Accutome ACCUPEN User manual

AccuPen
Tonometer
User’s Guide
®
Handheld
24-3002 Rev. E

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):
0086

i
Manufactured in the USA by:
Accutome, Inc.
3222 Phoenixville Pike
Malvern, Pennsylvania 19355
USA

ii
Introduction - - - - - - - - - - - - - - - - -1
AccuPen Overview - - - - - - - - - - - - - - - - 1
Features - - - - - - - - - - - - - - - - - - - - 2
Measurements - - - - - - - - - - - - - - - - 3
About This Manual - - - - - - - - - - - - - - - - 4
Safety - - - - - - - - - - - - - - - - - - - -4
Safety Information - - - - - - - - - - - - - - - - 4
Safety Issues to Consider When Using the AccuPen - -4
Indications for use- - - - - - - - - - - - - - - - 4
Symbol Definitions for the AccuPen - - - - - - - - - 5
Safety Precautions - - - - - - - - - - - - - - - - 6
Maintenance - - - - - - - - - - - - - - - - - 6
Disinfection and Cleaning - - - - - - - - - - - - 6
Cleaning - - - - - - - - - - - - - - - - - - - 7
Electrical Hazard and Safety - - - - - - - - - - 7
Avoiding Equipment Damage - - - - - - - - - - 8
Getting Started - - - - - - - - - - - - - - - - - - - - - - 9
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9
Unpacking Instructions - - - - - - - - - - - - - - 9
Battery Specification and Installation - - - - - - - 10
Battery Specification - - - - - - - - - - - - - - 10
Battery Installation - - - - - - - - - - - - - - - 11
Instructions for Use - - - - - - - - - - - - - - 12
Initial AccuPen Tonometer Setup - - - - - - - - 12
Calibration - - - - - - - - - - - - - - - - - - 13
Basic Operation - - - - - - - - - - - - - - - - 15
How to Power On the AccuPen- - - - - - - - - - 15
How to Start a New Patient - - - - - - - - - - - 16
How to Take a Measurement - - - - - - - - - - 17
How to Calculate Adjusted IOP - - - - - - - - - 18
Maintenance, Storage and Troubleshooting - 20
General Maintenance - - - - - - - - - - - - - - 20
Maintenance and Cleaning - - - - - - - - - - - - 21

iii
Accutome AccuPen User Guide
Battery Disposal - - - - - - - - - - - - - - - - 21
Instructions for Disposal - - - - - - - - - - - - 21
Disposal in Europe - - - - - - - - - - - - - - - 22
Disposal in US. - - - - - - - - - - - - - - - - 22
Storage - - - - - - - - - - - - - - - - - - - - 23
Troubleshooting - - - - - - - - - - - - - - - - 23
Specifications - - - - - - - - - - - - - - - 26
Overview - - - - - - - - - - - - - - - - - - - 26
Physical Specifications - - - - - - - - - - - - - 26
Environmental Specifications - - - - - - - - - - - - - - - - 27
Measurement Accuracy - - - - - - - - - - - - - 27
EMC Compliance Information - - - - - - - - - - - 28
Warranty & Repairs - - - - - - - - - - - - 32
Warranty - - - - - - - - - - - - - - - - - - - 33
Product Returns - - - - - - - - - - - - - - - - 33
Service and Repair - - - - - - - - - - - - - - 33
All Other Returns - - - - - - - - - - - - - - - 33
Non-Returnable Merchandise - - - - - - - - - - 33
Replacement Parts - - - - - - - - - - - - - - - 34

iv
List of Tables
Table 1 IOP Correction Values- - - - - - - - - - - - - - - - - - - - - - - 19
Table 2 AccuPen Troubleshooting Information - - - - - - - - - - - 24
Table 3 AccuPen Physical Specifications - - - - - - - - - - - - - - - 26
Table 4 Environmental Specifications - - - - - - - - - - - - - - - - - - 27
Table 5 Measurement Accuracy- - - - - - - - - - - - - - - - - - - - - - 27
Table 6 Guidance and manufacturer’s declaration -
electromagnetic emissions- - - - - - - - - - - - - - - - - - - - 28
Table 7 Guidance and manufacturer’s declaration -
electromagnetic emissions- - - - - - - - - - - - - - - - - - - - 29
Table 8 Guidance and manufacturer’s declaration -
electromagnetic immunity - - - - - - - - - - - - - - - - - - - - 30
Table 9 Recommended separation distances between
portable and mobile RF communications equipment
and the AccuPen - - - - - - - - - - - - - - - - - - - - - - - - - - 31
Table 10 Accutome Replacement Parts - - - - - - - - - - - - - - - - - 34

