Hologic SUPERSONIC IMAGINE AIXPLORER MultiWave Configuration guide

AIXPLORER CLEANING
INSTRUCTION GUIDE
PM.LAB.128 - A
1

This document refers to the following Aixplorer® User Guides and
Addendums:
• PM.LAB.064-A
• PM.LAB.026-B
• PM.LAB.032-A
2

Changing Printer Paper and
Toner
Refer to the user’s manual of your specific printer for guidance on how
to properly change printer paper and toner.
Cleaning the System
Cleaning Frequency
You can perform the maintenance operations as described in this chapter.
Cleaning of the Aixplorer® ultrasound system should occur at regular
intervals, or more frequently as needed.
SuperSonic Imagine provides the following recommended cleaning
intervals as guidelines:
Part Recommended
Cleaning Frequency
System Display Monitor Weekly, or as needed
System Control Panel Daily, or between patients
Touchscreen Display Daily, or between patients
System Exterior:
chassis and Handles Weekly, or as needed
Air Filters Inspect weekly; clean monthly;
replace annually
Transducers:
cleaning and disinfection Between patients
3

It is prudent to continually survey the system for maintenance
needs. Contact your SuperSonic Imagine Sales or Service authorized
representative for further details.
CAUTION
If you have any questions regarding basic maintenance, or prefer to have
maintenance service performed, contact your authorized SuperSonic
Imagine Service representative.
Always press the On/Off switch, turn off the power switch at the back
of the machine, and disconnect the system from the wall outlet before
performing maintenance or cleaning the system.
It is recommended that gloves and protective eyewear are used when
cleaning the system.
Do not spray any cleaning agents directly onto the system. They may leak
into the system, damaging the system and voiding the warranty.
Do not allow standing liquid to collect around the control panel keys.
Do not allow liquid to drip inside the system chassis.
4

Cleaning the Exterior of the Machine
The exterior of the system should be periodically cleaned with a soft
cloth, lightly moistened with water and a gentle soap. This includes the
system chassis, control panel and handles. Be sure to clean any unused
gel from the surface of the control panel after system use.
The products below have been tested and found to be compatible with
SuperSonic Imagine Aixplorer®.
Solution Manufacturer Cleaner/
Disinfectant Active ingredient
Sani-Cloth Active PDI Cleaner
Disinfectant
Quat. Ammonia
Sani-Cloth Af3 PDI Cleaner
Disinfectant
Quat. Ammonia
Cleaning the Monitor
A clean, soft cotton cloth dampened with an ammonia-based window
cleaner should be used to clean the Monitor display. Do not use paper
towels, as these may scratch the display monitor. The cleaning agent
should be sprayed onto the cloth, not directly onto the display surface.
Take care not to get any cleaning agent into the housing of the system.
This may lead to system damage.
Cleaning the Touch Screen Display
A clean, soft cotton cloth dampened with an ammonia-based window
cleaner should be used to clean the Touch Screen display. Do not use
paper towels, as these may scratch the display monitor. The cleaning
agent should be sprayed onto the cloth, not directly onto the display
surface. Take care not to get any cleaning agent into the housing of the
system. This may lead to system damage.
5

Cleaning Air Filters
The Aixplorer® ultrasound system is equipped with air filters. These
should be inspected every week and cleaned as needed. At first switch
on of the system after the first day of the month, the system displays an
icon as a reminder to check the air filters. Please refer to the following
air filter cleaning procedure, and click OK on the pop-up window.
The air filters are located:
• in a slot at the rear side of the system
• in a slot at the bottom side of the system.
To remove the rear air filter, open the cover on the back. To remove the
side air filter, open the left side cover with a pen. It is recommended
that air filters be cleaned monthly or more frequently if a significant
accumulation of dust or debris is noted.
NOTE
Please note that side filter may be missing on some models that do not
require it anymore.
Air filters may be removed, washed with mild soap and rinsed
thoroughly with water. Allow the filters to air dry before re-installing in
the system. Spare air filters are provided for immediate use. Additional
air filters can be ordered from SuperSonic Imagine Customer Service.
6

TO MAINTAIN AIR FILTERS
1. Remove the air filter cover by pulling the bottom of the cover towards
you.
2. Inspect the filter, and if it is dirty, replace it with a spare
3. Depending on the condition of the air filter, use either a vacuum
cleaner or soap and water to clean the dirty filter
4. Thoroughly dry the cleaned filters before re-installing
WARNING
Before performing maintenance or cleaning, always press the On/Off
switch, turn off the power switch at the back of the machine, and then
disconnect the system from the wall outlet.
Increased internal temperature can be caused by dirty air filters.
Failure to keep the air filters clean can result in the system becoming
unavailable during critical use.
Never install an air filter that is not completely dry.
CAUTION
Turn off power before you remove the air filters.
Do not turn power on without air filters installed.
7

