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95-116177 EU EN R3. STAT

IM

 6000B Operator’s Manual. 

Copyright 2021 Coltene SciCan. All rights reserved.

STAT

IM

®

 

B G4

+

Vacuum Autoclave

Operator’s Manual 

Benutzerhandbuch

Manuel de l’utilisateur - USB

 

Manuale per l’operatore - USB

EN

13060

Fu

lly

Compli

an

t

Summary of Contents for SciCan STATIM B G4+

Page 1: ...6000B Operator s Manual Copyright 2021 Coltene SciCan All rights reserved STATIM B G4 Vacuum Autoclave Operator s Manual Benutzerhandbuch Manuel de l utilisateur USB Manuale per l operatore USB E N13...

Page 2: ...41 0 41 727 7027 F 41 0 41 727 7029 US 701 Technology Drive Canonsburg PA 15317 USA T 1 724 820 1600 F 1 724 820 1479 TF 1 800 572 1211 STATIM is a registered trademark of SciCan Ltd All other tradem...

Page 3: ...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...

Page 4: ...IM 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 2...

Page 5: ...intenance 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...

Page 6: ...d 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 medic...

Page 7: ...sing 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 Thi...

Page 8: ...ace 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 s...

Page 9: ...are 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 qualit...

Page 10: ...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 Powe...

Page 11: ...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 Mod...

Page 12: ...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 bec...

Page 13: ...adiation 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 uni...

Page 14: ...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...

Page 15: ...ertical 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 e...

Page 16: ...le 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...

Page 17: ...g 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...

Page 18: ...nit 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 accumulati...

Page 19: ...ld 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 con...

Page 20: ...tings 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 t...

Page 21: ...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 cr...

Page 22: ...ure the unit contains distilled water or filtered water containing less than 5 ppm total dissolved solids having a conductivity of less than 10 uS cm 5 Check that the USB storage device is plugged int...

Page 23: ...is important to clean rinse and dry all instruments before loading them into the autoclave Disinfectant residues and solid debris may inhibit sterilisation and damage both the instruments and the STAT...

Page 24: ...ps and pouches that have been cleared for your market Using pouches Using the STATIM B pouch rack will enable you to process up to 12 pouches in a load Pouches can be arranged vertically and if an edg...

Page 25: ...rument manufacturer s instructions select the appropriate wrapped cycle and allow it to run to completion DO use the trays provided with your unit to hold unwrapped instruments DO arrange instruments...

Page 26: ...gical indicator usage and frequency follow the indicator manufacturer s instructions and your local regulations guidelines and standards CAUTION The following materials CANNOT be sterilised in the STA...

Page 27: ...ot be able to start a cycle if the reservoir level is below the minimum fill line 3 Open the drawer The LCD should display the UNLOCKED icon Turn the latch and pull the drawer open If the drawer will...

Page 28: ...d warming up can take up to 5 minutes Allow the cycle to run to completion 8 Cycle is complete When the cycle is complete press the STOP icon to unlock the drawer 9 Remove the load Open the drawer Wea...

Page 29: ...n is complete the unit will remind you that the load is NOT STERILE 3 Press the STOP icon to continue to the home screen To stop a cycle DURING the drying phase press the STOP icon at the bottom right...

Page 30: ...er after pressing STOP Once a cycle has been stopped the STOP button must be pressed before another cycle can be started To start a new cycle or to open the drawer 1 Press the STOP icon to continue 2...

Page 31: ...s the DELAYED START button 2 Enter the time you would like the unit to start Press the DELAYED START button to begin the countdown 3 The LCD will remain on the delayed start screen until the cycle beg...

Page 32: ...ief valve ring at the back right of the unit to exhaust steam from the chamber Hold the ring open until there is no more steam coming out of the valve 2 Lift the front of the unit with your left hand...

Page 33: ...correct air removal To perform a Bowie Dick test you will need a Bowie Dick device or test pack These are NOT supplied with your STATIM B To perform the test follow the instructions provided by the te...

Page 34: ...our service technician Presetting your Bowie Dick test To schedule a Bowie Dick test before the start of the next working day use the delayed start function 1 When you have finished using your sterili...

Page 35: ...screen select the TESTS icon 4 Select the HELIX TEST icon 5 Press START NOW 6 Press the STOP icon to open the drawer 7 Follow the test manufacturer s instructions to interpret the test results 8 If t...

Page 36: ...mode and let the drawer cool 1 From the home screen select the TESTS icon 2 To run a vacuum test press the V icon 3 Press START NOW Running a vacuum test can take a minimum of 15 minutes When the test...

Page 37: ...rature sterilisation time how long the cycle will hold the sterilisation temperature and drying time When you have completed your selections press the CHECK MARK to save your changes and exit 3 To con...

Page 38: ...TE When selecting a sterilisation cycle choose according to the load you are sterilizing and the instrument manufacturer s reprocessing instructions Sterilisation CYCLE INFORMATION Cycle Icon Cycle Ty...

Page 39: ...es Select Celsius or Fahrenheit Select country Select time zone System Display Set screensaver delay Set theme light or dark Set LCD brightness Sound Set button beep on off Set button beep volume Stan...

