USER MANUAL - Medical Dynamics, Inc.

USER MANUAL
Model No. PM60
PM60E
SAVE THESE INSTRUCTIONS
CAUTION
Federal (USA) law restricts this device to sale by or
on the order of a physician.
Your local distributor:
-624 -3952
300 Held Drive
Tel:866
(+001)
610-262-6090
www.thinkMDI.net
Northampton, PA 18067 USA
Fax:
(+001) 610-262-6080
www.precisionmedical.com
RECEIVING / INSPECTION
Remove the Precision Medical, Inc. Easy Vac Aspirator from packaging and inspect
for damage. If there is any damage, DO NOT USE and contact your Provider.
Intended Use
To supply a continuous vacuum source adequate within the stated operating
vacuum range, to aspirate fluids in medical suctioning procedures by trained
healthcare professionals.
READ ALL INSTRUCTIONS BEFORE USING
This manual instructs a Professional to install and operate the Easy Vac Aspirator.
This is provided for your safety and to prevent damage to the Easy Vac Aspirator.
If you do not understand this manual, DO NOT USE the Easy Vac Aspirator and
contact your Provider.
Explanation of abbreviations
inHg
Inches of Mercury
mmHg
Milimeters of Mercury
SAFETY Information - Warnings and Cautions
Indicates an imminently hazardous situation which, if
DANGER not avoided, will result in death or serious injury.
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
Type B equipment
DANGER
To reduce the risk of Electrocution:
• Always unplug the Easy Vac Aspirator immediately after using.
• DO NOT use while bathing.
• DO NOT place or store Aspirator where it can fall or be pulled into a
tub or sink.
• DO NOT place or drop into water or other liquid.
• DO NOT reach for a Aspirator that has fallen into water. Unplug immediately.
• DO NOT attempt to repair Aspirator. Any attempt could result in
electrical shock.
• DO NOT use near any type of flame or flammable/explosive substances.
• DO NOT allow Aspirator to exceed Operating or Storage Temperature
specifications.
• Caution must be exercised when using this Aspirator where oxygen is
being administered.
• The Easy Vac Aspirator is not suitable for use in the presence of a
flammable anesthetic mixture with air, oxygen or nitrous oxide.
WARNING
To reduce risk of burns, electrocution, fire, or injury to persons:
• The Easy Vac Aspirator should never be left unattended when running.
• Close supervision is necessary when the Aspirator is used by, on, or
near children or invalids.
• Use the Easy Vac Aspirator only for its "Intended Use" as described in
this manual.
• DO NOT use attachments not recommended by the Precision Medical, Inc.
• DO NOT use when sleepy or drowsy.
• DO NOT use if Easy Vac Aspirator has a damaged cord or plug.
• DO NOT use if Easy Vac Aspirator has been dropped or damaged.
• DO NOT cover air vents. Restriction of air flow will cause Aspirator to
overheat, causing the thermal reset to shut down the Aspirator.
• DO NOT drop or insert any object into any opening or hole.
• Connect this Aspirator to a properly grounded outlet only.
See “GROUNDING INSTRUCTIONS”.
• Keep the cord away from heated surfaces.
CAUTION
Ground reliability can only be achieved when the power cord is
connected to an equivalent receptacle marked "Hospital Grade".
SPECIFICATIONS
Operating Vacuum Range:
0-26 inHg
(0-660 mmHg)
Dimensions:
Length:
13.3 in
(33.7 cm)
Width:
8.0 in
(20.3 cm)
Height:
9.8 in
(24.8 cm)
Weight:
12.6 lbs (5.7 kg)
Shipping Weight:
14.5 lbs (6.6 kg)
Electrical:
PM60: 108 -132 VAC, 60 Hz, 4.8 Amps
PM60E: 207 - 253 VAC, 50 Hz, 2.4 Amps
Operating Temperature Range: 50°F to 104°F (10°C to 40°C)
Storage Temperature Range:
-4°F to 104°F (-20°C to 40°C)
Max 95% Noncondensing
Filter:
Inline, Hydrophobic
Safety Systems:
Automatic Resetting Thermal Limit Switch
Equipment Classification:
Class I - with respect to protection from electrical shock
Type B
- degree of protection against electrical shock
IPX0 - degree of protection against ingress of liquids
Mode of Operation
- continuous
The Easy Vac Aspirator meets the EMC requirements of EN 550011:1998.
Specifications are subject to change without prior notice.
Component description
CAUTION
If for any reason any label becomes illegible or lost, contact
Precision Medical, Inc.
Patient
Tubing
Connection
Vacuum
Gauge
Control
Knob
On/Off
Switch
Suction Feet
Inline
Hydrophobic
Filter
Standard 800cc
Suction Canister
with Float Shutoff
Power Cord
Power Cord
Keeper
Grounding Instructions
The Easy Vac Aspirator should be grounded. In the event of an electrical
short circuit, grounding reduces the risk of electrical shock by providing
an escape wire for the electrical current. This Aspirator is equipped with
a cord having a grounding wire with a grounding plug. The plug must be
plugged into an outlet that is properly installed and grounded.
DANGER
Improper use of the grounding plug can result in a risk of electrical
shock.
