ATMOS Scope REF 950 03xx 0 Operating Instructions Index 19 Jan 2019.pdf
Page 1
English
Operating Instructions
ATMOS® Scope
ATMOS® Scope Basic
GA1GB.150253.0
TPA191-158-1112-01_M
2019-01 Index: 19
Page 2
Content
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
3.6.1
3.6.2
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
Required additional devices.................................10
Installation at the place of operation....................10
Tests.....................................................................13
4.0
4.1
4.1.1
4.1.2
4.1.3
Operation............................................................14
Use/Operation......................................................14
Switching on and adjusting the system................14
Controller fine adjustment....................................15
Functions of the buttons with ATMOSoft /
ATMOS® Capture Suite........................................16
Disassembly.........................................................16
4.2
5.0
5.1
5.2
5.2.1
5.3
5.4
5.4.1
5.4.2
Cleaning and care..............................................17
General instructions.............................................17
Manual cleaning and disinfection.........................18
Cleaning and disinfection: Controller and
microphone..........................................................18
Cleaning and disinfection: ATMOS® Scope
handle with flexible endoscope part.....................18
Mechanical cleaning and disinfection..................20
Sterilization..........................................................21
General instructions.............................................21
Sterilization methods...........................................21
6.0
Maintenance and Service..................................23
7.0
Troubleshooting.................................................24
8.0
Accessories and spare parts............................25
9.0
Technical data....................................................27
10.0
Disposal..............................................................28
11.0
Notes on EMC.....................................................29
5.2.2
Further information, accessories, consumables and spare
parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Phone +49 7653 689-0
Fax: +49 7653 689-190
+49 7653 689-292 (Service Centre)
atmos@atmosmed.de
www.atmosmed.de
2
Page 3
1.0
Introduction
1.1 Notes on Operating Instructions
These operating instructions contain important notes on how to operate the ATMOS® Scope, correctly
and effectively. Their reading helps to avoid risks, and also to avoid repair costs and down-times. This
increases also the reliability and service-life of your 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. 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 and period tests 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 period tests may be carried out only 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 EC Directive of the council for
medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive.
• 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 general standard 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 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:
REF 950.0300.0
• ATMOS® Scope
®
REF 950.0330.0
• ATMOS Scope Basic
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Page 4
1.0
Introduction
1.2 Intended use
Name
ATMOS® Scope / ATMOS® Scope Basic
Main function
During an endoscopy procedure the use of the ATMOS® Scope / ATMOS® Scope
Basic is indicated for the temporary application in the oral cavity up to the throat
and in the nasal cavity. It enables the visualization of body orifices and body cavities.
Medical 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 light source makes endoscopy and
stroboscopy possible:
• Bright homogeneous 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 300 mm
• Angulation angle 2 x 160°
• 100% waterproof
Application organ
Nasal and oral cavities to the larynx, auditory canal to the ear drums
Application time
Temporary
Area of application
In clinics and practices for ENT doctors
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/re-sterilisation
Reprocessing is possible
1.3 Function
The flexible nasopharyngoscope 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
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 image storage is possible in connection with the ATMOSoft / ATMOS® Capture Suite
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Page 5
1.0
Introduction
1.4 Explanation of symbols
Short cuts / symbols contained in these operating instructions
Follow the arrows
■
General information
Move, plug... in this
direction
Please press where
dot indicates
●
Numeration
Turn, shift... in this
direction
Please read,
important information
→
Sub-numeration
Replace
Check
click
Engage, check
correct fit
Graphic symbols contained in these operating instructions
Warning; take extra care to
observe
!
)) Important information
Symbols of ATMOS® Scope
SN
Serial number
REF
Order number
Manufacturing date
Manufacturer
+68°F
-20°C
+158°F
+70°C
95%
Indicates the tolerable temperature
Indicates the tolerable air humidity
!
Professional disposal
2nd-edition IEC 60601-1: Caution, observe
accompanying documents
3rd-Edition IEC 60601-1: Caution
Follow operating instructions
Application part type BF acc. to EN 60601-1
R Only
Latex
MR
The US Federal Law restricts this product to sale
by or on the order of a physician
Indication that the product does not contain
natural rubber latex
Magnetic resonance unsafe
5%
106 kPa
Fuse
Indicates the tolerable air pressure
70kPa
This product complies with the relevant
requirements of the EU Directives.
