Tristel Stella System A Скачать руководство пользователя страница 38

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Weight

1560gm

Working temperature

10°C ~ 35°C

Storage temperature

-10°C to +40°C

Transport temperature

-20°C to +50°C

Charge temperature

10°C ~ 35°C

Low Voltage Directive

IEC/EN 61010-1, 61010-2-040 Part 2 – Washer Disinfectors

EMC Directive

IEC EN 61326-1

Battery Pack

Part No. 450LAH10YQM, 12V NiMH, 4500mAh, 622gm.

Battery standard charge

450mA (0.1C) 16hrs, 15Vmax

Battery Service Life

IEC Cycles test >250

Base capacity

5 Litres

Weight

5.9kg when empty

REGULATORY COMPLIANCE

REGULATORY

The Stella System is CE marked as a Class IIb medical device as per the Medical Device Directive 93/42/EEC and
the 2007/47/ EC amendments thereto, for washer – disinfectors intended for disinfecting invasive devices and
Low Voltage Directive (LVD) 2014/35/EU.

Council Directive (EU) 2017/745 of 5 April 2017 concerning medical devices

Directive (LVD) 2014/35/EU

Low Voltage Directive (LVD) 2014/35/EU enforced 23 April 2016

Directive (EMC) 2014/30/EU

Electromagnetic Compatibility (EMC) 2014/30/EU enforced 20 April 2016

BS EN ISO 13485:2016

Medical Devices - Qualitative management systems.

Requirements for regulatory purposes

BS EN 60601-1:2006 +A12:2014

Medical electrical equipment. General requirements for basic safety

and essential performance – (Relating to Power Adaptor)

AS 61010.1:2003(R2016) BS EN

61010-1:2010+A1:2019

IEC 61010-1 3.1: 2017

Medical Electrical Equipment. Part 1: Safety requirements for electrical equipment for

measurement, control, and laboratory use. General requirements

BS EN 61010-2-040:2015

Part 2-040

Safety requirements for electrical equipment for measurement, control and Laboratory use –

Particular requirements for sterilisers and washer disinfectors used to treat medical devices

BS EN 61326-1:2013

IEC 61326-1:2012

Electrical equipment for measurement, control and laboratory use.

EMC requirements. General requirements

BS EN 62366-1:2015

Medical devices. Application of usability engineering to medical devices

BS EN 62304:2006+A1:2015

Medical device software. Software life-cycle processes

BS EN 61000-3-2:2014

IEC 61000-3-2:2014 Ed4.0

Electromagnetic compatibility (EMC) - limits for harmonic current emissions

BS EN 61000-3-3:2013

IEC 61000-3-3:2013 Ed 3.0

Electromagnetic compatibility (EMC) - limitation of voltage changes,

voltage fluctuations and flicker in public low voltage supply systems

AS/NZS CISPR 11:2011

BS EN 55011:2009

CISPR11: 2009 + A1: 2010

Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics.

Limits and methods of measurement.

AS/NZS 61000-4-2:2013

BS EN 61000-4-2:2009

IEC 61000-4-2:2008

Electromagnetic compatibility (EMC) - testing and measurement techniques

– electrostatic discharge immunity test

Electromagnetic compatibility (EMC) - testing and measurement techniques

– radiated, radiofrequency, electromagnetic field immunity test

AS/NZS 61000-4-3:2013

BS EN 61000-4-3:2006 +A1: 2010

IEC 61000-4-3:2006

+A1:2007+A2:2010

Содержание Stella System A

Страница 1: ...1 USER GUIDE System ...

Страница 2: ... and understand the user instructions before operating Stella IQ or Pulse Never use Stella IQ Pulse or Cradle for any purpose other than the Intended Purpose Do not use Stella for the reprocessing of surgical equipment or medical devices intended for autoclaving Do not use Stella IQ Pulse or Cradle including IQ or Pulse power adaptors if they have been damaged or have changed in performance Should...

Страница 3: ...3 SECTION ONE INTENDED USE ...

Страница 4: ...lumened medical devices such as nasendoscopes transoesophageal echocardiography probes transvaginal probes transrectal probes manometry catheters and laryngoscope blades Indication for Use For the high level disinfection of non lumened see above and single lumened medical devices such as hysteroscopes cystoscopes intubation endoscopes and bronchoscopes Indication for Use For the cleaning and high ...

Страница 5: ...2 SECTION TWO COMPONENTRY ...

Страница 6: ...for closing the cut outs when they are not being used Cut outs Overflow compartment Device compartment Overflow outlet Cut outs Cut out for the IQ Handles STELLA BASE STELLA LID ACCESSORIES Handles SECTION 2 COMPONENTRY The Stella Jug for preparation of Tristel Fuse for Stella and Tristel Clean for Stella working solutions The Stella Lube a lubricant needed for set up and maintenance of the IQ The...

