| (On)

200

100

300

400

500

600

700

North American

High

Surgical/Free-Flow

Vacuum Regulators

Service Manual

|

(On)

LO

W

MED

40

60

100

80

120

Vacuum

140

-mm Hg

160

20

180

200

F ULL VAC

IG

H

Surgical/Free-Flow

North American

Standard

International

High

6700-0088-000 Rev.6 1

User Responsibility

Safety Instructions

This manual provides you with important information about the

Surgical/Free Flow Regulators. To ensure the safe and proper use of this device, READ and UNDERSTAND all of the safety and operating instructions. IF YOU DO NOT UNDERSTAND

THESE INSTRUCTIONS, OR HAVE ANY QUESTIONS,

REFER TO THIS SERVICE MANUAL, CONTACT YOUR

SUPERVISOR, DEALER OR THE MANUFACTURER

BEFORE ATTEMPTING TO USE THE DEVICE.

Receiving / Inspection:

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.

AAA A 12345 This alpha character indicates the year of product manufacture and when the Serial number was assigned;

“Y” = 1995, “Z” = 1996, “A” = 1997, etc.

“I” and “O” are not used.

CAUTIONS

Remove product from package and inspect for damage. If product is damaged, DO NOT USE and contact your dealer or equipment provider.

WARNINGS



Only competent individuals trained in the repair of this equipment should attempt to service it.

 Detailed information for more extensive repairs is included in this service manual.

 This device is to be used ONLY by persons who have

been properly trained on the operation of the device.

Incorrect use of this device may cause serious injury to a patient.

 Do not use this device in the presence of fl ammable

anesthetics. Static charges may not dissipate and a possible explosion hazard exists in the presence of these agents.

 Not for fi eld or transport use.*

* The categories of Field and Transport Use are specifi cally defined in ISO 10079-3 “Field” means accidents or emergencies outside the hospital. “Transport” means use in ambulances, cars and airplanes. These situations may expose the equipment to uneven support, dirt, water, mechanical shock and temperature extremes. Ohio

Medical suction equipment has not been tested to comply with the specifi c requirements of these categories.

.

 This device should ONLY be used for high fl ow,

high vacuum pressure applications. NEVER use the

Surgical Free-Flow Vacuum Regulator for low fl ow applications. Improper vacuum levels can cause a variety of injuries. To help reduce the risk of injury, appropriate suction applications MUST be used.

High Flow

vacuum pressure

Surgical/Free-Flow = high vacuum/high

fl ow regulator

When using the Surgical Free Flow Device, direct

contact with blood vessels and or vital organs should be avoided. Direct exposure of high vacuum levels to tissue may result in serious injury.

| (On)

O (Off)

= vacuum On

= vacuum Off

mmHg = Millimeters of Mercury

The Surgical Free Flow Device should never be

used for low fl ow vacuum applications, including endotracheal suctioning, nasogastric suctioning and

Chest Tube suction.

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 defective product should not be used. Parts that are broken, missing, 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 and any of its parts should only be repaired using 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

LPM in

o

C

o

F

DISS

= Liters per minute

= Inch

= Degress Celsius

= Degrees Fahrenheit

= Diameter Index Safety

System

= Consult Instructions for

Use

Table of Contents

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

1.1 Defi nitions ........................................................ 4

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

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

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

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

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

2.2 International Surgical/Free-Flow Vacuum

8.3.1 High Vacuum Gauges ONLY ................ 20

8.3.2 Standard Vacuum Gauges ONLY ......... 20

3/Description and Specifi cations .......................... 7

3.2 Specifi cations .................................................. 8

9/Maintenance ....................................................... 22

9.1 General Maintenance of Suction

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

4.1.1 Attaching the Overfl ow Safety Trap ...... 10

9.2 Recommended Maintenance Schedule ........ 22

9.2.1 Maintenance Schedule ......................... 22

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

4.4 Pre-use Checkout Procedure .........................11

5/Cleaning and Sterilization ................................. 13

10/Ordering Information ....................................... 24

10.1 Illustrated Parts ............................................. 24

10.2 Service Kit ..................................................... 25

5.1.1 Routine Exterior Cleaning .................... 13

5.1.1.1 Approved Cleaning Solutions ... 13

5.1.2 Internal Component Cleaning ............... 13

Appendix

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

6/Troubleshooting ................................................ 14

6700-0088-000 Rev.6 3

1/Precautions

1.1 Defi nitions

Note: A Note provides additional information to clarify a point in the text.

After patient use, regulators may be contaminated.

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

Important: An Important statement is similar to a note but of greater emphasis.

CAUTION:

Indicates a potentially hazardous situation, which if not avoided, could result in damage to the device or other property.

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

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

WARNING: I

ndicates a potentially hazardous situation, which if not avoided, could result in death or serious injury.

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).



Attention. Alerts you to a warning or caution in the text.

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.

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 qualifi ed service personnel.

