User Guide
46 Pages
Preview
Page 1
Federal law restricts this device to sale by or on the order of a physician. FEDERAL COMMUNICATIONS COMMISSION (FCC) UNINTENTIONAL EMITTER PER FCC PART 15 This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in an office installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions in the user manual, may cause harmful interference to radio or television reception. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause interference to radio and television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver
Connect the equipment to an outlet on a different circuit from that to which the receiver is connected
Consult Accutome Ultrasound, Inc or an experienced radio/TV technician for help. This device complies with Part 15 of the FCC Rules. Operation of this product is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CAUTION: Changes or modifications not expressly approved by Accutome Ultrasound, Inc. could void the FCC compliance and negate your authority to operate the product. Authorized Representative in Europe (for regulatory affairs only): Emergo Europe P.O. Box 18510 2502 EM The Hague The Netherlands Tel: (31) 70 345 8570 Fax: (31) 70 346 7299
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Contents
Introduction - - - - - - - - - - - - - - - - - 1 AccuPach VI Overview - - - - - - - - - - - - - - 1 Features - - - - - - - - - - - - - - - - - - - - 2 Measurements - - - - - - - - - - - - - - - - - 3 Components - - - - - - - - - - - - - - - - - - 3 Optional Components - - - - - - - - - - - - - 3 About This Manual - - - - - - - - - - - - - - - - 4
Safety - - - - - - - - - - - - - - - - - - - - 5 Safety Information - - - - - - - - - - - - - - - - 5 Safety Issues to Consider When Using the AccuPach VI - - - - - - - - - - - - - - - - - 5 Indications for use - - - - - - - - - - - - - - - - 5 Symbol Definitions for the AccuPach VI - - - - - - - 6 Safety Precautions - - - - - - - - - - - - - - - - 7 Sterilization- - - - - - - - - - - - - - - - - - - 8 Disinfection and Cleaning - - - - - - - - - - - - - 8 Cleaning - - - - - - - - - - - - - - - - - - - - 9 Electrical Hazard and Safety - - - - - - - - - - 11 Avoiding Equipment Damage - - - - - - - - - - 12 ALARA Principle - - - - - - - - - - - - - - - - 12
Getting Started - - - - - - - - - - - - - - - 13 Assembling the AccuPach VI - - - - - - - - - - - 13 What you need - - - - - - - - - - - - - - - - 13 Probe - - - - - - - - - - - - - - - - - - - 14 Keyboard - - - - - - - - - - - - - - - - - - 14 Foot Switch - - - - - - - - - - - - - - - - - 14 Placing the AccuPach VI - - - - - - - - - - - - 14 Connecting the Components - - - - - - - - - - 14 i
Accutome
AccuPach VI User Guide
Connecting the Footswitch - - - - - - - - - Connecting the Keyboard- - - - - - - - - - Connecting the Probe - - - - - - - - - - - Connecting the Power - - - - - - - - - - - How to Set Preferences - - - - - - - - - - - Setting the Speed of Sound - - - - - - - - - Setting the Method for Capturing Readings - - - Setting the Clock - - - - - - - - - - - - - - Setting the LCD Presentation - - - - - - - - - Setting the Annunciator - - - - - - - - - - - Returning to the Measure Screen - - - - - - - Basic Operation - - - - - - - - - - - - - - - How to Power On the AccuPach VI - - - - - - Using the Test Block - - - - - - - - - - - - How to Start a New Patient - - - - - - - - - How to Take a Measurement - - - - - - - - Notes - - - - - - - - - - - - - - - - - - How to Perform a Calculation- - - - - - - - - How to Save a Record - - - - - - - - - - - - - How to Print a Record - - - - - - - - - - - -
Maintenance
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General Maintenance
14 15 15 17 17 18 18 18 19 19 20 21 21 22 24 25 25 26 27 29
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Specifications - - - - - - - - - - - - - - -
32
Overview - - - - - - - Physical Specifications - - Environmental Specifications Measurement Accuracy - Operating Modes - - - - Acoustic Output - - - - - -
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32 32 34 34 35 36
Warranty & Repairs - - - - - - - - - - - -
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Warranty - - - - - - - - - - - - - - - - - - Product Returns - - - - - - - - - - - - - - - Service and Repair - - - - - - - - - - - - - -
37 38 38
