Icare HOME Скачать руководство пользователя страница 31

Страница: 31 / 42

www.icaretonometer.com

Icare HOME

Guidance and manufacturer’s declaration IEC 60601-1-2: Edition 4.0; 2014-02 - Electromagnetic immunity

Icare HOME (TA022) is intended for use in a home healthcare environment with electromagnetic

characteristics specified below. The customers or users of Icare HOME (TA022) should assurre that it is

used in such enviroment

Immunity test

IEC 60601 Test level

Compliance level

Electromagnetic

environment-Guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 8 kV contact

± 2kV, ±4kV, ±8kV, ±15 kV air

± 8 kV contact

± 15 kV air

Floors should be wood, concrete

or ceramic tile. If floors are

covered with synthetic material,

the relative humidity should be at

least 30%

Electrical fast

Transients / burst

IEC 61000-4-4

± 2 kV

100 kHz repetition

frequency

Not applicable

Icare HOME (TA022) tonometer

is not operational when

connected to an external

computer, Icare HOME (TA022)

batteries are not rechargeable

Surge

IEC 61000-4-5

±1 kV for line(s) to line(s)

±2 kV for line(s) to earth

Not applicable

Icare HOME (TA022) tonometer

is not operational when

connected to an external

computer, Icare HOME (TA022)

batteries are not rechargeable

Voltage dips, short

interruption and voltage

variations on power

supply lines

IEC 61000-4-11

0 % UT for 0.5 cycle

(1 phase)

0 % UT for 1 cycle 70

% UT for 25/30

cycles (50/60 Hz) 0 %

UT for 250/300

cycles

(50/60 Hz)

Not applicable

Icare HOME (TA022) tonometer

is not operational when

connected to an external

computer, Icare HOME (TA022)

batteries are not rechargeable

Power frequency

(50/60 Hz)

magnetic field IEC

61000-4-8

30 A/m

Power frequency magnetic

fields should be at levels

characteristic of a typical

location in a typical commercial

or hospital environment.

WARNING: Sources of power

frequency magnetic field should

be used no closer than 15 cm (6

inches) to any part of Icare

HOME (TA022), including cables

specified by the manufacturer.

Otherwise, degradation of the

performance could result.

English

Icare HOME tonometer Instruction manual for health care professionals

Icare HOME tonometer Instruction manual for health care professionals

ENGLISH

www.icare-usa.com

Содержание HOME

Страница 1: ...Icare HOME tonometer Instruction manual for health care professionals ENGLISH 1 www icare usa com INSTRUCTION MANUAL FOR HEALTH CARE PROFESSIONALS ENGLISH...

Страница 2: ...obe 10 10 Using the tonometer 12 10 1 Choosing the measurement mode 12 10 2 Adjusting the measurement position 13 10 3 Automatic eye recognition 14 10 4 Taking the measurements 15 11 Reading the measu...

Страница 3: ...ssionals must inform patients not to modify or discontinue their treatment plan without receiving instructions from the health care professional WARNING For cybersecurity do not connect to the USB por...

Страница 4: ...ns or decreased electromagnetic immunity of this equipment and result in improper operation WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could...

Страница 5: ...it is not used Do not carry out any other service procedures than those described in the chapters 10 12 Leave all other service and repairs to the manufacturer or a certified service center Update th...

Страница 6: ...following conditions are generally not eligible for use of the HOME tonometer as they have the potential to introduce unsafe conditions during use or to impair measurement acquisition 1 Uncorrected ne...

Страница 7: ...e recorded measurement information to a PC through a USB cable 7 PACKAGE CONTENTS WARNING Keep the tonometer out of reach of children because the probe base battery compartment cover and probes are so...

Страница 8: ...RY light 20 POWER button 10 Battery cover 11 Silicone lid USB cover 12 Type label 8 Forehead support adjustment wheel 9 Cheek support adjustment wheel FRONT PARTS TOP PARTS BACK PANEL BOTTOM PARTS SID...

Страница 9: ...mly and press the silicone lid in place to cover the USB port 9 2 TURNING THE TONOMETER ON PRECAUTION The tonometer turns off automatically after 3 minutes if it is not used Press the power button 20...

Страница 10: ...ncorrect measurement values in the breakdown of the probe cross contamination of bacteria or viruses and infection of the eye Re sterilization or re use will void all responsibilities and liabilities...

Страница 11: ...probe container upside down 4 Press the measurement button 13 briefly 1 second to activate the probe 5 The probe moves rapidly back and forth 6 See that the Measure light 15 flashes If so the probe is...

Страница 12: ...is especially useful for those patients who tend to blink heavily Here you press the measurement button briefly 1 second for each of the six measurements to obtain the final IOP reading see figure le...

Страница 13: ...me for the other eye as well unless only one eye needs monitoring 6 Verify that the support positions are correct each and every time the patient comes in for a clinic visit The tonometer has two adju...

Страница 14: ...The right hand transmitter sends invisible infrared light to the right and the left hand transmitter to the left The infrared light reflects from your nose to the sensor The sensor knows from which tr...

Страница 15: ...til the Measure light illuminates again 3 The patient should look straight ahead at a specific point while keeping eyes wide open as shown in the below figure 4 Bring the tonometer near the eye the pr...

