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USER’S GUIDE PHOTOTHERAPY UNIT FOR PROFESSIONAL USE 8
USER’S GUIDE PHOTOTHERAPY UNIT
FOR PROFESSIONAL USE
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2
SUMMARY
1 - Important safety information ...................................................................................................................................... P3
2 - Contraindications and environmental parameters ..................................................................................................... P5
3 - Description of the technology used .......................................................................................................................... P7
4 - Use of the unit and software .............................................................................................................................. P9
5 - Computer update procedure ................................................................................................................................ P21
6 - Guidance and manufacturer’s declaration .............................................................................................................. P23
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IMPORTANT SAFETY INFORMATION
READ ALL THE WARNINGS AND CAUTIONS CAREFULLY BEFORE USING YOUR UNIT.
WARNINGS
Follow the safety information to avoid the risk of injury, damage to the unit and operating errors.
Warning about risks for the eyes and the effects of applying to the eyes:Because of the risks involved, safety glasses must be worn by the practitioner and the patient during a session with the unit.Patient safety glasses must be completely opaque. Practitioner glasses must comply with the following optical densities:
WAVELENGTHOPTICAL DENSITY RECOMMENDED FOR
PROTECTION OF EYE
Blue 450 nm to 470 nm ≥0.5
Green 510 nm to 540 nm ≥0.5
Amber 580 nm to 600 nm ≥1
Red 610 nm to 635 nm ≥1.5
Deep red665 nm to 695 nm ≥3
745 nm to 775 nm ≥4.5
Infra red 800 nm to 835 nm ≥3
Safety glasses mentioned below are compatible with the use of ATP38®. The use of third party products outside of the list below is to be done at the practitioner‘s own risk.
Glass for practitioner Glass for patient
Bullier automationLPLF302
Bullier automationYL-800
The unit is not suitable for treating the eyes, and it is not recommended for use in the periocular areas (marked by the safety glasses). As with any bright light, avoid staring at the unit.The light emitted by this unit may interact with photosensitising medications. Before starting treatment with this unit, review the patient’s medications.People with pre-existing eye diseases, a family history of eye disease or a sensitivity to light should avoid using phototherapy.
Warnings about the electrical and electromagnetic risks: MEDICAL ELECTRICAL EQUIPMENT requires special precautions with regard to EMC. It should be installed and commissioned according to the EMC information provided by the ACCOMPANYING DOCUMENTS.The use of PARTS, transducers and cables other than those specified, may result in increased EMISSIONS or in decreased IMMUNITY of the UNIT. The UNIT or the EM SYSTEM should not be used alongside other devices or stacked with these, and if it is not possible to do otherwise, the UNIT or the EM SYSTEM should be monitored to verify normal operation in the configuration which it will be used in. To avoid any risk of electric shock, this unit should be only connected to a power supply network equipped with a protective earth.
Warning about the importance of complying with the recommendations in the Instructions:Follow the recommendations in these Instructions. Use this unit only for the applications for which it was designed.
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IMPORTANT SAFETY INFORMATION
CAUTIONS
The user of the phototherapy unit should consider the electromagnetic compatibility (EMC) and the impact of mobile and portable RF communications on the unit. The unit runs on the mains and it should not be used in an environment where there is a risk of it being splashed with water. Avoid operating this unit near heat sources, such as radiators, heat registers and other heating appliances. Avoid placing heavy objects on the power cord or on the unit. Never use a worn-out or damaged plug or electric cord, which may cause electric shocks, burns or fires. Use only the power supply provided. The use of power supplies other than those specified and provided could cause increased electromagnetic emissions. No modification of this equipment is allowed. Do not try to remove the arms from the unit. Never disconnect the connections when the device is switched.If a light is on continuously, even when the unit is switched off, this indicates an equipment malfunction, contact Customer Services immediately. In the event of a fault, emergency shutdown of the unit is carried out via the master switch.
OVERALL VIEW OF THE UNIT
The unit consists of the following components: A base (stand with castors) (1) with a switch and a cord to connect to the mains,A swing arm (2) with a panel with 4 foldable panels (3),A laptop computer with software that controls the wavelengths from the foldable panels (4) is connected by USB cable to a control board.
