TVGD-01 User Manual
Contents
1. testing unit is good to obtain practical skill in taking measurement by TVGD 01 tonometer The work on the testing unit is carried out under the following procedure 1 Open the tonometer case Fig 18 2 Take the Tomometer in your hand and arrange the open case with testing unit in it on the table fig 19 3 Turn the Tonometer with rod upward and remove the guard cap 4 Press the ON OFF button momentarily to switch the Tonometer on 5 Be sure of the Tonometer readiness to work according to arrow movements on the display fig 5a 6 Hold Tonometer with the fingers of your hand by body cylindrical part with in scription TVGD 01 Tonometer on it Hold Tonometer with the fingers of your hand by body cylindrical part with inscription TVGD 01 Tonometer on it 7 Place Tonometer with measuring rod down and arrange the Tonometer body so that you can see the Tonometer display Operating manual Page 15 TVGD 01 8 Place the Tonometer in vertical position with rod over the testing unit The edge of the hand with the Tonometer in it should be leaned on the table surface Rest the edge of the hand with the Tonometer in it on the table surface fig 19 Fig 19 Attention Tonometer is always to be in the vertical position when you take measurement 9 Easily move tonometer down not taking the edge of the hand from the table surface with the rod to the center of the testing unit fig 20 21 inserting the tonom2. 391351 Yelatma Kasimov district Ryazan region JSC ENS Additional information you can get by tel 7 49131 2 09 60 www elamed com Operating manual Page 18 TVGD 01 REPAIR Brief records about the made repair TVGD 01 Tonometer of intraocular pressure works serial No The cause of repair Information on repair made TGVD 01 tonometer of intraocular pressure works serial No is accepted according to obligatory requirements of state standards and the working engineering specifications and recognized as ready to operation The executor of the repair guarantees the device conformity to requirements of the working engineering specifications provided observance requirements of the present document by the consumer Warranty period of the device operation 12 months from the date of its acceptance by consumer Controller Technical control dep Signature First last name Seal Date month year Operating manual Page 19 TVGD 01 FOR NOTES Operating manual Page 20
3. TVGD 01 THE TABLE OF CONTENTS DESCRIPTION os ida id 2 TECHNICAL CHARACTERISTICS ooocccoccccococococcconoccnonccnonoconnnconnnnnrnncncnnn anar 2 ARRANGEMENT AND OPERA TON oocccoccccccocccconcconncccnncnnnncnnancnonoconannncnnncnnn cnc nnnnnnos 3 COMELETE SE La 3 E PEO a e a 4 INTENDED USE seana aa e a a r a A A teste 4 INTRAOCULAR PRESSURE MEASURE PROCEDURE cccoccococcccooccconccccccccccnccos 9 SARE TY MEASURE Std 11 MAINTENANCE SERVICE eda aed eva adn ia odias 11 ROUTINE MAINTENANCE aso tua is vacua cual cee et ee eee an ed 12 REPLACEMENT OF POWER SUPPLY ELEMENTS 0 eee eeeeeeeeeeeeeeeneees 12 PROBABLE FAULT CONDITIONS AND MEANS OF THEIR ELEMINATION 14 CHECK OF TONOMETER OPERABILITY ON THE TESTING UNIT 15 STORAGE AND TRANSPORTATION cecceeececeeeeeceeeeceeeeeeeeeseeeeeeeeeesaeesaeeesaeeneas 18 ACCEPTANCE CERTIFICATE cocinada 18 MANUFACTURER S WARRANTY 0 0 cececceececeeeeeceeceeeeeeeeeeeeeeeeeaaeeeaaeesaeeenaeeeseseeaes 18 RERA ae een ee eee ee er S ee ere 19 Operating manual Page 1 TVGD 01 DESCRIPTION TVGD 01 Tonometer of intraocular pressure hereinafter as Tonometer is design to measure intraocular pressure through the eyelid in the ranges from 5 to 60 mm Hg without the application of anesthetic for both adult and children The Tonometer is delivered in a case being equipped with testing unit The case serves for the Tonometer carriage and storage during all period of its use The t
4. ation when the device is switched on Fig 5 The Tonometer display state at the device different operating mode are shown in the fig 5 The property of the device to make intraocular pressure measurement continu ously facilitates an effective training According to statistic you can obtain meas urement practice in 10 20 minutes using for training such material as elastic dough or your finger cushion According to statistic data you can obtain measure Operating manual Page 5 TVGD 01 ment procedure practice in 10 20 minutes using for training elastic dough or your finger cushion Tonometer is able to carry out measurement at any accessible point of eye sclera or cornea through the eyelid But there are recommended points to take meas urement which are convenient both for doctors and patients fig 6 and 7 gq E g a T A Fig 6 Fig 7 The main conditions defining the measurement accuracy perpendicular position of the Tonometer s rod to the eye surface tonometer body vertical position softness and exactness of action movements with a speed about 2 sm a sec ond when IOP measurement being conducted The requirement of softness and exactness of action motions is easily provided by the hand with tonomerter in it leaned against forehead of a patient fig 6 and 7 Perpendicular position of the Tonometer s rod to the eye surface is an important condition To reach perpendicularity of Tonometer
