ATMOS S 61 CORIAN System Operating Instructions Index 02 Dec 2022

Table of contents 1 1.1 1.2 1.3 1.4 1.5 1.6

Introduction...4 Notes on operating instructions...4 Explanation of pictures and symbols...5 Intended use...6 Function...8 Scope of delivery...8 Transport and storage...9

2 2.1 2.2 2.3

Notes for your safety...10 General safety instructions... 10 Danger for users, patients, and third parties... 10 Avoiding damage to the device... 11

3 3.1 3.2

Setting up and starting up...12 Device overview... 12 Preparing the device... 12

4 Operation...13 4.1 Ambient conditions during operation... 13 4.2 Switching on the device (ATMOS S 61 CORIAN® integral)... 13 4.3 Switching off the device (ATMOS S 61 CORIAN® integral)... 13 4.4 Using the drawers... 13 4.5 Using the drawer for devices (optional)... 14 4.6 Inserting and removing the instrument disposal tray (optional)... 14 4.7 Using the waste disposal (optional)... 14 4.8 Using light sources (optional)... 15 4.8.1 Connecting the fiber optic light cable... 15 4.8.2 Removing the fiber optic light cable... 15 4.8.3 Changing the adapter... 15 4.8.4 Switching on the light source... 15 4.8.5 Adjusting brightness... 15 4.8.6 Stroboscopy capability of the light source (optional)... 16 4.9 Storing endoscopes (optional)... 17 5 Cleaning and disinfection...18 5.1 Reprocessing the product... 18 5.1.1 Reprocessing the endoscope quivers... 18 5.1.2 Reprocessing the instrument disposal trays... 18 5.1.3 Reprocessing the instrument trays... 19 5.1.4 Reprocessing the fiber optic light cables... 19 5.1.5 Reprocessing the surfaces... 19 5.2 Recommended disinfectants... 20 5.2.1 Surface disinfectants... 20 5.2.2 Instrument disinfectants... 21 6

2



Hygiene plan...23

7 7.1 7.2 7.3

Maintenance and service...25 Periodic tests... 25 Function check... 25 Sending in the device... 26

8

Troubleshooting...27

9

Accessories...28

10

Disposal...29

11

Technical data...30

12

Notes on EMC...33



3

1

Introduction

1.1

Notes on operating instructions These operating instructions contain important instructions on how to operate your product safely, correctly, and effectively. These operating instructions are designed for training and instructing new operating personnel in the use of the system, and also for use as a reference manual. This document may only be reprinted, either in part or in whole, with written permission from ATMOS. These operating instructions must always be kept to hand near the device. Care, periodic tests, regular cleaning, and proper application are essential. They ensure the operational safety and usability of the product. Maintenance, repairs, and periodic tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. The person in question must possess the necessary test devices and original spare parts required to carry out these measures. Read chapter “2 Notes for your safety” on page 10 before using the product for the first time. This will help you to avoid potentially dangerous situations. The product bears the CE marking CE in accordance with the European Medical Device Regulation (MDR) 2017/745. The product complies with all the applicable requirements of Directive 2011/65/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (“RoHS”). The Declarations of Conformity and our General Terms and Conditions can be viewed on our website at www.atmosmed.com. The quality management system at ATMOS has been certified according to international standard EN ISO 13485.

These operating instructions are valid for the following devices: • ATMOS S 61 CORIAN® integral

532.0800.0

• ATMOS S 61 CORIAN® instruments

532.1000.0

• ATMOS S 61 CORIAN® instruments XXL

532.0900.0

Corian® is a registered trademark of E. I. du Pont de Nemours and Company or its affiliated companies.

