ATMOS Scope (GA-en) - This is the ATMOS Content Delivery Network

English
Operating instructions
ATMOS® Scope
ATMOS® Scope Basic
REF 950.0300.B
REF 950.0330.B
TPA191-158-1112-01_L
2016-01 Index: 18
Table of contents
Further information, accessories, consumables and
spare parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Tel +49 7653 689-0
Fax +49 7653 689-190
+49 7653 689-292 (Service Center)
atmos@atmosmed.de
www.atmosmed.de
2
1.0
1.1
1.2
1.3
1.4
1.5
Introduction .................................................................. 3
Notes on operating instructions...................................... 3
Intended Use .................................................................. 4
Function ......................................................................... 4
Explanation of pictures and symbols.............................. 5
Scope of supply............................................................. 5
2.0
2.1
For your safety ............................................................. 6
Instructions for combination with
other Medical Products .................................................. 6
3.0
3.1
3.2
3.3
3.4
3.5
3.6
3.7
Setting up and starting up ........................................... 7
Overview ....................................................................... 7
Front view ATMOS® Scope controller ............................. 8
Rear view ATMOS® Scope controller ............................. 8
Overview Cables ............................................................ 9
Leakage tester and hose................................................ 9
Assembly/First Installation ........................................... 10
Tests ............................................................................. 16
4.0
4.1
4.2
4.3
Operation .................................................................... 18
Use/Operation .............................................................. 18
Disassembly ................................................................. 20
Functions of the buttons on the handle ........................ 20
5.0
5.1
5.2
5.3
5.4
5.4.1
5.4.2
Cleaning ...................................................................... 21
General Instructions ..................................................... 21
Manual Cleaning and Disinfection................................ 22
Mechanical Processing and Disinfection...................... 24
Sterilization................................................................... 25
General Instructions ..................................................... 25
Sterilization Methods .................................................... 25
6.0
Maintenance and service........................................... 27
7.0
Trouble shooting ........................................................ 28
8.0
Accessories and Spare parts .................................... 29
9.0
Technical specifications ............................................ 31
10.0
Disposal ...................................................................... 32
11.0
Notes on EMC ............................................................. 33
1.0
Introduction
1.1 Notes on operating instructions
These operating instructions contain important notes on how to operate the ATMOS® Scope safely,
correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and
down-time. That increases, amongst other things, the reliability and service-life of the device.
These operating instructions serve not only for new operating personnel to be instructed in its use,
but also for use as a reference manual. Reprints (also in extracts) only with permission in written
form by ATMOS.
These operating instructions must always be kept available near the device.
Care and safety inspections in conjunction with professional execution provide for operational safety
and readiness for use of your ATMOS® Scope and are therefore a must besides regular cleaning.
Repair work and safety inspections may only be carried out by expert personnel authorised by
ATMOS. By applying only original spare parts you will have the guarantee that operational safety,
readiness for work and the value of your ATMOS® Scope will be preserved.
● The product ATMOS® Scope bears CE marking CE according to the EU
guideline of the council for medical products 93/42/EEC and meets the basic requirements of
annex I of this guideline.
● The product ATMOS® Scope complies with all applicable requirements of the directive 2011/65/EC
restricting the use of certain hazardous substances in electrical and electronic equipment
(“RoHS”).
● The declaration of conformity and our standard general terms and conditions can be obtained on
our website at www.atmosmed.com.
● The quality management system applied at ATMOS has been certified according to international
standards EN ISO 9001 and EN ISO 13485.
● Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any
possible dangerous situations.
● These operating instructions are valid for the following devices:
ATMOS® Scope...............................REF 950.0300.0
ATMOS® Scope Basic .....................REF 950.0330.0
3
1.0
1.2
Introduction
Intended Use
Name:
ATMOS® Scope / ATMOS® Scope Basic
Main functions:
During an endoscopy procedure the use of the ATMOS® Scope / ATMOS® Scope Basic is indicated
for the temporary application in the mouth cavity up to the throat and in the nasal cavity. It enables the
visualization of body orifices and body cavities.
Med. indications/ application:
For the endoscopic visualisation and diagnosis in the mouth and the nasal cavities and in the upper
airway anatomy and in the auditory canal with the eardrums.
Specification of the main function:
With the all-in-one handle solutions and with the innovative chip-on-tip technology, the integrated
camera and integrated LED lightsource makes endoscopy and stroboscopy possible:
- Bright homogenous illumination
- 1/18” CMOS image sensor with a high resolution of 328 x 250
- Optical angle 85°
- Distal outer diameter 3.8 mm
- Working length 300mm
- Angulation angle 2 x 160°
- 100% waterproof
Application organ:
Nasal and oral cavities to the larynx, auditory canal to the ear drums
Application time:
Temporarily
Application site:
In clinics and practices for ENT doctors and phoniatricians.
Contraindications:
The use of CMOS-Video-Nasopharyngoscope is contraindicated if endoscopic applications are
contraindicated for any reason.
The product is:
Active
Sterility:
Not sterile
Single use product / reprocessing:
Reprocessing is possible
1.3
Function
The ATMOS® Scope/ATMOS® Scope Basic is an all-in-one solution for the flexible endoscopy. The flexible naso-pharyngoscope with
integrated camera and LED light source combines the following components in the handle:




LED light source
Microphone pre-amplifier and removable microphone (optional)
camera electronics
mechanics for controlling the angle
The innovatively-shaped handle of the ATMOS® Scope/ATMOS® Scope Basic embodies an entirely new way of performing endoscopy/stroboscopy, allowing insertion of the probe without any problem for the fatigue free examination of ear, nose, pharynx and larynx
without any signs of fatigue.
Thanks to optimised video pre-settings, camera setting and white balance are no longer required. The device automatically switches
to the desired stroboscopy mode.
The handle provides the following keys:


Start-stop for video recording
Single images storage is possible in connection with the ATMOSoft ENT
The ATMOS® Scope/ATMOS® Scope Basic fits perfectly into the ATMOS® treatment units. Networking with the ATMOS® Cam, the
ATMOS® Strobo 21 LED and a video monitor is always possible. Images and videos can be saved with the ATMOSoft ENT.
4
1.0
Introduction
1.4
Explanation of pictures and symbols
Abbreviations / symbols contained in this manual
Follow the arrows
whilst proceeding,
sequence
■
General information
Move, plug ... in this
direction
Please press where
dot indicates
●
Numeration
Turn, shift ... in this
direction
Please read,
important information
→
Subnumeration
Replace
Check
click
Engage, check correct
fit
Graphic symbols contained in the manual
Warning,
special diligent notice!
!

