I. Packing List of Rebound Tonometer Main Unit
|
Name |
Quantity/Description |
|
Rebound tonometer main unit |
1 pcs |
|
Probe loader |
1 pcs |
|
Probe base |
1 pcs |
|
AA battery |
4 pcs |
|
Aluminum case |
1 pcs |
|
Wrist strap of rebound tonometer main unit |
1 pcs |
|
Cross screwdriver |
1 pcs |
|
Operation instructions of rebound tonometer |
1 pcs |
|
Warranty card of rebound tonometer |
1 pcs |
|
Certificate of conformity for rebound tonometer |
1 pcs |
Note: Batteries are consumables in the course of normal use, the replacement cycle depends on the use, the service life of a battery is at least 1,000 measurements, when “Replace battery” is displayed, please replace four AA batteries in a timely manner.
Packing List of Rebound Tonometer Probe
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Name |
Quantity/Description |
|
Rebound tonometer probe |
50 pcs/box, irradiation sterilization |
|
Operation instructions of probe |
1 pcs |
|
Certificate of conformity for rebound tonometer probe |
1 pcs |
Ⅱ. Product Name and Model Specification
Product name: Rebound Tonometer.
Model specification: Rebound tonometer: IM-IOP; Rebound tonometer main unit: IM-100; Rebound tonometer probe: IM-P50.
Ⅲ. Scope of Application
This product is applicable to the measurement of human intraocular pressure.
Ⅳ. Contraindications
Use with caution in the presence of corneal lesions (e.g. edema, scarring, etc.); prohibited in the presence of severe corneal lesions (e.g. obvious corneal thinning, inflammation, etc.) and corneal infectious lesions.
Prohibited in the presence of other conditions determined by the physician as not applicable.
Ⅴ. Overview
The rebound tonometer is a hand-held device that uses the rebound tonometry to measure intraocular pressure, which can accurately and efficiently measure intraocular pressure with no need of anesthesia. Since the measurement is carried out with a disposable sterile probe, there is no risk of eye infection for the person being measured. Intraocular pressure can change due to influences such as pulse, breathing, eye movements and body posture, so this product is preset to take the average of six measurements to get an accurate reading.
Ⅵ. Product Features and Structural Composition
6.1 Product Features
（1）The rebound tonometer is a hand-held device and is easy to carry;
（2）The contact area between the rebound tonometry probe and the cornea of the person being measured is small;
（3）The rebound tonometer main unit has a large memory, which can store 4 groups of user data, each group of 100 pieces;
（4）No need for anesthesia, and no discomfort.
6.2 Structural Composition
The rebound tonometer consists of rebound tonometer main unit and accessories, rebound tonometer probe, and data export APP. The rebound tonometer main unit is hereinafter referred to as the “main unit”, and the rebound tonometer probe is hereinafter referred to as the “probe”. The schematic diagram of the product structure is shown in Figure 1.
Figure 1 Schematic diagram of the rebound tonometer
The names and functions of the structure are as follows:
【1】Main unit display: display information.
【2】Measurement button: Measure intraocular pressure.
【3】Start button: switch on/off the device, measure intraocular pressure, select the selected item.
【4】Left button: menu cycle switching, select the left eye when saving intraocular pressure results.
【5】Right button: menu cycle switching, select the right eye.
【6】Down button: return to the previous level.
【7】Upper forehead support pole: adjust the measuring distance.
【8】Face support pole: adjust the measuring distance.
【9】Battery cover: protect the battery.
【10】Battery cover screw: tighten the battery cover.
【11】Probe: contact the cornea and measure the intraocular pressure.
【12】Probe cap: replace the probe base.
【13】Probe base: fix the probe.
【14】Probe loader: probe installation.
【15】Wrist strap hole: wrist-strap installation.
【16】Wrist strap: wrap the wrist strap around the wrist to prevent the tonometer from accidentally falling.
Ⅶ. Product Performance
7.1 Product Main Parameters
Weight: 300±10g (including battery).
Operating voltage: DC 5V~6V [4 AA batteries].
Intraocular pressure measurement range: 7~50 mmHg.
Intraocular pressure measurement accuracy: ±1.2 mmHg (7 mmHg≤ IOP≤20 mmHg);
±2.0 mmHg（20 mmHg＜IOP≤30 mmHg）；
±2.5 mmHg（30 mmHg＜IOP≤50 mmHg）。
7.2 Security Classification
Classified according to type of protection against electric shock: internal power supply equipment.
Classified according to the degree of protection against electric shock: BF type application part.
Classified according to the degree of protection against liquid: IP22.
Mode of operation: continuous operation.
7.3 Operating Environment
Ambient temperature range: 5°C~40°C.
Relative humidity range: 5% RH~93% RH.
Atmospheric pressure range: 700 hPa~1060 hPa.
Rated voltage: DC 6V [4 AA batteries].
Ⅶ. Product Performance
7.1 Product Main Parameters
Weight: 300±10g (including battery).
Operating voltage: DC 5V~6V [4 AA batteries].
Intraocular pressure measurement range: 7~50 mmHg.
