ATMOS ENT Flexible fibre endoscope Operating Instructions Index 03 July 2021

Table of contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Introduction... 4 Notes on operating instructions...4 Explanation of pictures and symbols...5 Intended use...6 Function...7 Intended users...7 Scope of delivery...8 Transport and Storage...8

2 2.1 2.2 2.3

Hints for your safety... 9 General safety information...9 Danger for users, patients and third parties...9 Avoid damage to the device... 10

3 3.1 3.2 3.3

Setting up and starting up... 11 Device overview... 11 Preparing the device... 11 Using with other devices... 12

4 Operation... 14 4.1 Prior to use... 14 4.2 Potential movement... 14 4.2.1 Deflecting the tip... 14 4.3 Focussing... 14 4.4 After use... 15 5 Cleaning and disinfection... 16 5.1 Prepare for cleaning... 17 5.2 Manual cleaning and disinfection... 17 5.2.1 Stage I... 18 5.2.2 Stage II... 18 5.2.3 Stage III... 19 5.2.4 Stage IV... 19 5.2.5 Phase V... 19 5.2.6 Remove stubborn deposits from glass surfaces... 19 5.2.7 Conclude cleaning and disinfection... 19 5.3 Machine cleaning and disinfection... 20 5.4 Recommended disinfectants... 21 5.4.1 Recommended endoscope disinfectants... 21 5.5 Sterilization... 22 2



5.5.1 5.5.2

Preparing for sterilization... 22 Gas sterilization... 22

6 Maintenance and service... 23 6.1 Function check... 23 6.2 Further tests... 23 6.2.1 Leakage test... 23 6.2.2 Checking the fibre optics... 24 6.2.3 Checking the glass surfaces and the surface... 24 6.3 Sending in the device... 25 7

Troubleshooting... 26

8

Disposal... 28

9

Technical data... 29

10

For your notes... 30



3

1

Introduction

1.1

Notes on operating instructions These operating instructions contain important instructions on how to operate your product safely, correctly and effectively. These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Any reprint - even in extracts - only after written permission from ATMOS. These operating instructions must always be kept available near the device. Care, period tests, regular cleaning and proper application are indispensable. That increases, among other things, the reliability and service-life of the product. Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts. Peruse chapter „2 Hints for your safety“ on page 9, before using the product for the first time. This helps you avoid potentially dangerous situations. The product 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 at ATMOS has been certified according to international standards EN ISO 13485.

These operating instructions are valid for the following devices: • ATMOS nasopharyngoscope 3.2 mm

4

Introduction

950.0243.0

1.2

Explanation of pictures and symbols

In the operating instructions DANGER Warning of a danger which causes immediate death or serious injury. Observe the necessary measures. WARNING Beware of a danger which can cause death or serious injury. Observe the necessary measures. CAUTION Beware of a danger which can easily hurt you. Observe the necessary measures. ATTENTION Indication of a danger where the product or other items can be damaged. Observe the necessary measures. Warning of a danger which can cause death or serious injury. Information regarding possible material damage which can be caused.



Useful information on the handling of the device.

1.

Action. Go step by step.

»

Result of an action.

On device and type plate Refer to the operating instructions

Follow operating instructions (blue)

Manufacturer

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

Manufacturing date

Introduction

5

SN

Serial number Application part type BF

NON STERILE

1.3

6

Not sterile

REF

Order number

MR

Do not use in magnetic resonance areas Professional disposal

Intended use

Name:

ATMOS ENT flexible fibre endoscopes

Main function:

The application of the ATMOS ENT flexible fibre endoscopes is indicated for endoscopic procedures, for the short term application in the oral cavity up to the pharynx, in the auditory canal to the eardrum and in the nasal cavity for the visualization of orifices and visceral cavities.

Medical indication / application:

For application on humans

Specification of the main function:

High resolution flexible fibre endoscope with a pliable flexible tip, which enables an extended line of vision from 0° to 140° in two opposite directions. All standard C-mount adapters with camera heads can be attached to the eyepiece, this enables a video technical image transmission as live-image or a recording as a picture and/or film for documentation.

User profile:

Doctors and medically trained personnel

Patient groups (e.g. age, weight, health, state):

Patients of all ages without restrictions, where a endoscopic standard examination is to be performed.

Application organ:

Oral cavity, nasal cavity, auditory canal

Application time:

Application up to 60 minutes

Application site:

In ENT practices, outpatient departments, clinics, operating rooms and phoniatrists.

