SciCan SALUS User manual

SALUS™ - Hygiene Sterility Maintenance Container
Operator’s Manual
95-114369 CA EN FR R3 SALUS-10-AM-CA SALUS and Your Infection Control Specialist are trademarks of SciCan Ltd. All other trademarks referred to in this manual are the property of their respective owners. © 2016 SciCan Ltd. All rights reserved.
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1. INTENDED USE 3
2. DISCLAIMERS 3
3. SAFE HANDLING 3
4. OVERVIEW 4
4.1 Checking the Package Contents 4
4.2 Accessories 4
4.3 Spare Parts 4
4.4 Specification 5
5. PREPARING THE CONTAINER FOR SERVICE 5
6. HOW TO CALCULATE THE END OF LIFE 5
7. USING THE CONTAINER 6
7.1 To open the container 6
7.2 To close the container 6
7.3 Preparing and loading instruments 6
7.4 Load instruments 6
7.5 External label 6
7.6 Colour-coded pins (Optional) 6
7.7 Processing instruments in the container 7
8. INSTRUCTIONS FOR USE IN CASSETTE AUTOCLAVES 7
8.1 STAT-DRI Plus 8
9. TRANSPORTING AND STORING THE CONTAINER 8
9.1 Transporting 8
9.2 Storing 8
10. REMOVING INSTRUMENTS FROM THE CONTAINER 8
11. REPROCESSING OF INSTRUMENTS IN THE CONTAINER 8
11.1 After use - used instruments 8
11.2 Reprocess using an automatic washer 8
11.3 Reprocess using an ultrasonic cleaner 9
12. MAINTENANCE AND INSPECTION 9
12.1 Reusable filter inspection and care 9
12.2 Seal inspection and care 9
12.3 Container sleeve and rack inspection 10
13. MANUFACTURER AND CUSTOMER SERVICE INFORMATION 10
14. WARRANTY 11
15. SALUS - HYGIENE PLACEMENT IN RACKS 12
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INSTRUCTIONS FOR USE
INTENDED USE
The SALUS - Hygiene is a reusable instrument management container. Intended to enclose instruments that are designed to withstand washing and steam
sterilization, and to maintain sterility of the instruments during storage. The SALUS - Hygiene is suitable for use in thermal disinfectors (96°C/205°F), automatic
washers, ultrasonic cleaners and dynamic air removal steam sterilizers. Instruments kept inside a sterilized unopened SALUS - Hygiene will remain sterile for up to 30
days after sterilization. The SALUS - Hygiene is designed to provide a service life of 2,500 cycles.
SALUS - Hygiene is designed to be compliant with the following standards:
• ANSI/AAMI ST77: 2013
• ISO 11607-1:2006+A1:2014
• ISO 11607-2:2006+A1:2014
IMPORTANT: The SALUS - Hygiene is not designed to allow cleaning of instruments with lumens or channels.
IMPORTANT: The SALUS - Hygiene has not been validated to process implantable medical devices.
DISCLAIMERS
Do not permit any person other than certified personnel to supply parts for, service or maintain your SALUS - Hygiene. SciCan will not be liable for incidental, special
or consequential damages caused by any maintenance by a third party including lost profits, any commercial loss, economic loss, or loss arising from personal injury.
It is important to follow local guidelines governing verification of any sterilization process used to sterilize instruments when using the SALUS - Hygiene.
SAFE HANDLING
Symbols on the container indicate the following:
Sterilizable up to the temperature specified. Caution: Hot surface. Container is locked.
