141364

Organization name

AKTORmed GmbH

SRN

DE-MF-000006136

Manufacturer status

Active

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

• CW999

  The SOLOASSIST II may not be used for fields other than the application fields named above. The SOLOASSIST II may be used exclusively for holding and moving an endoscope.
• CW999

  Devices that are connected to the analogue and digital interfaces of the SOLOASSIST II must comply with the standards for electromedical devices. All configurations must meet the requirements of the system standard EN 60601-1. The person connecting additional devices is responsible for the compliance with this standard!
• CW999

  Never use the SOLOASSIST II if you detected any damage. Contact the corresponding service.
• CW009

  STERILE COVER - Do not reuse
• CW999

  The device is not intended for the operation in explosive areas. Ensure a sufficient distance to highly flammable gases (e.g. O2, anaesthetic gases).
• CW999

  The SOLOASSIST II 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 SOLOASSIST II should be monitored in order to check the proper operation with this arrangement.
• CW999

  Use only the original STERILE COVER which you have bought from the manufacturer or an authorised partner
• CW999

  In case of intraoperative complications not due to the use of the SOLOASSIST II, 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.

Primary placement in Austria; available across 1 country total.

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

Trade name

not provided

UDI-DI code

04260463843644

Basic UDI-DI

4260463840018T

Reference / catalog number

141364

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.

• Z1202018001ROBOTIC ARMS FOR VIDEOENDOSCOPY

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