4

Introduction

1.2

Explanation of pictures and symbols

In the operating instructions DANGER Warning of a danger that will result in immediate fatal or serious injury. Observe the necessary measures. WARNING Warning of a danger that can cause fatal or serious injury. Observe the necessary measures. CAUTION Warning of a danger that can cause minor injury. Observe the necessary measures. NOTICE Notice of a danger that can damage the product or other objects. Observe the necessary measures. Warning of a danger that can cause fatal or serious injury. Notice of potential material damage.



Useful information on the handling of the device.

1.

Action. Proceed step by step.

»

Result of an action. Move, plug in this direction.

click

Engage, check correct fit.

On device, type plate, and packaging

Follow operating instructions (blue) Consult operating instructions Warning; pay special attention This device complies with the relevant requirements of EU regulations. This device complies with the relevant requirements of the Eurasian Economic Union. Manufacturer Date of manufacture Country of manufacture REF

Reference number

Introduction

5

UDI

Unique Device Identifier of a medical device

MD

Medical device

SN

Serial number Professional disposal Fuse Alternating current (only with Servo-Drive® option) This side up Fragile, handle with care Keep dry Keep away from sunlight Temperature limit Humidity limitation 1060

Atmospheric pressure limitation 700

UDI application identifier (01)

UDI-DI: Identification of the manufacturer and the device

(11)

Date of manufacture

(21)

Serial number

1.3

Intended use

Product name:

ATMOS S 61 CORIAN® instruments ATMOS S 61 CORIAN® instruments XXL

Main functions:

• Instrument storage and deposit. • For expansion of the ATMOS S 61 Servant ENT workstation.

6

Introduction

Intended purpose:

Standard ENT examination and / or therapy

Intended Users / User profile:

Doctors and medical specialists

Intended Patient population:

All patients without any restrictions

Medical conditions to be diagnosed, treated or monitored:

Diagnostic examination of anatomy of all kinds

Application organ:

Ear, Nose, Throat

Application time:

< 60 min.

Application site:

Outpatient medical facilities, e.g. ENT practices, hospital outpatient departments, medical care centers

Indications:

Standard ENT examination and / or therapy

Medical contraindications:

None

The product is:

active

Sterility/specific microbial Not sterile status: Single use product / reprocessing:

Not a single use product. Reprocessing according to instructions for use.

Name:

ATMOS S 61 CORIAN® integral

Main functions:

• Electric power supply for visualization, illumination and illumination accessories • Instrument storage and deposit

Intended purpose:

Standard ENT examination and / or therapy

Intended users / User profile:

Doctors and medical specialists

Intended Patient population:

All patients without any restrictions

Medical conditions to be diagnosed, treated or monitored:

Diagnostic examination of anatomy of all kinds

Application organ:

Ear, Nose, Throat

Application time:

< 60 min.

Application site:

Outpatient medical facilities, e.g. ENT practices, hospital outpatient departments, medical care centers

Indications:

Standard ENT examination and / or therapy

Medical contraindications:

None

The product is:

active

Sterility/specific microbial Not sterile status: Single use product / reprocessing:

Not a single use product. Reprocessing according to instructions for use. Introduction

7

1.4

Function

The products ATMOS S 61 CORIAN® instruments, ATMOS S 61 CORIAN® instruments XXL, and ATMOS S 61 CORIAN® integral are cabinets for storing and organizing instruments, diagnostic and therapeutic devices, and visualization devices for ear, nose and throat specialists. The workspace as well as the options and accessories can be individually configured by the user according to his or her personal needs. The drawers can be fitted with optional electronic assistance for opening and closing (Servo-Drive®). The device is used in hospitals/clinics or in ENT practices. The product ATMOS S 61 CORIAN® integral offers additional storage space for ATMOS diagnostic equipment and ATMOS visualization equipment. The product also offers storage space for an optional light source and either heated or non-heated endoscope holders. Reprocessed endoscopes can be stored for short periods of time.

