Ohio Medical ISU, Pediatric ISU Intermittent Suction Unit Service Manual

Intermittent Suction

Unit (ISU)

Service Manual

ANSI

6700-0082-000 (Rev.4) 10/2012

ISO

1

2

User Responsibility

This Product will perform as described 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 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.

Technical Competence

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.

Abbreviations used in this manual

DISS

OES

NCG

BOC

NPT

NPTF

MPTS

I.D.

gal.

PTFE

NG

PED

NFPA

ISO inHg in

ISU kPa

LPM mmHg mm mL oz

| (CONT)

|O|O| (INTER)

O (OFF)

°C

°F

N-m ft-lb

Inches of mercury

Inch

Intermittent Suction Unit

Kilo pascals (kPa x 7.50 = mmHg)

Liters per minute

Millimeters of mercury (mmHg x .133 = kPa)

Millimeters

Milliliters

Ounces

Continuous (On)

Intermittent

Off

Degrees Celsius

Degrees Fahrenheit

Newton-Meter (N-m x .737 = ft-lb)

Foot-Pound Force (ft-lb x 1.356 = N-m)

Diameter Index Safety System

Oxequip Suction

National Compressed Gases (Chemetron)

British Oxygen Corporation

National Pipe Thread (USA)

National Pipe Thread Female (USA)

Multi-Purpose Therapy Stand

Inner Diameter gallon

Polytetrafluoroethylene

Nasogastric

Pediatric

National Fire Protection Association

International Organization for Standardization

6700-0082-000 (Rev.4) 10/2012

1/Precautions .......................................................... 4

1.1 Definitions ....................................................... 4

1.2 Warnings ......................................................... 4

1.3 Cautions .......................................................... 5

1.4 Intended Use ................................................... 5

2/Scope ................................................................. 6

2.1 North American Vacuum Regulators. .............. 6

2.2 English Vacuum Regulators ............................ 6

3/Description and Specifications .......................... 7

3.1 Description ...................................................... 7

3.2 Specifications .................................................. 8

4/Operation.............................................................. 9

4.1 Equipment Set-up ........................................... 9

4.1.1 Attaching the Overflow Safety Trap ...... 10

4.2 Mode Selection ............................................. 10

4.3 Setting the Suction Level .............................. 10

4.4 Pre-use Checkout Procedure ........................ 10

4.5 Patient Set-up ............................................... 11

5/Cleaning and Sterilization ................................. 11

5.1 Cleaning ........................................................ 11

5.1.1 Routine Exterior Cleaning .................... 11

5.1.2 Internal Component Cleaning .............. 11

5.1.3 Cold Flush Procedure .......................... 11

5.2 Sterilization .................................................... 12

6/Troubleshooting ................................................ 13

7/Service - Disassembly and Assembly ............. 15

7.1 Service Tools and Equipment ........................ 15

7.2 ISU and PED ISU .......................................... 15

7.2.1 Disassembly ......................................... 15

7.2.2 Assembly .............................................. 16

7.3 Regulator Module .......................................... 17

7.3.1 Disassembly ......................................... 17

7.3.2 Assembly .............................................. 18

7.4 Timing Valves ................................................ 18

7.4.1 Disassembly ......................................... 18

7.4.2 Assembly .............................................. 18

7.5 Vacuum Limit - Pediatric ISU Only ................ 18

8/Service Checkout Procedure............................ 19

8.1 Set-up ............................................................ 19

8.2 Leak Test - Supply Side ................................ 19

8.3 Flow Test ....................................................... 20

8.3.1 Continuous Mode Flow Test ................. 20

8.3.2 Intermittent Mode Flow Test ................. 20

Table of Contents

8.4 Gauge Test .................................................... 21

8.5 Regulation Test ............................................. 21

8.6 Timing Cycle Adjustment ............................... 21

8.7 Vacuum Build-up/Bleed-down

Test - Intermittent Mode ................................ 22

8.8 Bleed Test ..................................................... 22

8.9 Leak Test - Patient Side ................................ 22

8.10 Vacuum Limit Adjustment -

Pediatric ISU ONLY ....................................... 22

9/Maintenance ....................................................... 23

9.1 General Maintenance of Suction

Equipment ..................................................... 23

9.2 Recommended Maintenance Schedule ........ 23

9.2.1 Maintenance Schedule ......................... 23

9.3 Repair Policy ................................................. 24

9.4 Technical Assistance ..................................... 24

9.5 Return Instructions ........................................ 24

10/Ordering Information ....................................... 25

10.1 Illustrated Parts ............................................. 25

10.2 Service Kits ................................................... 26

Appendix A-1

Installation procedure for Adapters/Probes and Fittings. ...........................................................A-1

6700-0082-000 (Rev.4) 10/2012 3

4

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.

w

CAUTION: A CAUTION statement is used when the possibility of damage to the equipment exists.

w

WARNING: A WARNING statement is used when the possibility of injury to the patient or the operator exists.

1.2 Warnings

The pre-use checkout procedure (Section 4.4 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 positive pressure sources such as oxygen and medical air, even momentarily, could injure the patient or operator.

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 possible explosion hazard exists in the presence of these agents.

After patient use, regulators may be contaminated.

Handle in accordance with your hospital’s infection control policy.

Clean and sterilize all multiple use suction equipment before shipment to ensure transportation personnel and/or service personnel are not exposed to any hazardous contamination.

Clean and sterilize all multiple use 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 130 o F (54 o C).

If the vacuum regulator is repaired or disassembled in any manner, the service checkout procedure (Section

8 Service Checkout Procedure) must be performed before using the equipment on the patient.

If the flow control valve is rotated fully clockwise, the

ISU will not cycle in the intermittent mode. Drainage will cease.

For the Pediatric ISU, it may be possible to set the vacuum limit to zero. If there is no suction present, rotate the set screw counter-clockwise and/or check

Section 6 Troubleshooting.

If the screws on the timing valves are turned all the way clockwise, the ISU will not cycle.

6700-0082-000 (Rev.4) 10/2012

1.3 Cautions

Connect the vacuum regulator to the vacuum source only. Connection to positive pressure sources such as oxygen and medical air, even momentarily, could damage the equipment.

