Ohio Vacuum Regulator Service manual
6700-0078-000 Rev1 06/2009
Continuous Vacuum
Regulators
Service Manual
E
D
M
100
80
120
-mmHg
60
W
O
40
L
20
F
140
H
I
G
H
160
180
200
U
C
L
A
V
L
600
400
500
50
60
70
High Flow
High Vacuum
80
90
100
700
300
40
200
30
20
100
10
a
P
k
-
g
H
m
m
-
6700-0078-000 Rev1 06/2009
User Responsibility
This Product will perform in conformity with the description thereof contained in this 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
malfunctioning Product should not be used. Parts that
are broken, missing, plainly worn, destroyed or contaminated, should be replaced immediately. Should such
repair or replacement become necessary, Ohio Medical
recommends that a telephonic or written request for service advice be made to the nearest Ohio Medical Service
Office. This Product or any of its parts should not be
repaired other than in accordance with written instructions provided by Ohio Medical, or altered without the
prior written approval of Ohio Medical’s Safety
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 alterations by anyone other than Ohio Medical
Corporation.
Important: Federal law in the U.S.A. and Canada
restricts this device to sale by or on the order of a
licensed medical practitioner. This device is to be used
only by persons who have been adequately instructed in
its use.
Important: This document is not to be reproduced in any
manner, nor are the contents herein to be disclosed to
anyone without the express authorization of Ohio
Medical Corporation.
The procedures described in this service manual should
be performed by competent individuals who have a general knowledge of and experience with devices of this
nature. No repairs should ever be undertaken or attempted by anyone not having such qualifications.
Genuine replacement parts manufactured or sold by
Ohio Medical must be used for all repairs.
Read completely through each step in every procedure
before starting the procedure; any exceptions may result
in a failure to properly and safely complete the attempted procedure.
CCW Counterclockwise (Anti-clockwise)
MAX Full Line Vacuum
in Hg Inches of mercury
kPa Kilo pascals (kPa x 7.50 = mm Hg)
LPM Liters per minute
mm Hg Millimeters of mercury (mm Hg x .133 = kPa)
°C Degrees Celsius
°F Degrees Fahrenheit
N-m Newton-Meter (N-m x .737 = ft-lb)
ft-lb Foot-Pound Force (ft-lb x 1.356 = N-m)
oz Ounces
DISS Diameter Index Safety System
OES Oxequip Suction
NCG National Compressed Gases (Chemetron)
NPT National Pipe Thread (USA)
NPTF National Pipe Thread Female (USA)
MPTS Multi-Purpose Therapy Stand
gal Gallon
PTFE Teflon®
User Responsibility
User Responsibility
6700-0078-000 Rev1 06/2009
Table of Contents
1/Precautions
1.1 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
2/Scope
2.1 North American Vacuum Regulators. . . . . . . .2-1
2.2 International Vacuum Regulators . . . . . . . . . .2-2
3/Description and Specifications
3.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
3.2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . .3-2
4/Operation
4.1 Equipment Set-up . . . . . . . . . . . . . . . . . . . . .4-1
4.2 Attaching the Safety Trap . . . . . . . . . . . . . . .4-2
4.3 Mode Selection . . . . . . . . . . . . . . . . . . . . . . .4-3
4.4 Setting the Suction Level . . . . . . . . . . . . . . . .4-4
4.5 Pre-Use Checkout Procedure . . . . . . . . . . . .4-4
4.6 Patient Set-up . . . . . . . . . . . . . . . . . . . . . . . .4-7
5/Cleaning and Sterilization
5.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
5.1.1 Routine Exterior Cleaning . . . . . . . . . . .5-1
5.1.2 Internal Component Cleaning . . . . . . . .5-1
5.2 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
6/Troubleshooting
7/Service - Disassembly and Assembly
7.1 Service Tools and Equipment . . . . . . . . . . . .7-1
7.2 Continuous Vacuum Regulators (All Models)7-1
7.2.1 Disassembly . . . . . . . . . . . . . . . . . . . . .7-1
7.2.2 Assembly . . . . . . . . . . . . . . . . . . . . . . . .7-3
7.3 Suction Level Limit Setting - Low
Models ONLY . . . . . . . . . . . . . . . . . . . . . . . . .7-3
7.3.1 Low Vacuum Limiting Screws . . . . . . . .7-3
7.3.2 Vacuum Relief Valve Adjustment . . . . .7-4
7.4 Regulator Module . . . . . . . . . . . . . . . . . . . . . .7-4
7.4.1 Disassembly . . . . . . . . . . . . . . . . . . . . .7-4
7.4.2 Assembly . . . . . . . . . . . . . . . . . . . . . . . .7-5
8/Service Checkout Procedure
8.1 Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
8.2 Flow Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
