PlasmaTYPHOON+ Instructions for Use v08

PlasmaTYPHOON+ IFU

CONTENTS 1. Introduction ... 4 2. Indication ... 5 2.1

Intended use and performance ... 5

2.2

Intended users and operating location ... 5

2.3

Intended use and benefit ... 5

2.4

Contra-indication ... 5

3. General characteristics ... 6 3.1

Electrical and mechanical characteristics ... 6

3.2

Materials and substances ... 6

4. Installation ... 7 4.1

Operating and storage condition of the device ... 7

4.2

Electrical connection ... 7

4.3

Medical air inlet ... 7

4.4

Peripheral devices and network connection ... 8

4.5

Gas/plasma outlets ... 8

4.6

Switching ON ... 9

4.7

Device qualification ... 9

5. Operating instructions ... 10 5.1

Standby mode ... 10

5.2

User identification ... 10

5.3

Endoscope identification and cycle selection ... 11

5.4

Automatic endoscope type selection & ENDO database ... 15

5.5

Endoscope connection ... 16

5.6

Drying cycle ... 19

5.7

Endoscope storage ... 20

5.8

Storage time ... 22

5.9

Traceability ... 23

5.10

Switching OFF ... 24

6. Emergency stop and technical errors ... 25 6.1

Emergency stop ... 25

6.2

Possible technical errors... 25

6.3

Error acknowledgement ... 26

6.4

Electrical shutdown ... 26

7. Maintenance... 27 7.1

Cleaning ... 27

7.2

Technical maintenance ... 27

8. Warranty, lifetime and elimination ... 28 8.1

Warranty of the PlasmaTYPHOON+ ... 28

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8.2

Lifetime of the PlasmaTYPHOON+ ... 28

8.3

Elimination ... 28

9. Connection sets ... 29 9.1

Endoscope connection sets ... 29

9.2

Storage connection set ... 29

9.3

Maintenance of connection sets ... 29

9.4

Warranty of connection sets ... 30

9.5

Lifetime of connection sets ... 30

9.6

Elimination ... 30

10. PlasmaBAG ... 31 10.1

General characteristics ... 31

10.2

Step-by-step instructions for use ... 31

10.3

Storage of endoscope in the PlasmaBAG ... 34

10.4

Storage / packaging of the PlasmaBAGs ... 34

10.5

Lifetime of the PlasmaBAG ... 34

10.6

Elimination ... 34

11. Safety instructions: risks and precautions ... 35 11.1

Ozone generation ... 35

11.2

Risk of electric shock and electromagnetic field ... 35

11.3

Risk of damage of the PlasmaBAG ... 35

11.4

Risk of contamination by the PlasmaBAG during use ... 35

11.5

In the event of a serious incident ... 36

12. General information... 37 12.1

Labeling description ... 37

12.2

Regulations & standards... 37

13. Annex I – External drying of endoscope ... 38 13.1

Introduction ... 38

13.2

Procedure ... 38

14. Annex II – Disinfection of connection set ... 42 14.1

Introduction ... 42

14.2

Procedure ... 42

Manufacturer & service ... 45

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1. INTRODUCTION Drying and storage of endoscope are very important steps in the endoscope reprocessing procedure aiming to stop the proliferation of microorganisms within this device. PlasmaTYPHOON+ is a device designed for this purpose having two functionalities: fast drying of endoscope channels and storage of endoscope in a single-use bag under controlled atmosphere in order to preserve its disinfected state. PlasmaTYPHOON+ is a new, more advanced version of PlasmaTYPHOON, offering new features, higher performance, improved comfort of use and increased security. It is requested that you read this manual carefully before using the PlasmaTYPHOON+ for the first time. These instructions for use include installation and operating instructions, maintenance recommendations, safety instructions, as well as a list of possible error messages that may appear during PlasmaTYPHOON+ operation.

