Series 3 User Manual

Soluscope 3 GA

ENDOSCOPE REPROCESSING CYCLES

INTRODUCTION The Soluscope 3 is a fully automatic washer-disinfector for most flexible endoscopes, specifically designed to meet the latest Standards in endoscopic reprocessing for digestive and bronchial endoscopy departments. The Soluscope accommodates all currently used types and brands of flexible endoscopes and complies with the European Standards EN 158834 for washer-disinfectors. Of particular importance, the Soluscope 3 is noted for its unique function for checking of channel blockages or disconnected channels. The Soluscope in an endoscopic reprocessor that utilises a process that associates: A mechanical action, A chemical action, A thermal action, A computer program to manage and control the endoscope treatment, A specific method for connecting the endoscope to the machine. Additionally, a fully monitored automatic leak test facility during the entire reprocessing cycle protects the endoscope from inadvertent water ingress. In its standard presentation, the machine can be supplied on a trolley which includes:   

Storage for the reagents A pre-filtration unit Booster pump to pressurise the water pre-filtration system

In addition to specific cycles dedicated to the reprocessing of endoscopes, the Soluscope 3 offers:  

A self-disinfection cycle using a second biocide A prion deactivation cycle to reduce the risks of transmitting non-conventional transmissible agents.

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ENDOSCOPE REPROCESSING CYCLES

INSTALLATION. The Soluscope must be installed according to the instructions listed in the chapter « Installation and Connections ».

TRAINING / DIRECTIONS FOR USE. The Soluscope must only be used by individuals specifically trained on the equipment. This User Manual and any supplementary information enclosed must always be conveniently located and always at the users disposal. List of appendices:     

" Choice of connectors ", " Initiation of a cycle "; " User maintenance and + corresponding log charts ", " Use and error log chart " Safety data sheets.

CONNECTORS. The endoscope must be connected to the Soluscope using the connectors provided following the recommendations mentioned in the chapter « Endoscope preparation and connection ». Any modification of the connectors may compromise the irrigation of the endoscope channels and is not recommended.

MAINTENANCE AND SERVICING. The maintenance schedule of the Soluscope indicated in the chapter « User Maintenance » must be followed. A weekly table of recorded events is availablel in an appendix in this user manual.

The chronological account of events / errors must be recorded.

OPERATIONAL QUALIFICATIONS In accordance with the European standards EN 15883-4 dealing with the washer-disinfectors for flexible endoscopes, a preventative maintenance check must be carried out every 2000 cycles and a performance check must be carried out every alternate 1000 cycles

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ENDOSCOPE REPROCESSING CYCLES

THE AVAILABLE CYCLES ENDOSCOPES TREATMENT CYCLES :

Cycle 1 Standard cleaning

Cycle 2 Double cleaning

Cycle 4 Disinfection

Leak test

Leak test

Leak test

Pre-cleaning

Pre-cleaning

Pre-cleaning

Cleaning

Cleaning

Disinfection

Rinsing

Rinsing

Rinsing

Disinfection

Cleaning

Drying***

Rinsing

Rinsing

Drying***

Disinfection

TIME : 15* min.

Rinsing Drying TIME : 18* min.

Alcohol injection** Drying*** TIME : 23* min.

OTHER CYCLES FOR ENDOSCOPES (that do not disinfect the endoscope):

Cycle 5 Additional drying Drying

Cycle 11 Additional rinsing

Cycle 9 Measures of the passage times in the channels

Leak test Alcohol injection** Rinsing Drying***

Leak test Water circulation and times printing of the passage channel by channel. Drying***

TIME : 3* min.

TIME : 3* min.

TIME : of 5*the min. * The cycles times may vary according to the type of endoscope and the condition prefilters

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MAINTENANCE CYCLES FOR SOLUSCOPE : Without endoscope and with simulated endoscope fitting (Cf. chapter « Soluscope maintenance ») Cycle 6 Self Disinfection

Cycle 8 Descaling

Disinfection

Descaling With Soluscope scaler

Machine disinfection

Disinfection with a solution containing 2% of active chlorine

Rinsing

Rinsing

Rinsing Machine disinfection 0,2 µm water filter disinfection

Internal circuits drying TIME : 50* min.

Deferred rinsing, Initiated by the user

Cycle 12 Prion Inactivation

Rinçage

Drying

Séchage TIME : 80* min. DUREE : 80 min.