ALWAYS connect the regulator to the vacuum source and check its operation BEFORE attaching the patient connection.

Connect the vacuum regulator to the vacuum source ONLY. Connection to pressure sources, even momentarily, could injure the patient or operator and damage the equipment.

The fi tting 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 fl ammable anesthetics. Static charges may not dissipate and a possible explosion hazard exists in the presents of these agents.

1/Precautions

1.3 Cautions

1.4 Intended Use

Cleaning the gauge may cause damage which will result in inaccurate readings.

DO NOT steam autoclave or liquid sterilize the Surgical/

Free-Flow Vacuum Regulator. Severe impairment to the operation of the regulator will result. The only acceptable method of sterilization is with gas (ethylene

The Ohio Medical Corporation

®

Surgical/Free-Flow

Vacuum Regulator is a vacuum-powered body fl uid suction apparatus that is intended to collect and remove body fl uids in High Pressure/High Flow applications; generally in surgical procedures to aspirate fl uid and debris from surgical fi elds.

oxide).

DO NOT use any Loctite

®

products or any products which contain methacrylate ester as an active ingredient to seal the threads on the adapters/probes and fi ttings.

Only competent individuals trained in the repair of this equipment should attempt to service it.

Sterilization with ethylene oxide mixtures may cause crazing (minute superfi cial cracking) of some plastic parts. Crazing will be more pronounced when mixtures containing Freon

®

are used.

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, a safety trap and suction fi lter should be attached prior to its use. Aspirate in the regulator, wall outlet and pipeline equipment may impair its operation. The use of the safety trap and suction fi lter 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.

.

U

se of lubricants other than recommended may degrade plastic or rubber components (Section

7.1 Servcice Tools and Equipment).

6700-0088-000 Rev.6 5

2/Scope

This service manual contains service, maintenance, and parts information on fi ve models of the Surgical/

Free-Flow Vacuum Regulator:

2.1 North American Surgical/Free-

Flow Vacuum Regulators

2.2 International Surgical/Free-

Flow Vacuum Regulator

Note: Part numbers given are for vacuum regulators without fi ttings or adapters.

Note: Part numbers given are for vacuum regulators without fi ttings or adapters.

High

6700-1247-900

Clockwise

0 to 700 mmHg

| (On)

200

300

400

500

600

100

700

High

6700-1248-900

Counter-clockwise

0 to 760 mmHg

(0 to 101.3 kPa)

Standard

6700-1246-900

Clockwise

0 to 200 mmHg

| (On)

MED

W

LO 40

60

80

100

-mm Hg

120

140

160

20

180

200

F ULL VAC

Surgical/Free-Flow

3/Description and Specifi cations

3.1 Description

WARNING

and gauge from the vacuum circuit, preventing damage from aerosols and contaminants. For added durability, the regulator is housed in an impact resistant case.

 Do not use this device in the presence of

fl ammable anesthetics. Static charges may not dissipate and a possible explosion hazard exists in the presents of these agents.

All models contain a vacuum gauge which indicates suction supplied by the regulator. Both High Vacuum (0 to 760 mmHg [0 to 101.3 kPa]) and Standard (0 to 200 mmHg [0 to 26.7 kPa]) options are available.

The Surgical/Free-Flow Vacuum Regulator is designed for applications in high-use areas where high fl ow rates and minimal maintenance requirements are of signifi cant benefi t.

The Surgical/Free-Flow Vacuum Regulator is available with a wide variety of direct mounting and bracket mounting confi gurations. These confi gurations enable the regulator to be used with virtually any centrally piped system. The regulator can be easily disassembled for maintenance and cleaning.

Flow rates of up to 150 LPM are made possible by the use of a large bore, unobstructed passage through the regulator. In place of the conventional diaphragm-valve assembly, the regulator uses a unique device called a regulating bar to control suction. During use, as the fl ow requirement increases, the regulator bar automatically opens to maintain suction at the preset level. When the fl ow requirement decreases, the regulator bar automatically closes to maintain suction at the preset level. The same mechanism compensates for changes in supply vacuum to automatically maintain the preset suction level.

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

2. Mode Selector Switch - Allows quick mode changes.

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

b. | (On) - Suction can be adjusted with the suction control knob.

This unique design adds reliability and extended service life because it isolates the regulating apparatus

3. Vacuum Gauge - Displays the suction level to the patient during use.

Mode

Selector

Switch

| (On)

Vacuum

Gauge

200

300

400

500

600

100

700

Adapter

Port

Suction

Control

Knob Wrench

Fitting Port

Front and Side View

6700-0088-000 Rev.6 7

3/Descriptions and Specifi cations

3.2 Specifi cations

Gauge:

Flow Rate:

Accuracy: ±5% of full scale defl ection

0 to 150 LPM without fi ttings at full increase setting depending on supply vacuum and open air fl ow.