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2. INDICATION 2.1

INTENDED USE AND PERFORMANCE

PlasmaTYPHOON+ is used within the endoscope reprocessing procedure in order to dry the endoscope channels following a cleaning and disinfection operation, performed either manually or in an automated endoscope reprocessor (AER). The PlasmaTYPHOON+ endoscope drying cycle lasts between 1 and 3 minutes, depending on the endoscope type. Once dried, the endoscope can be placed in a single-use PlasmaBAG, which is specifically designed for endoscope storage. Insufflating plasma, containing ozone molecules, into the bag for 5 seconds ensures the endoscope’s disinfected state is maintained for up to 744 hours (31 days). National regulations may impose a more restrictive storage time for the endoscope (see Chapter 5.8). The endoscope drying and storage procedure using PlasmaTYPHOON+ has been validated by PlasmaBiotics according to the EN 16442:2015 standard. Validation test reports are available upon request. PlasmaTYPHOON+ is equipped with a traceability system, including a barcode scanner, RFID tag scanner and a printer. The barcode or the RFID scanner are used for operator and endoscope identification. The printer delivers a traceability label at the end of the drying and/or storage cycle. The history of all completed cycles is archived on the PlasmaTYPHOON+ hard drive and can be accessed via the Ethernet network.

2.2

INTENDED USERS AND OPERATING LOCATION

The intended users are medical and paramedical staff involved in endoscope reprocessing operations, such as a trained nurse or decontamination staff. A biomedical technician or biomedical engineer can operate the device for maintenance purposes. The PlasmaTYPHOON+ is intended for operation in hospitals as an active drying and clean storage system. The intended operating location is the clean area of an endoscope reprocessing unit or Central Sterilization (Service) Department (CS(S)D). Specific training on the use of the PlasmaTYPHOON+ is mandatory for healthcare operators.

2.3

INTENDED USE AND BENEFIT

The intended use of the PlasmaTYPHOON+ is as follows: - to dry endoscope channels following a cleaning and disinfection operation, and / or - to provide active storage for the endoscope in a single-use PlasmaBAG in order to maintain its disinfected state.

2.4

CONTRA-INDICATION

Warning: PlasmaBiotics does not warrant the correct functioning of the PlasmaTYPHOON+ without the validated connection sets and PlasmaBAG (when storage option is used). PlasmaBiotics assumes no warranty or liability for any damages on a PlasmaTYPHOON+, an endoscope, or any other damages, each resulting out of the use of an endoscope that has not been dried with validated connection sets and stored in the validated PlasmaBAG, including but not limited to damages suffered by patients treated with such an endoscope.

Warning: The PlasmaBAG is not destined for sterilisation. The PlasmaBAG is not a sterile barrier.

Warning: An endoscope shall not be stored in a PlasmaBAG if the endoscope was not previously appropriately dried with the PlasmaTYPHOON+.

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3. GENERAL CHARACTERISTICS 3.1

ELECTRICAL AND MECHANICAL CHARACTERISTICS

CHARACTERISTIC / PARAMETER

Sym

Model

PlasmaTYPHOON+

Reference

TYPHOON+

UDI ID

03701354408104

Medical device Power supply / electrical network Fuse Maximal power Frequency Overvoltage Power supply cable Pollution degree Pressure regulator – delivery pressure Dimension (length / width / height) Minimal air inlet pressure Maximal air inlet pressure Minimal gas flowrate

Class I 100-240 V T3.15AT 250VAC 500 W 50 Hz / 60 Hz Category II H05VV-F 3G 1mm² Degree 2 0 to 5 bar (75.52 psi) 300 / 280 / 260 mm (11.8 / 11.0 / 10.2 in) 3 bar (43.51 psi) 4 bar (58.02 psi) 60 l/min Internal diameter: 4 mm (0.16 in) External diameter: 6 mm (0.24 in) 10.7 kg (16.53 lb)

