Precision Medical Continuous Intermittent Vacuum Regulator User Manual

USER MANUAL

CONTINUOUS INTERMITTENT

MODEL SERIES: PM3300 (shown)
PM3400

SAVE THESE INSTRUCTIONS

CAUTION

300 Held Drive Tel: [phone]
Northampton, PA 18067 USA Fax: [phone]
ISO 13485 Certied www.precisionmedical.com

Federal (USA) law restricts this device to sale by or
on the order of a physician.

CONTENTS

RECEIVING / INSPECTION .......................................................... 2

INTENDED USE ............................................................................ 2

READ ALL INSTRUCTIONS BEFORE USING ............................. 2

EXPLANATION OF ABBREVIATIONS ......................................... 2

SAFETY INFORMATION - WARNINGS AND CAUTIONS ............ 2

SPECIFICATIONS ......................................................................... 3

OPERATING INSTRUCTIONS ...................................................... 4

PARTS DESCRIPTION ................................................................. 5

PARTS LIST .................................................................................. 5

REPAIR KITS ................................................................................ 6

DISASSEMBLY INSTRUCTIONS ................................................. 6

ASSEMBLY INSTRUCTIONS ....................................................... 6

VACUUM REGULATOR CLEANING ILLUSTRATION .................. 7

CLEANING / DECONTAMINATION .............................................. 8

MAINTENANCE ............................................................................ 8

RETURNS ..................................................................................... 8

DISPOSAL INSTRUCTIONS ......................................................... 9

TROUBLESHOOTING .................................................................. 9

LIMITED WARRANTY ................................................................ 10

DECLARATION OF CONFORMITY ............................................ 11

CONTINUOUS INTERMITTENT

1

RECEIVING / INSPECTION

Remove the Precision Medical, Inc. Vacuum Regulator from the packaging
and inspect for damage. If there is any damage, DO NOT USE and contact
your Provider.

INTENDED USE

The devices are intended to control and show the amount of vacuum from
a central vacuum system used in various medical suctioning procedures.

READ ALL INSTRUCTIONS BEFORE USING

This manual instructs a Professional to install and operate the Vacuum
Regulator. This is provided for your safety and to prevent damage to the

Vacuum Regulator. If you do not understand this manual, DO NOT USE
the Vacuum Regulator and contact your Provider.

EXPLANATION OF ABBREVIATIONS

l/min Liters Per Minute
mmHg Millimeters of Mercury
inHg Inches of Mercury
kPa Kilopascal

SAFETY INFORMATION - WARNINGS AND CAUTIONS

WARNING

CAUTION

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

Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury.

CAUTION

Used without the safety alert symbol indicates a
potentially hazardous situation which, if not avoided, may
result in property damage.

CONSULT ACCOMPANYING DOCUMENTS

Symbol indicates the device complies with the
requirements of Directive 93/42/EEC concerning medical
devices and all applicable International Standards.

(On CE marked Devices ONLY)

There are no components in this product made with
natural rubber latex.

WARNING

• DO NOT use this Vacuum Regulator for anything other than its Intended

Use. Personal injury and/or damage to Regulator may result from misuse.

• Only personnel instructed and trained in its use should operate this

Vacuum Regulator.

2

CONTINUOUS INTERMITTENT

SPECIFICATIONS

GAUGE RANGE:

GAUGE ACCURACY:

Analog: ± 5% of MAX
Digital/Analog, Dual Gauge:

Digital Display: ± 1% of Full Scale
Analog Gauge: ± 5% of MAX within ref. Indicator

VACUUM PORTS: 1/8 NPT Female

MODES:

PM3300: 0 - 200 mmHg - Full Vacuum

*PM3300E: 0 - 200 mmHg (0 - 26 kPa)
*PM3300EHV: 0 - 300 mmHg (0 - 40 kPa)

PM3300HV: 0 - 300 mmHg - Max Vacuum

PM3400: 0 - 150 mmHg

*PM3400E: 0 - 150 mmHg (0 - 20 kPa)

*Counterclockwise direction

REG. - (Regulated) provides an adjustable,

continuous vacuum level
OFF - No Vacuum
INT. - (Intermittent) provides an adjustable vacuum

level that cycles between ON and OFF

FLOW: Models

PM3300:

PM3400: 50 l/min

MAXIMUM FLOW

IS OBTAINED WITH A VACUUM SOURCE OF 21” Hg (71.1 kPa)

Mode Max Flow

REG

51 l/min

MAXIMUM VACUUM:

PM3300: REG. Mode @ Full Vac-396 mmHg (53 kPa)

PM3300HV: REG. Mode @ Max Vac-396 mmHg (53 kPa)

PM3400: Restricted to 170 mmHg ± 10 mmHg (1.3 kPa)

INTERMITTENT CYCLE TIME: Factory set at sixteen (16) seconds ON

and eight (8) seconds OFF ( Reference only)

Operating Environmental Limits: 0°F to 122°F (-18°C to 50°C)

Recommended Environmental Operating Limits:

Storage Environmental Limits:
Temperature Range: -4°F to 140°F (-20°C to 60°C)

Humidity: Max 95% Noncondensing

Battery: 3 Volt Lithium, AA (Digital Vacuum Gauge Models ONLY)

Specications are subject to change without prior notice.

