Safety Advice

regarding

Hand pendants for OPERON D 850, D 820 and D760 operating tables

Tuttlingen, June 10, 2013

From: Berchtold GmbH & Co. KG, Ludwigstaler Str. 25, 78532 Tuttlingen, Germany To: Users, OR managers, clinical directors, managing directors, dealers

Affected products: Hand pendants for OPERON D 850, D 820 and D760 operating tables

Dear customer and user,

As part of our global product monitoring, it is our duty to inform you of potential risks to patients and users that may arise when using the above-mentioned products. Our records indicate that you received the above-cited hand pendants sometime between June 2009 and February 2013.

BERCHTOLD has received reports from the American market about incidents with the hand pendants put on the market during that time period. Reports indicate that an accidental movement of a table segment was triggered by cleaning and disinfecting agents getting into the hand pendant. The likelihood of this happening is very low. Nonetheless this does pose a risk of injury to the patient and others should this type of unwanted movement occur during surgery.

The risk of accidental movement of a table segment exists only, if the hand pendant will not cleaned and disinfected according to the instructions in the operating manual.

BERCHTOLD GmbH & Co. KG AG Stuttgart HRA 450764 Kreissparkasse Tuttlingen (Sort code 643 500 70) 9214 Ludwigstaler Straße 25 PhG Berchtold + Fritz GmbH, Domicile Tuttlingen SWIFT-BIC: SOLADES1TUT 78532 Tuttlingen / Germany AG Stuttgart HRB 450406 IBAN DE07 6435 0070 0000 0092 14 Phone +49 (0) 74 61 / 181-0 Managing Director Dresdner Bank Tuttlingen (Sort code 643 800 11) 2 725 691 Fax +49 (0) 74 61 / 181-8109 Theo Fritz, Dipl. Wirtsch.-Ing. [email protected] www.BERCHTOLD.biz VAT Reg No. DE 142932906 Tax ID 21081/00519

Safety and procedural advice

To exclude the risk of accidental movement of a table segment you have to follow the following safety and procedural advices:

1. Follow the instructions for cleaning and care in the operating manual. In particular, do not use a wet cloth to clean and disinfect the hand pendant; use a damp cloth only. Never immerse the hand pendant in liquids. 2. Keep the hand pendant as dry as possible. 3. Use only undamaged hand pendants. If the housing, the keypad or the clip (on the back) are damaged or if the cable is pulled out, the hand pendant may not be used. 4. When the hand pendant is not in use, always attach it to the side rails or the head module. 5. In the case of unintended movement, the movement can be stopped at once by pressing the “POWER” button on the left top of the hand pendant. Do not use this hand pendant further more in this case.

Additional optional preventive actions can be done by the following activities:

1. Switch off the table after the patient has been positioned for the surgery. Therefore press the “POWER” button on the left top of the hand pendant. After that the OR-table is in the “Sleep”-mode and can be waked up by pressing of any key. Please consider to this also the operating manual.

Please ensure that your users and those staff responsible for the matter are aware of this safety advice.

The actions described are preventive in nature and are for the safety of patients and users.

For queries, please contact your dealer or [email protected]. The following contacts are also available to address any questions or concerns you may have:

Yours sincerely,

BERCHTOLD GmbH & Co. KG