Cleaning the gauge may result in damage.

Do not lubricate any internal components of the regulator module.

Do not over-tighten the timing valve stem; the needle portion of the valve may be damaged.

Do not steam autoclave the ISU. Severe impairment to the operation of the regulator will result. The only acceptable method of sterilization is with gas (ethylene oxide).

Do not use any Loctite ® products to seal the fitting and adapter/probe 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.

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.

The cap screws can strip the regulator module housing threads if they are screwed in too tight.

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.

To help prevent aspirate from entering the regulator, wall outlet and pipeline equipment, an overflow safety trap and/or a high flow suction filter should be attached prior to its use. Aspirate in the regulator, wall outlet and pipeline system will impair the operation. The use of the overflow safety trap and/or a high flow suction filter will help prevent this and extend the life of the suction equipment.

To prevent stripping the plastic threads, place the screw in the hole and turn counter-clockwise until it drops into the original threads, then tighten the screw.

Use of lubricants other than recommended, may degrade plastic or rubber components.

Not for field or transport use**

1/Precautions

1.4 Intended Use

The vacuum regulator is intended to be used in the medical facility as a means to evacuate media (i.e. fluids) from the body.

**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, cares 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.

6700-0082-000 (Rev.4) 10/2012 5

2/Scope

This service manual contains service, maintenance and parts information on four models of the ISU.

North American - ANSI ® (2)

International - ISO ® (2)

2.1 North American(ANSI) Vacuum Regulators

Note: Part numbers given are for vacuum regulators without fittings or adapters/probes.

0

(INTER)

0

0

(OFF)

(CONT)

W 40

60

20

0

M E D

120

140

160

H

G

H

Pediatric ISU

6700-1257-900

ISU

6700-1251-900

2.2 International (ISO) Vacuum Regulators

Note: Part numbers given are for vacuum regulators without fittings or adapters/probes.

6

ISU

6700-1253-900

0

(INTER)

0

0

(OFF)

160

140

180

120

100

80

20

18

16

14 12

10

8

6

4

2 24

26

F - k

Pa

60

-m m

Hg

40

20

(CONT)

Pediatric ISU

6700-1273-900

6700-0082-000 (Rev.4) 10/2012

3/Description and Specifications

3.1 Description

w

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 ISU is a dual purpose vacuum regulator which provides either intermittent or continuous suction. It can be used for NG (intermittent) or pharyngeal/tracheal

(continuous) suctioning throughout the hospital.

On the Pediatric ISU, the maximum vacuum limit is factory present to 135 mmHg (18.0 kPa) and the limit may be adjusted between 80 and 150 mmHg (10.7 and

20.0 kPa). The low gauge and the baby icon on the cover distinguish it from the standard ISU.

Each unit contains a regulator module to regulate and adjust suction, a vacuum gauge which indicates suction supplied, a patented Unilogic Module to silently switch suction on and off, and timing valves which select and adjust the length of the on and off cycles.

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.

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 pre-set level. The same mechanism compensates for changes in supply vacuum to automatically maintain the pre-set suction level.

1. Suction Control Knob - Allows easy adjustment of suction to the patient.

2. Mode Selector Knob - Allows quick and easy mode changes.

Note: In the text of this manual, the international graphic symbol for the intermittent mode normally written as:

|

O

|

O

| will be written as |O|O|.

a. |O|O| (INTER) - Suction is intermittent (cycles on and off) and the suction level can be adjusted with the suction control knob.

When used as an Intermittent Suction Unit, both the “On” and “Off” timing cycles are independently adjustable within a range of 3 to 30 seconds. These are pre-set at the factory at a supply vacuum of 500 mmHg (66.7 kPa) to provide approximately 15 seconds “On” and 8 seconds “Off” for the ISU. If the supply vacuum is different, the timing cycles will vary.

Adjustment procedures are outlined in the

Operations section of this manual (Section 8.6

Timing Cycle Adjustment).

b. O (OFF) - No suction is supplied to the patient.

c. | (CONT) - Suction is continuous and can be adjusted with the suction control knob.

3. Vacuum Gauge - The suction level to the patient is displayed during use.

Vacuum

Gauge

Mode

Selector

Knob

Adapter

Port

Suction

Control

Knob

Fitting Port

6700-0082-000 (Rev.4) 10/2012 7

3/Description and Specifications

3.2 Specifications

Gauge: Accuracy: ±5% of full scale deflection

Flow Rates:

Regulated Suction Range:

Pre-Set Timing Cycles:

Note: The Pre-set timing cycles are set at a supply vacuum of

500 mmHg (66.7 kPa).

Weight: (Less Fittings)

| (CONT) Mode: 0-80 LPM without fittings at full increase setting depending on supply vacuum and open air flow

|O|O| (INTER): 8 LPM with the suction control knob set to

120 mmHg (16.0 kPa)

Adult: 0 to 200 mmHg (0 to 26.7 kPa) and up to full wall vacuum

Pediatric: 0 to 135 mmHg (0 to 18.0 kPa)

On time cycle: 15 seconds ± 3 seconds

Off time cycle: 8 seconds ± 3 seconds

28 oz (794 grams)

Dimensions: (Less Fittings)

Environmental Specifications

Operating Temperature Range:

Storage Temperature Range:

Operating and Storage Relative Humidity:

Height: 6.6 in (168 mm)

Width: 3.5 in (89 mm)

Depth: 4.8 in (121 mm)

40 to 120°F (4 to 49°C)

0 to 160°F (-18 to 71°C)

5 to 95%

8 6700-0082-000 (Rev.4) 10/2012

4/Operation

4.1 Equipment Set-up

w WARNING: Always connect the regulator to the vacuum source and check its operation before attaching the patient connection. w WARNING: Connection to positive pressure sources such as oxygen and medical air, even momentarily could injure the patient or operator.

w CAUTION: Connection to positive pressure sources such as oxygen and medical air, even momentarily could damage the equipment.

If the regulator is equipped with an adapter/probe for wall outlets, 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 port and the wall outlet. Connect the collection canister or liner’s vacuum port to the regulator’s fitting or overflow safety trap with the appropriate vacuum tubing.

