AccuPen User Guide
Contents
1. L LJ L L LJ LJ LJ ASS 4 Used batteries should be shipped with the same regulations as those for new Lithium Thionyl Chlo ride batteries 5 Accutome recommends that cells and batteries for disposal should be collected transported and dis posed of in a manner that will prevent short circuit the terminals taped 6 Handling of used cells and batteries should be done according to the safety instructions of fresh cells 7 Recycling of the cells and batteries should be done in authorized facilities through licensed waste carrier A recycler in US is listed below Disposal in Europe The European Community EC has issued two directives 91 157 EEC and 93 86 EEC These directives are implemented by each member country in a different way Thus in each country the manufacturers importers and users are responsible for the proper disposal or recycling In accordance with these directives the AccuPen 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 Disposal in US Lithium batteries are neither specifically listed nor exempted from the Federal Environmental Protection Agency EPA hazardous waste regulations as conveyed by the Resources Conservation and Recovery Act RCRA The only metal of possible concern in the cell is the lithium meta2. D 3 Battery is low D 4 Replace battery See Section 3 D 4 Mechanical or D 5 Arrange for repair electronic damage through Accutome Technical Service Group See Section 9 E NO CALC E Out of calibration E Recalibrate unit displayed See Section 3 F ERR 0 dis F Measurable F Arrange for repair through played range out of tolle Accutome Technical Service rance Group See Section 9 G ERR 1 dis G Measurable G Arrange for repair played range out of tolle through Accutome Technical rance Service Group See Section 9 H ERR 2 dis H Measurable H Arrange for repair played range out of tolle through Accutome Technical rance Service Group See Section 9 25 Overview Physical Specifications This section provides the physical and operational specifications of the AccuPen Table 3 below lists the physical specifications of the AccuPen instrument and associated peripherals Table 3 AccuPen Physical Specifications Main Unit Dimensions 18 4 cm X 3 2 cm X 3 2 cm 7 25 X 1 25 X 1 25 Weight 85 g 3 02 Display Type Multi Segment Monochrome Liquid Crystal Display LCD Size 28 6 mm 1 13 Diagonal Viewable Area Distal Tip 300 Series Stainless Steel Sampling Rate 1 KHz Safety Meets EN 60601 1 Series electrical standards for medical equipment 26 Accutome AccuPen User Guide L L L o L L
3. L L L L Maintenance and Cleanin g Clean the AccuPen Tonometer by wiping everything except the tip with a clean lint free non abrasive cloth and alcohol Clean the AccuPen Tonometer tip by wiping the tip with alcohol 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 will damage the electronics and invalidate the warranty Note See Section 3 for battery specification and installation Battery Follow the procedure outlined below for proper disposal Disposal of lithium batteries Instructions for Disposal 1 Guidelines for the disposal of lithium batteries are continually under review Waste management companies can provide assistance in the disposal of these cells and batteries 2 Disposal should be done in accordance with appli cable regulations which vary from country to coun try In most countries disposal of used batteries in the trash is forbidden Disposal can be done through non profit organizations mandated by local authorities or organized by professionals 3 Cells and batteries should not be incinerated unless suitable procedures are followed and appropriate precautions have been taken by quali fied handlers Exposure of these cells to high tem peratures or fire can cause the cells to vent and or rupture 21 Maintenance Storage and Troubleshooting Battery Disposal
4. Calibration Probe Up Position 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 14 Getting Started Basic Operation Figure 7 Calibration Probe Down Position 5 Wait for beep a calibration number will be dis played on LCD 6 Press Main button again to exit calibration mode and store calibration number 7 If No Calc is displayed on LCD the calibration process was not performed correctly Basic The basic operation of the AccuPen consists of the Operation following steps 1 Power on the AccuPen instrument 2 Take up to nine measurements 3 Enter the measured CCT Central Corneal Thick ness and calculate the AIOP Adjusted IOP for each eye 4 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 2 The Product Information Screen is briefly shown and then the Measure Screen is displayed 15 Accutome AccuPen User Guide L L L L L LJ L L Pn ES EON How to Start a New Patient To start a new Patient 1 Hold the Up and Down control buttons on the AccuPen simultaneous
