Accutome PachPen User Manual

Accutome PachPen User Manual

Handheld pachymeter
Table of Contents

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PachPen
Handheld Pachymeter
PachPen User's Guide
24-5102
Rev-H

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Table of Contents
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Summary of Contents for Accutome PachPen

  • Page 1 PachPen Handheld Pachymeter PachPen User’s Guide 24-5102 Rev-H...
  • Page 2 (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.
  • Page 3: Table Of Contents

    PachPen Overview Features Measurements About This Manual Chapter 2: Safety Information Safety Issues to Consider When Using the PachPen Indications for Use Disposal Requirements Disposal of the product within the EU Symbol Definitions for the PachPen Safety Precautions Disinfection and Cleaning...
  • Page 4 Accutome PachPen Manual Instructions for Disposal Storage Troubleshooting Chapter 5: Specifications Overview Physical Specifications Environmental Specifications Measurement Accuracy Operating Modes Acoustic Output Chapter 6: Warranty & Repairs Warranty Product Returns Service and Repair All Other Returns NonReturnable Merchandise Replacement Parts www.accutome.com...
  • Page 5 Figure 3.6 - Measurement Screen Starting New Patient Figure 3.7 - True IOP Screen Table 3.1 - IOP Correction Values Table 4.1 - PachPen Troubleshooting Information Table 5.1 - PachPen Physical Specifications Table 5.2 - Environmental Specifications Table 5.3 - Measurement Accuracy Table 5.4 - Operating Modes...
  • Page 6: Chapter 1: Introduction

    • 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 •...
  • Page 7: Measurements

    Provides PachPen physical and operational specifications. Chapter 6 - Warranty and Repairs Describes PachPen warranty information and repair procedures. After reading this manual, you will be able to set up the PachPen, take measurements, and enter and calculate Corrected IOP. www.accutome.com...
  • Page 8: Chapter 2: Safety

    Disposal of Product marketing prohibit the disposal within the EU of the PachPen specified on the delivery note in domestic waste or by municipal waste disposal companies. If the PachPen or its components (800) 979-2020 US &...
  • Page 9: Safety Precautions

    Accutome PachPen Manual 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.
  • Page 10: Disinfection Of The Probes With Alcohol

    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 3.6V lithium battery.
  • Page 11: Avoiding Electromagnetic And Other Interference

    Accutome PachPen Manual Caution: Dropping the PachPen can result in damage to the housing or other parts of the device. To prevent unwanted damage to the device, be sure to use the lanyard provided when handling the unit. WARNING! OPERATING OR STORING THE DEVICE BEYOND THE ENVIRONMENTAL RANGES IN THE SPECIFICATIONS CHAPTER MAY RESULT IN ERRONEOUS READINGS AND/OR PREMATURE FAILURE OF THE DEVICE.
  • Page 12: Chapter 3: Getting Started

    Chapter 3: Getting Started 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:...
  • Page 13: Battery Installation

    Initial PachPen Pachymeter Setup The steps below outline the basic setup of the PachPen. If the battery is not installed in the PachPen, install the battery as described in “Battery Installation” above. 2. 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 www.accutome.com...
  • Page 14: Basic Operation

    4. Record the data in the Patient Record. How to Power On the PachPen With the battery installed, the PachPen is always powered. However, after a period of nonuse, the unit turns off sections of the electronics, including the LCD, to conserve power.
  • Page 15: How To Take A Measurement

    Starting New Patient Touch and hold the Up and Down Control Buttons on the PachPen simultaneously for 2 to 3 seconds to reset all measurements, averages, and IOP information to zero. 2. Press and release the Action Control Button. Two high pitched chirps (beeps) and a rotating line to the left of the average in the display indicate that the PachPen is ready to take a reading.
  • Page 16: Figure 3.7 - True Iop Screen

    Doughty and Zamen. This chart was reproduced from the Review of Ophthalmology, July 2002. Leon Herndon, MD, Duke University, Glaucoma Service, pp. 88—90. (800) 979-2020 US & CA • (610) 889-0200 International • +31 (0) 485-350300 Europe • www.accutome.com...
  • Page 17: Chapter 4: Maintenance, Storage, & Troubleshooting

    Clean the PachPen Pachymeter by wiping everything except the tip with a clean lint-free, nonabrasive cloth and alcohol. Clean the PachPen Pachymeter tip by dipping only the first ¼” of the tip into alcohol or in an ultrasonic cleaner and allowing it to air-dry.
  • Page 18 Thus, in each country, the manufacturers, importers, and users are responsible for proper disposal or recycling. In accordance with these directives, the PachPen Lithium cells do not contain dangerous substances. The reaction products are inorganic and do not represent environmental hazards, once the decomposition or neutralization process has terminated.
  • Page 19: Storage

    When not in use, the PachPen Pachymeter and all accessories should be placed in the storage case. 2. If the PachPen Pachymeter is not to be used for an extended period of time, remove the battery from the device. Troubleshooting Refer to Table 4.1 below for information in identifying and correcting problems that...
  • Page 20: Chapter 5: Specifications

    Chapter 5: Specifications Specifications Overview This section provides the physical and operational specifications of the PachPen. Physical Specifications Table 5.1 below lists the physical specifications of the PachPen instrument and associated peripherals. Table 5.1 - PachPen Physical Specifications Main Unit Dimensions 18.4 cm x 3.2 cm x 3.2 cm (7 1/4”...
  • Page 21: Measurement Accuracy

    Accutome PachPen Manual Measurement Accuracy Table 5.3 below lists the PachPen accuracy. Table 5.3 - Measurement Accuracy Measurement Corneal Thickness Clinical Accuracy (1 Sigma) +/- 5 Micrometers Electronic Resolution (@1640 m/sec) +/- 1 Micrometer Range 300—999 Micrometers Operating Modes The following table summarizes the mode/application possibilities for each system/transducer combination.
  • Page 22: Acoustic Output

    Specifications Acoustic Output Table 5.5 below provides the acoustic output reporting for the following: System: PachPen Transducer Model: A-Mode Probe Operating Mode: A-Mode Application(s): Ophthalmic Table 5.5 - Acoustic Output Reporting Table for Track 1 Non-Autoscanning Mode ISPTA.3 ISPPA.3 Acoustic Output...
  • Page 23: Electromagnetic Emissions

    Table 5.6 - Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The PachPen is intended for use in the electromagnetic environment specified below. The customer or the user of the PachPen should assure that it is used in such an environment. Emissions Test...
  • Page 24: Electromagnetic Immunity

    Table 5.8 - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The PachPen is intended for use in the electromagnetic environment specified below. The customer or the user of the PachPen should assure that it is used in such an environment. Immunity...
  • Page 25: Chapter 6: Warranty & Repairs

    Any product that is proven to be defective will be repaired or replaced, at our discretion, free of charge, up to one year from the date of purchase by the initial user of the equipment from Accutome, Inc., or any of its authorized distributors.
  • Page 26: Nonreturnable Merchandise

    • Merchandise held longer than 60 days Replacement Parts Table 6.1 below lists items that are available from Accutome, Inc. or from your local sales representative. Please be sure to use the Accutome part number for the item when placing an order.
  • Page 27 US and Canada (800) 979-2020 International (610) 889-0200 European Office +31 (0) 485-350300 Info@accutome.com www.accutome.com...

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