Medical air supply tube dimensions Weight Ingress protection rating

3.2

VALUE

IP20

MATERIALS AND SUBSTANCES

COMPONENT Box Discharge chamber PlasmaBAG Connection set Air supply tube Plasma delivered during storage cycle

Abr

LDPE

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PU O3

MATERIALS / SUBSTANCES Stainless Steel Macor and Tungsten (W) Low Density Polyethylene Silicone and Stainless Steel Polyurethane Ozone

PlasmaTYPHOON+ IFU

4. INSTALLATION Warning: The following instructions are intended to ensure that the PlasmaTYPHOON+ and its peripheral devices are operated appropriately. Non-compliance with these instructions may influence the efficiency of the drying cycle and may cause damages that are not covered by the manufacturer warranty (as mentioned in 2.4). The following must be ensured for appropriate installation of the PlasmaTYPHOON+: 1) Facility:  Power supply / electrical network.  Medical air grade supply with minimal pressure: 3 bar (43.51 psi), minimal flowrate: 60 l/min. 2) Provided by PENTAX Medical or local distributor:  Air pressure regulator, delivery pressure: 0 to 5 bar (72.52 psi), minimal flowrate: 60 l/min  Peripheral devices (e.g. printer, bar-code scanner, RFID tag scanner…)  PlasmaBiotics connection sets corresponding to different endoscope brands and models.

Figure 1. PlasmaTYPHOON+ with its peripheral devices (a barcode scanner and a printer)

4.1

OPERATING AND STORAGE CONDITION OF THE DEVICE

Store at ambient temperature: 15 – 40 °C (59 - 104 °F) and 30 – 85 % RH. Operate at ambient temperature: 15 – 40 °C (59 – 104 °F) and 30 – 85 % RH. Operation altitude: max 2000 m

4.2

ELECTRICAL CONNECTION

The power cable must be plugged into the electrical socket with 3 terminals (live, neutral and earth).

4.3

MEDICAL AIR INLET

PlasmaTYPHOON+ has a medical air inlet at the rear. This inlet must be connected to an external source of medical air (ex. medical air pipeline system). An air compressor for medical applications may also be used: oil-free, with filters, desiccation system and antimicrobial coating for the tank. A pressure regulator shall be used to set the medical air inlet pressure between 3 bar (43.51 psi) and 3.5 bar (50.76 psi) in static mode, in order to ensure the pressure of 3 bar (43.51 psi) in dynamic mode. The minimal gas flowrate of the supply system (gas pipeline system + pressure regulator) must be 60 l/min.

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In the event that an external source of medical air is not connected to the PlasmaTYPHOON+ or that the gas pressure or flowrate is too low, an error message will appear on the screen and it will not be possible to perform the cycle. The medical air inlet must be connected to an external source of medical air via a polyurethane tube of internal diameter: 4 mm (0.16 in) and external diameter: 6 mm (0.24 in) equipped with a CPC type connector. To connect the medical air supply tube to the PlasmaTYPHOON+, plug the CPC connector to the medical air inlet connector at the rear of the PlasmaTYPHOON+. To disconnect the tube, first disconnect the pressure regulator and then unplug the CPC connector while pressing the button (see Fig. 2).

Figure 2. Connection and disconnection of the medical air supply tube

Warning: The medical air supplying the PlasmaTYPHOON+ must be free from contamination and must be of a purity class according to local regulation. The vapor water concentration must be less than 67 ml/m3. 1. The PlasmaTYPHOON+ must not be operated, if the water vapor concentration is above 67 ml/m3. 2. The presence of liquid water in the medical air represents a risk of damaging the PlasmaTYPHOON+ equipment. The manufacturer is not liable for any damages in the event of water ingress via the medical air inlet.