Internal circuits drying TIME : 50 + 7* min.

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ENDOSCOPE REPROCESSING CYCLES

ENDOSCOPE PREPARATION BEFORE TREATMENT After examination and before being placed in the tank, the endoscope must be pre-cleaned according to the recommendations given by the manufacturer and Australian Standards and advisory boards GENCA

POSITIONING THE ENDOSCOPE IN THE TANK 1. Check that the grill at the bottom of the tank is present and installed. One can place the pistons of the endoscope on top of it. 2. Position the endoscope in the tank following the directions (see photo).

Important : Never place biopsy forceps, brushes or any other traumatic objects in the tank of the Soluscope. Only pistons are allowed, provided that they have been precleaned.

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ENDOSCOPE REPROCESSING CYCLES

IDENTIFICATION OF CHANNELS FOR CONNECTION Each endoscope is equipped with internal channels, and a valve to check integrity (water tightness). It is necessary to identify the opening of these channels and this valve because they are the points of connection to the Soluscope. The instructions given below are not exhaustive and may vary, considering the diversity of endoscopes and their evolution. The endoscopes are always delivered with a user manual which details the function and location of each channel. Please refer to it before any connection to the Soluscope.

GENERAL CASE – Endoscopes used in gastroenterology. The flexible endoscopes destined for the examination of the upper (ex. gastroscopes, duodenoscopes) and lower (ex. colonoscopes) digestive tracts are almost always equipped with, at least, the following points of connection :     

Biopsy channel, Suction channel, Air-jet channel, Water-jet channel, + a leak-test valve.

Biopsy channel opening. Note : It is the channel through which the biopsy forceps are inserted. Opening of the water-jet channel. Note : It is the connector onto which the water tank is attached.

Suction channel opening. Note : It is always a male connection.

Leak test valve opening. Note : present on the light source connector, it is not a channel opening.

Air-jet channel opening. Note : It is situated at the end of the link connector to the light source (not on Pentax)

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EXAMPLE 1 – Additional channels. The diagram on the previous page corresponds to the architecture found on most gastroscopes. For operational reasons, some endoscopes posses one or even two additional channels which need to be identified as well. The additional channels opening are most often found on the handle. The colonoscopes usually have an additional channel. The endoscopes which have a lateral optic (essentially duodenoscopes) are equipped with another type of additional channel. This is an elevator channel.

EXAMPLE 2 – Endoscopes used in pneumology (bronchoscopes). The bronchoscopes do not have air and water channels. They are easily recognizable by the small diameter of their insertion tubes.

EXAMPLE 3 – Endoscopes used in otorhinolaryngology. These endoscopes do not have internal circuits. They are connected to the Soluscope only by the leak test valve.

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ENDOSCOPE REPROCESSING CYCLES

ENDOSCOPE IDENTIFICATION / CHOICE OF CONNECTORS GROUPING THE ENDOSCOPE. The checking of the channels requires the distribution of the endoscopes into groups.  One group will identify the endoscopes with the same architecture (mainly number and types of channels).  Each endoscope is identified by a single number that links it to its group.  The identification number enables to associate each endoscope to one « connector » The identification number of each endoscope is indicated on its light connector. The list of your endoscopes with their identification number is normally at your disposal near your Soluscope (Cf. appendix « Connectics choice »).

THE EXISTING GROUPS. Biopsy Biopsy Fuji Suct. Add. Elevat. 1 2** “L” Chan. Chan.* Chan. Chan. Chan. 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 X X X X X X X X Only for endoscopes that have no channel NEVER INPUT A GROUP 10 FOR ENDOSCOPE WHOSE CHANNELS HAVE BEEN CONNECTED

Air Chan. Gr. 01 Gr. 02 Gr. 02 *** Gr. 03 Gr. 04 Gr. 05 Gr. 06 Gr. 07 Gr. 10

Water Chan.

It is possible to create other groups if a different architecture justifies it.

CODIFICATION OF THE ENDOSCOPES NUMBERS.

0315

All the identification numbers of the endoscopes are set as follows : (or 315)  The two first numbers correspond to the belonging group of endoscopes (here group 03 or 3)  The two last numbers represent the last two digits of the endoscope serial number.

