Table of Contents Section 1: Introduction ..................1 Before You Start ..................... 1 System Overview ....................1 Conventions Used in the Manual ................1 Explanation of the Symbols used on the System ........... 2 Section 2: Safety ....................3 The Patient ......................3 Treating Attendant ....................
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Section 6: DiolazeXL Treatment Information ............ 36 Instructions for Use ....................36 Contraindications ....................36 Possible Adverse Effects..................37 Pre-treatment Recommendations ............... 38 Tip Cleaning Instructions Prior to Use ..............38 Treatment Recommendations ................38 Treatment Schedule ..................... 40 Post-treatment Recommendations ..............40 Section 7: Vasculaze Treatment Information ............
– Laser, Intense Pulsed Light (IPL), and Radio-frequency (RF). The Optimas System operates while in contact with any of the following Handpieces: DiolazeXL (laser for hair removal), Vasculaze (laser for vascular lesions), Lumecca (IPL for skin rejuvenation), Fractora (RF for fractional resurfacing), and Forma (RF for facial wrinkle treatment).
Optimas System Operator Manual Section 1: Introduction Explanation of the Symbols used on the System Symbol Description CSA marking (212603 CSA master contract number) Do not discard in trash. Electronic equipment should be disposed of in an appropriate manner Fuse Type BF Equipment Type B Equipment.
Protective eyewear must be used by the patient during DiolazeXL laser, Vasculaze laser or Lumecca IPL treatments Treating Attendant ▪ Only authorized individuals with appropriate training and knowledge should operate, assist in the operation of, or provide maintenance to the Optimas System. 3 of 87...
Optimas System Operator Manual Section 2: Safety ▪ Personnel should not operate the System until they have been fully educated in its use. Make sure that all treatment personnel are familiar with the System controls and know how to shut down the System instantly.
Optimas System Operator Manual Section 2: Safety ▪ For the laser, remote interlock is provided, which can be connected to the treatment room doors, disabling laser output if the door is opened during a procedure. In addition, compliance with ANSI Z1 36.3 and EN 60825-l requires that laser safety signs be posted at all entrances whenever the laser is in use.
Optimas System Operator Manual Section 2: Safety Electrical and Mechanical Safety ▪ Keep all covers and panels of the System closed. Removing the covers creates a safety hazard. ▪ Keep hands away from the applicator during the System start-up. ▪...
Optimas System Operator Manual Section 2: Safety Safety Features of the System The System incorporates the following safety features. All personnel operating the System should be familiar with these features. ▪ The System has unique password to avoid device operation by non-authorized personnel.
Optimas System Operator Manual Section 2: Safety ▪ Temperature monitoring which disables System operation if the Handpiece sapphire temperature is outside the operating range. ▪ As a safety feature and in compliance with U.S. and international regulations, the DiolazeXL and Vasculaze Handpieces contain an electronic shutter to help prevent inadvertent laser emission.
This equipment is for use only by qualified medical professionals trained in the particular technique to be performed. Only handpieces manufactured or approved by InMode MD Ltd. should be used with Optimas System. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit.
The optical or RF energy and heating associated with the System can provide an ignition source. Observe fire precautions at all times. When using Optimas in the same room with any of these substances or gases, prevent their accumulation or pooling within the area where Optimas procedures are performed.
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Optimas System Operator Manual Section 2: Safety Figure 2-2: Laser Emission Warning Label Figure 2-3: Emergency STOP Label on Emergency Red Button Figure 2-4: 4 IPL Warning Label 11 of 87...
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Optimas System Operator Manual Section 2: Safety Figure 2-5: IPL Emissions Warning Label Figure 2-6: Interlock and Footswitch Label Figure 2-7: USA Federal Restriction Label 12 of 87...
Optimas System Operator Manual Section 2: Safety 2.12 Handpieces Labels The Handpiece certifications and identification labels are attached to connectors on the Handpieces. It states that the product conforms to the performance standards, and indicates the manufacturer’s name, date of manufacturing, model and serial number of the handpiece.
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Optimas System Operator Manual Section 2: Safety Figure 2-10: All Handpiece Identification Labels Figure 2-11: DiolazeXL 810 Handpiece Connector Label 14 of 87...
The Optimas System with Lumecca IPL Handpieces is classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE marking. The Optimas System with RF Handpieces - Fractora and Forma is classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE marking.
Optimas System Operator Manual Section 3: System Installation Section 3: System Installation Electrical Requirements ▪ The System will require a separate line supply of single phase (100Vac; 15A) or (115Vac; 15A) or (230Vac; 15A) or (240Vac; 15A) 50-60Hz. Zmax = 0.03Ω.