5. 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 g3 e eo ko 2 Introduction About this Manual L L L L L Li L Li L LJ L 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 Section3 Getting Started Provides assembly instructions overview of AccuPen basic operation Section 4 Maintenance Provides general maintenance instructions Section5 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 Safety The section lists Information Safety Precautions associated with the AccuPen Safety Precautions of a general nature Safet
6. period of time remove the battery from the device Troubleshoot Refer to Table 2 for information in identifying and Ing correcting problems that can occur with the AccuPen 23 Maintenance Storage and Troubleshooting ee 8 mee Troubleshooting 8 Table 2 AccuPen Troubleshooting Information able readings nique Symptom Probable Cause Correction A LOW BATT A Battery is low A Replace battery displayed See Section 3 B Multiple vari B 1 Improper tech B 1 Review measurement technique B 2 Battery is low B 2 Replace battery See Section 3 B 3 Mechanical or electronic damage B 3 Arrange for repair through Accutome Technical Service Group See Section 9 C No beep and or no display upon activation C 1 Action Control Button not held down long enough C 1 Hold down Action Con trol Button longer C 2 Incorrect bat tery installation C 2 Check battery C 3 Battery is low C 3 Replace battery See Section 3 C 4 Mechanical or electronic damage C 4 Arrange for repair through Accutome Technical Service Group See Section 6 D No readings D 1 Improper tech nique D 1 Review measurement technique D 2 Incorrect battery installation D 2 Check battery 24 Accutome AccuPen User Guide L L i L L L L
7. 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 C 0086 Introduction 1 AccuPen Overview 7 7 5 5 7 5 1 Features lt 4 4 4 4 2 826 o eee eee ee 2 Measurements 7 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 s c c oc s s Sos 6 Disinfection and Cleaning 6 Cleaning 7 Electrical Hazard and Safety 7 Avoiding Equipment Damage 8 ALARA Principle 8 Getting Started 9 Overview eee ee eee 9 Unpacking Instructions 9 Battery Specification and Ins
8. ACCUTOME AccuPer Handheld Tonometer User s Guide 24 3002 Rev A 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 o gt gt 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 e Ww A W This device complies with Part 15 of the FCC Rules Operation of this product is subject to
9. AccuPen Tonometer Setup The followiing steps outline the basic setup of the AccuPen 12 Getting Started Action Control Button 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 Up Button Calibration Down Button Figure 4 Control Buttons and LCD 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 13 Accutome AccuPen User Guide Str ec oe ee Ot Bry oS oe aih 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 m y Figure 6
10. J L Environmental Table 4 below lists the AccuPen system operating and Specifications storage values for temperature and humidity Table 4 Environmental Specifications Temperature Operating 10 C to 40 C 50 F to 104 F Storage 20 C to 60 C 4 F to 140 F Relative Humidity Operating 20 to 80 non condensing Storage 15 to 90 non condensing Atmospheric Pressure Operating 700 1060 hPa Storage 500 1060 hPa Measurement Table 5 below lists the AccuPen accuracy Accuracy Table 5 Measurement Accuracy Measurement IOP Sampling of Pressure Signal 1 KHz Range 7 60 mmHG 27 Warranty Accutome Inc warrants its new equipment to be free from defects in workmanship or materials 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 This warranty covers all repairs and servicing of parts that proved defective by manufacture and not by misuse or mishandling This type of service will be handled by our trained sales force or if necessary in our home office Shipping charges for returns or repair of non warranted items will be the responsibility of the customer Alteration repair or modification of any product that is p
11. 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 po not auTocLave WARNING po not immerse THE ENTIRE AccuPen IN ANY LIQUID Accutome AccuPen User Guide L L Li L L L L L 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 nece