Intraocular pressure measurement accuracy: ±1.2 mmHg (7 mmHg≤ IOP≤20 mmHg);
±2.0 mmHg（20 mmHg＜IOP≤30 mmHg）；
±2.5 mmHg（30 mmHg＜IOP≤50 mmHg）。
7.2 Security Classification
Classified according to type of protection against electric shock: internal power supply equipment.
Classified according to the degree of protection against electric shock: BF type application part.
Classified according to the degree of protection against liquid: IP22.
Mode of operation: continuous operation.
7.3 Operating Environment
Ambient temperature range: 5°C~40°C.
Relative humidity range: 5% RH~93% RH.
Atmospheric pressure range: 700 hPa~1060 hPa.
Rated voltage: DC 6V [4 AA batteries].
Ⅷ. Instructions for Use
8.1 Battery Installation
Open the battery cover with a cross screwdriver, load 4 AA batteries into the battery compartment according to the correct polarity, and close the battery cover. As shown in Figure 2.
Warning
Figure 2 Schematic diagram of battery installation
8.2 Wrist Strap Installation
Thread the thin end of the wrist strap through the wrist strap hole, and thread the thicker end of the wrist strap through the worn part of the thin end and tightened.
8.3 Boot
Wrap the wrist strap around your wrist to prevent the tonometer from accidentally dropping. Press and hold the “Start button” to turn on the device, and the display screen will display the power on screen, the date, time, battery level and software version information of the device, and then display “Measure”.
8.4 Menu Switching and Selection
Press the “Left button” or “Bight button” to cycle through the menu: “Measurement” – “Settings” – “Historical data” – “Information”.
Press the “Start button” to enter the currently displayed menu.
Pressing the “Down button” to return to the previous menu.
8.5 System Settings
Switch the menu interface to “Settings”, press “Start button” to enter the settings menu, press “Left button” and “Right Button” to switch the menu cycle: “Bluetooth” – “Language” – “Date” – “Time” – “Signal Light” – “Screen” – “Volume” – “User Selection”.
Press the “Start button” to enter the currently displayed menu.
Press the “Down button” to return to the previous menu.
- 1.Bluetooth setting
- Press “Left button” / “Right button” to turn on/off Bluetooth;
- Press the “Start button” to confirm the setting and return to the previous menu;
- Press the “Down button” to return to the “Settings” menu.
- 2.Language setting
- Press “Left button” and “Right button” to switch between Chinese and English for system language setting;
- Press the “Start button” to confirm the setting and return to the previous menu;
- Press the “Down button” to return to the “Setting” menu.
- 3.Date setting
- Press the “Start button” to set the date (year, month, day) in sequence.
- Press the “Left button” and “Right button” to add or subtract numbers;
- After modifying and confirming the year, month and day in turn, press the “Start button” to confirm the setting and return to the previous menu;
- Press the “Next button” to return to the “Setting” menu.
- 4.Time setting
- Press the “Start button” to set the time (hour and minute) in turn;
- Press the “Left button” and “Right button” to add or subtract numbers;
- After modifying and confirming the hour and minute in turn, press the “Start button” to confirm the setting and return to the previous menu;
- Press the “Down button” to return to the “Setting” menu.
Note: Please make sure the device is set to the correct date and time before measurement, otherwise it will cause the time information of the measurement in the historical data to be incorrect.
- 5.Signal light：
- Press the “Left button” and “Right button” to adjust the brightness of the signal light;
- Press the “Start button” to confirm the settings and return to the previous menu;
- Press the “Down button” to return to the “Settings” menu.
- 6.Screen：
- Press the “Left button” and “Right Button” to adjust the screen brightness.
- Press the “Start button” to confirm the setting and return to the previous menu;
- Press the “Down button” to return to the “Setting” menu;
- 7.Volume：
- Press the “Left button” and “Right button” to adjust the volume of the prompt tone;
- Press the “Start button” to confirm the setting and return to the previous level menu;
- Press the “Down button” to return to the “Setting” menu.
- 8.User selection: Select the current user, which is used to distinguish the historical measurement data information, and the measurement results will be saved under the currently selected user.
- Press the “Left button” and “Right button” to switch the user;
- Press the “Start button” to confirm the settings and return to the previous menu;
- Press the “Down button” to return to the “Settings” menu.
Note：
1）When the setting is completed each time, you have to press the “Start button” to save the setting, and press the “Down button” to exit without saving the setting.
2）After connecting to the main unit with the APP, the date and time can be synchronized automatically.
8.6 Intraocular Pressure Measurement
（1）Switch the menu interface to “Measure”, press the “Start button”, and the display will display “Probe detection” to remind the user to load the disposable sterile probe into the tonometer before measuring.
（2）Install the probe：
- 1.Place the probe loader on the probe cap;
- 2.Open the plastic tube containing the probe;
- 3.Paralleling locate the tube opening to the probe loader’s opening top, tilt the plastic tube till the probe slides freely into the probe port;
- 4.Remove the plastic tube and probe loader;
- 5.After the probe is loaded, the main unit display shows “Start measurement”, and the probe is magnetized and will not fall. A schematic diagram of probe installation is shown in Figure 3.
Figure 3 Schematic diagram of probe installation
Note: 1) After the probe is inserted, do not let the probe ball head face down until the main unit display shows “Start measurement” to prevent the probe from falling.