v
List of Figures
Figure 1 AccuPen® Tonometer - - - - - - - - - - - - - - - - - - - - - - - 1
Figure 2 AccuPen® Unpacked - - - - - - - - - - - - - - - - - - - - - - - 10
Figure 3 Battery Insertion - - - - - - - - - - - - - - - - - - - - - - - - - - 12
Figure 4 Control Buttons and LCD - - - - - - - - - - - - - - - - - - - - 13
Figure 5 Calibration Probe Horizontal Position - - - - - - - - - - - - 14
Figure 6 Calibration Probe Up Position - - - - - - - - - - - - - - - - - 14
Figure 7 Calibration Probe Down Position - - - - - - - - - - - - - - - 15
Figure 8 Measure Screen Starting New Patient - - - - - - - - - - - 16
Figure 9 Capturing a Measurement - - - - - - - - - - - - - - - - - - - - 17
Figure 10 Adjusted IOP Screen- - - - - - - - - - - - - - - - - - - - - - - - 18

1
Introduction
AccuPen
Overview
The Accutome AccuPen pictured below has all the
features that make it easy to obtain extreme accuracy
and improved patient outcomes.
Figure 1: AccuPen® Tonometer
Features The AccuPen 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
AccuPen lets you accomplish even the complex simply.
The AccuPen provides the following general features:

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Accutome AccuPen User Guide
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 (7.25" X 1.25" X
1.25" 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 CCT (Central Corneal
Thickness) and provides Adjusted IOP based
on manually entered corneal thickness
measurements
The body of the AccuPen 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
Display of measured IOP, entered corneal
thickness, Corrected IOP, and average for all
stored measurements
Capture and store up to nine measurements
along with the running average of all
measurements taken
Measurements
The high accuracy of the AccuPen measurements is
provided by the following:
High-resolution, real-time waveform analysis
High-speed signal digitalization which acquires
many date points per measurement in a
continuous acquisition until strict criteria are
recognized
Automatic offset control to acquire the
optimum signal
Sampling of the pressure signal is at a 1KHz
rate
Unit correlates matching (or multiple) readings
to insure accuracy
Uses a highly precision machined probe

3
Introduction About this Manual
Has Adjusted IOP feature to correct for varying
CCTs
Uses proprietary pressure waveform analysis
algorithm
About this
Manual This manual is a guide for technicians, optometrists, and
opthalmologists who are experienced in intraocular
pressure measurement 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 AccuPen basic
operation.
Section 4 Maintenance Provides general
maintenance
instructions
Section 5 Specifications Provides AccuPen
physical and
operational
specifications
Section 6 Warranty and Describes AccuPen
Repairs warranty information
and repair procedures.
Having read this manual you will be able to set up the
AccuPen, take measurements, and enter and calculate
Adjusted IOP.

4
Safety
Safety
Information
The section lists:
Safety Precautions associated with the
AccuPen
Safety Precautions of a general nature
Safety Issues to Consider When Using the AccuPen
The AccuPen is non-invasive. The strain gauge sensor
probe tip, covered with a single-use latex disposable,
touches the surface of the anesthetized cornea during
the scanning process.
Indications for use
This instrument is used for measuring the intraocular
pressure (IOP) of the eye. It is to be used in a medical
setting, and only by physicians, optometrists, and
technicians who are experienced in IOP measurement
techniques.
CAUTION: General indications for
use of the AccuPen
include on external,
structurally intact areas of
the eye globe and orbit
only.

