Precision Medical Pm3000 Vacuum Regulator Instruction Manual

Medical PM3000 Vacuum Regulator
Instruction ManualVacuumRegulator
CONTINUOUS & CONTINUOUS INTERMITTENT

Model Series:
PM3000, PM3100, PM3200, PM3300, PM3400, PM3500, PM3600
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician.

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

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
	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.

SPECIFICATIONS

GAUGE RANGE: *Counterclockwise direction

GAUGE ACCURACY:

VACUUM PORTS:
1/8 NPT Female

MODES OF OPERATION:

FLOW RATES:

* 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:

INTERMITTENT CYCLE TIME:
Factory set at approximately 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:
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% Non-condensing
Battery (Digital Vacuum Gauge Models ONLY):
3 Volt Lithium, ½ AA

OPERATING INSTRUCTIONS

CAUTION
Inspect the Vacuum Regulator for visual damage before use, DO NOT USE if damaged.
Failure to implement recommended protective devices may cause product contamination, malfunction and/or failure.
Contamination of the product voids all warranty claims.

NOTE: The vacuum regulator does not contain any protection from the ingress or passing of fluids. It is the user’s responsibility to provide a collection container with  overflow protection or a fluid trap and either a hydrophobic or micro-bacterial filter. Precision
Medical provides these accessories separately.
The Digital / Analog Dual Gauges operate independently; if the digital gauge fails, the analog gauge will still function and vice versa.

1. Turn the Selector Knob to the “OFF” position.
2. Connect the Vacuum Regulator to a vacuum source.
   A. REG. MODE (Regulated Mode) ALL MODELS
   a. Turn the Selector Knob to the “REG.” position.
   b. Block the bottom port of the Vacuum Regulator.
   c. 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
   a. Turn the Selector Knob to the “LINE” position.
   C. INT. MODE (Vacuum cycles ON and OFF.) PM3300 & PM3400 Series ONLY
   a. Turn the Selector Knob to the “REG.” position, to select desired vacuum level.
   b. Turn the Selector Knob to the “INT.” position.
   NOTE: The intermittent cycle starts in the “OFF” phase, therefore a delay occurs before the intermittent cycle begins.
3. Turn the Selector Knob to the “OFF” position to turn the Vacuum 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 fro procedure.
PM3300 & PM3400 ONLY: When turning the Vacuum Regulator to “REG.” or “INT.” from any position, The vacuum level will return to its previously regulated setting.
ALWAYS confirm vacuum setting prior to performing procedure.
The vacuum CAN NOT 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 confirm vacuum setting before use.
LINE MODE
Turn Selector Knob fully counterclockwise for line vacuum and confirm vacuum setting 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.
CONTINUOUS SERIES (PM3000, PM3100, PM3500 & PM3600)
CAUTION
Missing or illegible labels must be replaced, contact Precision Medical, Inc.

PARTS DESCRIPTION

PARTS LIST
PM3200 Models: contact Precision Medical, Inc.

* MR Models ONLY (PM3000MR, PM3100MR & PM3500MR)
** HV Models ONLY (PM3000HV & PM3100HV)

REPAIR KITS

DISASSEMBLY INSTRUCTIONS

PM3000, PM3100, PM3500 & PM3600 Series
(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.

CONTINUOUS INTERMITTENT SERIES (PM3300 & PM3400)

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

PARTS DESCRIPTION

PARTS LIST

REPAIR KITS

DISASSEMBLY INSTRUCTIONS

PM3300 & PM3400 Series
(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.

VACUUM REGULATOR CLEANING ILLUSTRATION

(See Cleaning/Decontamination Instructions)

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 fluids 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 MR.
Be sure all connections are tight and leak free.
Note: MR Conditional models have a MR Conditional label.

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 Cidex OPA or the like 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’ Bio-hazard protocol.

EXTERIOR CLEANING

1. Disconnect all gas connections and equipment before cleaning.
2. Clean exterior surfaces using Super Sani-Cloth germicidal disposable wipes. Remove all visible contamination from the external surfaces of the device and its accessories. Be sure to closely inspect and remove contamination from seams and recesses on the device that may trap contaminants. Wipe with clean paper towel to remove debris.
3. After all visible contamination is removed; use a second germicidal wipe to thoroughly wet the surfaces of the device and accessories. Allow to remain wet for 4 minutes.  Use additional wipes if needed to assure surfaces are wetted continuously for 4 minutes.
4. Allow device to air dry completely.
5. Visually inspect the device for visible contamination. Repeat cleaning/disinfection process if necessary.

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.
Note: Federal Law prohibits shipping of bio-hazard materials via U.S. mail.

DISPOSAL INSTRUCTIONS
Dispose of the Vacuum Regulators in accordance with local regulations
Please Recycle

WARNING
Bio-hazardous 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.

Applies to MRI labeled Vacuum Regulators only!
Indicates the device is MR Conditional and can be used in an MR Environment
WARNING! This product may be used near a MR Environment (e.g. in the MR System room near the scanner). It should not be utilized directly inside of the MR System  (e.g. inside of the bore of the scanner). The device must be securely attached to a wall Gas Outlet.

• This information must be kept with the device.
• MR Conditional with 1.5T MR systems.
• Service must be performed by qualified personnel.
• Vacuum Regulators must be kept to manufacturing specifications.
• Fittings must be kept MR conditional if serviced or replaced.
• MRI manufactures guidelines supersedes this information
• Consult MRI Manufacture if used with an Open MRI.

Applies to MRI labeled Vacuum Regulators only!
Indicates the device is MR Conditional and can be used in an MR Environment
WARNING! This product may be used near a MR Environment (e.g. in the MR System room near the scanner). It should not be utilized directly inside of the MR System  (e.g. inside of the bore of the scanner). The device must be securely attached to a wall Gas Outlet.

• This information must be kept with the device.
• MR Conditional with 1.5T MR systems.
• Service must be performed by qualified personnel.
• Vacuum Regulators must be kept to manufacturing specifications.
• Fittings must be kept MR conditional if serviced or replaced.
• MRI manufactures guidelines supersedes this information
• Consult MRI Manufacture if used with an Open MRI.

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 notification 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 modifications, 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 final, 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 profits, lost sales, or injury  to person or property. Correction of nonconformities as provided above shall constitute fulfillment 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  specifications without notice.
Precision Medical, Inc. reserves the right to correct clerical or typographical errors without penalty.

300 Held Drive
Northampton PA 18067, USA
www.precisionmedical.com
T: (+001) 610-262-6090
F: (+001) 610-262-6080
ISO 13485 Certified

References

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