WARNING
Ground reliability can only be achieved when the power cord is
connected to an equivalent receptacle marked "Hospital Grade".
OPERATING INSTRUCTIONS
CAUTION
Inspect the Easy Vac Aspirator for visual damage, DO NOT USE if
damaged.
1. Place Easy Vac Aspirator near a properly grounded electrical
receptacle on a table, floor or other horizontal, smooth, hard surface.
Allow a minimum of 4 in. (10 cm) clearance on all sides to ensure
adequate air flow for cooling of Aspirator.
2. Press down on Aspirator until Suction Feet are secure.
3. Be sure the On/Off Switch is in the “Off” position.
4. Be sure the Inline Hydrophobic Filter is properly connected to the
vacuum port on the Suction Canister lid.
• The Inline Hydrophobic Filter prevents liquid from entering the
vacuum pump.
CAUTION
DO NOT run the Easy Vac Aspirator without Inline Hydrophobic
Filter. This will void the warranty.
5. Plug the Aspirator into a properly grounded receptacle.
6. Turn the On/Off Switch to the “On” position.
7. Block the patient connection on the Suction Canister and adjust the
Vacuum Control Knob to the desired vacuum.
To INCREASE vacuum - Turn knob CLOCKWISE
To DECREASE vacuum - Turn knob COUNTERCLOCKWISE
• Vacuum should be set as prescribed by Provider.
8. Connect one end of the Patient Suction Tubing to the port on the
Canister marked Patient Tubing.
9. Connect the other end of the Patient Suction Tubing to the suction
catheter and begin procedure as instructed by Provider.
10. When procedure is completed, press the On/Off Switch to the “off”
position.
• DO NOT overfill the canister
11. Empty the Suction Canister as follows:
• Remove the canister from its bracket and empty as instructed by
your Provider.
CAUTION
Canister is for single patient use only.
12.Replace Suction Canister and reconnect all suctioning tubing.
Cleaning / maintenance
WARNING
Turn the Easy Vac Aspirator off and disconnect from any external
power source before cleaning.
Inline Hydrophobic Filter:
This filter cannot be cleaned. If it becomes contaminated or clogged, it must
be replaced.
To replace Inline Hydrophobic Filter:
1. Disconnect filter assembly from Suction Canister and remove Suction
Canister from the Aspirator.
2. Remove filter assembly from the Aspirator.
3. Dispose of filter.
4. Install new filter (Part #1690) and reconnect tubing and elbow.
Tubing is single patient use only. DO NOT clean.
Cleaning for Exterior Components:
1. Disconnect the Aspirator from power source and other connections before
cleaning.
2. Use a cloth or sponge dampened with soap and water.
3. Wipe dry with a clean cloth or paper towel.
4. Store the Aspirator in a clean area free form grease, oil, and other sources
of contamination.
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.
Disposal Instructions
Dispose of Bio-waste products as described by your Healthcare Professional
or Healthcare Facility protocol.
Please Recycle
WARNING
If Aspirator is used for treatment of infectious disease, consult your
Physician or Healthcare Professional for recommended procedures for
proper disposal.
Replacement Parts
Description
Part #
Patient Suction Tubing
1955
Filter
1690
Filter Assembly
502012
Elbow Canister Outlet
1616
800cc Canister, (Case-10 ea.)
502519-10
Troubleshooting
If the Easy Vac Aspirator fails to function, consult the Troubleshooting Guide
below. If the problem cannot be corrected, consult your Provider.
Problem
Probable Cause
Remedy
Aspirator will not
operate
1. On/Off switch in
“off” position
2. Power Cord not
connected properly
3. Thermal limit
exceeded
1. Push On/Off switch to
“On” position
2. Check plug at outlet
1. Hydrophobic Filter
not connected
properly
2. Suction Canister
not connected or
assembled properly
3. Defective Suction
Canister
4. Defective Regulator
1. Confirm and tighten
connections
NO vacuum
on gauge / NO
vacuum at Patient
Connection Tubing
3. Shut Aspirator off,
wait 15 minutes; be
sure vents are clear
2. Confirm and tighten
3. Replace Suction
Canister
4. Contact your Provider
NO vacuum on
gauge / vacuum at
Patient Connection
Tubing
1. Defective vacuum
gauge
1. Contact your Provider
Vacuum on gauge
/ NO vacuum at
Patient Suction
Tubing
1. Clogged
Hydrophobic filter
2. Canister overfilled
1. Replace Hydrophobic
filter
2. Empty canister
Unable to adjust
vacuum
1. Defective regulator
1. Contact your Provider
LIMITED WARRANTY
AND
LIMITATION OF LIABILITY
Precision Medical, Inc. warrants that EASY VAC Aspirator
(the Product) will be free of defects in workmanship and/or material for
the following period:
Five (5) years from 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 representatives 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.
Precision Medical, Inc.
300 Held Drive
Northampton, PA 18067 USA
Toll Free Tel: 800-272-7285
Toll Free Fax: 800-353-1240
Tel:(+001) 610-262-6090
Fax:(+001) 610-262-6080
ISO 13485 Certified
1907 Rev7 (E) 1/09 (5M) Printed in USA