ATMOS Scope Basic REF 950 0330 B Operating Instructions Ver 16 Jan 2016

Page 1

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

Page 3

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

Page 4

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

Page 5

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

Page 6

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.

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

6

Connection cable

Microphone interface

7

Page 8

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

Page 9

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

Page 10

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

Page 11

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

Page 12

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

Page 13

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

Page 14

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

Page 15

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

Page 16

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.

Page 17

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

Page 18

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

Page 19

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

Page 20

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

Page 21

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

Page 22

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

Page 23

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

Page 24

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.

Page 25

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