Soluscope
Sprint Model SL-V3-PA-G User Manual April 2018
User Manual
83 Pages
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Page 1
User Manual Enhanced Pre-Cleaning Program Enabled
Issue Date: April 18th 2018
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
APRIL 18TH, 2018
ENHANCED PRECLEAN PROGRAM ENABLED
WARNING PLEASE READ THROUGH THIS MANUAL THOROUGHLY In order for the Soluscope Sprint, model SL-V3-PA-G, to operate correctly please adhere to the following recommendations.
IF THE RECOMMENDATIONS IN THIS MANUAL ARE NOT FOLLOWED, THE MANUFACTURERS GUARANTEE WILL BE NULL AND VOID. Soluscope is a C.E marked medical device whose validation results from scientific evaluations with its dedicated consumables, specifically the chemicals Soluscope-A, Soluscope-P; Soluscope C+ or Soluscope CLN+; and the filters.
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
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TABLE OF CONTENTS INTRODUCTION... 1 SOLUSCOPE SPRINT FEATURE OVERVIEW... 2 REAR OF MACHINE ... 2 THE EXISTING GROUPS ... 3 CODING OF THE ENDOSCOPES NUMBERS ... 3 CYCLE SELECTION CHART ... 4 ENHANCED PRE-CLEANING SYSTEM PROCEDURE ... 5 SOLUSCOPE REQUIREMENTS ... 5 ENDOSCOPE PREPARATION BEFORE TREATMENT... 5 BEDSIDE PRE-CLEANING REQUIREMENT... 6 STARTING A CYCLE (1, 2, 3, 4, 5, 11) ... 11 CONNECTION OF ENDOSCOPE IN THE BOWL ... 11 SELECTING A CYCLE ... 12 ENTERING DATA ... 12 PROGRESS OF SELECTED CYCLE... 13 OPERATOR REQUEST AT END OF CYCLE ... 13 END OF CYCLE ... 13 USER DEFINED OPTIONS ... 14 HOW TO REPRINT A TICKET ... 16 HOW TO SELECT PRINT SCREEN ... 16 SOLUSCOPE SPRINT SELF-DISINFECTION – CYCLE 6 ... 17 STARTING CYCLE 6... 18 IN-CYCLE ALARM GENERATED BY SOLUSCOPE SPRINT ... 20 USER GENERATED STOPPAGE ... 21 CONSUMABLES ... 22 CHANGING CHEMISTRY ... 22 LID SEAL ... 24 REPLACING THE LID SEAL ... 24 CYCLE 10 - CLEANING AND DISINFECTING LID SEAL ... 25 FINAL 0.2UM AIR FILTER ... 26 0.2 UM WATER FILTER ... 27 REMOVAL OF THE BLOCKED FILTER ... 27 REPLACING THE PRINTER PAPER ... 28
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
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APPENDICES: APPENDIX A - CHEMICAL MONITORING STERILE CYCLE (CYCLE 3) APPENDIX B - PROPACT - BIOLOGICAL MONITORING OF STERILE CYCLE 3 APPENDIX C - MICROBIOLOGICAL TESTING APPENDIX D – REPROCESSING OF BLOCKED OR DISCONNECTED CHANNELS APPENDIX E - TROUBLESHOOTING APPENDIX F – ICON INDENTIFICATION APPENDIX G – AVAILABLE CONNECTORS FOR ENDOSCOPES APPENDIX H – MAINTENANCE TABLE APPENDIX I - DETERMINATION OF FILTER CHANGE APPENDIX J - THREE STAGE FILTRATION FILTER LOG APPENDIX K - FOUR STAGE FILTRATION FILTER LOG APPENDIX L – ENDOSCOPY PROOF OF PROCESS APPENDIX M - CONSUMABLE LOG APPENDIX N - ERROR LOG SHEET APPENDIX O - BIOLOGICAL AND CHEMICAL INDICATOR TEST RESULTS LOG
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
APRIL 18TH, 2018
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INTRODUCTION
Soluscope Sprint model, SL-V3-PA-G is a fully automatic washer-disinfector/steriliser for flexible endoscopes, designed to meet the requirements of all types of flexible endoscopes including ultrasound endoscopes in use today. The Soluscope Sprint complies with the Standard EN 15883-4 Washer Disinfector requirements, especially with its irrigation Control Function (detects Blocked and Disconnected channels) and with AS4187. It is TGA registered as a Washer, Disinfector and Steriliser. Please note that the Soluscope Sprint chemicals must be used in order to ensure you are following the correct validated process. It must be used with the following products Soluscope-A; Soluscope-P, Soluscope C+ or CLN+ and Soluscope L. The Soluscope Sprint carries out a process that combines: Mechanical action Treatment products (chemical action) Thermal action Computer program to manage and control the endoscope treatment Specific method for connecting the endoscope to the Soluscope Sprint This process operates using a TGA registered class IIb Disinfectants/Sterilants. The Disinfectant/Sterilant is a solution based on Peracetic Acid, and additional additive is added to the ingredient to protect the endoscope. The Soluscope Sprint may also be supplied on a trolley which includes: Accommodation of the Soluscope Sprint chemistry A pre-filtration unit For further information: In Australia Gallay Medical & Scientific Pty Ltd 1300 425 529 In New Zealand Gallay Medical & Scientific NZ Pty Ltd 0800 425 529