Страница 16: ...easure button briefly 1 second and continue the measurement See also section 9 Trouble shooting 8 Press the power button for three seconds to turn the tonometer off The probe slides out of the probe b...

Страница 17: ...every complete measurement sequence of six measurements The stored information includes the calculated final eye pressure reading in mmHg time and date of the measurement identification of the eye rig...

Страница 18: ...8mm 5 32 5 16 between the probe tip and the center of the cornea b Set the probe perpendicular to the center of the cornea Repeat light is flashing and Probe base light is flashing red Two long error...

Страница 19: ...RE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD...

Страница 20: ...ainer with 70 100 isopropyl alcohol Turn the power off Unscrew the probe base collar Invert the probe base over the container drop in the probe base into the container and let soak for 5 30 minutes Re...

Страница 21: ...ometrically by an attached calibrated pressure sensor as reference The measurements were taken using the Icare HOME and additionally verified by a reference tonometer Differences between Icare HOME an...

Страница 22: ...dy staff then acquired three measurements on the Icare TA01i tonometer then an eye care professional took two GAT measurements a third if the first two were not within 2 mm Hg of each other Other test...

Страница 23: ...meter after training and failed to complete the certification procedures described in the protocol The reasons for failing certification were three Home readings differed by 7mmHg 0 7 the first Home r...

Страница 24: ...atoconus Any other corneal or conjunctival pathology or infection Central corneal thickness greater than 0 60 mm or less than 0 50 mm in the study eye Inability to demonstrate proficiency with Icare H...

Страница 25: ...ort Not Spanish Hispanic Latin o Mexican Mexican Am Chicano Puerto Rican Other Spanish Hispanic Latino Handedness Right Left Ambidextrous Study Eye OD Right OS Left IOP Group 16 mmHg 16 to 23 mmHg 23...

Страница 26: ...Agreement between Home and Reference Effectiveness Analysis Cohort N is the number of eyes with measurements from both devices Difference HOME Reference 95 confidence interval CI for mean difference i...

Страница 27: ...of each study eye was used in the analysis The Mean Median of GAT was used in the analysis the median was used if the eye had three measurements Otherwise the mean was used if the eye had two measure...

Страница 28: ...HOME measurements to four plus the one GAT certification measurement the number of eyes experiencing an increase in staining increased to 11 3 however only five 1 3 eyes experienced a clinically signi...

Страница 29: ...r on the order of a physician Rx Only IP22 Sterilized using irradiation Stand by Do not discard this product with other household type waste Send to appropriate facility for recovery and recycling EU...

Страница 30: ...1 2 Edition 4 0 2014 02 Electromagnetic emissions Icare HOME TA022 is intended for use in a home healthcare environment with electromagnetic characteristics specified below The user of the Icare HOME...

Страница 31: ...line s to earth Not applicable Icare HOME TA022 tonometer is not operational when connected to an external computer Icare HOME TA022 batteries are not rechargeable Voltage dips short interruption and...

Страница 32: ...able RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the Icare HOME TA022 including cables s...

Страница 33: ...0 MHz 27 V m PM 50 18 Hz 430 470 MHz 28 V m FM 5 kHz 1 kHz sine PM 18 Hz 704 787 MHz 9 V m PM 50 217 Hz 800 960 MHz 28 V m PM 50 18 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 2400 2570 MHz 28 V m PM 50 217...

Страница 34: ...s green if the tonometer s position is horizontal enough otherwise it is red Explain that if there is an error in your measurement the probe base light flashes red and you hear two long error beeps Re...

Страница 35: ...nts straight at cornea Make sure probe base light is green If probe base light is red make sure you are facing straight ahead i e head held at a 90 angle and tilt tonometer until probe base light turn...

Страница 36: ...rements tab opens showing the copied results with date and time information that all is now stored to the PC STEP 3 Rehearsal 1 Position the tonometer on your HCP trainer own eye 2 3 measurements as i...

Страница 37: ...f use of the device if the following conditions are met a The reading taken by the trainer and the rst of the three readings taken by the HCP di er by 5 mmHg or less b The range max min of the three r...

Страница 38: ...rement At the same time the probe eye recognition system could not recognize the eye because of the incorrect position of the tonometer and you hear a long beep and the probe base light goes out the m...

Страница 39: ...n If the probe is not centered in your sight repeat steps 5 and 6 be tilted more than 10 degrees away from the center of the cornea 5 Explain how to take the measurement to measure IOP result and that...

Страница 40: ...t 2 Both English Icare HOME tonometer Instruction manual for health care professionals STEP 3 Supervised patient use of the icare home 1 Load a new probe and carefully without touching the patient s e...

Страница 41: ...retonometer com 41 Icare HOME English Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionals ENGLISH 41 www icare u...

Страница 42: ...patent applications combined with ISO 13485 certified quality system has made us a respected player in our field of expertise The advanced Icare product line offers reliable high precision reproducib...

Результаты поиска

Содержание HOME

Отзывы:

Похожие инструкции для HOME

Бренды по названию

Популярные бренды

Icare HOME, Инструкция по эксплуатации

Результаты поиска

Содержание HOME

Отзывы:

Похожие инструкции для HOME

Бренды по названию

Популярные бренды