Important information
ATMOS® Scope symbols
SN
Serial number
REF
Order number
Creation date
Manufacturer
+68°F
-20°C
Indicates the tolerable temperature
+158°F
+70°C
95%
Indicates the tolerable air humidity
!
Dispose of properly
2nd-Edition IEC 60601-1: Caution, observe
accompanying documents
3rd-Edition IEC 60601-1: Caution
Observe operating instructions!
Application part type BF acc. to EN 60601-1
R Only
Latex
MR
The federal law of the USA restricts the sale of
this device to physicians or orders on their behalf
Indication that the product does not contain
natural rubber latex
Magnetic resonance unsafe
5%
106 kPa
Fuse
Indicates the tolerable air pressure
70kPa
The CE sign shows that this product meets
the appropriate requirements of the EU
guidelines.
1.5
NON
STERILE
Sterilize prior to each use
Scope of supply
The ATMOS® Scope was functionally tested and carefully packed prior to delivery. Immediately after receiving the delivery check
for completeness (see delivery note).
ATMOS® Scope Basic: ATMOS® Scope handle, controller, leakage tester, pressure compensation cap, BNC video cable (2 pcs),
silicone hose, mains cable, BNC chinch adapter (2 pcs), USB 2.0 cable, remote cable for ATMOSoft, ATMOSoft demo CD, operating
instructions.
ATMOS® Scope: ATMOS® Scope handle, controller, leakage tester, pressure compensation cap, microphone, stroboscope cable,
BNC video cable (2 pcs), silicone hose, mains cable, BNC chinch adapter (2 pcs), USB 2.0 cable, remote cable for ATMOSoft,
ATMOSoft demo CD, transport case, operating instructions.
5
2.0
For your safety
!
For your safety
 The product may only be used observing the guidelines
of this IFU. If instructions, warnings and precautions are
not observed, this may lead to risks and serious
consequences during use.
Check and guarantee unrestricted function,
completeness and integrity of the product and/or
accessories before use.
 The system may only be operated with the delivered
cables. Make sure that all devices operated nearby
comply with the relevant EMC requirements.
The image quality could be affected by the
electromagnetic emissions of peripheral equipment
(e. g. monitor, video equipment) which is connected. In
case of extreme electromagnetic interferences, the
image quality may be influenced (e. g. slight stripes,
color changes on the monitor).
 Use in combination with MR
The product is MR unsafe - in areas with magnetic
resonance imaging, the product is unsafe
 Unsterile parts – danger of infection
Parts, which are delivered unsterile, have to be
processed before use.
 Improper use and maintenance, as well as application in
deviance to its intended use may lead to risks for patient
and user or early wear and tear of the product.
 Endoscopic procedures may only be carried out by
specialists who have corresponding training, knowledge
and experience.
 The product is susceptible in regard to bending, heavy
kinking, torsion, tension or pressure load. This may
damage the optical components and thus lead to
operating failure.
 Only operate the product within the specified operating
temperature range.


 When placing the product into the transport case, be
careful that no parts are pinched or clamped when
closing the lid. Otherwise the product could be damaged.
 Do not use the transport case for long-time storage.
 Accessories and/or peripheral devices, which are
connected to the interfaces of the product must comply
verifiably to the relevant normative specifications
(e. g. IEC 60601-1). Furthermore, all configurations of
the system standard IEC 60601-1-1 have to be fulfilled.
6
In this case, release deflection lever and carefully
withdraw the videoscope.
 Do not look directly into the light emission at the distal end
of the endoscope. This can lead to eye injury.
 Each light source can become warm due to absorption and
therefore damage to the biological tissue could occure.
Please make sure to keep the application period as short
as necessary, to switch off the light source when not in
use and if need be to check the heat generation prior to
application.
 To separate the device completely from the mains power
supply, pull the plug out of the mains socket at the
external power.
 The plug cap must be removed from the plug during
storage and transport. Otherwise, under certain
circumstances, an overpressure could occur within the
connection cable and could damage the cable.
Image interferences, image breakdown or breakdown of
the integrated light source could lead to risks.
 The ATMOS® Scope may only be operated in rooms
used for medical purposes, but not in areas subject to
explosion hazards and in oxygen rich environments.
2.1 Instructions for combination with
other medical products

Multiplication of leakage current - risk for patients
If the product is used with electro medical devices and/or
power driven endoscopic accessories, the leakage currents could multiplicate. Check external electrical devices
before use.

If the product or endoscopic accessories are used with
products of different manufacturers and in combination
with medical electrical products, ensure that the BF conditions (insulated, earth-free application part) are fulfilled.

