Accutome

PachPen Users Guide Rev D

Users Guide

40 Pages

File Type: PDF

File Size: 2.53 MB

File Name: Accutome - PachPen Users Guide Rev D.pdf

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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 PachPen Overview - - - - - - - - - - - - - - - - 1 Features - - - - - - - - - - - - - - - - - - - - 2 Measurements - - - - - - - - - - - - - - - - 3 About This Manual - - - - - - - - - - - - - - - - 4

Safety - - - - - - - - - - - - - - - - - - - - 5 Safety Information - - - - - - - - - - - - - - - - 5 Safety Issues to Consider When Using the PachPen 5 Indications for use - - - - - - - - - - - - - - - 5 Symbol Definitions for the PachPen - - - - - - - - - 6 Safety Precautions - - - - - - - - - - - - - - - - 7 Sterilization- - - - - - - - - - - - - - - - - - 7 Disinfection and Cleaning - - - - - - - - - - - - 7 Cleaning - - - - - - - - - - - - - - - - - - - 8 Electrical Hazard and Safety - - - - - - - - - - 9 Avoiding Equipment Damage - - - - - - - - - - 9 ALARA Principle - - - - - - - - - - - - - - - - 9

Getting Started - - - - - - - - - - - - - - - 11 Overview - - - - - - - - - - - - - - - - - - Unpacking Instructions - - - - - - - - - - - - Battery Specification and Installation - - - - - - Battery Specification - - - - - - - - - - - - - Battery Installation - - - - - - - - - - - - - - Instructions for Use - - - - - - - - - - - - - Initial PachPen Pachymeter Setup - - - - - - - Basic Operation - - - - - - - - - - - - - - - How to Power On the PachPen- - - - - - - - - i

11 11 12 12 13 14 14 16 16

Accutome

PachPen User Guide

How to Start a New Patient - How to Take a Measurement Notes - - - - - - - - - How to Perform a Calculation -

- - - - -

Maintenance, Storage and Troubleshooting General Maintenance - - - - Maintenance and Cleaning - - Battery Disposal - - - - - - Instructions for Disposal - - Disposal in Europe - - - - - Disposal in US. - - - - - - Storage - - - - - - - - - - Troubleshooting - - - - - - -

Specifications

- - - - - - - - - - - - - - - - -

17 18 18 19

- 21 -

21 22 22 22 23 23 24 25

- - - - - - - - - - - - - - - 27

Overview - - - - - - - - Physical Specifications - - Environmental Specifications Measurement Accuracy - - Operating Modes - - - - - Acoustic Output - - - - - -

Warranty & Repairs

- - - - - - -

27 27 28 28 29 30

- - - - - - - - - - - - 31

Warranty - - - - - - - - - - - - - - - - - - Product Returns - - - - - - - - - - - - - - - Service and Repair - - - - - - - - - - - - - All Other Returns - - - - - - - - - - - - - - Non-Returnable Merchandise - - - - - - - - - Replacement Parts - - - - - - - - - - - - - - -

31 32 32 32 32 33

List of Figures

Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8

PachPen® Pachymeter - - - - - - - - - - - - - - - - - - - - - - 1 PachPen® Unpacked - - - - - - - - - - - - - - - - - - - - - - - 12 Battery Insertion - - - - - - - - - - - - - - - - - - - - - - - - - - 14 Control Buttons and LCD - - - - - - - - - - - - - - - - - - - - 15 Speed of Sound Screen - - - - - - - - - - - - - - - - - - - - - 15 Measure Screen Displayed - - - - - - - - - - - - - - - - - - - 16 Measure Screen Starting New Patient - - - - - - - - - - - 17 True IOP Screen - - - - - - - - - - - - - - - - - - - - - - - - - - 19

iii

List of Tables

Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7 Table 8

IOP Correction Values- - - - - - - - - - - - - - - - - - - - - - - 20 PachPen Troubleshooting Information - - - - - - - - - - - 25 PachPen Physical Specifications - - - - - - - - - - - - - - - 27 Environmental Specifications - - - - - - - - - - - - - - - - - - 28 Measurement Accuracy- - - - - - - - - - - - - - - - - - - - - - 28 Operating Mode(s) - - - - - - - - - - - - - - - - - - - - - - - - - 29 Acoustic Output Reporting Table for Track 1 Non-Autoscanning Mode - - - - - - - - - - - - - - - - - - - - - 30 Accutome Replacement Parts - - - - - - - - - - - - - - - - - 33

Introduction

PachPen Overview

Figure 1

The Accutome PachPen pictured below has all the features that make it easy to obtain extreme accuracy and improved patient outcomes.

PachPen® Pachymeter

Accutome

PachPen User Guide

Features

The PachPen is designed for easy access to all screens and functions. The unsurpassed ease of use of the control buttons, 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 PachPen lets you accomplish even the complex simply. The PachPen provides the following general features:

Multisegment high resolution LCD screen with control buttons to provide an intuitive User Interface Long lasting lithium battery power source 18.4 cm X 3.2 cm X 3.2 cm (71/4" X 11/4" X 11/ 4 size), and 85 g (3 oz.) weight make the unit very portable Ergonomic design that fits comfortably into the hand for fast and accurate measurements Allows entry of Intraocular Pressure (IOP) and provides Corrected IOP based on corneal thickness measurements The body of the PachPen is angled from the probe tip and both the body and the tip have sighting lines that allow easy visualization of the cornea, facilitating both centration and perpendicularity User settable speed of sound Display of measured corneal thickness, entered IOP, Corrected IOP, and average for all stored measurements Automatically or manually capture and store up to nine measurements along with the running average of all measurements taken

Introduction

Features

Measurements The high accuracy of the PachPen 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

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About This Manual

PachPen User Guide

This manual is a guide for technicians, optometrists, 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 PachPen basic operation.

