Atmos iQam User manual

Operating Instructions
ATMOS iQam
English
GA1GB.150405.0
2021-06 Index 05

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.......................................................................................................7
1.5 Intended users............................................................................................7
1.6 Scope of delivery ........................................................................................7
1.7 Transport and storage ...............................................................................7
2 Notices for your safety...................................................................... 8
2.1 General safety instructions .......................................................................8
2.2 Danger for users, patients, and third parties..........................................8
2.3 Avoiding damage to the device.................................................................9
3 Setting up and starting up .............................................................. 10
3.1 Device overview ....................................................................................... 10
3.2 Using with other devices ........................................................................ 10
3.3 Preparing the device ............................................................................... 10
3.4 Installation of the Capture Suite Basic.................................................. 11
3.5 CongurationoftheATMOSiQamintheSoftware ............................ 11
3.6 Switching on............................................................................................. 11
3.7 Settings and operation ........................................................................... 12
4 Operation.......................................................................................... 13
4.1 Ambient conditions during operation .................................................. 13
4.2 Switching on the device.......................................................................... 13
4.3 Switchingothedevice.......................................................................... 13
4.4 Connecting and removing the endoscope ........................................... 13
4.4.1 Connecting the endoscope................................................................. 13
4.4.2 Removing the endoscope ................................................................... 14
4.5 Adjusting the image ................................................................................ 14
4.5.1 Focusing the image.............................................................................. 14
4.5.2 Zooming ................................................................................................ 14
4.6 Recording videos ..................................................................................... 14
4.7 Capturing a photo ................................................................................... 15
4.8 Setting the white balance....................................................................... 15
4.9 Changing the settings ............................................................................. 15
4.9.1 Disabling functions .............................................................................. 16
4.9.2 Changing actions by tapping on the camera head .......................... 17
4.9.3 Setting the time until standby mode is activated ............................ 17
4.9.4 Restoring factory settings ................................................................... 17

3
5 Reprocessing..................................................................................... 18
5.1 Safety instructions for reprocessing ..................................................... 18
5.1.1 General safety instructions................................................................. 18
5.1.2 Danger for users, patients, and third parties................................... 18
5.1.3 Avoiding damage to the device.......................................................... 18
5.1.4 Further cleaning instructions ............................................................. 19
5.2 Preparing and completing reprocessing .............................................. 19
5.3 Preparing surfaces .................................................................................. 19
5.3.1 Overview ............................................................................................... 19
5.3.2 Selecting process chemicals ............................................................... 20
5.3.3 Procedure ............................................................................................. 21
6 Maintenance and service................................................................ 22
6.1 Periodic tests............................................................................................ 22
6.2 Function check......................................................................................... 22
6.3 Sending in the device.............................................................................. 23
7 Troubleshooting ............................................................................... 24
8 Accessories ....................................................................................... 25
9 Spare parts........................................................................................ 27
10 Disposal............................................................................................. 28
11 Technical data .................................................................................. 29
12 Notices on EMC................................................................................. 31
Further information, accessories, consumables and spare parts are
available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch
Germany
Phone: [phone]
FAX [phone] (Switchboard)
FAX [phone] (Service)
E-Mail: [email protected]
Web: www.atmosmed.com

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 instruct-
ing new operating personnel in the use of the system and are also
intended 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 available 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 Notices for your safety” on page 8 before using
theproductforthersttime.Thiswillhelpyoutoavoidpotentially
dangerous situations.
The product bears the CE marking CE in accordance with EC Council
Directive 93/42/EEC concerning medical devices and meets the basic
requirements of Annex I of this directive.
The product complies with all the applicable requirements of Directive
2011/65/EU on the restriction of the use of certain hazardous sub-
stances in electrical and electronic equipment (“RoHS”).
The Declarations of Conformity and our General Terms and Condi-
tions 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 products:
• ATMOS iQam 507.6000.0

