Ohio Continuous Vacuum Regulators User manual

Page 1
6700-0078-000 Rev1 06/2009
Continuous Vacuum Regulators
Service Manual
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
-
Page 2
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
Page 3
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
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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
Page 5
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
Page 6
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
-
Page 7
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
Page 8
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
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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
Page 10
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
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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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6700-0078-000 Rev1 06/2009
4/Operation
4.4 Setting the Suction Level
1. Turn the mode selector switch to I (On).
2. Occlude or clamp tubing
3. Rotate the suction control knob until the vacuum gauge indicates the required setting.
WARNING
The regulator fitting port or patient connector must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction.
4.5 Pre-Use Checkout Procedure
WARNINGS 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.
Connect the vacuum regulator to the vacuum source only and check it's operation before attaching the patient connection. Connection to pressure sources, even momentarily, could injure the patient or operator and damage the equipment.
All tests must be performed with supply vacuum of 380 mm Hg (51 kPa) minimum.
1. Turn the mode selector switch to O (Off). Rotate the suction control knob one full turn clock-
wise (increase). Clamp tubing to occlude the fitting port. The gauge
needle should not move.
Clamp
Clamp
4-4
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
Page 13
6700-0078-000 Rev1 06/2009
Operation/4
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.
Regulator Setting Standard & Low: increase the suction to 100 mm Hg
(13 kPa)
High: increase the suction to 300 mm Hg
(40 kPa)
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.
For Standard 2 Mode Continuous, go to step 5.
Clamp
Clamp
Release Clamp
4-5
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
Page 14
6700-0078-000 Rev1 06/2009
4/Operation
4a. High and Standard 3 Mode Continuous
Turn the mode selector to MAX. Clamp tubing and check that the gauge needle indicates the maximum available suction.
Turn the mode selector to I (On).
4b. Low Continuous
Clamp tubing and rotate knob fully clockwise (increase) to verify the suction level does not exceed 150 mm Hg (20 kPa).
Clamp
Clamp
4-6
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
100
80
120
60
12
14
10
16
140
8
18
40
6
20
4
2
20
a
P
k
-
m
High Flow
m
-
Low Vacuum
Page 15
6700-0078-000 Rev1 06/2009
Operation/4
5. Reduce the suction level to zero and set the mode selector switch to O (Off).
4.6 Patient Setup
1. Make sure the Pre-Use Checkout Procedure has been performed.
2. Turn the mode selector switch to I (On) and clamp tubing.
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.
Clamp
4-7
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
Underwater Seal Line 2 cm H2O
Made in USA
Page 16
6700-0078-000 Rev1 06/2009
4/Operation
4. Turn the mode selector switch to O (Off).
5. Attach tubing to the vacuum port of the collection container.
6. Turn the mode selector switch to I (On). Important: The Low models do not deliver suction in excess of 150 mm Hg (20 kPa).
Patient Connective Tubing
4-8
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
20
80
90
700
100
10
100
a
P
k
-
g
H
m
m
-
Underwater Seal Line 2 cm H2O
Made in USA
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
Underwater Seal Line 2 cm H2O
Made in USA
Page 17
6700-0078-000 Rev1 06/2009
Cleaning and Sterilization/5
5.1 Cleaning
WARNING After patient use, regulators may be
contaminated. Handle in accordance with your hospital’s infection control policy.
5.1.1 Routine Exterior Cleaning
Routine cleaning of the regulator is recommended as a standard procedure after each use.
Wipe all exterior surfaces with a solution of water and mild detergent.
5.1.2 Internal Component Cleaning
CAUTION Cleaning the gauge may result in damage.
The regulator requires cleaning if it becomes flooded with patient fluid as a result of misuse.
1. Refer to the Service - Disassembly and Assembly instructions.
2. All internal components, with the exception of the gauge, may be cleaned with a solution of warm water and mild detergent, preferably an enzymatic cleaner.
3. Dry all components with a lint free cloth before assembly.
5.2 Sterilization
Should misuse occur, resulting in accidental flooding of the regulator, the regulator may be sterilized using Ethylene Oxide (ETO). After sterilization, follow the serv­ice checkout procedures in Section 8.
WARNING
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).
CAUTION
Do not steam autoclave or liquid sterilize the Continuous Vacuum Regulator. Severe impairment to the operation of the regulator will result. The only accept­able method of sterilization is with gas (ethylene oxide).
CAUTION
Sterilization with ethylene oxide mix­tures may cause crazing (minute super­ficial cracking) of some plastic parts. Crazing will be more pronounced when mixtures containing Freon® are used.
Note: The Vacuum Regulator should only be sterilized if it is contaminated or maintenance is to be performed.
1. The regulator should be sterilized with the mode selector switch in the | (On) position.
2. The only acceptable method of sterilization is with ethylene oxide. Ethylene oxide mixtures can be used at temperatures of 125 to 135 °F (52 - 57 °C). If this temperature cannot be obtained, room temperature sterilization with 100% ethylene oxide can also be used. Sterilization is not recommended as a stan­dard procedure after each use.
3. After each sterilization, check the condition of the internal filter. If the filter appears to have shrunk, replace it before placing the regulator back in serv­ice.