USER SKILLS
This device is reserved for certified and trained healthcare professionals: general practitioners, medical specialists, physiotherapists, kinesiologists and dentists.
(1)
(4)
(2)
(3)
SAFETY AND COMPLIANCE
COMMERCIAL REFERENCES
GENERAL INFORMATIONBefore using this unit, get accustomed with the instructions in this guide.
The safe use of this unit has been proven by tests performed by an independent laboratory to ensure compliance with the reference standards for medical electrical devices. The tests proved that the unit meets the safety standards EN60601-1 (2006) and EN60601-1-2 (2007).This unit is a medical device with CE marking, which meets the requirements of directive 93/42/EEC of the Council dated 14 June 1993.
ATP38®
1 option is available for the l’ATP38®:ATP38® with 1 additional arm with 3 foldable panels
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LIFETIMEThe life of the device is set at 18 months, after which the device requires regular preventive checking to ensure its proper functioning and offer you an optimum level of quality and safety.
POSSIBLE ADVERSE REACTIONSThe patient must be aware that problems may occur. Side effects in phototherapy are quite rare, generally limited to irritation around the eyes and sometimes some facial redness.
INSTRUCTIONS REGARDING THE PROCESSING OF USED PRODUCTSThe WEEE (Waste Electrical and Electronic Equipment) Directive 2020/96/EC was introduced to ensure that products are recycled using the best processing, recovery, and recycling techniques possible, and also to contribute to protecting the environment and human health. Your product was designed and manufactured with components and high-quality materials which may be recycled and reused.
Do not throw your old product out in your general waste bin for household waste. Please find out about the local facilities in place for the separate collection of electrical and electronic devices marked with this symbol. Any device marked with this symbol cannot be thrown in the waste bin with the other waste.
CONTRAINDICATIONS Phototherapy should not be used in patients with local and/or general contraindications. These contraindications must be carefully assessed during decision-making by the practitioner. These include eye diseases (such as macular degeneration, retinopathy, glaucoma, cataracts and retinal damage). Moreover, it appears that certain diseases and/or medications increase sensitivity to light. It is therefore recommended that anyone with a disease and/or taking photosensitising medication should warn the practitioner prior to use. The use of ATP38 is contraindicated in patients carrying a pacemaker, for epilepsy patients, pregnant women and in the context of pediatric use.
MAINTENANCEThe unit is sold non-sterile and it is not recommended to sterilise it prior to use. Never immerse the unit in water or in any other liquids. Clean the foldable panels with a soft, dry cloth. Do not use a wire brush or steel wool. When a cleaner is used, it should be a universal, slightly alkaline cleaner which contains if possible surfactants and phosphates. It is possible to use any type of disinfectant, but only products which do not contain chlorine or chlorine-releasing compounds.
CONTRAINDICATIONS AND ENVIRONMENTAL PARAMETERS
OPERATING ENVIRONMENT
CARRIAGE AND STORAGE CONDITIONS
Operating temperature range limits: +10°C to +40°C Humidity percentage: 30 - 75% uncondensed Air pressure: 800hPa/1060hPa
Operating temperature range limits: -10°C to +70°C Humidity percentage: 10% to 90% uncondensed Air pressure: 500hPa/1060hPa
The unit runs on the mains and it should not be used in an environment where there is a risk of it being splashed with water. Avoid operating it near heat sources, such as radiators, heat registers and other heating appliances.
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CONTRAINDICATIONS AND ENVIRONMENTAL PARAMETERS
MAINTENANCE AND CUSTOMER SERVICESNo maintenance or calibration is to be performed by the user. The unit has a guarantee of 2 years from purchase. Any change to this unit is prohibited. In case of a fault with the unit, the unit must be returned to Customer Services, which will carry out the maintenance itself.
A remote technical support is offered by the manufacturer in case of software related failures. This service uses the TeamViewer application which enables the manufacturer to take control of the computer. Contact Customer Services to know more about the procedure to follow.
