small organs Musculoskeletal (conventional and superficial) Intra-operative (abdominal, vascular)
Peripheral vascular This system transmits ultrasound energy into the various parts of the body using 2D and M Mode imaging to obtain ultrasound images. The most common structures imaged are carotid arteries, deep veins in the arms and legs, and great vessels in the abdomen. The system provides ultrasound guidance to assist in the placement of needles and catheters in vascular or other anatomical structures, peripheral line placement, as well as interventional radiology procedures. Small Organs and Musculoskeletal (Conventional and Superficial) This system transmits ultrasound energy into the various parts of the body to obtain 2D and M Mode images of normal structures and some pathologies of the breast, thyroid, superficial soft tissue, shoulder joints, wrist, ankle, and knee, which can be used to assess the presence and extent of some diseases and injuries. Intraoperative (abdominal and vascular) This system transmits ultrasound energy into the various parts of the body using 2D and M Mode imaging to obtain ultrasound images that provide guidance during interventional and intra-operative procedures. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, and provide assistance during abdominal and vascular intraoperative procedures. Version: 05B70EN01
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Safety information
$ NOTE: The user should always follow the ALARA (As Low As Reasonably Achievable) principle. Use the lowest amount of acoustic output power for the shortest duration of time to obtain the necessary clinical diagnostic information. Electrical Safety As defined in EN60601-1 (IEC Standard 601-1, Safety of Medical Electrical Equipment), this equipment is classified as Class II, type CF (probes). The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of system safety. - Use of the accessory in the PATIENT VICINITY: Evidence that safety certification of the ACCESSORY is in accordance with the appropriate IEC60601-1-1/IEC60950 and/or IEC60601-1-2 harmonized national standard. Electromagnetic Compatibility This equipment has been tested and found to comply with the limits for medical devices to the IEC60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one more of the following measures: Relocating the system Increasing the separation from other devices Powering the ultrasound system from an outlet different from the one of interfering device Contacting ESAOTE service personnel for help In the presence of RF interference, the physician must evaluate the image degradation and its diagnostic impact Warning: Use of accessories and cables other then those specified in the MyLabTMGuide manual, Chapter “System content and set-up”, may result in increased emission or decreased immunity of the system
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Guidance and manufacturer’s declaration – electromagnetic emissions The MyLabTMGuide is intended for use in the electromagnetic environment specified below. The customer or the user of the MyLabTMGuide should assure it is used in such an environment. Electromagnetic environment Emissions test Compliance guidance RF emissions Group 1 The MyLabTMGuide uses RF energy only CISPR 11 for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A CISPR 11 The MyLabTMGuide is suitable for use in all establishments other than domestic, Harmonic Not applicable and may be used in domestic emissions establishments and those directly CISPR 11 connected to the public network that IEC 61000-3-2 supplies buildings used for domestic Voltage Not applicable purposes, provided the following caution fluctuations/ is heeded: flicker emissions IEC 61000-3-3 Caution: This equipment/system is intended for use by healthcare professionals only. This is a CISPR 11 Class A medical equipment/system. In a domestic environment this equipment/system may cause radio interference, in which case it may be necessary to take adequate mitigation measures, such as re-orienting, relocating or shielding the MyLabTMGuide or filtering the connection to the public mains network. Warnings and Precautions
Before connecting and operating the scanner this section must be read carefully. Warnings To avoid a risk of explosion the equipment must not be operated in the presence of flammable anesthetics.