Introduction

Contraindications:

The application of the ATMOS HNO flexible fibre endoscope is contraindicated if endoscopic procedures are contraindicated.

The product is:

Not active

Sterility:

Not sterile

Single-use product/ reprocessing:

No single-use product. See cleaning and disinfecting instructions in the operating instructions.

1.4

Function

ATMOS endoscopes are indicated for the visualization of orifices and body cavities. Depending on the cross-section, length and locking possibilities, each of the endoscopes is designed for a specific purpose in a particular field of medicine. The natural orifices are illuminated via extremely thin fibreglass fibres which are thinner than human hair. With the aid of a camera an image can be transferred from the orifice to the screen or display via a substantially larger amount of similar fibreglass fibres.

1.5

Intended users

Endoscopic procedures may only be carried out by qualified professionals (e.g. doctors) with corresponding training and familiarity with endoscopic procedures. In that regard it is the responsibility of the user to continuously inform himself from the manufacturer regarding indication, contraindication, possible complications and risks as well as further developments in the endoscopic procedures. A thorough understanding of the principles and methods used in laser endoscopy and electro-surgical procedures is necessary to avoid shock and risk of burns to patients and users as well as damage to other equipment and instruments.

Introduction

7

1.6

Scope of delivery

• Flexible fibre endoscope • Aluminium carrying case • Leakage tester • Valve cap • Operating Instructions

1.7

Transport and Storage

Only transport the device in a shipping container, which is padded and offers sufficient protection. If damage occurs during transport: 1.

Document and report the transport damage.

2.

Send the product to ATMOS, see Chapter „6.3 Sending in the device“ on page 25.

Environmental conditions for transport and storage:

8

• Temperature:

-20...+70 °C

• Relative air humidity:

5...95 % without condensation

• Air pressure:

70...106 kPa

Introduction

2

Hints for your safety

The safety of the product complies with all the recognized rules of technology and the Directives of the Medical Devices Act. Read and follow the safety information carefully before using the product.

2.1

General safety information

Never operate the device, if it shows any obvious safety defects. Check the unit at regular intervals for safety and function.

2.2

Danger for users, patients and third parties

Reduce the risk of infection for you and your patients! Deadly diseases can be transmitted. •

Clean and disinfect the product after every use.

•

Clean and disinfect the device according to the operating instructions.

Avoid misapplication. Your patient may be seriously injured. •

Prior to each use a function check has to be performed.

•

Always have a replacement light source at hand or use light sources which have a substitute bulb.

•

The simultaneous use of NMR (Nuclear Magnetic Resonance) and endoscopes can lead to dangers and artefacts. Observe the necessary safety instructions.

Heat development on the light source. Burns are possible. •

Attention must be paid that the end of the light conductor does not touch the tissue.

•

If applicable, rinse the surgical field sufficiently.

Only a fully functional product meets the safety requirements of users, patients and third parties. Therefore, please also observe the following guidelines concerning your product.

Hints for your safety

9

2.3

Avoid damage to the device

Incorrect or careless handling of the product. The product may be damaged. •

Avoid bending the flexible fibre endoscope tightly, wrap it tightly, or subject it to strong impact.

•

Do not rotate, pull or put pressure on the flexible parts.

•

Always allow the product to cool down to room temperature without any additional cooling measures.

Improper cleaning, disinfection and sterilization. The product may be damaged. •

10

Observe the instructions for cleaning, disinfection and sterilization in chapter „5 Cleaning and disinfection“ on page 16.

Hints for your safety

3

Setting up and starting up

3.1

Device overview

10

9

13

11 12

8 7 1

6

2

5

4

3

1

Flexible fibre endoscope with vent valve

2

Vent valve

3

Diopter adjustment (focussing)

4

Deflection lever UP/DOWN

5

Light cable connection for ACM1/British Standard (on the opposite side of the housing)

6

Lens

7

Transfer sleeve for light cable

8

Light cable sleeve for AMCI connection

9

Light cable

10

Light cable sleeve for light sources

11

Valve cap

12

Leakage tester

13

Silicone hose

3.2

Preparing the device

The product is supplied non-sterile. Setting up and starting up

11

1.

Clean and disinfect the device prior to first use.

2.

Sterilize the device where it is necessary for the medical indication.

3.3

Using with other devices

Attention must be paid that devices which are used with the endoscope meet all safety requirements. Attention must be paid when using the endoscope with an electro medical device, that the terms and conditions for the application part are complied with type BF (insulated, floating application part). Combined with laser, HF-surgery, pneumatic or electrohydraulic lithotripters, various therapeutic applications are possible. 1.