4. Adequately aerate the regulator prior to disassembly, shipment or use. Aerate parts prior to reassembly.
®Freon is a registered trademark of the DuPont Company.
5-1
Page 18
6700-0078-000 Rev1 06/2009
6/Troubleshooting
Problem
A. No gauge indication and no suc-
tion in any setting
B. No gauge indication but suction
is being delivered
C. Gauge indication but no suction
is being delivered
D. Suction level cannot be adjusted
E. Insufficient flow through regula-
tor
Possible Causes
1. No supply vacuum
2. Kinked tube
3. Poor connection
4. Blocked adapter port
5. Blocked backplate
6. Blocked adapter
7. Blocked wall outlet
1. Blocked gauge pressure sensing orifice
2. Gauge mechanism locked by debris
3. Gauge mechanism damaged
1. Blocked fitting port
2. Overflow Safety Trap shut-off
3. Blocked external filter
4. Blocked fitting
1. Mode selector switch in MAX position
2. Regulator module small o-ring failure
3. Regulator module diaphragm rupture
4. Regulator module stem screw loose
1. Partial blockage in wall supply
2. Partial blockage in regulator
Remedy
1. Correct supply problems
2. Straighten tube
3. Check all connections and seals
4. Unblock port
5. Clean with soap and water and pipe cleaner
6. Replace adapter
7. Unblock outlet
1. Clean or replace gauge
2. Clean or replace gauge
3. Replace gauge
1. Clean port
2. Reset flow and/or empty trap
3. Replace filter
4. Clean fitting
1. Switch to I(On)
2. Replace rubber components with regulator module replacement kit
3. Replace rubber components with regulator module replacement kit
4. Tighten stem screw
1a. Confirm wall supply open air flow
meets minimum hospital require­ments
1b. Unblock if necessary 2a. Perform the Flow Test in the
Service Checkout Procedure Section of this manual
2b. Clear blockage if necessary
6-1
Page 19
6700-0078-000 Rev1 06/2009
Troubleshooting/6
Problem
F. Inaccurate gauge reading
Note: All gauge needles should come to rest within the zero range bracket or return to the stop pin when no suction is being supplied.
G. With the fitting port occluded,
unable to decrease the suction level and gauge needle does not return to zero when switched to O (Off)
H. No suction in any setting and
whistling noise from inside the regulator
Possible Causes
1. Damaged gauge
1. Blocked filter and/or orifice
2. Damaged gauge
1. Positive pressure safety relief valve failure
2. Vacuum relief valve failure (low models ONLY)
Remedy
1. Replace gauge
1. Clear orifice and replace filter
2. Replace gauge
1. Replace positive pressure safe­ty relief valve
2. Replace o-ring and ensure that the steel ball is present and clean
6-2
Page 20
6700-0078-000 Rev1 06/2009
7/Service - Disassembly and Assembly
7.1 Service Tools and Equipment
CAUTION
Use of lubricants other than recom­mended may degrade plastic or rubber components.
The following items should be on hand during any serv­ice procedure.
Supply vacuum: 500 mm Hg/ ± 10 mmHg (67 kPa ±
1.3 kPa) & 50 LPM open air flow minimum
Supply Vacuum Regulator with Gauge, 760 mm Hg (101.3 kPa) Full Scale.
Low Vacuum Calibration Gauge, 225 mm Hg (30 kPa) Full Scale* (Ohio Medical P/N 6700-0353-800)
High Vacuum Calibration Gauge, 760 mm Hg (101.3 kPa) Full Scale*(Ohio Medical P/N 6700-0352-800)
50 LPM Flowmeter (Ohio Medical P/N 6700-0355-
800)
Hexagonal Allen Wrench 3/32 inch
Phillips Head Screwdriver, No. 2
Flat Head Screwdriver, 1/4 inch
Pliers
Dow® 111 Grease (Ohio Medical P/N 6700-0074-
200)
Loctite® 242 Removable Thread Locker (Ohio Medical P/N 0220-5016-300)
Tubing Clamp
Bubble Leak Tester
Tweezers (Filter Remover)
Wooden Tooth Pick (O-ring Remover)
Pipe Cleaner
(*) Accuracy: ±1% of full scale deflection ®Dow is a registered trademark of the Dow Chemical Corporation
7.2 Continuous Vacuum Regulators (All Models)
7.2.1 Disassembly
WARNINGS If the Vacuum Regulator is repaired
or disassembled in any manner, the Service Checkout Procedure must be performed before using the equip­ment on a patient.
Clean and sterilize all suction equip­ment if contaminated before disas­sembly, to ensure service personnel are not exposed to hazardous con­tamination.
When servicing a Low Vacuum Regulator, perform the Vacuum Relief Valve Adjustment and Low Vacuum Limit Setting Procedure.
CAUTION
The gauge assembly must be handled with utmost care to retain its precision. If the lens is removed, do not rest the gauge on its face.
