Instructions For Safe Operations - PULOX PO-400 Mode D'emploi

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 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.

This device is not intended for treatment.
The User Manual is published by our company. All rights reserved.
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 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 device.

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 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 testee measured by MRI and CT.

Please do not break the wristband, for fear it becomes out of use, or the unexpected drop of the
device which is due to the looseness of the wristband in the process of using. Users who are allergic
to the wristband is not recommended to use it.

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,
Novidion GmbH
Fuggerstr. 30 • 51149 Köln
Tel.: +49 (0) 2203 / 9885 200
Fax: +49 (0) 2203 / 9885 206
www.pulox.de • Mail: info@novidion.de
EN