Ohio Medical Push-To-Set PTS-ISU User manual

Push-To-SetTM Intermittent
Suction Unit (PTS-ISU)
Service Manual
High Flow
High Vacuum
10
20
30
40
50
60
70
80
90
100
100
200
300
400
500
600
700
-
k
P
a
-
m
m
H
g
L
L
M
M
H
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F
F
MEDICAL VACUUM
ANSI
PTS-ISU - Analog
ANSI/ISO
PTS-ISU - Analog
ISO
PTS-ISU - Analog
8700-0001-000, Rev4 (11/2010)

8700-0001-000 Rev4
User Responsibility
IMPORTANT: Federal law in the U.S.A. and Canada
restricts this device for sale by or on the order of a
license medical practitioner.
WARNING: This device is to be used only by
persons who have been adequately instructed
in its use.
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.
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, see the
Ohio Medical service manual for service or repairs
to this product. For service advice, Ohio Medical
recommends that a telephone request 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 or 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.
The procedures described in this service manual
should be performed by trained and authorized
personnel only. Maintenance should only be
undertaken 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.
Technical Competence
This alpha character indicates the year of product manufacture
and when the serial number was assigned; “L” = 2007, “M” =
2008, “N” = 2009, etc. “I” and “O” are not used.
Product Date Coding:
AAAA 12345

8700-0001-000 Rev4
Table of Contents
1/ Definitions and Abbreviations
1.1 Definitions............................................................1
1.2 Abbreviations.......................................................1
2/ Scope
2.1 ANSI Vacuum Regulator......................................2
2.2 ISO Vacuum Regulator........................................2
3/ Description and Specifications
3.1 Description...........................................................2
3.2 Specifications ......................................................3
4/ Operation
4.1 Equipment Setup.................................................4
4.1.1 Attaching the OST ......................................4
4.2 Mode Selection....................................................5
4.3 Setting the Suction Level.....................................5
4.4 Pre-Use Checkout Procedure..............................5
4.5 Patient Setup.......................................................6
5/ Cleaning and Sterilization
5.1 Cleaning ..............................................................6
5.1.1 Routine Exterior Cleaning...........................6
5.1.1.1 Approved Cleaning Solutions .........6
5.1.2 Internal Component Cleaning.....................7
5.1.2.1 Approved Flush Solutions...............7
5.1.3 Cold Flush Procedure.................................7
5.2 Disinfection..........................................................7
6/ Troubleshooting............................................8
7/ Service – Disassembly and Assembly
7.1 Service Tools and Equipment............................11
7.2 PTS-ISU Disassembly/Assembly ......................11
7.2.1 Disassembly.............................................11
7.2.2 Assembly..................................................12
7.3 Regulator Module..............................................13
7.3.1 Disassembly.............................................13
7.3.2 Assembly..................................................13
7.4 Timing and Flow Control Valves........................13
7.4.1 Disassembly.............................................13
7.4.2 Assembly..................................................13
7.5 Digital Gauge.....................................................13
7.5.1 Removal of Batteries................................13
7.5.2 Inserting Batteries
8/ Service Checkout Procedure
8.1 Setup.................................................................14
8.2 Push-To-Set™ Test............................................14
8.3 Leak Test – Supply Side....................................14
8.4 Flow Test ...........................................................14
8.4.1 Continuous Mode Flow Test.....................14
8.4.2 Intermittent Mode Flow Test .....................14
8.5 Timing Cycle Adjustment...................................15
8.6 Gauge Test........................................................15
8.7 Regulation Test..................................................16
8.8 Vacuum Buildup/Bleed-down Test – Intermittent
Mode........................................................................16
8.9 Bleed Test..........................................................16
8.10 Leak Test – Patient Side..................................16
9/ Maintenance
9.1 General Maintenance of Suction
Equipment ...............................................................17
9.2 Recommended Maintenance Schedule.............17
9.2.1 Maintenance Schedule............................17
9.3 Repair Policy .....................................................18
9.4 Technical Assistance .........................................18
9.5 Return Instructions ............................................18
9.6 Installation Procedure for Adapters/Probes
and Fittings..............................................................18
10/Ordering Information
10.1 Illustrated Parts...........................................19-20
TOC

8700-0001-000 Rev4
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 equip-
ment exists.
WARNING: A WARNING statement is used
when the possibility of injury to the patient or
the operator exists.
1/Definitions and Abbreviations
in Hg
in
ISU
kPa
LPM
mm Hg
mm
oz
| (CONT)
|O|O (INT)
O (Off)
°C
°F
N-m
ft-lb
in-lb
DISS
OES
NCG
BOC
NPT
MPTS
I.D.
gal.
PTS
PTFE
NG
RH
Inches of mercury
Inch
Intermittent Suction Unit
Kilo pascals (kPa x 7.50 = mm Hg)
Liters per minute
Millimeters of mercury (mm Hg x .133 = kPa)
Millimeters
Ounces
Continuous (On)
Intermittent (On/Off)
Off
Degrees Celsius
Degrees Fahrenheit
Newton-Meter (N-m x .737 = ft-lb)
Foot-Pound Force (ft-lb x 1.356 = N-m)
Inch-Pound Force (ft-lb x 12 = in-lb)
Diameter Index Safety System
Oxequip Suction®
National Compressed Gases (Chemetron)
British Oxygen Corporation
National Pipe Thread (USA)
Multi-Purpose Therapy Stand
Inner Diameter
gallon
Push-To-SetTM
Teflon®
Naso - Gastric
Relative Humidity
1.2 Definitions
1