Note: For proper installation of adapters/probes and fittings see appendix (Appendix A-1).

For standard ISU operation, mount the collection canister or liner above the patient.

Connect the collection canister or liner’s vacuum port to the regulator’s fitting port or overflow safety trap with the appropriate suction filter and vacuum tubing.

Hospital supplied suction tubing must be used between the catheter and the collection canister or liner. The recommended minimum inside diameter is 0.25 in (6 mm). Select tubing that is collapse and kink resistant.

An Ohio Medical high flow filter and overflow safety trap should be used between the collection canister or liner and the vacuum regulator to prevent contamination of the regulator, wall outlet and pipeline system.

ISO 10079-3 (section 5.1.2) states that “the usable volume of the collection container shall be not less than 500 mL.

High Flow Suction Filters

Hydrophilic

Pkg of 20

Pkg of 200

6730-0350-800

6730-0351-800

Hydrophobic Filter

Pkg of 3

Pkg of 10

Pkg of 100

Tubing x 1/8” NPT x tubing nipple tubing nipple

6730-0570-800 6730-0580-800

6730-0571-800 6730-0581-800

6730-0572-800 6730-0582-800

Vacuum Port

Vacuum

Regulator

Connective

Tubing

Patient

Port

Disposable

Suction

Filter

Overflow

Safety

Trap

Equipment Set-Up

6700-0082-000 (Rev.4) 10/2012

Collection

Bottle

9

4/Operation

4.1.1 Attaching the Overflow Safety

Trap (OST) w

CAUTION: To help prevent aspirate from entering the regulator, wall outlet and pipeline system, 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.

Sleeve

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).

Wing Nut

4.2 Mode Selection

|O|O| (INTER) - Suction is intermittent (cycles on and off) and the suction level can be adjusted with the suction control knob.

O (OFF) - No suction is supplied to the patient.

| (CONT) - Suction is continuous and can be adjusted with the suction control knob.

4.3 Setting the Suction Level

w WARNING: 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.

1. Clamp the connective tubing to occlude the fitting port.

2. Turn the mode selector knob to | (CONT).

3. Rotate the suction control knob until the vacuum gauge indicates the required setting.

4.4 Pre-use Checkout

Procedure

w 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.

w WARNING: Always connect the regulator to the vacuum source and check its operation before attaching the patient connection.

Before the vacuum regulator is used, it must be tested for correct operation as outlined below. All tests must be performed with the regulator in its normal (vertical) operating position and with a minimum supply vacuum of 500 mmHg (66.7 kPa).

10 6700-0082-000 (Rev.4) 10/2012

4/Operation 5/Cleaning

1. Turn the mode selector knob to O (OFF).

2. Rotate the suction control knob one full turn clockwise (increase).

3. Clamp the connective tubing to occlude the fitting port. The gauge needle should not move.

4. Unclamp the connective tubing.


6. Rotate the suction control knob fully counterclockwise (decrease).

7. Clamp the connective tubing. The gauge needle should not move.

8. With the connective tubing clamped, increase the suction to 90 mmHg (12.0 kPa).

9. 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.

10. Turn the mode selector knob to |O|O| (INTER).

11. Clamp the connective tubing.

12. Ensure that the timing cycles are 15 seconds “On” and 8 seconds “Off” both with a tolerance of ± 3 seconds by observing the gauge needle.

Note: The ISU starts in the “Off” cycle.

13. Reduce the suction level to zero and turn the mode selector knob to O (OFF).

4.5 Patient Set-up

1. Make sure the pre-use checkout procedure

(Section 4.4 Pre-use Checkout Procedure) has been performed.

2. Clamp the connective tubing and turn the mode selector knob to | (CONT).

3. Set the prescribed suction level.

w

WARNING:

The regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction.


5. Attach the patient tubing to the collection canister or liner’s patient port.

6. Turn the mode selector knob to | (CONT) or |O|O|

(INTER).

5.1 Cleaning

w

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 w CAUTION: Cleaning the gauge may result in damage.

1. Refer to Section 7 Service - Disassembly and

Assembly for instructions.

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.

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 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. w CAUTION: Failure to adequately dry the product following a cold flush may damage the working parts which are designed for pneumatic air flow only. Ohio Medical is not responsible for unit failure due to cold flushing. Failure to disassemble to check O-ring and filter status may render the unit inoperative. Suction fluids drawn into a vacuum regulator do not stop in the regulator.

They proceed through it into the wall outlet and

6700-0082-000 (Rev.4) 10/2012 11

5/Cleaning and Sterilization

pipeline system. Failure to clean and disinfect the wall outlet and pipeline system may result in damage to this equipment. w WARNING: Perform the service checkout procedure (Section 8 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. Body fluids suctioned 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 contamination that contributes to nosocomial infection.

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.

w 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 130

(54 o procedure.

o F

C). Follow your hospital sterilization w CAUTION: Do not steam autoclave or liquid sterilize the ISU. Severe impairment to the operation of the regulator will result. The only acceptable method of sterilization is with gas

(ethylene oxide).

w 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: ISU should only be sterilized if it is contaminated or maintenance is to be performed.

1. The regulator should be sterilized with the mode selector knob in the |O|O| (INTER) 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 filters. Replace any shrunken filters before returning the regulator to service.

Place the regulator in the vertical position and connect to a supply vacuum of 500 mmHg (66.7 kPa).

12 6700-0082-000 (Rev.4) 10/2012

6/Troubleshooting

Problem

A. No gauge indication and no suction in any setting

10.

Pediatric ISU – Incorrect vacuum limit adjustment

B. Regulator module malfunction

C. No gauge indication but suction is being delivered

D. Gauge indication but no suction is being delivered

E. Suction level cannot be adjusted

11.

1.

Pediatric ISU – Bad or missing positive pressure relief valves

O-ring failure or diaphragm rupture

2.

1.

2.

3.

1.

2.

Stem screw loose

Blocked gauge pressure sensing orifice

Gauge mechanism locked by debris

Gauge mechanism damaged

Blocked fitting port

Overflow safety trap shut off

3.

4.

