INSTRUCTIONS OF USE

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VICTO

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VICTO+

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ACCESSORIES KIT

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REPLACEMENT KIT

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ADJUSTMENT KIT

ORDERING INFORMATION

Started Kits*

Description cuff size code
VICTO STARTER KIT 3.7 3.7 KIT-AUS-37-WS
VICTO STARTER KIT 4.0 4.0 KIT-AUS-40-WS
VICTO STARTER KIT 4.5 4.5 KIT-AUS-45-WS
VICTO STARTER KIT 5.0 5.0 KIT-AUS-50-WS
VICTO+ STARTER KIT 3.7 3.7 KIT-AUS-37
VICTO+ STARTER KIT 4.0 4.0 KIT-AUS-40
VICTO+ STARTER KIT 4.5 4.5 KIT-AUS-45
VICTO+ STARTER KIT 5.0 5.0 KIT-AUS-50
*Each Starter Kit contains an empty AUS system in the respective size and comes with the needles and syringes to fill the system.

Replacement Kit

PUMPS CODE
VICTO / VICTO+ PUMP KIT-RP-03-10-06
BALLOONS CODE
VICTO / VICTO+ BALLOON KIT-RB-01
CUFFS CODE
VICTO / VICTO+ CUFF 3.7 KIT-RC-37-10-06
VICTO / VICTO+ CUFF 4.0 KIT-RC-40-10-06
VICTO / VICTO+ CUFF 4.5 KIT-RC-45-10-06
VICTO / VICTO+ CUFF 5.0 KIT-RC-50-10-06

Accessories Kit

Description code
VICTO / VICTO+ ACCESSORIES KIT KIT-AD-06

Adjustment Kit

Description code
VICTO / VICTO+ ADJUSTMENT KIT KIT-AD-06

USEFUL INFORMATION

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Deactivation
Procedures

Magnetic Resonance (MR) Environment

Non-clinical testing performed in the worst case product has demonstrated that VICTO and VICTO+ implants are MR conditional. A patient with these devices can be safely scanned in an MR system meeting the following conditions:

  • Static magnetic field of 1.5 Tesla and 3 Tesla, with
  • Maximum spatial field gradient of 12,800 G/cm (128 T/m)
  • Maximum force product of 231 T²/m
  • Theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR ) of < 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the VICTO implants are expected to produce a maximum temperature rise of less than 1.0°C (2 W/kg, 1.5 Tesla) RF-related temperature increase with a background temperatura increase of ≈ 1.0°C (2 W/kg, 1.5 Tesla) 0.9°C (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of ≈ 1.0°C (2 W/kg, 3 Tesla) after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 18.3 mm from the VICTO implant at the "port of the pump" when imaged with a gradient echo pulse sequence and a 3 Tesla MR system.