SciCan STATCLAVE G4 Operator's Manual
STATCLAVE™G4 - Chamber Autoclave
Operator’s Manual
95-115362 CA EN R3
Manufacturer’s Information and Customer Service Information
For all ser vice and repair inquiries:
Canada: 1-800-870-7777
techservice.ca@scican.com
Manufactured by:
SciCan Ltd.
1440 Don Mills Road,
Toronto, ON M3B 3P9
Canada
Telephone: (416) 445-1600
Fax: (416) 445-2727
Toll fre e: 1- 800-667-7733
STATCLAVE G4 Operator’s Manual, Copyright 2019 SciCan Ltd. All rights reserved.
Quick Start Guide
1. Switch the autoclave ON.
3. Ensure BOTH drainage tubes are connected at the back.
2. Ensure BOTH reservoirs are filled with high quality distilled water.
IMPORTANT! Never Use Tap Water.
More informati on IN SECTION 4.
4. Pull up on the door latch to open the door.
More informati on in SECTION 2.3
5. Insert the load.
CAUTION! Hot Chamber.
More informati on in SECTION 5.
7. Select a cycle.
More informati on in SECTION 1.7
6. Close and latch the door.
8. Press the START icon.
More informati on in SECTION 7.
1. Your STATCLAVE 3
1.1 Checking the Package Contents 3
1.2 Important Information About Using Your STATCLAVE 4
1.3 Operating Principles, Key Features and Safety
Devices 5
1.4 Unit Overview 7
1.5 Touchscreen Overview 8
1.6 Using the Operation Screens 8
1.7 Unlocking the Door 9
9. Storing, Retrieving and Printing
Sterilization Records 45
9.1 Retrieving Cycle Information Using the Touchscreen 45
9.2 Retrieving Cycle Information Using the Web Portal 45
9.3 Retrieving Cycle Information Using
the USB Data Back Up 46
9.4 Connecting to a Printer 47
9.5 Adjusting your Print Settings 47
9.6 External Printer Specifications 47
2. Set Up 10
2.1 Installing Your STATCLAVE 10
2.2 Connecting and Powering Your STATCLAVE 11
2.3 Connecting Your STATCLAVE’s Water
Draining System 11
2.4 Connecting your STATCLAVE to a Network 13
3. Getting Started 15
4. Filling the Water Reservoirs 17
4.1 Manual Filling Using Reservoir Top 18
4.2 Manual Filling Using Quick Connector at Unit Front 19
4.3 Automatic Filling Using a VistaPure Specialized
Water Filtration System with Accumulation Tank 20
4.4 Automatic Filling Using External Water Tank
and Auxiliary Pump 21
5. Loading Instruments 22
5.1 Using the Chamber Rack 23
5.2 Wrapped Instruments 24
5.3 Unwrapped Instruments 26
5.4 Rubber and Plastic 27
5.5 Textiles and Surgical Packs 27
5.6 Using Biological and Chemical Indicators 27
6. Using Your STATCLAVE 28
6.1 Running a Cycle 28
6.2 Stopping a Cycle 30
6.3 Using the Delayed Start 31
6.4 Emergency Door Opening 32
6.5 Running a Bowie-Dick Test 33
6.6 Running a Vacuum Test 35
6.7 Using the Custom Cycle 35
10. Maintenance Procedures 48
10.1 Preventative Maintenance Message 48
10.2 Preventative Maintenance Schedule 48
10.3 Cleaning the Door Seal and Door Plate 49
10.4 Cleaning and Disinfecting the External Surfaces 49
10.5 Cleaning the Sterilization Chamber, Rack and Trays 49
10.6 Draining the Reservoirs for Cleaning 50
10.7 Cleaning the Water Reservoirs and Reservoir Filters 51
10.8 Cleaning the External Water Reservoir Tank 52
10.9 Cleaning the Chamber Filters 52
10.10 Replacing the Bacteriological Filter 53
10.11 Replacing the Door Seal 53
10.12 Using On-Screen Instructions 53
10.13 Enabling Remote Access for a Technician 54
10.14 Preparing the Unit for Shipping 54
11. Troubleshooting 55
12. Ordering Spare Parts and Accessories 58
13. Limited Warranty 59
14. Specifications 60
APPENDIX A – Software Icons 61
APPENDIX B – Software Screens 62
APPENDIX C – STATCLAVE Cybersecurity Statement 64
7. Sterilization Cycles 37
8. Using and Changing Settings 38
8.1 Setting Up Load Traceability with User ID, PIN,
and Process Enforced Function 40
8.2 Setting Drying Time 42
8.3 Setting the Stand-By Mode 42
8.4 Setting Up and Using Your STATCLAVE Web Portal 43
8.5 Registering for STATCLAVE Online Access 44
1. Your STATCLAVE
1.1 Checking the Package Contents
When you receive your STATCLAVE, the items listed below will be included. If any of the items are missing, contact your dealer
immediately.