NON
STERILE
Sterilize prior to each use
1.5 Scope of delivery
Prior to dispatch, the ATMOS® Scope was subjected to an extensive functional test and was carefully packed.
Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).
ATMOS® Scope Basic: ATMOS® Scope handle, controller, leakage tester, pressure compensation cap, BNC video cable (2 pcs),
silicone hose, power cable, BNC cinch adapter (2 pcs), USB 2.0 cable, remote cable for ATMOSoft / ATMOS® Capture Suite,
ATMOSoft / ATMOS® Capture Suite 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, power cable, BNC cinch adapter (2 pcs), USB 2.0 cable, remote cable for ATMOSoft /
ATMOS® Capture Suite, ATMOSoft / ATMOS® Capture Suite demo CD, transport case, operating instructions.
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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,
colour changes on the monitor).
• Use in combination with MR
The product is MR unsafe - in areas with magnetic
resonance imaging, the product is unsafe.
• 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.
• 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
• 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.
• Image interferences, image breakdown or breakdown of
the integrated light source could lead to risks.
ªª In this case, release deflection lever and carefully
withdraw the ATMOS® Scope.
• 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
occur. Please make sure to reduce duration of use to a
minimum, to switch off the light source when not in use
and to check heat development if necessary.
• The ATMOS® Scope may be operated only 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 conditions
are kept. Also, the relevant standard and the respective
national tolerances must be followed.
Page 7
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
Microphone interface
6
Connection cable
7
Page 8
3.0
Setting up and starting up
3.2 Front view ATMOS® Scope controller
13
14
Fig. 2
13
Socket for connection cable
14
ON/OFF switch
6
3.3 Rear view ATMOS® Scope controller
17
15
16
20
18
19
Fig. 3
8
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
20
Fuse holder with fuses
21
Mains connection
21
Page 9
3.0
Setting up and starting up
3.4 Overview cables
22
23
24
25
26
Fig. 4
22
BNC video cable
25
Remote cable
23
USB 2.0 cable
26
Stroboscope cable (optional)
24
Power 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
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3.0
Setting up and starting up
3.6 Assembly/First Installation
3.6.1 Required additional devices
• Monitor according to the medical device directive 93/42/EEC.
3.6.2 Installation at the place of operation
!
Connecting the controller to the mains supply
Ensure that the correct power cable is used for the respective country.
• Connect power cable 24 with power connection 21 at the controller.
• Plug the power 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 .
• Install the driver from the enclosed CD
ªª After the installation is completed the ATMOS® Scope will appear as a "USB 2820 Device" in the Device Manager.
• Remove software CD from the drive.
• Restart the PC.
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).
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3.0
Setting up and starting up
Connect stroboscope ATMOS® Strobo 21 LED (optional)
26
Rear side
ATMOS® Strobo 21 LED
Rear side
ATMOS® Scope control unit
Front view
ATMOS® Strobo 21 LED
Fig. 15
• Connect ATMOS® Strobo 21 LED with stroboscope cable 26 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 ATMOS® Scope
• Connect the ATMOS® Scope handle with the controller, plugging the plug of connection cable
connection cable 13 .
6
into the socket for
Application with the ATMOSoft / ATMOS® Capture Suite
The ATMOSoft / ATMOS® Capture Suite has separate operating instructions.
Please note:
Read these separate operating instructions very carefully.
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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. 17
•
•
•
•
•
•
•
•
!
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 hose 28 with pressure compensation cap 29 and leakage tester 27 .
Pump up the system to a pressure of 300 mmHg.
Wait for 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.
After the leakage test, remove pressure compensation cap 29 . Refasten dust protection cap.
The leakage test must be performed after each application.
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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
!
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 centre. Authorized repair centres can be inquired from the
manufacturer.
Risk for patients due to the use of products with sharp edges or damaged surfaces.
• Do not use these products.
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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.
4.1.1 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 ATMOS® Scope 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.
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4.0
Operation
4.1.2 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
• The settings menu is then hidden.
5
.
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.
“COLOUR-SATURATION”
Adjusts the colour saturation 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
15
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4.0
Operation
4.1.3 Functions of the buttons with ATMOSoft / ATMOS® Capture Suite
The ATMOSoft / ATMOS® Capture Suite has separate operating instructions.
Both cables must be plugged in
(see diagram). The Remote 1 in
the Remote 1 and Remote 2 in
Remote 2.
Button A: Remote 1
Button B Remote 2
Control box for connecting
the ATMOS® Scope with the
computer (USB connection)
Photo mode: Taking photo.
