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Instructions For Use
Description
The Atrium Oasis
TM
chest drain is a disposable, dry suction
operating system with 2100ml collection volume, dry suction
regulator, and calibrated water seal. Selected models include a
graduated air leak monitor. Sterile fluid is required for water seal
operation and air leak detection. The Oasis drain is packaged
sterile, or is packaged in a sterile fluid path format (only the
contents of the sterile patient tube pack can be entered into the
sterile field). This chest drain is non-pyrogenic and is for single
patient use only. Models equipped with a patient tube in-line
connector provide convenient system change out or attachment of
an Atrium in-line ATS Bag for postoperative autotransfusion. Oasis
ATS models include a filtered collection chamber with an access
line for continuous autotransfusion with an infusion pump, or for
use with an Atrium self-filling ATS blood bag.
Indications For Use
•
Evacuate air and/or fluid from the chest cavity or mediastinum.
•
Help re-establish lung expansion and restore breathing dynamics.
•
Facilitate postoperative collection and reinfusion of autologous
blood from the patient's pleural cavity or mediastinal area.
Warnings
1. Do not obstruct the positive pressure relief valve located on
top of drain.
2. Do not manually depress high negativity vent when patient is on
gravity drainage or when suction is not operating.
3. Do not separate patient tube in-line connector prior to clamping off
patient tube first.
4. Do not keep patient tube clamp closed during drainage collection
or patient transport.
5. Do not puncture patient tube with an 18 gauge or larger needle.
6. Do not use or puncture needleless luer port with needle.
7. Dual collection models (2 patient tubes) require both patient
tubes to remain connected to the patient. When using dual
collection models with only one patient tube connection (1 tube
only), the patient tube not in use must remain securely clamped
off at all times.
Precautions
1. For sterile fluid path models, only the contents of the sterile patient
tube pack can be entered into the sterile field.
2. Do not overfill water seal above the 2cm fill line.
3. Suction source should be set to -80mmHg or higher for chest
drain regulator settings of -20cmH
4. Chest drain must be kept below the patient's chest in an
upright position.
5. Replace chest drain if damaged or when collection volume meets
or exceeds maximum capacity.
6. Patient tube connections, water seal, suction regulator and bellows
should be checked regularly to confirm proper operation.
7. Pre-packaged sterile fluid for chest drainage use only.
Set Up
Step 1. Fill Water Seal To 2cm Line – Add 45ml of sterile water or
sterile saline via the suction port located on top of the drain.
For models available with sterile fluid, twist top off bottle and
insert tip into suction port. Squeeze contents into water seal
until fluid reaches 2cm fill line.
Step 2. Connect Patient Tube To Patient – Connect chest drain to
patient prior to initiating suction.
Step 3. Connect Suction To Chest Drain – Attach suction line to
suction port on top of chest drain.
Step 4. Turn Suction Source On – Increase suction source vacuum to
-80mmHg or higher. Suction regulator is preset to -20cmH
Adjust as required.
Set Up for Sterile Fluid Path Models
Step 1. Connect Patient Tube To Patient – Open sterile patient
tube pack and pass only the sterile patient tube into sterile
field. Close patient tube clamp prior to connecting patient
tube to catheter.
Step 2. Fill Water Seal To 2cm Fill Line – Add 45ml of sterile water
or sterile saline via the suction port located on top of the drain.
For models available with sterile fluid, twist top off bottle and
insert tip into suction port. Squeeze contents into water seal
until fluid reaches 2cm fill line.
Step 3. Connect Patient Tube To Chest Drain – Pass distal end of
patient tube out of sterile field for connection to chest drain.
Connect patient tube to chest drain prior to initiating suction.
Step 4. Connect Suction To Chest Drain – Attach suction line to
suction port on top of chest drain.
Step 5. Turn Suction Source On – Increase suction source vacuum to
-80mmHg or higher. Suction regulator is preset to -20cmH
Adjust as required.
Placement of Unit
Always place chest drain below the patient's chest in an upright
position. To avoid accidental knock-over, place the unit on the floor or
hang it bedside with the hangers provided.
Gravity Drainage
Disconnect the suction line and maintain drain below the patient's chest
in an upright position.
Suction Port
Suction port is located on top of the drain. It is not required to cap off
suction port when suction is not connected or operating.
Suction Source
Suction source should provide a minimum vacuum pressure of
-80mmHg at 20 liters of airflow per minute for a suction control setting
of -20cmH
O or greater.