5
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. Ob-
serve the necessary measures.
WARNING
Warning of a danger that can cause fatal or serious injury. Observe the neces-
sary measures.
CAUTION
Warning of a danger that can cause minor injury. Observe the necessary
measures.
ATTENTION
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t.
On device and type plate
Follow operating instructions (blue)
This product complies with the relevant requirements of the EU
Directives.
This product may be used in Canada and the USA with a UL-listed
product.
Manufacturer

6Introduction
Manufacturing date
SN Serial number
REF Order number
IP68 Degree of protection
Protection class (EN 60601-1) ll
Professional disposal
1.3 Intended use
Name: ATMOS iQam
Medical indications/
application:
Imaging of diagnostic endoscopy in ENT medicine
Specication of the
main function:
Endoscopic camera for the digitalization of the endo-
scopic image and subsequent transmission for process-
ing and representation on a PC
User prole: Doctors and medically trained personnel
Patient groups: Patients of all ages without restrictions
Application organ: Ear, mouth and pharynx, nose
Application time: <60min
Area of application: Outpatient medical facilities, e.g., ENT practices, hospi-
tal outpatient clinics, ambulatory healthcare centers
Contraindications: No contraindications
The product is: Active
Sterility: Not sterile
Single-use product/
reprocessing:
Not a disposable product. Options for reprocessing
according to the operating instructions.

7
Introduction
1.4 Function
The ATMOS iQam is a camera for digitizing an endoscopic image. Via the endo-
scopecoupleramedicalendoscopecanbettedsingle-handedly,thisisdetected
automatically and the optimal camera settings are used. The camera will switch
on automatically when you move or change the image and will automatically
go into standby mode after use. A status indicator on the camera head and a
vibration indicate the operating status of the camera.
The endoscopic image is transferred to a PC and displayed on a monitor. When
using the ATMOS Capture Suite Basic software, recordings can be documented
as a snapshot or video. The ATMOS Capture Suite Basic software also allows
individual camera settings.
1.5 Intended users
Doctors and medically trained personnel
1.6 Scope of delivery
ATMOS iQam with
camera cable
ATMOS Software,
operating instructions
(USBashdrive)
Quick Guide
1.7 Transport and storage
Onlytransportthedeviceinashippingcarton,whichispaddedandoers
sucientprotection.
If damage occurs during transport:
1. Document and report damages in transit.
2. Send the device to ATMOS; see chapter “6.3 Sending in the device” on page
23.
Ambient conditions for transport and storage:
• Temperature: -40...+80°C
• Relative humidity: 5...90%airhumiditywithoutcondensa-
tion
• Air pressure: 700...1060hPa

8Notices for your safety
2 Notices for your safety
Please read and pay attention to the safety instructions prior to using the
product.
2.1 General safety instructions
Onlyuseaccessoriesandoptionsthatarespecicallysuitedforcombinationwith
the product and that meet the performance and safety requirements.
The PC used must comply with the standard IEC 60950-1.
If you wish to connect more than one device or application part, you must always
observe their safety instructions.
The product uses vibration as haptic feedback. When used in combination with
the ATMOS Capture Suite Basic software, the vibration can be deactivated.
2.2 Danger for users, patients, and third parties
Electric shock due to unsuitable power connection, incorrect handling of
the product, or damage to product components
Slight injuries are possible.
• Prior to each use, check for damage to the device and the camera cable.
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.
• The device can only be disconnected from the power supply by pulling out
the camera cable.
• Position the device so that it can always be disconnected from the power
supply easily.
• Never touch the plug or power cable with wet hands.
• Never touch the device’s interfaces and the patient at the same time!
• Only use original accessories and original spare parts from ATMOS.
• Follow the instructions regarding periodic tests in chapter “6.1 Periodic tests”
on page 22.
• Assembly, new settings, alterations, extensions, and repairs may only be
carried out by authorized persons.
• Do not modify the device without the manufacturer’s permission.