4.4

PERIPHERAL DEVICES AND NETWORK CONNECTION

Peripheral devices barcode scanner and printer shall be connected to the PlasmaTYPHOON+ via the corresponding USB ports, named “SCAN” and “PRINT”, at the rear of the device (see Fig. 4). RFID scanner is connected to the PlasmaTYPHOON+ via a dongle installed on the USB port named “RFID”. All peripheral devices need to be configured in order to function with PlasmaTYPHOON+. PlasmaTYPHOON+ can be connected to the local network and/or internet via the Ethernet port at the rear of the device.

4.5

GAS/PLASMA OUTLETS

PlasmaTYPHOON+ has 4 gas/plasma outlets on the front (see Fig. 3): 1. Suction/operating channel – red colour 2. Air/water channel – blue colour 3. Water jet channel – yellow colour 4. Storage – green colour These gas/plasma outlets enable the medical air to be insufflated into the endoscope channels and the plasma to be insufflated into the PlasmaBAG via corresponding PlasmaBiotics connection sets. PlasmaBiotics connection sets are available for different endoscope types and brands.

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4.6

SWITCHING ON

In order to switch ON the PlasmaTYPHOON+, use the “ON/OFF” switch located at the rear of the device (see Fig. 4). PlasmaTYPHOON+ software runs automatically after switching ON the device. The PlasmaTYPHOON+ is in a Standby mode upon start-up: the display is ON and the user (operator) identification can be entered.

4.7

DEVICE QUALIFICATION

Installation of PlasmaTYPHOON+ equipment shall be followed by: 1. Installation qualification (performed by local service representative) 2. Operational qualification (performed by local service representative) 3. Performance qualification Please refer to the relevant regulations or guidelines in your country.

Control LED Touch screen

4 gas outlets

Figure 3. Front of the PlasmaTYPHOON+

Ethernet port

Medical air inlet

USB port for barcode scanner connection

USB port for printer connection

USB port for dongle used with RFID scanner

Power cable socket and ON/OFF switch Figure 4. Rear of the PlasmaTYPHOON+

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5. OPERATING INSTRUCTIONS 5.1

STANDBY MODE

The PlasmaTYPHOON+ is in Standby mode upon start-up. By pressing the PlasmaTYPHOON+ logo in the upper left corner of the screen, one can access the PlasmaTYPHOON+ homepage where manufacturer and distributor details are displayed. In addition, this page contains language settings. The left-side menu, that is permanently displayed on the screen, provides a direct access to the User ID and Endoscope ID page, by pressing the user and endoscope symbol, respectively. Once identified, the user and endoscope ID will be displayed next to the corresponding symbol. IFU of the PlasmaTYPHOON+ can be displayed on the screen by pressing the IFU symbol in the lower left corner of the screen. In addition, date and time are also displayed in the lower left corner of the screen. Homepage

Manufacturer & distributor details

User ID page Scope ID page Language IFU Date & time Figure 5. Homepage screen

5.2

USER IDENTIFICATION

User identification page can be accessed by pressing the user symbol in the left-side menu. A question mark displayed next to the user symbol indicates that the user has not been identified (see Fig. 6). If the user’s action is requested, the instruction is clearly indicated in the centre of the screen. In addition, a short recall of the requested action is also displayed in the central part of the left-side menu. User (operator) identification can be performed: 1. Using the barcode scanner: The user scans the barcode on his/her badge or ID card 2. Using the RFID tag scanner: The user scans his/her personal RFID tag 3. By entering a User ID: A user can enter his/her name or a personal user login (attributed to each user by the person in charge of the unit) via an alphanumerical keyboard that will appear on the screen when pressing the “Keyboard” button.

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Homepage

Power

User ID Scope ID Action IFU Date & time Figure 6. User ID page

When the alphanumerical keyboard is displayed, the user should type his/her name or login number. The typed name/number is displayed in the upper box. The user can use the backspace button “” to erase, as well as the “Cancel” button to return to the previous page.

Figure 7. User login via the alphanumerical keyboard

Once the user is identified, his/her login ID (name or number) will appear next to the user symbol in the left-side menu (e.g. “user test” in Fig. 8), and the device will proceed to the next step of the process.