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1. Sleeve
2. Filter cover
3. Reusable filter
4. Rack
5. Instrument cradle
6. Instrument cradle handles
7. Colour-coded pins (optional accessory)
8. Slot for label
9. Knob
10. Tamper-evident latch
11. Rack seal (back)
12. Suggested locations for fastening
chemical indicator
13. Rack seal (front)
4.3 Spare parts
Gasket seal, front 01-114201S
Gasket seal, back 01-114202S
Reusable filter 01-114196S
Rack handles (2/pack) 01-114365S
4.2 Accessories
Air/water syringe tip clip CASSETTE-CLIP
Labels (English/French, 100/pack) 01-114203
Autoclavable markers (3/pack) 01-114204
STATIM 5000 rack (required to ensure
drying)
01-114205
HYDRIM L110/M2 10 sleeve rack 01-114206
Medium rack assembly 01-114207
Medium sleeve assembly 01-114208
Colour-coded pins (Blue, 20/pack) 01-114211
Colour-coded pins (Yellow, 20/pack) 01-114210
Colour-coded pins (Red, 20/pack) 01-114209
Colour-coded pins (Assorted, 18/pack) 01-114217
OVERVIEW
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BACK
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4.1 Checking the package
contents
When you receive your SALUS - Hygiene
packing carton, the items listed below
will be included. If any of the items are
missing, contact your dealer immediately
so that situation can be corrected.
SALUS - Hygiene Sterility
Maintenance Container
(1 Sleeve + 1 Rack) QTY. 1
Instructions for Use (IFU) QTY. 1
Single-use labels QTY. 100
Autoclavable marker pen QTY. 1
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4.4 Specifications
Dimension (width x depth x height): 195mm x 165mm x 41mm (7.7” x 6.5” x 1.6”)
Recommended maximum container weight with load: 738 g (26 oz)
Weight: 425 g (15 oz) (container only)
Maximum steam sterilization temperature: 134 ºC (273 ºF)
Load type: 10 Hygiene instruments
Life span: 2,500 cycles
Sterility Maintenance: up to 30 days
Fits most standard commonly used hygiene instruments (instruments up to 175 mm (6.9”) in length)
PREPARING THE CONTAINER FOR SERVICE
1. Inspect the SALUS - Hygiene for shipping damage.
2. Write the date of service in the box, as shown, and the estimated “end of life” expiry date in the
box, as shown, on the filter cover using a non-toxic, autoclavable marker (included).
[See Fig. 1a]. Do not write on the reusable filters.
3. Write the date of service as shown, and the estimated “end of life” expiry date in the box, as
shown, on the slot for label in the rack using a non-toxic autoclavable marker. [See Fig. 1b].
4. Optional: If you are using the colour-coded pin system (available as an accessory) to identify instrument sets
or users, determine your code and insert the pins accordingly.
HOW TO CALCULATE THE END OF LIFE EXPIRY DATE
Using Table 1 below, find the number of sterilization cycles per day your office performs on one container
and the number of workdays per year your office is open. The result is an estimate of the year recommended to
retire your SALUS - Hygiene.
Example: A dental office runs 4 sterilization cycles a day and is open 150 days of the year, in 4 years
SALUS-Hygiene will need to be retired. Upon the filter label and the rack label, you would write
today’s date in the date of service box, add four years and write that date in the “end of life”
expiry date box.
Fig. 1a
Fig. 1b
Table 1: Tool for estimating how long it will take your practice to reach 2,500 cycles.
WORK DAYS/YEAR
Cycles/Day 100 150 200 250 300
213 8 6 5 4
386433
464322
553221
643211
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USING THE CONTAINER
7.1 To open the container:
1. Turn the latch counterclockwise to unlock the rack [See Fig. 2].
2. Pull the rack out from the sleeve.
7.2 To close the container:
1. Insert the rack fully into the sleeve [See Fig. 3].
2. Turn the latch clockwise to lock [See Fig. 4].
7.3 Preparing and loading instruments
Before loading any instruments into the SALUS - Hygiene, consult the instrument manufacturer’s reprocessing
instructions.
IMPORTANT: The SALUS - Hygiene is not designed to allow cleaning of instruments with lumens or channels.
7.4 Load instruments
1. Place the rack on a level surface.
2. Rest your thumbs against the handles on either side of the instrument cradle, gently push outwards to
unlatch and swing them open to release [See Fig. 5].