8700-0001-000 Rev4
2/Scope 3/Description/Specifications
This service manual contains service, maintenance
and parts information for the Push-To-SetTM
Intermittent Suction Unit (PTS-ISU)
2.1 ANSI Vacuum Regulator
Analog/Digital
Note: Part numbers given are for Vacuum Regulators
without fittings or adapters/probes.
2.1 ISO Vacuum Regulator
Analog/Digital
Note: Part numbers given are for Vacuum Regulators
without fittings or adapters/probes.
3.1 Description
WARNING: Do not use this device in the
presence of flammable anesthetics. Static
charges may not dissipate and possible
explosion hazard exists in the presence of
these agents.
The PTS-ISU is a dual purpose vacuum regulator
which provides either intermittent or continuous
suction. It can be used for NG drainage (intermittent)
or pharyngeal/tracheal (continuous) suctioning
throughout the hospital.
A patented safety feature Push-To-Set™ (PTS)
automatically occludes the patient circuit as the
desired vacuum level is selected. It prevents higher
than desired vacuum levels from being accidentally
delivered when patient suctioning begins. The suction
control knob must first be pushed and then turned to
set vacuum levels.
Each unit contains a dual spring regulator module
to regulate and adjust suction which is precise in
the critical care range (0-200 mmHg/26.7 kPa) and
quickly moves to full wall vacuum for resuscitation. It
requires only two turns from zero to full wall vacuum.
Each unit contains a vacuum gauge, an ON/OFF
switching module and adjustable timing valves.
In use, the vacuum source is connected through the
regulator module which functions as an automatic
valve. Rotating the suction control knob adjusts
the position of the regulator module and selects a
predetermined level of suction.
High Flow
High Vacuum
10
20
30
40
50
60
70
80
90
100
100
200
300
400
500
600
700
-
k
P
a
-
m
m
H
g
L
L
M
M
H
H
F
F
MEDICAL VACUUM
L
L
M
M
H
H
F
F
MEDICAL VACUUM
PTS-ISU
8700-1251-900
(1271,7251, 7271)
PTS-ISU Digital
8700-1351-900
(1371, 1372, 7351,
7371, 7372)
PTS-ISU
8700-1253-900
(1273)
PTS-ISU Digital
8700-6353-900
(6373, 6372)
Figure 2: Front and Side View
Vacuum
Gauge Mode Selector
Switch Adapter/Probe
Port
Suction
Control
Knob
Fitting Port
Figures 1
2

8700-0001-000 Rev4
3/Descriptions/Specifications
(3.1 Description Continued)
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 to
automatically maintain the pre-set suction level.
3.2 Specifications
Gauge: Accuracy (Analog): ±5% of full scale deflection
Accuracy (Digital): ±1% of full range @ 22oC
Flow Rates | Continuous (CONT) Mode - 0 - 80 LPM without
fittings at full increase setting depending on supply
vacuum and open air flow
|O|O Intermittent (INT) Mode - 8 LPM with the suction
control knob set to 120 mm Hg/16 kPa
Regulated Suction Range: 0 to 200 mm Hg/0 to 26 kPa and up to full wall
vacuum
Pre-Set Timing Cycles: On time cycle-15 seconds ± 3 seconds
Off time cycle-8 seconds ± 3 seconds
Weight: (Less Fittings) 20 oz/567 grams
Dimensions: (Less Fittings) Height: 6.5 inches/16.5 cm
Width: 2.8 inches/7.1 cm
Depth: 4.8 inches/12.2 cm
Environmental Specifications
Operating Temperature Range: 50oF (10oC) to 104oF (40oC)
Storage Temperature Range: -13oF (-25oC) to 158oF (70oC)
Operating and Storage Relative Humidity: 5 to 95% RH (Non-condensing)
3

8700-0001-000 Rev4
4/Operation
4.1 Equipment Setup
Insert the adapter/probe into the vacuum wall outlet.
If the regulator is mounted elsewhere, connect a
vacuum supply hose between the regulator’s adapter/
probe 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
vacuum regulator and the collection container, and
between the patient port of the collection container
and the patient (minimum inside diameter is 6
mm[0.25 in]).
An Ohio Medical Hydrophobic Filter or Hydrophilic
Filter and Overflow Safety Trap (OST) should be used
between the collection container and regulator to
prevent contamination of the regulator, wall outlet and
pipeline system.
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
Hydrophilic:
Nipple
20 Pack 6730-0350-800
200 Pack 6730-0351-8000
Hydrophobic:
Nipple Threaded
3 Pack 6700-0570-800 6700-0580-800
10 Pack 6700-0571-800 6700-0581-800
50 Pack 6700-0572-800 6700-0582-800
Note: For proper installation of adapters/probe and
fittings, see section 9.
4.1.1 Attaching the Overflow Safety Trap
(OST))
CAUTION: To help prevent aspirate from
entering the regulator as a result of misuse, an
OST should be attached prior to its use.Aspirate
in the regulator may impair its operation. The use
of the OST and suction filter will help prevent this
and extend the life of suction equipment.
Locking Gland Fitting
Figure 3
1. Raise the sleeve and insert the OST 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 nipple positioning.
3. Lower sleeve to lock trap in position.
1Regulator
2Sleeve
3OST
DISS fitting
Figure 4
1. Insert the OST into the regulator fitting. Situate
the nipple 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).
1Regulator
2Wing nut
3OST
1
2
3
1
2
3
4