5.3

ENDOSCOPE IDENTIFICATION AND CYCLE SELECTION

Endoscope identification page can be accessed by pressing the endoscope symbol in the left-side menu. A question mark displayed next to the endoscope symbol indicates that the endoscope has not been identified (see Fig. 8). If the user’s action is requested, the instruction is clearly indicated in the centre of the screen. In addition, a short recall of the requested action is also displayed in the central part of the left-side menu.

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Figure 8. Endoscope ID page

At this point, the user must identify the endoscope and select the corresponding treatment cycle. Endoscope identification can be performed: 1. Using the barcode scanner: The user scans the endoscope barcode 2. Using the RFID tag reader: The user scans the endoscope RFID tag 3. By entering an endoscope ID number: An endoscope ID number is attributed to each endoscope by the person in charge of the unit or by the biomedical engineer

Figure 9. Endoscope identification via the barcode scanner

If the endoscope identification is performed using the barcode or RFID scanner, the endoscope ID number automatically appears next to the endoscope symbol in the menu on the left side of the screen (e.g. “scope test” in Fig. 10). If the automatic selection of the endoscope type is activated (see section 5.4), the endoscope type selection is done automatically as soon as the endoscope is identified. In this case, the user only needs to select the treatment cycle that he/she wishes to perform: drying cycle, storage cycle or a succession of both drying and storage cycle (see Fig. 10). In case of endoscope without channel only storage cycle will be proposed.

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Drying cycle

Storage cycle

Drying & storage cycle

Figure 10. Treatment cycle selection page

If endoscope identification is performed by manually entering the endoscope ID number, the user must first press the “Keyboard” button in order to access the alphanumerical keyboard. Once entered and validated, the endoscope ID number is displayed next to the endoscope symbol in the left-side menu (see Fig. 12).

Figure 11. Endoscope identification via alphanumerical keyboard

In case of the absence of automatic selection of the endoscope type (see section 5.4), the user must select the corresponding endoscope type himself/herself. Following pages will appear in order to enable the user to select the corresponding endoscope type (see Fig. 12).

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Figure 12 Endoscope type selection pages

Finally, the user must select the treatment cycle that he/she wishes to perform: drying cycle, storage cycle or a succession of both drying and storage cycle (see Fig. 10). In case of endoscope without channel only storage cycle will be proposed (see Fig. 12).

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5.4

AUTOMATIC ENDOSCOPE TYPE SELECTION & ENDO DATABASE

Automatic endoscope type selection is a feature that enables automatic selection of the corresponding drying cycle depending on the endoscope type. For optimal operation of this feature, an endoscope database, named “ENDO”, must be set up during the PlasmaTYPHOON+ installation procedure. The database is a CSV file (see an example below, Fig. 13) containing a list of all endoscopes meant to be treated with PlasmaTYPHOON+. This list can be completed or amended when new endoscopes are purchased. The endoscope database “ENDO” includes:  endoscope ID number (barcode, RFID, or an attributed ID number)  endoscope type (see the table below)  endoscope brand  endoscope model  endoscope serial number  endoscope inventory number (optional) Endoscope types One shall use the following codes to indicate the endoscope type in the 2 nd column of the ENDO database: Code Description Specification GI-WJ Gastrointestinal (GI) endoscope with waterjet channel GI-NWJ Gastrointestinal (GI) endoscope without waterjet channel GI-DOCWJ Gastrointestinal (GI) endoscope with double operating channel and waterjet channel GI-DOCNWJ Gastrointestinal (GI) endoscope with double operating channel and without waterjet channel EUS-EC Ultrasound endoscope (EUS) with elevator channel EUS-NEC Ultrasound endoscope (EUS) without elevator channel BR-SC Bronchoscope, naso-laryngoscope with suction connector BR-LC Bronchoscope, naso-laryngoscope without suction connector, channel diameter > 1.5 mm BR-TC Bronchoscope, naso-laryngoscope without suction connector, channel diameter < 1.5 mm BR-EBUS Ultrasound bronchoscope (EBUS) CU-SC Cystoscope, ureteroscope with suction connector CU-LC Cystoscope, ureteroscope without suction connector, channel diameter > 1.5 mm CU-TC Cystoscope, ureteroscope without suction connector, channel diameter < 1.5 mm NCH Endoscope without channel An example of an ENDO database is presented in the Figure 13. Note: In case that the ENDO database is not correctly completed, or that there are some missing data (e.g. endoscope ID number, endoscope type, etc.), automatic endoscope type selection feature will not function. In that case, endoscope type selection pages (see Fig. 12) will appear immediately after endoscope identification.