Ensure that the corresponding interconnection c#onditions
are kept. Also, the relevant standard and the respective
national tolerances must be followed.
3.0
3.1
Setting up and starting up
Overview
2
3
1
4
5
6
10
7
11
8
9
3
Fig. 1
1
Deflection lever
7
Plug
2 Pressure compensation valve with dust protection cap 8
Plug cap
3
Microphone (optional)
9
Deflectable tip
4
Button A
10 Tip cover glass
5
Button B
11
6
Connection cable
Microphone interface
7
3.0
Setting up and starting up
3.2 Front view ATMOS® Scope controller
14
13
Fig. 2
13 Socket for connection cable 6
14 ON/OFF switch
3.3 Rear view ATMOS® Scope controller
17
Fig. 3
15
16
20
18
19
15
BNC video outputs (composite/CVBS signal)
16
3.5 mm jack plug (Remote 1 signal)
17
3.5 mm jack plug (Remote 2 signal)
18
Plug for stroboscope cable
19
USB 2.0 plug
20
Fuse holder with fuses
21
Mains connection
8
21
3.0
Setting up and starting up
3.4 Overview cables
23
22
24
25
25
26
Fig. 4
22 BNC video cable
25 remote cable
23 USB 2.0 cable
26 Stroboscope cable (optional)
24 Mains cable
3.5 Leakage tester and hose
29
30
28
27
Fig. 5
27 Leakage tester
29 Pressure compensation cap
28 Silicone hose
30 Pressure release valve
9
3.0
Setting up and starting up
3.6 Assembly/First Installation
Required additional devices:
 Monitor according to the medical device directive 93/42/EEC.
Recommended monitor size:
In combination with the present ATMOS® Scope the monitors described in chapter Product Description (medical 15" Neovo
monitor) will give best results.
Installation at the place of operation:
Connecting the controller to the mains supply
!
Ensure that the correct mains cable is used for the respective country.
● Connect mains cable 24 with mains connection 21 at the controller.
●
Plug the mains cable 24 into a mains socket and thus connect the system to the mains supply.
Connecting the monitor
●
Connect BNC video cable 22 with the BNC video output 15 of the controller and composite/CVBS input of the monitor.
Connecting the PC (optional)
The PC has to conform to the medical device directive 93/42/EEC.
Installing the USB Driver on the PC

Connect the ATMOS® Scope to the PC using the USB 2.0 connection cable (23). Depending on the configuration of the PC,
the new hardware will be identified and the Installation Assistant will start. Go to part b.

If the Installation Assistant does not start automatically, please continue the installation manually as follows:
a) Manual installation (Example Windows XP):

Click Start -> Control Panel.
Fig. 6
10
3.0
Setting up and starting up
 Double click on System, choose the Hardware tab, and then click on Device Manager.
Fig. 7
 Once inside the Device Manager, click on the “+” symbol next to Audio, Video and Game Controller.
 Double click on the USB device which has a yellow exclamation mark next to it. Search for new hardware.
Fig. 8
 The ATMOS® Scope driver will be listed as USB2820. Select this device. If this is not the case, click on Properties -> Drivers
-> Update.
11
3.0
Setting up and starting up
b) Normally, when the ATMOS® Scope is connected to the PC, the Hardware Update Assistant window should open automatically.
Fig. 9
 Choose No, not this time.
 Put the Software CD, included in your set, into the CD/DVD drive and then click Next.
Fig.10
12
3.0
Setting up and starting up
Fig. 11
 Here it is important to mark Search removable device (disk, CD…).
Then click on Next.
Fig. 12

The driver will be installed.
13
3.0

Setting up and starting up
When it is completed, click on Finish.
Fig. 13
Thereafter, a restart will be recommended.
Fig. 14
 Restart the PC. The installation is now complete.
 Remove software CD from the drive.
PC minimum requirements depend on the used software.
 Follow instructions on the software CD.
Recommendation when using the software on a PC and the availability of a medical grade monitor:
As an alternative to directly connecting the monitor via the BNC video output (composite/CVBS signal) (15), it is recommended to
connect the medical grade monitor directly to the PC via the PC’s external VGA output. The prerequisites for this are proper connectors on the PC and monitor, as well as the proper connection cables (not included).
14
3.0
Setting up and starting up
Connect stroboscope ATMOS® Strobo 21 LED (optional)
26
back view
back view
control unit
front view
Fig. 15

Connect ATMOS® Strobo 21 LED with stroboscope cable26 to the ATMOS® Scope controller: connect plug (a) with "optional
connection for ATMOS® Strobo 21 LED and EndoStroboscope L (F-Out)" at the rear side of the Stroboscope. Connect plug (c)
with "connection for microphone" at the front side of the stroboscope. Connect plug (b) with connection for stroboscope cable
18 at the controller of the ATMOS® Scope.
 For further details, refer to ATMOS® Strobo 21 LED operating instructions.
Connecting the videoscope
 Connect the videoscope handle with the controller, plugging the plug of connection cable 6 into the socket for connection
cable 13 .
Application with the ATMOSoft ENT
The ATMOSoft ENT has separate operating instructions.
Please pay attention:
Read these separate operating instructions very carefully.
15
3.0
Setting up and starting up
3.7 Tests
Depending on the working distance (see technical data) the endoscopy image must be high-resolving, bright and clear.
The following test sequence must be conducted on the device before processing and immediately before application.
Testing the glass surfaces
 Visual inspection of the glass surfaces. The surfaces must be clean and smooth.
 If damages are discovered during inspection please see chapter Troubleshooting.
Leakage test
30
27
8
28
7
29
2
Fig. 16
 Connect plug cap 8 onto plug 7 .
 Close pressure release valve 30 on the leakage tester 27 .
 Remove dust protection cap from pressure compensation valve 2 .
 Screw on pressure compensation cap 29 to pressure compensation valve 2 .
 Connect silicone tube 28 with pressure compensation cap 29 and leakage tester 27.
 Pump up the system to a pressure of 300 mmHg.
 Wait 30 seconds. By pressing the pressure release valve 30 , drop the pressure to 160 mmHg.

Wait 30 seconds and watch the pressure. The pressure must not drop down by more than 2 mmHG. If the pressure drops
more than 2 mmHg, then the system has a leak and needs to be serviced.
!
16
After the leakage test, remove pressure compensation cap 29 . Refasten dust protection cap.
The leakage test must be performed after each application.
3.0
Setting up and starting up
Testing the deflection mechanism

Slowly operate the deflection lever 1 (Fig. 1), to check the function.

Check if full deflection is achieved (see chapter Technical Data).
!
!
Limitations in deflection can indicate an endoscope defect. To avoid serious damage to the endoscope, only use the
endoscope if the deflection works smoothly and without limitation..
Risk for patients
Risk for patients due to the use of products with sharp edges or damaged surfaces.

