Instructions To User; Instructions For Safe Operations - PULOX PO-300 Manual De Instrucciones

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 apologize for this.
This product is a 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 special patients, there should be a more prudent inspectioning in the placing process. The device
can not be clipped on the edema and tender tissue.

The light (infrared is invisible) emitted from the device is harmful to the eyes, so the user and
maintenance personel 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 diagnosis.
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. In case of 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 accessory
appointed or recommended 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 is being measured by MRI and CT.

Be careful with the use of the lanyard cord. Improper use of the lanyard cord will cause device
damage not covered under the manufacturer's warranty. Swinging the device by the lanyard cord
will void the warranty. Please do not use lanyard cord if allergic to lanyard cord.

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.
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