Blocked external filter

Blocked fitting

1. Regulator module malfunction

F. Insufficient flow through regulator

G. Inaccurate gauge reading Note: All gauge needles should return to the stop pin when no suction is being supplied

Possible Causes

1.

2.

3.

4.

5.

6.

7.

8.

9.

No supply vacuum

Kinked tube

Poor connection

Blocked wall outlet

Blocked adapter port

Blocked backplate

Loose mounting plate

Bad or missing mounting plate gasket

Regulator module malfunction

1.

Partial blockage in wall supply

2.

Partial blockage in regulator

1. Damaged gauge

Remedy

1.

2.

3.

4.

5.

6.

7.

8.

Correct supply problems

Straighten tube

Check all connections and seals

Unblock outlet

Unblock port

Clean with soap and water and a pipe cleaner

Tighten the 4 mounting screws

Replace/Install gasket

9.

10.

11.

1.

2.

1.

See “Regulator module malfunction” under Problem column in this section of the manual

Reset vacuum limit. (See

Section 7.5 Vacuum Limit -

Pediatric ISU Only)

Replace/Install positive pressure relief valves

Replace rubber components with regulator module replacement kit

Tighten stem screw

Unblock orifice

2.

Remove debris

3.

1.

2.

3.

4.

1.

2.

Replace gauge

Unblock port

Reset float/empty overflow safety trap

Replace external filter

Replace fitting

1. See “Regulator module malfunction” under Problem column in this section of the manual

Confirm wall supply open air flow meets minimum hospital requirements. Unblock if necessary

Perform the Flow Test in

Section 8 Service Checkout

Procedure of this manual.

Clear blockage if necessary

2. Replace gauge

6700-0082-000 (Rev.4) 10/2012 13

6/Troubleshooting

Problem

H. With the fitting port occluded, unable to decrease the suction level and gauge needle does not return to Zero when switched to O

(OFF)

I.

Limited suction in any setting and whistling noise from inside the regulator

J. Suction is delivered in the | (CONT) mode but the |O|O| (INTER) will not cycle

K. Pediatric ISU - Maximum vacuum not limited

L. Pediatric ISU - Limited suction in any setting and whistling noise from back of regulator

Possible Causes

1.

2.

3.

4.

1.

2.

Blocked filter and/or orifice

Damaged gauge

Blocked unilogic module filter

Regulator module malfunction

Selector switch loose or bad selector switch O-rings

Missing internal components

Remedy

1.

2.

3.

4.

Clear orifice and replace filter

Replace gauge

Replace filter

See “Regulator module malfunction” under Problem column in this section of the manual

1.

2.

Tighten selector switch and/or replace O-ring

Disassemble regulator and inspect

1.

2.

3.

4.

5.

Flow control valve blocked or turned full in

Timing valves turned fully in and/ or clogged

Unilogic module malfunction/ missing

Missing O-ring in selector switch

Blocked backplate

1.

2.

3.

4.

5.

Turn valve counter-clockwise until unit cycles and/or inspect valve seat area

Turn valve counter-clockwise until unit cycles and/or inspect

Replace filters and/or module

Install O-ring

Inspect backplate flow paths and unblock if necessary

1. Incorrect vacuum limit adjustment 1. Reset vacuum limit. See

Section 7.5 Vacuum Limit -

Pediatric ISU Only

1. Bad or missing positive pressure relief valves

1. Replace/Install positive pressure relief valves

M. Pediatric ISU - Vacuum limit does not remain constant

1. Loctite on set screw is breaking down

1. Replace 2.42 Loctite on set screw. See Section 7.5

Vacuum Limit - Pediatric ISU

Only

14 6700-0082-000 (Rev.4) 10/2012

7/Service - Disassembly and Assembly

7.1 Service Tools and Equipment

w

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 (66.7 kPa) minimum

& 50 LPM open air flow minimum

• Supply vacuum regulator with gauge,

760 mmHg (101.3 kPa) full scale

• Low vacuum calibration gauge,

225 mmHg (30.0 kPa) full scale

(Ohio Medical P/N 6700-0353-800)

• 50 LPM flowmeter


• 10 LPM flowmeter


• Phillips head screwdriver, No. 2

• Flat head screwdriver, 1/4 inch

• Open end adjustable wrench

• Ball hex key wrench, 3/16 inch

• Open end wrench, 11/16 inch

• Pipe cleaner

• Wooden toothpick (O-ring remover)

• Tweezers (filter remover)

• Dow Corning ® 111 grease

Ohio Medical P/N 6700-0074-200)

• Tubing clamp

• 1/2 gallon reservoir

• Bubble leak tester

• Stop watch

• Hex key wrench, 1/16 inch (Pediatric ISU only)

• 242 Loctite (Pediatric ISU only)

7.2 ISU and Pediatric ISU

7.2.1 Disassembly w

WARNING: If the vacuum regulator is repaired or disassembled in any manner, the service checkout procedure (Section 8 Service

Checkout Procedure) must be performed before using the equipment on the patient.

w WARNING: Clean and sterilize all multiple use suction equipment if contaminated before disassembly, to ensure service personnel are not exposed to hazardous contamination.

w 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.

Note: See Section 10.1 Illustrated Parts

1. Remove all fittings from the regulator and ensure that the mode selector knob is in the O (OFF) position.

2. Remove the three cover screws from the back of the unit.

3. Rotate the suction control knob counter-clockwise

(decrease) until it is free from the regulator module.

Carefully pull the cover and knob assembly off of the backplate.

4. To remove the gauge assembly, grasp the dial mounting bracket and pull straight out. The snap-fit lens cover can also be removed (if applicable) for replacement. Replace gauge O-rings if required.

5. To remove the regulator module, grasp and pull it from the backplate.

Pull down plastic tab with right index finger while holding gauge frame with left hand

Snap-fit Lens Removal

Note: To disassemble the regulator module, refer to Section 7.3 Regulator Module.

6. Remove the unilogic module by carefully pulling the module away from the backplate. This releases the tubing connections. Replace beige and green filters and silastic tubes if required.

