Ohio Medical Thoracic Vacuum Regulator Instructions for Use

Thoracic Vacuum
Regulators
Instructions for Use
O
a
-kP
- cm
H2
User Responsibility
WARNINGS This device is to be used only by persons who have
been adequately instructed in its use.
Do not use this device in the presence of flammable
anesthetics. Static charges my not dissipate and a
possible explosion hazard exists in the presence of
these agents.
This Product will perform in conformity with the description thereof contained in
this operating manual and accompanying labels and/or inserts, when assembled,
operated, maintained and repaired in accordance with the instructions provided. This
Product must be checked periodically. A defective Product should not be used. Parts
that are broken, missing, plainly worn, distorted or contaminated should be replaced
immediately. Should such repair or replacement become necessary, Ohio Medical
recommends that a telephone or written request for service advice be made to the
nearest Ohio Medical Regional Service Center. This Product or any of its parts should
not be repaired other than in accordance with written instructions provided by Ohio
Medical and by Ohio Medical trained personnel. The Product must not be altered
without the prior written approval of Ohio Medical’s Quality Assurance Department.
The user of this Product shall have the sole responsibility for any malfunction which
results from improper use, faulty maintenance, improper repair, damage, or alteration
by anyone other than Ohio Medical.
AAA A 12345
This alpha character indicates the year of product
manufacture and when the serial number was assigned;
“Y” = 1995, “Z” = 1996, “A” = 1997, etc. “I” and “O” are
not used.
CAUTIONS Only competent individuals trained in the repair of this equipment
should attempt to service it.
Detailed information for more extensive repairs is included in the
service manual solely for convenience of users having proper
knowledge, tools and test equipment, and for service representatives trained by Ohio Medical.
Not for field or transport use.*
*
1
The categories of Field and Transport Use are specifically defined in ISO 10079-3 (BS 7259: Part 2) “Field” means accidents
or emergencies outside the hospital. “Transport” means use in ambulances, cars and airplanes. These situations may expose
the equipment to uneven support, dirt, water, mechanical shock and temperature extremes. Ohmeda suction equipment has
not been tested to comply with the specific requirements of these categories.
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1
Definitions
WARNING
= possible injury to patient or operator
CAUTION
= possible damage to equipment
Note
= Provides additional information to clarify a point in the text.
Important
= Similar to a note but of greater emphasis
= Attention. Alerts you to a warning or caution in the text.
High Flow
Low Vacuum
= high flow, low vacuum
I (On)
= on
O (Off)
= off
=
European Union Representative
Operation
1
Figure 1
Thoracic Vacuum Regulator
c Mode Selector Switch
d Vacuum Gauge
e Suction Control Knob
f Probe/Adapter Port
g Inlet Fitting
c
f
O
a
-kP
CS.18.029, CS.04.005
d
- cm
H2
e
g
2
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Operation
Equipment Setup
Insert the probe into the vacuum wall outlet. If the regulator is mounted elsewhere,
connect a vacuum supply hose between the regulator’s probe adapter and the wall
outlet.
WARNING
Connection to pressure sources, even momentarily,
could injure the patient or operator and damage the
equipment.
Use hospital-supplied suction tubing between the end piece and the collection
container, and between the patient port and the patient (minimum inside diameter is 6
mm [0.25 in.]).
An Ohmeda High Flow Suction Filter should be used between the collection container
and regulator to prevent contamination of the regulator.
ISO 10079-3 (BS 7259: Part 2, section 5.1.2) states that “the usable volume of the
collection container shall not be less than 500 ml.”
Suction Filters
Carton of 20
6730-0350-800
Carton of 200
6730-0351-800
Attaching the Safety Trap
CAUTION
To help prevent aspirate from entering the regulator as a result of
misuse, an Overflow Safety Trap should be attached prior to its
use. Aspirate in the regulator may impair its operation. The use of
the Overflow Safety Trap and suction filter will help prevent this
and extend the life of suction equipment.
Figure 2
Trap fitting
c
1. Raise the sleeve and insert
the trap into the regulator fitting.
2. Turn the trap clockwise about
one and a half turns to engage
the threads. The trap does not
need to be screwed tight; an
O-ring in the regulator fitting
provides a vacuum seal. The
trap should rotate freely to allow
the desired tubing positioning.
3. Lower sleeve to lock trap in position.
c Regulator
d Sleeve
3
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d
CS.20.031
2
3
Operation
Mode Selection
3
Figure 3
I (On)
I (On) - Suction can be
adjusted with the suction
control knob.
O (Off) - No suction is
supplied to the patient.