9
Notices for your safety
Keep the device fully functional at all times.
Malfunctions could cause injury to you and your patients.
• Please observe the notes on the electromagnetic compatibility (EMC) of the
device.
• If the camera fails, then use the endoscope without the camera.
• ATMOS recommends: Only use the original ATMOS software.
Risk of infection by germs on the product!
Diseases could be transmitted.
• Always wear disposable gloves when using the product.
• Clean and disinfect the product according to the operating instructions.
2.3 Avoiding damage to the device
Unsuitable mechanical stress.
Risk of damage to the camera cable.
• Make sure that the camera cable is not pinched, squeezed, knotted, or
clampedo.
• Do not pull on the camera cable.
Storage and operation in an unsuitable environment.
Risk of damage to the product.
• Please observe the ambient conditions regarding transport, storage, and
operation.

10 Setting up and starting up
3 Setting up and starting up
3.1 Device overview
Front view
1
4
2
5
678
3
9
10
11
1Camera head
2UniqueDeviceIdentication(UDI)
3ATMOS connector plug
4Camera cable
5Endoscope coupler
6Focusing ring
7Release lever
8Status indicator
9USB connector (optional)
10 Protection cap
11 ATMOS connector plug (optional)
3.2 Using with other devices
Onlyqualiedpersonnelareauthorizedtoinstallelectricalsystems.Theman-
ufacturer of an electrical medical system is responsible for ensuring that the
performance, safety, technical data, and intended use of the ATMOS iQam are
not impaired.
Observe the following information when connecting the device in the required
combination:
• RefertothespecicationsofIEC60601-1onmedicalelectricalsystems.
• Pay particular attention to the information on the patient environment,
multi-outlet power strips, and leakage currents.
3.3 Preparing the device
Risk of injury and risk of infection due to production residues.
1. Priortorstuse,preparetheproductaccordingtotheoperatinginstruc-
tions.
2. Connect the camera cable to the camera head. Make sure that the red dots
on the ATMOS connector plug and camera head are facing each other.
3. Perform a function check after connecting.

11
Setting up and starting up
Connecting to a PC
1. Connect the camera cable (USB connector) to a PC.
Connecting to an ENT treatment unit (ATMOS S 61 Servant vision or ATMOS
S 61 CORIAN® integral)
1. Connect the camera cable (ATMOS connector plug) to the corresponding
connection on the respective ENT treatment unit.
Corian® is a registered trademark of E. I. du Pont de Nemours and Company or
itsaliatedcompanies.
3.4 Installation of the Capture Suite Basic
1. OnlyusethesuppliedUSBashdrivewithamedicalPC.SelecttheCapture
SuiteBasicsetup.exeleandfollowtheinstallationinstructionsonthe
display.
3.5 Conguration of the ATMOS iQam in the Software
1. Launch the software
2. Open the window “Options”
3. Activate "iQam" in the camera selection (see chapter “3.7 Settings and
operation” on page 12)
4. Exit the software
3.6 Switching on
1. After successful installation, you can connect the ATMOS iQam via USB
interface.
2. Open the image display program ‘Capture Suite Basic’. The live image
appears. If necessary the correct camera must still be selected (see chapter
“3.7 Settings and operation” on page 12).
3. The pictures and videos that have already been recorded and saved can be
seen on the left hand side.

12 Setting up and starting up
3.7 Settings and operation
The setting options in live mode are shown in the following image:
Live image
Video recording Start/
Stop
Photograph
saved
image / video
sequences
zoom in or out
Options
Close
Camera settings
The language, storage paths and camera sources can be set using the
"Options button" in the software.

13
Operation
4 Operation
4.1 Ambient conditions during operation
• Temperature: +10...+35°C
• Relative humidity: 20...80%airhumiditywithoutcondensa-
tion
• Air pressure: 700...1060hPa
4.2 Switching on the device
1. Remove the camera from the camera mount or from the shelf.
» The camera turns on.
» The camera vibrates 2x.
» The status indicator lights up blue.
4.3 Switching o the device
1. Attach the camera to the camera mount or place the camera on the shelf.
» The camera goes into standby mode.
» A hint symbol appears momentarily on the monitor.
» The status indicator lights up blue at regular intervals („Breathing“).
To disconnect the camera from the power supply the plug of the camera
cable must be pulled.
4.4 Connecting and removing the endoscope
4.4.1 Connecting the endoscope
1. Launch the software.
2. Press the eyepiece lens of the endoscope
into the endoscope coupler of the camera.
» The camera automatically selects the
appropriate settings for the endoscope.
» The camera vibrates 2x.
» Therecognizedendoscopeproleappears
on the monitor.

