Accutome AccuPach VI User manual

AccuPach VI User’s Guide
24-6204 Rev-G
AccuPach VI
Tabletop Pachymeter

Accutome AccuPach VI User’s Guide
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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’s guide,
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 or 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 than the receiver is
connected to.
• Consult Accutome, 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, Inc., could void
the FCC compliance and negate your authority to operate the product.
The AccuPach VI is manufactured and trademarked by:
Accutome, Inc.
3222 Phoenixville Pike
Malvern, PA 19355 USA
Toll-Free (USA): [phone]
International: [phone]
Fax: [phone]

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Chapter 1: Introduction 1
AccuPach VI Overview 1
Features 1
Measurements 2
Components 2
Optional Components 2
About This Manual 2
Chapter 2: Safety 3
Safety Information 3
Safety Issues to Consider When Using the AccuPach VI 3
Indications for Use 3
Disposal Requirements 3
Disposal of the Product within the EU 3
Disinfection and Cleaning 3
Safety Precautions 4
Warnings 4
Cleaning Procedure at Point of Use 4
Disinfection of the Probes with Alcohol 5
High-Level Disinfection of the Probe 5
Electrical Hazard and Safety 5
Avoiding Equipment Damage 6
Avoiding Electromagnetic and Other Interference 6
Chapter 3: Getting Started 7
Assembling the AccuPach VI 7
What You Need 7
Placing the AccuPach VI 8
Connecting the Components 8
Connecting the Probe 8
Connecting the Power 9
How to Set Preferences 9
Basic Operation 11
How to Power On the AccuPach VI 11
Using the Test Block 11
How to Start a New Patient 12
How to Take a Measurement 12
How to Perform a Calculation 12
How to Save a Record 13
How to Print a Record 14
Table of Contents

Accutome AccuPach VI User’s Guide
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Chapter 4: Maintenance 15
General Maintenance 15
Chapter 5: Specifications 16
Overview 16
Physical Specifications 16
Environmental Specifications 17
Measurement Accuracy 17
Operating Modes 18
Acoustic Output 18
EMC Compliance Information 19
Chapter 6: Warranty & Repairs 21
Warranty 21
Product Returns 21
Service and Repair 21
All Other Returns 21
Nonreturnable Merchandise 22
Replacement Parts 22

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Figure 1.1 - AccuPach VI 1
Figure 3.1 - AccuPach VI Components 7
Figure 3.2 - Footswitch and Keyboard Connector 8
Figure 3.3 - Probe Connector (front of unit) 8
Figure 3.4 - Probe Connected 8
Figure 3.5 - Component Connectors (back of instrument) 9
Figure 3.6 - Measure Screen Displayed 11
Figure 3.7 - AccuPach VI Test Block (top of instrument) 11
Figure 3.8 - Measure Screen Starting New Patient 12
Table 3.1 - IOP Correction Values 13
Figure 3.9 - USB Flash Drive 13
Figure 3.10 - Example of Patient Record Printout 14
Table 5.1 - AccuPach VI Physical Specifications 16
Table 5.2 - Environmental Specifications 17
Table 5.3 - Measurement Accuracy 17
Table 5.4 - Operating Modes 18
Table 5.5 - Acoustic Output Reporting Table for Track 1 Nonautoscanning Mode 18
Table 5.6 - Guidance and Manufacturer’s Declaration -
Electromagnetic Emissions 19
Table 5.7 - Guidance and Manufacturer’s Declaration -
Electromagnetic Immunity 19
Table 5.8 - Guidance and Manufacturer’s Declaration -
Electromagnetic Immunity 20
Table 6.1 - Accutome Replacement Parts 22
List of Figures

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Chapter 1: Introduction
1Introduction
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 1.1 - AccuPach VI
Features
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 ensure 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