Cleaning and Disinfecting the
Barcode Scanner
Maintenance
Cleaning the Scanning Window
Reading performance may degrade if the scanner's window is not clean.
If the window is visibly dirty, or if the scanner isn't operating well, clean
the window with a soft cloth or lens tissue dampened with water (or a
mild detergent - water solution). If a detergent solution is used, rinse with
a clean lens tissue dampened with water only.
Cleaning the Scanning Housing
The HS-1M is IP54 rated when the cable is attached. This means that
liquids and dusts will not penetrate into the housing. However, the
scanner should not be submerged in water or other liquids. It is also good
practice to dampen the cleansing cloth vs. spraying the scanner directly.
The HS-1M housing is compatible with the following medical grade
cleaners:
• Sani-Cloth® HB
• Sani-Cloth® Plus
• Hydrogen Peroxide
• CaviWipes™
• 409® Glass and Surface Cleaner
• Windex® Blue
• Clorox® Bleach (100%)
• Isopropyl Alcohol
• Gentle dish soap and water
CAUTION
Do not submerge the HS-1M in water.
Do not use abrasive wipes or tissues on the HS-1M's window - abrasive
wipes may scratch the window.
8

Never use solvents (e.g., acetone, benzene, ether, or phenol-based agents)
on the housing or window - solvents may damage the finish or the
window.
9

Cleaning and Disinfecting
Transducers
Transducer Cleaning Safety
WARNING
Use care when handling and cleaning ultrasound transducers.
Do not use a damaged or defective transducer.
Do not immerse or allow liquid to penetrate a transducer which has had
its face or cable sheath compromised.
Failure to follow these precautions can result in serious injury and
equipment damage.
Follow these precautions to avoid injury and equipment damage.
Inspect the transducer prior to cleaning for damage or degeneration to the
lens, housing, cable and connector.
Do not use or apply liquid cleaning agents to a damaged or defective
transducer.
Do not immerse the transducer into any liquid beyond the level specified
for that transducer.
Never immerse the transducer connector or transducer adapters into any
liquid.
Transducer damage can result from contact with inappropriate coupling
or cleaning agents.
Use only cleaning agents which have been approved for the specified
transducer.
Do not soak, immerse, or maintain prolonged contact with solutions
containing alcohol, bleach, ammonium chloride compounds or hydrogen
peroxide.
10

The level of disinfection required for a device is dictated by the type of
tissue it will contact during use. Ensure the solution strength and duration
of contact are appropriate for the intended clinical use of the transducer.
Always use protective eyewear and gloves when cleaning, disinfecting
or sterilizing any equipment.
Be sure to observe the expiration date of the solution.
Avoid disinfectant contact with the connector label.
CAUTION
Biological hazards may exist if ultrasound transducers are not properly
cleaned, disinfected or sterilized.
This is especially true if the transducer comes in contact with mucous
membranes or bodily fluids.
Proper cleaning and disinfection are necessary to prevent disease
transmission and infection control.
It is the responsibility of the equipment user to verify and maintain the
effectiveness of the infection control procedures in use.
Foranyprocedureswherethetransducermaycomeincontactwithbodily
fluids or mucous membranes, the use of a legally marketed, sterile, non-
pyrogenic transducer sheath is recommended.
Only use disposable sheaths. Sheaths are never to be reused.
Use caution when using disinfectant products.
Wear rubber gloves and protective eyewear.
Always follow the manufacturer’s instructions.
In order for liquid chemical disinfectants to be effective, all visible
residues must be removed during the cleaning process.
For effective cleaning, follow the instructions accompanying the cleaner
or disinfectant product.
11

