Coltene SciCan STATIM B G4+ User manual

95-116177 EU EN R3. STATIM 6000B Operator’s Manual.
Copyright 2021 Coltene SciCan. All rights reserved.
STA T IM® B G4+
Vacuum A u t o cla v e
Operator’s Manual
Benutzerhandbuch
Manuel de l’utilisateur - USB
Manuale per l’operatore - USB
E
N
1
3
0
6
0
F
u
l
l
y
C
o
m
p
l
i
a
n
t

For all service and repair inquiries:
In Canada [phone]
United States: [phone]
Germany: [phone] - 0
International: [phone]
Email: [e-mail]
Technical Service location:
SciCan GmbH
Wangener Strasse 78
88299 Leutkirch
GERMANY
Manufactured by:
SciCan
1440 Don Mills Road,
Toronto ON M3B 3P9 / CANADA
T [phone]
F [phone]
TF [phone]
EU Representative
SciCan GmbH
Wangener Strasse 78
88299 Leutkirch / GERMANY
T [phone] - 0
F [phone] - 699
SciCan Medtech
Alpenstrasse 14
CH-6300 ZUG / SWITZERLAND
T [phone]
F [phone]
US
701 Technology Drive
Canonsburg, PA 15317 / USA
T [phone]
F [phone]
TF [phone]
STATIM is a registered trademark of SciCan Ltd. All other trademarks referred to in this manual are the property of their respective owners.
PDF reader software required.
For a hard copy, contact SciCan GmbH at [email protected]
PDF Lesersoftware erforderlich.
Eine gedruckte Version erhalten Sie von der SciCan GmbH unter [email protected]
Logiciel de lecture de PDF requis.
Pour une copie papier, contactez SciCan GmbH à l’adresse [email protected].
È necessario un software lettore di PDF.
Per una copia hardware contattare SciCan GmbH all’indirizzo [email protected].
https://www.scican.com/eu/products/autoclaves/statim/
USB

Quick Start Guide
1. Switch the autoclave ON.
3. Check that both red drain tubes are installed.
More information in Section 2.3
8. Press the START icon.
7. Select a cycle and holding time.
More information in Section 6
5. Insert the load.
More information in Section 4
4. Turn the latch to open the drawer.
2. Ensure there is high quality distilled water in the reservoir.
More information in Section 2.4
IMPORTANT! Never Use Tap Water.
6. Close and latch the drawer.
More information in Section 1.7

Contents
1. Your STATIM B 4
1.1 Checking the Package Contents 4
1.2 Important Information About Using your STATIM B 4
1.3 Operating Principles, Key Features and Safety Devices 6
1.4 Unit Overview 8
1.5 Touchscreen Overview 9
1.6 Using the Operation Screens 10
1.7 Unlocking the Drawer 10
2. Set Up 11
2.1 Installing your STATIM B 11
2.2 Connecting and Powering your STATIM B 12
2.3 Connecting your STATIM B to a Drain or Waste Bottle 13
2.4 Filling your STATIM B’s Water Reservoir 15
2.5 Connecting your STATIM B to a Network 18
3. Getting Started 20
4. Loading Instruments 21
4.1 Using the Drawer Rack 22
4.2 Wrapped Instruments 22
4.3 Unwrapped Instruments 23
4.4 Rubber and Plastic 24
4.5 Textiles and Surgical Packs 24
5. Using Your STATIM B 25
5.1 Running a Cycle 25
5.2 Stopping a Cycle 27
5.3 Using the Delayed Start 29
5.4 Emergency Drawer Opening 30
5.5 Running a Bowie-Dick Test 31
5.6 Running a Helix Test 33
5.7 Running a Vacuum Test 34
5.8 Using the Custom Cycle 35
6. Sterilisation Cycles 36

