TRANSPALPEBRAL "DIATON" TONOMETER

OPERATIONAL MANUAL

The present guide is part II of the operation manual (OM) for the Digital Portable Tonometer of Intraocular Pressure through the Eyelid Diaton and contains data necessary for the correct usage of the tonometer.

All rules and recommendations included in the guide, developed under the scientific direction of A.P.Nesterov the Academician of the Russian Academy of the Medical Sciences, should be studied prior to the operation of Diaton Tonometer.

Diaton Tonometer is protected with Russian, Japan and the USA patents for invention. It was awarded a Gold medal at the World Salon of Inventions in Brussels and in Geneva and is certified in Russia, EC countries, the USA and other countries.

1. General Information

1.1 Ophthalmotonometry is one of the leading methods used during screening examinations and while examining the patient suffered from ophthalmohypertension, glaucoma or with suspicion of glaucoma.

Before the first tonometers inventing the intraocular pressure (IOP) was evaluated approximately using the method of eye palpation through the upper eyelid. The palpation method is still widely used in clinical practice. Using this method the skilled ophthalmologist can evaluate approximately whether the IOP is normal, increased or decreased, distinguish normotension from hyper- or hypotension. The palpation method suffers from subjectivism, uncertainty of results at ophthalmotone moderate change, but at the same time shows the principal possibility of transpalpebral tonometry.

1.2 The eyeball is a reservoir of the spherical form, filled with fluid, incompressible contents. IOP is caused by the influence of the elastic forces, arising in eye coverings while they are being stretching.

IOP is a dynamic, continuously changing value. They distinguish its system, rhythmic fluctuations around relatively constant level and momentary changes of casual character, caused by changes in the tone of transpalpebral, orbicular muscle and perhaps by the tone of outer eye muscles. IOP fluctuations depend also on changes in blood filling of intraocular vessels and on outer pressure on the eyeball.

There are 3 types of rhythmic IOP fluctuations around the level:

• Eye pulse with amplitude from 0,5 to 2,5 mm Hg,
• Respiratory waves ( from 0 to 1 mm Hg),
• Hering-Traube waves or the waves of the third order (from 0 to 2,5 mm Hg).

The rhythmic fluctuations of blood filling and casual changes of the muscle tone explain difference between results of IOP successive measurings during tonometry.

Statistically normal IOP varies from 9 to 21 mm Hg (on average 15-16 mm Hg). This value has daily and seasonal fluctuations. The IOP distribution in the normal population is asymmetrical and is splayed to higher readings. In middle age the distribution asymmetry increased. More than 3% of healthy persons have IOP above 21 mm Hg. The ophthalmotone measuring accuracy in the area of the normal and reasonably increased IOP is especially important for a practical doctor.

1.3 The Digital Portable Tonometer of Intraocular Pressure through the Eyelid Diaton is considered to be a transpalpebral tonometer, in which the ballistic principle of tonometry based on the measuring of the eye elastic reaction during the momentarily influence on the eye covering of the free falling object with the definite weight is used.

1.4 Advantages of ballistic transpalpebral tonometry with Diaton Tonometer.

1.4.1 During the corneal tonometry it is very difficult to prevent the increasing of orbicular and palpebral muscles tone at the moment of measuring in reactive patients, that leads to IOP increasing. The ophthalmotone increasing may be also connected with the blood pressure increasing during the tonometer's bringing near the open eye. Diaton tonometer is out of the patient's field of vision.

1.4.2 It is known that a tear may contain pathogenic bacteria and viruses such as hepatitis B virus, herpes, adenoviruses, AIDS. But the problem of tonometers sterilization is far from perfection. During tonometry with Diaton device the direct contact with the eyeball is excluded.

1.4.3 The corneal tonometry is contraindicative in conjunctivitis, erosions, sores, hypostasis and cornea dimness. Using Diaton Tonometer the IOP measuring in most of such cases is possible.

1.4.4 The corneal tonometry is impossible without prior anesthesia, which often causes conjunctiva irritation, short-term IOP increasing, hypostasis and loosening of cornea epithelium and sometimes allergic reaction. These undesirable reactions are excluded while measuring with Diaton tonometer.