Regulated Suction Ranges:

Standard Model

High Models

Weight:

(Less Fittings)

Dimensions:

(Less Fittings)

Latex Tubing, 0.25 in (6.4 mm) ID X

12 in (30 cm) supplied:

Disposable tubing (Available separately in some markets;

6 mm ID X 450 mm, 750 mm and 2 m) to connect regulator and collection bottle

Disposable Suction Filter:

Environmental Specifi cations

Operating Temperature Range:

Storage Temperature Range:

Operating and Storage Relative Humidity

0 to 200 mmHg (0 to 26.7 kPa)

0 to 760 mmHg (0 to 101.3 kPa)

22 oz (624 g)

Height: 7 in (178 mm)

Width: 3.5 in (89 mm)

Depth: 4.6 in (117 mm)

0 to full vacuum

Flow dependent on source and setup

0 to full vacuum

Flow dependent on source and setup

0 to full vacuum

0 to 100 LPM @ 650 mmHg (86.7 kPa)

40 to 120 o F (4 to 49 o C)

0 to 160 o

F (-18 to 71 o

C)

5 to 95%

4/Operation

4.1 Equipment Set-up

Use hospital-supplied suction tubing between the vacuum regulator and the collection container, as well

WARNINGS:

as between the patient port of the collection container

 Connection to positive pressure sources

such as oxygen and medical air, even

and the patient (minimum inside diameter is 0.25 in [6 mm]).

momentarily, could injure the patient or operator.

An Ohio Medical ® high fl ow suction fi lter and/or overfl ow safety trap should be used between the collection

 Always connect the regulator to the vacuum

source and check its operation before

container and regulator to prevent contamination of the regulator, wall outlet and pipeline equipment.

attaching the patient connection.

ISO 10079-3 (Section 5.1.2.) states that “the usable

CAUTIONS:

volume of the collection container shall be not less than 500 mL.”

 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 for wall outlets, insert the adapter into the vacuum wall outlet. If the regulator is mounted elsewhere, connect a vacuum supply hose between the regulator’s adapter port and

High Flow Suction Filters

Hydrophilic

Pkg of 20 6730-0350-800

Pkg of 200 6730-0351-800

Hydrophobic

Tubing NPT

the wall outlet. Connect the collection bottle’s vacuum port to the regulator’s fi tting or overfl ow safety trap with the appropriate vacuum tubing.

Pkg of 3

Pkg of 10

Pkg of 50

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

6730-0570-800

6730-0571-800

6730-0572-800

6730-0580-800

6730-0581-800

6730-0582-800

Vacuum

Regulator

Vacuum

Port

O(OFF)

400

600

200

300

400

500

600

100

700

100

Patient Port

Connective

Tubing

Disposable

Suction Filter

Surgical/Free-Flow

Collection

Bottle

Underwater Seal Line

2

O

Made in USA

Overfl ow

Safety Trap

Equipment Set-up

6700-0088-000 Rev.6 9

4/Operation

4.1.1 Attaching the Overfl ow Safety

Trap (OST)

4.2 Mode Selection

CAUTION

| (On) - Suction can be adjusted with the suction control knob.

| (On)

 To help prevent aspirate from entering the regulator, wall outlet and pipeline equipment, a safety trap should be attached prior to its use.

Aspirate in the regulator, wall outlet and pipeline equipment may impair their operation. The use of the safety trap and suction fi lter will help prevent this and extend the life of suction equipment.

| (On)

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

O (Off)

Trap fi tting

1. Raise the sleeve and insert the trap into the regulator fi tting.

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 fi tting provides a vacuum seal. The trap should rotate freely to allow the desired tubing positioning.

3. Lower the sleeve to lock the trap in position.

 Regulator

 Sleeve

3 Safety Trap





4.3 Setting the Suction Level

WARNING

 The regulator MUST be occluded when

setting the prescribed suction level so that the patient does not receive higher than required suction.

1. Clamp the connective tubing to occlude the fi tting port.

2. Turn the mode selector switch to | (On).

| (On)

3

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

600

400

500

40

70

200

80

High Flow

High Vacuum

300

200

100

700 100

- kP a

-mm

Hg

Surgical/Free-Flow

DISS fi tting

1. Insert the trap into the regulator fi tting. Situate the tubing in the desired position.

2. Turn the DISS wing nut clockwise to engage the threads and tighten (there is no O-ring, so the vacuum seal depends on a tight connection).



 Regulator

 Wing Nut

3 Safety Trap



Clamp

3

4/Operation

4.4 Pre-use Checkout Procedure

WARNING

7. With the tubing still clamped, increase the suction to 300 mmHg (40.0 kPa). (For the standard model, increase the suction to 100 mmHg [13.3 kPa]).

 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 qualifi ed service personnel.

8. Slowly open and close the clamped tubing to create various fl ow rates through the regulator.

Ensure that the suction level is maintained when the tubing is clamped.

 Always connect the regulator to the vacuum

source and check its operation before attaching the patient connection.

