Precision Medical PM3000 User manual

USER MANUAL
MODEL SERIES: PM3000
PM3100 (shown)
PM3200
PM3500
PM3600
SAVE THESE INSTRUCTIONS
CAUTION Federal (USA) law restricts this device to sale by or
on the order of a physician.
300 Held Drive Tel: [phone]
Northampton, PA 18067 USA Fax: [phone]
ISO 13485 Certied www.precisionmedical.com

1
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

2
SAFETY INFORMATION - WARNINGS AND CAUTIONS
WARNING Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION 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.
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

3
SPECIFICATIONS
GAUGE RANGE: *Counterclockwise direction
PM3000: 0 - 200 mmHg - Full Vacuum PM3100HV: 0 - 300 mmHg - Full Vacuum
*PM3000E: 0 - 200 mmHg (0 - 26 kPa) *PM3200E: 0 - 100 kPa (750 mmHg) - Full Vacuum
PM3000HV: 0 - 300 mmHg - Full Vacuum PM3500: 0 - 150 mmHg
PM3100: 0 - 200 mmHg - Full Vacuum *PM3500E: 0 - 200 mmHg (0 - 26 kPa)
*PM3100E: 0 - 200 mmHg (0 - 26 kPa) PM3600: 0 - 760 mmHg
*PM3100EHV: 0 - 300 mmHg (0 - 40kPa) *PM3600E: 0 - 760 mmHg (0 - 100 kPa)
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:
PM3100, PM3200E3 & PM3600 Series:
PM3000, PM3200E & PM3500 Series:
LINE - Provides maximum, continuous vacuum
from the vacuum source
OFF - No Vacuum
REG. - (Regulated) provides an adjustable,
continuous vacuum level
OFF - No Vacuum
REG. - (Regulated) provides an adjustable,
continuous vacuum level
FLOW: Models Mode Max Flow
*PM3000, PM3100, PM3200 & PM3500: REG 51 l/min
LINE 55 l/min
**PM3600 SERIES: REG 71 l/min
LINE 82 l/min
* MAXIMUM FLOW IS OBTAINED WITH A VACUUM SOURCE OF 21” Hg (71.1 kPa)
** MAXIMUM FLOW IS OBTAINED WITH A VACUUM SOURCE OF 25” Hg (84.6 kPa)
MAXIMUM VACUUM:
PM3000 & PM3100: REG. Mode @ Full Vac - 396 mmHg (53 kPa)
PM3200: REG. Mode @ Full Vac - 100 kPa (750 mmHg)
PM3500D: Restricted to 170 mmHg (23 kPa) ± 10 mmHg (1.3 kPa)
PM3500E: Restricted to 160 mmHg (21 kPa)
PM3600: REG. Mode @ Full Vac - 760 mmHg (101 kPa)
Operating Environmental Limits: 0°F to 122°F (-18°C to 50°C)
Recommended Environmental Operating Limits: 55°F to 85°F (13°C to 29°C)
Storage Environmental Limits:
Temperature Range: -4°F to 140°F (-20°C to 60°C)
Humidity: Max 95% Noncondensing
Battery: 3 Volt Lithium, ½ AA (Digital Vacuum Gauge Models ONLY)
Specications are subject to change without prior notice.

4
OPERATING INSTRUCTIONS
CAUTION
Inspect the Vacuum Regulator for visual damage before use,
DO NOT USE if damaged.
NOTE: Overow protection should be used with the Vacuum Regulator.
(i.e. Filter, Vac Trap, Canister equipped with shut off).
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.
To INCREASE vacuum - Turn Knob CLOCKWISE
To DECREASE vacuum - Turn Knob COUNTERCLOCKWISE
B. LINE MODE (Full, unregulated vacuum)
PM3100 & PM3600 SERIES ONLY
1. Turn the Selector Knob to the “LINE’ position.
3. Turn the Selector Knob to the “OFF” position to turn the Regulator off .
WARNING
• When turning the 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.
• ALWAYS conrm 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.
REGULATE MODE
• Turn selector knob fully clockwise to the regulator mode and
conrm vacuum setting before use.
LINE MODE
• Turn the selector knob fully counterclockwise for line vacuum
and conrm vacuum settings before use.
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.

5
PARTS DESCRIPTION
CAUTION
Missing or illegible labels must be replaced, contact Precision Medical, Inc.
4
9
8
7
56
12
Selector
Knob
Regulator
Knob
1
QUANTITY -
6 PLACES
11
10
3-Analog
2
Check
Valve
3-Digital
PARTS LIST PM3200 Models; contact Precision Medical, Inc.
No. Description PM3000 PM3100 PM3500 PM3600
1Housing Assembly 1561
-- Check Valve (Export E) NA 502230 NA
2 Screw 503956 (*505152) 503956
3 Analog Gauge Assembly
Analog Gauge Assembly (Export E)
Analog Gauge Assembly (HV)
Analog Gauge Assembly (Export E)(HV)
Digital Assembly
Digital Assembly (HV)
Digital Assembly (Export E)
Digital Assembly (Export E) (HV)
503694 (*505163)
503923
504309
506384
505244 (0-200 mmHg)
505392 (0-300 mmHg)
506036
506038 (0-300 mmHg)
503826 (*505162)
504225
505391 (0-150 mmHg)
506034
505937
506555
505938
506040
4 Snubber 1396
5 O-ring 1016
6Selector Assembly 1563 1564 1563 505935
7 Selector Ring 502685
8 Wave Spring Washer 1614 (*505154) 1614
9Case Assembly 1565 1566 1565 1566
10 Regulator Module Assembly 1567 (*505164) (**505962) 1567 (*505164) 505962
-- Washer (metal) NA NA 502818 NA
-- Washer (plastic) NA NA 503879 NA
11 Set Screw 1391 (*505158) 1391
12 Control Knob Assembly 1568 (*505165) 1568
-- Battery for Digital Assembly 8066
* MRI Models ONLY (PM3000MR, PM3100MR & PM3500MR)
** HV Models ONLY (PM3000HV & PM3100HV)

