Dear users, thank you very much for purchasing the Pulse Oximeter.
This Manual is written and compiled in accordance with thecouncil directive MDD93/42/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.
The Manual describes, in accordance with the Pulse Oximeter’s features and requirements, main
structure, functions, specifications, correct methods for transportation, installation, usage, operation,
repair, maintenance and storage, etc. as well as the safety procedures to protect both the user and
equipment. Refer to the respective chapters for details.
Please read the User Manual carefully before using this product. The User Manual which describes
the operating procedures should be followed strictly.Failure to follow the User Manual may cause
measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible
for the safety, reliability and performance issues and any monitoring abnormality, human injury and
equipment damage due to users' negligence of the operation instructions. The manufacturer’s
warranty service does not cover such faults.
Owing to the forthcoming renovation, the specific products you received may not be totally in
accordance with the description of this User Manual. We would sincerely regret for that.
This product is medical device, which can be used repeatedly.
WARNING:
Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for
the microcirculation barrier patients. It is recommended that the sensor should not be
applied to the same finger for over 2 hours.
For the special patients, there should be a more prudent inspecting in the placing process.
The device can not be clipped on the edema and tender tissue.
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.
Testee can not use enamel or other makeup.
Testee’s fingernail can not be too long.
Please refer to the correlative literature about the clinical restrictions and caution.
II
This device is not intended for treatment.
The User Manual is published by our company. All rights reserved.
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 cables 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’s 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 Warnings
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 testee measured by MRI and CT.
The person who is allergic to rubber can not use this device.
The disposal of scrap instrument and its accessories and packings(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.
Please don't measure this device with function test paper for the device's related information.
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.
DO NOT operate keys on front panel with sharp materials.
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.
When cleaning the device with water, the temperature should be lower than 60℃.
As to the fingers which are too thin or too cold, it would probably affect the normal measure of
the patients' SpO2 and pulse rate, please clip the thick finger such as thumb and middle finger
deeply enough into the probe.
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).
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