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The unit uses collimated semiconductor technology and combines 2x8 wavelengths on each of the 4 foldable panels between 450 nm to 835 nm.
DESCRIPTION OF THE TECHNOLOGY USED
Each foldable panel includes 2 x the following 3 collimated semiconductor:
1 collimated polychromatic semiconductor 4 wavelengths,1 collimated polychromatic semiconductor 2 wavelengths,1 collimated single-wavelength semiconductor each one covering 1 wavelength.
The distribution of these 2 x 8 wavelengths on each foldable panel is as follows:
WAVELENGTHPOWER OF
COLLIMATED SEMICONDUCTOR
DISTRIBUTION PER COLLIMATED SEMI-
CONDUCTOR
NUMBER OF C PER FOLDABLE PANEL
SCC TYPE
Blue 450 nm to 470 nm 3.52 W
1 polychromaticsemiconductor
collimated2
Green 510 nm to 540 nm 4.03 W
Amber 580 nm to 600 nm 2.55 W
Red 610 nm to 635 nm 2.55 W
Deep red665 nm to 695 nm
8.59 W1 polychromaticsemiconductor
collimated2
745 nm to 775 nm
Infrared 800 nm to 835 nm 6.62 W1 single-wavelength
semiconductorcollimated
2
The energy fluence is electronically limited to 4 Joules/cm².
The emitted range has an emission spectrum ranging from 450 nm to 835 nm. The duration of the wavelengths emitted depends on the wavelengths, on the distance of the foldable panels in relation to the patient and the energy fluence, with a constant instantaneous light output and a fluence limited by hardware to 4 Joules per cm².
MAKE-UP OF THE 4 FOLDABLE PANELSThe 4 foldable panels each have a collimated semiconductor printed circuit board (PCB). In addition, 2 of the 4 foldable panels each have a driver board which is used to control the wavelengths. The first driver board monitors the wavelengths of the 3 foldable panels and the 2nd driver board monitors the wavelengths of the 4th foldable panel, since the wavelengths operate at the same time (the 2 driver cards are connected).
DESCRIPTION OF THE HUMAN-MACHINE-INTERFACE (HMI)The software is a HMI which enables the healthcare professional to control the wavelengths (via the driver boards and the control board) and to set the protocols that will be applied to each of their patients.
The unit is connected to the mains. It is operated with a switch and with the software. The switch must be set to «ON» and the computer with the software must be switched on and the software running. Once the protocol has been set by the healthcare professional, i.e. the parameters entered in the software, the healthcare professional performs their protocol. The wavelengths are triggered depending on the protocol set. The processing is performed according to the protocol. The monitoring of the protocol, including the processing time, is carried out via the HMI and the time is shown by countdown.
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DESCRIPTION OF THE TECHNOLOGY USED
The unit runs on the mains and with software which controls the following parameters:Wavelengths,Energy fluence in J/cm²,Duty cycle in %,Distance of the foldable panels in relation to the patient,Frequency in Hz per wavelength.
The software enables the user to select one or more wavelength(s) to be used and to vary the parameters depending on the treatment and the patient’s condition.
The parameter for the length of processing time is calculated according to the energy fluence selected and the distance at which the panel is placed in relation to the patient.
The software can be updated via the Internet.
Swiss Bio Inov releases any responsibilities in case of use of versions of software previous to the version available on the market.
Swiss Bio Inov has provided a video which explains how to use the software. This video is available on request.
INDICATIONS AND INTENDED CONDITIONS OF USE
The APT38® is a phototherapy unit which provides healthcare professionals (specialists, general practitioners, physiotherapists and dentists+) with a platform of 2x8 wavelengths from 450 nm to 835 nm for each of the foldable panels with each one having 2x3 collimated semiconductors single et polychromatic. The maximum energy fluence is 4 J/cm² per wavelength.The practitioner controls the wavelengths using the software (with the possibility of combining them or not).
It claimed use is for:Analgesic*,Anti-inflammatory,Scarring**.
Depending on the patient’s condition, the healthcare professional combines one or several wavelengths at the selected output. The output varies, as it depends on the condition being treated.