14 Operation
1
4.4.2 Removing the endoscope
1. Securely hold the endoscope and turn the
release lever 1to the right.
» The endoscope is released from the
camera.
4.5 Adjusting the image
4.5.1 Focusing the image
1. Launch the software.
2. Turn the focusing ring.
4.5.2 Zooming
1. Launch the software.
2. Zoom in on the live image display of the software.
4.6 Recording videos
Starting and stopping a recording
1. Launch the software.
2. Tap 2 x on the status indicator (to use this function the tab mode must be
activated and the video recording must be selected as a function for the
mode, see “4.9 Changing the settings” on page 15).
» The video recording starts.
» The status indicator lights up red.
» The camera vibrates 2x.
» A red dot appears in the live image.
3. Tap again 2 x on the status indicator.
4. The video recording stops.
» The status indicator lights up blue.
You can also start and stop the video recording via the software or a foot
switch.

15
Operation
Pausing a recording
1. Pause the recording via the button in the software.
» Thestatusindicatorashesred.
» Two red vertical bars appear in the live image.
4.7 Capturing a photo
1. Launch the software.
2. Tap 2 x on the status indicator (to use this function the tab mode must be
activated and the video recording must be selected as a function for the
mode, see “4.9 Changing the settings” on page 15).
» The photo is taken.
» Thestatusindicatorlightsupbluebriey.
» The camera vibrates 2x.
You can also start and stop the video recording via the software or a foot
switch.
4.8 Setting the white balance
Donotsetthewhitebalanceunderuorescentlightbecauseotherwisethe
result may not be satisfactory.
1. Launch the software.
2. Turn on the light source and wait until the light has stabilized.
3. If possible, carry out the white balance under natural lighting conditions.
Otherwise, use a white-gray surface.
4. Open the window camera settings .
5. Click the white balance button.
4.9 Changing the settings
You need the ATMOS Capture Suite software to use these functions. Observe the
operating instructions for the ATMOS Capture Suite software.

16 Operation
4.9.1 Disabling functions
You can disable the following functions:
Auto strobo function Display of the stroboscope parameters and
the corresponding camera settings while
stroboscoping
Haptic feedback Vibration of the camera
Tap function Response when tapping camera head
LED status indicator Status indicator
Automatic changeover Automatic changeover of video source
High-resolution snapshot Saves photo in highest possible resolution
Auto Detect Endoscope Automatic endoscope detection
Auto Standby/Wake-up Automatic transition to standby mode

17
Operation
1. Launch the ATMOS Capture Suite Basic software.
2. Open the window camera settings .
3. Select the ATMOS iQam tab.
4. Remove the check mark in the corresponding check box.
4.9.2 Changing actions by tapping on the camera head
1. Launch the ATMOS Capture Suite Basic software.
2. Open the window camera settings .
3. Select the appropriate entry in the tap function choice box:
• Snapshot recording / video recording start-stop: Snapshot mode: Capturing a
photo,videomode:Start/stopvideorecording
• White balance: Setting the white balance
4.9.3 Setting the time until standby mode is activated
1. Launch the ATMOS Capture Suite Basic software.
2. Open the window camera settings .
3. Select the desired time (in seconds) in auto standby.
4.9.4 Restoring factory settings
1. Launch the ATMOS Capture Suite Basic software.
2. Open the window camera settings .
3. Click the factory settings button.