1.5

Scope of delivery

ATMOS S 61 CORIAN® instruments

ATMOS S 61 CORIAN® instruments

Operating instructions

Servo-Drive®

Operating instructions Servo-Drive®

Servo-Drive®

Operating instructions Servo-Drive®

Isolation transformer operating instructions

Servo-Drive® Operating instructions Servo-Drive®

ATMOS S 61 CORIAN® instruments XXL

ATMOS S 61 CORIAN® instruments XXL

Operating instructions

ATMOS S 61 CORIAN® integral

ATMOS S 61 CORIAN® integral

8

Introduction

Operating instructions

Isolation transformer

1.6

Transport and storage

Only transport the device in a shipping carton that is padded and offers sufficient protection. If damage occurs during transport: 1. Document and report the transport damage. 2. Send the device to ATMOS; see chapter “7.3 Sending in the device” on page 26. Environmental conditions for transport and storage: • Temperature:

-10...+50 °C

• Air humidity without condensation: 30...95 % without condensation • Air pressure:

500...1060 hPa

Introduction

9

2

Notes for your safety

Please read and pay attention to the safety instructions prior to using the product.

2.1

General safety instructions

Report all serious incidents that have occurred in connection with this device to the manufacturer and your national competent authority. Only use accessories and options that are specifically suited for combination with the product and that meet the performance and safety requirements. If you wish to connect more than one device or applied part, you must always observe their safety instructions. CAUTION The device may only be transported when the drawers are secured against sliding out. Otherwise, the device may tip over. CAUTION Servo-Drive® may only be used in dry and closed rooms. Never place open containers of liquids in the cabinets. CAUTION The drawers may only be filled with a maximum load of 4.5 kg. CAUTION Please note that the light source will illuminate even if it is not connected to a fiber optic light cable.

2.2

Danger for users, patients, and third parties

Risk of infection due to patient secretion on the device! Risk of diseases being transmitted. •

Always wear disposable gloves if there is a risk of you coming into contact with secretions.

•

Do not set contaminated instruments or endoscopes down in areas other than those specifically designated for this purpose.

•

Clean heating modules regularly and disinfect if necessary; only heat clean instruments.

•

Clean and disinfect the product according to the operating instructions.

Danger of blinding due to the high light intensity. Eye injury is possible. There is a risk of blinding for people without a blink reflex or who are particularly sensitive to light. •

The light source may only be operated by qualified personnel.

•

Never look directly into the light source.

•

Never direct the light source into the patient’s eyes.

•

Never allow the patient to look into the light source.

10 Notes for your safety

Heat development of the light source. Risk of burns. •

Temperature control of the instruments by the user, e.g., on the back of the hand.

•

Pay attention to the heat development of the light source.

•

Switch off the light source when not in use.

•

Never reach into the light source output.

Avoid improper use. Risk of severe injury to your patient. •

The product is only permitted for use by trained, specialist personnel under supervision.

•

The product may only be applied by medically trained staff.

Keep the device fully functional at all times. Malfunctions could cause injury to you and your patients. •

Prior to each use, check whether the device is damaged. Do not operate the device if you notice any damage. In this case, clean and disinfect the device and send it to ATMOS for repair.

•

Perform a function check at least once a week, and also at any other time if you have any concerns with regard to the safety of the device.

•

Observe the specifications regarding periodic tests in chapter “7.1 Periodic tests” on page 25.

•

Do not modify the device without the manufacturer’s permission.

•

Only use original accessories and original spare parts from ATMOS.

•

Assembly, new settings, modifications, extensions, and repairs may only be carried out by persons who are authorized by ATMOS.

2.3

Avoiding damage to the device

Storage and operation in an unsuitable environment. Risk of damage to the product. •

Please observe the ambient conditions regarding transport, storage, and operation.