Each of these wavelengths, as well as the combinations, have a claimed and proven effect on the cells. Indeed, depending on the wavelength, they will penetrate the skin at variable depth and so supply the cells with energy.
The software enables the user to select one or more wavelength(s) to be used and to vary the parameters depending on the treatment and the patient’s condition.
The parameter for the length of processing time is calculated according to the energy fluence selected and the distance at which the panel is placed in relation to the patient.
+ The use by the dentists is authorized in Europe only. * Temporary effect. ** Wound healing.
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USE OF THE UNIT AND SOFTWARE
PRECAUTIONS FOR USE
The unit is intended for healthcare professionals (specialists, general practitioners, physiotherapists and dentists). It is not intended for domestic use. You must comply with the recommendations in these instructions.
Use this unit only for the applications for which it was designed. Wearing safety glasses is mandatory for the practitioner and the patient during the session (refer to warning section for the list of safety glasses compatible with ATP38®). You must comply with existing studies to use wavelengths commensurate with the treatment. A poor choice of parameters may result in under-utilisation of the unit. This is why the unit’s interface is clear, illustrated and large enough (via a computer screen) in order to select and enter the appropriate parameters correctly. Observe 72 hours between each treatment. Strong shocks or vibrations can cause damage to the system.
In the event of non-compliant use with these recommendations, the manufacturer disclaims all liability.
USE OF UNIT AND SOFTWARE
InstallationThe unit does not require installation and the computer software is already configured.
Handling of the articulated arm1. Hold the front part (A) of the articulated arm with one hand and then use the central handle (Z) with the other hand.2. To release the arm, turn the central handle (Z) counterclockwise (B) as much as necessary.3. Then move the device in the desired position.4. To secure it in place, turn the central handle (Z) clockwise (C).5. Check for proper hold and good handling of the articulated arm.
WARNING: DANGER OF SERIOUS INJURY
Before any release of the arm, firmly hold the frontpart handle. The articulated arm can move unexpectedly if the central handle (Z) is released.When you set the articulated arm, always keep one hand on the anterior portion (A) and press the center handle (Z) with the other.If the articulated arm is not secured correctly, it can move in unexpected ways or even drop, which can cause injury.
WARNING
The setting of the articulated arm relies on friction. Changing the position without loosening the holding mechanism can induce damage and shorten the devices life.The arm can be adjusted with little force. If the central locking handle (Z) was completely loose, then it must be screwed clockwise!
The ATP38® is systematically delivered with a computer equipped with a Windows 7 operating system and higher versions.
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USE OF THE UNIT AND SOFTWARE
IMPORTANT RECOMMENDATIONS: INSTALLATION PROCEDURE OF COMPUTER
Installation must be done following steps described into this procedure.
2.
3.
4.
1. UNPACK THE SYSTEM FROM THE TRANSPORT SUITCASE
FIX THE COMPUTER
CONNECT THE COMPUTER’S POWER CABLE
PLUG THE USB CONNECTOR
5. PLUG THE UNIT’S POWER CABLE
Always connect the machine to an earthed socket.
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2. START THE UNIT BY PRESSING THE ON/OFF BUTTON FOUND AT THE BOTTOM OF THE FRAME
The power button becomes green.
3. START THE COMPUTER BY PRESSING THE START BUTTON ON THE KEYBOARD, PRESS THE SPACEBAR AND ENTER THE CODE STATED ON THE COMPUTER
Note: If you do not touch the computer for 3 minutes, it goes into standby mode. Just press any key to turn it on again.
4. START THE SOFTWARE BY CLICKING ON THE «SOFTWARE» ICON
5. UNLOCK THE SAFETY AFTER ENSURING THAT THE PRECAUTIONS FOR USE HAVE BEEN READ
6. CREATING / EDITING A PATIENT FILE
1. CONNECT THE UNIT’S POWER CORD TO A 100V / 230AC OUTLET
Note: The unit must be plugged in to be used.
Use of the unit
Unplug the cable using the index to avoid damaging the power cord when disconnecting the system.
