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Accutome ACCUPEN User Manual

Other manuals for ACCUPEN: User Manual
Manual is about: HANDHELD TONOMETER

Summary of ACCUPEN

  • Page 1

    Accupen tonometer user’s guide ® handheld 24-3002 rev. E.

  • Page 2

    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 ...

  • Page 3: Manufactured In The Usa By:

    I manufactured in the usa by: accutome, inc. 3222 phoenixville pike malvern, pennsylvania 19355 usa.

  • Page 4

    Ii introduction - - - - - - - - - - - - - - - - -1 accupen overview - - - - - - - - - - - - - - - - 1 features - - - - - - - - - - - - - - - - - - - - 2 measurements - - - - - - - - - - - - - - - - 3 about this manual - - - - - - - - - - - - - - - - 4 safety - - - - - - - - - - - - - - - - - - - -4 ...

  • Page 5

    Iii accutome accupen user guide battery disposal - - - - - - - - - - - - - - - - 21 instructions for disposal - - - - - - - - - - - - 21 disposal in europe - - - - - - - - - - - - - - - 22 disposal in us. - - - - - - - - - - - - - - - - 22 storage - - - - - - - - - - - - - - - - - - - - 23 troublesh...

  • Page 6: List Of Tables

    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 - - - - - - - - - - - - -...

  • Page 7: List Of Figures

    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 - - - - - - - -...

  • Page 8: Introduction

    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...

  • Page 9

    2 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 tha...

  • Page 10

    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. ...

  • Page 11: Safety

    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 th...

  • Page 12

    5 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...

  • Page 13: Warning!

    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 dri...

  • Page 14: Caution:

    7 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 ...

  • Page 15

    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 anest...

  • Page 16: Getting Started

    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 shippin...

  • Page 17: Caution:

    10 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 ba...

  • Page 18: Caution:

    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 plac...

  • Page 19: Caution:

    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...

  • Page 20

    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 scr...

  • Page 21

    14 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...

  • Page 22

    15 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 perfor...

  • Page 23: Warning!

    16 accutome accupen user guide how to start a new patient to start a new patient: 1. Hold the up and down control buttons on the accupen simultaneously for two to three seconds. 2. A single beep from the instrument will indicate that all iop measurements, averages, cct entries and calculations are s...

  • Page 24

    17 getting started basic operation 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 contr...

  • Page 25

    18 accutome accupen user guide 3. You can review the measurements taken by press- ing the up and down control buttons. 4. 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 delet...

  • Page 26: Warning!

    19 getting started basic operation table 1 below provides the iop correction values. Warning! Cct adjustments are not supported by performance data. 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 ...

  • Page 27: Maintenance, Storage

    20 maintenance, storage and troubleshooting general maintenance maintenance that should be performed on the accupen 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 thr...

  • Page 28

    21 accutome accupen user guide maintenance and cleaning 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 an...

  • Page 29

    22 maintenance, storage and troubleshooting battery disposal 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 mann...

  • Page 30

    23 accutome accupen user guide 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 ...

  • Page 31

    24 maintenance, storage and troubleshooting troubleshooting table 2: accupen troubleshooting information symptom probable cause correction a. “low batt” displayed a. Battery is low a. Replace battery (see section 3.) b. Multiple vari- able readings b.1. Improper tech- nique b.1. Review measurement t...

  • Page 32

    25 accutome accupen user guide d.3. Battery is low d.4. Replace battery (see section 3.) d.4. Mechanical or electronic damage d.5. Arrange for repair through accutome technical service group (see section 9.) e. “no calc” displayed e. Out of calibration e. Recalibrate unit (see section 3.) f. "err 0"...

  • Page 33: Specifications

    26 specifications overview this section provides the physical and operational specifications of the accupen. Physical specifications table 3 below lists the physical specifications of the accupen instrument and associated peripherals. Table 3: accupen physical specifications main unit dimensions 18....

  • Page 34

    27 accutome accupen user guide environmental specifications table 4 below lists the accupen system operating and storage values for temperature and humidity. Measurement accuracy table 5 below lists the accupen accuracy. Table 5: measurement accuracy table 4: environmental specifications temperature...

  • Page 35

    28 specifications emc compliance information emc compliance information medical electrical equipment needs special precautions regarding emc and needs to be installed and put into service according to the emc information provided in this manual portable and mobile rf communications equipment can aff...

  • Page 36

    29 accutome accupen user guide table 7: guidance and manufacturer’s declaration - electromagnetic immunity the accupen is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the accupen should assure that it is used in such an environment. Immunity test...

  • Page 37

    30 specifications emc compliance information table 8: guidance and manufacturer’s declaration - electromagnetic immunity the accupen is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the accupen should assure that it is used in such an environment....

  • Page 38

    31 accutome accupen user guide table 9: recommended separation distances between portable and mobile rf communications equipment and the accupen the accupen is intended for use in an electromagnetic environment in which radiated rf disturbances are controlled. The customer or the user of the accupen...

  • Page 39: Warranty & Repairs

    32 warranty & repairs 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...

  • Page 40

    33 accutome accupen user guide product returns follow the instructions given below to return products to 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)...

  • Page 41

    34 warranty & repairs replacement parts replacement parts table 6 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. Table 10: accutome replacement parts description accu...