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Figure 13. Endoscope "ENDO" database example

5.5

ENDOSCOPE CONNECTION

Once the user has selected to perform a drying cycle by pressing “Dry” or “Dry & Store” button (see Fig. 10), a new page appears requesting the user to prepare the endoscope for the drying process (see Fig. 14). Before connecting the endoscope to the PlasmaTYPHOON+, all channel ports (eg. suction, working/biopsy/operating, air/water channel, waterjet channel) must be completely dried by using a single-use lint free cloth and/or an airgun. Dryness should be ensured by a visual inspection before connecting the corresponding adapter of the connection set. The user must connect all endoscope channels to the PlasmaTYPHOON+ gas outlets via the corresponding connection set. The connection sets are available for different endoscope types and brands, and can be found in the PlasmaBiotics Product Overview which can be provided by your distributor or local service representative. Connection cards providing instructions on the correct connection of PlasmaBiotics connection sets to the endoscopes are available for all connection set references and can be provided by your distributor or local service representative. Blinking text at the bottom of the screen indicates the endoscope channels that need to be connected to the corresponding gas outlets following the colour code of the connection tubes (see Fig. 14 and the table below).

Launching the drying cycle

Instruction for the user Connection instructions

Figure 14 Drying cycle preparation page

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Before starting the drying cycle by pressing “Dry” button, all endoscope channels must be connected to the PlasmaTYPHOON+ gas outlets using the corresponding PlasmaBiotics connection set (see Fig. 15). The user shall verify that the connection set is correctly connected to the endoscope and to the PlasmaTYPHOON+ before starting the drying cycle.

Warning: Incorrect connection of the endoscope to the PlasmaTYPHOON+, via inappropriately installed connection set, may lead to gas leakage causing a potential risk of ineffective drying of endoscope channels.

Figure 15 Connecting the connection set to the endoscope

Warning: The endoscope must be connected to the PlasmaTYPHOON+ using the provided connection sets only and following the recommendations of PlasmaBiotics. If the connection sets are modified, we cannot guarantee efficient and complete drying of the endoscope channels. Note: For FUJIFILM gastrointestinal (GI) endoscopes series 500 and 600, the air/water channel bridge must be set at the proximal end of the endoscope, where applicable (not needed for 700 series). Note: When drying duodenoscopes or linear ultrasound (EUS) endoscopes, the user must place the elevator in the lower (open) position. The following table provides instructions for connecting different endoscope types: Colour code

RED

BLUE

YELLOW

Endoscope type

Suction/operating channel

Air/water channel

Water jet/ elevator channel

To be used

To be used

/

To be used

To be used

To be used

Bronchoscope, naso-laryngoscope, ureteroscope, cystoscope

To be used

/

/

Ultrasound bronchoscope (EBUS)

To be used

/

To be used

Gastroscope, duodenoscope, enteroscope, ultrasound scope (EUS) without water jet or elevator channel Colonoscope, gastroscope, duodenoscope, ultrasound scope (EUS) with water jet or elevator channel