Clamp

| (On)

400

600

500

40

70

200

80

High Flow

High Vacuum

300

10

700

700

100

- kP a

-mm

Hg

200

100

Surgical/Free-Flow

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 450 mmHg (60.0 kPa).

Release

Clamp

1. Turn the mode selector switch to O (Off).

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

3. Clamp tubing to occlude the fi tting port. The gauge needle should not move.

O(OFF)

600

400

300

500

80

40

High Flow

High Vacuum

500

30

200

100

700 100

-mm

Hg

9. Reduce the suction level to zero and set the mode selector switch to O (Off).

O(OFF)

600

500

80

400

300

400

50

40

High Flow

High Vacuum

500

30

200

100

700 100

- kP a

-mm

Hg

Surgical/Free-Flow

Surgical/Free-Flow

Clamp

4. With the tubing still clamped, set the mode selector switch to | (On)

| (On)

5. The gauge needle should not move.

6. Rotate the suction control knob fully anti-clockwise (decrease).

600

500

400

80

300

40

High Flow

High Vacuum

500

30

200

100

700

100

- kP a

-mm

Hg

Surgical/Free-Flow

Clamp

6700-0088-000 Rev.6 11

4/Operation

4.5 Patient Set-up

1. Make sure the pre-use checkout procedure

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

6. Turn the mode selector switch to | (On).

| (On)

2. Clamp the connective tubing and set the mode selector switch to | (On).

400

600

500

50

40

70

200

80

High Flow

High Vacuum

300

200

100

700

100

- kP a

-mm

Hg

3. Set the prescribed suction level.

WARNING

 The regulator MUST be occluded when

setting the prescribed suction level so that the patient does not receive higher than required suction.

Surgical/Free-Flow

Underwater Seal Line

Made in USA

| (On)

600

400

500

40

70

200

80

High Flow

High Vacuum

300

10

700

700 100

- kP a

-mm

Hg

200

100

Surgical/Free-Flow

Underwater Seal Line 2 cm H

2O

Made in USA

Clamp

4. Turn the mode selector switch to O (Off).

5. Attach tubing to the vacuum port of the collection container.

Patient

Connective

Tubing

O(OFF)

500

600

80

400

300

40

High Flow

High Vacuum

500

30

200

100

700 100

- kP a

-mm

Hg

Surgical/Free-Flow

Underwater Seal Line

Made in USA

5/Cleaning, Disinfection and Sterilization

5.1 Cleaning and Disinfection 5.2 Sterilization

WARNING

Should misuse occur, resulting in accidental fl ooding

 After patient use, regulators may be of the regulator, the regulator may be sterilized using ethylene oxide (ETO). After sterilization, follow the

contaminated. Handle in accordance with

instructions in Section 8 Service Checkout Procedure.

your hospital’s infection control policy.

WARNING

5.1.1 Routine Exterior Cleaning

Routine cleaning of the regulator is recommended as a

 Following sterilization with ethylene oxide,

parts should be quarantined in a well

standard procedure after each use.

ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material.

Wipe all exterior surfaces with a solution of water and

Aerate parts for 8 hours at 130 o F (54 o C)

mild detergent and/or an approved cleaning solution.

CAUTION

5.1.1.1 Approved Cleaning Solutions

• Virex

®

(Quaternary Ammonium 0.2%): Mixture of

1 fl . oz. of Virex

®

to 1 gallon (128 fl . oz.) tap water using Virex ® 128

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

• 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

 Sterilization with ethylene oxide mixtures may cause crazing (minute superfi cial cracking) of some plastic parts. Crazing will be more pronounced when mixtures containing Freon® are used.

Note: The vacuum regulator should only be sterilized if it is contaminated or maintenance is to be performed.

1. The regulator should be sterilized with the mode selector switch in the | (On) position.

• Hydrogen Peroxide 3%

• Cavicide

5.1.2 Internal Component Cleaning

CAUTION

® : Ready to use full strength

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 to 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.

 Cleaning the gauge may cause damage which will result in inaccurate readings.

1. To disasssemble the unit, 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. After each sterilization check the condition of the fi lter. The fi lter is located just above the fi tting port at the rear of the regulator. If the fi lter appears to have shrunk, replace it before placing the regulator back in service.

3. Dry all components with a lint-free cloth before assembly.

Place the regulator in the vertical position and connect to a supply vacuum of 450 mmHg (60.0 kPa).

4. Perform service checkout procedure (Section 8

Service Checkout Procedure).

6700-0088-000 Rev.6 13

6/Troubleshooting

Problem

A.

No gauge indication and

B.

no suction in any setting

No gauge indication but suction is being delivered

Possible Causes

1.

2.

3.

4.

No supply vacuum

Poor connection

Blocked adapter port

Blocked backplate

Remedy

1.

2.

3.

4.

5.

Correct supply problem

Check all connections and seals

Unblock port

Clean with soap and water and a bottle brush

Unblock/replace

1.

Unblock orifi ce

5.

Blocked adapter

1.

2.

