Safety Note - Medela BiliBed Manual De Instrucciones

ISO International Organisation for Standardization
EN European Norm
FDA Food and Drug Administration
GMP Good Manufacturing Practices
Medela AG reserves the right to change technical
specifications for the improvement of the product
at any time without prior notice.
I

Safety Note

Dear Client
We would like to congratulate you on purchasing the Medela BiliBed
confident that you have made the right choice and that you will be fully satisfied.
The following pages show you how to use and maintain the BiliBed. If these
instructions are followed carefully, your BiliBed will have a long and reliable
operating life.
We would like to thank you for the confidence you have placed into our company
by purchasing this product.
We develop and produce our products with a certified quality-management system
according to EN ISO 13485:2003, as well as according to the guidelines of the
American FDA for GMP.
Working with the BiliBed requires precise knowledge of its areas of application as
well as adherence to these instructions. In cases where there is any uncertainty,
trained staff familiar with the equipment must be consulted.
Caution
The BiliBed may not be used in environments
• where there is a risk of explosion
• enriched with oxygen
• in an incubator
Attention
The use of these lamps for anything but their intended purpose can be hazardous.
Portable and mobile RF communication devices may influence the device.
Separation from the mains is only assured through the disconnection of the plug
and socket connection.
A small percentage of the population is sensitive to blue light. Do not use the
BiliBed without the Bilicombi.
In each of the following cases, the device must not be used and it must be
repaired by Customer Services:
• If the power cable or the plug are damaged
• If the device is not functioning perfectly
• If the device is damaged
• If the device shows clear safety defects
® . We are
EN 5