Included with your STATCLAVE
1 Chamber rack 1 USB Memory stick
1 Operator’s manual 1 Power cord
4 Stainless steel wire
instrument trays
1 Tray extractor with door
unlocking pin (in handle)
1 Waste bottle
2 Pouched instrument racks
The following terms appear in this manual:
CAUTION! A potential hazard to the operator or end patient
IMPORTANT! A situation that may affect the functioning of the unit.
TIP Additional information that may be helpful.
2 Long silicone tubes
with elbow connectors
3 Drying plates Direct-to-drain hardware
3
1 Reservoir drain tube
(for use when cleaning reservoirs)
1.2 Important Information About Using Your STATCLAVE
Intended Use
The STATCLAVE G4 is a dynamic air removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider
to sterilize medical products by means of pressurized steam.
It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE
G4 has not been designed to sterilize liquid loads, pharmaceutical products, bio-medical waste or materials not compatible
with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
For more information about instrument suitability for steam sterilization, consult the instrument manufacturers’ reprocessing
instructions.
Get to Know Your STAT C L AVE: Read this Manual
The details of installing, using and maintaining your STATCLAVE are all in this manual. Please read this manual before operating
the unit and keep it for future reference. Users should follow the operating instructions and maintenance schedule described
in this manual. Contents of this manual are subject to change without notice to reflect changes and improvements to the
STATCLAVE product.
Water Quality
High quality distilled water is recommended for use in your STATCLAVE. Deionized, demineralized, or specially filtered water
can also be used. Never use tap water.
User Qualifications
The operation and maintenance of this unit should be restricted to trained and authorized personnel.
Repair and Modifications
Do not permit any person other than certified personnel to supply parts, service or maintain your STATCLAVE. SciCan shall
not be liable for incidental, special or consequential damages caused by any maintenance or services performed on the
STATCLAVE by a third party, or for the use of equipment or parts manufactured by a third party, including lost profits, any
commercial loss, economic loss, or loss arising from personal injury.
Never remove unit panels. Never insert objects through holes or openings in the cabinetry (unless explicitly instructed as in the
emergency door opening procedure, for example). Doing so may damage the unit and / or pose a hazard to the operator.
WiFi Compliance
This device has been tested and found to comply with the limits for a Class B digital device pursuant to the Federal
Communications Commission’s Part 15 Subpart B. The total radiated energy from the main antenna connected to the wireless
card conforms to the FCC limit of the SAR (Specific Absorption Rate) requirement regarding 47 CFR Part 2 Section 1093, when
the autoclave was tested. The transmission antenna for the wireless card is located in the front fascia.
CAUTION! Follow your local guidelines governing the verification of a sterilization procedure.
4
Pay close attention to the following symbols that appear on the unit:
Caution: A potential hazard to the operator
Caution: Hot surface
Caution: Danger of electric shock.
Disconnect power supply when servicing unit.
Clean water fill Exhaust drain
1.3 Operating Principles, Key Features and Safety Devices
The STATCLAVE is a dynamic air removal (pre-vacuum) table-top steam sterilizer that uses steam to sterilize wrapped and
unwrapped instrument loads typically used in dental and medical offices. It has six validated sterilization cycles with optimized
drying for fast, effective instrument processing. An additional custom cycle can be configured using one of three temperature
settings but this cycle must be validated by the user.