2. Assignment

Digital Portable Tonometer of Intraocular Pressure through the Eyelid Diaton (hereinafter referred as tonometer) is assigned for transpalpebral measuring of true intraocular pressure in adults and children using no anesthesia.

3. Mechanism and functioning principal

3.1 Functioning principal

Due to the choose of dynamic (ballistic) method of dosated mechanical influence to determine the level of intraocular pressure we managed to avoid the eyelid influence on the tonometry results. The problem is solved by means of the eyelid pressing on the area with the diameter of 1,5 mm to such an extend that the pressed area of the eyelid acts as the transmissive part during the interaction of the falling rod with the eyelid.

In contrast to applanation tonometry according to Goldmann the IOP measuring using ballistic method is carried out nearly instantly. Due to this fact Diaton displays are influenced mainly by ophthalmotone rhythmic and casual fluctuations. As a rule these fluctuations do not exceed 2-4 mm Hg in normal or moderately increased IOP level, which is necessary to consider during the tonometer's usage.

Reliability of IOP measuring with the tonometer is provided with exact following of the measuring methodology, perfect technique of transpalpebral tonometry and sufficient practical experience in application (not less than 50 people during a month).

3.2 Mechanism description

The appearance of the Tonometer is shown in Fig.l. The Tonometer has a plastic body. The tip is assigned to rest the Tonometer on the eyeball through the upper eyelid during IOP measurement. The tip can freely move along the tonometer's axis relatively its body (up to 3 mm). It provides constant statical load on the eye during IOP measuring. The tip can be revolved on its axis using some force.

Figure 1 - the appearance of the tonometer

Figure 2 - the appearance of the tonometer in the case

For greater measuring accuracy the tip is provided with supports in the form of two protrusions, which helps to eliminate damping properties of the eyelid as well as to fix the position of the tonometer in relation to the eyeball during measuring.

There is a fluently moving rod inside the tonometer, which interacts in fall with the elastic surface of the eyeball through the eyelid.

STOP button is assigned to fix the rod inside the tonometer. The rod's extrication (unfixing) is carried out automatically the tonometer being in "tip down" position, the device's body being moved relatively to the rod. The rod falls free.

The OPERATION button on the tonometer's body is designed to control the tonometer's operating modes:

• tonometer's turning ON and OFF;
• automated receiving of mean IOP result of several measurings (averaging).

The turning of the tonemeter ON is realized by momentary pressing of the OPERATION button once, the turning OFF - by pressing of the same button twice, or by pressing the OPERATION button once, if there were no measurings or the averaging mode was used before the tonometer's turning OFF.

The averaging mode turning ON is realized by pressing of the OPERATION button once after carrying out of the measuring series from 2 to 6 measurings. The maximum number of measurings in the series is not more that 6. To carry out the following measuring series it is necessary to turn the tonometer OFF and then turn it ON again.

The device of the unit's capacity for work control - a pressure selector is built into the tonometer's case (Figure 2).

The tonometry result appears on the display and is preserved for 30 seconds followed by the tonometer's turning OFF automatically. The display has 4 digits: the leftmost digit is used for indication of the auxiliary information, indicated with "U", "L", "H", "µ", "A" symbols, two rightmost digits are used to indicate the tonometry results. (Figure 3).

Meanings of the auxiliary information symbols are shown in table 1.

Table 1

"0000" symbol should appear on the display immediately after turning the tonometer ON. If the symbol is displayed in the flickering mode it is necessary to put the rod into the initial position. (point.5.2.5).

"U" symbol, displayed in the leftmost position after turning the tonometer ON or during its work (Figure 4) shows the battery discharge to the minimum permissible level.

The cap protects the tonometer's rod mechanism from being dirty.

A built-in sound indicator of position (signaling indicator) helps to control the vertical position of the tonometer directly before or during measuring. Keeping the device in vertical position during tonometry provides optimal characteristics of the rod movement that increases measuring accuracy. An interrupted sound signal before measuring indicates the device's deviation from the vertical line for more than 4,5°, at that the frequency of the sound signals increases the tonometer being moved closer to the vertical line. Lack of the sound signal indicates that it is possible to carry out the measuring the device being in vertical position. The sound indication turns off when the tonometer's deviation from the vertical line is more than 45° (including the device's horizontal position)..