CS.18.030
O (Off)
WARNING
A positive pressure relief valve in the Thoracic regulator will prevent pressure buildup in the system only if
the system is not clamped between the regulator and
patient.
Setting the suction level
4
Figure 4
I (On)
1. Turn the mode selector
switch to I (on).
5
Figure 5
2. Occlude or clamp tubing
c
CS.20.008
c Clamp
4
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Operation
6
Figure 6
CS.18.032
3. Rotate the suction control knob
until the vacuum gauge indicates
the required setting.
WARNING
The regulator must be occluded when setting the
prescribed suction level so that the patient does not
receive higher than required suction.
Pre-Use Checkout Procedure
WARNING
The Pre-Use Checkout Procedure must be performed
before using the equipment on each patient. If the
regulator fails any part of the Pre-Use Checkout Procedure, it must be removed from service and repaired
by qualified service personnel.
All tests must be performed with supply vacuum of 40 kPa (-300 mm Hg) minimum.
1. Turn the mode selector switch to O (Off).
Rotate the suction control knob one full turn clockwise (increase).
Clamp tubing to occlude the fitting port. The gauge needle should not move.
2. Turn the mode selector switch to I (On).
Rotate the suction control knob fully anti-clockwise (decrease).
Clamp tubing. The gauge needle should not move.
3. Clamp tubing and increase the suction to 35 cm H2O
Slowly open and close the clamped tubing to create various flow rates through the
regulator. Check that the suction level is maintained when the tubing is clamped.
Rotate the suction control knob fully clockwise (increase) to check that the
relief valve activates between -50 to -60 cm H2O. When the relief valve opens a
“venting” sound will be produce.
Reduce the suction to zero and set the mode selector switch to O (Off).
5
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Operation
Patient Setup
1. Make sure the Pre-Use Checkout Procedure has been performed.
7
Figure 7
Setup with reusable
collection system
2. Turn the mode selector
switch to I (On) and
clamp tubing.
c Clamp
CS.18.033
c
6
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Operation
8
Figure 8
I
Setup with disposable
collection system
O
a
-kP
- cm
3. Turn the mode selector
switch to I (On), clamp
tubing and occlude vent
on disposable
collection system.
H2
c
c Clamp
d Occlude vent
CS.04.045
d
WARNING
When using a disposable collection system, the atmospheric vent at the top of the suction control chamber
must be occluded for proper suction regulation with
the Thoracic regulator.
Important: Once the atmospheric vent is occluded, the Thoracic regulator controls
vacuum level regardless of the presence or amount of water in the suction control
chamber.
4. Set the prescribed suction level.
WARNING The regulator must be occluded when setting the
prescribed suction level so that the patient does not
receive higher than required suction.
Important: Subtract 2 cm water seal amount from the level set on the regulator
gauge to determine the total suction level applied to the patient.
WARNING Continuing to rotate the suction control knob past the
point where the relief valve opens may result in suction levels higher than the preset relief pressure.
5. Turn the mode selector switch to O (Off).
7
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Operation
6. Attach tubing to the vacuum port of the collection container.
7. Connect the regulator to a reusable water seal or a disposable system with a
water seal.
WARNING A water seal must be used with the thoracic regulator
to prevent air from entering the pleural cavity, and to
indicate the presence of air leaks in the lungs and/or
the collection system.
8. With reusable collection systems, connect the water seal to the vacuum port of
the collection container.
9. Attach the patient tubing to the patient port of the collection container.
10. Turn the mode selector switch to I (on).
11. Clamp the patient tubing.
After a brief period the bubbling in the water seal should stop.
WARNING With the patient tubing occluded, all the bubbling in
the water seal should stop. If bubbling does not stop,
check all connections to eliminate leaks.
12.
Release the clamp on the patient tubing.
WARNINGS When a leak free collection system connected to a
patient is turned on, and after initial air in the system
is eliminated, only patient air will produce bubbles in
the water seal.
Do not clamp the tubing between the patient and the
collection bottle; a pressure build up in the catheter
and tubing will result.
Cleaning
Cleaning the regulator is recommended as a standard procedure after each use.
Wipe all exterior surfaces with a solution of water and mild detergent.
Should misuse occur resulting in accidental flooding of the regulator, the regulator
may be sterilized using ethylene oxide (ETO). See section 5 of the regulator service
manual. After sterilization follow the service checkout procedures in section 8 of the
regulator service manual.
WARNINGS After patient use, regulators may be contaminated.
Handle in accordance with your hospital’s infection
control policy.
Clean and sterilize all suction equipment before shipment to ensure transportation personnel and service
personnel are not exposed to any hazardous contamination.