!
Do not use these products.
Damaged products
Do not use products with damaged camera chip (e. g. recognizable by image interferences), damaged glass surfaces or
stubborn deposits, which cannot be removed by cleaning.
Send damaged products to the manufacturer or authorized repair center. Authorized repair centers can be inquired from the
manufacturer.
17
4.0
Operation
4.1 Use/Operation
Handle the system very carefully, as it contains sensible optical, mechanical and electronic components. Do not bump
the distal end on hard surfaces.
!
Do not jolt or drop the ATMOS® Scope, protect it from shocks and impacts.
Do not bend or kink the flexible endoscope part, nor tear or squeeze it. The outer coating and inner components could
be damaged.
Never move the tip of the flexible endoscope against a resistance.
The tip contains optical components, which may scratch or break when used incorrectly.
Switching on and adjusting the system.
!
Proper system operation cannot be guaranteed if the controller is switched on before the ATMOS® Scope handle is
connected.

Ensure, that the ATMOS® Scope is connected to the controller before switching on the system.
3
11
Fig. 17
 Plug the microphone 3 into the microphone interface 11 of the videoscope handle. Magnets inside the microphone
automatically orientate the microphone 3 to face in the direction of the flexible endoscope part.
 Switch on controller with the ON/OFF switch 14 . Switch on all additional devices.
 Switch on the monitor in the order to receive the signal from the controller.
 The tip can be moved in two directions with the deflection lever 1 . Please do not press the deflection lever with violence.
 Switch off controller with the ON/OFF switch 14 after use.
18
4.0
Operation
Controller fine adjustment
Generally the product does not need to be configured. However the user has the option to make fine adjustments.
 Turn the controller off by pressing the ON/OFF switch 14 .
 Press and hold either button A 4 or B 5 and turn controller ON. The Set-up menu will appear on the monitor.
 Release button A 4 or B 5 .
 By pressing button A 4 , the various setting options can be selected.
 By pressing button B 5 the selected function can be activated.
 When all the settings are accepted, please select "exit and save" with the button A 4 and confirm with button B 5
 The settings menu is then hidden.
SET-UP menu options
"SHOW/HIDE FREQUENCY"
Show or hide the stroboscopy frequency on the monitor
"STROBOFUNCTION MANUAL/AUTO"
Manual Mode: The stroboscopy function is activated by operating the foot switch.
If the stroboscope is not yet synchronized with the voice frequency, minimal image
inference may occur. Automatic Mode: The stroboscopy function begins once the
system is synchronized with the voice frequency.
"SWITCH FUNCTIONS"
Assigns different functions to buttons A and B.
“COLOUR-SATURATION”
Adjusts the colour temperature of the images in 5 steps
“FACTORY RESET”
Returns the settings back to the factory values
“EXIT”
Closes the menu and returns to live image without saving the settings
“SAVE AND EXIT”
Saves the new settings, closes the menu and returns to the live image
Standard function of Buttons A and B
The buttons A 4 and B 5 only work in combination with an optional PC.
With PC
Button A
4 saves photo memory function on the PC or starts/stops a videofrequency.
Button B
5
has no function in this combination.
If desired, the functions of the buttons can also be programmed alternately.
19
4.0
4.2
Operation
Disassembly
 Pull the microphone out of the microphone interface 11 and clean the ATMOS® Scope (see chapter Cleaning and Disinfection).
 Disconnect connection cable 6 from the controller. Tightly fix plug cap 8 .
4.3
Functions of the buttons on the ATMOS® Scope handle
Both cables must be plugged in
(see diagram). The Remote 1
in the Remote 1 and Remote 2
in Remote 2.
Control box for connecting
the ATMOS® Scope with
the computer
(USB connection)
ATMOSoft ENT 31, ATMOSoft ENT 41
The upper butto is for recording/
freezing an image. By pressing the
button the image is frozen. When
the button is pressed repeatedly the
camera is reactivated.
The lower operating button is for
switching, that means the reset images can be recorded.
Option video recording (ATMOSoft ENT 41)
By pressing the button "camera" it will take you to the video function.
By pressing the button on the ATMOS® Scope you can start resp. stop the recording.
20
5.0
5.1
Cleaning
General Instructions
Adhere to national legal regulations, national and international standards and regulations as well as internal hygiene regulations
for processing.
Reprocessing has to be carried out according to the manufacturer’s rules and instructions. Please use only recommended agents
and procedures. Prior to each reprocessing a leakage test must be performed to prevent the endoscope from damage by liquids.
Mechanical processing provides better and safer results and should therefore be preferred to manual cleaning.
Successful processing of this medical product can only be ensured if processing is peformed through a validated processing
procedure. The user/processor is responsible for the validation.
To prevent contamination of a loaded instrument tray during the procedure, do not put contaminated instruments back onto the
tray, but collect them separately.
Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause corrosion
of the stainless steel. To avoid this, the time interval between procedure and processing must not exceed 6 h. Furthermore do not
use any pre-cleaning temperature >45°C or cleaning or disinfection agents (active ingredients: aldehyde, alcohol) which
could fixate the residues even further.
Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading of laser inscriptions on
stainless steel surfaces.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the industrial water used
for cleaning, disinfecting and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of
stainless steel products. To remove such residues, the products must be rinsed sufficiently with fully desalinated water and dried
thoroughly.
Only use process chemicals that have been tested and approved (e.g. VAH/DGHM or FDA approval or CE mark) and which are
compatible with the product’s materials according to the chemical manufacturers’ recommendations.
All process parameters specified by the chemical’s manufacturer, such as temperature, concentration and exposure times, must
be strictly observed.
Failure to do so could result in the following problems:
 Optical deterioration of materials, e.g. fading or discoloration of titanium or aluminium surfaces. Visible surface changes could
occur for aluminium, with a pH > 8 in the application/process solution.
 Material damage, e.g. corrosion, cracks, breakage, premature aging or swelling.
Clean product directly after use.
Further detailed information for hygienically safe and gentle cleansing/reprocessing can be found under: www.a-k-i.org.
Preparation at the place of use
 If applicable, remove adapters and sealing cap (e. g. Luer Lock).
 If applicable, open valves/taps.
 Put the dry product into a closed disposal container and have it transferred to cleaning and disinfection within 6 h.
21
5.0
Cleaning
Cleaning/Disinfection
!
The product should not be cleaned and/or disinfected in an ultrasonic bath.
Conduct a leakage test before soaking the product in any liquids. (See chapter Tests.)
A leaking device can be damaged by ingress of liquids.
● Before cleaning, put plug cap 8 onto plug 7 .
● Ensure that the plug cap 8 is firmly connected to the plug 7 .
Only use detergents and disinfectants which are approved for the product. Observe manufacturer's instructions.
Observe the concentration, temperature, duration of use and contact time according to manufactuer's instructions.
Avoid excessive pressure and tension onto the flexible videoscope components.