THE ASSOCIATED CONNECTING PIECES. There is a specific connector for each endoscope according to its identification number. This connector takes the number of channels to irrigate into, taking into account the brand of endoscope as well (standard of connection points on the endoscope) Warning : Never change the connectors. To find the connector suitable to your endoscope, refer to appendix instructions « Connectics choice » posted above your Soluscope. In case of doubt about a connector or for any new endoscope: contact Gallay Scientific.

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USE OF CONNECTORS The connectors described hereunder are given as examples but do not constitute an exhaustive list. The appendix « Connectics choice » shows all the connectors that are available to date. Nevertheless, we reserve the right to complete or modify the list of the existing connectors at any time.

THE DIFFERENT FUNCTIONS OF THE CONNECTORS.

Pistons cages Stopping accessories. Separator + blocker for Fujinon endoscopes (with its blocker)

Separator + blocker for Olympus endoscopes series 140 ; 145 ; 160

Separator + blockers for Pentax endoscopes.

Connecting tube for the leak test. Non represented connector for leak test.

Irrigation blocks for channels. Biopsy channel

Air channel Water channel

Suction channel

Additional channel

Extension for additional channel. The connector is almost always a specific adaptor of the brand of your endoscope (supplied with the endoscope)

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ENDOSCOPE REPROCESSING CYCLES

PRELIMINARY CHECKS Check that the Soluscope has been switched on, as shown in the section « Turning on Soluscope », The Soluscope displays its initial menu ; otherwise, press "Main" (or F1), Current time

8 :13 : 05 1826

Press F3 to start

Number of cycles carried out by the machine

The endoscope has been correctly installed and all the channels have been connected to the Soluscope, The grill at the bottom of the tank is in place. Otherwise, refer to the « Endoscope preparation and connection » chapter.

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ENDOSCOPE REPROCESSING CYCLES

STARTING OF CYCLE 1 or 2 MANUAL ENTRY OF DATA

ENTRY OF DATA WITH BAR CODE

Starting initial menu:

Starting initial menu :

18:07:16 Press F3 576 to start Press "F3" Cycle number : _ 0 Press  Press 1 (or 2) then "" Endoscope n° : _ 0 Press  Enter the identification n° of your endoscope and gently close the lid. Ensure that one does not squeeze the connection pipes of the endoscope between tank and lid. Cycle 1 (or 2) / F3 Start (Endo n°) (SanEnd) Press " F3", and the cycle starts

18:07:16 Press F3 576 to start Press "F3" Cycle number : _ 0 Press  Press 1 (or 2) then "" Bar Code Reader Operator* Pass the bar code reader on the bar code that identifies the operator. After the beep, wait for the display change. Bar Code Reader Patient* Pass the bar code reader on the bar code that identifies the patient. After the beep, wait for the display change. Bar code Reader Endoscope Pass the bar code reader on the bar code that identifies the endoscope. After the beep, wait for the display change. Gently shut the lid. Ensure that you do not squeeze the connection pipes of the endoscope between tank and lid. Cycle 1 (or 2) / F3 Start (Endo n°) (Endo type) Press " F3", and the cycle starts

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ENDOSCOPE REPROCESSING CYCLES

*Display of this screen is optional, linked to the activation of the corresponding option (refer to " Bar code reader configuration")

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USER MANUAL

STARTING OF CYCLE 4 MANUAL ENTRY OF DATA

ENTRY OF DATA BY BAR CODE

Initial menu starting:

Initial menu starting:

18:07:16 Press F3 576 to start Press "F3"

18:07:16 Press F3 576 to start Press "F3"

Cycle number : _ 0 Press  Press 4 then "" Endoscope n° : _ 0 Press  Enter the identification number of the endoscope and gently shut the lid. Make sure that you do not squeeze the connection tubing of the endoscope. WITHOUT CLEANING F2 = OK

Cycle number : _ 0 Press  Press 4 then "" Bar Code Reader Operator * Pass the bar code reader over the bar code that identifies the operator. Bar Code Reader Patient * Pass the bar code reader over the bar code that identifies the patient.