Figure 3 - Indication of the mean measuring value

Figure 4 - Indication of the battery discharge

Description and meaning of all tonometer's sound signals are shown in table 2.

Table 2

While operating the tonometer the attention should be paid to the sound signals and the display information.

4. Operation Restrictions

4.1 Safety instruction

Being operated from low voltage power supply the tonometer is electrically safe.

Measuring of intraocular pressure with the tonometer is permitted only through the eyelid.

4.2 Usage indications

The tonometer's usage indications are the following :

• screening prophylactic mass examinations of the patients;
• IOP control during clinical observation of the patients suffered from glaucoma;
• ortoclinostatical probe, as an additional test during glaucoma diagnostics and during selection of adequate hypo-tensive therapy;
• ophthalmotone day monitoring (especially at night time);
• IOP measuring during contact correction (lenses are not taken out),
• IOP measuring in immobilized patients;
• IOP measuring in children.
• in the presence in patient of chronical conjunctivitis, cornea pathology, including keratitis, keratotone, cornea dimness, after penetrating keratoplastics, keratoprosthesis, laser refractive correction of the eyesight, high degree of ametropy, astigmatism;
• presence in patient of medicinal allergy;

4.3 Usage contraindications

The tonometer's usage contraindications are the following:

• upper lid pathology (inflammatory diseases, scars, eyelid deformation);
• expressed sclera and/or conjunctiva pathology in the measuring area.

5. Preparation of the tonometer for use

ATTENTION !

If the Tonometer was stored or transported at low temperatures it should be kept at room temperature not less then three hours before turning on.

To shorten the time of preparation for work during the cold season it is recommended to protect the tonometer from cooling (e.g. hold it in the coat or smock pocket). In such case the time of keeping the tonometer at room temperature before its turning ON should be not less than 5 minutes (the case cover must be opened). Then it is necessary to check its capability for work according to point 5.3.

5.1 Loading the battery

Loading the battery is carried out as the following (Figure 5):

• take the tonometer out of the case;
• remove the cover of the battery compartment slightly pressing it and moving as shown by the arrow (Figure 5a));
• press and hold the OPERATION button;
• insert the battery between lower and upper contact springs with the + terminal upwards (Figure 5b));
• release OPERATION button;
• place the cover in position.

When operating the Tonometer the battery compartment cover should be tightly closed.

Figure 5 a), b)

ATTENTION !

While non-observing the order of the battery loading mentioned above (e.g., OPERATION button is not pressed before and during the battery loading), the tonometer may fail to turn on.

In such case it is necessary:

• unload the battery;
• reload the battery not earlier than in 20 minutes strictly following the loading order mentioned above (while loading the battery the OPERATION button must be pressed).

5.2 Preparation of the tonometer for measuring

5.2.1 Take the tonometer out of the case, remove the protective cap.

5.2.2 Take the tonometer in hand as it is shown on Figure 6 a): the thumb is placed on the side of the device's body, opposite to STOP button, the middle one - on STOP button (do not press it), the forefinger - above the STOP button, third finger - below the STOP button, the tonometer's body being turned with its tip downwards.

The tonometer's position does not depend on what hand you are used to work - right or left. The correct position of the tonometer in hand provides the measuring accuracy.

5.2.3 Check the position of the tip supports: the tip supports must coincide with the level of the tonometer's exterior side as it is shown on Figure 6 b). Otherwise put the supports into initial position, revolving the tip on its axis. Watch the tip position during measurings.

Figure 6. Putting the rod into initial position

a)

b)

c)

5.2.4 Check the position of the rod in the tonometer:

• the rod is inside the tonometer (Figure 6 b)) - the initial position of the rod for a measuring,
• the rod is seen in the tip area (Figure 6 a)) - it is necessary to put it into initial position (point 5.2.5.).