Video mode: Start and end recording.
Photo mode: Switch to the next storage space. This
function must be activated in the software.
Video mode: Pause and continue recording.
4.2 Disassembly
• Remove the microphone from 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 .
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5.0
Cleaning and care
5.1 General instructions
Adhere to national legal regulations, national and international standards and regulations as well as internal hygiene regulations
for reprocessing.
Reprocessing has to be carried out according to the manufacturer’s rules and instructions. Only use 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 performed 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 discolouration 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.
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5.0
!
Cleaning and care
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 manufacturer'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
5.2.1 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.
5.2.2 Cleaning and disinfection: ATMOS® Scope handle with flexible endoscope part
Manual cleaning with 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.
Manual cleaning with immersion disinfection and cleaning with a brush
Phase
Step
T (°C/°F)
t (min)
Conc. (%)
Water quality
Chemistry
I
Cleaning
34-45/
95-113
3
0.8
D-W
Enzymatic cleaning agent,
e.g. Cidezyme/Enzol
II
Intermediate
rinsing
RT (cold)
3x1
---
D-W
---
III
Disinfection
20-25/
68-77
12
---
D-W
0.55 %
orthophtalaldehyde
solution, e.g. Cidex OPA
IV
Final rinsing
RT (cold)
3x2
---
V
Drying
RT
---
---
VE-W
sterile
---
-----
D-W Drinking water
RT
Room temperature
VE-W Purified water (demineralized, low germs, maximum 10 germs/ml and endotoxin-poor, maximum 0.25 endotoxin units/ml)
18
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5.0
Cleaning and care
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 set screws,
joints, lever etc. 3 times in each direction as far as possible.
• Thoroughly rinse these components with the cleaning solution (at least 5 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
set screws, joints, lever, etc. 3 times in each direction as far as possible. Use fresh water for each rinsing 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.
• Mobilize non-fixed components, such as set screws, joints, lever, 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.
Stage IV
• After disinfection the product should be thoroughly rinsed 3 times (all accessible surfaces) for at least 2 minutes. Mobilize
non-fixed components, such as set screws, joints, lever, etc. 3 times in each direction as far as possible. Use fresh water for
each rinsing 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.
Phase 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)
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5.0
Cleaning and care
5.3 Mechanical cleaning and disinfection
Hints for mechanical processing
Inspect visible surfaces for residual contamination after mechanical cleaning/disinfection. Repeat the cleaning process if
necessary.
The product is compatible with several automatic flexible endoscope reprocessors (AFER). For further details regarding the
operation refer to the operating instructions of AFER.
If it is unclear whether the product and all channels can be cleaned and disinfected with the existing AFER, contact the
manufacturer of the AFER, and check with the manufacturer which cleaning and disinfection programme 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.
!
Product damage due to excessive temperatures.
During mechanical cleaning and disinfection the temperature should not exceed 65°C.
• Position the endoscope according to the instructions of the manufacturer in the AFER.
• Connect tube of the AFER 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 programme. 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 AFER of Wassenburg, type WD 440.
Material compatibility releases exist for:
• neodisher® MediClean forte (Dr. Weigert)
• Cidex OPA-C (Johnson & Johnson)
• AdaptaClean (Johnson & Johnson)
Colour anodized parts or plastic components (e.g. serial rings, ocular) could fade during mechanical cleaning.
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5.0
Cleaning and care
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)
• Ethylene oxide (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)
Exposure time:
120 min
Aeration time:
12 h at 131 °F +/-5 °F, 55 °C +/- 2 °C
Material compatibility releases exist for:
Low temperature plasma sterilization
• STERRAD® 50 (Advanced Sterilization Products)
• STERRAD® 100S (Advanced Sterilization Products)
• STERRAD® 200 (Advanced Sterilization Products)
Screw on pressure compensation cap before sterilization.
Screw off pressure compensation cap after sterilization.
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.
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5.0
Cleaning and care
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.
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6.0
Maintenance and Service
Maintenance, repairs and period 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.
ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. This ensures that the repairs and
testing are carried out professionally, that original spare parts are used and that 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 conducting this inspection in accordance with the manufacturer‘s specifications.
Fuse exchange
• 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
• Pull the fuse holder straight out.
• Replace the damaged fuse(s).
• Reinsert the fuse holder.
• Make sure both latches snap back into locked position.
20 .