3.

4.

Blocked gauge pressure sensing orifi ce

Gauge mechanism locked by debris

Gauge mechanism damaged

Tubing connected to bellows is blocked or disconnected

2.

Remove debris

3.

4.

Replace gauge

Unblock or reconnect tubing

C. Gauge indication but no suction is being delivered

1.

2.

Blocked fi tting port

Overfl ow safety trap shut off

D. Suction level cannot be adjusted

3.

4.

5.

1.

2.

3.

Blocked external fi lter

Blocked fi tting

Gauge mechasim locked by debris

Loose regulating bar

Tubing connected to bellows is blocked or disconnected

Damaged or loose valve tube

E.

Inaccurate gauge reading

Note: All gauge needles should come to rest within the zero range bracket or return to the stop pin when no suction is being supplied.

F.

With the fi tting port occluded, unable to decrease the suction level and gauge needle does not return to zero when switched to O (Off)

G. Mode selector switch sticks in O (Off) or | (On) position

1. Damaged gauge

1.

2.

1.

2.

Blocked fi lter and/or orifi ce

Damaged gauge

Dry or damaged O-rings

Contaminated passage ways

1.

2.

3.

4.

5.

Unblock port

Reset fl oat and/or empty overfl ow safety trap

Replace external fi lter

Replace fi tting

Remove debris

1.

2.

Tighten regulating bar

Unblock or reconnect tubing

3.

Replace or reconnect valve tube

1. Replace gauge

1.

2.

Clear orifi ce and replace fi lter

Replace gauge

1.

2.

Lubricate or replace and lubricate

O-rings

Remove and clean mode selector switch assembly

H. Insuffi cient fl ow through regulator

1.

Partial blockage in wall supply

2.

Partial blockage in regulator

1.

2.

Confi rm wall supply open air fl ow meets minimum hospital requirements

Unblock if necessary.

Perform the fl ow test in the service checkout procedure section of this m anual (Section 8.2 Flow Test).

Clear blockage if necessary.

7/Service - Disassembly and Assembly

7.1 Service Tools and Equipment 7.2 Disassembly

CAUTION

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

The following items should be on hand during any service procedure.

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.

• Supply vacuum: 450 mmHg (60.0 kPa) minimum and 80 LPM open air fl ow minimum

• Low vacuum calibration gauge, 225 mmHg (30.0 kPa) full scale*(Ohio Medical P/N 6700-0353-800)

 Clean and sterilize all suction equipment

if contaminated before disassembly, to ensure service personnel are not exposed to hazardous contamination.

• High vacuum calibration gauge, 760 mmHg (101.3 kPa) full scale*(Ohio Medical P/N 6700-0352-800)

CAUTION

800)

 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.

• Bubble leak tester

• Hexagonal allen wrench, 3/32 in

• Phillips head screwdriver, No. 2

• Flat head screwdriver, 1/4 in

• Open end wrench, 5/16 in

• Wooden toothpick (O-ring remover)

Corning

®

111 grease Ohio Medical P/N 6700-

0074-200)

6700-0088-000 Rev.6 15

7/Service - Disassembly and Assembly

10

12

18

14

13

16

16

17

19

20

12

14

13

14

13

15

8

11

9

7

6

5

4

3

2

1

Item & Description

1. Screw, Socket Head Cap, 4-40 x 1/2”

3. Washer, Flat .28” OD, .125” ID

n)

| (O

21

9. Snap Fit Lens

10. O-rings (2), Gauge

11. Gauge Assembly (Includes gauge, O-rings, and lens)

12. Tubing, .125” OD (2)

13. Adapter (3)

14. O-ring (3)

15. Bellows

16. Nut, Elastic Stop, 6-32 (4)

17. O-ring, 2-010, Buna-N (2)

18. Surgical/Free-Flow Base

19. Bottom Connector

20. Screw, Flat Head 6-32 X 1/2” (2)

21. Selector Switch Assembly

22. Washer, Flat

23. Screw, Buttonhead Cap, 8-32 X 5/16”

24. Inlet Connector, Universal

25. Screw, Round Head 6-32 X 7/8” (2)

26. Filter

27. Screw, No. 6 Pan Head (4)

28. Valve Tube

29. Regulating Bar

30. Screw, Buttonhead Cap 8-32 X 3/8” (4)

31. Rear Window

32. Tubular Speed Clip

33. Locking Knob

30

33

32

30

31

25

24

23

22

17

29

28

26

27

(4 required)

18

16

7/Service - Disassembly and Assembly

1. Remove the four screws located at the corners of the back cover. Hold the regulator with the front cover and knob facing upward. Rotate the suction control knob clockwise until the cover/knob assembly is free of the rest of the regulator.

2. Unscrew the cap screw from the suction control knob on the front cover. Pull the suction control knob off.

3. Carefully pull the gauge assembly out of its mount on the base. The snap fi t lens can also be removed

(If applicable).

