SmartSuction HARMONY User Manual Rev AC Jan 2015.pdf
Page 1
User manual
HAEMONETICS CORPORATION
400 Wood Road, Braintree, MA
02184, USA
100789-50(AC)
January 2015
Page 2
ii
Publication information
Copyright
notice
© 2005–2009, 2014 Haemonetics Corporation. All rights reserved.
The contents of this manual are the property of the Haemonetics Corporation.
Any information or descriptions contained in this manual may not be
reproduced and released to any of the general public, or used in conjunction
with any professional instruction without written consent of Haemonetics
Corporation, USA.
Confidential /
Proprietary
notices
Use of any portion(s) of this document to copy, translate, disassemble or
decompile, or create or attempt to create by reverse engineering or otherwise
the source code from the object code of Haemonetics products is expressly
prohibited.
Disclaimer
This manual is intended as a guide to provide the operator with necessary
instructions on the proper use and maintenance of certain Haemonetics
Corporation products. This manual should be used in conjunction with
instruction and training supplied by qualified Haemonetics personnel.
Any failure to follow the instructions as described could result in impaired
product function, injury to the operator or others, or void applicable product
warranties. Haemonetics accepts no responsibility for liability resulting from
improper use or maintenance of its products.
Utilization of Haemonetics products may require the operator to handle and
dispose of blood-contaminated material. Operators must fully understand and
implement all regulations governing the safe handling of blood products and
waste, including the policies and procedures of their facility.
Handling and use of any blood products collected or stored using Haemonetics
equipment are subject to the decisions of the attending physician or other
qualified medical personnel. Haemonetics makes no warranty with respect to
such blood products.
The screenshots appearing in this guide are provided for illustrative purposes
only. All organization, donor/patient, and user names in this manual are
fictitious. Any similarity to the name of an organization or person is
unintentional. Patient diagnosis is the sole responsibility of the attending
physician or other qualified medical personnel.
P/N 100789-50, Manual revision: AC
Haemonetics® SmartSuction Harmony® User Manual
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Document
updates
The document is furnished for information use only, is subject to change
without notice and should not be construed as a commitment by Haemonetics
Corporation. Haemonetics Corporation assumes no responsibility or liability for
any errors or inaccuracies that may appear in the informational content
contained in this material. For the purpose of clarity, Haemonetics Corporation
considers only the most recent version of this document to be valid.
Trademarks and
patents
Haemonetics®, THE Blood Management Company®, Cell Saver®, OrthoPAT®,
cardioPAT®, HaemoLite®, SmartSuction®1 and SmartSuction Harmony® are
trademarks or registered trademarks of Haemonetics Corporation in the United
States and/or other countries.
Other product names in this document may be trademarks of their respective
proprietors and they are used for identification purposes only.
Reader
comments
Any comments or suggestions regarding this publication are welcomed and
should be forwarded to the attention of:
Corporate headquarters
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
U.S.A.
Tel.: +1 781 848 7100
Fax: +1 781 848 5106
International headquarters
Haemonetics S.A.
Rue des Fléchères
Signy Centre
P.O. Box 262
1274 Signy-Centre, Switzerland
Tel.: +41 22 363 9011
Fax: +41 22 363 9054
RxOnly
Caution: USA Federal Law restricts the sale, distribution, or use of this device
to, by, or on the order of a licensed healthcare practitioner.
Haemonetics
worldwide
For a list of worldwide office locations and contact information, visit
www.haemonetics.com.
1.
SmartSuction is registered in the U.S. Patent and Trademark Office.
Haemonetics® SmartSuction Harmony® User Manual
P/N 100789-50, Manual revision: AC
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iv
Symbols found
in this
document
The terms Note, Caution and Warning are used in this manual with the
following symbols to notify the operator of important and/or critical information.
Note: Provides useful information regarding a procedure or operating
technique when using Haemonetics material.
Caution: Advises the operator against initiating an action or creating a
situation that could result in damage to equipment, or impair the quality of the
blood products; personal injury is unlikely.
Warning: Advises the operator against initiating an action or creating a
situation that could result in serious personal injury to the surgeon,
patient, or operator.