Please clean carefully to prevent the device from damage. Hose and bendable end can be damaged by bending, twisting, pushing
or pulling. Coarse contaminations can be removed with a soft cloth or a soft brush.
Do not exceed a bending radius of 40 mm during reprocessing.
5.2
Manual Cleaning and Disinfection
Cleaning and disinfection controller and microphone
!
Controller and microphone should only be wiped off with a moist cloth. Do not immerse the controller and microphone
in liquids.
 Wipe off the outer surfaces of the controller with a soft cloth, moistened with water, a mild soap solution or isopropanol.
 Stains, which are difficult to remove, can be removed with a mild cleaning agent on ammoniac basis.
 Do not use scrubbing agents or dissolvers, as these may damage the coating or labels.
 Do not use wet sponges or cloths. Excessive cleaning agents could come into contact with electrical parts and could damage
the Unit.
 Only reconnect the system to the mains supply when all cleaned parts are completely dry.
Cleaning and disinfection of the ATMOS® Scope
Manual cleaning with Tristel Wipes
For processing the ATMOS® Scope handle we recommend the Tristel Wipes System.
Please follow the manufacturer's information and operating instructions.
Inspect visible surfaces for residual contamination after manual cleaning/disinfection. Repeat the cleaning process if necessary.
Optical surfaces should not be cleaned with a brush. Remove residues on optical surfaces with a pad moistened with alcohol
(70 % ethanol) or neutral cleaning agent.
22
5.0
Cleaning
Manual cleaning with immersion disinfection and cleaning with a brush
Stage
Step
T (°C/°F)
t (min)
Conc. (%)
Water
quality
Chemical
I
Cleaning
34-45/
95-113
3
0,8
D-W
Enzymatic cleaning
agent, e. g.
Cidezyme/Enzol
II
Intermediate
rinse
RT (cold)
3x1
---
D-W
--0.55 % orthophtalaldehyde
solution, e.
g. Cidex OPA
III
Disinfection
20-25/
68-77
IV
Final rinse
RT (cold)
3x2
---
VE-W
sterile
---
V
Drying
RT
---
---
---
---
12
---
D-W
D-W
Drinking water
RT
Room temperature
VE-W
Fully desalinated water (demineralized, low microbiological contamination, max. 10 germs/ml and low in endotoxins
value, max. 0.25 Endotoxin units/ml)
Stage I
 Fully immerse the product in the cleaning solution. Ensure that all accessible surfaces are moistened
 Clean the product while it is in the cleaning solution, using a soft cloth or a suitable cleaning brush, until all visible
residues have been removed from the surfaces.
 Brush all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens or complex geometry for at
least 1 minute until no more residues can be removed. During cleaning mobilize non-fixed components, such as focus ring,
set screws, links, etc. 3 times in each direction as far as possible.
 Thoroughly rinse these components with the cleaning solution (at least five times), using a disposable syringe (20 ml).
 Do not use metal cleaning brushes or other abrasives which could damage the product surfaces and could cause corrosion.
Stage II
 Thoroughly rinse the product 3 times (all accessible surfaces) for at least 1 minute. Mobilize non-fixed components, such as
focus ring, set screws, links, etc. during cleaning 3 times in each direction as far as possible. Use fresh water for every rinse
cycle.
 Thoroughly rinse all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens (e. g. working
channel) or complex geometry with a disposable syringe (20 ml) for at least 5 times.
 Allow water to drip off for a sufficient length of time.
Stage III
 Fully immerse the product in the disinfecting solution. Ensure that all accessible surfaces are moistened.
 During cleaning mobilize non-fixed components, such as focus ring, set screws, links, etc. 3 times in each direction as far as
possible.
 Thoroughly rinse all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens (e. g. working
channel) or complex geometry with a disposable syringe (20 ml) for at least 5 times.
23
5.0
Cleaning
Stage IV
 After disinfection the product should be thoroughly rinsed 3 times (all accessible surfaces) for at least 2 minutes. During
cleaning mobilize non-fixed components, such as focus ring, set screws, links, etc. 3 times in each direction as far as possible.
Use fresh water for every rinse cycle.
 Thoroughly rinse all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens (e. g. working
channel) or complex geometry with a disposable syringe (20 ml) for at least 5 times.
 Allow water to drip off for a sufficient length of time.
Stage V
 Dry the product with a soft, lint-free tissue.
 Areas, which cannot be reached with the lint-free tissue, can be dried with compressed air
(p max. = 0.5 bar).
Material compatibility releases exist for:
 Gigasept FF (new)
 Helipur HplusN (B. Braun Medical AG)
 Cidex OPA (Johnson & Johnson)
 Cidezyme/Enzol (Johnson & Johnson)
 Neodisher MediClean forte (Chem. Fabrik Dr. Weigert GmbH & Co. KG)
5.3
Mechanical Processing and Disinfection
Hints for mechanical processing
Inspect visible surfaces for residual contamination after mechanical processing/ disinfection. Repeat the cleaning process if
necessary.
The product is compatible with several automatic flexible endoscope reprocessors (AER). For further details regarding the
operation refer to the IFU of AER.
If it is unclear whether the product and all channels can be cleaned and disinfected with the existing AER, contact the
manufacturer of the AER, and check with the manufacturer which cleaning and disinfection program is suitable for the product.
!
Risk of infection for patients and/or user due to
● Residues of cleaning and disinfectants on the product.
● Insufficient cleaning, disinfection and sterilization of the product and accessories.
Depending on the degree of pollution of the product especially its working channel has to be pre-cleaned or brushed.
!
24
Product damage due to excessive temperatures.
During mechanical cleaning and disinfection, the temperature should not exceed 65°C.
5.0
Cleaning
 Position the endoscope according to the instructions of the manufacturer in the AER.
 Connect tube of the AER for the leakage test to the pressure compensation valve 2 of the ATMOS® Scope handle.
If necessary, use adapters.
The validation that the product can be cleaned and disinfected has been conducted using the automatic endoscope reprocessors
of Wassenburg Typ WD 440 in standard program. Thereby the cleaning agent AdaptaClean (Johnson & Johnson) and the disinfectant Cidex OPA-C (Johnson & Johnson) have been used.
The material compatibility has been tested and guaranteed using the AER of Wassenburg, type WD 440.
Material compatibility exists for:
 neodisher MediClean forte (Dr. Weigert)
 Cidex OPA-C (Johnson & Johnson)
 AdaptaClean (Johnson & Johnson)
Color anodized parts or plastic components (e. g. serial rings, ocular) could fade during mechanical cleaning.
5.4
Sterilization
5.4.1 General Instructions
!
Do not autoclave the product.
Before sterilization ensure that the endoscope has no restrictions in use. See chapter Start of Operation (section Tests).
Ensure that the sterilization agent can reach all surfaces.
The implementation of the sterilization lies within the responsibility of the user in order to attain the required degree of sterilization.
5.4.2 Sterilization Methods
Validated method
Gas sterilization (EtO)
 Ethylenoxid (Sterivit method)
!
Screw on pressure compensation cap before sterilization.
Screw off pressure compensation cap after sterilization.
Validated EtO parameters:
Gas mixture:
6 % EtO, 94 % CO2
Temperature:
131 °F +/- 5 °F, 55 °C +/- 2 °C
Relative air humidity:
40 - 90 %
Pressure (overpressure):
1,7 bar (170 kPa)
Reaction time:
120 min
Aerate time:
12 h bei 131 °F +/- 5 °F, 55 °C +/- 2 °C
25
5.0
Cleaning
Material compatibility exists for:
Low temperature plasma sterilization