6700-0082-000 (Rev.4) 10/2012 15


7. Remove the timing valves by pulling the valve stem out of the backplate. Replace the filters if required.

Note: To disassemble the timing valves, refer to

Section 7.4 Timing Valves.

8. If the mode selector switch needs service, carefully unscrew the center retaining screw while holding the main valve body. Remove the washers, detent plate, ball bearings, and valve body. Replace

O-rings if required.

9. Remove the gauge bleed hole filter from the backplate. Replace if required.

10. Remove the flow control valve by turning counterclockwise until it is out of the backplate.

11. For the Adult ISU - Remove the ISU mounting plate by removing the four screws and pulling the plate and gasket from the backplate. Replace gasket if required.

12. For the Pediatric ISU a. Remove the Pediatric ISU mounting plate by removing the four screws and pulling the plate and gasket from the backplate.

b. Replace gasket if required. Use Pediatric ISU gasket ONLY (6700-0221-500) c. To remove valves, grasp top of valve and pull. Replace positive pressure relief valves if required. d. Under the suction control knob there is a brass stud and a retaining ring. DO NOT remove these parts from the cover assembly.

7.2.2 Assembly w CAUTION: To prevent stripping the plastic threads, place the screw in the hole and turn counter-clockwise until it drops into the original threads, then tighten the screw.

1. Lubricate all O-rings and the gasket with a small amount of Dow Corning ® 111 grease before assembly.

2. For the Adult ISU - Place the lubricated mounting plate gasket onto the holes and install the mounting plate onto the backplate. Ensure the protruding posts on the mounting plate align in to the backplate properly.

3. For the Pediatric ISU - Install new positive pressure relief valves by pulling tail of valve through the small hole on the mounting plate. When installed, the three other vent holes should be covered. After valve is installed, clip the tail. Place the lubricated mounting plate gasket onto the backplate. Ensure the protruding posts on the mounting plate align into the backplate properly.

4. Install the flow control valve into its proper location.

Use the proper tool to rotate the valve clockwise approximately 3 full turns, taking extra care to ensure that the threads are engaged properly.

5. Place the gauge bleed hole filter into its proper location. Push until it bottoms on the backplate.

6. Mode Selector Switch Assembly a. Place the four selector switch O-rings into their proper location on the backplate. b. Install the main valve body on the backplate post with the protruding ear at the 3 o’clock position. Ensure the valve body seats on the four O-rings. c. Place the four ball bearings on top of the valve body. Place the detent plate on top of the four ball bearings (smooth side down). Place the spiral spring washer on top of the detent plate. Place the flat washer on top of the spiral spring washer.

d. Install the screw through the washer and into the backplate post. Tighten the screw.

7. Grasp the main valve body and rotate the switch in all three positions. Ensure that the protruding ear is near the 3 o’clock position after testing the switch.

8. Install the timing valves into their proper locations and push fully in so that the O-rings seats in the backplate.

9. Install the Unilogic Module by aligning the silastic tubes with the ports on the backplate and push fully in.

10. Install the regulator module into its proper location.

Rotate the module so that the protruding ears are at the 5 o’clock and 11 o’clock positions.

11. 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. If the lens is not the snap-fit type, simply place the lens onto the gauge ensuring it rotates easily and is resting properly.

12. Install the gauge assembly into its proper location so that the O-rings seat fully. Ensure the gauge is properly aligned. For the Pediatric ISU ONLY -

The suction control knob is NOT lockable.

16 6700-0082-000 (Rev.4) 10/2012


13. Place and align the cover and knob assembly onto the backplate with the mode selector knob in the

O (OFF) position. Rotate the suction control knob clockwise (increase) until the cover is flush with the backplate.

14. Install the three cover screws.

15. Install all fittings.

Note: For proper installation of adapters/probes and fittings see Appendix A-1.

7.3 Regulator Module

w CAUTION: Do not lubricate any internal components of the regulator module.

w CAUTION: The cap screws can strip the regulator module housing threads if they are screwed in too tight.

7.3.1 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.

11

10

8

9 11

7

6

Pediatric ISU Regulator Module

5

4

3

2

1

Description

1.

2.

3.

4.

5.

O-ring, Stem

O-ring

6.

7.

8.

9.

Housing

Stem

Spring

Piston

Diaphragm

Retainer

Stem Screw

10. Cap

11. Cap Screw

Parts and Descriptions

CAP

NOTE: The pediatric regulator cap is different from that of the standards ISU - shape and material (aluminum). Only use the cap pictured above on the

Pediatric ISU

6700-0082-000 (Rev.4) 10/2012 17


7.3.2 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 the 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 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 Corning ® 111 grease to the O-rings only.

10. Install O-rings onto the stem and housing.

Stem

Piston

Retainer

Stem

Screw

Diaphragm

7.4 Timing Valves

w CAUTION: Do not over-tighten the timing valve stem. Needle portion of the valve may be damaged.

7.4.1 Disassembly

1. Remove the O-rings from the valve base and replace if required.

2. Rotate the valve stem counter-clockwise until it is removed from the valve base.

3. Inspect the needle and O-ring. Replace O-ring if required.

7.4.2 Assembly

1. Install all O-rings and apply a small amount of Dow

Corning ® 111 grease to the O-rings.

2. Carefully insert the valve stem into the valve base

6 and rotate clockwise approximately 5 full turns.

The final valve stem position will be set in Section

8 Service Checkout Procedure.

1

5

4

3

2

Description

1. Valve Stem

2. O-Ring

3. Valve Base

4. O-ring

5. Filter

6. O-ring

Timing Valve Assembly

7.5 Vacuum Limit - Pediatric ISU

Only

This step is only necessary if the vacuum limit is not holding steady over time.

1. Remove the cover by removing the three cover screws from the back of the unit.

2. Remove the screw, washer, and black plastic cam form the suction control knob.

3. Place 1/16” hex key wrench through hole in stud to engage wit the internal adjusting set screw.

4. Hold suction control knob in place and turn the set screw clockwise to remove it out the back.

NOTE: Set screw can not be removed by turning it counter-clockwise.