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Haemonetics® SmartSuction Harmony® User Manual
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Table of
Contents
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
What is the purpose of this manual?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
How does the SmartSuction Harmony device work? . . . . . . . . . . . . . . . . 1
Device and disposable description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Device description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Disposable description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Operating the SmartSuction Harmony device . . . . . . . . . . . . . . . . . . . . . . . . 5
Setting up the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Starting suction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Disconnecting the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Cleaning/maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Cleaning supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Cleaning the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Troubleshooting, safety and service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Device and disposable specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Device specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Parts list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Use of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
IEC 60601-1-2:2001 standard requirements . . . . . . . . . . . . . . . . . . . . . . . . 19
Operation precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
EN 60601-1-2: 2007 standard requirements . . . . . . . . . . . . . . . . . . . . . . . . 23
Operation Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Haemonetics® SmartSuction Harmony® User Manual
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1
Overview
What is the
purpose of this
manual?
The SmartSuction Harmony® operation manual provides information needed to
safely operate and maintain the SmartSuction Harmony device. Use this
manual in conjunction with training provided by qualified Haemonetics®
personnel.
Intended use
The SmartSuction Harmony device is an AC-powered device intended to act
as an independent suction source to replace wall suction during surgery in the
operating room. The SmartSuction Harmony device is intended for use by
trained operating room personnel under the direction of a physician.
In addition, the SmartSuction Harmony device can be used with the
SmartSuction Harmony peri-operative regulator kit for peri-operative use.
Warning: The SmartSuction Harmony device is not intended for
endotracheal suction. The SmartSuction Harmony device automatically
adjusts suction up to 150 mmHg negative pressure when the suction tip
is occluded. Do not use SmartSuction Harmony device as a suction
source in any procedure where 150 mmHg of suction could damage
underlying tissue.
How does the
SmartSuction
Harmony device
work?
The SmartSuction Harmony device provides suction to the vacuum port of
blood collection devices used in the operating room or during post-operative
recovery to aspirate shed blood and fluids from the surgical field or closed
wound.
When used intra-operatively, the SmartSuction Harmony device is designed to
autoregulate suction levels to optimize fluid removal.
When the device detects a high air flow rate at the suction tip – indicating
surface skimming – the vacuum level is kept low.
When the device detects lower air flow rates – indicating submergence in
fluid – the vacuum level automatically increases.
No manual adjustment of suction levels is required. The range of vacuum
levels provided by the device is from 20 mmHg to 150 mmHg.
When used post-operatively in a closed wound, the regulator can be used to
manually control the suction to desired levels.
Efficient operation of the device depends on the use of a high air-flow
disposable vacuum line and aspiration and anticoagulant (A&A) line (see
“Parts list” on page 1-15), in conjunction with a reservoir that has a maximum
capacity of 3 liters.
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Caution: The SmartSuction Harmony device has been calibrated to optimize
performance with the use of Haemonetics proprietary disposables and
recommended suction tips. Suction and fluid removal performance may decline
if incorrect or non-Haemonetics disposables are used with the system.
The illustration below shows a typical set-up using the SmartSuction Harmony
as the suction source.
Components of surgical
suction assembly
3.
1. Suction tip
2. A&A line
3. Reservoir of blood collection system
4. Blood collection device
connection
2.
5.
SmartSuction Harmony
components
4.
6.
5. Filter
6. SmartSuction Harmony
vacuum line*
7. SmartSuction Harmony
device
1.
7.
Figure 1-1, Example of typical SmartSuction Harmony device set-up
*Example used is the Cell Saver® vacuum line
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Device and disposable description
Device
description
1.
1. Handle
2. Vacuum line release
switch
3. Stand-by/Preparatory
switch
4. Status LEDs (2)
5. Vacuum line receptacle
6. Indent for carrying (one
on each side of the device)
7. Air exhaust filter
(bottom of device)
8. Power entry module
(back of device)
9. ON/OFF switch
10. Power cord receptacle
8.
9.
2.
10
3.
4.
5.
6.
7.
Figure 1-2, The SmartSuction Harmony housing
Handle
The SmartSuction Harmony device has a handle on the top of the device and
an indent on each side of the device to facilitate lifting, carrying, and placement.
Vacuum line release switch
The vacuum line release switch is a large yellow button that facilitates the
disconnection of the vacuum line.
Control panel
Stand-by/Preparatory switch
The control panel consists of a single Stand-by/Preparatory switch which
starts and stops the vacuum. The switch is covered with a plastic membrane
which can be wiped down for easy cleaning and disinfecting.
Status LEDs
Two small lights (LEDs) below the Stand-by/Preparatory switch indicate the
operational status of the device.
