242791

Organization name

AKTORmed GmbH

SRN

DE-MF-000006136

Manufacturer status

Active

9 warnings recorded — scroll inside the panel to see all entries.

• CW999

  The RoboFIX® must not be used outside of the fields of application detailed above. The RoboFIX® may only be used to hold and move a joimax® endoscope.
• CW999

  This symbol indicates safety information. Non-compliance with the corresponding information may lead to damage or even injuries for the patients and / or the user.
• CW999

  Never use the RoboFIX® if you detected any damage. Contact the corresponding service.
• CW999

  The contraindications of the endoscopes used also apply to the use of the RoboFIX®.
• CW999

  In case of intraoperative complications not due to the use of the RoboFIX®, it may still be in order to remove the device as fast as possible from the OR surroundings in order to have better access to the patient.
• CW999

  MEDICAL ELECTRICAL DEVICES are subject to special precautionary measures in regard to EMC. The RoboFIX® may be installed and operated only in accordance with the EMC information contained in this manual.
• CW999

  427 0.docx @ 2074 4 @ @ 1 The RoboFIX® or the associated POWER SUPPLY may not be placed directly adjacent to other equipment or stacked with other equipment. If it is necessary to operate the device close to other equipment and stacked with other equipment, the RoboFIX® should be monitored in order to check the proper operation with this arrangement.
• CW009

  STERILE COVER: Do not reuse
• CW999

  Never use the RoboFIX® in the OR without having been instructed by an authorised person in its safe use.

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

not provided

UDI-DI code

04260463847918

Basic UDI-DI

42604638400899

Reference / catalog number

242791

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

incl. POWER SUPPLY, POWER CORD C7 and SUPPLY CABLE

Additional information URL

https://aktormed.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12029099VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification