Atmos Cam 21 Operating Instructions Manual

Operating Instructions English

Ludwig-Kegel-Straße 16 79853 Lenzkirch Germany Phone: + 49 7653 689-0 Fax: + 49 7653 689-190 + 49 7653 689-493 (Service Centre) E-mail: [email protected] Internet: www.atmosmed.de 1.0 Introduction .........................................................3 1.1 Notes on operating instructions ............................3 1.2 Intended use .........................................................4 1.3 Function ................................................................4 1.4 Explanation of symbols .........................................5 2.0 For your safety ....................................................6 3.0 Setting up and starting up .................................7 3.1 Construction ..........................................................7 3.2 Starting up ATMOS® Cam 21 / 31 .........................9 3.3 Digital monitor outlets ...........................................9 3.4 Starting up ATMOS® Strobo 21 LED ...................11 4.0 Cleaning and care .............................................13 4.1 General information on cleaning and disinfection.....................................13 4.2 Recommended instrument disinfectants .............14 4.3 Recommended surface disinfectants ..................14 5.0 Maintenance and Service .................................15 6.0 Options, accessories and consumables ........16 7.0 Technical data ...................................................18 8.0 Checking / Disposal ..........................................19 8.1 Checking .............................................................19 8.2 Disposal ..............................................................19 Content

These operating instructions contain important notes on how to operate the ATMOS® Endoscopy and Stroboscopy System, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This 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. Reproduction, even partial, is only permitted 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® Endoscopy and Stroboscopy System 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® Endoscopy and Stroboscopy System will be preserved. • The ATMOS® Endoscopy and Stroboscopy System 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® Endoscopy and Stroboscopy System 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: Endoscopy Trolley REF 950.0223.0 Stroboscopy Trolley REF 950.0226.0 in connection with the options: • ATMOS® Cam 21 / 31 • ATMOS® Strobo 21 LED Packing / Storage The ATMOS® Endoscopy and Stroboscopy System is delivered in cardboard boxes. Please check the consignment on any damage immediately on receipt. Please contact your dealer in case of any complaints or prior to returning the goods. Please observe the following limit values during storage of the ATMOS® Endoscopy and Stroboscopy System: Ambient temperature: 5 °C to + 50 °C Air humidity: 5 % to 85 % Please observe the separate operating instructions for ATMOS® Cam 21 / 31 and ATMOS® Strobo 21 LED. 1.0 Introduction

1.3 Scope of supply Standard scope of supply: Endoscopy Trolley 950.0223.0 Stroboscopy Trolley 950.0226.0 Further options, accessories and consumables can be added individually (see chapter 6.0). 1.0 Introduction Main function: • Storage room and power supply system for diagnostic devices • Instrument storage Application: For application in the surrounding of the patient, for storage in the surrounding of the patient and for storage of medical products and therapeutic appliances. Application restrictions: No Sterility: unsterile Active medical product Please observe the separate operating instructions for ATMOS® Cam 21 / 31 and ATMOS® Strobo 21 LED.

1.0 Introduction ! ■ ● → ~ Icons Foot switch inlet Interlink / Data Signal input and output Off (feed-in, power connection) On (feed-in, power connection) Alternating current Ground wire connection Control panel buttons of ATMOS® Cam 31 Endoscope Usage: Hysteroscopy Typ. ø: 2.7 mm Typ. angels: 0°, 30°, 45° Xenon light source Typical: 180 resp. 300 W Colour temperature: 5600...5800 K Halogen light source Typical: 150 resp. 250 W Colour temperature: 3200 K LED light source Typical: 2 W (e.g. ATMOS® LED light source → see accessories chapter 6.0 Extra-light source Stroboscopy for connection of an ATMOS® Strobo 21 LED Endoscope Usage: Hysteroscopy Typ. ø: 4 mm Typ. angels: 0°, 30°, 45° Flexible Endoscope Usage: Nose, throat, larynx examinations Microscope Usage: Examination of ears Warning, special diligent notice Application part type BF Fuse according to IEC 417/5016, DIN 30600/0186 Potential equalisation Short cuts / symbols Please press where dot indicates Subnumeration Numeration General information Follow the arrows Activate the optional foot switch Replace Check Please read, important information Move, plug... in this direction Engage, check correct fit Turn, shift ... in this direction Y/C / FBAS Signal output Audio IEEE 1394 DV port Only valid for ATMOS® Cam 31 DV Freeze (Storage) click

produced according to IEC 60601/EN 60601 and listed in the following classes: - VDE Class of protection I - Class I Medical Devices Act (German law for medical products) • The device may only be connected to a properly installed safety socket. • The ATMOS® Endoscopy and Stroboscopy System is designed in line with approved quality standards and safety-related regulations. It should only be used in accordance with regulations and under consideration of the information stated in the operating instructions. • Please do not perform any modifications of the ATMOS® Endoscopy and Stroboscopy System without approval by the manufacturer. Please observe general rules for accident avoidance as well as for environment protection. In order to guarantee correct function, please only use original spare parts ordered from the manufacturer. • The ATMOS® Endoscopy and Stroboscopy System may only be used by skilled staff who have been authorised by ATMOS and trained in its operation (IEC 60601-1 / EN 60601-1). • The mains voltage indicated on the type plate must correspond to the values of the supply network. • Make sure prior to every application of the equipment that it is technically safe and in proper condition. Damaged cables must be replaced immediately! • Correct configuration in assembly of country-specific connections: - green/yellow: protective conductor (PE) - blue: neutral conductor (N) - black or brown: phase (L) • Please observe that the mobile parts could cause injury and contusion! • The ambient conditions specified in the "Technical data" (chapter 7.0) must be strictly observed! • Switch off all function modules when you finish your daily business. • The ATMOS® Endoscopy and Stroboscopy System may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards. • The ATMOS® Endoscopy and Stroboscopy System meets the immunity to interference requirements of IEC 60601- 1-2 / EN 60601-1-2 „Electromagnetic Compatibility – Medical Electrical Devices“. • Please note that the insulation transformer has to be installed in the base of the trolley if more than one camera respectively stroboscopy module as well as further consumer loads are connected. • The ATMOS® Endoscopy and Stroboscopy System may not be operated with devices not complying with the requirements of standard EN 60601-1 „Medical Electrical Equipment“ and EN 60601-1-2 „Electromagnetic Compatibility“ (Medical Electrical Equipment). • There are no warranty claims whatsoever on defects which arise from the use of third party accessories or consumables. • ATMOS is not liable for personal injury and damage to property if - no original ATMOS parts are being used, - the advice for use in these operating instructions is not being observed, - assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS. • Also pay attention to the safety information in following chapters. 2.0 For your safety ! For your safety

metal sheet. Tighten the ATMOS® Strobo 21 LED from below on the left side. The ATMOS® Cam 21 / 31 you tighten on the right side. Screw the support for the LED light handle to the metal sheet on the left and the support for the camera head to the right. Afterwards please tighten the monitor to the monitor support. 3.0 Setting up and starting up

The power supply at the monitor is plugged in and fixed with the Velcro fastener below the metal sheet where camera and stroboscope are positioned. Connecting the SVHS cable Connecting the DVI cable

3.0 Setting up and starting up G E F D C I H Backside Nut for mains supply Audio input Data gateway Interlink interface for ATMOS® Stroboscope Connection for video output (Y/C) Connection for video output (FBAS) Connection for potential equalization J Connection for foot switch A B M E D C H I J G K Backside Nut for mains supply Data gateway Interlink interface for ATMOS® Strobo 21 LED Connection for video output (Y/C) Connection for video output (FBAS) Forefront Connection for camera head Connection for LED light source Control panel Buttons for selecting application part and light source Mains on/off switch IEEE 1394 connection Audio input Connection for foot switch Connection for potential equalization Only valid for ATMOS® Cam 21 DV / 31 DV L DVI-I-monitor output SXGA monitor output F Warning notice / safety note The cameras ATMOS® Cam 31 DV and ATMOS® Cam 21 DV have a digital monitor outlet with SXGA signal. The resolution is 1280 x 1024 pixels. Please make sure that only monitors are connected which support the stated resolution. Otherwise the camera and / or monitor could get damaged. ! 3.3 Digital monitor outlets

If required, analogue peripheral video equipment (monitor, video printer, etc) must be adjusted to NTSC video norm. For further details please look at the corresponding operating instructions. i Optional: Cable IEEE 1394 K 4 Only valid for ATMOS® Cam 21/31 DV Only valid for ATMOS® Cam 31 Y / C 3 ...or Connection for video output (Y/C) (S-VHS) Connection for video output (FBAS) (VHS) DVI-I-monitor output SXGA monitor output (VGA) M D C L ...or 3.0 Setting up and starting up

3.0 Setting up and starting up + ..... 3 B 1 2 5 4 K A C F Please pay attention, just to switch on the devices after they have been completely wired. When applying the ATMOS® Cam 21 / 31 for video stroboscopy please pay attention to connecting the dongle connector (Ref 507.4781.0) with the interlink connection of ATMOS® Cam 21 / 31 before startup of the devices! ATMOS® Cam 21 / 31 ATMOS® Strobo 21 LED ATMOS® Cam 31 DV Data or or A B Forefront Control panel On / Off switch Settings Control knob Connection for microphone Connection for LED light handle Indication for permanent light Indication for freeze image Indication for slow motion Display K F

and stroboscope housing are connected with each other. The 6pin interlink cable you plug in at the "interlink" jack. 6pin interlink 5pin data Connect the audio cable to the audio channel of the stroboscope with the black connector. Please do not connect the red cable. Plug in the other end of the audio cable at the audio channel of the camera housing. With it both housings are directly connected to each other with 3 cables. "Audio out" ATMOS® Cam "Audio in" ATMOS® Strobo 21 LED ATMOS® Strobo 21 LED ATMOS® Cam 21/31 3.0 Setting up and starting up

disinfection • Switch all devices off prior to cleaning and disinfection! • The described actions relating to cleaning and disinfection resp. sterilisation do not substitute the relevant instructions which must be adhered to prior to operation! • For disinfection, you may use all surface and instrument disinfectants listed on page 14. • Always observe the concentration specifications and instructions by the respective manufacturer! • Do not use - Disinfectants which contain organic or inorganic acids or bases as they could cause corrosion damage. - Disinfectants containing chloramides, phenol derivatives or anionic tensides, as these may cause stress cracks in the material used for the housing of the unit. 4.1.1 Cleaning the unit surface • The surfaces of the ATMOS® Endoscopy and Stroboscopy System are resistant against all surface disinfectants listed in on page 14. • Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution. • You may also use disinfectant sprays or disinfectant tissues for cleaning and disinfection. ª Please note that the alcohol contained in these agents could corrode or cloud the protective covers if employed on a long term basis. • Clean the ATMOS® Endoscopy and Stroboscopy System with a soft cloth. Alkalescent multi-purpose cleaner, e.g. soap sud can also be used. • Do not use any abrasives or solvents as these might damage the surface of the appliance. • For disinfection please use usual aldehyde surface disinfectants in a watery solution. The surfaces of the ATMOS® Endoscopy and Stroboscopy System are resistant against all disinfectants listed in chapter „Recommended surface disinfectants“. • Please do not use any disinfectants or cleaning agents which contain chlorine. By the use of disinfectants containing alcohol ignitable gas mixtures might occur. Disinfection sprays may cause corrosion at mechanical parts. 4.0 Cleaning and care

Disinfectant Ingredients (in 100 g) Manufacturer Gigasept FF (Application concentrate) succindialdehyde 11.0 g Schülke & Mayr, Norderstedt dimethoxytetrahydrofurane 3.0 g corrosion protection components non-ionic surfactants and perfumes Sekusept PLUS (Application concentrate) glucoprotamin 25.0 g Henkel, Düsseldorf non-ionic surfactants Solvents, complexing agents 4.3 Recommended surface disinfectants Disinfectant Ingredients (in 100 g) Manufacturer Incidin Plus (Application concentrate) glucoprotamin 26.0 g Henkel, Düsseldorf non-ionic surfactants Solvents, complexing agents Dismozon pur (Granulate) End of product 12/2014 Magnesium monoperoxyphthalate Bode Chemie, Ham- burg Hexahydrate 80 g Dismozon plus (Granulate) Magnesium monoperoxyphthalate Bode Chemie, Ham- burg Hexahydrate 95.8 g Green & Clean SK (Application concentrate) Alkyl dimethyl benzyl ammonium chloride < 1 g Metasys, Rum (Aus- tria) Dialkyl-dimethyl-ammonium chloride When using disinfectants containing aldehyde and amine at the same object colour changes may occur. 4.0 Cleaning and care

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. Period tests: Observe the specifications for the individual components. Exchanging castors: When exchanging a rear castor please remove the cover first. Then loosen the screws with an Allen key SW8. The front castors can be unscrewed with a jaw spanner SW13. Mounting the replacement castors is performed in reverse order. Exchanging drawers: Drawers can only be exchanged as complete components. Please observe the provided mounting instructions. Exchanging shelves: Loosen the screws with an Allen key SW4 and remove the shelf from the column. Mounting is performed in reverse order. Exchanging the handle: It is also possible to unscrew the handle with an Allen key SW4 and remove it from the column. Mounting is performed in reverse order. 5.0 Maintenance and Service 5.1 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 with 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.

Insulation transformer 100 VA with insulation monitor 950.0225.0 Metal quiver for storage of rigid scopes 508.0775.0 Quiver for storage of flexible scopes, max. 500 mm length 508.0790.0 Plastic quiver for used rigid scopes 443.0017.0 Quiver for used flexible scopes, max. 500 mm length 508.0795.0 Monitor support for endoscopy / stroboscopy 950.0224.0 Medical 17" TFT monitor 534.3010.0 ATMOS® Panel PC 507.3121.0 ATMOS® Panel-PC Touch 507.3122.0 ATMOS® Capture Suite lite license dongle 700.0045.0 ATMOS® Capture Suite license dongle 700.0046.0 ATMOS® Capture Suite HD license dongle 700.0047.0 ATMOS® Cam 21 507.4100.0 ATMOS® Cam 21 DV 507.4120.0 ATMOS® Cam 21 DV Data 507.5100.0 ATMOS® Cam 31 with image memory 507.5110.0 ATMOS® Cam 31 DV with image memory 507.5130.0 ATMOS® Cam 31 Data with image memory 507.5120.0 ATMOS® Cam 31 DV Data with image memory 507.5140.0 ATMOS® Cam 41 HD 507.5500.0 ATMOS® LS 21 LED 507.4600.0 ATMOS® LS 21 LED, warm white 507.4602.0 ATMOS® LS 31 LED 507.4800.0 ATMOS® Strobo 21 LED 507.4700.0 Trigger cable (Y-cable), LS 31 LED - Strobo 21 LED to 2016-09 507.4837.0 Trigger cable LS 31 LED - Strobo 21 LED 507.4838.0 ATMOS® Strobo 21 DATA cable USB 507.4784.0 SD Grabber 534.1204.0 HD Grabber 534.1205.0 There will be no warranty claims on defects, missing functions resp. poor image quality. If third party accessories (e.g. monitors), which differ from the above mentioned articles are used.