How it Works
The STATCLAVE uses a pre- and post-vacuum to condition the load at the beginning and end of each cycle.
› The pre-vacuum draw removes the air from the chamber before sterilization begins. This ensures more efficient steam
penetration into every load.
› The post-vacuum draw at the end of the cycle pulls the moist air from the chamber while heater bands warm the
chamber walls to speed drying.
› Finally, fresh, filtered air is drawn into the chamber to eliminate condensate and cool the chamber. This reduces the
cooling time and ensures the load is dry the moment you open the door.
Venturi reservoir drain
Clean water drain
Condenser drain (only used for shipping and
servicing)
Why Connect It
STATCLAVE’s WiFi-enabled G4 technology can connect and send cycle data to a smart device or computer, allowing staff
to focus on the most important thing in a dental practice, the patients. Maintenance reminders, instructions and the option
for automatic user interface software updates keep your STATCLAVE in good working order. Should your unit experience an
error, G4 technology connects it to specialized technicians who can provide remote support that can minimize unnecessary
downtime.
5
Other Features
Closed-door drying
Ensures your wrapped and pouched loads finish dry and ready to store.
Deep chamber
Holds up to 4 large and 4 small IMS cassettes or up to 20 pouched loads.
Reservoir fill options
Includes front and top options, as well as an autofill port at the back.
Chamber preheating
Programmable chamber preheating and unit Stand-by mode ensure the STATCLAVE is warm and ready when you need it.
Delayed start option
Every cycle features a delayed start option to help coordinate sterilization with your work flow or even start the day with a clean
instrument load.
Water quality sensor
Protects the unit from the long-term damage of unsuitable water.
Motor-less door latching mechanism
Provides improved reliability over motorized door locks.
Flip-top water reservoir
Makes the STATCLAVE easy to fill and clean.
Read-at-a-glance, colour touchscreen
Offers real-time monitoring of all the important sterilization parameters.
Easy-to-use emergency door opening
Simple procedure to open the door and retrieve instruments in the event of a power loss.
Programmable features
Automate your test cycles to be completed BEFORE the start of your work day.
Low water indicator
Know when there is not enough water to run a full cycle - before you start it.
Space-saving design
Front venting and recessed connections at the back allow the unit to fit snugly into compact steri-centres.
Door monitoring system
Tells you if the door is properly closed.
Safety Devices
Overheat thermostats
Band heater safety thermostats and steam generator safety thermostat protect the unit.
Pressure relief valve
Chamber pressure relief valve protects the unit and users.
Pressure or vacuum relief on power failure
Automatic pressure or vacuum relief protects users when the power is interrupted.
Electronics protection
Controller board fuses protect the unit’s electronics.
6
1.4 Unit Overview
7
31
42
8
5126
9
10
1. Venturi reservoir drain quick-connect (OUT)
2. Warm air exhaust
3. Clean water reservoir drain quick-connect (OUT)
4. Clean water reservoir fill quick-connect (IN)
5. Power switch
6. Bacteriological filter
(bacteria-retentive air filter)
7. Chamber rack
8. Touchscreen
9. USB port
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7
15
13
10. Power cord input
11. Ethernet port (not visible)
12. Auto fill port for clean water reservoir
13. Condenser drain port (to drain for shipping)
14. Overflow drain port for reservoirs
15. Exhaust drain port
16. RS232 port
17. Power port for external fill pump (optional)
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16 17
1.5 Touchscreen Overview
Home Screen
Solid /
Unwrapped
Solid /
Wrapped
Hollow /
Unwrapped
System icons:
Connectivity: Access network and Internet.
USB: View cycle history.
Door Lock: Unlock door.
Settings: Access settings menu.
Hollow /
Wrapped
Rubber & Plastic
Textiles/Porous
Custom Cycle
1.6 Using the Operation Screens
Test Cycles
Complete cycle information in Section 7
More inf ormati on on ico ns and sof twar e scree ns in Ap pendi ces A and B .