2) If the probe ball head comes into contact with hands or other non-sterile surfaces, it must not be used further.
(3) The subject may be in sitting or standing posture, and the tonometer may be used by the subject or by another person. Do not use anesthetics during the measurement. The subject should keep the eyes open and stare at a point directly in front while relaxing the body and maintaining a calm mood. Place the tonometer near the eye of the subject, the upper forehead support pole is close to the forehead, the face support pole is close to the cheek, and rotate the adjustment wheel of the upper forehead support pole and the face support pole appropriately to keep the distance from the tip of the probe ball head to the cornea of the subject within the range of 4~8 mm.
Do not shake the tonometer during measurement, make sure the tonometer is placed horizontally; the tonometer is placed at an angle of 90-degree to the subject’s face, and the probe should be perpendicular to the central cornea.
During the measurement, the tonometer has the function of measuring whether the placement is correct or not, if correctly placed, the main unit indicator will be green; if not correctly placed, the main unit indicator will be red, an error prompt tone will be issued when performing the measurement operation, and the position needs to be adjusted until the indicator light turns green. A schematic diagram of measurement is shown in Figure 4.
Figure 4 Schematic diagram of measurement
（4）Select the “Measure” menu, press the “Start button” or “Measure button” to perform the measurement, and the measurement result should be obtained by averaging the results of six measurements.
There are two modes of measurement:
1）Single mode: suitable for subjects who blinks frequently, a measurement will be taken for each press of the button, a short prompt sound will be issued after each successful measurement, and carry out six consecutive measurements to obtain the final intraocular pressure reading.
2）Continuous mode: Press and hold the “Measure button” for at least 3 seconds, and the tonometer can perform six measurements at a time to get the final intraocular pressure reading (please select this mode carefully for those who blink frequently).
In the event of a measurement error, the tonometer will sound an error prompt tone and display an error message on the main unit display. Press the “Measure button” to eliminate the error message and continue measuring. If more than one measurement error is displayed, please refer to Chapter 14 “Common Troubleshooting” of this manual.
（5）After successfully completing six measurements, the indicator light goes out with a long prompt sound, and the main unit display screen enters the interface of left and right eye selection, and the left eye or right eye can be selected by pressing the “Left button” or “Right button”, press the “Start button” to complete the measurement and the measurement result will be displayed.
（6）After completing the measurement, the system will automatically save this group of measured values. Figure 5 shows the display screen for measurement completion.
Figure 5 Schematic diagram of the measurement completion for rebound tonometer
（7）If the measurement is completed, please check the measurement result. The quality of the measurement is indicated by color (green or yellow), which is an indication of the changes between the six measurements, and is irrelevant to the level of intraocular pressure.
If the intraocular pressure measurement value is green, it means that the measurement quality is good; if the intraocular pressure value is yellow, it means that the measurement quality is acceptable; if the six measurement results deviate greatly, the display screen of the main unit will show the prompt “Re-measure”, press the “Measurement button” to clear the measurement count and the measured value this time, and prepare for another measurement.
8.7 Message Reminder and Clearance
When the following messages appears, press the “Measure button” to clear and re-measure.
（1）Measurement Error
1）The distance is too close: the display screen of the main host shows a “Too close” prompt (as shown in Figure 6), and the buzzer sends out 5 beeps. Please rotate the adjustment wheels of the upper forehead support pole and the face support pole appropriately, and keep the distance between the tip of the probe ball head and the cornea of the subject within the range of 4~8 mm.
2）The distance is too far: the display screen of the main host shows a “Too far” prompt (as shown in Figure 7), and the buzzer sends out 3 beeps. Please rotate the adjustment wheels of the upper forehead support pole and the face support pole appropriately, and keep the distance between the tip of the probe ball head and the cornea of the subject within the range of 4~8 mm.
Figure 6 Schematic diagram of “Too close” Figure 7 Schematic diagram of “Too far”
3）Six measurements deviate too much: after six measurements are completed, if the results of six measurements deviate too much, the main unit display will show “Re-measure” prompt (as shown in Figure 8), and the buzzer will send out 2 beeps. Please follow the instructions to re-measure.
Figure 8 Schematic diagram of “Re-measure”
4）Probe does not move: the probe does not move, the main unit display shows “change probe” (as shown in Figure 9), the buzzer sends out 2 beeps. Please change the probe and measure again.
Figure 9 Schematic diagram of “Change probe”
5）The probe does not move correctly or the intraocular pressure exceeds the measurement range: the display of the main unit shows the prompt “Re-measure” (as shown in Figure 10), and the buzzer sends out 2 beeps. Please follow the instructions to re-measure.
Figure 10 Schematic diagram of “Re-measure”
6）Probe alignment error: the display screen of the main unit prompts “Alignment error” (as shown in Figure 11), and the buzzer sends out 2 beeps. Please adjust the position of the main unit so that the probe is aimed at the cornea and measure again.
Figure 11 Schematic diagram of “Alignment error”
（2）System error
If a “System error” (as shown in Figure 12) is displayed on the main unit display, try to eliminate it by shut down and restart the device, if it cannot be eliminated, please contact the manufacturer/production enterprise or after-sales service company.