A green status LED illuminates if the device is ready for use.
A red status LED illuminates if the device detects an error condition.
Vacuum line receptacle
The vacuum line receptacle is the input for the vacuum line.
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Power entry module
The power entry module is located on the rear of the device. The module
consists of the ON/OFF switch and the power cord receptacle.
Disposable
description
Warning: Always inspect the disposables before use. Do not use a
disposable that has been opened, damaged or is missing components.
Vacuum line
The vacuum line connects the SmartSuction Harmony device to the vacuum
inlet port of the blood collection device.
The SmartSuction Harmony device requires protection against fluid ingress.
The filtered vacuum line contains an in-line hydrophobic filter and should
be used with blood collection devices that do not incorporate overflow
protection, like the Cell Saver reservoir.
The unfiltered vacuum line is designed for use with blood collection
devices that do contain integrated overflow protection, such as the
OrthoPAT® and cardioPAT® systems or on the Cell Saver system with the
SmartSuction Harmony peri-operative regulator kit.
Caution: Use of an incorrect or non-Haemonetics vacuum line may affect
suction performance and damage the device.
1. Filter
2. Blood collection device
connector
3. SmartSuction Harmony
device connector
1.
2.
3.
Figure 1-3, Example of a filtered vacuum line with protective caps
1. Blood collection device
connector
2. SmartSuction Harmony
device connector
1.
2.
Figure 1-4, Example of an unfiltered vacuum line with protective caps
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Haemonetics® SmartSuction Harmony® User Manual
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5
Operating the SmartSuction Harmony device
The device is designed for “walk-away” operation. Controls are kept at a
minimum, and, once activated, the device functions with little to no user
interaction. The device automatically adjusts its flow rate depending on the
amount of blood encountered in the surgical field.
Warning: Please read all associated cautions or warnings before
executing any instructions in the operation manual.
Setting up the
device
Use the following steps to set up the SmartSuction Harmony device for
operation.
1. Mount and secure the SmartSuction Harmony device according to the
instructions included with the IV pole or cart attachment kit.
Warning: Physically keep the IV pole steady during transport, or at any
time the device is being moved, particularly over thresholds, inclines or
declines. Pushing on the pole at a height greater than 35 in. (89 cm) when
a cardioPAT, OrthoPAT, or OrthoPAT advance device is also installed on
the pole could cause the pole to unbalance and tip over.
2. Apply the “No pushing” sticker that comes with the IV pole attachment kit
to the IV pole > 35 in. (89 cm) above the ground.
3. Ensure the collection reservoir of the blood collection device is as low as
possible (according to instructions in the blood collection device’s
Operation Manual) to ensure optimal recovery.
4. Plug the power cord into the power receptacle at the back of the
SmartSuction Harmony device and connect the other end to a hospitalgrade power source.
Note: When using the SmartSuction Harmony device with a Cell Saver 5
system that has a serial # prior to 01B077, a riser block kit is required in
addition to the cart attachment kit.
Caution: Do not power the SmartSuction Harmony device using a power cord
not supplied by Haemonetics, a multiple portable socket outlet or an extension
cord.
Warning: Do not position the SmartSuction Harmony device such that it
is difficult to reach the power switch and/or remove the power cord from
the inlet.
Note: The A&A line recommended for use with the SmartSuction Harmony
device (see “Parts list” on page 1-15), and a suction tip with an inner diameter
(ID) of 0.3” are designed to optimize the flow rates. Using an alternate A&A line
or a suction tip with a smaller ID may reduce the flow rates that can be
achieved.
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5. Switch on the ON/OFF switch located at the back of the device.
6. Insert the connector end of the vacuum line into the vacuum line
receptacle. The line secures in position with an audible click.
7. Use aseptic technique to attach the other end of the vacuum line to the
vacuum port of the blood collection device according to the instructions
included with the vacuum line.
8. Verify that there are no kinks or occlusions in the vacuum line.
Starting suction
When ready to start suctioning, press the Stand-by/Preparatory switch on the
SmartSuction Harmony device.
Disconnecting
the device
Warning: Follow local standard operating procedure for blood
precautions when operating the SmartSuction Harmony device.
To disconnect the SmartSuction Harmony device at the end of a procedure,
follow the steps below:
1. Press the Stand-by/Preparatory switch to stop vacuum.
2. Disconnect the vacuum line.
3. Dispose of the vacuum line in accordance with hospital guidelines and
procedures for biohazardous waste disposal.
