SciCan SALUS Operator's Manual
SALUS
®
- Hygiene Instrument
Reprocessing Container
Operator’s Manual
95-114168 US EN R2 SALUS-10-AM
SALUS is a registered trademark and Your Infection Control Specialist is a trademark of SciCan Ltd. All other trademarks referred to in this manual are the property
of their respective owners. © 2017 SciCan Ltd. All rights reserved.
1. INDICATIONS FOR USE 3
2. DISCLAIMERS 3
3. SAFE HANDLING 3
4. OVERVIEW 4
4.1 Checking the package contents 4
4.2 Acces sori es 4
4.3 Spare parts 4
4.4 Specifications 5
5. PREPARING THE CONTAINER FOR SERVICE 5
6. HOW TO CALCULATE THE END OF LIFE EXPIRY DATE 5
7. USING THE CONTAINER 6
7.1 Opening the contai ner: 6
7.2 Preparing and loading instruments 6
7.3 Load instruments 6
8. REPROCESSING SALUS – HYGIENE SLEEVE AND RACK WITH INSTRUMENTS 6
8.1 After u se - used instr uments 6
8.2 Cleaning the Rack wi th Instruments 7
8.2.1 In a medic al wash er or the rmal di sinfec tor 7
8.2.2 In an ultr asonic c lean er 7
8.3 Cleaning the Sleeve 7
8.3.1 In a medic al wash er or the rmal di sinfec tor 7
8.3.2 In an ultr asonic c lean er 7
8.3.3 Manua l clean ing 7
8.4 Preparing for sterilization 8
8.5 Closing the container 8
8.6 Sterilizing instruments in the co ntainer 8
9. TRANSPORTING AND STORING THE CONTAINER 9
9.1 Transpor ting 9
9.2 Storing 10
10. REMOVING INSTRUMENTS FROM THE CONTAINER 10
11. MAINTENANCE AND INSPECTION 10
11.1 Reusable filter in spec tion and care 11
11.2 Seal inspection and care 11
11.3 Cont aine r sleeve and rack insp ection 11
11.4 Rack ha ndle inspection and care 11
12. MANUFACTURER’S INFORMATION AND CUSTOMER SERVICE INFORMATION 12
13. WARR A NTY 13
14. SALUS - HYGIENE PL ACEMENT IN RACKS 14
3
INSTRUCTIONS FOR USE
1. INDICATIONS FOR USE
The SALUS® - Hygiene is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended
to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The SALUS® - Hygiene is a reusable
instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain
sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers. Please refer to the
chart below for validated sterilization cycles.
2. 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.
3. SAFE HANDLING
Symbols on the container indicate the following:
Steam Sterilizer Type Cycle
Sterilization
Temperature
-0/+6°F (-0 /+3°C)
Exposure
Time
Recommended
Drying Time
Load
Typ e
Maximum
Instrument
Load Per Container
Dynamic-air-removal
(pre-vacuum)
Wrapped 27 0° F (132°C) 4 minute s 16 mi nutes
Solid Hygiene
Instruments &
Lumen Hygiene
Instruments
(Ø .028” [0.7mm] x L
3.35” [85 mm], Qty. 1)
0.487lb (221g)
Dynamic-air-removal
(steam-flush, pressure-pulse, SFPP)
Wrapped 27 0° F (132°C) 4 minute s 30 minutes 0.478lb (217g)
Dynamic-air-removal
(pre-vacuum)
Wrapped 273°F (134°C) 4 minute s 30 minutes 0.473lb (215g)
Sterilizable up to the sterilization
temperature specified.
Caution: Hot surface. Container is locked.
4
1. Sleeve
2. Filter cover
3. Reusable filter
4. Rack
5. Instrument cradle
6. Instrument cradle
handles
7. Color-coded pins
(optional accessory)
4.3 Spare parts
Gasket seal, front 01-114777S
Gasket seal, back 01-1147 7 8 S
Reusable filter 01-114196S
Rack handles (2/
pack)
01-114365S
4.2 Accessories
Air/water syringe tip clip CASSETTE-CLIP
Labels (English/Spanish, 100/pack) 01-114360
Autoclavable markers (3/pack) 01-11420 4
HYDRIM L110/M2 10 sleeve rack 01-11420 6
Medium rack assembly 01-114430
Medium sleeve assembly 01-11420 8
Color-coded pins (Blue, 20/pack) 01-114211
Color-coded pins (Yellow, 20/pack) 01-11421 0
Color-coded pins (Red, 20/pack) 01-1142 0 9
Color-coded pins (Assorted, 18/pack) 01-114 2 17
4. OVERVIEW
1
2
11
3 4
109
BACK
of Rack
5
12
7
8
13
6
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 - Hyg iene S terility
Instrument Reprocessing
Container
(1 Sleeve + 1 Rack)
Qt y. 1
Instructions for Use (IFU) Qty. 1
Single-use labels Qt y. 10 0
Autoclavable marker pen Qty. 1
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)
5
4.4 Specifications
Dimension (width x depth x height): 7.7” x 6.5” x 1.6” (195mm x 165mm x 41mm)
Recommended maximum container weight with load: 23 oz (652 g)
Weight: 15 oz (425 g) (container only)
Maximum steam sterilization temperature: 273 ºF -0/+6°F (134°C -0/+3°C)
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 6.9” (175 mm) in length)
SALUS - Hygiene is designed to be compliant with ANSI/AAMI ST77: 2013
5. 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 color-coded pin system (available as an accessory) to identify
instrument sets or users, determine your code and insert the pins accordingly.
6. 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.
Table 1: Tool for estim ating how long it w ill take your practice to re ach 2,500 c ycles.
WORK DAYS/YEAR
Cycles/Day 100 150 200 250 300
2 13 8 6 5 4
3 8 6 4 3 3
4 6 4 3 2 2
5 5 3 2 2 1
6 4 3 2 1 1
Fi g. 1a
Fi g. 1b
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