5. e ter guard ring up to the stop into the ring slot of the testing unit The lower plate of the tonometer guard ring should be closely coincide with slot ring plate fig 22 23 We can feel the activated measuring mode as slight hand vibration Measuring mode is also followed with pressure indication on the Tonometer display 10 Holding a tonometer in this position observe of the digital value of pressure displayed on the display of a tonometer The mode of measurement will go on till rais ing tonometer up above the testing unit Indication of digital value on the display should not differ from that stated in the clause Technical characteristics more than by two figures 11 Smoothly raise the Tonometer up over the testing unit Measuring mode is stopped and on the Tonometer display there is appeared the measured value 12 Measuring mode can be repeated several times following items 9 10 and 11 of this clause 13 Press momentarily the on off button to switch the Tonometer off Operating manual Page 16 TVGD 01 14 Put the guard cap on turning tonometer with rod upward and put it back into the case Fig 20 Fig 21 Operating manual Page 17 TVGD 01 STORAGE AND TRANSPORTATION Tonometer in manufacture s package can be kept in the closed premise at the temperature between 50 C 40 C relative humidity up to 98 at 25 C Tonometer in manufacture s package can be transported by any covered trans portation
6. esting unit serves to make periodic check of the Tonometer fitness for operation Contraindications the pathological conditions of an upper eyelid inflammatory diseases scars eyelid deformation sclera and or conjunctivitis apparent pathology in the field of measurement TECHNICAL CHARACTERISTICS e Overall dimensions max 176x26x20 mm e Weight of the device without power supply elements 80g e Tonometer operation climatic conditions air temperature from 10 C to 35 C air relative humidity up to 80 at temperature 25 C e Tonometer feeding is provided from two power supply elements of AAAA 1 5 V type e Tonometer operating condition is provided by power supply voltage from ae 3 3 V to h1 2 0 V e Measurement absolute error comes to 2 mm Hg at pressure measurement in ranges from 5 up to 26 mm Hg the relative error comes to 10 of measured value at pressure measurement from 26 up to 60 mm Hg e Tonometer max current consumption switched off position 60 mkA switched on position in the measurement Wating mode 4 mA in measurement mode 60 mA e Time of one measurement max 2s e Tonometer external surfaces are steady to disinfection by chemical method with any disinfection solution allowed to application in medical practice for products made of plastic and metals against infection of dermatophytosis type e Tonometer readings with the application of control unit mm Hg s
7. facilities in microclimatic areas with both moderate and cold climate and ambient temperature between 50 C 50 C CERTIFICATE OF ACCEPTANCE TVGD 01 Tonometer of intraocular pressure works serial No Is manufactured and accepted in conformity with WKC 941329 101 TY and is recog nized as ready for operation Date of output Seal signature of the person responsible for acceptance TVGD 01 Tonometer of intraocular pressure is packed in accordance with the re quirements of technical specifications Package date The package is done by Seal MANUFACTURER S WARRANTY The manufacturer guarantees that the Tonometer quality is in compliance with the requirements of the Clause Technical characteristics of this operating manual Operation warranty period 12 months from the date of sale The present operating manual is the document to claim on the Seller in case it duly documented If in the operating manual there is no manufacturer s original seal the claims are not accepted Within the guarantee period manufacturer at his expense eliminates the defects or replaces the Tonometer provided its proper handling in accordance with the requirements of this operating manua The replacement is done at the place of the Tomometer buying The guaranty does not cover the Tonometer having mechanical damages For repair you should send the failed tonometer together with operating manual and the explanatory note at the address 25 Yanina st