Optimas System Operator Manual Section 3: System Installation ▪ User protective goggles ▪ Patient eyewear ▪ “Laser Danger” door sign Unpacking In order to unpack the device: Remove the paper strip and open the box Remove accessories and foams around the device.
Figure 3-1: Cradle Connections to the Device Filling Water Optimas System and DiolazeXL, Vasculaze and Lumecca Handpieces are shipped without water. Distilled water must be used and failure to do so will void the service warranty. For detailed instructions refer to Section 10 – System Maintenance.
Optimas System Operator Manual Section 3: System Installation ▪ Release the Wheel Brakes. ▪ Slowly push or pull the System using the handle. ▪ When moving the System to another facility, lift the System to the vehicle and lay it carefully on its side.
Optimas System Operator Manual Section 4: Device Description Section 4: Device Description Rear Panel Power Cord Inlet 100-240V~, 15A, 50-60Hz. Fuse Holder Rating is T 12A, 250V. Replace fuses if needed, only with fuses having exactly the same rating. ...
Optimas System Operator Manual Section 4: Device Description Front Panel and Operator Control Panel The Operator Control Panel is located on the upper side of the System. The Operator Control Panel consists of an LCD touch screen. On the front panel, there is a grey On/Off switch on your left, a red Emergency Stop Button on the right, and a Handpiece connector (arrow) in the center for either DiolazeXL, Vasculaze or Lumecca.
Optimas System Operator Manual Section 4: Device Description Software Screens The Progress screen appears after the On-Off switch is turned on. Figure 4-3: Progress Screen *The SW version number will be displayed according to the software version. After entering the individual code on the Login Screen, non-authorized use of the device is prevented.
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Optimas System Operator Manual Section 4: Device Description Software is loaded from the plug and self-test of the System modules is performed. After the end of the self-test the Menu Screen appears. Figure 4-5: Menu Screen The Menu Screen allows the selection of the connected Handpiece, or entry to the Utilities Screen.
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Optimas System Operator Manual Section 4: Device Description The Utility Screen contains: Volume This function allows the user to adjust the System volume. Drain / Fill Drain water from the DiolazeXL, Vasculaze and Lumecca Water Handpieces and System prior to shipment and fill water during installation.
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Optimas System Operator Manual Section 4: Device Description Cooling Normal and Strong cooling, 12 and 7 C, respectively, can be selected for DiolazeXL. Pulse Width Short or Long pulse can be selected for DiolazeXL. Pulse Mode Off (Single) 5-40J/cm2 1pps...
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Optimas System Operator Manual Section 4: Device Description The Vasculaze Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by the function keys. Fluence Fluence (laser energy density) is changed within the limits from 100 to 300J/cm², and the System starts up at the minimal setting.
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Optimas System Operator Manual Section 4: Device Description The Lumecca 580 or 515nmTreatment Screen contains: Selection The frame selects parameters that can be changed by the function Frame keys. Fluence Fluence (light energy density) is changed within the limits from 5 to 30J/cm²...
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Optimas System Operator Manual Section 4: Device Description Figure 4-10: Fractora Treatment Screen The Fractora Treatment Screen contains: Selection The frame selects parameters that can be changed by the function Frame keys. Tip Type Allows selecting between different tip types of Fractora.
Optimas System Operator Manual Section 4: Device Description The Forma Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by the function keys. Energy Delivered energy is changed from level 20 to 62 energy levels and the System starts up at the minimal power setting.
Optimas System Operator Manual Section 4: Device Description temperature drops below the Cut-off temperature, RF starts again, thus maintaining the desired temperature with safety and when reached, RF delivery is automatically stopped. Temperature is monitored by a temperature sensor in the Handpiece and serves as a safety feature.
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Optimas System Operator Manual Section 4: Device Description The Vasculaze Handpiece comprises applicator, cable and connector. Figure 4-13: Vasculaze Handpiece Applicator The Vasculaze laser comprises a cooled sapphire output window (3x4mm) and electronic shutter (Figure 4-13). Cable The Cable has a length of 170cm.
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Optimas System Operator Manual Section 4: Device Description Comprises flash lamp and reflector emitting optical energy through Applicator the pre-cooled light guide (30x10mm) (Figure 4-14). Cable The Cable has a length of 170cm. Connector The Connector is connected to the System.