5. Place a small drop of 242 Loctite ® on the threads near the head end of the set screw.

6. Assemble set screw back into the stud. Insert the hex key wrench through knob and stud and engage head end of set screw. From knob site, turn hex key wrench counter-clockwise to start threads. Continue to assemble by turning counterclockwise until the end of the set screw is only protruding a small amount.

e re re e o e e e e e Cover o o

Co ro e r e e re e

18 6700-0082-000 (Rev.4) 10/2012

7. Assemble screw, washer, and black plastic cam on suction control knob.

8. Assemble cover onto unit. See Section 7.2.2

Assembly, Step 13.

9. Reset vacuum limit. See Section 8.10 Vacuum

Limit Adjustment - Pediatric ISU ONLY.

w WARNING: If the vacuum regulator is repaired or disassembled in any manner, the service checkout procedure (Section

8 Service Checkout Procedure) must be performed before using the equipment on the patient.

Important: This entire procedure must be performed in numerical order.

8.1 Set-up

1. Verify that a minimum of 500 mmHg (66.7 kPa) vacuum exists at the supply vacuum gauge.

2. The supply open flow must be 50 LPM minimum.

8/Service Checkout Procedure

8.2 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. Set the supply vacuum to 500 mmHg ± 10 mmHg

(66.7 kPa ± 1.3 kPa) on the supply vacuum gauge.

4. Turn the mode selector knob to O (OFF). Allow the fitting port to be open to air.

5. Wait 5 seconds.

6. No more than 5 bubbles should appear in the bubble leak tester for 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.

Vacuum Regulator

Supply Vacuum Gauge

0-760 mmHg (0-101.1 kPa)

Adapter

Port

Supply Regulator

Set to 500 mmHg (66.7 kPa)

Supply

Vacuum

Port B Port A

Fitting

Port

1/4 in I.D. Clear Tubing with Knife Edge

Water

Bubble Leak Tester

Bubble Leak Test - Supply Side

6700-0082-000 (Rev.4) 10/2012

Sealed

19


8.3 Flow Test

1. Remove the bubble leak tester from the supply vacuum connection and connect the supply vacuum directly to the regulator adapter port.

2. Set the supply vacuum to 500 mmHg ± 10 mmHg

(66.7 kPa ± 1.3 kPa) on the supply vacuum gauge.

8.3.1 Continuous Mode Flow Test

1. Connect the regulator fitting port to the 50 LPM flowmeter.


3. Rotate the suction control knob fully clockwise

(increase).

4. Verify that the flow rate exceeds :

Adult ISU: 40 LPM

Pediatric ISU: 25 LPM

8.3.2 Intermittent Mode Flow Test

1. Pull the nameplate wrench from the front of the regulator to access the flow control valve.

2. Occlude the regulator fitting port.


4. Set 120 mmHg (16.0 kPa) on the regulator gauge.


6. Connect the regulator fitting port to the 10 LPM flowmeter.

7. Turn the mode selector knob to |O|O| (INTER).

8. Locate the flow control valve in the regulator.

9. The flow rate must be adjusted during the “On” cycle of the intermittent mode. Using the proper tool, either a Phillips head screwdriver or a ball hex key wrench, adjust the flow control valve to produce a flow rate of 8 LPM. To increase the flow rate turn the valve counter-clockwise. To decrease the flow rate turn the valve clockwise.

Vacuum Regulator

“ON” Timing

Valve

“OFF” Timing

Valve

Flow

Control

Valve

Supply Vacuum Gauge

0-760 mmHg (0-101.3 kPa)

Supply Regulator

Set to 500 mmHg (66.7 kPa)

Mode

Selector

Knob

Suction

Control

Knob

Supply Vacuum

500 mmHg (6 6.7

kPa)

Minimum and Open flow of 50 LPM Minimum

Flowmeter

50 LPM

20

Flowmeter

10 LPM

Occluded

Low Vacuum

Calibration Gauge

225 mmHg (30 .0

kPa)

Service Checkout Tests

6700-0082-000 (Rev.4) 10/2012

1/2 Gallon

Reservoir

“ON” Timing

Valve


8.4 Gauge Test

Note: All Ohio Medical gauges are supplied with an accuracy of ±5% of full scale deflection throughout their range. The ISU vacuum gauges have an accuracy of:

Gauge Range Accuracy

0-200 mmHg (0-26.7 kPa) ± 10 mmHg (± 1.3 kPa)

0-760 mmHg (0-101.3 kPa) ± 38 mmHg (± 5.1 kPa)

0-160 mmHg (0-21.3 kPa) ± 8 mmHg (± 1.1 kPa)

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.

When checking gauge accuracy, be sure that the calibration gauge has an accuracy of 1% of full scale deflection or better.

1. Connect the regulator fitting port to the low vacuum calibration gauge with tubing.


3. Ensure that the regulator gauge is in agreement with the low vacuum calibration gauge within the tolerances listed above. Recommended test points are:

Adult ISU: 40, 80, 140 and 200 mmHg (5.3,

10.7, 18.7 and 26.7 kPa)

Pediatric ISU: 40, 80 and 120 mmHg (5.3,

10.7, and 16.0 kPa)

4. Adult ISU ONLY - Rotate the suction control knob fully clockwise (increase) and verify the gauge’s reading is in the FULL VAC range.

5. Rotate the suction control knob fully counterclockwise (decrease) and verify the gauge’s reading decreases to zero.

8.6 Timing Cycle Adjustment

w

WARNING: If the screws on the timing valves are turned all the way clockwise, the ISU and the Pediatric 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.

2. Turn the selector mode knob to | (CONT).


4. Turn the mode selector knob to |O|O| (INTER) with the fitting port still occluded.

5. Wait 20 seconds.

6. If the regulator does not cycle “On,” use a flat-head screwdriver to rotate the “Off” timing valve stem counter-clockwise until the regulator cycles “On.”

7. Wait 20 seconds.

8. If the regulator does not cycle “Off,” use a flat-head screwdriver to rotate the “On” timing valve stem counter-clockwise until the regulator cycles “Off.”

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 counter-clockwise.

10. Use Ohio Medical VACUTIMER (P/N 6700-0428-

800) to digitally adjust timing cycles.