1. Select a cycle.
2. Press START.
Delayed start
More information in Section 6.3
Start
3. Cycle in progress.
Current chamber temperature
Current chamber pressure
Total time elapsed in the cycle - seen on cycle
screen for entire cycle
Appears during STERILIZATION and DRYING to show
time remaining
Stop
8
1.7 Unlocking the Door
The STATCLAVE will lock the chamber door when you select a cycle.
To unlock the door, go to the home screen and follow these steps:
1. PRESS lock icon.
2. PRESS unlock icon.
3. PRESS the back icon.
4. Lock icon is now changed to unlocked.
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2. Set Up
2.1 Installing Your STATCLAVE
› Place the STATCLAVE on a flat level surface
to support a 175 lbs (79.5 kg) load
.
strong enough
› Allow for at least 7” (180 mm) of space ABOVE the unit
to enable access to the reservoirs. If there is less than
7” (180 mm) above the unit, use a screwdriver to remove
the front hinge of the clean water reservoir so that the
reservoir panel can slide in and out of position from the front
of the unit.
› On the right side of the unit, allow for at least 2” (50 mm) of
space for ventilation.
› The unit vents warm air from below the door. Ensure the
door overhangs the level surface.
Unit Dimensions and Operating Environment
Height with front legs retracted 19” / 483 mm
Height with front legs fully extended 19.5” / 495 mm
Width 17.75” / 450 mm
Depth 25” / 635 mm
Weight (empty) 136 lbs/ 61.7 kg
Weight (with full reservoirs and full load) 175 lbs/ 79.5 kg
19”-
19.5”
17. 5 ”
7”
2”
25”
IMPORTANT! To improve drainage, ensure the unit is tilted
toward the back. Use the leveling feet to ensure the front of
the unit is 1” (25 mm) from the level surface.
Temperature and Humidity
Avoid installing your STATCLAVE in direct sunlight or close to a heat source such as vents or radiators. The recommended
operating temperatures are between 5˚C-40˚C / 41˚F-104˚F with a maximum humidity of 80%.
Electromagnetic Environment
Your STATCLAVE has been tested and meets applicable standards for electromagnetic emissions. While your unit does not
emit any radiation, it may itself be affected by other equipment that does. We recommend that your unit be kept away from
potential sources of interference.
1” gap
10
2.2 Connecting and Powering Your STATCLAVE
1. Ensure the power switch at the front right of the unit is in
the OFF position and connect the power cord supplied
to the power port at the back of the unit.
2. Connect directly to a power source.
Don’t use an extension cord.
3. Turn ON the power switch located at the front right of
the unit.
Electrical Connections
To power your unit, use properly grounded and fused power sources with the same voltage rating as indicated on the serial
number label at the back of your STATCLAVE.
› DO use an outlet that is protected by a 15A breaker.
› DO use a dedicated circuit, single phase 120 V~ 60Hz, 12A or 208-240 V~60Hz, 12A, depending on the voltage rating
indicated on the serial number label at the back of your unit.
Unit Electrical Characteristics:
› Protection class 1 device.
› Maximum power consumption of the autoclave is 1,440 Watts for 120V and 2,250-3,000 Watts for 208-240V.
2.3 Connecting Your STATCLAVE’s Water Draining System
IMPORTANT!
The STATCLAVE uses water from the Venturi reservoir to generate vacuum draws at the beginning and end of each cycle. For
the unit to operate, BOTH the clean water reservoir and the Venturi reservoir must contain the minimum required water levels.
When the chamber releases steam it travels through the condenser and drains from the condenser exhaust tube. Excess water
in both the Venturi reservoir and the clean water reservoir drains from the reservoir overflow tube. BOTH elbow fittings at the
back of the unit must be connected to a water draining system.
For the unit to function, BOTH reservoirs must be full and BOTH drain tubes must be connected.
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Connecting Directly to a Drain
Any new central drain point installation should be done by a technician. The drain points (C) must be located on the upper
portion of vertical drain pipe ABOVE the P-trap.
For direct-to-drain connections, you will need to use the direct-to-drain hardware (provided with the unit).
1. The unit is shipped with plugs in its ports. To remove a
plug, apply even pressure to the Inner Ring holding it
down on either side of the plug and pull out the plug.