7-1
Page 21
6700-0078-000 Rev1 06/2009
Service - Disassembly and Assembly/7
1. Cover Screw (4)
2. Cover Assembly
3. Low Vacuum Limiting Screws (2) (Not Shown) (On old versions of the Low Models Only)
1. Mode Selector Switch
2. Switch Plate
3. Screw
4. O-ring, Vacuum Relief Valve
(Low Models Only)
5. Vacuum Relief Valve & O-ring
(Low Models Only)
6. Gauge Assembly (includes gauge, o-rings, and lens)
7. Lens
8. O-ring (2), Gauge
9. Regulator Module
10. Positive Pressure Safety Relief Valve
11. Filter (Internal)
12. Base
13. O-ring, Stem
14. O-ring, Regulator Module
1. Remove the four cover screws from the back of the reg­ulator.
2. Carefully pull the cover assembly off the back body.
3. To remove the gauge assembly, grasp the assembly and pull straight out. The snap-fit lens can also be removed (if applicable) for replacement.
4. To remove the regulator module from the cover assem­bly , rotate the suction control knob counterclockwise until the regulator module is free.
5. Using tweezers, remove the filter. Replace with a new fil­ter.
6. Grasp the positive pressure safety relief valve, and pull it from the back body.
7. Remove the mounting screw from the switch plate assembly and remove the switch plate and mode switch.
8. Low models ONLY: Grasp the vacuum relief valve and pull it from the back body.
Pull down plastic tab with right index finger while holding gauge
Snap Fit Lens Removal
7-2
1
2
1
12
11
1
14
13
9
3
4
8
5
6
7
3
2
Page 22
6700-0078-000 Rev1 06/2009
7/Service - Disassembly and Assembly
7.2.2 Assembly
CAUTION To prevent stripping the plastic threads,
place the screw in the hole and turn counterclockwise until it drops into the original thread. Tighten screw.
1. Place the positive pressure safety relief valve in posi­tion and push onto the back body.
2. Low models ONLY: Lubricate the vacuum relief valve O-ring and install it in the valve housing.
3. Lubricate the switch gasket surface with a thin coat­ing of Dow 111 Grease. Place the mode switch on the base with the arrow at 12 o’clock. Place the switch plate onto the switch so that the OFF/O is under the arrow. Install and tighten the mounting screw. Test the mode switch at all positions.
4. Place the internal filter into the proper cavity and push until it hits the bottom of the base.
5. Place the regulator module into the cover with the screw thread facing the knob. Align the protruding ears at 3 and 9 o’clock and rotate the suction control knob clockwise until the threads engage.
6. Install the snap-fit lens by placing one of the retain­ing tabs over the edge of the gauge face, and then pressing lightly until the other tab snaps onto the gauge face. Rotate the lens to confirm proper instal­lation.
7. Install the gauge assembly by lubricating the gauge o-rings with a thin coating of Dow 111 Grease and pushing the gauge into the base mount. Ensure that the gauge is properly aligned.
8. Place the cover assembly onto the base and push together until the base and back of the cover are flush.
9. Install the 4 cover screws.
7.3Suction Level Limit Setting-Low Models ONLY
WARNING
This 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.
The design of the low continuous vacuum regulator has been changed to eliminate the low vacuum limiting set screws located inside the cover behind the suction con­trol knob. The vacuum relief valve has also been changed to limit the vacuum to the same level as the set screws did. This new vacuum relief valve has four vent holes; the old valve had two. If a new cover is used, a new vacuum relief valve must be used.
Versions with limiting screws have two means of limiting the suction level:
1. Low vacuum limiting screws in the cover; these can be set at 140 mmHg/19 kPa (± 10 mmHg/1.0 kPa).
2. Vacuum relief valve; this can be set at 165 mmHg ± 15 mmHg (22 kPa ± 2 kPa).
These vacuum limit settings may be reduced to accommodate user requirements. If the vacuum limit settings are reduced, the vacuum relief valve must be set 25 mmHg ± 15 mmHg (3 kPa ± 2 kPa) higher than the vacuum limiting screws.
Versions without the limiting screws use only the relief valve to limit the suction level. The relief valve can be set at 140 mmHg ± 5 mmHg (18.7 kPa ± 0.7 kPa).
7-3
Page 23
6700-0078-000 Rev1 06/2009
Service - Disassembly and Assembly/7
7.3.1 Low Vacuum Limiting Screws
CAUTION
When adjusting the vacuum limiting
screws, be sure to adjust them to an equal height.
CAUTION
Remove the “Increase” label careful-
ly. Press firmly in place when replacing.
1. Remove the “Increase” label and place it aside. Be careful not to damage the face or glued back of the label.
2. Adjust the two vacuum limiting screws located behind the suction control knob until they are the same height in the case. Use a 3/32” hexagonal allen wrench.
3. Connect the vacuum supply to the adapter port and occlude the fitting port.
4. Be certain that the screws remain at an equal height by adjusting both low vacuum limiting screws the same amount and in the same direction. Adjust the screws to supply a maximum vacuum of 150 mm Hg (20 kPa) and not less than 130 mm Hg (17 kPa).
