Icare Icare HOME TA022 Скачать руководство пользователя страница 3

www.icaretonometer.com

www.icaretonometer.com

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Icare HOME

Icare HOME

 

WARNING!

The safety and effectiveness of the Icare HOME tonometer has not been evaluated for 

patients with:

 

Uncorrected Near Visual Acuity of 20/200 or worse. Only one functional eye. 

Poor or eccentric fixation. Hearing impairment to the extent that the individual cannot 

hear and converse with others without an assistive aid and/or sign language. High corneal 

astigmatism >3D. Disabling arthritis or limited motor coordination affecting self-handling of 

the Icare tonometer. Lack of comprehension or willingness to use the tonometer as instructed. 

Corneal scarring. History of prior incisional glaucoma surgery or corneal surgery, including 

corneal laser surgery. Microphthalmos. Buphthalmos. Contact Lens Use

Dry eyes. Blepharospasm. Nystagmus. Keratoconus. Central corneal thickness greater than 

0.60mm or less than 0.50mm. Age < 40 years old.

 NOTE!

•  When you have opened the package, check for any external damage or faults, particularly 

for damage to the case. If you suspect that there is something wrong with the tonometer, 

contact the dealer who sold the tonometer to you. 

•  Use the tonometer only for measuring intraocular pressure. Any other use is improper 

and the manufacturer is not liable for any damage arising from improper use, or for the 

consequences of such use. 

•  Never open the casing of the tonometer, except for the battery compartment. 
•  Never allow the tonometer to get wet. 
•  Do not use the tonometer near flammable substances, including flammable anesthetic 

agents. 

•  Certain microbiological agents (for example, bacteria) can be transmitted from the 

forehead or cheek support. To prevent this, clean the forehead and cheek support for each 

new patient with disinfectant. See the chapter ‘Cleaning and disinfection’. 

•  The tonometer conforms to EMC requirements (IEC 60601-1-2), but interference may occur 

within the tonometer if used near (<1m) a device causing high intensity electromagnetic 

emissions, such as a cellular phone. Although the tonometer’s own electromagnetic 

emissions are well below the levels permitted by the relevant standards, they may cause 

interference in other, nearby devices, for example sensitive sensors. 

•  If you do not use the tonometer for a long time, remove the batteries, as they may leak. 
•  Be sure to dispose of the single-use probes properly (for example, in a container for 

disposable needles). 

•  Batteries, packaging materials and probe bases must be disposed of according to local 

regulations. 

•  Make sure you use batteries with built-in PTC protection, for example Energizer Lithium 

Photo 123 3V CR123A.

•  Do not cover the eye recognition transmitters or sensor during the measurement, for 

example with your fingers. Keep your hand, hair etc. and objects such as pillows away 

from the temple side of your eye, as they produce an infrared reflection that causes an 

error.

•  The tonometer turns off automatically after 3 minutes if you do not use it.
•  Do not carry out any other service procedures. Leave all other service and repairs to the 

manufacturer or a certified service center.

•  Update the tonometer’s time to your local time. It is done automatically by performing the 

steps 1 and 2 under section 8. Reading the measurement data.

2. INDICATIONS FOR USE

 

WARNING!

The safety and effectiveness of the Icare HOME tonometer has not been evaluated for 

patients with:

1.  Uncorrected Near Visual Acuity of 20/200 or worse
2.  Only one functional eye
3. 

Poor or eccentric fixation

4.  Hearing impairment to the extent that the individual cannot hear and converse 

with others without an assistive aid and/or sign language

5.  High corneal astigmatism >3D
6. 

Disabling arthritis or limited motor coordination affecting self-handling of the 

Icare tonometer

7.  Lack of comprehension or willingness to use the tonometer as instructed
8.  Corneal scarring
9.  History of prior incisional glaucoma surgery or corneal surgery, including 

corneal laser surgery

10.  Microphthalmos 
11.  Buphthalmos
12.  Contact Lens Use
13.  Dry eyes
14.  Blepharospasm
15.  Nystagmus
16.  Keratoconus
17.  Central corneal thickness greater than 0.60mm or less than 0.50mm
18.  Age < 40 years old

The Icare HOME tonometer is a prescription device intended for monitoring of 

intraocular pressure (IOP) of the human eye. It is indicated for use by patients or 

their caregivers under supervision of an eye care professional.

Icare HOME tonometer Instruction manual for health care professionals

Icare HOME tonometer Instruction manual for health care professionals

English

English

Содержание Icare HOME TA022

Страница 1: ...HOME INSTRUCTION MANUAL FOR HEALTH CARE PROFESSIONALS ENGLISH...

Страница 2: ...modification of this equipment is allowed WARNING Use only the original and certified probes made by the manufacturer The probes are for single use single pair of measurement sequences only Use probes...

Страница 3: ...arby devices for example sensitive sensors If you do not use the tonometer for a long time remove the batteries as they may leak Be sure to dispose of the single use probes properly for example in a c...

Страница 4: ...rly for damage to the case If you suspect that there is something wrong with the tonometer contact the dealer who sold the tonometer to you The package contains Icare HOME tonometer 10 sterilized sing...

Страница 5: ...re turned on briefly Following a brief pause the Load light flashes on the back panel to remind the user to load the single use probe into the tonometer prior to measurement 6 3 LOADING THE PROBE WARN...

Страница 6: ...ach of the six measurements to obtain the final IOP reading see figure left Series mode press the measurement button constantly Single mode press the measurement button briefly 1 second for each of th...

Страница 7: ...forehead and cheek supports with adjustment wheels 7 3 AUTOMATIC EYE RECOGNITION NOTE Do not cover the eye recognition transmitters or sensor during the measurement for example with your fingers Keep...

Страница 8: ...sition Incorrect measurement position Incorrect head and eye position Incorrect measurement position 5 Press the measurement button Single mode Press the button briefly 1 second and you hear a short b...

Страница 9: ...message a Set the correct distance 4 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...

Страница 10: ...At the same time the probe base light flashes red and you hear two short beeps The reason is either too much deviation in your measurement or the automatic eye recognition system could not recognize...

Страница 11: ...the tonometer Explain that the measurement button must be depressed to obtain the sequence of 6 measurements until a long beep is heard and the green Done light is illuminated on the back panel The pr...

Страница 12: ...certified prior to performing self tonometry STEP 1 Instruct the patient 1 Show and explain the tonometer s user interface including icons and status indicators Off no lights no signals Press power b...

Страница 13: ...strate measurements from your HCP s own eye 1 Position the tonometer on your HCP own eye as instructed above 2 Ask the patient to observe and learn STEP 3 Supervised patient use of the icare home 1 Lo...

Страница 14: ...strictions for professional use include Medivac vehicles or similar where vibration or noise levels are so high that the user cannot hear error signals Environmental restrictions for lay operators pat...

Страница 15: ...in all establishments including domestic establishments and those directly connected to public low voltage power supply network that supplies buildings used for domestic purposes Guidance and manufact...

Страница 16: ...he location in which the Icare HOME is used exceeds the applicable RF compliance level above the Icare HOME should be observed to verify normal operation If abnormal performance is observed additional...

Страница 17: ...www icaretonometer com 32 Icare HOME www icaretonometer com HOME Icare HOME tonometer Instruction manual for health care professionals English...

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