Страница 7: ...to the Base USB port and power port behind cover Note Only Stella power adaptors should be used which have an input power of 100 240V 50 60Hz LED light indicators ON OFF button Pulse lid USB port and power port behind cover STELLA IQ Note Only Stella power adaptors should be used which have an input power of 100 240V 50 60Hz ...

Страница 8: ...E Connectors to Pulse unit Tube mount Luer Lock for connection to a device lumen Disinfectant pick up filter Dual Luer Lock connector optional for devices with non removable tap PULSE TUBE SET STELLA A STELLA B AND C ...

Страница 9: ...Stella Pulse Stella Pulse Tube Set Power Adaptor Stella Cradle Pack Cradle Assembly Instructions Stella Cradle Shelf Pack Cradle Shelf Shelf Fixings Assembly Instructions Stella System Toolbox Small Parts Tray and Lid Stella Lube Grommets 2 Drainage Outlet Cap Stella Pump Hose Replacement Kit Surrogate Lumen Kit Dual Luer Lock Connector Stella Jug Manual Emergency Kit not available in Germany TABL...

Страница 10: ...pends on cradle levelling leg length Drainage Hose 6cm protruding 100cm tubing 6cm connector long SPECIFICATIONS AND STORAGE The Base and Lid can be easily stacked and transported When empty the weight is 5 5kg The Drainage Outlet Cap can be used when transporting the Base to contain any small droplets of disinfectant left in the Base IQ and Pulse should be operated and charged in temperatures bet...

Страница 11: ...8 SECTION THREE GETTING STARTED ...

Страница 12: ...er adaptors to charge IQ and Pulse for 12 16 hours before first use Install the Stella Suite Software SETTING UP THE STELLA SYSTEM It is important to ensure that Stella is operated on a stable and level surface Otherwise the automatic sensor that triggers the cycle will not operate reliably SECTION 3 GETTING STARTED Place Stella Cradle on the surface where the Stella System will be positioned Adju...

Страница 13: ...that the disinfectant pick up filter is sitting in the inner compartment of the Base The Stella System is now ready to use 3 6 Once level place the Base onto the Cradle Stand the Lid in an upright position at the rear of the Base Apply the grommets into the tray cut outs Apply a little amount of Lube lubricant onto the IQ drainage inlets See Section 5 Maintenance Lubing IQ Firmly attach the IQ to ...

Страница 14: ...11 SECTION FOUR HOW TO USE ...

Страница 15: ...itioned into one of the two positions available within the device compartment t0 the left or right of IQ Step 4 Prepare five litres of Tristel Fuse for Stella working solution in the Stella Jug in accordance with the user instructions Step 5 When prompted by IQ pour five litres of Tristel Fuse for Stella disinfectant into the device compartment It is recommended to position the Jug on the outer wa...

Страница 16: ... does not require rinsing based on clinical and toxicological studies Step 9 When the Base is empty you will hear a beep indicating that the cycle is complete Press the OK button to acknowledge that the cycle is complete The disinfected device can now be removed for immediate use or to be placed in storage Follow hospital procedures and manufacturer s instructions for device drying and storage Ste...

Страница 17: ...ion levels and guidance on how to place the devices into the Base Step 3 If the device features a lumen attach the Pulse Tube Set Luer Lock connector to the device s lumen port and ensure the tap is in the open position if applicable Some devices have two fixed ports that cannot be removed and taken apart These two ports will feed into the same working channel therefore both port entries must be d...

Страница 18: ... When IQ is turned off Pulse will switch off automatically If IQ is not turned off manually within 1 minute the backlight will dim if not attended with in 5 minutes the IQ and Pulse will shut down It is recommended to turn off IQ immediately after use to save the battery After IQ has been switched off it can be detached from the Base With the drainage outlet cap fitted into place the Base can be u...

Страница 19: ...facturer s instructions for immersion levels and guidance on how to place the devices into the Base Step 3 If the device to be cleaned disinfected features a lumen attach the Pulse Tube Set Luer Lock connector to the device s lumen port and ensure the tap is in the open position if applicable Some devices have two fixed ports that cannot be removed and taken apart These two ports will feed into th...

Страница 20: ...If a disinfection cycle does not follow within 30 minutes the cycle will be automatically aborted by IQ a new cleaning cycle must be started If any visible residual soiling remains in the Stella Base following the cleaning cycle this should be removed with a water wetted soft low or non linting wipe Step 9 Prepare five litres of Tristel Fuse for Stella working solution in the Stella Jug in accorda...