8700-0001-000 Rev4
4/Operation
4.2 Mode Selection
Figure 5
IOIO (INT)- suction is intermittent (cycled “on” and
“off”) and the suction level can be adjusted with the
suction control knob when cycled “ON”.
O (OFF)- No suction is supplied to the patient.
I (CONT) - Suction is continuous and can be
adjusted with the suction control knob.
4.3 Setting the Suction Level
Figure 6
1. Turn the mode selector switch to I (CONT).
Figure 7
2. Push and rotate the suction control knob until the
vacuum gauge indicates the required setting.
CAUTION: The suction control knob must be
completely depressed in order to adjust the
vacuum level. Failure to do so may damage the
vacuum regulator.
4.4 Pre-Use Checkout Procedure
WARNING: The Pre-Use Checkout Procedure
must be performed before using the
equipment on each patient. If the regulator
fails any part of the Pre-Use Checkout
Procedure, it must be removed from service
and repaired by qualified service personnel.
All tests must be performed with supply vacuum of
500 mmHg (67 kPa) minimum.
1. Turn the mode selector switch to O (OFF).
Push and rotate the suction control knob one full
turn clockwise (increase). Release. The gauge
needle should not move.
2. Move the mode selector switch to I (CONT). The
gauge should indicate vacuum. Push and rotate
the suction control knob fully counter-clockwise
(decrease) until it stops and release.The gauge
needle should move to zero and remain there.
3. Push the suction control knob and set the
following:
REGULATOR (Type) SETTING
PTS-ISU Increase the suction to
90 mmHg (12 kPa)
4. Slowly release and push the suction control knob
to create various flow rates through the regulator.
Check that the suction level is maintained when
the knob is fully pushed in.
5

8700-0001-000 Rev4
4/Operation 5/Cleaning
5. Move the mode selector knob to IOIO. Check that
the intermittent timing cycles are approximately
15 seconds on and 8 seconds off by observing
the gauge needle.
Note: The PTS-ISU starts in the ON cycle.
6. Push the suction control knob and reduce the
suction to zero. Set the mode selector to O (OFF).
4.5 Patient Setup
Figure 8
1. Make sure the Pre-Use Checkout Procedure has
been performed.
2. Move the mode selector switch to I (CONT) and
push suction control knob.
3. Set the prescribed suction level.
CAUTION: The suction control knob must be
completely pushed in to adjust the vacuum
level. Failure to do so may damage the vacuum
regulator.
4. Move the mode selector switch to O (OFF).
5. Attach tubing from the vacuum regulator to the
vacuum port of the collection container.
5.1 Cleaning
WARNING: After patient use, regulators may
be contaminated. Handle in accordance with
your hospital’s infection control policy.
WARNING: Perform a service checkout
procedure following cold flushing. Validate
the selected cleaning/disinfection procedure.
Failure to do so may result in patient use
of a product which is assumed to be clean/
disinfected and is not.
CAUTION: Unit failure due to cold flushing is
not the responsibility of Ohio Medical and may
invalidate the warranty. Failure to adequately
dry the product following a cold flush may
damage the working parts which are designed for
pneumatic air-flow only. Failure to disassemble to
check O-ring and filter status may render the unit
inoperative.
CAUTION: Suctioned fluids drawn into a vacuum
regulator do not stop in the regulator. They
proceed through it into the wall outlet and pipeline
system. Failure to clean and disinfect the wall
outlet and pipeline system may result in damage
to this equipment.
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.
5.1.1.1 Approved Cleaning Solutions
• Virex®(QuaternaryAmmonium 0.2%): Mixture of
1 fl. oz. of Virex®to 1 gallon (128 fl. oz.) tap water
using Virex®128
• Kleenaseptic® Full strength from spray can
• Bleach (Sodium Hypochlorite 0.5%): Mixture of
13 fl. oz. of Clorox household bleach to 1 gallon
(128 fl. oz.) tap water
• Betco®TB Plus Mixture of 1 fl. oz. to 1 gallon
(128 fl. oz.) tap water
• Glutaraldehyde
• Isopropyl Alcohol 70%
• Hydrogen Peroxide 3%
• Cavicide®: Ready to use full strength
6