STERRAD® 50 (Advanced Sterilization Products)

STERRAD® 100S (Advanced Sterilization Products)

STERRAD® 200 (Advanced Sterilization Products)
!
Before sterilization unscrew the compensation cup.
After the sterilization remount the compensation cup.
Observe manufacturer's instructions for all named methods.
The use of different sterilization methods in turn can lead to a shortened lifespan
of the product. Only use one of the approved methods.
Sterilization of the ATMOS® Scope with the STERRAD® sterilization method 100S
Please observe the operating instructions of the STERRAD® sterilizer and the STERRAD sterility guide from ASP.

Clean and disinfect the ATMOS® Scope manually or mechanically.

Allow the ATMOS® Scope to dry thoroughly before you sterilise it in the STERRAD sterilizer.
Humidity can lead to a termination of the sterilisation cycle.

Tighten the pressure compensation cap.

Place the ATMOS® Scope in a sterilisation basket.

Place a STERRAD® indicator strip in the basket.

Double wrap the sterilisation basket with non-woven polypropylene.

Position the basket as follows:
- sterilisation must be performed on every part.
- no parts can touch the sterilisation wall.

Start the sterilisation cycle according to the manufacturers instructions, e.g. STERRAD® 100S Short Cycle.

Please ensure that the sterility is ensured after reprocessing.

Remove the sterile goods from the sterilisation device.