6
REPAIR KITS
Analog Part# Digital Part#
PM3000 / PM3000D Vac Reg RK6000 RK6000D
PM3000E / PM3000DE Vac Reg RK6000E RK6000DE
PM3000HV / PM3000DHV Vac Reg RK6000HV RK6000DHV
PM3000DEHV Vac Reg N/A RK6000DEHV
PM3100 / PM3100D Vac Reg RK6100 RK6100D
PM3100E / PM3100DE Vac Reg RK6100E RK6100DE
PM3100HV / PM3100DHV Vac Reg RK6100HV RK6100DHV
PM3100EHV / PM3100DEHV Vac Reg RK6100EHV RK6100DEHV
PM3200E Vac Reg RK6200E N/A
PM3500 / PM3500D Vac Reg RK6500 RK6500D
PM3500E / PM3500DE Vac Reg RK6500E RK6500DE
PM3600 / PM3600D Vac Reg RK6600 RK6600D
PM3600E / PM3600DE Vac Reg RK6600E RK6600DE
Not all Repair Kits are listed above, contact Precision Medical, Inc. for
availability.
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 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 the Gauge Assembly (Item# 3).
ASSEMBLY INSTRUCTIONS
1. To assemble, perform the “DISASSEMBLY INSTRUCTIONS” in
reverse order.
NOTE: • Ensure the Selector Assembly is inserted into the control
knob assembly 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.

7
VACUUM REGULATOR CLEANING ILLUSTRATION
(Cleaning/Decontamination Instructions on page 8)
Suction
Tubing
Cold
Disinfection/
Sterilization
Solution
Patient
Port
Working
Vacuum
Regulator
Vacuum
Port
Suction
Collection
Canister
Suction
Tubing
Vacuum
Regulator
To Be
Cleaned
CAUTION
• DO NOT autoclave or immerse in liquid. This will cause damage
to the Vacuum Regulator and will 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.
• Be sure all connections are tight and leak free.
• This Vacuum Regulator contains magnetic, ferrous material that
may affect the results of an MRI.
(Model Series: PM3000MR, PM3100MR & PM3500MR are MRI
safe designated by MRI label.)
MRI Safe

8
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. Turn the 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 Regulator to be cleaned 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. 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.

9
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)
1. Regulator turned “OFF”
2. Loose connection
3. No vacuum to Regulator
4. Clogged vacuum Port
1. a. Turn selector knob
b. Adjust Regulator
knob
2. Tighten connection
3. Connect to a known
working vacuum
source
4. Disassemble & clean
No vacuum at
bottom port (gauge
showing vacuum)
Clogged Regulator Disassemble & clean
Vacuum at bottom
port (No reading on
gauge when port is
blocked)
Defective Gauge Replace Gauge
Gauge will not return
to zero
1. Clogged Snubber
2. Damaged Regulator
Module
3. Defective Gauge
1. Replace Snubber
2. Replace Regulator
Module
3. Replace Gauge
Vacuum Regulator
erratic
1. Dirty Regulator Module
2. Defective Regulator Module
1. Disassemble & clean,
Lubricate O-ring
2. Replace Module
Stiff movement of
Selector Knob
1. Dirty Regulator Module
and/or Selector Module
1. Disassemble & clean,
Lubricate O-rings
No digital display Dead battery Replace battery

10
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 EXCLUSIVEAND 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.

DECLARATION OF CONFORMITY
Precision Medical, Inc
300 Held Drive
Northampton PA 18067, USA
Emergo Europe (European Ofce)
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: [phone]
Fax: [phone]
0473
Vacuum Regulators:
PM3000E, PM3000DE, PM3000DEHV, PM3100E,
PM3100DE, PM3100DE-MG, PM3100DEHV, PM3100DEIN,
PM3100EHV, PM3100EHV-Y, PM3100EIN, PM3200E,
PM3200E-Y, PM3200E3, PM3500E, PM3500E-MG,
PM3500DE, PM3500DE-LB, PM3600E, PM3600DE
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: BS EN 1041, EN ISO 10079-3, EN ISO 14971, ISO 15223-1
Notied Body: AMTAC Certication Services Limited
0473
Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK
Certication Registration No’s: 1126 CE
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: Quality Manager
Position: Quality Systems/ISO Representative
Date of Issue: 04 August 2012
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503443 Rev13 1015 (?M) Printed in USA