8700-0001-000 Rev4
5/Cleaning
5.1.2 Internal Component Cleaning
CAUTION: Cleaning the gauge may result in
damage.
1. Refer to the Service - Disassembly and Assembly
instructions. (Section 7)
2. All internal components with the exception of the
gauge may be cleaned with a solution of warm
water and mild detergent.
3. Dry all components with a lint free cloth before
assembly. Dry internal passages using vacuum
flow or compressed air.
4. Perform Service Checkout Procedure (Section 8).
5.1.2.1 Approved Flush Solutions
Warm water and mild detergent
5.1.3 Cold Flush Procedure
If desired, the vacuum regulator can be cold-flushed
as part of a cleaning or disinfecting procedure. Set
up a collection canister or liner between the vacuum
source and the adapter/probe port of the vacuum
regulator to receive the flush solution. Suction
through the vacuum regulator an adequate amount
of cold disinfectant to satisfy the infection control
requirements of the hospital. Use only approved
cleaning/flushing solutions. Make sure those made
from concentrates are newly mixed to ensure
effectiveness.
Flush both the continuous and intermittent vacuum
circuits thoroughly. Adequately aerate both the
continuous and intermittent circuits with vacuum flow
or compressed air until all internal channels, switches,
gauge ports and regulating mechanisms are dry.
Disassemble to check O-rings for adequate lubricant
and filters for proper function following any cold flush
procedure. Perform Service Checkout Procedure
(Section 8).
5.2 Disinfection
Should misuse occur resulting in accidental flooding
of the regulator, the regulator may be disinfected
using Ethylene Oxide (ETO). After disinfection, follow
the service checkout procedures in Section 8.
WARNING: Following disinfection with
ethylene oxide, parts should be quarantined
in a well ventilated area to allow dissipation
of residual ethylene oxide gas absorbed
by the material. Follow ETO processor’s
recommendation for specific aeration periods
required.
CAUTION: Do not steam autoclave or liquid
sterilize the PTS-ISU. Severe impairment to the
operation of the regulator will result.
CAUTION: Disinfection with ethylene oxide
mixtures may cause crazing (minute superficial
cracking) of some plastic parts.
Note: The PTS-ISU should only be disinfected if it is
contaminated or maintenance is to be performed.
1. The regulator should be disinfected with the mode
selector switch in the |O|O (INT) position.
2. 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. Disinfection is NOT
recommended as a frequent procedure.
3. After each disinfection check the condition of
the internal filters. Replace any shrunken filters
before returning the regulator to service.
4. Perform Service Checkout Procedure (Section 8).
7

8700-0001-000 Rev4
6/Troubleshooting
Place the regulator in the vertical position and connect to a supply vacuum of 500 mmHg (66.7 kPa).
Problem Possible Causes Remedy
A. No gauge indication
and no suction in any
setting
1. No supply vacuum 1. Correct supply problems
2. Kinked tube 2. Straighten tube
3. Poor connection 3. Check all connections and seals
4. Blocked wall outlet 4. Unblock outlet
5. Blocked adapter/probe port 5. Unblock port
6. Blocked backplate 6. Clean with soap and water and a pipe
cleaner
7. Regulator module
malfunction 7. See “regulator module malfunction” under the Problem column in this section of the
manual
8. In the OFF cycle of the IOIO
mode 8. In the IOIO mode the regulator starts in the ON cycle. However, if the unit
was stopped in the OFF mode, and
immediately re-started, it may take about
5 seconds to enter ON mode.
9. Depleated batteries 9. Charge batteries
B. Regulator module
malfunction 1. O-ring, quad ring, or diaphragm failure 1. Replace rubber components
2. Cap not completely snapped
to housing 2. Fully snap cap onto housing
3. Springs are not installed
correctly 3. Ensure that springs are properly installed.
4. Pinched diaphragm 4. Reinstall or replace diaphragm
C. No gauge indication
but suction is being
delivered
1. Blocked gauge pressure
sensing orifice 1. Unblock orifice
2. Blocked gauge pathway
(through Unilogic Module) 2. Clear pathway
3. Failed gauge o-ring seal 3. Reinstall or replace the o-ring
4. Gauge mechanism/
electronics is damaged 4. Replace gauge
D. Gauge indication but
no suction is being
delivered
1. Knob fails to return when
pushed 1. Remedy
i.
ii.
iii.
iv.
v.
Jiggle knob
Verify actuator is installed properly
Replace worn drive gear
Replace cover if worn splines in well
Replace Push-To-Set™ assembly
2. Blocked fitting port 2. Unblock port
3. Overflow Protection Device
Shut-off 3. Reset float, empty the autoclave Overflow Protection Device
4. Blocked external filter 4. Replace external filter
5. Blocked fitting 5. Replace fitting
6. Leak in system 6. Remedy:
i.
ii.
Check lid is secure on the collection
container
Check tubing connections
8