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Haemonetics® SmartSuction Harmony® User Manual
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Cleaning and maintenance
Cleaning/
maintenance
schedule
Haemonetics recommends the following routine cleaning schedule for the
SmartSuction Harmony device and the suction peri-operative regulator.
Daily: Clean the exterior surfaces.
Daily: General inspection.
Quarterly: Replace the SmartSuction Harmony air exhaust filter.
Annually: Contact a qualified service representative to calibrate the
SmartSuction Harmony device and perform preventive maintenance.
Warning: To eliminate the potential danger of electrical shock, only clean
or perform maintenance on the SmartSuction Harmony device when it is
disconnected from the external power source.
Special cleaning needs, such as a fluid spill, should be dealt with
promptly. Follow local standard operating procedure for blood
precautions when cleaning up a blood spill or dealing with blood
contaminated components. Dispose of all cleaning materials as
biohazardous waste.
Cleaning
supplies
The following list describes the basic material recommended for routine
cleaning and maintenance:
Disinfectant cleaning solution, specific for blood-borne pathogens.
Clear warm water.
Mild detergent.
Lint-free gauze or cloth (for cleaning and drying).
Cotton swabs.
Personal protective equipment.
Caution:
1. Do not use solvents or strong alcohol solutions.
2. Do not immerse any part of the device in liquids.
3. Do not use abrasive cleaning agents.
Haemonetics® SmartSuction Harmony® User Manual
P/N 100789-50, Manual revision: AC
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Cleaning the
device
Exterior surfaces (daily)
1. Clean the exterior surfaces of the device after each use and/or after any
spill of liquids on the device.
2. Use only mild detergents, water and lint-free gauze or cloth.
Blood spill
In the event of a blood spill, disinfect the exterior surfaces using a disinfectant
solution such as a 10% bleach/90% water solution.
Note: If blood enters the housing of the SmartSuction Harmony device through
the vacuum port, or the housing of the regulator, remove from service and
contact the local Haemonetics representative (or the Haemonetics Customer
Care Center).
Maintenance
General inspection
1. Visually check the condition of the device before every use.
2. Remove from service any unit which shows physical damage.
Changing the air exhaust filter
Follow the steps below to change the air exhaust filter. If the filter cover is
damaged, contact the local Haemonetics representative (or the Haemonetics
Customer Care Center) for a replacement part.
Warning: Follow local standard operating procedure for blood
precautions when dealing with blood contaminated components.
1. Unplug the unit.
2. Carefully lay the SmartSuction Harmony device upside down on a flat,
padded surface.
3. Pull off the black plastic air exhaust filter cover. For easy removal pull
from the corner of the cover.
4. Remove the filter pad and dispose of it in accordance with hospital
guidelines and procedures for biohazardous waste disposal.
5. Insert a new filter pad. Ensure that the textured surface faces the device.
6. Place the black plastic cover back in position and press down on it gently
until it snaps into position.
Caution: Use only the SmartSuction Harmony replacement exhaust air filter
pad. Use of substitutes may affect device performance.
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Haemonetics® SmartSuction Harmony® User Manual
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Replacing the fuses
The fuses are covered by a black plastic fuse door, located in the power entry
module at the rear of the device. At the top of the fuse door is a small
indentation to allow the operator to open the fuse door. The door is hinged at
the bottom.
Follow the steps below to open the fuse door and replace the fuses:
1. Turn off and unplug the device.
2. Use a small screwdriver (1/8” flathead), to open the black plastic fuse
door by placing the screwdriver in the indent at the top of the door and
levering it open.
3. Using the screwdriver, gently pull out the black fuse holders by placing
the screwdriver under the white arrow and levering out the holder.
4. Place new fuses in the fuse holders. Be sure to use appropriately rated
fuses (see “Electrical specifications” on page 1-13).
5. Replace the fuse holders in the power entry module, ensuring that the
white arrows are pointing in the same direction as the arrows on the fuse
door.
6. Close the fuse door and press gently until it snaps into place.
Figure 1-5, Opening the fuse door
Haemonetics® SmartSuction Harmony® User Manual
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Troubleshooting, safety and service
Troubleshooting
Problem
Possible cause
Neither LED is lit.
Power failure
Corrective action
1. Check that the device is connected to a power
source and that the outlet is functional.
