Atmos S 61 CORIAN integral User manual

Operating Instructions
ATMOS S 61
CORIAN®
instruments
ATMOS S 61
CORIAN® integral
English
GA1GB.110107.0
2022-12 Index 02

2
Table of contents
1 Introduction.......................................................................................................4
1.1 Notes on operating instructions ..............................................................................4
1.2 Explanation of pictures and symbols ......................................................................5
1.3 Intended use...............................................................................................................6
1.4 Function.......................................................................................................................8
1.5 Scope of delivery........................................................................................................8
1.6 Transport and storage...............................................................................................9
2 Notes for your safety......................................................................................10
2.1 General safety instructions.................................................................................... 10
2.2 Danger for users, patients, and third parties ...................................................... 10
2.3 Avoiding damage to the device ............................................................................. 11
3 Setting up and starting up .............................................................................12
3.1 Device overview....................................................................................................... 12
3.2 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o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beropticlightcable ............................................................. 15
4.8.2 Removingtheber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ber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 Hygiene plan....................................................................................................23

3
7 Maintenance and service...............................................................................25
7.1 Periodic tests ........................................................................................................... 25
7.2 Function check......................................................................................................... 25
7.3 Sending in the device.............................................................................................. 26
8 Troubleshooting ..............................................................................................27
9 Accessories ......................................................................................................28
10 Disposal............................................................................................................29
11 Technical data .................................................................................................30
12 Notes on EMC ..................................................................................................33

4Introduction
1 Introduction
1.1 Notes on operating instructions
These operating instructions contain important instructions on how to
operateyourproductsafely,correctly,andeectively.
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 essen-
tial. 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rsttime.Thiswillhelpyoutoavoidpotentiallydanger-
ous 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substanc-
es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certiedaccord-
ing 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
aliatedcompanies.

5Introduction
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 neces-
sary 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t.
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

6Introduction
UDI UniqueDeviceIdentier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
700
1060
Atmospheric pressure limitation

(01) UDI-DI:Identication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.
Intended purpose: StandardENTexaminationand/ortherapy
Intended Users / User

Doctors and medical specialists

7Introduction
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 contra-
indications:
None
The product is: active

status:
Not sterile
Single use product /
reprocessing:
Not a single use product. Reprocessing according to
instructions for use.
Name: 
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

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 contra-
indications:
None
The product is: active

status:
Not sterile
Single use product /
reprocessing:
Not a single use product. Reprocessing according to
instructions for use.

8Introduction
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
conguredbytheuseraccordingtohisorherpersonalneeds.Thedrawerscanbetted
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oersadditionalstoragespaceforATMOS
diagnosticequipmentandATMOSvisualizationequipment.Theproductalsooers
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
Operating instruc-
tions
Servo-Drive® Operating instructions
Servo-Drive®

ATMOSS61
CORIAN®
instrumentsXXL
Operating instruc-
tions
Servo-Drive® Operating instructions
Servo-Drive®

ATMOSS61
CORIAN®
integral
Operating
instructions
Isolation
transformer
Isolation
transformer
operating
instructions
Servo-Drive® Operating
instructions
Servo-Drive®

9Introduction
1.6 Transport and storage
Onlytransportthedeviceinashippingcartonthatispaddedandoerssucient
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

10 Notes for your safety
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specically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lled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ber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specically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reexorwho
are particularly sensitive to light.
• Thelightsourcemayonlybeoperatedbyqualied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.

11Notes 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o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 supervi-
sion.
• Theproductmayonlybeappliedbymedicallytrainedsta.
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specications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,modications,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.

12 Setting up and starting up
3 Setting up and starting up
3.1 Device overview
Front view
1
2
3
4
6
8
5
1Instrumentdisposal(optional)
2Wastedisposal(optional)
3Drawer
4Endoscopeholder(optional)
5ATMOSLEDLightCubeCORIAN®control
panel(optional)
Lightsourceoutput(optional)
7USBconnections(optional)
8Storage space for ATMOS devices
(optional)
9Drawerfordevices(optional)
ATMOS LED Light Cube CORIAN® control panel (optional)
123
2
1
3
4
1Select light source
2Brightness display
3Brightness control
4Stroboscopy mode
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rsttime,reprocessitaccordingtotheoperating
instructions.
7
9

13Operation
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 
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 
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o.
2. Ifnecessary,switchothedevicesstoredintheATMOSS61CORIAN®integral.
Observe the corresponding operating instructions.
4.4 Using the drawers
1
2
Opening the drawers
1. Press against the drawer 1.
» The drawer will open.
Closing a drawer without Servo-Drive® (only
drawer for devices)
1. Push the drawer 2in until it clicks closed.
Closing a drawer with Servo-Drive®
1. Push the drawer 2closed until it is pulled in
automatically.