Observe the operating and safety instructions of the applied devices and accessories.

Using with high-frequency surgical devices WARNING Explosion and fire hazard! Burns and injuries are possible. •

Take the necessary measures to remove or avoid formation of combustible gases.

Predominant depression in the tissue can be caused due to low and unsuitable performance settings or incorrect application. Serious injury to the patient is possible.

12

•

The patient must be suitably prepared.

•

Set the performance setting based on clinical references and only with the necessary training and experience.

•

Only switch on the high-frequency current when the application part (electrode) can be seen through the endoscope.

Setting up and starting up

Using with laser devices WARNING Dangerous laser radiation. Serious damage to the eyes is possible. •

Wear suitable protection glasses.

Burns and undesirable depressions in the tissue •

The laser performance should only be activated when the tip of the laser fibre can be seen through the endoscope.

Setting up and starting up

13

4

Operation WARNING

Danger of infection due to secretion on the endoscope. Deadly diseases can be transmitted. •

Always keep a used endoscope separate from other reprocessed instruments.

•

Clean and disinfect the endoscope after each use within 6 hours.

4.1

Prior to use

1.

Connect the accessories and components.

2.

Perform a function check.

& Check the functionality of accessories and components.

4.2

Potential movement

The flexible fibre endoscope can be moved in three ways: • It can be moved in all directions along the longitudinal axis. • It can be rotated. • The distal end can be bent.

4.2.1 1.

Deflecting the tip

Press the deflection lever 1 .

1

4.3 1.

Focussing

Turn the diopter adjustment 2 .

2

14

Operation

4.4

After use

1.

Remove all used adapters from the light cable connection.

2.

Remove the seal cap from the luer-lock connection.

3.

Visible residue should be removed immediately after surgery using a lint-free disposable cloth.

4.

Transport the product dry in a closed disposal container for cleaning and disinfecting.

5.

Clean and disinfect the endoscope after each use within 6 hours.

Operation

15

5

Cleaning and disinfection

We recommend you to document any maintenance work and also any exchange of parts. It is the responsibility of the operator to ensure that the required results for cleaning and disinfection are adhered to. Generally validation and routine monitoring of the procedure is necessary. The amount of processing cycles depends on different factors and cannot be generalized. WARNING Risk of infection due to secretion on the product and accessories. Deadly diseases can be transmitted. •

Always wear disposable gloves during any cleaning.

•

Clean and disinfect the product after every use.

•

Clean and disinfect the device according to the operating instructions.

•

Observe relevant national legal regulations and standards for cleaning, disinfection and sterilization. This applies especially to patients with suspected Creutzfeldt-Jacob-Disease (CJD), or possible variants. ATTENTION

Dried up residue after surgery due to wrong cleaning. Corrosion damage and difficult cleaning are possible.

16

•

Clean and disinfect the endoscope after each use within 6 hours.

•

Do not use pre-cleaning temperatures >45°C.

•

Do not use fixing detergent with the substance aldehyde or alcohol.

Cleaning and disinfection

ATTENTION Incorrect cleaning and disinfectants. Damaged surface, faded laser marking or chemically damaged product. •

Observe the correct dosage for neutralizing agents and basic cleaners.

•

Do not use abrasives.

•

Only use cleaning and disinfectant agents which are recommended by the manufacturer of endoscopes.

•

Do not use cleaning and disinfectant agents which could cause stress cracks or corrosion in plastic.

•

Observe that the pH value of the application solution is <8.

Incorrect cleaning and disinfection: Damaged product. •

Never clean the product in an ultrasonic bath.

•

Only use cleaning and disinfection devices which are suitable for cleaning flexible fibre endoscopes.

•

Do not autoclave the product.

•

Only use the recommended disinfectant agents and sterilization methods.

•

Avoid excessive pressure or tension to the flexible probe area.

•

Ensure that the bending radius of the flexible probe area is at least 40 mm.

5.1 1.

Prepare for cleaning

Prior to every cleaning and disinfection a leakage test must be conducted, see chapter „6.2.1 Leakage test“ on page 23.

5.2

Manual cleaning and disinfection

Only clean the device when it is leakproof. See chapter „6.2.1 Leakage test“ on page 23. Following disinfection with non-virucidal agents, sterilization must be carried out.