2. Insert one elbow connector with silicone tube to the
metal exhaust port (A).
3. Insert the other elbow connector with silicone tube to
the plastic reservoir overflow
drain port (B).
4. Connect the exhaust tube with elbow fittings (A) to the
port installed on the drain pipe (C).
5. Connect the reservoir overflow tube (B) to the remaining
port on the drain pipe (C).
IMPORTANT! Avoid excess sagging in the lines; cut both tubes to measure.
IMPORTANT! Tubes should not be kinked, bent or otherwise obstructed. The connection point to the central drain
must be lower than the autoclave’s support surface otherwise the reservoirs may not drain correctly.
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Connecting the Waste Bottle
The unit is shipped with a waste bottle in case a direct-to-drain installation is not possible. To use the waste bottle, follow these
steps:
1. Set the waste bottle (D) on the ground or in the
cabinetry below the unit.
2. Connect the exhaust tube (A) to a port on the waste
bottle cap (C).
3. Connect the reservoir overflow tube (B) to a port on the
waste bottle cap (C).
IMPORTANT! Avoid excess sagging in the lines; cut both
tubes to measure.
IMPORTANT! Tubes should not be kinked, bent or
otherwise obstructed. The waste bottle must be lower than
the autoclave’s support surface otherwise the reservoirs
may not drain correctly.
Add a small amount of water to the empty waste bottle to
give it stability.
2.4 Connecting your STATCLAVE to a Network
Connecting to a Wired Network
Do you want to drain the unit prior to shipping or cleaning? For instructions on how to completely drain both
reservoirs for cleaning or shipping, see Sections 10.6 and 10.14.
1. Connect Ethernet cable to port at back of unit.
2. From the home screen select the CONNECTIVITY icon.
3. Confirm that the unit is connected to both the Network
and Internet and press the back icon to return to
the home screen.
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Connecting to a Wireless Network
From the unit’s home screen, select the SETTINGS icon, then follow these steps:
1. 2.
3. 4.
5. 6.
7. 8.
Data Security and WiFi
Ensuring your WiFi® connections are secure is an important element of safeguarding your organization’s data. A WiFi
network using WPA2™ provides both security (you can control who connects to it) and privacy (the transmissions
cannot be read by others) for communications as they travel across your network. For maximum security, your
network should include only devices with the latest in security technology – WiFi Protected Access® 2 (WPA2).
Tips for securing your network
Change the network name (SSID) from the default name.
Change the administrative credentials (username and password) that control the configuration settings of your Access
Point/Router/Gateway.
Enable WPA2-Personal (aka WPA2-PSK) with AES encryption.
Wireless transmission considerations
To comply with Federal Communications Commission and Industry Canada Radiofrequency exposure compliance
requirements, the antenna used for this transmitter has been installed to provide a separation distance of at least 20
cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter.
(The transmission antenna for the wireless card is located in the front fascia.)
For the STATCLAVE Cybersecurity Statement, see Appendix C.
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3. Getting Started
Preparing Your STATCLAVE for Use
Once the STATCLAVE has been correctly installed, and before using it for the first time, make sure BOTH the clean water and
Venturi reservoirs contain distilled water. The STATCLAVE uses water from the Venturi reservoir to generate vacuum draws at
the beginning and end of each cycle. Both reservoirs must contain the minimum required water levels for the unit to function.
IMPORTANT! DON’T run the STATCLAVE without the chamber rack in place.
1. Power on the unit.
2. Follow the screen prompts to connect your STATCLAVE
using either WiFi or an Ethernet cable connection. This
will automatically set the time and date for your unit.
If you do not wish to connect your STATCLAVE at this time, Press the FORWARD icon and select a language. Then
press the FORWARD icon and the SKIP icon to scroll to the end of the introduction. You must Agree or Disagree
with the Privacy Policy to get to the home screen. (For more information on the Privacy Policy screen see Section 8.
Using and Changing Settings.)
From the home screen, select the SETTINGS icon then the USER icon and then the GENERAL button to access
the menu for time, date, country, and time zone. (See Section 8 Using and Changing Settings)
(SciCan recommends connecting and registering your STATCLAVE. To do this at a later time, see Section 8.5
Registering for STATCLAVE Online Access.)