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Contents
All Other Returns - - - - - - - - - - - - - - - 38 Non-Returnable Merchandise - - - - - - - - - - 38 Replacement Parts - - - - - - - - - - - - - - - 39
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List of Tables
Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7
IOP Correction Values- - - - - - - - - - - - - - - - - - - - - - - 26 AccuPach VI Physical Specifications - - - - - - - - - - - - 32 Environmental Specifications - - - - - - - - - - - - - - - - - - 34 Measurement Accuracy- - - - - - - - - - - - - - - - - - - - - - 34 Operating Mode(s) - - - - - - - - - - - - - - - - - - - - - - - - - 35 Acoustic Output Reporting Table for Track 1 Non-Autoscanning Mode - - - - - - - - - - - - - - - - - - - - - 36 Accutome Replacement Parts - - - - - - - - - - - - - - - - - 49
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List of Figures
Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10
AccuPach VI - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1 AccuPach VI Components - - - - - - - - - - - - - - - - - - - 13 Probe Connector (Front of Instrument) - - - - - - - - - - - 15 Probe Connected - - - - - - - - - - - - - - - - - - - - - - - - - - 16 Component Connectors (Back of Instrument) - - - - - - 17 Measure Screen Displayed - - - - - - - - - - - - - - - - - - - 21 AccuPach VI Test Block (Top of Instrument) - - - - - - 22 Measure Screen Starting New Patient - - - - - - - - - - - 24 USB Flash Drive - - - - - - - - - - - - - - - - - - - - - - - - - - - 27 Example of Patient Record Printout - - - - - - - - - - - - - 29
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Introduction
AccuPach VI Overview
The Accutome AccuPach VI pictured below has all the features that make it easy to obtain extreme accuracy and improved patient outcomes.
Figure 1: AccuPach VI
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Accutome
Features
AccuPach VI User Guide
The AccuPach VI is designed for easy access to all screens and functions. The unsurpassed ease of use of the touchscreen, and the straightforward Graphical User Interface guide you through every operation. What you can’t see on the surface is also important. Industry-leading signal acquisition and processing helps you assure accurate measurements. Reliable design and efficient manufacturing provide fiscal value. Upgradeable software protects your investment. The AccuPach VI lets you accomplish even the complex simply. The AccuPach VI provides the following general features:
128 X 64 high resolution LCD screen with touchscreen to provide an intuitive User Interface External, universal input, worldwide power supply 10" X 10" X 2 3/4" size makes the unit very portable Synthesized voice output of each measurement for ease of use Allows entry of Intraocular Pressure (IOP) and provides Corrected IOP based on corneal thickness measurements Adjustable handle/stand allows viewing at different angles User settable speed of sound Display of measured corneal thickness, entered IOP, Corrected IOP, and average and standard deviation for all stored measurements Automatically or manually capture and store up to nine measurements for each eye along with the running average of all measurements taken
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Introduction
Features
Measurements The high accuracy of the AccuPach VI measurements is provided by the following: High-resolution, real-time waveform analysis High-speed signal digitalization that acquires over 4000 points per signal waveform Automatic gain control to acquire the optimum signal Highly sensitive 10.5MHz composite probe 20 individual signals acquired and analyzed to produce each measurement
Components The components that are standard with each AccuPach VI instrument are:
Ultrasonic probe Keyboard USB Flash Drive
Optional Components There are also several components which further simplify the use of the AccuPach VI:
Footswitch User Supplied Computer User Supplied External Printer
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Accutome
About This Manual
AccuPach VI User Guide
This manual is a guide for technicians and opthalmologists who are experienced in ultrasonic biometric techniques. This manual is organized as follows: Section 2
Safety
Summarizes safety precautions, warnings, symbols and terms.
