I-Tech FOX-200 Instructions To User

Issuing Date: April, 2020
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter.
This Manual is written and compiled in accordance with the council directive
MDD 93/42/EEC for medical devices and harmonized standards. In case of
modifications and software upgrades, the information contained in this
document is subject to change without notice.
Please read the User Manual carefully before using this product.
WARNING:
■ Uncomfortable or painful feeling may appear if using the device
ceaselessly, especially for the microcirculation barrier patient. It is
recommended that the sensor should not be applied to the same finger for
over 2 hours.
■ The light (the infrared is invisible) emitted from the device is harmful to the
eyes, so the user and the maintenance man should not stare at the light.
■ Enamel or Acrylic fingernail polish or other fingernail applications may
distort and/or produce inaccurate readings.
■ Please refer to the correlative literature about the clinical restrictions and
caution.
1 Safety
1.1 Instructions for Safe Operations
■ Check the main unit and all accessories periodically to make sure that
there is no visible damage that may affect patient's safety and monitoring
performance about cable and transducers. It is recommended that the device
should be inspected once a week at least. When there is obvious damage,
stop using the monitor.
■ Necessary maintenance must be performed by qualified service
engineers ONLY. Users are not permitted to maintain it by themselves.
■ The oximeter cannot be used together with devices not specified in User
Manual. Only the accessory that appointed or recommendatory by
manufacture can be used with this device.
■ This product is calibrated before leaving factory.
1.2 Warning
■ Explosive hazard---DO NOT use the oximeter in environment with
inflammable gas such as some ignitable anesthetic agents.
■ DO NOT use the oximeter while the user is measured by MRI and CT.
■ The person who is allergic to rubber cannot use this device.
■ The disposal of scrap instrument and its accessories and packing
(including battery, plastic bags, foams and paper boxes) should follow the
local laws and regulations.
■ Please check the packing before use to make sure the device and
accessories are totally in accordance with the packing list, or else the device
may have the possibility of working abnormally.
1.3 Attentions
● Keep the oximeter away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
● If the oximeter gets wet, please stop operating it.
● When it is carried from cold environment to warm or humid environment,
please do not use it immediately.
● High temperature or high-pressure steam disinfection of the oximeter is
not permitted. Refer to User Manual in the relative chapter for instructions of
cleaning and disinfection.
● Do not have the oximeter immerged in liquid. When it needs cleaning,
please wipe its surface with medical alcohol by soft material. Do not spray
any liquid on the device directly.
● Do not use the device on infant or neonatal patients.
● The product is suitable for children above four years old and
adults (Weight should be between 15kg to 110kg).
Pulse Oximeter
FOX-200 (JPD-500E(LED))
MNPG302-00