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Accutome AccuPen User Guide
Symbol
Definitions for
the
AccuPen
Statements, graphics and symbols listed below are used
on components of the AccuPen. 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
Disposal of Product within EU

6
Safety Safety Precautions
Safety
Precautions
There are several areas in the use of the AccuPen that
require special attention, as they may pose a safety
threat.
The AccuPen 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.
Maintenance
Remove AccuTip tonometer tip cover and dispose.
Clean the sensor with optical quality compressed gas
before the first use each day, prior to storage and in the
event of suspect readings.
Spray the compressed gas into the sensor for
approximately 2 seconds. Wait 3 minutes to allow the
instrument to thermally stabilize and place a new
AccuTip tonomter tip cover over the tip.
Disinfection and Cleaning
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.
WARNING! DO NOT AUTOCLAVE!
WARNING! DO NOT IMMERSE THE
ENTIRE AccuPen IN ANY
LIQUID.

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Accutome AccuPen User Guide
Cleaning
Keep the surfaces of the AccuPen 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 AccuPen.
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. Allow the unit to
completely dry before using again.
If the probe tip needs cleaning, it may be wiped with a
damp, soft, lint-free cloth as needed.
Electrical Hazard and Safety
The AccuPen 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 AccuPen, 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 AccuPen
without protective covers.
The system is intended to operate from a 3.6 V lithium
battery.

8
Safety Safety Precautions
Avoiding Equipment Damage
No peripheral equipment may be connected to the
AccuPen.
The AccuPen 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.

9
Getting Started
Overview The AccuPen is designed to be used in multiple medical
settings and can be rested on a surface, such as a
counter or desk. The AccuPen requires no assembly.
Unpacking
Instructions
Upon receiving the AccuPen:
1. Remove the AccuPen® Tonometer case from the
protective shipping materials. Save the shipping
materials for use if return or repair becomes nec-
essary.
2. Check for missing items. The AccuPen® Tonome-
ter, this manual, a battery, a bag of 100 AccuTip
single-use latex tip covers and a lanyard should be
included inside the case.
3. Visually inspect the AccuPen® Tonometer for
damage.
CAUTION: AccuTips contain natural
rubber latex which may
cause allergic reactions.
Question patients about
allergies to latex before
examining them with the
AccuPen.

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Accutome AccuPen User Guide
Figure 2: AccuPen® Unpacked
*Note: Notify Accutome, Inc. immediately if any
components are missing or damaged. See Section
6 of this manual for contact information.
Battery
Specification
and
Installation
The power source for the AccuPen is 3.6 V Lithium
battery. The battery is included with the AccuPen and
must be installed before use.
Battery Specification
Use only one (1) 3.6 volt, XENO model XLP-050F
Lithium battery, or an equivalent.
CAUTION: Use only the style and
type of battery specified.
Using another style or
type of battery may cause

11
Getting Started Battery Installation
damage to the product
and invalidate the
warranty.
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 AccuPen:
1. Locate the battery compartment (as shown in Fig-
ure 3) on the bottom of the AccuPen and open the
compartment by unscrewing the battery door
screw. The battery door is hinged to the bottom of
the handle and should not be removed from the
product.
2. Insert the XENO model XLP-050F Lithium battery,
or an equivalent, into the battery compartment as
shown in Figure 3.

12
Accutome AccuPen User Guide
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.
Figure 3: Battery Insertion
Instructions
for Use
CAUTION: DO NOT AUTOCLAVE
THE AccuPen®
TONOMETER.
Initial AccuPen Tonometer Setup
The followiing steps outline the basic setup of the
AccuPen.

13
Getting Started Calibration
1. If the battery is not installed in the AccuPen, install
the battery as described in “Battery Installation” on
page 11 and 12 of this manual.
2. 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
Calibration The AccuPen is calibrated during the manufacturing
process, so there is no need to calibrate unit prior to
using the AccuPen. The AccuPen does NOT require
further calibration.
Recalibration of the unit is recommended only after the
unit has been dropped or mishandled. The steps to
recalibrate the AccuPen are as follows.
1. With the AccuPen powered on, press and hold
Main button and Up button simultaneously for 5
seconds. Probe will enter calibration mode and
“PROB HORZ” will be displayed on LCD as shown
in Figure 5.
2. Hold AccuPen, so the probe is horizontal and
press Main button as shown in Figure 5.