7.3.2 Vacuum Relief Valve Adjustment
1. Remove the cover.
2. Connect the supply vacuum to the adapter port.
3. Turn the mode selector switch to I/ON.
4. Occlude the fitting port.
5. Slowly pull the regulator module away from the base. Note the suction level at which the relief valve opens. The relief valve should open at 165 mmHg ± 15 mmHg (22 kPa ± 2 kPa) on units with limiting setscrews and140 mmHg ± 5 mmHg (18.7 kPa ± 0.7 kPa) for units without limiting setscrews.
6. If adjustment is required, grip the vacuum relief valve firmly with pliers and rotate the screw about 1/8 turn with a screwdriver. Repeat the previous step and check the suction level at which the valve opens.
Note: Clockwise rotation will increase the suction level at which the relief valve opens. Counterclockwise rotation will decrease it.
WARNING
Excess Loctite® may seal the steel ball to the seat. This will disable the vacuum relief valve and may allow suction to exceed the preset limit.
CAUTION
When Loctite is used on the vacuum relief safety valve, ensure that it only contacts the metal parts. Loctite causes many plastic parts to deteriorate.
7. Lock the adjusting screw with a drop of removable thread locker such as Loctite 242. Repeat step 5 to veri­fy the vacuum relief valve setting.
® Loctite is a registered trademark of the Loctite Corporation.
Cover and Knob Assembly
Allen Wrench
Set Screws
Increase Label
Setting the Vacuum Limiting Screws
Vacuum Relief Valve
Valve Body
Steel Ball
O-Ring
Screw w/Magnet
Loctite 242
7-4
Page 24
6700-0078-000 Rev1 06/2009
7.4 Regulator Module
WARNING
If repairing or replacing a regulator module on a Low Vacuum Regulator, you must perform the Suction Level Limit Setting-Low Models ONLY Procedure. Failure to do this may result in suction exceeding the pre­scribed level.
CAUTION
Do not lubricate any internal compo­nents of the regulator module.
The cap screws can strip the regulator
module housing threads if they are screwed in too tight.
7.4.1 Disassembly
1. Remove the cap screws (2) and remove the cap.
2. Remove the o-rings (2).
3. Observe the position of the diaphragm convolution to aid in assembly.
4. Withdraw the diaphragm/stem assembly from the housing.
5. Remove the spring.
6. Grasp the stem with your fingers and unscrew the stem screw.
7. Remove the retainer, diaphragm and piston from the stem.
7/Service - Disassembly and Assembly
1. O-ring, Stem
2. O-ring
3. Housing
4. Stem
5. Spring
6. Piston
7. Diaphragm
8. Retainer
9. Stem Screw
10. Cap
11. Cap Screw
1
11
11
10
9
8
7
6
5
4
3
2
Regulator Module Parts and Descriptions
7-5
Page 25
6700-0078-000 Rev1 06/2009
Service - Disassembly and Assembly/7
7.4.2 Assembly
1. Return the diaphragm to its original position (convo­luted), with the molded number facing the retainer.
2. Assemble the diaphragm onto the retainer by lining up their center holes as shown in the diagram.
3. Insert the piston into the diaphragm and ensure that the retainer mates with the recess in the piston.
4. Insert the stem through the piston.
5. Holding the retainer/diaphragm/piston/stem as an assembly with your fingers, insert the stem screw and tighten.
6. Place the spring in the housing.
7. Insert the retainer/diaphragm/piston/stem assembly through the spring and into the cavity in the housing. Fit the diaphragm bead into the groove in the hous­ing.
8. Install the cap and the two cap screws.
9. Apply a small amount of Dow® 111 Grease to the o­rings only.
10. Install o-rings onto the stem and housing.
Diaphragm Assembly
Stem
Retainer
Set Screw
Diaphragm
Piston
7-6
Page 26
6700-0078-000 Rev1 06/2009
8/Service Checkout Procedure
WARNING
If the Vacuum Regulator is rep aired or disassembled in any manner, the Service Checkout Procedure must be performed before using the equip­ment on a patient.
Important: This entire Service Checkout Procedure
must be performed in numerical order.
8.1 Set-up
1. Verify that there is 500 mmHg ± 10 mmHg (67 kPa ±
1.3 kPa) vacuum on the supply gauge.
2. The supply open flow must be 50 LPM minimum.
3. Connect the supply vacuum to the adapter port.
8.2 Flow Test
1. Connect the regulator's fitting port to the flowmeter with tubing.
2. Rotate the suction control knob fully clockwise (increase).
3. Turn the mode selector switch to I (On) and verify that the flow rate exceeds 30 LPM.
4. Turn the mode selector switch to MAX (if available) and verify that the flow rate exceeds 30 LPM.
5. Turn the mode selector switch to O (Off).
6. Disconnect the flowmeter.
Mode Selector Switch
Supply Vacuum gauge 0-760 mmHg (0-101.3 kPa)
Supply Vacuum Reg. set to 500 mmHg +
10 mmHg
(64 kPa +
1.3 kPa)
Supply Vacuum 500 mmHg (67 kPa) Minimum and Open Flow of 50 LPM Minimum
Occluded
Low Vacuum Calibration Gauge 225 mmHg/30 kPa
High Vacuum Calibration Gauge 760 mmHg/101.3 kPa
Flowmeter 50 LPM
Service Checkout Tests
8-1
60
W
O
40
L
20
E
D
M
100
80
120
mmHg
140
H
I
G
H
160
180
200
F
U
C
L
A
L
V
Page 27
6700-0078-000 Rev1 06/2009
Service Check Out Procedure/8
8.3 Gauge Test
Note: All Ohio Medical gauges are supplied with an accu­racy of ±5% of full scale deflection throughout their range. The table below is provided for reference.