8. g unit differ from those stated in the clause technical characteristics more than 2 mm Hg no indication of the Tonometer readings on the display with the occurrence of rod vibration sound no indication of power supply voltage level signs Malfunctions during routine maintenance are eliminated by elements and details replacement or restoration adjustment of a Tonometer in conformity with the data of the present manual After the termination of the repair the Tonometer is delivered to the user with the setting of warranty period which begins from the date of its delivery Security measures There are no need in special security measures for the execution of repair works REPLACEMENT OF THE POWER SUPPLY ELEMENTS Power supply elements replacement is to be done when the battery voltage is lower than 2V Power supply voltage indicator at top left corner of the tonometer dis play shows the state of power supply elements see fig 15 The sign of the induca tor when battery voltage is more than 3 2V is shown in the fig 15a The sign of indi cator with the power voltage more than 2 8 V is shown in the fig 15b With the battery voltage lower than 2V see fig 15c a bo c Fig 15 Replacement of power supply elements is made when the Tonometer is switched off To make power supply elements replacement it is necessary to remove the cover of battery compartment see fig 16a Move the cover in the direction of arrow OPEN sh
9. hould be filled at product acceptance Tonometer everage service life min 5 years Operating manual Page 2 TVGD 01 ARRANGEMENT AND OPERATION The performance of the Tonometer is based on the method of both elastic sys tem consisting of eye cornea covered with eyelid and tonometer electomagnetic vibrator free motion period mesurement Period of these free motions characterizes the eyeball elastic properties which depend on the size of intraocular pressure The vibrator provides the system excitation and transformation of mechanical fluctuation into a signal of electric fluctuations Internal eye pressure displayed on the tonome ter screen is defined on the basis of this signal The influence of eyelid on the result of measurement is excluded in the process of measurement due to eyelid statistic contraction by rod Tonometer appearance two positions is shown in Fig 1 Guard ring On off button Guard cap Vibrator rod Display Battery compartment cover Power supply elements Fig 1 COMPLETE SET Delivery set includes TVGD 01 Tonometer of intraocular pressure Ipc including cap Ipc testing unit Ipc case Ipc power supply element AAAA 1 5V 2pcs Operating manual Ipc Educational film laser CD disk Ipc Consumer container Ipc supplied on customer request The note the other power supply elements with similar parameters on overall dimensions and voltage are supposed to be deli
10. ion e Hold the Tonometer body with an inscription Tonometer TVGD 01 on it with fingers of your hand Place the Tonometer with measuring rod downward so that you can see the Tonometer display e Stand a bit aside behind towards the patient See fig 10 e Focus and fix the patient eyesight with the help of test object take for exam ple A arm so that the patent s eyesight line is to be at the angle of 45 50 ee fig 12 e Rest the edge of the hand with the Tonometer in it on the patient s forehead to make the measurement easy The smoothness and accuracy of movements at mea surement is reached owing to the hand support on the patient forehead fig 12 2 Fig 12 With the finger of the other hand pull the upper eyelid toward the eyebrow with out pressing the eyeball so that the border of the upper eyelid coincides with the eyeball limb fig 13 Hold the eyelid in this position Don t let the eyelid shift on the cornea at moment of taking IOP measurement Don t press the eyeball Operating manual Page 9 TVGD 01 Fig 13 e The zone of the Tonometer rod exposure should fall on sclera area corre sponding to corona ciliaris in the meridian of 12 hours e Smoothly place the rod of the device on the eyelid 2 3mm from the eyelid edge over the iris upper border behind the ciliary wall Recommended points are shown in the fig 14 Fig 14 e Holding the Tonometer in vertical position smoothly lower the device b