8700-0001-000 Rev4
6/Troubleshooting
Problem Possible Causes Remedy
E. Suction level cannot
be adjusted 1. Failure to push knob and rotate 1. Push and rotate to set vacuum level
2. Regulator module is stuck in
full OFF or full ON position 2. Rotate knob to un-stick
3. Regulator module
malfunction 3. See “Regulator module malfunction” under the Problem column in this section of the
manual
F. Suction level can
be adjusted without
pushing the knob in
1. Worn or broken drive gear 1. Replace drive gear
2. Worn or broken splines in
well 2. Replace cover
3. Broken knob 3. Replace knob
G. Insufficient flow
through regulator 1. Partial blockage in wall supply 1. Confirm wall supply is open and air flow meets minimum hospital requirements
2. Partial blockage in regulator 2. Perform the Flow Test in the Service
Checkout Procedure section of this
manual
3. Push-to-Set™ spring
assembly does not return,
blocking the flow path
3. Remedy:
i.
ii. Jiggle knob Replace Push-To-Set™ assembly
4. Knob fails to return when
pushed 4. See remedy D1 in this section of the manual
5. Vacuum relief plug leaks or is
missing 5. Replace or install correctly
6. Positive pressure relief valve
leaks or is missing 6. Replace or install correctly
H. Inaccurate gauge
reading 1. Damaged gauge 1. Replace gauge
Note: The gauge needle
(analog gauge) should
return to the stop pin
when no suction is being
supplied.
I. With the knob pushed
in, unable to decrease
the suction level and
gauge does not return
to zero when switched
to O (OFF)
1. Blocked bleed filter and/or
orifice 1. Clear orifice and replace filter
2. Damaged gauge 2. Replace gauge
3. Cross threaded regulator
module 3. Install correctly
4. Regulator module
malfunction 4. See “Regulator module malfunction” under the Problem column in this section of the
manual
J. Limited suction in any
setting and whistling
noise from inside the
regulator
1. Selector switch not fully in
CONT or INT position 1. Move fully to desired position
2. Failed selector switch seal 2. Remedy:
a.
b. Ensure Unilogic Module screws are adequately tightened
Replace selector switch
9

8700-0001-000 Rev4
6/Troubleshooting
Problem Possible Causes Remedy
K. Whistling/buzzing
noise from inside the
regulator
1. Cap-foam plug missing or
deteriorated/shrunk 1. Replace
2. Cap-foam plug pushed too
far into cap 2. Replace or install just flush with underside of cap
L. Suction is delivered in
the CONT mode but
the INT mode will not
cycle
1. Flow control valve is blocked
or turned fully in 1. Turn valve counter-clockwise until unit cycles and/or inspect valve seat area
2. Timing valves turned fully in
and/or clogged 2. Turn valve counterclockwise until unit cycles and/or inspect valve seat area
Note: The regulator will
always start in the ON
mode. Be sure that you
wait at least 20 seconds
with the regulator port
occluded to determine if
regulator is functioning.
3. Unilogic Module malfunction 3. Replace filters and/or module
4. Failed selector switch seal 4. See remedy J2 in this section of the
manual
5. Blocked manifold 5. Inspect manifold flow paths
6. Missing, damaged or
incorrectly installed o-rings 6. Replace or install o-rings
7. Degraded or clogged
Unilogic Module filters 7. Remedy:
i.
ii. Replace filters Replace Unilogic Module
M. Longer than expected
O (OFF) cycle time 1. Clogged beige filter on the Unilogic Module 1. Replace filter
2. Gauge mount foam
misaligned 2. Align
N. Gauge not aligned 1. Gauge mount foam missing,
torn or misaligned 1. Replace or align
O. Longer than expected
gauge bleed down
time
1. Blocked or clogged gauge
bleed 1. 2. Unblock or unclog gauge bleed Replace filter
10

8700-0001-000 Rev4
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 mmHg/67 kPa minimum and
50 LPM open air flow minimum
• Phillips head screwdriver, No. 2
• Flat head screwdriver, 1/4 inch
• Phillips head screwdriver, No. 1
• Open end adjustable wrench
• Pipe Cleaner
• Wooden toothpick (O-ring remover)
• Tweezers (Filter remover)
• Tubing clamp
• 1500 ML suction canister with lid
• Bubble leak tester
• Stop watch or VACUTIMER (Ohio Medical P/N
6700-0438-800)
• Vacuum Calibration Gauge, zero to full
wall vacuum range (0-760 mmHg/0-101.3
kPa), recommend Dwyer Series DPG-100
Digital Pressure Gauge or equivalent (Dwyer
Instruments, Inc., 219-879-8000)
• 50 L/min Flowmeter, 6-50 L/min scale,
recommend Dwyer VFA-26 or equivalent (Dwyer
Instruments)
• 10 L/min Flowmeter, 1-10 L/min scale,
recommend Dwyer VFB-66 or equivalent (Dwyer
Instruments)
7.2 PTS-ISU
7.2.1 Disassembly/Assembly
WARNING: 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.
WARNING: To ensure service personnel are
not exposed to hazardous contamination,
clean and disinfect all suction equipment
before disassembly.
CAUTION: The GaugeAssembly must be
handled with utmost care. Do not rest the gauge
on its face.
Note: See SECTION 10.1 Illustrated Parts
1. Remove the four case screws from the back of
the unit.
2. Holding the unit face up, carefully pull the case
and Knob Assembly off the backplate. Remove,
clean, and/or replace the Cover Strip.
3. To remove the Gauge Assembly and foam, grasp
and pull straight out. Lubricate or change the
gauge o-rings if needed.
4. Remove Actuator and Push-To-SetTM Assembly.
5. To remove the Regulator Module, grasp the stud
and rotate clockwise.
Note: To disassemble the Regulator Module, refer
to the Regulator Module Assembly section.
6. Remove the Unilogic Module by removing the 2
deep center side screws (No. 1 Phillips). Remove
and check beige filter, green filter and seven
o-rings. Replace filters if needed. Replace or
lubricate o-rings if needed.
7. If needed, remove the Timing Valve and the
Flow Control Valve with a flathead screwdriver.
Replace or lubricate the o-rings if needed.
8. Remove the Detent Plate and the Mode Selector
Switch. Replace filter if excessive wear or
damaged.
9. Remove the Gauge Bleed Hole Filter from the
Manifold Assembly. Replace if needed.
10. Grasp the Positive Pressure Relief Valve, and pull
from the Manifold Assembly. Replace if torn or
damaged.
11. If needed, remove the Faceplate as follows:
a. Carefully peel back and remove label from the
knob.
b. Disconnect the knob from the Drive Gear by
grasping the knob to remove the knob screw.
c. Rotate the Faceplate Collar counterclockwise
to remove.
d. Remove the Faceplate.
12. Grab pull-tab on Vacuum Relief Plug and remove.
Replace if deteriorated.
11