2. Check that the device is turned on (toggle switch on
the back of the unit).
3. Check that the Stand-by/Preparatory switch has
been turned on.
4. Check and, if necessary, replace the fuses.
If the problem continues call the local Haemonetics
representative (or the Haemonetics Customer Care
Center).
Both the Green
and the Red LEDs
are lit.
Device failure
The device is non-functional. Call the local
Haemonetics representative (or the Haemonetics
Customer Care Center).
The Green LED is
lit and the Red LED
flashes every 3
seconds.
Obstruction
1. Check the vacuum tubing for obstruction or kinking.
The Green LED is
lit, but the device
will not aspirate.
Obstruction
2. Check the filter in the vacuum line (if present) for
fluid or discoloration. If needed, replace the vacuum
line.
1. For OrthoPAT and cardioPAT, check that the
suction mode on the blood collection device is
turned on.
2. Ensure that the vacuum line is the correct line for
the blood collection device in question.
3. Check the vacuum tubing for obstruction or kinking.
4. Check the A&A line for obstruction or kinking.
5. Ensure that the vacuum line is securely connected
to the device.
6. Check the filter in the vacuum line (if present) for
fluid or discoloration. If needed, replace the vacuum
line.
7. Check the air exhaust filter on the bottom of the
device for discoloration or moisture. If needed,
replace the filter.
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Haemonetics® SmartSuction Harmony® User Manual
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Problem
Possible cause
Air leak
Corrective action
1. Ensure the vacuum line is securely connected to
the device and the collection reservoir and check
for leaks.
2. Check that the collection reservoir has no open
tubes or ports.
3. Check to ensure the A&A line has been correctly
connected.
4. Check the collection reservoir for leaks.
The Green LED is
on, but sudden loss
of suction during
the procedure
occurs.
Obstruction
1. Check the vacuum tubing for obstruction or kinking.
2. Check the A&A line for obstruction or kinking.
3. Have surgeon check suction wand for possible
occlusion.
4. Check the junction of the A&A line and the
collection reservoir for occlusion.
5. Ensure the reservoir is not full.
Device cycles
intermittently when
vacuum line is
removed.
Safety
Internal obstruction
Contact the local Haemonetics representative (or the
Haemonetics Customer Care Center).
Electrical shock hazards
Always use the SmartSuction Harmony device with clean, dry hands or gloves.
The interior of the SmartSuction Harmony device contains various electrical
components. Contact with any of these components, when the device is
connected to an external power source, could result in an electrical shock to
the operator and/or donor/patient. The operator should never remove any of
the SmartSuction Harmony cabinet panels.
Note: Refer all servicing and repair to suitably qualified personnel.
Services
Clinical training
The local Haemonetics representative will provide staff training upon delivery
of SmartSuction Harmony equipment and should be contacted to organize
further instruction if needed.
Haemonetics® SmartSuction Harmony® User Manual
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12
Repair service
Haemonetics maintains a worldwide network of company-trained service
representatives responsible for responding to technical needs concerning
equipment. If service beyond the routine maintenance and cleaning described
in this manual is required, the local Haemonetics representative (or the
Haemonetics Customer Care Center) should be contacted to provide specific
instruction.
Returned goods authorization (RGA) system
Haemonetics seeks to provide the customer with equipment and material
which respects the highest established standards of quality in design and
manufacturing. If, for any reason, merchandise must be returned to the
company, the customer should refer to the Haemonetics Returned Goods
Authorization (RGA) system procedure to ensure proper handling and
subsequent analysis of the material.
First, the customer should contact the local Haemonetics representative [or the
Haemonetics Customer Service Department] and provide the following
information:
Product serial number, list number, lot number (if applicable), and
manufacture and/or expiration date.
Number of articles to be returned.
Description of defect.
Number of parcels being shipped.
The Haemonetics representative may ask for additional details, depending on
the nature of the problem. The customer should be prepared to provide a
thorough description of the problem encountered, as well as the product
information listed above.
If a contaminated disposable set must be returned by courier services, the
Haemonetics representative may provide specific instructions concerning
preparation for shipping blood-contaminated products. In addition to the
Haemonetics guidelines, the consumer should strictly follow the local standard
operating procedure related to the shipment of blood-contaminated materials
and thus minimize any potential health hazards involved.
In some cases, it may be necessary to dispose of the contaminated goods after
reporting the problem to the Haemonetics representative. This should be done
according to the locally established guidelines pertaining to the disposal of
biologically contaminated material.