If it is the chosen cycle, press "F2" Password :

Type 100** then "" WITHOUT CLEANING F2 = OK Cycle confirmation, press "F2" Cycle 4 / F3 Start (Endo n°) (Endo type) Press" F3", and the cycle starts

Bar Code Reader Endoscope Pass the bar code reader over the bar code that identifies the endoscope and gently shut the lid. WITHOUT CLEANING F2 = OK If it is the chosen cycle, press "F2" Password :

Type 100** then "" WITHOUT CLEANING F2 = OK Cycle confirmation, press "F2"

*Display of this screen optional, linked to the activation of the corresponding option (refer to "Configuration of the Bar code reader) ** The password remains 10 minutes memorized

Cycle 4 / F3 Start (Endo n°) (Endo type) Press " F3", and the cycle starts

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Soluscope 3 GA

USER MANUAL

STARTING OF THE CYCLES 5, 9, 11 Starting with the lid closed, the Soluscope displays its initial menu: 18:04: 05 106

Press F3 To Start

Press "F3" Cycle N° then press 

:_

0

"

Type 5 (or 9, or 11) then press "

DRYING ONLY* F2 = OK Press " F2" if you agree with the chosen cycle. Password :

"

Type 100** then "

DRYING ONLY* F2 = OK Press " F2" if you agree with the chosen cycle. Cycle N° 5 (9, 11) / F3 Without Endo. Press "F3" and the cycle starts.

* If cycle 9 : "CHANNELS CTRL TIMING", if cycle 11 : "RINSING ONLY" ** The password remains 10 minutes memorized.

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USER MANUAL

CORRECTION OF DATA PRIOR TO START OF CYCLE. If the cycle has not started, re-enter data. To do this, all that is necessary is to return to the initial menu by pressing "Main".

JUST AFTER START OF CYCLE. The data can not be modified once the cycle has started up. To interrupt the cycle press "F1". It will be possible to re-enter the data immediately if the cycle has not passed the endoscope leak test, otherwise wait for the end of rinsing. To go back to the main menu, wait for the end of the printing and press “F2”

LOW CONSUMABLE WARNINGS ON START-UP The programming of the Soluscope includes the taking into account of the number of doses consumed for each of the 2 products associated with the endoscope reprocessing. When the counter of doses reaches a value close to one requiring the replacement of one or more containers, an audible signal warns the users (regular beep) and the following message appears : Check Solus. D(or E) Then press F1

At this stage, the containers are not totally empty and there are two options: 

Continue the cycle and optimize product consumption. In this case it is possible for the machine to run out of product in the middle of cycle and requires a change of container.



Replace the container(s) immediately if you are not sure if someone will be present when the product runs out. Warning, all the while that the container has not been replaced and validated on the keyboard, the same message and the same audible alarm will appear at the starting of each cycle and will require an intervention. The procedure of products replacement are indicated under the section « Replacement of chemicals during normal use ».

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USER MANUAL

END OF CYCLE END OF CYCLE WARNING. A successfully completed cycle is displayed by the following:

VALIDATED CYCLE (Minutes) Press MAIN The Soluscope emits a specific end of cycle signal (2 beeps at regular intervals), and the endoscope whilst the optional additional drying continues.. The endoscope can be immediately removed from the tank. Press "F1" to stop the drying and the audible signal. If the drying is not interrupted, the cycle will terminate after 2 minutes.

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USER MANUAL

VALIDATION PRINTOUT. The print out is an essential element for the validation of the cycle. It is printed whatever result of the cycle. The ticket must be checked and verified by the operator.

Cycle successfully completed (example of ticket). 10:36:29 Cycle completed successfully in:20 mn 34 s DRYING Filling : 71 s STATIC RINSE Temperature : 45 C

Additional channel : 10.4 s DYNAMIC RINSE 2 DYNAMIC RINSE 1 A/W : ----------------------- 4.6 s B/S : ----------------- 3.4 s Contact time : 300.2 s Temperature : Min 45 C, Max : 45.6 C Number of controls : 3 Additional channel : 9.1 s Water : ---------------------------- 8.0 s Biopsy : -------------------- 3.3 s Air : -------------------------------- 8.3 s Suction : ------------------- 4.6 s Additional channel : 9.0 s Water : ---------------------------- 7.6 s Biopsy : -------------------- 3.9 s Air : -------------------------------- 8.9 s Suction : ------------------- 4.6 s Additional channel : 9.3 s Water : ---------------------------- 7.4 s Biopsy : -------------------- 3.6 s Air : -------------------------------- 8.4 s Suction : ------------------- 4.4 s Additional channel : 9.5 s