8700-0001-000 Rev4
7/Service - Disassembly and Assembly
7.2.2 Assembly
CAUTION: To prevent stripping the plastic case
threads, place the manifold screw in the hole
and turn counterclockwise until it drops into the
original threads. Tighten screw.
1. Before assembly, lubricate all o-rings and the
rubber surface on the inside of the Mode Selector
Switch with a small amount of 1Dow®111.
2. Place the Gauge Bleed Hole Filter in its proper
location.
3. Install the Positive Pressure Relief Valve and the
Vacuum Relief Plug.
1Dow Corning® 111 Valve Lubricant & Sealant, or equivalent
4. Unilogic Module Assembly
a. Install beige and green filters in the Unilogic
Module.
b. Install the seven o-rings on the posts of the
Unilogic Module.
c. If removed during disassembly, install Timing
Valves and/or Flow Control Valve. Rotate
each clockwise about 3 turns from thread
engagement.
5. Mode Selector Switch Assembly
a. Place the Mode Selector Switch into the
Manifold Assembly, rubberized side down.
b. Install the Detent Plate on the Manifold
Assembly, detent fingers facing down.
c. Install the Unilogic Module. Push down until
all posts and o-rings are seated into Manifold
Assembly. Firmly tighten the two small screws
(4 in/lbs or 0.45 N-m). The Unilogic Module
secures the Mode Selector Switch and seals
it against leaks.
d. After tightening the screws, test Mode
Selector Switch movement, which should be
firm. Do not over tighten.
6. Install the Regulator Module Assembly by turning
counterclockwise (left handed threads). Rotate
the stud so the flats are vertical.
7. Install Push-To-SetTM Assembly.
8. Position Actuator on Unilogic Module over
Regulator Module Assembly and resting on Push-
To-SetTM Assembly.
9. Gauge assembly
a. Attach small o-ring to the gauge post on the
Unilogic Module Assembly.
b. Also insert one o-ring into the gauge orifice.
Ensure o-ring is flush
c. Attach the foam to the back of the gauge
with the short leg at six o’clock. Connect the
Gauge Assembly to the gauge post on the
Unilogic Module Assembly. Ensure the Gauge
Assembly is properly aligned.
10. Installing Case
a. With Faceplate and Knob Installed:
i. With the flats on the outside of the drive
gear horizontal, pull the Knob to lock in
position.
ii. Holding manifold assembly face up, place
and align the Case and Knob Assembly
onto the Manifold Assembly with the Mode
Selector Switch in the O (OFF) position.
iii. Carefully center the slot in the Cover Strip
to fit around the Mode Selector Switch
tab.
iv. Install the four case screws.
b. Without Faceplate and Knob Installed:
i. Install Drive Gear on Regulator Module
Assembly stem.
ii. Holding Manifold Assembly face up, place
and align the Case onto the Manifold
Assembly with the Mode Selector Switch
in the O (OFF) position.
iii. Carefully center the slot in the Cover Strip
to fit around the Mode Selector Switch
tab.
iv. Install the four case screws.
v. Install the Faceplate with the top tab in the
case notch.
vi. Install Faceplate Collar, flat surface down
and finger-tighten clockwise.
vii. Place the Knob on the Drive Gear
protruding through Case and insert screw.
Hold the knob to tighten the screw.
viii. Replace the Knob label.
11. Install adapters/probes and fittings.
Note: For proper installation of Adapters/Probes and
Fittings, see section 9.
12

8700-0001-000 Rev4
7/Service - Disassembly and Assembly
7.3 Regulator Module
Note: See SECTION 10.1 Illustrated Parts
CAUTION: Do not lubricate any internal
components of the Regulator Module Assembly.
7.3.1 Disassembly
1. Remove small quad-ring from piston with stem
and o-ring from Housing. Lubricate or replace if
needed.
2. Lift and pull tabs to pry off and remove Cap.
3. Peel Diaphragm from Piston with Stem Assembly.
4. With piston facing down, lift threaded Housing to
separate.
5. Remove springs from stem.
7.3.2 Assembly
1. Place folded Diaphragm on Piston with stem.
Make sure small number on Diaphragm is
showing.
2. With stem up, install springs.
3. Place threaded Housing on Piston with Stem
Assembly.
4. Install quad ring on Piston with Stem.
5. Snap cap into place. Ensure small tabs are fully
seated against the Cap.
6. Install o-ring on threaded Housing.
7.4 Timing and Flow Control Valves
CAUTION: Do not over-tighten the Timing Valve
or Flow Control Valve stems. Needle portion of
valves may be damaged.
7.4.1 Disassembly
1. Remove Timing Valve and Flow Control Valve
by turning counterclockwise with a flat-head
screwdriver.
2. Replace and/or lubricate o-rings as needed.
7.4.2 Assembly
1. Carefully insert and tighten the Timing Valves.
2. Press Flow Control Valve in to engage threads
then tighten.
3. Rotate each clockwise about 3 turns from thread
engagement.
7.5 Digital gauge
Please Note: Both batteries are positioned with
the positive side facing up relative to the display.
7.5.1 Removal of Batteries
1. Remove digital gauge as described in 7.2.2.
2. Using a small flat head screwdriver, push
batteries out at a 45oangle.
7.5.2 Inserting Batteries
1. Place negative side of battery into battery slot first
(battery will be at an angle).
2. Then using a flat head screwdriver, gently push
in positive battery contact while sliding battery in
place.
13