Care should be taken to avoid applying disinfectant agents to the cable-
housing junction.
Do not allow any fluids to enter the cable-housing junction.
Do not use any alcohol or alcohol-based products on the transducer cable.
If the transducer shows signs of damage such as cracks, splitting,
delamination of the face or cable damage, discontinue use of the
transducer and contact your authorized SuperSonic Imagine Service
representative for assistance.
Transducer Cleaning and Disinfection
Guidance
Cleaning and disinfection is a two step process: a cleaning step followed
by a disinfection step.
CLEANING
Cleaning is intended to remove all foreign matter (blood, tissue, protein,
scanning gel, etc.) from the device.
DISINFECTION
The level of disinfection required for a device is dictated by the type
of tissue it will contact during use. There are three classifications: non-
critical, semi-critical, and critical. These are based on the degree of risk
of infection involved in the use of the device.
Non-critical applications are those where the device contacts only intact
skin;semi-criticalapplicationsare those where the device contacts mucus
membranesor minor skin breach;critical applications are thosewhere the
device enters a normally sterile environment, sterile tissue or vasculature.
Ultrasound transducers used for non-critical applications generally need
only to be cleaned and low-level disinfected between patient uses.
12

Transducer used in semi-critical application should be cleaned and high
level disinfected after use even if a sheath was used.
Transducers used in critical applications should be sterilized and the use
ofasterilesheathisrecommended. Transducer usedincritical application
should be cleaned and sterilized after use even if a sheath was used.
General Cleaning and Disinfection
Procedures for the Aixplorer®
Transducers
The SuperSonic Imagine Aixplorer® transducers are intended for use
in non-critical and semi-critical imaging applications. The transducer
must be thoroughly cleaned and disinfected after each use. In general,
only low-level disinfection is required for non-critical applications of the
SuperSonic Imagine Aixplorer® transducer.
Forsemi-criticalapplications,high-leveldisinfectionisrequiredandonly
one of the high-level disinfectants chosen from the list below should be
used.
High-level disinfection for semi-critical is recommended, carefully
following the manufacturer’s instructions with regard to application and
contact time as indicated on the product label.
PROCEDURE TO PREPARE TRANSDUCER FOR
DISINFECTION
1. After every patient exam, carefully wipe the face and housing of the
ultrasound transducer to remove any traces of ultrasound coupling gel.
2. Inspect the transducer for any signs of damage such as cracks,
splitting, delamination of the face or cable damage. If any damage is
noted, do not proceed with the cleaning or disinfecting procedures and
call your authorized SuperSonic Imagine Service representative for
assistance.
3. Wipe the transducer face, housing and cable with a water-moistened
soft cloth. The use of a mild soap, low-level cleaner or enzymatic
cleaner (from the table below) is acceptable.
13

4. If stubborn material has dried on the face or housing of the transducer,
carefully scrub the transducer using water moistened gauze, sponge
or surgeon’s soft bristle brush. Wipe away any material with a water-
moistened soft cloth.
5. Rinse the transducer thoroughly with water. Do not allow water to
access the cable-housing junction.
6. Air dry or dry using a soft dry cloth.
DISINFECTION PROCEDURE
1. Always clean the transducer prior to disinfection. (See steps above.)
2. When using an FDA or CE -cleared (as appropriate) disinfecting
agent, carefully follow the instructions provided by the manufacturer
of the product.
3. For low-level disinfection, the lens and housing of the transducer may
be wiped with any of the cleaners/low level disinfectants
listed in the associated transducer table.
4. For high-level disinfection, the transducer may be wiped or soaked
using one of the disinfectants listed in the associated transducer
table.
5. Air dry or dry using a soft dry cloth.
6. Re-inspect the transducer for any signs of damage such as cracks,
splitting, delamination of the face or cable damage before putting the
transducer back into use.
14

Cleaning and Disinfection Products
LIST OF COMPATIBLE PRODUCTS
The table below lists indicates the product compatibility ("YES") with
the Aixplorer® probes.
Only use compatible products with Aixplorer® probes.
Solution/
system Manufacturer Cleaner/ Disinfectant Active ingredient SL15-4
SL18-5
SL10-2
SMC12-3
SC6-1
SE12-3 SEV12-3 SEV12-3
GenII SLV16-5 XC6-1
XP5-1
SLH20-6
Alkaspray
GSA
(Cidalkan)
Alkapharm Cleaner
Disinfectant
Isopropyl alcohol
Alkylamine YES
Alkazyme Alkapharm Cleaner
Disinfectant
Quat. Ammonia YES
Anioxyde
1000 Anios Disinfectant Peracetic acid YES YES
Antigermix
S1 Germitec High-level
disinfectant UV-C YES
Cidex
OPA
(DISOPA
in Japan)
Advanced
Sterilization
Products
Disinfectant
Orthophtalaldehyde YES YES YES YES YES
Cidex Plus Advanced
Sterilization
Products
Disinfectant
Orthophtalaldehyde YES
Cidezyme Johnson and
Johnson Cleaner Proteolytic enzymes YES YES YES
Enzol Advanced
Sterilization
Products
Cleaner Proteolytic
enzymes YES
Gigasept
FF Schuller&Mayr
DisinfectantSuccindialdehyde,
dimethoxy-
tetrahydrofuran
YES YES YES
15