2
Suction Bellows
Suction bellows will expand to the L mark or beyond when suction is
connected and operating at a regulator setting of -20cmH
the bellows is expanded but less than the L mark, increase the
suction source vacuum to -80mmHg or higher. For regulator settings
less than -20cmH
O, any visible bellows expansion in bellows window
2
will confirm suction operation.
All manuals and user guides at all-guides.com
O or greater.
2
O.
2
O.
2
O or higher. If
2
Dry Suction Regulator
Suction regulator is preset to -20cmH
-10cmH
O to -40cmH
O. To change suction setting adjust rotary
2
2
suction regulator dial located on the side of the drain. Dial down to
lower suction pressure and dial up to increase suction pressure. To
lower regulator setting from a higher level (-40cmH
(-20cmH
O), adjust regulator down to lower setting and then
2
temporarily depress the manual high negativity vent located on top of
the drain to reduce excess vacuum.
Water Seal
The water seal must be filled to the 2cm fill line for system operation
and air leak detection. Once filled, water seal becomes tinted blue.
When air bubbles are observed going from right to left, this will
confirm an air leak.
Air Leak Monitor
For those models with a graduated air leak monitor, air leak bubbling
can range from 1 (low) to 5 (high). Air bubbles create an easy to follow
air leak pattern for monitoring patient air leak trends.
Collection Chamber
The Oasis 3600 Adult • Pediatric Model:
The first collection chamber is calibrated in 1ml increments up to
100ml and 2ml increments up to 200ml.
Chamber two is calibrated in 10ml increments up to 1090ml.
Chamber three is calibrated in 10ml increments up to 2100ml.
The Oasis 3620 Dual Collection Model:
Chamber 1 is calibrated in 1ml increments up to 100ml and 2ml
increments up to 200ml. Subsequent drainage is calibrated in
10ml increments up to 1090ml. Chamber 2 is calibrated in 10ml
increments up to 900ml.
The Oasis 3612 Baby Drain Model:
The pediatric collection chamber is calibrated in 1ml increments
up to 100ml and 2ml increments up to 200ml.
The Oasis 3650 and 3652 ATS Models:
The first collection chamber is calibrated in 10ml increments up
to 1100ml.
Chamber two is calibrated in 10ml increments from 1110ml up
to 2100ml.
Fluid level graduations are accurate within ± 3ml or 3% of scale.
Changes in Patient Pressure
With suction on, patient pressure will equal suction control setting A
plus the height of water seal column level B. For gravity drainage (no
suction) patient pressure will equal the height of the calibrated water
seal column level only.
Manual High Negativity Vent
To lower the height of the water seal column and to lower chest drain
vacuum pressure when connected to suction, depress the high
negativity vent located on top of the drain until the water seal column
lowers to the desired level.
Positive Pressure Relief Valve
PPRV located on top of drain opens instantly to release positive
pressure.
Sampling Drainage
Must be in accordance with approved hospital infection control
standards. Selected models include a needleless luer port on the patient
tube connector for sampling patient drainage. Alcohol swab luer port
prior to syringe attachment (no needle). Samples can also be taken
directly from the patient tube by inserting a 20 gauge needle or smaller
with syringe. Alcohol swab patient tube prior to inserting syringe needle
at a shallow angle.
System Disconnection
Clamp off patient tubes or all indwelling thoracic catheters prior to
disconnecting chest drain from patient.
System Disposal
Disposal of chest drain and its contents should be in accordance with
all applicable regulations.
SYMBOLS USED ON PRODUCT LABELS
REF
LOT
CODE NUMBER
LOT NUMBER
STERILE. STERILIZED BY ETHYLENE OXIDE.
STERILE
EO
SEE PACKAGE INSERT
ATS BAG COMPATIBLE
A
STERILE FLUID PATH PACKAGE
S
F
P
This device is covered under one or more of the following U.S. patents:
4,988,342; 5,114,416; 5,154,712; 5,286,262; 5,380,314;
5,397,299; 5,401,262.
Other patents pending.
Atrium and Oasis are trademarks of Atrium Medical Corporation.
©2004 All Rights Reserved.
ATRIUM MEDICAL CORPORATION
5 Wentworth Drive, Hudson, New Hampshire 03051 U.S.A.
603-880-1433
603-880-6718
O and can be adjusted from
2
O) to a lower level
2
SINGLE USE ONLY
EXPIRATION DATE
ATS CHAMBER
AT
Rx Only
PRESCRIPTION ONLY
European Representative:
ATRIUM MEDICAL CORPORATION
Rendementsweg 24, 3641 SL Mijdrecht, The Netherlands
+31-297-230-420
+31-297-230-422
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