Optical instruments      0° 30° 45° 70° 90°  Laryngoscopes  Laryngoscope 70°, Ø 10 mm, working length 176 mm, autoclavable, without light guide 950.0209.0 Laryngoscope 90°, Ø 10 mm, working length 174 mm, autoclavable, without light guide 950.0210.0 Laryngoscope 70°, Ø 8 mm, working length 166 mm, autoclavable, without light guide 950.0246.0 Tele-magnifying laryngoscope 70°, Ø 10 mm, working length 147.5 mm, can be immersed, without light guide 950.0211.0  Tele-magnifying laryngoscope 90°, Ø 10 mm, working length 145 mm, can be immersed, without light guide 950.0212.0 Ear endoscopes Wide-angle optic, 0°, working length: 50 mm, Ø 4 mm, autoclavable 950.0213.0  Wide-angle optic, 30°, working length: 50 mm, Ø 4 mm, autoclavable 950.0214.0 Wide-angle optic, 0° working length: 34 mm, Ø 2,7 mm, can be immersed incl. adapter for ear-speculum 950.0215.0 Nose / Pharynx endoscopes Ø 4 mm Wide-angle optic, 0°, working length: 180 mm, Ø 4 mm, autoclavable 950.0216.0 Wide-angle optic, 30°, working length: 180 mm, Ø 4 mm, autoclavable 950.0217.0  Wide-angle optic, 45°, working length: 180 mm, Ø 4 mm, autoclavable 950.0218.0 Wide-angle optic, 70°, working length: 180 mm, Ø 4 mm, autoclavable 950.0219.0 Nose/Pharynx endoscopes wide angle Ø 2.7 mm Wide-angle optic, 0°, working length: 110 mm, Ø 2.7 mm, autoclavable 950.0220.0  Wide-angle optic, 30°, working length: 110 mm, Ø 2.7 mm, autoclavable 950.0221.0 Flexible nasopharyngoscope  High resolution naso-pharyngoscope Ø 3,8 mm, working length 300 mm, 0°, angle of field of view 80°, depth of focus: 5 mm – infinite, angle: 125° / 125° Scope of delivery includes aluminium transport case and leak tester 950.0222.0 Flexible video-nasopharyngoscope ATMOS® Scope 950.0300.0 ATMOS® Scope Basic 950.0330.0

Isolation transformer Performance 600 VA Protection class (EN 60601-1) I Operating time Continuous operation Endoscopy Trolley / Stroboscopy Trolley Dimensions HxWxD 112.6 x 63.5 x 59.5 cm Weight 19 kg Ambient conditions for transport/ storage • Temperature -20 °C to +70 °C • Humidity without condensation 5 to 95 % • Air pressure 700 - 1060 hPa Ambient conditions for operation • Temperature +15 °C to +40 °C • Humidity without condensation 5 to 95 % • Air pressure 700 - 1060 hPa Classification according to Annex IX, EC Directive 93/42/EEC Class 1 CE marking CE GMDN code 11585 UMDNS code 11-585 ID No. (REF) 950.0223.0 Endoscopy Trolley 950.0226.0 Stroboscopy Trolley Please observe the separate operating instructions for ATMOS® Cam 21 / 31 and ATMOS® Strobo 21 LED.

• The housing is recyclable. • Device and accessories must be decontaminated prior to disposal. • Pay attention to a careful separation of the different materials. • Please observe national disposal regulations (e.g. waste incineration). Disposal within the EC The device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of professionally. According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please observe existing national laws and rules for disposal of old devices in the respective country. Disposal within the Federal Republic of Germany In order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it to ATMOS MedizinTechnik for disposal. Before disposal respectively before transport all parts, which came into contact with the patient must be thoroughly cleaned, disinfected. The device surface must be disinfected. Please observe the relevant instructions for disposal of modular devices. 8.1 Checking ATMOS® devices Observe the specifications for the individual components. Regular, thoroughly cleaning and disinfection of the devices and the application parts respectively the operation in line with the operating instructions are assumed. 8.0 Checking / Disposal

Ludwig-Kegel-Straße 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 [email protected] www.atmosmed.com