Gauge Range Tolerance
Standard 0-200 mmHg (0-26 kPa) ±10 mmHg (1.3 kPa)
Vacuum
Low 0-160 mmHg (0-20 kPa) ±8 mmHg (1.1 kPa)
Vacuum
High 0-760 mmHg (0-100 kPa) ±38 mmHg (5 kPa)
Vacuum
Note: All gauge needles should come to rest within the zero range bracket or return to the stop pin when no suc­tion is being supplied. Gauges which do not comply may be out of calibration.
When checking gauge accuracy , be sure that the calibra­tion gauge has an accuracy of 1% of full scale deflection or better.
8.3.1 High Vacuum Gauges ONLY
1. Connect the regulator's fitting port to the high calibra­tion gauge with tubing.
2. Turn the mode selector switch to I (On).
3. Assure that the gauge is in agreement with the high vacuum calibration gauge within the ±38 mmHg (5 kPa) tolerance. Recommended test points are 100, 300, and 500mm Hg.
8.3.2 Standard and Low Vacuum Gauges ONLY
1. Connect the regulator's fitting port to the low calibra­tion gauge with tubing.
2. Turn the mode selector switch to I (On).
3. Assure that the gauge is in agreement with the low vacuum calibration gauge within the ±10 mmHg (1.3 kPa) or the ±8 mmHg (1.1 kPa) tolerance for stan­dard and low gauges respectively. Recommended test points are 40, 80, and 140 mmHg.
4. For the Standard Gauge ONLY: Rotate the suction control knob fully clockwise (increase) and verify its reading is in the FULL VAC range.
8.4 Regulation Test
1. Disconnect the calibration gauge and occlude the fit­ting port.
2. If using a High Vacuum Regulator, set its gauge to 300 mmHg (40 kPa). If using a Low or Standard Vacuum Regulator, set its gauge to 100 mmHg/14 kPa.
3. Open and close the fitting port several times.
4. With the fitting port occluded, the gauge should return to the setting listed in step 2 within a tolerance of: ±38 mmHg (5 kPa) for high vacuum gauge
or ±10 mmHg (1.3 kPa) for the standard
vacuum gauges or ±8mmHg (1.1 kPa) for the low vacuum gauge.
8.5 Low Vacuum Regulators ONLY
1. Occlude the fitting port.
2. Rotate the suction control knob fully clockwise (increase).
3. Verify that the suction delivered does not exceed 150 mm Hg (20 kPa) or the maximum suction requested by the clinician.
Note: For setting the Suction level limit, refer to Suction Level Limit Setting-Low Models ONLY.
8.6 Bleed Test
1. Occlude the fitting port and set the vacuum level to 100 mm Hg (14 kPa).
2. Turn the selector switch to O (Off) and observe the gauge needle. It must return to the zero range brack­et or stop pin within 10 seconds.
8-2
Page 28
6700-0078-000 Rev1 06/2009
8/Service Checkout Procedure
8.7 Leak Test - Supply Side
1. Connect the supply vacuum tubing to port “A” of the Bubble Leak Tester.
2. Connect port “B” of the Bubble Leak Tester to the regulator adapter port.
3. Turn the mode selector switch to O (Off). Allow the fitting port to be open to air.
4. Wait 20 seconds. No More than 6 bubbles should appear in the next ten seconds. Important: Prior to venting port "A" of the Bubble Leak Tester to atmosphere (i.e. turning the supply regulator off),
ensure the tubing from port "B" has been disconnected from the adapter port of the vacuum regulator.
8.8 Leak Test - Patient Side
1. Connect the supply vacuum tubing to the regulator adapter port.
2. Connect the regulator fitting port to port “A” of the Bubble Leak Tester with tubing. Allow port “B” of the Bubble Leak Tester to be open to air.
3. Rotate the suction control knob a minimum of one full turn clockwise (increase). No bubbles should appear in the next ten seconds.
4. Rotate the suction control knob fully counterclockwise (decrease).
5. Turn the mode selector switch to I (On). No bubbles should appear in the next ten seconds.
Supply Vacuum Gauge 0-760 mmHg (0-101.3 kPa)
Bubble Leak Tester
1/4” I.D. Clear Tubing
Sealed
Port B
Port A
1.0 in.
Fitting port
Adapter Port
Vacuum Regulator
Supply Vacuum
Supply Regulator 500 mmHg (67 kPa)
Water
Bubble Leak Test - Supply Side
Mode Selector Switch
1.0 in.
Bubble Leak Tester
Water
1/4” I.D. Clear Tubing
Port B
Port A
Sealed
Suction Control Knob
Vacuum Regulator
Bubble Leak Test -Patient Side
8-3
E
D
M
100
80
120
mmHg
60
140
W
O
40
L
20
H
I
G
H
160
180
200
F
U
C
L
A
L
V
Page 29
6700-0078-000 Rev1 06/2009
Maintenance/9
WARNING
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.