3. If loading the instruments for cleaning, arrange solid unwrapped instruments in the cradles of the instrument
rack. If loading the instrument for sterilization, properly cleaned/disinfected hygiene lumened instruments,
such as an air/water syringe tip can be included in the cradles of the instrument rack.
NOTE: The cradles are set deeper on one side than the other. This is to allow easy removal of the
instrument. Ensure instruments are oriented with handles sitting in the deeper cradles. Place mirrors and
pliers in the outermost cradles that are designed for these instruments [See Fig. 6].
4. Chemical process indicators suitable for steam sterilizers are to be included in each load being sterilized.
There are four potential locations (marked on the cradle handles) designed to allow the cradle handles to
clamp down and secure the chemical indicator. Placing the indicator in one of these locations will allow
its result to be easily viewed through the container sleeve upon completion of sterilization cycle without
compromising sterility of the contents [See Fig. 6].
NOTE: Make sure the section of the chemical indicator that displays its results is visible through the window
of the container sleeve.
5. With the chemical indicator in one of these positions, push down on the instrument cradle handles to lock it
into position [See Fig. 7].
6. When attaching an air/water syringe tip, a cassette clip must be attached perpendicular to instruments to
one of the four areas shown in Fig.6.
7.5 External label
1. The external label is used to record when the load was processed and when the load sterility expires.
2. Using a non-toxic, autoclavable marker (included), write the dates and insert the label into the holder.
7.6 Colour-coded pins (Optional)
If you are using the colour-coded pin system (available as an accessory) to identify instrument sets or users,
place the pins according to your coding scheme.
Fig. 2
Fig. 3
Fig. 5
Fig. 6
Fig. 4
S
AHIGHER STANDARD
STERILIZATIONMONITOR - STEAM CLASS 4
INDICATEUR / INDICADOR
S
AHIGHER STANDARD
STERILIZATIONMONITOR - STEAM CLASS 4
INDICATEUR / INDICADOR
S
AHIGHER STANDARD
STERILIZATION MONITOR - STEAM CLASS 4
INDICATEUR / INDICADOR
S
AHIGHER STANDARD
STERILIZATIONMONITOR - STEAM CLASS 4
INDICATEUR / INDICADOR
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7.7 Processing instruments in the container
1. The SALUS - Hygiene has been designed for use in a steam sterilizer for wrapped loads, eliminating the
need for wrapping instruments. It should be processed in a steam sterilizer. Since sterilizers vary in design
and performance characteristics, users are strongly recommended to verify the cycle parameters for the
specific sterilizer they are using. SALUS - Hygiene has been validated in steam sterilizer cycles shown in
Table 2:
Users may also conduct sterilizer testing to:
• verify successful sterilization has been achieved using biological and chemical indicators
• determine drying times necessary to achieve dryness of particular load
2. Do not stack the SALUS-Hygiene containers for sterilization. Whenever possible, position the SALUS-
Hygiene vertically with the label facing forward to facilitate load drying.
3. When sterilization is complete and successful, remove the SALUS-Hygiene from the sterilizer.
CAUTION: Burns from hot surfaces. When removing the SALUS-Hygiene after a sterilization cycle, exercise
caution to avoid skin burns as the container surfaces may still be hot. Allow SALUS-Hygiene to cool
sufficiently before handling or wear Personal Protective Equipment.
4. Check the tamper-evident latch to ensure it is extended to indicate the SALUS - Hygiene has been
processed [See Fig. 8].
5. Check the chemical indicator to ensure it has reached recommended sterilization conditions.
6. If using the instruments immediately, transport the container to chairside for immediate use.
7. If the container is to be stored, inspect the container and its contents for dryness. If moisture is present,
reprocess and re-sterilize the load with a longer drying time. Before storing the container, write the expiry
date (30 days from the date it is processed) on the external label.