18 Reprocessing
5 Reprocessing
5.1 Safety instructions for reprocessing
5.1.1 General safety instructions
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 of cleaning
and disinfection are achieved. Validation and routine monitoring of the proce-
dure will usually be necessary.
Reprocessing may only be carried out by persons who have the necessary
expertise. The person in question must have the necessary test devices required
to carry out these measures.
5.1.2 Danger for users, patients, and third parties
Risk of infection due to unsuitable accessories.
Deadly diseases could be transmitted.
• Always wear your own personal protective equipment. The protective equip-
ment consists of protective gloves, protective clothing, safety glasses and
mouth and nose protection for all steps for which the product components
are contaminated.
• Only use accessories which can be easily sterilized or use disposable prod-
ucts.
5.1.3 Avoiding damage to the device
Unsuitable accessories.
Risk of damage to the product.
• Only use lint-free, soft cloths.
• Alwaysusedemineralizedwaterforthenalrinse.
• Follow the corresponding operating instructions of all accessories and
devices used.

19
Reprocessing
Unsuitable cleaning agents and disinfectants.
Risk of damage to the product.
• Do not use any process chemicals containing the following ingredients on
plastic parts:
• Chloramide or phenol derivatives
5.1.4 Further cleaning instructions
Imagequalitycouldbeaectedevenbytheslightestcontamination,suchas
ngerprints.Afteruse,thecameracanbeprotectedfromdustbystoringiton
the designated camera mount or by covering it. The external surfaces of optical
components should only be cleaned when necessary. Dust which has accumulat-
edontheopticalsurfacescanbeblownoorremovedwithasoft,cleanbrush.
5.2 Preparing and completing reprocessing
After reprocessing
1. Perform a function check.
5.3 Preparing surfaces
5.3.1 Overview
Surface After each application After each patient Daily Weekly Every 14 days Monthly Pre-cleaning Wipe cleaning Wipe disinfection Immersion disinfection Remarks
camera head X X X

20 Reprocessing
5.3.2 Selecting process chemicals
Observethemanufacturer’sspecicationsfortheprocesschemicals.
Product
(manufacturer) Active ingredients in 100 g Art Surface 1
Cleaning agents – manual reprocessing
Tristel Wipes® (Tristel
GmbH)
Oxidizing agent
Propan-2-ol
Wipes
Ready-to-use X
neodisher®
MediClean forte (Dr.
Weigert)
Enzymatic
<5 % nonionic and anionic surfactants, enzymes
Liquid
Concentrate X
mikrozid® sensitive
wipes
(Schülke & Mayr)
Quaternary ammonium compounds
0.26 g alkyl (C12-16) dimethylbenzylammonium chloride
Didecyldimethylammonium chloride (DDAC),
0.26 g Alkyl (C12-14) ethylbenzyl ammonium chloride
Wipes
Ready-to-use X
mikrozid® universal
wipes
(Schülke & Mayr)
Alcohols
Propan-2-ol
Ethanol
Wipes
Ready-to-use X
Gigasept® pearls
(Schülke & Mayr)
Peroxide compound
Sodium percarbonate, citric acid, sodium carbonate
Granulate X
Helipur® H plus N
(BBraun)
Aldehydes
Glutaraldehyde 12.0 g, propan-2-ol, 7.5 g, ethylhexanol 0.5 g,
anionic surfactants
Liquid
Concentrate X
Cidezyme®/ Enzol®
(Advanced Steriliza-
tion Products)
Enzymatic
Subtilisins (proteolytic enzymes)
Liquid
Concentrate X
Disinfectants – manual reprocessing
Tristel Wipes® (Tristel
GmbH)
Oxidizing agent
Propan-2-ol
Wipes
Ready to use X
mikrozid® sensitive
wipes (Schülke &
Mayr)
Quaternary ammonium compounds
0.26 g alkyl (C12-16) dimethylbenzylammonium chloride
Didecyldimethylammonium chloride (DDAC),
0.26 g alkyl (C12-14) ethylbenzylammonium chloride
Wipes
Ready-to-use X
mikrozid® universal
wipes (Schülke &
Mayr)
Alcohols
Propan-2-ol
Ethanol
Wipes
Ready-to-use X
Gigasept® pearls
(Schülke & Mayr)
Peroxide compound
Sodium percarbonate, citric acid, sodium carbonate
Granulate X