Contraindications - Boston Scientific ROTAGO Mode D'emploi

ROTAGO
Cart and Infusion Stand
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The ROTAGO Cart and Infusion Stand is a cart built for use with the Rotablator
Atherectomy System Console and the ROTAPRO
cart is solely offered as an optional item and is not required for use of any Rotablator Console
or ROTAPRO Console.
Figure 1. ROTAGO Cart and Infusion Stand
Black (K) ∆E ≤5.0
Rotational
™
Rotational Atherectomy System Console. The
™
Contents
Quantity Material
1 Cart and Infusion Stand
1 Shelf
Operating Principle
Primary cart functions include: compatible shelf for use with Rotablator or ROTAPRO Console,
pole-mounting options for use with the ROTAPRO Console, an IV pole, holding location for
compressed gas tanks, and the ability to be mobile.
Materials
This product contains dry natural rubber.
User Information
Intended users of the ROTAGO Cart and Infusion Stand include hospital personnel trained in
the set-up of the Rotablator Console and ROTAPRO Console.
INTENDED USE/INDICATIONS FOR USE
The ROTAGO Cart and Infusion Stand is for optional use with the Rotablator Console or
ROTAPRO Console and is intended to hold associated accessories and components.
Clinical Benefit
The ROTAGO Cart and Infusion Stand is for optional use with the Rotablator Console or
ROTAPRO Console and is intended to hold associated accessories and components.

CONTRAINDICATIONS

None known
WARNINGS
• To prevent tank mishandling read and follow the labels, guidelines, and handling
instructions provided by the gas manufacturer.
• To avoid tank damage and prevent personnel injury, exercise caution when loading gas tank
onto platform. Ensure the casters are locked and the cart is on a level, non-inclined surface.
• To keep tank from dislodging from cart, ensure that the straps are tightly secured around
the tank. If tank dislodges from cart, ensure tank is undamaged before re-loading tank
onto cart. Ensure casters are locked when loading or in use, and straps are tightly secured
around the tank.
PRECAUTIONS
• To prevent the cart from tipping do not step, stand, or lean on platform or shelf, do not
exceed 86 lb (39 kg) maximum tank weight and use caution when moving cart on uneven
or inclined surfaces. In the event the cart tips, stand the cart back up, and check gas
tanks or console for damage. Return the cart to an upright position and lock the casters.
Replace any damaged units before beginning or continuing with procedure.
• To avoid shelf damage do not exceed 13 lb (6 kg) maximum shelf capacity. In the event
the recommended weight limit is exceeded, the shelf may break. In the event of the shelf
breaking, replace the cart.
• To avoid tripping or hose damage, use hooks provided next to gas tank mounting
location for hose storage during transit. In the event of hose damage, replace the hoses
prior to beginning or continuing the procedure.
• To avoid shelf or console damage do not place items other than console onto shelf. In the
event of console damage, replace the console.
• To avoid cart tipping do not maneuver the cart by the IV pole.
• Caution: This product contains dry natural rubber.
HOW SUPPLIED
This product is supplied non-sterile and is intended for multiple use. Inspect the package
and product before first use. If the package or product has been damaged during shipping,
contact a Boston Scientific representative before using the product.
Do not use if labeling is incomplete or illegible.
Handling and Storage
This product has no special handling or storage requirements.
OPERATIONAL INSTRUCTIONS
Installation, Calibration, and Servicing
Installing Tank
1. Ensure hook and loop straps are open.
2. Lift tank onto platform using proper lifting technique.
3. Place tank against V brackets with regulator outlet in desired position.
4. Ensure tank is snug against V brackets.
5. Secure tank using top and bottom hook and loop straps.
ROTAPRO Console IV Pole Mounting
1. Loosen IV pole clamp and adjust pole to desired height, retighten IV pole clamp.
2. Ensure clamp on ROTAPRO Console is open.
2