Accutome

AccuPen Users Guide Rev A

Users Guide

36 Pages

File Type: PDF

File Size: 1.7 MB

File Name: Accutome - AccuPen Users Guide Rev A.pdf

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

0086

Introduction - - - - - - - - - - - - - - - - - 1 AccuPen Overview Features - - - Measurements About This Manual

- - - - - - - - -

- - - - -

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

- -1 - -2 - 3 - -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 ALARA Principle - - - - - - - - - - - - - - - - 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 i

Accutome

AccuPen User Guide

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

Specifications

- - - - - - - -

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

- - - - - - - -

21 21 21 22 22 23 23

- - - - - - - - - - - - - - - 26

Overview - - - - - - - - - - - - - - - - - - - 26 Physical Specifications - - - - - - - - - - - - - 26 Environmental Specifications - - - - - - - - - - - - - - - - 27 Measurement Accuracy - - - - - - - - - - - - - 27

Warranty & Repairs

- - - - - - - - - - - - 28

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

- - - - - - -

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

28 29 29 29 29 30

List of Tables

Table 1 Table 2 Table 3 Table 4 Table 5 Table 6

IOP Correction Values- - - - - - - - - - - - - - - - - - - - - - - 19 AccuPen Troubleshooting Information - - - - - - - - - - - 24 AccuPen Physical Specifications - - - - - - - - - - - - - - - 26 Environmental Specifications - - - - - - - - - - - - - - - - - - 27 Measurement Accuracy- - - - - - - - - - - - - - - - - - - - - - 27 Accutome Replacement Parts - - - - - - - - - - - - - - - - - 30

iii

List of Figures

Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10

AccuPen® Tonometer - - - - - - - - - - - - - - - - - - - - - - - 1 AccuPen® Unpacked - - - - - - - - - - - - - - - - - - - - - - - 10 Battery Insertion - - - - - - - - - - - - - - - - - - - - - - - - - - 12 Control Buttons and LCD - - - - - - - - - - - - - - - - - - - - 13 Calibration Probe Horizontal Position - - - - - - - - - - - - 14 Calibration Probe Up Position - - - - - - - - - - - - - - - - - 14 Calibration Probe Down Position - - - - - - - - - - - - - - - 15 Measure Screen Starting New Patient - - - - - - - - - - - 16 Capturing a Measurement - - - - - - - - - - - - - - - - - - - - 17 Adjusted IOP Screen- - - - - - - - - - - - - - - - - - - - - - - - 18

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.

Accutome

AccuPen User Guide

The AccuPen 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 (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 2

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 Repairs

Describes AccuPen 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.

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.

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

Safety

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! WARNING!

DO NOT AUTOCLAVE!

DO NOT IMMERSE THE ENTIRE AccuPen IN ANY LIQUID. 6

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.

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.

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.

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 necessary. Check for missing items. The AccuPen® Tonometer, this manual, a battery, a bag of 100 AccuTip single-use latex tip covers and a lanyard should be included inside the case. 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.

Accutome

AccuPen User Guide

Figure 2: AccuPen® 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 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 10

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 Figure 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. Insert the XENO model XLP-050F Lithium battery, or an equivalent, into the battery compartment as shown in Figure 3. 11

Accutome

AccuPen User Guide

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. 12

Getting Started

Calibration

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. 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.

Hold AccuPen, so the probe is horizontal and press Main button as shown in Figure 5.

Accutome

AccuPen User Guide

Figure 5: Calibration Probe Horizontal Position 3.

Wait for beep and then hold AccuPen, so that the probe is straight up in a vertical position and press Main button as shown in Figure 6. "PROB UP" will be displated on the LCD.

Figure 6: Calibration Probe Up Position 4.

Wait for beep again and then hold AccuPen, so that the probe is straight down in a vertical position and press Main button as shown in Figure 7. "PROB DOWN" will be displayed on the LCD.

Getting Started

Basic Operation

Figure 7: Calibration Probe Down Position 5. 6. 7.

Basic Operation

Wait for beep, a calibration number will be displayed on LCD. Press Main button again to exit calibration mode and store calibration number. If “No Calc” is displayed on LCD the calibration process was not performed correctly.

The basic operation of the AccuPen consists of the following steps: 1. 2. 3.

Power on the AccuPen instrument. Take up to nine measurements. Enter the measured CCT (Central Corneal Thickness) and calculate the AIOP (Adjusted IOP) for each eye. Record the data in the Patient Record,

How to Power On the AccuPen 1.

With the battery installed, the AccuPen is always powered. However, after a period of non-use, the unit turns off sections of the electronics including the LCD, to conserve power. To restore the unit to full power, press any control button.

The Product Information Screen is briefly shown and then the Measure Screen is displayed.

Previous Page Next Page