Page 40: ...prompting users to enter a PIN at the start of a cycle when they STOP or CANCEL a cycle and when they REMOVE a load Using Process Enforced does not restrict any functions it is simply a means of trac...

Page 41: ...y the general contents of the load to be processed by selecting from a list as well as whether a biological indicator and chemical indicator are included At the end of the cycle you will be prompted t...

Page 42: ...D BY LOW For low to average use Provides a balance between keeping the chamber at 70 C 158 F and using a minimum of electricity STAND BY HIGH For high use Optimizes your STATIM B for speed by keeping...

Page 43: ...a USB storage device or to an email address or by connecting a printer Coltene SciCan also provides a cloud based service that will automatically upload your unit s cycle data to an online storage ser...

Page 44: ...ice suggests this should be done once a week To transfer data using the USB port follow these steps 1 Insert the USB storage device into one of the unit s USB ports front or back 2 From the Cycle Log...

Page 45: ...o an email address follow these steps 1 From the Cycle Log screen press the FOLDER icon 2 Press the EXPORT icon 3 Select export to Email and press the check mark 4 Enter an email address and press NEX...

Page 46: ...n a unit is powered on for the first time You can also prompt your unit to run the Setup Wizard by selecting SETTINGS and following these steps 1 Select SYSTEM 2 Select Intro Setup 3 Follow the prompt...

Page 47: ...he prompts to connect it to an IP address 3 If using a local printer connect the printer to a USB port at back of unit 4 And select the printer type from the drop down menu Use the test page function...

Page 48: ...l Signature 9E7726C95F4CDA91 12D2D6DCF5BBC248 B9106A8FC7F49F08 365400FA91D368AF Model STATIM 6000B Serial Number 310800A03600 Unit Identifier Autoclave has been set up as number 000 Quality of water i...

Page 49: ...ssure 304kPa 341kPa for Unwrapped Wrapped cycle 205kPa 232kPa for Rubber and Plastics cycle Sterilisation Temperature Specified temp 0 4 134 C 138 C 121 C 125 C for Rubber and Plastics cycle data on C...

Page 50: ...nance When you press OK the maintenance notification counter will restart regardless of whether or not you have performed the maintenance OPTION 2 REMIND LATER If you press REMIND LATER the message wi...

Page 51: ...pened with water and if needed a mild detergent Dry the surfaces and remove any residue before powering ON the unit 9 4 Cleaning the Chamber and Trays Frequency Weekly Remove the sterilisation trays f...

Page 52: ...dverse water reservoir conditions drain the water reservoir at the end of the work week or at the end of every workday for ophthalmic use From the home screen select SETTINGS and follow theses steps 1...

Page 53: ...en by hand only 9 7 Cleaning the Water Reservoir Filter Frequency Monthly or every 160 cycles whichever is first 1 Remove the reservoir lid and remove the filter 2 Clean it under running water 3 Pat i...

Page 54: ...el of any debris 3 Put the new seal in place and start by pressing it into each corner You can wet the seal with water to ease installation 4 Then work the seal into the seal channel 9 9 Cleaning an E...

Page 55: ...STATIM B on screen help instructions can be found in the SETTINGS menu 1 From the home screen select SETTINGS 2 Press the INFORMATION icon 3 Press INSTRUCTIONS 4 Select the instructions you would like...

Page 56: ...een select SETTINGS 1 Select the remote access icon 2 Press ENABLE to generate a code Note The code is case sensitive 3 A pink frame will appear around the screen when it has been enabled for remote a...

Page 57: ...ycle Check the seal for misalignment or damage Replace the seal if required If the leak persists turn the unit OFF remove the load and contact your SciCan dealer The printer does not work Printer conn...

Page 58: ...stalling your STATIM B Vacuum test has failed The unit chamber was hot when the test was initiated Ensure stand by chamber warming system is turned OFF See Section 7 3 Setting the Stand by Mode Attemp...

Page 59: ...the steriliser Disinfectant residues and solid debris may inhibit sterilisation and damage the instruments Lubricated instruments must be wiped thoroughly and any excess lubricant should be removed be...

Page 60: ...Exhaust Tube 01 116298S Direct to Drain 01 116299S Water Filling 01 116300S Waste Bottle 01 116301S USB Memory Stick 01 116302S Water Reservoir Cap SCI BDSK134V Bowie Dick Test Kit 97902001 Helix Tes...

Page 61: ...ays of the date of such a failure and further provided that the defective part s are returned to SciCan prepaid This warranty shall be considered to be validated if the product is accompanied by the o...

Page 62: ...11 Back 5 cm 2 Water Quality 5 ppm 10 S cm conductivity at 25 C 77 F Minimum Distilled Water Volume required for cycle 0 3L 0 8 US gal PRV Value pressure relief valve Set at 2 8 bar gauge 40 6 PSIG to...

Page 63: ...61 14 Diagrams of Cycle Profiles Pressure kPa 134 C Cycle Profile Pressure 121 C Cycle Profile kPa...

Page 64: ...Declaration of Conformity All supporting documentation is retained at the manufacturer s premises DIRECTIVE General Applicable Directive Medical Device Directive Council Directive 93 42 EEC of 14 June...

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