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
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SOLUSCOPE SPRINT FEATURE OVERVIEW
Lid
Lid Open Touch Screen Display
Integrated Printer
0.2 μm Water Filter
Trolley
Access Drawer for Soluscope Sprint Chemistry
REAR OF MACHINE
Water Pre-filtration & Filtration
Barcode Reader Connection
Barcode Reader Air Filter Power Switch Drain Hose Connection Chemistry Inlets X 4 Water Inlet (Red Cap)
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
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THE EXISTING GROUPS
Gr. 01 Gr. 02 Gr. 02 *** Gr. 03 Gr. 04 Gr. 05 Gr. 06 Gr. 07 Gr. 08 Gr. 09 Gr. 10 Gr. 12 Gr. 13
Air Chan.
Water Chan.
X X X X
X X X X
Biopsy 1 Chan.
Biopsy 2** Chan.
Suct. Chan.
Add. Chan.*
Elevat. Chan.
Fuji “L” Chan.
Baloon Chan.
X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X Ultrasound endoscopes dedicated. Ultrasound endoscopes dedicated. Only for endoscopes that have no channel NEVER INPUT A GROUP 10 FOR ENDOSCOPE WHOSE CHANNELS HAVE BEEN CONNECTED Ultrasound endoscopes dedicated. Ultrasound endoscopes dedicated. Warning: Every new endoscope must be qualified by an authorized engineer trained on Soluscope at level 2a. This training should normally be provided to your biomedical engineer during the installation of your machine. The qualification of each endoscope requires also our after sales Dept written approval. Any disrespect of the qualification procedure is under the user's responsibility.
*Independent channel (Except elevator channel on duodenoscopes) ** Present on some unusual endoscopes *** In this case the « L » channel is considered as a classic additional channel
CODING OF THE ENDOSCOPES NUMBERS All the identification numbers of the endoscopes are set as follows: 0315 (or 315)
The two first numbers correspond to the belonging group of endoscopes (here group 03 or 3) The two last numbers represent the single number of the endoscope identification (endoscope N°15).
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
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CYCLE SELECTION CHART CYCLE 6* Self-disinfection with SOL-TABS End of day cycle
CYCLE 1 Cleaning & Disinfection
CYCLE 2 Double Cleaning & Disinfection Alcohol Flush
CYCLE 3 Sterile Cycle
CYCLE 4 Disinfection without cleaning
Leak Test
Leak Test
Leak Test
Leak Test
Drying**
Prerinse
Prerinse
Prerinse
Prerinse
Alcohol Injection
Dynamic high flow cleaning wash, with channel control
Dynamic high flow cleaning wash (1), with channel control
Dynamic high flow cleaning wash, with channel control
Disinfection with Channel Control
Drying**
Disinfection 0.2µm Terminal water filter
Rinsing
Rinsing
Rinsing
Rinsing
Rinsing with Channel Control
Hourly Recirculation in the circuits until activation of delayed rinsing
Disinfection
Disinfection with Channel Control
Dynamic high flow cleaning wash (2), with channel control
Sterile Cycle Double Dose PAA with channel flow control
Drying**
Delayed Rinsing, started by user
Rinsing
Rinsing with Channel Control
Rinsing
Rinsing with Channel Control
Internal Circuits Drying
Drying**
Drying**
Disinfection with Channel Control
Drying**
CYCLE 5 Additional Drying
CYCLE 8 Descaling
CYCLE 10 Lid Seal for cleaning (lid open)
CYCLE 11 Further Rinsing
Disinfection
Prerinse
Lid Seal Inflation
Leak Test
Machine Disinfection
Descaling
Rinsing
Rinsing Drying** Alcohol Injection Drying**
TIME: 24 min
STD = Standard Program
TIME: 31 min
TIME 28.30 min
TIME: 14 min
TIME: 3 min
THE DURATION OF CYCLES MAY VARY WITH THE TYPE OF ENDOSCOPE, WATER TEMPERATURE, PRESSURE AND FLOW RATE. Automatic alcohol injection in cycles 2 & 5 Alcohol injection option at end of cycle can be selected for Cycles 1, 3, 4, & 11
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific.
