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Related Manuals for Elamed EASYTON
Summary of Contents for Elamed EASYTON
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Page 2: Table Of Contents
11. APPENDIX A the order of a physician. IOP measurement is taken through closed eyelid and does EASYTON Tonometer is covered by Russian Federa on’s Patent No. 2335234. not require any anaesthesia. The tonometer complies with all the security requirements provided by IEC 60601-1:2005 and IEC 60601-1-2:2014-04 interna onal standards. - Page 3 Tonometer usage is contraindicated in the following cases: KEY SAFETY TIPS • pathological condi ons of the upper eyelid • Make sure to examine the Tonometer body and rod for (inflammatory condi ons, scars, eyelid deformi es); presence of mechanical damages. Using the Tonometer if •...
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Page 4: Description And Design Features
Key Design Features 1. DESCRIPTION AND DESIGN FEATURES. OPERATING PRINCIPLE When placing the Tonometer rod on the eyelid and applying light pressure to the device, the rod is slightly immersed in- side the device and the forma on of a measuring vibra onal eff... - Page 5 Display Symbols Complete Set • EASYTON Tonometer • Built-in tester case • 1.5 V battery standard size ААА, R03 • Opera ng Manual • Retail packaging Important Facts on Intraocular Pressure Intraocular pressure measurement is a method of eye health diagnostics used in ophthalmology.
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Page 6: Preparation For Operation
Turn the Tonometer over so 2. PREPARATION FOR OPERATION that its front panel is facing downwards. 2.1. Battery Installation and Replacement Slide the battery case cover The current ba ery status is marked with the power level indica- in the direction of the arrow tor in the top le corner of the Tonometer display. -
Page 7: Func Onality Checkup Using The Tester
2.2. Functionality Checkup Using the Tester Position the Tonometer vertically above the tester. The Tonometer func onality is to be checked on the tester at The heel of the hand holding least once a week, as well as in the following cases: the device should rest against •... -
Page 8: Disinfec On
Keeping the device fixed in this 2.3. Disinfection position, keep an eye on the Please disinfect the Tonometer while it is switched off. digital value of the pressure Disinfec on of the buffer ring and Tonometer rod should be performed displayed in the Tonometer before and a er each new pa ent’s IOP measurement. -
Page 9: Device Application Procedure
Disinfection of the outer surfaces of the Tonometer body Check the Tonometer functionality using (others than the rod and the buffer ring) is performed as the tester (see Cl. 2.2). may be needed, using 3% hydrogen peroxide solution mixed Before measuring, the patient should with 0.5% solution of a household detergent. - Page 10 • The heel of the hand holding the Tonometer should rest • Holding the Tonometer vertically against the patient’s forehead. The smoothness and down, smoothly lower it down preciseness of movements required for the measuring by 2-3 mm. At this point, dynamic process is achieved by resting the hand against the force is actuated, which is patient’s head (forehead), as well as trained through...
- Page 11 In case if the sound signal didn’t • Attention! To obtain the most accurate IOP come off at all or came off with a о measurement results, the following conditions о delay of more than 3 seconds, the must be observed: measuring needs to be repeated.
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Page 12: Possible Errors And Troubleshooting
4. POSSIBLE ERRORS AND TROUBLESHOOTING Problem Possible cause Troubleshooting method The Tonometer does not switch on The batteries are dead Replace the batteries The batteries are seated Insert the batteries with due regard to the incorrectly polarity markings (+ / -) The contact of the batteries is Replace the batteries. -
Page 13: Maintenance Service And Minor Repairs
Minor Repairs 5. MAINTENANCE SERVICE AND MINOR REPAIRS Minor repairs of the Tonometer are provided by the Maintenance Procedure Manufacturer or its representative facility, after a technical inspection of the malfunction nature and degree has been Procedure Frequency performed by the Manufacturer’s experts. Routine inspection At least once a day The following may indicate presence of a malfunction:... -
Page 14: Specifications
Parameter Parameter value (to be filled in at device acceptance) Device Transpalpebral digital tonometer for intraocular pressure measurement Model EASYTON IOP readings range, mmHg 7-50 Accuracy, mmHg, within the range of: 7. STORAGE AND TRANSPORTATION 7-23 mmHg ±2 above 23 mmHg ±5... -
Page 15: Marking
Safety and effectiveness of the tonometer in the intended 8. MARKING environment of use is supported by testing that was The Tonometer is marked with the following symbols: conducted in accordance with the following standards: ISO 10993-1 «Medical products. Assessment of medical Refer to the opera ng manual products biological effect. - Page 16 The resulting Pearson correlation coefficient is more 95% (see pictures below). This indicates the high accuracy of the EASYTON tonometer compared to the Goldman tonometer. As a result of the tests, the required accuracy and repeatability of the measurements were confirmed.
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Page 17: Manufacturer's Warranty
9. MANUFACTURER’S WARRANTY The warranty does not cover the following cases: • if the Tonometer bears traces of outside interference The Manufacturer hereby guarantees that the quality of or repair attempts by non-authorized servicing the Tonometer conforms to the requirements stated in the companies;... -
Page 18: Acceptance Certificate
10. ACCEPTANCE CERTIFICATE 11. APPENDIX A Table 1 EASYTON transpalpebral digital tonometer for intraocular pressure measurement factory serial number Manufacturer's manual and declaration – electromagnetic emission is manufactured and accepted in compliance with the The tonometer is intended for use in the electromagne c environment spec- technical specification GIKS.941329.102 TS and is hereby... - Page 19 Table 2 Manufacturer’s manual and declaration – interference resistance The tonometer is intended for use in the electromagne c environment specifi ed below. The purchaser or user of the tonometer should ensure its use in the specifi ed electromagne c environment. Interference resistance test The test level according to IEC 60601 Compliance level...
- Page 20 Table 3 Manufacturer’s manual and declaration – interference resistance The tonometer is intended for use in the electromagne c environment specifi ed below. The customer or the user of the tonometer should ensure its use in the specifi ed electromagne c environment. Interference resistance test The test level Compliance...
- Page 21 The fi eld density in the propaga on of radio waves from sta onary radio transmi ers, such as base sta ons of radio telephone networks (cellular / wire- less), and surface-mobile radios, amateur radio sta ons, AM and FM broadcast transmi ers, television transmi ers can not be determined by calcula on with suffi...
- Page 22 Tel/fax: +7 (4912) 293-418, +7 (49131) 2-04-57 WARRANTY SHEET WARRANTY SHEET for repairs (replacement) within the warranty period EASYTON for repairs (replacement) within the warranty period EASYTON transpalpebral digital tonometer for intraocular pressure measurement transpalpebral digital tonometer for intraocular pressure measurement...
- Page 24 «Yelatma Instrument Making Enterprise», JSC 391351, 25 Yanina st., Yelatma, Kasimov district, Ryazan region, Russia Tel/fax: +7 (4912) 293-418, +7 (49131) 2-04-57 WARRANTY SHEET for repairs (replacement) within the warranty period EASYTON transpalpebral digital tonometer for intraocular pressure measurement Manufacturing date Purchased...
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