Figure 12 Schematic diagram of “System error”
（3）Low battery
The main unit display shows “Replace battery” (as shown in Figure 13), please replace the battery immediately before operation.
Figure 13 Schematic diagram of “Replace battery”
8.8 Historical Data Viewing
Switch the menu interface to “Historical Data”, press the “Start Button” to enter the historical data viewing interface; press the “Right button” to scroll down from the serial number 1 to the last measurement serial number to view the measured values; and press the “Left Button” to scroll up from the last measurement serial number to the serial number 1 to view the measured values.
The historical data only displays the measurement results of the currently selected user, and a maximum of 4 users with 100 sets of data per user can be saved.
The historical data viewing interface is shown in Figure 14, the information from top to bottom are: the currently selected user, the current data serial number, the intraocular pressure measurement, the measurement time, the left and right eye information, and the arrow used to display the measurement posture.
Figure 14 Schematic diagram of historical data interface
The left and right eye information is the information saved during the measurement, if the left and right eyes are not selected during the measurement, the left and right eye information will not be displayed here.
8.9 Viewing Device Information
Switch the menu interface to “Information”, press the “Start button” to view the device serial number and device firmware version.
8.10 Switch off
In any state, press and hold the “Start button” for 3 seconds to actively confirm the shutdown;
If the device is not in use for 30 seconds, it will automatically enter standby mode and turn off the screen until it is used, if the device is not in use for 3 minutes, it will automatically switch off.
8.11 Mobile APP
The supporting APP of this product allows users to view the measurement history data.
- 1.Download and install the APP: Scan the QR code on this operation instructions (as shown in Figure 15) with a mobile phone (version requirements: Android 10.0 and above, HarmonyOS 2.0 and above) browser, download and install the APP.
Figure 15 APP QR code
（2）Login: Open the APP (turn on the positioning and Bluetooth function of the mobile phone at the same time), enter the login interface (as shown in Figure 16), enter the password to log in and enter the main interface; if you log in for the first time or forget the password, you can click “Lost Password” on the login interface, then the “Super Administrator” login interface will pop up, enter the super administrator password “ABC123” in the pop-up window and click “Confirm” (as shown in Figure 17) to jump to “Set Password” interface (as shown in Figure 18), you can set a new login password in the input box, click “Confirm” to enter the main interface.
Figure 16 Login interface Figure 17 Logging in as a Figure 18 Changing the
super administrator login password
（3）Homepage: You can switch between “Homepage”, “Measurement Chart”, “User Profile” and “Settings” in the navigation bar at the bottom of the main interface. After logging in to the APP, you will enter the “Homepage” interface by default (as shown in Figure 19), which can view the measurement data of the user’s current month and historical months.
Figure 19 “Homepage” interface
（4）Measurement chart: Click “Measurement Chart” on the main interface to enter the “Measurement Chart” interface, click the data synchronization icon “
Figure 20 “Measurement chart” interface
（5）User profile: Click “User Profile” on the main interface, enter the “User Profile” interface (as shown in Figure 21), and click “+” in the lower right corner to add a new user.
Figure 21 “User file” interface
（6）Settings: Click “Settings” on the main interface to enter the “Settings” interface (as shown in Figure 22), and the settings include “Switch language”, “Switch device” and “Log out”.
Figure 22 “Settings” interface
- 1.Switch language: Click “Switch Language” to switch the language of APP system to English, and click “Language” to switch the language of APP system to Chinese after switching to English.
- 2.Switch device: Click “Switch Device” to enter the “Replace Tonometer” interface (as shown in Figure 23), and you can view the information of the currently paired tonometer. Click an individual tonometer in the “Replace tonometer” list to switch tonometer.
Figure 23 “Replacing the tonometer” interface
- 3.Log out: Click “Sign out” to log out function.
（7）Connect to the main unit: APP searches and connects to the main unit via Bluetooth.
1）Turn on the Bluetooth of the main unit and the Bluetooth of the mobile phone.
2）Click the Bluetooth icon “
3）Click “Scan Bluetooth device” in the “Connect tonometer” interface to pair the tonometer.
If it is the main unit connected for the first time, the “Pairing request” interface will pop up 【as shown in Figure 24, the form of the pairing request interface is different for different models of mobile phones, the following takes Xiaomi mobile phone (Mi 11) as an example】, click “Pairing and connection”, enter the pairing number displayed on the main unit in the pop-up box (as shown in Figure 25), and click “OK” to successfully connect to the main unit.
Figure 24 “Pairing request” interface
Figure 25 Input Pairing Code
If it is not the first time to connect to the main unit, the main unit information will be displayed in the Bluetooth list, and you can directly click to connect.
4） Disconnect the main unit: Click “Bluetooth connected, go to disconnect the device” on the “Connect tonometer” interface to disconnect the main unit. In the pop-up Bluetooth list, you can select any other main unit and connect to it (as shown in Figure 26).
Figure 26 Disconnect the main unit
Ⅸ. Cautions and Warnings
9.1 Cautions
9.1.1 Storage, transportation and installation
- 1.When unpacking the product, please check for external damage or cracks. If you have any questions about the product, please contact the manufacturer/production enterprise, after-sales service company or distributor.