8.3 Gauge Test . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
8.3.1 High Vacuum Gauges ONLY . . . . . . . .8-2
8.3.2 Standard and Low Vacuum
Gauges ONLY . . . . . . . . . . . . . . . . . . .8-2
8.4 Regulation Test . . . . . . . . . . . . . . . . . . . . . . .8-2
8.5 Low Vacuum Regulators ONLY . . . . . . . . . . .8-2
8.6 Bleed Test . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
8.7 Leak Test - Supply Side . . . . . . . . . . . . . . . . .8-3
8.8 Leak Test - Patient Side . . . . . . . . . . . . . . . . . . .8-4
9/Maintenance
9.1 General Maintenance of Suction Equipment .9-1
9.2 Recommended Maintenance Schedule . . . . .9-1
9.2.1 Maintenance Schedule . . . . . . . . . . . . . . . . . .9-1
9.3 Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . .9-2
9.4 Technical Assistance . . . . . . . . . . . . . . . . . . .9-2
9.5 Return Instructions . . . . . . . . . . . . . . . . . . . . .9-2
10/Ordering Information
10.1 Illustrated Parts . . . . . . . . . . . . . . . . . . . . . .10-1
10.2 Service Kits . . . . . . . . . . . . . . . . . . . . . . . . .10-2
10.3 Fittings and Adapters . . . . . . . . . . . . . . . . . .10-2
10.4 International . . . . . . . . . . . . . . . . . . . . . . . . .10-3
10.4.1 Regulator Options . . . . . . . . . . . . . . .10-3
10.4.2 Other Options . . . . . . . . . . . . . . . . . .10-4
Appendix
Installation procedure for Adapters/Probes and Fittings.
A-1
6700-0078-000 Rev1 06/2009
1/Precautions
1.1 Definitions
Note: A Note provides additional information to clarify a point in the text.
Important: An Important statement is similar to a note but of greater emphasis.
CAUTION: A CAUTION statement is used when the possibility of damage to the equipment exists.
WARNING: AWARNING statement is used when the possibility of injury to the patient or the operator
exists.
= 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
I (On) = on
O (Off) = off
= European Union Representative
1.2 Warnings
The Pre-Use Checkout Procedure must be performed
before using this 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.
Connect the Vacuum Regulator to the vacuum source
only. Connection to pressure sources even momentarily
could injure the patient or operator and damage the
equipment.
Always connect the regulator to the vacuum source and
check its operation before attaching the patient connection.
The fitting port of the regulator must be occluded when
setting the prescribed suction level. This prevents the
patient from receiving higher than required suction levels.
Do not use this device in the presence of flammable
anesthetics. Static charges may not dissipate and a possible explosion hazard exists in the presents of these
agents.
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 or service to ensure transportation personnel
and/or service personnel are not exposed to any hazardous contamination.
Clean and sterilize all suction equipment if contaminated
before disassembly, to ensure service personnel are not
exposed to 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 130oF (54oC).
If the Vacuum Regulator is repaired or disassembled in
any manner, the Service Checkout Procedure must be
performed before using the equipment on the patient.
The Low Vacuum Limit Setting Procedure must be followed when repairing Low Vacuum Regulators. Failure
to do this may result in suction exceeding the prescribed
level.
1-1
6700-0078-000 Rev1 06/2009
Precautions/1
1.3 Cautions
Do not lubricate any internal components of the regulator
module.
Do not use any Loctite® products to seal the fitting and
adapter port threads (or products which contain
Methacrylate Ester as an active ingredient).
Only competent individuals trained in the repair of this
equipment should attempt to service it.
To help prevent aspirate from entering the regulator, as a
result of misuse, an Overflow Safety Trap and suction filter should be attached prior to its use. Aspirate in the regulator will impair the operation. The use of the Overflow
Safety Trap and suction filter will help prevent this and
extend the life of the suction equipment.
Use of lubricants other than recommended may degrade
plastic or rubber components.
Prior to placing the unit back into service after repair or
dissassembly , perform the Service Check-out Procedure.
Not for Field or Transport use**
®Loctite is a registered trademark of the Loctite Corp.
** The categories of Field and Transport Use are specifically defined in ISO
10079-3. "Field" means use at accidents or emergencies outside a hospital.