7. Using and Changing Settings 37
7.1 Setting Up Load Traceability with User ID, PIN
and Process Enforced Function 38
7.2 Setting Drying Time 40
7.3 Setting the Stand-By Mode 40
8. Storing, Retrieving and Printing Sterilisation Records 41
8.1 Retrieving Cycle Information Using the Touchscreen 41
8.2 Exporting Cycle Information using the unit’s USB or Email 42
8.3 Connecting to Online Storage 44
8.4 Connecting to a Printer 45
8.5 Cycle Printout - Full Cycle 46
8.6 Cycle Printout - Stop Button Pressed 47
9. Maintenance Procedures 48
9.1 Preventative Maintenance Message 48
9.2 Preventative Maintenance Schedule 48
9.3 Cleaning and Disinfecting the External Surfaces 49
9.4 Cleaning the Chamber and Trays 49
9.5 Draining the Reservoir 50
9.6 Replacing the Bacteriological Air Filter 51
9.7 Cleaning the Reservoir Filter 51
9.8 Replacing the Drawer Seal 52
9.9 Cleaning an External Fill Water Tank 52
9.10 Using On-Screen Instructions 53
9.11 Enabling Remote Access for a Technician 54
9.12 Preparing the Unit for Shipping 54
10 Troubleshooting 55
11 Ordering Spare Parts and Accessories 58
12 Limited Warranty 59
13 Specifications 60
14 Sterilisation Cycle Profiles - graph format 61
15 Declaration of Conformity 62

4
1. Your STATIM B
1.1 Checking the package contents
1 Instrument tray 1 Power cord
1 Waste water bottle
95-116177EUDR AFT 2. STATIM 6000B Oper ator’s Manual.
Copyright2020 Colte ne SciCan. All rights r eserved.
STA
T
IM
®
B
G4
+
Vacuum
A
u
t
o
cla
v
e
Operator’sManual
Manuel de l’utilisateur
Benutzerhandbuch
Manuale perl’operatore
Operator’s manual
1 Memory stick Direct-to-drain kit
2 Exhaust tubes 1 Pouch rack
1.2 Important information about using your STATIM B
Intended Use
The STATIM B is a dynamic air removal (pre- and post-vacuum) table-top steam steriliser intended for use by
a health care provider to sterilise medical products by means of pressurized steam.
It is suitable for the sterilisation of dental and medical instruments that are validated to be sterilised by
steam. The STATIM B has not been designed to sterilise liquid loads, pharmaceutical products, bio-medical
waste or materials not compatible with steam sterilisation. The processing of such loads may result in
incomplete sterilisation and / or damage to the autoclave.
For more information about instrument suitability for steam sterilisation, consult the instrument
manufacturers’ reprocessing instructions.
This STATIM B autoclave is fully compliant with EN 13060.

5
Get to Know Your STATIM B: Read this Manual
The details of installing, using and maintaining your STATIM B 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 STATIM B product.
Water Quality
High quality distilled water is recommended for use in your STATIM B. Deionized, demineralized, or specially
filtered water can also be used as long as the water produced contains less than 5 ppm total dissolved
solids (having a conductivity of less than 10 uS /cm). 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 STATIM B.
SciCan shall not be liable for incidental, special or consequential damages caused by any maintenance or
services performed on the STATIM B 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. Doing so may
damage the unit and / or pose a hazard to the operator.
WiFi Compliance
This product complies with the requirements of the following EU Directive: EUROPEAN DIRECTIVE 2014/53/
EU (Radio Equipment Directive). Compliance to this directive implies conformity to harmonized EU standards
that are noted in the EU Declaration of Conformity for the WiFi module.
This device has been tested and found to also comply with the ETSI and Industry Canada limits for a Class
B digital device pursuant to the U.S. 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.
Incident Reporting
Any serious incidents should be reported to the manufacturer and/or the competent authority in which the
user and/or patient resides.
Pay close attention to the following symbols that appear on the unit:
Caution: Refer to manual for details. MD Medical Device
Caution: Hot surface and/or hot steam. Caution: Risk of electrical shock.
Disconnect supply before servicing.
Steam distilled water only.
CAUTION! Follow your local guidelines governing the verification of a sterilisation procedure.