8700-0001-000 Rev4
8/Set-Up
8.1 Set-up
1. Verify 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/probe
port.
8.2 Push-To-Set™ Test
1. Connect the 10 LPM Flowmeter to the patient
port.
2. Set 200 mmHg/26.6 kpa on the gauge and keep
the knob pushed in.
3. Make certain leakage at the patient port
connection is no more than 1 LPM.
4. While observing the flowmeter, push and rotate
the knob. Leakage should be no more than 1
LPM. Release the knob. It should fully return.
8.3 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/probe port.
3. Turn the mode selector switch to O (Off).Allow
the fitting port to be open to air.
4. Wait 10 seconds. No More than 6 bubbles should
appear in the next 10 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/probe port of the
vacuum regulator.
OFF/ON
VACUUMPHASE
888
Figure 9: Service Checkout Procedure Setup
Vacutimer
0-10 LPM
Flowmeter 0-50 LPM
Flowmeter
Test
Gauge
Occlusion
1500cc
Canister
Patient/Fitting
Port
8.4 Flow Test
Remove the Bubble Leak Tester from the supply
vacuum connection and connect the supply vacuum
directly to the regulator adapter/probe port.
8.4.1 Continuous Mode Flow Test
1. Connect the regulator fitting port to the 50 LPM
flowmeter.
2. Turn the mode selector switch to I (CONT).
3. Push and rotate the suction control knob fully
clockwise (increase).
4. Verify the flow rate exceeds 40 LPM.
8.4.2 Intermittent Mode Flow Test
1. Remove the face plate as follows:
a. Carefully peel back and remove label from the
knob
b. Disconnect the knob from the drive gear by
grasping the knob to remove the knob screw.
c. Rotate the faceplate collar counterclockwise
to remove.
d. Remove the face plate.
888
Figure 10: Bubble Leak Test - Supply Side
Test Gauge
Adaptor/
Probe
Port
14

8700-0001-000 Rev4
2. Use a flathead screwdriver to rotate the flow
control valve two turns counterclockwise from its
seat.
3. Set 120 mmHg/16 kpa on the regulator gauge.
4. Connect the regulator fitting port to the 10 LPM
flowmeter.
5. Turn the mode selector switch to IOIO (INT).
6. During the “ON” cycle, adjust the intermittent flow
rate to 8 LPM +/- 1 LPM. To increase the flow rate
turn the valve counterclockwise. To decrease the
flow rate turn the valve clockwise.
Note: If the regulator does not cycle “OFF” after
20 seconds, use a flathead screwdriver and rotate
the “ON” timing valve stem counterclockwise until
the regulator cycles “OFF.”
8.5 Timing Cycle Adjustment
WARNING: If the screws on the timing valves
are turned all the way clockwise, the PTS-ISU
will not cycle.
Factory Settings:
“ON” Cycle: 15 seconds +/- 3 seconds
“OFF” Cycle: 8 seconds +/- 3 seconds
To set the timing cycles, perform the following
procedure.
1. Occlude the fitting port or connect Vacutimer to
fitting port.
2. Turn the selector switch to | (CONT).
3. Set 120 mm Hg/16 kPa on the regulator gauge.
4. Turn the mode selector switch to |O|O (INT) with
the fitting port still occluded.
5. Wait 20 seconds.
6. If the regulator does not cycle “OFF” use a flat-
head screwdriver to rotate the “ON” timing valve
stem counterclockwise until the regulator cycles
“OFF”.
7. Wait 20 seconds.
8. If the regulator does not cycle “ON”, use a flat-
head screwdriver to rotate the “OFF” timing valve
stem counterclockwise until the regulator cycles
“ON”.
9. Once the regulator has completed an “ON” and
“OFF” cycle, fine tune each cycle to the desired
time by adjusting the corresponding valve. To
increase the time, turn the timing valve stem
clockwise. To decrease the time, turn the timing
valve stem counterclockwise. Use Ohio Medical
VACUTIMER (P/N 6700-0438-800) to digitally
measure timing cycles.
10. Install the faceplate as follows:
a. Install the faceplate with the top tab in the
case notch.
b. Install faceplate collar, flat surface down and
finger-tighten clockwise.
c. Place the knob on the drive gear protruding
through and insert screw. Hold the knob to
tighten the screw.
d. Replace the knob label.
8.6 Gauge Test
Note: All Ohio Medical Analog Gauges are supplied
with an accuracy of +/- 5% of full scale deflection
throughout their range. The PTS-ISU vacuum
gauges have an accuracy of +/- 10 mmHg/1.3 kPa.
Note: Digital gauges are supplied with an accuracy
of +/- 1% of full range @ 22oC
Note: All gauge needles should return to the stop pin
when no suction is being supplied. Gauges which do
not comply may be out of calibration.
Note: When checking gauge accuracy, be sure that
the calibration gauge has an accuracy of +/-1% full
scale deflection or better.
Figure 11: Setting Timing Cycles and
Intermittent Flow Rate
“ON”
Valve
Brass Flow
Control Valve
“OFF”
Valve
8/Set-Up
15

