Safety Information; For Healthcare Professionals; For Patients And Healthcare Professionals - Icare HOME2 Instruction Manual

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Safety information

1.1

For healthcare professionals

WARNING! Federal law (U.S.) restricts this device to sale by or on the order of a
physician or properly licensed practitioner.
WARNING! Healthcare professionals must inform patients not to modify or discontinue
their treatment plan without receiving instructions from the healthcare professional.
WARNING! When reading the measurement data in a clinic or hospital environment,
make sure the tonometer and the computer or mobile device which are not medical
equipment are located outside of the patient environment, i.e. 1.5 m (5 feet) from the
patient.
WARNING! Connection of the tonometer to IT networks including other equipment could
result in previously unidentified risks to patients, operators, or third parties.
WARNING! The responsible organization should identify, analyze, evaluate, and control
any additional risks resulting from the tonometer connected to IT networks, including
other equipment.
PRECAUTION! Certain microbiological agents (for example, bacteria) can be transmitted
from the forehead or cheek support. To prevent this, clean the forehead and cheek
supports with disinfectant for each new patient.
PRECAUTION! Changes to the IT network could introduce new risks requiring additional
analysis by the responsible organization. The changes include:
• changes in the IT network configuration
• connection of additional items to the IT network
• disconnecting items from the IT network
• update or upgrade of equipment connected to the IT network
1.2

For patients and healthcare professionals

WARNING! The tonometer is intended for personal use only. Measuring other people,
animals, or objects is forbidden.
WARNING! Do not use the tonometer in the restricted environments defined in chapter
"5.2 Environmental restrictions" of this manual.
WARNING! Patients must not modify or discontinue their treatment plan without
receiving guidance from a healthcare professional.
WARNING! The tonometer must not be dropped. To avoid dropping the tonometer and
to ensure safe handling, always use the wrist strap to keep the tonometer attached to
your wrist when in use. If the tonometer is dropped and the tonometer casing opens,
press the casing to close the openings.
WARNING! Removing, covering, or defacing any label or sign on the tonometer voids all
the responsibilities and liabilities of the manufacturer concerning the safety and
effectiveness of the tonometer.
WARNING! Remove the batteries from the tonometer if it is not likely to be used for
some time.
WARNING! Only probes are intended for contacting the eye. Avoid touching the eye with
other parts of the tonometer. Do not push the tonometer into the eye.
WARNING! If you need help in using the iCare HOME2 tonometer, contact your
healthcare professional.
WARNING! Use of eye drops right before the measurement or topical anesthesia may
affect the measurement result.
WARNING! Do not use probes without a plastic tip. Do not use deformed probes.
Contact the manufacturer or local distributor if you notice faulty probes or probe
packages.
WARNING! Use only original and certified probes made by the manufacturer. The probes
are for single use (single pair of measurement sequences) only. Each session is defined
by one successful measurement in both eyes, but in case either eye is inflamed or
infected, measure the healthy eye first.
WARNING! Use probes taken only from an intact, original packaging. The manufacturer
cannot guarantee the sterility of the probe once the seal is compromised. Re-
sterilization or re-use of the probe could result in incorrect measurement values,
breakdown of the probe, cross-contamination of bacteria or viruses, and infection of the
eye. Re-sterilization or re-use will void all the responsibilities and liabilities of the
manufacturer concerning the safety and effectiveness of the tonometer.
WARNING! To prevent contamination, keep unused probes in their box. Do not touch a
bare probe. Do not use a probe if it touches a non-sterile surface such as a table or a
floor.
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