Section 4

Maintenance

Provides general maintenance instructions

Section 5

Specifications

Provides PachPen physical and operational specifications

Section 6

Warranty and Repairs

Describes PachPen warranty information and repair procedures.

Having read this manual you will be able to set up the PachPen, take measurements, and enter and calculate Corrected IOP.

Safety

Safety Information

The section lists: Safety Precautions associated with the PachPen Safety Precautions of a general nature

Safety Issues to Consider When Using the PachPen The PachPen 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 PachPen include on external, structurally intact areas of the eye globe and orbit only.

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PachPen User Guide

Symbol Definitions for the PachPen

Statements, graphics and symbols listed below are used on components of the PachPen. Descriptions and meanings are listed to the right of the symbols.

"Attention! Consult Instruction Manual."

Type B Medical Device

3.6 Volts Lithium 1/2 AA

Battery Replacement

Class II Insulation

Action Control Button

Safety

Safety Precautions

There are several areas in the use of the PachPen that require special attention, as they may pose a safety threat. The PachPen has an enclosure rated Degree of Protection of IP32. The enclosure provides protection for objects larger than 2.5 mm and dripping water. In the event of a spill contacting the unit, wipe the unit completely dry before returning it to service.

Sterilization Sterilization issues are confined to the PachPen 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 PachPen 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 disinfection techniques. The probe tip should be sterilized or disinfected before use on each patient. The recommended disinfection technique is to gently wipe the probe tip with isopropyl alcohol (and no other substance). It is imperative that the alcohol be given 7

Accutome

PachPen User Guide

time to evaporate before applying a probe to the patient’s eye.

WARNING! WARNING!

DO NOT AUTOCLAVE!

DO NOT IMMERSE THE ENTIRE PachPen IN ANY LIQUID. ALLOW TO DRY BEFORE USE.

Cleaning Keep the surfaces of the PachPen 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.

CAUTION:

No abrasive or harsh cleaning solutions should be used while cleaning the PachPen.

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.

Safety

Safety Precautions

If the probe tip needs cleaning, it may be wiped with a damp, soft, lint-free cloth as needed. Disinfect the probe after cleaning.

Electrical Hazard and Safety The PachPen is an electrical/electronic device. Reasonable care should be taken when making an electrical connection and handling electrically powered devices. Avoid the use of damaged electrical equipment. If repair or maintenance is to be performed on the PachPen, the equipment must be turned off and the battery removed. 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 PachPen without protective covers. The system is intended to operate from a 3.6 V lithium battery.

Avoiding Equipment Damage No peripheral equipment may be connected to the PachPen. The PachPen 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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PachPen User Guide

Getting Started

Overview

The PachPen is designed to be used in multiple medical settings and can be rested on a surface, such as a counter or desk. The PachPen requires no assembly. .

Unpacking Instructions

Upon receiving the PachPen: 1.

Remove the PachPen® Pachymeter case from the protective shipping materials. Save the shipping materials for use if return or repair becomes necessary. Check for missing items. The PachPen® Pachymeter, this manual, and a lanyard should be included inside the case. The additional openings in the case foam are for storing alcohol prep pads and a bottle of ophthalmic anesthetic if you wish. Visually inspect the PachPen® Pachymeter for damage.

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Figure 2

PachPen User Guide

PachPen® Unpacked

*Note:

Battery Specification and Installation

Notify Accutome, Inc. immediately if any components are missing or damaged. See Section 6 of this manual for contact information.

The power source for the PachPen is 3.6 V Lithium battery. The battery is included with the PachPen and must be installed before use.

Battery Specification Use only one (1) 3.6 volt, TADIRAN model TL-5902/S Lithium battery, or an equivalent.

CAUTION:

Use only the style and type of battery specified. Any other style or type of battery may cause damage to the product and invalidate the warranty. 12

Getting Started

Battery Installation

CAUTION:

The battery is polarized so that it only fits into the battery compartment one way. Check to be sure that the battery is installed correctly and do not force the battery into place. Incorrect battery installation could cause severe damage to the product and invalidate the warranty.

To install the battery in the PachPen: 1.

Locate the battery compartment (see Figure 3 below) on the bottom of the PachPen and open the compartment by unscrewing the captive battery door screw. The battery door is hinged to the bottom of the handle and should not be removed from the product. Insert the Tadiran model TL-5902/S Lithium battery, or an equivalent, into the battery compartment as shown in Figure 3. Close the battery compartment door and screw the captive battery door screw back into position to firmly hold the battery compartment door in a closed position. Do not over tighten the screw.

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Figure 3

PachPen User Guide

Battery Insertion

Instructions for Use

CAUTION:

DO NOT AUTOCLAVE THE PachPen® PACHYMETER.

Initial PachPen Pachymeter Setup The steps below outline the basic setup of the PachPen. 1.

If the battery is not installed in the PachPen, install the battery as described in "Battery Installation" on page 13 of this manual. If you wish to change the speed of sound setting for the unit, press and hold the Action Control Button for 2 to 3 seconds until the speed of sound 14

Getting Started

Instructions for Use

screen is shown on the LCD display. Then release the Action Control Button and use the Up and Down Control Buttons to set the speed of sound desired. To return to the Measurement screen, press and hold the Action Control Button for 2 to 3 seconds until the Measurement screen appears.

Figure 4

Control Buttons and LCD

Figure 5

Speed of Sound Screen 15

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