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(800) 979-2020 US & CA • (610) 889-0200 International • +31 (0) 485-350300 Europe • 

www.accutome.com

3

Information

The section lists:

•  Specific safety precautions 

associated with the PachPen

•  General safety precautions

Safety Issues to Consider When 
Using the PachPen

The PachPen is noninvasive. 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 
ophthalmologists who are experienced 
in ultrasonic biometric techniques.

CAUTION: General indications for use of 

the PachPen include external, structurally 

intact areas of the eye globe and orbit only.

Disposal Requirements

Disposal of the product within 
the EU 

The PachPen contains electronic 
components. At the end of its useful 
life, it must be properly disposed of in 
compliance with local regulations.

EU directives and national regulations 
currently in force at the time of 
marketing prohibit the disposal 
of the PachPen specified on the 
delivery note in domestic waste or by 
municipal waste disposal companies. 
If the PachPen or its components 

are resold, the seller has the duty to 
notify the buyer that the product must 
be disposed of in accordance with 
currently valid national regulations.

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.

Chapter 2: Safety

2

Safety

Attention! Consult 
Instruction Manual

Action Control 
Button

Battery 
Replacement

Type B Medical 
Device 

Class II Insulation

Disposal of Product 
within the EU 

Summary of Contents for PachPen

Page 1: ...PachPen User s Guide PachPen Handheld Pachymeter 24 5102 Rev H...

Page 2: ...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...

Page 3: ...the Probes with Alcohol 5 High Level Disinfection of the Probe 5 Electrical Hazard and Safety 5 Avoiding Equipment Damage 5 Avoiding Electromagnetic and Other Interference 6 Chapter 3 Getting Started...

Page 4: ...torage 14 Troubleshooting 14 Chapter 5 Specifications 15 Overview 15 Physical Specifications 15 Environmental Specifications 15 Measurement Accuracy 16 Operating Modes 16 Acoustic Output 17 Chapter 6...

Page 5: ...Correction Values 11 Table 4 1 PachPen Troubleshooting Information 14 Table 5 1 PachPen Physical Specifications 15 Table 5 2 Environmental Specifications 15 Table 5 3 Measurement Accuracy 16 Table 5...

Page 6: ...accomplish even the complex simply The PachPen provides the following general features Multi segment high resolution LCD screen with control buttons to provide an intuitive user interface Long lastin...

Page 7: ...guide for technicians optometrists and ophthalmologists who are experienced in ultrasonic biometric techniques This manual is organized as follows Chapter 2 Safety Summarizes safety precautions warni...

Page 8: ...posal Requirements Disposal of the product within the EU The PachPen contains electronic components At the end of its useful life it must be properly disposed of in compliance with local regulations E...

Page 9: ...ed 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 ef...

Page 10: ...ome probes Note Be sure to follow the disinfectant manufacturer s written protocol when using any antibacterial solution including high level disinfectants Electrical Hazard and Safety The PachPen is...

Page 11: ...EMATURE FAILURE OF THE DEVICE Avoiding Electromagnetic and Other Interference Do not use a cellular telephone or other device not compliant with EMC Class B requirements as its signals may cause the e...

Page 12: ...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 3 Visually inspect the PachPen...

Page 13: ...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 2 Insert the XENO model XLP 050F lithium battery or an e...

Page 14: ...consists of the following steps 1 Power on the PachPen instrument 2 Take up to nine measurements 3 Enter the measured IOP and calculate the corrected IOP for each eye 4 Record the data in the Patient...

Page 15: ...e expires Notes 1 The PachPen can take up to nine measurements and provide the average of those measurements This average is the number used when calculating the True IntraOccular Pressure TIOP 2 The...

Page 16: ...s Figure 3 7 True IOP Screen Table 3 1 IOP Correction Values Corneal Thickness micrometers Correction Values mmHg 405 7 425 6 445 5 465 4 485 3 505 2 525 1 545 0 565 1 585 2 605 3 625 4 645 5 665 6 68...

Page 17: ...alcohol or in an ultrasonic cleaner and allowing it to air dry Do not drop the device Avoid any shock or excessive vibration as this may damage the unit Do not immerse the device in any fluid This wil...

Page 18: ...s once the decomposition or neutralization process has terminated Disposal in the United States Lithium batteries are neither specifically listed nor exempted from the federal Environmental Protection...

Page 19: ...ptom Probable Cause Correction LOW BATT Displayed Battery is low Replace battery see chapter 3 Multiple variable readings Improper technique Review measurement technique Battery is low Replace battery...

Page 20: ...ght 85 g 3 oz Display Type Multi Segment Monochrome Liquid Crystal Display LCD Size 28 6 mm 1 13 Diagonal Viewable Area Probe Frequency 10 5 MHz Composite Sample Frequency 65 MHz Safety Meets EN 60601...

Page 21: ...Modes The following table summarizes the mode application possibilities for each system transducer combination Table 5 4 Operating Modes Clinical Application A B M PWD CWD CD Combined specify Other s...

Page 22: ...e A Mode Application s Ophthalmic Table 5 5 Acoustic Output Reporting Table for Track 1 Non Autoscanning Mode Acoustic Output MI ISPTA 3 mW cm2 ISPPA 3 W cm2 Global Maximum Value 0 154 0 0145 8 53 Ass...

Page 23: ...nnected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 N A Voltage fluctuations flicker emissions IEC 61000 3 3 Comp...

Page 24: ...etermined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Ra...

Page 25: ...sponsibility of the customer Alteration repair or modification of any product that is performed by persons not authorized by Accutome Inc will immediately void the warranty Product Returns Follow the...

Page 26: ...or 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 pa...

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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