- 2.When not in use, the product can be placed in an aluminum box to prevent damage.
- 3.The product cannot be exposed to rain or placed in liquid.
- 4.The product cannot be in contact with all kinds of chemicals or organic solvents.
- 5.The product cannot be placed in flammable and explosive places or dusty air environments.
9.1.2 Use
- 1.The probe used for intraocular pressure measurement is for single use only, please do not reuse it.
- 2.Before each measurement, please check and make sure that the probe is fully packaged.
- 3.Do not allow any part of the product other than the probe ball head to come into contact with the cornea.
- 4.The product can only be used for the intraocular pressure measurement of human eye and cannot be used for any other purpose, and the manufacturer/production enterprise shall not be responsible for any damage caused by improper use.
- 5.The battery must be installed correctly before use, if the product is not used for a long time, please remove the battery for storage.
- 6.Please use AA batteries, the use of rechargeable batteries may affect the accuracy of the product and damage the product.
- 7.Do not open the product case except for replacing the battery.
- 8.Do not shake the tonometer during measurement, make sure the tonometer is place horizontally; the tonometer is placed at an angle of 90-degree to the subject’s face, and the probe should be perpendicular to the central cornea.
- 9.To avoid the product from falling and ensure safe operation, please use a wrist strap to fix the product to the wrist during measurement.
- 10.The use of eye drops or local anesthesia before measurement may affect the results.
- 11.Adjust the distance between the product’s upper forehead support pole and face support pole appropriately to prevent the product from being too close or too far from the eye.
- 12.To prevent improper operation, avoid using this product next to or stacked with other equipment. If such use is necessary, observe this product and other equipment to ensure proper operation.
- 13.The use of accessories other than those specified or provided by the manufacturer/production enterprise may result in an increase in electromagnetic radiation or a decrease in electromagnetic immunity, etc., resulting in abnormalities or errors.
- 14.Stop measuring if your eyes become uncomfortable after using the product.
- 15.Do not use the product outside the operating environment specified in Section 7.3.
- 16.Make sure that the device is set to the correct date and time before taking measurements, otherwise the time information of the measurement data in the historical data will be incorrect.
- 17.Before taking out the tonometer from its package and before each use of the tonometer, visually check whether the tonometer has any external damage, especially whether the tonometer enclosure is damaged. If you suspect the tonometer is damaged, contact the manufacturer/production enterprise or distributor.
- 18.Although all parts that are expected to come into contact with the human body have been biologically evaluated and the biological safety meets the requirements of the standard, a very small number of users may still have allergic reactions, in which case the users should stop to use the device immediately.
- 19.The normal range of intraocular pressure is 10~21mmHg, if the measurement result is beyond the normal range, it is recommended to see a doctor in time.
- 20.The measurement results of this product are for reference only and cannot be used as the basis for the diagnosis of ophthalmic diseases such as glaucoma. The use of the measurement results should refer to the opinions of the attending doctor and ophthalmologist; if the measurement results of this product are inconsistent with the subject’s symptoms, the subject should go to the hospital for re-examination, and the test results of the hospital shall prevail; the subject shall not change or discontinue the diagnosis and treatment plan based on the intraocular pressure measurement results without the guidance of medical personnel.
9.2 Warning
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Warning: (1) Because parts such as the probe base, probe are very small, please make sure that the product is placed out of the reach of children to prevent them from accidentally swallowing the parts. |
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Warning: (2) It is strictly forbidden for children to operate the product. |
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Warning: (3) The location where the product is installed and used should not be directly exposed to sunlight or ultraviolet rays. |
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Warning: (4) There should be no equipment and high-frequency equipment that generate strong electromagnetic waves in the environment where the product is installed and used. |
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Warning: (5) If the product is used to measure intraocular pressure of the same subject, please use 75% medical alcohol cotton balls to wipe the upper forehead support pole and face support pole regularly. |
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Warning: (6) If the product is used to measure intraocular pressure of a different subject, in order to prevent the spread of certain microorganisms (such as bacteria) through the upper forehead support pole or the face support pole, please wipe the upper forehead support pole and face support role with 75% medical alcohol cotton balls before measuring. |
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Warning: (7) Please keep the display screen window of the main unit clean. |
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Warning: (8) Please make sure that the tip of the probe contains a small probe ball head, do not use a probe without a probe ball head; do not use a deformed probe. If you find a problem with your probe or probe case, please contact the manufacturer/production enterprise or distributor. |
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Warning: (9) Use only probes produced by the manufacturer/production enterprise of this product. |
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Warning: (10) Check the probe packaging before using the probe, if the probe packaging is damaged, the sterility of the probe cannot be guaranteed. Re-sterilization or reuse the probe may result in incorrect measurements, damage to the probe and eye infections. Re-sterilization or reuse will absolve the manufacturer/production enterprise of all responsibility and liability regarding the safety and effectiveness of the product. |
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Warning: (11) In order to prevent contamination, please put the unused probe into the probe case, do not touch the exposed probe, and do not continue to use the probe if it comes into contact with a non-sterile surface, such as table, floor, human body, etc. |