Warning: Haemonetics products must be properly cleaned and packaged
prior to their return. It remains an important responsibility of the
customer to reduce potential health hazards by being aware of the risks
involved in the shipping, handling and testing of this material.
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Haemonetics® SmartSuction Harmony® User Manual
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Device and disposable specifications
Device
specifications
Dimensions and weight
Characteristics
Housing
Height
9.6 in [24.4 cm]
Width
13.75 in [34.9 cm]
Depth
9.25 in [23.5 cm]
Weight
18.5 lbs [8.4 kg]
Environmental conditions
Conditions
Values
Device operating temperature
5°C to 35°C [41°F to 95°F]
Device operating humidity level
30–75%, non-condensing
Device storage temperature
–4°F to 122°F [–20°C to 50°C]
Device storage humidity level
< 90%, non-condensing
Disposable storage
temperature
–4°F to 122°F [–20°C to 50°C]
Disposable storage humidity
level
< 80%
Atmospheric pressure range
≤ 10,000 ft [3.048 m] above sea level
Pollution degree
Pollution degree 2
Electrical specifications
Characteristics
HAR-E-115
HAR-E-230
Voltage range
100 to 120 V~
220 to 240 V~
Operating current
1.5 Amp
0.8 Amp
Fuse
F2.5A, 250 V~
F1.5A, 250 V~
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Characteristics
HAR-E-115
HAR-E-230
Frequency
50 or 60 Hz, single phase
Note: Haemonetics ensures the proper voltage setting prior to shipment.
Warning: The power source used must be properly grounded.
Warning: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
Other specifications
Characteristics
Values
Recommended reservoir volume
≤3L
Recommended A&A line length
≤ 12 ft [3.6 m]
Recommended A&A line inner
diameter
0.3 in [7.6 mm]
Recommended suction tip inner
diameter
0.3 in [7.6 mm]
Power cord
2 wire plus ground; 15 ft [4.5 m]
Operating vacuum
20 to 150 mmHg
(2.7 to 20.0 kPa; 26.7 to 200 mbar)
Vacuum cutoff
175 mmHg
(23.3 kPa; 233 mbar)
Maximum free air flow
40 L/min
Noise level
< 65 dB
Device classification as defined by IEC 60601
Continuous operation
Type CF
Class I
IPX1
Caution: The SmartSuction Harmony device must be operated in an
environment compatible to the requirements of the EN 60601-1-2 Standard,
Electromagnetic compatibility (EMC).
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Note: Additional IEC compliance information is available at the end of this
operation manual.
Parts list
Part
Ordering
number
Qty per
case
Non-sterile vacuum line, filtered
HAR-A-1000
10
Non-sterile vacuum line, unfiltered
HAR-A-1001
10
Non-sterile peri-op vacuum line
HAR-A-1002
10
A&A line
HAR-A-1003
10
Air exhaust filter cover
100874-00
–
Air exhaust filter pad
100878-00
–
CS5/5+ cart attachment kit
101186-00
–
IV pole attachment kit
101709-00
–
CS5 riser block kit
102009-00*
–
* For use with Cell Saver 5 devices prior to serial # 01B077.
Use of symbols
The descriptions of the following symbols are based on information provided in
the following documents:
IEC Standard 60601-1, Medical Electrical Equipment,
Part 1: General requirements for safety.
IEC Standard 60417-1, Graphical symbols for use on equipment,
Part 1: Overview and application.
Symbols found on the device
The following symbols may be found on the device.
Stand-by/Preparatory
Power OFF
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Position of the main power switch indicating disconnection
from the mains.
Power ON
Position of the main power switch indicating connection to the
mains.
SN
Serial number
Type CF applied part
Provides a particular degree of protection against electric
shock; particularly regarding allowable leakage current and reliability of the protective earth connection. Suitable for cardiac
applications.
Protection against ingress of liquid
Indicates that the enclosure of the device is designed to be
drip-proof, providing a higher than ordinary level of protection
from drips, leaks and spills.
Attention
Consult accompanying documents.
Read the instruction manual
Non-ionizing electromagnetic radiation
Used to specify RF (Radio Frequency) transmission for data
communication.
Shock hazard
Alternating current
Indicates on the rating plate that the device is suitable for alternating current only.
Fuse symbol
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Identifies fuse boxes or the location of a fuse box.