Страница 21: ...WN PROCEDURE STELLA SYSTEM C Turn off IQ by pressing the OFF button You will hear a beep indicating that IQ is switching off When IQ is turned off Pulse will switch off automatically If IQ is not turned off manually within 1 minute the backlight will dim if not attended within 5 minutes the IQ and Pulse will shut down It is recommended to turn off IQ immediately after use to save the battery After...

Страница 22: ...19 SECTION FIVE MAINTENANCE ...

Страница 23: ...adaptors may damage the equipment or cause malfunctions Step 3 Once plugged in IQ will display the status of the charging Do not charge IQ or Pulse whilst they are attached to the Base or near solution Ingress of solution will cause damage or malfunctions to the equipment The battery is 76 100 full 60 80 cycles available The battery is 51 75 full 41 59 cycles available The battery is 26 50 full Th...

Страница 24: ...red and ready for use BARCODE VALIDATION QR CODE VALIDATION If utilizing a scanning software package for audit trail the Stella C variant can issue a Validation Barcode when a decontamination cycle has completed The barcode used is a 128 format This feature operates with a 2D image scanner A laser scanner cannot be used To enable this feature complete the following steps When a cycle has completed...

Страница 25: ...ere are two options for downloading the data from IQ Step 1 Open Stella Suite and connect the USB cable to your PC or Laptop and the IQ unit IQ must be turned off The connection port can be found on the back of the IQ under a protective cover Step 2 IQ will automatically detect the USB connection and the display will light up Do not press the ON button Step 3 The USB Download symbol will appear on...

Страница 26: ... to Step 5 Open Stella Suite On the tool bar select File Configure then select the Bluetooth tab Tick the Use Bluetooth box Select the PORT number from Step 4 Click OK Bluetooth download is now enabled Select Download in Stella Suite to download VIA BLUETOOTH Step 1 Enable Bluetooth communications on your PC or Laptop by going to Settings Devices Add Bluetooth or other devices and ensure Bluetooth...

Страница 27: ...ew the clear window and remove from Pulse Remove the pump hose by lifting the pump hose connector on one side Turn the green pump head clockwise to lift the curved hose and then lift the pump hose connector on the second side 1 2 The equipment you will need for the Pump Hose replacement process Pulse Pump Hose Replacement Set Flat Head Screwdriver located in the Toolbox The Pump Hose replacement c...

Страница 28: ... Dry with a soft cloth REPLACING THE TUBE SET The Stella B Tube Set should be replaced every 4 000 disinfection cycles The Stella C Tube Set should be replaced every 2 000 disinfection cycles The Stella Suite Report shows the number of cycles completed Remove the Tube Set from Pulse and attach the replacement Tube Set to Pulse by matching the male and female connectors Place the green tube mount p...

Страница 29: ...26 SECTION SIX TROUBLESHOOTING AND FREQUENTLY ASKED QUESTIONS ...

Страница 30: ...dvise them of the error code and graphics Stella xx Stella IQ xx Stella Pulse xx STELLA IQ SCREEN WHAT HAPPENED WHAT SHOULD BE DONE IQ has detected an obstruction and the ball valve will not close There is no disinfectant in the Base Remove IQ from the Base and inspect the IQ drainage outlets for blockages Remove any debris Refer to the Ball Valve Cleaning Procedure in the Service Manual Restart t...

Страница 31: ...n the solution that the Tube Set is connected to the device and that the Tube Set Connectors are connected to the Pulse unit Confirm these checks have been completed by pressing the ON button After three failed attempts or after one minute has passed the disinfection cycle will be aborted The disinfection cycle was not successful and must be repeated If this error persists contact your Stella Agen...

Страница 32: ...f liquid will flow into the overflow compartment and out through the Drainage Hose at the start of a cycle If there is a continuous leak throughout the cycle the valve may not have closed correctly Remove IQ from the Base If the system is operating with IQ only press the ON button so that the valve inside IQ closes If the system is operating with IQ and Pulse press the ON button on IQ and Pulse so...

Страница 33: ...allation User Guide which can be found in the Help section of the Stella Suite Stella Suite must be installed onto the computer and the Bluetooth link configured according to the Blue tooth device instructions used on the computer Why will IQ or Pulse not power up after a firmware update The firmware update may not have completed successfully The update should be repeated Open the Stella Suite con...

Страница 34: ...31 SECTION SEVEN WARRANTY ...

Страница 35: ...e notification to the Company must include a description of the problem in reasonable detail and the full report downloadable from the IQ using the Stella Suite showing all details starting seven 7 days before the defect was first noted Upon receiving the Company s official return goods authorisation RGA the customer must promptly return the defective part or Product to the Company or the authoris...

Страница 36: ...33 SECTION EIGHT COMPLIANCE ...