Notes for your safety 11

3

Setting up and starting up

3.1

Device overview

Front view 5

4

1 8

3

2

6 7

9

1 2 3 4

Instrument disposal (optional) Waste disposal (optional) Drawer Endoscope holder (optional)

5 6 7 8 9

ATMOS LED Light Cube CORIAN® control panel (optional) Light source output (optional) USB connections (optional) Storage space for ATMOS devices (optional) Drawer for devices (optional)

ATMOS LED Light Cube CORIAN® control panel (optional) 2

1

1 2 3

1

2

3

4

Select light source Brightness display Brightness control Stroboscopy mode

3

4

3.2

Preparing the device

1. Arrange for an authorized ATMOS service partner to connect the device. 2. Perform a function check; see chapter “7.2 Function check” on page 25. 3. Before using the product for the first time, reprocess it according to the operating instructions.

12 Setting up and starting up

4

Operation

4.1

Ambient conditions during operation

• Temperature:

+10 to +35 °C

• Relative humidity:

30 to 95 % without condensation

• Air pressure:

700...1060 hPa

4.2

Switching on the device (ATMOS S 61 CORIAN® integral)

1. Press the On/Off button on the ATMOS S 61 Servant ENT workstation. Observe the corresponding operating instructions. »

The ATMOS S 61 CORIAN® integral is now switched on.

2. If necessary, switch on the devices stored in the ATMOS S 61 CORIAN® integral. Observe the corresponding operating instructions.

4.3

Switching off the device (ATMOS S 61 CORIAN® integral)

1. Press the On/Off button on the ATMOS S 61 Servant ENT workstation. Observe the corresponding operating instructions. »

The ATMOS S 61 CORIAN® integral is now switched off.

2. If necessary, switch off the devices stored in the ATMOS S 61 CORIAN® integral. Observe the corresponding operating instructions.

4.4

Using the drawers Opening the drawers 1. Press against the drawer 1 . 1

»

The drawer will open.

Closing a drawer without Servo-Drive® (only drawer for devices) 2

1. Push the drawer 2 in until it clicks closed. Closing a drawer with Servo-Drive® 1. Push the drawer 2 closed until it is pulled in automatically.

Operation 13

4.5

Using the drawer for devices (optional) Inserting a device 1. Press against the drawer for devices 1 . » 2

The drawer for devices will open.

2. Insert the device 2 . 3. Close the drawer for devices 1 .

1

Removing a device 1. Press against the drawer for devices 1 . »

The drawer for devices will open.

2. Disconnect all the power cables from the device 2. 3. Remove the device 2 by lifting it upwards. 4. Close the drawer for devices 1 .

4.6

Inserting and removing the instrument disposal tray (optional) Inserting the instrument disposal tray 2

1. Press against the instrument disposal 1 . »

The instrument disposal will open.

2. Insert the instrument disposal tray with lid 2 . 1

3. Close the instrument disposal 1 . Removing the instrument disposal tray 1. Press against the instrument disposal 1 . »

The instrument disposal will open.

2. Remove the instrument disposal tray with lid 2 by lifting it upwards. 3. Close the instrument disposal 1 .

4.7

Using the waste disposal (optional) 1. Press against the waste disposal 1 . »

The waste disposal will open.

2. Attach a bin liner. 3. Close the waste disposal 1 . 1

14 Operation

4.8

Using light sources (optional) 4.8.1 Connecting the fiber optic light cable 1. Insert the fiber optic light cable 1 into the LED Light Cube adapter 2 until it clicks gently into place.

1 2 1

4.8.2 Removing the fiber optic light cable 1. Pull the fiber optic light cable 1 out of the LED Light Cube adapter 2 .

4.8.3 Changing the adapter 1. Pull the fiber optic light cable 1 out of the LED Light Cube adapter 2 .

1

2. Turn the LED Light Cube adapter 2 counterclockwise to unscrew it from the light source output 3 .

2 3

3. Turn the desired LED Light Cube adapter 2 clockwise to screw it into the light source output 3. 4. Insert the matching fiber optic light cable 1 into the LED Light Cube adapter 2 until it clicks gently into place. & Perform a function check; see chapter “7.2 Function check” on page 25.