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Warning: (12) The product must be turned off when replacing the probe base. |
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Warning: (13) The product must not be repaired or reassembled by anyone other the manufacturer/production enterprise or their authorized after-sales service enterprise. |
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Warning: (14) The product may be interfered in the vicinity of equipment labelled with a non-ionizing radiation symbol. |
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Warning: (15) Do not spray, pour or spill liquids onto the product and its accessories, if this happens inadvertently, wipe them dry immediately. |
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Warning: (16) It is strictly forbidden to use the product in flammable and explosive places and dusty air environments. |
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Warning: (17) Since the tonometer will accumulate dust or other impurities during long-term use, it is recommended to replace the probe base after about 1000 measurements or after 6 months of use, otherwise the measurement accuracy of the product may be affected. |
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Warning: (18) Replace the batteries within the product life. Do not dispose of the waste batteries at will, send them to the designated place for sorting treatment according to the requirements of the local environmental authorities. |
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Warning: (19) If the product and its components have reached the end of their service life, do not dispose of them at will, they should be handled properly, and they can be sent to the designated recycling point to avoid polluting the environment. |
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Warning: (20) Use beyond the measurement range of the product may affect the measurement accuracy. |
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Warning: (21) Do not use this product if the subject has any of the following conditions: 1）Pinkeye; 2）Trauma to the eye; 3）Severe difficulty in opening the eyes, including abnormal contraction or twitching of the eyelids; 4）Involuntary rapid repetitive movements of the eyes; 5）Other diseases determined by the physician as not suitable. |
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Warning: (22) Please follow the doctor’s advice when using this product if the subject has any of the following conditions: 1）Poor uncorrected near vision; 2）Poor fixation or off-center of the eyeball; 3）Poor hearing without hearing aids and/or using sign language for communication; 4）Use of contact lenses; 5）Having dry eyes; 6）Having with keratoconus; 7）Having congenital microphthalmia; 8）Having pediatric glaucoma with enlarged eyes; 9）Ophthalmic postoperative patients. |
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Warning: (23) Do not remove, cover, or deface the label or logo on the tonometer. |
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Warning: (24) The manufacturer/production enterprise shall be exempted from liability in any of the following circumstances: 1）The consequences caused by not operating in strict accordance with the operation instruction; 2）Measurement data errors caused by failing to store and transport this product in strict accordance with the operation instruction; 3）The measurement results of this product are for reference only and cannot be used as the basis for diagnosis. The consequences caused by self-diagnosis, treatment, change or discontinuation of the treatment plan based on the tonometer measurement results of this product without the guidance of medical personnel. |
X. Bluetooth Specification Information
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Item |
Specification |
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Bluetooth module |
nRF52840 |
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Communication |
BLE5.1 |
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RF range |
2.402GHz~2.48GHz |
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Output power |
0dB |
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Antenna gain |
1.69dBi |
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Effective radiated power |
16mW |
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Transmitting distance |
3m |
XⅠ. Electromagnetic Environment
- The rebound tonometer complies with the relevant requirements of the YY 9706.102-2021 standard for electromagnetic compatibility.
- The user shall install and use the product according to the electromagnetic compatibility information provided in the accompanying file.
- Portable and mobile radio frequency (RF) communication devices may affect the normal use of the rebound tonometer, please use the rebound tonometer in the recommended electromagnetic environment.
- The rebound tonometer may still be interfered by other equipment that comply with the corresponding national standards.
- The basic performance of the rebound tonometer is the accuracy of IOP measurement. The accuracy of IOP measurement may be lost or degraded due to electromagnetic interference, please refer to the following for the correct electromagnetic environment.
11.1 Electromagnetic Emission Guidelines and Manufacturer’ s Declaration
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Guidelines and Manufacturer’s Declarations – Electromagnetic Emissions |
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The rebound tonometer is intended to be used in the following electromagnetic environment, and the purchaser or user should ensure that it is used in this electromagnetic environment: |
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Emission tests |
Compliance |
Electromagnetic Environment - Guidelines |
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Radio frequency emission GB 4824 |
Group 1 |
The rebound tonometer uses radiofrequency energy for its internal functions only. As a result, it has very low RF emissions and little chance of interference with nearby electronics. |
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Radio frequency emission GB 4824 |
Class B |
Rebound tonometer is suitable for use in all facilities, including domestic facilities and low-voltage power supply network directly connected to domestic dwelling house. |
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Harmonic emission GB 17625.1 |
N/A |
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Voltage fluctuation/flicker emission GB/T 17625.2 |
N/A |
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11.2 Electromagnetic Immunity Guidelines and Manufacturer’ s Declarations
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Guidelines and Manufacturer’s Declaration - Electromagnetic Immunity |
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The rebound tonometer is intended to be used in the following electromagnetic environment, and the purchaser or user should ensure that it is used in this electromagnetic environment: |