Solution/
system Manufacturer Cleaner/ Disinfectant Active ingredient SL15-4
SL18-5
SL10-2
SMC12-3
SC6-1
SE12-3 SEV12-3 SEV12-3
GenII SLV16-5 XC6-1
XP5-1
SLH20-6
Hypernova
Chronos Germitec High-level
disinfectant UV-C YES
KlenZyme Steris Cleaner Proteolytic
enzymes YES
Linget’Anios Anios Cleaner
Disinfectant
Ethanol
Digluconate de
chlorhexidine
Alkylamino-
alkylglycine
YES YES YES
MetriZyme Metrex Cleaner Proteolytic
enzymes YES
Mikrobac
Tissues Bode DisinfectantBenzyl-C12-18- alkyldimethyl-
ammonium
chlorides
didecyl-
dimethyl-
ammonium
chloride
YES YES
Milton Milton Disinfectant Sodium
Hypochlorite YES
Opaster
Anios Anios Disinfectant
Orthophtalaldehyde YES
Sani-Cloth
Active PDI Cleaner
Disinfectant
Quat. Ammonia YES
Sani-
Cloth HB PDI Disinfectant Quat. Ammonia YES
Sani-
Cloth Plus PDI Disinfectant Quat. Ammonia YES
Sporox Reckitt &
Colman Disinfectant Hydrogen Peroxide YES
Sporox II Reckitt &
Colman Disinfectant Hydrogen Peroxide YES
Steranios Anios Disinfectant Glutaraldehyde YES YES
16

Solution/
system Manufacturer Cleaner/ Disinfectant Active ingredient SL15-4
SL18-5
SL10-2
SMC12-3
SC6-1
SE12-3 SEV12-3 SEV12-3
GenII SLV16-5 XC6-1
XP5-1
SLH20-6
Steranios
OPA Anios Disinfectant
Orthophtalaldehyde YES YES
Super
Sani Cloth PDI Disinfectant Quat. Ammonia YES
T-Spray Pharmaceutical
Innovations
Inc.
Disinfectant Quat. Ammonia YES
Transeptic
spray Parker laboratories Cleaner Chlorhexidine Gluconate,
Isopropyl
Alcohol
YES
Tristel
Duo Tristel Solutions
Limited
Disinfectant Chlorine dioxide YES YES
Tristel
Solo Tristel Solutions
Limited
Disinfectant Hexamethylene-
biguanide YES
Trophon Nanosonics High-level
disinfectant Hydrogen
peroxide mist
generated in
a disinfection
chamber
YES YES
Trophon 2 Nanosonics High-level
disinfectant Hydrogen
peroxide mist
generated in
a disinfection
chamber
YES YES YES
Wavicide
01 MCC Disinfectant Glutaraldehyde YES
WARNING
For endocavity probes, make sure the cleaner/disinfectant is compatible
with mucosa.
17

NOTE
Somecleaner/disinfectant products may cause coloration ordiscoloration
of the probe housing. This coloration/discoloration does not affect the
image quality of the probe.
GENERAL RECOMMENDATIONS FOR ALL
PROBES
The above cleaner and disinfectant products have been tested and found
to be compatible with SuperSonic Imagine Aixplorer® transducers
material solely. Questions regarding efficacy, instructions for use, and
proper handling should be directed to the manufacturer. Please check
whether the recommended products are approved for use in your country.
The use of a non-approved cleaner or disinfectant which results in
damage to the probe will void the warranty. The use of products outside
of those on this list is to be done at the user’s and patient’s own risk.
18

Soaking Limits
If soaking a transducer is required, the SL15-4, SL18-5, SL10-2, SC6-1,
SMC12-3 transducers may only be immersed in liquid to a level of 3cm
(1.18 in.) above the cable-strain relief junction. The SEV12-3, SLV16-5,
XP5-1, XC6-1, SLH20-6 and SE12-3 transducers may be immersed in
liquid to a level of 1m (39.37in.) above the cable-strain relief junction.
See figure below.
According to the IEC 60529 standard, all Aixplorer probes are IPX7
according to the figure below.
Never immerse the probe connector. Never immerse the cable-connector
junction. Do not leave the transducer immersed longer than required for
disinfection. See figure below.
19

20