WARNING
Clean and sterilize all suction equip­ment if contaminated before disas­sembly, to ensure service personnel are not exposed to hazardous con­tamination.
Continuous Vacuum Regulators should be kept in
use or used on a rotating basis. Unused equipment may tend to dete­riorate.
Maintenance of the vacuum piping system is as impor­tant as maintenance of the suction equipment. The use of Collection Bottles with reliable shut-off valves, Overflow Safety Trap assemblies and disposable suction filters will protect the regulator and piping system. The flow rate at the wall outlet should be checked on a year­ly basis and suitable cleaning of the outlets should be performed. The flow rate measurement should meet local standards.
Routine maintenance and inspection are important to the performance of suction equipment. The following is a recommended list for care of suction equipment after each patient use.
1. Perform a thorough cleaning by washing all bottles, tubing, metal connectors, etc, and removing all residue.
2. Wipe all exterior surfaces with a solution of water and mild detergent.
3. Perform a careful visual inspection.
4. Check that the High Flow Disposable Suction Filter is
clean and in good condition.
5. Check that all tubing is in good condition and con­nected securely to the correct ports.
6. Check the floats in the Overflow Safety Trap and Collection Bottle for correct operation.
7. Perform the Pre-Use Checkout Procedure.
9.2 Recommended Maintenance Schedule
In addition to the Pre-Use Checkout Procedure, the following periodic maintenance should be performed. 9 .2.1 Maintenance Schedule
Item Minimum Frequency Comments Service Checkout Every 12 months If the regulator does not pass the
Procedure Service Checkout Procedure, refer to the Troubleshooting section of this manual. Repair as necessary.
Elastometric As Required Cleaning and replacement interval Components,O-rings, will depend greatly on hours of usage and switch gasket, environmental conditions. Replace and reg. module diaphragm, repair as necessary. positive pressure safety valve) and Internal Filter
9-1
Page 30
6700-0078-000 Rev1 06/2009
9/Maintenance
9.3 Repair Policy
WARNING
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.
CAUTIONS Do not steam autoclave or liquid sterilize
the Continuous Vacuum Regulator. Severe impairment to the operation of the regulator will result. The only accept­able method of sterilization is with gas (ethylene oxide).
Only competent individuals trained in the
repair of this equipment should attempt to service it.
Do not use malfunctioning equipment. Make all neces­sary repairs. Have the equipment repaired by qualified service personnel or by Ohio Medical. Parts listed in the service manual for this product may be repaired or replaced by a competent, trained person who has expe­rience in repairing devices of this nature. After repair, per­form the Service Checkout Procedure to ensure that it is functioning properly, and complies with the published specifications.
9.4 Technical Assistance If technical assistance is required, contact Ohio Medical
technical support or field operations listed on the back cover.
9.5 Return Instructions
1. Call 866-549-6446 for a returned goods authoriza­tion.
2. Clean and sterilize the Vacuum Regulator.
3. Package the Vacuum Regulator securely for protec­tion; preferably in the original container.
4. Include a letter describing in detail any difficulties experienced with the Vacuum Regulator. Include the person, title, and telephone number to contact for functional questions.
5. Ohio Medical now offers a ten year warranty on vac­uum regulators sold on or after July 1, 2005. If the vacuum regulator was purchased on or after July 1, 2005 and is less than ten years old or if the vacuum regulator is covered under the previous warranty and is less than five years old, include the warranty infor­mation that came with the device and a copy of the invoice.
6. Include a purchase order to cover repair of a regula­tor not under warranty.
7. Ship the Vacuum Regulator prepaid. Write your return address and billing address information on the package or letter that comes with the package.
For all Repairs Contact your nearest Ohio Medical office or authorized Ohio Medical Distributor.
9-2
Page 31
6700-0078-000 Rev1 06/2009
Ordering Information/10
Description Part Number
1. Cover Screw (4) . . . . . . . . . . . . . . .6700-0152-400
2. Cover Assembly
Low* . . . . . . . . . . . . . . . . . . . . . . . .6700-0629-850
Std/High . . . . . . . . . . . . . . . . . . . . .6700-0628-850
3. Low Vacuum Limiting Screw (2) (Not Shown) (Low Models Only) . .6700-0058-400
* If current unit does not have limit screws inside the cover behind the control knob and the relief valve has 4 vent holes, the Std/High part can be purchased.