6
1.3 Operating Principles, Key Features and Safety Devices
The STATIM 6000B is a 6-litre tabletop autoclave that uses steam to sterilise wrapped and unwrapped
instrument loads typically used in dental and medical offices as well as laboratories. It has 11 sterilisation
programs each with a selection of holding times and each equipped with optimized drying for fast, effective
sterilisation. There are also two custom cycles.
How does it work?
The STATIM B uses a vacuum pump to draw air out of the chamber at the beginning and end of each cycle.
The first vacuum draw sequence removes the air from the chamber before it starts the sterilisation part of
the cycle. This ensures more efficient steam penetration into every load.
Another series of vacuum draws at the end of the cycle pulls the moist air from the chamber while heaters
at the top and bottom of the chamber warm the walls to speed the drying. Fresh, filtered air is then pulled
into the chamber to eliminate condensate. This increases evaporation and ensures the load is dry from the
moment you open the drawer.
Forward thinking
The STATIM 6000B’s WiFi-enabled G4+ technology records and monitors every cycle and can automatically
send error codes to off-site service technicians who can troubleshoot a problem before it costs your
operation time and money.
Features:
›Space-saving design – with the same footprint as the STATIM 5000, the STATIM 6000B fits anywhere
a cassette autoclave can. The recessed connections at the back keep tubing and power cord close to
the unit so that it can be placed almost flush against a back wall.
›Enhanced documentation mode adds more detail to your record keeping including indicator test
results and content tracking labels.
Chamber
›Mid-sized capacity chamber holds up to 2 large IMS cassettes and up to 12 pouched loads. At 6
litres, the STATIM 6000B is one of the largest tabletop drawer-type autoclaves on the market.
›The simple rack-and-pinion drawer latching system is designed to reduce service issues.
›Easy-to-use manual release for emergency drawer-opening lets you easily retrieve instruments in the
event of a power failure. (CAUTION: Instruments retrieved after or during a power failure must be re-
processed in the steriliser before use.)
›Drawer monitoring system keeps a cycle from starting if the drawer is improperly closed.
›Drawer-style autoclave allows for easy, one-handed opening and operation.
Programmable
›Programmable chamber preheating and unit standby mode options ensures the STATIM 6000B is
warm and ready when you need it.
›Scheduled start option for every sterilisation program allows you to set the exact time you want to run
a cycle to start the day with an instrument load or run a daily test when it suits your office’s workflow.
›Programmable features allow you to automate your daily vacuum tests to complete BEFORE the start
of your workday.

7
Touchscreen
›5-inch touchscreen is one of the largest screens available for drawer-type autoclaves. With an 800 x
480 aspect ratio, the screen offers high resolution demonstrations and instructions. Its easy-to-clean
glass surface is responsive to gloved fingers so you can scroll and swipe through menu features as
you would on a smart phone.
›Read-at-a-glance colour high definition screen offers real-time monitoring of all the important
sterilisation parameters and is the largest screen in the G4 series.
›The LCD’s large progress indicator animation lets you know exactly when your instruments will be
ready once the unit has reached the sterilisation phase.
›LED lights around the LCD display tell you the unit’s status – from stand-by, to operating, to cycle
complete – and lets you know when the unit requires user attention.
Connectivity
›Next generation G4+ features dual band WiFi that includes 5 GHz, and the 1 GB ethernet connection
allows for even faster user interface software updates. Intelligent G4+ technology also lets you
integrate with the other G4 and G4+ units so you can share a printer for cycle records and labels.
›Ability to connect securely to a third-party quality-control system means your sterilisation records can
be safely managed and stored off-site.
›Integrated water quality sensor protects the unit from the long-term damage from the use of
unsuitable water.
Reservoir
›Built-in reservoir holds enough water for 3 cycles, while the recommended autofill and auto drain
options can configure your STATIM B for easy daily use.
›Low water indicator keeps the unit from starting a cycle if there is not enough water to complete it.
›Reduced reservoir build-up. The automatic draining option to empty the reservoir at regular intervals
helps reduce algae and bio-film buildup.
Safety devices:
›Steam generator overheat thermostat protects the unit from overheating.
›Chamber pressure relief valve protects the unit and users from overpressure situations.
›Circuit breakers protect the unit’s electronics from power surges and can be easily reset by the user.
›Overheat thermostats for the upper and lower band heaters protect the unit from overheating.