8.5 Regulation Test

1. Disconnect the low vacuum calibration gauge from the regulator fitting port.

2. Occlude the fitting port.


4. Open and close the fitting port several times.

5. Check that the regulator gauge reads between:

Adult ISU: 80 mmHg (10.7 kPa) and 100 mmHg

(13.3 kPa) when the regulator fitting port is occluded.

Pediatric ISU: 82 mmHg (10.9 kPa) and 98 mmHg (13.1 kPa) when the regulator fitting port is occluded.

Timing valve stem

Flow Control valve access

Nameplate wrench

Setting the Timing Cycles and Intermittent Mode Flow Rate

6700-0082-000 (Rev.4) 10/2012 21


8.7 Vacuum Build-up/Bleed-

down Test - Intermittent

Mode

1. Connect the regulator fitting port to the 1/2 gallon reservoir.

2. During the “On” cycle, check that the suction increases to the preset 120 mmHg (16.0 kPa) on the regulator gauge in 5 seconds or less.

3. During the “Off” cycle, check that the suction decreases to zero on the regulator gauge (zero stop pin) in 5 seconds or less.

4. If the regulator fails either of the build-up or bleeddown tests, replace the regulator module.

8.8 Bleed Test


2. Occlude the regulator fitting port and set the vacuum level to 120 mmHg (16.0 kPa).

3. Turn the mode selector knob to O (OFF) and observe the gauge needle. It must return to zero within 10 seconds.

8.9 Leak Test - Patient Side


2. Connect the regulator fitting port tubing to port “A” of the bubble leak tester.

3. Rotate the suction control knob fully counterclockwise (decrease).


5. Wait 5 seconds.

6. No bubbles should appear in the bubble leak tester for the next 10 seconds.

8.10 Vacuum Limit Adjustment

- Pediatric ISU ONLY

w

WARNING: It may be possible to set the vacuum limit to zero. If there is no suction present, rotate set screw counter-clockwise and/or check Section 6 Troubleshooting.

To set the vacuum limit, perform the following procedure.

1. Occlude the regulator fitting port.

2. Remove the screw, washer and black plastic cam from the suction control knob.


4. Turn suction control knob until desired vacuum limit is reached. Factory set to 135 mmHg ± 10 mmHg (18.0 kPa ± 1.3 kPa).

Note: Internal adjusting set screw may need to be rotated counter-clockwise to reach desired vacuum limit; See Step 6.

5. Place 1/16” hex key wrench through hole in stud to engage with set screw.

6. Hold suction control knob in place and tighten set screw (clockwise) until the end of it bottoms out on the inside of the cap bore.

7. Turn suction control knob counter-clockwise and then back to the vacuum limit to test the limit setting.

8. Assemble screw, washer and black plastic cam on suction control knob.

Mode

Selector

Knob

Suction

Control

Knob

Sealed

Port B

Port A

Bubble Leak Tester

1/4” I.D. Clear

Tubing with

Knife Edge

Water

22

Bubble Leak Test - Patient Side

6700-0082-000 (Rev.4) 10/2012

9/Maintenance

9.1 General Maintenance of

Suction Equipment

w WARNING: The pre-use checkout procedure

(Section 4.4 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.

w WARNING: Clean and sterilize all suction equipment if contaminated before disassembly, to ensure service personnel are not exposed to hazardous contamination.

ISUs and Pediatric ISUs 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 canister 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. The flow rate measurement should meet NFPA ® 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. 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 canister for correct operation.

7. Perform the pre-use checkout procedure (Section

8 Service Checkout Procedure).

9.2 Recommended

Maintenance Schedule

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 8.4 Gauge

Test) and perform the pre-use checkout procedure

(Section 4.4 Pre-use Checkout Procedure). If the regulator does not pass, refer to troubleshooting

(Section 6 Troubleshooting).

2. Determine a maintenance schedule based on data from your periodic inspections. Following the guidelines below.

9.2.1 Maintenance Schedule

Item

Service Checkout Procedure

Minimum Frequency

Every 12 months

Elastomeric parts, O-rings, gaskets, diaphragms, positive pressure safety relief valves (Pediatric ISU ONLY), internal filters.

As required

Comments

If the regulator does not pass, refer to troubleshooting (Section 6

Troubleshooting). Repair as needed.

Cleaning, lubrication and replacement interval depends on hours of usage and environmental conditions. Replace and repair as needed.

6700-0082-000 (Rev.4) 10/2012 23


9.3 Repair Policy

w

WARNING: Clean and sterilize all multiple use suction equipment before shipment to ensure transportation personnel and /or service personnel are not exposed to any hazardous contamination.

w

CAUTION: Do not steam autoclave or liquid sterilize the ISU. Severe impairment to the operation of the regulator will result. The only acceptable method of sterilization is with gas

(ethylene oxide).

w

CAUTION: 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 this service manual 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

(Section 8 Service Checkout Procedure) to ensure that it is functioning properly and complies with the manufacturer’s 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. Clean and sterilize the vacuum regulator.

2. Package the vacuum regulator securely for protection, preferably in the original container.

3. 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.

4. Include a purchase order to cover repair of a regulator not under warranty.

5. Ship the vacuum regulator prepaid. Write your return address and billing address information on the package or letter that comes with the package.

For warranty and non-warranty repairs, mail the package to:

Ohio Medical Corporation

1111 Lakeside Drive

Gurnee, IL 60031

In other locations contact your nearest Ohio Medical office or authorized Ohio Medical distributor.

