Atmos iQam User manual

Operating Instructions
ATMOS iQam
English
GA1GB.150405.0
2019-11 Index 01-B

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 Notes 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 Combination with other devices............................................................ 10
3.3 Preparing the device ............................................................................... 11
3.4 Installing the software ............................................................................ 11
4 Operation.......................................................................................... 12
4.1 Ambient conditions during operation .................................................. 12
4.2 Switching on the device.......................................................................... 12
4.3 Switchingothedevice.......................................................................... 12
4.4 Connecting and removing the endoscope ........................................... 12
4.4.1 Connecting the endoscope................................................................. 12
4.4.2 Removing the endoscope ................................................................... 13
4.5 Adjusting the image ................................................................................ 13
4.5.1 Focusing the image.............................................................................. 13
4.5.2 Zooming ................................................................................................ 13
4.6 Recording videos ..................................................................................... 13
4.7 Capturing a photo ................................................................................... 14
4.8 Setting the white balance....................................................................... 14
4.9 Changing the settings ............................................................................. 15
4.9.1 Disabling functions .............................................................................. 15
4.9.2 Changing actions by tapping on the camera head .......................... 16
4.9.3 Setting the time until standby mode is activated ............................ 16
4.9.4 Restoring factory settings ................................................................... 16
5 Reprocessing..................................................................................... 17
5.1 Safety instructions for reprocessing ..................................................... 17

3
5.1.1 General safety instructions................................................................. 17
5.1.2 Danger for users, patients, and third parties................................... 17
5.1.3 Avoiding damage to the device.......................................................... 17
5.2 Preparing and completing reprocessing .............................................. 18
5.3 Preparing surfaces .................................................................................. 18
5.3.1 Overview ............................................................................................... 18
5.3.2 Selecting process chemicals ............................................................... 18
5.3.3 Procedure ............................................................................................. 20
6 Maintenance and service................................................................ 21
6.1 Periodic tests............................................................................................ 21
6.2 Function check......................................................................................... 21
6.3 Sending in the device.............................................................................. 22
7 Troubleshooting ............................................................................... 23
8 Accessories ....................................................................................... 24
9 Spare parts........................................................................................ 26
10 Disposal............................................................................................. 27
11 Technical data .................................................................................. 28
12 Notes on EMC.................................................................................... 30
13 Notes ................................................................................................. 31

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 Notes 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”).
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 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 in this direction plug in
click Engage,checkcorrectt.
On device and type plate
Observe operating instructions (only on stroboscope adapter)
Follow operating instructions (blue)
This product complies with the relevant requirements of EU
directives.
This product may be used in Canada and the USA with a UL-listed
product.

6Introduction
Manufacturer
Manufacturing date
SN Serial number
REF Order number
IP30 Degree of protection (only on stroboscope adapter)
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 group: 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 en-
doscopecoupleramedicalendoscopecanbettedusingonlyonehand;itis
detected automatically and the optimal camera settings are used. The camera
switches on automatically when moved or when the image changes and auto-
matically goes into standby mode after use. A status indicator on the camera
head and 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 software, recordings can be documented as
a photos or videos. The ATMOS Capture Suite 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
Demo-Version;
Operating instructions
(USB stick)
Quick Guide
1.7 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 damages in transit.
2. SendthedevicetoATMOS;seechapter“6.3 Sending in the device” on page
22.
Ambient conditions for transport and storage:
• Temperature: −40...+80°C
• Relative humidity: 5...90% air humidity without condensation
• Air pressure: 700...1060hPa

8Notes 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
Useonly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 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!
• Use only original accessories and original spare parts from ATMOS.
• Follow the instructions regarding periodic tests in chapter “6.1 Periodic tests”
on page 21.
• 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
Notes 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: Use only software from ATMOS.
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.
The camera cable can become damaged.
• 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.
The product can become damaged.
• 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 Combination 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.

11
Setting up and starting up
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.
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 Installing the software
Observe the operating instructions for the ATMOS Capture Suite software.

12 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. Secure the camera to the camera mount or place the camera on the shelf.
» The camera goes into standby mode.
» A note symbol appears momentarily on the monitor.
» The status indicator lights up blue at regular intervals („breathing“).
To disconnect the camera from the power supply, pull the camera cable plug.
4.4 Connecting and removing the endoscope
4.4.1 Connecting the endoscope
1. Launch the software.
2. Push the eyepiece lens of the endoscope
straight 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.

13
Operation
1
4.4.2 Removing the endoscope
1. Holdtheendoscopermly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
You need the ATMOS Capture Suite software to use this function.
1. Launch the software.
2. Zoom in on the live image display of the ATMOS Capture Suite software.
Observe the operating instructions for the ATMOS Capture Suite software.
4.6 Recording videos
You need the ATMOS Capture Suite software to use this function.
Starting and stopping a recording
1. Launch the software.
2. In the software, select the appropriate mode for video recording.
3. Tap 2x on the status indicator. (You need the ATMOS Capture Suite software
to use this function.)
» The video recording starts.
» The status indicator lights up red.
» The camera vibrates 2x.
» A red dot appears on the monitor.