CONTINUOUS INTERMITTENT

55°F to 85°F (13°C to 29°C)

3

OPERATING INSTRUCTIONS

CAUTION

Inspect the Vacuum Regulator for visual damage before use,
DO NOT USE if damaged.

NOTE: •

1. Turn the Selector Knob to the “OFF” position.

2. Attach the Vacuum Regulator to the vacuum source.
A. REG MODE (Regulated Mode) ALL MODELS

1. Turn the Selector Knob to the “REG.” position.

2. Block the bottom port of the Regulator.

3. Using the Regulator Knob, set the desired vacuum.

B. INT. MODE (Vacuum cycles ON and OFF.)

1. Turn the Selector Knob to the “REG.” position, to select

3.

Turn the Selector Knob to the “OFF” position to turn the Regulator off.

Overow protection should be used with the Vacuum Regulator.

(i.e. Filter, Vac Trap, Canister equipped with oat shutoff).

•

Gauges operate independently; if the digital gauge fails, the

analog gauge will still function.

To INCREASE vacuum - Turn Knob CLOCKWISE
To DECREASE vacuum - Turn Knob COUNTERCLOCKWISE

desired vacuum level.

2. Turn the Selector Knob to the “INT.” position.

NOTE: Intermittent cycles starts in the OFF phase, therefore a

delay occurs before the intermittent cycle begins.

WARNING

• ALWAYS conrm vacuum setting prior to performing procedure.

• When turning the Vacuum Regulator to “REG.” or “INT.” from any
position, the vacuum level will return to its previously regulated setting.

• Full Line Vacuum is present between settings.

• Vacuum levels will remain the same when switching from one
mode to the other.

CAUTION

DO NOT operate the Vacuum Regulator when the collection

canister is “full”. This may cause loss of vacuum and damage to
the Vacuum Regulator. This will void the warranty.

4

CONTINUOUS INTERMITTENT

PARTS DESCRIPTION

CAUTION

Missing or illegible labels must be replaced, contact Precision Medical, Inc.

3-Analog

2 QUANTITY -

6 PLACES

3-Digital

PM3400/

PM3400E

ONLY

4

14

13

1115

6 7 8 9

10

PARTS LIST

No. Description PM3300 PM3400

1 Housing Assembly 502102

2 Screw 503956

3 Analog Gauge Assembly

Analog Gauge Assembly (Export E)
Analog Gauge Assembly (HV)
Digital Assembly
Digital Assembly (HV)
Digital Assembly (Export E)
Digital Assembly Export E (HV)

4 Snubber 1396

5 O-ring 502231

6 Selector Assembly 1805

7 Index Ring 502685

8 Wave Spring Washer 1614

9 Case Assembly 1827

10 Regulator Module Assembly 1567 (*505962) 1567

11 Set Screw 1391

12 Control Knob Assembly 502100

13 Timing Module 502103

14 Rear Case 1831

* HV MODELS ONLY (PM3300HV)

503694
503923

504309
505244 (0-200 mmHg)
505392 (0-300 mmHg)

506036

506038

503826
504225

505391 (0-150 mmHg)

506034

12

Selector

Knob

Regulator

Knob

CONTINUOUS INTERMITTENT

5

REPAIR KITS

Analog Part# Digital Part#

PM3300 / PM3300D Vac Reg RK6300 RK6300D

PM3300HV / PM3300DHV Vac Reg RK6300HV RK6300DHV

PM3300E / PM3300DE Vac Reg RK6300E RK6300DE

PM3300EHV / PM3300DEHV Vac Reg RK6300EHV RK6300DEHV

PM3400 / PM3400D Vac Reg RK6400 RK6400D

PM3400E / PM3400DE Vac Reg RK6400E RK6400DE

DISASSEMBLY INSTRUCTIONS

(Reference “PARTS DESCRIPTION”)

1. Loosen the Set Screw (Item # 11) in Selector Knob.

2.