Remove the pressure compensation cap.
26
6.0
Maintenance and services
Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are
familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts.
ATMOS recommends: Work should be carried out by an authorized ATMOS service partner. This ensures that repairs and testing
are carried out professionally, original spare parts are used and warranty claims remain unaffected.
Period tests
At least every 24 months a repeat test of the electrical safety should be performed according to IEC 62353.
ATMOS recommends an inspection according to the manufacturer‘s specifications.
Changing the fuse
 Before changing the fuse, switch off the unit and disconnect it from the power network.
 Using a small screwdriver, press the upper and lower latch toward the middle of the fuse holder 20
 Pull the fuse holder straight out.
 Replace the damaged fuse(s).
 Reinsert the fuse holder.
 Make sure both latches snap back into locked position.
The present product is maintenance-free. It does not contain components which have to be maintained by the user or
manufacturer. However the manufacturer prescribes that a qualified person or a hospital technician inspects the product regularly
and conducts a safety technical control. The inspection should be conducted at least every 24 months.
For repairs, contact the manufacturer or authorized repair center. Authorized repair centers can be inquired at the manufacturer.
For a fast processing of your service requests, return the product indicating:
 Item number (REF)
 serial number (S/N)
 Detailed description of defects
For the protection of your staff, as well as the staff of the repair center, thoroughly clean, disinfect and sterilize the
!
product (and, if applicable, accessories) before shipment. If this is not possible, process the product as well as possible
and mark it accordingly. The repair center can refuse the repair of polluted or contaminated products due to safety
reasons.
Warranty
The manufacturer commits to a 24 months guarantee on the function of the product. This guarantee is restricted to claims, which
are sent in written form within the guarantee period starting from the date of the invoice, resp. with reference to repairs, indicating
the invoice number. Legal guarantee claims are not restricted by this warranty.
This guarantee is only applicable to defects which cannot be attributed to normal wear and tear, misuse or wrong handling, lack of
proper care or Act of nature.
Guarantee and warranty claims will not be accepted if the user himself or a non-authorized repair center performs maintenance or
repair work. In case a product needs to be maintained the same applies for maintenances, which are not permitted explicitely.
Liability claims which arise from improper handling or combination with other devices or accessories cannot be claimed.
27
7.0Troubleshooting
Problem
Cloudy image
Image too dark, insufficient
illumination
Corrosion, staining,
discolouring
System leakage
Deflection defective
Image is blurred
No image on the monitor
No image on PC
Poor colour recording
Color bands on monitor
Stroboscope does not react
Possible cause
Glass surfaces are dirty
Clean glass surfaces according to chapter
Cleaning and Disinfection
Lens system is defective or not sealed
Send endoscope system in for repair
Glass surfaces are dirty
Clean glass surfaces according to chapter
Cleaning and Disinfection
Stubborn residue on the glass surfaces
Remove residues according to chapter Cleaning and Disinfection; check water quality
Inadequate cleaning (e.g. protein residues)
Clean again, resp. rub thoroughly
Inadequate rinsing of the endoscope between processing phases (esp. before sterilization)
Ensure adequate rinsing between the
processing phases
Contaminated or disinfection and cleaning solutions
which are used too frequently
Replace the disinfection and cleaning solutions
at regular intervals
External rust (e.g. through steam or processing with
damaged or rusting instruments)
Check maintenance systems; in case of common processing, check material compatibility,
existing damages and avoid mutual contact with
the other objects
Leakage tester is connected incorrectly
Check the connections of the pressure compensation cap, silicone tube and the leakage tester
Probe tube is defective
Send endoscope system in for repair
Plug cap is not on plug
Push plug cap tightly onto plug
Tip mechanism is defective
Send endoscope system in for repair
Probe tip is dirty
Clean probe tip with alcohol and cotton swabs
Controller is without power
Connect controller according to chapter
Assembly/First Installation and switch it on
Fuse defect
Replace fuse. See chapter Maintenance and
Repair
Faulty connection of the Controller to the monitor
Make sure that the controller is correctly
connected to the monitor
Connection cable is defect or not connected to controller
Connect the ATMOS® Scope handle to the
controller. Ensure that the plug is dry
Monitor is not adjusted to the correct input channel
Adjust the monitor to the correct input channel
No light at the tip of the flexible endoscope
Make sure that the ATMOS® Scope is properly
attached to the controller
Camera USB driver is not installed on the PC
Install camera USB driver via software CD
ATMOS® Scope is not recognized by USB port.
Perhaps the USB port is turned off
USB port via Windows/control panel/power
settings must be permanently activated
Monitor is adjusted incorrectly
Adjust the monitor screen settings.
Defective video cable
Replace video cable or send the endoscope
system in for repair
ATMOS® Scope is defective
Send ATMOS® Scope in for repair
Microphone is not connected or is connected
incorrectly
Connect microphone correctly
Microphone is defective
Replace microphone
Stroboscope cable is connected incorrectly
ATMOS Scope is not
identified by the PC
®
28
Solution
Send the ATMOS® Scope system in for repair
Connect stroboscobe cable correctly
Stroboscope cable is defective
Replace stroboscope cable
USB port has switched off
The USB port via the energy options in Windows must be permanently actived.
8.0
Accessories and Spare parts
Description
REF
ATMOS® Strobo 21 LED
507.4700.0
ATMOS® Cam
on request
ATMOSoft ENT 31
700.0032.0
ATMOSoft ENT 41
700.0035.0
Medical 15" TFT monitor
534.3005.0
Microphone
950.0310.0
ATMOS® Scope case
950.0321.0
Leakage tester
950.0322.0
Controller
950.0319.0
ATMOS® Scope handle
950.0320.0
29
8.0
Accessories and Spare parts
Description
REF
Silicon hose for leakage tester
on request
Instruction card for cleaning with pressure
compensation pin
on request
Fuse 0.63 A (T); 5 x 20 mm (2 pcs)
on request
HF adapter
950.0323.0
BNC-BNC.2, 1.5 m
008.0670.0
USB cable 2.0 m
950.0324.0
Remote cable for analogue control
950.0325.0
ATMOSoft Remote, USB
700.0032.0
Mains cable
507.0859.0
Stroboscope cable ATMOS® Strobo 21 LED
950.0327.0
Structure-borne microphone adapter
507.0775.0
Optional still image/video archiving (digital)
For digital archiving, a PC can be connected via USB (from version 2.0) and images/videos can be recorded with a software.
Optional stroboscope controller
With the optional stroboscope controller (ATMOS® Strobo 21 LED), the physician has a system for stroboscopy at his
disposal. Thanks to its LED technology, a silent stroboscopy without speed reduction, as well as a vocal cord diagnostic
with flicker-free pilot light, freeze image and slow-motion mode are possible. The freeze image with variable phasing and
slow-motion mode with preselectable frequency can be adjusted via a foot-pedal.
The use of an additional adapter for the structure-borne microphone is required for certain patients.
30
9.0
Technical specifications
ATMOS® Scope
Dimensions:
Mains adapter:
Energy consumption:
Fuse:
277 x 60 x 268 mm (B x H x T)