14 Operation
4. Tap again 2x on the status indicator. (You need the ATMOS Capture Suite
software to use this function.)
» 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 (only with the ATMOS Capture Suite software).
Pausing a recording
You need the ATMOS Capture Suite software to use this function.
1. Pause the recording. Follow the operating instructions for the ATMOS
Capture Suite software.
» Thestatusindicatorashesred.
» Two vertical red bars appear on the monitor.
4.7 Capturing a photo
1. Launch the software.
2. In the software, select the appropriate mode for recording photos.
3. Tap 2x on the status indicator. (You need the ATMOS Capture Suite software
to use this function.)
» The photo is taken.
» Thestatusindicatorlightsupbluebriey.
» The camera vibrates 2x.
You can also record a photo via software or a foot switch (only with the
ATMOS Capture Suite software).
4.8 Setting the white balance
You need the ATMOS Capture Suite software to use this function.
Donotsetthewhitebalanceunderuorescentlightbecauseotherwisethe
result may not be satisfactory.
1. Launch the ATMOS Capture Suite software.
2. Turn on the light source and wait until the light has stabilized.
3. Set the white balance preferably under natural lighting conditions. (If
possible, point the camera out of the window.) Otherwise, use a white-gray
surface.
4. Open the OptiOns window.
5. Select the iQam tab.
6. Click the White balance button.

15
Operation
4.9 Changing the settings
You need the ATMOS Capture Suite software to use these functions. Follow the
operating instructions for the ATMOS Capture Suite software.
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
Image180°rotation Rotationoftheimageby180°ifthecamera
headisrotatedby180°
Tap function Response when tapping camera head
LED status indicator Status indicator
Automatic toggle Automatic changeover of video source
5 MP photo Saves photo in highest possible resolution
Auto Detect Endoscope Automatic endoscope detection
Auto Standby/Wake-up Automatic transition to standby mode

16 Operation
1. Launch the ATMOS Capture Suite software.
2. Open the OptiOns window.
3. Select the 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 software.
2. Open the OptiOns window.
3. Select the iQam tab.
4. Select the appropriate entry in the tap functiOn selection box:
• phOtO recOrding / videO start–stOp:Photomode:Capturephoto;Videomode:
Start/stop video recording
• selectiOn / pause videO:Photomode:Switchtonextstoragelocation;Video
mode: Pause and continue a recording
• tOggle phOtO / videO:Toggle between Photo/Video mode
• White balance:Set the white balance
4.9.3 Setting the time until standby mode is activated
1. Launch the ATMOS Capture Suite software.
2. Open the OptiOns window.
3. Select the iQam tab.
4. Select the desired time (in seconds) in autO standby.
4.9.4 Restoring factory settings
1. Launch the ATMOS Capture Suite software.
2. Open the OptiOns window.
3. Select the iQam tab.
4. Click the factOry settings button.

17
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 aids.
Deadly diseases can be transmitted.
• Always wear your own personal protective gear. The protective gear consists
of protective gloves, protective clothing, safety glasses, and mouth and nose
protection for all steps in which the product components are contaminated.
• Use only aids that can be easily sterilized or use disposable products.
5.1.3 Avoiding damage to the device
Unsuitable aids.
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 aids and devices used.

18 Reprocessing
Unsuitable cleaning agents and disinfectants.
Risk of damage to the product.
• For plastic parts, do not use process chemicals that contain the following
ingredients:
• Chloramides or phenol derivatives
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
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

19
Reprocessing
Product
(manufacturer) Active ingredients in 100 g Art Surface 1
mikrozid® sensitive
wipes
(Schülke & Mayr)
Quaternary ammonium compounds
0.26 g alkyl (C12-16) dimethylbenzyl ammonium chloride
Didecyldimethylammonium chloride
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
Gigasept® FF
(Schülke & Mayr)
Aldehydes
Reaction product of DMO-THF, ethanol and water,
phosphonates, anionic and non-ionic surfactants, perfumes,
methylisothiazolinones
Liquid
concentrate X
Revital-Ox® Resert®
(Steris)
Enzymatic
2-furancarboxylic acid, hydrogen peroxide, potassium hydroxide,
phosphoric acid, 1-hydroxyethane-1, 1-diphosphonic acid
Liquid
Concentrate X
Cidex OPA (ASP)® 0.55% ortho-phthalaldehyde Liquid
ready to use X

20 Reprocessing
5.3.3 Procedure
Pretreatment at the site
of use
Not necessary
Pre-clean Not necessary
Dismantle Not necessary
Manual cleaning and
disinfection
1. Clean the device evenly with a suitable cloth
and a suitable detergent under running
water.
2. Immerse the device in the cleaning solution
(follow manufacturer’s instructions) and clean
it in the solution evenly with a suitable cloth.
3. Disinfect the device evenly with a suitable
cloth and a suitable disinfectant. Observe
instructions regarding contact time.
Checking and maintain-
ing
1. Check wether reprocessing was successful
withasuitablelightmagnier.
2. If reprocessing was unsuccessful, the proce-
dure must be repeated.
Assembly Not necessary
Function check Other: coupler shoe function
Packaging Not necessary
Sterilizing Not necessary