"Transport" means use in ambulances, cards and airplanes. These situations
may expose the equipment to uneven support, water, dirt mechanical shock and
temperature extremes. Ohio Medical suction equipment has not been tested to
comply with the specific requirements of these categories.
1-2
6700-0078-000 Rev1 06/2009
2/Scope
This service manual contains service, maintenance and parts information on all models of the Continuous Vacuum
Regulator.
North American
International
2.1 North American Vacuum Regulators.
Note: Part numbers given are for Vacuum Regulators without fittings or adapters.
2.2 International Vacuum Regulators
Important: International Vacuum regulators comply with the requirements of EN ISO 10079-3 and are CE marked.
Note: Part numbers given are for Vacuum Regulators without fittings or adapters.
Standard Three Mode
Continuous
0-200 mmHg-FULL VAC
Low Continuous
0-135 mmHg
High Three Mode
Continuous
0-760 mmHg
Standard Two Mode
Continuous
0-200 mmHg-FULL VAC
Two Mode High Continuous
CCW
0-760 mmHg/0-100 kPa
Two Mode Low Continuous
CCW
0-135 mmHg/0-18 kPa
Three Mode High Continuous
CCW
0-760 mmHg/0-100 kPa
2-1
D
E
E
D
M
100
80
120
-mmHg
60
W
O
40
L
20
140
H
I
G
H
160
180
200
F
U
C
L
A
V
L
M
100
H
mm Hg
I
G
120
H
140
160
80
Low Vacuum
60
W
O
40
L
20
400
60
70
High Vacuum
100
50
High Flow
300
40
200
30
20
100
10
a
P
k
-
g
H
m
m
-
500
600
80
90
700
400
60
70
High Vacuum
100
50
High Flow
300
40
200
30
20
100
10
a
P
k
-
g
H
m
m
-
500
600
80
90
700
100
80
120
16
140
18
20
Low Vacuum
14
High Flow
60
12
10
8
40
6
4
2
20
a
P
k
-
g
H
m
m
-
6700-0078-000 Rev1 06/2009
Description and Specification/3
3.1 Description
WARNING
Do not use this device in the presence of flammable anesthetics. Static
charges may not dissipate and a possible explosion hazard exists in the
presence of these agents.
The Continuous V acuum Regulator is a lightweight, compact unit used throughout the hospital primarily for pharyngeal/tracheal suctioning (airway management).
Various models provide regulated or full-line vacuum for
hospital suction procedures.
There are several models of the Continuous Vacuum
Regulators. All models contain a vacuum gauge which
indicates suction supplied by the regulator. Each has a
positive pressure safety relief valve to prevent pressurization by either failed injector vacuum (venturi) units or
inadvertent cross connection to pressurized gasses. In
addition, the Low Continuous models include a vacuum
relief valve to limit maximum suction.
Some models operate in a regulated or non-regulated
(MAX) mode. Others operate only in the regulated (limited) mode.
In the non-regulated (MAX) mode, the vacuum source is
connected directly to the fitting port. The regulator module is bypassed and full-line vacuum is provided.
In the regulated (limited) mode, the vacuum source is
connected through the regulator module which functions
as an automatic valve. Turning the suction control knob
adjusts the position of the regulator module and allows
selection of a predetermined level of suction when set
according to instructions.
During use, as the flow requirement increases, the valve
automatically opens to maintain suction at the preset
level. Conversely , when the flow requirement decreases,
the valve automatically closes to maintain suction at the
preset level. The same mechanism compensates for
changes in supply vacuum and automatically maintains
the pre-set suction level when set according to instructions.
1. Suction Control Knob - Allows easy adjustment of
suction to the patient.
2. Mode Selector Switch - Allows quick and easy mode
changes.
a. | (On) - Suction can be adjusted with the suction
control knob.
b. O (Off) - No suction is supplied to the patient.
c. MAX - Maximum full-line vacuum is supplied to
the patient.
3. Vacuum Gauge - The suction level to the patient is
displayed during use.