15
3. Open the clean water reservoir located on the top right
of the unit. Using a large container, fill with distilled water
to the maximum fill level line or until you hear 3 BEEPs.
(For more fill options see Section 4. Filling the Water
Reservoirs.)
4. Open and fill the Venturi reservoir to the maximum fill
level.
5. Open the door, plug the USB storage device into the
USB port.
CAUTION! Hot Chamber.
The unit’s Stand-by mode is preset to maintain a hot
chamber.
6. Make sure the bacteriological filter is securely in place.
7. Check your national and local guidelines for any
additional protocols and tests required before using
your unit.
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4. Filling the Water Reservoirs
Normal operation of the STATCLAVE requires a minimum amount of distilled water in BOTH the clean water reservoir and
Venturi reservoir.
To fill the Venturi reservoir:
1. Open the Venturi reservoir lid located on the top left of
the unit.
2. Fill it with distilled water to the maximum fill line
indicated in the reservoir.
When filling the Venturi reservoir for the first time,
you will need to add an additional
0.5 US gal / 2 L of water. This will fill the steam cooling
system’s condenser. To do this, simply fill the Venturi
reservoir to the maximum fill line and wait as the
Venturi reservoir water fills the condenser, then top up
the Venturi reservoir to the maximum fill line again.
Setting the water reservoir filling mode
Your STATCLAVE’s default filling option is MANUAL. If you are manually filling the reservoir, you do not need to change the
unit’s fill option settings.
If you are connecting your STATCLAVE to an external filling device such as a VistaPure specialized water filtration system or
external water tank and auxiliary pump, make sure your unit is set to the AUTOMATIC filling mode.
To change this setting from the home screen, select SETTINGS then USER and then follow these steps:
1. 2.
To fill the clean water reservoir, there are four different methods:
› Manual filling using RESERVOIR TOP.
› Manual filling using the FRONT QUICK CONNECTOR.
› Automatic filling using VISTAPURE SPECIALIZED WATER FILTRATION SYSTEM with accumulation tank.
› Automatic filling using an EXTERNAL WATER TANK AND AUXILIARY PUMP.
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4.1 Manual Filling Using Reservoir Top
1. With the unit powered ON, flip open the clean water
reservoir lid located on the top right of the unit.
2. Using a large container, fill with distilled water to the
maximum fill line or until you hear three BEEPs.
When adding water for the first time, the reservoir may
take up to 1 US gal / 4 L.
3. With the door open, select any cycle from the LCD’s
home screen to view the pre-cycle information screen.
4. The clean water level check mark will turn yellow when
the minimum water level is reached and green when the
reservoir is filled to the maximum level.
You can start a cycle if water level icons are either yellow or green.
If your unit is not directly connected to the drain, empty the waste bottle regularly or each time you are filling the
clean water reservoir.
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4.2 Manual Filling Using Quick Connector at Unit Front
The front fill quick connector is for the refilling of the clean water reservoir. The Venturi reservoir does not have a front fill quick
connector because it is only filled on installation or after cleaning.
1. To use this method, you will need the manual fill
container (0.5 US gal / 2 L) with quick connect and
tubing (sold as an accessory).
2. Fill the accessory container with distilled water, keeping
it horizontal.
3. With the unit powered ON, connect the tube’s quick
connector to the unit’s clean water fill port at the front.
4. Hold or place the manual fill container at a level higher
than the unit’s fill port and loosen the cap on the
container to allow water to flow into the tank.
5. With the door open, access the LCD’s home screen
and select any cycle to view the pre-cycle information
screen.
6. The clean water level check mark will turn yellow when
the minimum water level is reached.
You can start a cycle if water level icons are either yellow or green.
7. Repeat this procedure a second time to fill the water
reservoir to max level. (Each fill takes 4 minutes.)
Continue until the clean water level
and you hear three
If your unit is not directly connected to the drain, empty the waste bottle regularly or each time you are filling the
clean water reservoir.
BEEPs.
indicator turns green
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