Following sterilization with ethylene oxide, parts
should be quarantined in a well ventilated area to
allow dissipation of residual ethylene oxide gas
absorbed by the material. Aerate parts for 8 hours at
54°C (130°F).
CAUTION
Do not steam autoclave or liquid sterilize the regulator. Severe
impairment to the operation of the regulator will result.
8
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Troubleshooting
If the regulator does not operate and you have performed the Pre-Use Checkout
Procedure, the following procedures may be used to attempt to correct the problem.
Problem
Possible Cause
Remedy
No suction
Mode selector is in the O (Off)
position or between positions
Switch to I (On)
Leak in system
Check lid is secure on
the collection container
Check tubing connections
Check tubing and replace
if necessary
Regulator
makes loud
“venting”
sound
Atmospheric vent open
(disposable only)
Occlude vent
Suction control knob
at full decrease
Rotate the suction
control knob in the
increase direction
(clockwise)
Limit of negative
pressure relief valve
is reached
Clamp patient tubing
and rotate suction control
knob in the decrease
direction (anti-clockwise)
Important: If the above actions do not correct the problems or other problems exist,
refer servicing to qualified service personnel.
9
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Warranty
This Product is sold by Ohio Medical under the warranties set forth in the following
paragraphs. Such warranties are extended only with respect to the purchase of this
Product directly from Ohio Medical or Ohio Medical’s Authorized Dealers as new
merchandise and are extended to the first Buyer thereof, other than for purpose of
resale.
For a period of thirty-six (36) months from the date of original delivery to Buyer or
to Buyer’s order, but in no event for a period of more than two years from the date of
original delivery by Ohio Medical to an Ohio Medical Authorized Dealer, this Product,
other than its expendable parts, is warranted to be free from functional defects
in materials and workmanship and to conform to the description of the Product
contained in this operation manual and accompanying labels and/or inserts, provided
that the same is properly operated under conditions of normal use, that regular
periodic maintenance and service is performed and that replacements and repairs
are made in accordance with the instructions provided. This same warranty is made
for a period of thirty (30) days with respect to the expendable parts. The foregoing
warranties shall not apply if the Product has been repaired other than by Ohio Medical
or in accordance with written instructions provided by Ohio Medical, or altered by
anyone other than Ohio Medical, or if the Product has been subject to abuse, misuse,
negligence, or accident.
Ohio Medical’s sole and exclusive obligation and Buyer’s sole and exclusive remedy
under the above warranties is limited to repairing or replacing, free of charge, at
Ohio Medical’s option, a Product, which is telephonically reported to the nearest
Ohio Medical Regional Service Office and which, if so advised by Ohio Medical, is
thereafter returned with a statement of the observed deficiency, not later than seven
(7) days after the expiration date of the applicable warranty, to the designated Ohio
Medical Service Office during normal business hours, transportation charges prepaid,
and which, upon Ohio Medical’s examination, is found not to conform with the above
warranties. Ohio Medical shall not be otherwise liable for any damages including but
not limited to incidental damages, consequential damages, or special damages.
There are no express or implied warranties which extend beyond the warranties
hereinabove set forth. Ohio Medical makes no warranty of merchantability or fitness
for a particular purpose with respect to the product or parts thereof.
10
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TM
Ohio Medical Corporation
1111 Lakeside Drive
Gurnee, Il 60031 USA
P: 866 549 6446
P: +1 847 855 0800
F: +1 847 855 6218
www.ohiomedical.com
Ohio Medical Corporation
Authorized Representative
(OxygenCare Ltd.)
Corrig Road
Sandyford Industrial Est.
Dublin 8
Ireland
Phone +35 31 295 3421
North America
United States
Customer Service and
Distribution Center
Ohio Medical Corporation
1111 Lakeside Drive
Gurnee, IL 60031 USA
P: 866 549 6446
P: +1 847 855 0800
F: +1 847 855 6218
Technical Support
Ohio Medical Corporation
1111 Lakeside Drive
Gurnee, IL 60031 USA
P: 866 549 6446
P: +1 847 855 0800
F: +1 847 855 6218
Sales and Service
Ohio Medical Corporation
1111 Lakeside Drive
Gurnee, IL 60031 USA
P: 866 549 6446
P: +1 847 855 0800
F: +1 847 855 6218
Equipment Service Center
Ohio Medical Corporation1
111 Lakeside Drive
Gurnee, IL 60031 USA
P: 866 549 6446
P: +1 847 855 0800
F: +1 847 855 6218
IFU
6700 0373 000
12 01 05 Rev B
Printed in USA