Mode
Selector
Switch
Front and Side View
Fitting Port
Adapter
Port
Suction
Control
Knob
Vacuum
Gauge
3-1
400
50
60
High Flow
High Vacuum
300
40
200
30
20
100
10
a
P
k
-
g
H
m
m
-
500
70
600
80
90
100
700
6700-0078-000 Rev1 06/2009
3/Description and Specifications
3.2 Specifications
Gauge: Accuracy: ±5% of full scale deflection
Flow Rate: 0 to 80 LPM without fittings at full increase setting depending on supply vacuum and open
air flow
Positive Pressure Safety Located in the vacuum supply line to prevent pressurization of the patient connection by
Relief Valve: failed injector vacuum (venturi) units, or inadvertent cross connection to pressurized
gases
Ranges: Gauge Range Regulated Suction
Standard Models 0 to 200 mm Hg/0 to 26 kPa 0 to 760 mm Hg/0 to 100 kPa
High Models 0 to 760 mm Hg/0 to 100 kPa 0 to 760 mm Hg/0 to 100 kPa
Low Models 0 to 160 mm Hg/0 to 21 kPa 0 to 135 mm Hg/0 to 18 kPa*
* When measured with an independent measuring device.
Vacuum Relief Valve 140 mm Hg ± 5 mm Hg/18.7 kPa ± 0.7 kPa
(Low Vacuum models ONLY):
Weight: 11 oz/312 grams
(Less fittings)
Weight
Low Vacuum models: 12 oz/340 grams
(Less fittings)
Dimensions: Height: 5.7 inches/145 mm
(Less fittings) Width: 3.0 inches/76 mm
Depth: 3.8 inches/96 mm
Latex tubing, 0.25 in (6.4 mm) I.D. X 0 to full vacuum
12 in (30 cm) supplied: Flow dependent on source and setup
Disposable tubing (Available 0 to full vacuum
separate in some markets; Flow dependent on source and setup
6 mm I.D. X 450 mm, 750 mm
and 2M) to connect regulator
and collection bottle
Disposable Suction Filter: 0 to full vacuum
0 to 100 Lpm @ 650 mmHg (-87 kPa)
Environmental Specifications
Operating Temperature Range: 40oF (4oC) to 120oF (49oC)
Storage Temperature Range: 0oF (-18oC) to 150oF (71oC)
Operating and Storage Relative Humidity: 5 to 95%
3-2
6700-0078-000 Rev1 06/2009
Operation/4
4.1 Equipment Set-up
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
Connect the vacuum regulator to the
vacuum source only and check its
operation before attaching the patient
connection. Connection to pressure
sources, even momentarily, could
injure the patient or operator and
damage the equipment.
Note: For proper installation of Adapters/Probes and
Fittings see Appendix.
Connect the collection bottle's vacuum port to the regu-
lator's fitting port or Overflow Safety Trap with the appropriate suction filter and vacuum tubing.
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.]).
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.”
An Ohio Medical High Flow Suction Filter should be
used between the collection container and regulator to
prevent contamination of the regulator. Hospital-supplied suction tubing must be used between the catheter
and the collection bottle. Recommended minimum
inside diameter is 0.25 in (6 mm).
Suction Filters - Hydrophilic
Pkg of 20 6730-0350-800
Pkg of 200 6730-0351-800
Suction Filters - Hydrophobic
Tubing x 1/8 NPT x
tubing nipple
tubing nipple
Pkg of 3 6730-0570-800 6730-0580-800
Pkg of 10 6730-0571-800 6730-0581-800
Pkg of 100 6730-0572-900 6730-0582-800
Vacuum
Regulator
Overflow
Safety Trap
Equipment Set-Up
Collection
Bottle
Connective Tubing
Patient Port
Vacuum Port
Disposable
Suction Filter
4-1
400
80
90
70
100
50
60
High Flow
High Vacuum
300
40
200
30
20
100
10
a
P
k
-
g
H
m
m
-
500
600
700
Underwater Seal Line 2 cm H2O
Made in USA
6700-0078-000 Rev1 06/2009
4/Operation
4.2 Attaching the Safety Trap
CAUTION
To help prevent aspirate from entering
the regulator, wall outlet and pipeline
system as a result of misuse, an
Overflow Safety Trap should be
attached prior to its use. Aspirate in the
regulator, wall outlet and pipeline system
may impair their operation. The use of
the Overflow Safety Trap and suction filter will help prevent this and extend the
life of suction equipment.
Standard fitting
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.
DISS fitting
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).
Sleeve
Wing nut
4-2
6700-0078-000 Rev1 06/2009
Operation/4
4.3 Mode Selection
| (On) - Suction can be adjusted with the suction control
knob.
O (Off) - No suction is supplied to the patient.
MAX - Maximum, full-line vacuum is supplied to the
patient.
Note: available on three mode vacuum regulators only.
2 - Mode Switch
3 - Mode Switch
I/(On)
2 - Mode Switch
3 - Mode Switch
O/(Off)
3 - Mode Switch
MAX
4-3
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