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To avoid a risk of electric shock do not open the equipment. Refer servicing to qualified personnel only. If the ultrasound equipment or other devices are defective, there is a risk of electrical shock. Be careful not to place the patient into contact with the ultrasound equipment or other devices. The use of non-Esaote components with this scanner may result in damage to Esaote components. To prevent hazards, refer to your local requirements for adequate electrical installation in case of class II type CF equipment. Do not subject the equipment to excessive mechanical shock, for example, when moving the equipment. If the equipment is repeatedly subjected to excessive mechanical shock, mechanical parts may be damaged. The manufacturer, assembler, installer or importer considers himself responsible for the effects on safety, reliability and performance of this product only if: o Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by authorized personnel. o The electrical installation of the relevant room complies with the IEC requirements. o The product is used in accordance with the instructions for use. While there is no danger to a patient with a pacemaker, ultrasonic scanning equipment could cause mechanical damage to the pacemaker if used directly over the device's implant site. Do not use the equipment in locations subject to intense electric or magnetic fields (near transformers, for example). Do not use the equipment near devices generating high frequencies (such as medical telemeters and cordless telephones). If used near such devices, the equipment may malfunction or adversely affect such devices. To guarantee proper unit operation do not operate the scanner in an environment with a temperature in excess of 10 ÷ 40 °C (50 ÷ 104 °F). Avoid use and storage near a heater or in direct sunlight. For correct image contrast, only TFT-LCD screens properly adjusted by the manufacturer may be used on the scanner. Inspect the probe carefully if dropped or strikes hard surface. If it appears damaged, remove from use. See detailed instructions how to clean the probe in this manual. The LCD screen is fragile and must be handled accordingly.
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Electromagnetic compatibility. This system complies with the EN60601-1-2. It is a class A device. This is a class A product. The product is suitable for use in all establishments other than domestic. This product is also allowed in domestic establishments under jurisdiction of a health care professional (according IEC60601-1-2 clause 36.201.1.8). A warning is displayed to the operator when the internal temperature is equal or higher than: 60 °C (140 °F). In the case of high temperature message displayed on the screen, the user has to end the examination as soon as possible. The system shuts down when the internal temperature exceeds: 70 °C (158 °F). Precautions Cleaning the probe is done by first removing the ultrasound coupling gel with a soft tissue. Then gently wipe the probe dry using a new tissue or dry cloth. When additional cleaning is required, use only a mild detergent or hand soap with water and a soft cloth. For cleaning and disinfection issues related to the MyLabTMGuide unit, its probe and accessories, please refer to “Cleaning, Disinfection and Maintenance” paragraph in this manual. To avoid damage, the probe cable must not be coiled to a diameter of less than 9 cm (3.5 inch).
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Battery: Do not open, throw in fire, heat, or short circuit. Charge only with provided charger. Do not use the battery pack in any other devices than specified. Do not connect directly to a power outlet. Be sure to charge the battery within a temperature range of 8 to 40 °C. Storage temperature: min -20 °C / -4 °F max 60 °C / 140 °F. Storage pressure: 700 – 1060 hPa (10.2 – 15.4psi) 1. Connect the battery to the scanner with the provided battery cable. 2. When the battery is almost depleted, a low-battery indication will appear on the screen. The battery will operate for another 10 minutes. Disconnect the battery from the system and connect the battery to the charger. Insert the charger’s electrical cord into an electrical wall socket. When the battery is recharged a green light will be visible. In the case of battery low charged message displayed on the screen, the user has to end the examination as soon as possible.
The battery pack contains a rechargeable nickel metal hydride battery. DO NOT dispose of it in water, fire, or solid waste landfill. Federal and local laws may apply to the disposal of this battery.
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MyLabTMGuide User Manual
System Content and Set Up
Contents of the Package The package of the MyLabTMGuide consists of the following: • • • • • •
Scanner and probe hardwired to the unit 1 Battery (cable included) Battery charger and travel kit User manual AC Power Supply Bottle of gel
Options Article #
Description
97154 410057
Battery Pack
97154 411227
MyLabTMGuide Communication Package
97154 411038
AC Power Supply
97154 411267
Battery Charger
97154 411043
Desk Stand
97154 411042
Roll Stand
97154 411102
Roll Stand Adapter
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MyLabTMGuide User Manual
MyLabTMGuide Set Up Inspection of the MyLabTMGuide Upon opening the shipping box check the transport case, the probe (housing, cable and connection) and the scanner for damage. Rear panel of the MyLabTMGuide: Power connection
Video output
Probe cable
The Power connection on the rear panel of the scanner lets the system be supplied only as follows: MyLabTMGuide Battery MyLabTMGuide AC Power Supply
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