Страница 37: ... Vdc 200mA Ingress Protection IP64 with power cover closed Dust tight protected from water splash Pollution Degree Assessed to pollution degree 3 Conductive pollution is to be expected Humidity 10 to 90 Weight 840gm Working Temperature 10 C 35 C Transport Temperature 20 C to 50 C Storage Temperature 10 C to 40 C Charge Temperature 10 C 35 C Low Voltage Directive IEC EN 61010 1 61010 2 040 Part 2 W...

Страница 38: ...cal Equipment Part 1 Safety requirements for electrical equipment for measurement control and laboratory use General requirements BS EN 61010 2 040 2015 Part 2 040 Safety requirements for electrical equipment for measurement control and Laboratory use Particular requirements for sterilisers and washer disinfectors used to treat medical devices BS EN 61326 1 2013 IEC 61326 1 2012 Electrical equipme...

Страница 39: ...hould not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Stella System should be observed to verify normal operation in the configuration in which it will be used OPERATION IN WET AREAS Keep IQ and Pulse clear from wet areas when they are placed on charge or connected to a computer terminal using a USB cable Do not attempt to use the Stella System f...

Страница 40: ... A A A A AC Power Including protective earth Voltage dip Short interruptions Burst Surge Conducted RF IEC 61000 4 11 IEC 61000 4 11 IEC 61000 4 4 IEC 61000 4 5 IEC 61000 4 6 0 during half cycle 0 during 1 cycle 70 during 25 30 cycles 0 during 250 300 cycles 1 kV 5 50 ns 5 kHz 0 5 kV 1 kV 3 V 150 kHz to 80 MHz B B C C B B A DC power including protective earth Burst Surge Conducted RF IEC 61000 4 4 ...

Страница 41: ... All establishments including domestic AC power Conducted emissions CISPR 11 150 kHz 30 MHz Enclosure Radiated emissions CISPR 11 Group 1 equipment 30 MHz to 1 GHz OATS AC power Harmonic emissions IEC 61000 3 2 Measurement up to 40th harmonic AC power Flicker IEC 61000 3 3 Traceable results only Complies Electromagnetic environment guidance Group 1 The Stella System uses RF energy only for its int...

Страница 42: ... the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey A should be less than the compliance level in each frequency range B Interference may occur in the vicinity of equipment marked with the following symbol At 80 MHz and 800 MHz the higher frequency applies These guidelines ...

Страница 43: ...s equipment Rated maximum output power of transmitter Watts W Separation distance to frequency of transmitter meters m 150 kHz to 80 MHz d 1 2 P 150 kHz to 80 MHz d 1 2 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distances in meters m can be estimated using the equati...

Страница 44: ...aptor to a regular power outlet Protect connectors from moisture and damp areas Prevent property damage Never carry the power adaptor by its electrical cable or pull at the cable To remove the adaptor from the power outlet always pull on the plug never the cable The DC power cable must be installed safely to avoid tripping over Disconnect the power supply during thunderstorms Only use original spa...

Страница 45: ...f manufacture Fragile Handle with care Do not stack pallets MANUFACTURER Tristel Solutions Limited Lynx Business Park Fordham Road Snailwell Cambridgeshire CB8 7NY United Kingdom T 44 0 1638 721 500 F 44 0 1638 721 911 E mail tristel com W www tristel com The Stella system is CE marked as a Class IIb medical device as per the Medical Device Directive MDD 93 42 EEC and the 2007 47 EC amendments the...

Страница 46: ...43 SECTION NINE STELLA AGENTS ...

Страница 47: ...inach Switzerland T 41 61 717 55 55 E info anklin ch ICELAND Icepharma Lyngháls 13 110 Reykjavík Iceland T 354 540 4324 E soley icepharma is ITALY Tristel Italia S r l Via E Collamarini 14 40138 Bologna Italy T 39 051 0014912 E www tristel it PORTUGAL Teprel Equipamentos Médicos S A Adress Rua D Marcos da Cruz 1997 1º Poente 4455 482 Perafita Portugal T 351 22 999 9880 E info teprel com REPUBLIC O...

Страница 48: ... Pte Ltd 29 Media Circle 04 23 Singapore 138565 T 65 6100 5060 E orders eo com sg PAKISTAN Uniprom Healthcare L 151 2nd Floor Sehba Akhter Road Block 13 G Gulshan e Iqbal Karachi Pakistan T 92 41 871 3751 E info unipromhealthcare com SAUDI ARABIA Fal Care Trading Est P O Box 48520 Jeddah 21414 Saudi Arabia E info cayane net UNITED ARAB EMIRATES BAHRAIN KUWAIT QATAR OMAN JORDAN LEBANON Fal Care FZE...

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