Description . . . . . . . . . . . . . . . . . . . . . . . .Part Number
1. Switch . . . . . . . . . . . . . . . . . . . . . . .6700-0078-500
2. Switch Plate
3 Mode . . . . . . . . . . . . . . . . . . . . . .6700-0193-500
2 Mode/Low . . . . . . . . . . . . . . . . . .6700-0194-500
3. Screw . . . . . . . . . . . . . . . . . . . . . . .6700-0152-400
4. O-ring, Vacuum Relief Valve
(Low Models Only) . . . . . . . . . . . . .6700-0135-500
5. Vacuum Relief Valve
& O-ring (Low Models Only) . . . . . .6700-0660-850
6. Gauge Assembly (Includes gauge, o-rings and lens) North American Standard,
0-200 mmHg . . . . . . . . . . . . . . . . . .6700-0050-206
North American Low, 0-160 mmHg 6700-0050-207 North American High, 0-760 mmHg6700-0050-208
International Low . . . . . . . . . . . . . .6700-0050-209
International High . . . . . . . . . . . . . .6700-0050-210
International Standard . . . . . . . . . . .6700-0050-211
7. Lens . . . . . . . . . . . . . . . . . . . . . . . .6700-0087-500
8. O-ring (2), Gauge . . . . . . . . . . . . . .6700-0130-500
10.1 Illustrated Parts
9. Regulator Module
Standard/High Models . . . . . . . . . .6700-1225-800
Low * . . . . . . . . . . . . . . . . . . . . . . . .6700-0428-800
10. Positive Pressure Safety Relief
Valve . . . . . . . . . . . . . . . . . . . . . . . .6700-0115-800
11. Filter (Internal) . . . . . . . . . . . . . . . .0206-5159-300
12. Base North American Standard & High
(2 & 3 Mode) . . . . . . . . . . . . . . . . . .6700-0018-203
North American Low . . . . . . . . . . . .6700-0029-203
International Low . . . . . . . . . . . . . .6700-0029-200
International Standard & High . . . .6700-0018-200
13. O-ring, Stem . . . . . . . . . . . . . . . . . .0210-0527-300
14. O-ring, Regulator Module . . . . . . . .6700-0136-500
* If current unit does not have limit screws inside the cover behind the control knob and the relief valve has 4 vent holes, the Std/High part can be purchased.
1
10
14
13
12
11
1
2
3
4
8
5
9
6
7
3
2
10-1
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6700-0078-000 Rev1 06/2009
10.2 Service Kits
Standard and High Models . . . . . . . . . .6700-0043-200
Includes the following parts: O-ring (2), Gauge Filter (Internal) Positive Pressure Safety Relief Valve Regulator Module Replacement Kit
Low Models . . . . . . . . . . . . . . . . . . . . . .6700-0044-200
Includes the following parts: O-ring (2), Gauge Filter (Internal) Positive Pressure Safety Relief Valve Regulator Module Replacement Kit O-ring, Vacuum Relief Valve Increase Label (Universal) Regulator Module
Replacement Kit . . . . . . . . . . . . . . . . . .6700-0030-700
Includes the following parts: O-ring, Stem These parts are available O-ring only in kit form. If other Diaphragm parts are needed for re­Stem Screw placement, the entire Cap Screw (3) Module must be ordered
(6700-1225-800).
O-rings and Filters Kit . . . . . . . . . . . . . .0221-5871-870
Includes the internal filter and 6 O-rings
Continuous Regulator Module (6) . . . . .6700-0028-700
Low Cont. Regulator Module (6)* . . . . .6700-0190-700
Regulator Module Replacement
Parts Kit (6) . . . . . . . . . . . . . . . . . . . . . .6700-0031-700
The following kits for U.S. regulators only
Standard Vacuum Gauge (4) . . . . . . . .0205-8689-871
High Vacuum Gauge (4) . . . . . . . . . . . .6700-0097-201
Low Vacuum Gauge (4) . . . . . . . . . . . .6700-0098-201
Standard & High Backplate (4) . . . . . . .6700-0194-700
Low Backplate (4) . . . . . . . . . . . . . . . . .6700-0198-700
* If current unit does not have limit screws inside the cover behind the control knob and the relief valve has 4 vent holes, the continuous regulator modules can be purchased.
10/Ordering Information
10.3 Fittings and Adapters
Description . . . . . . . . . . . . . . . . . . . . . . . .Part Number
1. Diamond Adapter . . . . . . . . . . . . . .0221-2685-802
2. NCG Adapter (Round) . . . . . . . . . .0221-0204-802
NCG Adapter (Rectangle) . . . . . . . .0221-0205-800
3. Schrader Adapter . . . . . . . . . . . . . .0221-0690-731
4. DISS Union Nut & Gland . . . . . . . .6700-0094-700
5. DISS Hand-I-Twist Nut & Gland . . .0204-6717-800
6. OES Adapter . . . . . . . . . . . . . . . . . .0221-0152-300
7. Puritan Adapter . . . . . . . . . . . . . . . .0221-0106-300
8. Medstar Adapter . . . . . . . . . . . . . . .0221-0163-300
9. 90° Tubing Nipple . . . . . . . . . . . . . .6700-0095-700
10. 45° Locking Gland . . . . . . . . . . . . .6700-0143-700
11. 45° Threaded Locking Gland . . . . .6700-0141-700
12. Tubing Nipple . . . . . . . . . . . . . . . . .0204-9020-535
13. Locking Gland . . . . . . . . . . . . . . . . .6700-0144-700