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The drying cycle for gastrointestinal ultrasound endoscopes (EUS) is performed in three steps. The procedure is different depending on the endoscope brand. Please, follow the instructions indicated in the table below: Brand

FUJIFILM

OLYMPUS

PENTAX

Prep

Install the air/water bridge (A)

Step 1

Connect the ultrasound endoscope (EUS) to the PlasmaTYPHOON+ using the corresponding connection set and run the corresponding drying cycle

Message: “Install the closure valves on suction and air/water connector, then click OK” Install the closure valve on the suction connector (B) Step 2

Keep the air/water bridge (A) in place

Install the air/water bridge (A)

Install the closure valve on the air insufflation connector (C) Step 3

Click OK to continue the drying cycle

Below one can find examples of different ways of installing closure valves and air/water bridges depending on the ultrasound endoscope brand (see Fig. 16).

FUJIFILM

OLYMPUS

PENTAX

A

B

B

B

C A

C Figure 16. Installing the closure valves and air/water bridge on EUS endoscopes

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Figure 17. Screenshot of EUS drying cycle pause

5.6

DRYING CYCLE

Once all endoscope channels are connected to the PlasmaTYPHOON+ via the corresponding connection set, the user can start the drying cycle by pressing “Dry” button (see Fig. 14). The progress status of the drying cycle is displayed in the central part of the screen (see Fig. 18). The selected endoscope type determining the corresponding drying cycle is indicated below the progress bar. The drying cycle can be stopped at any moment by pressing the “Cancel” button.

Warning: Do not attempt to disconnect the endoscope from the PlasmaTYPHOON+ during the drying cycle.

Warning: In case of uncompleted drying cycle or accidental disconnection of the connection set during the drying cycle, run a new drying cycle.

Warning: Pay attention not to obstruct endoscope channels outlets by placing the endoscope in an inappropriate manner. Nothing shall obstruct the flow of the medical air in order to guarantee effective drying of endoscope channels.

Progress status of the drying cycle

Stop the drying cycle

Selected endoscope type

Figure 18. Drying cycle in progress

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The drying time depends on the endoscope type: Endoscope type

Drying time

Cystoscope, ureteroscope

1 min

Bronchoscope, ultrasound bronchoscope (EBUS), naso-laryngoscope

1 min 30 s

Gastroscope, duodenoscope, enteroscope, colonoscope

2 min 30 s

Gastrointestinal ultrasound endoscope (EUS), GI endoscope with double operating channel

3 min

Note: The entire outer surface of the endoscope, including on and in between the steering wheels, must be completely dried by using a single-use lint free cloth and/or an airgun. Dryness should be ensured by a visual inspection. See Annex I for more details. At the end of the drying cycle, five beeps indicate to the user that the treatment has been completed successfully and a message “Drying completed” appears on the screen. The PlasmaTYPHOON+ is in a standby mode and the user may disconnect the endoscope. The user has a possibility to proceed to the storage cycle by pressing the “Store” button, end the treatment by pressing the “OK” button or reprint a traceability label by pressing the “Reprint” button. In case that the user terminated the use of PlasmaTYPHOON+, he/she can logout by pressing the “LOGOUT” button.

Proceed to storage cycle

End the treatment

Logout

Reprint the traceability label

Figure 19. Drying cycle completed

5.7

ENDOSCOPE STORAGE

Once the endoscope dried, the user may proceed to the storage of the endoscope in a single-use PlasmaBAG, which is specifically designed for endoscope storage. In order to do so, the user can press the “Store” button (see Fig. 10 and Fig. 19). A new page appears requesting the user to prepare the endoscope for the storage process (see Fig. 20). Before placing the endoscope in the PlasmaBAG, the user needs to check that the entire outer surface, including all channel ports (e.g. suction, working/biopsy/operating, air/water channel, waterjet channel) and both, on and in between the steering wheels has been completely dried using a single-use lint free cloth and/or an airgun. Dryness should be ensured by a visual inspection.

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