Pull the Control Knob Assembly (Item # 12) away from case. (The Regulator
Module (Item # 10) is threaded onto the Control Knob Assembly.)

3. Remove the screws (Item # 2) from the back of the product.

4. Remove the Rear Case (Item # 14) by pulling away from product.

5. Remove screws (Item# 2) from the top of the Timing Module.

6. Remove the Timing Module (Item# 13) by pulling away from the
Housing Assembly (Item# 1).

7. Separate the Case Assembly (Item# 9) by pulling it away from the
Housing Assembly (Item# 1).

8. Remove the Selector Assembly (Item# 6) by pulling it away from the
Housing Assembly (Item# 1).

9. Remove the Gauge Assembly (Item# 3).

ASSEMBLY INSTRUCTIONS

1. To assemble, perform the “DISASSEMBLY INSTRUCTIONS” in
reverse order.

NOTE:• Ensure the Selector Assembly is inserted with the groove in

the 12 o’clock position.

• Ensure tabs and slots on various components are properly
aligned and engaged when reassembling.

2. Lubricate all O-rings and cavities with Vacuum grease (part# 1775)
supplied in the Vacuum Regulator Repair Kit.

3. Repeat steps 1 through 3 of “OPERATING INSTRUCTIONS”.

4. Prior to returning Vacuum Regulator to service verify accuracy of gauge.

6

CONTINUOUS INTERMITTENT

VACUUM REGULATOR CLEANING ILLUSTRATION

(Cleaning/Decontamination Instructions on page 8)

Working

Vacuum Regulator

To Be Cleaned

Suction

Tubing

Suction

Tubing

Vacuum

Regulator

Vacuum

Port

Cold

Disinfection/

Sterilization

Patient

Port

Suction

Collection

Canister

Solution

CAUTION

• DO NOT autoclave or immerse in liquid.

This will cause damage to the Vacuum Regulator and will void the
warranty.

• DO NOT set the Vacuum Regulator to the “INT“(Intermittent) mode when

cleaning. Pulling cleaning uids thru the Intermittent mode will damage the

timing module and void the warranty.

• If Vacuum Regulator becomes internally contaminated, warranty is voided,

DO NOT send back to Precision Medical, Inc. for repair. Follow your facilities
contaminated equipment protocol.

• This Vacuum Regulator contains magnetic, ferrous material that may affect

the results of an MRI.

• Be sure all connections are tight and leak free.

CONTINUOUS INTERMITTENT

7

CLEANING / DECONTAMINATION

(As needed)

1. Attach a working Vacuum Regulator with a continuous regulated

mode to a minimum vacuum source of 15 inHg.

2. Mix cold disinfection / sterilization solution according to its

manufacturer’s directions.

3. Connect tubing as shown in Cleaning Illustration on previous page.

4.

Turn the working Vacuum Regulator on to a continuous regulated mode.

5. Adjust the vacuum to a minimum of 120 mmHg.

6. Set the Vacuum Regulator to be cleaned to the “REG .” mode, and

set at 100 mmHg.

7. Allow cold disinfection / sterilization solution to pass through and collect

in Suction Canister. Procedure should continue for time recommended
by the manufacturer of the cold disinfection / sterilization solution for the
desired level of disinfection or sterilization.

8. Set working Vacuum Regulator to its maximum vacuum setting.

9. Thoroughly dry the internal components by drawing maximum

vacuum through the Regulator to be cleaned for at least 30 seconds
in “REG.” mode.

NOTE:

If it is not possible to pass cold disinfection / sterilization
solution through the Regulator, then the passageways are
totally blocked and disassembly of the Regulator is required.
Be sure to follow your facilities’ Biohazard protocol.

MAINTENANCE

Before each use; visually inspect Vacuum Regulator for any sign of
damage, DO NOT USE if damaged.

RETURNS

Returned products require a Returned Goods Authorization (RGA) number,
contact Precision Medical, Inc. All returns must be packaged in sealed
containers to prevent damage. Precision Medical, Inc. will not be responsible
for goods damaged in transit. Refer to Precision Medical, Inc. Return Policy
available on the Internet, www.precisionmedical.com.

Manuals available on our Website; www.precisionmedical.com

8

CONTINUOUS INTERMITTENT

DISPOSAL INSTRUCTIONS

Dispose of the Vacuum Regulator in accordance with the local regulations.

Please Recycle

WARNING

Product should be cleaned before being disposed of. Potential for Biohazard.

TROUBLESHOOTING

If the Vacuum Regulator fails to function, consult the Troubleshooting
Table below. If problem cannot be solved, consult your Provider.