14. Threaded Locking Gland . . . . . . . .6700-0142-700
15. DISS Male . . . . . . . . . . . . . . . . . . .0204-7989-535
1
2
3
4 5
6
7
8
9
10 11 12 13 14 15
10-2
Page 33
6700-0078-000 Rev1 06/2009
Ordering Information/10
10.4 International
10.4.1 Regulator Options
Instructions: Select the vacuum regulator and fittings to form an 11-digit part number. (For yellow cover, replace 5700 with 4700)
Example: 5700-1229-901 = Three Mode High Continuous Regulator w/Tubing Nipple
5700-12XX-900 w/o Inlet Fittings
5700-12XX-901 w/Tubing Nipple
5700-12XX-902 w/Tubing Nipple, 12" Tubing, 1/2 gal. Bottle, Cap & Float Assembly and Wall Slide (Straight)
5700-12XX-904 w/Locking Gland
5700-12XX-905 w/Locking Gland and Overflow Safety Trap
5700-12XX-906 w/Locking Gland, Overflow Safety Trap, 12" Tubing, 1/2 gal. Bottle, Cap & Float Assembly and Wall Slide (Straight)
5700-12XX-911 w/Locking Gland, Overflow Safety Trap, 12"Tubing, 1/2 gal. Bottle, Cap & Float Assembly and Wall "V" Slide (International)
5700-12XX-912 w/Tubing Nipple, 12" Tubing, 1/2 gal. Bottle, Cap & Float Assembly and Wall "V" Slide (International)
0221-2685-802 Diamond
0204-6717-800 Hand-I-Twist
0221-0205-800 NCG (Rectangle)
0221-0204-802 NCG (Round)
0221-0106-300 Puritan
0221-0163-300 MedStar
0204-9020-535 Tubing Nipple
0221-0152-300 OES
0221-0690-731 Schrader
6700-0094-700 DISS Nut & Gland
6700-0095-700 90° Tubing Nipple
Regulators Inlet Fittings Probes 5700-12XX-9XX 5700-12XX-9XX 4700-12XX-9XX 4700-12XX-9XX
5700-1229-9XX Three Mode High Continuous (Anti-clockwise)
5700-1233-9XX Two Mode Low Continuous (Anti-clockwise)
5700-1230-9XX Two Mode High Continuous (Anti-clockwise0
10-3
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
100
80
120
60
12
14
10
16
140
8
18
40
6
20
4
2
20
a
P
k
-
g
H
m
High Flow
m
-
Low Vacuum
Page 34
6700-0078-000 Rev1 06/2009
10/Ordering Information
10.4.2 Other Options (International)
Instructions: Select the desired configuration and write down the first four and the last three digits of the part num-
ber. Select the vacuum regulator desired (below) and insert the middle four digits in the "XXXX" section of the selected 11-digit part number.
Example: 5711-1229-913 = Three Mode High Continuous Regulator with MPTS (Slide) Bracket and
Overflow Safety Trap
5700-1229-9XX Three Mode High Continuous (Anti-clockwise)
5700-1233-9XX Two Mode Low Continuous (Anti-clockwise)
5700-1230-9XX Two Mode High Continuous (Anti-clockwise0
Regulator 12XX Options for Additional Accessories
Regulator with 30
o
Fitting, Overflow Safety Trap
5711-XXXX-930
Regulator & MPTS (Slide) Bracket, Overflow Safety Trap
5711-XXXX-913
Regulator and Dovetail Bracket, Overflow Safety Trap
5711-XXXX-935
10-4
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
400
300
500
50
60
40
200
30
70
High Flow
High Vacuum
600
700
20
80
90
100
10
100
a
P
k
-
g
H
m
m
-
120
16
140
18
20
Low Vacuum
100
14
High Flow
80
60
12
10
8
40
6
4
2
20
a
P
k
-
g
H
m
m
-
Page 35
6700-0078-000 Rev1 06/2009
Appendix
Installation procedure for Adapters/Probes and Fittings.
All adapters/probes and fittings should be sealed and installed properly to prevent leaks and to support the equipment when mounted. Both vacuum regulator ports are 1/8-27 NPTF tapered pipe threads. It is important to note that adapters/probes and fittings seal on the thread and may have threads exposed after they have been tightened properly.
Prior to installing the adapter/probe or fitting, seal the thread with Teflon® (PTFE) tape or one of the following lubricants:
Dow® 111 (Ohio Medical P/N 6700-0074-200) Ball Vac Kote (37951M) (Ohio Medical P/N 0220-0091-
300)
CAUTION
Do not use any Loctite products to seal the threads (or products which contain Methacrylate Ester as an active ingredi­ent).
The torque range for installing adapters/probes and fit­tings is 4.0 ft-lb (5.4 N-m) minimum to 10.0 ft-lb (13.6 N­m) maximum.
Adapters/probes and fittings which are not keyed for specific orientation, should be torqued to approximately
6.0 ft-lb (8.1 N-m). Adapters/probes and fittings that are keyed to specific
orientation, must be torqued initially to 4.0 ft-lbs. Additional torque is applied only until orientation is cor­rect.
®Teflon is a registered trademark of the DuPoint Company.
A-1
Page 36
6700-0078-000 Rev1 06/2009
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 Technical Support Sales and Service Equipment Service Center
Ohio Medical Corporation 1111 Lakeside Drive Gurnee, Il, 60031-4099 USA Toll free: 866-549-6446 Phone: +1 847-855-0800
Fax: +1 847-855-6218
www.ohiomedical.com
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