1

4.8.4 Switching on the light source

3 6 4 5

2

1. Take the fiber optic light cable 1 out of the fiber optic light cable holder 2 . »

The LED on the corresponding button will light up 3 .

& You can use buttons 1 to 3 3 to switch the light source on manually.

4.8.5 Adjusting brightness 1. Switch on the light source. 2. Press the Up 4 button to increase the brightness or the Down 5 button to reduce the brightness. 3. Display of the brightness 6 of the light source & The last setting is retained when the device is switched off.

Operation 15

4.8.6 Stroboscopy capability of the light source (optional) If you have integrated an ATMOS Strobo 21 LED in the storage space for ATMOS visualization devices, stroboscoping is possible with one of the three light sources of the ATMOS LED Light Cube. To do this, proceed as follows: 1

1. Select a light source as described in chapter 4.8.4 “Switching on the light source.” 2. Press the button for stroboscopy mode 1 to turn on the stroboscopy capability for the selected light source. If the stroboscopy mode is active, a green LED lights up next to the button for stroboscopy mode. & If the LED lights up red, no trigger signal is present. The ATMOS Strobo 21 LED is switched off or no ATMOS Strobo 21 LED is connected. & If the LED does not light up, the ATMOS LED Light Cube is ready for use. Use as described in chapter 4.8.6 “Stroboscopy capability of the light source (optional).” & When the device is switched off, the stroboscopy mode setting is retained. & The brightness setting as described in chapter 4.8.5 “Adjusting brightness” does not apply to the brightness setting for stroboscopy capability. & The brightness setting for stroboscopy mode is made via the ATMOS Strobo 21 LED. Observe the operating instructions for the ATMOS Strobo 21 LED. & The display of the brightness also applies here, as described in point 3 of chapter 4.8.5 “Adjusting brightness.”

16 Operation

4.9

Storing endoscopes (optional)

WARNING Risk of infection from contaminated endoscopes. Risk of diseases being transmitted. •

Only use the endoscope quivers to store reprocessed endoscopes.

•

Do not set contaminated endoscopes down in areas other than those specifically designated for this purpose. CAUTION

Risk of burns from heated endoscopes. Risk of minor burns. •

Check the temperature of the endoscope before using it on the patient. To do this, hold the endoscope against the back of your hand. Wear gloves to ensure that you do not contaminate the endoscope. 1 2 2

1

Rigid endoscopes (optionally heated) Flexible endoscopes

& If your product comes with heated endoscope quivers, these will be heated for as long as the ATMOS S 61 Servant ENT workstation remains switched on. After approx. 15 minutes, the endoscopes will reach a temperature of approx. 40 °C.

Operation 17

5

Cleaning and disinfection

We recommend that you always document all maintenance work and part replacements in writing. It is the responsibility of the user to ensure that the required results for cleaning and disinfection are adhered to. Validation and routine monitoring of the procedure will generally be necessary. WARNING Risk of infection due to germs on equipment and accessories. Risk of diseases being transmitted. •

Wear disposable gloves during all cleaning and disinfection measures.

•

If the CORIAN® surface is scratched or contaminated with difficult-to-remove soiling, please contact ATMOS.

•

Clean and disinfect the product according to the operating instructions.

5.1

Reprocessing the product

5.1.1 Reprocessing the endoscope quivers Reprocess endoscope quivers daily. 1. Dismantle the endoscope quiver: • Quiver sleeve • Sealing ring • Quiver stopper • Endoscope quiver adapter (optional) 2. Clean the individual parts using a brush. 3. Rinse the individual parts under running water. 4. Clean and disinfect the individual parts manually or mechanically using a suitable instrument disinfectant; see chapter “5.2.2 Instrument disinfectants” on page 21. • Manual procedure: immersion disinfection; rinse thoroughly afterwards • Mechanical procedure: 93 °C

5.1.2 Reprocessing the instrument disposal trays Reprocess instrument disposal trays with lid daily. 1. Dismantle the instrument disposal tray: • Instrument disposal tray • Lid for instrument disposal tray 2. Clean the instrument disposal tray using a brush. 3. Clean and disinfect the individual parts manually using a suitable instrument disinfectant; see chapter “5.2.2 Instrument disinfectants” on page 21.