Problem Probable Cause Remedy

No vacuum at
bottom port (gauge
at zero)

No vacuum at
bottom port (gauge
showing vacuum)

Vacuum at bottom
port (No reading on
gauge when port is
blocked)
Gauge will not return
to zero

Vacuum Regulator
erratic

Stiff movement of
Selector Knob

No Intermittent (INT.)
cycle

No digital display

1. Regulator turned “OFF”

2. Loose connection

3. No vacuum to Regulator

4. Clogged vacuum Port

Clogged Regulator Disassemble & clean

Defective Gauge Replace Gauge

1. Clogged Snubber

2. Damaged Regulator
Module

3. Defective Gauge

1. Dirty Regulator Module

2.

Defective Regulator Module

1. Dirty Regulator Module
and/or Selector Module

1. Improper mode selected

2.

Defective Timing Module

Dead Battery

1. a. Turn selector knob

1. b. Adjust Regulator

knob

2. Tighten connection

3.

Connect to a known

working vacuum source

4. Disassemble & clean

1. Replace Snubber

2. Replace Regulator

Module

3. Replace Gauge

1. Disassemble & clean,

Lubricate O-ring

2. Replace Module

1. Disassemble & clean,

Lubricate O-rings

1. Turn Selector Knob to

“INT.” mode

2.

Replace Timing Module

Replace Battery

CONTINUOUS INTERMITTENT

9

LIMITED WARRANTY

AND

LIMITATION OF LIABILITY

Precision Medical, Inc. warrants that the Medical Vacuum
Regulator (the Product) will be free of defects in workmanship
and/or material for the following period:

Ten (10) years from date of shipment.

Should any failure to conform to this warranty appear within the
applicable period, Precision Medical, Inc. shall, upon written

notication thereof and substantiation that the goods have been

stored, installed, maintained and operated in accordance with
Precision Medical, Inc.’s instructions and standard industry

practice, and that no modications, substitutions, or alterations

have been made to the goods, correct such defect by suitable
repair or replacement at its own expense.

ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES.

The representative of Precision Medical, Inc. or any retailers are
not authorized to make oral warranties about the merchandise
described in this contract, and any such statements shall not be
relied upon and are not part of the contract for sale. Thus, this

writing is a nal, complete and exclusive statement of the terms

of that contract.

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY
WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY,
WHETHER EXPRESS OR IMPLIED.

Precision Medical, Inc. shall not under any circumstances be liable
for special, incidental or consequential damages including but not

limited to lost prots, lost sales, or injury to person or property.

Correction of non-conformities as provided above shall constitute

fulllment of all liabilities of Precision Medical, Inc. whether based

on contract, negligence, strict tort or otherwise. Precision Medical,
Inc. reserves the right to discontinue manufacture of any product or

change product materials, designs, or specications without notice.

Precision Medical, Inc. reserves the right to correct clerical or
typographical errors without penalty.

10

CONTINUOUS INTERMITTENT

DECLARATION OF CONFORMITY

0473

Precision Meidcal, Inc
300 Held Drive
Northampton PA 18067

Emergo Europe (European Ofce)

Motenstraat 15
2513 BH, The Hague
The Netherlands
Phone: [phone]
Fax: [phone]

Vacuum Regulators:

PM3300E, PM3300E-P, PM3300EHV, PM3300DE,
PM3300DE-G, PM3300DE-MG, PM3300DE-Y,
PM3300DEHV, PM3300DEHV-MG, PM3400E, PM3400DE

Classication: IIa
Classication criteria: Clause 3.2 Rule 11 of Annex IX of MDD

We hereby declare that an examination of the under mentioned production quality
assurance system has been carried out following the requirements of the UK national
legislation to which the undersigned is subjected, transposing Annex II, 3 of the
Directive 93/42/EEC and Directive 2007/47/EC on medical devices.

We certify that the production quality system conforms to the relevant provisions of
the aforementioned legislation, and the result entitles the organization to use the
CE 0473 marking on those products listed above.

Applied Standards:

Notied Body: AMTAC Certication Services Limited

Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK

Certication Registration No’s:

Date of Expiry: 03 August 2017

Devices already manufactured: S/N traceability Device History Records
Validity of DOC: 04 August 2012 to Date of Expiry

Manufacture Representative:

Position: Quality Systems/ISO Representative

Date of Issue:

BS EN 1041, EN ISO 10079-3, EN ISO 14971, ISO 15223-1

1126 CE

Quality Manager

04 August 2012

Tell us how we are doing!

Visit us at www.precisionmedical.com

1949 Rev20 1/15 (??M) Printed in USA