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• Automatically or manually capture and store up to nine measurements for
each eye, along with the running average of all measurements taken
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 4,000 points per signal
waveform
• Automatic gain control to acquire the optimum signal
• Highly sensitive 10.5 MHz 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 that further simplify the use of the AccuPach
VI:
• Footswitch
• User-supplied computer
• User-supplied external printer
About This Manual
This manual is organized as follows:
Chapter 2 - Safety
Summarizes safety precautions, warnings, symbols, and terms.
Chapter 3 - Getting Started
Provides assembly instructions and overview of AccuPach VI basic operation.
Chapter 4 - Maintenance
Provides general maintenance instructions.
Chapter 5 - Specifications
Provides AccuPach VI physical and operational specifications.
Chapter 6 - Warranty & Repairs
Describes AccuPach VI warranty information and repair procedures.
After reading 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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Chapter 2: Safety
2Safety
Safety Information
The section lists:
• Specific safety precautions associated with the AccuPach VI
• General safety precautions
Safety Issues to Consider When Using the AccuPach VI
The AccuPach VI is noninvasive. The ultrasonic biometry probe touches the surface
of the anesthetized cornea during the scanning process.
Contraindications
There are no known contraindications for the AccuPach VI device.
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.
Disposal Requirements
The AccuPach VI contains electronic components. At the end of its useful life, it
must be properly disposed of in compliance with local regulations.
Disposal of the Product within the EU
EU directives and national regulations currently in force at the time of marketing
prohibit the disposal of the AccuPachVI specified on the delivery note in domestic
waste or by municipal waste-disposal companies. If the AccuPach Vi or its
components are resold, the seller has the duty to notify the buyer that the product
must be diposed of in accordance with currently valid national regulations.
Safety Precautions
There are several areas in the use of the above AccuPach VI that require special
attention, as they may pose a safety threat.
Disinfection and Cleaning
Disinfection issues are confined to the Accutome probe that comes in contact
with the patient’s eye. In order to prevent the transmission of disease, refer to the
OSHA and CDC guidelines for proper control of disinfection. These guidelines are
frequently updated so be sure to contact OSHA, CDC, or your local disease-control
for the latest information and disinfection technique.

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Accessories such as the extension handle
or Goldman Tonometer Adapter that might
come in contact with eye fluids should be
cleaned with an FDA-cleared high-level
disinfectant.
The probe must be cleaned between patients
to prevent patient-to-patient transfer of
infection. It is the user’s responsibility to
ensure that the relevant standards are
maintained and that the products and
procedures are effective and appropriate
for ophthalmic applications. The following
information is provided for the guidance
of users, and specific products are
mentioned for illustration only. Accutome
does not endorse the use of these or any
other product. Products must be used
in accordance with the manufacturer’s
instructions.
Warnings
DO NOT AUTOCLAVE THE PROBES OR
CONNECTORS.
DO NOT IMMERSE THE PROBE’S CABLES
OR METAL CONNECTORS. ALLOW TO DRY
BEFORE USE.
DO NOT IMMERSE THE PROBE TIPS IN
TAP WATER. USE DISTILLED WATER FOR
CLEANING AND DISINFECTION
Cleaning Procedure at Point of
Use
1. Wear protective gloves when
performing the cleaning process.
2. Disconnect the probe from the
system.
3. Use a soft cloth lightly dampened in
a mild soap or compatible cleaning
solution to remove any particulate
matter or body fluids that remain on
the probe or cable.
4. To remove remaining particulates,
rinse with a distilled water–dampened
cloth to remove soap residue, and
then wipe with a dry cloth.
Symbol Definitions for
the AccuPach VI
Attention! Consult
Instruction Manual
No User
Serviceable Parts
Single Phase
Alternating Current
Keyboard
Connector
Footswitch Input
Connector
Electrical Shock
Hazard
Ultrasound Probe
Connector
Fuse
Type B Medical
Device
Do Not Use
Near Flammable
Gases
Disposal of Product
within the EU

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Disinfection of the Probes with Alcohol
One recommended disinfection technique is to clean the probe assemblies with
70% isopropyl alcohol.
A 5- to 10- minute exposure is recommended. It is imperative that the alcohol
be given time to evaporate before applying a probe to a patient’s eye. Do not
completely immerse the probe or cable; only the tip of the probe should be placed in
the solution.
After cleaning, rinse the end of the probe thoroughly with distilled water to remove
all traces of alcohol.
Probe surfaces should be dried with a lint-free cloth.
High-Level Disinfection of the Probe
If high-level disinfection is required by your facility, the probe may be cleaned using
an FDA-cleared high-level disinfectant, such as Cidex OPA Activated Dialdehyde
Solution.
If your facility is located in the EU, Mikrozid wipes are a compatible method of high-
level disinfection for Accutome probes.
Note: Be sure to follow the disinfectant manufacturer’s written protocol when
using any antibacterial solution, including high-level disinfectants.
CAUTION: No abrasive or harsh cleaning solutions should be used while cleaning the
AccuPach VI or any of its components.
Electrical Hazard and Safety
The instrument, footswitch, and probe of the AccuPach VI are electrical/electronic
devices. Reasonable care should be taken when making an 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.
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.
Safety