5.2.5 If the rod is seen in the tip area (Figure 6 a)) put the rod into initial position:

• take the tonometer vertically with its tip downwards (points 5.2.2);
• press the STOP button with the middle finger and holding it move the tonometer fluently with its tip upwards as it shown in Figure 6b). The rod is fixed in initial position;
• return the tonometer fluently without quick movements in the position with its tip downwards still holding the STOP button. The rod must be fixed inside the tonometer and not seen in the tip area (Figure 6 b)). Release the STOP button.

ATTENTION !

Because of the incorrect putting of the rod into initial position its fixation may fail.

The most common mistakes:

• pressing of the STOP button before the tonometer is put vertically with its tip downwards (first it is necessary to put the tonometer with its tip downwards and then press the STOP button);
• the STOP button is released before turning the tonometer in the position with its tip downwards (first it is necessary to turn the tonometer with its tip upwards holding the STOP button pressed, then return it into initial position with its tip downwards and only after that release the STOP button).

5.2.6 If the rod is put into initial position (is fixed inside the tonometer), press the OPERATION button, holding the tonometer with its tip downwards. When turning the device on "0000" symbol appears on the display and a short sound signal is heard. The tonometer is ready for work.

If the tonometer is hold with its tip downwards not strictly vertically, an interrupted sound signal of the tonometer position indicator turns on. This is an additional information that helps to control the tonometer's vertical position. The tonometer's position being strictly vertical the sound signal stops.

ATTENTION !

If the rod is not in the initial position then, the device being turned on, the "0000" symbol is being displayed in a flickering mode. In this case without turning the tonometer OFF (without pressing the OPERATION button), it is necessary to put the rod into initial position (point 5.2.5.). The rod being put into initial position, the flickering of the "0000" symbol on the display stops. The tonometer is ready for work. Information of the tonometer's readiness for work ("0000" symbol) is kept on the display for 30 sec., then the tonometer turns OFF automatically. In this case, if necessary, turn the tonometer ON, pressing the OPERATION button momentarily.

If "U" symbol (Figure 4) is displayed after pressing the OPERATION button it is necessary to turn the tonometer OFF pressing the OPERATION button momentarily and to change the battery. (point 5.1). After changing the battery prepare the tonometer for work (point 5.2).

5.3 Checking of the tonometer's capacity for work

Checking of the tonometer's capacity for work is carried out once a day before its operation;

• each time before measuring of the patient's IOP while working during cold season not in a stationary conditions;
• if you have doubts in the tonometer's intactness.

5.3.1 Prepare the tonometer for measuring (point. 5.2).

5.3.2. Check the tonometer's displays on the testing device (pressure selector) placed in the case as follows (Figure 7) :

• place the tip supports into the bushing of the testing device (Figure 7 a)) holding the tonometer strictly vertically, (the lack of sound signal indicates the correct tonometer's position);
• move the tonometer's body fluently down until the rod falls, which is accompanied with a short sound signal. The result of capacity for work checking is displayed in two rightmost digits. (Figure 7 b)).

The tonometer is considered operative, if the received digital measuring result is in the limits of (20 ± 2) mm Hg, and there are no "L" or "Ѕ" symbols in the display's leftmost digit.

If "L" symbol appears it is necessary to carry out the checking again (points 5.2.5, 5.3.2), keeping the tonometer strictly vertically during the checking.

If "H" symbol appears or the measuring result value on the testing device differs from (20 ± 2) mm Hg, the tonometer is considered inoperative.

The ways of the tonometer's repair are mentioned in point 6 part I of the OM.

5.3.3 Turn the tonometer OFF, momentarily pressing the OPERATION button twice.

The testing device may be used to get the minimum experience in the device's correct placing, observance of the vertical position and the tonometer's confident handling that makes for receiving of more accurate results of IOP measurings in the patients.

Figure 7 (a, b)- Checking of the tonometer's capacity for work

a)

b)

5.4 Disinfections Procedure

5.4.1 Disinfect the base of the tip and the lower portion of the rod holding the tonometer with the tip downwards using a sterile piece of cloth moistened with Veltosept solution. Other ethyl alcohol-based disinfectants non-reactive with metals may be used. Care should be taken to prevent disinfections solution from penetrating into the rod mechanism.

