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
H
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