Filling : 86 s 10 :24 :24 : Sol. D injected Filling : 71 s DESINFECTION STAGE Temperature : 45 C Additional channel : 2.8 s DYNAMIC RINSE 1 A/W : --------------------------- 4.6 s B/S : --------------------- 3.5 s Contact time : 86.7 s Temperature : Min 45.3C, Max : 45.5 C Number of controls : 1 Additional channel : 9.3 s Water : ---------------------------- 7.7 s Biopsy : -------------------- 3.4 s Air : -------------------------------- 8.5 s Suction : ------------------- 4.4 s Additional channel : 9.3 s Temperature : Min 45.2 C, Max : 45.5 C Filling : 86 s 10 :14 :27 : Sol. C injected Filling : 65 s CLEANING STAGE Temperature : 40.2 C Time to inflate endoscope : 26.5 s Endoscope : 210 Patient : Opérator : Smith Start :03-06-04 10 :12 :12 CYCLE 1 / Counter cycle : 1245 Soluscope S3Gluta: 3061/PrgVers. : 2.6 ------------------------------------------- Ticket :

27------------------------

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USER MANUAL

WARNING NOTIFICATION 1 : 0.2 µM FILTER BLOCKAGE WARNING When the 0,2 µm water filter of the machine is about to become blocked, a notice is printed on the end of cycle ticket with the information « FILTER ALMOST BLOCKED» It is advisable to proceed with the replacement of the filter as soon as possible otherwise the cycle will be interrupted.

WARNING NOTIFICATION 2 : "ALCOHOL NOT INJECTED" This message is in accordance with the alcohol drying option activation (Refer to "Soluscope configuration"). The treatment of this malfunction is detailed in the appendix 4 "Malfunction treatment level 1".

CYCLE INTER All interrupted cycles must be re-started, whatever the reason of the interruption.

INTERRUPTION AT THE START OF A CYCLE. Press "F1". The endoscope can be removed immediately if at the commencement of the cycle the leak test has not yet been performed.

INTERRUPTION OF A CYCLE IN PROGRESS / DETECTION OF A MALFUNCTION. 1. The SOLUSCOPE central processing unit continually monitors many parameters. The detection of the slightest malfunction interrupts the cycle in progress immediately. 2. A ticket is printed with the alarm code and its wording (see example). CYCLE IS NOT COMPLETE 10:51:21 B/A channel disconnected Error : 24 Step : 5.6 A/W : --------------------------- 4.6 s B/S : --------------------- 3.5 s Contact time : 86.7 s Temperature : Min 45.3C, Max : 45.5 C Number of controls : 1 Additional channel : 9.3 s Water : ---------------------------- 7.7 s Biopsy : -------------------- 3.4 s Air : -------------------------------- 8.5 s Suction : ------------------- 4.4 s Additional channel : 9.3 s Temperature : Min 45.2 C, Max : 45.5 C Filling : 86 s 10 :14 :27 : Sol. C injected Filling : 65 s CLEANING STAGE Temperature : 45.2 C Time to inflate endoscope : 26.5 s Endoscope : 210 Patient : Opérator : Magali Start :03-06-04 10 :12 :12 CYCLE 1 / Counter cycle : 1108 Soluscope S3Gluta: 3055/PrgVers. : 2.6 ------------------------------------------- Ticket :

27------------------------

3. If the cycle has passed the endoscope leak test the Soluscope automatically rinses the endoscope. An interruption code is displayed. 4. At the end of the rinsing, a specific audible sound (4 repeated beeps every 10 seconds) warns the users. Press F1 to return to the initial menu and, if possible, remedy the problem by referring to the appendix “Use and process anomalies treatment” that lists all the possible malfunctions and how to deal with them. Page 19

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USER MANUAL

BLACKOUT : POWER CUT. In case of a power cut, the cycle in progress is interrupted, but without the Soluscope setting off an alarm. If the current is restored, the Soluscope directly starts with a rinsing of the endoscope and the machine. The message that is printed and displayed is : 43 User interruption

The malfunctions noticed outside a cycle in progress cannot be taken into account by the Soluscope automaton. A non-exhaustive list of these malfunctions is in the appendix “Use and process anomalies treatment” with the means to solve them.

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