Ohio Medical ISU, Pediatric ISU Intermittent Suction Unit Instructions for Use

Intermittent
Suction Unit (ISU)
Instructions for Use
400
300
500
60
70
600
700
50
40
80
20
90
10
100
- kP
0
0
a
-mm
(INTER)
0
(OFF)
(CONT)
200
High Flow 30
High Vacuum
Hg
100
Regulator Identification
Intermittent Suction Unit (ISU)
1
Figure 1
f Fitting Port
g Probe/Adapter Port
CS.20.030
c Vacuum Gauge
d Mode Selector Switch
e Suction Control Knob
400
300
500
60
70
c
600
50
40
20
90
700
10
0
d
100
100
- kP
0
200
High Flow 30
High Vacuum
80
a
-mm
Hg
(INTER)
0
(OFF)
g
(CONT)
f
e
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1
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.*
*
2
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.
6700-0370-000 RevC
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2
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.
MAX
= maximum
High Flow
High Vacuum
= high flow, high vacuum
High Flow
Low Vacuum
= high flow, low vacuum
IOIOI (INTER)
= intermittent; cycles on and off
I (Cont)
= on
O (Off)
= off
=
European Union Representative
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
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6700-0370-000 RevC
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.
05/08/06
3
Operation
Trap fitting
2
Figure 2
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
c
CS.20.031
d
DISS fitting
3
Figure 3
1. Insert trap into the regulator fitting. Situate the tubing in the desired position.
2. Turn the DISS wing nut clockwise to engage threads and tighten (there is no
O-ring, so the vacuum seal depends on a tight
connection).
c Regulator
d Wing nut
c
CS.20.032
d
4
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Operation
Mode Selection
4
Figure 4
Note: In this text, the international graphic symbol:
I
O
I
O
I
will be written as IOIOI.
IOIOI - suction is intermittent (cycled “on” and “off”) and the suction level can
be adjusted with the suction control knob.
O - No suction is supplied to the patient.
I - Suction is continuous and can be adjusted with the suction control knob.
0
0
(INTER)
0
(OFF)
(CONT)
0
0
(INTER)
0
(OFF)
0
0
(INTER)
0
(OFF)
CS.02.035
(CONT)
(CONT)
Setting the suction level
5
Figure 5
CS.20.007
1. Turn the mode selector switch to I (Cont).
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Operation
6
Figure 6
(
2. Occlude or clamp tubing
)
c
CS.20.008
c Clamp
7
Figure 7
3. Rotate the suction control knob until the vacuum gauge
indicates the required setting.
0
0
(INTER)
0
(OFF)
CS.02.034
(CONT)
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
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6700-0370-000 RevC
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.
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Operation
All tests must be performed with supply vacuum of -67 kPa (-500 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 (Cont).
Rotate the suction control knob fully anti-clockwise (decrease).
Clamp tubing. The gauge needle should not move.
3. Clamp tubing.
REGULATOR
SETTING
Intermittent Suction
Unit (ISU)
Standard: increase the suction to -12 kPa (-90 mm Hg)
High: increase the suction to -40 kPa (-300 mm Hg)
Pediatric ISU
Low: increase the suction to -8 kPa (-60 mm Hg)
4. 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.
Pediatric ISU Only: Clamp tubing and rotate suction control knob fully clockwise
(increase) to verify that the suciton level does not exceed -21 kPa (-160 mm Hg)
to verify this is a limited unit.
5. Turn the mode selector knob to IOIOI.
6. Clamp tubing.
7. Check that the timing cycles are approximately 15 seconds on and 8 seconds off
by observing the gauge needle.
Note: The ISU starts in the off cycle.
Reduce the suction to zero and set the mode selector to O (off).
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Operation
Patient Setup
1. Make sure the Pre-Use Checkout Procedure has been performed.
8
Figure 8
2. Turn the mode selector switch to I (Cont) and clamp tubing.
c Clamp
400
300
500
60
50
40
200
High Flow 30
70
High Vacuum
600
20
80
90
700
10
100
100
a
- kP
0
0
Hg
-mm
(INTER)
0
(OFF)
(CONT)
c
Underwater Seal Line
2 cm H2O
CS.20.033
Made in USA
3. 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.
4. Turn the mode selector switch to O (Off).
5. Attach tubing to the vacuum port of the collection container.
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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 CAUTION
Clean and sterilize all suction equipment before shipment to ensure transportation personnel and service
personnel are not exposed to any hazardous contamination.
After patient use, regulators may be contaminated.
Handle in accordance with your hospital’s infection
control policy.
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).
Do not steam autoclave or liquid sterilize the regulator. Severe
impairment to the operation of the regulator will result.
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)or
between positions
Switch to I (Cont) or
IOIOI (INTER) position
Leak in system
Check lid is secure on the
collection container
Check tubing connections
No suction
Suction control knob
at full decrease
Rotate the suction control
knob in the increase
direction (clockwise)
In the off cycle of
the IOIOI mode
In the IOIOI mode the
regulator starts in the off
cycle. Wait at least 20
seconds to determine if the
regulator is functioning.
Important: If the above actions do not correct the problems or other problems exist,
refer servicing to qualified service personnel.
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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 sixty (60) 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.
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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 0370 000
05 08 06 Rev C
Printed in USA
Addendum, Instructions for Use, Intermittent Suction Unit
6700-0370-000
05/99
Additions for Pediatric ISU:
Definitions:
High Flow
Low Vacuum
= high flow, low vacuum
Pre-Use Checkout Procedure:
All tests must be performed with supply vacuum of -67 kPa (-500 mm Hg) minimum.
3…
REGULATOR SETTING
Pediatric ISU Low: increase the suction to -8 kPa (-60 mm Hg)
Pediatric ISU Only: Clamp tubing and rotate suction control knob fully clockwise
(increase) to verify that the suction level does not exceed -21 kPa (-160 mm Hg) to verify
this is a limited unit.
6700-0401-000
01/2006
1