After the disinfection is done, wipe the tip and the lower part of the rod with a dry sterile piece of cloth. Disinfection of the tip base and the rod should be carried out both before each patient's tonometry and after.

5.4.2 If necessary disinfection of outer surfaces (with the exception of the tip and rod) of the tonometer's body is carried out by using 3% - solution of hydrogen peroxide added with 0.5% - detergent or by 1% - solution of chloramine.

ATTENTION !

The disinfecting solution is barred from getting inside the tonometer.

It is prohibited to use absorbent cotton or other fibrous materials, which fibers may get inside the tonometer while disinfecting the tip's base and the rod.

6. Order of IOP measuring

6.1 Take the tonometer out of the case, remove the protective cap and disinfect the base of the tip and the lower portion of the rod according to point 5.4.1.

Prepare the tonometer to carry out the measuring (point 5.2.2.-5.2.6).

6.2 IOP measuring is possible in two patient's positions:

• in a sitting position the patient's head is thrown back horizontally on the head support;
• in the reclining position the patient's head is placed horizontally on the couch's cushion or bolster. (the head's throwing back is not allowed).

Stand at the side and behind on the left of the patient (if the device is in the right hand) or at the side and behind on the right of the patient (if the device is in the left hand).

ATTENTION !

To avoid inaccurate IOP measuring while there's the pathology of the spine's cervical section the horizontal position of the patient's head must be kept only for a short time. Between the measurements the patient is proposed to rest for some minutes in a free posture.

6.3 Place and fix the patient's glance using the test object (for instance, the patient's hand), the glance line being oriented approximately at the angle of 450 as it is shown in Figures 8 a) and 10.

Figure 8 - Measuring of the patient's IOP

a)

b)

6.4 Measuring of the intraocular pressure

6.4.1 Using the finger of a free hand stretch the patient's upper lid without pulling it and pressing the eyeball so that the edge of the upper lid coincides with the limb as it is shown in Figure 8 a). To do this correct the patient's eyeball position within small limits according to the patient's anatomic peculiarities by means of the test object moving. Place the hand with the tonometer with the palm's edge on the patient's forehead. Make sure that the tonometer is turned ON and the rod is in initial position.

6.4.2 Moving the tonometer's tip closly to the eyelid position the tonometer vertically until the interrupted sound signal stops. Place the tonometer's tip on the lid's cartilaginous part tightly to the front edge in parallel to it, as it is shown in Figures 8 b), 9, 10. At that the tonometer must be kept vertically (the lack of the sound signal indicates the correct position of the tonometer).

Figure 9

Figure 10

The influence zone of the tonometer's rod must be the part of sclera corresponding to corona ciliaris.

6.4.3 Fluently move the tonometer's body down keeping its vertical position (there's no interrupted sound signal) until the rod falls on the eyelid, which is accompanied with a short sound signal. Do not let the eyelid removal to the cornea at the moment of the measurement. Do not press on the eyelid with the tonometer. The measuring result is being displayed. Take the tonometer away. Put the rod into the initial position. (point 5.2.5).

ATTENTION !

An interrupted sound signal indicates the tonometer's deviation from the vertical line at the moment of the measurement and the displayed measuring result in such a case is accompanied with "L" symbol. The following measurings should be carried out keeping the tonometer's vertical position.

If "H" symbol appears on the display after the measuring together with the digital value it shows that the tonometer's rod mechanism is dirty. In such case it is necessary to clean the rod mechanism according to the directions of point 5.2 part I of the OM.

The tonometer's display indication during the IOP measurings is shown in Figure 11.

6.4.4 Carry out several IOP measurings of the same eye (points 5.2.5, 6.4.1-6.4.3) with the interval not more than 30 sec. until a single long signal or two long sound signals are heard.

6.4.5 When you hear a single long sound signal which allows to turn on the averaging mode of IOP measuring results, press the OPERATION button momentarily. Symbol "°" and the mean IOP value are displayed in nonflickering mode. The result is reliable, the IOP measuring of the eye being studies is finished.

