USER MANUAL
CONTINUOUS &
CONTINUOUS INTERMITTENT
MODEL SERIES: PS3000 PS3400
PS3100 PS3500
PS3300 PS3600
Patent Pending
PS3300 (Shown)
PS3100 (Shown)
SAVE THESE INSTRUCTIONS
CAUTION
300 Held Drive Tel: (+001) 610-262-6090
Northampton, PA 18067 USA Fax: (+001) 610-262-6080
ISO 13485 Certied 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
REPAIR KITS ................................................................................6
DISASSEMBLY INSTRUCTIONS
DISASSEMBLY INSTRUCTIONS
for PS3000, PS3100, PS3500 & PS3600 Series
for PS3300 & PS3400 Series
.....................7
....7
ASSEMBLY INSTRUCTIONS .......................................................7
VACUUM REGULATOR CLEANING ILLUSTRATION ..................8
CLEANING / DECONTAMINATION ..............................................9
MAINTENANCE ............................................................................9
RETURNS .....................................................................................9
DISPOSAL INSTRUCTIONS .......................................................10
TROUBLESHOOTING ................................................................10
LIMITED WARRANTY ................................................................ 11
CONTINUOUS & CONTINUOUS INTERMITTENT
1
RECEIVING / INSPECTION
Remove the Precision Medical, Inc. Preset Vacuum Regulator from the
packaging and inspect for damage. If there is any damage, DO NOT USE
and contact your Provider.
INTENDED USE
The Preset Vacuum Regulator is intended to regulate and display 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 how to install and operate the Preset
Vacuum Regulator. This is provided for your safety and to prevent damage
to the Preset Vacuum Regulator. If you do not understand how to use the
Preset Vacuum Regulator, please contact your Provider.
EXPLANATION OF ABBREVIATIONS
l/min Liters Per Minute
mmHg Millimeters of Mercury
inHg Inches of Mercury (1 inHg = 25.4 mmHg)
SAFETY INFORMATION - WARNINGS AND CAUTIONS
WARNING
CAUTION
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.
Used without the safety alert symbol indicates a
potentially hazardous situation which, if not avoided,
may result in property damage.
CONSULT ACCOMPANYING DOCUMENTS
There are no components in this product made with
natural rubber latex.
WARNING
•
DO NOT use the Preset 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 the
Preset Vacuum Regulator.
2
CONTINUOUS & CONTINUOUS INTERMITTENT
SPECIFICATIONS
CALIBRATED RANGE
PS3000: 0 - 200 mmHg
PS3000HV: 0 - 300 mmHg
PS3100: 0 - 200 mmHg
GAUGE ACCURACY
Analog Gauge ± 5% of MAX calibrated range
Dual Analog/Digital Gauge
Digital Display ± 1% of Full Scale
Analog Gauge ± 5% of MAX calibrated range within ref. Indicator
INLET/OUTLET CONNECTIONS 1/8 NPT Female
MODES OF OPERATION
PS3000 Series
PS3500 Series
PS3100 Series
PS3600Series
OFF - No Vacuum
REG. -
OFF - No Vacuum
REG. LINE -
PS3300 Series
PS3400 series
OFF - No Vacuum
REG. INT. - Intermittent) Provides an adjustable vacuum level that cycles
FLOW RATES
PS3000, PS3100 & PS3300
PS3000HV, PS3100HV & PS3300HV
PS3300 & PS3400
PS3600
FLOW RATES ARE OBTAINED WITH A VACUUM SOURCE OF 21” Hg
INTERMITTENT CYCLE TIME: Factory set at sixteen (16) seconds ON
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, 1/2 AA (Digital Vacuum Gauge Models ONLY)
Specications are subject to change without prior notice.
PS3100HV: 0 - 300 mmHg
PS3300: 0 - 200 mmHg
PS3300HV: 0 - 300 mmHg
PS3400: 0 - 150 mmHg
PS3500: 0 - 150 mmHg
PS3600: 0 - 760 mmHg
(Regulated) Provides an adjustable, continuous vacuum level
(Regulated) Provides an adjustable, continuous vacuum level
Provides maximum, continuous vacuum from the vacuum source
(Regulated) Provides an adjustable, continuous vacuum level
between ON and OFF
REG MODE @ 200 mmHg 48 l/min
LINE MODE 55 l/min
INT. MODE (PS3300 Only) 10 l/min
REG MODE @ 300 mmHg 50 l/min
LINE MODE 55 l/min
INT. MODE (PS3300HV Only) 10 l/min
REG MODE @ 150 mmHg 50 l/min
INT. Mode (PS3300 only) 10 l/min
INT. MODE (PS3400 only) 3 l/min
REG MODE @ 635 mmHg 71 l/min
LINE MODE 82 l/min
and eight (8) seconds OFF (Reference only)
55°F to 85°F (13°C to 29°C)
CONTINUOUS & CONTINUOUS INTERMITTENT
3
OPERATING INSTRUCTIONS
CAUTION
Inspect the Preset Vacuum Regulator for visual damage before use, DO NOT USE if damaged.
