Transcript
Operating Instructions
ATMOS Full-HD Monitor ®
English
507.3115.B / 507.3116.B / 507.3117.B / 507.3118.B 2016-05 Index 01
Table of contents 1 Introduction.................................... 3 1.1 Information on operating instructions..........................................3 1.2 Explanation of pictures and symbols................................................4 1.3 Intended use........................................5 1.3.1 Monitor 21.5" Full-HD, Monitor 24" Full-HD...............................................5 1.3.2 Monitor 21.5“ FullHD with Touch, Monitor 24“ Full HD with Touch.....5 1.4 Function................................................6 1.5 Intended users.....................................6 1.6 Scope of delivery.................................6 1.7 Transport and Storage........................7 2 Hints for your safety...................... 8 2.1 General safety information................8 2.2 Dangers for users, patients and third parties...................................................8 2.3 Damage to the device.........................8 3 3.1 3.2 3.3
Installation and Commissioning... 9 Device overview...................................9 Unpacking the device........................10 Installing and connecting the device .................................................10 3.3.1 Installing the device.......................10 3.3.2 Connecting the device...................11 3.4 Use with other devices.....................12 4 Operation ...................................... 13 4.1 Environmental conditions during operation............................................13
2
4.2 Switching the device on....................13 4.3 Switching the device off ...................13 4.4 Setting the display up ......................13 4.4.1 Signal source...................................14 4.4.2 Image settings ...............................14 4.4.3 Colour settings ..............................14 4.4.4 Image format .................................14 4.4.5 Sound settings................................15 4.4.6 Settings menu.................................15 4.4.7 System.............................................15 5 Cleaning and Disinfection............ 16 5.1 Cleaning and disinfecting the monitor ..............................................16 5.2 Recommended disinfectant.............16 5.2.1 Surface disinfectant.......................17 6 6.1 6.2 6.3
Maintenance and Service............. 18 Period tests........................................18 Function check...................................18 Sending the device in........................18
7 Troubleshooting............................ 19 8 Accessories.................................... 20 9 Disposal.......................................... 21 10 Technical data............................... 22 11 Information on EMC...................... 24
1 Introduction 1.1 Information on operating instructions These operating instructions contain important information on how your ATMOS® Monitor can be used safety, properly and effectively. The instructions are intended for the training and teaching of operating personnel and are intended as a reference. Reproduction, even partial, is only permitted with 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. They ensure the reliability and operability of the ATMOS® Monitor. 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. Read Chapter „2 Hints for your safety“ on page 8 before using the device for the first time. This helps you avoid potentially dangerous situations. The ATMOS® Monitor bears the CE marking according to the EU Medical Device Directive 93/42/EEC and complies with the essential requirements of Annex I to this Directive. The ATMOS® Monitor satisfies all applicable requirements of Directive 2011/65/EU on the restriction of 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 used at ATMOS is certified according to international standards EN ISO 9001 and EN ISO 13485. These operating instructions are valid for the following devices: •
Monitor 21.5“ FullHD
507.3115.0
•
Monitor 21.5“ FullHD with Touch 507.3116.0
•
Monitor 24“ FullHD
507.3117.0
•
Monitor 24“ FullHD with Touch
507.3118.0
All variants are hereinafter referred to as ATMOS® Monitor.
Introduction
3
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. Move, plug in this direction.
click
Engage, check correct fit.
Device and nameplate
REF MENUE
Warning, special diligent notice
Refer to the operating instructions.
This product complies with the relevant requirements of EU directives
Do not dispose in the household waste
Manufacturer
Manufacturing date
Article number
Introduction
Serial number
Settings menu
Enter
Up
Down
Signal source
4
SN
Accessories This product complies with the relevant requirements of EU directives
Do not dispose in the household waste
Protection class II
UL Approval, this product meets the requirements of the USA and Canada
DC voltage
Certified by TÜV Rheinland R
Rheinland CERTIFIED
1.3 Intended use 1.3.1 Monitor 21.5" Full-HD, Monitor 24" Full-HD Name: 21.5” or 24" Medical Monitor Main functions: Viewing of pictures and videos from medical photo and video sources. Medical indications/ application: The Monitor is used to represent photos and play videos which are recorded with medical cameras and video sources, as a live image. Specification of the main function: Image and video representation User profile: Medically trained professionals and doctors. Patient groups: All patients during microscopic and endoscopic examinations with imaging method. Application organ: Throat, nose, ears, vagina, uterus, bladder, urethra and ureter. Operating life: temporary (up to max. 180 minutes per patient) Application site: Application sites are clinics, surgery centres, outpatient clinics and practices of ENT doctors, gynaecologists or urologists. The device may only be applied by medical professionals. Contraindications: Not intended for use in explosion-hazardous areas. The product is: active Sterility: not sterile Disposable/reprocessing: not a disposable product
1.3.2 Monitor 21.5“ FullHD with Touch, Monitor 24“ Full HD with Touch Name: 21.5” or 24" Medical Monitor Main functions: Viewing of pictures and videos from medical photo and video sources. Medical indications/ application: The Monitor is used to represent photos and play videos which are recorded with medical cameras and video sources, as a live image. Specification of the main function: Image and video playback and touch function, which provide, in conjunction with medical devices, the operation and control of these devices by touch (Capacitive Touch). User profile: Medically trained professionals and doctors. Patient groups: All patients during microscopic and endoscopic examinations with
Introduction
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imaging method. Application organ: Throat, nose, ears, vagina, uterus, bladder, urethra and ureter. Operating life: temporary (up to max. 180 minutes per patient) Application site: Application sites are clinics, surgery centres, outpatient clinics and practices of ENT doctors, gynaecologists or urologists. The device may only be applied by medical professionals. Contraindications: Not intended for use in explosion-hazardous areas. The product is: active Sterility: not sterile Disposable/reprocessing: not a disposable product
1.4 Function The Monitor shows photos and videos captured using medical cameras and video sources as a live image. The Monitor can be connected using various video signal cables (DVI, S-Video, Display Port, RCA) with photo and video sources. The maximum resolution is 1920 x 1080 pixels Full HD, with a brightness of 250 cd/m2 and 16.7 million colours. The True Flat Display has its entire surface covered with a glass pane and can be disinfected particularly easy. The interface cover on the back corresponds to protection class IP 54 and therefore complies with all hygiene requirements. The Monitor with Touch function can be used in conjunction with medical devices if they provide and allow operation and control by touching the screen (Capacitive Touch). The Monitor with touch function provides a USB signal and are connected with a USB cable to another device.
1.5 Intended users Medically trained assistance and technical personnel, doctors.
1.6 Scope of delivery Monitor 21.5" Full-HD, Monitor 24" Full-HD
1 x ATMOS® Monitor
1 x power supply
1 x power cable 1 x operating instructions
Monitor 21.5“ FullHD with Touch, Monitor 24“ FullHD with Touch
1 x ATMOS® Monitor
6
Introduction
1 x power supply
1 x power cable 1 x USB cable
1 x 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. Fill in form QD 434 “customer complaint/return shipment”. The form comes with the product and can be found at www.atmosmed.de. 3. Send the device to ATMOS (Chapter „6.3 Sending the device in“ on page 18). Environmental conditions for transport and storage: •
Temperature:
-20...+60°C
•
Relative air humidity: 10...85% without condensation
•
Air pressure
500...1060 hPa
Introduction
7
2 Hints for your safety The safety of the ATMOS® Monitor corresponds to the recognised technical regulations and the guidelines in the German Medical Devices Act Read and follow the safety instructions carefully before using the product.
2.1 General safety information Only use the device when installed vertically. Do not use the device if it is in a horizontal position.
2.2 Dangers for users, patients and third parties Protect yourself from electric shocks! Burns and cardiac arrhythmia and even death are possible. •
Do not remove any housing or fixed parts from the Monitor. The interface cover can be removed.
•
Disconnect the device from the mains before cleaning or disinfecting it.
•
The device can be disconnected from the power supply by pulling the plug out. Unplug the power cable from the wall socket. Separate the power cable from the device.
•
Position the device so that it can always be easily separated from the mains supply.
•
Check before each use if the device or the power cord are damaged. Do not use the device if you observe damage. In the case, clean and disinfect the device and send it to ATMOS for repair.
•
Only use original accessories and original spare parts from ATMOS. This applies to the mains cable in particular.
•
Please pay attention to the period tests in chapter „6 Maintenance and Service“ on page 18.
•
Do not change the device without the manufacturer's permission.
•
Assembly, repairs, modifications and period tests may only be carried out by authorized persons.
2.3 Damage to the device Only a fully functional product meets the safety requirements of users, patients and third parties. Follow the following guidelines concerning your product. Avoid pressure on the Panel PC Monitor. The display may be damaged. •
8
Do not exert any increased pressure on the display.
Hints for your safety
3 Installation and Commissioning 3.1 Device overview Front view and controls
1
2
3
1
Menu key
2
Enter key
3
Up key
4
Down key
5
Signal source key (without function)
6
On/Off key
4
5
6
Rear view
1 1
Supply jack (behind interface cover)
2
VESA100 interface
3
Connections (behind interface cover)
4
Nameplate
5
Equipotential bonding
2
3
4
5
Installation and Commissioning
9
Connections 4
3
2
1
2
No. Connection class
3
4
1
5
6
Connection
1
USB (only on Monitor with Touch function)
PC (connection with Touch function)
2
DVI
Video source with HD video signal
3
Display port
Video source with HD video signal
4
Cinch
Video source with SD video signal
5
S-Video
Video source with SD video signal
6
AC adaptor jack
Mains supply
3.2 Unpacking the device 1. Place the package on a solid surface. The display may be scratched by sharp objects. 2. Do not use sharp or pointed objects. 3. Open the packaging carefully. 4. Remove the Monitor and place the Panel PC on a solid, clean surface. Damage due to condensation liquid. 5. Remove the protective film and leave the device for at least 2 hours in the operating room. && The device can acclimatise.
3.3 Installing and connecting the device WARNING Protect yourself from electric shocks! Burns and cardiac arrhythmia and even death are possible. •
Only trained personnel, may install, connect and operate the device.
•
Do not remove any housing or fixed parts from the Monitor. The interface cover must not be removed.
3.3.1 Installing the device The installation area must meet the following requirements: •
Closed room.
•
The Monitor must be protected against moisture.
•
The Monitor must not be exposed to direct sunlight.
•
The Monitor has to be easily separated from the supply network.
1. Read the safety instructions in Chapter "2 Safety information" on page 8 carefully before using the product.
10 Installation and Commissioning
Damage due to condensation liquid. 2. Remove the protective film and leave the device for at least 2 hours in the operating room. && The device can acclimatise. 3. Check the device for any transport damage. If the device is damaged: Document and report the transport damage. Send the device to ATMOS, see Chapter „6.3 Sending the device in“ on page 18. 4. Select a suitable operating location. 5. Refer to the manufacturer's instructions for the stand to which the Monitor is attached. Refer to any weight restrictions. && Only use the pre-installed thumbscrews provided for the ATMOS® Monitor. 6. Attach the Monitor PC via the VESA 100 interface on the back.
3.3.2 Connecting the device && ATMOS recommends that the device is installed first and then connected. Display scratched during the connection process. 1. If the Monitor is not yet mounted, then place it on a clean, flat surface with the display facing down. 2. Refer to the guidelines for electrical medical systems in Chapter „3.4 Use with other devices“ on page 12. 3. Check that the mains voltage and device voltage match. && The device's details can be found on the nameplate. Do not connect the device if the details do not match. 4. Loosen the screws on the interface cover with a Torx T10 screwdriver. 5. Remove the interface cover. 6. Loosen the rubber inserts from their mounts in the interface cover. 7. Place a rubber insert on each cable. && If you have a monitor with Touch function, connect the Monitor and PC using the USB cable. 8. Pass the cable through the interface cover. && The rubber inserts on the cables must be on the front of the interface cover.
9. Connect the cable to the monitor. 10. Secure the connection to the power supply using the screw provided. 11. Press the rubber inserts into the interface cover together with the cable. 12. Attach the interface cover to the Monitor. 13. Connect the mains cable to the mains supply. 14. Connect the equipotential bonding if required. && The equipotential bonding must be connected if the spatial environment in which the product is used requires this. Refer to the specifications of IEC/EN 60601-1. Installation and Commissioning 11
15. Perform a function check, see Chapter „6.2 Function check“ on page 18.
3.4 Use with other devices Only qualified personnel may install electrical systems. The person who installs an electrical medical system is responsible for ensuring that the performance, installation and commissioning, safety, specifications and use of the ATMOS® Monitor are not affected. Note the following when using the device in connection with other devices. •
Refer to the specifications of IEC/EN 60601-1 on electrical medical systems.
•
Note in particular the information on the patient environment, multiple sockets and leakage
12 Installation and Commissioning
4 Operation 4.1 Environmental conditions during operation •
Temperature:
+10...+ 40°C
•
Relatiev humidity:
10...85% without condensation
•
Air pressure
700...1060 hPa
4.2 Switching the device on 1. Press On/Off for 3 seconds. »» The On/Off key is blue. »» All other keys are white and are ready for use. »» The ATMOS logo is displayed on the monitor. »» The monitor searches for an input signal. && The input signal search can be disabled, see Chapter „4.4.1 Signal source“ on page 14.
4.3 Switching the device off 1. Press On/Off for 3 seconds. »» The On/Off key is white. && The device can be disconnected from the power supply only by pulling the plug out. Unplug the power cable from the wall socket first. Then separate the power cable from the device.
4.4 Setting the display up The display can be set up using the following keys. The keys flash blue after being pressed. && The settings menu closes automatically as soon as it is unused for a few seconds. && The OSD menu is operated with the keys even when the touch function is included. Key
Function
Menu key
Opens the settings menu to configure the display. In the settings menu: Confirms an entry or selects a menu item.
Back key
Goes to the next higher menu level.
Up key
Goes up in the menu or increases the value.
Down key
Goes down in the menu or decreases the value.
Operation 13
4.4.1 Signal source To set the signal source up, go to Source options. •
Main screen channel: Selects audio input, the image is displayed.
•
Input search: Enable or disable the automatic search for connected inputs.
•
PiP Mode: The images of the two inputs can be displayed simultaneously (Picture in Picture). The inputs are displayed side by side or in a separate box in any corner of the screen
•
Picture in Picture: Selects additional video input to be displayed in PiP mode.
•
PiP Position: Selects which corner the additional video input is displayed in.
•
Main & PiP swap: The additional audio input to the main channel.
4.4.2 Image settings To set the image up, go to Image Set-up. •
Sharpness: Sharpens filter or smooths filter (only available for video input via RCA and S-Video available).
•
Gamma: Sets up gamma correction.
•
Advanced: Enables additional set-up options.
4.4.3 Colour settings To adjust the colours, go to Colour Set-up. •
Scheme: Colour scheme: Vivid, Cinema, Gaming.
•
Lighting: Intensity of the background light.
•
Brightness:
•
Contrast
•
Colour tone: Colour tone in Kelvins.
&& Select User in the menu to disable the colour tone and use the individual settings in RGB. •
RGB: Individual settings.
•
Aspect ratio (only available for Cinch and S-Video).
•
Colour tone (only available for Cinch and S-Video).
•
Automatic colour matching
4.4.4 Image format The ratio of image width to image height can be adjusted in Scale.
14 Operation
•
Main scale: Sets up aspect ratio: Full Screen, Expand, Aspect and Native.
•
Zoom: Sets the aspect ratio manually.
•
Zoom Position: Sets the image position.
4.4.5 Sound settings To adjust the sound settings, go to Audio Set-up. •
Volume
•
Balance: Sets the right and left audio channel.
•
Bass: Sets the pitch depth.
•
Treble: Sets the pitch height.
•
Auto Volume
4.4.6 Settings menu To adjust the settings menu, go to OSD settings. •
OSD Timeout: Time, after which the settings menu closes.
•
OSD Hor. Pos.: Horizontal position of the settings menu.
•
OSD Ver. Pos.: Vertical position of the settings menu.
•
OSD Blend: Transparency of the settings menu.
•
OSD Orientation: Orientation of the settings menu.
•
OSD Language: English, German, French, Italian, Spanish.
4.4.7 System To adjust the system, go to System Set-up. •
Info: Displays the main channel, the resolution and frequency, the firmware version and the monitor type.
•
Mode Info: More system information.
•
Restore user defaults: Restores saved user settings.
•
Save user defaults: Stores user preferences.
•
Restore user defaults: Restores factory settiongs.
Operation 15
5 Cleaning and Disinfection We recommend that you always document all maintenance and replacement operations in writing. WARNING Risk of infection due to germs on equipment and accessories. Diseases may be transmitted. •
Wear disposable gloves during all cleaning measures.
•
Clean the device after each use.
•
Clean and disinfect the device according to the operating instructions.
5.1 Cleaning and disinfecting the monitor WARNING Electric shock caused by fluids inside the device. Burns and cardiac arrhythmia and even death are possible. •
Do not rinse the device under running water and do not immerse it in liquids.
•
Make sure that the cleaning cloth is only damp and not wet.
•
Do not subject the device to an autoclave or sterilisation.
•
Do not immerse the device in disinfectant solution.
1. Turn the ATMOS® Monitor off. 2. Separate the ATMOS® Monitor from the mains supply. 3. Moisten a clean, lint-free and anti-static cloth with all purpose cleaner or surface cleaner. 4. Clean the device. 5. Disinfect the device with a recommended disinfectant, see Chapter „5.2 Recommended disinfectant“ on page 16.
5.2 Recommended disinfectant Refer to the manufacturer's instructions concerning disinfectant. Note in particular the information on the concentration and material compatibility. ATTENTION Unsuitable disinfectant. Damaged device. •
Do not use acidic or corrosive disinfectants.
16 Cleaning and Disinfection
5.2.1 Surface disinfectant Disinfectant
Constituents
Hexaquart forte
benzalkonium chloride (benzyl-C12-18 alkyldimethylammonium, chloride) didecyldimethylammonium chloride Non-ionic surfactant NTA
Meliseptol® Wipes sensitive
1-Propanol didecyldimethylammonium chloride Non-ionic surfactant
17 g BBraun, 0.23 g Melsungen <5%
Meliseptol® Foam pure
1-Propanol didecyldimethylammonium chloride Non-ionic surfactant
17 g BBraun, 0.23 g Melsungen <5%
®
in 100 g Manufacturer 20 g BBraun, 7.9 g Melsungen 5 – 15 % <5%
Cleaning and Disinfection 17
6 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.
6.1 Period tests At least every 24 months a repeat test of the electrical safety should be performed according to IEC 62353. ATMOS recommends an inspection according to the manufacturer‘s specifications.
6.2 Function check Do not use the device if you observe damage. In this case, clean and disinfect the device and send it to ATMOS for repair. 1. Check before each use if the device, the power cord or other cables are damaged. 2. Switch on the device. 3. Check whether all connected parts are functional.
6.3 Sending the device in 1. Clean and disinfect the device and accessories beforehand according to the operating instructions. 2. Place the accessories with the device. 3. Fill in the form “customer complaint/return shipment” and enclose it to the consignment. The form comes with the product and can be found at www.atmosmed.de. 4. The device must be well padded and packed in suitable packaging. 5. Send the device to ATMOS or to your dealer.
18 Maintenance and Service
7 Troubleshooting The ATMOS® Monitor was subject to a thorough inspection in the factory. However, should an error occur, you may be able to solve this yourself. Error indication
Possible cause
Remedy
Device does not turn on.
The power cable is defective.
1. Check the connection to the mains supply.
Defective network cable.
1. Change the network cable.
Defective electronics.
1. Send in the device for repair.
Incorrect resolution.
1. Set the resolution to 1920 x 1080 (Full HD).
Picture disproportionate.
The device does not Temporary software respond. error.
