ATMOS Scope REF 950 03xx 0 Operating Instructions Index 19 Jan 2019

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) [email protected] www.atmosmed.de

2

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

3

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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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

The US Federal Law restricts this product to sale by or on the order of a physician

Latex

Indication that the product does not contain natural rubber latex

MR

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.

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, 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.

3.0

Setting up and starting up

3.1

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

3.0

Setting up and starting up

3.2 Front view ATMOS® Scope controller

13

14

Fig. 2 13

Socket for connection cable 6

14

ON/OFF switch

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

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

9

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 6 into the socket for connection cable 13 . 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 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.

“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

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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)

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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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