18 Cleaning and disinfection

5.1.3 Reprocessing the instrument trays Reprocess instrument trays daily. 1. Thoroughly rinse the instrument tray under running water. 2. Clean all the surfaces with a damp, clean, lint-free cloth and a cleaning agent. 3. Disinfect the surfaces with a clean, lint-free cloth and a suitable instrument disinfectant; see chapter “5.2.2 Instrument disinfectants” on page 21.

5.1.4 Reprocessing the fiber optic light cables 1. Clean and disinfect the fiber optic light cables in accordance with the corresponding operating instructions provided by the manufacturer of the fiber optic light cable.

5.1.5 Reprocessing the surfaces NOTICE Liquids in the light source output. Damaged lens. •

Make sure that no liquids penetrate the light source output. Material

Surface

CORIAN®

Worktop Endoscope holder Drawer, front Drawer for devices, front Side panel Base

Metal sheet, coated

Drawer, inside Rear side

Other

ATMOS LED Light Cube CORIAN®

1. Switch off the device. 2. Remove all the accessories. 3. Clean all the surfaces with a damp, clean, lint-free cloth and a cleaning agent. 4. Disinfect the surfaces with a clean, lint-free cloth and a suitable surface disinfectant; see chapter “5.2.1 Surface disinfectants” on page 20. 5. Attach the reprocessed accessories. 6. Perform a function check; see chapter “7.2 Function check” on page 25.

Cleaning and disinfection 19

5.2

Recommended disinfectants

NOTICE Unsuitable disinfectants. Risk of damage to the surface, corrosion damage, and stress cracks. •

Only use disinfectants recommended by ATMOS.

•

Do not use process chemicals that contain any of the following ingredients on CORIAN® surfaces: • Strong acids (e.g., concentrated sulphuric acid) • Ketones (e.g., acetone) • Chloric solvents (e.g., chloroform) • Strong solvent mixtures (e.g., paint remover)

5.2.1 Surface disinfectants CORIAN® Disinfectant

Ingredients

terralin protect (Application concentrate)

Benzyl-C12-16 alkyldimethyl-, chloride 2-phenoxyethanol aminoalkylglycine Non-ionic surfactants, perfumes

®

In 100 g Manufacturer

22 g Schülke 17 g & Mayr, 0.9 g Norderstedt

Other suitable active ingredients: • Ortho-phthalaldehyde • Glutaraldehyde • Glutaraldehyde and phenol • Hydrogen peroxide • Hydrogen peroxide and peracetic acid • Peracetic acid • Phenol • Sodium hypochlorite • Quaternary ammonium compounds Coated surfaces Disinfectant

Ingredients

Green & Clean SK

Di alkyl dimethyl ammonium chloride Alkyl dimethyl ethyl benzyl ammonium chloride Alkyl dimethyl benzyl ammonium chloride Magnesium monoperoxyphthalate hexahydrate Glutaral Benzyl-C12-C18-alkyldimethyl-ammonium chloride Didecyldimethylammonium chloride Pentapotassium-bis(peroxymonosulphate)bis(sulphate)

Dismozon® plus (Granulate) Kohrsolin® FF (Application concentrate) Perform®

20 Cleaning and disinfection

In 100 g Manufacturer

< 1 g Metasys, Rum < 1 g (Austria) <1g 95.8 g Bode Chemie, Hamburg 5 g Bode Chemie, 3 g Hamburg 3g 45 g Schülke & Mayr, Norderstedt