Section 3
Getting Started
Provides assembly instructions, overview of AccuPach VI basic operation.
Section 4
Maintenance
Provides general maintenance instructions
Section 5
Specifications
Provides AccuPach VI physical and operational specifications
Section 6
Warranty and Repairs
Describes AccuPach VI warranty information and repair procedures.
Having read this manual you will be able to set up the AccuPach VI, take measurements, enter and calculate Corrected IOP, and print and save Patient records.
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Safety
Safety Information
The section lists: Safety Precautions associated with the AccuPach VI Safety Precautions of a general nature
Safety Issues to Consider When Using the AccuPach VI The AccuPach VI is non-invasive. The ultrasonic biometry probe touches the surface of the anesthetized cornea during the scanning process.
Indications for Use This instrument is used for measuring the corneal thickness of the eye. It is to be used in a medical setting, and only by technicians, optometrists, and opthalmologists who are experienced in ultrasonic biometric techniques.
CAUTION:
General indications for use of the AccuPach VI include on external, structurally intact areas of the eye globe and orbit only.
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Accutome
Symbol Definitions for the AccuPach VI
AccuPach VI User Guide
Statements, graphics and symbols listed below are used on components of the AccuPach VI. Descriptions and meanings are listed to the right of the symbols. Single phase alternating current
Keyboard Connector
Foot switch input connector
"Attention! Consult Instruction Manual."
Type B Medical Device
Do not use near flammable or explosive gasses.
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Safety
Safety Precautions
Electrical Shock Hazard
No user serviceable parts inside
Fuse
Ultrasound Probe Connector
Safety Precautions
There are several areas in the use of the AccuPach VI that require special attention, as they may pose a safety threat. The AccuPach VI has an enclosure rated Degree of Protection of IP32. The enclosure provides protection for objects larger than 2.5 mm and dripping water. The foot switch is rated IP20. In the event of a spill contacting the unit, disconnect the mains cord and wipe the unit completely dry before returning it to service.
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Accutome
AccuPach VI User Guide
Sterilization Sterilization issues are confined to the AccuPach VI probe that comes in contact with the patient’s eye. In order to prevent the transmission of disease, medical authority(ies) having jurisdiction guidelines are referenced for proper control of sterilization issues. These guidelines are frequently updated so be sure to contact your local disease control officer for the latest information and sterilization techniques. The probe tip should be sterilized or disinfected before use on each patient. The recommended sterilization technique is to immerse the probe tip (and only the probe tip) in an antibacterial solution. Follow the manufacturer’s written protocol when using any antibacterial solution.
Disinfection and Cleaning Disinfection issues are confined to the AccuPach VI probe that comes in contact with the patient’s eye and to the test block. In order to prevent the transmission of disease, medical authority(ies) having jurisdiction guidelines are referenced for proper control of sterilization issues. These guidelines are frequently updated so be sure to contact your local disease control officer for the latest information and disinfection techniques. The probe tip should be sterilized or disinfected before use on each patient. The test block should be disinfected after each use. The recommended disinfection technique is to gently wipe the probe tip or the test block with isopropyl alcohol (and no other substance). It is imperative that the alcohol be given time to evaporate before applying a probe to the patient’s eye.
WARNING!
DO NOT AUTOCLAVE! 8
Safety
Safety Precautions
WARNING!
DO NOT IMMERSE THE PROBE’S CABLE OR METAL CONNECTOR IN ANY LIQUID. ALLOW TO DRY BEFORE USE.
WARNING!
DO NOT USE THE TEST BLOCK AND THEN TAKE A PATIENT MEASUREMENT. STERILIZE OR DISINFECT THE PROBE TIP AFTER USING THE TEST BLOCK AND BEFORE TAKING A PATIENT MEASUREMENT.