Cleaning and disinfection

17

Stage Step

Temperature

Time

Concentration

Water quality

I

Cleaning

35 - 45 °C / 95-113 °F

5 min

0.8 %

Drinking Cidezyme / water Enzol1

II

Intermedi- Room temate rinsing perature (cold)

3X 1 min

---

Drinking --water

III

Disinfection

20 - 25 °C / 68 - 77 °F

12 min ---

Drinking Cidex OPA2 water

IV

Final rinsing

Room temperature (cold)

3X 2 min

---

VE-W sterile3

V

Drying

Room temperature

---

---

Drinking --water

1

Enzymatic cleaner

2

Ready-to-use solution, 0,55 % orthophtalaldehyd

Chemistry

---

Demineralized water (demineralised, low germs, maximum 10 germs/ml and endotoxin-poor, maximum 0.25 endotoxin units/ml)

3

5.2.1

Stage I

& The concentration of the cleaning agent depends on the contamination of the product. Observe the manufacturer's instructions for use of the cleaning solution. 1.

The product must be completely immersed in the cleaning solution so that all accessible surfaces are covered. Damaged product due to cleaning with a metal brush.

2.

Place the product in the solution and clean with a soft cloth or a suitable soft cleaning brush.

»

There is no visible residue on the surface.

3.

Operate the movable components like focussing and deflection lever in the solution.

4.

Thoroughly rinse the movable components with the cleaning solution, at least 5 times, using a disposable syringe (20 ml)

5.2.2

Stage II

Use fresh water for each rinsing cycle. 18

Cleaning and disinfection

1.

Thoroughly rinse all accessible surfaces of the product three times for at least 1 minute.

2.

Operate the movable components like focussing and deflection lever in the solution.

3.

Allow the rest of the water to drain off.

5.2.3

Stage III

1.

The product must be completely immersed in the cleaning solution so that all accessible surfaces are covered.

2.

Operate the movable components like focussing and deflection lever in the solution.

5.2.4

Stage IV

Corrosion damage due to chlorine- and chloride residues. Use fresh, demineralised water for each rinse and rinse thoroughly. 1.

Thoroughly rinse the product 3 times completely, all accessible surfaces, for at least 2 minutes.

2.

Operate the movable components like focussing and deflection lever in the solution.

3.

Allow the remaining water to drain off sufficiently.

& If the product is not sufficiently rinsed, stubborn residue could develop on the glass surface.

5.2.5

Phase V

1.

Dry the product with a lint-free cloth.

2.

Areas which cannot be accessed with a cloth must be dried with medical-quality compressed air (p max. = 0.5 bar).

5.2.6

Remove stubborn deposits from glass surfaces

& Stubborn deposits develop when the device is not rinsed sufficiently. 1.

Clean the glass surfaces with suitable cleaning paste or with a cotton bud soaked in alcohol.

5.2.7 1.

Conclude cleaning and disinfection

Check whether all visible surfaces are without residue. If residue is found, repeat the cleaning and disinfection. Cleaning and disinfection

19

2.

If you have disinfected with non-virucidal disinfectants, you must sterilize the product.

& If stubborn residue cannot be removed by cleaning, the product must be sent to ATMOS or an authorized dealer.

5.3

Machine cleaning and disinfection

Check whether your cleaning and disinfection device for endoscopes is suitable for the ATMOS ENT flexible fibre endoscope. If necessary, check with the manufacturer of your cleaning and disinfection device for endoscopes. Only clean the device when it is leakproof. See chapter „6.2.1 Leakage test“ on page 23. Following disinfection with non-virucidal agents, sterilization must be carried out. 1.

If the endoscope is highly contaminated, then clean it manually beforehand.

2.

Remove the valve cap from the vent valve. Damaged endoscope due to connection of the wrong hose.

3.

Connect the pressure equalization hose of the cleaning and disinfection device for endoscopes to the valve cap. If necessary use an adapter. Damaged endoscope from temperatures > 65 °C.

4.

Select a suitable cleaning and disinfection program with a temperature < 65 °C.

5.

Clean and disinfect the endoscope.

6.

Check whether all visible surfaces are without residue. If residue is found, repeat the cleaning and disinfection.

7.

Soak a cotton bud in lens cleaner or with 70 %- Isopropylalkohol.

8.

Clean the following parts with a cotton bud, wiping with circular movements: • Objective (distal end) • Eyepiece • Light guide connection

9.

If you have disinfected with non-virucidal disinfectants, you must sterilize the product.

& If stubborn residue cannot be removed by cleaning, the product must be sent to ATMOS or an authorized dealer. 20

Cleaning and disinfection