14 Operation
4.5 Using the drawer for devices (optional)
1
2
Inserting a device
1. Press against the drawer for devices 1.
» The drawer for devices will open.
2. Insert the device 2.
3. Close the drawer for devices 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 2by lifting it upwards.
4. Close the drawer for devices 1.
4.6 Inserting and removing the instrument disposal tray
(optional)
1
2
Inserting the instrument disposal tray
1. Press against the instrument disposal 1.
» The instrument disposal will open.
2. Insert the instrument disposal tray with lid 2.
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
1. Press against the waste disposal 1.
» The waste disposal will open.
2. Attach a bin liner.
3. Close the waste disposal 1.

15Operation
4.8 Using light sources (optional)
4.8.1 
cable
1. Inserttheberopticlightcable 1intotheLED
LightCubeadapter 2until it clicks gently into
place.
4.8.2 
1. Pulltheberopticlightcable 1outoftheLED
LightCubeadapter 2.
1
2
3
4.8.3 Changing the adapter
1. Pulltheberopticlightcable 1outoftheLED
LightCubeadapter 2.
2. TurntheLEDLightCubeadapter 2
counterclockwise to unscrew it from the light
source output 3.
3. TurnthedesiredLEDLightCubeadapter 2
clockwise to screw it into the light source output
3.
4. Insertthematchingberopticlightcable 1into
theLEDLightCubeadapter 2until it clicks gently
into place.
Perform a function check; see chapter “7.2
Function check” on page 25.
1
2
3
4
5
6
4.8.4 Switching on the light source
1. Taketheberopticlightcable 1outoftheber
optic light cable holder 2.
» TheLEDonthecorrespondingbuttonwilllight
up 3.
You can use buttons 1 to 3 3to switch the light
source on manually.
4.8.5 Adjusting brightness
1. Switch on the light source.
2. Press the Up4button to increase the brightness
or the DOwn 5button to reduce the brightness.
3. Display of the brightness 6of the light source
The last setting is retained when the device is
switchedo.
1
1
2

16 Operation
1
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. Select a light source as described in chapter 4.8.4
“Switching on the light source.”
2. Press the button for stroboscopy mode 1to 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
o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o,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.”

17Operation
4.9 Storing endoscopes (optional)
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specically
designated for this purpose.
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
1Rigidendoscopes(optionallyheated)
2Flexible 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.
WARNING
CAUTION

18 Cleaning and disinfection
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.
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dicult-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 disin-
fectant; see chapter “5.2.2 Instrument disinfectants” on page 21.
WARNING

19Cleaning 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 disinfect-
ant; see chapter “5.2.2 Instrument disinfectants” on page 21.
5.1.4 
1. Cleananddisinfecttheberopticlightcablesinaccordancewiththecorresponding
operatinginstructionsprovidedbythemanufactureroftheberopticlightcable.
5.1.5 Reprocessing the surfaces
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o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.
NOTICE

20 Cleaning and disinfection
5.2 Recommended disinfectants
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 In 100 g Manufacturer
terralin®protect
(Application
concentrate)
Benzyl-C12-16alkyldimethyl-,chloride 22 g Schülke
& Mayr,
Norderstedt
2-phenoxyethanol 17 g
aminoalkylglycine 0.9 g
Non-ionic surfactants, perfumes
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 In 100 g Manufacturer
Green & Clean SK Di alkyl dimethyl ammonium chloride < 1 g Metasys, Rum
(Austria)
Alkyldimethylethylbenzylammonium
chloride
< 1 g
Alkyldimethylbenzylammoniumchloride < 1 g
Dismozon®plus
(Granulate)
Magnesium monoperoxyphthalate
hexahydrate
95.8 g Bode Chemie,
Hamburg
Kohrsolin® FF
(Application
concentrate)
Glutaral 5 g Bode Chemie,
Hamburg
Benzyl-C12-C18-alkyldimethyl-ammonium
chloride
3 g
Didecyldimethylammonium chloride 3 g
Perform® Pentapotassium-bis(peroxymonosulphate)-
bis(sulphate)
45 g Schülke
& Mayr,
Norderstedt
NOTICE