Cleaning Keep the surfaces of the AccuPach VI free of dust and dirt and store the instrument in a dry and cool place so as not to adversely affect any electronic parts. No specific cleaning interval is recommended.
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Accutome
AccuPach VI User Guide
WARNING!
DISCONNECT THE AccuPach VI FROM THE MAIN POWER SOURCE BEFORE ATTEMPTING ANY CLEANING.
CAUTION:
No abrasive or harsh cleaning solutions should be used while cleaning the AccuPach VI, or any of its components.
When the unit needs cleaning, use only a damp, soft, lint-free cloth. Do not pour or spray any liquids or cleaners onto the unit at any time. The damp, lint-free cloth may contain mild soap if necessary. Gently wipe down the instrument surfaces and component cables as needed. Allow the unit to completely dry before using again. If the probe needs cleaning it may be wiped with a damp, soft, lint-free cloth as needed. Disinfect the probe after cleaning.
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Safety
Safety Precautions
Electrical Hazard and Safety The instrument, foot switch and probe of the AccuPach VI are electrical/electronic devices. Reasonable care should be taken when making electrical connection and handling electrically powered devices. Avoid the use of damaged electrical equipment or frayed electrical cords. If repair or maintenance is to be performed on the AccuPach VI, the equipment must be turned off and the power cord disconnected. Do not use probes or foot switches that have frayed or damaged connection cables. The device covers must not be removed except by qualified personnel. There are no user controls inside the unit. To avoid injury, do not operate the AccuPach VI without protective covers. The system is intended to operate from a power source of 100 - 240 VAC, 47 - 63 Hz. Protective earth grounding through the grounding connection in the power cord is essential for safe system operation. Use only a hospital-grade power cord and the connectors supplied with the AccuPach VI. Also, be sure the power cord and connector are in good condition.
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Accutome
AccuPach VI User Guide
Avoiding Equipment Damage The only peripheral equipment that may be connected to an AccuPach VI is a printer that has been selected and installed in compliance with EN60601-1 requirements. The AccuPach VI provides no explosion protection from static discharge or arcing components. Do not operate the instrument in the presence of explosive gases such as flammable mixtures of anesthetic and air, or nitrous oxide.
ALARA Principle This instrument has no user operated controls or settings that affect the acoustic output. When using the device, the ALARA (As Low As Reasonably Achievable) principle should be followed. This principle is used to reduce unnecessary, potentially hazardous exposure to individuals, by keeping doses and test repetition As Low As Reasonably Achievable to achieve the required diagnostic information.
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Getting Started
Assembling the AccuPach VI
The AccuPach VI is designed to be used in multiple medical settings and can be rested on a surface, such as a counter or desk. The AccuPach VI requires little assembly. All components, standard and optional, can be quickly and easily connected.
What you need For a complete AccuPach VI medical setting you will need the following:
AccuPach VI instrument including display Ultrasonic Probe Keyboard Power Cord USB Flash Drive Footswitch - Optional Accessory Computer and Printer- User Supplied
Figure 2: AccuPach VI Components 13
Accutome
AccuPach VI User Guide
Probe The probe provided with the AccuPach VI is an essential component of the AccuPach VI. No other probes should be used with the instrument.
Keyboard The keyboard is not required for operation but provides convenience for entering alphanumeric data when saving a patient report to the USB Flash Drive.
Foot Switch The foot switch can be used to capture measurements.
*Note:
The foot switch is ONLY to be used on the floor and only actuated by the operator's foot. It is never to be operated as a hand-held switch
USB Flash Drive The USB Flash Drive is used to store patient data, which can be transferred to a computer for storage or printed.
Placing the AccuPach VI The AccuPach VI is designed to be placed on a surface, such as a counter or a desk.
Connecting the Components All of the connectors for the AccuPach VI components, except for the probe and USB Flash Drive, are located on the back of the instrument.
Connecting the Footswitch To connect the footswitch: 1. 2.
Locate the footswitch connector, on the back of the instrument (see on page 17). Insert the connector of foot switch cable into the foot switch connector.
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