Merit Medical One-Vac Mode D'emploi page 2

One-Vac™ Evacuated Drainage Bottle
INSTRUCTIONS FOR USE
PRODUCT DESCRIPTION
The One-Vac™ Evacuated Drainage Bottle is used to collect fluid from
patients during drainage procedures. The bottle contains a vacuum that's
activated by turning the handle counterclockwise to allow the vacuum in
the bottle to remove fluid.
INDICATIONS FOR USE
The One-Vac Evacuated Drainage Bottle is indicated for use to aspirate,
remove, or sample body fluids.
CLINICAL BENEFITS
The One-Vac Evacuated Drainage Bottle is made from shatter resistant
plastic, provides fast fluid removal and provides a means to easily remove
the fluid contents.
CONTRAINDICATIONS
• None known.
WARNINGS
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse,
reprocessing or resterilization may compromise the structural integrity
of the device and/or lead to device failure which, in turn, may result
in patient injury, illness or death. Reuse, reprocessing or resterilization
may also create a risk of contamination of the device and/or cause
patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the
patient.
• This product is non-sterile.
• After use, dispose of device in a manner consistent with standard
protocols for biohazard waste disposal.
• In the EU, any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority of
the applicable Member State.
PRECAUTIONS
• RX Only Caution - Federal law (USA) restricts this device to sale by or on
the order of a physician.
• Inspect the One-Vac Evacuated Drainage Bottle to ensure there is no
damage.
POTENTIAL COMPLICATIONS
Potential complications (in alphabetical order) of removing fluid include,
but are not limited to any of the following complications:
• Electrolyte imbalance
• Exposure to bodily fluids
• Hypotension (low blood pressure) subsequent to drainage
• Loculation of fluid cavity
• Low flow rate/prolonged drainage
• Pain during fluid removal
• Pneumothorax
• Protein depletion
• Re-expansion pulmonary edema (swelling or fluid buildup in the lung
due to rapid re-expansion of the lung) is an additional complication
that may result from draining pleural fluid.
DRAINAGE INSTRUCTIONS
1. Connect appropriate drainage tubing to the female luer of the One-
Vac Evacuated Drainage Bottle.
2. Connect the other end of the drainage tubing to the drainage catheter.
3. Place the bottle upright on a flat surface with the bottle handle
accessible.
4. Open the bottle by rotating the handle counterclockwise until the
arrow in the handle lines up with the tubing (approximately half a
turn). Let fluid drain until the bottle is full or the fluid stops flowing.
NOTE: If drainage is to be stopped for any reason prior to the bottle
becoming full or full evacuation of fluid, rotate the handle clockwise
until the handle stops (approximately half a turn). To begin drainage
again, rotate the handle counterclockwise until the arrow in the handle
lines up with the tubing (approximately half a turn).
English CAUTION: While the bottle is connected to the catheter, do not rotate
the handle past where the arrow in the handle lines up with the tubing
(approximately half a turn) until you are ready to empty the bottle. If
the handle is rotated too far while connected to the catheter, air could
enter the system causing a pneumothorax. If air enters the system,
disconnect the tubing from the catheter and use another bottle.
NOTE: When rotating the handle a bump may be felt. This is an
indication to stop rotating the handle until ready to remove the handle
completely. Do not rotate the handle past this feature until the bottle
has been disconnected from the catheter and you are ready to empty
the contents of the bottle.
CAUTION: A kink or loop in the line can stop flow early. If this occurs,
remove the kink or loop.
CAUTION: If fluid does not flow, check the catheter and tubing for
kink(s) or loops. If there are no kinks or loops, the patient may need to
adjust positions to move fluid to the catheter drainage holes. If fluid
still does not flow, replace the One-Vac Evacuated Drainage Bottle
with a new one.
NOTE: To slow fluid flow, the handle may be rotated clockwise. It may
be better to regulate flow with a mechanism (such as a roller clamp)
on the tubing.
5. When fluid flow stops or the bottle is full, disconnect the drainage
tubing from the One-Vac Evacuated Drainage Bottle.
NOTE: Rotate the handle counterclockwise until it stops before
disconnecting the drainage tubing. This will prevent fluid from leaking.
6. To empty fluid from the bottle, rotate the handle counterclockwise
until it detaches from the bottle. Empty the fluid in accordance with
accepted physician instructions and standard protocols for biohazard
waste disposal.
7. To replace the handle, rotate the handle clockwise.
SYMBOL DESIGNATION
Use By: YYYY-MM-DD
Lot Number
Catalog Number
Do Not Use If Package is Damaged and Consult
Instructions for Use
Single Use
Caution
Non-sterile
Caution: Federal (USA) law restricts this device to
sale by or on the order of a physician
Medical Device
Unique Device Identifier
Consult Instructions for Use
For electronic copy scan QR code, or go to www.
merit.com/ifu and enter IFU ID. For printed copy,
call U.S.A. or EU Customer Service
Authorized Representative in European Community
Manufacturer
Date of Manufacture: YYYY-MM-DD