8
1.4 Unit Overview
LED colour What it means
White Unit is idle and ready for operation
Red Cycle in operation
Blue Cycle complete
Orange Cycle stopped or cycle fault condition
3
1
4
2
5
6
17 7
8
9
10
11
12
13
14
15
16
1. Reservoir top fill
2. Touchscreen
3. Drawer rack
4. USB port
5. Drawer
6. Drawer latch
7. Dual USB ports
8. Power port (5V DC) for
optional external fill pump
9. Ethernet port
10. Fuse reset buttons
11. Power switch
12. Power cord input
13. Exhaust drain port
14. Reservoir overflowdrain port
15. Bacteriological air filter (bacteria-
retentive air filter)
16. Pressure relief safety valve
17. Auto fill port (to connect fill
options)

9
1.5 Touchscreen Overview
Home screen
Changing the display from light mode to dark mode
Your STATIM B’s default screen mode is set to light. To change it to dark mode, go to SETTINGS and select
DISPLAY and follow these steps:
1. On the DISPLAY screen, select dark, press the
check mark to save your change and then the
HOME icon to return to the home screen.
2. The home screen in Dark Mode.
Test cycles
Cycle count
Solid / Unwrapped
Solid / Wrapped
Universal
Network name USB key status
Rubber and
Plastic
Custom cycles
SettingsConnectivityCycle recordsDrawer lock status

10
1.6 Using the Operation Screens
1. Select a cycle and then select the holding
time.
2. Press START NOW or DELAYED START.
3. Cycle in progress.
1.7 Unlocking the Drawer
The STATIM B will lock the drawer when you select a cycle. To unlock the drawer, go to the home screen
and press the flashing green lock icon:
Lock Icon Drawer Latch Position What it Means Action Required
The drawer is open and/or
the latch is not locked None
The drawer is closed and
the latch is locked Press the lock icon to unlock
The drawer is locked because
the chamber is still under pressure Wait for lock to turn green
The drawer is safe to open Press the lock icon to unlock then
unlatch the drawer
The drawer remains locked,
not safe to open Power OFF the unit
The drawer remains unlocked,
unsafe to start cycle
Check the load to make sure the
drawer is closing correctly

11
2. Set Up
2.1 Installing Your STATIM B
›Place the STATIM B on a flat, level, water resistant surface.
›Leave a minimum of 5 cm (2 inches) between the top, sides and back of the unit
and any wall or partition.
›The unit vents warm air from the back.
›Weight (without water): 24 kg (54 lbs)
Temperature and Humidity
Avoid installing your STATIM B 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 STATIM B 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.
Disposing of Packaging and Decommissioned Units
Your unit is shipped in a cardboard box. Please break down and recycle or dispose according to municipal
requirements. A decommissioned sterilizer should not be disposed of in the regular domestic waste.
Doing so is potentially harmful to people and the environment. It has been used in a healthcare setting and
represents a minor infection control risk. It also contains several recyclable materials that can be extracted
and reused in the manufacture of other products. Contact your municipality to learn about its policies and
programs governing the disposal of electronic devices.
5 cm / 2”
5 cm / 2”
Length: 61cm / 24”
Width: 45cm / 17.75”
Height: 19.5cm / 7.7”
5 cm / 2”
5 cm / 2”
5 cm / 2”

12
2.2 Connecting and Powering Your STATIM B
1. Ensure the power switch at the back 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 back
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 STATIM B.
›DO use an outlet that is protected by a 15A breaker.
›DO use a dedicated circuit, single phase 220-240 V 50~60Hz, 15A in Europe, Australia, New Zealand
and Switzerland, and 220-240 V 50~60Hz, 13A for United Kingdom.

13
2.3 Connecting Your STATIM B to a Drain or Waste Bottle
The STATIM B produces waste water when the steam used to sterilise the load is exhausted from the
chamber and condenses into water. This water can be drained from the unit into the waste bottle or directly
to a connection on a drain pipe.
Connecting Directly to a Drain
For direct-to-drain connections, you will need to use the direct-to-drain hardware (provided with the unit).
Any new central drain point installation should be done by a technician. The drain points must be located on
the upper portion of vertical drain pipe ABOVE the P-trap.
1. Insert the exhaust tube into the fitting on the
back of the unit and pull gently to confirm it is
holding correctly.
2. Cut the tube to length and slide the other end
into the fitting to the port installed on the drain
pipe.
IMPORTANT! Avoid excess sagging in the drain
tube, cut the tube to measure.
IMPORTANT! Tube should not be kinked,
bent or otherwise obstructed. The connection
point to the waste bottle or central drain must
be lower than the autoclave’s support surface
otherwise the unit may not drain correctly.
IMPORTANT! It is best to have a direct-to-drain waste connection when using an automatic filling
option. Use of an external waste bottle with automatic filling will require careful monitoring and
frequent emptying.