1. Unplug the device for a few minutes.
Troubleshooting 19
8 Accessories
20 Accessories
Accessories
REF
Carrier
507.3125.0
DVI cable - Display port, 2m
507.5507.0
9 Disposal Packaging 1. Recycle the device's packaging. ATMOS® Monitor Do not dispose of the device with household waste. The ATMOS® Monitor does not include any hazardous substances. 1. Clean and disinfect the device. 2. In Germany: Send the device to ATMOS or back to your specialist dealer. They will dispose of the device properly. 3. In other countries: Dispose of the device properly and in accordance with countryspecific laws and regulations. In Germany, the device is exempt from the Electrical and Electronic Equipment Register because it may be contaminated. Do not dispose of the device with electronic waste. The housing is fully recyclable. Refer to the country-specific laws and regulations.
Disposal 21
10 Technical data Voltage
100-240 V~ ± 10 %; 50-60 Hz
Power input
max. 1.6 A
Power consumption
80 W max (230 VAC)
Fuses
3.15 AT
Other safety equipment
Short circuit protection, overvoltage protection, overload protection: Shutdown with auto recovery
Resolution
1920 x 1080 pixels (Full HD)
Angle of view
178 degrees horizontal/vertical
Brightness:
250 cd/m2
Colour display
16.7 million colours
Pixel size
0.2475 mm
Interfaces
1 x DVI, 1 x S-Video, 1 x Display port, 1 x Cinch
Mounting
1 x VESA 100
Operating time
Continuous operation
Protective earth conductor resistance
max. 0.1 W
Earth leakage current
max. 0.1 mA
Enclosure leakage current Patient leakage current
max. 0.5 mA max. 0.1 mA
Ambient conditions Transport / storage
-20...+60°C 10...85 % air pressure without condensation at an air pressure of 500...1060 hPa
Ambient conditions Operation
+10...+40°C 10...85 % air pressure without condensation at an air pressure of 700...1060 hPa
Maximum operating height
3000 m (NN)
Overvoltage category
II
Dimensions HxWxD
21.5“ 543 x 348 x 60 mm 24“ 595 x 379 x 60 mm
Weight
21.5“ ~8kg 24“ ~ 10kg
Period tests
Repeat test of the electrical safety every 24 months. Recommended: inspection according to the manufacturer‘s specifications.
Safety class (EN 60601-1)
Safety class 2 - without PE (external power supply)
Protection class
IP54 Front IP65 Back
Classification in accordance with Annex IX to EC Directive 93/42/EEC
22 Technical data
Class I, Standard 12
CE-Marking
Class 1, CE
GMDN code
16603
UMDNS code
16-603
ID No. (REF)
507.3115.0, 507.3116.0, 507.3117.0, 507.3118.0
Technical data 23
11 Information on EMC •
Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC notes.
•
Portable and mobile HF communication facilities can influence medical electrical equipment.
•
The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced interference immunity of the equipment or system.
•
The electrical medical device must not be stacked next to or with other devices. When operation is required close to or in combination with other equipment, the electrical medical equipment must be observed to verify its intended operation in this arrangement.
Guidance and manufacturer's declaration - electromagnetic emissions The ATMOS® Monitor is designed for operation in the electromagnetic environment specified below. The customer or user of the ATMOS® Monitor should ensure that it is used in such an environment. Emissions Test
Compliance
HF transmission according to CISPR 11
Group 1
HF transmission according to CISPR 11
Class B
Harmonic emissions according to IEC 610003-2
Inapplicable
Voltage fluctuations/ flicker according to IEC 61000-3-3
Inapplicable
24 Information on EMC
Electromagnetic Environment Guidance The ATMOS® Monitor uses HF energy for its internal functions. Therefore, its HF emissions are very low and it is unlikely that nearby electronic devices will be affected. The ATMOS® Monitor is suitable for use in all establishments, including domestic and those connected directly to a public power supply network that supplies buildings used for residential purposes.
Guidance and manufacturer's declaration - electromagnetic immunity The ATMOS® Monitor is designed for operation in the electromagnetic environment specified below. The customer or user of the ATMOS® Monitor should ensure that it is used in such an environment. IEC 60601- Test Level
Compliance level
Electromagnetic Environment - Guidance
Electrostatic discharge (ESD) according to IEC 61000-4-2
± 6 kV Contact
± 6 kV Contact
± 8 kV Air
± 8 kV Air
Floors should be wood, concrete, or ceramics tile. If floors are synthetic, the relative humidity should be at least 30 %.
Fast electrical transient/burst IEC 61000-4-4
± 2 kV Mains
± 2 kV Mains
± 1 kV I/Os
± 1 kV I/Os
Immunity Test
Impulse voltage/ ± 1 kV commonsurges according mode to IEC 61000-4-5 ± 2 kV differential mode
± 1 kV commonmode
Voltage dips, short interruptions and voltage variations according to IEC 61000-4-11
< 5 % UT (> 95 % Dip of the UT) for 0,5 Cycles
< 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle
40 % UT (60 % Dip of the UT ) for 5 Cycles
40 % UT (60 % Dip of the UT) for 5 Cycles
70 % UT 30 % Dip of the UT ) for 25 Cycles
70 % UT (30 % Dip of the UT) for 25 Cycles
< 5 % UT (>95 % Dip of the UT) for 5 s
< 5 % UT (> 95 % Dip of the UT) for 5 s
Magnetic field 3 A/m at the supply frequency (50/60 Hz) according to IEC 61000-4-8
± 2 kV differential mode
10 A/m
Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS® Monitor requires continued operation upon the occurrence of disruptions in the energy supply, the ATMOS® Monitor should make use of an uninterruptible power supply or a battery.
Power frequency magnetic fields should be that of a typical commercial or hospital environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
Information on EMC 25
Guidance and manufacturer's declaration - electromagnetic immunity The ATMOS® Monitor is designed for operation in the electromagnetic environment specified below. The customer or user of the ATMOS® Monitor should ensure that it is used in such an environment. Immunity Test
IEC 60601Test Level
Conducted interference according to IEC 61000-4-6
3 VEffective value
Radiated HF disturbances according to IEC 61000-4-3
3 V/m
150 kHz to 80 MHz 80 MHz to 2.5 Hz
Compliance level 3 VEffective value
10 V/m
Electromagnetic Environment Guidance Portable and mobile radio equipment should be used no closer to the ATMOS® Monitor, including cables, than the recommended distance calculated according to that which applies to the transmission frequency. Recommended distances: d = 1.2*√P d = 0.35*√P for 80 MHz to 800 MHz d = 0.70*√P for 800 MHz to 2.5 GHz where „P“ is the max. power in watts (W) and D is the recommended separation distance in meters (m). Field strengths from fixed transmitters, as determined by an electromagnetic site (a) survey, should be less than the compliance level (b). Interference may occur in the vicinity of equipment containing following symbol:
NOTE 1: With 80 MHz and 800 MHz the higher frequency range applies. NOTE 2: These guidelines cannot be applied in any case. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people. (A) The field strength of stationary transmitters, such as base stations of radio telephones and land mobile radio devices, amateur radio stations, AM and FM radio broadcast and TV broadcast cannot be accurately predicted theoretically. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to be considered. If the field strength measured at the site where the ATMOS® Monitor is used exceeds the compliance level above, the ATMOS® Monitor must be observed to demonstrate proper function. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ATMOS® Monitor. (B) Over the frequency range of 150 kHz to 80 MHz, field strengths should be lower than 3 V/m.
26 Information on EMC
Recommended separation distances between portable and mobile HF communications equipment and the ATMOS® Monitor The ATMOS® Monitor is intended for use in an electromagnetic environment in which HF disturbances are controlled. The customer or user of the ATMOS® Monitor can thereby help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communication equipment (transmitters) and the ATMOS® Monitor - depending on the output of the communication device as indicated below. Separation distance, depending on transmit-frequency m Power of transmitter W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = (3.5/V1) *√P
d = (3.5/E1) *√P
d = (7/E1) *√P
0.01
0.12
0.035
0.07
0.1
0.38
0.11
0.22
1
1.2
0.35
0.7
10
3.8
1.11
2.2
100
12
3.5
7
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended separation distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specification. NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies. NOTE 2 These guidelines may not apply in all cases. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people.
Information on EMC 27
ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0
[email protected]
www.atmosmed.com