12. ed Basic Operation L LJ L Table 1 below provides the IOP correction values Table 1 IOP Correction Values Corneal Thickness micrometers Correction Values mm Hg 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 6 685 7 705 8 Correction Values according to corneal thickness of 545 micrometers These correction values are modified from the work of Doughty and Zamen This chart was reproduced from the Review of Ophthalmology July 2002 Leon Herndon MD Duke University Glaucoma Service Pages 88 89 90 WARNING cct Adjustments are not supported by performance data 19 PEA TTA Ki Ps LAD Trou JH ne IG General Maintenance that should be performed on the AccuPen Maintenance consists of activities such as keeping surfaces free of dust and dirt and storing in a dry and cool place so as to not adversely effect electronic parts Refer to Chapter 2 page 7 through page 8 for details on sterilization disinfection and cleaning before doing any sterilization disinfection or cleaning of the AccuPen CAUTION No abrasives or harsh cleaning solutions should be used while cleaning the AccuPen Note The unit does not contain any user replaceable parts other than the battery 20 Accutome AccuPen User Guide L L L L L
13. erformed by persons not authorized by Accutome Inc will result in immediate loss of warranty 28 Accutome AccuPen User Guide L L L L L L L Product Follow the instructions given below to return products to Returns Accutome Inc Service and Repair Before returning instruments for service or repair contact the Accutome Technical Service Group for a Return Goods Authorization RGA number Toll Free in USA 1 800 979 2020 Tech Service 1 610 889 0200 Fax 1 610 889 3233 After receiving authorization print the RGA number on the outside of the package and send the instrument to Technical Service Group Accutome Inc 3222 Phoenixville Pike Malvern PA 19355 All Other Returns Returns for non service related reasons must be authorized by the Accutome Customer Service Department Please contact Customer Service for an RGA number Merchandise returned within 60 days of date of invoice will be credited as follows Full credit for all merchandise returned in resalable condition Non Returnable Merchandise Accutome Inc will not authorize a return for Merchandise held longer than 60 days 29 Warranty amp Repairs Replacement Parts LJ LJ LJ L L L Replacement Table 6 below lists items that are available from Parts Accutome Inc or from your local sales representative Please be sure to use the Accutome part number
14. essing 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 L L I L L L L L L L 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 s ae eo ko Measurements The high accuracy of the AccuPen measurements is provided by the following High resolution real time waveform analysis High speed signal digitalization which
15. for the item when placing an order Table 6 Accutome Replacement Parts Description Accutome Part No Standard Parts Battery 24 5101 AccuTip Tonometer Probe AX9950 Caps Sanitized Proparacaine 15 ml AX0500 30
16. ied Using another style or type of battery may cause 10 Getting Started Battery Installation L L LJ damage to the product and invalidate the warranty Battery Installation CAUTION Tre 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 11 Accutome AccuPen User Guide L L I L L L L L L 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 lt a wo SS sev CiTHIUM BATTER xiP 050F TYJ8 020 T Ll Figure 3 Battery Insertion Instructions for Use CAUTION Donor auTtoctave THE AccuPen TONOMETER Initial
17. ing the Adjusted Intraocular Pressure AIOP 2 The symbol by a measurement indicates the reading which is furthest away from the average 17 Accutome eo moe woe 8 AccuPen User Guide L L L L L L L You can review the measurements taken by press ing the Up and Down control buttons You can delete any measurement taken by touch ing and holding either the Up or Down control but ton for several seconds until the unit emits a high pitched chirp After deleting a measurement the unit will automatically recalculate the average of the measurements How to Calculate Adjusted IOP After you have completed a Patient s measurements you can calculate the Adjusted IOP for the Patient You can perform the calculation from the MCCT Manual Central Corneal Thickness Screen To calculate Adjusted IOP 1 From the Measurement Screen select the MCCT screen by pressing and holding the Action Control button for two to three seconds 530um will appear as default Enter the measured CCT by pressing the Up and Down control buttons until the proper measured CCT is displayed If you make a mistake just reselect the correct value The Adjusted IOP based on the average of the measurements taken is displayed below the mea sured IOP Return to the Measurement Screen by pressing and holding the Action Control button until the Measurement Screen appears Figure 10 Adjusted IOP Screen 18 Getting Start