*After 72 hours: A cycle 6 (Soluscope Sprint self-disinfection) is mandatory *** The drying is enough to reuse the endoscope within a short time. For long term storage, it is recommended to have the endoscope kept in a Soluscope drying cabinet.
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ENHANCED PRE-CLEANING SYSTEM PROCEDURE SOLUSCOPE REQUIREMENTS WARNING: The use of automated cleaning in the standard Soluscope Sprint is not validated. ONLY those Soluscope Sprints that display the label: “ENHANCED PRE-CLEANING PROGRAM ENABLED” have been validated for this process. 1) Soluscope Sprint requires program update to provide the ‘Enhanced pre-cleaning’ capability. 2) Sol-CLN+ is the enhanced pre-cleaning chemistry for use within the Soluscope Sprint enhanced precleaning enabled system. 3) The cleaning phase of the Soluscope Sprint will increase by 3 minutes. 4) Bedside pre-cleaning chemistry to use: Asepti Rapidzyme. 5) Cylindrical sponge (“Endochoice Koala” or “Endochoice Koala Plus” brand) for manual wipe down of endoscope post procedure. 6) Labelling of Soluscope Sprint to indicate ‘Enhanced Pre-Cleaning Enabled’ Part Number BM821085 EC-SSB-210-50 EC-SES-240-50 EC-SIK-242-24 EC-SIK-243-24 SOL-CLN+ SOL-PLC-Enhance BMD-71-000-96
Description Asepti Rapidzyme EndoChoice Koala sponge EndoChoice Koala Plus Pure Enzymatic sponge EndoChoice SafeStart EndoChoice SafeStart CP Soluscope CLN+ Cleaner Software update Soluscope Enhanced Pre-cleaning Asepti Active Wipes (2-in-1 cleaning & disinfection )
Qty 2 x 5L Pack 50 Pack 50 Pack 24 Pack 24 5L
3 x 250 tubs
ENDOSCOPE PREPARATION BEFORE TREATMENT The following steps should be undertaken immediately after an endoscopic procedure, this step is called pre-cleaning (at bedside).
As soon as the endoscope is taken out of the patient the following procedure shall be used at the bedside.
With the endoscope still attached to the light source, it shall be wiped down on the outside with a Soluscope approved detergent.
Using the Soluscope approved detergent, wipe down the outside of the endoscope i.e. insertion tube (at control head) to distal tip of endoscope then place distal tip in detergent solution, aspirate suction channel to dislodge any debris in endoscope until clear solution is observed and then aspirate the air/water channel.
Depress and release the air/water button to flush the channel.
Flush the additional channel if present.
Check channels for patency
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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The nurse can now (depending on local regulations) place the above mentioned endoscope directly into the Soluscope Sprint thus bypassing the manual cleaning process. This step replaces the nurse taking the Colonoscope or Gastroscope into the cleaning room for the manual cleaning process (leak test, brushing, flushing of scope channels).
Please note the time between the bedside cleaning and insertion into the Soluscope Sprint must be no more than one hour. If greater than one hour the endoscope must be manually brushed and cleaned.
BEDSIDE PRE-CLEANING REQUIREMENT It is important that the correct GENCA guidelines are followed at the bedside to ensure correct pretreatment prior to reprocessing within 1 hour. WARNING: Refer to the GENCA Guidelines Third Edition 2010, additions to procedure required for Soluscope enhanced pre-cleaning program enabled conformance.
Enhanced Pre-Cleaning Enabled Protocol: Soluscope
Machine Requirements:
Chemical requirements :
Updated program to “Enhanced PreCleaning Enabled Program”
Soluscope Sprint Machine uses Sol-CLN+ for cleaning phase.
The machine will display the label: “ENHANCED PRE-CLEANING PROGRAM ENABLED”
Bedside: 0.5% solution of Rapidzyme Pr for post proceedure flushing Cleaning sponge/wipe
Bedside Procedure
Prepare flush solution using 5ml/l Rapidzyme-PR Enhanced Enzymatic precleaner 1.1 Immediately after each procedure with the endoscope still attached to the light source, grasp the control head. Using a disposable sponge soaked in detergent solution (Rapidzyme –PR), wipe the insertion tube from control head to the distal tip. Use the sponge to protect distal tip for transport.
