Related Manuals for Atmos ENT
Summary of Contents for Atmos ENT
- Page 1 Operating Instructions ATMOS ENT fl exible fi bre ® endoscope English GA1GB.150252.0 2017-07 Index 02...
-
Page 2: Table Of Contents
Table of contents Introduction ..................4 Notes on operating instructions ...............4 1.2 Explanation of pictures and symbols ............5 Intended use ....................6 Function .......................7 Intended users ....................7 1.6 Scope of delivery ..................8 Transport and Storage ................8 Hints for your safety ................9 2.1 General safety information ...............9 2.2 Danger for users, patients and third parties ..........9 2.3 Avoid damage to the device .............. - Page 3 5.5.1 Preparing for sterilization ..............22 5.5.2 Gas sterilization ..................22 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 Troubleshooting ................26 Disposal .....................
-
Page 4: Introduction
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 fi rst time. This helps you avoid potentially dangerous situations. The product bears the 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 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 certifi ed according to international standards EN ISO 13485. These operating instructions are valid for the following devices: • ATMOS nasopharyngoscope 3.2 mm 950.0243.0 ® Introduction... -
Page 5: Explanation Of Pictures And Symbols
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. & Action. Go step by step. » Result of an action. On device and type plate Refer to the operating Follow operating instructions instructions (blue) This product complies with The US Federal Law the relevant requirements restricts this product to of the EU Directive... -
Page 6: Intended Use
Serial number Order number Application part type BF Do not use in magnetic resonance areas Not sterile Professional disposal STERILE 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 / For application on humans application: Specification of the High resolution flexible fibre endoscope with a main function: 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,... -
Page 7: Function
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/ No single-use product. See cleaning and reprocessing: disinfecting instructions in the operating instructions. 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. 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... -
Page 8: Scope Of Delivery
Scope of delivery • Flexible fibre endoscope • Aluminium carrying case • Leakage tester • Valve cap • Operating Instructions Transport and Storage Only transport the device in a shipping container, which is padded and offers sufficient protection. If damage occurs during transport: Document and report the transport damage. Send the product to ATMOS, see Chapter „6.3 Sending in the device“ on page 25. Environmental conditions for transport and storage: • Temperature: -20...+70 °C • Relative air humidity: 5...95 % without condensation • Air pressure: 70...106 kPa Introduction... -
Page 9: Hints For Your Safety
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. General safety information Never operate the device, if it shows any obvious safety defects. Check the unit at regular intervals for safety and function. 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. -
Page 10: Avoid Damage To The Device
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. • Observe the instructions for cleaning, disinfection and sterilization in chapter „5 Cleaning and disinfection“ on page 16. Hints for your safety... -
Page 11: Setting Up And Starting Up
Setting up and starting up Device overview Flexible fibre endoscope with vent valve Vent valve Diopter adjustment (focussing) Deflection lever UP/DOWN Light cable connection for ACM1/British Standard (on the opposite side of the housing) Lens Transfer sleeve for light cable Light cable sleeve for AMCI connection Light cable Light cable sleeve for light sources Valve cap Leakage tester Silicone hose Preparing the device The product is supplied non-sterile. Setting up and starting up... -
Page 12: Using With Other Devices
Clean and disinfect the device prior to fi rst use. Sterilize the device where it is necessary for the medical indication. 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, fl oating application part). Combined with laser, HF-surgery, pneumatic or electrohydraulic lithotripters, various therapeutic applications are possible. Observe the operating and safety instructions of the applied devices and accessories. Using with high-frequency surgical devices WARNING Explosion and fi re 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. - Page 13 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 fi bre can be seen through the endoscope. Setting up and starting up...