24 6700-0082-000 (Rev.4) 10/2012

10.1 Illustrated Parts

Parts Multi-Paks

10/Ordering Information

Kits*

Description

1. Gauge Assy. (Includes O-rings

and Lens)

North American Std, 0-200 mmHg

North American Low, 0-160 mmHg

International Std, ccw, 0-200 mmHg

International Low, ccw, 0-160 mmHg

2. Gauge Lens

3. O-ring, 2-012 Buna-N

4. Screw

5. Retaining Washer

6. Spiral Spring Washer

7. Detent Plate

8. Ball

9. Switch Main Valve Body


11. Regulator Module

Standard Model

Pediatric Model

12. Screw, 4-20, Ph. Hd

13. Screw, 4-40, Ph. Hd

14. Diaphragm



17. Gauge Filter

18. Flow Control Valve


20. Timing Valve



23. Filter

24. Unilogic Module

25. Filter, Green

26. Filter, Beige

27. Tube

28. Backplate Assy.

North American

International

28A. Backplate Assy. with Mount

Plate

North American Standard

North American Low

International Standard CE

International Low CE

29. Cover Screw

30. Nameplate Wrench

31. Cover & Knob Assy.

Standard Model

Pediatric Model

32. Mode Selector Knob

33. Suction Control Knob

Standard Model

Pediatric Model (order item 31)

34. Mounting Plate, Std ISU

Standard Model


35. Gasket

Standard Model


36. Screw

37. Positive Pressure Relief Valves

(Pediatric ISU Only)

38. Pediatric Mounting Plate

Assembly Only

39. Service Manual

Part Number

6700-0050-200

6700-0050-202

6700-0090-200

6700-0050-205

6700-0087-500

6700-0130-500

6700-0150-400

0402-0748-300

6700-0168-400

0214-3213-300

0409-1684-300

0221-5891-300

6700-0131-500

6700-1225-800

6700-0685-850

6700-0136-500

0210-0527-300

0210-6540-300

0207-0132-300

6700-0133-500

0207-8295-300

0210-0593-300

6700-0135-500

0221-5883-300

6700-0093-200

0221-5879-300

0221-5880-300

6700-0095-400

6700-0426-850

6700-0427-850

6700-0002-700

6700-0680-850

6700-0003-700

6700-0682-850

6700-0152-400

6700-0043-400

6700-0009-700

6700-0683-850

0221-5897-300

0221-5898-300

6700-0053-400

6700-0252-400

6700-0030-500

6700-0221-500

6700-0151-400

6700-0689-850

6700-0199-700

Part Number

0205-8689-870

6700-0098-200

6700-0026-700

6700-0686-850

0207-8298-870

6700-0024-700

6700-0090-700

6700-0681-850

6700-0091-700

6700-0684-850

0221-5852-870

0221-5853-870

6700-0687-850

*Kits contain the noted quantities of items in the

corresponding rows

4

4

6

6

6

4

4

4

4

4

6

6

2

2

4

2

1

2

1

2

4

2

1

1

2

4

1

4

2

2

1

6700-0082-000 (Rev.4) 10/2012

0221-5884-870 Filter Kit 6700-0030-700 Diaphragm Rpl Kit

1

1

2

1

1

1

2

1

1

25

10/Ordering Information

3

Description Part Number

1. Mounting Plate, ISU ................. 6700-0053-400

2. Gasket ..................................... 6700-0030-500

3. Serial Number Label

4. Screw (4 or 5) .......................... 6700-0151-400

10. Backplate Assembly ................ 6700-0043-500

(*)These parts are available as service kits. See section 10.2

.

10 4

2

1

10.2 Service Kits

1. Regulator Module Replacement

Kit ...............................................6700-0030-700

Includes the following parts:

O-ring, Stem

O-ring

Diaphragm

Stem Screw

Cap Screw (2)

These parts are available only in kit form. If other parts are needed for replacement, the entire Module must be ordered. (6700-1225-

800)

2. Complete Filter and O-ring

Replacement Kit ..........................0221-5887-300

Includes all O-rings (16) and Filters (5) for servicing the regulator

3. Complete O-ring Replacement

Kit ................................................0210-0474-870

Includes all O-rings (16) for servicing the regulator

4. Complete Filter Replacement

Kit ................................................0221-5884-870

Includes all Filters (5) for servicing the regulator

5. Mode Selector Knob Replacement

Kit ................................................0221-5897-300


Mode Selector Knob

Extension

Hardware

6. Suction Control Knob Replacement

Kit ................................................0221-5898-300


Suction Control Knob

Threaded Stud

Hardware

7a. ISU Backplate Replacement Kit,

North American ...........................6700-0002-700


Backplate Assembly

Gasket

ISU Mounting Plate

Screw (4)

7b. ISU Backplate Replacement Kit,

International ................................6700-0003-700


Backplate Assembly

Gasket

ISU Mounting Plate

Screw (4)

26 6700-0082-000 (Rev.4) 10/2012

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.

w 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

N-m) maximum.

Prior to installing the adapter/probe or fitting, seal the thread with Teflon ® (PTFE) tape or one of the following lubricants:

Dow Corning

Ball Vac Kote

0091-300)

® 111 (Ohio Medical P/N 6700-0074-200)

® (27951M) (Ohio Medical P/N 0220-

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.

6700-0082-000 (Rev.4) 10/2012

North America

United States

Customer Service, Distribution Center

Technical Support, Sales and Service

Equipment Service Center

Ohio Medical Corporation

1111 Lakeside Drive

Gurnee, IL 60031 USA

P: +1 866 549 6446

P: +1 847 855 0800

F: +1 847 855 6218

Ohio Medical Corporation Authorized

Representative

EC REP

OxygenCare Ltd.

2 Holfeld Business Park

Kilmacanogue Co Wicklow

Ireland

Tel: +353 1 2769700

Fax: +353 1 2764970

© 2012 Ohio Medical Corporation.

This document contains information that is proprietary and confidential to Ohio Medical Corporation. Use of this information is under license from Ohio Medical Corporation. Any use other than that authorized by Ohio Medical Corporation is prohibited.

Ohio Medical, Ohio Medical Corporation, and the Ohio Medical Corporation Logo are registered trademarks of Ohio Medical Corporation.

ISO is a registered trademark of International Organization for Standardization.

Loctite is a registered trademark of Loctite Corporation.

Teflon is a registered trademark of E.I. duPont de Demurs and Company

NFPA is a registered trademark of National Fire Protection Association, Inc.

Freon is a registered trademark of E.I. du Pont de Nemours and Company

Dow Corning is a registered trademark of Dow Corning Corporation

Vac Kote is a registered trademark of Ball Aerospace & Technology Corporation

ANSI is a registered trademark of American National Standards Institute

28 6700-0082-000 (Rev.4) 10/2012

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