11. ody 2 3 mm down You ll feel the the light vibration as a result of the activation of the dy namic impact Carrying the IOP measurement out you should avoid the touch of the eyelid with guard ring The last should be placed 2 3 mm above the eyelid If the body is moved down an inadmissible low the disturbing sound signal is formed by the Tonometer which is switched off automatically with the body raise to the working height e Smoothly move the Tonometer down 1 2 seconds later you can hear a sound signal of measurement termination Smoothly move the Tonometer up to complete the procedure of measurement The moment of measurement completion is followed with sound signal and the appearance of IOP measurement value on the display Operating manual Page 10 TVGD 01 e lf there is no sound signal or it was generated with more than 3 second delay the measurement is to be taken again e Press momentarily the on off button to switch the Tonometer off e When the Tonometer is switched off put the guard cap on turning the Tono meter with rod upward and put it back into case SAFETY MEASURES Be sure that the Tonometer body and rod have no mechanical damages It is FORBIDDEN to use the defective Tonometer Protect the Tonometer from shock or impact For carrying put the tonometer into case lodgement with the cap put on its working part Avoid the moisture penetration inside the Tonometer If there is liquid inside the tonometer bef
12. ore its use keep it at room temperature for at least 4 hours and then check its state of operability with a help of testing unit Avoid temperature excess Avoid drastic temperature differences that can affect the work of the Tonometer ATTENTION Remember that the rod excessive impact on the eyeball may do harm to the patient MAINTENANCE The order of Tonometer maintenance is given in the table below 1 Tonometer preventive mainte Not less than once a day nance inspection 2 Dusting and cleaning When neccessary 3 Working capacity test Before each use 4 Inspection and replacing the pow With the appearance of sign er supply source G on the display When carrying preventive inspection pay special attention to the integrity of the Tonometer body and vibrator s rod mechanical damages The check of the Tonometer state of operation is to be carried out according to the procedure stated in the clause The check of the Tonometer state of operation with the help of testing unit Operating manual Page 11 TVGD 01 ROUTINE MAINTENANCE General instruction Tonometer operating repair is carried out under the Agreement between medical institution and the manufacturing plant or its agency after the nature and degree of its malfunction technical survey by representatives of the manufacturer The signs of the Tonometer mulfunction are tonometer body and or vibrators rod mechanical damages tonometer readings with the use of testin
13. own on the cover to open it The right arrangement of power supply ele Operating manual Page 12 TVGD 01 ments is shown in fig 16a n 16b On the printed circuit board under the power supply elements there is marking for batteries right position a b Fig 16 It is convenient to take power supple elements out of battery holder by means of a plastic or wooden ruler or a cover of battery compartment see fig 17 Pa LS Fig 17 For battery installation in holders it is necessary to place a battery atop of elastic clips of battery holders with the right battery connection polarity and then install a battery easy pressing battery down up to its lock in holders Operating manual Page 13 TVGD 01 ATTENTION Right away after power supply elements installations it is ne cessary to switch the Tonometer on and off pressing momentarily on off button This way you can check the right order of power supply elements in stallation and the Tonometer is transformed in the mode of current microcon sumption PROBABLE MALFUNCTIONS AND METHODS OF THEIR ELIMINATION The tonometer Power supply elements Power supply elements are to be re doesn t switch on batteries are dis placed charged stallation switched on properly Replacement of power supply batteries of power supply batteries Battery holders contacts clearing Repair is carried out in the condition of after sales service establishment Repair is carried o
14. setting it is necessary to com bine Tonometer rod axis with the geometrical center of an eyeball fig 8 Operating manual Page 6 TVGD 01 Fig 8 Vertical setting of the device body is an important condition too Especially during the period of training and at the initial stage of the device application While taking IOP measurement it is necessary to know that the vertical deviation angle is to be not more than 15 degree fig 9 keeping the condition of the device perpendicular set ting But with the experience it is possible to take IOP measurement accuracy with 30 degree angle vertical deviation without reducing of measurement accuracy Fig 9 Operating manual Page 7 TVGD 01 During the IOP measurement procedure the patient should be in lying or sit ting position The mandatory requirement here is position of the patient head it should be as much as possible horizontal see fig 10 11 Fig 10 Operating manual Page 8 TVGD 01 IOP MEASUREMENT PROCEDURE e Take the Tonometer out of the case e Turn the Tonometer in the position with its rod upward and remove the guard cap e Press on off button momentarily to switch the Tonometer on Be sure of the the device operationability according to the movements of the arrow on the display fig 5a e Check the Tonometer operationability by testing unit e Make both vibrator rod and guard ring disinfection wiping them by calico napkin moistened in solut