Figure 11 - The tonometer's display indication during the IOP measurings

a) Initially, before the measurings	b) After the correct measuring
c) After measuring, the tonometer being deviated from the vertical line	d) After measuring the tonometer's rod mechanism being dirty

While two long sound signals are heard "E" symbol and the last measured value are displayed simultaneously. Press the OPERATION button momentarily. Three variants of the information could be displayed:

• symbol "°" and the mean IOP value in nonflickering mode. The result is reliable, the IOP measuring of the eye being studies is finished;
• symbol "°" in flickering mode and the mean IOP value in flickering mode. Such result should be considered as approximate, but if IOP is equal or less than 19 mm Hg., it may be considered as reliable.

It is recommended to let the patient rest for some minutes in the sitting position and to carry out the repeated measuring of the eye being studied . (points 5.2.5, 5.2.6, 6.2, 6.3, 6.4.1-6.4.5) ;

• symbol "° 00" in a flickering mode. The result is considered erroneous. In this case it is recommended to let the patient rest for some minutes in the sitting position and to carry out the repeated IOP measuring (points 5.2.5, 5.2.6, 6.2, 6.3, 6.4.1-6.4.5).

6.4.6 The tonometer provides for the possibility of receiving the mean value before hearing one long or 2 long sound signals by pressing OPERATION button momentarily after carrying out of a series from 2 to 5 measurings. In this case symbol "°" and the mean IOP value in flickering mode is displayed. The doctor makes a decision regarding the mean result reliability himself.

6.4.7. Register the mean value of IOP measuring in the patient's sheet. Turn the tonometer OFF, pressing the OPERATION button momentarily.

ATTENTION !

After turning on of the averaging mode of several measuring results or after carrying out of the series of the six simultaneous measurings the new series of measurings should be carried out only after turning the tonometer OFF and turning it ON again.

6.4.8 Measure the IOP of the other eye (points 5.2.5, 5.2.6, 6.2, 6.3, 6.4.1-6.4.5).

6.4.9 Disinfect the base of the tip and the lower portion of the rod according to point 5.4.1.

Put on the protective cap, put the tonometer in the case, close the cover.

ATTENTION !

Before the first IOP measuring with the tonometer it is recommended to demonstrate the patient the tonometer's painless effect, for instance on the finger's pad.

6.5 Possible errors during IOP measuring

Unreliable IOP measuring with the tonometer is mainly connected with nonobservance of the tonometry's methodology and with inadequate researcher's experience.

Possible mistakes and the results received at that are shown in table 3.

Table 3

7. Cleaning the Tonometer's rod mechanism from dust and dirt should be carried out as the following (fig. 12).

Figure 12 - Preparation of the Tonometer for rod mechanism cleaning

• take the Tonometer out of the case, remove the cap;
• holding the Tonometer with the tip downward, make sure that the rod is not fixed (projected from the tip). Otherwise, with the free hand move the tip up till the rod is unlocked;
• holding the Tonometer's body with one hand take the tip away with the free hand, pulling it along the axis with some force;
• turn the Tonometer into horizontal position. Using the screwdriver included in the delivery set unscrew the bush screwing it counter-clockwise and take the rod away;
• wipe the tip and the rod using the cloth, wetted with ethyl alcohol;
• roll the cloth, wetted with ethyl alcohol, in a plait manner and clean the openings in the tip and the bush.

The total consumption of ethyl alcohol for one cleaning is 5 ml.

ATTENTION !

While cleaning the rod mechanism do not use absorbent cotton or other fibrous materials.

Put the cleaned parts on the clean cloth and carry out the following rod mechanism assembling holding the parts through the cloth.

The assembling order is as the following:

• holding the Tonometer with the opening upwards place the rod. Make sure that the rod moves freely;
• place the bush screwing it clocwise to the full making no unnecessary efforts;
• place the tip and make sure that it is fixed and can be revolved on its axis using some force;
• check the Tonometer's capacity for work according to point 5.3. of part II of the Operation Manual.