Pull down plastic tab with right index fi nger whuile holding gauge frame with left hand.

Snap Fit Lens Removal

4. Remove the two small tubes which are connected from the bellows to the base.

5. Use the locking wrench to remove the two screws holding the rear window in place. Remove the window.

6. Locate the regulating bar inside the recessed enclosure. Unscrew the two retaining screws and remove the regulating bar and bellows.

7. Remove the valve tube from the recessed enclosure.

8. Remove the adapter and fi tting ports and associated

O-rings.

9. Pull the internal fi lter out of the socket using a pair of tweezers.

10. Loosen the screw that holds the selector switch assembly in position and pull the selector switch assembly out of the base.

Detail Back Cover

6700-0088-000 Rev.6 17

7/Service - Disassembly and Assembly

7.3 Assembly

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 the adapter and fi tting port O-rings. appropriate O-rings to the base.

8. Place the knurled end of the control shaft through its hole in the front cover and slide the suction control knob onto the shaft. Place the curved spring washer and fl at washer in the center hole of the knob.

9. Start the cap screw in the hole. Run the screw all the way in until the knob is locked in position. The locking cam should be in place on the screw head so that it seats against the tab in the control knob from a clockwise direction.

2. Install a new fi lter.

3. Connect the valve tube and install the bellows and regulating bar to the base.

10. Loosen the cap screw one turn counter-clockwise until the cam hits the tab on the control knob. If the suction control knob does not turn freely, loosen the cap screw.

4. Install the rear window. Use the locking wrench to tighten the two screws.

11. Hold the base assembly with the bellows and gauge facing upward.

5. Connect the two small tubes from the bellows to the base.

6. Lubricate the selector switch assembly O-rings and fi t into the base assembly. Tighten the retaining screw which holds the selector switch assembly in place. To prevent damage to the plastic base, do not over tighten the screw.

12. Place the cover over the base and engage the control shaft with the bellows by turning the suction control knob counter-clockwise.

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

7. Lubricate the gauge assembly O-rings. Fit the gauge into the base assembly.

14. Perform the service checkout procedure (Secton 8

Service Checkout Procedure) before returning the regulator to service.

WARNING

 If the vacuum regulator is repaired or

disassembled in any manner, the service checkout procedure must be performed before using the equipment on a patient.

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

8/Service Checkout Procedure

Mode

Selector

Switch

| (On)

Supply Vacuum Gauge

0 to 760 mmHg (0 to 101.3 kPa)

200

400

300

Vacuum

500

600

100

700

Vacuum

Regulator

Suction

Control

Knob

Supply Vacuum

450 mmHg (60.0 kPa) minimum and open fl ow of 80 LPM minimum

Occluded

Flowmeter

50 LPM

High Vacuum

Calibration Gauge

760 mmHg (101.3 kPa)

Low Vacuum

Calibration Gauge

225 mmHg (30.0 kPa)

Service Checkout Tests

6700-0088-000 Rev.6 19

8/Service Checkout Procedure

8.1 Set-up

8.3.2 Standard Vacuum Gauge ONLY

1. Verify that there is a minimum of 450 mmHg (60.0 kPa) vacuum on the supply gauge.

1. Connect the regulator’s fi tting port to the low calibration gauge with tubing.

2. The supply open fl ow must be 50 LPM minimum.

2. Set the mode selector switch to | (On).

3. Connect the supply vacuum to the adapter port.

8.2 Flow Test

3. Ensure that the gauge is in agreement with the low vacuum calibration gauge within the ± 10 mmHg

(± 1.3 kPa) tolerance. Recommended test points are 40, 80, and 140 mmHg. (5.3, 10.7, and 18.7 kPa)

1. Connect the regulator’s fi tting port to the fl owmeter with tubing.

2. Set the mode selector switch to | (On) and rotate the suction control knob fully clockwise (increase).

3. Verify that the fl ow rate exceeds 30 LPM.

8.4 Regulation Test

1. Disconnect the calibration gauge and occlude the fi tting port.

4. Set the mode selector to O (Off).

2. Depending on the type of regulator, perform one of the following.

8.3 Gauge Test

Note: All Ohio Medical gauges are supplied with an accuracy of ±5% of full scale defl ection throughout their range. The table below is provided for reference.

a. If using a high vacuum regulator (North American or International), set the gauge to 300 mmHg

(40.0 kPa).

b. If using a standard vacuum regulator (North

American), set the gauge to 100 mmHg (13.3 kPa).

3. Open and close the fi tting port several times.

Standard

Vacuum

0 to 200 mmHg

(0 to 26.7 kPa)

± 10 mmHg

(± 1.3 kPa)

4. With the fi tting port occluded, the gauge should return to the setting listed in step 2 within a tolerance of:

High

Vacuum

0 to 760 mmHg

(0 to 101.3 kPa)

± 38 mmHg

(± 5.1 kPa)

Note: All gauge needles should come to rest within the zero range bracket or return to the stop pin when no suction is being supplied. Gauge needles which do not comply may be out of calibration.