15. the form of moving arrow in the display informing of the fact that the device is ready to start the procedure of measurement Fig 2 gt Fig 2 Right before measurement procedure of intraocular pressure with the device switched on state it is necessary to place the tip of measuring rod through the up per eyelid on the eye in area of sclera or cornea in the recommended or any point of an eye an initial stage of measurement Then body of the device is necessary to be smoothly lowered 2 3 mm down ward And at the same time you can feel the slight vibration as a result of activation Operating manual Page 4 TVGD 01 of dynamic force exposure the working stage of measurement At measurement the Tonometer guard ring should not touch the eyes and should be placed 2 3 mm over the eyelid Fig 3 and 4 show both the initial and working stages of measurement process Fig 3 In a second after its lowering the Tonometer starts to generate sound signal indi cating measurement readiness and displays measured value of intraocular pressure The measurement however will be going on till you take the device up To complete measurement you should smoothly take the device up Measured value will be stored in the display till the device be switched off or up to the next measurement To switch the device off you should momentarily press the on off button a gt E a readiness for operation 6 measurement mode B measurement termin
16. ut in the condition of after sales service establishment Testing unit tonometer Improper check of to To gain working practices with testing readings are differ nometer state of oper unit The check of tonometer state of from those stated in ability with the help of operability with a help of testing unit the passport more testing unit than two units Adjustment is carried out in the condi justed tion of after sales service establishment Repair is carried out in the condition of after sales service establishment After measurement at Rod motion sensor is Adjustment is carried out in the condi raising tonometer up non adjusted tion of after sales service establishment vibrating action does not stop or stops with a delay more than second Upon switching to Failed tonometer dis Repair is carried out in the condition of nometer on there is play after sales service establishment both no indication on the display and gen eration of the alarm signal Power supply battery Excess power con Repair is carried out in the condition of are quickly discharged sumption after sales service establishment Operating manual Page 14 TVGD 01 CHECK OF TONOMETER OPERABILITY ON THE TESTING UNIT The check of the tonometer operability on the testing unit is to be carried out not less than once a week as well as after a long work break device falling down and when you are not sure that the Tonometer is in good order The work with a
17. vered Operating manual Page 3 TVGD 01 MARKING The mark denoting according to TOCT P 50267 0 92 necessity to consult the operational documents according to IEC 60601 1 2005 it is the mark used in the operational documents as warning relating to product op eration safety and efficiency The working part of B type Tt The mark pointing out that the device electric shock safety is made of ac cording to B type TOCT P 50267 0 92 IEC 601 1 88 INTENDED USE Preparation of the Tonometer for use After the long storage and transportation at the temperature below 10 C the Tonometer is to be kept in the premise at temperature from 10 to 35 C at least for four hours Disinfection of the Tonometer plastic outer surfaces if required is to be carried out with its twice wiping by the calico napkin moistened in solution with 10 15 minute interval between wiping the napkin should be wrung out in order to prevent disinfection solution from penetration inside a device Tonometer metal surfaces being in direct contact to patient eyelid vibrator rod and guard ring should be disinfected by calico napkin moistened in solution right before measurement Operation order Before taking measurement first take the Tonometer out of case then turning it with rod upward take the guard cap off Press on off button momentarily to switch the Tonometer on The activation of the Tonometer is followed with sound signal and visual signal in
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