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Immunity test |
IEC 60601 test level |
Compliance level |
Electromagnetic Environment - Guidelines |
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Electrostatic discharge GB/T 17626.2 |
± 6 kV contact discharge ± 8 kV air discharge |
± 6 kV contact discharge ± 8 kV air discharge |
The floor should preferably be wood, concrete or tile. If the floor is covered with synthetic materials, the relative humidity should be at least 30%. |
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Electrically fast transient GB/T 17626.4 |
± 2 kV to power cord ± 1 kV to input/output wires |
N/A |
N/A |
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Surge GB/T 17626.5 |
± 1 kV wire-to-wire ± 2 kV wire to ground |
N/A |
N/A |
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Voltage dip, short interruption, and voltage change on the power input line GB/T 17626.11 |
<5% UT for 0.5 cycles (on UT, > 95% dip) 40% UT for 5 cycles (on UT, 60% dip) 70% UT for 25 cycles (on UT, 30% dip) <5% UT for 5s (on UT, > 95% dip) |
N/A |
N/A |
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Power frequency magnetic field （50 Hz/60 Hz） GB/T 17626.8 |
3A/m |
3A/m |
The power frequency magnetic field should have the characteristics of the level of power frequency magnetic field in a typical commercial or hospital environment. |
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Note: UT refers to the AC network voltage before the test voltage is applied. |
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Guidelines and Manufacturer’s Declaration - Electromagnetic Immunity
There rebound tonometer is intended to be used in the following electromagnetic environment, and the purchaser or user should ensure that it is used in this electromagnetic environment:
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic Environment - Guidelines
Radio frequency conduction GB/T 17626.6
Radio frequency radiation GB/T 17626.3
3 V（Effective value）
150 kHz~80 MHz
3V/m
80 MHz~2.5 GHz
N/A
3V/m
The portable and mobile RF communication devices should not be used closer to any part of the rebound tonometer (including cables) than the recommended isolation distance. This distance is calculated by a formula corresponding to the transmitter frequency.
Recommended isolation distance:
d =1.2
d =1.2
d =2.3
where:
P - the maximum rated output power of the transmitter provided by the transmitter manufacturer, in watts (W);
d – the recommended isolation distance, in meters (m).
The field strength of a fixed RF transmitter is determined by surveying the electromagnetic sitea, and it is desirable to be lower than the compliance level in each frequency rangeb.
Interference may occur near devices marked with the following symbol.
Note 1: At the 80 MHz and 800 MHz frequency points, the formula for the higher frequency bands is used.
Note 2: These guidelines may not be appropriate for all situations, and electromagnetic propagation is affected by absorption and reflection by building, object and human body.
a The field strength of fixed transmitters, such as base stations for wireless (cellular/cordless) telephones and terrestrial mobile radios, amateur radios, AM and FM radio broadcasts, and television broadcasts, cannot be accurately predicted in theory. In order to assess the electromagnetic environment of a fixed RF transmitter, it is advisable to consider the survey of electromagnetic sites. If the field strength of the rebound tonometer is higher than the applicable RF compliance level above, it is advisable to observe the rebound tonometer to verify that it can operate properly. Additional measures may be necessary (e.g. reorient or reposition the rebound tonometer) if abnormal performance is observed.
b In the entire frequency range of 150 kHz~80 MHz, the field strength should be lower than 3V/m.
11.3 Recommended Isolation Distance between Portable or Mobile RF Communication Equipment and this Product
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Recommended isolation distance between portable or mobile RF communication devices and rebound tonometer |
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Rebound tonometer is intended for use in an electromagnetic environment where RF radiation disturbance is controlled. Depending on the maximum rated output power of the communication equipment, the purchaser or user can prevent electromagnetic interference by maintaining the minimum distance between portable or mobile RF communication equipment (transmitter) and the rebound tonometer as recommended below. |
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Maximum rated output power of the transmitter/W |
Isolation distance corresponding to different frequencies of the transmitter/m |
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150 kHz～80 MHz d=1.2 |
80 MHz～800 MHz d=1.2 |
800 MHz～2.5 GHz d=2.3 |
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0.01 |
0.12 |
0.12 |
0.23 |
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0.1 |
0.38 |
0.38 |
0.73 |
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1 |
1.2 |
1.2 |
2.3 |
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10 |
3.8 |
3.8 |
7.3 |
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100 |
12 |
12 |
23 |
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For the maximum rated output power of the transmitter not listed in the table above, the recommended isolation distance d, in meters (m), can be determined using the formula in the corresponding transmitter frequency column. Here P is the maximum rated output power of the transmitter provided by the transmitter manufacturer, in watts (W). Note 1: At the 80 MHz and 800 MHz frequency points, the formula for the higher frequency bands is used. Note 2: These guidelines may not be appropriate for all situations, and electromagnetic propagation is affected by absorption and reflection by building, object and human body. |
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XⅡ. Product Maintenance, Cleaning and Disinfection
12.1 Maintenance
The rebound tonometer does not contain any user-serviceable parts except for the battery and probe base. The rebound tonometer does not require any routine repair or calibration, and only needs to replace the probe base once after about 1000 measurements or after 6 months of use. If the main unit of the product needs to be repaired, or if the main unit system software or mobile APP cannot be used and needs to be maintained, please contact the manufacturer/production enterprise or after-sales service company. The manufacturers/production enterprise may provide information on request that will assist maintenance personnel in repairing serviceable parts of the product. After the product is repaired, the manufacturer/production enterprise will perform a calibration of the basic performance of the product.