-
Page 14: Operation
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. Prior to use Connect the accessories and components. Perform a function check. & Check the functionality of accessories and components. Potential movement The fl exible fi bre 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 Defl ecting the tip Press the defl ection lever Focussing Turn the diopter adjustment... -
Page 15: After Use
After use Remove all used adapters from the light cable connection. Remove the seal cap from the luer-lock connection. Visible residue should be removed immediately after surgery using a lint-free disposable cloth. Transport the product dry in a closed disposal container for cleaning and disinfecting. Clean and disinfect the endoscope after each use within 6 hours. Operation... -
Page 16: Cleaning And Disinfection
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 diff erent 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 diffi cult cleaning are possible. -
Page 17: Prepare For Cleaning
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. 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. -
Page 18: Stage I
Stage Step Tempera- Time Concen- Water Chemistry ture tration quality Cleaning 35 - 45 °C / 5 min 0.8 % Drinking Cidezyme / 95-113 °F water Enzol Intermedi- Room tem- Drinking ate rinsing perature 1 min water (cold) Disinfec- 20 - 25 °C / 12 min --- Drinking Cidex OPA tion 68 - 77 °F water Final Room tem- VE-W rinsing perature 2 min... -
Page 19: Stage Iii
Thoroughly rinse all accessible surfaces of the product three times for at least 1 minute. Operate the movable components like focussing and defl ection lever in the solution. Allow the rest of the water to drain off . 5.2.3 Stage III The product must be completely immersed in the cleaning solution so that all accessible surfaces are covered. Operate the movable components like focussing and defl ection 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. Thoroughly rinse the product 3 times completely, all accessible surfaces, for at least 2 minutes. Operate the movable components like focussing and defl ection lever in the solution. Allow the remaining water to drain off suffi ciently. & If the product is not suffi ciently rinsed, stubborn residue could develop on the glass surface. 5.2.5 Phase V Dry the product with a lint-free cloth. -
Page 20: Machine Cleaning And Disinfection
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. Machine cleaning and disinfection Check whether your cleaning and disinfection device for endoscopes is suitable for the ATMOS ENT fl exible fi bre 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. If the endoscope is highly contaminated, then clean it manually beforehand. Remove the valve cap from the vent valve. Damaged endoscope due to connection of the wrong hose. 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. Select a suitable cleaning and disinfection program with a temperature < 65 °C. Clean and disinfect the endoscope. Check whether all visible surfaces are without residue. If residue is found, repeat the cleaning and disinfection. Soak a cotton bud in lens cleaner or with 70 %- Isopropylalkohol. Clean the following parts with a cotton bud, wiping with circular movements: •... -
Page 21: Recommended Disinfectants
Recommended disinfectants The recommendation of the disinfectant refers exclusively to the compatibility with the product material. The effectiveness of the product is the responsibility of the user. ATTENTION Wrong disinfectant. Damaged product. • Only use the recommended disinfectants. • Do not place the product in alcohol. • Observe the operating instructions of the manufacturer of the disinfectant. Pay particular attention to the information regarding the concentration and material compatibility. 5.4.1 Recommended endoscope disinfectants Manual disinfection of endoscopes Disinfectant Manufacturer Remarks: Gigasept FF (new) Schülke & Mayr, Norderstedt Not virucidal ® (application concentrate) Cidezyme / Enzol Johnson & Johnson, New Not virucidal ® ® Brunswick (USA) Helipur H plus N... -
Page 22: Sterilization
Sterilization Following disinfection with non-virucidal agents, sterilization must be carried out. The effectiveness of the sterilization is the responsibility of the user. & The product cannot be autoclaved. 5.5.1 Preparing for sterilization The product must be checked prior to every sterilization. Check whether the endoscope, especially the optical surface is clean. Perform a leakage test, see chapter „6.2.1 Leakage test“ on page 23. Check the fibre optics, see chapter „6.2.2 Checking the fibre optics“ on page 24. Check the glass surfaces and the surface, see chapter „6.2.3 Checking the glass surfaces and the surface“ on page 24. The product must not be sterilized if damage or defects are detected. Remedy the defect or send the product to ATMOS or an authorized dealer. 5.5.2 Gas sterilization The endoscope can be gas sterilized with ethylene oxide (sterivite method). Observe the operating instructions of the manufacturer. Prepare for sterilization, see chapter „5.5.1 Preparing for sterilization“ on page 22. Attach the valve cap. Perform the gas sterilization. Remove the valve cap. Validated ETO parameters Gas mixture: 6 % ETO, 94 % C0 Temperature: 131 °F +/- 5 °F, 55 °C +/- 2 °C... -
Page 23: Maintenance And Service