Mains voltage115 - 230 V AC, max.0,5 A, 50/60 Hz
max. 30 VA, protection class: 1
T0.63 A; 5 x 20 mm (2 pcs)
ATMOS® Scope handle
Integrated illumination:
Probe diameter:
Probe length:
Deflection:
Direction of view:
Field of view:
Focus field:
Analog TV system:
Outputs:
Length connection cable to camera
controller:
yes
3.8 mm
300 mm
2 x 160°
0°
85°
6 - 60 mm
NTSC image sensor: 82.000 pixel
2 x composite video (FBAS)
1 x USB 2.0
2 x remote
1 x stroboscope output
2m
Transport and storage
Temperature:
Relative air humidity:
Air pressure:
- 20 °C to + 70 °C
5 % to 95 %
70 kPa to 106 kPa
Store processed products in germ-proof packaging, protected against dust in a dry, dark room at normal temperature.
Operation
Temperature:
+15 °C to +40 °C
UMDNS Code:
GMDN Code:
12-709
45043
Classification acc. to Annex IX
EC Directive 93/42/EEC
I
31
10.0 Disposal
● The ATMOS® Scope does not contain any hazardous materials.
● The housing is fully recyclable.
● Device and accessories must be decontaminated prior to disposal.
● Please ensure a careful separation of the different materials.
● Please observe national disposal regulations (e.g. waste incineration).
Disposal within the EC
The device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed
of professionally. According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste.
Please observe existing national laws and rules for disposal of old devices.
Disposal within the Federal Republic of Germany
In order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer
or send it directly to ATMOS MedizinTechnik for a professional disposal.
Before disposal respectively before transport, all parts, which came into contact with the patient must be thoroughly
cleaned, disinfected. The device surface must be disinfected.
32
11.0 Notes on EMC
■ Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc.
to following EMC notes.
■ Portable and mobile HF communication facilities could influence medical electrical equipment.
■ The use of other accessories, other converters and cables than stated may lead to an increased emission
or a reduced interference immunity of the equipment or system.
11.1 Guidelines and Manufacturer's Declaration - Emissions
The ATMOS® Scope is intended for use in the electromagnetic environment specified below. The customer or user of
the ATMOS® Scope should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1
The ATMOS® Scope uses HF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
to nearby electronic equipment.
RF Emissions
CISPR 11
Class B
Harmonics IEC 61000-3-2
Class A
Flicker
IEC 61000-3-3
match
The ATMOS® Scope is suitable for use in all establishments, including domestic, and those directly
connected to the public low-voltage power supply
network which supplies buildings used for domestic
purposes.
11.2 Guidelines and Manufacturer's Declaration - Electromagnetic immunity
The ATMOS® Scope is intended for use in the electromagnetic environment specified below. The customer or user of
the ATMOS® Scope should ensure that it is used in such an environment.
Immunity Test
IEC 60601Test Level
Compliance Level
Electromagnetic Environment - Guidance
ESD
IEC 61000-4-2
± 6 kV Contact discharge ± 6 kV Contact
discharge
± 8 kV Air discharge
± 8 kV Air discharge
Floors should be wood, concrete,
or ceramis tile. If floors are synthetic, the relative humidity should
be at least 30%.
EFT
IEC 61000-4-4
± 2 kV Mains
± 1 kV I/Os
± 2 kV Mains
inapplicable
± 1 kV I/Os
Mains power quality should be that
of a typical commercial or hospital
environment.
Surges
IEC 61000-4-5
± 1 kV Differential
± 2 kV Common
± 1 kV Differential
± 2 kV Common
Mains power quality should be that
of a typical commercial or hospital
environment.
Power Frequency
50/60 Hz
Magnetic field
IEC 61000-4-8
3 A/m
applicable
3 A/m
Power frequency magnetic fields
should be that of a typical commercial or hospital environment.
33
11.0 Notes on EMC
Immunity Test
Voltage Dips / Dropout
IEC 61000-4-11
NOTE
IEC 60601Test Level
Compliance Level
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
40 % UT
(60% Dip of the UT)
for 5 Cycles
40 % UT
(60% Dip of the UT)
for 5 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
< 5 % UT
(>95 % Dip of the UT)
for 5 s
< 5 % UT
(>95 % Dip of the UT)
for 5 s
Electromagnetic Environment - Guidance
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the ATMOS® Scope demands continued
function even during interruptions
of the power supply, it is recommended to supply the ATMOS®
Scope from an uninterruptible
power supply or a battery.
UT is the mains alternating current prior to application of the test levels.
11.3 Guidelines and Manufacturer´s Declaration - Electromagnetic immunity
The ATMOS® Scope is intended for use in the electromagnetic environment specified below. The customer or user of
the ATMOS® Scope should ensure that it is used in such an environment.
Immunity Test
IEC 60601Test Level
Compliance Level
Conducted RF
IEC 61000-4-6
V1 = 3 Veff
150 kHz to 80 MHz
3V
Radiated RF
IEC 61000-4-3
E1 = 3 V/m
80 MHz to 2,5 GHz
3 V/m
Electromagnetic Environment Guidance
Portable and mobile communications
equipment should be separated from the
ATMOS® Scope incl. the cables by no less
than the distances calculated/listed below.
Recommended distances:
According to the manufacturer's recommendations where „P“ is the max. power
in watts (W) and D is the recommended
separation distance in meters (m).
Field strengths from fixed transmitters, as
determined by an on site (a) evaluation,
should be less than the compliance level
(b).
Interference may occur in the vicinity of
equipment containing the following symbol
34
11.0 Notes on EMC
NOTE 1
With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines might not be applicable in all cases. The propagation of electromagnetic sizes is
influenced by absorptions and reflections of buildings, objects and people.
a
The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio
equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly.
To determine the electromagnetic environment in regard to stationary transmitters, a study of the location
should be considered. If the measured field strength at the location where the ATMOS® Scope
is used exceeds the above compliance level, the ATMOS® Scope should be observed to verify normal
operation.
If abnormal performance characteristics are noted, additional measures may be necessary, e. g. a changed
arrangement or another location for the device.
b
Within the frequency range of 150 kHz to 80 MHz the field strength should be below 3 V/m.
11.4 Recommended separation distances between portable and mobile RF
communications equipment and the ATMOS® Scope
The ATMOS® Scope is intended for use in electromagnetic environment in which RF disturbances are controlled.
The customer or user of the ATMOS® Scope can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the
ATMOS® Scope as recommended below, according to the maximum output power of the communications equipment.
Separation distance, depending on transmit-frequency m
Nominal output of the
transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = [ 3,5 / 3] √P
d = [ 3,5 / 3] √P
d = [ 7,0 / 3] √P
0.01
0.12
0.12
0.233
0.1
0.37
0.37
0.74
1
1.16
1.16
2.33
10
3.69
3.69
7.38
100
11.66
11.66
23.33
W
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended separation distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specification.
NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines may not be applicable in all cases. The propagation of electromagnetic sizes is
influenced by absorptions and reflections of buildings, objects and people.
35
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-0
atmos@atmosmed.de
www.atmosmed.com
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