Output; exit
Indicates the main exhaust for the device.
Filter cleaning/changing
To identify or advise cleaning or changing a filter.
175 mmHg
Maximum vacuum
Electric energy
Electrical and electronic equipment waste (applies to EU
only)
Dispose of the device using a separate collection method (according to EU and local regulation for waste electrical and
electronic equipment).
Manufacturer (address for)
Authorized representative in the European community
(address for)
Rx only (applies to USA only)
Federal (USA) Law restricts the device to sale by or on the order of a Physician.
CSA mark
Product is certified by CSA for both US and Canadian markets
to the applicable American and Canadian standards.
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Symbols found on packaging
The following symbols may be found on the device packaging.
Catalog number
Storage conditions, KEEP DRY
Storage conditions, humidity level
Storage conditions, temperature level
Fragile, handle with care
Miscellaneous symbols
If the device is mounted on an IV pole, the following symbol may be found on
the pole.
No pushing
Indicates that pushing on the pole at a height greater than 35
in. (89 cm) when a cardioPAT, OrthoPAT, or OrthoPAT advance device is also installed on the pole could cause the pole
to unbalance and tip over.
The following symbol may be found on third-party disposable sets. For a full list
of symbols found on Haemonetics disposable sets, refer to the documentation
that accompanies the sets.
Do not reuse
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EN 60601-1-2: 2007 standard requirements
Caution: The SmartSuction Harmony device must be operated in an
environment compatible to the requirements of the EN 60601-1-2 Standard,
Electromagnetic compatibility (EMC).
Operation
Precautions
A power cord is supplied with the device. Do not replace the power cord with a
substitute. If necessary, contact the Haemonetics Customer Care Center for a
replacement. Always ensure the power cord is connected to an appropriately
grounded power source.
Mobile radio frequency (RF) communication equipment that is not approved by
Haemonetics, and portable communication equipment can affect the system.
Any accessories and cables not approved by Haemonetics, used in
conjunction with the device, may increase hazards and influence compatibility
with EMC requirements. Therefore, non-approved accessories and cables
must not be used.
In addition, the SmartSuction Harmony device and accessories must not be
placed directly adjacent to, or on top of, other equipment unless specifically
approved by Haemonetics.
Caution: Grounding reliability can only be achieved when the equipment is
connected to a properly grounded outlet.
Electromagnetic
Compatibility
Table 1: Guidance and manufacturer’s declaration - electromagnetic emissions
The SmartSuction Harmony device is intended for use in the electromagnetic environment specified
below. The customer or user of the SmartSuction Harmony device should ensure that it is used in such
an environment.
Emissions test
Compliance
Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1
The SmartSuction Harmony system uses RF
energy only for its internal functions.
Therefore, its RF emissions are very low and
are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
EN 61000-3-2
Class A
The SmartSuction Harmony system is
suitable for use in all establishments, other
than domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Voltage fluctuations/flicker emissions
EN 61000-3-3
Complies
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Table 6: Guidance and manufacturer’s declaration - electromagnetic immunity
The SmartSuction Harmony system is intended for use in the electromagnetic environment specified
below. The customer or operator of the SmartSuction Harmony system should ensure that it is used in
such an environment.
Immunity test
EN 60601 test level
Compliance level
Electromagnetic environment
guidance
Electrostatic
discharge (ESD)
EN 61000-4-2
±6 kV contact
±6kV contact
±8 kV air
±8 kV air
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast
transient burst
EN 61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV for input/
output lines
±1 kV differential
mode
±1 kV differential
mode
±2 kV common
mode
±2 kV common
mode
<5% UT (>95% dip in
UT) for 0.5 cycles
<5% UT (>95% dip in
UT) for 0.5 cycles
40% UT (60% dip in
UT) for 5 cycles
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5 sec.
<5% UT (>95% dip in
UT) for 5 sec.
3 A/m
3 A/m
Surge
EN 61000-4-5
Voltage dips,
short
interruptions,
voltage variations
on power supply
input lines.
EN 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
EN 61000-4-8
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
If the operator of the
SmartSuction Harmony system
requires continued operation
during power mains
interruptions, it is
recommended that the
SmartSuction Harmony system
be powered from an
uninterruptable power supply or
battery or Haemonetics
approved battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
P/N 100789-50, Manual revision: AC
Haemonetics® SmartSuction Harmony® User Manual