Gallay recommends a full sponge such as the Endochoice Koala sponge for uniform contact on wipe down of insertion tube
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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Bedside Procedure
1.2Place the Distal Tip in detergent solution. Aspirate through the suction channel – depress and release suction button rapidly to promote debris dislodgement. Alternately suction cleaning fluid and air by raising the instrument tip in and out of the cleaning solution. Continue aspiration until clear fluid is observed.
1.3Depress and release air/water button several times to flush water channel. Occlude (block off) air button to force air through the channel. (Watch for the waste line to run clear, usually about 30 seconds)
1.4 Depending on the brand of endoscope, either: 1) insert the special air/water channel feed button and depress the button to flush then release for air flow to expel the water; (OR) 2) move the lever on the water feed connector to close off the water supply, then depress the water feed button until water is expelled; (OR) 3) disconnect the water bottle connector from the endoscope taking care not to contaminate its end, then seal water connector port on the light guide plug and depress the water feed button until all water is expelled.
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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Bedside Procedure 1.5 The endoscope should be removed from the light source and taken to the cleaning area. Endoscopes should be transported in a manner that avoids environmental contamination from drips or spills. Ensure protective caps are applied before immersing in solutions or AFER’s. It is essential that the endoscope is not allowed to dry prior to cleaning as this will allow organic material to dry, making removal from channels difficult or impossible. It should be noted that when reprocessing endoscopes in new ‘Enhanced Pre-cleaning Program Enabled’ Soluscope 3CC PAA the reprocessing cycle must be commenced within 1 hour of the procedure. Endoscopes should never be left soaking for long periods.
Recommended transport systems: MI Transporter Endochoice Cinchpad Endochoice Koala Sponge on distal tip
Checking for Patency
1.6 Pass a brush once down each brush-able channel to check for patency
** Please note it is important that bedside pre-cleaning and purging flush is carried out fully in accordance with the current GENCA Guidelines. This is a critical part of your process to ensure success with the Pre-Cleaning Enhanced Soluscope Sprint system. *** Scopes that are heavily soiled or show presence of seeds need to undergo the full GENCA procedure for manual brushing of the endoscope. **** If the Endoscope is used on an emergency patient without a bowel preparation then the full GENCA guidelines for manual brushing shall be carried out.
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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Machine Procedure
ENHANCED PRECLEAN PROGRAM ENABLED
Within 1 hour of end of Procedure
1. Arrange the Endoscope, whilst it is in the transport tray in a coiled shape as it would sit inside the machine 2. Remove all valves and buttons 3. Transport to Soluscope Loading area
4 Soluscope ready waiting with Disinfectant/Cleaning Impregnated Wipe plus a dry cloth or wipe
5. Load endoscope as per normal taking care not to contaminate the surrounding area. 6. Wipe the leak test port with a disinfectant impregnated cloth. (This is to decontaminate the covered leak test connection) 7. Dry the leak test port with a dry cloth. (This is to remove moisture that can enter the leak test port while in the AFER)
8 Connect all the ports on the Endoscope as per normal
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Machine Procedure
Within 1 hour of end of Procedure
9. Once all the connections to the Endoscope have been made, take a disinfectant wipe. Wipe the top surface of the Soluscope and inside the bowl where the lid seal makes contact. 10.Taking these precautions will ensure the safety of the nurse and patient. (This is to ensure minimization of risk of cross contamination of an endoscope due to its movement through your Procedure room)
11. At the end of the cycle remove the cleaned & processed Endoscope, transfer to a clean transport tray lined accordingly.
NOTE: Heavily soiled endoscopes must be manually cleaned
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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STARTING A CYCLE (1, 2, 3, 4, 5, 11) The power switch is at the rear of the Soluscope Sprint and must be switched on. It takes approximately 30 seconds for the Soluscope Sprint display to show its main menu. MAIN MENU UPON START-UP User details
Endoscope cycles
IT Soluscope connection status Alarm status
Configuration menu
Soluscope cycles
CONNECTION OF ENDOSCOPE IN THE BOWL
Ensure the endoscope is correctly positioned; all connectors are securely plugged in the Soluscope Sprint and connected to endoscope channels, including Biopsy/Suction, Air/Water connectors, blockerseparator connector, additional channel if applicable and leak test connector. Check that the connector tubes must not be kinked and ensure upon closing the lid all is neatly in place.