± 38 mmHg (± 5.1 kPa) for the high vacuum gauge or

± 10 mmHg (± 1.3 kPa) for the standard vacuum gauge

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

8.5 Bleed Test

100 mmHg (13.3 kPa).

8.3.1 High Vacuum Gauges ONLY

1. Connect the regulator’s fi tting port to the high calibration gauge with tubing.

2. Set the selector switch to O (Off) and observe the gauge needle. It must return to the zero range bracket or stop pin within 10 seconds.

2. Turn the mode selector switch to | (On).

3. Ensure that the gauge is in agreement with the high vacuum calibration gauge within the ± 38 mmHg

(± 5.1 kPa) tolerance. Recommended test points are 100, 300, and 400 mmHg (13.3, 40.0, and 53.3 kPa).

8.6 Leak Test

1. Set the mode selector switch to O (Off).

tester port A with tubing.

3. Rotate the suction control knob 1/2 turn in the clockwise (increase) direction.

4. Observe the bubble leak tester. No bubbles should appear.

5. Rotate the suction control knob fully in the counterclockwise (decrease) direction.

6. Set the mode selector switch to | (On).

7. Observe the bubble leak tester. No bubbles should appear.

8/Service Checkout Procedure

Mode

Selector

Switch

O (OFF)

200

400

300

Vacuum

500

600

100

700

Port B

Vacuum

Regulator

Port A

Suction

Control

Knob

Sealed

1/4” ID Clear

Tubing with

Knife Edge

1.0 in

Water

Bubble Leak Tester

Bubble Leak Test Set-up

6700-0088-000 Rev.6 21

9/Maintenance

9.1 General Maintenance of

Suction Equipment

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.

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 qualifi ed service personnel.

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.

 To reduce service personnel exposure

4. Check that the high fl ow disposable suction fi lter is

to hazardous contamination, clean and

clean and in good condition.

disinfect all suction equipment before disassembly. Surgical/Free-Flow Vacuum

5. Check that all tubing is in good condition and

Regulators should be kept in use or used

connected securely to the correct ports.

on a rotating basis. Unused equipment may tend to deteriorate.

6. Check the fl oats in the overfl ow safety trap and collection bottle for correct operation.

Maintenance of the vacuum piping system is as important as maintenance of the suction equipment.

The use of collection bottles with reliable shut-off valves, overfl ow safety trap assemblies and disposable suction fi lters will protect the regulator and piping system. The fl ow rate at the wall outlet should be checked on a yearly basis and suitable cleaning of the outlets should be performed. The fl ow rate measurement should meet local standards.

7. Perform the pre-use checkout procedure.

9.2 Recommended Maintenance

Schedule

In addition to the pre-use checkout procedure, the following periodic maintenance should be performed.

9.2.1 Maintenance Schedule

Item

Service Checkout Procedure

Minimum Frequency

Every 4 months

O-Rings Inspect every 4 months; Replace every 24 months

Comments

If the regulator does not pass th e service checkout procedure

(Section 8 Service Checkout

Procedure), refer to Section 6

Troubleshooting of this manual.

Repair as necessary.

Replace as necessary to minimize in use failures.

Internal Filters

Valve Tube

High Flow Disposable Suction

Filter

Inspect every 4 months;

Inspect every 4 months

Replace after each patient use

Replace as necessary.

Replacement interval will depend greatly on hours of usage and condition of operating environment.

Replace as necessary

Replace more frequently if fl ow deteriorates

9/Maintenance

9.3 Repair Policy 9.5 Return Instructions

WARNING

of this equipment should attempt to service it.

1. Call for a Return Material Authorization (RMA) number before sending any items for warranty and/

before shipment for service to ensure

sterilization is with gas (ethylene oxide).

or non-warranty repair. (1-866-549-6446)

transportation personnel and/or service

2. Clean and sterilize the vacuum regulator.

personnel are not exposed to any hazardous contamination.

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

CAUTIONS

4. Include a letter describing in detail any diffi culties

 Do not steam autoclave or liquid sterilize the

Surgical/Free-Flow Vacuum Regulator. Severe experienced with the vacuum regulator. Include the impairment to the operation of the regulator person, title, and telephone number to contact for will result. The only acceptable method of functional questions.

5. If the vacuum regulator is under warranty, include the warranty information that came with the device and a copy of the invoice.

Do not use malfunctioning equipment. Make all necessary repairs. Have the equipment repaired by qualifi ed service personnel or by Ohio Medical. Parts listed in the service manual for this product may be repaired or replaced by a competent, trained person who has experience in repairing devices of this nature.

After repair, perform the service checkout procedure

(Section 8 Service Checkout Procedure) to ensure that it is functioning properly, and complies with the published specifi cations.