NOTE: •
Overow protection should be used with the Vacuum Regulator.
(i.e. Filter, Vac Trap, Canister equipped with oat shutoff).
• The Digital / Analog Dual Gauges operate independently; if the digital gauge fails, the
1. Turn the Selector Knob to the “OFF” position.
2. Connect the Preset Vacuum Regulator to a vacuum source.
A. REG. MODE (Regulated Mode) ALL MODELS
B. LINE MODE (Full, unregulated vacuum) PS3100 & PS3600 Series ONLY
C. INT. MODE (Vacuum cycles ON and OFF.) PS3300 Series ONLY
3. Turn the Selector Knob to the “OFF” position to turn the Vacuum off.
analog gauge will still function and vice versa.
a. Turn the gray Preset Knob to desired vacuum range.
b. Block the bottom port of the Vacuum Regulator with your nger and turn the white Selector Knob
to the “REG.” position.
c. The preset vacuum range should correspond with the gauge readings along with the increase
and decrease in suction felt with the nger on blocked off bottom port.
d. Adjust vacuum as required.
To INCREASE vacuum - Turn gray Knob CLOCKWISE
To DECREASE vacuum - Turn gray Knob COUNTERCLOCKWISE
a. Block off bottom port of the Vacuum Regulator with your nger and turn the Selector Knob
to the “LINE” position. The gauge will indicate Max. vacuum and suction should be felt with
nger on blocked off bottom port. In this mode the vacuum level cannot be set and will be full
unregulated vacuum.
a. Turn the gray Preset Knob to desired vacuum range.
b. Block the bottom port of the Vacuum Regulator with your nger and turn the Selector Knob to
the “REG.” position.
c. The preset vacuum range should correspond with the gauge readings along with the suction felt
with the nger on blocked off bottom port.
d. Adjust vacuum as required.
To INCREASE vacuum - Turn gray Knob CLOCKWISE
To DECREASE vacuum - Turn gray Knob COUNTERCLOCKWISE
e. Turn the Selector Knob to the “INT.” position.
f. The intermittent cycle starts in the “OFF” phase. There will be approximately an 8 second
delay before the device cycles to the “ON” phase for approximately 16 seconds. During the
“ON” phase the gauge vacuum level should correspond with the preset vacuum level.
WARNING
•
When turning the Preset Vacuum Regulator to “REG.” from “LINE” or “OFF”, the vacuum level
will return to its previously regulated setting. Vacuum may be set at improper level for procedure.
•
PS3300 & PS3400 Series ONLY: When turning the Preset Vacuum Regulator to “REG.” or “INT.”
from any position, the vacuum level will return to its previously regulated setting.
Vacuum levels will remain the same when switching from one mode to the other.
•
ALWAYS conrm vacuum setting prior to performing procedure.
•
The vacuum CANNOT be regulated when the Selector Knob is set to the “LINE” position.
•
Full Line Vacuum is present between settings.
•
The desired vacuum mode (“REG”, “LINE”, “INT.”) and vacuum level should always be set and
conrmed before interface with patient to perform suctioning procedure.
CAUTION
DO NOT operate the Preset Vacuum Regulator when the collection canister is “full”. This
may cause loss of vacuum and damage to the Preset Vacuum Regulator. This will void the
warranty.
4
CONTINUOUS & CONTINUOUS INTERMITTENT
PARTS DESCRIPTION
CAUTION
Missing or illegible labels must be replaced, contact Precision Medical, Inc.
PS3000, PS3100, PS3500 & PS3600 Series
8
3-Digital
9
(0-200 mmHg)
507480
*507481
(0-300 mmHg)
10
These
components must
always be kept
together as a
matched set.