18. ividuals by keeping doses and test repetition As Low As Reasonably Achievable to achieve the required diagnostic information Overview The AccuPen is designed to be used in multiple medical settings and can be rested on a surface such asa counter or desk The AccuPen requires no assembly Unpacking Upon receiving the AccuPen Instructions 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 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 f The power source for the AccuPen is 3 6 V Lithium Specification battery The battery is included with the AccuPen and and must be installed before use Installation 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 specif
19. l that is not listed or characterized as a toxic hazardous waste Significant amount of spent cells and batteries that are untreated and not fully discharged are considered as reactive hazardous waste Thus hazardous waste of spent cells and batteries can be disposed after they are first neutralized through an approved secondary treatment prior to disposal as 22 Accutome AccuPen User Guide L L i L L L L L ARI pee ee ee es required by U S Land Ban Restriction of the Hazardous and Solid Waste Amendments of 1984 Disposal of spent batteries should be performed by authorized professional disposal company which has the knowledge in the requirements of the Federal the State and the Local authorities regarding hazardous materials transportation and waste disposal In any case it is recommended to contact the local EPA Office PROPER SHIPPING NAME Waste lithium Batteries UN NUMBER 3090 LABEL REQUIREMENTS MISCELLANEOUS HAZARDOUS WASTE DISPOSAL CODE D003 Following is a suggestion for battery recycler and collector in the US ToxCo Inc 3200E Frontera Anaheim California 92806 Contact Person David Miller Email DMiller320 aol com Tel 714 879 2076 Fax 714 441 0857 www Toxco com Storage 1 When not in use the AccuPen Tonometer and all accessories should be replaced in the storage case 2 If the AccuPen Tonometer is not to be used for an extended
20. ly for two to three seconds 2 A single beep from the instrument will indicate that all IOP measurements averages CCT entries and Calculations are set to zero Figure 8 Measure Screen Starting New Patient WARNING The AccuTip cover must be replaced before taking any measurements on a new patient 16 Getting Started Basic Operation LJ L L J L J Bo eee NN EEEE EEEE EEEE ENE NOOO OE EEE How to Take a Measurement To take a patient measurement 1 Touch and hold the Up and Down control buttons on the AccuPen simultaneously for two to three 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 AccuPen is ready to take a reading 3 Gently tap the sensor tip on the patient s eye 4 The AccuPen will automatically proceed to the next empty measurement if it is available 5 The AccuPen will emit a high pitched chirp beep when you have automatically acquired a measure ment 6 The AccuPen will emit three high pitched chirps beeps when the 9th measurement has been taken or if the measurement time expires Figure 9 Capturing a Measurement Notes 1 The AccuPen can take up to 9 measurements and provide the average of those measurements This average is the number used when calculat
21. ssary 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 Precautions LJ LJ L L LJ 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 ind
22. tallation 10 Battery Specification 10 Battery Installation 11 Instructions for Use 12 Initial AccuPen Tonometer Setup 12 Calibration ee 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 Accutome AccuPen User Guide Maintenance and Cleaning 21 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 Warranty amp Repairs 28 Warranty 28 Product Returns 29 Service and Repair 29 All Other Returns 29 Non Returnable Merchandise 29 Replacement Parts 30 Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 IOP Correction Val
23. ues 19 AccuPen Troubleshooting Information 24 AccuPen Physical Specifications 26 Environmental Specifications 27 Measurement Accuracy 27 Accutome Replacement Parts 30 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 AccuPen Overview The Accutome AccuPen pictured below has all the features that make it easy to obtain extreme accuracy and improved patient outcomes Features Figure 1 AccuPen Tonometer 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 proc
24. y 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 L LJ L LJ L LJ L L LJ Symbol Statements graphics and symbols listed below are used Definitions for on components of the AccuPen Descriptions and the meanings are listed to the right of the symbols AccuPen Attention Consult Instruction Manual K Type B Medical Device 3 6 Volts Lithi B ry Repl men Lithium 0 attery Replacement Class II Insulation Action Control Button Safety Safety Precautions Safety There are several areas in the use of the AccuPen that Precautions 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
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