- 1.Replace the batteries
Open the battery cover, remove the used batteries, put 4 new AA batteries into the battery compartment according to the correct polarity, and close the battery cover.
- 2.Replace the probe base
Since the tonometer will accumulate dust or other impurities during long-term use, it is recommended to replace the probe base after about 1000 measurement or after 6 months of use. The steps to replace the probe base are as follows:
- 1.Turn off the tonometer.
- 2.Unscrew the probe base ring and place it in a safe place.
- 3.Remove the probe base by tilting the tonometer downward and pulling the probe base out of the tonometer with your fingers.
- 4.Insert the new probe base into the tonometer.
- 5.Tighten the probe base ring to lock the probe base.
12.2 Cleaning and Disinfection
According to the GB/T 26373-2020 Hygienic Requirements for Alcohol Disinfectants, it is recommended to use the following disinfectant to clean the main unit of rebound tonometer:
Ethanol disinfectant 【ethanol content is not less than 60% (volume fraction) or 52% (mass fraction); ±10% of the active ingredient content should meet the labelled amount】, and medical alcohol (concentration 75%) is recommended.
Specific practice: turn off the tonometer, gently wipe the surface of the main unit with a clean cotton cloth dipped in 75% medical alcohol solution, and dry it naturally or use another clean cotton cloth to dry the surface of the product.
Note: If the product is used to measure intraocular pressure of the same subject, please use 75% medical alcohol cotton balls to wipe the upper forehead support pole and facial support pole regularly;
if the product is used to measure intraocular pressure of a different subject, in order to prevent the spread of certain microorganisms (e.g., bacteria) through the upper forehead support pole or facial support pole, please wipe the upper forehead support pole and facial support pole with 75% medical alcohol cotton balls before measuring.
XⅢ. Storage and Transportation Conditions
Climatic and environmental conditions for the storage/transportation of the product in the complete packaging and the secondary use of the product after the removal of the protective packaging: relative humidity range 5% RH ~93% RH, temperature range -10°C~55°C, atmospheric pressure range 700hPa~1060hPa, place without corrosive gas, avoid direct sunlight, and keep the environment clean and cool.
During the transportation of the product, it should be prevented from heavy pressure, vibration, collision, exposure to the sunlight and wetting. Please ensure that all packaging and labels of the product are complete.
After the product has been stored or transported at the lowest or highest temperature, the product should be placed at room temperature for 1 hour before use.
XⅣ. Common Troubleshooting
If you encounter any malfunction regarding this product, please refer to the following.
If you encounter a fault that is not described in this section, or if the measures given do not resolve the fault, please contact the manufacturer/production enterprise, after-sales service enterprise or distributor.
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Common faults |
Possible causes |
Measures |
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Black screen |
Battery drain |
Replace batteries |
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System stays on the boot screen |
Turned on the device for less than 10 seconds; Software system corruption |
Press the “Start button” and wait for 10 seconds; If the problem is still not resolved, please contact the manufacturer/production enterprise or after-sales service company |
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System crash |
Circuit failure; Software system corruption |
Reinstall the battery; If the problem is still not resolved, please contact the manufacturer/production enterprise or after-sales service company |
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The probe pops up abnormally |
The battery is low; Probe skewed; The probe base is clogged |
Replace batteries; Replace the probe; Replace the probe base |
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The probe cannot reach the cornea |
The measurement distance is too far |
Adjust the distance by turning the adjustment wheels of the upper forehead support pole and the face support pole appropriately |
XV. Warranty Regulations
With valid certificates such as invoice and warranty card, consumers can enjoy the following services:
（1）Replacement service for non-human quality problems within seven days from the date of purchase;
（2）Warranty service for the whole device within one year from the date of purchase for non-human factor quality problems (except for fragile and consumable products);
（3）The manufacturer/production enterprise will provide repair service of parts/components at a reasonable cost for product failures that exceed one year to the end of the service life.
If necessary, please contact the after-sales service enterprise. If it is not possible to provide a valid proof of purchase such as an invoice, the warranty period shall be determined from one month after the product number or production date.
The following conditions are not covered by the warranty:
- 1.Fragile and consumable products (e.g. battery).
- 2.Damage caused by unauthorized disassembly, repair or modification of the product.
- 3.Damage caused by accidental collision, dropping, and immersion during use or transfer.
- 4.Damage caused by improper use or failure to use the product in accordance with the operation instructions.
- 5.Damage caused by force majeure.
- 6.Damage caused by improper repairs of unauthorized units.
- 7.Products out of the warranty period.
【Explanation of the graphics and symbols used in labels】
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Symbol |
Description |
Symbol |
Description |
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Manufacturer |
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Follow the operating instructions |
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BF type application part |
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Non-ionizing radiation |
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Temperature limit |
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Humidity limit |
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Keep dry |
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Fragile |
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Batch code |
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Date of manufacture |
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Serial number |
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Waring |
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Radiation sterilization |
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Secondary sterilization is prohibited. |
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For single use only |
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Do not use if package is damaged. |
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Service life |
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Stacking layer limit |
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Enclosure protection level (dust resistance: prevents solid foreign objects with a diameter of ≥12.5 mm from entering the product, water resistance: without harmful effects for water droplets dripping from 15-degree angle to the enclosure) |
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