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Optimas System Operator Manual Section 4: Device Description The Forma Handpiece comprises applicator, cable, connector and an integral temperature sensor (Figure 4-17). Figure 4-17: Forma Handpiece The Tip is a part of the Handpiece, comprising RF electrodes and a temperature sensor.
Optimas System Operator Manual Section 5: System Operation Section 5: System Operation This section of the manual explains how to start the device, operate it, and turn it off. Prior to using or connecting the Handpiece, inspect the System and Handpiece for possible mechanical damage.
Optimas System Operator Manual Section 5: System Operation Press Standby icon that will change to Ready. Press the Footswitch and then press trigger button on the Handpiece to start the treatment for DiolazeXL and Vasculaze; After pressing the foot-switch the icon will change to Armed.
810nm is a universal hair removal for all skin types. Instructions for Use The Optimas System with the DiolazeXL 810nm Handpiece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
Optimas System Operator Manual Section 6: DiolazeXL Treatment Information ▪ Known skin photosensitivity or using drugs increasing skin photosensitivity. ▪ Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria. ▪ Certain delay is recommended if other recent treatments like light, laser or RF were performed on the same area.
Optimas System Operator Manual Section 6: DiolazeXL Treatment Information Pre-treatment Recommendations During the patient’s first visit the treating attendant should: ▪ Complete or update the patient's medical and physical history. ▪ Exclude from treatment anyone with the listed contraindications. ▪...
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Optimas System Operator Manual Section 6: DiolazeXL Treatment Information Prior to using water-based gel, ensure that the container of ultrasound gel has not passed the expiration date Make a test-spot with to see epidermal end-points of perifollicular erythema/edema. Use Strong Cooling while treating for better comfort and safety.
Optimas System Operator Manual Section 6: DiolazeXL Treatment Information Move to adjacent site with small overlap and apply next pulses to cover all treatment area. Pulse Mode may vary from Off (single pulse) or 1, 2 pulses per second (pps) and Glide (5pps), restricted by certain fluence, as described in Device Description in Section 4.
1mm in diameter. Indications for Use The InMode System with the Vasculaze Handpiece is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venous lake, leg veins, spider veins, and poikiloderma of Civatte.
Optimas System Operator Manual Section 7: Vasculaze Treatment Information ▪ Certain delay is recommended if other recent treatments like light, laser or RF were performed on the same area. ▪ Fresh tan from sun, sunbeds or chemicals. ▪ Vitiligo. ▪...
Optimas System Operator Manual Section 7: Vasculaze Treatment Information ▪ Sunscreen is advisable during outdoor activity at daylight hours. ▪ The patient should discontinue any irritant topical agents for 2-3 days prior the treatment. ▪ Stop anticoagulants 7-10 days prior to treatment, if medically permitted.
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Optimas System Operator Manual Section 7: Vasculaze Treatment Information Skin Fluence Pulse Width Cooling Type [J/cm 250-300 Short Strong/Normal 225-300 Short Strong/Normal 200-300 Short Strong/Normal 200-250 Long Strong/Normal Always start with a low settings level to check patient tolerance. Test, watch epidermal response, and increase or decrease settings gradually.
Optimas System Operator Manual Section 7: Vasculaze Treatment Information Treatment Schedule The number of treatments is typically varied from 1-3 sessions every 4-8 weeks. Larger veins that are typically deeper require more sessions and longer time should elapse between the treatment sessions.
Optimas System Operator Manual Section 8: Lumecca Treatment Information Section 8: Lumecca Treatment Information IPL Lumecca treatment is based on principles of selective photothermolysis. The light penetrates into the skin and is selectively absorbed by lesion chromophore (melanin or hemoglobin) having darker color than surrounding tissue. Absorbed energy is converted into heat, coagulating the lesion which fades during a few weeks following the treatment.
Optimas System Operator Manual Section 8: Lumecca Treatment Information ▪ Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria. ▪ Vitiligo. ▪ Skin type V and VI and excessively tanned skin from sun, tanning beds or tanning creams and sprays within the last two weeks.
Optimas System Operator Manual Section 8: Lumecca Treatment Information ▪ Instruct the patient about the safety warnings. ▪ Advise the patient to avoid skin tanning for 3-4 weeks prior to the treatment and use at least 30 SPF sunblock during outdoor activity at daylight hours.
Optimas System Operator Manual Section 8: Lumecca Treatment Information Treatment Recommendations Follow Device Start-Up Procedure from System Operation section. Ensure that skin is clean. Apply thin to thick layer of water-based gel to the treated area, mostly face. Prior to using water-based gel, ensure that the container of ultrasound gel has not passed the expiration date.
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Optimas System Operator Manual Section 8: Lumecca Treatment Information Typical treatment parameters are shown in the table below: Handpiece Fluence Skin Pulse Lesions type Cooling type width [nm] [J/cm²] I-II Pigmented 8-12 Short Strong lesions /Long Vascular 12-16 Short Strong...
Optimas System Operator Manual Section 8: Lumecca Treatment Information Post-treatment Recommendations After each treatment session, the physician should advise the patient on proper care. ▪ Sun block should be used for 3 weeks following the treatment. ▪ Moisturizer may be applied after each treatment.
Optimas System Operator Manual Section 9: Fractora Treatment Information Section 9: Fractora Treatment Information Fractional Skin Resurfacing The Fractora Handpiece is designed for delivering RF energy to the skin surface in a fractional manner with the energy applied to <10% of the total coverage area. The energy is delivered to the skin through bipolar arrays of pins and results in localized heating and ablation of the skin that is in direct contact with the pins.
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Optimas System Operator Manual Section 9: Fractora Treatment Information ▪ Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications. ▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
Optimas System Operator Manual Section 9: Fractora Treatment Information Possible Adverse Side Effects Possible adverse effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation), and scarring.
Optimas System Operator Manual Section 9: Fractora Treatment Information ▪ Clean the treatment area. ▪ Apply anesthesia: – Many patients can tolerate the treatment with no anesthesia at low energy levels of 5-20 energy levels and sometimes more. Topical anesthetic can be applied as needed prior to treatment.
Optimas System Operator Manual Section 9: Fractora Treatment Information ▪ Establish and confirm treatment parameters: if the desired end-point of erythema and edema – in a tip-shaped pattern – has not been achieved within 10-15 minutes, increase the RF energy. If the response is excessive, decrease the parameters.
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Optimas System Operator Manual Section 9: Fractora Treatment Information Weeks Down Clinical Treatment Energy between Time Sessions Indications Area Sessions Days Level Deep Soft tissue ablation of Non- wrinkles, Coated scars Deep Bony area 20-30 ablation of Non- wrinkles, Coated...
Optimas System Operator Manual Section 9: Fractora Treatment Information Treat dark skin (V-VI) with the 24 coated pin tip, restrict energy, starting at energy level 15 or lower, adding 5 levels each visit (every 3-4 weeks) to a maximum of energy level 40 on soft tissue, and energy level 25 over bone, preferably following bleaching regimen.
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Optimas System Operator Manual Section 9: Fractora Treatment Information ▪ Tiny scabs may appear after 1-3 days and stay for several days following the treatment. The scabs should not be touched or scratched even if they itch and should be allowed to flake off naturally.
Optimas System Operator Manual Section 10: Forma Treatment Information Section 10: Forma Treatment Information 10.1 Indications for Use The Forma Handpiece is intended for use in dermatologic procedures for noninvasive treatment of mild to moderate facial wrinkles and rhytids. Hand pieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
Optimas System Operator Manual Section 10: Forma Treatment Information ▪ History of bleeding coagulopathies, or use of anticoagulants in the last 10 days, as per the practitioner discretion. ▪ Facial dermabrasion, laser resurfacing and deep chemical peeling within the last 3 months prior Forma treatment.
Optimas System Operator Manual Section 10: Forma Treatment Information ▪ Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec and repeat as necessary. ▪ Leave it for complete drying. Pre-Use Check: Before each use of the Handpiece, the device must pass the following: ▪...
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Optimas System Operator Manual Section 10: Forma Treatment Information Follow the Device Start-Up procedure from Section 5. Set treatment parameters according to current QRG (Quick Reference Guide). Suggested facial treatment parameters for Forma are shown in the table below: Facial Treatment...
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Optimas System Operator Manual Section 10: Forma Treatment Information Figure 10-1: Recommended Forma Facial and Neck Treatment Zones Apply 2-4mm clear ultrasound gel (not oil) to the treated zone and to adjacent zone that can serve as a warm gel reservoir for replenishing gel in the treatment zone with minimal delay.
Optimas System Operator Manual Section 10: Forma Treatment Information After treating the zone, move to the next zone. For excessive heat sensation, you may increase the movement speed, reduce the RF power and lastly, reduce the cut-off temperature for patient comfort. If this does not help, stop the treatment and move to the next zone.
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Optimas System Operator Manual Section 10: Forma Treatment Information ▪ After each treatment session, the patient should be advised to contact the physician if there is any indication of infection, excessive swelling, redness, pain, or any other unusual or untoward symptom.
Optimas System Operator Manual Section 11: System Maintenance Section 11: System Maintenance 11.1 Maintenance & Frequency The following list suggests how often each of the maintenance procedures should be performed by the operator. 11.2 Before and after each treatment Wipe the device with a damp soft cloth. The Handpiece elements that are in contact with the skin should be disinfected with 70% alcohol between patients, as described in detail for each handpiece in “Handpiece Cleaning Instruction Prior to Use”.
Handpieces! 11.6 Filling Water for DiolazeXL, Vasculaze and Lumecca Optimas System, as well as, DiolazeXL, Vasculaze and Lumecca Handpieces are shipped without water. When filling water upon installation, distilled water must be used and failure to do so will void the service warranty.
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Optimas System Operator Manual Section 11: System Maintenance Select “Water Drain/Fill” (Figure 11.5). Pressing the UP arrow will activate the pump and count down from 600 seconds (10 minutes) to 0 seconds (Figure 11.6). Figure 11-4: Menu Screen Figure 11-5: Utilities Screen...
Ensure the water level is checked periodically. 11.7 Draining Water for VASCULAZE, DIOLAZEXL and LUMECCA For shipping and storage, the Optimas Systems and optical Handpieces must be drained of water during freezing temperature. Failure to do so will void the service warranty.
When only applicators are shipped or stored, follow applicators draining instructions below. It is possible to connect them to the System and perform the draining procedure, as above. It is also possible to use the InMode Water-draining tool (Figure 11.10).
Damage to the System or Handpieces by frozen water will not be covered under System's warranty. Only InMode draining mechanical hand pumps (InMode P/N AT604837x) could be used to drain DiolazeXL, Vasculaze and Lumecca Handpieces. To order the water drain tool contact our Service department.
Optimas System Operator Manual Section 11: System Maintenance To install a new Deionizer Cartridge: Connect the water hose into the Deionizer filter until is securely locked. Remove the water bottle from the compartment, pour out the distilled water from the bottle according to “Draining Water” procedure and wash it with new fresh water.
Optimas System Operator Manual Section 11: System Maintenance To install a new Capsule Filter: Hold the Capsule Filter when the arrow on the filter body pointing upwards. Push the lower system water hose into lower filter’s quick black connector as much as possible (Figure 11.12 right).
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Optimas System Operator Manual Section 11: System Maintenance Cleaning method • Remove back cover door and wash it under tap water until filter net is clean from a dust. Air pressure can used carefully if available. • Shake and dry the back cover door before use.
Optimas System Operator Manual Section 12: Troubleshooting Section 12: Troubleshooting The Optimas System provides monitoring of all critical parameters to ensure safety of patient and user. If any of the following faults are detected by the System automatically goes to STAND BY mode.
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Optimas System Operator Manual Section 12: Troubleshooting Problem Description and Checks Fault H800E- System Call Technical Service if the problem persists. Incompatible Software Version Fault H800E- System Call Technical Service if the problem persists. Incompatible Software Version Fault H800F- System Call Technical Service if the problem persists.
Optimas System Operator Manual Section 13: System Specifications Section 13: System Specifications Input Power Main Line Frequency (nominal) 50-60Hz Input Voltage (nominal) 100-240VAC Input Current (rms) Operating Parameters Ambient Temperature Range 15 – 30°C [59 – 86°F] Relative Humidity 30% to 80%, non-condensing...
Optimas System Operator Manual Section 13: System Specifications 13.1 Output Power Curves The curves that follow depict the changes for each RF mode at specific power settings. Figure 13-1: Fractora 24 Pin Output Power versus Impedance Figure 13-2: Fractora 60 Pin Output Power versus Impedance...
Connect the device into an outlet on a circuit different from that which was previously used. ▪ Consult InMode service personnel for help. Interference to the device may be caused by portable and mobile RF communication equipment. In case of an interruption, beware of such a device in the vicinity.
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Guidance and manufacturer’s declaration – electromagnetic emissions The Optimas System is intended for use in the electromagnetic environment specified below. The customer or the user of the Optimas should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
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Optimas System Operator Manual Section 13: System Specifications Guidance and manufacturer’s declaration – electromagnetic immunity intended for use in the electromagnetic environment specified below. The The System is customer or the user should assure that it is used in such an environment...
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Optimas System Operator Manual Section 13: System Specifications Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
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Optimas System Operator Manual Section 13: System Specifications 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 System The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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