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. To carry out these measures the person must have the necessary test devices and original spare parts. ATMOS recommends: Work should be carried out by an authorized ATMOS service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected. Function check Prior to each use a function check has to be performed. Never operate the device if you detect any damage. In this case, clean and disinfect the device and send it to ATMOS for repair. & A show-through of light along the highly flexible, thin-walled probe tube is due to the ever-present sheath losses in the case of illumination fibres. This phenomenon does not have a perceptible influence on the illumination intensity at the tip of the endoscope even when it occurs in varying intensity. Carry out a function check Check that the endoscope is not damaged: • The product is hygienically harmless. • The surfaces are undamaged. • The endoscope has no sharp edges. • The distal and proximal glass surfaces are undamaged. • The image quality is inconspicuous. Further tests 6.2.1... -
Page 24: Checking The Fibre Optics
» A pressure drop of max. 2 mmHg is normal. & If the pressure drop is >2 mmHg, send the product to ATMOS or an authorized distributor. 6.2.2 Checking the fibre optics & For this test do not use any cold light source. Hold one side of the fibre optics (e.g. the distal end) toward a bright ceiling light or the like. View the other side relatively close to the eye. » The individual fibres appear to be bright. Move the side facing the bright ceiling light back and forth. » The brightness of the fibres now change a little. & If individual fibres remain dark, this is unobjectionable. However, working with the endoscope is severely hampered by a fracture rate of about 10 - 20%. Check that the surfaces of the light inlets and outlets are smooth and clean. If the surfaces show certain deposit layers, or rough fibres can be felt or are withdrawn, send the product to ATMOS for inspection or to an authorized dealer. & An endoscope with damaged fibre optics can lead to inadequate illumination or if used or prepared in this condition, it may lead to continuous damage of the endoscope. & A show-through of light along the highly flexible, thin-walled probe tube is due to the ever-present sheath losses in the case of illumination fibres. This phenomenon does not have a perceptible influence on the illumination intensity at the tip of the endoscope even when it occurs in varying intensity. 6.2.3... -
Page 25: Sending In The Device
Check that the surfaces are undamaged and have no sharp edges. Pay attention to dents, mechanical or thermal damage e.g. due to high frequency or laser surgery devices as well as cracks and spallings at the eyepiece. If glass surfaces are damaged, the image quality is impaired or the surfaces are damaged or deformed, the product must no longer be used. Send the product to ATMOS or an authorized dealer. Sending in the device Remove and properly dispose of consumables. Clean and disinfect the product and accessories according to the operating instructions. Place used accessories with the product. Fill in the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate. & This form is enclosed to each delivery and can be found at www. atmosmed.com. The device must be well padded and packed in suitable packaging. Place the form QD 434 „Delivery complaint / return shipment” and the respective decontamination certificate in an envelope. Affix the envelope to the outside of the package. Send the product to ATMOS or to your dealer. Maintenance and service... -
Page 26: Troubleshooting
Troubleshooting The product was subjected to a thorough quality control in the factory. Nevertheless, if a problem should occur you can possibly solve it yourself. Error Possible cause Remedy indication Image is dull, Dirty glass surfaces Clean the glass surfaces, dusky see chapter „5.2 Manual cleaning and disinfection“ on page 17. Stubborn residue, Remove the residue, see encrusting on the „5.2.6 Remove stubborn glass surfaces deposits from glass surfaces“ on page 19. Check the water quality. Leaky defective lens Send in the product for system repair. Image is Dirty glass surfaces Clean the glass surfaces, too dark, see chapter „5.2 Manual insufficient cleaning and disinfection“ on illumination page 17. Stubborn residue, Remove the residue, see encrusting on the „5.2.6 Remove stubborn glass surfaces... - Page 27 Error Possible cause Remedy indication Yellowish light Dirty fibre optics Clean the glass surfaces, see chapter „5.2 Manual cleaning and disinfection“ on page 17. Send in the device for repair. Dirty defective light Check the light cable e.g. by cable illuminating a white surface. Spotting, Inadequate cleaning Subsequent cleaning of the discolouration (e.g. protein residue) endoscope, if required by thorough rubbing. Inadequate rinsing Ensure adequate rinsing of the endoscope between the individual between the reprocessing steps. reprocessing steps (especially before sterilization) Infected or too Regularly replace the frequently used disinfection and cleaning cleaning and solutions.
-
Page 28: Disposal
Disposal Packaging Please recycle the packing. Flexible fibre endoscope Do not dispose of the product with household waste. The endoscope does not contain any hazardous materials. Clean and disinfect the product according to the operating instructions. In Germany: Send in the product to ATMOS or your specialized dealer. They will dispose of the device professionally. In other countries: Dispose of the product professionally and according to country-specific laws and regulations. Disposal... -
Page 29: Technical Data
Technical data External diameter 3.2 mm Operating length 300 mm Direction of view 0° Field of view 85° Depth of focus 6 - 1000 mm Deflection of the tip on 140° both sides Imaging fibres 16,000 Pixel Ambient conditions +15 - +40 °C operation 5 to 95 % air humidity (without condensation) 70 to 106 kPa air pressure Ambient conditions for -20 - +70 °C transport 5 to 95 % air humidity (without condensation) 70 to 106 kPa air pressure Technical data... -
Page 30: 10 For Your Notes
10 For your notes For your notes... - Page 31 For your notes...
- Page 32 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 atmos@atmosmed.de www.atmosmed.com...