14
Connecting to a Waste Bottle
To connect the waste bottle to the STATIM B, follow these steps:
1. Insert the exhaust tube into the fitting on the
back of the unit and pull gently to confirm it is
holding correctly.
2. Cut the tube to length and slide the other end
into the fitting on the bottle.
3. Unscrew the lid from the bottle.
4. Fill the bottle with water to the MIN line and re-
install the lid and copper condenser assembly.
5. Place the waste bottle below the unit to allow
proper drainage.
IMPORTANT! Avoid excess sagging in the drain
tube, cut the tube to measure.
IMPORTANT! Tube should not be kinked,
bent or otherwise obstructed. The connection
point to the waste bottle or central drain must
be lower than the autoclave’s support surface
otherwise the unit may not drain correctly.

15
2.4 Filling Your STATIM B’s Water Reservoir
When filling the reservoir, only use distilled or filtered water containing less than 5 ppm total dissolved solids
(having a conductivity of less than 10 uS /cm).
NOTE: Impurities and additives in other water sources will cause the water quality sensor to protect the unit
by preventing a cycle from starting.
To fill the water reservoir, there are three different methods:
1. Automatic fill using a WATER FILTRATION SYSTEM.
2. Automatic fill using an EXTERNAL WATER TANK AND AUXILIARY PUMP.
3. MANUAL fill. (Default)
Automatic Fill
If you are connecting your STATIM B to an external filling device such as a water filtration system or external
water tank and auxiliary pump, make sure your unit is set to the AUTOMATIC filling mode. Your STATIM B’s
default filling option is MANUAL.
To change this setting, follow these steps:

16
Automatic Fill using a WATER FILTRATION SYSTEM
When connecting your STATIM B to an external filling device such as a water filtration system, make sure
your unit is set to the AUTOMATIC filling mode. (See section above on setting the water reservoir filling
mode.)
1. Connect the water filtration system’s Teflon
tube (or other suitable tube) to the automatic fill
port at the back of the unit.
2. Ensure the tube runs freely from the water
filtration system. It should not be sharply bent,
crushed or obstructed in any way.
3. Open the valve on the water filtration system to
fill the accumulation tank.
4. Open the accumulation tank’s valve to facilitate
the flow of water to the STATIM B.
5. Go to the home screen and select any cycle to
activate the filling system.
IMPORTANT! When selecting an automatic filling option, it is best to use a direct-to-drain
waste connection. Use of an external waste bottle will require careful monitoring and frequent
emptying.
WATER
FILTRATION
SYSTEM

17
Automatic Fill using an EXTERNAL WATER TANK AND AUXILIARY PUMP.
When connecting your STATIM B to an automatic filling system such as an external water tank and auxiliary
pump, make sure your unit is set to the AUTOMATIC filling mode (see section above on setting the water
reservoir filling mode.)
An input hose can be connected to the STATIM B from an external tank that uses an automatic water pump
to feed the internal reservoir automatically when it reaches the minimum level. Be sure to monitor the water
level of your external tank. The STATIM B does not monitor the water level in the external tank and the
auxiliary water pump should not run dry.
To use this method, you will need the automatic fill pump (sold as an accessory) and an external tank with a
minimum diameter opening of 50mm (2”) through which you can insert the pump.
To connect the automatic fill pump to the STATIM B, follow these steps:
1. Connect the fitting at the end of the pump’s
tubing to the automatic fill port.
2. Connect the automatic fill pump’s power
source to the 5V DC power connection
located at the back of the unit.
3. Fill the external tank with distilled water.
4. Place the submersible automatic fill pump in
the external tank.
5. Go to the home screen and select any cycle to
activate the filling system.
IMPORTANT! When selecting an automatic
filling option, it is best to use a direct-to-
drain waste connection. Use of an external
waste bottle will require careful monitoring
and frequent emptying.

18
Manual Fill
Your STATIM B’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.
To manually fill the reservoir, follow these steps:
1. Remove the reservoir cap.
2. Pour distilled water into the reservoir until
almost full (a maximum of 1.2 L (0.32 US
gallons).
3. Replace and secure the cap.
2.5 Connecting your STATIM B to a Network
Connecting to a Wireless Network
From the unit’s home screen, select the SETTINGS icon, then follow these steps: