NOUVAG
Ultrasonic 2000 User Manual Aug 2005
User Manual
81 Pages

Preview
Page 1
NOUVAG AG
Ultrasonic 2000
TABLE OF CONTENTS 1
Product description 1.1 1.2 1.3 1.4 1.5 1.6
Use Operation Technical data Ambient conditions for operation Ambient conditions for transport and storage Device symbols
2 2 2 2 2 2 3
2
Safety instructions
3
3
Supplied equipment
3
Device assembly
4
4
4.1 4.2 4.3
5
Operation 5.1 5.2 5.3 5.4 5.5 5.6 5.7
6
4 5 6
6
Switching on the Ultrasonic 2000 Actuators Continuous operation Timer operation Functional test / Operational test Nebulization of drugs with the drug cup Particle sizes
6 6 7 7 8 8 9
Disinfection, cleaning and sterilisation
11
6.1 6.2
7
Device overview Assembly Operation with hose heating
Control unit Bacteria filter:
Maintenance 7.1 7.2 7.3 7.4
Fan wheel and coarse air filter Replacing device fuses Functional test after maintenance or cleaning Discarding instructions
11 11
12 12 12 12 12
8
Faults and fault detection
13
9
Spare parts with order numbers
14
No. 31796 32/05
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Ultrasonic 2000
NOUVAG AG 1 Product description
1.1 Use The ULTRASONIC 2000 ultrasonic nebulizer is used for inhalation therapy and breathing air humidification. It is designed for dosed drug inhalation in hospitals, nursing homes and for private use. The ultrasonic nebulizer is primarily used for the medical treatment of diseases of the respiratory tract.
1.2 Operation A crystal quartz located at the bottom of the nebulizing chamber ensures dispersion of the medium (distilled water) using ultrasound. The produced fog is transported to the patient through a hose with an air flow. In order to protect the patient from bacteria and germs in the ambient air, the aspired air passes through a coarse medical air filter installed in front of the fan chamber and which can be easily replaced. After passing through the fan wheel, the air flow passes through a bacteria filter with a fineness of 0.5 μm. With these two filters, a high purity of the aspired air can be achieved.
1.3 Technical data Voltage: ... switchable: 230 V/ 50 Hz or 115 V/ 60 Hz (Internal) device fuse : ... 2 x T1A Power: ...110 VA Heating fuse ( F1 - back of device) : ...T 6.3A EMC interference suppression : ...CISPR 11, class A Device protection class: ... Class II Application part type : ... BF Control device dimensions: (B x D x H) : ...190 x 250 x 130mm Control device net weight: ...3 kg Max. sound pressure level: ... 45 dB(A) Adjustable nebulizing performance: ...10 to 120 ml/h Fog density: ...10 to 200 mg/l Particle size (MMAD) : - Air flow 5 / rate 1 ... 3.2 - 3.5 µm - Air flow 5 / rate 5 ... 3.8 – 4.0 µm - Air flow 5 / rate 10 ... 4.3 – 4.5 µm Aerosol delivery rate without drug cup: - Air flow 5 / rate 1 ...0.32 ml/min - Air flow 5 / rate 5 ...0.49 ml/min - Air flow 5 / rate 10 ...1.05 ml/min Aerosol delivery rate with drug cup : - Air flow 5 / rate 1 ...0.16 ml/min - Air flow 5 / rate 5 ...0.43 ml/min - Air flow 5 / rate 10 ...0.75 ml/min Aerosol delivery rate with drug cup @ 8ml : - Air flow 5 / rate 1 ...2.12 ml - Air flow 5 / rate 5 ...2.15 ml - Air flow 5 / rate 10 ...2.15 ml Adjustable air flow : ...1 to 10 l/min HF frequency : ... 2.4 MHz Timer :...0 to 60 min or continuous operation
1.4
Ambient conditions for operation
Rel. air humidity: ... max. 80% Temperature: ... 10 to 40°C Air pressure: ... 800 to 1060 hPa
2
1.5
Ambient conditions for transport and storage
Rel. air humidity: ... max. 90% Temperature: ...0 to 60°C Air pressure: ... 500 to 1060 hPa
No. 31796 32/05
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Ultrasonic 2000
1.6 Device symbols
: Caution: refer to enclosed documentation
: Device protection class: II
: Application part type BF
: Device with functional ground connection
1275 : EU conformity symbol
: Old electrical and electronic equipment must be disposed separately and may not be included in regular domestic waste.
2 Safety instructions We are very much concerned with your safety, your team’s safety and of course your patient’s safety. Therefore, it is imperative for you to comply with the following instructions: •
The Ultrasonic 2000 may only be operated by experienced trained personnel!
•
Please ensure that operating voltage and mains voltage agree!
•
Only distilled water may be used for nebulization!
•
Salt water bath, saline solutions and drugs may only be nebulized in the drug cup, as the device may otherwise be damaged!
•
The device may not be used in connection with artificial respiration equipment used for anaesthesia or with pulmonary artificial respiration equipment!
•
Repairs may only be carried out by authorised NOUVAG service engineers!
•
Improper use and repair of the device as well as not complying with the instructions relieve us from any obligations regarding guarantee or other claims!
3 Supplied equipment 3231 - Control device Ultrasonic 2000 ...1 item 3222 - Nebulizing chamber (sterilisable) ...1 item 3248 - Nebulizing chamber lid (sterilisable) ...1 item 3251 - Nebulizing chamber lid with float system (sterilisable) ...1 item 3249 - Drug cup (not sterile) ...10 items 3250 - Medisealing for drug cup (sterilisable) ...1 item 3229 - Lid silicone plug (sterilisable) ...1 item 3263 - Ventilated plug-in cannula (not sterile) ...10 items 3220 - Silicone supply hose ø7 x 100mm (sterilisable) ...1 item 3244 - Aquadest infusion solution 1 litre ...1 item 3020 - T-piece, white ...1 item 3232 - Mouthpiece, white ...1 item 3010 - Aerosol mask for adults ...1 item 3213 - Bacteria filter ...1 item 3218 - Spiral hose, soft PVC ø22 x 300mm (sterilisable) ...1 item No. 31796 32/05
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Ultrasonic 2000
NOUVAG AG
Only for articles 3202 & 3203 : 3209 - Spiral hose, soft PVC ø22 x 600mm (sterilisable) ...1 item 3268 - Heating spiral hose ø22 x 600mm with plug (sterilisable) ...1 item 3264 - Small support for complete Ultrasonic ...1 item Only for articles 3204 & 3205 : 3219 - Spiral hose, soft PVC ø22 x 900mm (sterilisable) ...1 item 3269 - Heating spiral hose ø22 x 1200mm with plug (sterilisable) ...1 item 3225 - Mobile support with bottle holder for complete Ultrasonic ...1 item •
All accessories are supplied unsterile. Hoses, nebulizing lid, silicone plug and medisealing can be sterilised. Drug cup, plug-in cannula, mouthpiece, T-piece and aerosol mask are designed for single use only.
•
All sterilisable parts should be sterilised prior to first-time use (and of course before each subsequent use).
•
Sterilisable components cannot be sterilised in the supplied packaging. They must be unpacked into the bags supplied for that purpose prior to autoclaving.
•
The listed parts are necessary for correct functioning of the device. They must be in accordance with the EN 13544-1 standard for nebulizing equipment.
Sterilisable components can be autoclaved up to 50 times. It is recommended to replace them after 50 times. Disposable components must be replaced after each treatment. The bacteria filter should be replaced after 10 operating hours at the latest, as a soiled filter inhibits air supply to the nebulizing chamber.
4 Device assembly
4.1 Device overview 1. 2. 3. 4. 5. 6.
4
Device Knurled nut for support Nebulizing chamber Nebulizing chamber lid Silicone supply hose Patient hose
7. 8. 9. 10. 11. 12.
Lead-over cannula Mouthpiece Hose clamp Liquid container Hose retaining arm Support pipe
13. Bottle holder 14. Clamping device 15. Connection hose ø22x300 mm 16. Bacteria filter 17. Hose supports
No. 31796 32/05
NOUVAG AG
Ultrasonic 2000
13 14 12 11
9
10
10
7 7
15 6
8
5
5
4
16
4
3 17
2
1
4.2 Assembly 1)
Place device (1) on an even horizontal surface or on the support ( 3225 )
2)
Pour liquid into nebulizing chamber (3) until the liquid level mark has been reached. → Do not fill beyond the mark, as this may otherwise decrease nebulizing performance!
3)
Put nebulizing chamber on the device.
4)
Put chamber lid (4) on nebulizing chamber.
5)
Put up bacteria filter (16) on hose supports (17)
6)
Put up 300 mm connection hose (15) on bacteria filter and chamber lid.
7)
Loosen knurled nut (2) with two anticlockwise turns
8)
Insert support pipe (12) into the device up to the end stop.
9)
Tighten knurled nut.
10) Put up clamping device (14) on support hose and fix with knurled nut. 11) Put up hose clamp (9) on hose retaining arm (11). 12) Place bottle holder (13) on support pipe and tighten with knurled screw. 13) Insert lead-over cannula (7) into silicone supply hose (5) → Cannula must be completely inserted! 14) Hold liquid container (10) vertically and insert lead-over cannula (7) into rubber plug of liquid container. → Cannula must be completely inserted into the rubber plug of the liquid container! 15) Place silicone supply hose (5) on feed opening of the chamber lid (4). 16) Hang liquid container to the bottle holder. If necessary, adjust position and height of bottle holder. 17) Insert mouthpiece (8) into patient hose (6). 18) Place patient hose (6) on chamber lid. 19) Insert patient hose into hose clamp (9). 20) Put hose retaining arm (11) into desired position. 21) Establish mains connection.
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Ultrasonic 2000
NOUVAG AG
•
Please ensure that operating voltage and mains voltage agree!
•
In order to prevent dripping of condensed water from the mouthpiece, the patient hose must slope towards the nebulizing chamber, so condensed water can flow back into the chamber!
The device can now be operated!
4.3 Operation with hose heating All ULTRASONIC devices are equipped with heating hose connection as standard. The heating hoses are installed on the patient side and heat the bypassing air and fog stream to a pleasant temperature. The socket for the heating connection is located at the back of the device.
)
The warm-up phase of the heating hose lasts 5 minutes.
5 Operation
5.1 Switching on the Ultrasonic 2000 The control device is respectively switched "ON/OFF" with the main switch.
5.2 Actuators Front side: 3 1
2
4 5
6
1. "RATE":
Nebulizing intensity adjusting keys: ▼ Down: Reducing nebulizing intensity (1 step = 10%) ▲ UP: Increasing nebulizing intensity (1 step = 10%) Light bars: Nebulizing intensity display (scale: 10 - 100%)
2. "AIR FLOW":
Air flow adjusting keys ▼ Down: Reducing air flow ▲ UP: Increasing air flow Light bars: Air flow display (scale: 10 - 100%)
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Ultrasonic 2000
3. "TIME":
Time display ▼ Down: Reducing inhalation time (1 step = 1 minute) ▲ UP: Increasing inhalation time (1 step = 1 minute)
4. "LIQUID":
Liquid shortage display: illuminated when liquid level too low.
5. "TVAR":
Shift key for continuous operation / timer operation: Key illuminated when continuous operation activated.
6. "ON / OFF":
Switch on/off key for inhalation operation Key illuminated when inhalation operation activated.
Back: 9
1. 2. 3. 4. 5. 6. 7. 8. 9.
Control device ULTRASONIC 2000 Socket for heating hose Fuse T6.3A (heating) Voltage commutator 115V/230V Mains socket Fan housing lid Coarse air filter Hose supports Nebulizing chamber
8
1
7 6
2 3
4
5
Please ensure that the operating voltage matches the mains voltage by checking the commutator at the back!
1
230
5.3 Continuous operation Start continuous operation: 1. Continuous operation is adjusted once the device has been switched on ("TVAR" illuminated). 2. Start nebulization with "ON/OFF". 3. On key panel "RATE" reduce or increase nebulizing intensity with ▼ / ▲ keys. 4. On key panel "AIR FLOW" reduce or increase air flow with ▼ / ▲ keys. Stop continuous operation: Nebulization can be interrupted or stopped with "ON/OFF" key. An acoustic signal is heard during this process. When the liquid in the nebulizing chamber is completely nebulized, the safety cut-off is activated. → "LIQUID display is illuminated and an acoustic signal is heard.
5.4 Timer operation Start timer operation: No. 31796 32/05
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Ultrasonic 2000
NOUVAG AG
1. Press "TVAR" key →"TVAR" lamp goes out. 2. On key panel "TIME" set nebulizing time in the display with ▼ / ▲ keys.
)
Maximum duration in timer operation is 60 minutes.
3. Start nebulization with "ON / OFF" key. 4. On key panel "RATE" reduce or increase nebulizing intensity with ▼ / ▲ keys. 5. On key panel "AIR FLOW" reduce or increase air flow with ▼ / ▲ keys. Stop timer operation: Nebulization is stopped after setting the time or by activating "ON/OFF" key. An acoustic signal is heard during this process. When the liquid in the nebulizing chamber is completely nebulized, the safety cut-off is activated. → "LIQUID display is illuminated and an acoustic signal is heard.
5.5 Functional test / Operational test If the device is assembled as specified in chapter 4, it should be subjected to a functional test prior to each usage. 1.
Switch on device ÎAir flow ( Air Flow ) and nebulizing rate ( Rate ) displays are set to an average value, time display is set to "00".
2.
Check whether the nebulizing chamber is filled with liquid up to the mark. Fill the nebulizing chamber automatically through the lid with float system and check whether the ball- float stops the inflow at the filling mark level.
3.
Set device to continuous operation ( with "TVAR" key).
4.
Start nebulization with "ON/OFF" key.
5.
Adjust air flow and nebulizing rate by pressing the keys "▼" and "▲" and check whether the device reacts accordingly.
6.
When working with a heating hose, check whether the latter heats up.
7.
When using the lid with float system, let the device stand for approx. 3 min and check whether the nebulizing chamber slowly fills up. If the sealing at the inlet is soiled, the nebulizing chamber may overflow.
8.
Remove cup from device. Î The "Liquid" warning light is illuminated.
9.
Put cup back into place.
10. Switch off device.
5.6 Nebulization of drugs with the drug cup Nebulization of all usual medicines mixed with water is possible with ULTRASONIC 2000. In order to achieve the most effective nebulization, highest concentration and utilization of a drug, the drug cup which the drug is poured into is used. The drug cup is used together with a chamber lid without float system and a sealing ring.
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Ultrasonic 2000 die Verneblerkammer beim Aufsetzen und Entfernen vom Gerät niemals verdrehen, da sich sonst der Anschluss löst oder beschädigt wird. Das Gerät wird somit undicht.
Pour drug directly:
Pour drug via feed opening:
1. Pour drug directly into drug cup:
1. Push drug cup into the chamber lid from underneath.
2. Push drug cup into the chamber lid from underneath.
2. Put chamber lid with drug cup on nebulizing chamber.
3. Put chamber lid with drug cup on nebulizing chamber.
3. Remove silicone plug from feed opening of chamber lid.
4. Attach hoses.
4. Pour drug into drug cup via feed opening. 5. Close feed opening with silicone plug again. 6. Attach hoses.
)
Pour liquid into nebulizing chamber until the liquid mark is reached. Do not fill beyond the mark, as otherwise insufficient nebulizing performance may be produced. Î Maximum filling volume: up to the mark Î Minimum filling volume: the drug cup must be immersed at least 3 mm into the water. Never twist the nebulizing chamber when putting it on or removing it from the device, as otherwise the connection may be dissolved or damaged, thus resulting into the device becoming untight.
5.7 Particle sizes Particle size distribution with drug cup 100 90 80 70
Cumulative proportion of undersized particles [%]
60 50 40 30 20 10 0 0,1
1
10
100
Particle size [µm] Rate 1
No. 31796 32/05
Rate 5
Rate 10
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Ultrasonic 2000
NOUVAG AG
Mass Median Aerodynamic Particle Diameter (MMAD) : Nebulizing rate 1 Nebulizing rate 5 Nebulizing rate 10
(Rate 1) : (Rate 5) : (Rate 10) :
3.2µm ( GSD : 2.24 ) 3.8µm ( GSD : 2.12 ) 4.3µm ( GSD : 1.61 )
Data on particle sizes, aerosol delivery and the aerosol delivery rate in chapter 1.3. Technical Data do not apply to drugs available as suspension or to highly viscous drugs. In these cases, information should be obtained from the supplier of the drug.
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Ultrasonic 2000 6 Disinfection, cleaning and sterilisation
For care of the material, please do not fail to comply with the following important points: Pull out the power plug from the socket when cleaning! Do not use cleaning agents containing solvents ! Parts may no be sterilised with hot air! Always autoclave packed material in transparent bag! Parts may not be autoclaved when they are installed together ! Autoclave material up to maximum 134°C ! Should the sterilised material not be used immediately, it should be labelled on the packaging with sterilisation indicator and sterilisation date!
6.1 Control unit 1. Take off patient hose and connection hose. 2. Take off bottle with lead-over cannula and silicone supply hose. 3. Take off chamber lid from nebulizing chamber. 4. Take off nebulizing chamber from device and pour out liquid. 5. Clean fan housing and coarse air filter if discoloured. 6. Rub off control device with wet cloth. 7. First clean autoclavable parts with water and then sterilise in the autoclave. The following parts of the ULTRASONIC CAN be autoclaved in the autoclave at a maximum of 134°C : • • • • • • •
Nebulizing chamber Chamber lid Silicone supply hose Connection hose Patient hose Heating hoses Drug cup sealing
The following parts of the ULTRASONIC CANNOT be autoclaved: • • • • • •
Control device Mouthpiece T-piece Aerosol mask Lead-over cannula Drug cup
6.2 Bacteria filter: The bacteria filter between device and connection hose is a disposable article and cannot be washed nor sterilised. It is recommended to replace the bacteria filter periodically (after approx. 10 operating hours).
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Ultrasonic 2000
NOUVAG AG 7 Maintenance
7.1 Fan wheel and coarse air filter Ensure that the power plug is pulled out before removing the coarse air filter and the fan wheel!
Fan housing elements: 1. 2. 3. 4. 5.
Fan housing Fan wheel Retainer ring for coarse air filter Coarse air filter Fan housing lid
1
2 3
Dismantling and cleaning:
4
5
1. Take off lid from fan housing. 2. Remove retainer ring and coarse air filter from lid. 3. If the coarse air filter is discoloured, it must be replaced. 4. Pull out fan wheel from fan housing. 5. Cleaning of fan housing. Fan wheel installation: 1. Put fan wheel on axle in fan housing. →Fan wheel must be pushed up to the end stop! 2. Put coarse air filter in lid. 3. Put retainer ring in lid. 4. Put lid on fan housing.
7.2 Replacing device fuses Defective device fuses can be replaced independently by the user. They are located at the back of the device: 1. Plug out mains cable. 2. Open fuse housing by unscrewing anticlockwise. 3. Replace defective fuse (see 1.3 Technical Data). 4. Close fuse casing again by screwing clockwise. 5. Connect power cable again.
7.3 Functional test after maintenance or cleaning See chapter 5.5 Functional test / Operational test.
7.4 Discarding instructions When discarding the device, device components and accessories, please comply with the issued statutory regulations. 12
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Ultrasonic 2000 8 Faults and fault detection
Fault: Device does not function at all
Cause: Control unit not switched on Wrong operating voltage No connection to the mains Defective fuse
No fog formation
Nebulizing chamber overflowing with water.
No liquid flow despite full bottle No liquid flow Red lamp in "LIQUID"field is illuminated
No message on the display Heating hose does not heat
Liquid level too low Liquid level too high Timer expired Residues on crystal quartz in the nebulizing chamber
Add liquid Pour out liquid from the chamber Set new running time Replace nebulizing chamber
Insert lead-over cannula completely into silicone supply hose Lead-over cannula not fully Insert lead-over cannula inserted into rubber plug of liquid completely into rubber plug of container liquid container Silicone supply hose or lead-over Replace silicone supply hose and lead-over cannula cannula untight Remove air buffer in silicone Air buffer in silicone supply hose hose by slightly tapping on the silicone hose Bottle empty Attach new bottle Lead-over cannula not fully inserted into the silicone hose
Timer expired
Set new running time
No liquid in nebulizing chamber Nebulizing chamber not correctly installed There is no power connection Plug-in connection on device not correct
Add liquid Check fit of nebulizing chamber in the holder on the device Establish power connection
Heating hose not heated up Error messages
Elimination: Switch "ON/OFF" main switch to "ON"-position Check mains voltage Connect control unit to the mains Check fuses and replace if necessary
"nC" ( no Chamber ) Nebulization was started without nebulizing chamber "nF" ( no Fuse ) No fuse for the heating hose or defective fuse "Ex" ( Error No. x )
Check plug-in connection Wait 5 min after connecting heating hose Put on nebulizing chamber Replace (F1 ) fuse at the back of the device Switch off device and contact service engineer
If a fault cannot be eliminated, please contact the supplier or an authorised service agent. Addresses can be found on the last page of the operating instructions.
No. 31796 32/05
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Ultrasonic 2000
NOUVAG AG 9 Spare parts with order numbers
Part
Ord. no.
Nebulizing chamber ... 3222 Nebulizing chamber lid with float system ... 3251 Nebulizing chamber lid ... 3248 Drug cup (10 items) ... 3249 Drug cup seal ... 3250 Chamber lid silicone plug ... 3229 Aqua Dest (1 litre)... 3244 Ventilated plug-in cannula (50 items, sterile) ... 3272 Silicone supply hose ø7 x 100mm... 3220 Bacteria filter... 3213 T-piece, white ... 3020 Connection piece for O2 - hoses ... 3024 Mouthpiece, white ... 3232 Aerosol mask for adults, Ultrasonic... 3010 Aerosol mask for children Ultrasonic... 3011 Coarse air filter for control device Ultrasonic (10 items) ... 3212 Filter lid for coarse air filter ... 3239 Fan wheel ... 3241 Spiral hose, soft PVC ø22 x 300mm ... 3218 Spiral hose, soft PVC ø22 x 600mm ... 3209 Spiral hose, soft PVC ø22 x 900mm ... 3219 Spiral hose, soft PVC ø22 x 1200mm ... 3199 Heating spiral hose ø22 x 600mm with connector ... 3268 Heating spiral hose ø22 x 1200mm with connector ... 3269 For orders of other parts, please contact our customer service agents who will be glad to assist you.
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Electromagnetic compatibility (EMC) Remark: The Product subsequently referred to herein always denotes the Ultrasonic 2000. Changes or modifications to this product not expressly approved by the manufacturer may result in increased emissions or decreased immunity performance of the product and could cause EMC issues with this or other equipment. This product is designed and tested to comply with applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows. WARNING Use of portable phones or other radio frequency (RF) emitting equipment near the product may cause unexpected or adverse operation. WARNING The product shall not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the product shall be tested to verify normal operation in the configuration in which it is being used. Compliant Cables and Accessories WARNING The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the product. The table below lists cables, transducers, and other applicable accessories for which the manufacturer claims EMC compliance. NOTE: Any supplied accessories that do not affect EMC compliance are not listed. Description Length max. Nebulizing Chamber 0.02m
Guidance and manufacturer’s declaration – electromagnetic emissions The Product is intended for use in the electromagnetic environment specified below. The customer or the user of the Product should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Product uses RF energy only for its CISPR 11 internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Product is suitable for use in all RF emissions Class A establishments other than domestic CISPR 11 establishments and those directly connected to Harmonic emissions Class A the public low-voltage power supply network IEC 61000-3-2 that supplies buildings used for domestic Voltage fluctuations/flicker emissions Complies purposes. IEC 61000-3-3
Guidance and manufacturer’s declaration – electromagnetic immunity The Product is intended for use in the electromagnetic environment specified below. The customer or the user of the Product should assure that it is used in such an environment. Immunity tests IEC 60601 Compliance level Electromagnetic environment - guidance Test level Electrostatic discharge +/- 6 kV contact +/- 6 kV contact Floors should be wood, concrete or ceramic (ESD) tile. If floors are covered with synthetic +/- 8 kV air +/- 8 kV air material, the relative humidity should be at IEC 61000-4-2 least 30 %. Electrical fast +/- 2 kV for power supply +/- 2 kV for power supply Mains power quality should be that of a typical transient/burst lines lines commercial or hospital environment. IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
+/- 1 kV for input/output lines +/- 1 kV differential mode
+/- 1 kV for input/output lines +/- 1 kV differential mode
+/- 2 kV common mode < 5 % UT (> 95 % dip in UT ) for 0,5 cycle
+/- 2 kV common mode < 5 % UT (> 95 % dip in UT ) for 0,5 cycle
Mains power quality should bet hat of a typical commercial or hospital environment.
40 % UT (60 % dip in UT ) for 5 cycles
40 % UT (60 % dip in UT ) for 5 cycles
If the user of the Product requires continued operation during power mains interruptions, it is recommended that the Product be powered from an uninterruptible power supply or a battery.
70 % UT (30 % dip in UT ) for 25 cycles
70 % UT (30 % dip in UT ) for 25 cycles
< 5 % UT (> 95 % dip in UT ) for 5 sec 3 A/m
< 5 % UT (> 95 % dip in UT ) for 5 sec 3 A/m
Power frequency (50/60Hz) magnetic field IEC 61000-4-8 Note: UT is the a.c. mains voltage prior to application of the test level.
Mains power quality should be that of a typical commercial or hospital environment.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Guidance and manufacturer’s declaration – electromagnetic immunity for not life support equipment The Product is intended for use in the electromagnetic environment specified below. The customer or the user of the Product should assure that it is used in such an environment. Immunity tests IEC 60601 Compliance level Electromagnetic environment - guidance Test level Portable and mobile RF communications equipment should be used no closer to any part of the Product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
3 V rms 150 kHz to 80 MHz outside ISM bands 3 V/m 80 MHz to 2.5 GHz
3 V rms 150 kHz to 80 MHz outside ISM bands 3 V/m 80 MHz to 2.5 GHz
d = 1,2
P
d = 1,2
P 80 MHz to 800 MHz
d = 2,3
P 800 MHz to 2,5 GHz
where P is the maximum output power rating in the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Fixed strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Product is used exceeds the applicable RF compliance level above, the Product should b observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Product.
a
b
over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the not life support equipment The Product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Product can help prevent electromagnet interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Product as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W
Separation distance according to frequency of transmitter m 80 MHz to 800 MHz 800 MHz to 2.5 GHz 150 kHz to 80 MHz
d = 1,2 P d = 1,2 P d = 2,3 P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the higher frequency range applies. Note 1: Note 2:
At 80 MHz and 800 MHz, the separation distance fort the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Servicestellen / Servicecenter / Service / Assistenza tecnica / Centro de Servicio SWITZERLAND
(Hersteller/ Producer/ Producteur/ Produttore/ Productor)
NOUVAG AG St. Gallerstrasse 23-25 CH - 9403 Goldach Switzerland
GERMANY
Phone: Fax: E-Mail:
+41 (0)71 846 66 00 +41 (0)71 845 35 36 info@nouvag.com
(Europ. Bevollmächtigter / European Mandatory / Mandataire Européen / Mandatario Europeo)
NOUVAG GmbH Schulthaißstrasse 15 D - 78462 Konstanz Germany
Phone: Fax: E-Mail:
+49 (0)7531 1290-0 +49 (0)7531 1290-12 info-de@nouvag.com
Phone: Fax: Toll Free: E-Mail
+1 (661) 724 0217 +1 (661) 724 1590 (800) 673 7427 paul@nouvagusa.com
Phone: Fax: E-Mail:
+33 (0)494 44 87 34 +33 (0)494 44 87 34 dtr.europe@wanadoo.fr
Phone: Fax: E-Mail:
+44 (0)1733 571958 +44 (0)1733 571958 srelectromatics@hotmail.co.uk
Phone: Fax: E-Mail:
+852 2604 9389 +852 2694 0866 general@amscl.com
USA NOUVAG USA Inc. 18058 Albyn Court Lake Hughes CA 93532 USA
FRANCE DTR - Dentaire Turbine Repair Europe 55, allée de Châtaigniers F - 83600 Les Adrets de l`Estérel France
GREAT BRITAIN S.R.Electromatics 511 Fulbridge Road Werrington GB - PE4 6SB Peterborough Great Britain
ASIA Associated Medical Supplies Co. Ltd. Room 1201, Fo Tan Industrial Center 26 Au Pui Wan Street Fo Tan, Shatin Hong Kong
D
Wir bitten Sie, bei Benötigung von Service, Reparatur oder Ersatzteilen, den Händler oder Vertreter Ihres Landes zu kontaktieren.
GB In case of service, maintenance and spare part questions – we kindly ask you to contact your dealer or representitiv in your area. F
En cas de demandes regardent le service technique, l’entretien ou pièces détachées, nous vous prions de contacter le revendeur ou représentant dans votre région.
I
La preghiamo di contattare il suo rivenditore o il nostro rappresentante della sua zona, riguardo l’assistenza technica, la manuntenzione o per richiedere pezzi di ricambio.
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Por favor contactar al distribuidor en su area, para preguntas concernientes a servicio, mantenimento y repuestos.