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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SELECTING A CYCLE
Press the Endoscope cycles icon
in the main menu to access the following screen:
Cycle numbers To main menu Back to previous page of the display
Endoscope Cycles Menu
ENTERING DATA The Soluscope Sprint will request Endoscope number (barcode) and Operator ID Barcode. The Doctor ID and Patient ID will only be requested if this option is activated. Please call technical service if required.
Scope number Operator ID Doctor ID (grey unless activated) Patient ID (grey unless activated)
After scanning or manually entering the IDs, the following screen appears:
NOTE:
As long as the start of the cycle has not been confirmed then the data can be re-entered, or the operator can go back to previous page using the Or Press
icon and reselect cycle.
to return to the main menu.
Once entered and data confirmed close the lid. Press
to start the cycle
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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PROGRESS OF SELECTED CYCLE As the cycle progresses each step will flash and become green after completion.
Temperature of water in Soluscope Sprint bowl
Access to cycle screen To stop the cycle
Cycle Timer Cycle Steps
Once the cycle has started data can no longer be changed. To stop the cycle, press the icon and confirm the cycle stoppage with
.
OPERATOR REQUEST AT END OF CYCLE
Enter manually or scan operator bar code and validate with . The ticket is printed. The display will return to the following screen. Check the printout then press the blue button to open the lid. Remove the endoscope with the printout.
END OF CYCLE The Soluscope Sprint beeps at the end of the cycle and the following on screen display will show a green tick indicating end of cycle. You can return to the main menu by pressing the green tick icon. At this stage the lid can be opened and after ensuring that the connectors are still connected to the endoscope, the endoscope can be disconnected and removed from the bowl. No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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USER DEFINED OPTIONS Ticket Options The printed ticket is essential data for validating the cycle. It is issued regardless of the result of the cycle. The ticket must, in all cases, be checked before filing. Your Soluscope Sprint enables you to choose between two types of traceability ticket: Example of a long ticket listing all the values and settings of the cycle, the information on users and consumables along with the result of the endoscope reprocessing. 2.2 s
300.1 s
21 4.0 s 2.4 s 4.3 s
Gallay Medical
10.7 s 11.4 s 2.3 s
4.0 s
48.3 s
ENDO 45.4°C - 45.5°C
1
22681
2
V1.31
V1.31
1
21
100.1 s 3.9 s
3
04/11/2016 10:23:11 1402
U02
4
1
2
20.0 s 1.9 s
19.8 s 37.1 s
46.2°C - 46.4°C
Pentax gas
19.8 s
7.3 s
HLD
-----
1
47.5 s
ANA MARIA 0139
8.1 s
5
10:31:00
1402
10:31:46
04/11/2016 10:43:23
63.9 s
00:19:51
46.6°C --> 00.0 s 2.6-10.0 0.0-10..0 2.6-10.0
3.5-30. 0 3.5-30.0 0.0-10.0
24.11 s
2.4 s
1 Soluscope serial number 2 Program version
4.2 s 2.5s 4.5 s
12.3 s 12.7 s 2.4 s
3 Number of cycles 4 Endoscope barcode 5 Result of cycle
CLN
4.2 s 2.5 s 4.5 s
12.4 s 12.8 s 2.4 s
4.2.s 2.6 s 4.6 s
12.4 s 12.8 s 2.5 s
44.2°C - 44.3°C 10:25:31 51.4 s 45.5°C --> 0.1 s
46.4°C - 46.8°C
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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An example of a short ticket summarising the main data of the cycle and the result of the endoscope reprocessing.
21
23
Gallay Medical
Gallay Medical
ENDO
Endoscopy
22681
Sprint – PROTO
V1.31
V1.31
V1.31
V1.31
1
21
2
23
05/11/2015 10:23:11
04/11/2016 15:27:34
1402
U01
U02
ANA MARIA
PIERRE DUPONT
0139
0139
1402
MACHIDA
05/11/2015 10:43:23
6789
DR O
00:19:51
15:55:52
1402
Check - Alcohol injected in Cycle 2 & 5. Other Cycles if the option is selected.
04/11/2016 15:58:47 00:30:59
Please, refer to the Appendix for the details of the icons description.
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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HOW TO REPRINT A TICKET HOW TO SELECT PRINT SCREEN In the “Print Menu” you can choose the type and the number of tickets you want:
PRESS THE OPTIONS ICON
Long ticket printed at each cycle: YES/ NO
Reprint the last ticket
PRESS THE PRINTER ICON
Number of short tickets printed by cycle (0 = no short ticket printed)
Progress bar while printing the last ticket
No part of this publication may be reproduced in any form or by any means without prior permission from Soluscope/Gallay Medical & Scientific
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