9.4 Technical Assistance

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

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

For U.S.A. Warranty and Non-Warranty Repairs, mail the package to:

Ohio Medical Corporation

1111 Lakeside Drive

Gurnee, IL 60031

RMA #________________

If technical assistance is required, contact Ohio Medical technical support listed on the back cover.

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

9.6 Disposal Instructions

Dispose of vacuum regulator in accordance with local regulations.

6700-0088-000 Rev.6 23

10/Ordering Information

10

18

16

12

16

14

10

14

13

19

17

20

12

13

14

15

8

11

9

10.1 Illustrated Parts

Item & Description Part Number

1. Screw, Socket Head Cap,

4-40 X 1/2” .................................6700-0170-400

3. Washer, Flat .28” OD, .125” ID .....6700-0174-400

7

6

5

4

3

2

1

North American ..........................6700-0250-100

International ...............................0206-5154-300

9. Snap Fit Lens ...............................6700-0087-500

10. O-rings (2), Gauge .......................6700-0130-500

11. Gauge Assembly (Includes gauge, O-ring, and

lens)

North American Standard ...........6700-0050-200

North American High ..................6700-0050-201

International High .......................6700-0050-204

12. Tubing, .125” OD (2) ....................0206-5186-300

13. Adapter (3) ...................................6700-0173-400

14. O-ring (3) ......................................0210-0593-300

15. Bellows Assembly (Includes bellows, adapters and O-rings) ..................6700-0165-700

16. Nut, Elastic Stop, 6-32 (4) ............6700-0175-400

17. O-ring (2) ......................................6700-0131-500

18. Base Assembly (Includes base, adapter, and serial number label)

North American ..........................6700-0161-700

International ...............................6700-0162-700

19. Bottom Connector ..........................0206-5195-300

20. Screw, Flat Head 6-32 X 1/2” (2) ...6700-0171-400

10/Ordering Information

n)

| (O

21

16

24

23

22

17

18

25

26

30

27

(4 required)

29

30

28

31

32

33

Item & Description Part Number

21. Selector Switch Assembly

North American ..........................6700-0067-700

International ...............................6700-0067-701

22. Washer, Flat .................................6700-0164-400

23. Screw, Buttonhead Cap,

8-32 X 5/16” ...............................6700-0165-400

24. Inlet Connector, Universal ............0206-5149-300

25. Screw, Round Head

6-32 X 7/8” (2) ............................6700-0176-400

26. Filter .............................................0206-5181-300

27. Screw, No. 6 Pan Head (4)...........6700-0151-400

28. Valve Tube ....................................0206-5182-300

29. Regulating Bar..............................0206-5183-300

30. Screw, Buttonhead Cap

8-32 X 3/8” (4) ............................6700-0172-400

31. Rear Window ................................0206-5180-300

32. Tubular Speed Clip .......................0206-5163-300

33. Locking Knob................................0212-1932-300

10.2 Service Kit

Selector Switch Assembly Replacement

Kit, ..................................................... 6700-0013-200

Kit includes:

Buttonhead Screw, 8-32

Flat Washer

Selector Switch Assembly

6700-0088-000 Rev.6 25

Appendix

Installation procedure for Adapters/Probes and

Fittings.

CAUTION

All adapters/probes and fi ttings 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 fi ttings seal on the thread and may have threads exposed after they have been tightened properly.

 Do not use any Loctite ®

products or any products which contain methacrylate ester as an active ingredient to seal the threads on the adapters/ probes and fi ttings.

The torque range for installing adapters/probes and fi ttings 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 fi tting, seal the thread with Tefl on® (PTFE) tape or one of the following lubricants:

Adapters/probes and fi ttings which are not keyed for specifi c orientation, should be torqued to approximately

6.0 ft-lb (8.1 N-m).

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

Ball Vac Kote

®

(37951M) (Ohio Medical P/N 0220-

0091-300)

Adapters/probes and fi ttings that are keyed to specifi c orientation, must be torqued initially to 4.0 ft-lbs.

Additional torque is applied only until orientation is correct.

Notes

6700-0088-000 Rev.6 27

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 0500

F: +1 847 855 6218

EC REP

OxygenCare Ltd.

2 Holfeld Business Park

Kilmacanogue Co Wicklow

Ireland

Tel: +353 1 2769700

Fax: +353 1 2764970

© 2013 Ohio Medical Corporation.

This document contains information that is proprietary and confi dential 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 Corporation is a registered trademark and Push-to-Set is a trademark of Ohio Medical Corporation.

ISO is a registered trademark of International Organization for Standardization.

Vac Kote is a registered trademark of the Ball Aerospace & Technology Corp.

Loctite is a registered trademark of Henkel Corporation.

Tefl on and Freon are registered trademarks of E.I. du Pont de Nemours and Company.

Cavicide is a registered trademark of Metrex Research Corporation.

Virex is a registered trademark of S.C. Johnson & Son, Inc.

Kleenaseptic is a registered trademark of Metrex Research Corporation.

Betco is a registered trademark of Betco Corporation.

6700-0088-000 04/2013