Sending in the device
• Remove all consumables and dispose of them properly.
• Clean and disinfect the product and accessories in accordance with the operating instructions.
• Place any used accessories with the product.
• Fill in the QD 434 “Delivery complaint/return shipment” form and the corresponding decontamination certificate.
)) This form is enclosed with each delivery and can be found at www.atmosmed.com .
• The device must be well padded and packed in suitable packaging.
• Place the QD 434 “Delivery complaint/return shipment” form and the corresponding decontamination certificate in an
envelope.
• Affix the envelope to the outside of the package.
• Send the product in to ATMOS or your dealer.
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 force majeure.
Guarantee and warranty claims will not be accepted if the user himself or a non-authorized repair centre performs maintenance
or repair work. In case a product needs to be maintained the same applies for maintenances, which are not permitted explicitly.
Liability claims which arise from improper handling or combination with other devices or accessories cannot be claimed.
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7.0
Troubleshooting
Problem
Cloudy image
Image is too
dark, insufficient
illumination
Corrosion,
staining,
discolouring
Leakiness
Distortion is tight,
defective
Image is blurred
No image on the
monitor
Possible cause
Glass surfaces dirty
Leaky, defective
lens system
Glass surfaces dirty
Stubborn residue on the glass surfaces
Inadequate cleaning (e.g. protein residue)
Inadequate rinsing of the endoscope between
re-sterilisation steps (especially before actual
sterilisation)
Disinfecting and cleaning solutions contaminated
or used too frequently
Extraneous rust (e.g. by rusty steam or
processing with damaged or non-stainless
instruments)
Leakage tester is connected incorrectly
Probe tube is defective
Plug cap is not on plug
Defective peak mechanism
Probe tip is dirty
Controller is without power
Fuse defect
Faulty connection of the controller to the monitor
Connection cable is defect or not connected to
controller
Monitor is not adjusted to the correct input
channel
No light at the tip of the flexible endoscope part
No image on the
monitor
Poor colour
recording
Colour bands on
monitor
Camera USB driver is not installed on the PC
ATMOS® Scope is not recognized by USB port.
Perhaps the USB port is turned off
Monitor is adjusted incorrectly
Defective video cable
ATMOS® Scope is defective
Stroboscope does Microphone is not connected or is connected
not react
incorrectly
Microphone is defective
Stroboscope cable is connected incorrectly
ATMOS Scope
is not identified by
the PC
®
24
Stroboscope cable is defective
USB port has switched off
Solution
Clean glass surfaces according to chapter Cleaning and
Disinfection
Send ATMOS® Scope in for repair
Clean glass surfaces according to chapter Cleaning and
Disinfection
Remove residues according to chapter Cleaning and
Disinfection; check water quality
Clean again, resp. rub thoroughly
Ensure adequate rinsing between the processing
phases
Replace the disinfecting and cleaning solutions at
regular intervals
Check supply systems; ensure material compatibility
during common processing, pay attention to existing
damage and avoid mutual contact
Check the connections of the pressure compensation
cap, silicone tube and the leakage tester
Send ATMOS® Scope in for repair
Push plug cap tightly onto plug
Send ATMOS® Scope in for repair
Clean probe tip with alcohol and cotton swabs
Connect controller according to chapter Assembly/First
Installation and switch it on
Replace fuse (see chapter Maintenance and Repair)
Make sure that the controller is correctly connected to
the monitor
Connect the ATMOS® Scope handle to the controller.
Ensure that the plug is dry
Adjust the monitor to the correct input channel
Make sure that the ATMOS® Scope is properly attached
to the controller
Install camera USB driver via software CD
USB port via Windows/control panel/power settings
must be permanently activated
Adjust the monitor screen settings
Replace video cable or send the endoscope system in
for repair
Send ATMOS® Scope in for repair
Connect microphone correctly
Replace microphone
Send ATMOS® Scope in for repair
Connect stroboscope cable correctly
Replace stroboscope cable
The USB port via the energy options in Windows must
be permanently activated
Page 25
8.0
Accessories and spare parts
Name
REF
ATMOS® Strobo 21 LED
507.4700.0
ATMOS® Capture Suite lite
ATMOS® Capture Suite
ATMOS® Capture Suite HD
700.0045.0
700.0046.0
700.0047.0
ATMOS® Medical Monitor HD 21.5“
ATMOS® Medical Panel PC Touch 21.5“ i7
507.3115.0
507.3122.0
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
25