8700-0001-000 Rev4
1. Connect the regulator fitting port to the vacuum
calibration gauge with tubing.
2. Turn the mode selector switch to I (CONT).
3. Assure the regulator gauge is in agreement with
the vacuum calibration gauge within the +/- 10
mmHg/1.3 kPa tolerance. Recommended test
points are:
PTS-ISU: 40, 80, 140, and 200 mmHg (5, 10,
18, and 26 kPa)
4. Push and rotate the suction control knob fully
clockwise (increase) and verify the gauge reading
is in the FULL VAC range (vacuum calibration
gauge should read 450 mmHg/59.8 kpa or
higher).
5. Turn the mode selector switch to IOIO (INT).
6. Verify the gauge reading is in the FULL VAC
range (vacuum calibration gauge should read 400
mmHg/50 kPa or higher).
7. Turn the mode selector switch to I (CONT).
8. Push and rotate the suction control knob fully
counterclockwise (decrease) and verify the gauge
reading decreases to zero.
8.7 Regulation Test
1. Disconnect the vacuum calibration gauge from
the regulator fitting port.
2. Push and rotate the knob to set 90 mmHg/12 kPa.
3. Without rotating, release and push the knob
several times.
4. Check that the regulator gauge reads between:
PTS-ISU: 80 mmHg/10.7 kPa and
100 mmHg/13.3 kPa when the knob
is pushed.
8.8 Vacuum Buildup/Bleed-down Test –
Intermittent Mode
1. Turn the mode selector switch to IOIO (INT).
2. Connect the regulator fitting port to the 1500 ml
suction canister with lid.
3. Push and rotate the knob to set 120 mmHg/16
kPa.
4. During the “ON” cycle, check that the suction
increases to the preset 120 mmHg/16 kPa on the
regulator gauge in 5 seconds or less.
5. During the “OFF” cycle, check that the suction
decreases to zero on the regulator gauge (zero
stop pin) in 5 seconds.
6. If the regulator fails either the build-up or bleed-
down test, replace the regulator module.
8.9 Bleed Test
1. Turn the mode selector switch to I (CONT).
2. Push and rotate the knob to set 120 mmHg/16
kPa.
3. Turn the mode selector switch to O (OFF) and
observe the gauge needle. It must return to zero
within 10 seconds.
8.10 Leak Test – Patient Side
1. Turn the mode selector switch to O (OFF).
2. Connect the regulator fitting port tubing to port “A”
of the bubble leak tester.
3. Keep port “B” open to air.
4. Push and rotate the suction control knob fully
counterclockwise (decrease).
5. Turn the mode selector switch to I (CONT).
6. Wait 5 seconds.
7. No bubbles should appear in the bubble leak
tester for the next 10 seconds.
Figure 12: Bubble Leak Test - patient Side
Fitting/
Patient
Port
8/Set-Up
16

8700-0001-000 Rev4
9.1 General Maintenance of Suction
Equipment
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 disinfect all
suction equipment if contaminated before
disassembly to ensure service personnel are
not exposed to hazardous contamination.
PTS-ISU should be kept in use or used on a rotating
basis. Internal parts of 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 canisters with reliable shut-
off valves, Overflow Safety Trap assemblies and
disposable suction filters will protect the regulator,
wall outlet, 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
as needed. The flow rate measurement should meet
NFPA99 and/or ISO 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. Keep connecting tubing, fittings and adapters/
probes clean.
2. Wipe all exterior surfaces with a solution of
water and mild detergent or approved cleaning
solutions.
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 Protection Device
and collection canister for correct operation.
7. Perform the Pre-Use Checkout Procedure.
9.2 Recommended Maintenance
Schedule
Ohio Medical vacuum regulators function for decades.
They are proven to provide trouble-free service with
minimum care.
We recommend the following to determine the
maintenance schedule appropriate for each facility:
1. Periodically (as required, but no less than
annually) inspect the overall condition of the
vacuum regulator. Test gauge accuracy (section
8.6 Gauge Test) and perform the Pre-Use
Checkout Procedure (section 4.4). If the regulator
does not pass, refer to Troubleshooting (Section
6).
2. Determine a maintenance schedule based on
data from your periodic inspections. Follow the
guidelines below.
9.2.1 Maintenance Schedule
Item Minimum Frequency Comments
Service Checkout Procedure Every 24 months or as required If the regulator does not pass, refer to
Troubleshooting (Section 6). Repair as
needed
Elastomeric parts, O-rings,
gaskets, diaphragms, inter-
nal filters
As required Cleaning, lubrication and replacement
interval depends on hours of usage and en-
vironmental conditions. Replace, lubricate,
and repair as needed
9/General Maintenance of Suction Equipment
17