11
507730
(0-150
mmHg)
507731
(0-760
mmHg)
3-Analog
QTY - 6
PLACES
2
4
5
QTY - 4
PLACES
1
No. Description PS3000 PS3100 PS3500 PS3600
1 Housing Assembly 1561
2 Screw 503956
3 Analog Gauge (0-150 mmHg) - - 503826 -
Analog Gauge (0-200 mmHg) 503694 - -
Analog Gauge (HV) (0-300 mmHg) 504309 - -
Analog Gauge (0-760 mmHg) - - - 505937
Dual Analog /Digital Gauge (0-150 mmHg) - - 505391 -
Dual Analog /Digital Gauge (0-200 mmHg) 505244 - -
Dual Analog /Digital Gauge (HV) (0-300 mmHg) 505392 - -
Dual Analog /Digital Gauge (0-760 mmHg) - - - 505938
4 Snubber 1396
5 O-ring 1016
6 Selector Assembly 1563 1564 1563 505935
7 Selector Ring 502685
8 Wave Spring Washer 1614
9 Case Assembly 1565 1566 1565 1566
10 Regulator Module/Control Knob Assembly
11 Set Screw 1391
-- Battery for Dual Analog/Digital Gauge 8066
* HV Models ONLY (PS3000HV, PS3100HV & PS3300HV)
6
7
PARTS LIST
CONTINUOUS & CONTINUOUS INTERMITTENT
5
PS3300 SERIES
QTY - 6
2
PLACES
13
No. Description PS3300 PS3400
1 Housing Assembly 502102
2 Screw 503956
3 Analog Gauge (0-150 mmHg) - 503826
Analog Gauge (0-200 mmHg) 503694 -
Analog Gauge (HV) (0-300 mmHg) 504309 -
Dual Analog /Digital Gauge (0-150 mmHg) - 505391
Dual Analog /Digital Gauge (0-200 mmHg) 505244 -
Dual Analog /Digital Gauge (HV) (0-300 mmHg) 505392 -
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/ Control Knob Assembly
11 Set Screw 1391
12 Timing Module 502103
13 Back Case 1831
-- Battery for Dual Analog/Digital Gauge 8066
* HV Models ONLY (PS3300HV)
REPAIR KITS Analog Part# Digital Part#
PS3000 / PS3000D Vac Reg RKPS6000 RKPS6000D
PS3000HV / PS3000DHV Vac Reg RKPS6000HV RKPS6000DHV
PS3100 / PS3100D Vac Reg RKPS6100 RKPS6100D
PS3100HV / PS3100DHV Vac Reg RKPS6100HV RKPS6100DHV
PS3300/PS3300D Vac Reg RKPS6300 RKPS6300D
PS3300HV / PS3300DHV Vac Reg RKPS6300HV RK6300DHV
PS3400 / PS3400D Vac Reg RKPS6400 RKPS6400D
PS3500 / PS3500D Vac Reg RKPS6500 RKPS6500D
PS3600 / PS3600D Vac Reg RKPS6600 RKPS6600D
12
3-Analog
1
5
QTY - 4
PLACES
PARTS LIST
4
6 7
3-Digital
8
(0 - 200 mmHg)
(0 - 300 mmHg)
9
507480
*507481
components must
always be kept
together as a
matched set.
507730
(0-150 mmHg)
These
11
10
6
CONTINUOUS & CONTINUOUS INTERMITTENT
DISASSEMBLY INSTRUCTIONS for PS3000, PS3100, PS3500
& PS3600 Series
(Reference “PARTS DESCRIPTION”)
1. Loosen the Set Screw (Item# 11) in Selector Knob.
2. Pull the Regulator Module/Control Knob Assembly (Item # 12) away from case.
(The Regulator Module (Item # 10) is threaded onto the Control Knob Assembly.
Note: These components must always be kept together as a matched set.)
3. Remove the screws (Item# 2) from the back of the Regulator.
4. Separate the Case Assembly (Item# 9) by pulling it away from the Housing
Assembly (Item# 1).
5. Remove the Selector Assembly (Item# 6) by pulling it away from the Housing
Assembly (Item# 1).
6. Remove Gauge by pulling vertically out of socket (Item# 3).
DISASSEMBLY INSTRUCTIONS
(Reference “PARTS DESCRIPTION”)
1. Loosen the Set Screw (Item # 11) in Selector Knob.
2. Pull the Regulator Module/Control Knob Assembly (Item # 12) away from
case. (The Regulator Module (Item # 10) is threaded onto the Control Knob
Assembly. Note: These components must always be kept together as a
matched set.)
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 Gauge by pulling vertically out of socket (Item# 3).
for PS3300 & PS3400 Series
ASSEMBLY INSTRUCTIONS
1. To assemble, perform the “DISASSEMBLY INSTRUCTIONS” in reverse order.
Note: • Ensure the tab on the Regulator Module is inserted into the internal
2. Lubricate all O-rings and cavities with Vacuum grease (part# 1775) supplied in
the Preset Vacuum Regulator Repair Kit.