INSTRUCTIONS FOR USE IN CASSETTE AUTOCLAVES
After cleaning the cassette chamber, spray a liberal amount of STAT-DRI Plus on all interior surfaces of the
cassette chamber. Wipe with a paper towel and allow a coating to remain. When processing with the SALUS -
Hygiene containers, reapply STAT-DRI Plus to the interior surfaces of the cassette chamber before every cycle
to ensure complete dryness. Follow the Operator’s Manual of the cassette autoclave for instructions for the
frequency of cleaning the cassette chamber.
Fig. 7
Fig. 8
8.
Table 2: Steam sterilizer cycles validated with SALUS - Hygiene.
* No visible condensation or pooling on the external surface of the container and the contents are free of visible condensation
[ANSI/AAMI ST77:2013 Sections 4.4.2 & 5.7]
Steam Sterilizer Type Cycle Sterilization
Temperature Exposure
Time
Recommended Drying
Time*
Dynamic-air-removal
(pre-vacuum)
Wrapped 134°C (273°F) 4 minutes 30 minutes
Dynamic-air-removal (steam-flush,
pressure-pulse, SFPP)
Wrapped 132°C (270°F) 5 minutes
6 minutes
30 minutes
30 minutes
Dynamic-air-removal (steam-flush,
pressure-pulse)
Wrapped 134°C (273°F) 3.5 minutes 30 minutes
Dynamic-air-removal (steam-flush,
pressure-pulse)
Wrapped 134°C (273°F) 6 minutes 30 minutes (STATIM 5000
NA wrapped cycle)
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8.1 STAT-DRI PLUS
STAT-DRI Plus is a rinse agent, with corrosion inhibitors, which helps instruments and smooth surfaces to shed
water during the drying process.
Use of STAT-DRI Plus will help to reduce the formation of water spots and rust. STAT-DRI Plus should be used
before every cycle when processing with SALUS - Hygiene containers to ensure complete dryness.
TRANSPORTING AND STORING THE CONTAINER
9.1 Transporting
IMPORTANT: The SALUS - Hygiene is not designed to be stacked when transporting to storage.
9.2 Storing
SALUS - Hygienes can be stacked in storage and the sterility of the container contents is ensured for 30 days.
SALUS-Hygiene should be stored in a manner that reduces the potential for contamination. Recommended
storage conditions for SALUS- Hygiene are between 18 and 24 Cº (64 and 75 Fº) with relative humidity between
30 to 70%. Closed or covered cabinets are recommended for the storage of SALUS- Hygiene.
When removing from storage, it is important to check the SALUS - Hygiene’s integrity before bringing stored
instruments into service. Ensure the tamper-evident latch is activated and that the expiry date on the external
label has not been exceeded.
REMOVING INSTRUMENTS FROM THE CONTAINER
1. Place the container on a level surface.
2. Ensure that the tamper-evident latch is activated and that the chemical indicator indicates sterilization
conditions have been reached.
3. Unlock the container by manually pushing the tamper-evident lock all the way back until a click is heard.
4. Turn the latch counterclockwise and pull the rack out from the sleeve. Ensure sterilized contents do not
come in contact with the outside of the container and the inner surfaces of the sleeve opening to allow
aseptic presentation of contents at the point of use.
5. Place the rack on top of the sleeve.
6. Rest your thumbs against the handles on either side of the instrument cradle, gently push outwards to
unlatch and swing them open to release.
7. To remove a selected instrument, press down on its handle to tip it up so that the instrument can be
grasped with your thumb and forefinger [See Fig. 9].
REPROCESSING OF INSTRUMENTS IN THE CONTAINER
11.1 After use - used instruments
After use, instruments should be replaced in the SALUS - Hygiene for safe handling.
IMPORTANT: The SALUS - Hygiene is not designed to allow cleaning of instruments with lumens or channels.