USE OF THE UNIT AND SOFTWARE
Option 1: Creating a new patient
Click on the «Create» icon,Fill in the fields.
Option 2: Patient already registered
Click on the «Patient List» icon,The patient list is displayed,Select the patient.
It is possible to view the treatment history by clicking on the patient’s name:
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7.
The patient may be laying down, mainly for their comfort during the session. Note: The unit can be moved easily with the castors. Lock the castors before handling the arm.
SETTING THE UNIT UP NEAR THE PATIENT
8.
Wearing glasses is mandatory for the patient and the practitioner, if they remain nearby, as eye damage may occur. Do not remove the glasses while using the device and do not replace them with sunglasses or glasses with smoked glass lenses (Refer to warning section for the list of safety glasses compatible with ATP38®).
WEARING OF SAFETY GLASSES BY THE PATIENT AND THE PRACTITIONER (BEFORE STARTING THE TREATMENT)
9.
The panels must be placed around or in the area to be treated, but not touching the patient.Full ranges are obtained in the arm hinges by positioning in the notch. Do not try to move the arm once the adjuster knob has been fully turned.
Note: Ensure that the castors are locked before handling the arm to prevent the unit from moving.
SETTING UP THE FOLDABLE PANELS IN THE AREAS TO BE TREATED AND THEN LOCKING THE ARM WITH THE ADJUSTER KNOB
USE OF UNIT AND SOFTWARE
For ease of use, the arm can rotate in 2 directions provided that it is manipulated horizontally.
After reviewing the recommendations, click.
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USE OF THE UNIT AND SOFTWARE
Then:
Click on the «ON» icon to start the treatment.
1. Tick the screen 1 and/or 2.2. Indicate the distance of panels compared to the patient. The distance can vary between 10 and 40 mm.3. Click on the blue «start» button.
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11. ONCE THE TREATMENT HAS BEEN COMPLETED, REMOVE THE FOLDING PANELS ON THE 3 ARMS FROM THE TREATED AREAS USING THE HANDLE ON THE CENTRAL PANEL
CLOSE THE SOFTWARE BY CLICKING ON THE CLOSE BUTTON IN THE SOFTWARE
TURN THE COMPUTER OFF
12.
13.
Start Menu on Windows and select «turn the computer off».
TURN THE UNIT OFF BY PRESSING ON THE ON/OFF BUTTON14.
See step 5.
UNPLUG THE UNIT FROM THE OUTLET 15.
Note: When you disconnect the unit, hold the power supply directly to avoid damaging the cord. Never pull on the electrical cord to disconnect the power supply from the outlet.
CLEANING THE FOLDABLE PANELS16.
Refer to the recommendations in the Maintenance section.
STORING THE UNIT17.
The unit does not have to be packaged. Do not touch the arms and do not try to remove them from the unit. If an arm is removed from the unit, the guarantee will no longer be valid. Contact the manufacturer if it is necessary to remove one or more arms.
USE OF THE UNIT AND SOFTWARE
10.
The wavelengths selected in the protocol are emitted for the specified time.
Note: All the steps are triggered automatically after each countdown.
Once the countdown has finished, the wavelengths are turned off and the unit no longer emits any more energy.
START THE PROGRAMME BY PRESSING THE «ON» BUTTON AND THE COUNTDOWN STARTS
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CREATING A TREATMENT PROGRAM
Click on the «Practitioner’s treatments» icon.
Click on «more» to add a new treatment to the list.
Enter a name for the treatment; it is possible to add information in the «Notes» section.
The distance of panels compared to the patient is still modifiable according to the treatment.
USE OF THE SOFTWARE
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Add a step.
Note: The configured treatment programme may consist of 1 or several steps.
Select the wavelengths, frequency, duty cycles and joules and then confirm the step.
You must comply with existing studies to use wavelengths commensurate with the treatment. A poor choice of parameters may result in under-utilisation of the unit.
USE OF THE SOFTWARE
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Confirm the other steps and click on more again.
USE OF THE SOFTWARE
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Once the treatment is created, confirm it using the corresponding icon.
Look for the treatment in: practitioner’s treatment but via the patient sheet.
A protocol specific to the patient can be created only in the patient’s sheet.
USE OF THE SOFTWARE
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Other functions:
1. REMOVING A PATIENT
Open the patient file.Click on the icon representing the patient.
Click on the recycle bin to remove the patient file.
USE OF THE SOFTWARE
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2. REMOVING A TREATMENT
Select the treatment.
Click on the treatment to be removed and then click on the recycle bin icon.
Step
USE OF THE SOFTWARE
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COMPUTER UPDATE PROCEDURE
Click on this icon at the bottom left of the screen Click on “Windows Update Settings”
Click on “Search for updates”
Your search results will show either the following:
Or it will show that you have updates, in which case, you simply need to launch them. However, we advise you to do this at the end of the day, since in some cases updates can take several hours.
Click on “Settings”
Click on:
Click on:
Another procedure:
Go to the “Search Windows” icon
Tick “Windows Update”
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CHARACTERISTICS
Electrical characteristicsPower supply 100-230 VACRated frequency 50-60 HzMaximum power consumption 250 V 27 Vcc 450 WIntensity Duty cycle adjustable from 0 to 100%Modulation Frequency adjustable from 0 to 100 Hz (Continuous-Pulsed)
Computer characteristicsOs Windows®* 7 or higher versionsIntel® Atom™ processor or higherClocked at 1.33 GHz minimumRAM memory 2.00 GB minimumUSB 2 and USB 3 portWifi or LAN connectivity
Dimensional characteristicsTotal weight 22 kgHeight 1 metreWidth 40 cm
MaterialsFrame Material SteelPanel Material Aluminium
INFORMATION REGARDING EMC
The user should consider the electromagnetic compatibility (EMC) and the impact of mobile and portable RF communications on the unit. MEDICAL ELECTRICAL EQUIPMENT requires special precautions with regard to EMC. They should be installed and commissioned according to the EMC information provided by the ACCOMPANYING DOCUMENTS. The use of PARTS, transducers and cables other than those specified, may result in increased EMISSIONS or in decreased IMMUNITY of the UNIT. The UNIT or the EM SYSTEM should not be used alongside other devices or stacked with these, and if it is not possible to do otherwise, the UNIT or the EM SYSTEM should be monitored to verify normal operation in the configuration which it will be used in.
The phototherapy unit is designed to be used in the electromagnetic environment described below. The user must ensure that the unit is used in this environment.
DESCRIPTION OF THE TECHNOLOGY USED
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GUIDANCE AND MANUFACTURER’S DECLARATION
EMC COMPLIANCE ACCORDING TO IEC/EN 60601-1-2 (2007)
The ATP38® are intended for use in the electromagnetic environment specified below. The customer or user of the ATP38® should ensure that they are used in such an environment.
EMISSIONS TEST STANDARD COMPLIANCEELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
RF Emissions CISPR 11 Group 1
The ATP38® uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference
in nearby electronic equipment.
RF Emissions CISPR 11 Class B The ATP38® is suitable for use in all establishments, including domestic establishments, and those directly
connected to the public low-voltage power supply network that supplies buildings for domestic purposes.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations /Flicker emissions
IEC 61000-3-3 Compliant
The ATP38® are intended for use in the electromagnetic environment specified below. The customer or the user of the ATP38® should ensure that they are used in such an environment.
IMMUNITY TEST TEST LEVEL IEC 60601 COMPLIANCE LEVELELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Electrostatic discharges (ESD)IEC 61000-4-2
6 kV contact8 kV air
6 kV contact8 kV air
Floors should be wood, concrete, or ceramic tiles. If floors are covered with synthetic materials, the relative humidity should be at least 30%
Fasttransients in burstsIEC 61000-4-4
± 2 kV for power supply lines± 1 kV for input/
output lines
± 2 kV for powersupply lines
The quality of the power supply network should be that of a
typical commercial or hospital environment.
Transientovervoltage
IEC 61000-4-5
± 1 kV between phases± 2 kV between phase and Earth
± 1 kV between phases± 2 kV between phase and Earth
The quality of the power supply network should be that of a
typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on the
power supply inputlines
IEC 61000-4-11
<5% UT (>95% drop in UT)for 0.5 cycle
40% UT (60% drop in UT)for 5 cycles
70% UT (30% drop in UT)for 25 cycles
<5% UT (>95% drop in UT)for 5 s
<5% UT (>95% drop in UT)for 0.5 cycle
40% UT (60% drop in UT)for 5 cycles
70% UT (30 % drop in UT)for 25 cycles
<5% UT (>95% drop in UT)for 5 s
The quality of the power supply network should be that of a typical commercial or hospital environ-ment. If the user of the ATP38® requires continuous operation
during interruptions in the power supply network, it is recommended
to supply the ATP38® from an uninterruptible power supply or a battery. NOTE UT is the AC mains voltage before application of the
test level.
Power frequency magnetic field (50/60 Hz)IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com-mercial or hospital environment.
GUIDANCE AND MANUFACTURER’S DECLARATION
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IMMUNITY TEST TEST LEVEL IEC 60601 COMPLIANCE LEVELELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Conductive RF interferenceIEC 61000-4-6
3 Vrms150 kHz-80 MHz
3 Vrms
Portable and mobile RF communi-cations equipment
should be no closer to any part of the ATP38®, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency
of the transmitter.Recommended separation distance
where P is the maximum output power rating of the transmitter in watts (W), according to the trans-mitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic survey on site a,
should be less than the compliance level in each frequency range. bInterference may occur in the
vicinity of equipment marked with the following symbol:
Radiated RF interference IEC 61000-4-3
3 V/m80 MHz-2.5 GHz
NOTE 1. At 80 MHz and at 800 MHz, the highest 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.
a. Field strengths from fixed transmitters, such as base stations for radio telephones (cellular/cordless) and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmit-ters, an electromagnetic site survey should be considered. If the measured field strength in the location where the ATP38® is used, exceeds the applicable RF compliance level above, the ATP38® should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or repositioning the ATP38®. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
GUIDANCE AND MANUFACTURER’S DECLARATION
25
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RFCOMMUNICATIONS EQUIPMENT AND THE ATP38®
The ATP38® are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ATP38® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ATP38® as recommended below, according to the maximum power output of the communications equipment.
RATED MAXIMUM OUTPUT POWER
OF THE TRANSMITTER (W)
SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER(M)
150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz
0.01 0.117 0.117 0.233
0.1 0.369 0.369 0.737
1 1.167 1.167 2.330
10 3.690 3.690 7.368
100 11.67 11.67 23.300
For transmitters rated at a maximum output power rating 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 of the transmitter in watts (W) according to the
transmitter manufacturer. NOTE 1. At 80 MHz and at 800 MHz, the separation distance for the highest 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.
INFORMATION Please contact the manufacturer for any further information.
MANUFACTURERSwiss Bio Inov SARoute de la Croix 641741 COTTENSSWITZERLANDTel.: 0041 79 715 14 50
The French text will be the reference.Date of last revision of the instructions: 26/06/2017
GUIDANCE AND MANUFACTURER’S DECLARATION
MANUFACTURER
CATALOGUE REFERENCE
BATCH CODE
SERIAL NUMBER
MANUFACTURING DATE
STORE AWAY FROM SUNLIGHT
PROTECT FROM HUMIDITY
ATTENTION, SEE THE INSTRUCTIONS
SHOULD BE DISPOSED OF IN AN APPROPRIATE RECOVERY OR RECYCLING FACILITY
PART APPLIED TYPE B
PROTECTIVE EARTH (GROUND)
ALTERNATIVE CURRENT
TEMPERATURE RANGES. INDICATES THE HIGHEST AND LOWEST STORAGE TEMPERATURES
EUROPEAN CONFORMITY MARK WITH THE NUMBER OF THE NOTIFIED ORGANIZATION OF SWISS BIO INOV
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GUIDANCE AND MANUFACTURER’S DECLARATION
27
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Swiss Bio Inov SARoute de la Croix 641741 COTTENS - SUISSETél.: 0041 79 715 14 50
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