3. Repeat steps 1 through 3 of “OPERATING INSTRUCTIONS”.
4. Prior to returning Preset Vacuum Regulator to service verify preset vacuum
level with gauge reading.
slot on the Selector Module at the 9 o’clock position.
• Ensure the tab on the Control Knob Assembly at the 12 o’clock
position is aligned with the outer circumference slot on the
Selector Module at the 12 o’clock position.
CONTINUOUS & CONTINUOUS INTERMITTENT
7
PRESET VACUUM REGULATOR CLEANING ILLUSTRATION
(Cleaning/Decontamination Instructions on page 9)
Preset Vacuum
Regulator
To Be Cleaned
Working
Vacuum
Regulator
Back (Inlet) Connection
Suction
Tubing
Suction
Tubing
Vacuum
Port
Cold
Disinfection/
Sterilization
Solution
Patient
Port
Suction
Collection
Canister
CAUTION
•
DO NOT autoclave or immerse in liquid. This will cause damage
to the Preset Vacuum Regulator and will void the warranty.
•
If Preset Vacuum Regulator becomes internally contaminated,
warranty is voided, DO NOT send back to Precision Medical, Inc. for
repair. Follow the contaminated equipment protocol at your facility.
•
Ensure all connections are tight and leak free.
•
The Preset Vacuum Regulator contains magnetic, ferrous
material that may affect the results of an MRI.
Tell us how we are doing!
Visit us at www.precisionmedical.com
8
CONTINUOUS & CONTINUOUS INTERMITTENT
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 “Preset” Vacuum Regulator to be cleaned to the “REG.”
mode, and set at 100 mmHg.
7. Allow cold disinfection/sterilization solution to pass through Preset
Vacuum Regulator 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. Turn the Preset Vacuum Regulator to be cleaned to the “LINE” mode
(if applicable).
9. Allow remaining cold disinfection/sterilization solution to pass through
and collect in Suction Canister.
10.
Set working Vacuum Regulator to its maximum vacuum setting.
11. Thoroughly dry the internal components by drawing maximum
vacuum through the cleaned Regulator for at least 30 seconds in
both “REG.” and “LINE” modes (if applicable).
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. Ensure to follow
the Biohazard protocol at your facility.
MAINTENANCE
Before each use, visually inspect Preset 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.
Note: Federal Law prohibits shipping of BioHazard materials Via U.S. mail.
Manuals available on our Website; www.precisionmedical.com
CONTINUOUS & CONTINUOUS INTERMITTENT
9
DISPOSAL INSTRUCTIONS
Dispose of the Preset Vacuum Regulator in accordance with local regulations.
Please Recycle
WARNING
Biohazardous devices should be disposed of properly.
TROUBLESHOOTING
If the Preset 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 Regulation
erratic
Stiff movement of
white Selector Knob
No digital display Dead battery Replace battery
PS3300/PS3400 Series ONLY:
No Intermittent
(INT.) cycle
1. Regulator turned “OFF”
2. Loose connection
3.
No vacuum to Regulator
4. Clogged vacuum Port
Clogged Regulator Disassemble and clean
Defective Gauge Replace Gauge
1. Clogged Snubber
2. Damaged Regulator
Module
3. Defective Gauge
1. Dirty Regulator Module
2. Defective Regulator
Module
Dirty Selector Module
cavity or O-rings
1. Improper mode
selected
2.
Defective Timing Module
1. a. Turn white Selector
Knob to “REG.” mode
b.
Adjust gray Preset Knob
2. Tighten connection
3.
Connect to a known
working vacuum source
4. Disassemble and clean
1. Replace Snubber
2. Replace Regulator
Module
3. Replace Gauge
1. Disassemble, clean and
lubricate O-ring
2. Replace Module
Disassemble, clean casting
cavity and lubricate cavity
and O-rings
1. Turn Selector Knob to
“INT.” mode
2.
Replace Timing Module
10
CONTINUOUS & CONTINUOUS INTERMITTENT
LIMITED WARRANTY
AND
LIMITATION OF LIABILITY
Precision Medical, Inc. warrants that the Medical Preset 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 notication 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 modications, 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.
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 EXPRESSED OR IMPLIED.
Precision Medical, Inc. shall not under any circumstances be liable for special,
incidental or consequential damages including but not limited to lost prots, lost
sales, or injury to person or property. Correction of non-conformities as provided
above shall constitute fulllment 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 specications without notice.
Precision Medical, Inc. reserves the right to correct clerical or typographical
errors without penalty.
507440 Rev2 (?M) 8/14 Printed in USA
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