11.2 Reprocess using an automatic washer
1. Unlock the container latch and separate the rack from the sleeve.
2. Remove any large debris.
3. Place the rack and the sleeve separately in an automated washer and reprocess according to the washer
manufacturer’s instructions.
Fig. 9
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11.3 Reprocess using an ultrasonic cleaner
1. Unlock the container latch and separate the rack from the sleeve.
2. Remove any large debris.
3. Rinse the sleeve with cold tap water while using a soft-bristle cleaning brush until no visible soil is observed.
Do not place sleeve in ultrasonic cleaner.
4. Place the rack in an ultrasonic cleaner and reprocess according to the ultrasonic cleaner and/or cleaning
solution manufacturer’s instructions.
NOTE: Conduct cleaning tests to verify exposure times to ensure that cleaning efficacy has been achieved.
MAINTENANCE AND INSPECTION
• Inspect rack seals to ensure they are free of cracks, tears and that they are properly seated in their retaining
grooves. Note the date of service of rack. If the end of life expiry date has been reached, discard the rack.
• Inspect both the sleeve and rack for cracks.
• Inspect reusable filters for punctures, discolouration, note date of service. If the “end of life” expiry date has
been reached, discard the sleeve.
• Inspect the tamper-evident latch before and after a sterilization cycle. if the tamper-evident latch cannot be
reset before a cycle or does not fully extend after a cycle, do not use the container.
NOTE: Since sleeves and racks are interchangable, when the sleeve expires, it does not necessarily mean the
rack is also expired.
12.1 Reusable filter inspection and care
The SALUS - Hygiene filter is designed for a service life of 2,500 cycles. If the filter is damaged or punctured, it
must be replaced. Replacement of the filter DOES NOT prolong the service life of the SALUS - Hygiene.
To replace the filter:
1. Unlock the SALUS - Hygiene and remove the rack from the container sleeve.
2. Slide the filter cover towards the container sleeve opening to remove [See Fig. 10].
3. The filter has a clearly indicated inner (unprinted) and outer (printed) side. Ensure the printed side is facing
outwards and put the new filter into position.
4. Re-install the filter cover.
5. Run a test cycle with a chemical indicator to ensure proper steam penetration is achieved.
12.2 Seal inspection and care
The SALUS - Hygiene has a gasket seal on both sides (front and rear) of the rack. Inspect the gasket seals
to ensure they are free of tears, deterioration, debris and indentation. A damaged seal must be replaced.
Replacement of the gasket seals DOES NOT prolong the service life of the SALUS - Hygiene.
To replace the front or rear gasket seal:
1. Unlock the SALUS - Hygiene and remove the rack from the container sleeve.
2. Remove the seal and replace with a new seal.
3. Ensure it is properly seated in the retaining groove [See Fig. 11].
4. Run a test cycle with a chemical indicator to ensure it is properly functioning.
Fig. 10
Fig. 11
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12.3 Container sleeve and rack inspection
The SALUS - Hygiene is designed for a service life of 2,500 cycles. Inspect the sleeve and rack for cracks before every use. Do not use the
container if cracks are found.
MANUFACTURER’S INFORMATION AND CUSTOMER SERVICE INFORMATION
For all service and repair inquiries:
In Canada: 1-800-870-7777
United States: 1-800-572-1211
Germany: [phone]
International: [phone]
[email protected]
Manufactured by:
SciCan Ltd.
1440 Don Mills Road,
Toronto, ON M3B 3P9
Canada
Telephone: [phone]
Fax: [phone]
Toll free: 1-800-667-7733
SciCan Inc.
701 Technology Drive
Canonsburg, PA 15317
USA
Telephone: [phone]
Fax: [phone]
Toll free: 1-800-572-1211
EU Representative:
SciCan GmbH
Wangener Straße 78
88299 Leutkirch
Germany
Telephone: [phone]
Fax: [phone]
SciCan Medtech
Alpenstrasse 16
166300 Zug Switzerland
Telephone: [phone]
Fax: [phone]
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